Datasets:

eu_regulatory_ir

like 2

32002L0061

2002

Directive 2002/61/EC of the European Parliament and of the Council of 19 July 2002 amending for the nineteenth time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (azocolourants) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposals from the Commission(1), Having regard to the opinion of the Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Work on the internal market should gradually improve the quality of life, health protection and consumer safety. The measures provided for in this Directive ensure a high level of health and consumer protection. (2) Textile and leather articles containing certain azodyes have the capacity to release certain arylamines, which may pose cancer risks. (3) Limitations already adopted or planned by certain Member States on the use of azodyed textile and leather articles concern the completion and functioning of the internal market. It is therefore necessary to approximate the laws of the Member States in this field and, consequently, to amend Annex I to Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations(4). (4) The Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE), after being consulted by the Commission, has confirmed that cancer risks posed by textile and leather goods coloured by certain azodyes, give cause for concern. (5) In order to protect human health, the use of dangerous azodyes and the placing on the market of some articles coloured with such dyes should be prohibited. (6) For textile articles made of recycled fibres, a maximum concentration of 70 ppm for the amines listed in point 43 in the appendix to Directive 76/769/EEC should be applied. This should be the case for a transitional period until 1 January 2005 if the amines are released by the residues deriving from the previous dyeing of the same fibres. This will allow for the recycling of textiles, which has overall benefits for the environment. (7) Harmonised testing methods are necessary for the application of this Directive. The Commission, in accordance with Article 2a of Directive 76/769/EEC, should establish such methods. The testing methods should preferably be developed at European level, if appropriate by the European Committee for Standardisation (CEN). (8) In the light of new scientific knowledge, testing methods should be reviewed, including testing methods for analysing 4-amino azobenzene. (9) In the light of new scientific knowledge, the provisions on certain azocolourants should be reviewed, in particular with regard to the need to include other materials not covered by this Directive, as well as other aromatic amines. Special attention should be paid to possible risks to children. (10) This Directive applies without prejudice to Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC(5) and in individual directives based thereon, in particular Council Directive 90/394/EEC(6) and Directive 98/24/EC of the European Parliament and of the Council(7), Article 1 Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive. Article 2 Testing methods for the application of point 43 of Annex I to Directive 76/769/EEC shall be adopted by the Commission in accordance with the procedure laid down in Article 2a of that Directive. Article 3 1. Member States shall adopt and publish, not later than 11 September 2003, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply these provisions from 11 September 2003. 2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 4 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32002L0051

2002

Directive 2002/51/EC of the European Parliament and of the Council of 19 July 2002 on the reduction of the level of pollutant emissions from two- and three-wheel motor vehicles and amending Directive 97/24/EC (Text with EEA relevance) - Statement by the Commission - Commission declaration as complement Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 1 May 2002, Whereas: (1) The fifth programme of action of the European Community on protection of the environment, which in its general approach was approved by the Council in the Resolution of the Council and the Representatives of the Governments of the Member States, meeting within the Council, of 1 February 1993(4), provides for additional efforts to be made for a considerable reduction in the present level of emissions of pollutants from motor vehicles. (2) Directive 97/24/EC of the European Parliament and of the Council of 17 June 1997 on certain components and characteristics of two or three-wheel motor vehicles(5) is one of the separate Directives under the type-approval procedure laid down by Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two- or three-wheel motor vehicles(6). (3) Under Article 5 of Directive 97/24/EC, the Commission is required to submit, to the European Parliament and the Council, within 24 months from the date of adoption of the Directive, a proposal prepared on the basis of research and an assessment of the costs and benefits deriving from the application of tightened-up limit values and laying down a subsequent stage during which measures will be adopted aimed at further tightening of the limit values for pollutants of the vehicles concerned. Such action is limited to motorcycles, since a subsequent stage entailing tighter limit values for mopeds, to be applied from 17 June 2002, is already provided for in Directive 97/24/EC. (4) On the basis of the assessment of the technical feasibility and cost-effectiveness, a single set of new Type I test limits, applicable from 2003 for all motorcycles, has been identified, corresponding to a reduction of 60 % for hydrocarbons and carbon monoxide for four-stroke motorcycles, and 70 % for hydrocarbons and 30 % for carbon monoxide for two-stroke motorcycles. For four-stroke motorcycles, further reductions in nitrogen oxides were not considered feasible with the envisaged technologies. For two-stroke motorcycles, the application of advanced direct injection technology, which has the greatest reduction potential in terms of carbon monoxide and hydrocarbons, is inevitably linked to a moderate increase of the nitrogen oxides limit, relative to the present-day limit value, bringing the limit in line with four-stroke motorcycles. On the basis of the emission inventory, which confirms the marginal share of motorcycles in total road-transport emissions of nitrogen oxides, this is regarded as acceptable. (5) In the light of the special characteristics and the use of certain categories of vehicle known as enduro and trial motorcycles and having regard to their very small contribution to overall emissions, owing to the small number of such vehicles sold each year in Europe, a temporary derogation, in respect of the entry into force of the new limits in 2003, should be granted in order to allow manufacturers to introduce the appropriate technology. (6) Inspection and maintenance are regarded as essential to ensure that emission levels of new vehicles do not exceed in-use acceptable levels. In this respect, and in line with the provisions for passenger cars, the requirements for type II testing, and in particular the limit for carbon monoxide content of 4,5 % by volume, should be replaced by requirements to measure and record the necessary data for the purpose of roadworthiness testing. (7) Tricycles and quadricycles are equipped either with spark ignition or compression ignition (diesel) engines; in line with emission limits for passenger cars, each category requires a separate set of limit values. In this respect the question of particulate emissions needs to be addressed in the future. (8) The characteristics of the reference fuels used for emission testing should be aligned with those applicable to passenger cars, thereby reflecting the changes in the specifications of market fuel in accordance with Community legislation on the quality of petrol and diesel fuels. (9) Member States should be allowed, by way of tax incentives, to expedite the placing on the market of vehicles which satisfy the requirements adopted at Community level and to promote more environmentally advanced technologies on the basis of mandatory emission values; such incentives should satisfy certain conditions intended to avoid distortions of the internal market; this Directive does not affect the Member States' right to include emissions of pollutants and other substances in the basis for calculating road traffic taxes on two- and three-wheel vehicles. (10) In accordance with the Treaty, Member States may inter alia offer fiscal or financial incentives for the retrofitting of older two- and three-wheel motor vehicles, if they thereby meet the limit values contained in this Directive or in the earlier version of Directive 97/24/EC. (11) A new type-approval test cycle should be introduced which will allow a more representative evaluation of the emissions performance, in test conditions that more closely resemble those encountered by vehicles in use, and which takes into account the difference in driving patterns between small and large motorcycles. Additional development work is in progress in order to support the introduction of a new test cycle in a scientifically sound manner. (12) It is necessary to establish a further stage of mandatory emission limits with effect from 2006 comprising further substantial reductions with respect to the limit values for 2003. (13) In order to ensure compliance with emission limit values, conformity testing of in-service two- and three-wheel motor vehicles (in-service tests) should be introduced from 1 January 2006. Specific requirements for the correct operation of emission-control devices during the normal life of two or three-wheel motor vehicles should be introduced as from 1 January 2006 for up to 30000 km. (14) It should also be ensured that operating conditions of two- and three-wheel motor vehicles in use correspond to the settings for the test cycle and that no defeat devices or other by-pass arrangements are used. (15) As two- and three-wheel motor vehicles produce an increasing proportion of total CO2 emissions from transport sources, CO2 emissions and/or the fuel consumption of two- and three-wheel motor vehicles should be established as soon as possible and incorporated in the Community strategy for reducing road-transport CO2 emissions. (16) In view of the global market for motorcycles and of similar problems of air quality worldwide, it is worth striving for a harmonised test cycle. It is noted that the Commission will maintain its efforts to finalise such a harmonised test cycle with all other parties involved in other markets and conclude this as soon as possible. The worldwide motorcycle emission test cycle currently elaborated in Geneva by Working Party 29 of the United Nations Economic Commission for Europe is a good basis. It is appropriate to introduce such a new world-wide test cycle as an alternative type-approval procedure for the second stage in 2006. When it has been widely recognised and for all further reduction stages the new test cycle could become the regular basis for type-approval. (17) The objective of the proposed action, namely the reduction of the level of pollutant emissions from two and three-wheel motor vehicles, cannot be sufficiently achieved by the Member States and can therefore by reason of the scale or effects of the action be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (18) Directive 97/24/EC should be amended accordingly, Article 1 This Directive aims at reducing the level of pollutant emissions from two- and three-wheel motor vehicles by tightening the limit values for such emissions. Article 2 1. With effect from 1 April 2003, no Member State may, on grounds relating to the measures to be taken against air pollution: (a) refuse to grant EC type-approval pursuant to Article 4(1) of Directive 92/61/EEC, or (b) prohibit the registration, sale or entry into service of vehicles, if the measures to be taken against air pollution comply with the requirements of Directive 97/24/EC. 2. With effect from 1 April 2003, Member States shall refuse to grant EC type-approval pursuant to Article 4(1) of Directive 92/61/EEC for any type of vehicle on grounds relating to the measures to be taken against air pollution, if it fails to comply with the provisions of Directive 97/24/EC. For the type I test, the limit values set out in row A of the Table in Chapter 5, Annex II, Section 2.2.1.1.5 to Directive 97/24/EC shall be used. 3. With effect from 1 July 2004, Member States shall: (a) consider certificates of conformity which accompany new vehicles pursuant to Directive 92/61/EEC as no longer valid; and (b) refuse the registration, sale or entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 92/61/EEC, on grounds relating to the measures to be taken against air pollution, if the vehicles fail to comply with the provisions of Directive 97/24/EC. For the type I test for mopeds, the limit values set out in the second row of the Table in Chapter 5, Annex I, Section 2.2.1.1.3 to Directive 97/24/EC shall be used. For the type I test for motorcycles and tricycles, the limit values set out in rows A of the table in Chapter 5, Annex II, Section 2.2.1.1.5 to Directive 97/24/EC shall be used. 4. For trial and enduro motorcycles with two wheels, in accordance with Directive 92/61/EEC, the date set in paragraph 2 shall be 1 January 2004 and the date set in paragraph 3 shall be 1 July 2005. Trial motorcycles are defined as vehicles with the following characteristics: (a) Maximum seat height: 700 mm; (b) Minimum ground clearance: 280 mm; (c) Maximum fuel tank capacity: 41 l; (d) Minimum overall gear ratio in the highest gear (primary ratio × gear ratio × final drive ratio) of 7,5. Enduro motorcycles are defined as vehicles having the following characteristics: (a) Minimum seat height of 900 mm; (b) Minimum ground clearance of 310 mm; (c) Minimum overall gear ratio in the highest gear (primary ratio × gear ratio × final drive ratio) of 6,0. Article 3 1. With effect from 1 January 2006, Member States shall refuse to grant EC type-approval pursuant to Article 4(1) of Directive 92/61/EEC for a new vehicle type on grounds relating to measures to be taken against air pollution, if it fails to comply with the provisions of Directive 97/24/EC. For the type I test, the limit values set out in rows B of the Table in Chapter 5, Annex II, Section 2.2.1.1.5 to Directive 97/24/EC shall be used. 2. With effect from 1 January 2007, Member States shall: (a) consider certificates of conformity which accompany new vehicles pursuant to Directive 92/61/EEC as no longer valid, and (b) refuse the registration, sale or entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 92/61/EEC, on grounds relating to the measures to be taken against air pollution, if the vehicles fail to comply with the provisions of Directive 97/24/EC. For the type I test, the limit values set out in rows B of the Table in Chapter 5, Annex II, Section 2.2.1.1.5 to Directive 97/24/EC shall be used. For vehicle types of which no more than 5000 units are sold annually in the European Union, the date shall be 1 January 2008. Article 4 1. Member States may make provision for tax incentives only in respect of vehicles which comply with Directive 97/24/EC. Such incentives shall comply with either of the following conditions: (a) they shall apply to all new vehicles offered for sale on the market of a Member State which comply in advance with the mandatory limit values set out in row A of the Table in Chapter 5, Annex II, Section 2.2.1.1.5 to Directive 97/24/EC; they shall be terminated with effect from the mandatory application of the emission limit values laid down in Article 2(3) for new vehicles; or (b) they shall apply to all new vehicles offered for sale on the market of a Member State which comply in advance with the mandatory limit values set out in rows B of the Table in Chapter 5, Annex II, Section 2.2.1.1.5 of Directive 97/24/EC. They shall end on the date for the mandatory application of the emission limit values for new vehicles laid down in Article 3(2) of this Directive. 2. For each type of vehicle referred to in paragraph 1, the tax incentives shall be for an amount lower than the additional cost of obtaining and fitting on the vehicle the technical solutions introduced to ensure compliance with the values set in either row A or row B of the Table in Chapter 5, Annex II, Section 2.2.1.1.5 to Directive 97/24/EC. 3. The Commission shall be informed in sufficient time of plans to create or change the tax incentives referred to in paragraph 1, so that it can submit its observations. Article 5 Type-approvals shall also confirm the correct operation of the emission-control devices during the normal life of two and three-wheel motor vehicles as from 1 January 2006 for new vehicle types and as from 1 January 2007 for all vehicle types for up to 30000 km. To this end, the Commission shall submit to the European Parliament and the Council by 31 December 2002 a proposal defining "normal life" and establishing supplementary provisions. In its cost-benefit-analysis the Commission shall particularly pay attention to the effects its proposals have on small and medium-sized enterprises. Article 6 1. With effect from 1 January 2006 for new two and three-wheel motor vehicles and from 1 January 2007 for all vehicle types, type-approvals granted to vehicles shall also require confirmation of the correct operation of emission-control devices during the normal life of the vehicle under normal conditions of use (conformity of in-service vehicles properly maintained and used). 2. To this end, the Commission shall submit a proposal to the European Parliament and the Council defining "normal life" and establishing supplementary provisions. They shall include, inter alia, if appropriate: - criteria for carrying out checks, - criteria for selecting the vehicles to be tested, - criteria for carrying out the tests, - rules to eliminate possible errors, - the criterion that there shall be no charge for the owner/holder of the vehicle. In its cost-benefit analysis the Commission shall particularly pay attention to the effects its proposals have on small and medium-sized enterprises. Article 7 1. With effect from 1 January 2006 Member States may no longer grant EC type approval and shall refuse national type approval for a two- or three-wheel vehicle if its CO2-emission and fuel consumption are not established in accordance with the relevant provisions. 2. With effect from 1 January 2007 Member States shall: - consider certificates of conformity which accompany new two-wheel motor vehicles with an engine capacity of over 150 cm3 pursuant to Directive 92/61/EEC as no longer valid, and - refuse the registration, sale or entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 92/61/EEC, if their CO2-emissions and fuel consumptions are not established in accordance with the relevant provisions. Article 8 1. The Commission shall consider a further tightening of the emission standards of vehicles falling within the scope of this Directive, taking into account: (a) technical developments in the field of emission control technology and their technical and economic feasibility with regard to their application to motorcycles, as well as their application in the diverse market that these vehicles satisfy; (b) the advances in the development of a more representative test cycle for motorcycles which remedies the current limitations of the current test cycle, such as cold start and high driving dynamics; (c) the opportunity to harmonise the test cycle on a worldwide basis; (d) the correlation of limit values between the current and the new test cycle; (e) further work on particulate emissions, and the issue of particulate emissions from compression ignition and spark ignition engines; (f) ongoing work on durability and in-use compliance; (g) further work on cold starting, on-board diagnostics (OBD) systems, and evaporation emissions; (h) ongoing work on replacement catalytic converters; (i) the economic impact on small series production and on small volume manufacturers; The Commission furthermore will develop a methodology for measuring specific CO2 emissions from two- or three-wheel motor vehicles. 2. The Commission shall, not later than 31 December 2002, submit to the Committee for Adaptation to Technical Progress a proposal setting out a test method for the measurement of particulate emissions in accordance with the results of the studies as prescribed in paragraph 1(e), to be applied to new type-approvals from 1 January 2004. 3. The Commission shall, not later than 31 December 2002, submit a proposal to the European Parliament and the Council, containing: (a) mandatory emission limit values to be used in the Type I test for tricycles and quadricycles for the second mandatory stage from 2006 and mandatory emission limit values for particulate emissions in accordance with the results of the studies as prescribed in paragraph 1(e). (b) an obligation to measure specific CO2 emissions in type approval in accordance with Article 7. The Commission shall also submit appropriate proposals for the inclusion of two- and three-wheel motor vehicles in the Community strategy for reducing transport CO2 emissions (agreement to reduce average CO2 emissions, labelling, tax incentives); (c) provisions relating to durability to be applied from 1 January 2006, in accordance with Article 5; (d) requirements to include conformity testing on in-service vehicles (in-service tests) in the type-approval procedure for two- or three-wheel motor vehicles with effect from 1 January 2006 pursuant to Article 6; (e) a new set of limit values (stage III) for mopeds, including particulate emissions in accordance with the results of the studies as prescribed in paragraph 1(e), to be applied from 2006. The provisions on durability requirements and the obligation to measure specific CO2 emissions in type approval will also be applied to mopeds. 4. The Commission shall submit proposals to the European Parliament and Council concerning inspection and maintenance, OBD and evaporative emission control. The Commission shall also ensure that only replacement and retrofit parts for exhaust systems which comply with Directive 97/24/EC and this Directive are placed on the market. The issuing of type-approval must be sufficiently verifiable and the data on the type-approvals issued must be quickly, efficiently and transparently retrievable and traceable in a European data system. 5. As soon as possible and at the latest after the technical development of the worldwide test cycle, the Commission shall present a proposal for its inclusion and a new set of limit values, including particulate emissions for compression ignition engines and two-stroke spark-ignition engines. These limit values should be set in correlation to the second mandatory stage in 2006 of this Directive (row B, in the table in Chapter 5, Annex II, Section 2.2.1.1.5 to (Directive 97/24/EC)) in order to guarantee the same emission level. The test cycle should be introduced together with these new limit values (row C to be inserted in the table in Chapter 5, Annex II, section 2.2.1.1.5 to Directive 97/24/EC) as an alternative type-approval procedure at the choice of the manufacturer for the second mandatory stage in 2006. In line with the adoption of the new worldwide test cycle in other regions it will then become the only regular type-approval procedure. For further stages in the reduction of exhaust emissions after 2006 the new test cycle with limit values based on this cycle will be the only valid type-approval procedure. Article 9 Chapter 5 of Directive 97/24/EC shall be amended in accordance with the text in the Annex hereto. Article 10 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 April 2003. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 11 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 12 This Directive is addressed to the Member States.

32002L0070

2002

Commission Directive 2002/70/EC of 26 July 2002 establishing requirements for the determination of levels of dioxins and dioxin-like PCBs in feedingstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to the Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs(1), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 2 thereof, Whereas: (1) Council Directive 1999/29/EC of 22 April 1999 on the undesirable substances and products in animal nutrition(2), as last amended by Directive 2001/102/EC(3), establishes maximum limits for dioxins and furans in several feed materials and feedingstuffs. (2) It is necessary to establish requirements with which the method of analysis should comply in order to ensure that laboratories use methods of analysis with comparable levels of performance. (3) The provisions for sampling and methods of analysis have been drawn up on the basis of present knowledge and they may be adapted to take account of advances in scientific and technological knowledge. (4) The provisions laid down in this Directive relate only to the analysis of dioxins and dioxin-like PCBs for the implementation of Directive 2001/102/EC amending Directive 1999/29/EC on the undesirable substances and products in animal nutrition (5) An active approach should be pursued in order to obtain comprehensive reliable data on the presence of dioxin-like PCBs in feed materials and feedingstuffs. Requirements should therefore be laid down as regards the methods of analysis to be used for the determination of dioxin-like PCBs in feed materials and feedingstuffs. (6) A screening method of analysis with proven, widely acceptable validation and high throughput could be used to select the samples with significant levels of dioxins. The levels of dioxins in these samples need to be determined by a confirmatory method of analysis. It is therefore appropriate to establish requirements for the confirmatory methods of analysis and for the screening method. (7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Member States shall ensure that the sampling for the official control of the levels of dioxins and furans and the determination of the levels of dioxin-like PCBs in feedingstuffs is carried out in accordance with the methods described in Annex I. Article 2 The Member States shall ensure that sample preparation and methods of analyses used for the official control of the levels of dioxins and furans and the determination of the levels of dioxin-like PCBs in feedingstuffs comply with the criteria described in Annex II. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 February 2003 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32002L0069

2002

Commission Directive 2002/69/EC of 26 July 2002 laying down the sampling methods and the methods of analysis for the official control of dioxins and the determination of dioxin-like PCBs in foodstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption(1), and in particular Article 1 thereof, Whereas: (1) Commission Regulation (EC) No 466/2001(2), as last amended by Regulation (EC) No 563/2002(3), and amended by Council Regulation (EC) No 2375/2001(4) establishes maximum limits for dioxins and furans in certain foodstuffs. (2) Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs(5) lays down the general principles for the performance of control of foodstuffs. Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs(6) introduces a system of quality standards for laboratories entrusted by the Member States with the official control of foodstuffs. (3) Directive 85/591/EEC has fixed general criteria for methods of sampling and analysis. However, in certain cases it is necessary to lay down more specific criteria and or requirements with which the method of analysis should comply in order to ensure that laboratories use methods of analysis with comparable levels of performance. (4) The provisions for sampling and methods of analysis have been drawn up on the basis of present knowledge and they may be adapted to take account of advances in scientific and technological knowledge. (5) The provisions laid down in this Directive relate only to the sampling and analysis of dioxins and dioxin-like PCBs for the implementation of Regulation (EC) No 466/2001 and do not affect the sampling strategy, sampling levels and frequency as specified in Annexes III and IV to Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC(7). They do not affect the targeting criteria for sampling as laid down in Commission Decision 98/179/EC of 23 February 1998 laying down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products(8). (6) An active approach should be pursued in order to obtain comprehensive reliable data on the presence of dioxin-like PCBs in foodstuffs. Requirements should therefore be laid down as regards the methods of analysis to be used for the determination of dioxin-like PCBs in foodstuffs. (7) A screening method of analysis with proven, widely acceptable validation and high throughput could be used to select the samples with significant levels of dioxins. The levels of dioxins in these samples need to be determined by a confirmatory method of analysis. It is therefore appropriate to establish strict requirements for the confirmatory methods of analysis and minimum requirements for the screening method. (8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food chain and Animal Health, Article 1 The Member States shall ensure that the sampling for the official control of the levels of dioxins and furans and the determination of the levels of dioxin-like PCBs in foodstuffs is carried out in accordance with the methods described in Annex I. Article 2 The Member States shall ensure that sample preparation and methods of analyses used for the official control of the levels of dioxins and furans and the determination of the levels of dioxin-like PCBs in foodstuffs comply with the criteria described in Annex II. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 February 2003 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32002L0072

2002

Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs(1), and in particular Article 3 thereof, After consulting the Scientific Committee on Food, Whereas: (1) Commission Directive 90/128/EEC of 23 February 1990 relating to plastic materials and articles intended to come into contact with foodstuffs(2), as last amended by Directive 2002/17/EC(3), has been frequently and substantially amended; for reasons of clarity and rationality, it should therefore be consolidated. (2) Article 2 of Directive 89/109/EEC lays down that materials and articles, in their finished state, must not transfer their constituents to foodstuffs in quantities which could endanger human health or bring about an unacceptable change in the composition of the foodstuffs. (3) In order to achieve this objective in the case of plastic materials and articles, a suitable instrument is a specific Directive within the meaning of Article 3 of Directive 89/109/EEC, the general provisions of which are also applicable to the case in question. (4) The scope of this Directive must coincide with that of Council Directive 82/711/EEC(4). (5) Since the rules established in this Directive are not suitable for ion-exchange resins, these materials and articles will be covered by a subsequent specific Directive. (6) Silicones should be regarded as elastomeric materials rather than plastic materials and therefore should be excluded from the definition of plastic. (7) The establishment of a list of approved substances accompanied by a limit on overall migration and, where necessary, by other specific restrictions will be sufficient to achieve the objective laid down in Article 2 of Directive 89/109/EEC. (8) Besides the monomers and other starting substances fully evaluated and authorised at Community level, there are also monomers and starting substances evaluated and authorised in at least one Member State which may continue to be used pending their evaluation by the Scientific Committee on Food and the decision on their inclusion in the Community list; this Directive will accordingly be extended in due course to the substances and sectors provisionally excluded. (9) The current list of additives is an incomplete list inasmuch as it does not contain all the substances which are currently accepted in one or more Member States; accordingly, these substances continue to be regulated by national laws pending a decision on inclusion in the Community list. (10) This Directive establishes specifications for only a few substances. The other substances, which may require specifications, therefore remain regulated in this respect by national laws pending a decision at Community level. (11) For certain additives the restrictions established in this Directive cannot yet be applied in all situations pending the collection and evaluation of all the data needed for a better estimation of the exposure of the consumer in some specific situations; therefore, these additives appear in a list other than that of the additives fully regulated at Community level. (12) Directive 82/711/EEC lays down the basic rules necessary for testing migration of the constituents of plastic materials and articles and Council Directive 85/572/EEC(5) establishes the list of simulants to be used in the migration tests. (13) The determination of a quantity of a substance in a finished material or article is simpler than the determination of its specific migration level. The verification of compliance through the determination of quantity rather than specific migration level should therefore be permitted under certain conditions. (14) For certain types of plastics the availability of generally recognised diffusion models based on experimental data allows the estimation of the migration level of a substance under certain conditions, therefore avoiding complex, costly and time-consuming testing. (15) The overall migration limit is a measure of the inertness of the material and prevents an unacceptable change in the composition of the foodstuffs, and, moreover, reduces the need for a large number of specific migration limits or other restrictions, thus giving effective control. (16) Council Directive 78/142/EEC(6) lays down limits for the quantity of vinyl chloride present in plastic materials and articles prepared with this substance and for the quantity of vinyl chloride released by these materials and articles, and Commission Directives 80/766/EEC(7) and 81/432/EEC(8) establish the Community methods of analysis for controlling these limits. (17) In view of potential liability, there is a need for the written declaration provided for in Article 6(5) of Directive 89/109/EEC whenever professional use is made of plastic materials and articles which are not by their nature clearly intended for food use. (18) Commission Directive 80/590/EEC(9) determines the symbol that may accompany any material and article intended to come into contact with foodstuffs. (19) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of ensuring the free movement of plastic materials and articles intended to come into contact with foodstuffs, to lay down rules on the definition of plastics and permitted substances. This Directive confines itself to what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty. (20) In accordance with Article 3 of Directive 89/109/EEC, the Scientific Committee on Food has been consulted on the provisions liable to affect public health. (21) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health. (22) This Directive should be without prejudice to the deadlines set out in Annex VII, Part B within which the Member States are to comply with Directive 90/128/EEC, and the acts amending it, Article 1 1. This Directive is a specific Directive within the meaning of Article 3 of Directive 89/109/EEC. 2. This Directive shall apply to plastic materials and articles and parts thereof: (a) consisting exclusively of plastics; or (b) composed of two or more layers of materials, each consisting exclusively of plastics, which are bound together by means of adhesives or by any other means, which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs are intended for that purpose. 3. For the purposes of this Directive, "plastics" shall mean the organic macromolecular compounds obtained by polymerisation, polycondensation, polyaddition or any other similar process from molecules with a lower molecular weight or by chemical alteration of natural macromolecules. Other substances or matter may be added to such macromolecular compounds. However, the following shall not be regarded as "plastics": (a) varnished or unvarnished regenerated cellulose film, covered by Commission Directive 93/10/EEC(10); (b) elastomers and natural and synthetic rubber; (c) paper and paperboard, whether modified or not by the addition of plastics; (d) surface coatings obtained from: - paraffin waxes, including synthetic paraffin waxes, and/or micro-crystalline waxes, - mixtures of the waxes listed in the first indent with each other and/or with plastics, (e) ion-exchange resins; (f) silicones. 4. This Directive shall not apply, until further action by the Commission, to materials and articles composed of two or more layers, one or more of which does not consist exclusively of plastics, even if the one intended to come into direct contact with foodstuffs does consist exclusively of plastics. Article 2 Plastic materials and articles shall not transfer their constituents to foodstuffs in quantities exceeding 10 milligrams per square decimetre of surface area of material or article (mg/dm2) (overall migration limit). However, this limit shall be 60 milligrams of the constituents released per kilogram of foodstuff (mg/kg) in the following cases: (a) articles which are containers or are comparable to containers or which can be filled, with a capacity of not less than 500 millilitres (ml) and not more than 10 litres (l); (b) articles which can be filled and for which it is impracticable to estimate the surface area in contact with foodstuffs; (c) caps, gaskets, stoppers or similar devices for sealing. Article 3 1. Only those monomers and other starting substances listed in Annex II, Sections A and B, may be used for the manufacture of plastic materials and articles subject to the restrictions specified. 2. By way of derogation from the first paragraph the monomers and other starting substances listed in Annex II, Section B, may continue to be used until 31 December 2004 at latest, pending their evaluation by the Scientific Committee on Food. 3. The list in Annex II, Section A, may be amended: - either by adding substances listed in Annex II, Section B, according to the criteria in Annex II of Directive 89/109/EEC, or - by including "new substances", i.e. substances which are listed neither in Section A nor in Section B of Annex II, according to Article 3 of Directive 89/109/EEC. 4. No Member State shall authorise any new substance for use within its territory except under the procedure in Article 4 of Directive 89/109/EEC. 5. The lists appearing in Annex II, Sections A and B, do not yet include monomers and other starting substances used only in the manufacture of: - surface coatings obtained from resinous or polymerised products in liquid, powder or dispersion form, such as varnishes, lacquers, paints, etc., - epoxy resins, - adhesives and adhesion promoters, - printing inks. Article 4 An incomplete list of additives, which may be used for the manufacture of plastic materials and articles, together with the restrictions and/or specifications on their use, is set out in Annex III, Sections A and B. For the substances in Annex III, Section B, the specific migration limits are applied as from 1 January 2004 when the verification of compliance is carried out in simulant D or in test media of substitute tests as laid down in Directives 82/711/EEC and 85/572/EEC. Article 5 Only the products obtained by means of bacterial fermentation listed in Annex IV may be used in contact with foodstuffs. Article 6 1. General specifications related to plastic materials and articles are laid down in Annex V, Part A. Other specifications related to some substances appearing in Annexes II, III and IV are laid down in Annex V, Part B. 2. The meaning of the numbers between brackets appearing in the column "Restrictions and/or specifications" is explained in Annex VI. Article 7 The specific migration limits in the list set out in Annex II are expressed in mg/kg. However, such limits are expressed in mg/dm2 in the following cases: (a) articles which are containers or are comparable to containers or which can be filled, with a capacity of less than 500 ml or more than 10 l; (b) sheet, film or other materials which cannot be filled of for which it is impracticable to estimate the relationship between the surface area of such materials and the quantity of foodstuffs in contact therewith. In these cases, the limits set out in Annex II, expressed in mg/kg shall be divided by the conventional conversion factor of 6 in order to express them in mg/dm2. Article 8 1. Verification of compliance with the migration limits shall be carried out in accordance with the rules laid down in Directives 82/711/EEC and 85/572/EEC and the further provisions set out in Annex I. 2. The verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if it can be established that compliance with the overall migration limit laid down in Article 2 implies that the specific migration limits are not exceeded. 3. The verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if it can be established that, by assuming complete migration of the residual substance in the material or article, it cannot exceed the specific limit of migration. 4. The verification of compliance with the specific migration limits provided for in paragraph 1 may be ensured by the determination of the quantity of a substance in the finished material or article provided that a relationship between that quantity and the value of the specific migration of the substance has been established either by an adequate experimentation or by the application of generally recognised diffusion models based on scientific evidence. To demonstrate the non-compliance of a material or article, confirmation of the estimated migration value by experimental testing is obligatory. Article 9 1. At the marketing stages other than the retail stages, the plastic materials and articles which are intended to be placed in contact with foodstuffs shall be accompanied by a written declaration in accordance with Article 6(5) of Directive 89/109/EEC. 2. Paragraph 1 does not apply to plastic materials and articles, which by their nature are clearly intended to come into contact with foodstuffs. Article 10 1. Directive 90/128/EEC, as amended by the Directives set out in Annex VII, Part A, is hereby repealed without prejudice to the obligations of the Member States in respect of the deadlines for transposition and application laid down in Annex VII, Part B. 2. References to the repealed Directives shall be construed as references to this Directive and be read in accordance with the correlation table set out in Annex VIII. Article 11 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 12 This Directive is addressed to the Member States.

32002L0071

2002

Commission Directive 2002/71/EC of 19 August 2002 amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for pesticide residues (formothion, dimethoate and oxydemeton-methyl) in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables(1), as last amended by Commission Directive 2002/66/EC(2), and in particular Article 5 thereof, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(3), as last amended by Directive 2002/66/EC, and in particular Article 10 thereof, Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(4), as last amended by Directive 2002/66/EC, and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on products of plant origin, including fruit and vegetables(5), as last amended by Directive 2002/66/EC, and in particular Article 7 thereof, Whereas: (1) In the case of cereals and products of plant origin including fruit and vegetables, residue levels reflect the use of minimum quantities of pesticides necessary to achieve effective protection of plants, applied in such a manner that the amount of residue is both as low as is practicable and toxicologically acceptable, having regard, in particular to the protection of the environment and the estimated dietary intake of consumers. In the case of foodstuffs of animal origin, residue levels reflect the consumption by animals of cereals and products of plant origin treated with pesticides, and where relevant, the direct consequences of the use of veterinary medicines. Community maximum residue levels (MRLs) represent the upper limit of the amount of such residues that might be expected to be found in commodities when good agricultural practices have been respected. (2) MRLs for pesticides should be kept under review and may be changed to take account of new information and data. MRLs are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported by the necessary data. (3) In the case of dimethoate and oxydemeton-methyl some Member States informed the Commission of their desire to revise national MRLs in accordance with Article 8 of Directive 90/642/EEC, in the light of concerns about consumer intake. Proposals for the review of Community MRLs were submitted to the Commission. The Commission concluded that it is prudent to modify some of the MRLs in view of the possible risks to consumers. It is important that additional risk management measures should be taken by the Member States to adequately protect the consumer. For dimethoate and oxydemeton-methyl Member States shall have to review existing authorisations in accordance with Article 4 of Directive 91/414/EEC(6), as last amended by Commission Directive 2002/64/EC(7) in order that authorised uses do not lead to MRLs being exceeded. (4) The lifetime exposure of consumers to these pesticides in this Directive via food products has been reassessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation(8). It is calculated that the MRLs fixed in this Directive will not lead to the acceptable daily intakes being exceeded. The ADI for oxydemeton-methyl is 0,0003 mg/kg bw (JMPR 1989), the ARfD is 0,005 mg/kg bw, the ADI for dimethoate is 0,002 mg/kg bw (JMPR 1996), the ARfD is 0,03 mg/kg bw. (5) Where relevant, the acute exposure of consumers to these pesticides via each of the food products that may contain residues of these pesticides has been assessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation. It is concluded that the presence of pesticide residues at or below the MRLs proposed in this Directive will not cause acute toxic effects. (6) For formothion no uses are reported worldwide. In the absence of sufficient data on residues and toxicology it is appropriate to set Maximum Residue Levels for formothion for all products at the Lower Limit of Analytical Determination. (7) Through the World Trade Organisation, the Community's trading partners were consulted about the levels for formothion, dimethoate and oxydemeton-methyl proposed in this Directive and their comments on these levels were taken into account. (8) The opinions of the Scientific Committee for Plants have been taken into account, in particular its advice and recommendations concerning the methodology to be followed for the protection of consumers of agricultural products treated with pesticides. (9) Annexes to Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended. (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 In Annex II to Directive 76/895/EEC the entries relating to "dimethoate", "omethoate", "formothion", "oxydemeton-methyl", "demeton-S-methyl", and "demeton-S-methylsulfone" are deleted. Article 2 In part A of Annex II to Directive 86/362/EEC the following rows are added: "" Article 3 In part B of Annex II to Directive 86/363/EEC the following rows are added: "" Article 4 The maximum residue levels listed in the Annex to this Directive are added or replace those listed in Annex II to Directive 90/642/EEC for the pesticides in question. Article 5 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2002 at the latest. They shall forthwith inform the Commission thereof. They shall apply those provisions with effect from 1 January 2003. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 6 This Directive shall enter into force on the seventh day following that of its publication in the Official Journal of the European Communities. Article 7 This Directive is addressed to the Member States.

32002L0076

2002

Commission Directive 2002/76/EC of 6 September 2002 amending the Annexes to Council Directives 86/362/EEC and 90/642/EEC as regards the fixing of maximum levels for pesticide residues (metsulfuron methyl) in and on cereals and certain products of plant origin, including fruit and vegetables (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(1), as last amended by Commission Directive 2002/71/EC(2), and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables(3), as last amended by Directive 2002/71/EC, and in particular Article 7 thereof, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(4), as last amended by Commission Directive 2002/64/EC(5), and in particular Article 4(1)(f) thereof, Whereas: (1) The existing active substance metsulfuron methyl, was included in Annex I to Directive 91/414/EEC by Commission Directives 2000/49/EC(6), for use as herbicides, but without specifying particular conditions having an impact on crops which may be treated with plant protection products containing this active substance. (2) The inclusion in Annex I to Directive 91/414/EEC of the active substance concerned was based on the assessment of the information submitted concerning the proposed use. Information relating to this use has been submitted by certain Member States in accordance with Article 4(1)(f) of Directive 91/414/EEC. The information available has been reviewed and is sufficient to allow certain maximum residue levels (MRLs) to be fixed. (3) Where no Community MRL or provisional MRL exists, Member States are to establish a national provisional MRL in accordance with Article 4(1)(f) of Directive 91/414/EEC before plant protection products containing this active substance may be authorised. (4) With respect to the inclusion in Annex I to Directive 91/414/EEC of the active substance concerned, the related technical and scientific evaluations were finalised in the form of Commission review report. The report was finalised on 16 June 2000. The report fixed the Acceptable Daily Intake (ADI) for metsulfuron methyl at 0,22 mg/kg bw/day. The lifetime exposure of consumers of food products treated with the active substance concerned has been assessed and evaluated in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation(7) and the opinion of the Scientific Committee for Plants(8) on the methodology employed. It is concluded that MRLs proposed will not lead to those ADIs being exceeded. No acute toxic effects requiring the setting of an Acute Reference Dose were noted during the evaluation and discussion preceding the inclusion of metsulfuron methyl in Annex I to Directive 91/414/EEC. (5) In order to ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it is prudent to set provisional MRLs at the lower limit of analytical determination for all such products covered by Directives 86/362/EEC and 90/642/EEC. (6) The setting at Community level of such provisional MRLs does not prevent the Member States from establishing provisional maximum residue levels for metsulfuron methyl in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. It is considered that a period of four years is sufficient to permit further uses of the active substance concerned. The provisional MRL should then become definitive. (7) The Annexes to Directives 86/362/EEC and 90/642/EEC should therefore be amended accordingly. (8) The Commission notified this Directive in draft form to the World Trade Organisation and the comments received have been considered in finalising the Directive. The possibility of fixing import tolerance MRLs for specific pesticide/crop combinations will be examined by the Commission on the basis of the acceptable data submitted. (9) This Directive is in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The following maximum pesticide residue level is added to Part A of Annex II to Directive 86/362/EEC: "" Article 2 The maximum pesticide residue levels for metsulfuron methyl as shown in the Annex to this Directive are added to Annex II to Directive 90/642/EEC. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2002 at the latest. They shall forthwith inform the Commission thereof. They shall apply these provisions with effect from 1 January 2003. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32002L0074

2002

Directive 2002/74/EC of the European Parliament and of the Council of 23 September 2002 amending Council Directive 80/987/EEC on the approximation of the laws of the Member States relating to the protection of employees in the event of the insolvency of their employer (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 137(2) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the Economic and Social Committee(2), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) The Community Charter of Fundamental Social Rights for Workers adopted on 9 December 1989 states, in point 7, that the completion of the internal market must lead to an improvement in the living and working conditions of workers in the European Community and that this improvement must cover, where necessary, the development of certain aspects of employment regulations such as procedures for collective redundancies and those regarding bankruptcies. (2) Directive 80/987/EEC(4) aims to provide a minimum degree of protection for employees in the event of the insolvency of their employer. To this end, it obliges the Member States to establish a body which guarantees payment of the outstanding claims of the employees concerned. (3) Changes in insolvency law in the Member States and the development of the internal market mean that certain provisions of that Directive must be adapted. (4) Legal certainty and transparency also require clarification with regard to the scope and certain definitions of Directive 80/987/EEC. In particular the possible exclusions granted to the Member States should be indicated in the enacting provisions of the Directive and consequently the Annex thereto should be deleted. (5) In order to ensure equitable protection for the employees concerned, the definition of the state of insolvency should be adapted to new legislative trends in the Member States and should also include within this concept insolvency proceedings other than liquidation. In this context, Member States should, in order to determine the liability of the guarantee institution, be able to lay down that where an insolvency situation results in several insolvency proceedings, the situation be treated as a single insolvency procedure. (6) It should be ensured that the employees referred to in Directive 97/81/EC of 15 December 1997 concerning the Framework Agreement on part-time work concluded by UNICE, CEEP and the ETUC(5), Council Directive 1999/70/EC of 28 June 1999 concerning the framework agreement on fixed-term work concluded by the ETUC, UNICE and CEEP(6) and Council Directive 91/383/EEC of 25 June 1991 supplementing the measures to encourage improvements in the safety and health at work of workers with a fixed-duration employment relationship or a temporary employment relationship(7) are not excluded from the scope of this Directive. (7) In order to ensure legal certainty for employees in the event of insolvency of undertakings pursuing their activities in a number of Member States, and to strengthen workers' rights in line with the established case law of the Court of Justice, provisions should be introduced which expressly state which institution is responsible for meeting pay claims in these cases and establishes as the aim of cooperation between the competent administrative authorities of the Member States the early settlement of employees' outstanding claims. Furthermore it is necessary to ensure that the relevant arrangements are properly implemented by making provision for collaboration between the competent administrative authorities in the Member States. (8) Member States may set limitations on the responsibility of the guarantee institutions which should be compatible with the social objective of the Directive and may take into account the different levels of claims. (9) In order to make it easier to identify insolvency proceedings in particular in situations with a cross-border dimension, provision should be made for the Member States to notify the Commission and the other Member States about the types of insolvency proceedings which give rise to intervention by the guarantee institution. (10) Directive 80/987/EEC should be amended accordingly. (11) Since the objectives of the proposed action, namely the amendment of certain provisions of Directive 80/987/EEC to take account of changes in the activities of undertakings in the Community, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (12) The Commission should submit to the European Parliament and the Council a report on the implementation and application of this Directive in particular as regards the new forms of employment emerging in the Member States, Article 1 Directive 80/987/EEC is hereby amended as follows: 1. the title shall be replaced by the following: "Council Directive 80/987/EEC of 20 October 1980 on the protection of employees in the event of the insolvency of their employer"; 2. Section I shall be replaced by the following: "SECTION I Scope and definitions Article 1 1. This Directive shall apply to employees' claims arising from contracts of employment or employment relationships and existing against employers who are in a state of insolvency within the meaning of Article 2(1). 2. Member States may, by way of exception, exclude claims by certain categories of employee from the scope of this Directive, by virtue of the existence of other forms of guarantee if it is established that these offer the persons concerned a degree of protection equivalent to that resulting from this Directive. 3. Where such provision already applies in their national legislation, Member States may continue to exclude from the scope of this Directive: (a) domestic servants employed by a natural person; (b) share-fishermen. Article 2 1. For the purposes of this Directive, an employer shall be deemed to be in a state of insolvency where a request has been made for the opening of collective proceedings based on insolvency of the employer, as provided for under the laws, regulations and administrative provisions of a Member State, and involving the partial or total divestment of the employer's assets and the appointment of a liquidator or a person performing a similar task, and the authority which is competent pursuant to the said provisions has: (a) either decided to open the proceedings, or (b) established that the employer's undertaking or business has been definitively closed down and that the available assets are insufficient to warrant the opening of the proceedings. 2. This Directive is without prejudice to national law as regards the definition of the terms 'employee', 'employer', 'pay', 'right conferring immediate entitlement' and 'right conferring prospective entitlement'. However, the Member States may not exclude from the scope of this Directive: (a) part-time employees within the meaning of Directive 97/81/EC; (b) workers with a fixed-term contract within the meaning of Directive 1999/70/EC; (c) workers with a temporary employment relationship within the meaning of Article 1(2) of Directive 91/383/EEC. 3. Member States may not set a minimum duration for the contract of employment or the employment relationship in order for workers to qualify for claims under this Directive. 4. This Directive does not prevent Member States from extending workers' protection to other situations of insolvency, for example where payments have been de facto stopped on a permanent basis, established by proceedings different from those mentioned in paragraph 1 as provided for under national law. Such procedures shall not however create a guarantee obligation for the institutions of the other Member States in the cases referred to in Section IIIa."; 3. Articles 3 and 4 shall be replaced by the following: "Article 3 Member States shall take the measures necessary to ensure that guarantee institutions guarantee, subject to Article 4, payment of employees' outstanding claims resulting from contracts of employment or employment relationships, including, where provided for by national law, severance pay on termination of employment relationships. The claims taken over by the guarantee institution shall be the outstanding pay claims relating to a period prior to and/or, as applicable, after a given date determined by the Member States. Article 4 1. Member States shall have the option to limit the liability of the guarantee institutions referred to in Article 3. 2. When Member States exercise the option referred to in paragraph 1, they shall specify the length of the period for which outstanding claims are to be met by the guarantee institution. However, this may not be shorter than a period covering the remuneration of the last three months of the employment relationship prior to and/or after the date referred to in Article 3. Member States may include this minimum period of three months in a reference period with a duration of not less than six months. Member States having a reference period of not less than 18 months may limit the period for which outstanding claims are met by the guarantee institution to eight weeks. In this case, those periods which are most favourable to the employee are used for the calculation of the minimum period. 3. Furthermore, Member States may set ceilings on the payments made by the guarantee institution. These ceilings must not fall below a level which is socially compatible with the social objective of this Directive. When Member States exercise this option, they shall inform the Commission of the methods used to set the ceiling."; 4. the following Section shall be inserted: "SECTION IIIa Provisions concerning transnational situations Article 8a 1. When an undertaking with activities in the territories of at least two Member States is in a state of insolvency within the meaning of Article 2(l), the institution responsible for meeting employees' outstanding claims shall be that in the Member State in whose territory they work or habitually work. 2. The extent of employees' rights shall be determined by the law governing the competent guarantee institution. 3. Member States shall take the measures necessary to ensure that, in the cases referred to in paragraph 1, decisions taken in the context of insolvency proceedings referred to in Article 2(1), which have been requested in another Member State, are taken into account when determining the employer's state of insolvency within the meaning of this Directive. Article 8b 1. For the purposes of implementing Article 8a, Member States shall make provision for the sharing of relevant information between their competent administrative authorities and/or the guarantee institutions mentioned in Article 3, making it possible in particular to inform the guarantee institution responsible for meeting the employees' outstanding claims. 2. Member States shall notify the Commission and the other Member States of the contact details of their competent administrative authorities and/or guarantee institutions. The Commission shall make these communications publicly accessible."; 5. in Article 9 the following paragraph shall be added: "Implementation of this Directive shall not under any circumstances be sufficient grounds for a regression in relation to the current situation in the Member States and in relation to the general level of protection of workers in the area covered by it."; 6. in Article 10 the following point shall be added: "(c) to refuse or reduce the liability referred to in Article 3 or the guarantee obligation referred to in Article 7 in cases where the employee, on his or her own or together with his or her close relatives, was the owner of an essential part of the employer's undertaking or business and had a considerable influence on its activities."; 7. the following Article shall be inserted: "Article 10a Member States shall notify the Commission and the other Member States of the types of national insolvency proceedings falling within the scope of this Directive, and of any amendments relating thereto. The Commission shall publish these communications in the Official Journal of the European Communities."; 8. the Annex shall be deleted. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 8 October 2005. They shall forthwith inform the Commission thereof. They shall apply the provisions referred to in the first subparagraph to any state of insolvency of an employer occurring after the date of entry into force of those provisions. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 4 By 8 October 2010 at the latest, the Commission shall submit to the European Parliament and the Council a report on the implementation and application of this Directive in the Member States. Article 5 This Directive is addressed to the Member States.

32002L0065

2002

Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services and amending Council Directive 90/619/EEC and Directives 97/7/EC and 98/27/EC Having regard to the Treaty establishing the European Community, and in particular Article 47(2), Article 55 and Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) It is important, in the context of achieving the aims of the single market, to adopt measures designed to consolidate progressively this market and those measures must contribute to attaining a high level of consumer protection, in accordance with Articles 95 and 153 of the Treaty. (2) Both for consumers and suppliers of financial services, the distance marketing of financial services will constitute one of the main tangible results of the completion of the internal market. (3) Within the framework of the internal market, it is in the interest of consumers to have access without discrimination to the widest possible range of financial services available in the Community so that they can choose those that are best suited to their needs. In order to safeguard freedom of choice, which is an essential consumer right, a high degree of consumer protection is required in order to enhance consumer confidence in distance selling. (4) It is essential to the smooth operation of the internal market for consumers to be able to negotiate and conclude contracts with a supplier established in other Member States, regardless of whether the supplier is also established in the Member State in which the consumer resides. (5) Because of their intangible nature, financial services are particularly suited to distance selling and the establishment of a legal framework governing the distance marketing of financial services should increase consumer confidence in the use of new techniques for the distance marketing of financial services, such as electronic commerce. (6) This Directive should be applied in conformity with the Treaty and with secondary law, including Directive 2000/31/EC(4) on electronic commerce, the latter being applicable solely to the transactions which it covers. (7) This Directive aims to achieve the objectives set forth above without prejudice to Community or national law governing freedom to provide services or, where applicable, host Member State control and/or authorisation or supervision systems in the Member States where this is compatible with Community legislation. (8) Moreover, this Directive, and in particular its provisions relating to information about any contractual clause on law applicable to the contract and/or on the competent court does not affect the applicability to the distance marketing of consumer financial services of Council Regulation (EC) No 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgements in civil and commercial matters(5) or of the 1980 Rome Convention on the law applicable to contractual obligations. (9) The achievement of the objectives of the Financial Services Action Plan requires a higher level of consumer protection in certain areas. This implies a greater convergence, in particular, in non harmonised collective investment funds, rules of conduct applicable to investment services and consumer credits. Pending the achievement of the above convergence, a high level of consumer protection should be maintained. (10) Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts(6), lays down the main rules applicable to distance contracts for goods or services concluded between a supplier and a consumer. However, that Directive does not cover financial services. (11) In the context of the analysis conducted by the Commission with a view to ascertaining the need for specific measures in the field of financial services, the Commission invited all the interested parties to transmit their comments, notably in connection with the preparation of its Green Paper entitled "Financial Services - Meeting Consumers' Expectations". The consultations in this context showed that there is a need to strengthen consumer protection in this area. The Commission therefore decided to present a specific proposal concerning the distance marketing of financial services. (12) The adoption by the Member States of conflicting or different consumer protection rules governing the distance marketing of consumer financial services could impede the functioning of the internal market and competition between firms in the market. It is therefore necessary to enact common rules at Community level in this area, consistent with no reduction in overall consumer protection in the Member States. (13) A high level of consumer protection should be guaranteed by this Directive, with a view to ensuring the free movement of financial services. Member States should not be able to adopt provisions other than those laid down in this Directive in the fields it harmonises, unless otherwise specifically indicated in it. (14) This Directive covers all financial services liable to be provided at a distance. However, certain financial services are governed by specific provisions of Community legislation which continue to apply to those financial services. However, principles governing the distance marketing of such services should be laid down. (15) Contracts negotiated at a distance involve the use of means of distance communication which are used as part of a distance sales or service-provision scheme not involving the simultaneous presence of the supplier and the consumer. The constant development of those means of communication requires principles to be defined that are valid even for those means which are not yet in widespread use. Therefore, distance contracts are those the offer, negotiation and conclusion of which are carried out at a distance. (16) A single contract involving successive operations or separate operations of the same nature performed over time may be subject to different legal treatment in the different Member States, but it is important that this Directive be applied in the same way in all the Member States. To that end, it is appropriate that this Directive should be considered to apply to the first of a series of successive operations or separate operations of the same nature performed over time which may be considered as forming a whole, irrespective of whether that operation or series of operations is the subject of a single contract or several successive contracts. (17) An "initial service agreement" may be considered to be for example the opening of a bank account, acquiring a credit card, concluding a portfolio management contract, and "operations" may be considered to be for example the deposit or withdrawal of funds to or from the bank account, payment by credit card, transactions made within the framework of a portfolio management contract. Adding new elements to an initial service agreement, such as a possibility to use an electronic payment instrument together with one's existing bank account, does not constitute an "operation" but an additional contract to which this Directive applies. The subscription to new units of the same collective investment fund is considered to be one of "successive operations of the same nature". (18) By covering a service-provision scheme organised by the financial services provider, this Directive aims to exclude from its scope services provided on a strictly occasional basis and outside a commercial structure dedicated to the conclusion of distance contracts. (19) The supplier is the person providing services at a distance. This Directive should however also apply when one of the marketing stages involves an intermediary. Having regard to the nature and degree of that involvement, the pertinent provisions of this Directive should apply to such an intermediary, irrespective of his or her legal status. (20) Durable mediums include in particular floppy discs, CD-ROMs, DVDs and the hard drive of the consumer's computer on which the electronic mail is stored, but they do not include Internet websites unless they fulfil the criteria contained in the definition of a durable medium. (21) The use of means of distance communications should not lead to an unwarranted restriction on the information provided to the client. In the interests of transparency this Directive lays down the requirements needed to ensure that an appropriate level of information is provided to the consumer both before and after conclusion of the contract. The consumer should receive, before conclusion of the contract, the prior information needed so as to properly appraise the financial service offered to him and hence make a well-informed choice. The supplier should specify how long his offer applies as it stands. (22) Information items listed in this Directive cover information of a general nature applicable to all kinds of financial services. Other information requirements concerning a given financial service, such as the coverage of an insurance policy, are not solely specified in this Directive. This kind of information should be provided in accordance, where applicable, with relevant Community legislation or national legislation in conformity with Community law. (23) With a view to optimum protection of the consumer, it is important that the consumer is adequately informed of the provisions of this Directive and of any codes of conduct existing in this area and that he has a right of withdrawal. (24) When the right of withdrawal does not apply because the consumer has expressly requested the performance of a contract, the supplier should inform the consumer of this fact. (25) Consumers should be protected against unsolicited services. Consumers should be exempt from any obligation in the case of unsolicited services, the absence of a reply not being construed as signifying consent on their part. However, this rule should be without prejudice to the tacit renewal of contracts validly concluded between the parties whenever the law of the Member States permits such tacit renewal. (26) Member States should take appropriate measures to protect effectively consumers who do not wish to be contacted through certain means of communication or at certain times. This Directive should be without prejudice to the particular safeguards available to consumers under Community legislation concerning the protection of personal data and privacy. (27) With a view to protecting consumers, there is a need for suitable and effective complaint and redress procedures in the Member States with a view to settling potential disputes between suppliers and consumers, by using, where appropriate, existing procedures. (28) Member States should encourage public or private bodies established with a view to settling disputes out of court to cooperate in resolving cross-border disputes. Such cooperation could in particular entail allowing consumers to submit to extra-judicial bodies in the Member State of their residence complaints concerning suppliers established in other Member States. The establishment of FIN-NET offers increased assistance to consumers when using cross-border services. (29) This Directive is without prejudice to extension by Member States, in accordance with Community law, of the protection provided by this Directive to non-profit organisations and persons making use of financial services in order to become entrepreneurs. (30) This Directive should also cover cases where the national legislation includes the concept of a consumer making a binding contractual statement. (31) The provisions in this Directive on the supplier's choice of language should be without prejudice to provisions of national legislation, adopted in conformity with Community law governing the choice of language. (32) The Community and the Member States have entered into commitments in the context of the General Agreement on Trade in Services (GATS) concerning the possibility for consumers to purchase banking and investment services abroad. The GATS entitles Member States to adopt measures for prudential reasons, including measures to protect investors, depositors, policy-holders and persons to whom a financial service is owed by the supplier of the financial service. Such measures should not impose restrictions going beyond what is required to ensure the protection of consumers. (33) In view of the adoption of this Directive, the scope of Directive 97/7/EC and Directive 98/27/EC of the European Parliament and of the Council of 19 May 1998 on injunctions for the protection of consumers' interests(7) and the scope of the cancellation period in Council Directive 90/619/EEC of 8 November 1990 on the coordination of laws, regulations and administrative provisions relating to direct life assurance, laying down provisions to facilitate the effective exercise of freedom to provide services(8) should be adapted. (34) Since the objectives of this Directive, namely the establishment of common rules on the distance marketing of consumer financial services cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principles of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary to achieve that objective, Article 1 Object and scope 1. The object of this Directive is to approximate the laws, regulations and administrative provisions of the Member States concerning the distance marketing of consumer financial services. 2. In the case of contracts for financial services comprising an initial service agreement followed by successive operations or a series of separate operations of the same nature performed over time, the provisions of this Directive shall apply only to the initial agreement. In case there is no initial service agreement but the successive operations or the separate operations of the same nature performed over time are performed between the same contractual parties, Articles 3 and 4 apply only when the first operation is performed. Where, however, no operation of the same nature is performed for more than one year, the next operation will be deemed to be the first in a new series of operations and, accordingly, Articles 3 and 4 shall apply. Article 2 Definitions For the purposes of this Directive: (a) "distance contract" means any contract concerning financial services concluded between a supplier and a consumer under an organised distance sales or service-provision scheme run by the supplier, who, for the purpose of that contract, makes exclusive use of one or more means of distance communication up to and including the time at which the contract is concluded; (b) "financial service" means any service of a banking, credit, insurance, personal pension, investment or payment nature; (c) "supplier" means any natural or legal person, public or private, who, acting in his commercial or professional capacity, is the contractual provider of services subject to distance contracts; (d) "consumer" means any natural person who, in distance contracts covered by this Directive, is acting for purposes which are outside his trade, business or profession; (e) "means of distance communication" refers to any means which, without the simultaneous physical presence of the supplier and the consumer, may be used for the distance marketing of a service between those parties; (f) "durable medium" means any instrument which enables the consumer to store information addressed personally to him in a way accessible for future reference for a period of time adequate for the purposes of the information and which allows the unchanged reproduction of the information stored; (g) "operator or supplier of a means of distance communication" means any public or private, natural or legal person whose trade, business or profession involves making one or more means of distance communication available to suppliers. Article 3 Information to the consumer prior to the conclusion of the distance contract 1. In good time before the consumer is bound by any distance contract or offer, he shall be provided with the following information concerning: (1) the supplier (a) the identity and the main business of the supplier, the geographical address at which the supplier is established and any other geographical address relevant for the customer's relations with the supplier; (b) the identity of the representative of the supplier established in the consumer's Member State of residence and the geographical address relevant for the customer's relations with the representative, if such a representative exists; (c) when the consumer's dealings are with any professional other than the supplier, the identity of this professional, the capacity in which he is acting vis-à-vis the consumer, and the geographical address relevant for the customer's relations with this professional; (d) where the supplier is registered in a trade or similar public register, the trade register in which the supplier is entered and his registration number or an equivalent means of identification in that register; (e) where the supplier's activity is subject to an authorisation scheme, the particulars of the relevant supervisory authority; (2) the financial service (a) a description of the main characteristics of the financial service; (b) the total price to be paid by the consumer to the supplier for the financial service, including all related fees, charges and expenses, and all taxes paid via the supplier or, when an exact price cannot be indicated, the basis for the calculation of the price enabling the consumer to verify it; (c) where relevant notice indicating that the financial service is related to instruments involving special risks related to their specific features or the operations to be executed or whose price depends on fluctuations in the financial markets outside the supplier's control and that historical performances are no indicators for future performances; (d) notice of the possibility that other taxes and/or costs may exist that are not paid via the supplier or imposed by him; (e) any limitations of the period for which the information provided is valid; (f) the arrangements for payment and for performance; (g) any specific additional cost for the consumer of using the means of distance communication, if such additional cost is charged; (3) the distance contract (a) the existence or absence of a right of withdrawal in accordance with Article 6 and, where the right of withdrawal exists, its duration and the conditions for exercising it, including information on the amount which the consumer may be required to pay on the basis of Article 7(1), as well as the consequences of non-exercise of that right; (b) the minimum duration of the distance contract in the case of financial services to be performed permanently or recurrently; (c) information on any rights the parties may have to terminate the contract early or unilaterally by virtue of the terms of the distance contract, including any penalties imposed by the contract in such cases; (d) practical instructions for exercising the right of withdrawal indicating, inter alia, the address to which the notification of a withdrawal should be sent; (e) the Member State or States whose laws are taken by the supplier as a basis for the establishment of relations with the consumer prior to the conclusion of the distance contract; (f) any contractual clause on law applicable to the distance contract and/or on competent court; (g) in which language, or languages, the contractual terms and conditions, and the prior information referred to in this Article are supplied, and furthermore in which language, or languages, the supplier, with the agreement of the consumer, undertakes to communicate during the duration of this distance contract; (4) redress (a) whether or not there is an out-of-court complaint and redress mechanism for the consumer that is party to the distance contract and, if so, the methods for having access to it; (b) the existence of guarantee funds or other compensation arrangements, not covered by Directive 94/19/EC of the European Parliament and of the Council of 30 May 1994 on deposit guarantee schemes(9) and Directive 97/9/EC of the European Parliament and of the Council of 3 March 1997 on investor compensation schemes(10). 2. The information referred to in paragraph 1, the commercial purpose of which must be made clear, shall be provided in a clear and comprehensible manner in any way appropriate to the means of distance communication used, with due regard, in particular, to the principles of good faith in commercial transactions, and the principles governing the protection of those who are unable, pursuant to the legislation of the Member States, to give their consent, such as minors. 3. In the case of voice telephony communications (a) the identity of the supplier and the commercial purpose of the call initiated by the supplier shall be made explicitly clear at the beginning of any conversation with the consumer; (b) subject to the explicit consent of the consumer only the following information needs to be given: - the identity of the person in contact with the consumer and his link with the supplier, - a description of the main characteristics of the financial service, - the total price to be paid by the consumer to the supplier for the financial service including all taxes paid via the supplier or, when an exact price cannot be indicated, the basis for the calculation of the price enabling the consumer to verify it, - notice of the possibility that other taxes and/or costs may exist that are not paid via the supplier or imposed by him, - the existence or absence of a right of withdrawal in accordance with Article 6 and, where the right of withdrawal exists, its duration and the conditions for exercising it, including information on the amount which the consumer may be required to pay on the basis of Article 7(1). The supplier shall inform the consumer that other information is available on request and of what nature this information is. In any case the supplier shall provide the full information when he fulfils his obligations under Article 5. 4. Information on contractual obligations, to be communicated to the consumer during the pre-contractual phase, shall be in conformity with the contractual obligations which would result from the law presumed to be applicable to the distance contract if the latter were concluded. Article 4 Additional information requirements 1. Where there are provisions in the Community legislation governing financial services which contain prior information requirements additional to those listed in Article 3(1), these requirements shall continue to apply. 2. Pending further harmonisation, Member States may maintain or introduce more stringent provisions on prior information requirements when the provisions are in conformity with Community law. 3. Member States shall communicate to the Commission national provisions on prior information requirements under paragraphs 1 and 2 of this Article when these requirements are additional to those listed in Article 3(1). The Commission shall take account of the communicated national provisions when drawing up the report referred to in Article 20(2). 4. The Commission shall, with a view to creating a high level of transparency by all appropriate means, ensure that information, on the national provisions communicated to it, is made available to consumers and suppliers. Article 5 Communication of the contractual terms and conditions and of the prior information 1. The supplier shall communicate to the consumer all the contractual terms and conditions and the information referred to in Article 3(1) and Article 4 on paper or on another durable medium available and accessible to the consumer in good time before the consumer is bound by any distance contract or offer. 2. The supplier shall fulfil his obligation under paragraph 1 immediately after the conclusion of the contract, if the contract has been concluded at the consumer's request using a means of distance communication which does not enable providing the contractual terms and conditions and the information in conformity with paragraph 1. 3. At any time during the contractual relationship the consumer is entitled, at his request, to receive the contractual terms and conditions on paper. In addition, the consumer is entitled to change the means of distance communication used, unless this is incompatible with the contract concluded or the nature of the financial service provided. Article 6 Right of withdrawal 1. The Member States shall ensure that the consumer shall have a period of 14 calendar days to withdraw from the contract without penalty and without giving any reason. However, this period shall be extended to 30 calendar days in distance contracts relating to life insurance covered by Directive 90/619/EEC and personal pension operations. The period for withdrawal shall begin: - either from the day of the conclusion of the distance contract, except in respect of the said life assurance, where the time limit will begin from the time when the consumer is informed that the distance contract has been concluded, or - from the day on which the consumer receives the contractual terms and conditions and the information in accordance with Article 5(1) or (2), if that is later than the date referred to in the first indent. Member States, in addition to the right of withdrawal, may provide that the enforceability of contracts relating to investment services is suspended for the same period provided for in this paragraph. 2. The right of withdrawal shall not apply to: (a) financial services whose price depends on fluctuations in the financial market outside the suppliers control, which may occur during the withdrawal period, such as services related to: - foreign exchange, - money market instruments, - transferable securities, - units in collective investment undertakings, - financial-futures contracts, including equivalent cash-settled instruments, - forward interest-rate agreements (FRAs), - interest-rate, currency and equity swaps, - options to acquire or dispose of any instruments referred to in this point including equivalent cash-settled instruments. This category includes in particular options on currency and on interest rates; (b) travel and baggage insurance policies or similar short-term insurance policies of less than one month's duration; (c) contracts whose performance has been fully completed by both parties at the consumer's express request before the consumer exercises his right of withdrawal. 3. Member States may provide that the right of withdrawal shall not apply to: (a) any credit intended primarily for the purpose of acquiring or retaining property rights in land or in an existing or projected building, or for the purpose of renovating or improving a building, or (b) any credit secured either by mortgage on immovable property or by a right related to immovable property, or (c) declarations by consumers using the services of an official, provided that the official confirms that the consumer is guaranteed the rights under Article 5(1). This paragraph shall be without prejudice to the right to a reflection time to the benefit of the consumers that are resident in those Member States where it exists, at the time of the adoption of this Directive. 4. Member States making use of the possibility set out in paragraph 3 shall communicate it to the Commission. 5. The Commission shall make available the information communicated by Member States to the European Parliament and the Council and shall ensure that it is also available to consumers and suppliers who request it. 6. If the consumer exercises his right of withdrawal he shall, before the expiry of the relevant deadline, notify this following the practical instructions given to him in accordance with Article 3(1)(3)(d) by means which can be proved in accordance with national law. The deadline shall be deemed to have been observed if the notification, if it is on paper or on another durable medium available and accessible to the recipient, is dispatched before the deadline expires. 7. This Article does not apply to credit agreements cancelled under the conditions of Article 6(4) of Directive 97/7/EC or Article 7 of Directive 94/47/EC of the European Parliament and of the Council of 26 October 1994 on the protection of purchasers in respect of certain aspects of contracts relating to the purchase of the right to use immovable properties on a timeshare basis(11). If to a distance contract of a given financial service another distance contract has been attached concerning services provided by the supplier or by a third party on the basis of an agreement between the third party and the supplier, this additional distance contract shall be cancelled, without any penalty, if the consumer exercises his right of withdrawal as provided for in Article 6(1). 8. The provisions of this Article are without prejudice to the Member States' laws and regulations governing the cancellation or termination or non-enforceability of a distance contract or the right of a consumer to fulfil his contractual obligations before the time fixed in the distance contract. This applies irrespective of the conditions for and the legal effects of the winding-up of the contract. Article 7 Payment of the service provided before withdrawal 1. When the consumer exercises his right of withdrawal under Article 6(1) he may only be required to pay, without any undue delay, for the service actually provided by the supplier in accordance with the contract. The performance of the contract may only begin after the consumer has given his approval. The amount payable shall not: - exceed an amount which is in proportion to the extent of the service already provided in comparison with the full coverage of the contract, - in any case be such that it could be construed as a penalty. 2. Member States may provide that the consumer cannot be required to pay any amount when withdrawing from an insurance contract. 3. The supplier may not require the consumer to pay any amount on the basis of paragraph 1 unless he can prove that the consumer was duly informed about the amount payable, in conformity with Article 3(1)(3)(a). However, in no case may he require such payment if he has commenced the performance of the contract before the expiry of the withdrawal period provided for in Article 6(1) without the consumer's prior request. 4. The supplier shall, without any undue delay and no later than within 30 calendar days, return to the consumer any sums he has received from him in accordance with the distance contract, except for the amount referred to in paragraph 1. This period shall begin from the day on which the supplier receives the notification of withdrawal. 5. The consumer shall return to the supplier any sums and/or property he has received from the supplier without any undue delay and no later than within 30 calendar days. This period shall begin from the day on which the consumer dispatches the notification of withdrawal. Article 8 Payment by card Member States shall ensure that appropriate measures exist to allow a consumer: - to request cancellation of a payment where fraudulent use has been made of his payment card in connection with distance contracts, - in the event of such fraudulent use, to be re-credited with the sum paid or have them returned. Article 9 Unsolicited services Without prejudice to Member States provisions on the tacit renewal of distance contracts, when such rules permit tacit renewal, Member States shall take the necessary measures to: - prohibit the supply of financial services to a consumer without a prior request on his part, when this supply includes a request for immediate or deferred payment, - exempt the consumer from any obligation in the event of unsolicited supplies, the absence of a reply not constituting consent. Article 10 Unsolicited communications 1. The use by a supplier of the following distance communication techniques shall require the consumer's prior consent: (a) automated calling systems without human intervention (automatic calling machines); (b) fax machines. 2. Member States shall ensure that means of distance communication other than those referred to in paragraph 1, when they allow individual communications: (a) shall not be authorised unless the consent of the consumers concerned has been obtained, or (b) may only be used if the consumer has not expressed his manifest objection. 3. The measures referred to in paragraphs 1 and 2 shall not entail costs for consumers. Article 11 Sanctions Member States shall provide for appropriate sanctions in the event of the supplier's failure to comply with national provisions adopted pursuant to this Directive. They may provide for this purpose in particular that the consumer may cancel the contract at any time, free of charge and without penalty. These sanctions must be effective, proportional and dissuasive. Article 12 Imperative nature of this Directive's provisions 1. Consumers may not waive the rights conferred on them by this Directive. 2. Member States shall take the measures needed to ensure that the consumer does not lose the protection granted by this Directive by virtue of the choice of the law of a non-member country as the law applicable to the contract, if this contract has a close link with the territory of one or more Member States. Article 13 Judicial and administrative redress 1. Member States shall ensure that adequate and effective means exist to ensure compliance with this Directive in the interests of consumers. 2. The means referred to in paragraph 1 shall include provisions whereby one or more of the following bodies, as determined by national law, may take action in accordance with national law before the courts or competent administrative bodies to ensure that the national provisions for the implementation of this Directive are applied: (a) public bodies or their representatives; (b) consumer organisations having a legitimate interest in protecting consumers; (c) professional organisations having a legitimate interest in acting. 3. Member States shall take the measures necessary to ensure that operators and suppliers of means of distance communication put an end to practices that have been declared to be contrary to this Directive, on the basis of a judicial decision, an administrative decision or a decision issued by a supervisory authority notified to them, where those operators or suppliers are in a position to do so. Article 14 Out-of-court redress 1. Member States shall promote the setting up or development of adequate and effective out-of-court complaints and redress procedures for the settlement of consumer disputes concerning financial services provided at distance. 2. Member States shall, in particular, encourage the bodies responsible for out-of-court settlement of disputes to cooperate in the resolution of cross-border disputes concerning financial services provided at distance. Article 15 Burden of proof Without prejudice to Article 7(3), Member States may stipulate that the burden of proof in respect of the supplier's obligations to inform the consumer and the consumer's consent to conclusion of the contract and, where appropriate, its performance, can be placed on the supplier. Any contractual term or condition providing that the burden of proof of the respect by the supplier of all or part of the obligations incumbent on him pursuant to this Directive should lie with the consumer shall be an unfair term within the meaning of Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts(12). Article 16 Transitional measures Member States may impose national rules which are in conformity with this Directive on suppliers established in a Member State which has not yet transposed this Directive and whose law has no obligations corresponding to those provided for in this Directive. Article 17 Directive 90/619/EC In Article 15(1) of Directive 90/619/EEC the first subparagraph shall be replaced by the following: "1. Each Member State shall prescribe that a policyholder who concludes an individual life-assurance contract shall have a period of 30 calendar days, from the time when he was informed that the contract had been concluded, within which to cancel the contract." Article 18 Directive 97/7/EC Directive 97/7/EC is hereby amended as follows: 1. the first indent of Article 3(1) shall be replaced by the following: "- relating to any financial service to which Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services and amending Council Directive 90/619/EEC and Directives 97/7/EC and 98/27/EC(13) applies,"; 2. Annex II shall be deleted. Article 19 Directive 98/27/EC The following point shall be added to the Annex of Directive 98/27/EC: "11. Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services and amending Council Directive 90/619/EEC and Directives 97/7/EC and 98/27/EC(14)." Article 20 Review 1. Following the implementation of this Directive, the Commission shall examine the functioning of the internal market in financial services in respect of the marketing of those services. It should seek to analyse and detail the difficulties that are, or might be faced by both consumers and suppliers, in particular arising from differences between national provisions regarding information and right of withdrawal. 2. Not later than 9 April 2006 the Commission shall report to the European Parliament and the Council on the problems facing both consumers and suppliers seeking to buy and sell financial services, and shall submit, where appropriate, proposals to amend and/or further harmonise the information and right of withdrawal provisions in Community legislation concerning financial services and/or those covered in Article 3. Article 21 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 9 October 2004. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive together with a table showing how the provisions of this Directive correspond to the national provisions adopted. Article 22 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 23 Addressees This Directive is addressed to the Member States.

32002L0073

2002

Directive 2002/73/EC of the European Parliament and of the Council of 23 September 2002 amending Council Directive 76/207/EEC on the implementation of the principle of equal treatment for men and women as regards access to employment, vocational training and promotion, and working conditions (Text with EEA relevance) Having regard to the Treaty establishing the European Community and, in particular, Article 141(3) thereof, Having regard to the proposal from the Commission(1), Having regard to the Opinion of the Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 19 April 2002, Whereas: (1) In accordance with Article 6 of the Treaty on European Union, the European Union is founded on the principles of liberty, democracy, respect for human rights and fundamental freedoms, and the rule of law, principles which are common to the Member States, and shall respect fundamental rights as guaranteed by the European Convention for the Protection of Human Rights and Fundamental Freedoms and as they result from the constitutional traditions common to the Member States, as general principles of Community law. (2) The right to equality before the law and protection against discrimination for all persons constitutes a universal right recognised by the Universal Declaration of Human Rights, the United Nations Convention on the Elimination of all forms of Discrimination Against Women, the International Convention on the Elimination of all Forms of Racial Discrimination and the United Nations Covenants on Civil and Political Rights and on Economic, Social and Cultural Rights and by the Convention for the Protection of Human Rights and Fundamental Freedoms, to which all Member States are signatories. (3) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. (4) Equality between women and men is a fundamental principle, under Article 2 and Article 3(2) of the EC Treaty and the case-law of the Court of Justice. These Treaty provisions proclaim equality between women and men as a "task" and an "aim" of the Community and impose a positive obligation to "promote" it in all its activities. (5) Article 141 of the Treaty, and in particular paragraph 3, addresses specifically equal opportunities and equal treatment of men and women in matters of employment and occupation. (6) Council Directive 76/207/EEC(4) does not define the concepts of direct or indirect discrimination. On the basis of Article 13 of the Treaty, the Council has adopted Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin(5) and Directive 2000/78/EC of 27 November 2000 establishing a general framework for equal treatment in employment and occupation(6) which define direct and indirect discrimination. Thus it is appropriate to insert definitions consistent with these Directives in respect of sex. (7) This Directive does not prejudice freedom of association, including the right to establish unions with others and to join unions to defend one's interests. Measures within the meaning of Article 141(4) of the Treaty may include membership or the continuation of the activity of organisations or unions whose main objective is the promotion, in practice, of the principle of equal treatment between women and men. (8) Harassment related to the sex of a person and sexual harassment are contrary to the principle of equal treatment between women and men; it is therefore appropriate to define such concepts and to prohibit such forms of discrimination. To this end it must be emphasised that these forms of discrimination occur not only in the workplace, but also in the context of access to employment and vocational training, during employment and occupation. (9) In this context, employers and those responsible for vocational training should be encouraged to take measures to combat all forms of sexual discrimination and, in particular, to take preventive measures against harassment and sexual harassment in the workplace, in accordance with national legislation and practice. (10) The appreciation of the facts from which it may be inferred that there has been direct or indirect discrimination is a matter for national judicial or other competent bodies, in accordance with rules of national law or practice. Such rules may provide in particular for indirect discrimination to be established by any means including on the basis of statistical evidence. According to the case-law of the Court of Justice(7), discrimination involves the application of different rules to a comparable situation or the application of the same rule to different situations. (11) The occupational activities that Member States may exclude from the scope of Directive 76/207/EEC should be restricted to those which necessitate the employment of a person of one sex by reason of the nature of the particular occupational activities concerned, provided that the objective sought is legitimate, and subject to the principle of proportionality as laid down by the case-law of the Court of Justice(8). (12) The Court of Justice has consistently recognised the legitimacy, in terms of the principle of equal treatment, of protecting a woman's biological condition during and after pregnancy. It has moreover consistently ruled that any unfavourable treatment of women related to pregnancy or maternity constitutes direct sex discrimination. This Directive is therefore without prejudice to Council Directive 92/85/EEC of 19 October 1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding(9) (tenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC), which aims to ensure the protection of the physical and mental state of women who are pregnant, women who have recently given birth or women who are breastfeeding. The preamble to Directive 92/85/EEC provides that the protection of the safety and health of pregnant workers, workers who have recently given birth or workers who are breastfeeding should not involve treating women who are on the labour market unfavourably nor work to the detriment of Directives concerning equal treatment for men and women. The Court of Justice has recognised the protection of employment rights of women, in particular their right to return to the same or an equivalent job, with no less favourable working conditions, as well as to benefit from any improvement in working conditions to which they would be entitled during their absence. (13) In the Resolution of the Council and of the Ministers for Employment and Social Policy meeting within the Council of 29 June 2000 on the balanced participation of women and men in family and working life(10), Member States were encouraged to consider examining the scope for their respective legal systems to grant working men an individual and untransferable right to paternity leave, while maintaining their rights relating to employment. In this context, it is important to stress that it is for the Member States to determine whether or not to grant such a right and also to determine any conditions, other than dismissal and return to work, which are outside the scope of this Directive. (14) Member States may, under Article 141(4) of the Treaty, maintain or adopt measures providing for specific advantages, in order to make it easier for the under-represented sex to pursue a vocational activity or to prevent or compensate for disadvantages in professional careers. Given the current situation, and bearing in mind Declaration No 28 to the Amsterdam Treaty, Members States should, in the first instance, aim at improving the situation of women in working life. (15) The prohibition of discrimination should be without prejudice to the maintenance or adoption of measures intended to prevent or compensate for disadvantages suffered by a group of persons of one sex. Such measures permit organisations of persons of one sex where their main object is the promotion of the special needs of those persons and the promotion of equality between women and men. (16) The principle of equal pay for men and women is already firmly established by Article 141 of the Treaty and Council Directive 75/117/EEC of 10 February 1975 on the approximation of the laws of the Member States relating to the application of the principle of equal pay for men and women(11) and is consistently upheld by the case-law of the Court of Justice; the principle constitutes an essential and indispensable part of the acquis communautaire concerning sex discrimination. (17) The Court of Justice has ruled that, having regard to the fundamental nature of the right to effective judicial protection, employees enjoy such protection even after the employment relationship has ended(12). An employee defending or giving evidence on behalf of a person protected under this Directive should be entitled to the same protection. (18) The Court of Justice has ruled that, in order to be effective, the principle of equal treatment implies that, whenever it is breached, the compensation awarded to the employee discriminated against must be adequate in relation to the damage sustained. It has furthermore specified that fixing a prior upper limit may preclude effective compensation and that excluding an award of interest to compensate for the loss sustained is not allowed(13). (19) According to the case-law of the Court of Justice, national rules relating to time limits for bringing actions are admissible provided that they are not less favourable than time limits for similar actions of a domestic nature and that they do not render the exercise of rights conferred by the Community law impossible in practice. (20) Persons who have been subject to discrimination based on sex should have adequate means of legal protection. To provide a more effective level of protection, associations, organisations and other legal entities should also be empowered to engage in proceedings, as the Member States so determine, either on behalf or in support of any victim, without prejudice to national rules of procedure concerning representation and defence before the courts. (21) Member States should promote dialogue between the social partners and, within the framework of national practice, with non-governmental organisations to address different forms of discrimination based on sex in the workplace and to combat them. (22) Member States should provide for effective, proportionate and dissuasive sanctions in case of breaches of the obligations under Directive 76/207/EEC. (23) In accordance with the principle of subsidiarity as set out in Article 5 of the Treaty, the objectives of the proposed action cannot be sufficiently achieved by the Member States and can therefore be better achieved by the Community. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary for that purpose. (24) Directive 76/207/EEC should therefore be amended accordingly, Article 1 Directive 76/207/EEC is hereby amended as follows: 1. in Article 1, the following paragraph shall be inserted: "1a. Member States shall actively take into account the objective of equality between men and women when formulating and implementing laws, regulations, administrative provisions, policies and activities in the areas referred to in paragraph 1."; 2. Article 2 shall be replaced by the following: "Article 2 1. For the purposes of the following provisions, the principle of equal treatment shall mean that there shall be no discrimination whatsoever on grounds of sex either directly or indirectly by reference in particular to marital or family status. 2. For the purposes of this Directive, the following definitions shall apply: - direct discrimination: where one person is treated less favourably on grounds of sex than another is, has been or would be treated in a comparable situation, - indirect discrimination: where an apparently neutral provision, criterion or practice would put persons of one sex at a particular disadvantage compared with persons of the other sex, unless that provision, criterion or practice is objectively justified by a legitimate aim, and the means of achieving that aim are appropriate and necessary, - harassment: where an unwanted conduct related to the sex of a person occurs with the purpose or effect of violating the dignity of a person, and of creating an intimidating, hostile, degrading, humiliating or offensive environment, - sexual harassment: where any form of unwanted verbal, non-verbal or physical conduct of a sexual nature occurs, with the purpose or effect of violating the dignity of a person, in particular when creating an intimidating, hostile, degrading, humiliating or offensive environment. 3. Harassment and sexual harassment within the meaning of this Directive shall be deemed to be discrimination on the grounds of sex and therefore prohibited. A person's rejection of, or submission to, such conduct may not be used as a basis for a decision affecting that person. 4. An instruction to discriminate against persons on grounds of sex shall be deemed to be discrimination within the meaning of this Directive. 5. Member States shall encourage, in accordance with national law, collective agreements or practice, employers and those responsible for access to vocational training to take measures to prevent all forms of discrimination on grounds of sex, in particular harassment and sexual harassment at the workplace. 6. Member States may provide, as regards access to employment including the training leading thereto, that a difference of treatment which is based on a characteristic related to sex shall not constitute discrimination where, by reason of the nature of the particular occupational activities concerned or of the context in which they are carried out, such a characteristic constitutes a genuine and determining occupational requirement, provided that the objective is legitimate and the requirement is proportionate. 7. This Directive shall be without prejudice to provisions concerning the protection of women, particularly as regards pregnancy and maternity. A woman on maternity leave shall be entitled, after the end of her period of maternity leave, to return to her job or to an equivalent post on terms and conditions which are no less favourable to her and to benefit from any improvement in working conditions to which she would be entitled during her absence. Less favourable treatment of a woman related to pregnancy or maternity leave within the meaning of Directive 92/85/EEC shall constitute discrimination within the meaning of this Directive. This Directive shall also be without prejudice to the provisions of Council Directive 96/34/EC of 3 June 1996 on the framework agreement on parental leave concluded by UNICE, CEEP and the ETUC(14) and of Council Directive 92/85/EEC of 19 October 1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding (tenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(15). It is also without prejudice to the right of Member States to recognise distinct rights to paternity and/or adoption leave. Those Member States which recognise such rights shall take the necessary measures to protect working men and women against dismissal due to exercising those rights and ensure that, at the end of such leave, they shall be entitled to return to their jobs or to equivalent posts on terms and conditions which are no less favourable to them, and to benefit from any improvement in working conditions to which they would have been entitled during their absence. 8. Member States may maintain or adopt measures within the meaning of Article 141(4) of the Treaty with a view to ensuring full equality in practice between men and women."; 3. Article 3 shall be replaced by the following: "Article 3 1. Application of the principle of equal treatment means that there shall be no direct or indirect discrimination on the grounds of sex in the public or private sectors, including public bodies, in relation to: (a) conditions for access to employment, to self-employment or to occupation, including selection criteria and recruitment conditions, whatever the branch of activity and at all levels of the professional hierarchy, including promotion; (b) access to all types and to all levels of vocational guidance, vocational training, advanced vocational training and retraining, including practical work experience; (c) employment and working conditions, including dismissals, as well as pay as provided for in Directive 75/117/EEC; (d) membership of, and involvement in, an organisation of workers or employers, or any organisation whose members carry on a particular profession, including the benefits provided for by such organisations. 2. To that end, Member States shall take the necessary measures to ensure that: (a) any laws, regulations and administrative provisions contrary to the principle of equal treatment are abolished; (b) any provisions contrary to the principle of equal treatment which are included in contracts or collective agreements, internal rules of undertakings or rules governing the independent occupations and professions and workers' and employers' organisations shall be, or may be declared, null and void or are amended."; 4. Articles 4 and 5 shall be deleted; 5. Article 6 shall be replaced by the following: "Article 6 1. Member States shall ensure that judicial and/or administrative procedures, including where they deem it appropriate conciliation procedures, for the enforcement of obligations under this Directive are available to all persons who consider themselves wronged by failure to apply the principle of equal treatment to them, even after the relationship in which the discrimination is alleged to have occurred has ended. 2. Member States shall introduce into their national legal systems such measures as are necessary to ensure real and effective compensation or reparation as the Member States so determine for the loss and damage sustained by a person injured as a result of discrimination contrary to Article 3, in a way which is dissuasive and proportionate to the damage suffered; such compensation or reparation may not be restricted by the fixing of a prior upper limit, except in cases where the employer can prove that the only damage suffered by an applicant as a result of discrimination within the meaning of this Directive is the refusal to take his/her job application into consideration. 3. Member States shall ensure that associations, organisations or other legal entities which have, in accordance with the criteria laid down by their national law, a legitimate interest in ensuring that the provisions of this Directive are complied with, may engage, either on behalf or in support of the complainants, with his or her approval, in any judicial and/or administrative procedure provided for the enforcement of obligations under this Directive. 4. Paragraphs 1 and 3 are without prejudice to national rules relating to time limits for bringing actions as regards the principle of equal treatment."; 6. Article 7 shall be replaced by the following: "Article 7 Member States shall introduce into their national legal systems such measures as are necessary to protect employees, including those who are employees' representatives provided for by national laws and/or practices, against dismissal or other adverse treatment by the employer as a reaction to a complaint within the undertaking or to any legal proceedings aimed at enforcing compliance with the principle of equal treatment."; 7. the following Articles shall be inserted: "Article 8a 1. Member States shall designate and make the necessary arrangements for a body or bodies for the promotion, analysis, monitoring and support of equal treatment of all persons without discrimination on the grounds of sex. These bodies may form part of agencies charged at national level with the defence of human rights or the safeguard of individuals' rights. 2. Member States shall ensure that the competences of these bodies include: (a) without prejudice to the right of victims and of associations, organisations or other legal entities referred to in Article 6(3), providing independent assistance to victims of discrimination in pursuing their complaints about discrimination; (b) conducting independent surveys concerning discrimination; (c) publishing independent reports and making recommendations on any issue relating to such discrimination. Article 8b 1. Member States shall, in accordance with national traditions and practice, take adequate measures to promote social dialogue between the social partners with a view to fostering equal treatment, including through the monitoring of workplace practices, collective agreements, codes of conduct, research or exchange of experiences and good practices. 2. Where consistent with national traditions and practice, Member States shall encourage the social partners, without prejudice to their autonomy, to promote equality between women and men and to conclude, at the appropriate level, agreements laying down anti-discrimination rules in the fields referred to in Article 1 which fall within the scope of collective bargaining. These agreements shall respect the minimum requirements laid down by this Directive and the relevant national implementing measures. 3. Member States shall, in accordance with national law, collective agreements or practice, encourage employers to promote equal treatment for men and women in the workplace in a planned and systematic way. 4. To this end, employers should be encouraged to provide at appropriate regular intervals employees and/or their representatives with appropriate information on equal treatment for men and women in the undertaking. Such information may include statistics on proportions of men and women at different levels of the organisation and possible measures to improve the situation in cooperation with employees' representatives. Article 8c Member States shall encourage dialogue with appropriate non-governmental organisations which have, in accordance with their national law and practice, a legitimate interest in contributing to the fight against discrimination on grounds of sex with a view to promoting the principle of equal treatment. Article 8d Member States shall lay down the rules on sanctions applicable to infringements of the national provisions adopted pursuant to this Directive, and shall take all measures necessary to ensure that they are applied. The sanctions, which may comprise the payment of compensation to the victim, must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 5 October 2005 at the latest and shall notify it without delay of any subsequent amendment affecting them. Article 8e 1. Member States may introduce or maintain provisions which are more favourable to the protection of the principle of equal treatment than those laid down in this Directive. 2. The implementation of this Directive shall under no circumstances constitute grounds for a reduction in the level of protection against discrimination already afforded by Member States in the fields covered by this Directive." Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 5 October 2005 at the latest or shall ensure, by that date at the latest, that management and labour introduce the requisite provisions by way of agreement. Member States shall take all necessary steps to enable them at all times to guarantee the results imposed by this Directive. They shall immediately inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. The Member States shall communicate to the Commission, within three years of the entry into force of this Directive, all the information necessary for the Commission to draw up a report to the European Parliament and the Council on the application of this Directive. 3. Without prejudice to paragraph 2, Member States shall communicate to the Commission, every four years, the texts of laws, regulations and administrative provisions of any measures adopted pursuant to Article 141(4) of the Treaty, as well as reports on these measures and their implementation. On the basis of that information, the Commission will adopt and publish every four years a report establishing a comparative assessment of any measures in the light of Declaration No 28 annexed to the Final Act of the Treaty of Amsterdam. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32002L0078

2002

Commission Directive 2002/78/EC of 1 October 2002 adapting to technical progress Council Directive 71/320/EEC on the approximation of the laws of the Member States relating to the braking devices of certain categories of motor vehicles and their trailers Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(1), as last amended by Commission Directive 2001/116/EC(2), and in particular Article 13(2) thereof, Having regard to Council Directive 71/320/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to the braking devices of certain categories of motor vehicles and their trailers(3), as last amended by Commission Directive 98/12/EC(4), and in particular Article 5 thereof, Whereas: (1) Directive 71/320/EEC is one of the separate Directives of the EC type-approval procedure which has been established by Directive 70/156/EEC. Consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to Directive 71/320/EEC. (2) It is not considered necessary to apply the requirements concerning the approval of after-market replacement brake lining assemblies to those assemblies used in the approval of the braking system, provided such assemblies can be identified in accordance with the requirements of this Directive. (3) It is necessary to clarify the application of Directive 71/320/EEC to the after-market replacement brake lining assemblies with regard to their marking and packaging. Differentiation needs to be made between those replacement brake lining assemblies that are identical to the original equipment supplied for the specified vehicles and those that are not. (4) Directive 71/320/EEC should be amended accordingly; (5) The measures provided for in this Directive are in accordance with the opinion of the Committee for adaptation to technical progress established by Directive 70/156/EEC, Article 1 Annexes I, IX and XV to Directive 71/320/EEC are amended in accordance with the Annex to this Directive. Article 2 With effect from 1 January 2003 Member States shall not, on grounds relating to vehicle braking systems prohibit the sale or entry into service of replacement brake linings if the replacement brake linings comply with the requirements of Directive 71/320/EEC, as amended by this Directive. Article 3 1. With effect from 1 June 2003 Member States may, on grounds relating to vehicle braking systems prohibit the sale or entry into service of replacement brake linings if the replacement brake linings do not comply with the requirements of Directive 71/320/EEC, as amended by this Directive. 2. Notwithstanding the provision of paragraph 1, for the purpose of replacement parts, Member States shall permit the sale or entry into service of replacement brake linings intended for fitting to vehicle types for which type-approval was granted prior to the entry into force of Directive 71/320/EEC, as amended by Directive 98/12/EC, and on condition that such replacement brake linings do not contravene the provisions of the previous version of Directive 71/320/EEC, as amended by Directive 98/12/EC, which was applicable at the time of entry into service of these vehicles. In any case these brake linings shall not contain asbestos. Article 4 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2002 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 5 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.

32002L0079

2002

Commission Directive 2002/79/EC of 2 October 2002 amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for certain pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables (Text with EEA relevance.) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables(1), as last amended by Commission Directive 2002/71/EC(2), and in particular Article 5 thereof, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(3), as last amended by Commission Directive 2002/76/EC(4), and in particular Article 10 thereof, Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(5), as last amended by Directive 2002/71/EC, and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on products of plant origin, including fruit and vegetables(6), as last amended by Directive 2002/76/EC, and in particular Article 7 thereof, Whereas: (1) The Annexes to Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC, consist of lists of pesticide residues and their maximum levels. (2) On re-examination of the available data it has been determined that sufficient information exists to permit maximum levels be fixed for certain pesticide residues, namely abamectin, azocyclotin, bioresmethrin, bifenthrin, bitertanol, bromopropylate, clofentezine, cyromazine, cyhexatin, fenpropimorph, flucytrinate, hexaconazol, metacrifos, myclobutanil, penconazole, prochloraz, profenofos, resmethrin, tridemorph, triadimefon and triadimenol. (3) Pesticide residues may arise in food of animal origin as a result of agricultural practices. It is necessary to take into account relevant data obtained both from authorised pesticide use and from supervised trials and animal feeding studies. (4) The information available has been reviewed. For many pesticide/agricultural product combinations the data is sufficient to allow the calculation of a maximum residue level at which residues of the pesticide concerned may be considered safe for human health. Where this level exceeds the lower limit of analytical determination it is appropriate to fix the maximum residue level at the level calculated. For some combinations the information available is inadequate and it is appropriate to fix maximum residue levels at the lower limit of analytical determination. For other positions the information is adequate but demonstrates that the setting of a maximum residue level above the lower limit of analytical determination may give rise to an unacceptable, acute or chronic exposure of the consumer to the residues. In such cases, it is appropriate to fix maximum residue levels at the lower limit of analytical determination. (5) The lifetime exposure and the acute exposure of consumers to these pesticides via food products that may contain residues of these pesticides has been assessed and evaluated in accordance with the Community procedures and practices taking account of guidelines published by the World Health Organisation(7). For abamectin, maximum residue limits have been established in accordance with Council Regulation (EEC) No 2377/90(8), as last amended by Commission Regulation (EC) No 1752/2002(9) resulting from the use of veterinary medicinal products containing the same substance for the treatment of food-producing animal species (Commission Regulation (EC) No 3425/93(10). These uses and the evaluation of the acceptable daily intake provided by the Committee for Veterinary Medicinal Products on which these maximum residue limits were based were taken into account. It has been concluded that the maximum residue levels proposed in this Directive do not lead to the acceptable daily intakes being exceeded or to acute toxic effects. (6) To ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it is prudent to set maximum residue levels at the lower limit of analytical determination for all such products covered by Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. (7) Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly. (8) The Community's trading partners have been consulted about the levels proposed in this Directive through the World Trade Organisation, and their comments on these levels have been considered. (9) The opinions of the Scientific Committee for Plants, and in particular advice and recommendations concerning the protection of consumers of food crops treated with plant protection products, have been taken into account(11). (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 In Annex II to Directive 76/895/EEC, the entry relating to "bromopropylate" is deleted. Article 2 In part A of Annex II to Directive 86/362/EEC the maximum pesticide residue levels for abamectin, azocyclotin and cyhexatin, bifenthrin, bitertanol, bromopropylate, clofentezine, cyromazine, fenpropimorph, flucytrinate, hexaconazole, metacrifos, myclobutanil, penconazole, prochloraz, profenofos, resmethrin and bioresmethrin, tridemorph, triadimefon and triadimenol listed in Annex I to the present Directive are added. Article 3 Annex II to Directive 86/363/EEC is amended as follows: (a) in part A maximum pesticide residue levels for abamectin, bifenthrin, bitertanol, bromopropylate, cyromazine, flucytrinate, metacrifos, penconazole, prochloraz, profenofos, resmethrin and bioresmethrin, tridemorph, triadimefon and triadimenol, listed in Annex II to the present Directive are added; (b) in part B the maximum pesticide residue levels for azocyclotin and cyhexatin, fenpropimorph, clofentezine and myclobutanil, listed in Annex III to the present Directive are added. Article 4 Annex II to Directive 90/642/EEC is amended as follows: (a) the maximum pesticide residue levels for abamectin, azocyclotin and cyhexatin, bifenthrin, bitertanol, bromopropylate, clofentezine, cyromazine, fenpropimorph, flucytrinate, hexaconazol, metacrifos, myclobutanil, penconazole, prochloraz, profenofos, resmethrin and bioresmethrin, tridemorph, triadimefon and triadimenol, listed in Annex IV to the present Directive are added; (b) the maximum pesticide residue level for ethion in tea is replaced by 3 mg/kg. Article 5 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 4(b) of the present Directive by 31 December 2002. They shall forthwith inform the Commission thereof. They shall apply these provisions with effect from 1 January 2003. 2. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with of Articles 1, 2 and 3 and Article 4(a) by 31 May 2003. They shall forthwith inform the Commission thereof. They shall apply these provisions with effect from 1 August 2003. 3. When Member States adopt the provisions provided for in paragraphs 1 and 2, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 6 This Directive shall enter into force on the seventh day following that of its publication in the Official Journal of the European Communities. Article 7 This Directive is addressed to the Member States.

32002L0082

2002

Commission Directive 2002/82/EC of 15 October 2002 amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption(1), as amended by Directive 94/34/EC of the European Parliament and of the Council(2) and in particular Article 3(3)(a) thereof, After consulting the Scientific Committee on Food, Whereas: (1) Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners(3), as last amended by Directive 2001/5/EC(4), lists those substances which may be used as additives other than colours and sweeteners in foodstuffs. (2) Commission Directive 96/77/EC(5), as last amended by Directive 2001/30/EC(6) sets out the purity criteria for the additives other than colours and sweeteners mentioned in Directive 95/2/EC. (3) It is necessary to adapt to technical progress existing purity criteria set out in Directive 96/77/EC and to establish new purity criteria for those food additives for which these were failing. (4) It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). (5) Directive 96/77/EC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Annex to Directive 96/77/EC is amended as set out in the Annex to this Directive. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 August 2003 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32002L0033

2002

Directive 2002/33/EC of the European Parliament and of the Council of 21 October 2002 amending Council Directives 90/425/EEC and 92/118/EEC as regards health requirements for animal by-products Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the Economic and Social Committee(2), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Numerous Community acts lay down animal and public health conditions for the processing and disposal of animal waste and for the production, placing on the market, trade and importation of products of animal origin not intended for human consumption. (2) Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down the health rules concerning animal by-products not intended for human consumption(4) has replaced the rules contained in those acts. (3) To take account of those new rules, Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market(5) and Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC(6), should therefore be amended, Article 1 In Directive 90/425/EEC, the seventh indent of section 1 of Chapter I of Annex A shall be replaced by the following: "- Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October laying down the health rules concerning animal by-products not intended for human consumption (OJ L 273, 10.10.2002, p. 1)." Article 2 Directive 92/118/EEC is hereby amended as follows: 1. in Article 2, points (e) and (g) shall be deleted; 2. Article 3 shall be amended as follows: (a) in the first indent, the following words shall be deleted: "together with gelatins not intended for human consumption"; and (b) the second indent shall be replaced by the following: "- any new product of animal origin intended for human consumption whose placing on the market in a Member State is authorised after the date provided for in Article 20 may not be the subject of trade or importation until a decision has been taken in accordance with the first paragraph of Article 15 after evaluation, if appropriate in the light of the opinion of the Scientific Veterinary Committee set up by Decision 81/651/EEC, of the real risk of the spread of serious transmissible diseases which could result from movement of the product, not only for the species from which the product originates but also for other species which could carry the disease, become a focus of disease or a risk to human health,"; 3. in Article 10(2), subparagraph (b) shall be replaced by the following: "(b) unless otherwise specified in Annex II, products must come from establishments on a Community list to be drawn up in accordance with the procedure laid down in Article 18;"; 4. Annex I shall be amended as follows: (a) Chapters 1, 3 and 4 shall be deleted; (b) Chapter 5 shall be amended as follows: (i) in the title, the following words shall be added: "intended for human consumption"; (ii) in part A, the following shall be deleted: "A. where they are intended for human or animal consumption:"; (iii) part B shall be deleted; (c) Chapter 6 shall be amended as follows: (i) in the title, the following words shall be added: "intended for human consumption"; (ii) part I shall be amended as follows: - paragraph A shall be replaced by the following: "A. As regards trade, to the production of the document or certificate provided for in Directive 77/99/EEC, stating that the requirements of that Directive have been complied with;", - in paragraph B(1), point (a) shall be replaced by the following: "a) the products fulfil the requirements of Directive 80/215/EEC;"; (d) in Chapter 7, part II shall be deleted; and (e) Chapters 8, 10 and 12 to 15 shall be deleted. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 30 April 2003. They shall forthwith inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 4 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32002L0085

2002

Directive 2002/85/EC of the European Parliament and of the Council of 5 November 2002 amending Council Directive 92/6/EEC on the installation and use of speed limitation devices for certain categories of motor vehicles in the Community Having regard to the Treaty establishing the European Community, and in particular Article 71 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the Economic and Social Committee(2), Following consultation of the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Transport safety and environmental issues connected with transport are vital in ensuring sustainable mobility. (2) The use of speed limitation devices for heaviest-motor vehicle categories has had a positive effect on the improvement of road safety. It has also contributed to environmental protection. (3) Council Directive 92/6/EEC(4) provides that, depending on technical possibilities and experiences in Member States, the requirements on installation and use of speed limitation devices could subsequently be extended to light goods vehicles. (4) The extension of the scope of Directive 92/6/EEC to vehicles of more than 3,5 tonnes designed for transporting goods or passengers was one of the measures advocated by the Council in its resolution of 26 June 2000 on the improvement of road safety(5), in accordance with the Commission communication of 20 March 2000 on priorities in EU road safety. (5) The scope of Directive 92/6/EEC should be extended to motor vehicles of category M2, to vehicles of category M3 having a maximum mass of more than 5 tonnes but not exceeding 10 tonnes and to vehicles of category N2. (6) Since the objectives of the proposed action, namely the introduction of modifications to the Community-wide arrangements for the installation and use of speed limitation devices on certain heavy vehicle categories, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale or effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary to achieve those objectives. (7) Directive 92/6/EEC should therefore be amended accordingly, Article 1 Directive 92/6/EEC is hereby amended as follows: 1. Articles 1 to 5 shall be replaced by the following: "Article 1 For the purposes of this Directive, 'motor vehicle' means any power-driven vehicle falling within category M2, M3, N2 or N3, intended for use on the road and having at least four wheels and a maximum design speed exceeding 25 km/h. Categories M2, M3, N2 and N3 shall be understood to be those defined in Annex II to Directive 70/156/EEC(6). Article 2 Member States shall take the necessary measures to ensure that motor vehicles of categories M2 and M3 referred to in Article 1 may be used on the road only if equipped with a speed limitation device set in such a way that their speed cannot exceed 100 kilometres per hour. Category M3 vehicles registered before 1 January 2005 with a maximum mass exceeding 10 tonnes may continue to be equipped with devices on which the maximum speed is set at 100 kilometres per hour. Article 3 1. Member States shall take the necessary measures to ensure that motor vehicles of categories N2 and N3 may be used on the road only if equipped with a speed limitation device set in such a way that their speed cannot exceed 90 kilometres per hour. 2. Member States shall be authorised to require that the speed limitation device in vehicles registered in their territory and used exclusively for the transport of dangerous goods is set in such a way that those vehicles cannot exceed a maximum speed of less than 90 kilometres per hour. Article 4 1. For motor vehicles of category M3 having a maximum mass of more than 10 tonnes and motor vehicles of category N3, Articles 2 and 3 shall be applied: (a) to vehicles registered as from 1 January 1994, from 1 January 1994; (b) to vehicles registered between 1 January 1988 and 1 January 1994: (i) from 1 January 1995, in the case of vehicles used for both national and international transport; (ii) from 1 January 1996, in the case of vehicles used exclusively for national transport. 2. For motor vehicles of category M2, vehicles of category M3 having a maximum mass of more than 5 tonnes but not exceeding 10 tonnes and vehicles of category N2, Articles 2 and 3 shall apply at the latest: (a) to vehicles registered as from 1 January 2005; (b) to vehicles complying with the limit values set out in Directive 88/77/EEC(7) registered between 1 October 2001 and 1 January 2005: (i) from 1 January 2006 in the case of vehicles used for both national and international transport operations; (ii) from 1 January 2007 in the case of vehicles used solely for national transport operations. 3. For a period of no more than three years from 1 January 2005, any Member State may exempt from the provisions of Articles 2 and 3 category M2 vehicles and category N2 vehicles with a maximum mass of more than 3,5 tonnes but not exceeding 7,5 tonnes, registered in the national register and not travelling on the territory of another Member State. Article 5 1. The speed limitation devices referred to in Articles 2 and 3 must satisfy the technical requirements laid down in the Annex to Directive 92/24/EEC(8). However, all vehicles covered by this Directive and registered before 1 January 2005 may continue to be equipped with speed limitation devices which satisfy the technical requirements laid down by the competent national authorities. 2. Speed limitation devices shall be installed by workshops or bodies approved by the Member States." 2. The following Article shall be inserted: "Article 6a As part of the road safety action programme for the period 2002 to 2010, the Commission shall assess the road safety and road traffic implications of adjusting the speed limitation devices used by category M2 vehicles and by category N2 vehicles with a maximum mass of 7,5 tonnes or less to the speeds laid down by this Directive. If necessary, the Commission shall submit appropriate proposals." Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2005 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32002L0083

2002

DIRECTIVE 2002/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 November 2002 concerning life assurance Having regard to the Treaty establishing the European Community, and in particular Articles 47(2) and Article 55 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) First Council Directive 79/267/EEC of 5 March 1979 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct life assurance (4), the second Council Directive 90/619/EEC of 8 November 1990 on the coordination of laws, regulations and administrative provisions relating to direct life assurance, laying down provisions to facilitate the effective exercise of freedom to provide services and amending Directive 79/267/EEC (5) and Council Directive 92/96/EEC of 10 November 1992 on the coordination of laws, regulations and administrative provisions relating to direct life assurance and amending Directives 79/267/EEC and 90/619/EEC (third life assurance Directive) (6) have been substantially amended several times. Since further amendments are to be made, the Directives should be recast in the interests of clarity. (2) In order to facilitate the taking-up and pursuit of the business of life assurance, it is essential to eliminate certain divergences which exist between national supervisory legislation. In order to achieve this objective and at the same time ensure adequate protection for policy holders and beneficiaries in all Member States, the provisions relating to the financial guarantees required of life assurance undertakings should be coordinated. (3) It is necessary to complete the internal market in direct life assurance, from the point of view both of the right of establishment and of the freedom to provide services in the Member States, to make it easier for assurance undertakings with head offices in the Community to cover commitments situated within the Community and to make it possible for policy holders to have recourse not only to assurers established in their own country, but also to assurers which have their head office in the Community and are established in other Member States. (4) Under the Treaty, any discrimination with regard to freedom to provide services based on the fact that an undertaking is not established in the Member State in which the services are provided is prohibited. That prohibition applies to services provided from any establishment in the Community, whether it be the head office of an undertaking or an agency or branch. (5) This Directive therefore represents an important step in the merging of national markets into an integrated market and that stage must be supplemented by other Community instruments with a view to enabling all policy holders to have recourse to any assurer with a head office in the Community who carries on business there, under the right of establishment or the freedom to provide services, while guaranteeing them adequate protection. (6) This Directive forms part of the body of Community legislation in the field of life assurance which also includes Council Directive 91/674/EEC of 19 December 1991 on the annual accounts and consolidated accounts of insurance undertakings (7). (7) The approach adopted consists in bringing about such harmonisation as is essential, necessary and sufficient to achieve the mutual recognition of authorisations and prudential control systems, thereby making it possible to grant a single authorisation valid throughout the Community and apply the principle of supervision by the home Member State. (8) As a result, the taking up and the pursuit of the business of assurance are subject to the grant of a single official authorisation issued by the competent authorities of the Member State in which an assurance undertaking has its head office. Such authorisation enables an undertaking to carry on business throughout the Community, under the right of establishment or the freedom to provide services. The Member State of the branch or of the provision of services may not require assurance undertakings which wish to carry on assurance business there and which have already been authorised in their home Member State to seek fresh authorisation. (9) The competent authorities should not authorise or continue the authorisation of an assurance undertaking where they are liable to be prevented from effectively exercising their supervisory functions by the close links between that undertaking and other natural or legal persons. Assurance undertakings already authorised must also satisfy the competent authorities in that respect. (10) The definition of ‘close links’ in this Directive lays down minimum criteria and that does not prevent Member States from applying it to situations other than those envisaged by the definition. (11) The sole fact of having acquired a significant proportion of a company's capital does not constitute participation, within the meaning of ‘close links’, if that holding has been acquired solely as a temporary investment which does not make it possible to exercise influence over the structure or financial policy of the undertaking. (12) The principles of mutual recognition and of home Member State supervision require that Member States' competent authorities should not grant or should withdraw authorisation where factors such as the content of programmes of operations or the geographical distribution of the activities actually carried on indicate clearly that an assurance undertaking has opted for the legal system of one Member State for the purpose of evading the stricter standards in force in another Member State within whose territory it carries on or intends to carry on the greater part of its activities. An assurance undertaking must be authorised in the Member State in which it has its registered office. In addition, Member States must require that an assurance undertaking's head office always be situated in its home Member State and that it actually carries on its business there. (13) For practical reasons, it is desirable to define provision of services taking into account both the assurer's establishment and the place where the commitment is to be covered. Therefore, commitment should also be defined. Moreover, it is desirable to distinguish between activities pursued by way of establishment and activities pursued by way of freedom to provide services. (14) A classification by class of assurance is necessary in order to determine, in particular, the activities subject to compulsory authorisation. (15) Certain mutual associations which, by virtue of their legal status, fulfil requirements as to security and other specific financial guarantees should be excluded from the scope of this Directive. Certain organisations whose activity covers only a very restricted sector and is limited by their articles of association should also be excluded. (16) Life assurance is subject to official authorisation and supervision in each Member State. The conditions for the granting or withdrawal of such authorisation should be defined. Provision must be made for the right to apply to the courts should an authorisation be refused or withdrawn. (17) It is desirable to clarify the powers and means of supervision vested in the competent authorities. It is also desirable to lay down specific provisions regarding the taking up, pursuit and supervision of activity by way of freedom to provide services. (18) The competent authorities of home Member States should be responsible for monitoring the financial health of assurance undertakings, including their state of solvency, the establishment of adequate technical provisions and the covering of those provisions by matching assets. (19) It is appropriate to provide for the possibility of exchanges of information between the competent authorities and authorities or bodies which, by virtue of their function, help to strengthen the stability of the financial system. In order to preserve the confidential nature of the information forwarded, the list of addressees must remain within strict limits. (20) Certain behaviour, such as fraud and insider offences, is liable to affect the stability, including integrity, of the financial system, even when involving undertakings other than assurance undertakings. (21) It is necessary to specify the conditions under which the abovementioned exchanges of information are authorised. (22) Where it is stipulated that information may be disclosed only with the express agreement of the competent authorities, these may, where appropriate, make their agreement subject to compliance with strict conditions. (23) Member States may conclude agreements on exchange of information with third countries provided that the information disclosed is subject to appropriate guarantees of professional secrecy. (24) For the purposes of strengthening the prudential supervision of assurance undertakings and protection of clients of assurance undertakings, it should be stipulated that an auditor must have a duty to report promptly to the competent authorities, wherever, as provided for by this Directive, he/she becomes aware, while carrying out his/her tasks, of certain facts which are liable to have a serious effect on the financial situation or the administrative and accounting organisation of an assurance undertaking. (25) Having regard to the aim in view, it is desirable for Member States to provide that such a duty should apply in all circumstances where such facts are discovered by an auditor during the performance of his/her tasks in an undertaking which has close links with an assurance undertaking. (26) The duty of auditors to communicate, where appropriate, to the competent authorities certain facts and decisions concerning an assurance undertaking which they discover during the performance of their tasks in a non-assurance undertaking does not in itself change the nature of their tasks in that undertaking nor the manner in which they must perform those tasks in that undertaking. (27) The performance of the operations of management of group pension funds cannot under any circumstances affect the powers conferred on the respective authorities with regard to the entities holding the assets with which that management is concerned. (28) Certain provisions of this Directive define minimum standards. A home Member State may lay down stricter rules for assurance undertakings authorised by its own competent authorities. (29) The competent authorities of the Member States must have at their disposal such means of supervision as are necessary to ensure the orderly pursuit of business by assurance undertakings throughout the Community whether carried on under the right of establishment or the freedom to provide services. In particular, they must be able to introduce appropriate safeguards or impose sanctions aimed at preventing irregularities and infringements of the provisions on assurance supervision. (30) The provisions on transfers of portfolios should include provisions specifically concerning the transfer to another undertaking of the portfolio of contracts concluded by way of freedom to provide services. (31) The provisions on transfers of portfolios must be in line with the single legal authorisation system provided for in this Directive. (32) Undertakings formed after the dates referred to in Article 18(3) should not be authorised to carry on life assurance and non-life insurance activities simultaneously. Member States should be allowed to permit undertakings which, on the relevant dates referred to in Article 18(3), carried on these activities simultaneously to continue to do so provided that separate management is adopted for each of their activities, in order that the respective interests of life policy holders and non-life policy holders are safeguarded and the minimum financial obligations in respect of one of the activities are not borne by the other activity. Member States should be given the option of requiring those existing undertakings established in their territory which carry on life assurance and non-life insurance simultaneously to put an end to this practice. Moreover, specialised undertakings should be subject to special supervision where a non-life undertaking belongs to the same financial group as a life undertaking. (33) Nothing in this Directive prevents a composite undertaking from dividing itself into two undertakings, one active in the field of life assurance, the other in non-life insurance. In order to allow such division to take place under the best possible conditions, it is desirable to permit Member States, in accordance with Community rules of competition law, to provide for appropriate tax arrangements, in particular with regard to the capital gains such division could entail. (34) Those Member States which so wish should be able to grant the same undertaking authorisations for the classes referred to in Annex I and the insurance business coming under classes 1 and 2 in the Annex to Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of direct insurance other than life assurance (8). That possibility may, however, be subject to certain conditions as regards compliance with accounting rules and rules on winding-up. (35) It is necessary from the point of view of the protection of lives assured that every assurance undertaking should establish adequate technical provisions. The calculation of such provisions is based for the most part on actuarial principles. Those principles should be coordinated in order to facilitate mutual recognition of the prudential rules applicable in the various Member States. (36) It is desirable, in the interests of prudence, to establish a minimum of coordination of rules limiting the rate of interest used in calculating the technical provisions. For the purposes of such limitation, since existing methods are all equally correct, prudential and equivalent, it seems appropriate to leave Member States a free choice as to the method to be used. (37) The rules governing the calculation of technical provisions and the rules governing the spread, localisation and matching of the assets used to cover technical provisions must be coordinated in order to facilitate the mutual recognition of Member States' rules. That coordination must take account of the liberalisation of capital movements provided for in Article 56 of the Treaty and the progress made by the Community towards economic and monetary union. (38) The home Member State may not require assurance undertakings to invest the assets covering their technical provisions in particular categories of assets, as such a requirement would be incompatible with the liberalisation of capital movements provided for in Article 56 of the Treaty. (39) It is necessary that, over and above technical provisions, including mathematical provisions, of sufficient amount to meet their underwriting liabilities, assurance undertakings should possess a supplementary reserve, known as the solvency margin, represented by free assets and, with the agreement of the competent authority, by other implicit assets, which shall act as a buffer against adverse business fluctuations. This requirement is an important element of prudential supervision for the protection of insured persons and policy holders. In order to ensure that the requirements imposed for such purposes are determined according to objective criteria whereby undertakings of the same size will be placed on an equal footing as regards competition, it is desirable to provide that this margin shall be related to all the commitments of the undertaking and to the nature and gravity of the risks presented by the various activities falling within the scope of this Directive. This margin should therefore vary according to whether the risks are of investment, death or management only. It should accordingly be determined in terms of mathematical provisions and capital at risk underwritten by an undertaking, of premiums or contributions received, of provisions only or of the assets of tontines. (40) Directive 92/96/EEC provided for a provisional definition of a regulated market, pending the adoption of a directive on investment services in the securities field, which would harmonise that concept at Community level. Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field (9) provides for a definition of regulated market, although it excludes from its scope life assurance activities. It is appropriate to apply the concept of regulated market also to life assurance activities. (41) The list of items of which the solvency margin required by this Directive may be made up takes account of new financial instruments and of the facilities granted to other financial institutions for the constitution of their own funds. In the light of market developments in the nature of reinsurance cover purchased by primary insurers, there is a need for the competent authorities to be empowered to decrease the reduction to the solvency margin requirement in certain circumstances. In order to improve the quality of the solvency margin, the possibility of including future profits in the available solvency margin should be limited and subject to conditions and should in any case cease after 2009. (42) It is necessary to require a guarantee fund, the amount and composition of which are such as to provide an assurance that the undertakings possess adequate resources when they are set up and that in the subsequent course of business the solvency margin in no event falls below a minimum of security. The whole or a specified part of this guarantee fund must consist of explicit asset items. (43) To avoid major and sharp increases in the amount of the minimum guarantee fund in the future, a mechanism should be established providing for its increase in line with the European index of consumer prices. This Directive should lay down minimum standards for the solvency margin requirements and home Member States should be able to lay down stricter rules for insurance undertakings authorised by their own competent authorities. (44) The provisions in force in the Member States regarding contract law applicable to the activities referred to in this Directive differ. The harmonisation of assurance contract law is not a prior condition for the achievement of the internal market in assurance. Therefore, the opportunity afforded to the Member States of imposing the application of their law to assurance contracts covering commitments within their territories is likely to provide adequate safeguards for policy holders. The freedom to choose, as the law applicable to the contract, a law other than that of the State of the commitment may be granted in certain cases, in accordance with rules which take into account specific circumstances. (45) For life assurance contracts the policy holder should be given the opportunity of cancelling the contract within a period of between 14 and 30 days. (46) Within the framework of an internal market it is in the policy holder's interest that they should have access to the widest possible range of assurance products available in the Community so that they can choose that which is best suited to their needs. It is for the Member State of the commitment to ensure that there is nothing to prevent the marketing within its territory of all the assurance products offered for sale in the Community as long as they do not conflict with the legal provisions protecting the general good in force in the Member State of the commitment and in so far as the general good is not safeguarded by the rules of the home Member State, provided that such provisions must be applied without discrimination to all undertakings operating in that Member State and be objectively necessary and in proportion to the objective pursued. (47) The Member States must be able to ensure that the assurance products and contract documents used, under the right of establishment or the freedom to provide services, to cover commitments within their territories comply with such specific legal provisions protecting the general good as are applicable. The systems of supervision to be employed must meet the requirements of an internal market but their employment may not constitute a prior condition for carrying on assurance business. From this standpoint, systems for the prior approval of policy conditions do not appear to be justified. It is therefore necessary to provide for other systems better suited to the requirements of an internal market which enable every Member State to guarantee policy holders adequate protection. (48) It is necessary to make provision for cooperation between the competent authorities of the Member States and between those authorities and the Commission. (49) Provision should be made for a system of penalties to be imposed when, in the Member State in which the commitment is entered into, an assurance undertaking does not comply with those provisions protecting the general good that are applicable to it. (50) It is necessary to provide for measures in cases where the financial position of the undertaking becomes such that it is difficult for it to meet its underwriting liabilities. In specific situations where policy holders' rights are threatened, there is a need for the competent authorities to be empowered to intervene at a sufficiently early stage, but in the exercise of those powers, competent authorities should inform the insurance undertakings of the reasons motivating such supervisory action, in accordance with the principles of sound administration and due process. As long as such a situation exists, the competent authorities should be prevented from certifying that the insurance undertaking has a sufficient solvency margin. (51) For the purposes of implementing actuarial principles in conformity with this Directive, the home Member State may require systematic notification of the technical bases used for calculating scales of premiums and technical provisions, with such notification of technical bases excluding notification of the general and special policy conditions and the undertaking's commercial rates. (52) In an internal market for assurance the consumer will have a wider and more varied choice of contracts. If he/she is to profit fully from this diversity and from increased competition, he/she must be provided with whatever information is necessary to enable him/her to choose the contract best suited to his/her needs. This information requirement is all the more important as the duration of commitments can be very long. The minimum provisions must therefore be coordinated in order for the consumer to receive clear and accurate information on the essential characteristics of the products proposed to him/her as well as the particulars of the bodies to which any complaints of policy holders, assured persons or beneficiaries of contracts may be addressed. (53) Publicity for assurance products is an essential means of enabling assurance business to be carried on effectively within the Community. It is necessary to leave open to assurance undertakings the use of all normal means of advertising in the Member State of the branch or of provision of services. Member States may nevertheless require compliance with their national rules on the form and content of advertising, whether laid down pursuant to Community legislation on advertising or adopted by Member States for reasons of the general good. (54) Within the framework of the internal market, no Member State may continue to prohibit the simultaneous carrying on of assurance business within its territory under the right of establishment and the freedom to provide services. (55) Some Member States do not subject assurance transactions to any form of indirect taxation, while the majority apply special taxes and other forms of contribution. The structures and rates of such taxes and contributions vary considerably between the Member States in which they are applied. It is desirable to prevent existing differences leading to distortions of competition in assurance services between Member States. Pending subsequent harmonisation, application of the tax systems and other forms of contribution provided for by the Member States in which commitments entered into are likely to remedy that problem and it is for the Member States to make arrangements to ensure that such taxes and contributions are collected. (56) It is important to introduce Community coordination on the winding-up of assurance undertakings. It is henceforth essential to provide, in the event of the winding-up of an assurance undertaking, that the system of protection in place in each Member State must guarantee equality of treatment for all assurance creditors, irrespective of nationality and of the method of entering into the commitment. (57) The coordinated rules concerning the pursuit of the business of direct insurance within the Community should, in principle, apply to all undertakings operating on the market and, consequently, also to agencies and branches where the head office of the undertaking is situated outside the Community. As regards the methods of supervision this Directive lays down special provisions for such agencies or branches, in view of the fact that the assets of the undertakings to which they belong are situated outside the Community. (58) It is desirable to provide for the conclusion of reciprocal agreements with one or more third countries in order to permit the relaxation of such special conditions, while observing the principle that such agencies and branches should not obtain more favourable treatment than Community undertakings. (59) A provision should be made for a flexible procedure to make it possible to assess reciprocity with third countries on a Community basis. The aim of this procedure is not to close the Community's financial markets but rather, as the Community intends to keep its financial markets open to the rest of the world, to improve the liberalisation of the global financial markets in other third countries. To that end, this Directive provides for procedures for negotiating with third countries. As a last resort, the possibility of taking measures involving the suspension of new applications for authorisation or the restriction of new authorisations should be provided for using the regulatory procedure under Article 5 of Council Decision 1999/468/EC (10). (60) This Directive should establish provisions concerning proof of good repute and no previous bankruptcy. (61) In order to clarify the legal regime applicable to life assurance activities covered by this Directive, some provisions of Directives 79/267/EEC, 90/619/EEC and 92/96/EEC should be adapted. For that purpose some provisions concerning the establishment of the solvency margin and the rights acquired by branches of assurance undertakings established before 1 July 1994 should be amended. The content of the scheme of operation of branches of third-country undertakings to be established in the Community should also be defined. (62) Technical adjustments to the detailed rules laid down in this Directive may be necessary from time to time to take account of the future development of the assurance industry. The Commission will make such adjustments as and when necessary, after consulting the Insurance Committee set up by Council Directive 91/675/EEC (11), in the exercise of the implementing powers conferred on it by the Treaty. These measures being measures of general scope within the meaning of Article 2 of Decision 1999/468/EC, they should be adopted by the use of the regulatory procedure provided for in Article 5 of that Decision. (63) Pursuant to Article 15 of the Treaty, account should be taken of the extent of the effort which must be made by certain economies at different stages of development. Therefore, transitional arrangements should be adopted for the gradual application of this Directive by certain Member States. (64) Directives 79/267/EEC and 90/619/EEC granted special derogation with regard to some undertakings existing at the time of the adoption of these Directives. Such undertakings have thereafter modified their structure. Therefore they do not need any longer such special derogation. (65) This Directive should not affect the obligations of Member States concerning the deadlines for transposition and for application of the Directives set out in Annex V(B), TITLE I DEFINITIONS AND SCOPE 10 Article 1 Definitions 10 Article 2 Scope 11 Article 3 Activities and bodies excluded 11 TITLE II THE TAKING-UP OF THE BUSINESS OF LIFE ASSURANCE 12 Article 4 Principle of authorisation 12 Article 5 Scope of authorisation 12 Article 6 Conditions for obtaining authorisation 12 Article 7 Scheme of operations 13 Article 8 Shareholders and members with qualifying holdings 14 Article 9 Refusal of authorisation 14 TITLE III CONDITIONS GOVERNING THE BUSINESS OF ASSURANCE 14 Chapter 1 Principles and methods of financial supervision 14 Article 10 Competent authorities and object of supervision 14 Article 11 Supervision of branches established in another Member State 14 Article 12 Prohibition on compulsory ceding of part of underwriting 14 Article 13 Accounting, prudential and statistical information: supervisory powers 14 Article 14 Transfer of portfolio 15 Article 15 Qualifying holdings 15 Article 16 Professional secrecy 16 Article 17 Duties of auditors 18 Article 18 Pursuit of life assurance and non-life insurance activities 18 Article 19 Separation of life assurance and non-life insurance management 19 Chapter 2 Rules relating to technical provisions and their representation 19 Article 20 Establishment of technical provisions 19 Article 21 Premiums for new business 21 Article 22 Assets covering technical provisions 21 Article 23 Categories of authorised assets 21 Article 24 Rules for investment diversification 22 Article 25 Contracts linked to UCITS or share index 23 Article 26 Matching rules 24 Chapter 3 Rules relating to the solvency margin and to the guarantee fund 24 Article 27 Available solvency margin 24 Article 28 Required solvency margin 25 Article 29 Guarantee fund 26 Article 30 Review of the amount of the guarantee fund 26 Article 31 Assets not used to cover technical provisions 26 Chapter 4 Contract law and conditions of assurance 27 Article 32 Law applicable 27 Article 33 General good 27 Article 34 Rules relating to conditions of assurance and scales of premiums 27 Article 35 Cancellation period 27 Article 36 Information for policy holders 27 Chapter 5 Assurance undertakings in difficulty or in an irregular situation 28 Article 37 Assurance undertakings in difficulty 28 Article 38 Financial recovery plan 28 Article 39 Withdrawal of authorisation 29 TITLE IV PROVISIONS RELATING TO RIGHT OF ESTABLISHMENT AND FREEDOM TO PROVIDE SERVICES 29 Article 40 Conditions for branch establishment 29 Article 41 Freedom to provide services: prior notification to the home Member State 30 Article 42 Freedom to provide services: notification by the home Member State 30 Article 43 Freedom to provide services: changes in the nature of commitments 30 Article 44 Language 30 Article 45 Rules relating to conditions of assurance and scales of premiums 30 Article 46 Assurance undertakings not complying with the legal provisions 30 Article 47 Advertising 31 Article 48 Winding up 31 Article 49 Statistical information on cross-border activities 31 Article 50 Taxes on premiums 31 TITLE V RULES APPLICABLE TO AGENCIES OR BRANCHES ESTABLISHED WITHIN THE COMMUNITY AND BELONGING TO UNDERTAKINGS WHOSE HEAD OFFICES ARE OUTSIDE THE COMMUNITY 32 Article 51 Principles and conditions of authorisation 32 Article 52 Rules applicable to branches of third country undertakings 32 Article 53 Transfer of portfolio 33 Article 54 Technical provisions 33 Article 55 Solvency margin and guarantee fund 33 Article 56 Advantages to undertakings authorised in more than one Member State 34 Article 57 Agreements with third countries 34 TITLE VI RULES APPLICABLE TO SUBSIDIARIES OF PARENT UNDERTAKINGS GOVERNED BY THE LAWS OF A THIRD COUNTRY AND TO THE ACQUISITIONS OF HOLDINGS BY SUCH PARENT UNDERTAKINGS 34 Article 58 Information from Member States to the Commission 34 Article 59 Third-country treatment of Community assurance undertakings 34 TITLE VII TRANSITIONAL AND OTHER PROVISIONS 35 Article 60 Derogations and abolition of restrictive measures 35 Article 61 Proof of good repute 35 TITLE VIII FINAL PROVISIONS 36 Article 62 Cooperation between the Member States and the Commission 36 Article 63 Reports on the development of the market under the freedom to provide services 36 Article 64 Technical adjustment 36 Article 65 Committee procedure 36 Article 66 Rights acquired by existing branches and assurance undertakings 36 Article 67 Right to apply to the courts 37 Article 68 Review of amounts expressed in euro 37 Article 69 Implementation of new provisions 37 Article 70 Information to the Commission 37 Article 71 Transitional period for Articles 3(6), 27, 28, 29, 30 and 38 37 Article 72 Repealed directives and their correlation with this Directive 37 Article 73 Entry into force 38 Article 74 Addressees 38 Annex I Classes of assurance 39 Annex II Matching rules 39 Annex III Information for policy holders 40 Annex IV 41 Annex V 45 Part A Repealed directives together with their successive amendments (referred to in Article 72) 45 Part B Deadlines for implementation (referred to in Article 72) 45 Annex VI Correlation table 46 TITLE I DEFINITIONS AND SCOPE Article 1 Definitions 1. For the purposes of this Directive: (a) ‘assurance undertaking’ shall mean an undertaking which has received official authorisation in accordance with Article 4; (b) ‘branch’ shall mean an agency or branch of an assurance undertaking; Any permanent presence of an undertaking in the territory of a Member State shall be treated in the same way as an agency or branch, even if that presence does not take the form of a branch or agency, but consists merely of an office managed by the undertaking's own staff or by a person who is independent but has permanent authority to act for the undertaking as an agency would; (c) ‘establishment’ shall mean the head office, an agency or a branch of an undertaking; (d) ‘commitment’ shall mean a commitment represented by one of the kinds of insurance or operations referred to in Article 2; (e) ‘home Member State’ shall mean the Member State in which the head office of the assurance undertaking covering the commitment is situated; (f) ‘Member State of the branch’ shall mean the Member State in which the branch covering the commitment is situated; (g) ‘Member State of the commitment’ shall mean the Member State where the policy holder has his/her habitual residence or, if the policy holder is a legal person, the Member State where the latter's establishment, to which the contract relates, is situated; (h) ‘Member State of the provision of services’ shall mean the Member State of the commitment, if the commitment is covered by an assurance undertaking or a branch situated in another Member State; (i) ‘control’ shall mean the relationship between a parent undertaking and a subsidiary, as defined in Article 1 of Council Directive 83/349/EEC (12), or a similar relationship between any natural or legal person and an undertaking; (j) ‘qualifying holding’ shall mean a direct or indirect holding in an undertaking which represents 10 % or more of the capital or of the voting rights or which makes it possible to exercise a significant influence over the management of the undertaking in which a holding subsists; For the purposes of this definition, in the context of Articles 8 and 15 and of the other levels of holding referred to in Article 15, the voting rights referred to in Article 92 of Directive 2001/34/EC of the European Parliament and of the Council of 28 May 2001 on the admission of securities to official stock exchange listing and on information to be published on those securities (13) shall be taken into consideration; (k) ‘parent undertaking’ shall mean a parent undertaking as defined in Articles 1 and 2 of Directive 83/349/EEC; (l) ‘subsidiary’ shall mean a subsidiary undertaking as defined in Articles 1 and 2 of Directive 83/349/EEC; any subsidiary of a subsidiary undertaking shall also be regarded as a subsidiary of the undertaking which is those undertakings' ultimate parent undertaking; (m) ‘regulated market’ shall mean: — in the case of a market situated in a Member State, a regulated market as defined in Article 1(13) of Directive 93/22/EEC, and — in the case of a market situated in a third country, a financial market recognised by the home Member State of the assurance undertaking which meets comparable requirements. Any financial instruments dealt in on that market must be of a quality comparable to that of the instruments dealt in on the regulated market or markets of the Member State in question; (n) ‘competent authorities’ shall mean the national authorities which are empowered by law or regulation to supervise assurance undertakings; (o) ‘matching assets’ shall mean the representation of underwriting liabilities which can be required to be met in a particular currency by assets expressed or realisable in the same currency; (p) ‘localisation of assets’ shall mean the existence of assets, whether movable or immovable, within a Member State but shall not be construed as involving a requirement that movable assets be deposited or that immovable assets be subjected to restrictive measures such as the registration of mortgages; assets represented by claims against debtors shall be regarded as situated in the Member State where they are realisable; (q) capital at risk shall mean the amount payable on death less the mathematical provision for the main risk; (r) ‘close’ links shall mean a situation in which two or more natural or legal persons are linked by: (i) participation, which shall mean the ownership, direct or by way of control, of 20 % or more of the voting rights or capital of an undertaking; or (ii) control, which shall mean the relationship between a parent undertaking and a subsidiary, in all the cases referred to in Article 1(1) and (2) of Directive 83/349/EEC, or a similar relationship between any natural or legal person and an undertaking; any subsidiary undertaking of a subsidiary undertaking shall also be considered a subsidiary of the parent undertaking which is at the head of those undertakings. A situation in which two or more natural or legal persons are permanently linked to one and the same person by a control relationship shall also be regarded as constituting a close link between such persons. 2. Wherever this Directive refers to the euro, the conversion value in national currency to be adopted shall as from 31 December of each year be that of the last day of the preceding month of October for which euro conversion values are available in all the relevant Community currencies. Article 2 Scope This Directive concerns the taking-up and pursuit of the self-employed activity of direct insurance carried on by undertakings which are established in a Member State or wish to become established there in the form of the activities defined below: 1. the following kinds of assurance where they are on a contractual basis: (a) life assurance, that is to say, the class of assurance which comprises, in particular, assurance on survival to a stipulated age only, assurance on death only, assurance on survival to a stipulated age or on earlier death, life assurance with return of premiums, marriage assurance, birth assurance; (b) annuities; (c) supplementary insurance carried on by life assurance undertakings, that is to say, in particular, insurance against personal injury including incapacity for employment, insurance against death resulting from an accident and insurance against disability resulting from an accident or sickness, where these various kinds of insurance are underwritten in addition to life assurance; (d) the type of insurance existing in Ireland and the United Kingdom known as permanent health insurance not subject to cancellation; 2. the following operations, where they are on a contractual basis, in so far as they are subject to supervision by the administrative authorities responsible for the supervision of private insurance: (a) tontines whereby associations of subscribers are set up with a view to jointly capitalising their contributions and subsequently distributing the assets thus accumulated among the survivors or among the beneficiaries of the deceased; (b) capital redemption operations based on actuarial calculation whereby, in return for single or periodic payments agreed in advance, commitments of specified duration and amount are undertaken; (c) management of group pension funds, i.e. operations consisting, for the undertaking concerned, in managing the investments, and in particular the assets representing the reserves of bodies that effect payments on death or survival or in the event of discontinuance or curtailment of activity; (d) the operations referred to in (c) where they are accompanied by insurance covering either conservation of capital or payment of a minimum interest; (e) the operations carried out by assurance undertakings such as those referred to in Chapter 1, Title 4 of Book IV of the French ‘Code des assurances’. 3. Operations relating to the length of human life which are prescribed by or provided for in social insurance legislation, when they are effected or managed at their own risk by assurance undertakings in accordance with the laws of a Member State. Article 3 Activities and bodies excluded This Directive shall not concern: 1. subject to the application of Article 2(1)(c), the classes designated in the Annex to Directive 73/239/EEC; 2. operations of provident and mutual-benefit institutions whose benefits vary according to the resources available and which require each of their members to contribute at the appropriate flat rate; 3. operations carried out by organisations other than undertakings referred to in Article 2, whose object is to provide benefits for employed or self-employed persons belonging to an undertaking or group of undertakings, or a trade or group of trades, in the event of death or survival or of discontinuance or curtailment of activity, whether or not the commitments arising from such operations are fully covered at all times by mathematical provisions; 4. subject to the application of Article 2(3), insurance forming part of a statutory system of social security; 5. organisations which undertake to provide benefits solely in the event of death, where the amount of such benefits does not exceed the average funeral costs for a single death or where the benefits are provided in kind; 6. mutual associations, where: — the articles of association contain provisions for calling up additional contributions or reducing their benefits or claiming assistance from other persons who have undertaken to provide it, and — the annual contribution income for the activities covered by this Directive does not exceed EUR 5 million for three consecutive years. If this amount is exceeded for three consecutive years this Directive shall apply with effect from the fourth year. Nevertheless, the provisions of this paragraph shall not prevent a mutual assurance undertaking from applying, or continuing, to be licensed under this Directive; 7. the ‘Versorgungsverband deutscher Wirtschaftsorganisationen’ in Germany unless its statutes are amended as regards the scope of its activities; 8. the pension activities of pension insurance undertakings prescribed in the Employees. Pension Act (TEL) and other related Finnish legislation provided that: (a) pension insurance companies which already under Finnish law are obliged to have separate accounting and management systems for their pension activities will furthermore, as from the date of accession, set up separate legal entities for carrying out these activities; (b) the Finnish authorities shall allow in a non-discriminatory manner all nationals and companies of Member States to perform according to Finnish legislation the activities specified in Article 2 related to this exemption whether by means of: — ownership or participation in an existing insurance company or group, — creation or participation of new insurance companies or groups, including pension insurance companies; (c) the Finnish authorities will submit to the Commission for approval a report within three months from the date of accession, stating which measures have been taken to separate TEL activities from normal insurance activities carried out by Finnish insurance companies in order to conform to all the requirements of this Directive. TITLE II THE TAKING UP OF THE BUSINESS OF LIFE ASSURANCE Article 4 Principle of authorisation The taking up of the activities covered by this Directive shall be subject to prior official authorisation. Such authorisation shall be sought from the authorities of the home Member State by: (a) any undertaking which establishes its head office in the territory of that State; (b) any undertaking which, having received the authorisation required in the first subparagraph, extends its business to an entire class or to other classes. Article 5 Scope of authorisation 1. Authorisation shall be valid for the entire Community. It shall permit an assurance undertaking to carry on business there, under either the right of establishment or freedom to provide services. 2. Authorisation shall be granted for a particular class of assurance as listed in Annex I. It shall cover the entire class, unless the applicant wishes to cover only some of the risks pertaining to that class. The competent authorities may restrict authorisation requested for one of the classes to the operations set out in the scheme of operations referred to in Article 7. Each Member State may grant authorisation for two or more of the classes, where its national laws permit such classes to be carried on simultaneously. Article 6 Conditions for obtaining authorisation 1. The home Member State shall require every assurance undertaking for which authorisation is sought to: (a) adopt one of the following forms: — in the case of the Kingdom of Belgium: ‘société anonyme/naamloze vennootschap’, ‘société en commandite par actions/commanditaire vennootschap op aandelen’, ‘association d'assurance mutuelle/onderlinge verzekeringsvereniging’, ‘société coopérative/coöperatieve vennootschap’, — in the case of the Kingdom of Denmark: ‘aktieselskaber’, ‘gensidige selskaber’, ‘pensionskasser omfattet af lov om forsikringsvirksomhed (tværgående pensionskasser)’, — in the case of the Federal Republic of Germany: ‘Aktiengesellschaft’, ‘Versicherungsverein auf Gegenseitigkeit’, ‘öffentlich-rechtliches Wettbewerbsversicherungsunternehmen’, — in the case of the French Republic: ‘société anonyme’, ‘société d'assurance mutuelle’, ‘institution de prévoyance régie par le code de la sécurité sociale’, ‘institution de prévoyance régie par le code rural’ and ‘mutuelles régies par le code de la mutualité’, — in the case of Ireland: ‘incorporated companies limited by shares or by guarantee or unlimited’, ‘societies registered under the Industrial and Provident Societies Acts’ and ‘societies registered under the Friendly Societies Acts,’ — in the case of the Italian Republic: ‘societá per azioni’, ‘societá cooperativa’, ‘mutua di assicurazione’, — in the case of the Grand Duchy of Luxembourg: ‘société anonyme’, ‘société en commandite par actions’, ‘association d'assurances mutuelles’, ‘société coopérative’, — in the case of the Kingdom of the Netherlands: ‘naamloze vennootschap’, ‘onderlinge waarborgmaatschappij’, — in the case of the United Kingdom: ‘incorporated companies limited by shares or by guarantee or unlimited’, ‘societies registered under the Industrial and Provident Societies Acts’, ‘societies registered or incorporated under the Friendly Societies Acts’, ‘the association of underwriters known as Lloyd's’, — in the case of the Hellenic Republic: ‘ανώνυμη εταιρία’, — in the case of the Kingdom of Spain: ‘sociedad anónima’, ‘sociedad mutua’, ‘sociedad cooperativa’, — in the case of the Portuguese Republic: ‘sociedade anónima’, ‘mútua de seguros’, — in the case of the Republic of Austria: ‘Aktiengesellschaft’, ‘Versicherungsverein auf Gegenseitigkeit’, — in the case of the Republic of Finland: ‘keskinäinen vakuutusyhtiö/ömsesidigt försäkringsbolag’, ‘vakuutusosakeyhtiö/försäkringsaktiebolag’, ‘vakuutusyhdistys/försäkringsförening’, — in the case of Kingdom of Sweden: ‘försäkringsaktiebolag’, ‘ömsesidiga försäkringsbolag’, ‘understödsföreningar’. An assurance undertaking may also adopt the form of a European company when that has been established. Furthermore, Member States may, where appropriate, set up undertakings in any public-law form provided that such bodies have as their object insurance operations under conditions equivalent to those under which private-law undertakings operate; (b) limit its objects to the business provided for in this Directive and operations directly arising therefrom, to the exclusion of all other commercial business; (c) submit a scheme of operations in accordance with Article 7; (d) possess the minimum guarantee fund provided for in Article 29(2); (e) be effectively run by persons of good repute with appropriate professional qualifications or experience. 2. Where close links exist between the assurance undertaking and other natural or legal persons, the competent authorities shall grant authorisation only if those links do not prevent the effective exercise of their supervisory functions. The competent authorities shall also refuse authorisation if the laws, regulations or administrative provisions of a non-member country governing one or more natural or legal persons with which the assurance undertaking has close links, or difficulties involved in their enforcement, prevent the effective exercise of their supervisory functions. The competent authorities shall require assurance undertakings to provide them with the information they require to monitor compliance with the conditions referred to in this paragraph on a continuous basis. 3. Member States shall require that the head offices of insurance undertakings be situated in the same Member State as their registered offices. 4. An assurance undertaking seeking authorisation to extend its business to other classes or to extend an authorisation covering only some of the risks pertaining to one class shall be required to submit a scheme of operations in accordance with Article 7. It shall, furthermore, be required to show proof that it possesses the solvency margin provided for in Article 28 and the guarantee fund referred to in Article 29(1) and (2). 5. Member States shall not adopt provisions requiring the prior approval or systematic notification of general and special policy conditions, of scales of premiums, of the technical bases, used in particular for calculating scales of premiums and technical provisions or of forms and other printed documents which an assurance undertaking intends to use in its dealings with policy holders. Notwithstanding the first subparagraph, for the sole purpose of verifying compliance with national provisions concerning actuarial principles, the home Member State may require systematic notification of the technical bases used for calculating scales of premiums and technical provisions, without that requirement constituting a prior condition for an assurance undertaking to carry on its business. Nothing in this Directive shall prevent Member States from maintaining in force or introducing laws, regulations or administrative provisions requiring approval of the memorandum and articles of association and the communication of any other documents necessary for the normal exercise of supervision. Not later than 1 July 1999, the Commission shall submit a report to the Council on the implementation of this paragraph. 6. The provisions referred to in paragraphs 1 to 5 may not require that any application for authorisation be considered in the light of the economic requirements of the market. Article 7 Scheme of operations The scheme of operations referred to in Article 6(1)(c) and (4) shall include particulars or evidence of: (a) the nature of the commitments which the assurance undertaking proposes to cover; (b) the guiding principles as to reassurance; (c) the items constituting the minimum guarantee fund; (d) estimates relating to the costs of setting up the administrative services and the organisation for securing business and the financial resources intended to meet those costs; in addition, for the first three financial years: (e) a plan setting out detailed estimates of income and expenditure in respect of direct business, reassurance acceptances and reassurance cessions; (f) a forecast balance sheet; (g) estimates relating to the financial resources intended to cover underwriting liabilities and the solvency margin. Article 8 Shareholders and members with qualifying holdings The competent authorities of the home Member State shall not grant an undertaking authorisation to take up the business of assurance before they have been informed of the identities of the shareholders or members, direct or indirect, whether natural or legal persons, who have qualifying holdings in that undertaking and of the amounts of those holdings. The same authorities shall refuse authorisation if, taking into account the need to ensure the sound and prudent management of an assurance undertaking, they are not satisfied as to the qualifications of the shareholders or members. Article 9 Refusal of authorisation Any decision to refuse an authorisation shall be accompanied by the precise grounds for doing so and notified to the undertaking in question. Each Member State shall make provision for a right to apply to the courts should there be any refusal. Such provision shall also be made with regard to cases where the competent authorities have not dealt with an application for an authorisation upon the expiry of a period of six months from the date of its receipt. TITLE III CONDITIONS GOVERNING THE BUSINESS OF ASSURANCE CHAPTER 1 PRINCIPLES AND METHODS OF FINANCIAL SUPERVISION Article 10 Competent authorities and object of supervision 1. The financial supervision of an assurance undertaking, including that of the business it carries on either through branches or under the freedom to provide services, shall be the sole responsibility of the home Member State. If the competent authorities of the Member State of the commitment have reason to consider that the activities of an assurance undertaking might affect its financial soundness, they shall inform the competent authorities of the undertaking's home Member State. The latter authorities shall determine whether the undertaking is complying with the prudential principles laid down in this Directive. 2. That financial supervision shall include verification, with respect to the assurance undertaking's entire business, of its state of solvency, the establishment of technical provisions, including mathematical provisions, and of the assets covering them, in accordance with the rules laid down or practices followed in the home Member State pursuant to the provisions adopted at Community level. 3. The competent authorities of the home Member State shall require every assurance undertaking to have sound administrative and accounting procedures and adequate internal control mechanisms. Article 11 Supervision of branches established in another Member State The Member State of the branch shall provide that, where an assurance undertaking authorised in another Member State carries on business through a branch, the competent authorities of the home Member State may, after having first informed the competent authorities of the Member State of the branch, carry out themselves, or through the intermediary of persons they appoint for that purpose, on-the-spot verification of the information necessary to ensure the financial supervision of the undertaking. The authorities of the Member State of the branch may participate in that verification. Article 12 Prohibition on compulsory ceding of part of underwriting Member States may not require assurance undertakings to cede part of their underwriting of activities listed in Article 2 to an organisation or organisations designated by national regulations. Article 13 Accounting, prudential and statistical information: supervisory powers 1. Each Member State shall require every assurance undertaking whose head office is situated in its territory to produce an annual account, covering all types of operation, of its financial situation and solvency. 2. Member States shall require assurance undertakings with head offices within their territories to render periodically the returns, together with statistical documents, which are necessary for the purposes of supervision. The competent authorities shall provide each other with any documents and information that are useful for the purposes of supervision. 3. Every Member State shall take all steps necessary to ensure that the competent authorities have the powers and means necessary for the supervision of the business of assurance undertakings with head offices within their territories, including business carried on outside those territories, in accordance with the Council directives governing those activities and for the purpose of seeing that they are implemented. These powers and means must, in particular, enable the competent authorities to: (a) make detailed enquiries regarding the assurance undertaking's situation and the whole of its business, inter alia, by: — gathering information or requiring the submission of documents concerning its assurance business, — carrying out on-the-spot investigations at the assurance undertaking's premises; (b) take any measures, with regard to the assurance undertaking, its directors or managers or the persons who control it, that are appropriate and necessary to ensure that the undertaking's business continues to comply with the laws, regulations and administrative provisions with which the undertaking must comply in each Member State and in particular with the scheme of operations in so far as it remains mandatory, and to prevent or remedy any irregularities prejudicial to the interests of the assured persons; (c) ensure that those measures are carried out, if need be by enforcement, where appropriate through judicial channels. Member States may also make provision for the competent authorities to obtain any information regarding contracts which are held by intermediaries. Article 14 Transfer of portfolio 1. Under the conditions laid down by national law, each Member State shall authorise assurance undertakings with head offices within its territory to transfer all or part of their portfolios of contracts, concluded under either the right of establishment or the freedom to provide services, to an accepting office established within the Community, if the competent authorities of the home Member State of the accepting office certify that after taking the transfer into account, the latter possesses the necessary solvency margin. 2. Where a branch proposes to transfer all or part of its portfolio of contracts, concluded under either the right of establishment or the freedom to provide services, the Member State of the branch shall be consulted. 3. In the circumstances referred to in paragraphs 1 and 2, the authorities of the home Member State of the transferring assurance undertaking shall authorise the transfer after obtaining the agreement of the competent authorities of the Member States of the commitment. 4. The competent authorities of the Member States consulted shall give their opinion or consent to the competent authorities of the home Member State of the transferring assurance undertaking within three months of receiving a request; the absence of any response within that period from the authorities consulted shall be considered equivalent to a favourable opinion or tacit consent. 5. A transfer authorised in accordance with this Article shall be published as laid down by national law in the Member State of the commitment. Such transfers shall automatically be valid against policy holders, the assured persons and any other person having rights or obligations arising out of the contracts transferred. This provision shall not affect the Member States' rights to give policy holders the option of cancelling contracts within a fixed period after a transfer. Article 15 Qualifying holdings 1. Member States shall require any natural or legal person who proposes to hold, directly or indirectly, a qualifying holding in an assurance undertaking first to inform the competent authorities of the home Member State, indicating the size of the intended holding. Such a person must likewise inform the competent authorities of the home Member State if he/she proposes to increase his/her qualifying holding so that the proportion of the voting rights or of the capital held by him/her would reach or exceed 20 %, 33 % or 50 % or so that the assurance undertaking would become his/her subsidiary. The competent authorities of the home Member State shall have a maximum of three months from the date of the notification provided for in the first subparagraph to oppose such a plan if, in view of the need to ensure sound and prudent management of the assurance undertaking, they are not satisfied as to the qualifications of the person referred to in the first subparagraph. If they do not oppose the plan in question they may fix a maximum period for its implementation. 2. Member States shall require any natural or legal person who proposes to dispose, directly or indirectly, of a qualifying holding in an assurance undertaking first to inform the competent authorities of the home Member State, indicating the size of his/her intended holding. Such a person must likewise inform the competent authorities if he/she proposes to reduce his/her qualifying holding so that the proportion of the voting rights or of the capital held by him/her would fall below 20 %, 33 % or 50 % or so that the assurance undertaking would cease to be his/her subsidiary. 3. On becoming aware of them, assurance undertakings shall inform the competent authorities of their home Member States of any acquisitions or disposals of holdings in their capital that cause holdings to exceed or fall below one of the thresholds referred to in paragraphs 1 and 2. They shall also, at least once a year, inform them of the names of shareholders and members possessing qualifying holdings and the sizes of such holdings as shown, for example, by the information received at the annual general meetings of shareholders and members or as a result of compliance with the regulations relating to companies listed on stock exchanges. 4. Member States shall require that, if the influence exercised by the persons referred to in paragraph 1 is likely to operate to the detriment of the prudent and sound management of the assurance undertaking, the competent authorities of the home Member State shall take appropriate measures to put an end to that situation. Such measures may consist, for example, in injunctions, sanctions against directors and managers, or the suspension of the exercise of the voting rights attaching to the shares held by the shareholders or members in question. Similar measures shall apply to natural or legal persons failing to comply with the obligation to provide prior information, as laid down in paragraph 1. If a holding is acquired despite the opposition of the competent authorities, the Member States shall, regardless of any other sanctions to be adopted, provide either for exercise of the corresponding voting rights to be suspended, or for the nullity of votes cast or for the possibility of their annulment. Article 16 Professional secrecy 1. Member States shall provide that all persons working or who have worked for the competent authorities, as well as auditors or experts acting on behalf of the competent authorities, shall be bound by the obligation of professional secrecy. This means that no confidential information which they may receive in the course of their duties may be divulged to any person or authority whatsoever, except in summary or aggregate form, such that individual assurance undertakings cannot be identified, without prejudice to cases covered by criminal law. Nevertheless, where an assurance undertaking has been declared bankrupt or is being compulsorily wound up, confidential information which does not concern third parties involved in attempts to rescue that undertaking may be divulged in civil or commercial proceedings. 2. Paragraph 1 shall not prevent the competent authorities of the different Member States from exchanging information in accordance with the directives applicable to assurance undertakings. That information shall be subject to the conditions of professional secrecy indicated in paragraph 1. 3. Member States may conclude cooperation agreements providing for exchange of information with the competent authorities of third countries or with authorities or bodies of third countries as defined in paragraphs 5 and 6 only if the information disclosed is subject to guarantees of professional secrecy at least equivalent to those referred to in this Article. Such exchange of information must be intended for the performance of the supervisory task of the authorities or bodies mentioned. Where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have disclosed it and, where appropriate, solely for the purposes for which those authorities gave their agreement. 4. Competent authorities receiving confidential information under paragraphs 1 or 2 may use it only in the course of their duties: — to check that the conditions governing the taking-up of the business of assurance are met and to facilitate monitoring of the conduct of such business, especially with regard to the monitoring of technical provisions, solvency margins, administrative and accounting procedures and internal control mechanisms, or — to impose sanctions, or — in administrative appeals against decisions of the competent authority, or — in court proceedings initiated pursuant to Article 67 or under special provisions provided for in this Directive and other directives adopted in the field of assurance undertakings. 5. Paragraphs 1 and 4 shall not preclude the exchange of information within a Member State, where there are two or more competent authorities in the same Member State, or, between Member States, between competent authorities and: — authorities responsible for the official supervision of credit institutions and other financial organisations and the authorities responsible for the supervision of financial markets, — bodies involved in the liquidation and bankruptcy of assurance undertakings and in other similar procedures, and — persons responsible for carrying out statutory audits of the accounts of assurance undertakings and other financial institutions, in the discharge of their supervisory functions, and the disclosure, to bodies which administer (compulsory) winding-up proceedings or guarantee funds, of information necessary to the performance of their duties. The information received by these authorities, bodies and persons shall be subject to the obligation of professional secrecy laid down in paragraph 1. 6. Notwithstanding paragraphs 1 to 4, Member States may authorise exchanges of information between the competent authorities and: — the authorities responsible for overseeing the bodies involved in the liquidation and bankruptcy of assurance undertakings and other similar procedures, or — the authorities responsible for overseeing the persons charged with carrying out statutory audits of the accounts of insurance undertakings, credit institutions, investment firms and other financial institutions, or — independent actuaries of insurance undertakings carrying out legal supervision of those undertakings and the bodies responsible for overseeing such actuaries. Member States which have recourse to the option provided for in the first subparagraph shall require at least that the following conditions are met: — this information shall be for the purpose of carrying out the overseeing or legal supervision referred to in the first subparagraph, — information received in this context shall be subject to the conditions of professional secrecy imposed in paragraph 1, — where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have disclosed it and, where appropriate, solely for the purposes for which those authorities gave their agreement. Member States shall communicate to the Commission and to the other Member States the names of the authorities, persons and bodies which may receive information pursuant to this paragraph. 7. Notwithstanding paragraphs 1 to 4, Member States may, with the aim of strengthening the stability, including integrity, of the financial system, authorise the exchange of information between the competent authorities and the authorities or bodies responsible under the law for the detection and investigation of breaches of company law. Member States which have recourse to the option provided for in the first subparagraph shall require at least that the following conditions are met: — the information shall be for the purpose of performing the task referred to in the first subparagraph, — information received in this context shall be subject to the conditions of professional secrecy imposed in paragraph 1, — where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have disclosed it and, where appropriate, solely for the purposes for which those authorities gave their agreement. Where, in a Member State, the authorities or bodies referred to in the first subparagraph perform their task of detection or investigation with the aid, in view of their specific competence, of persons appointed for that purpose and not employed in the public sector, the possibility of exchanging information provided for in the first subparagraph may be extended to such persons under the conditions stipulated in the second subparagraph. In order to implement the third indent of the second subparagraph, the authorities or bodies referred to in the first subparagraph shall communicate to the competent authorities which have disclosed the information, the names and precise responsibilities of the persons to whom it is to be sent. Member States shall communicate to the Commission and to the other Member States the names of the authorities or bodies which may receive information pursuant to this paragraph. Before 31 December 2000, the Commission shall draw up a report on the application of this paragraph. 8. Member States may authorise the competent authorities to transmit: — to central banks and other bodies with a similar function in their capacity as monetary authorities, — where appropriate, to other public authorities responsible for overseeing payment systems, information intended for the performance of their task and may authorise such authorities or bodies to communicate to the competent authorities such information as they may need for the purposes of paragraph 4. Information received in this context shall be subject to the conditions of professional secrecy imposed in this Article. 9. In addition, notwithstanding paragraphs 1 and 4, Member States may, under provisions laid down by law, authorise the disclosure of certain information to other departments of their central government administrations responsible for legislation on the supervision of credit institutions, financial institutions, investment services and assurance undertakings and to inspectors acting on behalf of those departments. However, such disclosures may be made only where necessary for reasons of prudential control. However, Member States shall provide that information received under paragraphs 2 and 5 and that obtained by means of the on-the-spot verification referred to in Article 11 may never be disclosed in the cases referred to in this paragraph except with the express consent of the competent authorities which disclosed the information or of the competent authorities of the Member State in which on-the-spot verification was carried out. Article 17 Duties of auditors 1. Member States shall provide at least that: (a) any person authorised within the meaning of Council Directive 84/253/EEC (14), performing in an assurance undertaking the task described in Article 51 of Council Directive 78/660/EEC (15), Article 37 of Directive 83/349/EEC or Article 31 of Council Directive 85/611/EEC (16) or any other statutory task, shall have a duty to report promptly to the competent authorities any fact or decision concerning that undertaking of which he/she has become aware while carrying out that task which is liable to: — constitute a material breach of the laws, regulations or administrative provisions which lay down the conditions governing authorisation or which specifically govern pursuit of the activities of assurance undertakings, or — affect the continuous functioning of the assurance undertaking or — lead to refusal to certify the accounts or to the expression of reservations; (b) that person shall likewise have a duty to report any facts and decisions of which he/she becomes aware in the course of carrying out a task as described in (a) in an undertaking having close links resulting from a control relationship with the assurance undertaking within which he/she is carrying out the abovementioned task. 2. The disclosure in good faith to the competent authorities, by persons authorised within the meaning of Directive 84/253/EEC, of any fact or decision referred to in paragraph 1 shall not constitute a breach of any restriction on disclosure of information imposed by contract or by any legislative, regulatory or administrative provision and shall not involve such persons in liability of any kind. Article 18 Pursuit of life assurance and non-life insurance activities 1. Without prejudice to paragraphs 3 and 7, no undertaking may be authorised both pursuant to this Directive and pursuant to Directive 73/239/EEC. 2. By way of derogation from paragraph 1, Member States may provide that: — undertakings authorised pursuant to this Directive may also obtain authorisation, in accordance with Article 6 of Directive 73/239/EEC for the risks listed in classes 1 and 2 in the Annex to that Directive, — undertakings authorised pursuant to Article 6 of Directive 73/239/EEC solely for the risks listed in classes 1 and 2 in the Annex to that Directive may obtain authorisation pursuant to this Directive. 3. Subject to paragraph 6, undertakings referred to in paragraph 2 and those which on: — 1 January 1981 for undertakings authorised in Greece, — 1 January 1986 for undertakings authorised in Spain and Portugal, — 1 January 1995 for undertakings authorised in Austria, Finland and Sweden, and — 15 March 1979 for all other undertakings, carried on simultaneously both the activities covered by this Directive and those covered by Directive 73/239/EEC may continue to carry on those activities simultaneously, provided that each activity is separately managed in accordance with Article 19 of this Directive. 4. Member States may provide that the undertakings referred to in paragraph 2 shall comply with the accounting rules governing assurance undertakings authorised pursuant to this Directive for all of their activities. Pending coordination in this respect, Member States may also provide that, with regard to rules on winding-up, activities relating to the risks listed in classes 1 and 2 in the Annex to Directive 73/239/EEC carried on by the undertakings referred to in paragraph 2 shall be governed by the rules applicable to life assurance activities. 5. Where an undertaking carrying on the activities referred to in the Annex to Directive 73/239/EEC has financial, commercial or administrative links with an assurance undertaking carrying on the activities covered by this Directive, the competent authorities of the Member States within whose territories the head offices of those undertakings are situated shall ensure that the accounts of the undertakings in question are not distorted by agreements between these undertakings or by any arrangement which could affect the apportionment of expenses and income. 6. Any Member State may require assurance undertakings whose head offices are situated in its territory to cease, within a period to be determined by the Member State concerned, the simultaneous pursuit of activities in which they were engaged on the dates referred to in paragraph 3. 7. The provisions of this Article shall be reviewed on the basis of a report from the Commission to the Council in the light of future harmonisation of the rules on winding-up, and in any case before 31 December 1999. Article 19 Separation of life assurance and non-life insurance management 1. The separate management referred to in Article 18(3) must be organised in such a way that the activities covered by this Directive are distinct from the activities covered by Directive 73/239/EEC in order that: — the respective interests of life policy holders and non-life policy holders are not prejudiced and, in particular, that profits from life assurance benefit life policy holders as if the assurance undertaking only carried on the activity of life assurance, — the minimum financial obligations, in particular solvency margins, in respect of one or other of the two activities, namely an activity under this Directive and an activity under Directive 73/239/EEC, are not borne by the other activity. However, as long as the minimum financial obligations are fulfilled under the conditions laid down in the second indent of the first subparagraph and, provided the competent authority is informed, the undertaking may use those explicit items of the solvency margin which are still available for one or other activity. The competent authorities shall analyse the results in both activities so as to ensure that the provisions of this paragraph are complied with. 2. (a) Accounts shall be drawn up in such a manner as to show the sources of the results for each of the two activities, life assurance and non-life insurance. To this end all income (in particular premiums, payments by re-insurers and investment income) and expenditure (in particular insurance settlements, additions to technical provisions, reinsurance premiums, operating expenses in respect of insurance business) shall be broken down according to origin. Items common to both activities shall be entered in accordance with methods of apportionment to be accepted by the competent authority. (b) Assurance undertakings must, on the basis of the accounts, prepare a statement clearly identifying the items making up each solvency margin, in accordance with Article 27 of this Directive and Article 16(1) of Directive 73/239/EEC. 3. If one of the solvency margins is insufficient, the competent authorities shall apply to the deficient activity the measures provided for in the relevant Directive, whatever the results in the other activity. By way of derogation from the second indent of the first subparagraph of paragraph 1, these measures may involve the authorisation of a transfer from one activity to the other. CHAPTER 2 RULES RELATING TO TECHNICAL PROVISIONS AND THEIR REPRESENTATION Article 20 Establishment of technical provisions 1. The home Member State shall require every assurance undertaking to establish sufficient technical provisions, including mathematical provisions, in respect of its entire business. The amount of such technical provisions shall be determined according to the following principles. A. (i) the amount of the technical life-assurance provisions shall be calculated by a sufficiently prudent prospective actuarial valuation, taking account of all future liabilities as determined by the policy conditions for each existing contract, including: — all guaranteed benefits, including guaranteed surrender values, — bonuses to which policy holders are already either collectively or individually entitled, however those bonuses are described — vested, declared or allotted, — all options available to the policy holder under the terms of the contract, — expenses, including commissions, taking credit for future premiums due; (ii) the use of a retrospective method is allowed, if it can be shown that the resulting technical provisions are not lower than would be required under a sufficiently prudent prospective calculation or if a prospective method cannot be used for the type of contract involved; (iii) a prudent valuation is not a ‘best estimate’ valuation, but shall include an appropriate margin for adverse deviation of the relevant factors; (iv) the method of valuation for the technical provisions must not only be prudent in itself, but must also be so having regard to the method of valuation for the assets covering those provisions; (v) technical provisions shall be calculated separately for each contract. The use of appropriate approximations or generalisations is allowed, however, where they are likely to give approximately the same result as individual calculations. The principle of separate calculation shall in no way prevent the establishment of additional provisions for general risks which are not individualised; (vi) where the surrender value of a contract is guaranteed, the amount of the mathematical provisions for the contract at any time shall be at least as great as the value guaranteed at that time; B. the rate of interest used shall be chosen prudently. It shall be determined in accordance with the rules of the competent authority in the home Member State, applying the following principles: (a) for all contracts, the competent authority of the assurance undertaking's home Member State shall fix one or more maximum rates of interest, in particular in accordance with the following rules: (i) when contracts contain an interest rate guarantee, the competent authority in the home Member State shall set a single maximum rate of interest. It may differ according to the currency in which the contract is denominated, provided that it is not more than 60 % of the rate on bond issues by the State in whose currency the contract is denominated. If a Member State decides, pursuant to the second sentence of the first subparagraph, to set a maximum rate of interest for contracts denominated in another Member State's currency, it shall first consult the competent authority of the Member State in whose currency the contract is denominated; (ii) however, when the assets of the assurance undertaking are not valued at their purchase price, a Member State may stipulate that one or more maximum rates may be calculated taking into account the yield on the corresponding assets currently held, minus a prudential margin and, in particular for contracts with periodic premiums, furthermore taking into account the anticipated yield on future assets. The prudential margin and the maximum rate or rates of interest applied to the anticipated yield on future assets shall be fixed by the competent authority of the home Member State; (b) the establishment of a maximum rate of interest shall not imply that the assurance undertaking is bound to use a rate as high as that; (c) the home Member State may decide not to apply paragraph (a) to the following categories of contracts: — unit-linked contracts, — single-premium contracts for a period of up to eight years, — without-profits contracts, and annuity contracts with no surrender value. In the cases referred to in the second and third indents of the first subparagraph, in choosing a prudent rate of interest, account may be taken of the currency in which the contract is denominated and corresponding assets currently held and where the undertaking's assets are valued at their current value, the anticipated yield on future assets. Under no circumstances may the rate of interest used be higher than the yield on assets as calculated in accordance with the accounting rules in the home Member State, less an appropriate deduction; (d) the Member State shall require an assurance undertaking to set aside in its accounts a provision to meet interest-rate commitments vis-à-vis policy holders if the present or foreseeable yield on the undertaking's assets is insufficient to cover those commitments; (e) the Commission and the competent authorities of the Member States which so request shall be notified of the maximum rates of interest set under (a); C. the statistical elements of the valuation and the allowance for expenses used shall be chosen prudently, having regard to the State of the commitment, the type of policy and the administrative costs and commissions expected to be incurred; D. in the case of participating contracts, the method of calculation for technical provisions may take into account, either implicitly or explicitly, future bonuses of all kinds, in a manner consistent with the other assumptions on future experience and with the current method of distribution of bonuses; E. allowance for future expenses may be made implicitly, for instance by the use of future premiums net of management charges. However, the overall allowance, implicit or explicit, shall be not less than a prudent estimate of the relevant future expenses; F. the method of calculation of technical provisions shall not be subject to discontinuities from year to year arising from arbitrary changes to the method or the bases of calculation and shall be such as to recognise the distribution of profits in an appropriate way over the duration of each policy. 2. Assurance undertakings shall make available to the public the bases and methods used in the calculation of the technical provisions, including provisions for bonuses. 3. The home Member State shall require every assurance undertaking to cover the technical provisions in respect of its entire business by matching assets, in accordance with Article 26. In respect of business written in the Community, these assets must be localised within the Community. Member States shall not require assurance undertakings to localise their assets in a particular Member State. The home Member State may, however, permit relaxations in the rules on the localisation of assets. 4. If the home Member State allows any technical provisions to be covered by claims against reassurers, it shall fix the percentage so allowed. In such case, it may not require the localisation of the assets representing such claims. Article 21 Premiums for new business Premiums for new business shall be sufficient, on reasonable actuarial assumptions, to enable assurance undertakings to meet all their commitments and, in particular, to establish adequate technical provisions. For this purpose, all aspects of the financial situation of an assurance undertaking may be taken into account, without the input from resources other than premiums and income earned thereon being systematic and permanent in such a way that it may jeopardise the undertaking's solvency in the long term. Article 22 Assets covering technical provisions The assets covering the technical provisions shall take account of the type of business carried on by an assurance undertaking in such a way as to secure the safety, yield and marketability of its investments, which the undertaking shall ensure are diversified and adequately spread. Article 23 Categories of authorised assets 1. The home Member State may not authorise assurance undertakings to cover their technical provisions with any but the following categories of assets: A. investments (a) debt securities, bonds and other money- and capital-market instruments; (b) loans; (c) shares and other variable-yield participations; (d) units in undertakings for collective investment in transferable securities (UCITS) and other investment funds; (e) land, buildings and immovable-property rights; B. debts and claims (f) debts owed by reassurers, including reassurers' shares of technical provisions; (g) deposits with and debts owed by ceding undertakings; (h) debts owed by policy holders and intermediaries arising out of direct and reassurance operations; (i) advances against policies; (j) tax recoveries; (k) claims against guarantee funds; C. others (l) tangible fixed assets, other than land and buildings, valued on the basis of prudent amortisation; (m) cash at bank and in hand, deposits with credit institutions and any other body authorised to receive deposits; (n) deferred acquisition costs; (o) accrued interest and rent, other accrued income and prepayments; (p) reversionary interests. 2. In the case of the association of underwriters known as ‘Lloyd's’, asset categories shall also include guarantees and letters of credit issued by credit institutions within the meaning of Directive 2000/12/EC of the European Parliament and of the Council (17) or by assurance undertakings, together with verifiable sums arising out of life assurance policies, to the extent that they represent funds belonging to members. 3. The inclusion of any asset or category of assets listed in paragraph 1 shall not mean that all these assets should automatically be accepted as cover for technical provisions. The home Member State shall lay down more detailed rules fixing the conditions for the use of acceptable assets; in this connection, it may require valuable security or guarantees, particularly in the case of debts owed by reassurers. In determining and applying the rules which it lays down, the home Member State shall, in particular, ensure that the following principles are complied with: (i) assets covering technical provisions shall be valued net of any debts arising out of their acquisition; (ii) all assets must be valued on a prudent basis, allowing for the risk of any amounts not being realisable. In particular, tangible fixed assets other than land and buildings may be accepted as cover for technical provisions only if they are valued on the basis of prudent amortisation; (iii) loans, whether to undertakings, to a State or international organisation, to local or regional authorities or to natural persons, may be accepted as cover for technical provisions only if there are sufficient guarantees as to their security, whether these are based on the status of the borrower, mortgages, bank guarantees or guarantees granted by assurance undertakings or other forms of security; (iv) derivative instruments such as options, futures and swaps in connection with assets covering technical provisions may be used in so far as they contribute to a reduction of investment risks or facilitate efficient portfolio management. They must be valued on a prudent basis and may be taken into account in the valuation of the underlying assets; (v) transferable securities which are not dealt in on a regulated market may be accepted as cover for technical provisions only if they can be realised in the short term or if they are holdings in credit institutions, in assurance undertakings, within the limits permitted by Article 6, or in investment undertakings established in a Member State; (vi) debts owed by and claims against a third party may be accepted as cover for the technical provisions only after deduction of all amounts owed to the same third party; (vii) the value of any debts and claims accepted as cover for technical provisions must be calculated on a prudent basis, with due allowance for the risk of any amounts not being realisable. In particular, debts owed by policy holders and intermediaries arising out of assurance and reassurance operations may be accepted only in so far as they have been outstanding for not more than three months; (viii) where the assets held include an investment in a subsidiary undertaking which manages all or part of the assurance undertaking's investments on its behalf, the home Member State must, when applying the rules and principles laid down in this Article, take into account the underlying assets held by the subsidiary undertaking; the home Member State may treat the assets of other subsidiaries in the same way; (ix) deferred acquisition costs may be accepted as cover for technical provisions only to the extent that this is consistent with the calculation of the mathematical provisions. 4. Notwithstanding paragraphs 1, 2 and 3, in exceptional circumstances and at an assurance undertaking's request, the home Member State may, temporarily and under a properly reasoned decision, accept other categories of assets as cover for technical provisions, subject to Article 22. Article 24 Rules for investment diversification 1. As regards the assets covering technical provisions, the home Member State shall require every assurance undertaking to invest no more than: (a) 10 % of its total gross technical provisions in any one piece of land or building, or a number of pieces of land or buildings close enough to each other to be considered effectively as one investment; (b) 5 % of its total gross technical provisions in shares and other negotiable securities treated as shares, bonds, debt securities and other money- and capital-market instruments from the same undertaking, or in loans granted to the same borrower, taken together, the loans being loans other than those granted to a State, regional or local authority or to an international organisation of which one or more Member States are members. This limit may be raised to 10 % if an undertaking invests not more than 40 % of its gross technical provisions in the loans or securities of issuing bodies and borrowers in each of which it invests more than 5 % of its assets; (c) 5 % of its total gross technical provisions in unsecured loans, including 1 % for any single unsecured loan, other than loans granted to credit institutions, assurance undertakings — in so far as Article 6 allows it — and investment undertakings established in a Member State. The limits may be raised to 8 % and 2 % respectively by a decision taken on a case-by-case basis by the competent authority of the home Member State; (d) 3 % of its total gross technical provisions in the form of cash in hand; (e) 10 % of its total gross technical provisions in shares, other securities treated as shares and debt securities which are not dealt in on a regulated market. 2. The absence of a limit in paragraph 1 on investment in any particular category does not imply that assets in that category should be accepted as cover for technical provisions without limit. The home Member State shall lay down more detailed rules fixing the conditions for the use of acceptable assets. In particular it shall ensure, in the determination and the application of those rules, that the following principles are complied with: (i) assets covering technical provisions must be diversified and spread in such a way as to ensure that there is no excessive reliance on any particular category of asset, investment market or investment; (ii) investment in particular types of asset which show high levels of risk, whether because of the nature of the asset or the quality of the issuer, must be restricted to prudent levels; (iii) limitations on particular categories of asset must take account of the treatment of reassurance in the calculation of technical provisions; (iv) where the assets held include an investment in a subsidiary undertaking which manages all or part of the assurance undertaking's investments on its behalf, the home Member State must, when applying the rules and principles laid down in this Article, take into account the underlying assets held by the subsidiary undertaking; the home Member State may treat the assets of other subsidiaries in the same way; (v) the percentage of assets covering technical provisions which are the subject of non-liquid investments must be kept to a prudent level; (vi) where the assets held include loans to or debt securities issued by certain credit institutions, the home Member State may, when applying the rules and principles contained in this Article, take into account the underlying assets held by such credit institutions. This treatment may be applied only where the credit institution has its head office in a Member State, is entirely owned by that Member State and/or that State's local authorities and its business, according to its memorandum and articles of association, consists of extending, through its intermediaries, loans to, or guaranteed by, States or local authorities or of loans to bodies closely linked to the State or to local authorities. 3. In the context of the detailed rules laying down the conditions for the use of acceptable assets, the Member State shall give more limitative treatment to: — any loan unaccompanied by a bank guarantee, a guarantee issued by an assurance undertaking, a mortgage or any other form of security, as compared with loans accompanied by such collateral, — UCITS not coordinated within the meaning of Directive 85/611/EEC and other investment funds, as compared with UCITS coordinated within the meaning of that Directive, — securities which are not dealt in on a regulated market, as compared with those which are, — bonds, debt securities and other money- and capital-market instruments not issued by States, local or regional authorities or undertakings belonging to zone A as defined in Directive 2000/12/EC or the issuers of which are international organisations not numbering at least one Community Member State among their members, as compared with the same financial instruments issued by such bodies. 4. Member States may raise the limit laid down in paragraph 1(b) to 40 % in the case of certain debt securities when these are issued by a credit institution which has its head office in a Member State and is subject by law to special official supervision designed to protect the holders of those debt securities. In particular, sums deriving from the issue of such debt securities must be invested in accordance with the law in assets which, during the whole period of validity of the debt securities, are capable of covering claims attaching to debt securities and which, in the event of failure of the issuer, would be used on a priority basis for the reimbursement of the principal and payment of the accrued interest. 5. Member States shall not require assurance undertakings to invest in particular categories of assets. 6. Notwithstanding paragraph 1, in exceptional circumstances and at the assurance undertaking's request, the home Member State may, temporarily and under a properly reasoned decision, allow exceptions to the rules laid down in paragraph 1(a) to (e), subject to Article 22. Article 25 Contracts linked to UCITS or share index 1. Where the benefits provided by a contract are directly linked to the value of units in an UCITS or to the value of assets contained in an internal fund held by the insurance undertaking, usually divided into units, the technical provisions in respect of those benefits must be represented as closely as possible by those units or, in the case where units are not established, by those assets. 2. Where the benefits provided by a contract are directly linked to a share index or some other reference value other than those referred to in paragraph 1, the technical provisions in respect of those benefits must be represented as closely as possible either by the units deemed to represent the reference value or, in the case where units are not established, by assets of appropriate security and marketability which correspond as closely as possible with those on which the particular reference value is based. 3. Articles 22 and 24 shall not apply to assets held to match liabilities which are directly linked to the benefits referred to in paragraphs 1 and 2. References to the technical provisions in Article 24 shall be to the technical provisions excluding those in respect of such liabilities. 4. Where the benefits referred to in paragraphs 1 and 2 include a guarantee of investment performance or some other guaranteed benefit, the corresponding additional technical provisions shall be subject to Articles 22, 23, and 24. Article 26 Matching rules 1. For the purposes of Articles 20(3) and 54, Member States shall comply with Annex II as regards the matching rules. 2. This Article shall not apply to the commitments referred to in Article 25. CHAPTER 3 RULES RELATING TO THE SOLVENCY MARGIN AND TO THE GUARANTEE FUND Article 27 Available solvency margin 1. Each Member State shall require of every assurance undertaking whose head office is situated in its territory an adequate available solvency margin in respect of its entire business at all times which is at least equal to the requirements in this Directive. 2. The available solvency margin shall consist of the assets of the assurance undertaking free of any foreseeable liabilities, less any intangible items, including: (a) the paid-up share capital or, in the case of a mutual assurance undertaking, the effective initial fund plus any members' accounts which meet all the following criteria: (i) the memorandum and articles of association must stipulate that payments may be made from these accounts to members only in so far as this does not cause the available solvency margin to fall below the required level, or, after the dissolution of the undertaking, if all the undertaking's other debts have been settled; (ii) the memorandum and articles of association must stipulate, with respect to any payments referred to in point (i) for reasons other than the individual termination of membership, that the competent authorities must be notified at least one month in advance and can prohibit the payment within that period; (iii) the relevant provisions of the memorandum and articles of association may be amended only after the competent authorities have declared that they have no objection to the amendment, without prejudice to the criteria stated in points (i) and (ii); (b) reserves (statutory and free) not corresponding to underwriting liabilities; (c) the profit or loss brought forward after deduction of dividends to be paid; (d) in so far as authorised under national law, profit reserves appearing in the balance sheet where they may be used to cover any losses which may arise and where they have not been made available for distribution to policy holders. The available solvency margin shall be reduced by the amount of own shares directly held by the assurance undertaking. 3. The available solvency margin may also consist of: (a) cumulative preferential share capital and subordinated loan capital up to 50 % of the lesser of the available solvency margin and the required solvency margin, no more than 25 % of which shall consist of subordinated loans with a fixed maturity, or fixed-term cumulative preferential share capital, provided that binding agreements exist under which, in the event of the bankruptcy or liquidation of the assurance undertaking, the subordinated loan capital or preferential share capital ranks after the claims of all other creditors and is not to be repaid until all other debts outstanding at the time have been settled. Subordinated loan capital must also fulfil the following conditions: (i) only fully paid-up funds may be taken into account; (ii) for loans with a fixed maturity, the original maturity must be at least five years. No later than one year before the repayment date, the assurance undertaking must submit to the competent authorities for their approval a plan showing how the available solvency margin will be kept at or brought to the required level at maturity, unless the extent to which the loan may rank as a component of the available solvency margin is gradually reduced during at least the last five years before the repayment date. The competent authorities may authorise the early repayment of such loans provided application is made by the issuing assurance undertaking and its available solvency margin will not fall below the required level; (iii) loans the maturity of which is not fixed must be repayable only subject to five years' notice unless the loans are no longer considered as a component of the available solvency margin or unless the prior consent of the competent authorities is specifically required for early repayment. In the latter event the assurance undertaking must notify the competent authorities at least six months before the date of the proposed repayment, specifying the available solvency margin and the required solvency margin both before and after that repayment. The competent authorities shall authorise repayment only if the assurance undertaking's available solvency margin will not fall below the required level; (iv) the loan agreement must not include any clause providing that in specified circumstances, other than the winding-up of the assurance undertaking, the debt will become repayable before the agreed repayment dates; (v) the loan agreement may be amended only after the competent authorities have declared that they have no objection to the amendment; (b) securities with no specified maturity date and other instruments, including cumulative preferential shares other than those mentioned in point (a), up to 50 % of the lesser of the available solvency margin and the required solvency margin for the total of such securities and the subordinated loan capital referred to in point (a) provided they fulfil the following: (i) they may not be repaid on the initiative of the bearer or without the prior consent of the competent authority; (ii) the contract of issue must enable the assurance undertaking to defer the payment of interest on the loan; (iii) the lender's claims on the assurance undertaking must rank entirely after those of all non-subordinated creditors; (iv) the documents governing the issue of the securities must provide for the loss-absorption capacity of the debt and unpaid interest, while enabling the assurance undertaking to continue its business; (v) only fully paid-up amounts may be taken into account. 4. Upon application, with supporting evidence, by the undertaking to the competent authority of the home Member State and with the agreement of that competent authority, the available solvency margin may also consist of: (a) until 31 December 2009 an amount equal to 50 % of the undertaking's future profits, but not exceeding 25 % of the lesser of the available solvency margin and the required solvency margin. The amount of the future profits shall be obtained by multiplying the estimated annual profit by a factor which represents the average period left to run on policies. The factor used may not exceed six. The estimated annual profit shall not exceed the arithmetical average of the profits made over the last five financial years in the activities listed in Article 2(1). Competent authorities may only agree to include such an amount for the available solvency margin: (i) when an actuarial report is submitted to the competent authorities substantiating the likelihood of emergence of these profits in the future; and (ii) in so far as that part of future profits emerging from hidden net reserves referred to in point (c) has not already been taken into account; (b) where Zillmerising is not practised or where, if practised, it is less than the loading for acquisition costs included in the premium, the difference between a non-Zillmerised or partially Zillmerised mathematical provision and a mathematical provision Zillmerised at a rate equal to the loading for acquisition costs included in the premium. This figure may not, however, exceed 3,5 % of the sum of the differences between the relevant capital sums of life assurance activities and the mathematical provisions for all policies for which Zillmerising is possible. The difference shall be reduced by the amount of any undepreciated acquisition costs entered as an asset; (c) any hidden net reserves arising out of the valuation of assets, in so far as such hidden net reserves are not of an exceptional nature; (d) one half of the unpaid share capital or initial fund, once the paid-up part amounts to 25 % of that share capital or fund, up to 50 % of the lesser of the available and required solvency margin. 5. Amendments to paragraphs 2, 3 and 4 to take into account developments that justify a technical adjustment of the elements eligible for the available solvency margin shall be adopted in accordance with the procedure laid down in Article 65(2). Article 28 Required solvency margin 1. Subject to Article 29, the required solvency margin shall be determined as laid down in paragraphs 2 to 7 according to the classes of assurance underwritten. 2. For the kinds of assurance referred to in Article 2(1)(a) and (b) other than assurances linked to investment funds and for the operations referred to in Article 2(3), the required solvency margin shall be equal to the sum of the following two results: (a) first result: a 4 % fraction of the mathematical provisions relating to direct business and reinsurance acceptances gross of reinsurance cessions shall be multiplied by the ratio, for the last financial year, of the total mathematical provisions net of reinsurance cessions to the gross total mathematical provisions. That ratio may in no case be less than 85 %; (b) second result: for policies on which the capital at risk is not a negative figure, a 0,3 % fraction of such capital underwritten by the assurance undertaking shall be multiplied by the ratio, for the last financial year, of the total capital at risk retained as the undertaking's liability after reinsurance cessions and retrocessions to the total capital at risk gross of reinsurance; that ratio may in no case be less than 50 %. For temporary assurance on death of a maximum term of three years the fraction shall be 0,1 %. For such assurance of a term of more than three years but not more than five years the above fraction shall be 0,15 %. 3. For the supplementary insurance referred to in Article 2(1)(c) the required solvency margin shall be equal to the required solvency margin for insurance undertakings as laid down in Article 16a of Directive 73/239/EEC, excluding the provisions of Article 17 of that Directive. 4. For permanent health insurance not subject to cancellation referred to in Article 2(1)(d), the required solvency margin shall be equal to: (a) a 4 % fraction of the mathematical provisions, calculated in compliance with paragraph 2(a) of this Article; plus (b) the required solvency margin for insurance undertakings as laid down in Article 16a of Directive 73/239/EEC, excluding the provisions of Article 17 of that Directive. However, the condition contained in Article 16a(6)(b) of that Directive that a provision be set up for increasing age may be replaced by a requirement that the business be conducted on a group basis. 5. For capital redemption operations referred to in Article 2(2)(b), the required solvency margin shall be equal to a 4 % fraction of the mathematical provisions calculated in compliance with paragraph 2(a) of this Article. 6. For tontines, referred to in Article 2(2)(a), the required solvency margin shall be equal to 1 % of their assets. 7. For assurances covered by Article 2(1)(a) and (b) linked to investment funds and for the operations referred to in Article 2(2)(c), (d) and (e), the required solvency margin shall be equal to the sum of the following: (a) in so far as the assurance undertaking bears an investment risk, a 4 % fraction of the technical provisions, calculated in compliance with paragraph 2(a) of this Article; (b) in so far as the undertaking bears no investment risk but the allocation to cover management expenses is fixed for a period exceeding five years, a 1 % fraction of the technical provisions, calculated in compliance with paragraph 2(a) of this Article; (c) in so far as the undertaking bears no investment risk and the allocation to cover management expenses is not fixed for a period exceeding five years, an amount equivalent to 25 % of the last financial year's net administrative expenses pertaining to such business; (d) in so far as the assurance undertaking covers a death risk, a 0,3 % fraction of the capital at risk calculated in compliance with paragraph 2(b) of this Article. Article 29 Guarantee fund 1. One third of the required solvency margin as specified in Article 28 shall constitute the guarantee fund. This fund shall consist of the items listed in Article 27(2), (3) and, with the agreement of the competent authority of the home Member State, (4)(c). 2. The guarantee fund may not be less than a minimum of EUR 3 million. Any Member State may provide for a one-fourth reduction of the minimum guarantee fund in the case of mutual associations and mutual-type associations and tontines. Article 30 Review of the amount of the guarantee fund 1. The amount in euro as laid down in Article 29(2) shall be reviewed annually starting on 20 September 2003, in order to take account of changes in the European index of consumer prices comprising all Member States as published by Eurostat. The amount shall be adapted automatically, by increasing the base amount in euro by the percentage change in that index over the period between 20 March 2002 and the review date and rounded up to a multiple of EUR 100 000. If the percentage change since the last adaptation is less than 5 %, no adaptation shall take place. 2. The Commission shall inform annually the European Parliament and the Council of the review and the adapted amount referred to in paragraph 1. Article 31 Assets not used to cover technical provisions 1. Member States shall not prescribe any rules as to the choice of the assets that need not be used as cover for the technical provisions referred to in Article 20. 2. Subject to Article 20(3), Article 37(1), (2), (3) and (5), and the second subparagraph of Article 39(1), Member States shall not restrain the free disposal of those assets, whether movable or immovable, that form part of the assets of authorised assurance undertakings. 3. Paragraphs 1 and 2 shall not preclude any measures which Member States, while safeguarding the interests of the lives assured, are entitled to take as owners or members of or partners in the assurance undertakings in question. CHAPTER 4 CONTRACT LAW AND CONDITIONS OF ASSURANCE Article 32 Law applicable 1. The law applicable to contracts relating to the activities referred to in this Directive shall be the law of the Member State of the commitment. However, where the law of that State so allows, the parties may choose the law of another country. 2. Where the policy holder is a natural person and has his/her habitual residence in a Member State other than that of which he/she is a national, the parties may choose the law of the Member State of which he/she is a national. 3. Where a State includes several territorial units, each of which has its own rules of law concerning contractual obligations, each unit shall be considered a country for the purposes of identifying the law applicable under this Directive. A Member State in which various territorial units have their own rules of law concerning contractual obligations shall not be bound to apply the provisions of this Directive to conflicts which arise between the laws of those units. 4. Nothing in this Article shall restrict the application of the rules of the law of the forum in a situation where they are mandatory, irrespective of the law otherwise applicable to the contract. If the law of a Member State so stipulates, the mandatory rules of the law of the Member State of the commitment may be applied if and in so far as, under the law of that Member State, those rules must be applied whatever the law applicable to the contract. 5. Subject to paragraphs 1 to 4, the Member States shall apply to the assurance contracts referred to in this Directive their general rules of private international law concerning contractual obligations. Article 33 General good The Member State of the commitment shall not prevent a policy holder from concluding a contract with an assurance undertaking authorised under the conditions of Article 4 as long as that does not conflict with legal provisions protecting the general good in the Member State of the commitment. Article 34 Rules relating to conditions of assurance and scales of premiums Member States shall not adopt provisions requiring the prior approval or systematic notification of general and special policy conditions, scales of premiums, technical bases used in particular for calculating scales of premiums and technical provisions or forms and other printed documents which an assurance undertaking intends to use in its dealings with policy holders. Notwithstanding the first subparagraph, for the sole purpose of verifying compliance with national provisions concerning actuarial principles, the home Member State may require systematic communication of the technical bases used in particular for calculating scales of premiums and technical provisions, without that requirement constituting a prior condition for an assurance undertaking to carry on its business. Not later than 1 July 1999 the Commission shall submit a report to the Council on the implementation of those provisions. Article 35 Cancellation period 1. Each Member State shall prescribe that a policy holder who concludes an individual life-assurance contract shall have a period of between 14 and 30 days from the time when he/she was informed that the contract had been concluded within which to cancel the contract. The giving of notice of cancellation by the policy holder shall have the effect of releasing him/her from any future obligation arising from the contract. The other legal effects and the conditions of cancellation shall be determined by the law applicable to the contract as defined in Article 32, notably as regards the arrangements for informing the policy holder that the contract has been concluded. 2. The Member States need not apply paragraph 1 to contracts of six months' duration or less, nor where, because of the status of the policy holder or the circumstances in which the contract is concluded, the policy holder does not need this special protection. Member States shall specify in their rules where paragraph 1 is not applied. Article 36 Information for policy holders 1. Before the assurance contract is concluded, at least the information listed in Annex III(A) shall be communicated to the policy holder. 2. The policy-holder shall be kept informed throughout the term of the contract of any change concerning the information listed in Annex III(B). 3. The Member State of the commitment may require assurance undertakings to furnish information in addition to that listed in Annex III only if it is necessary for a proper understanding by the policy holder of the essential elements of the commitment. 4. The detailed rules for implementing this Article and Annex III shall be laid down by the Member State of the commitment. CHAPTER 5 ASSURANCE UNDERTAKINGS IN DIFFICULTY OR IN AN IRREGULAR SITUATION Article 37 Assurance undertakings in difficulty 1. If an assurance undertaking does not comply with Article 20, the competent authority of its home Member State may prohibit the free disposal of its assets after having communicated its intention to the competent authorities of the Member States of commitment. 2. For the purposes of restoring the financial situation of an assurance undertaking, the solvency margin of which has fallen below the minimum required under Article 28, the competent authority of the home Member State shall require that a plan for the restoration of a sound financial position be submitted for its approval. In exceptional circumstances, if the competent authority is of the opinion that the financial situation of the assurance undertaking will further deteriorate, it may also restrict or prohibit the free disposal of the assurance undertaking's assets. It shall inform the authorities of other Member States within the territories of which the assurance undertaking carries on business of any measures it has taken and the latter shall, at the request of the former, take the same measures. 3. If the solvency margin falls below the guarantee fund as defined in Article 29, the competent authority of the home Member State shall require the assurance undertaking to submit a short-term finance scheme for its approval. It may also restrict or prohibit the free disposal of the assurance undertaking's assets. It shall inform the authorities of other Member States within the territories of which the assurance undertaking carries on business accordingly and the latter shall, at the request of the former, take the same measures. 4. The competent authorities may further take all measures necessary to safeguard the interests of the assured persons in the cases provided for in paragraphs 1, 2 and 3. 5. Each Member State shall take the measures necessary to be able in accordance with its national law to prohibit the free disposal of assets located within its territory at the request, in the cases provided for in paragraphs 1, 2 and 3, of the assurance undertaking's home Member State, which shall designate the assets to be covered by such measures. Article 38 Financial recovery plan 1. Member States shall ensure that the competent authorities have the power to require a financial recovery plan for those insurance undertakings where competent authorities consider that policy holders' rights are threatened. The financial recovery plan must as a minimum include particulars or proof concerning for the next three financial years: (a) estimates of management expenses, in particular current general expenses and commissions; (b) a plan setting out detailed estimates of income and expenditure in respect of direct business, reinsurance acceptances and reinsurance cessions; (c) a forecast balance sheet; (d) estimates of the financial resources intended to cover underwriting liabilities and the required solvency margin; (e) the overall reinsurance policy. 2. Where policy holders' rights are threatened because the financial position of the undertaking is deteriorating, Member States shall ensure that the competent authorities have the power to oblige insurance undertakings to have a higher required solvency margin, in order to ensure that the insurance undertaking is able to fulfil the solvency requirements in the near future. The level of this higher required solvency margin shall be based on a financial recovery plan referred to in paragraph 1. 3. Member States shall ensure that the competent authorities have the power to revalue downwards all elements eligible for the available solvency margin, in particular, where there has been a significant change in the market value of these elements since the end of the last financial year. 4. Member States shall ensure that the competent authorities have the powers to decrease the reduction, based on reinsurance, to the solvency margin as determined in accordance with Article 28 where: (a) the nature or quality of reinsurance contracts has changed significantly since the last financial year; (b) there is no or an insignificant risk transfer under the reinsurance contracts. 5. If the competent authorities have required a financial recovery plan for the insurance undertaking in accordance with paragraph 1, they shall refrain from issuing a certificate in accordance with Article 14(1), Article 40(3), second subparagraph, and Article 42(1)(a), as long as they consider that policy holders' rights are threatened within the meaning of paragraph 1. Article 39 Withdrawal of authorisation 1. Authorisation granted to an assurance undertaking by the competent authority of its home Member State may be withdrawn by that authority if that undertaking: (a) does not make use of the authorisation within 12 months, expressly renounces it or ceases to carry on business for more than six months, unless the Member State concerned has made provision for authorisation to lapse in such cases; (b) no longer fulfils the conditions for admission; (c) has been unable, within the time allowed, to take the measures specified in the restoration plan or finance scheme referred to in Article 37; (d) fails seriously in its obligations under the regulations to which it is subject. In the event of the withdrawal or lapse of the authorisation, the competent authority of the home Member State shall notify the competent authorities of the other Member States accordingly and they shall take appropriate measures to prevent the assurance undertaking from commencing new operations within their territories, under either the freedom of establishment or the freedom to provide services. The home Member State's competent authority shall, in conjunction with those authorities, take all necessary measures to safeguard the interests of the assured persons and shall restrict, in particular, the free disposal of the assets of the assurance undertaking in accordance with Article 37(1), (2), second subparagraph, and (3), second subparagraph. 2. Any decision to withdraw an authorisation shall be supported by precise reasons and notified to the assurance undertaking in question. TITLE IV PROVISIONS RELATING TO RIGHT OF ESTABLISHMENT AND FREEDOM TO PROVIDE SERVICES Article 40 Conditions for branch establishment 1. An assurance undertaking that proposes to establish a branch within the territory of another Member State shall notify the competent authorities of its home Member State. 2. The Member States shall require every assurance undertaking that proposes to establish a branch within the territory of another Member State to provide the following information when effecting the notification provided for in paragraph 1: (a) the Member State within the territory of which it proposes to establish a branch; (b) a scheme of operations setting out, inter alia, the types of business envisaged and the structural organisation of the branch; (c) the address in the Member State of the branch from which documents may be obtained and to which they may be delivered, it being understood that that address shall be the one to which all communications to the authorised agent are sent; (d) the name of the branch's authorised agent, who must possess sufficient powers to bind the assurance undertaking in relation to third parties and to represent it in relations with the authorities and courts of the Member State of the branch. With regard to Lloyd's, in the event of any litigation in the Member State of the branch arising out of underwritten commitments, the assured persons must not be treated less favourably than if the litigation had been brought against businesses of a conventional type. The authorised agent must, therefore, possess sufficient powers for proceedings to be taken against him and must in that capacity be able to bind the Lloyd's underwriters concerned. 3. Unless the competent authorities of the home Member State have reason to doubt the adequacy of the administrative structure or the financial situation of the assurance undertaking or the good repute and professional qualification or experience of the directors or managers or the authorised agent, taking into account the business planned, they shall, within three months of receiving all the information referred to in paragraph 2, communicate that information to the competent authorities of the Member State of the branch and shall inform the undertaking concerned accordingly. The competent authorities of the home Member State shall also attest that the assurance undertaking has the minimum solvency margin calculated in accordance with Articles 28 and 29. Where the competent authorities of the home Member State refuse to communicate the information referred to in paragraph 2 to the competent authorities of the Member State of the branch, they shall give the reasons for their refusal to the assurance undertaking concerned within three months of receiving all the information in question. That refusal or failure to act shall be subject to a right to apply to the courts in the home Member State. 4. Before the branch of an assurance undertaking starts business, the competent authorities of the Member State of the branch shall, within two months of receiving the information referred to in paragraph 3, inform the competent authority of the home Member State, if appropriate, of the conditions under which, in the interest of the general good, that business must be carried on in the Member State of the branch. 5. On receiving a communication from the competent authorities of the Member State of the branch or, if no communication is received from them, on expiry of the period provided for in paragraph 4, the branch may be established and start business. 6. In the event of a change in any of the particulars communicated under paragraph 2(b), (c) or (d), an assurance undertaking shall give written notice of the change to the competent authorities of the home Member State and of the Member State of the branch at least one month before making the change so that the competent authorities of the home Member State and the competent authorities of the Member State of the branch may fulfil their respective roles under paragraphs 3 and 4. Article 41 Freedom to provide services: prior notification to the home Member State Any assurance undertaking that intends to carry on business for the first time in one or more Member States under the freedom to provide services shall first inform the competent authorities of the home Member State, indicating the nature of the commitments it proposes to cover. Article 42 Freedom to provide services: notification by the home Member State 1. Within one month of the notification provided for in Article 41, the competent authorities of the home Member State shall communicate to the Member State or Member States within the territory of which the assurance undertaking intends to carry on business by way of the freedom to provide services: (a) a certificate attesting that the assurance undertaking has the minimum solvency margin calculated in accordance with Articles 28 and 29; (b) the classes which the assurance undertaking has been authorised to offer; (c) the nature of the commitments which the assurance undertaking proposes to cover in the Member State of the provision of services. At the same time, they shall inform the assurance undertaking concerned accordingly. 2. Where the competent authorities of the home Member State do not communicate the information referred to in paragraph 1 within the period laid down, they shall give the reasons for their refusal to the assurance undertaking within that same period. The refusal shall be subject to a right to apply to the courts in the home Member State. 3. The assurance undertaking may start business on the certified date on which it is informed of the communication provided for in the first subparagraph of paragraph 1. Article 43 Freedom to provide services: changes in the nature of commitments Any change which an assurance undertaking intends to make to the information referred to in Article 41 shall be subject to the procedure provided for in Articles 41 and 42. Article 44 Language The competent authorities of the Member State of the branch or the Member State of the provision of services may require that the information which they are authorised under this Directive to request with regard to the business of assurance undertakings operating in the territory of that State shall be supplied to them in the official language or languages of that State. Article 45 Rules relating to conditions of assurance and scales of premiums The Member State of the branch or of the provision of services shall not lay down provisions requiring the prior approval or systematic notification of general and special policy conditions, scales of premiums, technical bases used in particular for calculating scales of premiums and technical provisions, forms and other printed documents which an assurance undertaking intends to use in its dealings with policy holders. For the purpose of verifying compliance with national provisions concerning assurance contracts, it may require an assurance undertaking that proposes to carry on assurance business within its territory, under the right of establishment or the freedom to provide services, to effect only non-systematic notification of those policy conditions and other printed documents without that requirement constituting a prior condition for an assurance undertaking to carry on its business. Article 46 Assurance undertakings not complying with the legal provisions 1. Any assurance undertaking carrying on business under the right of establishment or the freedom to provide services shall submit to the competent authorities of the Member State of the branch and/or of the Member State of the provision of services all documents requested of it for the purposes of this Article in so far as assurance undertakings the head office of which is in those Member States are also obliged to do so. 2. If the competent authorities of a Member State establish that an assurance undertaking with a branch or carrying on business under the freedom to provide services in its territory is not complying with the legal provisions applicable to it in that State, they shall require the assurance undertaking concerned to remedy that irregular situation. 3. If the assurance undertaking in question fails to take the necessary action, the competent authorities of the Member State concerned shall inform the competent authorities of the home Member State accordingly. The latter authorities shall, at the earliest opportunity, take all appropriate measures to ensure that the assurance undertaking concerned remedies that irregular situation. The nature of those measures shall be communicated to the competent authorities of the Member State concerned. 4. If, despite the measures taken by the home Member State or because those measures prove inadequate or are lacking in that State, the assurance undertaking persists in violating the legal provisions in force in the Member State concerned, the latter may, after informing the competent authorities of the home Member State, take appropriate measures to prevent or penalise further irregularities, including, in so far as is strictly necessary, preventing that undertaking from continuing to conclude new assurance contracts within its territory. Member States shall ensure that in their territories it is possible to serve the legal documents necessary for such measures on assurance undertakings. 5. Paragraphs 2, 3 and 4 shall not affect the emergency power of the Member States concerned to take appropriate measures to prevent or penalise irregularities committed within their territories. This shall include the possibility of preventing assurance undertakings from continuing to conclude new assurance contracts within their territories. 6. Paragraphs 2, 3 and 4 shall not affect the power of the Member States to penalise infringements within their territories. 7. If an assurance undertaking which has committed an infringement has an establishment or possesses property in the Member State concerned, the competent authorities of the latter may, in accordance with national law, apply the administrative penalties prescribed for that infringement by way of enforcement against that establishment or property. 8. Any measure adopted under paragraphs 3 to 7 involving penalties or restrictions on the conduct of assurance business must be properly reasoned and communicated to the assurance undertaking concerned. 9. Every two years, the Commission shall submit to the Insurance Committee a report summarising the number and type of cases in which, in each Member State, authorisation has been refused pursuant to Articles 40 or 42 or measures have been taken under paragraph 4 of this Article. Member States shall cooperate with the Commission by providing it with the information required for that report. Article 47 Advertising Nothing in this Directive shall prevent assurance undertakings with head offices in other Member States from advertising their services through all available means of communication in the Member State of the branch or Member State of the provision of services, subject to any rules governing the form and content of such advertising adopted in the interest of the general good. Article 48 Winding-up Should an assurance undertaking be wound up, commitments arising out of contracts underwritten through a branch or under the freedom to provide services shall be met in the same way as those arising out of that undertaking's other assurance contracts, without distinction as to nationality as far as the lives assured and the beneficiaries are concerned. Article 49 Statistical information on cross-border activities Every assurance undertaking shall inform the competent authority of its home Member State, separately in respect of transactions carried out under the right of establishment and those carried out under the freedom to provide services, of the amount of the premiums, without deduction of reassurance, by Member State and by each of classes I to IX, as defined in Annex I. The competent authority of the home Member State shall, within a reasonable time and on an aggregate basis forward this information to the competent authorities of each of the Member States concerned which so requests. Article 50 Taxes on premiums 1. Without prejudice to any subsequent harmonisation, every assurance contract shall be subject exclusively to the indirect taxes and parafiscal charges on assurance premiums in the Member State of the commitment, and also, with regard to Spain, to the surcharges legally established in favour of the Spanish ‘Consorcio de Compensación de Seguros’ for the performance of its functions relating to the compensation of losses arising from extraordinary events occurring in that Member State. 2. The law applicable to the contract pursuant to Article 32 shall not affect the fiscal arrangements applicable. 3. Pending future harmonisation, each Member State shall apply to those assurance undertakings which cover commitments situated within its territory its own national provisions for measures to ensure the collection of indirect taxes and parafiscal charges due under paragraph 1. TITLE V RULES APPLICABLE TO AGENCIES OR BRANCHES ESTABLISHED WITHIN THE COMMUNITY AND BELONGING TO UNDERTAKINGS WHOSE HEAD OFFICES ARE OUTSIDE THE COMMUNITY Article 51 Principles and conditions of authorisation 1. Each Member State shall make access to the activities referred to in Article 2 by any undertaking whose head office is outside the Community subject to an official authorisation. 2. A Member State may grant an authorisation if the undertaking fulfils at least the following conditions: (a) it is entitled to undertake insurance activities covered by Article 2 under its national law; (b) it establishes an agency or branch in the territory of such Member State; (c) it undertakes to establish at the place of management of the agency or branch accounts specific to the activity which it carries on there and to keep there all the records relating to the business transacted; (d) it designates a general representative, to be approved by the competent authorities; (e) it possesses in the Member State where it carries on an activity assets of an amount equal in value to at least one half of the minimum amount prescribed in Article 29(2), first subparagraph, in respect of the guarantee fund and deposits one quarter of the minimum amount as security; (f) it undertakes to keep a solvency margin complying with Article 55; (g) it submits a scheme of operations in accordance with the provisions of paragraph 3. 3. The scheme of operations of the agency or branch referred to in paragraph 2(g) shall contain the following particulars or evidence of: (a) the nature of the commitments which the undertaking proposes to cover; (b) the guiding principles as to reinsurance; (c) the state of the undertaking's solvency margin and guarantee fund referred to in Article 55; (d) estimates relating to the cost of setting up the administrative services and the organisation for securing business and the financial resources intended to meet those costs; and, in addition shall include, for the first three financial years: (e) a plan setting out detailed estimates of income and expenditure in respect of direct business, reinsurance acceptances and reinsurance cessions; (f) a forecast balance sheet; (g) estimates relating to the financial resources intended to cover underwriting liabilities and the solvency margin. 4. A Member State may require systematic notification of the technical bases used for calculating scales of premiums and technical provisions, without that requirement constituting a prior condition for an assurance undertaking to carry on its business. Article 52 Rules applicable to branches of third-country undertakings 1. (a) Subject to point (b), agencies and branches referred to in this Title may not simultaneously carry on in a Member State the activities referred to in the Annex to Directive 73/239/EEC and those covered by this Directive. (b) Subject to point (c), Member States may provide that agencies and branches referred to in this Title which on the relevant date referred to in Article 18(3) carried on both activities simultaneously in a Member State may continue to do so there provided that each activity is separately managed in accordance with Article 19. (c) Any Member State which under Article 18(6) requires undertakings established in its territory to cease the simultaneous pursuit of the activities in which they were engaged on the relevant date referred to in Article 18(3) must also impose this requirement on agencies and branches referred to in this Title which are established in its territory and simultaneously carry on both activities there. (d) Member States may provide that agencies and branches referred to in this Title whose head office simultaneously carries on both activities and which on the dates referred to in Article 18(3) carried on in the territory of a Member State solely the activity covered by this Directive may continue their activity there. If the undertaking wishes to carry on the activity referred to in Directive 73/239/EEC in that territory it may only carry on the activity covered by this Directive through a subsidiary. 2. Articles 13 and 37 shall apply mutatis mutandis to agencies and branches referred to in this title. For the purposes of applying Article 37, the competent authority which supervises the overall solvency of agencies or branches shall be treated in the same way as the competent authority of the head-office Member State. 3. In the case of a withdrawal of authorisation by the authority referred to in Article 56(2), this authority shall notify the competent authorities of the other Member States where the undertaking operates and the latter authorities shall take the appropriate measures. If the reason for the withdrawal of authorisation is the inadequacy of the solvency margin calculated in accordance with Article 56(1)(a), the competent authorities of the other Member States concerned shall also withdraw their authorisations. Article 53 Transfer of portfolio 1. Under the conditions laid down by national law, each Member State shall authorise agencies and branches set up within its territory and covered by this Title to transfer all or part of their portfolios of contracts to an accepting office established in the same Member State if the competent authorities of that Member State or, if appropriate, those of the Member State referred to in Article 56 certify that after taking the transfer into account the accepting office possesses the necessary solvency margin. 2. Under the conditions laid down by national law, each Member State shall authorise agencies and branches set up within its territory and covered by this Title to transfer all or part of their portfolios of contracts to an assurance undertaking with a head office in another Member State, if the competent authorities of that Member State certify that after taking the transfer into account the accepting office possesses the necessary solvency margin. 3. If under the conditions laid down by national law, a Member State authorises agencies and branches set up within its territory and covered by this Title to transfer all or part of their portfolios of contracts to an agency or branch covered by this Title and set up within the territory of another Member State, it shall ensure that the competent authorities of the Member State of the accepting office or, if appropriate, of the Member State referred to in Article 56 certify that after taking the transfer into account the accepting office possesses the necessary solvency margin, that the law of the Member State of the accepting office permits such a transfer and that the State has agreed to the transfer. 4. In the circumstances referred to in paragraphs 1, 2 and 3 the Member State in which the transferring agency or branch is situated shall authorise the transfer after obtaining the agreement of the competent authorities of the Member State of the commitment, where different from the Member State in which the transferring agency or branch is situated. 5. The competent authorities of the Member States consulted shall give their opinion or consent to the competent authorities of the home Member State of the transferring assurance undertaking within three months of receiving a request; the absence of any response from the authorities consulted within that period shall be considered equivalent to a favourable opinion or tacit consent. 6. A transfer authorised in accordance with this Article shall be published as laid down by national law in the Member State of the commitment. Such transfers shall automatically be valid against policy holders, assured persons and any other persons having rights or obligations arising out of the contracts transferred. This provision shall not affect the Member States' right to give policy holders the option of cancelling contracts within a fixed period after a transfer. Article 54 Technical provisions Member States shall require undertakings to establish provisions, referred to in Article 20, adequate to cover the underwriting liabilities assumed in their territories. Member States shall see that the agency or branch covers such provisions by means of assets which are equivalent to such provisions and matching assets in accordance with Annex II. The law of the Member States shall be applicable to the calculation of such provisions, the determination of categories of investment and the valuation of assets, and, where appropriate, the determination of the extent to which these assets may be used for the purpose of covering such provisions. The Member State in question shall require that the assets covering these provisions, shall be localised in its territory. Article 20(4) shall, however, apply. Article 55 Solvency margin and guarantee fund 1. Each Member State shall require of agencies or branches set up in its territory a solvency margin consisting of the items listed in Article 27. The minimum solvency margin shall be calculated in accordance with Article 28. However, for the purpose of calculating this margin, account shall be taken only of the operations effected by the agency or branch concerned. 2. One third of the minimum solvency margin shall constitute the guarantee fund. However, the amount of this fund may not be less than one half of the minimum required under Article 29(2) first subparagraph. The initial deposit lodged in accordance with Article 51(2)(e) shall be counted towards such guarantee fund. The guarantee fund and the minimum of such fund shall be constituted in accordance with Article 29. 3. The assets representing the minimum solvency margin must be kept within the Member State where activities are carried on up to the amount of the guarantee fund and the excess within the Community. Article 56 Advantages to undertakings authorised in more than one Member State 1. Any undertaking which has requested or obtained authorisation from more than one Member State may apply for the following advantages which may be granted only jointly: (a) the solvency margin referred to in Article 55 shall be calculated in relation to the entire business which it carries on within the Community; in such case, account shall be taken only of the operations effected by all the agencies or branches established within the Community for the purposes of this calculation; (b) the deposit required under Article 51(2)(e) shall be lodged in only one of those Member States; (c) the assets representing the guarantee fund shall be localised in any one of the Member States in which it carries on its activities. 2. Application to benefit from the advantages provided for in paragraph 1 shall be made to the competent authorities of the Member States concerned. The application must state the authority of the Member State which in future is to supervise the solvency of the entire business of the agencies or branches established within the Community. Reasons must be given for the choice of authority made by the undertaking. The deposit shall be lodged with that Member State. 3. The advantages provided for in paragraph 1 may only be granted if the competent authorities of all Member States in which an application has been made agree to them. They shall take effect from the time when the selected competent authority informs the other competent authorities that it will supervise the state of solvency of the entire business of the agencies or branches within the Community. The competent authority selected shall obtain from the other Member States the information necessary for the supervision of the overall solvency of the agencies and branches established in their territory. 4. At the request of one or more of the Member States concerned, the advantages granted under this Article shall be withdrawn simultaneously by all Member States concerned. Article 57 Agreements with third countries The Community may, by means of agreements concluded pursuant to the Treaty with one or more third countries, agree to the application of provisions different from those provided for in this Title, for the purpose of ensuring, under conditions of reciprocity, adequate protection for policy holders in the Member States. TITLE VI RULES APPLICABLE TO SUBSIDIARIES OF PARENT UNDERTAKINGS GOVERNED BY THE LAWS OF A THIRD COUNTRY AND TO THE ACQUISITIONS OF HOLDINGS BY SUCH PARENT UNDERTAKINGS Article 58 Information from Member States to the Commission The competent authorities of the Member States shall inform the Commission: (a) of any authorisation of a direct or indirect subsidiary one or more parent undertakings of which are governed by the laws of a third country. The Commission shall inform the Committee referred to in Article 65(1) accordingly; (b) whenever such a parent undertaking acquires a holding in a Community assurance undertaking which would turn the latter into its subsidiary. The Commission shall inform the Committee referred to in Article 65(1) accordingly. When authorisation is granted to the direct or indirect subsidiary of one or more parent undertakings governed by the law of third countries, the structure of the group shall be specified in the notification which the competent authorities shall address to the Commission. Article 59 Third-country treatment of Community assurance undertakings 1. The Member States shall inform the Commission of any general difficulties encountered by their assurance undertakings in establishing themselves or carrying on their activities in a third country. 2. Periodically, the Commission shall draw up a report examining the treatment accorded to Community assurance undertakings in third countries, in the terms referred to in paragraphs 3 and 4, as regards establishment and the carrying-on of insurance activities, and the acquisition of holdings in third-country insurance undertakings. The Commission shall submit those reports to the Council, together with any appropriate proposals. 3. Whenever it appears to the Commission, either on the basis of the reports referred to in paragraph 2 or on the basis of other information, that a third country is not granting Community assurance undertakings effective market access comparable to that granted by the Community to insurance undertakings from that third country, the Commission may submit proposals to the Council for the appropriate mandate for negotiation with a view to obtaining comparable competitive opportunities for Community assurance undertakings. The Council shall decide by a qualified majority. 4. Whenever it appears to the Commission, either on the basis of the reports referred to in paragraph 2 or on the basis of other information, that Community assurance undertakings in a third country are not receiving national treatment offering the same competitive opportunities as are available to domestic insurance undertakings and that the conditions of effective market access are not being fulfilled, the Commission may initiate negotiations in order to remedy the situation. In the circumstances described in the first subparagraph, it may also be decided at any time, and in addition to initiating negotiations, in accordance with the procedure laid down in Article 65(2), that the competent authorities of the Member States must limit or suspend their decisions: — regarding requests pending at the moment of the decision or future requests for authorisations, and — regarding the acquisition of holdings by direct or indirect parent undertakings governed by the laws of the third country in question. The duration of the measures referred to may not exceed three months. Before the end of that three-month period, and in the light of the results of the negotiations, the Council may, acting on a proposal from the Commission, decide by a qualified majority whether the measures shall be continued. Such limitations or suspension may not apply to the setting up of subsidiaries by assurance undertakings or their subsidiaries duly authorised in the Community, or to the acquisition of holdings in Community assurance undertakings by such undertakings or subsidiaries. 5. Whenever it appears to the Commission that one of the situations described in paragraphs 3 and 4 has arisen, the Member States shall inform it at its request: (a) of any request for the authorisation of a direct or indirect subsidiary one or more parent undertakings of which are governed by the laws of the third country in question; (b) of any plans for such an undertaking to acquire a holding in a Community assurance undertaking such that the latter would become the subsidiary of the former. This obligation to provide information shall lapse whenever an agreement is reached with the third country referred to in paragraph 3 or 4 when the measures referred to in the second and third subparagraphs of paragraph 4 cease to apply. 6. Measures taken under this Article shall comply with the Community's obligations under any international agreements, bilateral or multilateral, governing the taking up and pursuit of the business of insurance undertakings. TITLE VII TRANSITIONAL AND OTHER PROVISIONS Article 60 Derogations and abolition of restrictive measures 1. Undertakings set up in the United Kingdom by Royal Charter or by private Act or by special Public Act may carry on their activity in the legal form in which they were constituted on 15 March 1979 for an unlimited period. The United Kingdom shall draw up a list of such undertakings and communicate it to the other Member States and the Commission. 2. The societies registered in the United Kingdom under the Friendly Societies Acts may continue the activities of life assurance and savings operations which, in accordance with their objects, they were carrying on on 15 March 1979. Article 61 Proof of good repute 1. Where a Member State requires of its own nationals proof of good repute and proof of no previous bankruptcy, or proof of either of these, that State shall accept as sufficient evidence in respect of nationals of other Member States the production of an extract from the ‘judicial record’ or, failing this, of an equivalent document issued by a competent judicial or administrative authority in the home Member State or the Member State from which the foreign national comes showing that these requirements have been met. 2. Where the home Member State or the Member State from which the foreign national concerned comes does not issue the document referred to in paragraph 1, it may be replaced by a declaration on oath — or in States where there is no provision for declaration on oath by a solemn declaration — made by the person concerned before a competent judicial or administrative authority or, where appropriate, a notary in the home Member State or the Member State from which that person comes; such authority or notary shall issue a certificate attesting the authenticity of the declaration on oath or solemn declaration. The declaration in respect of no previous bankruptcy may also be made before a competent professional or trade body in the said country. 3. Documents issued in accordance with paragraphs 1 and 2 must not be produced more than three months after their date of issue. 4. Member States shall designate the authorities and bodies competent to issue the documents referred to in paragraphs 1 and 2 and shall forthwith inform the other Member States and the Commission thereof. Each Member State shall also inform the other Member States and the Commission of the authorities or bodies to which the documents referred to in this Article are to be submitted in support of an application to carry on in the territory of this Member State the activities referred to in Article 2. TITLE VIII FINAL PROVISIONS Article 62 Cooperation between the Member States and the Commission The Commission and the competent authorities of the Member States shall collaborate closely with a view to facilitating the supervision of the kinds of insurance and the operations referred to in this Directive within the Community. Each Member State shall inform the Commission of any major difficulties to which application of this Directive gives rise, inter alia, any arising if a Member State becomes aware of an abnormal transfer of business referred to in this Directive to the detriment of undertakings established in its territory and to the advantage of agencies and branches located just beyond its borders. The Commission and the competent authorities of the Member States concerned shall examine such difficulties as quickly as possible in order to find an appropriate solution. Where necessary, the Commission shall submit appropriate proposals to the Council. Article 63 Reports on the development of the market under the freedom to provide services The Commission shall forward to the European Parliament and to the Council regular reports, the first on 20 November 1995, on the development of the market in assurance and operations transacted under conditions of freedom to provide services. Article 64 Technical adjustment The following technical adjustments to be made to this Directive shall be adopted in accordance with the procedure laid down in Article 65(2): — extension of the legal forms provided for in Article 6(1)(a), — amendments to the list set out in Annex I, or adaptation of the terminology used in that list to take account of the development of assurance markets, — clarification of the items constituting the solvency margin listed in Article 27 to take account of the creation of new financial instruments, — alteration of the minimum guarantee fund provided for in Article 29(2) to take account of economic and financial developments, — amendments, to take account of the creation of new financial instruments, to the list of assets acceptable as cover for technical provisions set out in Article 23 and to the rules on the spreading of investments laid down in Article 24, — changes in the relaxations in the matching rules laid down in Annex II, to take account of the development of new currency-hedging instruments or progress made in economic and monetary union, — clarification of the definitions in order to ensure uniform application of this Directive throughout the Community, — the technical adjustments necessary to the rules for setting the maxima applicable to interest rates, pursuant to Article 20, in particular to take account of progress made in economic and monetary union. Article 65 Committee procedure 1. The Commission shall be assisted by the Insurance Committee instituted by Directive 91/675/EEC. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. Article 66 Rights acquired by existing branches and assurance undertakings 1. Branches which started business, in accordance with the provisions in force in the Member State of the branch, before 1 July 1994 shall be presumed to have been subject to the procedure laid down in Article 40(1) to (5). They shall be governed, from that date by Articles 13, 20, 37, 39 and 46. 2. Articles 41 and 42 shall not affect rights acquired by assurance undertakings carrying on business under the freedom to provide services before 1 July 1994. Article 67 Right to apply to the courts Member States shall ensure that decisions taken in respect of an assurance undertaking under laws, regulations and administrative provisions adopted in accordance with this Directive may be subject to the right to apply to the courts. Article 68 Review of amounts expressed in euro 1. The Commission shall submit to the Council before 15 March 1985 a report dealing with the effects of the financial requirements imposed by this Directive on the situation in the insurance markets of the Member States. 2. The Council, acting on a proposal from the Commission, shall every two years examine and, where appropriate, revise the amounts expressed in euro in this Directive, in the light of how the Community's economic and monetary situation has evolved. Article 69 Implementation of new provisions 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 1(1)(m), Article 18(3), Article 51(2)(g), (3) and (4), Article 60(2) and Article 66(1) not later than 19 June 2004. They shall immediately inform the Commission thereof. 2. Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with Article 16(3) not later than 17 November 2002. They shall forthwith inform the Commission thereof. Before this date, Member States shall apply the provision referred to in Annex IV(1). 3. Member States shall adopt by 20 September 2003 the laws, regulations and administrative provisions necessary to comply with Articles 3(6), 27, 28, 29, 30 and 38. They shall forthwith inform the Commission thereof. Member States shall provide that the provisions referred to in the first subparagraph shall first apply to the supervision of accounts for financial years beginning on 1 January 2004 or during that calendar year. Before this date, Member States shall apply the provisions referred to in Annex IV(2) and (3). 4. When Member States adopt the measures mentioned in paragraphs (1), (2) and (3), they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 5. Not later than 1 January 2007 the Commission shall submit to the European Parliament and to the Council a report on the application of Articles 3(6), 27, 28, 29, 30 and 38 and, if necessary, on the need for further harmonisation. The report shall indicate how Member States have made use of the possibilities under those articles and, in particular, whether the discretionary powers afforded to the national supervisory authorities have resulted in major supervisory differences in the single market. Article 70 Information to the Commission The Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 71 Transitional period for Articles 3(6), 27, 28, 29, 30 and 38 1. Member States may allow assurance undertakings which at 20 March 2002 provided assurance in their territories in one or more of classes referred to in Annex I, a period of five years, commencing on that same date, in order to comply with the requirements set out in Articles 3(6), 27, 28, 29, 30 and 38. 2. Member States may allow any undertakings referred to in paragraph 1, which upon the expiry of the five-year period have not fully established the required solvency margin, a further period not exceeding two years in which to do so provided that such undertakings have, in accordance with Article 37, submitted for the approval of the competent authorities, the measures which they propose to take for such purpose. Article 72 Repealed directives and their correlation with this Directive 1. The Directives listed in Annex V, part A, are hereby repealed, without prejudice to the obligations of the Member States concerning the time limits for transposition and for application of the said Directives listed in Annex V, part B. 2. References to the repealed Directives shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex VI. Article 73 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 74 Addressees This Directive is addressed to the Member States.

32002L0084

2002

Directive 2002/84/EC of the European Parliament and of the Council of 5 November 2002 amending the Directives on maritime safety and the prevention of pollution from ships (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the Economic and Social Committee(2), Having regard to the opinion of the Committee of the Regions(3), Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), Whereas: (1) The Directives in force in the field of maritime safety make reference to the committee set up by Council Directive 93/75/EEC of 13 September 1993 concerning minimum requirements for vessels bound for or leaving Community ports and carrying dangerous or polluting goods(5) and, in certain cases, to an ad hoc committee set up by the pertinent directive. These committees were governed by the rules set out in Council Decision 87/373/EEC of 13 July 1987 laying down the procedures for the exercise of implementing powers conferred on the Commission(6). (2) Decision 87/373/EEC has been replaced by Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7). The measures required to implement the Directives in force in the field of maritime safety should be adopted in accordance with Council Decision 1999/468/EC. (3) Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002, establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS)(8) centralises the tasks of the committees established under the pertinent Community legislation on maritime safety, the prevention of pollution from ships and the protection of shipboard living and working conditions. (4) Council Directives 93/75/EEC, 94/57/EC(9), 95/21/EC(10), 96/98/EC(11), 97/70/EC(12), 98/18/EC(13), 98/41/EC(14), 1999/35/EC(15), and Directives 2000/59/EC(16), 2001/25/EC(17) and 2001/96/EC(18) of the European Parliament and of the Council in the field of maritime safety should therefore be amended in order to replace the existing committees by COSS. (5) The aforementioned Directives should also be amended in order to apply to them the amendment procedures laid down by Regulation (EC) No 2099/2002 and the relevant provisions of that Regulation designed to facilitate their adaptation to take account of changes to the international instruments referred to in Community legislation in the field of maritime safety, Article 1 Purpose The purpose of this Directive is to improve the implementation of Community legislation on maritime safety, the prevention of pollution from ships and shipboard living and working conditions: (a) by making reference to the COSS; (b) by accelerating the update and facilitating the amendment of such legislation in the light of developments in the international instruments applicable in the field of maritime safety, prevention of pollution from ships and shipboard living and working conditions, pursuant to Regulation (EC) No 2099/2002. Article 2 Amendment to Directive 93/75/EEC Directive 93/75/EEC is hereby amended as follows: 1. in Article 2, points (e), (f), (g), (h) and (i) shall be replaced by the following: "(e) 'Marpol 73/78' means the International Convention for the Prevention of Pollution from Ships, 1973, as amended by the Protocol of 1978 relating thereto, in their up-to-date versions; (f) 'IMDG Code' means the International Maritime Dangerous Goods Code, in its up-to-date version; (g) 'IBC Code' means the IMO International Code for construction and equipment of ships carrying dangerous chemicals in bulk, in its up-to-date version; (h) 'IGC Code' means the IMO International Code for the construction and equipment of ships carrying liquefied gases in bulk, in its up-to-date version; (i) 'INF Code' means the IMO code for the safe carriage of irradiated nuclear fuel, plutonium and high-level radioactive wastes in flasks on board ships, in its up-to-date version"; 2. the following subparagraph shall be added to Article 11:"The amendments to the international instruments referred to in Article 2 may be excluded from the scope of this Directive, pursuant to Article 5 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS)(19)."; 3. Article 12 shall be replaced by the following: "Article 12 1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) created by Article 3 of Regulation (EC) No 2099/2002. 2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(20) shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at two months. 3. The Committee shall adopt its rules of procedure." Article 3 Amendment to Directive 94/57/EC Directive 94/57/EC is hereby amended as follows: 1. in Article 2(d), the words "in force on 19 December 2001" shall be replaced by "in its up-to-date version"; 2. in Article 7, point 1 shall be replaced by the following: "1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) created by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS)(21)."; 3. the following subparagraph shall be added to Article 8(2):"The amendments to the international instruments referred to in Article 2(d) and Article 6 may be excluded from the scope of this Directive, pursuant to Article 5 of Regulation (EC) No 2099/2002." Article 4 Amendment to Directive 95/21/EC Directive 95/21/EC is hereby amended as follows: 1. Article 2 shall be amended as follows: (a) in point 1, the words "in force on 19 December 2001" shall be replaced by "in its up-to-date version"; (b) in point 2, the words "as it stands on 19 December 2001" shall be replaced by "in its up-to-date version"; 2. in Article 18, point 1 shall be replaced by the following: "1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) created by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS)(22)."; 3. Article 19 is hereby amended as follows: (a) point (c) shall be replaced by the following: "(c) update, in Article 2(1), the list of international conventions which are relevant for the purposes of this Directive." (b) the following subparagraph shall be added:"The amendments to the international instruments referred to in Article 2 may be excluded from the scope of this Directive, pursuant to Article 5 of Regulation (EC) No 2099/2002." Article 5 Amendment to Directive 96/98/EC Directive 96/98/EC is hereby amended as follows: 1. in Article 2, points (c), (d) and (n), the words "in force on 1 January 2001" shall be replaced by "in its up-to-date version"; 2. Article 17 shall be replaced by the following: "Article 17 This Directive may be amended in accordance with the procedure laid down in Article 18(2), in order: - to apply subsequent amendments of international instruments for the purposes of this Directive, - to update Annex A, both by introducing new equipment and by transferring equipment from Annex A.2 to Annex A.1 and vice versa, - to add the possibility of using modules B and C and module H for equipment listed in Annex A.1, and by amending the columns for the conformity assessment modules, - to include other standardisation organisations in the definition of 'testing standards' in Article 2. The conventions and testing standards referred to in points (c), (d) and (n) of Article 2 shall be understood without prejudice to any measures taken in application of Article 5 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002, establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS)(23)."; 3. Article 18 shall be replaced by the following: "Article 18 1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) created by Article 3 of Regulation (EC) No 2099/2002. 2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(24) shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at two months. 3. The Committee shall adopt its rules of procedure." Article 6 Amendment to Directive 97/70/EC Directive 97/70/EC is hereby amended as follows: 1. the following subparagraph shall be added to Article 8:"The amendments to the international instrument referred to in Article 2(4) may be excluded from the scope of this Directive, pursuant to Article 5 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS)(25)."; 2. Article 9 shall be replaced by the following: "Article 9 Committee 1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) created by Article 3 of Regulation (EC) No 2099/2002. 2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(26) shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at two months. 3. The Committee shall adopt its rules of procedure." Article 7 Amendment to Directive 98/18/EC Directive 98/18/EC is hereby amended as follows: 1. in Article 2, points (a), (b), (c), (d) and (f) shall be replaced by the following: "(a) 'International Conventions' means the 1974 International Convention for the Safety of Life at Sea (the 1974 Solas Convention), and the 1966 International Convention on Load Lines, together with Protocols and amendments thereto, in their up-to-date versions; (b) 'Intact Stability Code' means the 'Code on Intact Stability for all types of ships covered by IMO Instruments' contained in IMO Assembly Resolution A.749(18) of 4 November 1993, in its up-to-date version; (c) 'High Speed Craft Code' means the 'International Code for Safety of High Speed Craft' contained in IMO Maritime Safety Committee Resolution MSC 36 (63) of 20 May 1994, in its up-to-date version; (d) 'GMDSS' means the Global Maritime Distress and Safety System as laid down in Chapter IV of the 1974 Solas Convention, in its up-to-date version; (...) (f) 'a high speed passenger craft' means a high speed craft as defined in Regulation X/1 of the 1974 Solas Convention, in its up-to-date version, which carries more than 12 passengers; passenger ships engaged on domestic voyages in sea areas of Class B, C or D shall not be considered as high speed passenger craft when: - their displacement corresponding to the design waterline is less than 500 m3, and - their maximum speed, as defined in paragraph 1.4.30 of the High Speed Craft Code, is less than 20 knots;" 2. in Article 6(1), points (b) and (c), Article 6(2), point (a)(i), and Article 6(3), point (a), the words as amended at the date of adoption of this Directive shall be replaced by in its up-to-date version; 3. Article 8 shall be replaced by the following: "Article 8 Adaptations In accordance with the procedure laid down in Article 9(2): (a) (i) the definitions in Article 2(a), (b), (c), (d) and (t); and (ii) the provisions relating to procedures and guidelines for surveys referred to in Article 10; (iii) the provisions concerning the Solas Convention and the International Code of Safety of High Speed Craft, and including its subsequent amendments laid down in Articles 4.3, 6.4, 10.3 and 11.3; and (iv) the specific references to the 'International Conventions' and IMO resolutions referred to in Articles 2(f), (k) and (o), 3.2(a), 6.1(b) and (c), 6.2(b) and 11.3, may be adapted in order to take account of developments at international level, in particular within IMO; (b) Annexes may be amended in order to: (i) apply, for the purpose of this Directive, amendments made to international conventions; (ii) improve the technical specifications thereof, in the light of experience. The amendments to the international instruments referred to in Article 2 may be excluded from the scope of this Directive, pursuant to Article 5 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS)(27)."; 4. Article 9 shall be replaced by the following: "Article 9 Committee 1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) created by Article 3 of Regulation (EC) No 2099/2002. 2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(28) shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at two months. 3. The Committee shall adopt its rules of procedure." Article 8 Amendment to Directive 98/41/EC Directive 98/41/EC is hereby amended as follows: 1. in Article 2, third indent, the words "as in force at the time of the adoption of this Directive" shall be replaced by the words "in its up-to-date version"; 2. the following subparagraph shall be added to Article 12:"The amendments to the international instruments referred to in Article 2 may be excluded from the scope of this Directive, pursuant to Article 5 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS)(29)."; 3. Article 13 shall be replaced by the following: "Article 13 1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) created by Article 3 of Regulation (EC) No 2099/2002. 2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(30) hall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at two months. 3. The Committee shall adopt its rules of procedure." Article 9 Amendment to Directive 1999/35/EC Directive 1999/35/EC is hereby amended as follows: 1. in Article 2, points (b), (d), (e) and (o) shall be replaced by the following: "(b) 'High Speed Passenger Craft' shall mean a high speed craft as defined in Regulation X/1 of the 1974 Solas Convention, in its up-to-date version, which carries more than 12 passengers; (...) (d) '1974 Solas Convention' shall mean the International Convention for the Safety of Life at Sea, together with Protocols and amendments thereto, in its up-to-date version; (e) 'High Speed Craft Code' shall mean the 'International Code for Safety of High Speed Craft' contained in IMO Maritime Safety Committee Resolution MSC 36 (63) of 20 May 1994, in its up-to-date version; (...) (o) 'company' shall mean a company operating one or more ro-ro ferries to which a document of compliance has been issued in compliance with Article 5(2) of Council Regulation (EC) No 3051/95 of 8 December 1995 on the safety management of roll on roll off passenger ferries (ro-ro ferries) or a company operating high speed passenger craft, to which a document of compliance has been issued in accordance with Regulation IX/4 of the 1974 Solas Convention, in its up-to-date version"; 2. Article 16 shall be replaced by the following: "Article 16 Committee 1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) created by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS)(31). 2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(32) shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at two months. 3. The Committee shall adopt its rules of procedure."; 3. the following subparagraph shall be added to Article 17:"The amendments to the international instruments referred to in Article 2 may be excluded from the scope of this Directive, pursuant to Article 5 of Regulation (EC) No 2099/2002"; 4. Annex I is hereby amended as follows: in point 7, the words "MSC Resolution... (70)" shall be replaced by the words "IMO Assembly Resolution A.893(21)". Article 10 Amendment to Directive 2000/59/EC Directive 2000/59/EC is hereby amended as follows: 1. in Article 2(b) the words "as in force at the date of adoption of this Directive" shall be replaced by "in its up-to-date version"; 2. Article 14(1) shall be replaced by the following: "1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) created by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS)(33)."; 3. the following paragraph shall be added to Article 15:"The amendments to the international instruments referred to in Article 2 may be excluded from the scope of this Directive, pursuant to Article 5 of Regulation (EC) No 2099/2002." Article 11 Amendment to Directive 2001/25/EC Directive 2001/25/EC is hereby amended as follows: 1. in Article 1, points 16, 17, 18, 21, 22, 23 and 24 shall be replaced by the following: "16. 'chemical tanker' shall mean a ship constructed or adapted and used for the carriage in bulk of any liquid product listed in Chapter 17 of the International Bulk Chemical Code, in its up-to-date version; 17. 'liquefied-gas tanker' shall mean a ship constructed or adapted and used for the carriage in bulk of any liquefied gas or other product listed in Chapter 19 of the International Gas Carrier Code, in its up-to-date version; 18. 'Radio Regulations' shall mean the revised radio regulations, adopted by the World Administrative Radio Conference for the Mobile Service in their up-to-date version; (...) 21. 'STCW Convention' shall mean the International Convention on Standards of Training, Certification and Watchkeeping for Seafarers as it applies to the matters concerned taking into account the transitional provisions of Article VII and Regulation I/15 of the Convention and including, where appropriate, the applicable provisions of the STCW code, all being applied in its up-to-date version; 22. 'radio duties' shall include, as appropriate, watchkeeping and technical maintenance and repairs conducted in accordance with the Radio Regulations, the International Convention for the Safety of Life at Sea (1974), (Solas Convention) and, at the discretion of each Member State, the relevant recommendations of the International Maritime Organisation (IMO), in their up-to-date versions; 23. 'ro-ro passenger ship' shall mean a passenger ship with ro-ro cargo spaces or special-category spaces as defined in the Solas Convention, in its up-to-date version; 24. 'STCW Code' shall mean the Seafarers' Training, Certification and Watchkeeping (STCW) Code as adopted by Resolution 2 of the 1995 STCW Conference of Parties, in its up-to-date version"; 2. the following paragraph shall be added to Article 22: "4. The amendments to the international instruments referred to in Article 1 may be excluded from the scope of this Directive, pursuant to Article 5 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS)(34)." 3. in Article 23, point 1 shall be replaced by the following: "1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) created by Article 3 of Regulation (EC) No 2099/2002." Article 12 Amendment to Directive 2001/96/EC Directive 2001/96/EC is hereby amended as follows: 1. in Article 3(2), the words "in force on 4 December 2001" shall be replaced by "in its up-to-date version"; 2. in Article 14, point 1 shall be replaced by the following: "1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) created by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS)(35)."; 3. the following paragraph shall be added to Article 15: "3. The amendments to the international instruments referred to in Article 3 may be excluded from the scope of this Directive, pursuant to Article 5 of Regulation (EC) No 2099/2002." Article 13 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 23 November 2003. They shall forthwith inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall notify to the Commission the main provisions of their national law which they adopt in the field governed by this Directive. Article 14 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 15 Addressees This Directive is addressed to the Member States.

32002L0090

2002

Council Directive 2002/90/EC of 28 November 2002 defining the facilitation of unauthorised entry, transit and residence Having regard to the Treaty establishing the European Community, and in particular Article 61(a) and Article 63(3)(b) thereof, Having regard to the initiative of the French Republic(1), Having regard to the opinion of the European Parliament(2), Whereas: (1) One of the objectives of the European Union is the gradual creation of an area of freedom, security and justice, which means, inter alia, that illegal immigration must be combated. (2) Consequently, measures should be taken to combat the aiding of illegal immigration both in connection with unauthorised crossing of the border in the strict sense and for the purpose of sustaining networks which exploit human beings. (3) To that end it is essential to approximate existing legal provisions, in particular, on the one hand, the precise definition of the infringement in question and the cases of exemption, which is the subject of this Directive and, on the other hand, minimum rules for penalties, liability of legal persons and jurisdiction, which is the subject of Council framework Decision 2002/946/JHA of 28 November 2002 on the strengthening of the penal framework to prevent the facilitation of unauthorised entry, transit and residence(3). (4) The purpose of this Directive is to provide a definition of the facilitation of illegal immigration and consequently to render more effective the implementation of framework Decision 2002/946/JHA in order to prevent that offence. (5) This Directive supplements other instruments adopted in order to combat illegal immigration, illegal employment, trafficking in human beings and the sexual exploitation of children. (6) As regards Iceland and Norway, this Directive constitutes a development of provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis(4), which fall within the area referred to in Article 1(E) of Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of that Agreement(5). (7) The United Kingdom and Ireland are taking part in the adoption and application of this Directive in accordance with the relevant provisions of the Treaties. (8) In accordance with Articles 1 and 2 of the Protocol on the position of Denmark annexed to the Treaty on European Union and to the Treaty establishing the European Community, Denmark is not taking part in the adoption of this Directive and is not bound by it or subject to its application. Given that this Directive builds upon the Schengen acquis under the provisions of Title IV of Part Three of the Treaty establishing the European Community, Denmark shall, in accordance with Article 5 of the said Protocol, decide within a period of six months after the Council has adopted this Directive whether it will implement it in its national law, Article 1 General infringement 1. Each Member State shall adopt appropriate sanctions on: (a) any person who intentionally assists a person who is not a national of a Member State to enter, or transit across, the territory of a Member State in breach of the laws of the State concerned on the entry or transit of aliens; (b) any person who, for financial gain, intentionally assists a person who is not a national of a Member State to reside within the territory of a Member State in breach of the laws of the State concerned on the residence of aliens. 2. Any Member State may decide not to impose sanctions with regard to the behaviour defined in paragraph 1(a) by applying its national law and practice for cases where the aim of the behaviour is to provide humanitarian assistance to the person concerned. Article 2 Instigation, participation and attempt Each Member State shall take the measures necessary to ensure that the sanctions referred to in Article 1 are also applicable to any person who: (a) is the instigator of, (b) is an accomplice in, or (c) attempts to commit an infringement as referred to in Article 1(1)(a) or (b). Article 3 Sanctions Each Member State shall take the measures necessary to ensure that the infringements referred to in Articles 1 and 2 are subject to effective, proportionate and dissuasive sanctions. Article 4 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 5 December 2004. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of their national law which they adopt in the field covered by this Directive, together with a table showing how the provisions of this Directive correspond to the national provisions adopted. The Commission shall inform the other Member States thereof. Article 5 Repeal Article 27(1) of the 1990 Schengen Convention shall be repealed as from 5 December 2004. Where a Member State implements this Directive pursuant to Article 4(1) in advance of that date, the said provision shall cease to apply to that Member State from the date of implementation. Article 6 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 7 Addressees This Directive is addressed to the Member States in accordance with the Treaty establishing the European Community.

32002L0089

2002

Council Directive 2002/89/EC of 28 November 2002 amending Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Parliament(2), Having regard to the opinion of the Economic and Social Committee(3), Whereas: (1) Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(4) sets out the Community plant health regime, specifying the phytosanitary conditions, procedures and formalities to which plants and plant products are subjected when introduced into, or moved within, the Community. (2) With respect to the procedures and formalities, to which plants and plant products are subjected when introduced in the Community, certain clarifications should be provided and further detailed provisions are required in certain areas. (3) The phytosanitary procedures and formalities should be completed before customs clearance takes place. Since consignments of plants or plant products do not necessarily undergo phytosanitary procedures and formalities in the same Member State as that in which customs clearance takes place, a system of cooperation in communication and information among the responsible official bodies and the customs offices should be established. (4) In order to improve the protection against the introduction into the Community of organisms harmful to plants or plant products, Member States should intensify the checks required. Those checks should be effective and carried out in a harmonised manner throughout the Community. (5) The fees charged for such checks should be based on a transparent cost calculation and aligned in all Member States as much as possible. (6) In the light of experience, several other provisions of Directive 2000/29/EC should be completed, clarified or amended in the light of developments. (7) Since the implementation of the conditions of the internal market, phytosanitary certificates as established in the International Plant Protection Convention (IPPC) of the Food and Agriculture Organisation (FAO) are no longer used for the marketing of plants or plant products within the Community. It is however important to keep standardised certificates issued by Member States under the IPPC. (8) Some of the functions of the "single authority" of each Member State for coordination and contact in the practical operations of the Community plant health regime require specific scientific or technical knowledge. It must therefore be made possible, to delegate specific tasks to another service. (9) The current provisions on the procedure for the amendment of the Annexes of Directive 2000/29/EC by the Commission and for the adoption of derogation decisions include some procedural conditions which are no longer necessary or justified. It is also necessary to base amendments to the Annexes, more explicitly, on a technical justification consistent with the pest risk involved. The procedure for the adoption of emergency measures does not provide the possibility for a rapid adoption of interim measures consistent with the level of emergency in specific cases. The provisions on these three procedures should therefore be amended accordingly. (10) The list of tasks in respect of which the Commission may organise plant health checks under its authority, should be extended, to take into account the widening of the field of plant health activities through new practices and experiences. (11) It is appropriate to clarify certain aspects of the procedure for the refunding of the Community Phytosanitary contribution. (12) Some provisions of Directive 2000/29/EC (first, second and fourth subparagraphs of Article 3(7)), as well as Articles 7, 8 and 9 have been superseded by other provisions since 1 June 1993, and have therefore become redundant since then. They should consequently be deleted. (13) Under Article 4 of the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), the Community must recognise, under certain conditions, the equivalence of phytosanitary measures of other Parties to that Agreement. The procedures for such recognition in the field of plant health should be specified in Directive 2000/29/EC. (14) The measures necessary for the implementation of Directive 2000/29/EC should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5), Article 1 Directive 2000/29/EC is hereby amended as follows: 1. Article 1 shall be amended as follows: (a) in the second subparagraph of paragraph 1, the following point shall be added: "(d) the model of 'Phytosanitary Certificates' and 'phytosanitary certificates for Re-export' or their electronic equivalent issued by Member States under the International Plant Protection Convention (IPPC)."; (b) Paragraph 4 shall be replaced by the following: "(4) The Member States shall ensure a close, rapid, immediate and effective cooperation between themselves and the Commission in relation to matters covered by this Directive. To this end, each Member State shall establish or designate a single authority, which shall be responsible, at least, for the coordination and contact in relation to such matters. The official plant protection organisation set up under the IPPC shall preferably be designated for this purpose. This authority and any subsequent change shall be notified to the other Member States and to the Commission. In accordance with the procedure referred to in Article 18(2) the single authority may be authorised to assign or delegate tasks of coordination or contact, insofar as they relate to distinct plant health matters covered by this Directive, to another service."; 2. Article 2(1) shall be amended as follows: (a) point (a) shall be amended as follows: (i) the first subparagraph shall be replaced by the following: "plants shall be considered to mean: living plants and specified living parts thereof, including seeds;" (ii) The second subparagraph shall be amended as follows: - the following seventh indent shall be inserted after the sixth indent: "- leaves, foliage," - the existing seventh indent shall become the eight indent, - the following ninth indent shall be added: "- live pollen" - the following tenth indent shall be added: "- bud-wood, cuttings, scions" - the following eleventh indent shall be added: "- any other part of plants, which may be specified in accordance with the procedure referred to in Article 18(2)."; (b) point (e) shall be replaced by the following: "(e) harmful organisms shall be considered to mean: any species, strain or biotype of plant, animal or pathogenic agent injurious to plants or plant products"; (c) in point (f), third subparagraph, the terms "Article 8" shall be replaced by "Article 18(2)"; (d) point (g), shall be amended as follows: (i) In the first subparagraph, in point (i), the word "services(s)" shall be replaced by the word "organisation(s)". (ii) The fifth subparagraph shall be replaced by the following:"The single authority referred to in Article 1(4) shall inform the Commission of the responsible official bodies in the Member State concerned. The Commission shall forward that information to the other Member States."; (e) in point (h), third subparagraph, in the second sentence and in the fifth subparagraph, the words "in writing" shall be inserted between the words "notified" and "to the Commission"; (f) in point (i), first subparagraph, the first indent shall be replaced by the following: "- by representatives of the official national plant protection organisation of a third country or, under their responsibility, by other public officers who are technically qualified and duly authorised by that official national plant protection organisation, in the case of statements or measures related to the issuing of the phytosanitary certificates and phytosanitary certificates for re-exports, or their electronic equivalent"; (g) the following points shall be added: "(j) point of entry shall be considered to mean: the place where plants, plant products or other objects are brought for the first time into the customs territory of the Community: the airport in the case of air transport, the port in the case of maritime or fluvial transport, the station in the case of railway transport, and the place of the customs office responsible for the area where the Community inland frontier is crossed, in the case of any other transport; (k) official body of point of entry shall be considered to mean: the responsible official body in a Member State in charge of the point of entry; (l) official body of destination shall be considered to mean: the responsible official body in a Member State in charge of the area where the 'customs office of destination' is situated; (m) customs office of point of entry shall be considered to mean: the office of the point of entry as defined in (j) above; (n) customs office of destination shall be considered to mean: the office of destination within the meaning of Article 340b(3) of Commission Regulation (EEC) No 2454/93(6); (o) lot shall be considered to mean: a number of units of a single commodity, identifiable by its homogeneity of composition and origin, and forming part of a consignment; (p) consignment shall be considered to mean: A quantity of goods being covered by a single document required for customs formalities or for other formalities, such as a single phytosanitary certificate or a single alternative document or mark; a consignment may be composed of one or more lots; (q) customs-approved treatment or use shall be considered to mean: the customs-approved treatments or uses referred to in point 15 of Article 4 of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code(7) (hereafter referred to as the Community Customs Code); (r) transit shall be considered to mean: the movement of goods which are subject to customs supervision from one point to another within the customs territory of the Community as referred to in Article 91 of Regulation (EEC) No 2913/92."; 3. Article 3 shall be amended as follows: (a) paragraph 3 shall be replaced by the following: "3. Paragraphs 1 and 2 shall not apply in accordance with conditions which may be determined in accordance with the procedure referred to in Article 18(2), in the case of slight contamination of plants other than those intended for planting by harmful organisms listed in Annex I, Part A, or in Annex II, Part A, or in the case of appropriate tolerances established for harmful organisms listed in Annex II, Part A, Section II as regards plants intended for planting which have previously been selected in agreement with the authorities representing the Member States in the field of plant health, and based on a relevant pest risk analysis."; (b) paragraph 7 shall be replaced by the following paragraphs 7, 8 and 9: "7. In accordance with the procedure referred to in Article 18(2), implementing provisions may be adopted to lay down conditions for the introduction into the Member States and the spread within the Member States of: (a) organisms which are suspected of being harmful to plants or plant products but are not listed in Annexes I and II; (b) organisms, which are listed in Annex II, but which occur on plants or plant products other than those listed in that Annex, and which are suspected of being harmful to plants or plant products; (c) organisms, which are listed in Annexes I and II, which are in an isolated state and which are considered to be harmful in that state to plants or plant products. 8. Paragraphs 1 and 5(a) and paragraph 2 and 5(b) and paragraph 4 shall not apply, in accordance with the conditions which shall be determined pursuant to the procedure referred to in Article 18(2), for trial or scientific purposes and for work on varietal selections. 9. After the measures provided for in paragraph 7 have been adopted, that paragraph shall not apply, in accordance with the conditions which shall be determined pursuant to the procedure referred to in Article 18(2), for trial or scientific purposes and for work on varietal selections."; 4. Articles 7, 8 and 9 shall be deleted; 5. Article 10 shall be amended as follows: (a) paragraph 1 shall be amended as follows: (i) in the first subparagraph, the words "instead of the phytosanitary certificates referred to in Articles 7 or 8" shall be deleted; (ii) the following subparagraph shall be inserted after the first subparagraph:"However, in the case of seeds mentioned in Article 6(4), a plant passport need not be issued, where it is ensured in accordance with the procedure referred to in Article 18(2) that the documents issued in accordance with the Community provisions applicable to the marketing of officially certified seed provide evidence for the compliance with the requirements referred to in Article 6(4). In such case, the documents shall be considered for all purposes to be plant passports within the meaning of Article 2(1)(f)."; (b) in paragraph 2, in the first subparagraph, before the words "may not be moved" and in the second subparagraph, before the words "may not be introduced" the words "and seeds mentioned in Article 6(4)" shall be inserted; 6. In Article 11(2), the following shall be added at the end of the paragraph:"and a plant passport may be used." 7. Article 12 shall be replaced by the following: "Article 12 1. Member States shall organise official checks to ensure compliance with the provisions of this Directive, in particular with Article 10(2), which shall be carried out at random and without any discrimination in respect of the origin of the plants, plant products or other objects, and in accordance with the following provisions: - occasional checks, at any time and at any place where plants, plant products or other objects are moved, - occasional checks on premises where plants, plant products or other objects are grown, produced, stored or offered for sale, as well as on the premises of purchasers, - occasional checks at the same time as any other documentary check, which is carried out for reasons other than plant health. The checks must be regular in premises listed in an official register in accordance with Article 10(3) and Article 13c(1b), and may be regular in premises listed in an official register in accordance with Article 6(6). The checks must be targeted if facts have come to light to suggest that one or more provisions of this Directive have not been complied with. 2. Commercial purchasers of plants, plant products or other objects shall, as final users professionally engaged in plant production, retain the related plant passports for at least one year and enter the references in their records. Inspectors shall have access to the plants, plant products or other objects at all stages in the production and marketing chain. They shall be entitled to make any investigation necessary for the official checks concerned, including those related to the plant passports and the records. 3. The Member States may be assisted in the official checks by the experts referred to in Article 21. 4. Where it is established, through the official checks carried out in accordance with paragraphs 1 and 2, that plants, plant products or other objects present a risk of spreading harmful organisms, they shall be the subject of official measures in accordance with Article 11(3). Without prejudice to the notifications and information required under Article 16, Member States shall ensure, where the plants, plant products or other objects concerned come from another Member State, that the single authority of the receiving Member State informs immediately the single authority of that Member State and the Commission of the findings and of the official measures which it intends to take or has taken. In accordance with the procedure referred to in Article 18(2), a standardised information system may be set up."; 8. Article 13 shall be replaced by the following Articles 13, 13a, 13b, 13c, 13d and 13e: "Article 13 1. Member States shall ensure, without prejudice to: - the provisions of Article 3(3),13b(1), (2), (3), (4) and (5), - the specific requirements and conditions laid down in derogations adopted pursuant to Article 15(1), in equivalency measures adopted pursuant to Article 15(2), or in emergency measures adopted pursuant to Article 16, and - specific agreements concluded on matters dealt with in this Article between the Community and one or more third countries, that plants, plant products or other objects, listed in Annex V, Part B, which come from a third country and are brought into the customs territory of the Community, shall, from the time of their entry, be subject to customs supervision pursuant to Article 37(1) of the Community Customs Code and also to supervision by the responsible official bodies. They may only be placed under one of the customs procedures as specified in Article 4(16)(a), (d), (e), (f), (g) of the Community Customs Code, if the formalities as specified in Article 13a have been completed in accordance with the provisions of Article 13c(2), such as to conclude, as a result of these formalities and as far as can be determined: (i) - that the plants, plant products or other objects are not contaminated by harmful organisms listed in Annex I, Part A, and - in the case of plants or plant products listed in Annex II, Part A, that they are not contaminated by the relevant harmful organisms listed in that Annex, and - in the case of plants, plant products or other objects listed in Annex IV, Part A, that they comply with the relevant special requirements indicated in that Annex, or, where applicable, with the option declared in the certificate pursuant to Article 13a(4)(b), and (ii) that the plants, plant products or other objects are accompanied by the respective original of the required official 'phytosanitary certificate' or 'phytosanitary certificate for re-export' issued in accordance with the provisions laid down in Article 13a(3) and (4), or, where relevant, that the original of alternative documents or marks as specified and permitted in implementing provisions accompany, or are attached to, or otherwise put on, the object concerned. Electronic certification may be recognised, provided that the respective conditions specified in implementing provisions are met. Officially certified copies may also be recognised in exceptional cases which shall be specified in implementing provisions. The implementing provisions referred to in (ii) above may be adopted in accordance with the procedure referred to in Article 18(2). 2. Paragraph 1 shall apply, in cases of plants, plant products or other objects intended for a protected zone, in respect of harmful organisms and of special requirements listed in Annex I, Part B, Annex II, Part B and Annex IV, Part B respectively, for that protected zone. 3. Member States shall provide that plants, plant products or objects other than those referred to in paragraph 1 or 2, which come from a third country and are brought into the customs territory of the Community, may, from the time of their entry, be subject to supervision by the responsible official bodies, in respect of the first, second or third indent of paragraph 1(i). These plants, plant products or objects include wood in the form of dunnage, spacers, pallets or packing material, which are actually in use in the transport of objects of all kinds. Where the responsible official body makes use of that faculty, the plants, plant products or objects concerned shall remain under the supervision referred to in paragraph 1, until the relevant formalities have been completed such as to conclude, as a result for these formalities and as far as can be determined, that they comply with the relevant requirements laid down in or under this Directive. Implementing provisions as regards type of information and the means of transmission thereof to be supplied by importers, or their customs representatives, to the responsible official bodies, as regards the plants, plant products or objects including the different types of wood, as referred to in the first subparagraph, shall be adopted in accordance with the procedure referred to in Article 18(2). 4. Without prejudice to Article 13c(2)(a) Member States shall, if there is a risk of spread of harmful organisms, also apply paragraphs 1, 2 and 3 to plants, plant products or other objects being placed under one of the customs-approved treatments or uses as specified in Article 4(15)(b), (c), (d), (e) of the Community Customs Code or under the Customs procedures as specified in Article 4(16)(b), (c) of that Code. Article 13a 1. (a) The formalities referred to in Article 13(1) shall consist of meticulous inspections by the responsible official bodies on at least: (i) each consignment declared, under the customs formalities, to consist of or to contain plants, plant products or other objects, referred to in Article 13(1), (2) or (3) under the respective conditions, or (ii) in the case of a consignment which is composed of different lots, each lot declared, under the customs formalities, to consist of, or to contain, such plants, plant products or other objects. (b) The inspections shall determine whether: (i) the consignment or lot is accompanied by the required certificates, alternative documents or marks, as specified in Article 13(1)(ii) (documentary checks), (ii) in its entirety or on one or more representative samples, the consignment or lot consists of, or contains the plants, plant products or other objects, as declared on the required documents (identity checks), and (iii) in its entirety or on one or more representative samples, including the packaging and, where appropriate, the transport vehicles, the consignment or lot or their wood packing material comply with the requirements laid down in this Directive, as specified in Article 13(1)(i) (plant health checks), and whether Article 16(2) applies. 2. The identity checks and plant health checks shall be carried out at reduced frequency, if: - activities of inspection on plants, plant products or other objects in the consignment or lot were already carried out in the consignor third country under technical arrangements referred to in Article 13b(6), or - the plants, plant products or other objects in the consignment or lot are listed in the implementing provisions adopted for this purpose pursuant to paragraph 5(b), or - the plants, plant products or other objects in the consignment or lot came from a third country for which in or under comprehensive international phytosanitary agreements based on the principle of reciprocal treatment between the Community and a third country, provision for a reduced frequency of identity and plant health checks is mentioned, unless there is a serious reason to believe that the requirements laid down in this Directive are not complied with. The plant health checks may also be carried out at reduced frequency, if there is evidence, collated by the Commission and based on experience gained from earlier introduction of such material of the same origin into the Community as confirmed by all Member States concerned, and after consultation within the Committee referred to in Article 18, to believe that the plants, plant products or other objects in the consignment or lot comply with the requirements laid down in this Directive, provided that the detailed conditions specified in implementing provisions pursuant to paragraph 5(c) are met. 3. The official 'phytosanitary certificate' or 'phytosanitary certificate for re-export' referred to in Article 13(1)(ii) shall have been issued in at least one of the official languages of the Community and in accordance with the laws or regulations of the third country of export or re-export which have been adopted, whether a contracting party or not, in compliance with the provisions of the IPPC. It shall be addressed to the 'Plant Protection Organisations of the Member States of the European Community' as referred to in Article 1(4), first subparagraph, last sentence. The certificate shall not have been made out more than 14 days before the date on which the plants, plant products or other objects covered by it have left the third country in which it was issued. It shall contain information in accordance with the models specified in the Annex to the IPPC, irrespective of its format. It shall be in one of the models determined by the Commission pursuant to paragraph 4. The certificate shall have been issued by authorities empowered to this effect on the basis of laws or regulations of the third country concerned, as submitted, in accordance with the provisions of the IPPC, to the Director General of FAO, or, in the case of third countries non-party to the IPPC, to the Commission. The Commission shall inform the Member States of the submissions received. 4. (a) In accordance with the procedure referred to in Article 18(2), the acceptable models as specified in the different versions of the Annex to the IPPC shall be determined. In accordance with the same procedure, alternative specifications for the 'phytosanitary certificates' or 'phytosanitary certificates for re-export' may be laid down for third countries non-party to the IPPC. (b) Without prejudice to Article 15(4), the certificates, in the case of plants, plant products or other objects listed in Annex IV Part A section I or Part B, shall specify, under the heading 'Additional Declaration' and where relevant, which special requirement out of those listed as alternatives in the relevant position in the different parts of Annex IV have been complied with. This specification shall be given through reference to the relevant position in Annex IV. (c) In the case of plants, plant products or other objects, to which special requirements laid down in Annex IV, Part A, or Part B apply, the official 'phytosanitary certificate' referred to in Article 13(1)(ii) shall have been issued in the third country in which the plants, plant products or other objects originate (country of origin). (d) However, in the case where the relevant special requirements can be fulfilled also at places other than that of origin, or where no special requirement applies, the 'phytosanitary certificate' may have been issued in the third country where the plants, plant products or other objects come from (consignor country). 5. In accordance with the procedure referred to in Article 18(2), implementing provisions may be adopted to: (a) lay down procedures for the carrying out of plant health checks referred to in paragraph 1(b), point (iii), including minimum numbers and minimum sizes of samples, (b) establish lists of plants, plant products or other objects on which plant health checks shall be carried out at reduced frequency pursuant to paragraph 2, first subparagraph, second indent, (c) specify the detailed conditions for the evidence referred to in paragraph 2, second subparagraph, and the criteria for the type and level of reduction of the plant health checks. The Commission may include guidelines in respect of paragraph 2 in the recommendations referred to in Article 21(6). Article 13b 1. Member States shall ensure that consignments or lots which come from a third country, but are not declared, under the customs formalities, to consist of, or to contain plants, plant products or other objects listed in Annex V, Part B are also inspected by the responsible official bodies, where there is serious reason to believe that such plants, plant products or other objects are present. Member States shall ensure that whenever a customs inspection reveals that a consignment or lot coming from a third country consists of or contains non-declared plants, plant products or other objects listed in Annex V, Part B, the inspecting customs office shall immediately inform the official body of its Member State, under the cooperation referred to in Article 13c(4). If, at the outcome of the inspection by the responsible official bodies, doubts remain in respect of the identity of the commodity, in particular concerning the genus or species of plants or plant products or their origin, the consignment shall be considered to contain plants, plant products or other objects as listed in Annex V, Part B. 2. Provided that there is no risk of harmful organisms spreading in the Community: (a) Article 13(1) shall not apply to the entry, into the Community, of plants, plant products or other objects which are moved from one point to another within the Community passing through the territory of a third country without any change in their customs status (internal transit), (b) Article 13(1) and Article 4(1) shall not apply to the entry, into the Community, of plants, plant products or other objects which are moved from one point to another within one or two third countries passing through the territory of the Community under appropriate customs procedures without any change in their customs status. 3. Without prejudice to the provisions of Article 4 in respect of Annex III, and provided that there is no risk of harmful organisms spreading in the Community, Article 13(1) need not apply to the entry, into the Community, of small quantities of plants, plant products, foodstuffs or animal feedingstuffs as far as they relate to plants or plant products,where they are intended for use by the owner or recipient for non-industrial and non-commercial purposes, or for consumption during transport. In accordance with the procedure referred to in Article 18(2) detailed rules may be adopted specifying the conditions for the implementation of this provision, including the determination of 'small quantities'. 4. Article 13(1) shall not apply, under specified conditions, to the entry, into the Community, of plants, plant products or other objects for use in trials, for scientific purposes or for work on varietal selections. The specified conditions shall be determined in accordance with the procedure referred to in Article 18(2). 5. Provided that there is no risk of harmful organisms spreading in the Community, a Member State may adopt a derogation that Article 13(1) shall not apply in specified individual cases to plants, plant products or other objects which are grown, produced or used in its immediate frontier zone with a third country and introduced into that Member State in order to be worked in nearby locations in the frontier zone of its territory. When granting such a derogation, the Member State shall specify the location and the name of the person working it. Such details, which shall be updated regularly, shall be made available to the Commission Plants, plant products and other objects which form the subject of a derogation under the first subparagraph shall be accompanied by documentary evidence of the location in the relevant third country from which the said plants, plant products and other objects originate. 6. It may be agreed, in technical arrangements made between the Commission and the competent bodies in certain third countries and approved in accordance with the procedure referred to in Article 18(2), that activities referred to in Article 13(1)(i) may also be carried out under the authority of the Commission and in accordance with the relevant provisions of Article 21 in the consignor third country, in cooperation with the official plant protection organisation of that country. Article 13c 1. (a) The formalities as specified in Article 13a(1), the inspections as provided for in Article 13b(1) and the checks for compliance with the provisions of Article 4 in respect of Annex III shall be carried out in connection with, as specified in paragraph 2, the formalities required for the placing under a customs procedure as referred to in Article 13(1) or Article 13(4). They shall be carried out in compliance with the provisions of the International Convention on the Harmonisation of Frontier Controls of Goods, in particular Annex 4 thereof, as approved by Council Regulation (EEC) No 1262/84(8). (b) Member States shall provide that importers, whether or not producers, of plants, plant products or other objects, listed in Annex V, Part B, must be included in an official register of a Member State under an official registration number. The provisions of Article 6(5), third and fourth subparagraphs, shall apply accordingly to such importers. (c) Member States shall also provide that: (i) importers, or their customs representatives, of consignments consisting of, or containing, plants, plant products or other objects, listed in Annex V, Part B, shall make reference, on at least one of the documents required for the placing under a customs procedure as referred to in Article 13(1) or Article 13(4) to such composition of the consignment by means of the following information: - reference to the type of plants, plant products or other objects, in using the code of the 'Integrated tariff of the European Communities (Taric)', - statement 'This consignment contains produce of phytosanitary relevance', or any equivalent alternative mark as agreed between the customs office of point of entry and the official body of point of entry, - reference number(s) of the required phytosanitary documentation, - official registration number of the importer, as referred to in (b) above; (ii) airport authorities, harbour authorities or either importers or operators, as arranged between them, give, as soon as they are aware of the imminent arrival of such consignments, advance notice thereof to the customs office of point of entry and to the official body of point of entry. Member States may apply this provision, mutatis mutandis, to cases of land transport, in particular where the arrival is expected outside normal working hours of the relevant official body or other office as specified in paragraph 2. 2. (a) 'Documentary checks' and also the inspections as provided for in Article 13b(1) and the checks for compliance with the provisions of Article 4 in respect of Annex III must be made by the official body of point of entry or, in agreement between the responsible official body and the customs authorities of that Member State, by the customs office of point of entry. (b) 'Identity checks' and 'plant health checks' must be made, without prejudice to (c) and (d) below, by the official body of point of entry in connection with the customs formalities required for placing under a customs procedure as referred to in Article 13(1) or Article 13(4), and either at the same place as these formalities, on the premises of the official body of point of entry or at any other place close by and designated or approved by the customs authorities and by the responsible official body, other than the place of destination as specified under (d). (c) However, in case of transit of non-Community goods, the official body of point of entry may decide, in agreement with the official body or bodies of destination, that all or part of the 'identity checks' or 'plant health checks' shall be made by the official body of destination, either on its premises or at any other place close by and designated or approved by the customs authorities and by the responsible official body, other than the place of destination as specified under (d). If no such agreement is made, the entire 'identity check' or 'plant health check' shall be made by the official body of the point of entry at either of the places specified in (b). (d) In accordance with the procedure referred to in Article 18(2), certain cases or circumstances may be specified in which 'identity checks' and 'plant health checks' may be carried out at the place of destination, such as a place of production, approved by the official body and customs authorities responsible for the area where that place of destination is located, instead of the aforesaid other places, provided that specific guarantees and documents as regards the transport of plants, plant products and other objects are complied with. (e) In accordance with the procedure referred to in Article 18(2), implementing provisions shall be laid down concerning: - the minimum conditions for the carrying out of the 'plant health checks' under (b), (c) and (d), - the specific guarantees and documents as regards the transport of the plants, plant products or other objects to the places specified in (c) and (d), to ensure that there is no risk of harmful organisms spreading during transport, - together with the specification of cases under (d), specific guarantees and minimum conditions concerning the qualification of the place of destination for storage and concerning the storage conditions. (f) In all cases, the plant 'health checks' shall be considered to be an integral part of the formalities referred to in Article 13(1). 3. Member States shall lay down that the respective original, or the electronic form of the certificates or of the alternative documents other than marks, as specified in Article 13(1)(ii), which is produced to the responsible official body for 'documentary checks' in accordance with the provisions of Article 13a(1)(b)(i), upon inspection shall be marked with a 'visa' of that body, together with its denomination and the date of presentation of the document. In accordance with the procedure referred to in Article 18(2), a standardised system may be set up to ensure that information included in the certificate, in case of specified plants intended for planting, shall be forwarded to the official body in charge of each Member State or area where plants from the consignment are to be destined or planted. 4. The Member States shall forward to the Commission and the other Member States in writing the list of places designated as points of entry. Any changes to this list shall also be forwarded in writing without delay. The Member States shall establish a list of the places as specified under 2(b) and 2(c) and places of destinations as identified under 2(d) under their respective responsibility. These lists shall be accessible to the Commission. Each official body of point of entry, and each official body of destination carrying out identity or plant health checks, must satisfy certain minimum conditions in respect of infrastructure, staffing and equipment. In accordance with the procedure referred to in Article 18(2), the aforesaid minimum conditions shall be laid down in implementing provisions. In accordance with the same procedure, detailed rules shall be laid down concerning: (a) the type of documents required for the placing under a customs procedure, on which the information specified in paragraph 1(c)(i) shall be made, (b) the cooperation between: (i) the official body of point of entry and the official body of destination, (ii) the official body of point of entry and the customs office of point of entry, (iii) the official body of destination and the customs office of destination, and (iv) the official body of point of entry and the customs office of destination. Those rules shall include model forms of documents to be used in that cooperation, the means of transmission of these documents, the procedures for exchange of information between the official bodies and offices above, as well as the measures which must be taken to maintain the identity of the lots and consignments and to safeguard against the risk of spreading harmful organisms, in particular during transport, until the completion of the required customs formalities. 5. There shall be a Community financial contribution to Member States in order to strengthen inspection infrastructures in so far as they relate to plant health checks carried out in accordance with paragraph 2(b) or (c). The purpose of this contribution shall be to improve the provision, at inspection posts other than those at the place of destination, of the equipment and the facilities required to carry out inspection and examination and, where necessary, to carry out the measures provided for in paragraph 7, beyond the level already achieved by complying with the minimum conditions stipulated in the implementing provisions pursuant to paragraph 2(e). The Commission shall propose the entry of suitable appropriations for that purpose in the general budget of the European Union. Within the limits set by the appropriations available for these purposes, the Community contribution shall cover up to 50 % of expenditure relating directly to improving equipment and facilities. Detailed rules concerning the Community financial contribution shall be laid down in an implementing Regulation adopted in accordance with the procedure referred to in Article 18(2). The allocation and the amount of the Community financial contribution shall be decided in accordance with the procedure referred to in Article 18(2), in the light of the information and documents submitted by the Member State concerned and, where appropriate, of the results of investigations carried out under the Commission's authority by the experts referred to in Article 21, and depending on the appropriations available for the purposes concerned. 6. Article 10(1) and (3) shall apply mutatis mutandis to plants, plant products or other objects referred to in Article 13 insofar as they are listed in Annex V, Part A, and where it is considered, on the basis of the formalities referred to in Article 13(1), that the conditions laid down therein are fulfilled. 7. Where it is not considered on the basis of the formalities referred to in Article 13(1), that the conditions laid down therein are fulfilled, one or more of the following official measures shall be taken immediately: (a) refusal of entry into the Community of all or part of the consignment, (b) movement, under official supervision, in accordance with the appropriate customs procedure, during their movement within the Community, to a destination outside the Community, (c) removal of infected/infested produce from the consignment, (d) destruction, (e) imposition of a quarantine period until the results of the examinations or official tests are available, (f) exceptionally and only in specific circumstances, appropriate treatment where it is considered by the responsible official body of the Member State that, as a result of the treatment, the conditions will be fulfilled and the risk of spreading harmful organisms is obviated; the measure of appropriate treatment may also be taken in respect of harmful organisms not listed in Annex I or Annex II. Article 11(3), second subparagraph, shall apply mutatis mutandis. In the case of a refusal referred to in (a) or movement to a destination outside the Community referred to in (b) or of a removal referred to in (c), the Member States shall lay down that the phytosanitary certificates or the phytosanitary certificates for re-export, and any other document which have been produced when the plants, plant products or other objects were submitted for introduction into their territory, be cancelled by the responsible official body. Upon cancellation, the said certificates or documents shall bear on their face and in a prominent position a triangular stamp in red, marked 'certificate cancelled' or 'document cancelled' from the said official body, together with its denomination and the date of refusal, of the start of the movement to a destination outside the Community or of removal. It shall be in capital letters, and in at least one of the official languages, of the Community. 8. Without prejudice to the notifications and information required under Article 16, Member States shall ensure that the responsible official bodies inform the plant protection organisation of the third country of origin or consignor third country and the Commission of all cases where plants, plant products or other objects coming from the relevant third country have been intercepted as not complying with the plant health requirements, and the reasons of the interception, without prejudice to the action which the Member State may take or has taken in respect of the intercepted consignment. The information shall be given as soon as possible so that the plant protection organisations concerned and, where appropriate, also the Commission, may study the case with a view, in particular, to taking the steps necessary to prevent further occurrences similar to the intercepted one. In accordance with the procedure referred to in Article 18(2), a standardised information system may be set up. Article 13d 1. Member States shall ensure the collection of fees (Phytosanitary fee) to cover the costs occasioned by the documentary checks, identity checks and plant health checks provided for in Article 13a(1), which are carried out pursuant to Article 13. The level of the fee shall reflect: (a) the salaries, including social security, of the inspectors involved in the above checks; (b) the office, other facilities, tools and equipment for these inspectors; (c) the sampling for visual inspection or for laboratory testing; (d) laboratory testing; (e) the administrative activities (including operational overheads) required for carrying out the checks concerned effectively, which may include the expenditure required for pre- and in-service training of inspectors. 2. Member States may either set the level of the Phytosanitary fee on the basis of a detailed cost calculation carried out in accordance with paragraph 1, or apply the standard fee as specified in Annex VIIIa. When, pursuant to Article 13a(2), for a certain group of plants, plant products or other objects originating in certain third countries, identity checks and plant health checks are being carried out at reduced frequency, Member States shall collect a proportionally reduced Phytosanitary fee from all consignments and lots of that group, whether subjected to inspection or not. In accordance with the procedure referred to in Article 18(2), implementing measures may be adopted to specify the level of this reduced Phytosanitary fee. 3. When the Phytosanitary fee is set by a Member State on the basis of the costs borne by the responsible official body of that Member State, the Member States concerned shall communicate to the Commission reports specifying the method for calculating the fees in relation to the elements listed in paragraph 1. Any fee imposed in accordance with the first subparagraph shall be no higher than the actual cost borne by the responsible official body of the Member State. 4. No direct or indirect refund of the fees provided for in this Directive shall be permitted. However the possible application by a Member State of the standard fee as specified in Annex VIIIa shall not be considered an indirect refund. 5. The standard fee as specified in Annex VIIIa is without prejudice to extra charges to cover additional costs incurred in special activities relating to the checks, such as exceptional travelling by inspectors or waiting periods of inspectors due to delays in the arrival of consignments out of schedule, checks carried out outside normal working hours, supplementary checks or laboratory testing required in addition to those provided for in Article 13 for confirmation of conclusions drawn from the checks, special phytosanitary measures as required under Community acts based on Articles 15 or 16, measures taken pursuant to Article 13c(7), or the translation of required documents. 6. Member States shall designate the authorities empowered to charge the Phytosanitary fee. The fee shall be payable by the importer, or his customs representatives. 7. The Phytosanitary fee shall replace all other charges or fees levied in the Member States at national, regional or local level for the checks referred to in paragraph 1, and the attestation thereof. Article 13e 'Phytosanitary certificates' and 'phytosanitary certificates for re-export', which Member States issue under the IPPC shall be in the format of the standardised model given in Annex VII". 9. In Article 14, the second subparagraph shall be amended as follows: (a) the terms "Article 17" shall be replaced by the terms "Article 18(2)"; (b) in point (c), the words "in agreement with the Member State concerned" shall be replaced by "in consultation with the Member State concerned"; (c) point (d) shall be replaced by the following: "(d) any amendment to the Annexes to be made in the light of developments in scientific or technical knowledge, or when technically justified, consistent with the pest risk involved"; (d) the following point (e) shall be added: "(e) 'amendments to Annex VIIIa'.". 10. Article 15 shall be amended as follows: (a) in paragraph 1, the introduction to, and the first two indents of the first subparagraph shall be replaced by the following: "1. In accordance with the procedure referred to in Article 18(2), derogations may be provided for: - from Article 4(1) and (2) with regard to Annex III, Part A and Part B, without prejudice to the provisions of Article 4(5), and from Article 5(1) and (2) and the third indent of Article 13(1)(i) with regard to requirements referred to in Annex IV, Part A, Section I and Annex IV, Part B, - from Article 13(1)(ii) in the case of wood, if equivalent safeguards are ensured by means of alternative documentation or marking," (b) paragraphs 2 and 3 shall be replaced by the following paragraphs 2, 3 and 4: "2. In accordance with the procedures referred to in the first subparagraph of paragraph 1, phytosanitary measures adopted by a third country for export into the Community shall be recognised as equivalent to the phytosanitary measures laid down in this Directive, in particular to those specified in Annex IV, if that third country objectively demonstrates to the Community that its measures achieve the Community's appropriate level of phytosanitary protection and if this is confirmed by the conclusions resulting from findings made on the occasion of reasonable access of the experts referred to in Article 21 for inspection, testing and other relevant procedures in the relevant third country. Upon request by a third country, the Commission will enter into consultations with the aim of achieving bilateral or multilateral agreements on recognition of the equivalence of specified phytosanitary measures. 3. Decisions providing for derogations pursuant to the first subparagraph of paragraph 1 or recognition of equivalence pursuant to paragraph 2, shall require that compliance with the conditions laid down therein has been officially established in writing by the exporting country for each individual case of use, and shall set out the details of the official statement confirming compliance. 4. Decisions referred to in paragraph 3 shall specify whether or in what manner Member States shall inform the other Member States and the Commission of each individual case of use or groups of cases of use."; 11. Article 16 shall be amended as follows: (a) in paragraph 1, in the first sentence of the first subparagraph, the words "in writing" shall be inserted between the words "notify and" the "Commission"; (b) in paragraph 2, in the first sentence of the first and third subparagraphs, the words "in writing" shall be inserted between the words "notify" and "the Commission"; (c) in paragraph 3, in the third sentence, the words "based on a pest risk analysis or a preliminary pest risk analysis in cases referred to in paragraph 2" shall be inserted between "measures" and "may be adopted", and the terms "Article 19" shall be replaced by "Article 18(2)"; (d) the following paragraph 5 shall be added: "5. If the Commission has not been informed of measures taken under paragraphs 1 or 2, or if it considers the measures taken to be inadequate, it may, pending the meeting of the Standing Committee on Plant Health, take interim protective measures based on a preliminary pest risk analysis to eradicate, or if that is not possible, inhibit the spread of the harmful organism concerned. These measures shall be submitted to the Standing Committee on Plant Health as soon as possible to be confirmed, amended or cancelled in accordance with the procedure referred to in Article 18(2)."; 12. Article 17 shall be deleted; 13. Article 18 shall be replaced by the following: "Article 18 1. The Commission shall be assisted by the Standing Committee on Plant Health instituted by Council Decision 76/894/EEC(9) hereafter referred to as 'the Committee'. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure."; 14. Article 19 shall be deleted; 15. Article 21 shall be amended as follows: (a) paragraph 3 shall be replaced by the following: "3. The checks referred to in paragraph 1 may be carried out in respect of the following tasks: - monitoring examinations pursuant to Article 6, - carrying out the official checks pursuant to Article 12(3), - monitoring or, within the framework of the provisions laid down in the fifth subparagraph of paragraph 5, carrying out in cooperation with the Member States inspections pursuant to Article 13(1), - carrying out or monitoring the activities specified in the technical arrangements referred to in Article 13b(6), - making the investigations referred to in Article 15(1), 15(2) and Article 16(3), - monitoring activities required under the provisions establishing the conditions under which certain harmful organisms, plants, plant products or other objects may be introduced into, or moved within, the Community or certain protected zones thereof, for trial or scientific purposes or for work on varietal selection referred to in Articles 3(9), 4(5), 5(5) and 13b(4), - monitoring activities required under authorisations granted pursuant to Article 15, under measures taken by Member States pursuant to Article 16(1) or (2), or under measures adopted pursuant to Article 16(3) or (5), - assisting the Commission in the matters referred to in paragraph 6, - carrying out any other duty assigned to the experts in the detailed rules referred to in paragraph 7,"; (b) in paragraph 5, in the second subparagraph, the following sentence shall be added after the third sentence:"This provision shall not apply to expenses resulting from the following types of requests made on the occasion of the participation of the said experts in the Member States' import inspections: laboratory testing and sampling for visual inspection or for laboratory testing, and already covered by the fees referred to in Article 13d."; 16. In Article 24(3), the following subparagraph shall be added:"The amounts to be refunded under paragraph 3 shall be fixed in accordance with the procedure referred to in Article 18(2)."; 17. In Articles 25 and 26, the respective references to "Article 13(9)" shall be replaced by "Article 13c(5)."; 18. In Annex VII, Part B shall be amended as follows: (a) The title shall be replaced by the following: "B. Model phytosanitary certificate for re-export". (b) In box 2 of the model certificate, the words "REFORWARDING PHYTOSANITARY CERTIFICATE" shall be replaced by "PHYTOSANITARY CERTIFICATE FOR RE-EXPORT". 19. The following Annex VIIIa shall be inserted in the Directive after Annex VIII: "ANNEX VIIIa The standard fee referred to in Article 13d(2) shall be set at the following levels: >TABLE> Where a consignment does not consist exclusively of products coming under the description of the relevant indent, those parts thereof consisting of products coming under the description of the relevant indent (lot or lots) shall be treated as separate consignment." 20. When in any provision other than those amended in paragraph 1 to 18 reference is made to "in accordance with the procedure laid down in Article 17" or to "in accordance with the procedure laid down in Article 18", these words shall be replaced by the words "in accordance with the procedure referred to in Article 18(2)." Article 2 Member States shall adopt and publish before 1 January 2005, the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 January 2005. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Member States shall communicate to the Commission the text of the main provisions of national law, which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32002L0088

2002

Directive 2002/88/EC of the European Parliament and of the Council of 9 December 2002 amending Directive 97/68/EC on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the Economic and Social Committee(2), Following consultation of the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) The Auto oil II programme was aimed at identifying cost effective strategies to meet the air quality objectives of the Community. The Commission Communication Review on the Auto oil II programme concluded that there is a need for further measures, especially to address the issues of ozone and particulate emissions. Recent work on the development of national emissions ceilings has shown that further measures are needed to meet the air quality objectives decided upon in the Community legislation. (2) Stringent standards on emissions from vehicles on highways have been gradually introduced. It has already been decided that those standards should be strengthened. The relative contribution of pollutants from non-road mobile machinery will thus be more predominant in the future. (3) Directive 97/68/EC(4) introduced emission limit values for gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery. (4) Although Directive 97/68/EC initially applied only to certain compression ignition engines, recital 5 of that Directive envisages the subsequent extension of its scope to include in particular gasoline engines. (5) The emissions from small spark ignition engines (gasoline engines) in different types of machinery contribute significantly to identified air quality problems, both current and future, especially ozone formation. (6) Emissions from small spark ignition engines are subject to strict environmental standards in the USA, showing that it is possible significantly to reduce the emissions. (7) The absence of Community legislation means it is possible to place on the market engines with old fashioned technology from an environmental point of view, thereby jeopardising the air quality objectives in the Community, or to implement national legislation in this field, with the potential to create barriers to trade. (8) Directive 97/68/EC is closely aligned with the corresponding US legislation, and continuing alignment will have benefits for industry, as well as for the environment. (9) A certain lead time is necessary for the European industry, especially for those manufacturers that are not yet operating on a global basis, to be able to meet the emission standards. (10) A two-step approach is used in Directive 97/68/EC for compression ignition engines as well as in the US regulations on spark ignition engines. Although it might have been possible to adopt a one-step approach in the Community legislation, this would have left the field unregulated for another four to five years. (11) To achieve the necessary flexibility for worldwide alignment, a possible derogation, to be made under the comitology procedure, is included. (12) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5). (13) Directive 97/68/EC should be amended accordingly, Article 1 Directive 97/68/EC is hereby amended as follows: 1. In Article 2: (a) the eighth indent shall be replaced by the following: "- 'placing on the market' shall mean the action of making an engine available for the first time on the market, for payment or free of charge, with a view to distribution and/or use in the Community,"; (b) the following indents shall be added: "- 'replacement engines' shall mean a newly built engine to replace an engine in a machine, and which has been supplied for this purpose only, - 'hand-held engine' shall mean an engine that meets at least one of the following requirements: (a) the engine must be used in a piece of equipment that is carried by the operator throughout the performance of its intended function(s); (b) the engine must be used in a piece of equipment that must operate multipositionally, such as upside down or sideways, to complete its intended function(s); (c) the engine must be used in a piece of equipment for which the combined engine and equipment dry weight is under 20 kilograms and at least one of the following attributes is also present: (i) the operator must alternatively provide support or carry the equipment throughout the performance of its intended function(s); (ii) the operator must provide support or attitudinal control for the equipment throughout the performance of its intended function(s); (iii) the engine must be used in a generator or a pump; - 'non-hand-held engine' shall mean an engine which does not fall under the definition of a hand-held engine, - 'professional use multipositional hand-held engine' shall mean a hand-held engine which meets the requirements of both (a) and (b) of the hand-held engine definition and in relation to which the engine manufacturer has satisfied an approval authority that a Category 3 Emissions Durability Period (according to section 2.1 of Appendix 4 to Annex IV) would be applicable to the engine, - 'emission durability period' shall mean the number of hours indicated in Annex IV, Appendix 4, used to determine the deterioration factors, - 'small volume engine family' shall mean a spark-ignition (SI) engine family with a total yearly production of fewer than 5000 units, - 'small volume engine manufacturer of SI engines' shall mean a manufacturer with a total yearly production of fewer than 25000 units." 2. Article 4 is hereby amended as follows: (a) paragraph 2 shall be amended as follows: (i) in the first sentence "Annex VI" shall be replaced by "Annex VII"; (ii) in the second sentence "Annex VII" shall be replaced by "Annex VIII"; (b) paragraph 4 shall be amended as follows: (i) in point (a) "Annex VIII" shall be replaced by "Annex IX"; (ii) in point (b) "Annex IX" shall be replaced by "Annex X"; (c) in paragraph 5, "Annex X" shall be replaced by "Annex XI". 3. Article 7(2) shall be replaced by the following: "2. Member States shall accept type-approvals and, where applicable, the pertaining approval marks listed in Annex XII as being in conformity with this Directive." 4. Article 9 is hereby amended as follows: (a) the heading "Timetable" shall be replaced by the heading "Timetable-compression ignition engines"; (b) in paragraph 1, "Annex VI" shall be replaced by "Annex VII"; (c) paragraph 2 shall be amended as follows: (i) "Annex VI" shall be replaced by "Annex VII"; (ii) "section 4.2.1 of Annex I" shall be replaced by "section 4.1.2.1 of Annex I"; (d) paragraph 3 shall be amended as follows: (i) "Annex VI" shall be replaced by "Annex VII"; (ii) "section 4.2.3 of Annex I" shall be replaced by "section 4.1.2.3 of Annex I"; (e) in the first subparagraph of paragraph 4, the phrase "placing on the market of new engines" shall be replaced by "placing on the market of engines". 5. The following Article shall be inserted: "Article 9a Timetable - Spark ignition engines 1. DIVIDING INTO CLASSES For the purpose of this Directive, spark-ignition engines shall be divided into the following classes. Main class S: small engines with a net power <= 19 kW The main class S shall be divided into two categories: H: engines for hand-held machinery N: engines for non-hand-held machinery >TABLE> 2. GRANT OF TYPE APPROVALS After 11 August 2004, Member States may not refuse to grant type-approval for an SI engine type or engine family or to issue the document as described in Annex VII, and may not impose any other type-approval requirements with regard to air-polluting emissions for non-road mobile machinery in which an engine is installed, if the engine meets the requirements specified in this Directive as regards the emissions of gaseous pollutants. 3. TYPE-APPROVALS STAGE 1 Member States shall refuse to grant type-approval for an engine type or engine family and to issue the documents as described in Annex VII, and shall refuse to grant any other type-approval for non-road mobile machinery in which an engine is installed after 11 August 2004 if the engine fails to meet the requirements specified in this Directive and where the emissions of gaseous pollutants from the engine do not comply with the limit values as set out in the table in section 4.2.2.1 of Annex I. 4. TYPE-APPROVALS STAGE II Member States shall refuse to grant type-approval for an engine type or engine family and to issue the documents as described in Annex VII, and shall refuse to grant any other type-approval for non-road mobile machinery in which an engine is installed: after 1 August 2004 for engine classes SN:1 and SN:2 after 1 August 2006 for engine class SN:4 after 1 August 2007 for engine classes SH:1, SH:2 and SN:3 after 1 August 2008 for engine class SH:3, if the engine fails to meet the requirements specified in this Directive and where the emissions of gaseous pollutants from the engine do not comply with the limit values as set out in the table in section 4.2.2.2 of Annex I. 5. PLACING ON THE MARKET: ENGINE PRODUCTION DATES Six months after the dates for the relevant category of engine in paragraphs 3 and 4, with the exception of machinery and engines intended for export to third countries, Member States shall permit placing on the market of engines, whether or not already installed in machinery, only if they meet the requirements of this Directive. 6. LABELLING OF EARLY COMPLIANCE WITH STAGE II For engine types or engine families meeting the limit values set out in the table in section 4.2.2.2 of Annex I, before the dates laid down in point 4 of this Article, Member States shall allow special labelling and marking to show that the equipment concerned meets the required limit values before the dates laid down. 7. EXEMPTIONS The following machinery shall be exempted from the implementation dates of stage II emission limit requirements for a period of three years after the entry into force of those emission limit requirements. For those three years, the stage I emission limit requirements shall continue to apply: - hand-held chainsaw: a hand-held device designed to cut wood with a saw chain, designed to be supported with two hands and having an engine capacity in excess of 45 cm3, according to EN ISO 11681-1, - top handle machine (i.e., hand-held drills and tree service chainsaws): a hand-held device with the handle on top of the machine designed to drill holes or to cut wood with a saw chain (according to ISO 11681-2), - hand-held brush cutter with an internal combustion engine: a hand-held device with a rotating blade made of metal or plastic intended to cut weeds, brush, small trees and similar vegetation. It must be designed according to EN ISO 11806 to operate multi-positionally, such as horizontally or upside down, and have an engine capacity in excess of 40 cm3; - hand-held hedge trimmer: a hand-held device designed for trimming hedges and bushes by means of one or more reciprocating cutter blades, according to EN 774, - hand-held power cutter with an internal combustion engine: a hand-held device intended for cutting hard materials such as stone, asphalt, concrete or steel by means of a rotating metal blade with a displacement in excess of 50 cm3, according to EN 1454, and - non-hand-held, horizontal shaft class SN:3 engine: only those class SN:3 non-hand-held engines with a horizontal shaft that produce power equal to or less than 2,5 kW and are used mainly for select, industrial purposes, including tillers, reel cutters, lawn aerators and generators. 8. OPTIONAL IMPLEMENTATION DELAY Nevertheless, for each category, Member States may postpone the dates in paragraphs 3, 4 and 5 for two years in respect of engines with a production date prior to those dates." 6. Article 10 is hereby amended as follows: (a) paragraph 1 shall be replaced by the following: "1. The requirements of Article 8(1) and (2), Article 9(4) and Article 9a (5) shall not apply to: - engines for use by the armed services, - engines exempted in accordance with paragraphs 1a and 2."; (b) the following paragraph shall be inserted: "1a. A replacement engine shall comply with the limit values that the engine to be replaced had to meet when originally placed on the market. The text 'REPLACEMENT ENGINE' shall be attached to a label on the engine or inserted into the owner's manual."; (c) the following paragraphs shall be added: "3. The requirements of Article 9a(4) and (5) shall be postponed by three years for small volume engine manufacturers. 4. The requirements of Article 9a(4) and (5) shall be replaced by the corresponding stage I requirements for a small volume engine family to a maximum of 25000 units providing that the various engine families involved all have different cylinder displacements." 7. Articles 14 and 15 shall be replaced by the following Articles: "Article 14 Adaptation to technical progress Any amendments which are necessary in order to adapt the Annexes to this Directive, with the exception of the requirements specified in section 1, sections 2.1 to 2.8 and section 4 of Annex I, to take account of technical progress shall be adopted by the Commission in accordance with the procedure referred to in Article 15(2). Article 14a Procedure for derogations The Commission shall study possible technical difficulties in complying with the stage II requirements for certain uses of the engines, in particular mobile machinery in which engines of classes SH:2 and SH:3 are installed. If the Commission studies conclude that for technical reasons certain mobile machinery, in particular, professional use, multi-positional, hand-held engines, cannot meet these deadlines, it shall submit, by 31 December 2003, a report accompanied by appropriate proposals for extensions of the period referred to in Article 9a(7) and/or further derogations, not exceeding five years, unless in exceptional circumstances, for such machinery, under the procedure laid down in Article 15(2). Article 15 Committee 1. The Commission shall be assisted by the Committee on Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Motor Vehicle Sector (hereinafter referred to as 'the Committee'). 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC(6) shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure." 8. The following list of Annexes shall be added at the beginning of the Annexes: "List of Annexes >TABLE>". 9. The Annexes shall be amended in accordance with the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 11 August 2004. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of the national law which they adopt in the field governed by this Directive. Article 3 Not later than 11 August 2004, the Commission shall submit to the European Parliament and the Council a report and, if appropriate, a proposal regarding the potential costs, benefits and feasibility of: (a) reducing particulate emissions from small spark ignition engines with special attention to two stroke engines. The report shall take into account: (i) estimates of the contribution of such engines to the emission of particles, and the way proposed emission reduction measures could contribute towards improving air quality and reduced health effects; (ii) tests, measurement procedures and equipment which could be used to assess particulate emissions from small spark ignition engines at type approval; (iii) work and conclusion within the particulate measurement programme; (iv) developments in test procedures, engine technology, exhaust purification as well as enhanced standards for fuel and engine oil; and (v) costs of reducing particulate emissions from small spark ignition engines and the cost effectiveness of any proposed measures; (b) reducing emissions from those recreational vehicles, including snowmobiles and go-carts, currently not covered; (c) reducing exhaust gas and particulate emissions from small compression ignition engines under 18 Kw; (d) reducing exhaust gas and particulate emissions from locomotive compression ignition engines. A test cycle should be formulated in order to measure such emissions. Article 4 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32002L0094

2002

COMMISSION DIRECTIVE 2002/94/EC of 9 December 2002 laying down detailed rules for implementing certain provisions of Council Directive 76/308/EEC on mutual assistance for the recovery of claims relating to certain levies, duties, taxes and other measures Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/308/EEC of 15 March 1976 on mutual assistance for the recovery of claims relating to certain levies, duties, taxes and other measures (1), as last amended by Directive 2001/44/EC (2), and in particular Article 22 thereof, Whereas: (1) The system of mutual assistance between the competent authorities of Member States, as set out in Directive 76/308/EEC, has been amended as regards the information to be supplied to the applicant authority, the notification of the addressee concerning the applicable instruments and decisions, the adoption of precautionary measures, and the recovery by the requested authority of claims on behalf of the applicant authority. (2) As regards each of those aspects, therefore, Commission Directive 77/794/EEC of 4 November 1977 laying down detailed rules for implementing certain provisions of Directive 76/308/EEC on mutual assistance for the recovery of claims resulting from operations forming part of the system of financing the European Agricultural Guidance and Guarantee Fund, and of agricultural levies and customs duties, and in respect of value added tax (3), as last amended by Directive 86/489/EEC (4), should be amended accordingly. (3) Furthermore, detailed rules should be laid down concerning the means by which communications between authorities may be transmitted. (4) In the interests of clarity, Directive 77/794/EEC should be replaced. (5) The measures provided for in this Directive are in accordance with the opinion of the Committee on Recovery, CHAPTER I GENERAL PROVISIONS Article 1 This Directive lays down the detailed rules for implementing Article 4(2) and (4), Article 5(2) and (3), Article 7, Article 8, Article 9, Article 11, Article 12(1) and (2), Article 14, Article 18(3) and Article 25 of Directive 76/308/EEC. It also lays down the detailed rules on conversion, transfer of sums recovered, the fixing of a minimum amount for claims which may give rise to a request for assistance, as well as the means by which communications between authorities may be transmitted. Article 2 For the purposes of this Directive: 1. transmission ‘by electronic means’ shall mean transmission using electronic equipment for processing (including digital compression) of data and employing wires, radio transmission, optical technologies or other electromagnetic means; 2. ‘CCN/CSI’ network shall mean the common platform based on the Common Communication Network (CCN) and Common System Interface (CSI), developed by the Community to ensure all transmissions by electronic means between competent authorities in the area of Customs and Taxation. CHAPTER II REQUESTS FOR INFORMATION Article 3 The request for information referred to in Article 4 of Directive 76/308/EEC shall be made out in writing in accordance with the model in Annex I to this Directive. If the request cannot be transmitted by electronic means, it shall bear the official stamp of the applicant authority and shall be signed by an official thereof duly authorised to make such a request. Where a similar request has been addressed to any other authority, the applicant authority shall indicate in its request for information the name of that authority. Article 4 The request for information may relate to: 1. the debtor; 2. any person liable for settlement of the claim under the law in force in the Member State in which the applicant authority is situated (hereinafter ‘the Member State of the applicant authority’); 3. any third party holding assets belonging to one of the persons mentioned under point 1 or 2. Article 5 1. The requested authority shall acknowledge receipt of the request for information in writing as soon as possible and in any event within seven days of such receipt. 2. Immediately upon receipt of the request the requested authority shall, where appropriate, ask the applicant authority to provide any additional information necessary. The applicant authority shall provide all additional necessary information to which it normally has access. Article 6 1. The requested authority shall transmit each item of requested information to the applicant authority as and when it is obtained. 2. Where all or some of the requested information cannot be obtained within a reasonable time, having regard to the particular case, the requested authority shall so inform the applicant authority, indicating the reasons therefor. In any event, at the end of six months from the date of acknowledgement of receipt of the request, the requested authority shall inform the applicant authority of the outcome of the investigations which it has conducted in order to obtain the information requested. In the light of the information received from the requested authority, the applicant authority may request the latter to continue its investigations. That request shall be made in writing within two months of the receipt of the notification of the outcome of the investigations carried out by the requested authority, and shall be treated by the requested authority in accordance with the provisions applying to the initial request. Article 7 If the requested authority decides not to comply with the request for information, it shall notify the applicant authority in writing of the reasons for the refusal to comply with the request, specifying the provisions of Article 4 of Directive 76/308/EEC on which it relies. Such notification shall be given by the requested authority as soon as it has taken its decision and in any event within three months of the date of the acknowledgement of the receipt of the request. Article 8 The applicant authority may at any time withdraw the request for information which it has sent to the requested authority. The decision to withdraw shall be transmitted to the requested authority in writing. CHAPTER III REQUESTS FOR NOTIFICATION Article 9 The request for notification referred to in Article 5 of Directive 76/308/EEC shall be made out in writing in duplicate in accordance with the model in Annex II to this Directive. The said request shall bear the official stamp of the applicant authority and shall be signed by an official thereof duly authorised to make such a request. Two copies of the instrument or decision, notification of which is requested, shall be attached to the request. Article 10 The request for notification may relate to any natural or legal person who, in accordance with the law in force in the Member State of the applicant authority, is required to be informed of any instrument or decision which concerns that person. In so far as such is not indicated in the instrument or decision of which notification is requested, the request for notification shall refer to the rules in force in the Member State of the applicant authority governing the procedure for contestation of the claim or for its recovery. Article 11 1. The requested authority shall acknowledge receipt of the request for notification in writing as soon as possible and in any event within seven days of such receipt. Immediately upon receipt of the request for notification, the requested authority shall take the necessary measures to effect notification in accordance with the law in force in the Member State in which it is situated. If necessary, but without jeopardising the final date for notification indicated in the request for notification, the requested authority shall ask the applicant authority to provide additional information. The applicant authority shall provide all additional information to which it normally has access. The requested authority shall in any event not question the validity of the instrument or decision of which notification is requested. 2. The requested authority shall inform the applicant authority of the date of notification as soon as this has been effected, by returning to it one of the copies of the request with the certificate on the reverse side duly completed. CHAPTER IV REQUESTS FOR RECOVERY OR FOR PRECAUTIONARY MEASURES Article 12 1. Requests for recovery or for precautionary measures referred to in Articles 6 and 13 respectively of Directive 76/308/EEC shall be made out in writing in accordance with the model in Annex III to this Directive. Such requests, which shall include a declaration that the conditions laid down in Directive 76/308/EEC for initiating the mutual assistance procedure have been fulfilled, shall bear the official stamp of the applicant authority and shall be signed by an official thereof duly authorised to make such a request. 2. The instrument permitting enforcement shall accompany the request for recovery or for precautionary measures. A single instrument may be issued in respect of several claims where they concern one and the same person. For the purposes of Articles 13 to 20 of this Directive, all claims covered by the same instrument permitting enforcement shall be deemed to constitute a single claim. Article 13 Requests for recovery or for precautionary measures may relate to any person referred to in Article 4. Article 14 1. If the currency of the Member State of the requested authority is different from the currency of the Member State of the applicant authority, the applicant authority shall express the amount of the claim to be recovered in both currencies. 2. The rate of exchange to be used for the purposes of paragraph 1 shall be the latest selling rate recorded on the most representative exchange market or markets of the Member State of the applicant authority on the date when the request for recovery is signed. Article 15 1. The requested authority shall, in writing, as soon as possible and in any event within seven days of receipt of the request for recovery or for precautionary measures: (a) acknowledge receipt of the request; (b) ask the applicant authority to complete the request if it does not contain the information or other particulars mentioned in Article 7 of Directive 76/308/EEC. The applicant authority shall provide all information to which it has access. 2. If the requested authority does not take the requisite action within the three-month period laid down in Article 8 of Directive 76/308/EEC, it shall, as soon as possible and in any event within seven days of the expiry of that period, inform the applicant authority in writing of the grounds for its failure to comply with the time limit. Article 16 Where, within a reasonable time having regard to the particular case, all or part of the claim cannot be recovered or precautionary measures cannot be taken, the requested authority shall so inform the applicant authority, indicating the reasons therefor. No later than at the end of each six-month period following the date of acknowledgement of the receipt of the request, the requested authority shall inform the applicant authority of the state of progress or the outcome of the procedure for recovery or for precautionary measures. In the light of the information received from the requested authority, the applicant authority may request the latter to re-open the procedure for recovery or for precautionary measures. That request shall be made in writing within two months of the receipt of the notification of the outcome of that procedure, and shall be treated by the requested authority in accordance with the provisions applying to the initial request. Article 17 1. Any action contesting the claim or the instrument permitting its enforcement which is taken in the Member State of the applicant authority shall be notified to the requested authority in writing by the applicant authority immediately after the latter has been informed of such action. 2. If the laws, regulations and administrative practices in force in the Member State of the requested authority do not permit precautionary measures or the recovery requested under the second subparagraph of Article 12(2) of Directive 76/308/EEC, the requested authority shall notify the applicant authority to that effect as soon as possible and in any event within one month of the receipt of the notification referred to in paragraph 1. 3. Any action which is taken in the Member State of the requested authority for reimbursement of sums recovered or for compensation in relation to recovery of contested claims under the second subparagraph of Article 12(2) of Directive 76/308/EEC shall be notified to the applicant authority in writing by the requested authority immediately after the latter has been informed of such action. The requested authority shall as far as possible involve the applicant authority in the procedures for settling the amount to be reimbursed and the compensation due. Upon a reasoned request from the requested authority, the applicant authority shall transfer the sums reimbursed and the compensation paid within two months of the receipt of that request. Article 18 1. If the request for recovery or for precautionary measures becomes devoid of purpose as a result of payment of the claim or of its cancellation or for any other reason, the applicant authority shall immediately inform the requested authority in writing so that the latter may stop any action which it has undertaken. 2. Where the amount of the claim which is the subject of the request for recovery or for precautionary measures is adjusted for any reason, the applicant authority shall immediately inform the requested authority in writing, and if necessary issue a new instrument permitting enforcement. 3. If the adjustment entails a reduction in the amount of the claim, the requested authority shall continue the action which it has undertaken with a view to recovery or to the taking of precautionary measures, but that action shall be limited to the amount still outstanding. If, at the time when the requested authority is informed of the reduction in the amount of the claim, an amount exceeding the amount still outstanding has already been recovered by it but the transfer procedure referred to in Article 19 has not yet been initiated, the requested authority shall repay the amount overpaid to the person entitled thereto. 4. If the adjustment entails an increase in the amount of the claim, the applicant authority shall as soon as possible address to the requested authority an additional request for recovery or for precautionary measures. That additional request shall, as far as possible, be dealt with by the requested authority at the same time as the original request from the applicant authority. Where, in view of the state of progress of the existing procedure, consolidation of the additional request with the original request is not possible, the requested authority shall be required to comply with the additional request only if it concerns an amount not less than that referred to in Article 25(2). 5. In order to convert the adjusted amount of the claim into the currency of the Member State of the requested authority, the applicant authority shall use the exchange rate used in its original request. Article 19 Any sum recovered by the requested authority, including, where applicable, the interest referred to in Article 9(2) of Directive 76/308/EEC, shall be transferred to the applicant authority in the currency of the Member State of the requested authority. The transfer shall take place within one month of the date on which recovery was effected. The competent authorities of the Member States may agree different arrangements for the transfer of amounts below the threshold referred to in Article 25(2) of this Directive. Article 20 Irrespective of any amounts collected by the requested authority by way of the interest referred to in Article 9(2) of Directive 76/308/EEC, the claim shall be deemed to have been recovered in proportion to the recovery of the amount expressed in the national currency of the Member State of the requested authority, on the basis of the exchange rate referred to in Article 14(2) of this Directive. CHAPTER V TRANSMISSION OF COMMUNICATIONS Article 21 1. All information communicated in writing pursuant to this Directive shall, as far as possible, be transmitted only by electronic means, except for: (a) the request for notification referred to in Article 5 of Directive 76/308/EEC and the instrument or decision of which notification is requested; (b) requests for recovery or for precautionary measures referred to in Articles 6 and 13 respectively of Directive 76/308/EEC, and the instrument permitting enforcement. 2. The competent authorities of the Member States may agree to waive the communication on paper of the requests and instruments specified in paragraph 1. Article 22 Each Member State shall designate a central office with principal responsibility for communication by electronic means with other Member States. That office shall be connected to the CCN/CSI network. Where several authorities are appointed in a Member State for the purpose of applying this Directive, the central office shall be responsible for the forwarding of all communication by electronic means between those authorities and the central offices of other Member States. Article 23 1. Where the competent authorities of the Member States store information in electronic data bases and exchange such information by electronic means, they shall take all measures necessary to ensure that any information communicated in whatever form pursuant to this Directive is treated as confidential. It shall be covered by the obligation of professional secrecy and shall enjoy the protection extended to similar information under the national law of the Member State which received it. 2. The information referred to in paragraph 1 may be made available only to the persons and authorities referred to in Article 16 of Directive 76/308/EEC. Such information may be used in connection with judicial or administrative proceedings initiated for the recovery of levies, duties, taxes and other measures referred to in Article 2 of Directive 76/308/EEC. Persons duly accredited by the Security Accreditation Authority of the European Commission may have access to this information only in so far as is necessary for the care, maintenance and development of the CCN/CSI network. 3. Where the competent authorities of the Member States communicate by electronic means, they shall take all measures necessary to ensure that all communications are duly authorised. Article 24 Information and other particulars communicated by the requested authority to the applicant authority shall be conveyed in the official language or one of the official languages of the Member State of the requested authority or in another language agreed between the applicant and requested authorities. CHAPTER VI ELIGIBILITY AND REFUSAL OF REQUESTS FOR ASSISTANCE Article 25 1. A request for assistance may be made by the applicant authority in respect of either a single claim or several claims where those are recoverable from one and the same person. 2. No request for assistance may be made if the total amount of the relevant claim or claims listed in Article 2 of Directive 76/308/EEC is less than EUR 1 500. Article 26 If the requested authority decides, pursuant to the first paragraph of Article 14 of Directive 76/308/EEC, to refuse a request for assistance, it shall notify the applicant authority in writing of the reasons for the refusal. Such notification shall be given by the requested authority as soon as it has taken its decision and in any event within three months of the date of receipt of the request for assistance. CHAPTER VII REIMBURSEMENT ARRANGEMENTS Article 27 Each Member State shall appoint at least one official duly authorised to agree reimbursement arrangements under Article 18(3) of Directive 76/308/EEC. Article 28 1. If the requested authority decides to request reimbursement arrangements it shall notify the applicant authority in writing of the reasons for its view that recovery of the claim poses a specific problem, entails very high costs or relates to the fight against organised crime. The requested authority shall append a detailed estimate of the costs for which it requests reimbursement by the applicant authority. 2. The applicant authority shall acknowledge receipt of the request for reimbursement arrangements in writing as soon as possible and in any event within seven days of receipt. Within two months of the date of acknowledgement of receipt of the said request, the applicant authority shall inform the requested authority whether and to what extent it agrees with the proposed reimbursement arrangements. 3. If no agreement is reached between the applicant and requested authority with respect to reimbursement arrangements, the requested authority shall continue recovery procedures in the normal way. CHAPTER VIII FINAL PROVISIONS Article 29 Each Member State shall inform the Commission before 15 March each year, as far as possible by electronic means, of the use made of the procedures laid down in Directive 76/308/EEC and of the results achieved in the previous calendar year, in accordance with the model in Annex IV to this Directive. Article 30 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 April 2003 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 31 The Commission shall communicate to the other Member States the measures which each Member State takes for implementing this Directive. Each Member State shall notify the other Member States and the Commission of the name and address of the competent authorities for the purpose of applying this Directive, as well as of the officials authorised to agree arrangements under Article 18(3) of Directive 76/308/EEC. Article 32 Directive 77/794/EEC is hereby repealed. References to the repealed Directive shall be construed as references to this Directive. Article 33 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 34 This Directive is addressed to the Member States.

32002L0092

2002

Directive 2002/92/EC of the European Parliament and of the Council of 9 December 2002 on insurance mediation Having regard to the Treaty establishing the European Community, and in particular Article 47(2) and Article 55 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Insurance and reinsurance intermediaries play a central role in the distribution of insurance and reinsurance products in the Community. (2) A first step to facilitate the exercise of freedom of establishment and freedom to provide services for insurance agents and brokers was made by Council Directive 77/92/EEC of 13 December 1976 on measures to facilitate the effective exercise of freedom of establishment and freedom to provide services in respect of the activities of insurance agents and brokers (ex ISIC Group 630) and, in particular, transitional measures in respect of those activities(4). (3) Directive 77/92/EEC was to remain applicable until the entry into force of provisions coordinating national rules concerning the taking-up and pursuit of the activities of insurance agents and brokers. (4) Commission Recommendation 92/48/EEC of 18 December 1991 on insurance intermediaries(5) was largely followed by Member States and helped to bring closer together national provisions on the professional requirements and registration of insurance intermediaries. (5) However, there are still substantial differences between national provisions which create barriers to the taking-up and pursuit of the activities of insurance and reinsurance intermediaries in the internal market. It is therefore appropriate to replace Directive 77/92/EEC with a new directive. (6) Insurance and reinsurance intermediaries should be able to avail themselves of the freedom of establishment and the freedom to provide services which are enshrined in the Treaty. (7) The inability of insurance intermediaries to operate freely throughout the Community hinders the proper functioning of the single market in insurance. (8) The coordination of national provisions on professional requirements and registration of persons taking up and pursuing the activity of insurance mediation can therefore contribute both to the completion of the single market for financial services and to the enhancement of customer protection in this field. (9) Various types of persons or institutions, such as agents, brokers and "bancassurance" operators, can distribute insurance products. Equality of treatment between operators and customer protection requires that all these persons or institutions be covered by this Directive. (10) This Directive contains a definition of "tied insurance intermediary" which takes into account the characteristics of certain Member States' markets and whose purpose is to establish the conditions for registration applicable to such intermediaries. This definition is not intended to preclude Member States from having similar concepts in respect of insurance intermediaries who, while acting for and on behalf of an insurance undertaking and under the full responsibility of that undertaking, are entitled to collect premiums or amounts intended for the customer in accordance with the financial guarantees laid down by this Directive. (11) This Directive should apply to persons whose activity consists in providing insurance mediation services to third parties for remuneration, which may be pecuniary or take some other form of agreed economic benefit tied to performance. (12) This Directive should not apply to persons with another professional activity, such as tax experts or accountants, who provide advice on insurance cover on an incidental basis in the course of that other professional activity, neither should it apply to the mere provision of information of a general nature on insurance products, provided that the purpose of that activity is not to help the customer conclude or fulfil an insurance or reinsurance contract, nor the professional management of claims for an insurance or reinsurance undertaking, nor the loss adjusting and expert appraisal of claims. (13) This Directive should not apply to persons practising insurance mediation as an ancillary activity under certain strict conditions. (14) Insurance and reinsurance intermediaries should be registered with the competent authority of the Member State where they have their residence or their head office, provided that they meet strict professional requirements in relation to their competence, good repute, professional indemnity cover and financial capacity. (15) Such registration should allow insurance and reinsurance intermediaries to operate in other Member States in accordance with the principles of freedom of establishment and freedom to provide services, provided that an appropriate notification procedure has been followed between the competent authorities. (16) Appropriate sanctions are needed against persons exercising the activity of insurance or reinsurance mediation without being registered, against insurance or reinsurance undertakings using the services of unregistered intermediaries and against intermediaries not complying with national provisions adopted pursuant to this Directive. (17) Cooperation and exchange of information between competent authorities are essential in order to protect customers and ensure the soundness of insurance and reinsurance business in the single market. (18) It is essential for the customer to know whether he is dealing with an intermediary who is advising him on products from a broad range of insurance undertakings or on products provided by a specific number of insurance undertakings. (19) This Directive should specify the obligations which insurance intermediaries should have in providing information to customers. A Member State may in this area maintain or adopt more stringent provisions which may be imposed on insurance intermediaries independently of their place of residence where they are pursuing mediation activities on its territory provided that any such more stringent provisions comply with Community law, including Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce)(6). (20) If the intermediary declares that he is giving advice on products from a broad range of insurance undertakings, he should carry out a fair and sufficiently wide-ranging analysis of the products available on the market. In addition, all intermediaries should explain the reasons underpinning their advice. (21) There is less of a need to require that such information be disclosed when the customer is a company seeking reinsurance or insurance cover for commercial and industrial risks. (22) There is a need for suitable and effective complaint and redress procedures in the Member States in order to settle disputes between insurance intermediaries and customers, using, where appropriate, existing procedures. (23) Without prejudice to the right of customers to bring their action before the courts, Member States should encourage public or private bodies established with a view to settling disputes out-of-court, to cooperate in resolving cross-border disputes. Such cooperation could for example be aimed at enabling customers to contact extra-judicial bodies established in their Member State of residence about complaints concerning insurance intermediaries established in other Member States. The setting up of the FIN-NET network provides increased assistance to consumers when they use cross-border services. The provisions on procedures should take into account Commission Recommendation 98/257/EC of 30 March 1998 on the principles applicable to the bodies responsible for out-of-court settlement of consumer disputes(7). (24) Directive 77/92/EEC should accordingly be repealed, CHAPTER I SCOPE AND DEFINITIONS Article 1 Scope 1. This Directive lays down rules for the taking-up and pursuit of the activities of insurance and reinsurance mediation by natural and legal persons which are established in a Member State or which wish to become established there. 2. This Directive shall not apply to persons providing mediation services for insurance contracts if all the following conditions are met: (a) the insurance contract only requires knowledge of the insurance cover that is provided; (b) the insurance contract is not a life assurance contract; (c) the insurance contract does not cover any liability risks; (d) the principal professional activity of the person is other than insurance mediation; (e) the insurance is complementary to the product or service supplied by any provider, where such insurance covers: (i) the risk of breakdown, loss of or damage to goods supplied by that provider, or (ii) damage to or loss of baggage and other risks linked to the travel booked with that provider, even if the insurance covers life assurance or liability risks, provided that the cover is ancillary to the main cover for the risks linked to that travel; (f) the amount of the annual premium does not exceed EUR 500 and the total duration of the insurance contract, including any renewals, does not exceed five years. 3. This Directive shall not apply to insurance and reinsurance mediation services provided in relation to risks and commitments located outside the Community. This Directive shall not affect a Member State's law in respect of insurance mediation business pursued by insurance and reinsurance intermediaries established in a third country and operating on its territory under the principle of freedom to provide services, provided that equal treatment is guaranteed to all persons carrying out or authorised to carry out insurance mediation activities on that market. This Directive shall not regulate insurance mediation activities carried out in third countries nor activities of Community insurance or reinsurance undertakings, as defined in First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance(8) and First Council Directive 79/267/EEC of 5 March 1979 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct life assurance(9), carried out through insurance intermediaries in third countries. Article 2 Definitions For the purpose of this Directive: 1. "insurance undertaking" means an undertaking which has received official authorisation in accordance with Article 6 of Directive 73/239/EEC or Article 6 of Directive 79/267/EEC; 2. "reinsurance undertaking" means an undertaking, other than an insurance undertaking or a non-member-country insurance undertaking, the main business of which consists in accepting risks ceded by an insurance undertaking, a non-member-country insurance undertaking or other reinsurance undertakings; 3. "insurance mediation" means the activities of introducing, proposing or carrying out other work preparatory to the conclusion of contracts of insurance, or of concluding such contracts, or of assisting in the administration and performance of such contracts, in particular in the event of a claim. These activities when undertaken by an insurance undertaking or an employee of an insurance undertaking who is acting under the responsibility of the insurance undertaking shall not be considered as insurance mediation. The provision of information on an incidental basis in the context of another professional activity provided that the purpose of that activity is not to assist the customer in concluding or performing an insurance contract, the management of claims of an insurance undertaking on a professional basis, and loss adjusting and expert appraisal of claims shall also not be considered as insurance mediation; 4. "reinsurance mediation" means the activities of introducing, proposing or carrying out other work preparatory to the conclusion of contracts of reinsurance, or of concluding such contracts, or of assisting in the administration and performance of such contracts, in particular in the event of a claim. These activities when undertaken by a reinsurance undertaking or an employee of a reinsurance undertaking who is acting under the responsibility of the reinsurance undertaking are not considered as reinsurance mediation. The provision of information on an incidental basis in the context of another professional activity provided that the purpose of that activity is not to assist the customer in concluding or performing a reinsurance contract, the management of claims of a reinsurance undertaking on a professional basis, and loss adjusting and expert appraisal of claims shall also not be considered as reinsurance mediation; 5. "insurance intermediary" means any natural or legal person who, for remuneration, takes up or pursues insurance mediation; 6. "reinsurance intermediary" means any natural or legal person who, for remuneration, takes up or pursues reinsurance mediation; 7. "tied insurance intermediary" means any person who carries on the activity of insurance mediation for and on behalf of one or more insurance undertakings in the case of insurance products which are not in competition but does not collect premiums or amounts intended for the customer and who acts under the full responsibility of those insurance undertakings for the products which concern them respectively. Any person who carries on the activity of insurance mediation in addition to his principal professional activity is also considered as a tied insurance intermediary acting under the responsibility of one or several insurance undertakings for the products which concern them respectively if the insurance is complementary to the goods or services supplied in the framework of this principal professional activity and the person does not collect premiums or amounts intended for the customer; 8. "large risks" shall be as defined by Article 5(d) of Directive 73/239/EEC; 9. "home Member State" means: (a) where the intermediary is a natural person, the Member State in which his residence is situated and in which he carries on business; (b) where the intermediary is a legal person, the Member State in which its registered office is situated or, if under its national law it has no registered office, the Member State in which its head office is situated; 10. "host Member State" means the Member State in which an insurance or reinsurance intermediary has a branch or provides services; 11. "competent authorities" means the authorities which each Member State designates under Article 7; 12. "durable medium" means any instrument which enables the customer to store information addressed personally to him in a way accessible for future reference for a period of time adequate to the purposes of the information and which allows the unchanged reproduction of the information stored. In particular, durable medium covers floppy disks, CD-ROMs, DVDs and hard drives of personal computers on which electronic mail is stored, but it excludes Internet sites, unless such sites meet the criteria specified in the first paragraph. CHAPTER II REGISTRATION REQUIREMENTS Article 3 Registration 1. Insurance and reinsurance intermediaries shall be registered with a competent authority as defined in Article 7(2), in their home Member State. Without prejudice to the first subparagraph, Member States may stipulate that insurance and reinsurance undertakings and other bodies may collaborate with the competent authorities in registering insurance and reinsurance intermediaries and in the application of the requirements of Article 4 to such intermediaries. In particular, in the case of tied insurance intermediaries, they may be registered by an insurance undertaking or by an association of insurance undertakings under the supervision of a competent authority. Member States need not apply the requirement referred to in the first and second subparagraphs to all the natural persons who work in an undertaking and pursue the activity of insurance or reinsurance mediation. As regards legal persons, Member States shall register such persons and shall also specify in the register the names of the natural persons within the management who are responsible for the mediation business. 2. Member States may establish more than one register for insurance and reinsurance intermediaries provided that they lay down the criteria according to which intermediaries are to be registered. Member States shall see to it that a single information point is established allowing quick and easy access to information from these various registers, which shall be compiled electronically and kept constantly updated. This information point shall also provide the identification details of the competent authorities of each Member State referred to in paragraph 1, first subparagraph. The register shall indicate further the country or countries in which the intermediary conducts business under the rules on the freedom of establishment or on the freedom to provide services. 3. Member States shall ensure that registration of insurance intermediaries - including tied ones - and reinsurance intermediaries is made subject to the fulfilment of the professional requirements laid down in Article 4. Member States shall also ensure that insurance intermediaries - including tied ones - and reinsurance intermediaries who cease to fulfil these requirements are removed from the register. The validity of the registration shall be subject to a regular review by the competent authority. If necessary, the home Member State shall inform the host Member State of such removal, by any appropriate means. 4. The competent authorities may provide the insurance and reinsurance intermediaries with a document enabling any interested party by consultation of the register(s) referred to in paragraph 2 to verify that they are duly registered. That document shall at least provide the information specified in Article 12(1)(a) and (b), and, in the case of a legal person, the name(s) of the natural person(s) referred to in the fourth subparagraph of paragraph 1 of this Article. The Member State shall require the return of the document to the competent authority which issued it when the insurance or reinsurance intermediary concerned ceases to be registered. 5. Registered insurance and reinsurance intermediaries shall be allowed to take up and pursue the activity of insurance and reinsurance mediation in the Community by means of both freedom of establishment and freedom to provide services. 6. Member States shall ensure that insurance undertakings use the insurance and reinsurance mediation services only of registered insurance and reinsurance intermediaries and of the persons referred to in Article 1(2). Article 4 Professional requirements 1. Insurance and reinsurance intermediaries shall possess appropriate knowledge and ability, as determined by the home Member State of the intermediary. Home Member States may adjust the required conditions with regard to knowledge and ability in line with the activity of insurance or reinsurance mediation and the products distributed, particularly if the principal professional activity of the intermediary is other than insurance mediation. In such cases, that intermediary may pursue an activity of insurance mediation only if an insurance intermediary fulfilling the conditions of this Article or an insurance undertaking assumes full responsibility for his actions. Member States may provide that for the cases referred to in the second subparagraph of Article 3(1), the insurance undertaking shall verify that the knowledge and ability of the intermediaries are in conformity with the obligations set out in the first subparagraph of this paragraph and, if need be, shall provide such intermediaries with training which corresponds to the requirements concerning the products sold by the intermediaries. Member States need not apply the requirement referred to in the first subparagraph of this paragraph to all the natural persons working in an undertaking who pursue the activity of insurance or reinsurance mediation. Member States shall ensure that a reasonable proportion of the persons within the management structure of such undertakings who are responsible for mediation in respect of insurance products and all other persons directly involved in insurance or reinsurance mediation demonstrate the knowledge and ability necessary for the performance of their duties. 2. Insurance and reinsurance intermediaries shall be of good repute. As a minimum, they shall have a clean police record or any other national equivalent in relation to serious criminal offences linked to crimes against property or other crimes related to financial activities and they should not have previously been declared bankrupt, unless they have been rehabilitated in accordance with national law. Member States may, in accordance with the provisions of the second subparagraph of Article 3(1), allow the insurance undertaking to check the good repute of insurance intermediaries. Member States need not apply the requirement referred to in the first subparagraph of this paragraph to all the natural persons who work in an undertaking and who pursue the activity of insurance and reinsurance mediation. Member States shall ensure that the management structure of such undertakings and any staff directly involved in insurance or reinsurance mediation fulfil that requirement. 3. Insurance and reinsurance intermediaries shall hold professional indemnity insurance covering the whole territory of the Community or some other comparable guarantee against liability arising from professional negligence, for at least EUR 1000000 applying to each claim and in aggregate EUR 1500000 per year for all claims, unless such insurance or comparable guarantee is already provided by an insurance undertaking, reinsurance undertaking or other undertaking on whose behalf the insurance or reinsurance intermediary is acting or for which the insurance or reinsurance intermediary is empowered to act or such undertaking has taken on full responsibility for the intermediary's actions. 4. Member States shall take all necessary measures to protect customers against the inability of the insurance intermediary to transfer the premium to the insurance undertaking or to transfer the amount of claim or return premium to the insured. Such measures shall take any one or more of the following forms: (a) provisions laid down by law or contract whereby monies paid by the customer to the intermediary are treated as having been paid to the undertaking, whereas monies paid by the undertaking to the intermediary are not treated as having been paid to the customer until the customer actually receives them; (b) a requirement for insurance intermediaries to have financial capacity amounting, on a permanent basis, to 4 % of the sum of annual premiums received, subject to a minimum of EUR 15000; (c) a requirement that customers' monies shall be transferred via strictly segregated client accounts and that these accounts shall not be used to reimburse other creditors in the event of bankruptcy; (d) a requirement that a guarantee fund be set up. 5. Pursuit of the activities of insurance and reinsurance mediation shall require that the professional requirements set out in this Article be fulfilled on permanent basis. 6. Member States may reinforce the requirements set out in this Article or add other requirements for insurance and reinsurance intermediaries registered within their jurisdiction. 7. The amounts referred to in paragraphs 3 and 4 shall be reviewed regularly in order to take account of changes in the European Index of Consumer Prices as published by Eurostat. The first review shall take place five years after the entry into force of this Directive and the successive reviews every five years after the previous review date. The amounts shall be adapted automatically by increasing the base amount in euro by the percentage change in that Index over the period between the entry into force of this Directive and the first review date or between the last review date and the new review date and rounded up to the nearest euro. Article 5 Retention of acquired rights Member States may provide that those persons who exercised a mediation activity before 1 September 2000, who were entered in a register and who had a level of training and experience similar to that required by this Directive, shall be automatically entered in the register to be created, once the requirements set down in Article 4(3) and (4) are complied with. Article 6 Notification of establishment and services in other Member States 1. Any insurance or reinsurance intermediary intending to carry on business for the first time in one or more Member States under the freedom to provide services or the freedom of establishment shall inform the competent authorities of the home Member State. Within a period of one month after such notification, those competent authorities shall inform the competent authorities of any host Member States wishing to know, of the intention of the insurance or reinsurance intermediary and shall at the same time inform the intermediary concerned. The insurance or reinsurance intermediary may start business one month after the date on which he was informed by the competent authorities of the home Member State of the notification referred to in the second subparagraph. However, that intermediary may start business immediately if the host Member State does not wish to be informed of the fact. 2. Member States shall notify the Commission of their wish to be informed in accordance with paragraph 1. The Commission shall in turn notify all the Member States of this. 3. The competent authorities of the host Member State may take the necessary steps to ensure appropriate publication of the conditions under which, in the interest of the general good, the business concerned must be carried on in their territories. Article 7 Competent authorities 1. Member States shall designate the competent authorities empowered to ensure implementation of this Directive. They shall inform the Commission thereof, indicating any division of those duties. 2. The authorities referred to in paragraph 1 shall be either public authorities or bodies recognised by national law or by public authorities expressly empowered for that purpose by national law. They shall not be insurance or reinsurance undertakings. 3. The competent authorities shall possess all the powers necessary for the performance of their duties. Where there is more than one competent authority on its territory, a Member State shall ensure that those authorities collaborate closely so that they can discharge their respective duties effectively. Article 8 Sanctions 1. Member States shall provide for appropriate sanctions in the event that a person exercising the activity of insurance or reinsurance mediation is not registered in a Member State and is not referred to in Article 1(2). 2. Member States shall provide for appropriate sanctions against insurance or reinsurance undertakings which use the insurance or reinsurance mediation services of persons who are not registered in a Member State and who are not referred to in Article 1(2). 3. Member States shall provide for appropriate sanctions in the event of an insurance or reinsurance intermediary's failure to comply with national provisions adopted pursuant to this Directive. 4. This Directive shall not affect the power of the host Member States to take appropriate measures to prevent or to penalise irregularities committed within their territories which are contrary to legal or regulatory provisions adopted in the interest of the general good. This shall include the possibility of preventing offending insurance or reinsurance intermediaries from initiating any further activities within their territories. 5. Any measure adopted involving sanctions or restrictions on the activities of an insurance or reinsurance intermediary must be properly justified and communicated to the intermediary concerned. Every such measure shall be subject to the right to apply to the courts in the Member State which adopted it. Article 9 Exchange of information between Member States 1. The competent authorities of the various Member States shall cooperate in order to ensure the proper application of the provisions of this Directive. 2. The competent authorities shall exchange information on insurance and reinsurance intermediaries if they have been subject to a sanction referred to in Article 8(3) or a measure referred to in Article 8(4) and such information is likely to lead to removal from the register of such intermediaries. The competent authorities may also exchange any relevant information at the request of an authority. 3. All persons required to receive or divulge information in connection with this Directive shall be bound by professional secrecy, in the same manner as is laid down in Article 16 of Council Directive 92/49/EEC of 18 June 1992 on the coordination of laws, regulations and administrative provisions relating to direct insurance other than life assurance and amending Directives 73/239/EEC and 88/357/EEC (third non-life insurance Directive)(10) and Article 15 of Council Directive 92/96/EEC of 10 November 1992 on the coordination of laws, regulations and administrative provisions relating to direct life assurance and amending Directives 79/267/EEC and 90/619/EEC (third life assurance Directive)(11). Article 10 Complaints Member States shall ensure that procedures are set up which allow customers and other interested parties, especially consumer associations, to register complaints about insurance and reinsurance intermediaries. In all cases complaints shall receive replies. Article 11 Out-of-court redress 1. Member States shall encourage the setting-up of appropriate and effective complaints and redress procedures for the out-of-court settlement of disputes between insurance intermediaries and customers, using existing bodies where appropriate. 2. Member States shall encourage these bodies to cooperate in the resolution of cross-border disputes. CHAPTER III INFORMATION REQUIREMENTS FOR INTERMEDIARIES Article 12 Information provided by the insurance intermediary 1. Prior to the conclusion of any initial insurance contract, and, if necessary, upon amendment or renewal thereof, an insurance intermediary shall provide the customer with at least the following information: (a) his identity and address; (b) the register in which he has been included and the means for verifying that he has been registered; (c) whether he has a holding, direct or indirect, representing more than 10 % of the voting rights or of the capital in a given insurance undertaking; (d) whether a given insurance undertaking or parent undertaking of a given insurance undertaking has a holding, direct or indirect, representing more than 10 % of the voting rights or of the capital in the insurance intermediary; (e) the procedures referred to in Article 10 allowing customers and other interested parties to register complaints about insurance and reinsurance intermediaries and, if appropriate, about the out-of-court complaint and redress procedures referred to in Article 11. In addition, an insurance intermediary shall inform the customer, concerning the contract that is provided, whether: (i) he gives advice based on the obligation in paragraph 2 to provide a fair analysis, or (ii) he is under a contractual obligation to conduct insurance mediation business exclusively with one or more insurance undertakings. In that case, he shall, at the customer's request provide the names of those insurance undertakings, or (iii) he is not under a contractual obligation to conduct insurance mediation business exclusively with one or more insurance undertakings and does not give advice based on the obligation in paragraph 2 to provide a fair analysis. In that case, he shall, at the customer's request provide the names of the insurance undertakings with which he may and does conduct business. In those cases where information is to be provided solely at the customer's request, the customer shall be informed that he has the right to request such information. 2. When the insurance intermediary informs the customer that he gives his advice on the basis of a fair analysis, he is obliged to give that advice on the basis of an analysis of a sufficiently large number of insurance contracts available on the market, to enable him to make a recommendation, in accordance with professional criteria, regarding which insurance contract would be adequate to meet the customer's needs. 3. Prior to the conclusion of any specific contract, the insurance intermediary shall at least specify, in particular on the basis of information provided by the customer, the demands and the needs of that customer as well as the underlying reasons for any advice given to the customer on a given insurance product. These details shall be modulated according to the complexity of the insurance contract being proposed. 4. The information referred to in paragraphs 1, 2 and 3 need not be given when the insurance intermediary mediates in the insurance of large risks, nor in the case of mediation by reinsurance intermediaries. 5. Member States may maintain or adopt stricter provisions regarding the information requirements referred to in paragraph 1, provided that such provisions comply with Community law. Member States shall communicate to the Commission the national provisions set out in the first subparagraph. In order to establish a high level of transparency by all appropriate means, the Commission shall ensure that the information it receives relating to national provisions is also communicated to consumers and insurance intermediaries. Article 13 Information conditions 1. All information to be provided to customers in accordance with Article 12 shall be communicated: (a) on paper or on any other durable medium available and accessible to the customer; (b) in a clear and accurate manner, comprehensible to the customer; (c) in an official language of the Member State of the commitment or in any other language agreed by the parties. 2. By way of derogation from paragraph 1(a), the information referred to in Article 12 may be provided orally where the customer requests it, or where immediate cover is necessary. In those cases, the information shall be provided to the customer in accordance with paragraph 1 immediately after the conclusion of the insurance contract. 3. In the case of telephone selling, the prior information given to the customer shall be in accordance with Community rules applicable to the distance marketing of consumer financial services. Moreover, information shall be provided to the customer in accordance with paragraph 1 immediately after the conclusion of the insurance contract. CHAPTER IV FINAL PROVISIONS Article 14 Right to apply to the courts Member States shall ensure that decisions taken in respect of an insurance intermediary, reinsurance intermediary or an insurance undertaking under the laws, regulations and administrative provisions adopted in accordance with this Directive may be subject to the right to apply to the courts. Article 15 Repeal Directive 77/92/EEC is hereby repealed with effect from the date referred to in Article 16(1). Article 16 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 15 January 2005. They shall forthwith inform the Commission thereof. These measures shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the laws, regulations and administrative provisions which they adopt in the field governed by this Directive. In that communication they shall provide a table indicating the national provisions corresponding to this Directive. Article 17 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 18 Addressees This Directive is addressed to the Member States.

32002L0091

2002

Directive 2002/91/EC of the European Parliament and of the Council of 16 December 2002 on the energy performance of buildings Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the Economic and Social Committee(2), Having regard to the opinion of the Committee of the Regions(3), Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), Whereas: (1) Article 6 of the Treaty requires environmental protection requirements to be integrated into the definition and implementation of Community policies and actions. (2) The natural resources, to the prudent and rational utilisation of which Article 174 of the Treaty refers, include oil products, natural gas and solid fuels, which are essential sources of energy but also the leading sources of carbon dioxide emissions. (3) Increased energy efficiency constitutes an important part of the package of policies and measures needed to comply with the Kyoto Protocol and should appear in any policy package to meet further commitments. (4) Demand management of energy is an important tool enabling the Community to influence the global energy market and hence the security of energy supply in the medium and long term. (5) In its conclusions of 30 May 2000 and of 5 December 2000, the Council endorsed the Commission's action plan on energy efficiency and requested specific measures in the building sector. (6) The residential and tertiary sector, the major part of which is buildings, accounts for more than 40 % of final energy consumption in the Community and is expanding, a trend which is bound to increase its energy consumption and hence also its carbon dioxide emissions. (7) Council Directive 93/76/EEC of 13 September 1993 to limit carbon dioxide emissions by improving energy efficiency (SAVE)(5), which requires Member States to develop, implement and report on programmes in the field of energy efficiency in the building sector, is now starting to show some important benefits. However, a complementary legal instrument is needed to lay down more concrete actions with a view to achieving the great unrealised potential for energy savings and reducing the large differences between Member States' results in this sector. (8) Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products(6) requires construction works and their heating, cooling and ventilation installations to be designed and built in such a way that the amount of energy required in use will be low, having regard to the climatic conditions of the location and the occupants. (9) The measures further to improve the energy performance of buildings should take into account climatic and local conditions as well as indoor climate environment and cost-effectiveness. They should not contravene other essential requirements concerning buildings such as accessibility, prudence and the intended use of the building. (10) The energy performance of buildings should be calculated on the basis of a methodology, which may be differentiated at regional level, that includes, in addition to thermal insulation other factors that play an increasingly important role such as heating and air-conditioning installations, application of renewable energy sources and design of the building. A common approach to this process, carried out by qualified and/or accredited experts, whose independence is to be guaranteed on the basis of objective criteria, will contribute to a level playing field as regards efforts made in Member States to energy saving in the buildings sector and will introduce transparency for prospective owners or users with regard to the energy performance in the Community property market. (11) The Commission intends further to develop standards such as EN 832 and prEN 13790, also including consideration of air-conditioning systems and lighting. (12) Buildings will have an impact on long-term energy consumption and new buildings should therefore meet minimum energy performance requirements tailored to the local climate. Best practice should in this respect be geared to the optimum use of factors relevant to enhancing energy performance. As the application of alternative energy supply systems is generally not explored to its full potential, the technical, environmental and economic feasibility of alternative energy supply systems should be considered; this can be carried out once, by the Member State, through a study which produces a list of energy conservation measures, for average local market conditions, meeting cost-effectiveness criteria. Before construction starts, specific studies may be requested if the measure, or measures, are deemed feasible. (13) Major renovations of existing buildings above a certain size should be regarded as an opportunity to take cost-effective measures to enhance energy performance. Major renovations are cases such as those where the total cost of the renovation related to the building shell and/or energy installations such as heating, hot water supply, air-conditioning, ventilation and lighting is higher than 25 % of the value of the building, excluding the value of the land upon which the building is situated, or those where more than 25 % of the building shell undergoes renovation. (14) However, the improvement of the overall energy performance of an existing building does not necessarily mean a total renovation of the building but could be confined to those parts that are most relevant for the energy performance of the building and are cost-effective. (15) Renovation requirements for existing buildings should not be incompatible with the intended function, quality or character of the building. It should be possible to recover additional costs involved in such renovation within a reasonable period of time in relation to the expected technical lifetime of the investment by accrued energy savings. (16) The certification process may be supported by programmes to facilitate equal access to improved energy performance; based upon agreements between organisations of stakeholders and a body appointed by the Member States; carried out by energy service companies which agree to commit themselves to undertake the identified investments. The schemes adopted should be supervised and followed up by Member States, which should also facilitate the use of incentive systems. To the extent possible, the certificate should describe the actual energy-performance situation of the building and may be revised accordingly. Public authority buildings and buildings frequently visited by the public should set an example by taking environmental and energy considerations into account and therefore should be subject to energy certification on a regular basis. The dissemination to the public of this information on energy performance should be enhanced by clearly displaying these energy certificates. Moreover, the displaying of officially recommended indoor temperatures, together with the actual measured temperature, should discourage the misuse of heating, air-conditioning and ventilation systems. This should contribute to avoiding unnecessary use of energy and to safeguarding comfortable indoor climatic conditions (thermal comfort) in relation to the outside temperature. (17) Member States may also employ other means/measures, not provided for in this Directive, to encourage enhanced energy performance. Member States should encourage good energy management, taking into account the intensity of use of buildings. (18) Recent years have seen a rise in the number of air-conditioning systems in southern European countries. This creates considerable problems at peak load times, increasing the cost of electricity and disrupting the energy balance in those countries. Priority should be given to strategies which enhance the thermal performance of buildings during the summer period. To this end there should be further development of passive cooling techniques, primarily those that improve indoor climatic conditions and the microclimate around buildings. (19) Regular maintenance of boilers and of air-conditioning systems by qualified personnel contributes to maintaining their correct adjustment in accordance with the product specification and in that way will ensure optimal performance from an environmental, safety and energy point of view. An independent assessment of the total heating installation is appropriate whenever replacement could be considered on the basis of cost-effectiveness. (20) The billing, to occupants of buildings, of the costs of heating, air-conditioning and hot water, calculated in proportion to actual consumption, could contribute towards energy saving in the residential sector. Occupants should be enabled to regulate their own consumption of heat and hot water, in so far as such measures are cost effective. (21) In accordance with the principles of subsidiarity and proportionality as set out in Article 5 of the Treaty, general principles providing for a system of energy performance requirements and its objectives should be established at Community level, but the detailed implementation should be left to Member States, thus allowing each Member State to choose the regime which corresponds best to its particular situation. This Directive confines itself to the minimum required in order to achieve those objectives and does not go beyond what is necessary for that purpose. (22) Provision should be made for the possibility of rapidly adapting the methodology of calculation and of Member States regularly reviewing minimum requirements in the field of energy performance of buildings with regard to technical progress, inter alia, as concerns the insulation properties (or quality) of the construction material, and to future developments in standardisation. (23) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7), Article 1 Objective The objective of this Directive is to promote the improvement of the energy performance of buildings within the Community, taking into account outdoor climatic and local conditions, as well as indoor climate requirements and cost-effectiveness. This Directive lays down requirements as regards: (a) the general framework for a methodology of calculation of the integrated energy performance of buildings; (b) the application of minimum requirements on the energy performance of new buildings; (c) the application of minimum requirements on the energy performance of large existing buildings that are subject to major renovation; (d) energy certification of buildings; and (e) regular inspection of boilers and of air-conditioning systems in buildings and in addition an assessment of the heating installation in which the boilers are more than 15 years old. Article 2 Definitions For the purpose of this Directive, the following definitions shall apply: 1. "building": a roofed construction having walls, for which energy is used to condition the indoor climate; a building may refer to the building as a whole or parts thereof that have been designed or altered to be used separately; 2. "energy performance of a building": the amount of energy actually consumed or estimated to meet the different needs associated with a standardised use of the building, which may include, inter alia, heating, hot water heating, cooling, ventilation and lighting. This amount shall be reflected in one or more numeric indicators which have been calculated, taking into account insulation, technical and installation characteristics, design and positioning in relation to climatic aspects, solar exposure and influence of neighbouring structures, own-energy generation and other factors, including indoor climate, that influence the energy demand; 3. "energy performance certificate of a building": a certificate recognised by the Member State or a legal person designated by it, which includes the energy performance of a building calculated according to a methodology based on the general framework set out in the Annex; 4. "CHP" (combined heat and power): the simultaneous conversion of primary fuels into mechanical or electrical and thermal energy, meeting certain quality criteria of energy efficiency; 5. "air-conditioning system": a combination of all components required to provide a form of air treatment in which temperature is controlled or can be lowered, possibly in combination with the control of ventilation, humidity and air cleanliness; 6. "boiler": the combined boiler body and burner-unit designed to transmit to water the heat released from combustion; 7. "effective rated output (expressed in kW)": the maximum calorific output specified and guaranteed by the manufacturer as being deliverable during continuous operation while complying with the useful efficiency indicated by the manufacturer; 8. "heat pump": a device or installation that extracts heat at low temperature from air, water or earth and supplies the heat to the building. Article 3 Adoption of a methodology Member States shall apply a methodology, at national or regional level, of calculation of the energy performance of buildings on the basis of the general framework set out in the Annex. Parts 1 and 2 of this framework shall be adapted to technical progress in accordance with the procedure referred to in Article 14(2), taking into account standards or norms applied in Member State legislation. This methodology shall be set at national or regional level. The energy performance of a building shall be expressed in a transparent manner and may include a CO2 emission indicator. Article 4 Setting of energy performance requirements 1. Member States shall take the necessary measures to ensure that minimum energy performance requirements for buildings are set, based on the methodology referred to in Article 3. When setting requirements, Member States may differentiate between new and existing buildings and different categories of buildings. These requirements shall take account of general indoor climate conditions, in order to avoid possible negative effects such as inadequate ventilation, as well as local conditions and the designated function and the age of the building. These requirements shall be reviewed at regular intervals which should not be longer than five years and, if necessary, updated in order to reflect technical progress in the building sector. 2. The energy performance requirements shall be applied in accordance with Articles 5 and 6. 3. Member States may decide not to set or apply the requirements referred to in paragraph 1 for the following categories of buildings: - buildings and monuments officially protected as part of a designated environment or because of their special architectural or historic merit, where compliance with the requirements would unacceptably alter their character or appearance, - buildings used as places of worship and for religious activities, - temporary buildings with a planned time of use of two years or less, industrial sites, workshops and non-residential agricultural buildings with low energy demand and non-residential agricultural buildings which are in use by a sector covered by a national sectoral agreement on energy performance, - residential buildings which are intended to be used less than four months of the year, - stand-alone buildings with a total useful floor area of less than 50 m2. Article 5 New buildings Member States shall take the necessary measures to ensure that new buildings meet the minimum energy performance requirements referred to in Article 4. For new buildings with a total useful floor area over 1000 m2, Member States shall ensure that the technical, environmental and economic feasibility of alternative systems such as: - decentralised energy supply systems based on renewable energy, - CHP, - district or block heating or cooling, if available, - heat pumps, under certain conditions, is considered and is taken into account before construction starts. Article 6 Existing buildings Member States shall take the necessary measures to ensure that when buildings with a total useful floor area over 1000 m2 undergo major renovation, their energy performance is upgraded in order to meet minimum requirements in so far as this is technically, functionally and economically feasible. Member States shall derive these minimum energy performance requirements on the basis of the energy performance requirements set for buildings in accordance with Article 4. The requirements may be set either for the renovated building as a whole or for the renovated systems or components when these are part of a renovation to be carried out within a limited time period, with the abovementioned objective of improving the overall energy performance of the building. Article 7 Energy performance certificate 1. Member States shall ensure that, when buildings are constructed, sold or rented out, an energy performance certificate is made available to the owner or by the owner to the prospective buyer or tenant, as the case might be. The validity of the certificate shall not exceed 10 years. Certification for apartments or units designed for separate use in blocks may be based: - on a common certification of the whole building for blocks with a common heating system, or - on the assessment of another representative apartment in the same block. Member States may exclude the categories referred to in Article 4(3) from the application of this paragraph. 2. The energy performance certificate for buildings shall include reference values such as current legal standards and benchmarks in order to make it possible for consumers to compare and assess the energy performance of the building. The certificate shall be accompanied by recommendations for the cost-effective improvement of the energy performance. The objective of the certificates shall be limited to the provision of information and any effects of these certificates in terms of legal proceedings or otherwise shall be decided in accordance with national rules. 3. Member States shall take measures to ensure that for buildings with a total useful floor area over 1000 m2 occupied by public authorities and by institutions providing public services to a large number of persons and therefore frequently visited by these persons an energy certificate, not older than 10 years, is placed in a prominent place clearly visible to the public. The range of recommended and current indoor temperatures and, when appropriate, other relevant climatic factors may also be clearly displayed. Article 8 Inspection of boilers With regard to reducing energy consumption and limiting carbon dioxide emissions, Member States shall either: (a) lay down the necessary measures to establish a regular inspection of boilers fired by non-renewable liquid or solid fuel of an effective rated output of 20 kW to 100 kW. Such inspection may also be applied to boilers using other fuels. Boilers of an effective rated output of more than 100 kW shall be inspected at least every two years. For gas boilers, this period may be extended to four years. For heating installations with boilers of an effective rated output of more than 20 kW which are older than 15 years, Member States shall lay down the necessary measures to establish a one-off inspection of the whole heating installation. On the basis of this inspection, which shall include an assessment of the boiler efficiency and the boiler sizing compared to the heating requirements of the building, the experts shall provide advice to the users on the replacement of the boilers, other modifications to the heating system and on alternative solutions; or (b) take steps to ensure the provision of advice to the users on the replacement of boilers, other modifications to the heating system and on alternative solutions which may include inspections to assess the efficiency and appropriate size of the boiler. The overall impact of this approach should be broadly equivalent to that arising from the provisions set out in (a). Member States that choose this option shall submit a report on the equivalence of their approach to the Commission every two years. Article 9 Inspection of air-conditioning systems With regard to reducing energy consumption and limiting carbon dioxide emissions, Member States shall lay down the necessary measures to establish a regular inspection of air-conditioning systems of an effective rated output of more than 12 kW. This inspection shall include an assessment of the air-conditioning efficiency and the sizing compared to the cooling requirements of the building. Appropriate advice shall be provided to the users on possible improvement or replacement of the air-conditioning system and on alternative solutions. Article 10 Independent experts Member States shall ensure that the certification of buildings, the drafting of the accompanying recommendations and the inspection of boilers and air-conditioning systems are carried out in an independent manner by qualified and/or accredited experts, whether operating as sole traders or employed by public or private enterprise bodies. Article 11 Review The Commission, assisted by the Committee established by Article 14, shall evaluate this Directive in the light of experience gained during its application, and, if necessary, make proposals with respect to, inter alia: (a) possible complementary measures referring to the renovations in buildings with a total useful floor area less than 1000 m2; (b) general incentives for further energy efficiency measures in buildings. Article 12 Information Member States may take the necessary measures to inform the users of buildings as to the different methods and practices that serve to enhance energy performance. Upon Member States' request, the Commission shall assist Member States in staging the information campaigns concerned, which may be dealt with in Community programmes. Article 13 Adaptation of the framework Points 1 and 2 of the Annex shall be reviewed at regular intervals, which shall not be shorter than two years. Any amendments necessary in order to adapt points 1 and 2 of the Annex to technical progress shall be adopted in accordance with the procedure referred to in Article 14(2). Article 14 Committee 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. Article 15 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive at the latest on 4 January 2006. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States may, because of lack of qualified and/or accredited experts, have an additional period of three years to apply fully the provisions of Articles 7, 8 and 9. When making use of this option, Member States shall notify the Commission, providing the appropriate justification together with a time schedule with respect to the further implementation of this Directive. Article 16 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 17 Addressees This Directive is addressed to the Member States.

32002L0099

2002

Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Parliament(2), Having regard to the opinion of the European Economic and Social Committee(3), Whereas: (1) In the context of the single market, specific animal health rules have been laid down to govern intra-Community trade in the production, processing, distribution and introduction from third countries of products of animal origin for human consumption included in Annex I to the Treaty. (2) Those rules have allowed the removal of obstacles to trade in the products concerned, thereby contributing to the creation of the internal market whilst ensuring a high level of animal health protection. (3) The aim of those rules is to prevent the introduction or spread of animal diseases resulting from the placing on the market of products of animal origin. They also contain common provisions concerning in particular the restrictions applicable to the placing on the market of products coming from a holding or area infected by epizootic diseases and the obligation to subject products coming from restricted areas to treatment to destroy the disease agent. (4) Those common provisions should be harmonised in order to remove possible inconsistencies introduced when the specific animal health rules were adopted. Such harmonisation will also ensure uniform implementation of animal health rules throughout the Community and introduce greater transparency in the structure of Community legislation. (5) Veterinary checks on products of animal origin intended for trade must be carried out in accordance with Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market(4). Directive 89/662/EEC contains safeguard measures that may be implemented in the event of a serious hazard to animal health. (6) Products imported from third countries must not present an animal health hazard for Community livestock. (7) To that end, procedures should be introduced to prevent the introduction of epizootic diseases. Such procedures include a regular evaluation of the animal health situation in the third countries concerned. (8) Procedures must also be introduced for establishing general or specific rules or criteria to be applied to imports of products of animal origin. (9) Provisions concerning the importation of meat of domestic ungulates and meat products prepared from or with such meat are already contained in Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries(5). (10) The procedures applicable to the importation of meat and meat products can be used as a model for the importation of other products of animal origin. (11) Veterinary checks on products of animal origin imported into the Community from third countries must be carried out in accordance with Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries(6); Directive 97/78/EC contains safeguard measures that may be implemented in case of a serious hazard to animal health. (12) Account must be taken of the guidelines laid down by the World Organisation for Animal Health (OIE) when adopting rules for international trade. (13) Community audits and inspections must be organised in order to ensure the uniform application of the animal health provisions. (14) The products covered by this Directive are listed in Annex I to the Treaty. (15) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7), Article 1 Scope This Directive lays down the general animal health rules governing all stages of the production, processing and distribution within the Community and the introduction from third countries of products of animal origin and products obtained therefrom intended for human consumption. These rules do not affect the provisions laid down in Directives 89/662/EEC and 97/78/EC and the Directives listed in Annex I. Article 2 Definitions For the purposes of this Directive, the definitions in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(8) and Directive 97/78/EC shall apply as necessary. The following definitions shall also apply: 1. "all stages of the production, processing and distribution" means any stage from and including the primary production of a food of animal origin, up to and including its storage, transport, sale or supply to the final consumer; 2. "introduction" means the bringing of goods into one of the territories listed in Annex I to Directive 97/78/EC for the purpose of placing them under the customs procedures referred to in Article 4(16)(a) to (f) of Council Regulation (EC) No 2913/92 of 12 October 1992 establishing the Community Customs Code(9); 3. "official veterinarian" means a veterinarian qualified to act in that capacity appointed by the competent authority; 4. "products of animal origin" means products obtained from animals and products obtained therefrom, for human consumption, including live animals where they are prepared for such use. CHAPTER I ANIMAL HEALTH REQUIREMENTS APPLICABLE TO ALL STAGES OF THE PRODUCTION, PROCESSING AND DISTRIBUTION OF PRODUCTS OF ANIMAL ORIGIN WITHIN THE COMMUNITY Article 3 General animal health requirements 1. Member States shall take measures to ensure that at all stages of the production, processing and distribution of products of animal origin within the Community, food business operators do not cause the spread of diseases transmissible to animals, in accordance with the following provisions. 2. Products of animal origin must be obtained from animals which fulfil the animal health conditions laid down by the relevant Community legislation. 3. Products of animal origin shall be obtained from animals: (a) which do not come from a holding, establishment, territory or part of a territory subject to animal health restrictions applicable to the animals and products concerned, under the rules set out in Annex I; (b) which, in the case of meat and meat products, were not slaughtered in an establishment in which animals infected or suspected of being infected with one of the diseases covered by the rules referred to in (a), or carcasses or parts thereof of such animals, were present during the slaughtering or production process, unless such suspicion has been ruled out; (c) which, in the case of aquaculture animals and products, comply with Directive 91/67/EEC(10). Article 4 Derogations 1. Notwithstanding Article 3 and subject to compliance with the disease control measures referred to in Annex I, Member States may authorise the production, processing and distribution of products of animal origin which come from a territory or part of a territory subject to animal health restrictions but which do not come from a holding which is infected or suspected of being infected, provided that: (i) before being subjected to the treatment referred to below, the products have been obtained, handled, transported and stored separately, or at different times, from products fulfilling all the animal health conditions, and the conditions for transport out of the territory subject to animal health restrictions have been approved by the competent authority; (ii) the products which are to undergo treatment are clearly identified; (iii) the products undergo treatment enabling the animal health problem concerned to be eliminated, and (iv) the treatment is applied at an establishment approved for that purpose by the Member State in which the animal health problem occurred. The provisions of the first subparagraph shall be applied in accordance with Annexes II and III(1) hereto, or with detailed rules to be adopted in accordance with the procedure referred to in Article 12(2). 2. The production, processing and distribution of aquaculture products not complying with the conditions laid down in Article 3 shall be authorised, subject to the conditions laid down in Directive 91/67/EEC and, where necessary, in accordance with further conditions to be adopted in accordance with the procedure referred to in Article 12(2). 3. Furthermore, where the health situation so permits, derogations from Article 3 may be granted in certain situations, in accordance with the procedure referred to in Article 12(2). In such cases, particular account shall be taken of: (a) the specific characteristics of the disease in the species concerned, and (b) any tests or measures to which the animals must be subjected. Where such derogations are granted, steps must be taken to ensure that the degree of protection from animal disease will in no way be impaired. Any measures needed to ensure the protection of animal health in the Community shall therefore be adopted in accordance with the same procedure. Article 5 Veterinary certificates 1. Member States shall ensure that products of animal origin intended for human consumption are subjected to veterinary certification where: - provisions adopted for animal health reasons under Article 9 of Directive 89/662/EEC require products of animal origin from a Member State to be accompanied by a health certificate, or - a derogation has been granted under Article 4(3). 2. Under the procedure referred to in Article 12(2), detailed implementing rules, and in particular a model for such certificates, may be drawn up taking into account the general principles set out in Annex IV. Certificates may include details required in accordance with other Community public and animal health legislation. Article 6 Official veterinary controls 1. Pending adoption of Regulations of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and rules for controls applicable to foodstuffs and animal feed, Member States shall ensure that official animal health controls are carried out by their competent authorities to ensure compliance with this Directive, its implementing rules and any safeguard measures relating to products of animal origin adopted pursuant to this Directive. As a general rule, inspections must be unannounced and checks carried out in accordance with the provisions of Directive 89/662/EEC. 2. Pending adoption of Regulations of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and rules for controls applicable to foodstuffs and animal feed, where infringements of animal health rules are identified, Member States shall take the necessary measures to remedy the situation in accordance with the provisions of Directive 89/662/EEC. 3. Experts from the Commission may carry out on-the-spot checks, including audits, in cooperation with the competent authorities of the Member States, insofar as is necessary for the uniform application of this Directive. The Member States in whose territory checks are made shall provide the experts with all the assistance necessary for carrying out their duties. The Commission shall inform the competent authority of the results of the checks made. If a serious animal health risk is identified during a Commission audit or inspection, the Member State concerned shall immediately take all measures necessary to safeguard animal health. If such measures are not taken, or if they are considered to be insufficient, the Commission shall, in accordance with the procedure referred to in Article 12(2), take the measures necessary to safeguard animal health and inform the Member States thereof. 4. The rules for the application of this Article, and in particular those governing the procedure for cooperation with the national authorities, shall be adopted in accordance with the procedure referred to in Article 12(2). CHAPTER II IMPORTS FROM THIRD COUNTRIES Article 7 General provisions Member States shall take measures to ensure that products of animal origin intended for human consumption are introduced from third countries only if they comply with the requirements of Chapter I applicable to all stages of the production, processing and distribution of such products in the Community or if they offer equivalent animal health guarantees. Article 8 Compliance with Community rules In order to ensure compliance with the general obligation laid down in Article 7, the following shall be established in accordance with the procedure referred to in Article 12(2): 1. Lists of the third countries or regions of third countries from which imports of specified products of animal origin are permitted. A third country shall appear on such lists only if a Community audit of that country has taken place and demonstrates that the competent veterinary authority provides appropriate guarantees as regards compliance with Community legislation. When drawing up or updating those lists, particular account shall be taken of: (a) the legislation of the third country; (b) the organisation of the competent veterinary authority and its inspection services in the third country, the powers of these services, the supervision to which they are subject, and the means at their disposal, including staff capacity, to apply their legislation effectively; (c) the actual animal health requirements applying to the production, manufacture, handling, storage and dispatch of products of animal origin intended for the Community; (d) the assurances which the competent veterinary authority of the third country can give regarding compliance or equivalence with the relevant animal health conditions; (e) any experience of marketing the product from the third country and the results of any import controls carried out; (f) the results of Community inspections and/or audits carried out in the third country, in particular the results of the assessment of the competent authorities or, where the Commission so requests, the report submitted by the competent authorities of the third country on the inspections which they have carried out; (g) the health status of livestock, other domestic animals and wildlife in the third country, with particular regard to exotic animal diseases and any aspects of the general health situation in the country which might pose a risk to public or animal health in the Community; (h) the regularity, speed and accuracy with which the third country supplies information on the existence of infectious or contagious animal diseases in its territory, particularly the notifiable diseases listed by the World Organisation for Animal Health (OIE) or, in the case of diseases of aquaculture animals, the notifiable diseases listed in the Aquatic Animal Health Code of the OIE; (i) the rules on the prevention and control of infectious or contagious animal diseases in force in the third country and their implementation, including rules on imports from other countries. 2. The Commission shall arrange for up-to-date versions of all lists drawn up or updated in accordance with this Article to be available to the public. Lists drawn up in accordance with this Article may be combined with other lists drawn up for animal and public health purposes and may also include models of health certificates. 3. Rules of origin for products of animal origin and the animals from which such products are obtained shall be established in accordance with the procedure referred to in Article 12(2). 4. Special import conditions for each third country or group of third countries, having regard to the animal health situation of the third country or countries concerned shall be established in accordance with the procedure referred to in Article 12(2). 5. Where necessary: - the detailed rules for the application of this Article, - criteria for classifying third countries and regions thereof with regard to animal diseases, and - specific rules concerning types of introduction or particular products, such as the introduction of products by travellers or the introduction of commercial samples, may be established in accordance with the procedure referred to in Article 12(2). Article 9 Documents 1. A veterinary certificate meeting the requirements set out in Annex IV shall be presented with consignments of products of animal origin upon their entry into the Community. 2. The veterinary certificate shall certify that the products satisfy: (a) the requirements laid down for such products under this Directive and under the Community legislation laying down animal health requirements or provisions that are equivalent to those requirements; and (b) any special import conditions established in accordance with the procedure referred to in Article 12(2). 3. Documents may include details required under other provisions of Community public and animal health legislation. 4. In accordance with the procedure referred to in Article 12(2): (a) provision may be made for the use of electronic documents, (b) model documents may be drawn up, (c) rules and certification for transit may be established. Article 10 Community inspections and audits 1. Community inspections and/or audits at all stages covered by this Directive may be carried out in third countries by experts from the Commission in order to verify conformity with or equivalence to Community animal health rules. The experts from the Commission may be accompanied by experts from the Member States authorised by the Commission to carry out these inspections and/or audits. 2. The inspections and/or audits in third countries referred to in paragraph 1 shall be carried out on behalf of the Community, and the Commission shall meet the costs incurred. 3. The procedure for carrying out the inspections and/or audits in third countries referred to in paragraph 1 may be established or modified in accordance with the procedure referred to in Article 12(2). 4. If a serious animal health risk is identified during a Community inspection or audit, the Commission shall immediately take the measures necessary to safeguard animal health, in accordance with Article 22 of Directive 97/78/EC, and inform the Member States thereof. CHAPTER III FINAL PROVISIONS Article 11 Update of technical annexes The annexes hereto may be amended in accordance with the procedure referred to in Article 12(2) in order to take account in particular of: (i) scientific opinions and scientific knowledge, particularly concerning new risk assessments; (ii) technical developments; and (iii) the setting of safety targets for animal health. Article 12 Committee procedure 1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up by Article 58 of Regulation (EC) No 178/2002. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure. Article 13 Transitional provisions 1. As from the date referred to in Article 14(1), the animal health rules laid down by the Directives listed in Annex V shall no longer apply. 2. Implementing rules adopted on the basis of such provisions shall remain in force until they are replaced by rules having the same effect adopted on the basis of this Directive. 3. Transitional measures may be laid down in accordance with the procedure referred to in Article 12(2). Article 14 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 2005. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for making such reference shall be adopted by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive. Article 15 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 16 This Directive is addressed to the Member States.

32002L0087

2002

Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate and amending Council Directives 73/239/EEC, 79/267/EEC, 92/49/EEC, 92/96/EEC, 93/6/EEC and 93/22/EEC, and Directives 98/78/EC and 2000/12/EC of the European Parliament and of the Council Having regard to the Treaty establishing the European Community, and in particular Article 47(2) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the Economic and Social Committee(2), After consulting the Committee of the Regions, Having regard to the opinion of the European Central Bank(3), Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), Whereas: (1) The current Community legislation provides for a comprehensive set of rules on the prudential supervision of credit institutions, insurance undertakings and investment firms on a stand alone basis and credit institutions, insurance undertakings and investment firms which are part of respectively a banking/investment firm group or an insurance group, i.e. groups with homogeneous financial activities. (2) New developments in financial markets have led to the creation of financial groups which provide services and products in different sectors of the financial markets, called financial conglomerates. Until now, there has been no form of prudential supervision on a group-wide basis of credit institutions, insurance undertakings and investment firms which are part of such a conglomerate, in particular as regards the solvency position and risk concentration at the level of the conglomerate, the intra-group transactions, the internal risk management processes at conglomerate level, and the fit and proper character of the management. Some of these conglomerates are among the biggest financial groups which are active in the financial markets and provide services on a global basis. If such conglomerates, and in particular credit institutions, insurance undertakings and investment firms which are part of such a conglomerate, were to face financial difficulties, these could seriously destabilise the financial system and affect individual depositors, insurance policy holders and investors. (3) The Commission Action Plan for Financial Services identifies a series of actions which are needed to complete the Single Market in Financial Services, and announces the development of supplementary prudential legislation for financial conglomerates which will address loopholes in the present sectoral legislation and additional prudential risks to ensure sound supervisory arrangements with regard to financial groups with cross-sectoral financial activities. Such an ambitious objective can only be attained in stages. The establishment of the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate is one such stage. (4) Other international forums have also identified the need for the development of appropriate supervisory concepts with regard to financial conglomerates. (5) In order to be effective, the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate should be applied to all such conglomerates, the cross-sectoral financial activities of which are significant, which is the case when certain thresholds are reached, no matter how they are structured. Supplementary supervision should cover all financial activities identified by the sectoral financial legislation and all entities principally engaged in such activities should be included in the scope of the supplementary supervision, including asset management companies. (6) Decisions not to include a particular entity in the scope of supplementary supervision should be taken, bearing in mind inter alia whether or not such entity is included in the group-wide supervision under sectoral rules. (7) The competent authorities should be able to assess at a group-wide level the financial situation of credit institutions, insurance undertakings and investment firms which are part of a financial conglomerate, in particular as regards solvency (including the elimination of multiple gearing of own funds instruments), risk concentration and intra-group transactions. (8) Financial conglomerates are often managed on a business-line basis which does not fully coincide with the conglomerate's legal structures. In order to take account of this trend, the requirements for management should be further extended, in particular as regards the management of the mixed financial holding company. (9) All financial conglomerates subject to supplementary supervision should have a coordinator appointed from among the competent authorities involved. (10) The tasks of the coordinator should not affect the tasks and responsibilities of the competent authorities as provided for by the sectoral rules. (11) The competent authorities involved, and especially the coordinator, should have the means of obtaining from the entities within a financial conglomerate, or from other competent authorities, the information necessary for the performance of their supplementary supervision. (12) There is a pressing need for increased collaboration between authorities responsible for the supervision of credit institutions, insurance undertakings and investment firms, including the development of ad hoc cooperation arrangements between the authorities involved in the supervision of entities belonging to the same financial conglomerate. (13) Credit institutions, insurance undertakings and investment firms which have their head office in the Community can be part of a financial conglomerate, the head of which is outside the Community. These regulated entities should also be subject to equivalent and appropriate supplementary supervisory arrangements which achieve objectives and results similar to those pursued by the provisions of this Directive. To this end, transparency of rules and exchange of information with third-country authorities on all relevant circumstances are of great importance. (14) Equivalent and appropriate supplementary supervisory arrangements can only be assumed to exist if the third-country supervisory authorities have agreed to cooperate with the competent authorities concerned on the means and objectives of exercising supplementary supervision of the regulated entities of a financial conglomerate. (15) This Directive does not require the disclosure by competent authorities to a financial conglomerates committee of information which is subject to an obligation of confidentiality under this Directive or other sectoral directives. (16) Since the objective of the proposed action, namely the establishment of rules on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and the effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve this objective. Since this Directive defines minimum standards, Member States may lay down stricter rules. (17) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. (18) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5). (19) Technical guidance and implementing measures for the rules laid down in this Directive may from time to time be necessary to take account of new developments on financial markets. The Commission should accordingly be empowered to adopt implementing measures, provided that these do not modify the essential elements of this Directive. (20) The existing sectoral rules for credit institutions, insurance undertakings and investment firms should be supplemented to a minimum level, in particular to avoid regulatory arbitrage between the sectoral rules and those for financial conglomerates. Therefore, First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of direct insurance other than life assurance(6), First Council Directive 79/267/EEC of 5 March 1979 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of direct life assurance(7), Council Directive 92/49/EEC of 18 June 1992 on the coordination of laws, regulations and administrative provisions relating to direct insurance other than life insurance (third non-life insurance Directive)(8), Council Directive 92/96/EEC of 10 November 1992 on the coordination of laws, regulations and administrative provisions relating to direct life assurance (third life insurance Directive)(9), Council Directive 93/6/EEC of 15 March 1993 on the capital adequacy of investments firms and credit institutions(10) and Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field(11), as well as Directive 98/78/EC of the European Parliament and of the Council of 27 October 1998 on the supplementary supervision of insurance undertakings in an insurance group(12) and Directive 2000/12/EC of the European Parliament and of the Council of 20 March 2000 relating to the taking up and pursuit of the business of credit institutions(13) should be amended accordingly. The objective of further harmonisation can, however, only be achieved by stages and needs to be based on careful analysis. (21) In order to assess the need for and prepare any possible future harmonisation of the treatment of asset management companies under sectoral rules, the Commission should report on Member States' practices in this field, CHAPTER I OBJECTIVE AND DEFINITIONS Article 1 Objective This Directive lays down rules for supplementary supervision of regulated entities which have obtained an authorisation pursuant to Article 6 of Directive 73/239/EEC, Article 6 of Directive 79/267/EEC, Article 3(1) of Directive 93/22/EEC or Article 4 of Directive 2000/12/EC, and which are part of a financial conglomerate. It also amends the relevant sectoral rules which apply to entities regulated by the Directives referred to above. Article 2 Definitions For the purposes of this Directive: 1. "credit institution" shall mean a credit institution within the meaning of the second subparagraph of Article 1(1) of Directive 2000/12/EC; 2. "insurance undertaking" shall mean an insurance undertaking within the meaning of Article 6 of Directive 73/239/EEC, Article 6 of Directive 79/267/EEC or Article 1(b) of Directive 98/78/EC; 3. "investment firm" shall mean an investment firm within the meaning of Article 1(2) of Directive 93/22/EEC, including the undertakings referred to in Article 2(4) of Directive 93/6/EEC; 4. "regulated entity" shall mean a credit institution, an insurance undertaking or an investment firm; 5. "asset management company" shall mean a management company within the meaning of Article 1a(2) of Council Directive 85/611/EEC of 20 December 1985 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS)(14), as well as an undertaking the registered office of which is outside the Community and which would require authorisation in accordance with Article 5(1) of that Directive if it had its registered office within the Community; 6. "reinsurance undertaking" shall mean a reinsurance undertaking within the meaning of Article 1(c) of Directive 98/78/EC; 7. "sectoral rules" shall mean the Community legislation relating to the prudential supervision of regulated entities, in particular laid down in Directives 73/239/EEC, 79/267/EEC, 98/78/EC, 93/6/EEC, 93/22/EEC and 2000/12/EC; 8. "financial sector" shall mean a sector composed of one or more of the following entities: (a) a credit institution, a financial institution or an ancillary banking services undertaking within the meaning of Article 1(5) and (23) of Directive 2000/12/EC (the banking sector); (b) an insurance undertaking, a reinsurance undertaking or an insurance holding company within the meaning of Article 1(i) of Directive 98/78/EC (the insurance sector); (c) an investment firm or a financial institution within the meaning of Article 2(7) of Directive 93/6/EEC (the investment services sector); (d) a mixed financial holding company; 9. "parent undertaking" shall mean a parent undertaking within the meaning of Article 1 of Seventh Council Directive 83/349/EEC of 13 June 1983 on consolidated accounts(15) and any undertaking which, in the opinion of the competent authorities, effectively exercises a dominant influence over another undertaking; 10. "subsidiary undertaking" shall mean a subsidiary undertaking within the meaning of Article 1 of Directive 83/349/EEC and any undertaking over which, in the opinion of the competent authorities, a parent undertaking effectively exercises a dominant influence; all subsidiary undertakings of subsidiary undertakings shall also be considered as subsidiary undertakings of the parent undertaking; 11. "participation" shall mean a participation within the meaning of the first sentence of Article 17 of Fourth Council Directive 78/660/EEC of 25 July 1978 on the annual accounts of certain types of companies(16), or the direct or indirect ownership of 20 % or more of the voting rights or capital of an undertaking; 12. "group" shall mean a group of undertakings, which consists of a parent undertaking, its subsidiaries and the entities in which the parent undertaking or its subsidiaries hold a participation, as well as undertakings linked to each other by a relationship within the meaning of Article 12(1) of Directive 83/349/EEC; 13. "close links" shall mean a situation in which two or more natural or legal persons are linked by: (a) "participation", which shall mean the ownership, direct or by way of control, of 20 % or more of the voting rights or capital of an undertaking; or (b) "control", which shall mean the relationship between a parent undertaking and a subsidiary, in all the cases referred to in Article 1(1) and (2) of Directive 83/349/EEC, or a similar relationship between any natural or legal person and an undertaking; any subsidiary undertaking of a subsidiary undertaking shall also be considered a subsidiary of the parent undertaking which is at the head of those undertakings. A situation in which two or more natural or legal persons are permanently linked to one and the same person by a control relationship shall also be regarded as constituting a close link between such persons; 14. "financial conglomerate" shall mean a group which meets, subject to Article 3, the following conditions: (a) a regulated entity within the meaning of Article 1 is at the head of the group or at least one of the subsidiaries in the group is a regulated entity within the meaning of Article 1; (b) where there is a regulated entity within the meaning of Article 1 at the head of the group, it is either a parent undertaking of an entity in the financial sector, an entity which holds a participation in an entity in the financial sector, or an entity linked with an entity in the financial sector by a relationship within the meaning of Article 12(1) of Directive 83/349/EEC; (c) where there is no regulated entity within the meaning of Article 1 at the head of the group, the group's activities mainly occur in the financial sector within the meaning of Article 3(1); (d) at least one of the entities in the group is within the insurance sector and at least one is within the banking or investment services sector; (e) the consolidated and/or aggregated activities of the entities in the group within the insurance sector and the consolidated and/or aggregated activities of the entities within the banking and investment services sector are both significant within the meaning of Article 3(2) or (3). Any subgroup of a group within the meaning of point 12 which meets the criteria in this point shall be considered as a financial conglomerate; 15. "mixed financial holding company" shall mean a parent undertaking, other than a regulated entity, which together with its subsidiaries, at least one of which is a regulated entity which has its head office in the Community, and other entities, constitutes a financial conglomerate; 16. "competent authorities" shall mean the national authorities of the Member States which are empowered by law or regulation to supervise credit institutions, and/or insurance undertakings and/or investment firms whether on an individual or a group-wide basis; 17. "relevant competent authorities" shall mean: (a) Member States' competent authorities responsible for the sectoral group-wide supervision of any of the regulated entities in a financial conglomerate; (b) the coordinator appointed in accordance with Article 10 if different from the authorities referred to in (a); (c) other competent authorities concerned, where relevant, in the opinion of the authorities referred to in (a) and (b); this opinion shall especially take into account the market share of the regulated entities of the conglomerate in other Member States, in particular if it exceeds 5 %, and the importance in the conglomerate of any regulated entity established in another Member State; 18. "intra-group transactions" shall mean all transactions by which regulated entities within a financial conglomerate rely either directly or indirectly upon other undertakings within the same group or upon any natural or legal person linked to the undertakings within that group by "close links", for the fulfilment of an obligation, whether or not contractual, and whether or not for payment; 19. "risk concentration" shall mean all exposures with a loss potential borne by entities within a financial conglomerate, which are large enough to threaten the solvency or the financial position in general of the regulated entities in the financial conglomerate; such exposures may be caused by counterparty risk/credit risk, investment risk, insurance risk, market risk, other risks, or a combination or interaction of these risks. Article 3 Thresholds for identifying a financial conglomerate 1. For the purposes of determining whether the activities of a group mainly occur in the financial sector, within the meaning of Article 2(14)(c), the ratio of the balance sheet total of the regulated and non-regulated financial sector entities in the group to the balance sheet total of the group as a whole should exceed 40 %. 2. For the purposes of determining whether activities in different financial sectors are significant within the meaning of Article 2(14)(e), for each financial sector the average of the ratio of the balance sheet total of that financial sector to the balance sheet total of the financial sector entities in the group and the ratio of the solvency requirements of the same financial sector to the total solvency requirements of the financial sector entities in the group should exceed 10 %. For the purposes of this Directive, the smallest financial sector in a financial conglomerate is the sector with the smallest average and the most important financial sector in a financial conglomerate is the sector with the highest average. For the purposes of calculating the average and for the measurement of the smallest and the most important financial sectors, the banking sector and the investment services sector shall be considered together. 3. Cross-sectoral activities shall also be presumed to be significant within the meaning of Article 2(14)(e) if the balance sheet total of the smallest financial sector in the group exceeds EUR 6 billion. If the group does not reach the threshold referred to in paragraph 2, the relevant competent authorities may decide by common agreement not to regard the group as a financial conglomerate, or not to apply the provisions of Articles 7, 8 or 9, if they are of the opinion that the inclusion of the group in the scope of this Directive or the application of such provisions is not necessary or would be inappropriate or misleading with respect to the objectives of supplementary supervision, taking into account, for instance, the fact that: (a) the relative size of its smallest financial sector does not exceed 5 %, measured either in terms of the average referred to in paragraph 2 or in terms of the balance sheet total or the solvency requirements of such financial sector; or (b) the market share does not exceed 5 % in any Member State, measured in terms of the balance sheet total in the banking or investment services sectors and in terms of gross premiums written in the insurance sector. Decisions taken in accordance with this paragraph shall be notified to the other competent authorities concerned. 4. For the application of paragraphs 1, 2 and 3, the relevant competent authorities may by common agreement: (a) exclude an entity when calculating the ratios, in the cases referred to in Article 6(5); (b) take into account compliance with the thresholds envisaged in paragraphs 1 and 2 for three consecutive years so as to avoid sudden regime shifts, and disregard such compliance if there are significant changes in the group's structure. Where a financial conglomerate has been identified according to paragraphs 1, 2 and 3, the decisions referred to in the first subparagraph of this paragraph shall be taken on the basis of a proposal made by the coordinator of that financial conglomerate. 5. For the application of paragraphs 1 and 2, the relevant competent authorities may, in exceptional cases and by common agreement, replace the criterion based on balance sheet total with one or both of the following parameters or add one or both of these parameters, if they are of the opinion that these parameters are of particular relevance for the purposes of supplementary supervision under this Directive: income structure, off-balance-sheet activities. 6. For the application of paragraphs 1 and 2, if the ratios referred to in those paragraphs fall below 40 % and 10 % respectively for conglomerates already subject to supplementary supervision, a lower ratio of 35 % and 8 % respectively shall apply for the following three years to avoid sudden regime shifts. Similarly, for the application of paragraph 3, if the balance sheet total of the smallest financial sector in the group falls below EUR 6 billion for conglomerates already subject to supplementary supervision, a lower figure of EUR 5 billion shall apply for the following three years to avoid sudden regime shifts. During the period referred to in this paragraph, the coordinator may, with the agreement of the other relevant competent authorities, decide that the lower ratios or the lower amount referred to in this paragraph shall cease to apply. 7. The calculations referred to in this Article regarding the balance sheet shall be made on the basis of the aggregated balance sheet total of the entities of the group, according to their annual accounts. For the purposes of this calculation, undertakings in which a participation is held shall be taken into account as regards the amount of their balance sheet total corresponding to the aggregated proportional share held by the group. However, where consolidated accounts are available, they shall be used instead of aggregated accounts. The solvency requirements referred to in paragraphs 2 and 3 shall be calculated in accordance with the provisions of the relevant sectoral rules. Article 4 Identifying a financial conglomerate 1. Competent authorities which have authorised regulated entities shall, on the basis of Articles 2, 3 and 5, identify any group that falls under the scope of this Directive. For this purpose: - competent authorities which have authorised regulated entities in the group shall, where necessary, cooperate closely, - if a competent authority is of the opinion that a regulated entity authorised by that competent authority is a member of a group which may be a financial conglomerate, which has not already been identified according to this Directive, the competent authority shall communicate its view to the other competent authorities concerned. 2. The coordinator appointed in accordance with Article 10 shall inform the parent undertaking at the head of a group or, in the absence of a parent undertaking, the regulated entity with the largest balance sheet total in the most important financial sector in a group, that the group has been identified as a financial conglomerate and of the appointment of the coordinator. The coordinator shall also inform the competent authorities which have authorised regulated entities in the group and the competent authorities of the Member State in which the mixed financial holding company has its head office, as well as the Commission. CHAPTER II SUPPLEMENTARY SUPERVISION SECTION 1 SCOPE Article 5 Scope of supplementary supervision of regulated entities referred to in Article 1 1. Without prejudice to the provisions on supervision contained in the sectoral rules, Member States shall provide for the supplementary supervision of the regulated entities referred to in Article 1, to the extent and in the manner prescribed in this Directive. 2. The following regulated entities shall be subject to supplementary supervision at the level of the financial conglomerate in accordance with Articles 6 to 17: (a) every regulated entity which is at the head of a financial conglomerate; (b) every regulated entity, the parent undertaking of which is a mixed financial holding company which has its head office in the Community; (c) every regulated entity linked with another financial sector entity by a relationship within the meaning of Article 12(1) of Directive 83/349/EEC. Where a financial conglomerate is a subgroup of another financial conglomerate which meets the requirements of the first subparagraph, Member States may apply Articles 6 to 17 to the regulated entities within the latter group only and any reference in the Directive to the terms group and financial conglomerate will then be understood as referring to that latter group. 3. Every regulated entity which is not subject to supplementary supervision in accordance with paragraph 2, the parent undertaking of which is a regulated entity or a mixed financial holding company, having its head office outside the Community, shall be subject to supplementary supervision at the level of the financial conglomerate to the extent and in the manner prescribed in Article 18. 4. Where persons hold participations or capital ties in one or more regulated entities or exercise significant influence over such entities without holding a participation or capital ties, other than the cases referred to in paragraphs 2 and 3, the relevant competent authorities shall, by common agreement and in conformity with national law, determine whether and to what extent supplementary supervision of the regulated entities is to be carried out, as if they constitute a financial conglomerate. In order to apply such supplementary supervision, at least one of the entities must be a regulated entity as referred to in Article 1 and the conditions set out in Article 2(14)(d) and (e) must be met. The relevant competent authorities shall take their decision, taking into account the objectives of the supplementary supervision as provided for by this Directive. For the purposes of applying the first subparagraph to "cooperative groups", the competent authorities must take into account the public financial commitment of these groups with respect to other financial entities. 5. Without prejudice to Article 13, the exercise of supplementary supervision at the level of the financial conglomerate shall in no way imply that the competent authorities are required to play a supervisory role in relation to mixed financial holding companies, third-country regulated entities in a financial conglomerate or unregulated entities in a financial conglomerate, on a stand-alone basis. SECTION 2 FINANCIAL POSITION Article 6 Capital adequacy 1. Without prejudice to the sectoral rules, supplementary supervision of the capital adequacy of the regulated entities in a financial conglomerate shall be exercised in accordance with the rules laid down in Article 9(2) to (5), in Section 3 of this Chapter, and in Annex I. 2. The Member States shall require regulated entities in a financial conglomerate to ensure that own funds are available at the level of the financial conglomerate which are always at least equal to the capital adequacy requirements as calculated in accordance with Annex I. The Member States shall also require regulated entities to have in place adequate capital adequacy policies at the level of the financial conglomerate. The requirements referred to in the first and second subparagraphs shall be subject to supervisory overview by the coordinator in accordance with Section 3. The coordinator shall ensure that the calculation referred to in the first subparagraph is carried out at least once a year, either by the regulated entities or by the mixed financial holding company. The results of the calculation and the relevant data for the calculation shall be submitted to the coordinator by the regulated entity within the meaning of Article 1 which is at the head of the financial conglomerate, or, where the financial conglomerate is not headed by a regulated entity within the meaning of Article 1, by the mixed financial holding company or by the regulated entity in the financial conglomerate identified by the coordinator after consultation with the other relevant competent authorities and with the financial conglomerate. 3. For the purposes of calculating the capital adequacy requirements referred to in the first subparagraph of paragraph 2, the following entities shall be included in the scope of supplementary supervision in the manner and to the extent defined in Annex I: (a) a credit institution, a financial institution or an ancillary banking services undertaking within the meaning of Article 1(5) and (23) of Directive 2000/12/EC; (b) an insurance undertaking, a reinsurance undertaking or an insurance holding company within the meaning of Article 1(i) of Directive 98/78/EC; (c) an investment firm or a financial institution within the meaning of Article 2(7) of Directive 93/6/EEC; (d) mixed financial holding companies. 4. When calculating the supplementary capital adequacy requirements with regard to a financial conglomerate by applying method 1 (Accounting consolidation) referred to in Annex I, the own funds and the solvency requirements of the entities in the group shall be calculated by applying the corresponding sectoral rules on the form and extent of consolidation as laid down in particular in Article 54 of Directive 2000/12/EC and Annex I.1.B. of Directive 98/78/EC. When applying methods 2 or 3 (Deduction and aggregation, Book value/Requirement deduction) referred to in Annex I, the calculation shall take account of the proportional share held by the parent undertaking or undertaking which holds a participation in another entity of the group. "Proportional share" means the proportion of the subscribed capital which is held, directly or indirectly, by that undertaking. 5. The coordinator may decide not to include a particular entity in the scope when calculating the supplementary capital adequacy requirements in the following cases: (a) if the entity is situated in a third country where there are legal impediments to the transfer of the necessary information, without prejudice to the sectoral rules regarding the obligation of competent authorities to refuse authorisation where the effective exercise of their supervisory functions is prevented; (b) if the entity is of negligible interest with respect to the objectives of the supplementary supervision of regulated entities in a financial conglomerate; (c) if the inclusion of the entity would be inappropriate or misleading with respect to the objectives of supplementary supervision. However, if several entities are to be excluded pursuant to (b) of the first subparagraph, they must nevertheless be included when collectively they are of non-negligible interest. In the case mentioned in (c) of the first subparagraph the coordinator shall, except in cases of urgency, consult the other relevant competent authorities before taking a decision. When the coordinator does not include a regulated entity in the scope under one of the cases provided for in (b) and (c) of the first subparagraph, the competent authorities of the Member State in which that entity is situated may ask the entity which is at the head of the financial conglomerate for information which may facilitate their supervision of the regulated entity. Article 7 Risk concentration 1. Without prejudice to the sectoral rules, supplementary supervision of the risk concentration of regulated entities in a financial conglomerate shall be exercised in accordance with the rules laid down in Article 9(2) to (4), in Section 3 of this Chapter and in Annex II. 2. The Member States shall require regulated entities or mixed financial holding companies to report on a regular basis and at least annually to the coordinator any significant risk concentration at the level of the financial conglomerate, in accordance with the rules laid down in this Article and in Annex II. The necessary information shall be submitted to the coordinator by the regulated entity within the meaning of Article 1 which is at the head of the financial conglomerate or, where the financial conglomerate is not headed by a regulated entity within the meaning of Article 1, by the mixed financial holding company or by the regulated entity in the financial conglomerate identified by the coordinator after consultation with the other relevant competent authorities and with the financial conglomerate. These risk concentrations shall be subject to supervisory overview by the coordinator in accordance with Section 3. 3. Pending further coordination of Community legislation, Member States may set quantitative limits or allow their competent authorities to set quantitative limits, or take other supervisory measures which would achieve the objectives of supplementary supervision, with regard to any risk concentration at the level of a financial conglomerate. 4. Where a financial conglomerate is headed by a mixed financial holding company, the sectoral rules regarding risk concentration of the most important financial sector in the financial conglomerate, if any, shall apply to that sector as a whole, including the mixed financial holding company. Article 8 Intra-group transactions 1. Without prejudice to the sectoral rules, supplementary supervision of intra-group transactions of regulated entities in a financial conglomerate shall be exercised in accordance with the rules laid down in Article 9(2) to (4), in Section 3 of this Chapter, and in Annex II. 2. The Member States shall require regulated entities or mixed financial holding companies to report, on a regular basis and at least annually, to the coordinator all significant intra-group transactions of regulated entities within a financial conglomerate, in accordance with the rules laid down in this Article and in Annex II. Insofar as no definition of the thresholds referred to in the last sentence of the first paragraph of Annex II has been drawn up, an intra-group transaction shall be presumed to be significant if its amount exceeds at least 5 % of the total amount of capital adequacy requirements at the level of a financial conglomerate. The necessary information shall be submitted to the coordinator by the regulated entity within the meaning of Article 1 which is at the head of the financial conglomerate or, where the financial conglomerate is not headed by a regulated entity within the meaning of Article 1, by the mixed financial holding company or by the regulated entity in the financial conglomerate identified by the coordinator after consultation with the other relevant competent authorities and with the financial conglomerate. These intra-group transactions shall be subject to supervisory overview by the coordinator. 3. Pending further coordination of Community legislation, Member States may set quantitative limits and qualitative requirements or allow their competent authorities to set quantitative limits and qualitative requirements, or take other supervisory measures that would achieve the objectives of supplementary supervision, with regard to intra-group transactions of regulated entities within a financial conglomerate. 4. Where a financial conglomerate is headed by a mixed financial holding company, the sectoral rules regarding intra-group transactions of the most important financial sector in the financial conglomerate shall apply to that sector as a whole, including the mixed financial holding company. Article 9 Internal control mechanisms and risk management processes 1. The Member States shall require regulated entities to have, in place at the level of the financial conglomerate, adequate risk management processes and internal control mechanisms, including sound administrative and accounting procedures. 2. The risk management processes shall include: (a) sound governance and management with the approval and periodical review of the strategies and policies by the appropriate governing bodies at the level of the financial conglomerate with respect to all the risks they assume; (b) adequate capital adequacy policies in order to anticipate the impact of their business strategy on risk profile and capital requirements as determined in accordance with Article 6 and Annex I; (c) adequate procedures to ensure that their risk monitoring systems are well integrated into their organisation and that all measures are taken to ensure that the systems implemented in all the undertakings included in the scope of supplementary supervision are consistent so that the risks can be measured, monitored and controlled at the level of the financial conglomerate. 3. The internal control mechanisms shall include: (a) adequate mechanisms as regards capital adequacy to identify and measure all material risks incurred and to appropriately relate own funds to risks; (b) sound reporting and accounting procedures to identify, measure, monitor and control the intra-group transactions and the risk concentration. 4. The Member States shall ensure that, in all undertakings included in the scope of supplementary supervision pursuant to Article 5, there are adequate internal control mechanisms for the production of any data and information which would be relevant for the purposes of the supplementary supervision. 5. The processes and mechanisms referred to in paragraphs 1 to 4 shall be subject to supervisory overview by the coordinator. SECTION 3 MEASURES TO FACILITATE SUPPLEMENTARY SUPERVISION Article 10 Competent authority responsible for exercising supplementary supervision (the coordinator) 1. In order to ensure proper supplementary supervision of the regulated entities in a financial conglomerate, a single coordinator, responsible for coordination and exercise of supplementary supervision, shall be appointed from among the competent authorities of the Member States concerned, including those of the Member State in which the mixed financial holding company has its head office. 2. The appointment shall be based on the following criteria: (a) where a financial conglomerate is headed by a regulated entity, the task of coordinator shall be exercised by the competent authority which has authorised that regulated entity pursuant to the relevant sectoral rules; (b) where a financial conglomerate is not headed by a regulated entity, the task of coordinator shall be exercised by the competent authority identified in accordance with the following principles: (i) where the parent of a regulated entity is a mixed financial holding company, the task of coordinator shall be exercised by the competent authority which has authorised that regulated entity pursuant to the relevant sectoral rules; (ii) where more than one regulated entity with a head office in the Community have as their parent the same mixed financial holding company, and one of these entities has been authorised in the Member State in which the mixed financial holding company has its head office, the task of coordinator shall be exercised by the competent authority of the regulated entity authorised in that Member State. Where more than one regulated entity, being active in different financial sectors, have been authorised in the Member State in which the mixed financial holding company has its head office, the task of coordinator shall be exercised by the competent authority of the regulated entity active in the most important financial sector. Where the financial conglomerate is headed by more than one mixed financial holding company with a head office in different Member States and there is a regulated entity in each of these States, the task of coordinator shall be exercised by the competent authority of the regulated entity with the largest balance sheet total if these entities are in the same financial sector, or by the competent authority of the regulated entity in the most important financial sector; (iii) where more than one regulated entity with a head office in the Community have as their parent the same mixed financial holding company and none of these entities has been authorised in the Member State in which the mixed financial holding company has its head office, the task of coordinator shall be exercised by the competent authority which authorised the regulated entity with the largest balance sheet total in the most important financial sector; (iv) where the financial conglomerate is a group without a parent undertaking at the top, or in any other case, the task of coordinator shall be exercised by the competent authority which authorised the regulated entity with the largest balance sheet total in the most important financial sector. 3. In particular cases, the relevant competent authorities may by common agreement waive the criteria referred to in paragraph 2 if their application would be inappropriate, taking into account the structure of the conglomerate and the relative importance of its activities in different countries, and appoint a different competent authority as coordinator. In these cases, before taking their decision, the competent authorities shall give the conglomerate an opportunity to state its opinion on that decision. Article 11 Tasks of the coordinator 1. The tasks to be carried out by the coordinator with regard to supplementary supervision shall include: (a) coordination of the gathering and dissemination of relevant or essential information in going concern and emergency situations, including the dissemination of information which is of importance for a competent authority's supervisory task under sectoral rules; (b) supervisory overview and assessment of the financial situation of a financial conglomerate; (c) assessment of compliance with the rules on capital adequacy and of risk concentration and intra-group transactions as set out in Articles 6, 7 and 8; (d) assessment of the financial conglomerate's structure, organisation and internal control system as set out in Article 9; (e) planning and coordination of supervisory activities in going concern as well as in emergency situations, in cooperation with the relevant competent authorities involved; (f) other tasks, measures and decisions assigned to the coordinator by this Directive or deriving from the application of this Directive. In order to facilitate and establish supplementary supervision on a broad legal basis, the coordinator and the other relevant competent authorities, and where necessary other competent authorities concerned, shall have coordination arrangements in place. The coordination arrangements may entrust additional tasks to the coordinator and may specify the procedures for the decision-making process among the relevant competent authorities as referred to in Articles 3, 4, 5(4), 6, 12(2), 16 and 18, and for cooperation with other competent authorities. 2. The coordinator should, when it needs information which has already been given to another competent authority in accordance with the sectoral rules, contact this authority whenever possible in order to prevent duplication of reporting to the various authorities involved in supervision. 3. Without prejudice to the possibility of delegating specific supervisory competences and responsibilities as provided for by Community legislation, the presence of a coordinator entrusted with specific tasks concerning the supplementary supervision of regulated entities in a financial conglomerate shall not affect the tasks and responsibilities of the competent authorities as provided for by the sectoral rules. Article 12 Cooperation and exchange of information between competent authorities 1. The competent authorities responsible for the supervision of regulated entities in a financial conglomerate and the competent authority appointed as the coordinator for that financial conglomerate shall cooperate closely with each other. Without prejudice to their respective responsibilities as defined under sectoral rules, these authorities, whether or not established in the same Member State, shall provide one another with any information which is essential or relevant for the exercise of the other authorities' supervisory tasks under the sectoral rules and this Directive. In this regard, the competent authorities and the coordinator shall communicate on request all relevant information and shall communicate on their own initiative all essential information. This cooperation shall at least provide for the gathering and the exchange of information with regard to the following items: (a) identification of the group structure of all major entities belonging to the financial conglomerate, as well as of the competent authorities of the regulated entities in the group; (b) the financial conglomerate's strategic policies; (c) the financial situation of the financial conglomerate, in particular on capital adequacy, intra-group transactions, risk concentration and profitability; (d) the financial conglomerate's major shareholders and management; (e) the organisation, risk management and internal control systems at financial conglomerate level; (f) procedures for the collection of information from the entities in a financial conglomerate, and the verification of that information; (g) adverse developments in regulated entities or in other entities of the financial conglomerate which could seriously affect the regulated entities; (h) major sanctions and exceptional measures taken by competent authorities in accordance with sectoral rules or this Directive. The competent authorities may also exchange with the following authorities such information as may be needed for the performance of their respective tasks, regarding regulated entities in a financial conglomerate, in line with the provisions laid down in the sectoral rules: central banks, the European System of Central Banks and the European Central Bank. 2. Without prejudice to their respective responsibilities as defined under sectoral rules, the competent authorities concerned shall, prior to their decision, consult each other with regard to the following items, where these decisions are of importance for other competent authorities' supervisory tasks: (a) changes in the shareholder, organisational or management structure of regulated entities in a financial conglomerate, which require the approval or authorisation of competent authorities; (b) major sanctions or exceptional measures taken by competent authorities. A competent authority may decide not to consult in cases of urgency or where such consultation may jeopardise the effectiveness of the decisions. In this case, the competent authority shall, without delay, inform the other competent authorities. 3. The coordinator may invite the competent authorities of the Member State in which a parent undertaking has its head office, and which do not themselves exercise the supplementary supervision pursuant to Article 10, to ask the parent undertaking for any information which would be relevant for the exercise of its coordination tasks as laid down in Article 11, and to transmit that information to the coordinator. Where the information referred to in Article 14(2) has already been given to a competent authority in accordance with sectoral rules, the competent authorities responsible for exercising supplementary supervision may apply to the first-mentioned authority to obtain the information. 4. Member States shall authorise the exchange of the information between their competent authorities and between their competent authorities and other authorities, as referred to in paragraphs 1, 2 and 3. The collection or possession of information with regard to an entity within a financial conglomerate which is not a regulated entity shall not in any way imply that the competent authorities are required to play a supervisory role in relation to these entities on a stand-alone basis. Information received in the framework of supplementary supervision, and in particular any exchange of information between competent authorities and between competent authorities and other authorities which is provided for in this Directive, shall be subject to the provisions on professional secrecy and communication of confidential information laid down in the sectoral rules. Article 13 Management body of mixed financial holding companies Member States shall require that persons who effectively direct the business of a mixed financial holding company are of sufficiently good repute and have sufficient experience to perform those duties. Article 14 Access to information 1. Member States shall ensure that there are no legal impediments within their jurisdiction preventing the natural and legal persons included within the scope of supplementary supervision, whether or not a regulated entity, from exchanging amongst themselves any information which would be relevant for the purposes of supplementary supervision. 2. Member States shall provide that, when approaching the entities in a financial conglomerate, whether or not a regulated entity, either directly or indirectly, their competent authorities responsible for exercising supplementary supervision shall have access to any information which would be relevant for the purposes of supplementary supervision. Article 15 Verification Where, in applying this Directive, competent authorities wish in specific cases to verify the information concerning an entity, whether or not regulated, which is part of a financial conglomerate and is situated in another Member State, they shall ask the competent authorities of that other Member State to have the verification carried out. The authorities which receive such a request shall, within the framework of their competences, act upon it either by carrying out the verification themselves, by allowing an auditor or expert to carry it out, or by allowing the authority which made the request to carry it out itself. The competent authority which made the request may, if it so wishes, participate in the verification when it does not carry out the verification itself. Article 16 Enforcement measures If the regulated entities in a financial conglomerate do not comply with the requirements referred to in Articles 6 to 9 or where the requirements are met but solvency may nevertheless be jeopardised or where the intra-group transactions or the risk concentrations are a threat to the regulated entities' financial position, the necessary measures shall be required in order to rectify the situation as soon as possible: - by the coordinator with respect to the mixed financial holding company, - by the competent authorities with respect to the regulated entities; to that end, the coordinator shall inform those competent authorities of its findings. Without prejudice to Article 17(2), Member States may determine what measures may be taken by their competent authorities with respect to mixed financial holding companies. The competent authorities involved, including the coordinator, shall where appropriate coordinate their supervisory actions. Article 17 Additional powers of the competent authorities 1. Pending further harmonisation between sectoral rules, the Member States shall provide that their competent authorities shall have the power to take any supervisory measure deemed necessary in order to avoid or to deal with the circumvention of sectoral rules by regulated entities in a financial conglomerate. 2. Without prejudice to their criminal law provisions, Member States shall ensure that penalties or measures aimed at ending observed breaches or the causes of such breaches may be imposed on mixed financial holding companies, or their effective managers, which infringe laws, regulations or administrative provisions enacted to implement this Directive. In certain cases, such measures may require the intervention of the courts. The competent authorities shall cooperate closely to ensure that such penalties or measures produce the desired results. SECTION 4 THIRD COUNTRIES Article 18 Parent undertakings outside the Community 1. Without prejudice to the sectoral rules, in the case referred to in Article 5(3), competent authorities shall verify whether the regulated entities, the parent undertaking of which has its head office outside the Community, are subject to supervision by a third-country competent authority, which is equivalent to that provided for by the provisions of this Directive on the supplementary supervision of regulated entities referred to in Article 5(2). The verification shall be carried out by the competent authority which would be the coordinator if the criteria set out in Article 10(2) were to apply, on the request of the parent undertaking or of any of the regulated entities authorised in the Community or on its own initiative. That competent authority shall consult the other relevant competent authorities, and shall take into account any applicable guidance prepared by the Financial Conglomerates Committee in accordance with Article 21(5). For this purpose the competent authority shall consult the Committee before taking a decision. 2. In the absence of equivalent supervision referred to in paragraph 1, Member States shall apply to the regulated entities, by analogy, the provisions concerning the supplementary supervision of regulated entities referred to in Article 5(2). As an alternative, competent authorities may apply one of the methods set out in paragraph 3. 3. Member States shall allow their competent authorities to apply other methods which ensure appropriate supplementary supervision of the regulated entities in a financial conglomerate. These methods must be agreed by the coordinator, after consultation with the other relevant competent authorities. The competent authorities may in particular require the establishment of a mixed financial holding company which has its head office in the Community, and apply this Directive to the regulated entities in the financial conglomerate headed by that holding company. The methods must achieve the objectives of the supplementary supervision as defined in this Directive and must be notified to the other competent authorities involved and the Commission. Article 19 Cooperation with third-country competent authorities 1. Article 25(1) and (2) of Directive 2000/12/EC and Article 10a of Directive 98/78/EC shall apply mutatis mutandis to the negotiation of agreements with one or more third countries regarding the means of exercising supplementary supervision of regulated entities in a financial conglomerate. 2. The Commission, the Banking Advisory Committee, the Insurance Committee and the Financial Conglomerates Committee shall examine the outcome of the negotiations referred to in paragraph 1 and the resulting situation. CHAPTER III POWERS CONFERRED ON THE COMMISSION AND COMMITTEE PROCEDURE Article 20 Powers conferred on the Commission 1. The Commission shall adopt, in accordance with the procedure referred to in Article 21(2), the technical adaptations to be made to this Directive in the following areas: (a) a more precise formulation of the definitions referred to in Article 2 in order to take account of developments in financial markets in the application of this Directive; (b) a more precise formulation of the definitions referred to in Article 2 in order to ensure uniform application of this Directive in the Community; (c) the alignment of terminology and the framing of definitions in the Directive in accordance with subsequent Community acts on regulated entities and related matters; (d) a more precise definition of the calculation methods set out in Annex I in order to take account of developments on financial markets and prudential techniques; (e) coordination of the provisions adopted pursuant to Articles 7 and 8 and Annex II with a view to encouraging uniform application within the Community. 2. The Commission shall inform the public of any proposal presented in accordance with this Article and will consult interested parties prior to submitting the draft measures to the Financial Conglomerates Committee referred to in Article 21. Article 21 Committee 1. The Commission shall be assisted by a Financial Conglomerates Committee, hereinafter referred to as the "Committee". 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure. 4. Without prejudice to the implementing measures already adopted, on the expiry of a four-year period following the entry into force of this Directive, the application of the provisions thereof requiring the adoption of technical rules and decisions in accordance with the procedure referred to in paragraph 2 shall be suspended. On a proposal from the Commission, the European Parliament and the Council may renew the provisions concerned in accordance with the procedure laid down in Article 251 of the Treaty and, to that end, they shall review them prior to the expiry of the period referred to above. 5. The Committee may give general guidance as to whether the supplementary supervision arrangements of competent authorities in third countries are likely to achieve the objectives of the supplementary supervision as defined in this Directive, in relation to the regulated entities in a financial conglomerate, the head of which has its head office outside the Community. The Committee shall keep any such guidance under review and take into account any changes to the supplementary supervision carried out by such competent authorities. 6. The Committee shall be kept informed by Member States of the principles they apply concerning the supervision of intra-group transactions and risk concentration. CHAPTER IV AMENDMENTS TO EXISTING DIRECTIVES Article 22 Amendments to Directive 73/239/EEC Directive 73/239/EEC is amended as follows: 1. the following Article shall be inserted: "Article 12a 1. The competent authorities of the other Member State involved shall be consulted prior to the granting of an authorisation to an insurance undertaking, which is: (a) a subsidiary of an insurance undertaking authorised in another Member State; or (b) a subsidiary of the parent undertaking of an insurance undertaking authorised in another Member State; or (c) controlled by the same person, whether natural or legal, who controls an insurance undertaking authorised in another Member State. 2. The competent authority of a Member State involved responsible for the supervision of credit institutions or investment firms shall be consulted prior to the granting of an authorisation to an insurance undertaking which is: (a) a subsidiary of a credit institution or investment firm authorised in the Community; or (b) a subsidiary of the parent undertaking of a credit institution or investment firm authorised in the Community; or (c) controlled by the same person, whether natural or legal, who controls a credit institution or investment firm authorised in the Community. 3. The relevant competent authorities referred to in paragraphs 1 and 2 shall in particular consult each other when assessing the suitability of the shareholders and the reputation and experience of directors involved in the management of another entity of the same group. They shall inform each other of any information regarding the suitability of shareholders and the reputation and experience of directors which is of relevance to the other competent authorities involved for the granting of an authorisation as well as for the ongoing assessment of compliance with operating conditions." 2. the following subparagraphs shall be added to Article 16(2): "The available solvency margin shall also be reduced by the following items: (a) participations which the insurance undertaking holds in - insurance undertakings within the meaning of Article 6 of this Directive, Article 6 of First Directive 79/267/EEC of 5 March 1979 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of the business of direct life assurance(17), or Article 1(b) of Directive 98/78/EC of the European Parliament and of the Council(18), - reinsurance undertakings within the meaning of Article 1(c) of Directive 98/78/EC, - insurance holding companies within the meaning of Article 1(i) of Directive 98/78/EC, - credit institutions and financial institutions within the meaning of Article 1(1) and (5) of Directive 2000/12/EC of the European Parliament and of the Council(19), - investment firms and financial institutions within the meaning of Article 1(2) of Directive 93/22/EEC(20) and of Article 2(4) and (7) of Directive 93/6/EEC(21); (b) each of the following items which the insurance undertaking holds in respect of the entities defined in (a) in which it holds a participation: - instruments referred to in paragraph 3, - instruments referred to in Article 18(3) of Directive 79/267/EEC, - subordinated claims and instruments referred to in Article 35 and Article 36(3) of Directive 2000/12/EC. Where shares in another credit institution, investment firm, financial institution, insurance or reinsurance undertaking or insurance holding company are held temporarily for the purposes of a financial assistance operation designed to reorganise and save that entity, the competent authority may waive the provisions on deduction referred to under (a) and (b) of the fourth subparagraph. As an alternative to the deduction of the items referred to in (a) and (b) of the fourth subparagraph which the insurance undertaking holds in credit institutions, investment firms and financial institutions, Member States may allow their insurance undertakings to apply mutatis mutandis methods 1, 2, or 3 of Annex I to Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate(22). Method 1 (Accounting consolidation) shall only be applied if the competent authority is confident about the level of integrated management and internal control regarding the entities which would be included in the scope of consolidation. The method chosen shall be applied in a consistent manner overtime. Member States may provide that, for the calculation of the solvency margin as provided for by this Directive, insurance undertakings subject to supplementary supervision in accordance with Directive 98/78/EC or to supplementary supervision in accordance with Directive 2002/87/EC, need not deduct the items referred to in (a) and (b) of the fourth subparagraph which are held in credit institutions, investment firms, financial institutions, insurance or reinsurance undertakings or insurance holding companies which are included in the supplementary supervision. For the purposes of the deduction of participations referred to in this paragraph, participation shall mean a participation within the meaning of Article 1(f) of Directive 98/78/EC." Article 23 Amendments to Directive 79/267/EEC Directive 79/267/EC is amended as follows: 1. the following Article shall be inserted: "Article 12a 1. The competent authorities of the other Member State involved shall be consulted prior to the granting of an authorisation to a life assurance undertaking, which is: (a) a subsidiary of an insurance undertaking authorised in another Member State; or (b) a subsidiary of the parent undertaking of an insurance undertaking authorised in another Member State; or (c) controlled by the same person, whether natural or legal, who controls an insurance undertaking authorised in another Member State. 2. The competent authority of a Member State involved, responsible for the supervision of credit institutions or investment firms, shall be consulted prior to the granting of an authorisation to a life assurance undertaking, which is: (a) a subsidiary of a credit institution or investment firm authorised in the Community; or (b) a subsidiary of the parent undertaking of a credit institution or investment firm authorised in the Community; or (c) controlled by the same person, whether natural or legal, who controls a credit institution or investment firm authorised in the Community. 3. The relevant competent authorities referred to in paragraphs 1 and 2 shall in particular consult each other when assessing the suitability of the shareholders and the reputation and experience of directors involved in the management of another entity of the same group. They shall inform each other of any information regarding the suitability of shareholders and the reputation and experience of directors which is of relevance to the other competent authorities involved for the granting of an authorisation as well as for the ongoing assessment of compliance with operating conditions." 2. the following subparagraphs shall be added to Article 18(2): "The available solvency margin shall also be reduced by the following items: (a) participations which the assurance undertaking holds, in - insurance undertakings within the meaning of Article 6 of this Directive, Article 6 of Directive 73/239/EEC(23), or Article 1(b) of Directive 98/78/EC of the European Parliament and of the Council(24), - reinsurance undertakings within the meaning of Article 1(c) of Directive 98/78/EC, - insurance holding companies within the meaning of Article 1(i) of Directive 98/78/EC, - credit institutions and financial institutions within the meaning of Article 1(1) and (5) of Directive 2000/12/EC of the European Parliament and of the Council(25), - investment firms and financial institutions within the meaning of Article 1(2) of Directive 93/22/EEC(26) and of Articles 2(4) and 2(7) of Directive 93/6/EEC(27); (b) each of the following items which the assurance undertaking holds in respect of the entities defined in (a) in which it holds a participation: - instruments referred to in paragraph 3, - instruments referred to in Article 16(3) of Directive 73/239/EEC, - subordinated claims and instruments referred to in Article 35 and Article 36(3) of Directive 2000/12/EC. Where shares in another credit institution, investment firm, financial institution, insurance or reinsurance undertaking or insurance holding company are held temporarily for the purposes of a financial assistance operation designed to reorganise and save that entity, the competent authority may waive the provisions on deduction referred to under (a) and (b) of the third subparagraph. As an alternative to the deduction of the items referred to in (a) and (b) of the third subparagraph which the insurance undertaking holds in credit institutions, investment firms and financial institutions, Member States may allow their insurance undertakings to apply mutatis mutandis methods 1, 2, or 3 of Annex I to Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate(28). Method 1 (Accounting consolidation) shall only be applied if the competent authority is confident about the level of integrated management and internal control regarding the entities which would be included in the scope of consolidation. The method chosen shall be applied in a consistent manner over time. Member States may provide that, for the calculation of the solvency margin as provided for by this Directive, insurance undertakings subject to supplementary supervision in accordance with Directive 98/78/EC or to supplementary supervision in accordance with Directive 2002/87/EC, need not deduct the items referred to in (a) and (b) of the third subparagraph which are held in credit institutions, investment firms, financial institutions, insurance or reinsurance undertakings or insurance holding companies which are included in the supplementary supervision. For the purposes of the deduction of participations referred to in this paragraph, participation shall mean a participation within the meaning of Article 1(f) of Directive 98/78/EC." Article 24 Amendments to Directive 92/49/EEC Directive 92/49/EEC is amended as follows: 1. the following paragraph shall be inserted in Article 15: "1a. If the acquirer of the holdings referred to in paragraph 1 is an insurance undertaking, a credit institution or an investment firm authorised in another Member State, or the parent undertaking of such an entity, or a natural or legal person controlling such an entity, and if, as a result of that acquisition, the undertaking in which the acquirer proposes to hold a holding would become a subsidiary or subject to the control of the acquirer, the assessment of the acquisition must be subject to the prior consultation referred to in Article 12a of Directive 73/239/EEC." 2. Article 16(5c) shall be replaced by the following: "5c. This Article shall not prevent a competent authority from transmitting - to central banks and other bodies with a similar function in their capacity as monetary authorities, - where appropriate, to other public authorities responsible for overseeing payment systems, information intended for the performance of their task, nor shall it prevent such authorities or bodies from communicating to the competent authorities such information as they may need for the purposes of paragraph 4. Information received in this context shall be subject to the conditions of professional secrecy imposed in this Article." Article 25 Amendments to Directive 92/96/EEC Directive 92/96/EEC is amended as follows: 1. the following paragraph shall be inserted in Article 14: "1a. If the acquirer of the holdings referred to in paragraph 1 is an insurance undertaking, a credit institution or an investment firm authorised in another Member State, or the parent undertaking of such an entity, or a natural or legal person controlling such an entity, and if, as a result of that acquisition, the undertaking in which the acquirer proposes to hold a holding would become a subsidiary or subject to the control of the acquirer, the assessment of the acquisition must be subject to the prior consultation referred to in Article 12a of Directive 79/267/EEC." 2. Article 15(5c) shall be replaced by the following: "5c. This Article shall not prevent a competent authority from transmitting - to central banks and other bodies with a similar function in their capacity as monetary authorities, - where appropriate, to other public authorities responsible for overseeing payment systems, information intended for the performance of their task, nor shall it prevent such authorities or bodies from communicating to the competent authorities such information as they may need for the purposes of paragraph 4. Information received in this context shall be subject to the conditions of professional secrecy imposed in this Article." Article 26 Amendments to Directive 93/6/EEC In Article 7(3) of Directive 93/6/EEC the first and the second indents shall be replaced by the following: "- 'financial holding company' shall mean a financial institution, the subsidiary undertakings of which are either exclusively or mainly investment firms or other financial institutions, at least one of which is an investment firm, and which is not a mixed financial holding company within the meaning of Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate(29), - 'mixed-activity holding company' shall mean a parent undertaking, other than a financial holding company or an investment firm or a mixed financial holding company within the meaning of Directive 2002/87/EC, the subsidiaries of which include at least one investment firm." Article 27 Amendments to Directive 93/22/EEC Directive 93/22/EEC is amended as follows: 1. in Article 6 the following paragraphs shall be added: "The competent authority of a Member State involved, responsible for the supervision of credit institutions or insurance undertakings, shall be consulted prior to the granting of an authorisation to an investment firm which is: (a) a subsidiary of a credit institution or insurance undertaking authorised in the Community; or (b) a subsidiary of the parent undertaking of a credit institution or insurance undertaking authorised in the Community; or (c) controlled by the same person, whether natural or legal, who controls a credit institution or insurance undertaking authorised in the Community. The relevant competent authorities referred to in the first and second paragraphs shall in particular consult each other when assessing the suitability of the shareholders and the reputation and experience of directors involved in the management of another entity of the same group. They shall inform each other of any information regarding the suitability of shareholders and the reputation and experience of directors which is of relevance to the other competent authorities involved for the granting of an authorisation as well as for the ongoing assessment of compliance with operating conditions." 2. Article 9(2) shall be replaced by the following: "2. If the acquirer of the holding referred to in paragraph 1 is an investment firm, a credit institution or an insurance undertaking authorised in another Member State, or the parent undertaking of an investment firm, credit institution or insurance undertaking authorised in another Member State, or a natural or legal person controlling an investment firm, credit institution or insurance undertaking authorised in another Member State, and if, as a result of that acquisition, the undertaking in which the acquirer proposes to acquire a holding would become the acquirer's subsidiary or come under his control, the assessment of the acquisition must be subject to the prior consultation provided for in Article 6." Article 28 Amendments to Directive 98/78/EC Directive 98/78/EC is amended as follows: 1. in Article 1 points (g), (h), (i) and (j) shall be replaced by the following: "(g) 'participating undertaking' shall mean an undertaking which is either a parent undertaking or other undertaking which holds a participation, or an undertaking linked with another undertaking by a relationship within the meaning of Article 12(1) of Directive 83/349/EEC; (h) 'related undertaking' shall mean either a subsidiary or other undertaking in which a participation is held, or an undertaking linked with another undertaking by a relationship within the meaning of Article 12(1) of Directive 83/349/EEC; (i) 'insurance holding company' shall mean a parent undertaking, the main business of which is to acquire and hold participations in subsidiary undertakings, where those subsidiary undertakings are exclusively or mainly insurance undertakings, reinsurance undertakings, or non-member-country insurance undertakings, at least one of such subsidiary undertakings being an insurance undertaking, and which is not a mixed financial holding company within the meaning of Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate(30); (j) 'mixed-activity insurance holding company' shall mean a parent undertaking, other than an insurance undertaking, a non-member country insurance undertaking, a reinsurance undertaking, an insurance holding company or a mixed financial holding company within the meaning of Directive 2002/87/EC, which includes at least one insurance undertaking among its subsidiary undertakings." 2. in Article 6(3) the following sentence shall be added: "The competent authority which made the request may, if it so wishes, participate in the verification when it does not carry out the verification itself." 3. in Article 8(2) the first subparagraph shall be replaced by the following: "Member States shall require insurance undertakings to have in place adequate risk management processes and internal control mechanisms, including sound reporting and accounting procedures, in order to identify, measure, monitor and control transactions as provided for in paragraph 1 appropriately. Member States shall also require at least annual reporting by insurance undertakings to the competent authorities of significant transactions. These processes and mechanisms shall be subject to overview by the competent authorities." 4. the following Articles shall be inserted: "Article 10a Cooperation with third countries' competent authorities 1. The Commission may submit proposals to the Council, either at the request of a Member State or on its own initiative, for the negotiation of agreements with one or more third countries regarding the means of exercising supplementary supervision over: (a) insurance undertakings which have, as participating undertakings, undertakings within the meaning of Article 2 which have their head office situated in a third country; and (b) non-member country insurance undertakings which have, as participating undertakings, undertakings within the meaning of Article 2 which have their head office in the Community. 2. The agreements referred to in paragraph 1 shall in particular seek to ensure both: (a) that the competent authorities of the Member States are able to obtain the information necessary for the supplementary supervision of insurance undertakings which have their head office in the Community and which have subsidiaries or hold participations in undertakings outside the Community; and (b) that the competent authorities of third countries are able to obtain the information necessary for the supplementary supervision of insurance undertakings which have their head office in their territories and which have subsidiaries or hold participations in undertakings in one or more Member States. 3. The Commission and the Insurance Committee shall examine the outcome of the negotiations referred to in paragraph 1 and the resulting situation. Article 10b Management body of insurance holding companies The Member States shall require that persons who effectively direct the business of an insurance holding company are of sufficiently good repute and have sufficient experience to perform these duties." 5. in Annex I.1.B. the following paragraph shall be added: "Where there are no capital ties between some of the undertakings in an insurance group, the competent authority shall determine which proportional share will have to be taken account of." 6. in Annex I.2. the following point shall be added: "2.4a. Related credit institutions, investment firms and financial institutions When calculating the adjusted solvency of an insurance undertaking which is a participating undertaking in a credit institution, investment firm or financial institution, the rules laid down in Article 16(1) of Directive 73/239/EEC and in Article 18 of Directive 79/267/EEC on the deduction of such participations shall apply mutatis mutandis, as well as the provisions on the ability of Member States under certain conditions to allow alternative methods and to allow such participations not to be deducted." Article 29 Amendments to Directive 2000/12/EC Directive 2000/12/EC is amended as follows: 1. Article 1 shall be amended as follows: (a) Point (9) shall be replaced by the following: "9. 'participation for the purposes of supervision on a consolidated basis and for the purposes of points 15 and 16 of Article 34(2)' shall mean participation within the meaning of the first sentence of Article 17 of Directive 78/660/EEC, or the ownership, direct or indirect, of 20 % or more of the voting rights or capital of an undertaking;" (b) Points (21) and (22) shall be replaced by the following: "21. 'financial holding company' shall mean a financial institution, the subsidiary undertakings of which are either exclusively or mainly credit institutions or financial institutions, at least one of such subsidiaries being a credit institution, and which is not a mixed financial holding company within the meaning of Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate(31); 22. 'mixed-activity holding company' shall mean a parent undertaking, other than a financial holding company or a credit institution or a mixed financial holding company within the meaning of Directive 2002/87/EC, the subsidiaries of which include at least one credit institution;" 2. in Article 12 the following paragraphs shall be added: "The competent authority of a Member State involved, responsible for the supervision of insurance undertakings or investment firms, shall be consulted prior to the granting of an authorisation to a credit institution which is: (a) a subsidiary of an insurance undertaking or investment firm authorised in the Community; or (b) a subsidiary of the parent undertaking of an insurance undertaking or investment firm authorised in the Community; or (c) controlled by the same person, whether natural or legal, who controls an insurance undertaking or investment firm authorised in the Community. The relevant competent authorities referred to in the first and second paragraphs shall in particular consult each other when assessing the suitability of the shareholders and the reputation and experience of directors involved in the management of another entity of the same group. They shall inform each other of any information regarding the suitability of shareholders and the reputation and experience of directors which is of relevance to the other competent authorities involved for the granting of an authorisation as well as for the ongoing assessment of compliance with operating conditions." 3. Article 16(2) shall be replaced by the following: "2. If the acquirer of the holdings referred to in paragraph 1 is a credit institution, insurance undertaking or investment firm authorised in another Member State or the parent undertaking of a credit institution, insurance undertaking or investment firm authorised in another Member State or a natural or legal person controlling a credit institution, insurance undertaking or investment firm authorised in another Member State, and if, as a result of that acquisition, the institution in which the acquirer proposes to hold a holding would become a subsidiary or subject to the control of the acquirer, the assessment of the acquisition must be subject to the prior consultation referred to in Article 12." 4. Article 34(2) shall be amended as follows: (a) in the first subparagraph points 12 and 13 shall be replaced by the following: "12. holdings in other credit and financial institutions amounting to more than 10 % of their capital; 13. subordinated claims and instruments referred to in Article 35 and Article 36(3) which a credit institution holds in respect of credit and financial institutions in which it has holdings exceeding 10 % of the capital in each case; 14. holdings in other credit and financial institutions of up to 10 % of their capital, the subordinated claims and the instruments referred to in Article 35 and Article 36(3) which a credit institution holds in respect of credit and financial institutions other than those referred to in points 12 and 13 of this subparagraph in respect of the amount of the total of such holdings, subordinated claims and instruments which exceed 10 % of that credit institution's own funds calculated before the deduction of items in points 12 to 16 of this subparagraph; 15. participations within the meaning of Article 1(9) which a credit institution holds in - insurance undertakings within the meaning of Article 6 of Directive 73/239/EEC, Article 6 of Directive 79/267/EEC or Article 1(b) of Directive 98/78/EC of the European Parliament and of the Council(32), - reinsurance undertakings within the meaning of Article 1(c) of Directive 98/78/EC, - insurance holding companies within the meaning of Article 1(i) of Directive 98/78/EC; 16. each of the following items which the credit institution holds in respect of the entities defined in point (15) in which it holds a participation: - instruments referred to in Article 16(3) of Directive 73/239/EEC, - instruments referred to in Article 18(3) of Directive 79/267/EEC;" (b) the second subparagraph shall be replaced by the following: "Where shares in another credit institution, financial institution, insurance or reinsurance undertaking or insurance holding company are held temporarily for the purposes of a financial assistance operation designed to reorganise and save that entity, the competent authority may waive the provisions on deduction referred to in points 12 to 16. As an alternative to the deduction of the items referred to in points 15 and 16, Member States may allow their credit institutions to apply mutatis mutandis methods 1, 2, or 3 of Annex I to Directive 2002/87/EC. Method 1 (Accounting consolidation) shall only be applied if the competent authority is confident about the level of integrated management and internal control regarding the entities which would be included in the scope of consolidation. The method chosen shall be applied in a consistent manner over time. Member States may provide that for the calculation of own funds on a stand-alone basis, credit institutions subject to supervision on a consolidated basis in accordance with Chapter 3 or to supplementary supervision in accordance with Directive 2002/87/EC, need not deduct the items referred to in points 12 to 16 which are held in credit institutions, financial institutions, insurance or reinsurance undertakings or insurance holding companies, which are included in the scope of consolidated or supplementary supervision. This provision shall apply to all the prudential rules harmonised by Community acts." 5. Article 51(3) shall be replaced by the following: "3. The Member States need not apply the limits laid down in paragraphs 1 and 2 to holdings in insurance companies as defined in Directive 73/239/EEC and Directive 79/267/EEC, or in reinsurance companies as defined in Directive 98/78/EC." 6. the last sentence in Article 52(2) shall be replaced by the following: "Without prejudice to Article 54a, the consolidation of the financial situation of the financial holding company shall not in any way imply that the competent authorities are required to play a supervisory role in relation to the financial holding company on a stand-alone basis." 7. Article 54 shall be amended as follows: (a) in paragraph 1 the following subparagraph shall be added: "In the case where undertakings are linked by a relationship within the meaning of Article 12 (1) of Directive 83/349/EEC, the competent authorities shall determine how consolidation is to be carried out." (b) in paragraph 4, first subparagraph, the third indent shall be deleted; 8. the following Article shall be inserted: "Article 54a Management body of financial holding companies The Member States shall require that persons who effectively direct the business of a financial holding company are of sufficiently good repute and have sufficient experience to perform those duties." 9. the following Article shall be inserted: "Article 55a Intra-group transactions with mixed-activity holding companies Without prejudice to the provisions of Title V, Chapter 2, Section 3, of this Directive, Member States shall provide that, where the parent undertaking of one or more credit institutions is a mixed-activity holding company, the competent authorities responsible for the supervision of these credit institutions shall exercise general supervision over transactions between the credit institution and the mixed-activity holding company and its subsidiaries. Competent authorities shall require credit institutions to have in place adequate risk management processes and internal control mechanisms, including sound reporting and accounting procedures, in order to identify, measure, monitor and control transactions with their parent mixed-activity holding company and its subsidiaries appropriately. Competent authorities shall require the reporting by the credit institution of any significant transaction with these entities other than the one referred to in Article 48. These procedures and significant transactions shall be subject to overview by the competent authorities. Where these intra-group transactions are a threat to a credit institution's financial position, the competent authority responsible for the supervision of the institution shall take appropriate measures." 10. in Article 56(7) the following sentence shall be added: "The competent authority which made the request may, if it so wishes, participate in the verification when it does not carry out the verification itself." 11. the following Article shall be inserted: "Article 56a Third-country parent undertakings Where a credit institution, the parent undertaking of which is a credit institution or a financial holding company, the head office of which is outside the Community, is not subject to consolidated supervision under Article 52, the competent authorities shall verify whether the credit institution is subject to consolidated supervision by a third-country competent authority which is equivalent to that governed by the principles laid down in Article 52. The verification shall be carried out by the competent authority which would be responsible for consolidated supervision if the fourth subparagraph were to apply, at the request of the parent undertaking or of any of the regulated entities authorised in the Community or on its own initiative. That competent authority shall consult the other competent authorities involved. The Banking Advisory Committee may give general guidance as to whether the consolidated supervision arrangements of competent authorities in third countries are likely to achieve the objectives of consolidated supervision as defined in this Chapter, in relation to credit institutions, the parent undertaking of which has its head office outside the Community. The Committee shall keep any such guidance under review and take into account any changes to the consolidated supervision arrangements applied by such competent authorities. The competent authority carrying out the verification specified in the second subparagraph shall take into account any such guidance. For this purpose the competent authority shall consult the Committee before taking a decision. In the absence of such equivalent supervision, Member States shall apply the provisions of Article 52 to the credit institution by analogy. As an alternative, Member States shall allow their competent authorities to apply other appropriate supervisory techniques which achieve the objectives of the supervision on a consolidated basis of credit institutions. Those methods must be agreed upon by the competent authority which would be responsible for consolidated supervision, after consultation with the other competent authorities involved. Competent authorities may in particular require the establishment of a financial holding company which has its head office in the Community, and apply the provisions on consolidated supervision to the consolidated position of that financial holding company. The methods must achieve the objectives of consolidated supervision as defined in this Chapter and must be notified to the other competent authorities involved and the Commission." CHAPTER V ASSET MANAGEMENT COMPANIES Article 30 Asset management companies Pending further coordination of sectoral rules, Member States shall provide for the inclusion of asset management companies: (a) in the scope of consolidated supervision of credit institutions and investment firms, and/or in the scope of supplementary supervision of insurance undertakings in an insurance group; and (b) where the group is a financial conglomerate, in the scope of supplementary supervision within the meaning of this Directive. For the application of the first paragraph, Member States shall provide, or give their competent authorities the power to decide, according to which sectoral rules (banking sector, insurance sector or investment services sector) asset management companies shall be included in the consolidated and/or supplementary supervision referred to in (a) of the first paragraph. For the purposes of this provision, the relevant sectoral rules regarding the form and extent of the inclusion of financial institutions (where asset management companies are included in the scope of consolidated supervision of credit institutions and investment firms) and of reinsurance undertakings (where asset management companies are included in the scope of supplementary supervision of insurance undertakings) shall apply mutatis mutandis to asset management companies. For the purposes of supplementary supervision referred to in (b) of the first paragraph, the asset management company shall be treated as part of whichever sector it is included in by virtue of (a) of the first paragraph. Where an asset management company is part of a financial conglomerate, any reference to the notion of regulated entity and any reference to the notion of competent authorities and relevant competent authorities shall therefore, for the purposes of this Directive, be understood as including, respectively, asset management companies and the competent authorities responsible for the supervision of asset management companies. This applies mutatis mutandis as regards groups referred to in (a) of the first paragraph. CHAPTER VI TRANSITIONAL AND FINAL PROVISIONS Article 31 Report by the Commission 1. By 11 August 2007, the Commission shall submit to the Financial Conglomerates Committee referred to in Article 21 a report on Member States' practices, and, if necessary, on the need for further harmonisation, with regard to - the inclusion of asset management companies in group-wide supervision, - the choice and the application of the capital adequacy methods set out in Annex I, - the definition of significant intra-group transactions and significant risk concentration and the supervision of intra-group transactions and risk concentration referred to in Annex II, in particular regarding the introduction of quantitative limits and qualitative requirements for this purpose, - the intervals at which financial conglomerates shall carry out the calculations of capital adequacy requirements as set out in Article 6(2) and report to the coordinator on significant risk concentration as set out in Article 7(2). The Commission shall consult the Committee before making its proposals. 2. Within one year of agreement being reached at international level on the rules for eliminating the double gearing of own funds in financial groups, the Commission shall examine how to bring the provisions of this Directive into line with those international agreements and, if necessary, make appropriate proposals. Article 32 Transposition Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 11 August 2004. They shall forthwith inform the Commission thereof. Member States shall provide that the provisions referred to in the first subparagraph shall first apply to the supervision of accounts for the financial year beginning on 1 January 2005 or during that calendar year. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 33 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 34 Addressees This Directive is addressed to the Member States.

32003L0002

2003

Commission Directive 2003/2/EC of 6 January 2003 relating to restrictions on the marketing and use of arsenic (tenth adaptation to technical progress to Council Directive 76/769/EEC) (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations(1), as last amended by Commission Directive 2002/62/EC(2) and in particular Article 2(a) thereof, introduced by Council Directive 89/678/EEC(3), Whereas: (1) Council Directive 89/677/EEC(4) amending for the eighth time Directive 76/769/EEC places certain restrictions on the marketing and use of arsenic. (2) A risk assessment and an analysis of advantages and drawbacks of further restrictions on arsenic in certain wood preservatives(5) were carried out in the framework of a review of Community legislation concerning the use of arsenic compounds for wood preservation following the accession of Austria, Finland and Sweden to the European Union in 1995. (3) The risk assessment was referred to the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) for peer review(6) and the CSTEE concluded that the main risks had been identified correctly. These risks included those to human health from the disposal of wood treated with wood preservatives containing copper, chrome and arsenic (CCA) and in particular risks to children's health from the use of CCA-treated wood in playground equipment. A risk to the aquatic environment in certain marine waters was also identified. (4) The CSTEE further advised that in the light of a serious knowledge gap in relation to arsenic-treated wood in landfills it would be advisable to exercise caution by limiting the use of arsenic-based wood preservation to those situations where it is absolutely necessary. (5) In a further consideration of the health effects of arsenic(7) the CSTEE has concluded that the substance is both genotoxic and a well known carcinogen, and that it may be appropriate to consider that no threshold exists for carcinogenic effect. (6) Waste CCA-treated wood has been classified as hazardous waste pursuant to Commission Decision 2000/532/EC of 3 May 2000 replacing Decision 94/3/EC establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on waste and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to Article 1(4) of Council Directive 91/689/EC on hazardous waste(8) as last amended by Council Decision 2001/573/EC(9). (7) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market(10) lays down provisions for harmonising the authorisation of biocides at Community level and Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products(11) requires wood preservatives to be evaluated as a priority in the review programme established under Directive 98/8/EC. Arsenic has been identified and notified as an active substance within the time limit set out in Regulation (EC) No 1896/2000. A complete dossier for evaluation of arsenic as an existing substance will have to be presented by 28 March 2004. (8) With regard to the risk assessment and taking account of the precautionary principle, pending harmonisation of rules under Directive 98/8/EC or a Decision pursuant to Article 6(3) of Regulation (EC) No 1896/2000, it is necessary to adapt the restrictions on arsenic in Directive 76/769/EEC to technical progress. This Directive does not apply to CCA-treated wood already in place. (9) This Directive should apply without prejudice to Community legislation laying down minimum requirements for the protection of workers, in particular, Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(12), Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(13), as last amended by Directive 1999/38/EC(14) and Council Directive 98/24/EC of 7 April 1998 on the protection of workers from chemical agents at work (14th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(15). (10) The measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of directives on the removal of technical barriers to trade in dangerous substances and preparations, Article 1 Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish the provisions necessary to comply with this Directive by 30 June 2003 at the latest. They shall forthwith inform the Commission thereof. They shall apply these provisions by 30 June 2004 at the latest. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32003L0005

2003

Commission Directive 2003/5/EC of 10 January 2003 amending Council Directive 91/414/EEC to include deltamethrin as active substance (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 2002/81/EC(2), and in particular Article 6(1) thereof, Whereas: (1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market(3), as last amended by Regulation (EC) No 2266/2000(4), establishes a list of active substances of plant protection products to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list is contained in Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Regulation (EEC) No 3600/92(5), as last amended by Regulation (EC) No 2230/95(6), and includes deltamethrin. (2) For deltamethrin the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. By Regulation (EC) No 933/94 Sweden was designated as rapporteur Member State. Sweden submitted the relevant assessment reports and recommendations to the Commission on 6 October 1998 in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92. (3) This assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 18 October 2002 in the format of the Commission review report for deltamethrin. (4) The review did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants. (5) It has appeared from the various examinations made that plant protection products containing deltamethrin may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include deltamethrin in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive. (6) The Commission review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Directive 91/414/EEC. It is, therefore, appropriate to provide that the finalised review report, except for confidential information, should be kept available or made available by the Member States for consultation by any interested parties. (7) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. (8) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant protection products containing deltamethrin, and in particular, to review existing authorisations to ensure that the conditions regarding deltamethrin set out in Annex I to Directive 91/414/EEC are satisfied. A longer period should be provided for the submission and assessment of the complete dossier of each plant protection product in accordance with the uniform principles laid down in Directive 91/414/EEC. (9) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall keep available the review report for deltamethrin, except for confidential information within the meaning of Article 14 of Directive 91/414/EEC, for consultation by any interested parties or shall make it available to them on specific request. Article 3 Member States shall adopt and publish by 30 April 2004 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 May 2004. When Member States adopt this provision, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 4 1. Member States shall review the authorisation for each plant protection product containing deltamethrin to ensure that the conditions relating to deltamethrin set out in Annex I to Directive 91/414/EEC are complied with. Where necessary and by 30 April 2004 at the latest, they shall amend or withdraw the authorisation. 2. Member States shall, for each authorised plant protection product containing deltamethrin as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 October 2003 at the latest, re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 31 October 2007 at the latest, they shall amend or withdraw the authorisation. Article 5 This Directive shall enter into force on 1 November 2003. Article 6 This Directive is addressed to the Member States.

32002L0096

2003

Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste electrical and electronic equipment (WEEE) - Joint declaration of the European Parliament, the Council and the Commission relating to Article 9 Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission(1), Having regard to the Opinion of the Economic and Social Committee(2), Having regard to the Opinion of the Committee of Regions(3), Acting in accordance with the procedure laid down in Article 251 of the Treaty in the light of the joint text approved by the Conciliation Committee on 8 November 2002(4), Whereas: (1) The objectives of the Community's environment policy are, in particular, to preserve, protect and improve the quality of the environment, protect human health and utilise natural resources prudently and rationally. That policy is based on the precautionary principle and principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay. (2) The Community programme of policy and action in relation to the environment and sustainable development (Fifth Environmental Action Programme)(5) states that the achievement of sustainable development calls for significant changes in current patterns of development, production, consumption and behaviour and advocates, inter alia, the reduction of wasteful consumption of natural resources and the prevention of pollution. It mentions waste electrical and electronic equipment (WEEE) as one of the target areas to be regulated, in view of the application of the principles of prevention, recovery and safe disposal of waste. (3) The Commission Communication of 30 July 1996 on review of the Community strategy for waste management states that, where the generation of waste cannot be avoided, it should be reused or recovered for its material or energy. (4) The Council in its Resolution of 24 February 1997 on a Community strategy for waste management(6) insisted on the need for promoting waste recovery with a view to reducing the quantity of waste for disposal and saving natural resources, in particular by reuse, recycling, composting and recovering energy from waste and recognised that the choice of options in any particular case must have regard to environmental and economic effects but that until scientific and technological progress is made and life-cycle analyses are further developed, reuse and material recovery should be considered preferable where and in so far as they are the best environmental options. The Council also invited the Commission to develop, as soon as possible, an appropriate follow-up to the projects of the priority waste streams programme, including WEEE. (5) The European Parliament, in its Resolution of 14 November 1996(7), asked the Commission to present proposals for Directives on a number of priority waste streams, including electrical and electronic waste, and to base such proposals on the principle of producer responsibility. The European Parliament, in the same Resolution, requests the Council and the Commission to put forward proposals for cutting the volume of waste. (6) Council Directive 75/442/EEC of 15 July 1975 on waste(8) provides that specific rules for particular instances or supplementing those of Directive 75/442/EEC on the management of particular categories of waste may be laid down by means of individual Directives. (7) The amount of WEEE generated in the Community is growing rapidly. The content of hazardous components in electrical and electronic equipment (EEE) is a major concern during the waste management phase and recycling of WEEE is not undertaken to a sufficient extent. (8) The objective of improving the management of WEEE cannot be achieved effectively by Member States acting individually. In particular, different national applications of the producer responsibility principle may lead to substantial disparities in the financial burden on economic operators. Having different national policies on the management of WEEE hampers the effectiveness of recycling policies. For that reason the essential criteria should be laid down at Community level. (9) The provisions of this Directive should apply to products and producers irrespective of the selling technique, including distance and electronic selling. In this connection the obligations of producers and distributors using distance and electronic selling channels should, as far as is practicable, take the same form and should be enforced in the same way in order to avoid other distribution channels having to bear the costs of the provisions of this Directive concerning WEEE for which the equipment was sold by distant or electronic selling. (10) This Directive should cover all electrical and electronic equipment used by consumers and electrical and electronic equipment intended for professional use. This Directive should apply without prejudice to Community legislation on safety and health requirements protecting all actors in contact with WEEE as well as specific Community waste management legislation, in particular Council Directive 91/157/EEC of 18 March 1991 on batteries and accumulators containing certain dangerous substances(9). (11) Directive 91/157/EEC needs to be revised as soon as possible, particularly in the light of this Directive. (12) The establishment, by this Directive, of producer responsibility is one of the means of encouraging the design and production of electrical and electronic equipment which take into full account and facilitate their repair, possible upgrading, reuse, disassembly and recycling. (13) In order to guarantee the safety and health of distributors' personnel involved in the take-back and handling of WEEE, Member States should, in accordance with national and Community legislation on safety and health requirements, determine the conditions under which take-back may be refused by distributors. (14) Member States should encourage the design and production of electrical and electronic equipment which take into account and facilitate dismantling and recovery, in particular the re-use and recycling of WEEE, their components and materials. Producers should not prevent, through specific design features or manufacturing processes, WEEE from being reused, unless such specific design features or manufacturing processes present overriding advantages, for example with regard to the protection of the environment and/or safety requirements. (15) Separate collection is the precondition to ensure specific treatment and recycling of WEEE and is necessary to achieve the chosen level of protection of human health and the environment in the Community. Consumers have to actively contribute to the success of such collection and should be encouraged to return WEEE. For this purpose, convenient facilities should be set up for the return of WEEE, including public collection points, where private households should be able to return their waste at least free of charge. (16) In order to attain the chosen level of protection and harmonised environmental objectives of the Community, Member States should adopt appropriate measures to minimise the disposal of WEEE as unsorted municipal waste and to achieve a high level of separate collection of WEEE. In order to ensure that Member States strive to set up efficient collection schemes, they should be required to achieve a high level of collection of WEEE from private households. (17) Specific treatment for WEEE is indispensable in order to avoid the dispersion of pollutants into the recycled material or the waste stream. Such treatment is the most effective means of ensuring compliance with the chosen level of protection of the environment of the Community. Any establishment or undertakings carrying out recycling and treatment operations should comply with minimum standards to prevent negative environmental impacts associated with the treatment of WEEE. Best available treatment, recovery and recycling techniques should be used provided that they ensure human health and high environmental protection. Best available treatment, recovery and recycling techniques may be further defined in accordance with the procedures of Directive 96/61/EC. (18) Where appropriate, priority should be given to the reuse of WEEE and its components, subassemblies and consumables. Where reuse is not preferable, all WEEE collected separately should be sent for recovery, in the course of which a high level of recycling and recovery should be achieved. In addition, producers should be encouraged to integrate recycled material in new equipment. (19) Basic principles with regard to the financing of WEEE management have to be set at Community level and financing schemes have to contribute to high collection rates as well as to the implementation of the principle of producer responsibility. (20) Users of electrical and electronic equipment from private households should have the possibility of returning WEEE at least free of charge. Producers should therefore finance collection from collection facilities, and the treatment, recovery and disposal of WEEE. In order to give maximum effect to the concept of producer responsibility, each producer should be responsible for financing the management of the waste from his own products. The producer should be able to choose to fulfil this obligation either individually or by joining a collective scheme. Each producer should, when placing a product on the market, provide a financial guarantee to prevent costs for the management of WEEE from orphan products from falling on society or the remaining producers. The responsibility for the financing of the management of historical waste should be shared by all existing producers in collective financing schemes to which all producers, existing on the market when the costs occur, contribute proportionately. Collective financing schemes should not have the effect of excluding niche and low-volume producers, importers and new entrants. For a transitional period, producers should be allowed to show purchasers, on a voluntary basis at the time of sale of new products, the costs of collecting, treating and disposing in an environmentally sound way of historical waste. Producers making use of this provision should ensure that the costs mentioned do not exceed the actual costs incurred. (21) Information to users about the requirement not to dispose of WEEE as unsorted municipal waste and to collect WEEE separately, and about the collection systems and their role in the management of WEEE, is indispensable for the success of WEEE collection. Such information implies the proper marking of electrical and electronic equipment which could end up in rubbish bins or similar means of municipal waste collection. (22) Information on component and material identification to be provided by producers is important to facilitate the management, and in particular the treatment and recovery/recycling, of WEEE. (23) Member States should ensure that inspection and monitoring infrastructure enable the proper implementation of this Directive to be verified, having regard, inter alia, to Recommendation 2001/331/EC of the European Parliament and the Council of 4 April 2001 providing for minimum criteria for environmental inspections in the Member States(10). (24) Information about the weight or, if this is not possible, the numbers of items of electrical and electronic equipment put on the market in the Community and the rates of collection, reuse (including as far as possible reuse of whole appliances), recovery/recycling and export of WEEE collected in accordance with this Directive is necessary to monitor the achievement of the objectives of this Directive. (25) Member States may choose to implement certain provisions of this Directive by means of agreements between the competent authorities and the economic sectors concerned provided that particular requirements are met. (26) The adaptation to scientific and technical progress of certain provisions of the Directive, the list of products falling under the categories set out in Annex IA, the selective treatment for materials and components of WEEE, the technical requirements for storage and treatment of WEEE and the symbol for the marking of EEE should be effected by the Commission under a committee procedure. (27) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(11), Article 1 Objectives The purpose of this Directive is, as a first priority, the prevention of waste electrical and electronic equipment (WEEE), and in addition, the reuse, recycling and other forms of recovery of such wastes so as to reduce the disposal of waste. It also seeks to improve the environmental performance of all operators involved in the life cycle of electrical and electronic equipment, e.g. producers, distributors and consumers and in particular those operators directly involved in the treatment of waste electrical and electronic equipment. Article 2 Scope 1. This Directive shall apply to electrical and electronic equipment falling under the categories set out in Annex IA provided that the equipment concerned is not part of another type of equipment that does not fall within the scope of this Directive. Annex IB contains a list of products which fall under the categories set out in Annex IA. 2. This Directive shall apply without prejudice to Community legislation on safety and health requirements and specific Community waste management legislation. 3. Equipment which is connected with the protection of the essential interests of the security of Member States, arms, munitions and war material shall be excluded from this Directive. This does not, however, apply to products which are not intended for specifically military purposes. Article 3 Definitions For the purposes of this Directive, the following definitions shall apply: (a) "electrical and electronic equipment" or "EEE" means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields falling under the categories set out in Annex IA and designed for use with a voltage rating not exceeding 1000 Volt for alternating current and 1500 Volt for direct current; (b) "waste electrical and electronic equipment" or "WEEE" means electrical or electronic equipment which is waste within the meaning of Article 1(a) of Directive 75/442/EEC, including all components, subassemblies and consumables which are part of the product at the time of discarding; (c) "prevention" means measures aimed at reducing the quantity and the harmfulness to the environment of WEEE and materials and substances contained therein; (d) "reuse" means any operation by which WEEE or components thereof are used for the same purpose for which they were conceived, including the continued use of the equipment or components thereof which are returned to collection points, distributors, recyclers or manufacturers; (e) "recycling" means the reprocessing in a production process of the waste materials for the original purpose or for other purposes, but excluding energy recovery which means the use of combustible waste as a means of generating energy through direct incineration with or without other waste but with recovery of the heat; (f) "recovery" means any of the applicable operations provided for in Annex IIB to Directive 75/442/EEC; (g) "disposal" means any of the applicable operations provided for in Annex IIA to Directive 75/442/EEC; (h) "treatment" means any activity after the WEEE has been handed over to a facility for depollution, disassembly, shredding, recovery or preparation for disposal and any other operation carried out for the recovery and/or the disposal of the WEEE; (i) "producer" means any person who, irrespective of the selling technique used, including by means of distance communication in accordance with Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts(12): (i) manufactures and sells electrical and electronic equipment under his own brand, (ii) resells under his own brand equipment produced by other suppliers, a reseller not being regarded as the "producer" if the brand of the producer appears on the equipment, as provided for in subpoint (i), or (iii) imports or exports electrical and electronic equipment on a professional basis into a Member State. Whoever exclusively provides financing under or pursuant to any finance agreement shall not be deemed a "producer" unless he also acts as a producer within the meaning of subpoints (i) to (iii); (j) "distributor" means any person who provides electrical or electronic equipment on a commercial basis to the party who is going to use it; (k) "WEEE from private households" means WEEE which comes from private households and from commercial, industrial, institutional and other sources which, because of its nature and quantity, is similar to that from private households; (l) "dangerous substance or preparation" means any substance or preparation which has to be considered dangerous under Council Directive 67/548/EEC(13) or Directive 1999/45/EC of the European Parliament and of the Council(14). (m) "finance agreement" means any loan, lease, hiring or deferred sale agreement or arrangement relating to any equipment whether or not the terms of that agreement or arrangement or any collateral agreement or arrangement provide that a transfer of ownership of that equipment will or may take place. Article 4 Product design Member States shall encourage the design and production of electrical and electronic equipment which take into account and facilitate dismantling and recovery, in particular the reuse and recycling of WEEE, their components and materials. In this context, Member States shall take appropriate measures so that producers do not prevent, through specific design features or manufacturing processes, WEEE from being reused, unless such specific design features or manufacturing processes present overriding advantages, for example, with regard to the protection of the environment and/or safety requirements. Article 5 Separate collection 1. Member States shall adopt appropriate measures in order to minimise the disposal of WEEE as unsorted municipal waste and to achieve a high level of separate collection of WEEE. 2. For WEEE from private households, Member States shall ensure that by the 13 August 2005: (a) systems are set up allowing final holders and distributors to return such waste at least free of charge. Member States shall ensure the availability and accessibility of the necessary collection facilities, taking into account in particular the population density; (b) when supplying a new product, distributors shall be responsible for ensuring that such waste can be returned to the distributor at least free of charge on a one-to-one basis as long as the equipment is of equivalent type and has fulfilled the same functions as the supplied equipment. Member States may depart from this provision provided they ensure that returning the WEEE is not thereby made more difficult for the final holder and provided that these systems remain free of charge for the final holder. Member States making use of this provision shall inform the Commission thereof; (c) without prejudice to the provisions of (a) and (b), producers are allowed to set up and operate individual and/or collective take-back systems for WEEE from private households provided that these are in line with the objectives of this Directive; (d) having regard to national and Community health and safety standards, WEEE that presents a health and safety risk to personnel because of contamination may be refused for return under (a) and (b). Member States shall make specific arrangements for such WEEE. Member States may provide for specific arrangements for the return of WEEE as under (a) and (b) if the equipment does not contain the essential components or if the equipment contains waste other than WEEE. 3. In the case of WEEE other than WEEE from private households, and without prejudice to Article 9, Member States shall ensure that producers or third parties acting on their behalf provide for the collection of such waste. 4. Member States shall ensure that all WEEE collected under paragraphs 1, 2 and 3 above is transported to treatment facilities authorised under Article 6 unless the appliances are reused as a whole. Member States shall ensure that the envisaged reuse does not lead to a circumvention of this Directive, in particular as regards Articles 6 and 7. The collection and transport of separately collected WEEE shall be carried out in a way which optimises reuse and recycling of those components or whole appliances capable of being reused or recycled. 5. Without prejudice to paragraph 1, Member States shall ensure that by 31 December 2006 at the latest a rate of separate collection of at least four kilograms on average per inhabitant per year of WEEE from private households is achieved. The European Parliament and the Council, acting on a proposal from the Commission and taking account of technical and economic experience in the Member States, shall establish a new mandatory target by 31 December 2008. This may take the form of a percentage of the quantities of electrical and electronic equipment sold to private households in the preceding years. Article 6 Treatment 1. Member States shall ensure that producers or third parties acting on their behalf, in accordance with Community legislation, set up systems to provide for the treatment of WEEE using best available treatment, recovery and recycling techniques. The systems may be set up by producers individually and/or collectively. To ensure compliance with Article 4 of Directive 75/442/EEC, the treatment shall, as a minimum, include the removal of all fluids and a selective treatment in accordance with Annex II to this Directive. Other treatment technologies ensuring at least the same level of protection for human health and the environment may be introduced in Annex II under the procedure referred to in Article 14(2). For the purposes of environmental protection, Member States may set up minimum quality standards for the treatment of collected WEEE. Member States which opt for such quality standards shall inform the Commission thereof, which shall publish these standards. 2. Member States shall ensure that any establishment or undertaking carrying out treatment operations obtains a permit from the competent authorities, in compliance with Articles 9 and 10 of Directive 75/442/EEC. The derogation from the permit requirement referred to in Article 11(1)(b) of Directive 75/442/EEC may apply to recovery operations concerning WEEE if an inspection is carried out by the competent authorities before the registration in order to ensure compliance with Article 4 of Directive 75/442/EEC. The inspection shall verify: (a) the type and quantities of waste to be treated; (b) the general technical requirements to be complied with; (c) the safety precautions to be taken. The inspection shall be carried out at least once a year and the results shall be communicated by the Member States to the Commission. 3. Member States shall ensure that any establishment or undertaking carrying out treatment operations stores and treats WEEE in compliance with the technical requirements set out in Annex III. 4. Member States shall ensure that the permit or the registration referred to in paragraph 2 includes all conditions necessary for compliance with the requirements of paragraphs 1 and 3 and for the achievement of the recovery targets set out in Article 7. 5. The treatment operation may also be undertaken outside the respective Member State or the Community provided that the shipment of WEEE is in compliance with Council Regulation (EEC) No 259/93 of 1 February 1993 on the supervision and control of shipments of waste within, into and out of the European Community(15). WEEE exported out of the Community in line with Council Regulation (EEC) No 259/93, Council Regulation (EC) No 1420/1999(16) of 29 April 1999 establishing common rules and procedures to apply to shipments to certain non-OECD countries of certain types of waste and Commission Regulation (EC) No 1547/1999(17) of 12 July 1999 determining the control procedures under Council Regulation (EEC) No 259/93 to apply to shipments of certain types of waste to certain countries to which OECD Decision C(92)39 final does not apply, shall only count for the fulfilment of obligations and targets of Article 7(1) and (2) of this Directive if the exporter can prove that the recovery, reuse and/or recycling operation took place under conditions that are equivalent to the requirements of this Directive. 6. Member States shall encourage establishments or undertakings which carry out treatment operations to introduce certified environmental management systems in accordance with Regulation (EC) No 761/2001 of the European Parliament and of the Council of 19 March 2001 allowing voluntary participation by organisations in a Community eco-management and audit scheme (EMAS)(18). Article 7 Recovery 1. Member States shall ensure that producers or third parties acting on their behalf set up systems either on an individual or on a collective basis, in accordance with Community legislation, to provide for the recovery of WEEE collected separately in accordance with Article 5. Member States shall give priority to the reuse of whole appliances. Until the date referred to in paragraph 4, such appliances shall not be taken into account for the calculation of the targets set out in paragraph 2. 2. Regarding WEEE sent for treatment in accordance with Article 6, Member States shall ensure that, by 31 December 2006, producers meet the following targets: (a) for WEEE falling under categories 1 and 10 of Annex IA, - the rate of recovery shall be increased to a minimum of 80 % by an average weight per appliance, and - component, material and substance reuse and recycling shall be increased to a minimum of 75 % by an average weight per appliance; (b) for WEEE falling under categories 3 and 4 of Annex IA, - the rate of recovery shall be increased to a minimum of 75 % by an average weight per appliance, and - component, material and substance reuse and recycling shall be increased to a minimum of 65 % by an average weight per appliance; (c) for WEEE falling under categories 2, 5, 6, 7 and 9 of Annex IA, - the rate of recovery shall be increased to a minimum of 70 % by an average weight per appliance, and - component, material and substance reuse and recycling shall be increased to a minimum of 50 % by an average weight per appliance; (d) for gas discharge lamps, the rate of component, material and substance reuse and recycling shall reach a minimum of 80 % by weight of the lamps. 3. Member States shall ensure that, for the purpose of calculating these targets, producers or third parties acting on their behalf keep records on the mass of WEEE, their components, materials or substances when entering (input) and leaving (output) the treatment facility and/or when entering (input) the recovery or recycling facility. The Commission shall, in accordance with the procedure laid down in Article 14(2), establish the detailed rules for monitoring compliance, including specifications for materials, of Member States with the targets set out in paragraph 2. The Commission shall submit this measure by 13 August 2004. 4. The European Parliament and the Council, acting on a proposal from the Commission, shall establish new targets for recovery and reuse/recycling, including for the reuse of whole appliances as appropriate, and for the products falling under category 8 of Annex IA, by 31 December 2008. This shall be done with account being taken of the environmental benefits of electrical and electronic equipment in use, such as improved resource efficiency resulting from developments in the areas of materials and technology. Technical progress in reuse, recovery and recycling, products and materials, and the experience gained by the Member States and the industry, shall also be taken into account. 5. Member States shall encourage the development of new recovery, recycling and treatment technologies. Article 8 Financing in respect of WEEE from private households 1. Member States shall ensure that, by 13 August 2005, producers provide at least for the financing of the collection, treatment, recovery and environmentally sound disposal of WEEE from private households deposited at collection facilities, set up under Article 5(2). 2. For products put on the market later than 13 August 2005, each producer shall be responsible for financing the operations referred to in paragraph 1 relating to the waste from his own products. The producer can choose to fulfil this obligation either individually or by joining a collective scheme. Member States shall ensure that each producer provides a guarantee when placing a product on the market showing that the management of all WEEE will be financed and that producers clearly mark their products in accordance with Article 11(2). This guarantee shall ensure that the operations referred to in paragraph 1 relating to this product will be financed. The guarantee may take the form of participation by the producer in appropriate schemes for the financing of the management of WEEE, a recycling insurance or a blocked bank account. The costs of collection, treatment and environmentally sound disposal shall not be shown separately to purchasers at the time of sale of new products. 3. The responsibility for the financing of the costs of the management of WEEE from products put on the market before the date referred to in paragraph 1 (historical waste) shall be provided by one or more systems to which all producers, existing on the market when the respective costs occur, contribute proportionately, e.g. in proportion to their respective share of the market by type of equipment. Member States shall ensure that for a transitional period of eight years (10 years for category 1 of Annex IA) after entry into force of this Directive, producers are allowed to show purchasers, at the time of sale of new products, the costs of collection, treatment and disposal in an environmentally sound way. The costs mentioned shall not exceed the actual costs incurred. 4. Member States shall ensure that producers supplying electrical or electronic equipment by means of distance communication also comply with the requirements set out in this Article for the equipment supplied in the Member State where the purchaser of that equipment resides. Article 9 Financing in respect of WEEE from users other than private households Member States shall ensure that, by 13 August 2005, the financing of the costs for the collection, treatment, recovery and environmentally sound disposal of WEEE from users other than private households from products put on the market after 13 August 2005 is to be provided for by producers. For WEEE from products put on the market before 13 August 2005 (historical waste), the financing of the costs of management shall be provided for by producers. Member States may, as an alternative, provide that users other than private households also be made, partly or totally, responsible for this financing. Producers and users other than private households may, without prejudice to this Directive, conclude agreements stipulating other financing methods. Article 10 Information for users 1. Member States shall ensure that users of electrical and electronic equipment in private households are given the necessary information about: (a) the requirement not to dispose of WEEE as unsorted municipal waste and to collect such WEEE separately; (b) the return and collection systems available to them; (c) their role in contributing to reuse, recycling and other forms of recovery of WEEE; (d) the potential effects on the environment and human health as a result of the presence of hazardous substances in electrical and electronic equipment; (e) the meaning of the symbol shown in Annex IV. 2. Member States shall adopt appropriate measures so that consumers participate in the collection of WEEE and to encourage them to facilitate the process of reuse, treatment and recovery. 3. With a view to minimising the disposal of WEEE as unsorted municipal waste and to facilitating its separate collection, Member States shall ensure that producers appropriately mark electrical and electronic equipment put on the market after 13 August 2005 with the symbol shown in Annex IV. In exceptional cases, where this is necessary because of the size or the function of the product, the symbol shall be printed on the packaging, on the instructions for use and on the warranty of the electrical and electronic equipment. 4. Member States may require that some or all of the information referred to in paragraphs 1 to 3 shall be provided by producers and/or distributors, e.g. in the instructions for use or at the point of sale. Article 11 Information for treatment facilities 1. In order to facilitate the reuse and the correct and environmentally sound treatment of WEEE, including maintenance, upgrade, refurbishment and recycling, Member States shall take the necessary measures to ensure that producers provide reuse and treatment information for each type of new EEE put on the market within one year after the equipment is put on the market. This information shall identify, as far as it is needed by reuse centres, treatment and recycling facilities in order to comply with the provisions of this Directive, the different EEE components and materials, as well as the location of dangerous substances and preparations in EEE. It shall be made available to reuse centres, treatment and recycling facilities by producers of EEE in the form of manuals or by means of electronic media (e.g. CD-ROM, online services). 2. Member States shall ensure that any producer of an electrical or electronic appliance put on the market after 13 August 2005 is clearly identifiable by a mark on the appliance. Furthermore, in order to enable the date upon which the appliance was put on the market to be determined unequivocally, a mark on the appliance shall specify that the latter was put on the market after 13 August 2005 The Commission shall promote the preparation of European standards for this purpose. Article 12 Information and reporting 1. Member States shall draw up a register of producers and collect information, including substantiated estimates, on an annual basis on the quantities and categories of electrical and electronic equipment put on their market, collected through all routes, reused, recycled and recovered within the Member States, and on collected waste exported, by weight or, if this is not possible, by numbers. Member States shall ensure that producers supplying electrical and electronic equipment by means of distance communication provide information on the compliance with the requirements of Article 8(4) and on the quantities and categories of electrical and electronic equipment put on the market of the Member State where the purchaser of that equipment resides. Member States shall ensure that the information required is transmitted to the Commission on a two-yearly basis within 18 months after the end of the period covered. The first set of information shall cover the years 2005 and 2006. The information shall be provided in a format which shall be established within one year after the entry into force of this Directive in accordance with the procedure referred to in Article 14(2) with a view to establishing databases on WEEE and its treatment. Member States shall provide for adequate information exchange in order to comply with this paragraph, in particular for treatment operations as referred to in Article 6(5). 2. Without prejudice to the requirements of paragraph 1, Member States shall send a report to the Commission on the implementation of this Directive at three-year intervals. The report shall be drawn up on the basis of a questionnaire or outline drafted by the Commission in accordance with the procedure laid down in Article 6 of Council Directive 91/692/EEC of 23 December 1991 standardising and rationalising reports on the implementation of certain Directives relating to the environment(19). The questionnaire or outline shall be sent to the Member States six months before the start of the period covered by the report. The report shall be made available to the Commission within nine months of the end of the three-year period covered by it. The first three-year report shall cover the period from 2004 to 2006. The Commission shall publish a report on the implementation of this Directive within nine months after receiving the reports from the Member States. Article 13 Adaptation to scientific and technical progress Any amendments which are necessary in order to adapt Article 7(3), Annex IB, (in particular with a view to possibly adding luminaires in households, filament bulbs and photovoltaic products, i.e. solar panels), Annex II (in particular taking into account new technical developments for the treatment of WEEE), and Annexes III and IV to scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 14(2). Before the Annexes are amended the Commission shall inter alia consult producers of electrical and electronic equipment, recyclers, treatment operators and environmental organisations and employees' and consumer associations. Article 14 Committee 1. The Commission shall be assisted by the Committee set up by Article 18 of Directive 75/442/EEC. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure. Article 15 Penalties Member States shall determine penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties thus provided for shall be effective, proportionate and dissuasive. Article 16 Inspection and monitoring Member States shall ensure that inspection and monitoring enable the proper implementation of this Directive to be verified. Article 17 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 13 August 2004. They shall immediately inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of all laws, regulations and administrative provisions adopted in the field covered by this Directive. 3. Provided that the objectives set out in this Directive are achieved, Member States may transpose the provisions set out in Articles 6(6), 10(1) and 11 by means of agreements between the competent authorities and the economic sectors concerned. Such agreements shall meet the following requirements: (a) agreements shall be enforceable; (b) agreements shall specify objectives with the corresponding deadlines; (c) agreements shall be published in the national official journal or an official document equally accessible to the public and transmitted to the Commission; (d) the results achieved shall be monitored regularly, reported to the competent authorities and the Commission and made available to the public under the conditions set out in the agreement; (e) the competent authorities shall ensure that the progress reached under the agreement is examined; (f) in case of non-compliance with the agreement Member States must implement the relevant provisions of this Directive by legislative, regulatory or administrative measures. 4. (a) Greece and Ireland which, because of their overall: - recycling infrastructure deficit, - geographical circumstances such as the large number of small islands and the presence of rural and mountain areas, - low population density, and - low level of EEE consumption, are unable to reach either the collection target mentioned in the first subparagraph of Article 5(5) or the recovery targets mentioned in Article 7(2) and which, under the third subparagraph of Article 5(2) of Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste(20), may apply for an extension of the deadline mentioned in that Article, may extend the periods referred to in Articles 5(5) and 7(2) of this Directive by up to 24 months. These Member States shall inform the Commission of their Decisions at the latest at the time of transposition of this Directive. (b) The Commission shall inform other Member States and the European Parliament of these decisions. 5. Within five years after the entry into force of this Directive, the Commission shall submit a report to the European Parliament and the Council based on the experience of the application of this Directive, in particular as regards separate collection, treatment, recovery and financing systems. Furthermore the report shall be based on the development of the state of technology, experience gained, environmental requirements and the functioning of the internal market. The report shall, as appropriate, be accompanied by proposals for revision of the relevant provisions of this Directive. Article 18 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 19 Addressees This Directive is addressed to the Member States.

32002L0095

2003

Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the Economic and Social Committee(2), Having regard to the opinion of the Committee of Regions(3), Acting in accordance with the procedure laid down in Article 251 of the Treaty in the light of the joint text approved by the Conciliation Committee on 8 November 2002(4), Whereas: (1) The disparities between the laws or administrative measures adopted by the Member States as regards the restriction of the use of hazardous substances in electrical and electronic equipment could create barriers to trade and distort competition in the Community and may thereby have a direct impact on the establishment and functioning of the internal market. It therefore appears necessary to approximate the laws of the Member States in this field and to contribute to the protection of human health and the environmentally sound recovery and disposal of waste electrical and electronic equipment. (2) The European Council at its meeting in Nice on 7, 8 and 9 December 2000 endorsed the Council Resolution of 4 December 2000 on the precautionary principle. (3) The Commission Communication of 30 July 1996 on the review of the Community strategy for waste management stresses the need to reduce the content of hazardous substances in waste and points out the potential benefits of Community-wide rules limiting the presence of such substances in products and in production processes. (4) The Council Resolution of 25 January 1988 on a Community action programme to combat environmental pollution by cadmium(5) invites the Commission to pursue without delay the development of specific measures for such a programme. Human health also has to be protected and an overall strategy that in particular restricts the use of cadmium and stimulates research into substitutes should therefore be implemented. The Resolution stresses that the use of cadmium should be limited to cases where suitable and safer alternatives do not exist. (5) The available evidence indicates that measures on the collection, treatment, recycling and disposal of waste electrical and electronic equipment (WEEE) as set out in Directive 2002/96/EC of 27 January 2003 of the European Parliament and of the Council on waste electrical and electronic equipment(6) are necessary to reduce the waste management problems linked to the heavy metals concerned and the flame retardants concerned. In spite of those measures, however, significant parts of WEEE will continue to be found in the current disposal routes. Even if WEEE were collected separately and submitted to recycling processes, its content of mercury, cadmium, lead, chromium VI, PBB and PBDE would be likely to pose risks to health or the environment. (6) Taking into account technical and economic feasibility, the most effective way of ensuring the significant reduction of risks to health and the environment relating to those substances which can achieve the chosen level of protection in the Community is the substitution of those substances in electrical and electronic equipment by safe or safer materials. Restricting the use of these hazardous substances is likely to enhance the possibilities and economic profitability of recycling of WEEE and decrease the negative health impact on workers in recycling plants. (7) The substances covered by this Directive are scientifically well researched and evaluated and have been subject to different measures both at Community and at national level. (8) The measures provided for in this Directive take into account existing international guidelines and recommendations and are based on an assessment of available scientific and technical information. The measures are necessary to achieve the chosen level of protection of human and animal health and the environment, having regard to the risks which the absence of measures would be likely to create in the Community. The measures should be kept under review and, if necessary, adjusted to take account of available technical and scientific information. (9) This Directive should apply without prejudice to Community legislation on safety and health requirements and specific Community waste management legislation, in particular Council Directive 91/157/EEC of 18 March 1991 on batteries and accumulators containing certain dangerous substances(7). (10) The technical development of electrical and electronic equipment without heavy metals, PBDE and PBB should be taken into account. As soon as scientific evidence is available and taking into account the precautionary principle, the prohibition of other hazardous substances and their substitution by more environmentally friendly alternatives which ensure at least the same level of protection of consumers should be examined. (11) Exemptions from the substitution requirement should be permitted if substitution is not possible from the scientific and technical point of view or if the negative environmental or health impacts caused by substitution are likely to outweigh the human and environmental benefits of the substitution. Substitution of the hazardous substances in electrical and electronic equipment should also be carried out in a way so as to be compatible with the health and safety of users of electrical and electronic equipment (EEE). (12) As product reuse, refurbishment and extension of lifetime are beneficial, spare parts need to be available. (13) The adaptation to scientific and technical progress of the exemptions from the requirements concerning phasing out and prohibition of hazardous substances should be effected by the Commission under a committee procedure. (14) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(8), Article 1 Objectives The purpose of this Directive is to approximate the laws of the Member States on the restrictions of the use of hazardous substances in electrical and electronic equipment and to contribute to the protection of human health and the environmentally sound recovery and disposal of waste electrical and electronic equipment. Article 2 Scope 1. Without prejudice to Article 6, this Directive shall apply to electrical and electronic equipment falling under the categories 1, 2, 3, 4, 5, 6, 7 and 10 set out in Annex IA to Directive No 2002/96/EC (WEEE) and to electric light bulbs, and luminaires in households. 2. This Directive shall apply without prejudice to Community legislation on safety and health requirements and specific Community waste management legislation. 3. This Directive does not apply to spare parts for the repair, or to the reuse, of electrical and electronic equipment put on the market before 1 July 2006. Article 3 Definitions For the purposes of this Directive, the following definitions shall apply: (a) "electrical and electronic equipment" or "EEE" means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields falling under the categories set out in Annex IA to Directive 2002/96/EC (WEEE) and designed for use with a voltage rating not exceeding 1000 volts for alternating current and 1500 volts for direct current; (b) "producer" means any person who, irrespective of the selling technique used, including by means of distance communication according to Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts(9): (i) manufactures and sells electrical and electronic equipment under his own brand; (ii) resells under his own brand equipment produced by other suppliers, a reseller not being regarded as the "producer" if the brand of the producer appears on the equipment, as provided for in subpoint (i); or (iii) imports or exports electrical and electronic equipment on a professional basis into a Member State. Whoever exclusively provides financing under or pursuant to any finance agreement shall not be deemed a "producer" unless he also acts as a producer within the meaning of subpoints (i) to (iii). Article 4 Prevention 1. Member States shall ensure that, from 1 July 2006, new electrical and electronic equipment put on the market does not contain lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) or polybrominated diphenyl ethers (PBDE). National measures restricting or prohibiting the use of these substances in electrical and electronic equipment which were adopted in line with Community legislation before the adoption of this Directive may be maintained until 1 July 2006. 2. Paragraph 1 shall not apply to the applications listed in the Annex. 3. On the basis of a proposal from the Commission, the European Parliament and the Council shall decide, as soon as scientific evidence is available, and in accordance with the principles on chemicals policy as laid down in the Sixth Community Environment Action Programme, on the prohibition of other hazardous substances and the substitution thereof by more environment-friendly alternatives which ensure at least the same level of protection for consumers. Article 5 Adaptation to scientific and technical progress 1. Any amendments which are necessary in order to adapt the Annex to scientific and technical progress for the following purposes shall be adopted in accordance with the procedure referred to in Article 7(2): (a) establishing, as necessary, maximum concentration values up to which the presence of the substances referred to in Article 4(1) in specific materials and components of electrical and electronic equipment shall be tolerated; (b) exempting materials and components of electrical and electronic equipment from Article 4(1) if their elimination or substitution via design changes or materials and components which do not require any of the materials or substances referred to therein is technically or scientifically impracticable, or where the negative environmental, health and/or consumer safety impacts caused by substitution are likely to outweigh the environmental, health and/or consumer safety benefits thereof; (c) carrying out a review of each exemption in the Annex at least every four years or four years after an item is added to the list with the aim of considering deletion of materials and components of electrical and electronic equipment from the Annex if their elimination or substitution via design changes or materials and components which do not require any of the materials or substances referred to in Article 4(1) is technically or scientifically possible, provided that the negative environmental, health and/or consumer safety impacts caused by substitution do not outweigh the possible environmental, health and/or consumer safety benefits thereof. 2. Before the Annex is amended pursuant to paragraph 1, the Commission shall inter alia consult producers of electrical and electronic equipment, recyclers, treatment operators, environmental organisations and employee and consumer associations. Comments shall be forwarded to the Committee referred to in Article 7(1). The Commission shall provide an account of the information it receives. Article 6 Review Before 13 February 2005, the Commission shall review the measures provided for in this Directive to take into account, as necessary, new scientific evidence. In particular the Commission shall, by that date, present proposals for including in the scope of this Directive equipment which falls under categories 8 and 9 set out in Annex IA to Directive 2002/96/EC (WEEE). The Commission shall also study the need to adapt the list of substances of Article 4(1), on the basis of scientific facts and taking the precautionary principle into account, and present proposals to the European Parliament and Council for such adaptations, if appropriate. Particular attention shall be paid during the review to the impact on the environment and on human health of other hazardous substances and materials used in electrical and electronic equipment. The Commission shall examine the feasibility of replacing such substances and materials and shall present proposals to the European Parliament and to the Council in order to extend the scope of Article 4, as appropriate. Article 7 Committee 1. The Commission shall be assisted by the Committee set up by Article 18 of Council Directive 75/442/EEC(10). 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to Article 8 thereof. The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure. Article 8 Penalties Member States shall determine penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties thus provided for shall be effective, proportionate and dissuasive. Article 9 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 13 August 2004. They shall immediately inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of all laws, regulations and administrative provisions adopted in the field covered by this Directive. Article 10 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 11 Addressees This Directive is addressed to the Member States.

32003L0008

2003

Council Directive 2002/8/EC of 27 January 2003 to improve access to justice in cross-border disputes by establishing minimum common rules relating to legal aid for such disputes Having regard to the Treaty establishing the European Community, and in particular Articles 61(c) and 67 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Parliament(2), Having regard to the opinion of the Economic and Social Committee(3), Whereas: (1) The European Union has set itself the objective of maintaining and developing an area of freedom, security and justice in which the free movement of persons is ensured. For the gradual establishment of such an area, the Community is to adopt, among others, the measures relating to judicial cooperation in civil matters having cross-border implications and needed for the proper functioning of the internal market. (2) According to Article 65(c) of the Treaty, these measures are to include measures eliminating obstacles to the good functioning of civil proceedings, if necessary by promoting the compatibility of the rules on civil procedure applicable in the Member States. (3) The Tampere European Council on 15 and 16 October 1999 called on the Council to establish minimum standards ensuring an adequate level of legal aid in cross-border cases throughout the Union. (4) All Member States are contracting parties to the European Convention for the Protection of Human Rights and Fundamental Freedom of 4 November 1950. The matters referred to in this Directive shall be dealt with in compliance with that Convention and in particular the respect of the principle of equality of both parties in a dispute. (5) This Directive seeks to promote the application of legal aid in cross-border disputes for persons who lack sufficient resources where aid is necessary to secure effective access to justice. The generally recognised right to access to justice is also reaffirmed by Article 47 of the Charter of Fundamental Rights of the European Union. (6) Neither the lack of resources of a litigant, whether acting as claimant or as defendant, nor the difficulties flowing from a dispute's cross-border dimension should be allowed to hamper effective access to justice. (7) Since the objectives of this Directive cannot be sufficiently achieved by the Member States acting alone and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (8) The main purpose of this Directive is to guarantee an adequate level of legal aid in cross-border disputes by laying down certain minimum common standards relating to legal aid in such disputes. A Council directive is the most suitable legislative instrument for this purpose. (9) This Directive applies in cross-border disputes, to civil and commercial matters. (10) All persons involved in a civil or commercial dispute within the scope of this Directive must be able to assert their rights in the courts even if their personal financial situation makes it impossible for them to bear the costs of the proceedings. Legal aid is regarded as appropriate when it allows the recipient effective access to justice under the conditions laid down in this Directive. (11) Legal aid should cover pre-litigation advice with a view to reaching a settlement prior to bringing legal proceedings, legal assistance in bringing a case before a court and representation in court and assistance with or exemption from the cost of proceedings. (12) It shall be left to the law of the Member State in which the court is sitting or where enforcement is sought whether the costs of proceedings may include the costs of the opponent imposed on the recipient of legal aid. (13) All Union citizens, wherever they are domiciled or habitually resident in the territory of a Member State, must be eligible for legal aid in cross-border disputes if they meet the conditions provided for by this Directive. The same applies to third-country nationals who habitually and lawfully reside in a Member State. (14) Member States should be left free to define the threshold above which a person would be presumed able to bear the costs of proceedings, in the conditions defined in this Directive. Such thresholds are to be defined in the light of various objective factors such as income, capital or family situation. (15) The objective of this Directive could not, however, be attained if legal aid applicants did not have the possibility of proving that they cannot bear the costs of proceedings even if their resources exceed the threshold defined by the Member State where the court is sitting. When making the assessment of whether legal aid is to be granted on this basis, the authorities in the Member State where the court is sitting may take into account information as to the fact that the applicant satisfies criteria in respect of financial eligibility in the Member State of domicile or habitual residence. (16) The possibility in the instant case of resorting to other mechanisms to ensure effective access to justice is not a form of legal aid. But it can warrant a presumption that the person concerned can bear the costs of the procedure despite his/her unfavourable financial situation. (17) Member States should be allowed to reject applications for legal aid in respect of manifestly unfounded actions or on grounds related to the merits of the case in so far as pre-litigation advice is offered and access to justice is guaranteed. When taking a decision on the merits of an application, Member States may reject legal aid applications when the applicant is claiming damage to his or her reputation, but has suffered no material or financial loss or the application concerns a claim arising directly out of the applicant's trade or self-employed profession. (18) The complexity of and differences between the legal systems of the Member States and the costs inherent in the cross-border dimension of a dispute should not preclude access to justice. Legal aid should accordingly cover costs directly connected with the cross-border dimension of a dispute. (19) When considering if the physical presence of a person in court is required, the courts of a Member State should take into consideration the full advantage of the possibilities offered by Council Regulation (EC) No 1206/2001 of 28 May 2001 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters(4). (20) If legal aid is granted, it must cover the entire proceeding, including expenses incurred in having a judgment enforced; the recipient should continue receiving this aid if an appeal is brought either against or by the recipient in so far as the conditions relating to the financial resources and the substance of the dispute remain fulfilled. (21) Legal aid is to be granted on the same terms both for conventional legal proceedings and for out-of-court procedures such as mediation, where recourse to them is required by the law, or ordered by the court. (22) Legal aid should also be granted for the enforcement of authentic instruments in another Member State under the conditions defined in this Directive. (23) Since legal aid is given by the Member State in which the court is sitting or where enforcement is sought, except pre-litigation assistance if the legal aid applicant is not domiciled or habitually resident in the Member State where the court is sitting, that Member State must apply its own legislation, in compliance with the principles of this Directive. (24) It is appropriate that legal aid is granted or refused by the competent authority of the Member State in which the court is sitting or where a judgment is to be enforced. This is the case both when that court is trying the case in substance and when it first has to decide whether it has jurisdiction. (25) Judicial cooperation in civil matters should be organised between Member States to encourage information for the public and professional circles and to simplify and accelerate the transmission of legal aid applications between Member States. (26) The notification and transmission mechanisms provided for by this Directive are inspired directly by those of the European Agreement on the transmission of applications for legal aid, signed in Strasbourg on 27 January 1977, hereinafter referred to as "1977 Agreement". A time limit, not provided for by the 1977 Agreement, is set for the transmission of legal aid applications. A relatively short time limit contributes to the smooth operation of justice. (27) The information transmitted pursuant to this Directive should enjoy protection. Since Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data(5), and Directive 97/66/EC of the European Parliament and of the Council of 15 December 1997 concerning the processing of personal data and the protection of privacy in the telecommunications sector(6), are applicable, there is no need for specific provisions on data protection in this Directive. (28) The establishment of a standard form for legal aid applications and for the transmission of legal aid applications in the event of cross-border litigation will make the procedures easier and faster. (29) Moreover, these application forms, as well as national application forms, should be made available on a European level through the information system of the European Judicial Network, established in accordance with Decision 2001/470/EC(7). (30) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(8). (31) It should be specified that the establishment of minimum standards in cross-border disputes does not prevent Member States from making provision for more favourable arrangements for legal aid applicants and recipients. (32) The 1977 Agreement and the additional Protocol to the European Agreement on the transmission of applications for legal aid, signed in Moscow in 2001, remain applicable to relations between Member States and third countries that are parties to the 1977 Agreement or the Protocol. But this Directive takes precedence over provisions contained in the 1977 Agreement and the Protocol in relations between Member States. (33) The United Kingdom and Ireland have given notice of their wish to participate in the adoption of this Directive in accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland annexed to the Treaty on European Union and to the Treaty establishing the European Community. (34) In accordance with Articles 1 and 2 of the Protocol on the position of Denmark annexed to the Treaty on European Union and to the Treaty establishing the European Community, Denmark is not taking part in the adoption of this Directive and is not bound by it or subject to its application, CHAPTER I SCOPE AND DEFINITIONS Article 1 Aims and scope 1. The purpose of this Directive is to improve access to justice in cross-border disputes by establishing minimum common rules relating to legal aid in such disputes. 2. It shall apply, in cross-border disputes, to civil and commercial matters whatever the nature of the court or tribunal. It shall not extend, in particular, to revenue, customs or administrative matters. 3. In this Directive, "Member State" shall mean Member States with the exception of Denmark. Article 2 Cross-border disputes 1. For the purposes of this Directive, a cross-border dispute is one where the party applying for legal aid in the context of this Directive is domiciled or habitually resident in a Member State other than the Member State where the court is sitting or where the decision is to be enforced. 2. The Member State in which a party is domiciled shall be determined in accordance with Article 59 of Council Regulation (EC) No 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters(9). 3. The relevant moment to determine if there is a cross-border dispute is the time when the application is submitted, in accordance with this Directive. CHAPTER II RIGHT TO LEGAL AID Article 3 Right to legal aid 1. Natural persons involved in a dispute covered by this Directive shall be entitled to receive appropriate legal aid in order to ensure their effective access to justice in accordance with the conditions laid down in this Directive. 2. Legal aid is considered to be appropriate when it guarantees: (a) pre-litigation advice with a view to reaching a settlement prior to bringing legal proceedings; (b) legal assistance and representation in court, and exemption from, or assistance with, the cost of proceedings of the recipient, including the costs referred to in Article 7 and the fees to persons mandated by the court to perform acts during the proceedings. In Member States in which a losing party is liable for the costs of the opposing party, if the recipient loses the case, the legal aid shall cover the costs incurred by the opposing party, if it would have covered such costs had the recipient been domiciled or habitually resident in the Member State in which the court is sitting. 3. Member States need not provide legal assistance or representation in the courts or tribunals in proceedings especially designed to enable litigants to make their case in person, except when the courts or any other competent authority otherwise decide in order to ensure equality of parties or in view of the complexity of the case. 4. Member States may request that legal aid recipients pay reasonable contributions towards the costs of proceedings taking into account the conditions referred to in Article 5. 5. Member States may provide that the competent authority may decide that recipients of legal aid must refund it in whole or in part if their financial situation has substantially improved or if the decision to grant legal aid had been taken on the basis of inaccurate information given by the recipient. Article 4 Non-discrimination Member States shall grant legal aid without discrimination to Union citizens and third-country nationals residing lawfully in a Member State. CHAPTER III CONDITIONS AND EXTENT OF LEGAL AID Article 5 Conditions relating to financial resources 1. Member States shall grant legal aid to persons referred to in Article 3(1) who are partly or totally unable to meet the costs of proceedings referred to in Article 3(2) as a result of their economic situation, in order to ensure their effective access to justice. 2. The economic situation of a person shall be assessed by the competent authority of the Member State in which the court is sitting, in the light of various objective factors such as income, capital or family situation, including an assessment of the resources of persons who are financially dependant on the applicant. 3. Member States may define thresholds above which legal aid applicants are deemed partly or totally able to bear the costs of proceedings set out in Article 3(2). These thresholds shall be defined on the basis of the criteria defined in paragraph 2 of this Article. 4. Thresholds defined according to paragraph 3 of this Article may not prevent legal aid applicants who are above the thresholds from being granted legal aid if they prove that they are unable to pay the cost of the proceedings referred to in Article 3(2) as a result of differences in the cost of living between the Member States of domicile or habitual residence and of the forum. 5. Legal aid does not need to be granted to applicants in so far as they enjoy, in the instant case, effective access to other mechanisms that cover the cost of proceedings referred to in Article 3(2). Article 6 Conditions relating to the substance of disputes 1. Member States may provide that legal aid applications for actions which appear to be manifestly unfounded may be rejected by the competent authorities. 2. If pre-litigation advice is offered, the benefit of further legal aid may be refused or cancelled on grounds related to the merits of the case in so far as access to justice is guaranteed. 3. When taking a decision on the merits of an application and without prejudice to Article 5, Member States shall consider the importance of the individual case to the applicant but may also take into account the nature of the case when the applicant is claiming damage to his or her reputation but has suffered no material or financial loss or when the application concerns a claim arising directly out of the applicant's trade or self-employed profession. Article 7 Costs related to the cross-border nature of the dispute Legal aid granted in the Member State in which the court is sitting shall cover the following costs directly related to the cross-border nature of the dispute: (a) interpretation; (b) translation of the documents required by the court or by the competent authority and presented by the recipient which are necessary for the resolution of the case; and (c) travel costs to be borne by the applicant where the physical presence of the persons concerned with the presentation of the applicant's case is required in court by the law or by the court of that Member State and the court decides that the persons concerned cannot be heard to the satisfaction of the court by any other means. Article 8 Costs covered by the Member State of the domicile or habitual residence The Member State in which the legal aid applicant is domiciled or habitually resident shall provide legal aid, as referred to in Article 3(2), necessary to cover: (a) costs relating to the assistance of a local lawyer or any other person entitled by the law to give legal advice, incurred in that Member State until the application for legal aid has been received, in accordance with this Directive, in the Member State where the court is sitting; (b) the translation of the application and of the necessary supporting documents when the application is submitted to the authorities in that Member State. Article 9 Continuity of legal aid 1. Legal aid shall continue to be granted totally or partially to recipients to cover expenses incurred in having a judgment enforced in the Member State where the court is sitting. 2. A recipient who in the Member State where the court is sitting has received legal aid shall receive legal aid provided for by the law of the Member State where recognition or enforcement is sought. 3. Legal aid shall continue to be available if an appeal is brought either against or by the recipient, subject to Articles 5 and 6. 4. Member States may make provision for the re-examination of the application at any stage in the proceedings on the grounds set out in Articles 3(3) and (5), 5 and 6, including proceedings referred to in paragraphs 1 to 3 of this Article. Article 10 Extrajudicial procedures Legal aid shall also be extended to extrajudicial procedures, under the conditions defined in this Directive, if the law requires the parties to use them, or if the parties to the dispute are ordered by the court to have recourse to them. Article 11 Authentic instruments Legal aid shall be granted for the enforcement of authentic instruments in another Member State under the conditions defined in this Directive. CHAPTER IV PROCEDURE Article 12 Authority granting legal aid Legal aid shall be granted or refused by the competent authority of the Member State in which the court is sitting, without prejudice to Article 8. Article 13 Introduction and transmission of legal aid applications 1. Legal aid applications may be submitted to either: (a) the competent authority of the Member State in which the applicant is domiciled or habitually resident (transmitting authority); or (b) the competent authority of the Member State in which the court is sitting or where the decision is to be enforced (receiving authority). 2. Legal aid applications shall be completed in, and supporting documents translated into: (a) the official language or one of the languages of the Member State of the competent receiving authority which corresponds to one of the languages of the Community institutions; or (b) another language which that Member State has indicated it can accept in accordance with Article 14(3). 3. The competent transmitting authorities may decide to refuse to transmit an application if it is manifestly: (a) unfounded; or (b) outside the scope of this Directive. The conditions referred to in Article 15(2) and (3) apply to such decisions. 4. The competent transmitting authority shall assist the applicant in ensuring that the application is accompanied by all the supporting documents known by it to be required to enable the application to be determined. It shall also assist the applicant in providing any necessary translation of the supporting documents, in accordance with Article 8(b). The competent transmitting authority shall transmit the application to the competent receiving authority in the other Member State within 15 days of the receipt of the application duly completed in one of the languages referred to in paragraph 2, and the supporting documents, translated, where necessary, into one of those languages. 5. Documents transmitted under this Directive shall be exempt from legalisation or any equivalent formality. 6. The Member States may not charge for services rendered in accordance with paragraph 4. Member States in which the legal aid applicant is domiciled or habitually resident may lay down that the applicant must repay the costs of translation borne by the competent transmitting authority if the application for legal aid is rejected by the competent authority. Article 14 Competent authorities and language 1. Member States shall designate the authority or authorities competent to send (transmitting authorities) and receive (receiving authorities) the application. 2. Each Member State shall provide the Commission with the following information: - the names and addresses of the competent receiving or transmitting authorities referred to in paragraph 1, - the geographical areas in which they have jurisdiction, - the means by which they are available to receive applications, and - the languages that may be used for the completion of the application. 3. Member States shall notify the Commission of the official language or languages of the Community institutions other than their own which is or are acceptable to the competent receiving authority for completion of the legal aid applications to be received, in accordance with this Directive. 4. Member States shall communicate to the Commission the information referred to in paragraphs 2 and 3 before 30 November 2004. Any subsequent modification of such information shall be notified to the Commission no later than two months before the modification enters into force in that Member State. 5. The information referred to in paragraphs 2 and 3 shall be published in the Official Journal of the European Communities. Article 15 Processing of applications 1. The national authorities empowered to rule on legal aid applications shall ensure that the applicant is fully informed of the processing of the application. 2. Where applications are totally or partially rejected, the reasons for rejection shall be given. 3. Member States shall make provision for review of or appeals against decisions rejecting legal aid applications. Member States may exempt cases where the request for legal aid is rejected by a court or tribunal against whose decision on the subject of the case there is no judicial remedy under national law or by a court of appeal. 4. When the appeals against a decision refusing or cancelling legal aid by virtue of Article 6 are of an administrative nature, they shall always be ultimately subject to judicial review. Article 16 Standard form 1. To facilitate transmission, a standard form for legal aid applications and for the transmission of such applications shall be established in accordance with the procedure set out in Article 17(2). 2. The standard form for the transmission of legal aid applications shall be established at the latest by 30 May 2003. The standard form for legal aid applications shall be established at the latest by 30 November 2004. CHAPTER V FINAL PROVISIONS Article 17 Committee 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply. 3. The Committee shall adopt its Rules of Procedure. Article 18 Information The competent national authorities shall cooperate to provide the general public and professional circles with information on the various systems of legal aid, in particular via the European Judicial Network, established in accordance with Decision 2001/470/EC. Article 19 More favourable provisions This Directive shall not prevent the Member States from making provision for more favourable arrangements for legal aid applicants and recipients. Article 20 Relation with other instruments This Directive shall, as between the Member States, and in relation to matters to which it applies, take precedence over provisions contained in bilateral and multilateral agreements concluded by Member States including: (a) the European Agreement on the transmission of applications for legal aid, signed in Strasbourg on 27 January 1977, as amended by the additional Protocol to the European Agreement on the transmission of applications for legal aid, signed in Moscow in 2001; (b) the Hague Convention of 25 October 1980 on International Access to Justice. Article 21 Transposition into national law 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 November 2004 with the exception of Article 3(2)(a) where the transposition of this Directive into national law shall take place no later than 30 May 2006. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 22 Entry into force This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities. Article 23 Addressees This Directive is addressed to the Member States in accordance with the Treaty establishing the European Community.

32002L0098

2003

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(a) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the Economic and Social Committee(2), Having regard to the opinion of the Committee of the Regions(3), Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), in the light of the joint text approved by the Conciliation Committee on 4 November 2002, Whereas: (1) The extent to which human blood is used therapeutically demands that the quality and safety of whole blood and blood components be ensured in order to prevent in particular the transmission of diseases. (2) The availability of blood and blood components used for therapeutic purposes is dependent largely on Community citizens who are prepared to donate. In order to safeguard public health and to prevent the transmission of infectious diseases, all precautionary measures during their collection, processing, distribution and use need to be taken making appropriate use of scientific progress in the detection and inactivation and elimination of transfusion transmissible pathogenic agents. (3) The quality, safety, and efficacy requirements of proprietary industrially-prepared medicinal products derived from human blood or plasma were ensured through Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(5). The specific exclusion of whole blood, plasma and blood cells of human origin from that Directive, however, has led to a situation whereby their quality and safety, in so far as they are intended for transfusion and not processed as such, are not subject to any binding Community legislation. It is essential, therefore, that whatever the intended purpose, Community provisions should ensure that blood and its components are of comparable quality and safety throughout the blood transfusion chain in all Member States, bearing in mind the freedom of movement of citizens within Community territory. The establishment of high standards of quality and safety, therefore, will help to reassure the public that human blood and blood components which are derived from donations in another Member State nonetheless meet the same requirements as those in their own country. (4) In respect of blood or blood components as a starting material for the manufacture of proprietary medicinal products, Directive 2001/83/EC refers to measures to be taken by Member States to prevent the transmission of infectious diseases, comprising the application of the monographs of the European Pharmacopoeia and the recommendations of the Council of Europe and the World Health Organisation (WHO) as regards in particular the selection and testing of blood and plasma donors. Furthermore, Member States should take measures to promote Community self-sufficiency in human blood or blood components and to encourage voluntary unpaid donations of blood and blood components. (5) In order to ensure that there is an equivalent level of safety and quality of blood components, whatever their intended purpose, technical requirements for the collection and testing of all blood and blood components including starting materials for medicinal products should be established by this Directive. Directive 2001/83/EC should be amended accordingly. (6) The Commission's Communication of 21 December 1994 on Blood Safety and Self-sufficiency in the European Community identified the need for a blood strategy in order to reinforce confidence in the safety of the blood transfusion chain and promote Community self-sufficiency. (7) In its Resolution of 2 June 1995, on blood safety and self-sufficiency in the Community(6), the Council invited the Commission to submit appropriate proposals in the framework of the development of a blood strategy. (8) In its Resolution of 12 November 1996 on a strategy towards blood safety and self-sufficiency in the European Community(7), the Council invited the Commission to submit proposals as a matter of urgency with a view to encouraging the development of a coordinated approach to the safety of blood and blood products. (9) In its Resolutions of 14 September 1993(8), 18 November 1993(9), 14 July 1995(10), and 17 April 1996(11) on blood safety and self-sufficiency through voluntary unpaid donations in the European Community, the European Parliament stressed the importance of ensuring the highest level of blood safety and has reiterated its continued support for the objective of Community self-sufficiency. (10) In elaborating the provisions of this Directive account has been taken of the opinion of the Scientific Committee for Medicinal Products and Medical Devices as well as international experience in this field. (11) The nature of autologous transfusion necessitates a specific consideration in respect of how and when to apply the different provisions of this Directive. (12) Hospital blood banks are hospital units which perform a limited number of activities, storage, distribution, and compatibility tests. In order to ensure that the quality and safety of blood and blood components are preserved during the whole transfusion chain, while taking account of the specific nature and functions of hospital blood banks, only provisions relevant to these activities should apply to hospital blood banks. (13) Member States should ensure that an appropriate mechanism for designating, authorising, accrediting or licensing exists to ensure that the activities of blood establishments are performed in accordance with the requirements of this Directive. (14) Member States should organise inspection and control measures, to be carried out by officials representing the competent authority, to ensure the compliance of the blood establishment with the provisions of this Directive. (15) Personnel directly involved in the collection, testing, processing, storage and distribution of blood and blood components need to be appropriately qualified and provided with timely and relevant training, without prejudice to existing Community legislation on the recognition of professional qualifications and on the protection of workers. (16) Blood establishments should establish and maintain quality systems involving all activities that determine the quality policy objectives and responsibilities and implement them by such means as quality planning, quality control, quality assurance, and quality improvement within the quality system, taking into account the principles of good manufacturing practice as well as the EC conformity assessment system. (17) An adequate system to ensure traceability of whole blood and blood components should be established. Traceability should be enforced through accurate donor, patient, and laboratory identification procedures, through record maintenance, and through an appropriate identification and labelling system. It is desirable that a system is developed in order to enable the unique and unmistakable identification of donations of blood and blood components in the Community. In the case of blood and blood components imported from third countries, it is important that an equivalent level of traceability be ensured by the blood establishments in the stages preceding importation into the Community. The same requirements of traceability which apply to blood and blood components collected in the Community should be ensured in the stages following importation. (18) It is important to introduce a set of organised surveillance procedures to collect and evaluate information on the adverse or unexpected events or reactions resulting from the collection of blood or blood components in order to prevent similar or equivalent events or reactions from occurring thereby improving the security of transfusion by adequate measures. To this end a common system of notification of serious adverse events and reactions linked to the collection, processing, testing, storage, and distribution of blood and blood components should be established in Member States. (19) It is important that when abnormal findings are reported to the donor, relevant counselling is also provided. (20) Modern blood-transfusion practice has been founded on the principles of voluntary donor services, anonymity of both donor and recipient, benevolence of the donor, and absence of profit on the part of the establishments involved in blood transfusion services. (21) All necessary measures need to be taken in order to provide prospective donors of blood or blood components with assurances regarding the confidentiality of any health-related information provided to the authorised personnel, the results of the tests on their donations as well as any future traceability of their donation. (22) According to Article 152(5) of the Treaty, the provisions of this Directive cannot affect national provisions on the donations of blood. Article 152(4)(a) of the Treaty states that Member States cannot be prevented from maintaining or introducing more stringent protective measures as regards standards of quality and safety of blood and blood components. (23) Voluntary and unpaid blood donations are a factor which can contribute to high safety standards for blood and blood components and therefore to the protection of human health. The efforts of the Council of Europe in this area should be supported and all necessary measures should be taken to encourage voluntary and unpaid donations through appropriate measures and initiatives and through ensuring that donors gain greater public recognition, thereby also increasing self-sufficiency. The definition of voluntary and unpaid donation of the Council of Europe should be taken into account. (24) Blood and blood components used for therapeutic purposes or for use in medical devices should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation and that any risk of transmission of infectious diseases is minimised; each and every blood donation should be tested in accordance with rules which provide assurances that all necessary measures have been taken to safeguard the health of individuals who are the recipients of blood and blood components. (25) Directive 95/46/EC of the European Parliament and the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and the free movement of such data(12) requires that data related to the health of an individual be subject to reinforced protection. However, it covers only personal data and not that rendered anonymous. This Directive should therefore introduce additional safeguards to prevent any unauthorised changes to donation registries, or processing records, or the unauthorised disclosure of information. (26) The Commission should be empowered to establish technical requirements and adopt any necessary changes thereto and to the Annexes in order to take into account scientific and technical progress. (27) Setting of technical requirements and adaptation to progress should take into account the Council recommendation of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the EC(13), relevant recommendations of the Council of Europe and the WHO as well as indications of relevant European institutions and organisations such as the monographs of the European Pharmacopoeia. (28) It is necessary that the best possible scientific advice is available to the Community in relation to the safety of blood and blood components, in particular as regards adapting the provisions of this Directive to scientific and technical progress. (29) Tests should be carried out in conformity with the latest scientific and technical procedures that reflect current best practice as defined by, and regularly reviewed and updated through, an appropriate expert consultation process. This review process should also take due account of scientific advances in the detection, inactivation and elimination of pathogens which can be transmitted via transfusion. (30) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(14). (31) In order to increase the effective implementation of the provisions adopted under this Directive it is appropriate to provide for penalties to be applied by Member States. (32) Since the objectives of this Directive, namely to contribute to general confidence both in the quality of donated blood and blood components and in the health protection of donors, to attain self-sufficiency at a Community level and to enhance confidence in the safety of the transfusion chain among the Member States, cannot be sufficiently achieved by the Member States and can therefore by reason of its scale and effects be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (33) Responsibility for the organisation of health services and the provision of medical care should remain the responsibility of each Member State, CHAPTER I GENERAL PROVISIONS Article 1 Objectives This Directive lays down standards of quality and safety of human blood and of blood components, in order to ensure a high level of human health protection. Article 2 Scope 1. This Directive shall apply to the collection and testing of human blood and blood components, whatever their intended purpose, and to their processing, storage, and distribution when intended for transfusion. 2. Where blood and blood components are collected and tested for the sole purpose and exclusive use in autologous transfusion and are clearly identified as such, the requirements to be complied with in respect thereof shall be in accordance with those referred to in Article 29(g). 3. This Directive shall apply without prejudice to Directives 93/42/EEC(15), 95/46/EC or 98/79/EC(16). 4. This Directive does not apply to blood stem cells. Article 3 Definitions For the purposes of this Directive: (a) "blood" shall mean whole blood collected from a donor and processed either for transfusion or for further manufacturing; (b) "blood component" shall mean a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods; (c) "blood product" shall mean any therapeutic product derived from human blood or plasma; (d) "autologous transfusion" shall mean transfusion in which the donor and the recipient are the same person and in which pre-deposited blood and blood components are used; (e) "blood establishment" shall mean any structure or body that is responsible for any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion. This does not include hospital blood banks; (f) "hospital blood bank" shall mean a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities; (g) "serious adverse event" shall mean any untoward occurrence associated with the collection, testing, processing, storage and distribution, of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity; (h) "serious adverse reaction" shall mean an unintended response in donor or in patient associated with the collection or transfusion of blood or blood components that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity; (i) "blood component release" shall mean a process which enables a blood component to be released from a quarantine status by the use of systems and procedures to ensure that the finished product meets its release specification; (j) "deferral" shall mean suspension of the eligibility of an individual to donate blood or blood components such suspension being either permanent or temporary; (k) "distribution" shall mean the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood and plasma derived products. It does not include the issuing of blood or blood components for transfusion. (l) "haemovigilance" shall mean a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors; (m) "inspection" shall mean formal and objective control according to adopted standards to assess compliance with this Directive and other relevant legislation and to identify problems. Article 4 Implementation 1. Member States shall designate the competent authority or authorities responsible for implementing the requirements of this Directive. 2. This Directive shall not prevent a Member State from maintaining or introducing in its territory more stringent protective measures which comply with the provisions of the Treaty. In particular, a Member State may introduce requirements for voluntary and unpaid donations, which include the prohibition or restriction of imports of blood and blood components, to ensure a high level of health protection and to achieve the objective set out in Article 20(1), provided that the conditions of the Treaty are met. 3. In carrying out the activities covered by this Directive the Commission may have recourse to technical and/or administrative assistance to the mutual benefit of the Commission and of the beneficiaries, relating to identification, preparation, management, monitoring, audit and control, as well as to support expenditure. CHAPTER II OBLIGATIONS ON MEMBER STATES AUTHORITIES Article 5 Designation, authorisation, accreditation or licensing of blood establishments 1. Member States shall ensure that activities relating to the collection and testing of human blood and blood components, whatever their intended purpose, and to their preparation, storage, and distribution when intended for transfusion, are undertaken only by the blood establishments which have been designated, authorised, accredited or licensed by the competent authority for that purpose. 2. For the purpose of paragraph 1, the blood establishment shall submit the information listed in Annex I to the competent authority. 3. The competent authority, having verified whether the blood establishment complies with the requirements set out in this Directive, shall indicate to the blood establishment which activities it may undertake and which conditions apply. 4. No substantial change in activities shall be undertaken by the blood establishment without prior written approval by the competent authority. 5. The competent authority may suspend or revoke the designation, authorisation, accreditation or licence of a blood establishment if inspection or control measures demonstrate that the blood establishment does not comply with the requirements of this Directive. Article 6 Hospital blood banks Articles 7, 10, 11(1), 12(1), 14, 15, 22 and 24 shall apply to hospital blood banks. Article 7 Provisions for existing establishments Member States may decide to maintain national provisions for nine months after the date laid down in Article 32 so as to enable blood establishments operating under their legislation to comply with the requirements of this Directive. Article 8 Inspection and control measures 1. Member States shall ensure that the competent authority organise inspections and appropriate control measures in blood establishments to ensure that the requirements of this Directive are complied with. 2. Inspection and control measures shall be organised by the competent authority on a regular basis. The interval between two inspections and control measures shall not exceed two years. 3. Such inspection and control measures shall be carried out by officials representing the competent authority who must be empowered to: (a) inspect blood establishments as well as facilities of any third parties on its own territory entrusted by the holder of the designation, authorisation, accreditation or licence referred to in Article 5 with the task of carrying out evaluation and testing procedures pursuant to Article 18; (b) take samples for examination and analysis; (c) examine any documents relating to the object of the inspection, subject to the provisions in force in the Member States at the time of the entry into force of this Directive and which place restrictions on these powers with regard to the descriptions of the method of preparation. 4. The competent authority shall organise inspection and other control measures as appropriate in the event of any serious adverse event or reaction or suspicion thereof in accordance with Article 15. CHAPTER III PROVISIONS FOR BLOOD ESTABLISHMENTS Article 9 Responsible person 1. Blood establishments shall designate a person (responsible person), responsible for: - ensuring that every unit of blood or blood components has been collected and tested, whatever its intended purpose, and processed, stored, and distributed, when intended for transfusion, in compliance with the laws in force in the Member State, - providing information to the competent authority in the designation, authorisation, accreditation or licensing procedures as required in Article 5, - the implementation of the requirements of Articles 10, 11, 12, 13, 14 and 15 in the blood establishment. 2. The responsible person shall fulfil the following minimum conditions of qualification: (a) he/she shall possess a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned; (b) he/she shall have practical post-graduate experience in relevant areas for at least two years, in one or more establishments which are authorised to undertake activities related to collection and/or testing of human blood and blood components, or to their preparation, storage, and distribution. 3. The tasks specified in paragraph 1 may be delegated to other persons who shall be qualified by training and experience to perform such tasks. 4. Blood establishments shall notify the competent authority of the name of the responsible person referred to in paragraph 1 and other persons referred to in paragraph 3 together with information on the specific tasks for which they are responsible. 5. Where the responsible person or such other persons referred to in paragraph 3 are permanently or temporarily replaced, the blood establishment shall provide immediately the name of the new responsible person and his or her date of commencement to the competent authority. Article 10 Personnel Personnel directly involved in collection, testing, processing, storage, and distribution of human blood and blood components shall be qualified to perform those tasks and be provided with timely, relevant and regularly updated training. CHAPTER IV QUALITY MANAGEMENT Article 11 Quality system for blood establishments 1. Member States shall take all necessary measures to ensure that each blood establishment establishes and maintains a quality system for blood establishments based on the principles of good practice. 2. The Commission shall establish the Community standards and specifications referred to in Article 29(h) for the activities relating to a quality system to be carried out by a blood establishment. Article 12 Documentation 1. Member States shall take all necessary measures in order to ensure that blood establishments maintain documentation on operational procedures, guidelines, training and reference manuals, and reporting forms. 2. Member States shall take all necessary measures in order to ensure that access is provided to these documents for officials entrusted with inspection and control measures referred to in Article 8. Article 13 Record keeping 1. Member States shall take all necessary measures to ensure that blood establishments maintain records of the information required in Annexes II and IV and under Article 29(b), (c) and (d). The records shall be kept for a minimum of 15 years. 2. The competent authority shall keep records of the data received from the blood establishments according to Articles 5, 7, 8, 9 and 15. CHAPTER V HAEMOVIGILANCE Article 14 Traceability 1. Member States shall take all necessary measures in order to ensure that blood and blood components collected, tested, processed, stored, released and/or distributed on their territory can be traced from donor to recipient and vice versa. To this end, Member States shall ensure that blood establishments implement a system for identification of each single blood donation and each single blood unit and components thereof enabling full traceability to the donor as well as to the transfusion and the recipient thereof. The system must unmistakably identify each unique donation and type of blood component. This system shall be established in accordance with the requirements referred to in Article 29(a). With regard to blood and blood components imported from third countries, Member States shall ensure that the donor identification system to be implemented by blood establishments permits an equivalent level of traceability. 2. Member States shall take all necessary measures in order to ensure that the system used for the labelling of blood and blood components collected, tested, processed, stored, released and/or distributed on their territory complies with the identification system referred to in paragraph 1 and the labelling requirements listed in Annex III. 3. Data needed for full traceability in accordance with this Article shall be kept for at least 30 years. Article 15 Notification of serious adverse events and reactions 1. Member States shall ensure that: - any serious adverse events (accidents and errors) related to the collection, testing, processing, storage and distribution of blood and blood components which may have an influence on their quality and safety, as well as any serious adverse reactions observed during or after transfusion which may be attributed to the quality and the safety of blood and blood components are notified to the competent authority, - blood establishments have in place a procedure accurately, efficiently and verifiably to withdraw from distribution blood or blood components associated with the notification referred to above. 2. These serious adverse events and reactions shall be notified in accordance with the procedure and notification format referred to in Article 29(i). CHAPTER VI PROVISIONS FOR THE QUALITY AND SAFETY OF BLOOD AND BLOOD COMPONENTS Article 16 Provision of information to prospective donors Member States shall ensure that all prospective donors of blood or blood components in the Community are provided with information referred to in Article 29(b). Article 17 Information required from donors Member States shall take all necessary measures to ensure that, upon agreement of a willingness to commence the donation of blood or blood components, all donors in the Community provide the information referred to in Article 29(c) to the blood establishment. Article 18 Eligibility of donors 1. Blood establishments shall ensure that there are evaluation procedures in place for all donors of blood and blood components and that the criteria for donation referred to in Article 29(d) are met. 2. The results of the donor evaluation and testing procedures shall be documented and any relevant abnormal findings shall be reported to the donor. Article 19 Examination of donors An examination of the donor, including an interview, shall be carried out before any donation of blood or blood components. A qualified health professional shall be responsible, in particular, for giving to and gathering from donors the information which is necessary to assess their eligibility to donate and shall, on the basis thereof, assess the eligibility of donors. Article 20 Voluntary and unpaid blood donation 1. Member States shall take the necessary measures to encourage voluntary and unpaid blood donations with a view to ensuring that blood and blood components are in so far as possible provided from such donations. 2. Member States shall submit reports to the Commission on these measures two years after the entry into force of this Directive, and thereafter every three years. On the basis of these reports the Commission shall inform the European Parliament and the Council of any necessary further measure it intends to take at Community level. Article 21 Testing of donations Blood establishments shall ensure that each donation of blood and blood components is tested in conformity with requirements listed in Annex IV. Member States shall ensure that blood and blood components imported into the Community are tested in conformity with requirements listed in Annex IV. Article 22 Storage, transport and distribution conditions Blood establishments shall ensure that the storage, transport and distribution conditions of blood and blood components comply with the requirements referred to in Article 29(e). Article 23 Quality and safety requirements for blood and blood components Blood establishments shall ensure that quality and safety requirements for blood and blood components meet the high standards in compliance with the requirements referred to in Article 29(f). CHAPTER VII DATA PROTECTION Article 24 Data protection and confidentiality Member States shall take all necessary measures to ensure that all data, including genetic information, collated within the scope of this Directive to which third parties have access have been rendered anonymous so that the donor is no longer identifiable. For that purpose, they shall ensure: (a) that data security measures are in place as well as safeguards against unauthorised data additions, deletions or modifications to donor files or deferral records, and transfer of information; (b) that procedures are in place to resolve data discrepancies; (c) that no unauthorised disclosure of such information occurs, whilst guaranteeing the traceability of donations. CHAPTER VIII EXCHANGE OF INFORMATION, REPORTS AND PENALTIES Article 25 Information exchange The Commission shall hold regular meetings with the competent authorities designated by the Member States, delegations of experts from blood establishments and other relevant parties to exchange information on the experience acquired with regard to the implementation of this Directive. Article 26 Reports 1. Member States shall send to the Commission, commencing on 31 December 2003 and every three years thereafter, a report on the activities undertaken in relation to the provisions of this Directive, including an account of the measures taken in relation to inspection and control. 2. The Commission shall transmit to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions, the reports submitted by the Member States on the experience gained in implementing this Directive. 3. The Commission shall transmit to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions, commencing on 1 July 2004 and every three years thereafter, a report on the implementation of the requirements in this Directive, and in particular those relating to inspection and control. Article 27 Penalties Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate, and dissuasive. Member States shall notify those provisions to the Commission by the date specified in Article 32 at the latest and shall notify it without delay of any subsequent amendments affecting them. CHAPTER IX COMMITTEES Article 28 Regulatory procedure 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure. Article 29 Technical requirements and their adaptation to technical and scientific progress The adaptation of the technical requirements set out in Annexes I to IV to technical and scientific progress shall be decided in accordance with the procedure referred to in Article 28(2). The following technical requirements and their adaptation to technical and scientific progress shall be decided in accordance with the procedure referred to in Article 28(2): (a) traceability requirements; (b) information to be provided to donors; (c) information to be obtained from donors including the identification, health history, and the signature of the donor; (d) requirements concerning the suitability of blood and plasma donors and the screening of donated blood including - permanent deferral criteria and possible exemption thereto - temporary deferral criteria; (e) storage, transport and distribution requirements; (f) quality and safety requirements for blood and blood components; (g) requirements applicable to autologous transfusions; (h) Community standards and specifications relating to a quality system for blood establishments; (i) Community procedure for notifying serious adverse reactions and events and notification format. Article 30 Consultation of scientific committee(s) The Commission may consult the relevant scientific committee(s) when establishing the technical requirements referred to in Article 29 and when adapting the technical requirements set out in Annexes I to IV to scientific and technical progress, in particular with a view to ensuring an equivalent level of quality and safety of blood and blood components used for transfusion and blood and blood components used as a starting material for the manufacture of medicinal products. CHAPTER X FINAL PROVISIONS Article 31 Amendment of Directive 2001/83/EC Article 109 of Directive 2001/83/EC shall be replaced by the following: "Article 109 For the collection and testing of human blood and human plasma, Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC(17) shall apply." Article 32 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 8 February 2005. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law that they have already adopted or which they adopt in the field governed by this Directive. Article 33 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 34 Addressees This Directive is addressed to the Member States.

32003L0009

2003

Council Directive 2003/9/EC of 27 January 2003 laying down minimum standards for the reception of asylum seekers Having regard to the Treaty establishing the European Community, and in particular point (1)(b) of the first subparagraph of Article 63 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Parliament(2), Having regard to the opinion of the Economic and Social Committee(3), Having regard to the opinion of the Committee of the Regions(4), Whereas: (1) A common policy on asylum, including a Common European Asylum System, is a constituent part of the European Union's objective of progressively establishing an area of freedom, security and justice open to those who, forced by circumstances, legitimately seek protection in the Community. (2) At its special meeting in Tampere on 15 and 16 October 1999, the European Council agreed to work towards establishing a Common European Asylum System, based on the full and inclusive application of the Geneva Convention relating to the Status of Refugees of 28 July 1951, as supplemented by the New York Protocol of 31 January 1967, thus maintaining the principle of non-refoulement. (3) The Tampere Conclusions provide that a Common European Asylum System should include, in the short term, common minimum conditions of reception of asylum seekers. (4) The establishment of minimum standards for the reception of asylum seekers is a further step towards a European asylum policy. (5) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. In particular, this Directive seeks to ensure full respect for human dignity and to promote the application of Articles 1 and 18 of the said Charter. (6) With respect to the treatment of persons falling within the scope of this Directive, Member States are bound by obligations under instruments of international law to which they are party and which prohibit discrimination. (7) Minimum standards for the reception of asylum seekers that will normally suffice to ensure them a dignified standard of living and comparable living conditions in all Member States should be laid down. (8) The harmonisation of conditions for the reception of asylum seekers should help to limit the secondary movements of asylum seekers influenced by the variety of conditions for their reception. (9) Reception of groups with special needs should be specifically designed to meet those needs. (10) Reception of applicants who are in detention should be specifically designed to meet their needs in that situation. (11) In order to ensure compliance with the minimum procedural guarantees consisting in the opportunity to contact organisations or groups of persons that provide legal assistance, information should be provided on such organisations and groups of persons. (12) The possibility of abuse of the reception system should be restricted by laying down cases for the reduction or withdrawal of reception conditions for asylum seekers. (13) The efficiency of national reception systems and cooperation among Member States in the field of reception of asylum seekers should be secured. (14) Appropriate coordination should be encouraged between the competent authorities as regards the reception of asylum seekers, and harmonious relationships between local communities and accommodation centres should therefore be promoted. (15) It is in the very nature of minimum standards that Member States have the power to introduce or maintain more favourable provisions for third-country nationals and stateless persons who ask for international protection from a Member State. (16) In this spirit, Member States are also invited to apply the provisions of this Directive in connection with procedures for deciding on applications for forms of protection other than that emanating from the Geneva Convention for third country nationals and stateless persons. (17) The implementation of this Directive should be evaluated at regular intervals. (18) Since the objectives of the proposed action, namely to establish minimum standards on the reception of asylum seekers in Member States, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the proposed action, be better achieved by the Community, the Community may adopt measures in accordance with the principles of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (19) In accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland, annexed to the Treaty on European Union and to the Treaty establishing the European Community, the United Kingdom gave notice, by letter of 18 August 2001, of its wish to take part in the adoption and application of this Directive. (20) In accordance with Article 1 of the said Protocol, Ireland is not participating in the adoption of this Directive. Consequently, and without prejudice to Article 4 of the aforementioned Protocol, the provisions of this Directive do not apply to Ireland. (21) In accordance with Articles 1 and 2 of the Protocol on the position of Denmark, annexed to the Treaty on European Union and to the Treaty establishing the European Community, Denmark is not participating in the adoption of this Directive and is therefore neither bound by it nor subject to its application, CHAPTER I PURPOSE, DEFINITIONS AND SCOPE Article 1 Purpose The purpose of this Directive is to lay down minimum standards for the reception of asylum seekers in Member States. Article 2 Definitions For the purposes of this Directive: (a) "Geneva Convention" shall mean the Convention of 28 July 1951 relating to the status of refugees, as amended by the New York Protocol of 31 January 1967; (b) "application for asylum" shall mean the application made by a third-country national or a stateless person which can be understood as a request for international protection from a Member State, under the Geneva Convention. Any application for international protection is presumed to be an application for asylum unless a third-country national or a stateless person explicitly requests another kind of protection that can be applied for separately; (c) "applicant" or "asylum seeker" shall mean a third country national or a stateless person who has made an application for asylum in respect of which a final decision has not yet been taken; (d) "family members" shall mean, in so far as the family already existed in the country of origin, the following members of the applicant's family who are present in the same Member State in relation to the application for asylum: (i) the spouse of the asylum seeker or his or her unmarried partner in a stable relationship, where the legislation or practice of the Member State concerned treats unmarried couples in a way comparable to married couples under its law relating to aliens; (ii) the minor children of the couple referred to in point (i) or of the applicant, on condition that they are unmarried and dependent and regardless of whether they were born in or out of wedlock or adopted as defined under the national law; (e) "refugee" shall mean a person who fulfils the requirements of Article 1(A) of the Geneva Convention; (f) "refugee status" shall mean the status granted by a Member State to a person who is a refugee and is admitted as such to the territory of that Member State; (g) "procedures" and "appeals", shall mean the procedures and appeals established by Member States in their national law; (h) "unaccompanied minors" shall mean persons below the age of eighteen who arrive in the territory of the Member States unaccompanied by an adult responsible for them whether by law or by custom, and for as long as they are not effectively taken into the care of such a person; it shall include minors who are left unaccompanied after they have entered the territory of Member States; (i) "reception conditions" shall mean the full set of measures that Member States grant to asylum seekers in accordance with this Directive; (j) "material reception conditions" shall mean the reception conditions that include housing, food and clothing, provided in kind, or as financial allowances or in vouchers, and a daily expenses allowance; (k) "detention" shall mean confinement of an asylum seeker by a Member State within a particular place, where the applicant is deprived of his or her freedom of movement; (l) "accommodation centre" shall mean any place used for collective housing of asylum seekers. Article 3 Scope 1. This Directive shall apply to all third country nationals and stateless persons who make an application for asylum at the border or in the territory of a Member State as long as they are allowed to remain on the territory as asylum seekers, as well as to family members, if they are covered by such application for asylum according to the national law. 2. This Directive shall not apply in cases of requests for diplomatic or territorial asylum submitted to representations of Member States. 3. This Directive shall not apply when the provisions of Council Directive 2001/55/EC of 20 July 2001 on minimum standards for giving temporary protection in the event of a mass influx of displaced persons and on measures promoting a balance of efforts between Member States in receiving such persons and bearing the consequences thereof(5) are applied. 4. Member States may decide to apply this Directive in connection with procedures for deciding on applications for kinds of protection other than that emanating from the Geneva Convention for third-country nationals or stateless persons who are found not to be refugees. Article 4 More favourable provisions Member States may introduce or retain more favourable provisions in the field of reception conditions for asylum seekers and other close relatives of the applicant who are present in the same Member State when they are dependent on him or for humanitarian reasons insofar as these provisions are compatible with this Directive. CHAPTER II GENERAL PROVISIONS ON RECEPTION CONDITIONS Article 5 Information 1. Member States shall inform asylum seekers, within a reasonable time not exceeding fifteen days after they have lodged their application for asylum with the competent authority, of at least any established benefits and of the obligations with which they must comply relating to reception conditions. Member States shall ensure that applicants are provided with information on organisations or groups of persons that provide specific legal assistance and organisations that might be able to help or inform them concerning the available reception conditions, including health care. 2. Member States shall ensure that the information referred to in paragraph 1 is in writing and, as far as possible, in a language that the applicants may reasonably be supposed to understand. Where appropriate, this information may also be supplied orally. Article 6 Documentation 1. Member States shall ensure that, within three days after an application is lodged with the competent authority, the applicant is provided with a document issued in his or her own name certifying his or her status as an asylum seeker or testifying that he or she is allowed to stay in the territory of the Member State while his or her application is pending or being examined. If the holder is not free to move within all or a part of the territory of the Member State, the document shall also certify this fact. 2. Member States may exclude application of this Article when the asylum seeker is in detention and during the examination of an application for asylum made at the border or within the context of a procedure to decide on the right of the applicant legally to enter the territory of a Member State. In specific cases, during the examination of an application for asylum, Member States may provide applicants with other evidence equivalent to the document referred to in paragraph 1. 3. The document referred to in paragraph 1 need not certify the identity of the asylum seeker. 4. Member States shall adopt the necessary measures to provide asylum seekers with the document referred to in paragraph 1, which must be valid for as long as they are authorised to remain in the territory of the Member State concerned or at the border thereof. 5. Member States may provide asylum seekers with a travel document when serious humanitarian reasons arise that require their presence in another State. Article 7 Residence and freedom of movement 1. Asylum seekers may move freely within the territory of the host Member State or within an area assigned to them by that Member State. The assigned area shall not affect the unalienable sphere of private life and shall allow sufficient scope for guaranteeing access to all benefits under this Directive. 2. Member States may decide on the residence of the asylum seeker for reasons of public interest, public order or, when necessary, for the swift processing and effective monitoring of his or her application. 3. When it proves necessary, for example for legal reasons or reasons of public order, Member States may confine an applicant to a particular place in accordance with their national law. 4. Member States may make provision of the material reception conditions subject to actual residence by the applicants in a specific place, to be determined by the Member States. Such a decision, which may be of a general nature, shall be taken individually and established by national legislation. 5. Member States shall provide for the possibility of granting applicants temporary permission to leave the place of residence mentioned in paragraphs 2 and 4 and/or the assigned area mentioned in paragraph 1. Decisions shall be taken individually, objectively and impartially and reasons shall be given if they are negative. The applicant shall not require permission to keep appointments with authorities and courts if his or her appearance is necessary. 6. Member States shall require applicants to inform the competent authorities of their current address and notify any change of address to such authorities as soon as possible. Article 8 Families Member States shall take appropriate measures to maintain as far as possible family unity as present within their territory, if applicants are provided with housing by the Member State concerned. Such measures shall be implemented with the asylum seeker's agreement. Article 9 Medical screening Member States may require medical screening for applicants on public health grounds. Article 10 Schooling and education of minors 1. Member States shall grant to minor children of asylum seekers and to asylum seekers who are minors access to the education system under similar conditions as nationals of the host Member State for so long as an expulsion measure against them or their parents is not actually enforced. Such education may be provided in accommodation centres. The Member State concerned may stipulate that such access must be confined to the State education system. Minors shall be younger than the age of legal majority in the Member State in which the application for asylum was lodged or is being examined. Member States shall not withdraw secondary education for the sole reason that the minor has reached the age of majority. 2. Access to the education system shall not be postponed for more than three months from the date the application for asylum was lodged by the minor or the minor's parents. This period may be extended to one year where specific education is provided in order to facilitate access to the education system. 3. Where access to the education system as set out in paragraph 1 is not possible due to the specific situation of the minor, the Member State may offer other education arrangements. Article 11 Employment 1. Member States shall determine a period of time, starting from the date on which an application for asylum was lodged, during which an applicant shall not have access to the labour market. 2. If a decision at first instance has not been taken within one year of the presentation of an application for asylum and this delay cannot be attributed to the applicant, Member States shall decide the conditions for granting access to the labour market for the applicant. 3. Access to the labour market shall not be withdrawn during appeals procedures, where an appeal against a negative decision in a regular procedure has suspensive effect, until such time as a negative decision on the appeal is notified. 4. For reasons of labour market policies, Member States may give priority to EU citizens and nationals of States parties to the Agreement on the European Economic Area and also to legally resident third-country nationals. Article 12 Vocational training Member States may allow asylum seekers access to vocational training irrespective of whether they have access to the labour market. Access to vocational training relating to an employment contract shall depend on the extent to which the applicant has access to the labour market in accordance with Article 11. Article 13 General rules on material reception conditions and health care 1. Member States shall ensure that material reception conditions are available to applicants when they make their application for asylum. 2. Member States shall make provisions on material reception conditions to ensure a standard of living adequate for the health of applicants and capable of ensuring their subsistence. Member States shall ensure that that standard of living is met in the specific situation of persons who have special needs, in accordance with Article 17, as well as in relation to the situation of persons who are in detention. 3. Member States may make the provision of all or some of the material reception conditions and health care subject to the condition that applicants do not have sufficient means to have a standard of living adequate for their health and to enable their subsistence. 4. Member States may require applicants to cover or contribute to the cost of the material reception conditions and of the health care provided for in this Directive, pursuant to the provision of paragraph 3, if the applicants have sufficient resources, for example if they have been working for a reasonable period of time. If it transpires that an applicant had sufficient means to cover material reception conditions and health care at the time when these basic needs were being covered, Member States may ask the asylum seeker for a refund. 5. Material reception conditions may be provided in kind, or in the form of financial allowances or vouchers or in a combination of these provisions. Where Member States provide material reception conditions in the form of financial allowances or vouchers, the amount thereof shall be determined in accordance with the principles set out in this Article. Article 14 Modalities for material reception conditions 1. Where housing is provided in kind, it should take one or a combination of the following forms: (a) premises used for the purpose of housing applicants during the examination of an application for asylum lodged at the border; (b) accommodation centres which guarantee an adequate standard of living; (c) private houses, flats, hotels or other premises adapted for housing applicants. 2. Member States shall ensure that applicants provided with the housing referred to in paragraph 1(a), (b) and (c) are assured: (a) protection of their family life; (b) the possibility of communicating with relatives, legal advisers and representatives of the United Nations High Commissioner for Refugees (UNHCR) and non-governmental organisations (NGOs) recognised by Member States. Member States shall pay particular attention to the prevention of assault within the premises and accommodation centres referred to in paragraph 1(a) and (b). 3. Member States shall ensure, if appropriate, that minor children of applicants or applicants who are minors are lodged with their parents or with the adult family member responsible for them whether by law or by custom. 4. Member States shall ensure that transfers of applicants from one housing facility to another take place only when necessary. Member States shall provide for the possibility for applicants to inform their legal advisers of the transfer and of their new address. 5. Persons working in accommodation centres shall be adequately trained and shall be bound by the confidentiality principle as defined in the national law in relation to any information they obtain in the course of their work. 6. Member States may involve applicants in managing the material resources and non-material aspects of life in the centre through an advisory board or council representing residents. 7. Legal advisors or counsellors of asylum seekers and representatives of the United Nations High Commissioner for Refugees or non-governmental organisations designated by the latter and recognised by the Member State concerned shall be granted access to accommodation centres and other housing facilities in order to assist the said asylum seekers. Limits on such access may be imposed only on grounds relating to the security of the centres and facilities and of the asylum seekers. 8. Member States may exceptionally set modalities for material reception conditions different from those provided for in this Article, for a reasonable period which shall be as short as possible, when: - an initial assessment of the specific needs of the applicant is required, - material reception conditions, as provided for in this Article, are not available in a certain geographical area, - housing capacities normally available are temporarily exhausted, - the asylum seeker is in detention or confined to border posts. These different conditions shall cover in any case basic needs. Article 15 Health care 1. Member States shall ensure that applicants receive the necessary health care which shall include, at least, emergency care and essential treatment of illness. 2. Member States shall provide necessary medical or other assistance to applicants who have special needs. CHAPTER III REDUCTION OR WITHDRAWAL OF RECEPTION CONDITIONS Article 16 Reduction or withdrawal of reception conditions 1. Member States may reduce or withdraw reception conditions in the following cases: (a) where an asylum seeker: - abandons the place of residence determined by the competent authority without informing it or, if requested, without permission, or - does not comply with reporting duties or with requests to provide information or to appear for personal interviews concerning the asylum procedure during a reasonable period laid down in national law, or - has already lodged an application in the same Member State. When the applicant is traced or voluntarily reports to the competent authority, a duly motivated decision, based on the reasons for the disappearance, shall be taken on the reinstallation of the grant of some or all of the reception conditions; (b) where an applicant has concealed financial resources and has therefore unduly benefited from material reception conditions. If it transpires that an applicant had sufficient means to cover material reception conditions and health care at the time when these basic needs were being covered, Member States may ask the asylum seeker for a refund. 2. Member States may refuse conditions in cases where an asylum seeker has failed to demonstrate that the asylum claim was made as soon as reasonably practicable after arrival in that Member State. 3. Member States may determine sanctions applicable to serious breaching of the rules of the accommodation centres as well as to seriously violent behaviour. 4. Decisions for reduction, withdrawal or refusal of reception conditions or sanctions referred to in paragraphs 1, 2 and 3 shall be taken individually, objectively and impartially and reasons shall be given. Decisions shall be based on the particular situation of the person concerned, especially with regard to persons covered by Article 17, taking into account the principle of proportionality. Member States shall under all circumstances ensure access to emergency health care. 5. Member States shall ensure that material reception conditions are not withdrawn or reduced before a negative decision is taken. CHAPTER IV PROVISIONS FOR PERSONS WITH SPECIAL NEEDS Article 17 General principle 1. Member States shall take into account the specific situation of vulnerable persons such as minors, unaccompanied minors, disabled people, elderly people, pregnant women, single parents with minor children and persons who have been subjected to torture, rape or other serious forms of psychological, physical or sexual violence, in the national legislation implementing the provisions of Chapter II relating to material reception conditions and health care. 2. Paragraph 1 shall apply only to persons found to have special needs after an individual evaluation of their situation. Article 18 Minors 1. The best interests of the child shall be a primary consideration for Member States when implementing the provisions of this Directive that involve minors. 2. Member States shall ensure access to rehabilitation services for minors who have been victims of any form of abuse, neglect, exploitation, torture or cruel, inhuman and degrading treatment, or who have suffered from armed conflicts, and ensure that appropriate mental health care is developed and qualified counselling is provided when needed. Article 19 Unaccompanied minors 1. Member States shall as soon as possible take measures to ensure the necessary representation of unaccompanied minors by legal guardianship or, where necessary, representation by an organisation which is responsible for the care and well-being of minors, or by any other appropriate representation. Regular assessments shall be made by the appropriate authorities. 2. Unaccompanied minors who make an application for asylum shall, from the moment they are admitted to the territory to the moment they are obliged to leave the host Member State in which the application for asylum was made or is being examined, be placed: (a) with adult relatives; (b) with a foster-family; (c) in accommodation centres with special provisions for minors; (d) in other accommodation suitable for minors. Member States may place unaccompanied minors aged 16 or over in accommodation centres for adult asylum seekers. As far as possible, siblings shall be kept together, taking into account the best interests of the minor concerned and, in particular, his or her age and degree of maturity. Changes of residence of unaccompanied minors shall be limited to a minimum. 3. Member States, protecting the unaccompanied minor's best interests, shall endeavour to trace the members of his or her family as soon as possible. In cases where there may be a threat to the life or integrity of the minor or his or her close relatives, particularly if they have remained in the country of origin, care must be taken to ensure that the collection, processing and circulation of information concerning those persons is undertaken on a confidential basis, so as to avoid jeopardising their safety. 4. Those working with unaccompanied minors shall have had or receive appropriate training concerning their needs, and shall be bound by the confidentiality principle as defined in the national law, in relation to any information they obtain in the course of their work. Article 20 Victims of torture and violence Member States shall ensure that, if necessary, persons who have been subjected to torture, rape or other serious acts of violence receive the necessary treatment of damages caused by the aforementioned acts. CHAPTER V APPEALS Article 21 Appeals 1. Member States shall ensure that negative decisions relating to the granting of benefits under this Directive or decisions taken under Article 7 which individually affect asylum seekers may be the subject of an appeal within the procedures laid down in the national law. At least in the last instance the possibility of an appeal or a review before a judicial body shall be granted. 2. Procedures for access to legal assistance in such cases shall be laid down in national law. CHAPTER VI ACTIONS TO IMPROVE THE EFFICIENCY OF THE RECEPTION SYSTEM Article 22 Cooperation Member States shall regularly inform the Commission on the data concerning the number of persons, broken down by sex and age, covered by reception conditions and provide full information on the type, name and format of the documents provided for by Article 6. Article 23 Guidance, monitoring and control system Member States shall, with due respect to their constitutional structure, ensure that appropriate guidance, monitoring and control of the level of reception conditions are established. Article 24 Staff and resources 1. Member States shall take appropriate measures to ensure that authorities and other organisations implementing this Directive have received the necessary basic training with respect to the needs of both male and female applicants. 2. Member States shall allocate the necessary resources in connection with the national provisions enacted to implement this Directive. CHAPTER VII FINAL PROVISIONS Article 25 Reports By 6 August 2006, the Commission shall report to the European Parliament and the Council on the application of this Directive and shall propose any amendments that are necessary. Member States shall send the Commission all the information that is appropriate for drawing up the report, including the statistical data provided for by Article 22 by 6 February 2006. After presenting the report, the Commission shall report to the European Parliament and the Council on the application of this Directive at least every five years. Article 26 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 6 February 2005. They shall forthwith inform the Commission thereof. When the Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such a reference is to be made. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field relating to the enforcement of this Directive. Article 27 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 28 Addressees This Directive is addressed to the Member States in accordance with the Treaty establishing the European Union.

32003L0006

2003

Directive 2003/6/EC of the European Parliament and of the Council of 28 January 2003 on insider dealing and market manipulation (market abuse) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Having regard to the opinion of the European Central Bank(3), Acting in accordance with the procedure laid down in Article 251(4), Whereas: (1) A genuine Single Market for financial services is crucial for economic growth and job creation in the Community. (2) An integrated and efficient financial market requires market integrity. The smooth functioning of securities markets and public confidence in markets are prerequisites for economic growth and wealth. Market abuse harms the integrity of financial markets and public confidence in securities and derivatives. (3) The Commission Communication of 11 May 1999 entitled "Implementing the framework for financial markets: action plan" identifies a series of actions that are needed in order to complete the single market for financial services. The Lisbon European Council of April 2000 called for the implementation of that action plan by 2005. The action plan stresses the need to draw up a Directive against market manipulation. (4) At its meeting on 17 July 2000, the Council set up the Committee of Wise Men on the Regulation of European Securities Markets. In its final report, the Committee of Wise Men proposed the introduction of new legislative techniques based on a four-level approach, namely framework principles, implementing measures, cooperation and enforcement. Level 1, the Directive, should confine itself to broad general "framework" principles while Level 2 should contain technical implementing measures to be adopted by the Commission with the assistance of a committee. (5) The Resolution adopted by the Stockholm European Council of March 2001 endorsed the final report of the Committee of Wise Men and the proposed four-level approach to make the regulatory process for Community securities legislation more efficient and transparent. (6) The Resolution of the European Parliament of 5 February 2002 on the implementation of financial services legislation also endorsed the Committee of Wise Men's report, on the basis of the solemn declaration made before Parliament the same day by the Commission and the letter of 2 October 2001 addressed by the Internal Market Commissioner to the chairman of Parliament's Committee on Economic and Monetary Affairs with regard to the safeguards for the European Parliament's role in this process. (7) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5). (8) According to the Stockholm European Council, Level 2 implementing measures should be used more frequently, to ensure that technical provisions can be kept up to date with market and supervisory developments, and deadlines should be set for all stages of Level 2 work. (9) The European Parliament should be given a period of three months from the first transmission of draft implementing measures to allow it to examine them and to give its opinion. However, in urgent and duly justified cases, this period may be shortened. If, within that period, a resolution is passed by the European Parliament, the Commission should re-examine the draft measures. (10) New financial and technical developments enhance the incentives, means and opportunities for market abuse: through new products, new technologies, increasing cross-border activities and the Internet. (11) The existing Community legal framework to protect market integrity is incomplete. Legal requirements vary from one Member State to another, leaving economic actors often uncertain over concepts, definitions and enforcement. In some Member States there is no legislation addressing the issues of price manipulation and the dissemination of misleading information. (12) Market abuse consists of insider dealing and market manipulation. The objective of legislation against insider dealing is the same as that of legislation against market manipulation: to ensure the integrity of Community financial markets and to enhance investor confidence in those markets. It is therefore advisable to adopt combined rules to combat both insider dealing and market manipulation. A single Directive will ensure throughout the Community the same framework for allocation of responsibilities, enforcement and cooperation. (13) Given the changes in financial markets and in Community legislation since the adoption of Council Directive 89/592/EEC of 13 November 1989 coordinating regulations on insider dealing(6), that Directive should now be replaced, to ensure consistency with legislation against market manipulation. A new Directive is also needed to avoid loopholes in Community legislation which could be used for wrongful conduct and which would undermine public confidence and therefore prejudice the smooth functioning of the markets. (14) This Directive meets the concerns expressed by the Member States following the terrorist attacks on 11 September 2001 as regards the fight against financing terrorist activities. (15) Insider dealing and market manipulation prevent full and proper market transparency, which is a prerequisite for trading for all economic actors in integrated financial markets. (16) Inside information is any information of a precise nature which has not been made public, relating, directly or indirectly, to one or more issuers of financial instruments or to one or more financial instruments. Information which could have a significant effect on the evolution and forming of the prices of a regulated market as such could be considered as information which indirectly relates to one or more issuers of financial instruments or to one or more related derivative financial instruments. (17) As regards insider dealing, account should be taken of cases where inside information originates not from a profession or function but from criminal activities, the preparation or execution of which could have a significant effect on the prices of one or more financial instruments or on price formation in the regulated market as such. (18) Use of inside information can consist in the acquisition or disposal of financial instruments by a person who knows, or ought to have known, that the information possessed is inside information. In this respect, the competent authorities should consider what a normal and reasonable person would know or should have known in the circumstances. Moreover, the mere fact that market-makers, bodies authorised to act as counterparties, or persons authorised to execute orders on behalf of third parties with inside information confine themselves, in the first two cases, to pursuing their legitimate business of buying or selling financial instruments or, in the last case, to carrying out an order dutifully, should not in itself be deemed to constitute use of such inside information. (19) Member States should tackle the practice known as "front running", including "front running" in commodity derivatives, where it constitutes market abuse under the definitions contained in this Directive. (20) A person who enters into transactions or issues orders to trade which are constitutive of market manipulation may be able to establish that his reasons for entering into such transactions or issuing orders to trade were legitimate and that the transactions and orders to trade were in conformity with accepted practice on the regulated market concerned. A sanction could still be imposed if the competent authority established that there was another, illegitimate, reason behind these transactions or orders to trade. (21) The competent authority may issue guidance on matters covered by this Directive, e.g. definition of inside information in relation to derivatives on commodities or implementation of the definition of accepted market practices relating to the definition of market manipulation. This guidance should be in conformity with the provisions of the Directive and the implementing measures adopted in accordance with the comitology procedure. (22) Member States should be able to choose the most appropriate way to regulate persons producing or disseminating research concerning financial instruments or issuers of financial instruments or persons producing or disseminating other information recommending or suggesting investment strategy, including appropriate mechanisms for self-regulation, which should be notified to the Commission. (23) Posting of inside information by issuers on their internet sites should be in accordance with the rules on transfer of personal data to third countries as laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the movement of such data(7). (24) Prompt and fair disclosure of information to the public enhances market integrity, whereas selective disclosure by issuers can lead to a loss of investor confidence in the integrity of financial markets. Professional economic actors should contribute to market integrity by various means. Such measures could include, for instance, the creation of "grey lists", the application of "window trading" to sensitive categories of personnel, the application of internal codes of conduct and the establishment of "Chinese walls". Such preventive measures may contribute to combating market abuse only if they are enforced with determination and are dutifully controlled. Adequate enforcement control would imply for instance the designation of compliance officers within the bodies concerned and periodic checks conducted by independent auditors. (25) Modern communication methods make it possible for financial market professionals and private investors to have more equal access to financial information, but also increase the risk of the spread of false or misleading information. (26) Greater transparency of transactions conducted by persons discharging managerial responsibilities within issuers and, where applicable, persons closely associated with them, constitutes a preventive measure against market abuse. The publication of those transactions on at least an individual basis can also be a highly valuable source of information to investors. (27) Market operators should contribute to the prevention of market abuse and adopt structural provisions aimed at preventing and detecting market manipulation practices. Such provisions may include requirements concerning transparency of transactions concluded, total disclosure of price-regularisation agreements, a fair system of order pairing, introduction of an effective atypical-order detection scheme, sufficiently robust financial instrument reference price-fixing schemes and clarity of rules on the suspension of transactions. (28) This Directive should be interpreted, and implemented by Member States, in a manner consistent with the requirements for effective regulation in order to protect the interests of holders of transferable securities carrying voting rights in a company (or which may carry such rights as a consequence of the exercise of rights or conversion) when the company is subject to a public take-over bid or other proposed change of control. In particular, this Directive does not in any way prevent a Member State from putting or having in place such measures as it sees fit for these purposes. (29) Having access to inside information relating to another company and using it in the context of a public take-over bid for the purpose of gaining control of that company or proposing a merger with that company should not in itself be deemed to constitute insider dealing. (30) Since the acquisition or disposal of financial instruments necessarily involves a prior decision to acquire or dispose taken by the person who undertakes one or other of these operations, the carrying out of this acquisition or disposal should not be deemed in itself to constitute the use of inside information. (31) Research and estimates developed from publicly available data should not be regarded as inside information and, therefore, any transaction carried out on the basis of such research or estimates should not be deemed in itself to constitute insider dealing within the meaning of this Directive. (32) Member States and the European System of Central Banks, national central banks or any other officially designated body, or any person acting on their behalf, should not be restricted in carrying out monetary, exchange-rate or public debt management policy. (33) Stabilisation of financial instruments or trading in own shares in buy-back programmes can be legitimate, in certain circumstances, for economic reasons and should not, therefore, in themselves be regarded as market abuse. Common standards should be developed to provide practical guidance. (34) The widening scope of financial markets, the rapid change and the range of new products and developments require a wide application of this Directive to financial instruments and techniques involved, in order to guarantee the integrity of Community financial markets. (35) Establishing a level playing field in Community financial markets requires wide geographical application of the provisions covered by this Directive. As regards derivative instruments not admitted to trading but falling within the scope of this Directive, each Member State should be competent to sanction actions carried out on its territory or abroad which concern underlying financial instruments admitted to trading on a regulated market situated or operating within its territory or for which a request for admission to trading on such a regulated market has been made. Each Member State should also be competent to sanction actions carried out on its territory which concern underlying financial instruments admitted to trading on a regulated market in a Member State or for which a request for admission to trading on such a market has been made. (36) A variety of competent authorities in Member States, having different responsibilities, may create confusion among economic actors. A single competent authority should be designated in each Member State to assume at least final responsibility for supervising compliance with the provisions adopted pursuant to this Directive, as well as international collaboration. Such an authority should be of an administrative nature guaranteeing its independence of economic actors and avoiding conflicts of interest. In accordance with national law, Member States should ensure appropriate financing of the competent authority. That authority should have adequate arrangements for consultation concerning possible changes in national legislation such as a consultative committee composed of representatives of issuers, financial services providers and consumers, so as to be fully informed of their views and concerns. (37) A common minimum set of effective tools and powers for the competent authority of each Member State will guarantee supervisory effectiveness. Market undertakings and all economic actors should also contribute at their level to market integrity. In this sense, the designation of a single competent authority for market abuse does not exclude collaboration links or delegation under the responsibility of the competent authority, between that authority and market undertakings with a view to guaranteeing efficient supervision of compliance with the provisions adopted pursuant to this Directive. (38) In order to ensure that a Community framework against market abuse is sufficient, any infringement of the prohibitions or requirements laid down pursuant to this Directive will have to be promptly detected and sanctioned. To this end, sanctions should be sufficiently dissuasive and proportionate to the gravity of the infringement and to the gains realised and should be consistently applied. (39) Member States should remain alert, in determining the administrative measures and sanctions, to the need to ensure a degree of uniformity of regulation from one Member State to another. (40) Increasing cross-border activities require improved cooperation and a comprehensive set of provisions for the exchange of information between national competent authorities. The organisation of supervision and of investigatory powers in each Member State should not hinder cooperation between the competent national authorities. (41) Since the objective of the proposed action, namely to prevent market abuse in the form of insider dealing and market manipulation, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the measures, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (42) Technical guidance and implementing measures for the rules laid down in this Directive may from time to time be necessary to take account of new developments on financial markets. The Commission should accordingly be empowered to adopt implementing measures, provided that these do not modify the essential elements of this Directive and the Commission acts according to the principles set out in this Directive, after consulting the European Securities Committee established by Commission Decision 2001/528/EC(8). (43) In exercising its implementing powers in accordance with this Directive, the Commission should respect the following principles: - the need to ensure confidence in financial markets among investors by promoting high standards of transparency in financial markets, - the need to provide investors with a wide range of competing investments and a level of disclosure and protection tailored to their circumstances, - the need to ensure that independent regulatory authorities enforce the rules consistently, especially as regards the fight against economic crime, - the need for high levels of transparency and consultation with all market participants and with the European Parliament and the Council, - the need to encourage innovation in financial markets if they are to be dynamic and efficient, - the need to ensure market integrity by close and reactive monitoring of financial innovation, - the importance of reducing the cost of, and increasing access to, capital, - the balance of costs and benefits to market participants on a long-term basis (including small and medium-sized businesses and small investors) in any implementing measures, - the need to foster the international competitiveness of EU financial markets without prejudice to a much-needed extension of international cooperation, - the need to achieve a level playing field for all market participants by establishing EU-wide regulations every time it is appropriate, - the need to respect differences in national markets where these do not unduly impinge on the coherence of the single market, - the need to ensure coherence with other Community legislation in this area, as imbalances in information and a lack of transparency may jeopardise the operation of the markets and above all harm consumers and small investors. (44) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and in particular by Article 11 thereof and Article 10 of the European Convention on Human Rights. In this regard, this Directive does not in any way prevent Member States from applying their constitutional rules relating to freedom of the press and freedom of expression in the media, Article 1 For the purposes of this Directive: 1. "Inside information" shall mean information of a precise nature which has not been made public, relating, directly or indirectly, to one or more issuers of financial instruments or to one or more financial instruments and which, if it were made public, would be likely to have a significant effect on the prices of those financial instruments or on the price of related derivative financial instruments. In relation to derivatives on commodities, "inside information" shall mean information of a precise nature which has not been made public, relating, directly or indirectly, to one or more such derivatives and which users of markets on which such derivatives are traded would expect to receive in accordance with accepted market practices on those markets. For persons charged with the execution of orders concerning financial instruments, "inside information" shall also mean information conveyed by a client and related to the client's pending orders, which is of a precise nature, which relates directly or indirectly to one or more issuers of financial instruments or to one or more financial instruments, and which, if it were made public, would be likely to have a significant effect on the prices of those financial instruments or on the price of related derivative financial instruments. 2. "Market manipulation" shall mean: (a) transactions or orders to trade: - which give, or are likely to give, false or misleading signals as to the supply of, demand for or price of financial instruments, or - which secure, by a person, or persons acting in collaboration, the price of one or several financial instruments at an abnormal or artificial level, unless the person who entered into the transactions or issued the orders to trade establishes that his reasons for so doing are legitimate and that these transactions or orders to trade conform to accepted market practices on the regulated market concerned; (b) transactions or orders to trade which employ fictitious devices or any other form of deception or contrivance; (c) dissemination of information through the media, including the Internet, or by any other means, which gives, or is likely to give, false or misleading signals as to financial instruments, including the dissemination of rumours and false or misleading news, where the person who made the dissemination knew, or ought to have known, that the information was false or misleading. In respect of journalists when they act in their professional capacity such dissemination of information is to be assessed, without prejudice to Article 11, taking into account the rules governing their profession, unless those persons derive, directly or indirectly, an advantage or profits from the dissemination of the information in question. In particular, the following instances are derived from the core definition given in points (a), (b) and (c) above: - conduct by a person, or persons acting in collaboration, to secure a dominant position over the supply of or demand for a financial instrument which has the effect of fixing, directly or indirectly, purchase or sale prices or creating other unfair trading conditions, - the buying or selling of financial instruments at the close of the market with the effect of misleading investors acting on the basis of closing prices, - taking advantage of occasional or regular access to the traditional or electronic media by voicing an opinion about a financial instrument (or indirectly about its issuer) while having previously taken positions on that financial instrument and profiting subsequently from the impact of the opinions voiced on the price of that instrument, without having simultaneously disclosed that conflict of interest to the public in a proper and effective way. The definitions of market manipulation shall be adapted so as to ensure that new patterns of activity that in practice constitute market manipulation can be included. 3. "Financial instrument" shall mean: - transferable securities as defined in Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field(9), - units in collective investment undertakings, - money-market instruments, - financial-futures contracts, including equivalent cash-settled instruments, - forward interest-rate agreements, - interest-rate, currency and equity swaps, - options to acquire or dispose of any instrument falling into these categories, including equivalent cash-settled instruments. This category includes in particular options on currency and on interest rates, - derivatives on commodities, - any other instrument admitted to trading on a regulated market in a Member State or for which a request for admission to trading on such a market has been made. 4. "Regulated market" shall mean a market as defined by Article 1(13) of Directive 93/22/EEC. 5. "Accepted market practices" shall mean practices that are reasonably expected in one or more financial markets and are accepted by the competent authority in accordance with guidelines adopted by the Commission in accordance with the procedure laid down in Article 17(2). 6. "Person" shall mean any natural or legal person. 7. "Competent authority" shall mean the competent authority designated in accordance with Article 11. In order to take account of developments on financial markets and to ensure uniform application of this Directive in the Community, the Commission, acting in accordance with the procedure laid down in Article 17(2), shall adopt implementing measures concerning points 1, 2 and 3 of this Article. Article 2 1. Member States shall prohibit any person referred to in the second subparagraph who possesses inside information from using that information by acquiring or disposing of, or by trying to acquire or dispose of, for his own account or for the account of a third party, either directly or indirectly, financial instruments to which that information relates. The first subparagraph shall apply to any person who possesses that information: (a) by virtue of his membership of the administrative, management or supervisory bodies of the issuer; or (b) by virtue of his holding in the capital of the issuer; or (c) by virtue of his having access to the information through the exercise of his employment, profession or duties; or (d) by virtue of his criminal activities. 2. Where the person referred to in paragraph 1 is a legal person, the prohibition laid down in that paragraph shall also apply to the natural persons who take part in the decision to carry out the transaction for the account of the legal person concerned. 3. This Article shall not apply to transactions conducted in the discharge of an obligation that has become due to acquire or dispose of financial instruments where that obligation results from an agreement concluded before the person concerned possessed inside information. Article 3 Member States shall prohibit any person subject to the prohibition laid down in Article 2 from: (a) disclosing inside information to any other person unless such disclosure is made in the normal course of the exercise of his employment, profession or duties; (b) recommending or inducing another person, on the basis of inside information, to acquire or dispose of financial instruments to which that information relates. Article 4 Member States shall ensure that Articles 2 and 3 also apply to any person, other than the persons referred to in those Articles, who possesses inside information while that person knows, or ought to have known, that it is inside information. Article 5 Member States shall prohibit any person from engaging in market manipulation. Article 6 1. Member States shall ensure that issuers of financial instruments inform the public as soon as possible of inside information which directly concerns the said issuers. Without prejudice to any measures taken to comply with the provisions of the first subparagraph, Member States shall ensure that issuers, for an appropriate period, post on their Internet sites all inside information that they are required to disclose publicly. 2. An issuer may under his own responsibility delay the public disclosure of inside information, as referred to in paragraph 1, such as not to prejudice his legitimate interests provided that such omission would not be likely to mislead the public and provided that the issuer is able to ensure the confidentiality of that information. Member States may require that an issuer shall without delay inform the competent authority of the decision to delay the public disclosure of inside information. 3. Member States shall require that, whenever an issuer, or a person acting on his behalf or for his account, discloses any inside information to any third party in the normal exercise of his employment, profession or duties, as referred to in Article 3(a), he must make complete and effective public disclosure of that information, simultaneously in the case of an intentional disclosure and promptly in the case of a non-intentional disclosure. The provisions of the first subparagraph shall not apply if the person receiving the information owes a duty of confidentiality, regardless of whether such duty is based on a law, on regulations, on articles of association or on a contract. Member States shall require that issuers, or persons acting on their behalf or for their account, draw up a list of those persons working for them, under a contract of employment or otherwise, who have access to inside information. Issuers and persons acting on their behalf or for their account shall regularly update this list and transmit it to the competent authority whenever the latter requests it. 4. Persons discharging managerial responsibilities within an issuer of financial instruments and, where applicable, persons closely associated with them, shall, at least, notify to the competent authority the existence of transactions conducted on their own account relating to shares of the said issuer, or to derivatives or other financial instruments linked to them. Member States shall ensure that public access to information concerning such transactions, on at least an individual basis, is readily available as soon as possible. 5. Member States shall ensure that there is appropriate regulation in place to ensure that persons who produce or disseminate research concerning financial instruments or issuers of financial instruments and persons who produce or disseminate other information recommending or suggesting investment strategy, intended for distribution channels or for the public, take reasonable care to ensure that such information is fairly presented and disclose their interests or indicate conflicts of interest concerning the financial instruments to which that information relates. Details of such regulation shall be notified to the Commission. 6. Member States shall ensure that market operators adopt structural provisions aimed at preventing and detecting market manipulation practices. 7. With a view to ensuring compliance with paragraphs 1 to 5, the competent authority may take all necessary measures to ensure that the public is correctly informed. 8. Public institutions disseminating statistics liable to have a significant effect on financial markets shall disseminate them in a fair and transparent way. 9. Member States shall require that any person professionally arranging transactions in financial instruments who reasonably suspects that a transaction might constitute insider dealing or market manipulation shall notify the competent authority without delay. 10. In order to take account of technical developments on financial markets and to ensure uniform application of this Directive, the Commission shall adopt, in accordance with the procedure referred to in Article 17(2), implementing measures concerning: - the technical modalities for appropriate public disclosure of inside information as referred to in paragraphs 1 and 3, - the technical modalities for delaying the public disclosure of inside information as referred to in paragraph 2, - the technical modalities designed to favour a common approach in the implementation of the second sentence of paragraph 2, - the conditions under which issuers, or entities acting on their behalf, are to draw up a list of those persons working for them and having access to inside information, as referred to in paragraph 3, together with the conditions under which such lists are to be updated, - the categories of persons who are subject to a duty of disclosure as referred to in paragraph 4 and the characteristics of a transaction, including its size, which trigger that duty, and the technical arrangements for disclosure to the competent authority, - technical arrangements, for the various categories of person referred to in paragraph 5, for fair presentation of research and other information recommending investment strategy and for disclosure of particular interests or conflicts of interest as referred to in paragraph 5. Such arrangements shall take into account the rules, including self-regulation, governing the profession of journalist, - technical arrangements governing notification to the competent authority by the persons referred to in paragraph 9. Article 7 This Directive shall not apply to transactions carried out in pursuit of monetary, exchange-rate or public debt-management policy by a Member State, by the European System of Central Banks, by a national central bank or by any other officially designated body, or by any person acting on their behalf. Member States may extend this exemption to their federated States or similar local authorities in respect of the management of their public debt. Article 8 The prohibitions provided for in this Directive shall not apply to trading in own shares in "buy-back" programmes or to the stabilisation of a financial instrument provided such trading is carried out in accordance with implementing measures adopted in accordance with the procedure laid down in Article 17(2). Article 9 This Directive shall apply to any financial instrument admitted to trading on a regulated market in at least one Member State, or for which a request for admission to trading on such a market has been made, irrespective of whether or not the transaction itself actually takes place on that market. Articles 2, 3 and 4 shall also apply to any financial instrument not admitted to trading on a regulated market in a Member State, but whose value depends on a financial instrument as referred to in paragraph 1. Article 6(1) to (3) shall not apply to issuers who have not requested or approved admission of their financial instruments to trading on a regulated market in a Member State. Article 10 Each Member State shall apply the prohibitions and requirements provided for in this Directive to: (a) actions carried out on its territory or abroad concerning financial instruments that are admitted to trading on a regulated market situated or operating within its territory or for which a request for admission to trading on such market has been made; (b) actions carried out on its territory concerning financial instruments that are admitted to trading on a regulated market in a Member State or for which a request for admission to trading on such market has been made. Article 11 Without prejudice to the competences of the judicial authorities, each Member State shall designate a single administrative authority competent to ensure that the provisions adopted pursuant to this Directive are applied. Member States shall establish effective consultative arrangements and procedures with market participants concerning possible changes in national legislation. These arrangements may include consultative committees within each competent authority, the membership of which should reflect as far as possible the diversity of market participants, be they issuers, providers of financial services or consumers. Article 12 1. The competent authority shall be given all supervisory and investigatory powers that are necessary for the exercise of its functions. It shall exercise such powers: (a) directly; or (b) in collaboration with other authorities or with the market undertakings; or (c) under its responsibility by delegation to such authorities or to the market undertakings; or (d) by application to the competent judicial authorities. 2. Without prejudice to Article 6(7), the powers referred to in paragraph 1 of this Article shall be exercised in conformity with national law and shall include at least the right to: (a) have access to any document in any form whatsoever, and to receive a copy of it; (b) demand information from any person, including those who are successively involved in the transmission of orders or conduct of the operations concerned, as well as their principals, and if necessary, to summon and hear any such person; (c) carry out on-site inspections; (d) require existing telephone and existing data traffic records; (e) require the cessation of any practice that is contrary to the provisions adopted in the implementation of this Directive; (f) suspend trading of the financial instruments concerned; (g) request the freezing and/or sequestration of assets; (h) request temporary prohibition of professional activity. 3. This Article shall be without prejudice to national legal provisions on professional secrecy. Article 13 The obligation of professional secrecy shall apply to all persons who work or who have worked for the competent authority or for any authority or market undertaking to whom the competent authority has delegated its powers, including auditors and experts instructed by the competent authority. Information covered by professional secrecy may not be disclosed to any other person or authority except by virtue of provisions laid down by law. Article 14 1. Without prejudice to the right of Member States to impose criminal sanctions, Member States shall ensure, in conformity with their national law, that the appropriate administrative measures can be taken or administrative sanctions be imposed against the persons responsible where the provisions adopted in the implementation of this Directive have not been complied with. Member States shall ensure that these measures are effective, proportionate and dissuasive. 2. In accordance with the procedure laid down in Article 17(2), the Commission shall, for information, draw up a list of the administrative measures and sanctions referred to in paragraph 1. 3. Member States shall determine the sanctions to be applied for failure to cooperate in an investigation covered by Article 12. 4. Member States shall provide that the competent authority may disclose to the public every measure or sanction that will be imposed for infringement of the provisions adopted in the implementation of this Directive, unless such disclosure would seriously jeopardise the financial markets or cause disproportionate damage to the parties involved. Article 15 Member States shall ensure that an appeal may be brought before a court against the decisions taken by the competent authority. Article 16 1. Competent authorities shall cooperate with each other whenever necessary for the purpose of carrying out their duties, making use of their powers whether set out in this Directive or in national law. Competent authorities shall render assistance to competent authorities of other Member States. In particular, they shall exchange information and cooperate in investigation activities. 2. Competent authorities shall, on request, immediately supply any information required for the purpose referred to in paragraph 1. Where necessary, the competent authorities receiving any such request shall immediately take the necessary measures in order to gather the required information. If the requested competent authority is not able to supply the required information immediately, it shall notify the requesting competent authority of the reasons. Information thus supplied shall be covered by the obligation of professional secrecy to which the persons employed or formerly employed by the competent authorities receiving the information are subject. The competent authorities may refuse to act on a request for information where: - communication might adversely affect the sovereignty, security or public policy of the Member State addressed, - judicial proceedings have already been initiated in respect of the same actions and against the same persons before the authorities of the Member State addressed, or - where a final judgment has already been delivered in relation to such persons for the same actions in the Member State addressed. In any such case, they shall notify the requesting competent authority accordingly, providing as detailed information as possible on those proceedings or the judgment. Without prejudice to Article 226 of the Treaty, a competent authority whose request for information is not acted upon within a reasonable time or whose request for information is rejected may bring that non-compliance to the attention of the Committee of European Securities Regulators, where discussion will take place in order to reach a rapid and effective solution. Without prejudice to the obligations to which they are subject in judicial proceedings under criminal law, the competent authorities which receive information pursuant to paragraph 1 may use it only for the exercise of their functions within the scope of this Directive and in the context of administrative or judicial proceedings specifically related to the exercise of those functions. However, where the competent authority communicating information consents thereto, the authority receiving the information may use it for other purposes or forward it to other States' competent authorities. 3. Where a competent authority is convinced that acts contrary to the provisions of this Directive are being, or have been, carried out on the territory of another Member State or that acts are affecting financial instruments traded on a regulated market situated in another Member State, it shall give notice of that fact in as specific a manner as possible to the competent authority of the other Member State. The competent authority of the other Member State shall take appropriate action. It shall inform the notifying competent authority of the outcome and, so far as possible, of significant interim developments. This paragraph shall not prejudice the competences of the competent authority that has forwarded the information. The competent authorities of the various Member States that are competent for the purposes of Article 10 shall consult each other on the proposed follow-up to their action. 4. A competent authority of one Member State may request that an investigation be carried out by the competent authority of another Member State, on the latter's territory. It may further request that members of its own personnel be allowed to accompany the personnel of the competent authority of that other Member State during the course of the investigation. The investigation shall, however, be subject throughout to the overall control of the Member State on whose territory it is conducted. The competent authorities may refuse to act on a request for an investigation to be conducted as provided for in the first subparagraph, or on a request for its personnel to be accompanied by personnel of the competent authority of another Member State as provided for in the second subparagraph, where such an investigation might adversely affect the sovereignty, security or public policy of the State addressed, or where judicial proceedings have already been initiated in respect of the same actions and against the same persons before the authorities of the State addressed or where a final judgment has already been delivered in relation to such persons for the same actions in the State addressed. In such case, they shall notify the requesting competent authority accordingly, providing information, as detailed as possible, on those proceedings or judgment. Without prejudice to the provisions of Article 226 of the Treaty, a competent authority whose application to open an inquiry or whose request for authorisation for its officials to accompany those of the other Member State's competent authority is not acted upon within a reasonable time or is rejected may bring that non-compliance to the attention of the Committee of European Securities Regulators, where discussion will take place in order to reach a rapid and effective solution. 5. In accordance with the procedure laid down in Article 17(2), the Commission shall adopt implementing measures on the procedures for exchange of information and cross-border inspections as referred to in this Article. Article 17 1. The Commission shall be assisted by the European Securities Committee instituted by Decision 2001/528/EC (hereinafter referred to as the "Committee"). 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof, provided that the implementing measures adopted according to this procedure do not modify the essential provisions of this Directive. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure. 4. Without prejudice to the implementing measures already adopted, on the expiry of a four-year period following the entry into force of this Directive, the application of its provisions requiring the adoption of technical rules and decisions in accordance with paragraph 2 shall be suspended. On a proposal from the Commission, the European Parliament and the Council may renew the provisions concerned in accordance with the procedure laid down in Article 251 of the Treaty and, to that end, they shall review them prior to the expiry of the period referred to above. Article 18 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 12 October 2004. They shall forthwith inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 19 Article 11 shall not prejudge the possibility for a Member State to make separate legal and administrative arrangements for overseas European territories for whose external relations that Member State is responsible. Article 20 Directive 89/592/EEC and Article 68(1) and Article 81(1) of Directive 2001/34/EC of the European Parliament and of the Council of 28 May 2001 on the admission of securities to official stock exchange listing and on information to be published on those securities(10) shall be repealed with effect from the date of entry into force of this Directive. Article 21 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 22 This Directive is addressed to the Member States.

32003L0004

2003

Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Having regard to the opinion of the Committee of the Regions(3), Acting in accordance with the procedure laid down in Article 251 of the Treaty(4) in the light of the joint text approved by the Conciliation Committee on 8 November 2002, Whereas: (1) Increased public access to environmental information and the dissemination of such information contribute to a greater awareness of environmental matters, a free exchange of views, more effective participation by the public in environmental decision-making and, eventually, to a better environment. (2) Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment(5) initiated a process of change in the manner in which public authorities approach the issue of openness and transparency, establishing measures for the exercise of the right of public access to environmental information which should be developed and continued. This Directive expands the existing access granted under Directive 90/313/EEC. (3) Article 8 of that Directive requires Member States to report to the Commission on the experience gained, in the light of which the Commission is required to make a report to the European Parliament and to the Council together with any proposal for revision of the Directive which it may consider appropriate. (4) The report produced under Article 8 of that Directive identifies concrete problems encountered in the practical application of the Directive. (5) On 25 June 1998 the European Community signed the UN/ECE Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters ("the Aarhus Convention"). Provisions of Community law must be consistent with that Convention with a view to its conclusion by the European Community. (6) It is appropriate in the interest of increased transparency to replace Directive 90/313/EEC rather than to amend it, so as to provide interested parties with a single, clear and coherent legislative text. (7) Disparities between the laws in force in the Member States concerning access to environmental information held by public authorities can create inequality within the Community as regards access to such information or as regards conditions of competition. (8) It is necessary to ensure that any natural and legal person has a right of access to environmental information held by or for public authorities without his having to state an interest. (9) It is also necessary that public authorities make available and disseminate environmental information to the general public to the widest extent possible, in particular by using information and communication technologies. The future development of these technologies should be taken into account in the reporting on, and reviewing of, this Directive. (10) The definition of environmental information should be clarified so as to encompass information in any form on the state of the environment, on factors, measures or activities affecting or likely to affect the environment or designed to protect it, on cost-benefit and economic analyses used within the framework of such measures or activities and also information on the state of human health and safety, including the contamination of the food chain, conditions of human life, cultural sites and built structures in as much as they are, or may be, affected by any of those matters. (11) To take account of the principle in Article 6 of the Treaty, that environmental protection requirements should be integrated into the definition and implementation of Community policies and activities, the definition of public authorities should be expanded so as to encompass government or other public administration at national, regional or local level whether or not they have specific responsibilities for the environment. The definition should likewise be expanded to include other persons or bodies performing public administrative functions in relation to the environment under national law, as well as other persons or bodies acting under their control and having public responsibilities or functions in relation to the environment. (12) Environmental information which is physically held by other bodies on behalf of public authorities should also fall within the scope of this Directive. (13) Environmental information should be made available to applicants as soon as possible and within a reasonable time and having regard to any timescale specified by the applicant. (14) Public authorities should make environmental information available in the form or format requested by an applicant unless it is already publicly available in another form or format or it is reasonable to make it available in another form or format. In addition, public authorities should be required to make all reasonable efforts to maintain the environmental information held by or for them in forms or formats that are readily reproducible and accessible by electronic means. (15) Member States should determine the practical arrangements under which such information is effectively made available. These arrangements shall guarantee that the information is effectively and easily accessible and progressively becomes available to the public through public telecommunications networks, including publicly accessible lists of public authorities and registers or lists of environmental information held by or for public authorities. (16) The right to information means that the disclosure of information should be the general rule and that public authorities should be permitted to refuse a request for environmental information in specific and clearly defined cases. Grounds for refusal should be interpreted in a restrictive way, whereby the public interest served by disclosure should be weighed against the interest served by the refusal. The reasons for a refusal should be provided to the applicant within the time limit laid down in this Directive. (17) Public authorities should make environmental information available in part where it is possible to separate out any information falling within the scope of the exceptions from the rest of the information requested. (18) Public authorities should be able to make a charge for supplying environmental information but such a charge should be reasonable. This implies that, as a general rule, charges may not exceed actual costs of producing the material in question. Instances where advance payment will be required should be limited. In particular cases, where public authorities make available environmental information on a commercial basis, and where this is necessary in order to guarantee the continuation of collecting and publishing such information, a market-based charge is considered to be reasonable; an advance payment may be required. A schedule of charges should be published and made available to applicants together with information on the circumstances in which a charge may be levied or waived. (19) Applicants should be able to seek an administrative or judicial review of the acts or omissions of a public authority in relation to a request. (20) Public authorities should seek to guarantee that when environmental information is compiled by them or on their behalf, the information is comprehensible, accurate and comparable. As this is an important factor in assessing the quality of the information supplied the method used in compiling the information should also be disclosed upon request. (21) In order to increase public awareness in environmental matters and to improve environmental protection, public authorities should, as appropriate, make available and disseminate information on the environment which is relevant to their functions, in particular by means of computer telecommunication and/or electronic technology, where available. (22) This Directive should be evaluated every four years, after its entry into force, in the light of experience and after submission of the relevant reports by the Member States, and be subject to revision on that basis. The Commission should submit an evaluation report to the European Parliament and the Council. (23) Since the objectives of the proposed Directive cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (24) The provisions of this Directive shall not affect the right of a Member State to maintain or introduce measures providing for broader access to information than required by this Directive, Article 1 Objectives The objectives of this Directive are: (a) to guarantee the right of access to environmental information held by or for public authorities and to set out the basic terms and conditions of, and practical arrangements for, its exercise; and (b) to ensure that, as a matter of course, environmental information is progressively made available and disseminated to the public in order to achieve the widest possible systematic availability and dissemination to the public of environmental information. To this end the use, in particular, of computer telecommunication and/or electronic technology, where available, shall be promoted. Article 2 Definitions For the purposes of this Directive: 1. "Environmental information" shall mean any information in written, visual, aural, electronic or any other material form on: (a) the state of the elements of the environment, such as air and atmosphere, water, soil, land, landscape and natural sites including wetlands, coastal and marine areas, biological diversity and its components, including genetically modified organisms, and the interaction among these elements; (b) factors, such as substances, energy, noise, radiation or waste, including radioactive waste, emissions, discharges and other releases into the environment, affecting or likely to affect the elements of the environment referred to in (a); (c) measures (including administrative measures), such as policies, legislation, plans, programmes, environmental agreements, and activities affecting or likely to affect the elements and factors referred to in (a) and (b) as well as measures or activities designed to protect those elements; (d) reports on the implementation of environmental legislation; (e) cost-benefit and other economic analyses and assumptions used within the framework of the measures and activities referred to in (c); and (f) the state of human health and safety, including the contamination of the food chain, where relevant, conditions of human life, cultural sites and built structures inasmuch as they are or may be affected by the state of the elements of the environment referred to in (a) or, through those elements, by any of the matters referred to in (b) and (c). 2. "Public authority" shall mean: (a) government or other public administration, including public advisory bodies, at national, regional or local level; (b) any natural or legal person performing public administrative functions under national law, including specific duties, activities or services in relation to the environment; and (c) any natural or legal person having public responsibilities or functions, or providing public services, relating to the environment under the control of a body or person falling within (a) or (b). Member States may provide that this definition shall not include bodies or institutions when acting in a judicial or legislative capacity. If their constitutional provisions at the date of adoption of this Directive make no provision for a review procedure within the meaning of Article 6, Member States may exclude those bodies or institutions from that definition. 3. "Information held by a public authority" shall mean environmental information in its possession which has been produced or received by that authority. 4. "Information held for a public authority" shall mean environmental information which is physically held by a natural or legal person on behalf of a public authority. 5. "Applicant" shall mean any natural or legal person requesting environmental information. 6. "Public" shall mean one or more natural or legal persons, and, in accordance with national legislation or practice, their associations, organisations or groups. Article 3 Access to environmental information upon request 1. Member States shall ensure that public authorities are required, in accordance with the provisions of this Directive, to make available environmental information held by or for them to any applicant at his request and without his having to state an interest. 2. Subject to Article 4 and having regard to any timescale specified by the applicant, environmental information shall be made available to an applicant: (a) as soon as possible or, at the latest, within one month after the receipt by the public authority referred to in paragraph 1 of the applicant's request; or (b) within two months after the receipt of the request by the public authority if the volume and the complexity of the information is such that the one-month period referred to in (a) cannot be complied with. In such cases, the applicant shall be informed as soon as possible, and in any case before the end of that one-month period, of any such extension and of the reasons for it. 3. If a request is formulated in too general a manner, the public authority shall as soon as possible, and at the latest within the timeframe laid down in paragraph 2(a), ask the applicant to specify the request and shall assist the applicant in doing so, e.g. by providing information on the use of the public registers referred to in paragraph 5(c). The public authorities may, where they deem it appropriate, refuse the request under Article 4(1)(c). 4. Where an applicant requests a public authority to make environmental information available in a specific form or format (including in the form of copies), the public authority shall make it so available unless: (a) it is already publicly available in another form or format, in particular under Article 7, which is easily accessible by applicants; or (b) it is reasonable for the public authority to make it available in another form or format, in which case reasons shall be given for making it available in that form or format. For the purposes of this paragraph, public authorities shall make all reasonable efforts to maintain environmental information held by or for them in forms or formats that are readily reproducible and accessible by computer telecommunications or by other electronic means. The reasons for a refusal to make information available, in full or in part, in the form or format requested shall be provided to the applicant within the time limit referred to in paragraph 2(a). 5. For the purposes of this Article, Member States shall ensure that: (a) officials are required to support the public in seeking access to information; (b) lists of public authorities are publicly accessible; and (c) the practical arrangements are defined for ensuring that the right of access to environmental information can be effectively exercised, such as: - the designation of information officers; - the establishment and maintenance of facilities for the examination of the information required, - registers or lists of the environmental information held by public authorities or information points, with clear indications of where such information can be found. Member States shall ensure that public authorities inform the public adequately of the rights they enjoy as a result of this Directive and to an appropriate extent provide information, guidance and advice to this end. Article 4 Exceptions 1. Member States may provide for a request for environmental information to be refused if: (a) the information requested is not held by or for the public authority to which the request is addressed. In such a case, where that public authority is aware that the information is held by or for another public authority, it shall, as soon as possible, transfer the request to that other authority and inform the applicant accordingly or inform the applicant of the public authority to which it believes it is possible to apply for the information requested; (b) the request is manifestly unreasonable; (c) the request is formulated in too general a manner, taking into account Article 3(3); (d) the request concerns material in the course of completion or unfinished documents or data; (e) the request concerns internal communications, taking into account the public interest served by disclosure. Where a request is refused on the basis that it concerns material in the course of completion, the public authority shall state the name of the authority preparing the material and the estimated time needed for completion. 2. Member States may provide for a request for environmental information to be refused if disclosure of the information would adversely affect: (a) the confidentiality of the proceedings of public authorities, where such confidentiality is provided for by law; (b) international relations, public security or national defence; (c) the course of justice, the ability of any person to receive a fair trial or the ability of a public authority to conduct an enquiry of a criminal or disciplinary nature; (d) the confidentiality of commercial or industrial information where such confidentiality is provided for by national or Community law to protect a legitimate economic interest, including the public interest in maintaining statistical confidentiality and tax secrecy; (e) intellectual property rights; (f) the confidentiality of personal data and/or files relating to a natural person where that person has not consented to the disclosure of the information to the public, where such confidentiality is provided for by national or Community law; (g) the interests or protection of any person who supplied the information requested on a voluntary basis without being under, or capable of being put under, a legal obligation to do so, unless that person has consented to the release of the information concerned; (h) the protection of the environment to which such information relates, such as the location of rare species. The grounds for refusal mentioned in paragraphs 1 and 2 shall be interpreted in a restrictive way, taking into account for the particular case the public interest served by disclosure. In every particular case, the public interest served by disclosure shall be weighed against the interest served by the refusal. Member States may not, by virtue of paragraph 2(a), (d), (f), (g) and (h), provide for a request to be refused where the request relates to information on emissions into the environment. Within this framework, and for the purposes of the application of subparagraph (f), Member States shall ensure that the requirements of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data are complied with(6). 3. Where a Member State provides for exceptions, it may draw up a publicly accessible list of criteria on the basis of which the authority concerned may decide how to handle requests. 4. Environmental information held by or for public authorities which has been requested by an applicant shall be made available in part where it is possible to separate out any information falling within the scope of paragraphs 1(d) and (e) or 2 from the rest of the information requested. 5. A refusal to make available all or part of the information requested shall be notified to the applicant in writing or electronically, if the request was in writing or if the applicant so requests, within the time limits referred to in Article 3(2)(a) or, as the case may be, (b). The notification shall state the reasons for the refusal and include information on the review procedure provided for in accordance with Article 6. Article 5 Charges 1. Access to any public registers or lists established and maintained as mentioned in Article 3(5) and examination in situ of the information requested shall be free of charge. 2. Public authorities may make a charge for supplying any environmental information but such charge shall not exceed a reasonable amount. 3. Where charges are made, public authorities shall publish and make available to applicants a schedule of such charges as well as information on the circumstances in which a charge may be levied or waived. Article 6 Access to justice 1. Member States shall ensure that any applicant who considers that his request for information has been ignored, wrongfully refused (whether in full or in part), inadequately answered or otherwise not dealt with in accordance with the provisions of Articles 3, 4 or 5, has access to a procedure in which the acts or omissions of the public authority concerned can be reconsidered by that or another public authority or reviewed administratively by an independent and impartial body established by law. Any such procedure shall be expeditious and either free of charge or inexpensive. 2. In addition to the review procedure referred to in paragraph 1, Member States shall ensure that an applicant has access to a review procedure before a court of law or another independent and impartial body established by law, in which the acts or omissions of the public authority concerned can be reviewed and whose decisions may become final. Member States may furthermore provide that third parties incriminated by the disclosure of information may also have access to legal recourse. 3. Final decisions under paragraph 2 shall be binding on the public authority holding the information. Reasons shall be stated in writing, at least where access to information is refused under this Article. Article 7 Dissemination of environmental information 1. Member States shall take the necessary measures to ensure that public authorities organise the environmental information which is relevant to their functions and which is held by or for them, with a view to its active and systematic dissemination to the public, in particular by means of computer telecommunication and/or electronic technology, where available. The information made available by means of computer telecommunication and/or electronic technology need not include information collected before the entry into force of this Directive unless it is already available in electronic form. Member States shall ensure that environmental information progressively becomes available in electronic databases which are easily accessible to the public through public telecommunication networks. 2. The information to be made available and disseminated shall be updated as appropriate and shall include at least: (a) texts of international treaties, conventions or agreements, and of Community, national, regional or local legislation, on the environment or relating to it; (b) policies, plans and programmes relating to the environment; (c) progress reports on the implementation of the items referred to in (a) and (b) when prepared or held in electronic form by public authorities; (d) the reports on the state of the environment referred to in paragraph 3; (e) data or summaries of data derived from the monitoring of activities affecting, or likely to affect, the environment; (f) authorisations with a significant impact on the environment and environmental agreements or a reference to the place where such information can be requested or found in the framework of Article 3; (g) environmental impact studies and risk assessments concerning the environmental elements referred to in Article 2(1)(a) or a reference to the place where the information can be requested or found in the framework of Article 3. 3. Without prejudice to any specific reporting obligations laid down by Community legislation, Member States shall take the necessary measures to ensure that national, and, where appropriate, regional or local reports on the state of the environment are published at regular intervals not exceeding four years; such reports shall include information on the quality of, and pressures on, the environment. 4. Without prejudice to any specific obligation laid down by Community legislation, Member States shall take the necessary measures to ensure that, in the event of an imminent threat to human health or the environment, whether caused by human activities or due to natural causes, all information held by or for public authorities which could enable the public likely to be affected to take measures to prevent or mitigate harm arising from the threat is disseminated, immediately and without delay. 5. The exceptions in Article 4(1) and (2) may apply in relation to the duties imposed by this Article. 6. Member States may satisfy the requirements of this Article by creating links to Internet sites where the information can be found. Article 8 Quality of environmental information 1. Member States shall, so far as is within their power, ensure that any information that is compiled by them or on their behalf is up to date, accurate and comparable. 2. Upon request, public authorities shall reply to requests for information pursuant to Article 2(1)b, reporting to the applicant on the place where information, if available, can be found on the measurement procedures, including methods of analysis, sampling, and pre-treatment of samples, used in compiling the information, or referring to a standardised procedure used. Article 9 Review procedure 1. Not later than 14 February 2009, Member States shall report on the experience gained in the application of this Directive. They shall communicate the report to the Commission not later than 14 August 2009. No later than 14 February 2004, the Commission shall forward to the Member States a guidance document setting out clearly the manner in which it wishes the Member States to report. 2. In the light of experience and taking into account developments in computer telecommunication and/or electronic technology, the Commission shall make a report to the European Parliament and to the Council together with any proposal for revision, which it may consider appropriate. Article 10 Implementation Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 14 February 2005. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 11 Repeal Directive 90/313/EEC is hereby repealed with effect from 14 February 2005. References to the repealed Directive shall be construed as referring to this Directive and shall be read in accordance with the correlation table in the Annex. Article 12 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 13 Addressees This Directive is addressed to the Member States.

32003L0010

2003

Directive 2003/10/EC of the European Parliament and of the Council of 6 February 2003 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (noise) (Seventeenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) Having regard to the Treaty establishing the European Community, and in particular Article 137(2) thereof, Having regard to the proposal from the Commission(1), submitted after consultation with the Advisory Committee on Safety, Hygiene and Health Protection at Work, Having regard to the opinion of the Economic and Social Committee(2), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 8 November 2002, Whereas: (1) Under the Treaty, the Council may adopt, by means of directives, minimum requirements for encouraging improvements, especially in the working environment, to guarantee a better level of protection of the health and safety of workers. Such directives are to avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings. (2) While, in accordance with the Treaty, this Directive does not prevent any Member State from maintaining or introducing more stringent protective measures, its implementation should not serve to justify any regression in relation to the situation which already prevails in each Member State. (3) Council Directive 86/188/EEC of 12 May 1986 on the protection of workers from the risks related to exposure to noise at work(4) made provision for its re-examination by the Council on a proposal from the Commission and with a view to reducing the risks concerned, taking into account in particular progress made in scientific knowledge and technology. (4) The communication from the Commission on its programme concerning safety, hygiene and health at work(5) provides for the adoption of measures to promote safety at work, particularly with a view to extending the scope of Directive 86/188/EEC and the re-evaluation of the threshold values. The Council, in its resolution of 21 December 1987 on safety, hygiene and health at work(6), took note of this. (5) The communication from the Commission concerning its action programme relating to the implementation of the Community Charter of the Fundamental Social Rights of Workers provides for the introduction of minimum health and safety requirements regarding the exposure of workers to the risks caused by physical agents. In September 1990 the European Parliament adopted a resolution concerning this action programme(7), inviting the Commission in particular to draw up a specific directive on the risks caused by noise and vibration and by any other physical agent at the workplace. (6) As a first step, the European Parliament and the Council adopted on 25 June 2002 Directive 2002/44/EC on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (vibration) (sixteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(8). (7) As a second step, it is considered appropriate to introduce measures protecting workers from the risks arising from noise owing to its effects on the health and safety of workers, in particular damage to hearing. These measures are intended not only to ensure the health and safety of each worker on an individual basis, but also to create a minimum basis of protection for all Community workers in order to avoid possible distortions of competition. (8) Current scientific knowledge of the effects which exposure to noise may have on health and safety is not sufficient to enable precise exposure levels covering all risks to health and safety, especially as regards the effects of noise other than those of an auditory nature, to be set. (9) A system of protection against noise must limit itself to a definition, free of excessive detail, of the objectives to be attained, the principles to be observed and the fundamental values to be used, in order to enable Member States to apply the minimum requirements in an equivalent manner. (10) The level of exposure to noise can be more effectively reduced by incorporating preventive measures into the design of work stations and places of work and by selecting work equipment, procedures and methods so as to give priority to reducing the risks at source. Provisions relating to work equipment and methods thus contribute to the protection of the workers involved. In accordance with the general principles of prevention as laid down in Article 6(2) of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(9), collective protection measures have priority over individual protection measures. (11) The Code on noise levels on board ships of the International Maritime Organisation Resolution A 468(12) provides guidance for achieving a reduction of noise at source on board ships. Member States should be entitled to provide for a transitional period with regard to the personnel on board seagoing vessels. (12) In order to correctly assess the exposure of workers to noise it is useful to apply an objective measuring method, and thus references to the generally recognised standard ISO 1999:1990 are made. The assessed or objectively measured values should be decisive for initiating the actions envisaged at the lower and upper exposure action values. Exposure limit values are needed to avoid irreversible damage to workers' hearing; the noise reaching the ear should be kept below the exposure limit values. (13) The particular characteristics of the music and entertainment sectors require practical guidance to allow for an effective application of the provisions laid down by this Directive. Member States should be entitled to make use of a transitional period for the development of a code of conduct providing for practical guidelines which would help workers and employers in those sectors to attain the levels of protection established in this Directive. (14) Employers should make adjustments in the light of technical progress and scientific knowledge regarding risks related to exposure to noise, with a view to improving the health and safety protection of workers. (15) Since this Directive is an individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC, that Directive applies to the exposure of workers to noise, without prejudice to more stringent and/or specific provisions contained in this Directive. (16) This Directive constitutes a practical step towards creating the social dimension of the internal market. (17) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(10), SECTION I GENERAL PROVISIONS Article 1 Aim and scope 1. This Directive, which is the 17th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC, lays down minimum requirements for the protection of workers from risks to their health and safety arising or likely to arise from exposure to noise and in particular the risk to hearing. 2. The requirements of this Directive shall apply to activities in which workers are or are likely to be exposed to risks from noise as a result of their work. 3. Directive 89/391/EEC shall apply fully to the whole area referred to in paragraph 1, without prejudice to more stringent and/or specific provisions contained in this Directive. Article 2 Definitions For the purposes of this Directive, the physical parameters used as risk predictors are defined as follows: (a) peak sound pressure (ppeak): maximum value of the "C"-frequency weighted instantaneous noise pressure; (b) daily noise exposure level (LEX,8h) (dB(A) re. 20 μPa): time-weighted average of the noise exposure levels for a nominal eight-hour working day as defined by international standard ISO 1999: 1990, point 3.6. It covers all noises present at work, including impulsive noise; (c) weekly noise exposure level (LEX,8h ): time-weighted average of the daily noise exposure levels for a nominal week of five eight-hour working days as defined by international standard ISO 1999:1990, point 3.6 (note 2). Article 3 Exposure limit values and exposure action values 1. For the purposes of this Directive the exposure limit values and exposure action values in respect of the daily noise exposure levels and peak sound pressure are fixed at: (a) exposure limit values: LEX,8h = 87 dB(A) and ppeak = 200 Pa(11) respectively; (b) upper exposure action values: LEX,8h 85 dB(A) and ppeak = 140 Pa(12) respectively; (c) lower exposure action values: LEX,8h = 80 dB(A) and ppeak = 112 Pa(13) respectively. 2. When applying the exposure limit values, the determination of the worker's effective exposure shall take account of the attenuation provided by the individual hearing protectors worn by the worker. The exposure action values shall not take account of the effect of any such protectors. 3. In duly justified circumstances, for activities where daily noise exposure varies markedly from one working day to the next, Member States may, for the purposes of applying the exposure limit values and the exposure action values, use the weekly noise exposure level in place of the daily noise exposure level to assess the levels of noise to which workers are exposed, on condition that: (a) the weekly noise exposure level as shown by adequate monitoring does not exceed the exposure limit value of 87 dB(A); and (b) appropriate measures are taken in order to reduce the risk associated with these activities to a minimum. SECTION II OBLIGATIONS OF EMPLOYERS Article 4 Determination and assessment of risks 1. In carrying out the obligations laid down in Articles 6(3) and 9(1) of Directive 89/391/EEC, the employer shall assess and, if necessary, measure the levels of noise to which workers are exposed. 2. The methods and apparatus used shall be adapted to the prevailing conditions particularly in the light of the characteristics of the noise to be measured, the length of exposure, ambient factors and the characteristics of the measuring apparatus. These methods and this apparatus shall make it possible to determine the parameters defined in Article 2 and to decide whether, in a given case, the values fixed in Article 3 have been exceeded. 3. The methods used may include sampling, which shall be representative of the personal exposure of a worker. 4. The assessment and measurement referred to in paragraph 1 shall be planned and carried out by competent services at suitable intervals, taking particular account of the provisions of Article 7 of Directive 89/391/EEC concerning the necessary competent services or persons. The data obtained from the assessment and/or measurement of the level of exposure to noise shall be preserved in a suitable form so as to permit consultation at a later stage. 5. When applying this Article, the assessment of the measurement results shall take into account the measurement inaccuracies determined in accordance with metrological practice. 6. Pursuant to Article 6(3) of Directive 89/391/EEC, the employer shall give particular attention, when carrying out the risk assessment, to the following: (a) the level, type and duration of exposure, including any exposure to impulsive noise; (b) the exposure limit values and the exposure action values laid down in Article 3 of this Directive; (c) any effects concerning the health and safety of workers belonging to particularly sensitive risk groups; (d) as far as technically achievable, any effects on workers' health and safety resulting from interactions between noise and work-related ototoxic substances, and between noise and vibrations; (e) any indirect effects on workers' health and safety resulting from interactions between noise and warning signals or other sounds that need to be observed in order to reduce the risk of accidents; (f) information on noise emission provided by manufacturers of work equipment in accordance with the relevant Community directives; (g) the existence of alternative work equipment designed to reduce the noise emission; (h) the extension of exposure to noise beyond normal working hours under the employer's responsibility; (i) appropriate information obtained following health surveillance, including published information, as far as possible; (j) the availability of hearing protectors with adequate attenuation characteristics. 7. The employer shall be in possession of an assessment of the risk in accordance with Article 9(1)(a) of Directive 89/391/EEC, and shall identify which measures must be taken in accordance with Articles 5, 6, 7 and 8 of this Directive. The risk assessment shall be recorded on a suitable medium, according to national law and practice. The risk assessment shall be kept up to date on a regular basis, particularly if there have been significant changes which could render it out of date, or when the results of health surveillance show it to be necessary. Article 5 Provisions aimed at avoiding or reducing exposure 1. Taking account of technical progress and of the availability of measures to control the risk at source, the risks arising from exposure to noise shall be eliminated at their source or reduced to a minimum. The reduction of such risks shall be based on the general principles of prevention set out in Article 6(2) of Directive 89/391/EEC, and take into account in particular: (a) other working methods that require less exposure to noise; (b) the choice of appropriate work equipment, taking account of the work to be done, emitting the least possible noise, including the possibility of making available to workers work equipment subject to Community provisions with the aim or effect of limiting exposure to noise; (c) the design and layout of workplaces and work stations; (d) adequate information and training to instruct workers to use work equipment correctly in order to reduce their exposure to noise to a minimum; (e) noise reduction by technical means: (i) reducing airborne noise, e.g. by shields, enclosures, sound-absorbent coverings; (ii) reducing structure-borne noise, e.g. by damping or isolation; (f) appropriate maintenance programmes for work equipment, the workplace and workplace systems; (g) organisation of work to reduce noise: (i) limitation of the duration and intensity of the exposure; (ii) appropriate work schedules with adequate rest periods. 2. On the basis of the risk assessment referred to in Article 4, if the upper exposure action values are exceeded, the employer shall establish and implement a programme of technical and/or organisational measures intended to reduce the exposure to noise, taking into account in particular the measures referred to in paragraph 1. 3. On the basis of the risk assessment referred to in Article 4, workplaces where workers are likely to be exposed to noise exceeding the upper exposure action values shall be marked with appropriate signs. The areas in question shall also be delimited and access to them restricted where this is technically feasible and the risk of exposure so justifies. 4. Where, owing to the nature of the activity, a worker benefits from the use of rest facilities under the responsibility of the employer, noise in these facilities shall be reduced to a level compatible with their purpose and the conditions of use. 5. Pursuant to Article 15 of Directive 89/391/EEC, the employer shall adapt the measures referred to in this Article to the requirements of workers belonging to particularly sensitive risk groups. Article 6 Personal protection 1. If the risks arising from exposure to noise cannot be prevented by other means, appropriate, properly fitting individual hearing protectors shall be made available to workers and used by them in accordance with the provisions of Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (third individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(14) and Article 13(2) of Directive 89/391/EEC and under the conditions set out below: (a) where noise exposure exceeds the lower exposure action values, the employer shall make individual hearing protectors available to workers; (b) where noise exposure matches or exceeds the upper exposure action values, individual hearing protectors shall be used; (c) the individual hearing protectors shall be so selected as to eliminate the risk to hearing or to reduce the risk to a minimum. 2. The employer shall make every effort to ensure the wearing of hearing protectors and shall be responsible for checking the effectiveness of the measures taken in compliance with this Article. Article 7 Limitation of exposure 1. Under no circumstances shall the exposure of the worker as determined in accordance with Article 3(2) exceed the exposure limit values. 2. If, despite the measures taken to implement this Directive, exposures above the exposure limit values are detected, the employer shall: (a) take immediate action to reduce the exposure to below the exposure limit values; (b) identify the reasons why overexposure has occurred; and (c) amend the protection and prevention measures in order to avoid any recurrence. Article 8 Worker information and training Without prejudice to Articles 10 and 12 of Directive 89/391/EEC the employer shall ensure that workers who are exposed to noise at work at or above the lower exposure action values, and/or their representatives, receive information and training relating to risks resulting from exposure to noise concerning, in particular: (a) the nature of such risks; (b) the measures taken to implement this Directive in order to eliminate or reduce to a minimum the risks from noise, including the circumstances in which the measures apply; (c) the exposure limit values and the exposure action values laid down in Article 3 of this Directive; (d) the results of the assessment and measurement of the noise carried out in accordance with Article 4 of this Directive together with an explanation of their significance and potential risks; (e) the correct use of hearing protectors; (f) why and how to detect and report signs of hearing damage; (g) the circumstances in which workers are entitled to health surveillance and the purpose of health surveillance, in accordance with Article 10 of this Directive; (h) safe working practices to minimise exposure to noise. Article 9 Consultation and participation of workers Consultation and participation of workers and/or of their representatives shall take place in accordance with Article 11 of Directive 89/391/EEC on the matters covered by this Directive, in particular: - the assessment of risks and identification of measures to be taken, referred to in Article 4, - the actions aimed at eliminating or reducing risks arising from exposure to noise, referred to in Article 5, - the choice of individual hearing protectors referred to in Article 6(1)(c). SECTION III MISCELLANEOUS PROVISIONS Article 10 Health surveillance 1. Without prejudice to Article 14 of Directive 89/391/EEC, Member States shall adopt provisions to ensure the appropriate health surveillance of workers where the results of the assessment and measurement provided for in Article 4(1) of this Directive indicate a risk to their health. Those provisions, including the requirements specified for health records and their availability, shall be introduced in accordance with national law and/or practice. 2. A worker whose exposure exceeds the upper exposure action values shall have the right to have his/her hearing checked by a doctor or by another suitably qualified person under the responsibility of a doctor, in accordance with national law and/or practice. Preventive audiometric testing shall also be available for workers whose exposure exceeds the lower exposure action values, where the assessment and measurement provided for in Article 4(1) indicate a risk to health. The objectives of these checks are to provide early diagnosis of any loss of hearing due to noise, and to preserve the hearing function. 3. Member States shall establish arrangements to ensure that, for each worker who undergoes surveillance in accordance with paragraphs 1 and 2, individual health records are made and kept up to date. Health records shall contain a summary of the results of the health surveillance carried out. They shall be kept in a suitable form so as to permit any consultation at a later date, taking into account any confidentiality. Copies of the appropriate records shall be supplied to the competent authority on request. The individual worker shall, at his or her request, have access to the health records relating to him or her personally. 4. Where, as a result of surveillance of the hearing function, a worker is found to have identifiable hearing damage, a doctor, or a specialist if the doctor considers it necessary, shall assess whether the damage is likely to be the result of exposure to noise at work. If this is the case: (a) the worker shall be informed by the doctor or other suitably qualified person of the result which relates to him or her personally; (b) the employer shall: (i) review the risk assessment carried out pursuant to Article 4; (ii) review the measures provided for to eliminate or reduce risks pursuant to Articles 5 and 6; (iii) take into account the advice of the occupational healthcare professional or other suitably qualified person or the competent authority in implementing any measures required to eliminate or reduce risk in accordance with Articles 5 and 6, including the possibility of assigning the worker to alternative work where there is no risk of further exposure; and (iv) arrange systematic health surveillance and provide for a review of the health status of any other worker who has been similarly exposed. Article 11 Derogations 1. In exceptional situations where, because of the nature of the work, the full and proper use of individual hearing protectors would be likely to cause greater risk to health or safety than not using such protectors, Member States may grant derogations from the provisions of Articles 6(1)(a) and (b) and 7. 2. The derogations referred to in paragraph 1 shall be granted by Member States following consultation with both sides of industry and, where appropriate, with the medical authorities responsible, in accordance with national laws and/or practice. Such derogations must be accompanied by conditions which guarantee, taking into account the special circumstances, that the resulting risks are reduced to a minimum and that the workers concerned are subject to increased health surveillance. Such derogations shall be reviewed every four years and withdrawn as soon as the justifying circumstances no longer obtain. 3. Every four years Member States shall forward to the Commission a list of derogations referred to in paragraph 1, indicating the exact reasons and circumstances which made them decide to grant the derogations. Article 12 Technical amendments Amendments of a strictly technical nature shall be adopted in accordance with the regulatory procedure laid down in Article 13(2) and in line with: (a) the adoption of directives in the field of technical harmonisation and standardisation with regard to the design, building, manufacture or construction of work equipment and/or workplaces; and (b) technical progress, changes in the most appropriate harmonised European standards or specifications and new findings concerning noise. Article 13 Committee 1. The Commission shall be assisted by the Committee referred to in Article 17 of Directive 89/391/EEC. 2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. Article 14 Code of conduct In the context of the application of this directive Member States shall draw up in consultation with the social partners, in accordance with national law and practice, a code of conduct providing for practical guidelines to help workers and employers in the music and entertainment sectors to meet their legal obligations as laid down in this Directive. Article 15 Repeal Directive 86/188/EEC is hereby repealed with effect from the date set out in the first subparagraph of Article 17(1). SECTION IV FINAL PROVISIONS Article 16 Reports Every five years Member States shall provide a report to the Commission on the practical implementation of this Directive, indicating the points of view of both sides of industry. It shall contain a description of best practice for preventing noise with a harmful effect on health and of other forms of work organisation, together with the action taken by the Member States to impart knowledge of such best practice. On the basis of those reports, the Commission shall carry out an overall assessment of the implementation of this Directive, including implementation in the light of research and scientific information, and, inter alia, taking into account the implications of this Directive for the music and entertainment sectors. The Commission shall inform the European Parliament, the Council, the European Economic and Social Committee and the Advisory Committee on Safety, Hygiene and Health Protection at Work thereof and, if necessary, propose amendments. Article 17 Transposition 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 15 February 2006. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. In order to take account of particular conditions, Member States may, if necessary, have an additional period of five years from 15 February 2006, that is to say a total of eight years, to implement the provisions of Article 7 with regard to the personnel on board seagoing vessels. In order to allow for the drawing up of a code of conduct providing for practical guidelines for the implementation of the provisions of this Directive, Member States shall be entitled to make use of a maximum transitional period of two years from 15 February 2006, that is to say a total of five years from the entry into force of this Directive, to comply with this Directive, with regard to the music and entertainment sectors on the condition that during this period the levels of protection already achieved in individual Member States, with regard to the personnel in these sectors, are maintained. 3. The Member States shall communicate to the Commission the text of the provisions of national law which they adopt or have already adopted in the field covered by this Directive. Article 18 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 19 Addressees This Directive is addressed to the Member States.

32003L0014

2003

Commission Directive 2003/14/EC of 10 February 2003 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses(1), as last amended by Directive 1999/41/EC of the European Parliament and of the Council(2), and in particular Article 4(1) thereof, Having regard to the opinion of the Scientific Committee on Food, Whereas: (1) Article 6 of Commission Directive 91/321/EEC(3), as last amended by Directive 1999/50/EC(4), stipulates that infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants and young children. (2) On the basis of opinions given by the Scientific Committee on Food on 19 September 1997 and 4 June 1998, Directive 91/321/EEC established a general maximum residue level of 0,01 mg/kg for any individual pesticide in infant formulae and follow-on formulae. (3) In the case of a small number of pesticides or metabolites of pesticides even a maximum residue level of 0,01 mg/kg might, under worst-case intake conditions, allow infants and young children to exceed the acceptable daily intake. This is the case for pesticides or metabolites of pesticides with an acceptable daily intake lower than 0,0005 mg/kg body weight. (4) Directive 91/321/EEC establishes the principle of the prohibition of the use of these pesticides in the production of agricultural products intended for infant formulae and follow-on formulae. The pesticides in question should be listed in Annex IX to Directive 91/321/EEC. However, this prohibition does not necessarily guarantee that products are free from such pesticides, since some pesticides contaminate the environment and their residues may be found in the products concerned. (5) The health of infants and young children can be better protected by applying additional requirements which can be enforced by analysis regardless of a product's origin. (6) Most of the pesticides which have acceptable daily intake values lower than 0,0005 mg/kg body weight are already prohibited in the Community or will be prohibited by July 2003. The prohibited pesticides should not be detectable in infant formulae and follow-on formulae by state of the art analytical methods. However, some pesticides degrade slowly and still contaminate the environment. They might be present in infant formulae and follow-on formulae even if they have not been used. For the purposes of control, a harmonised approach has to be followed. (7) Pending Commission decisions on whether they satisfy the safety requirements of Article 5 of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(5), as last amended by Commission Directive 2003/5/EC(6), the continued use of authorised pesticides should be permitted as long as their residues comply with the maximum residue levels established in the present Directive. The latter should be set at levels ensuring that their respective acceptable daily intake values are not exceeded by infants and young children under worst-case intake conditions. (8) Directive 91/321/EEC should be amended accordingly. (9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Directive 91/321/EEC is amended as follows: 1. Article 6 is amended as follows: - Paragraph 1 is replaced by the following: "1. Infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants and young children. Necessary maximum levels for substances other than those referred to in paragraphs 2 and 3 shall be established without delay." - Paragraph 3 is replaced by the following: "3. (a) Those pesticides listed in Annex IX shall not be used in agricultural products intended for the production of infant formulae and follow-on formulae. However, for the purpose of control: (i) pesticides listed in Table 1 of Annex IX are considered not to have been used if their residues do not exceed a level of 0,003 mg/kg. This level which is considered to be the limit of quantification of the analytical methods shall be kept under regular review in the light of technical progress; (ii) pesticides listed in Table 2 of Annex IX are considered not to have been used if their residues do not exceed a level of 0,003 mg/kg. This level shall be kept under regular review in the light of data on environmental contamination. (b) By derogation of paragraph 2, for the pesticides listed in Annex X, the maximum residue levels specified therein shall apply. For pesticides listed in Annex X, where a decision concerning the non-inclusion of an active substance in Annex I to Directive 91/414/EEC is taken, Annex IX and Annex X to this Directive shall be amended accordingly. (c) The levels referred to in subparagraphs (a) and (b) shall apply to the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers." 2. Annex IX is replaced by Annex I to this Directive. 3. Annex II to this Directive is added as Annex X. Article 2 1. The Member States shall authorise trade in products which comply with Article 6(3) of Directive 91/321/EEC by 6 March 2004 at the latest. 2. The Member States shall prohibit trade in products which do not comply with Article 6(3) of Directive 91/321/EEC by 6 March 2005. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 6 March 2004 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32003L0013

2003

Commission Directive 2003/13/EC of 10 February 2003 amending Directive 96/5/EC on processed cereal-based foods and baby foods for infants and young children (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses(1), as last amended by Directive 1999/41/EC of the European Parliament and of the Council(2), and in particular Article 4(1) thereof, Having regard to the opinion of the Scientific Committee on Food, Whereas: (1) Article 6 of Commission 96/5/EC(3), as last amended by Directive 1999/39/EC(4), stipulates that processed cereal-based foods and baby foods shall not contain any substance in such quantity as to endanger the health of infants and young children. (2) On the basis of opinions given by the Scientific Committee on Food on 19 September 1997 and 4 June 1998, Directive 96/5/EC established a general maximum residue level of 0,01 mg/kg for any individual pesticide in processed cereal-based foods and baby foods. (3) In the case of a small number of pesticides or metabolites of pesticides even a maximum residue level of 0,01 mg/kg might, under worst-case intake conditions, allow infants and young children to exceed the acceptable daily intake. This is the case for pesticides or metabolites of pesticides with an acceptable daily intake lower than 0,0005 mg/kg body weight. (4) Directive 96/5/EC establishes the principle of the prohibition of the use of these pesticides in the production of agricultural products intended for processed cereal-based foods and baby foods. The pesticides in question should be listed in Annex VIII to Directive 96/5/EC. However, this prohibition does not necessarily guarantee that products are free from such pesticides, since some pesticides contaminate the environment and their residues may be found in the products concerned. (5) The health of infants and young children can be better protected by applying additional requirements which can be enforced by analysis regardless of a product's origin. (6) Most of the pesticides which have acceptable daily intake values lower than 0,0005 mg/kg body weight are already prohibited in the Community or will be prohibited by July 2003. The prohibited pesticides should not be detectable in processed cereal-based foods and baby foods by state of the art analytical methods. However, some pesticides degrade slowly and still contaminate the environment. They might be present in processed cereal-based foods and baby foods even if they have not been used. For the purposes of control, a harmonised approach has to be followed. (7) Pending Commission decisions on whether they satisfy the safety requirements of Article 5 of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(5), as last amended by Commission Directive 2003/5/EC(6), the continued use of authorised pesticides should be permitted as long as their residues comply with the maximum residue levels established in the present Directive. The latter should be set at levels ensuring that their respective acceptable daily intake values are not exceeded by infants and young children under worst-case intake conditions. (8) Directive 96/5/EC should be amended accordingly. (9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Directive 96/5/EC is amended as follows: 1. Article 6 is amended as follows: - Paragraph 1 is replaced by the following: "1. Processed cereal-based foods and baby foods shall not contain any substance in such quantity as to endanger the health of infants and young children. Necessary maximum levels for substances other than those referred to in paragraphs 2 and 3 shall be established without delay." - Paragraph 3 is replaced by the following: "3. (a) Those pesticides listed in Annex VIII shall not be used in agricultural products intended for the production of processed cereal-based foods and baby foods. However, for the purpose of control: (i) pesticides listed in Table 1 of Annex VIII are considered not to have been used if their residues do not exceed a level of 0,003 mg/kg. This level which is considered to be the limit of quantification of the analytical methods shall be kept under regular review in the light of technical progress; (ii) pesticides listed in Table 2 of Annex VIII are considered not to have been used if their residues do not exceed a level of 0,003 mg/kg. This level shall be kept under regular review in the light of data on environmental contamination. The levels referred to in (i) and (ii) shall apply to the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers. (b) For pesticides listed in Annex VII, where a decision concerning the non-inclusion of an active substance in Annex I to Directive 91/414/EEC is taken, Annex VII and Annex VIII to this Directive shall be amended accordingly." 2. Annex VII is replaced by Annex I to this Directive. 3. Annex VIII is replaced by Annex II to this Directive. Article 2 1. The Member States shall authorise trade in products which comply with Article 6(3) of Directive 96/5/EC by 6 March 2004 at the latest. 2. The Member States shall prohibit trade in products which do not comply with Article 6(3) of Directive 96/5/EC by 6 March 2005. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 6 March 2004 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32003L0017

2003

Directive 2003/17/EC of the European Parliament and of the Council of 3 March 2003 amending Directive 98/70/EC relating to the quality of petrol and diesel fuels (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the Opinion of the European Economic and Social Committee(2), After consultation of the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 20 January 2003, Whereas: (1) Directive 98/70/EC(4) lays down the environmental specifications for market fuels. (2) Article 95 of the Treaty provides that Commission proposals having as their object the establishment and functioning of the internal market and concerning, inter alia, health and environmental protection, will take as a base a high level of protection and that the European Parliament and the Council will also seek to achieve this objective. (3) A revision of Directive 98/70/EC is foreseen in order to meet the requirements of Community air quality standards and related objectives and in order to incorporate additional specifications to complement those mandatory specifications already laid down in Annex III and Annex IV to the Directive. (4) A reduction of the sulphur content of petrol and diesel fuels has been identified as a means of contributing to the achievement of those objectives. (5) The adverse effect of sulphur in petrol and diesel fuels on the effectiveness of catalytic exhaust gas after-treatment technologies is well established for on-road vehicles and increasingly in the case of non-road mobile machinery. (6) Road vehicles are increasingly reliant upon catalytic after-treatment devices to attain the emissions limits laid down in Council Directive 70/220/EEC of 20 March 1970 on the approximation of the laws of the Member States on measures to be taken against air pollution by emissions from motor vehicles(5) and Council Directive 88/77/EEC of 3 December 1987 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from compression ignition engines for use in vehicles, and the emission of gaseous pollutants from positive ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles(6). Accordingly a reduction in the sulphur content of petrol and diesel fuels is likely to have a larger impact on exhaust emissions than changes to the other fuel parameters. (7) The introduction of fuels with a maximum sulphur content of 10 mg/kg will improve the fuel efficiency attainable with new, emerging vehicle technologies and should be examined in the case of non-road mobile machinery and should lead to significant reductions in emissions of conventional air pollutants when used in existing vehicles. These benefits will compensate for the increased emissions of CO2 associated with the production of lower sulphur petrol and diesel fuels. (8) It is therefore appropriate to lay down measures ensuring the introduction and availability of fuels with a maximum sulphur content of 10 mg/kg. In this regard fiscal incentives have been shown to be effective in promoting the early introduction of higher quality fuels according to national needs and priorities and to shorten the transition period where two different qualities are distributed in the market. The use of fiscal measures, at the appropriate national or Community level, should be promoted and encouraged. (9) The widespread availability of fuels with a maximum sulphur content of 10 mg/kg will provide a basis for automobile manufacturers to make significant additional progress towards improving the fuel efficiency of new vehicles. The potential contribution of fuels with a maximum sulphur content of 10 mg/kg towards the attainment of the Community's target of 120 g/km for the average CO2 emissions of the new car fleet will be assessed when the current environmental commitments with the automobile manufacturers are reviewed in 2003. (10) It is necessary to ensure that sufficient quantities of petrol and diesel fuels with a maximum sulphur content of 10 mg/kg are available from 1 January 2005 on an appropriately balanced geographical basis in order to permit the free circulation of new vehicles requiring these fuels whilst ensuring that CO2 emissions reductions from new vehicles outweigh those additional emissions associated with the production of these fuels. (11) The complete penetration of petrol and diesel fuels with a maximum sulphur content of 10 mg/kg should be provided for from 1 January 2009 in order to allow the fuel manufacturing industry enough time to make the necessary investments to adapt its production plans. In addition, the full introduction of petrol and diesel fuels with a maximum sulphur content of 10 mg/kg from 1 January 2009 will reduce emissions of conventional pollutants from the existing fleet of vehicles leading to an improvement in air quality, whilst ensuring that there is no overall increase in greenhouse gas emissions. In this context it will be necessary to confirm this date in the case of diesel fuels no later than 31 December 2005. (12) In order to protect human health and/or the environment in specific agglomerations or in specific ecologically or environmentally sensitive areas with special pollution problems, Member States should be permitted, subject to a procedure established in this Directive, to require that fuels may be marketed only if they comply with more stringent environmental specifications, related to pollutants of concern, than those established under this Directive. This procedure is a derogation from the information procedure laid down in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services(7). (13) The emissions from engines installed in non-road mobile machinery and agricultural and forestry tractors have to comply with the limits stipulated in Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery(8) and in Directive 2000/25/EC of the European Parliament and of the Council of 22 May 2000 on action to be taken against the emission of gaseous and particulate pollutants by engines intended to power agricultural or forestry tractors(9). Attainment of these emission limits will become increasingly dependent upon the quality of the gas oils used by these engines and so it is important to include a definition for such fuels in Directive 98/70/EC. (14) It is appropriate to provide for a uniform system of fuel quality monitoring or national systems that ensure results of equivalent confidence and for systems of reporting in order to assess compliance with the mandated environmental fuel quality specifications. (15) A procedure should be laid down for updating the measurement methods used to ensure compliance with the mandated fuel quality specifications. (16) The measures necessary for the implementation of Directive 98/70/EC should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down procedures for the exercise of implementing powers conferred on the Commission(10). (17) Provision should be made for a review of the provisions in Directive 98/70/EC in order to take account of new Community air quality legislation and related environmental objectives, such as the need to encourage alternative fuels, including biofuels, the development of new pollution abatement technologies and the impact of metallic additives and other relevant issues on their performance and to confirm, or otherwise, the date for full introduction of diesel fuels with a maximum sulphur content of 10 mg/kg in order to ensure that there is no overall increase in emissions of greenhouse gases. (18) A comprehensive review of alternative fuels, including biofuels, should be undertaken, including the discussion of the need for specific legislation. (19) Member States should lay down rules on penalties applicable to infringements of the provisions of Directive 98/70/EC and ensure that they are implemented. (20) Directive 98/70/EC should therefore be amended accordingly, Article 1 Directive 98/70/EC is hereby amended as follows: 1. Article 2 shall be replaced by the following: "Article 2 Definitions For the purposes of this Directive: 1. 'petrol' means any volatile mineral oil intended for the operation of internal combustion positive-ignition engines for the propulsion of vehicles and falling within CN codes 2710 11 41, 2710 11 45, 2710 11 49, 2710 11 51 and 2710 11 59 (11); 2. 'diesel fuels' means gas oils falling within CN code 2710 19 41 (12) and used for self-propelling vehicles as referred to in Directive 70/220/EEC and Directive 88/77/EEC; 3. 'gas oils intended for use by non-road mobile machinery and agricultural and forestry tractors' means any petroleum-derived liquid, falling within CN codes 2710 19 41 and 2710 19 45 (13), intended for use in engines referred to in Directives 97/68/EC(14) and 2000/25/EC(15); 4. 'outermost regions' means France with regard to the French overseas departments, Portugal with regard to the Azores and Madeira, and Spain with regard to the Canary Islands. For Member States with arctic or severe winter conditions the maximum distillation point of 65 % at 250 °C for diesel fuels and gas oils may be replaced with a maximum distillation point of 10 % (vol/vol) at 180 °C."; 2. the following subparagraphs shall be added to Article 3(2): "(d) Without prejudice to the provisions of subparagraph (c), Member States shall take all necessary measures to ensure that in due time, and no later than 1 January 2005, unleaded petrol with a maximum sulphur content of 10 mg/kg is marketed within their territories. Member States shall ensure that such unleaded petrol is available on an appropriately balanced geographical basis and complies in all other respects with the specifications set out in Annex III. However, Member States may, for the outermost regions, make specific provisions for the introduction of petrol of a maximum sulphur content of 10 mg/kg. Member States making use of this provision shall inform the Commission accordingly. The Commission shall develop guidance for recommending what, for the purposes of this subparagraph, constitutes availability on an appropriately balanced geographical basis. (e) By no later than 1 January 2009, Member States shall ensure that unleaded petrol may be marketed in their territory only if it complies with the environmental specification set out in Annex III except for the sulphur content which shall be a maximum of 10 mg/kg."; 3. in Article 4: (a) the following subparagraphs shall be added to paragraph 1: "(d) Without prejudice to the provisions of subparagraph (c), Member States shall take all necessary measures to ensure that in due time, and no later than 1 January 2005, diesel fuel with a maximum sulphur content of 10 mg/kg is marketed within their territories. Member States shall ensure that such diesel fuel is available on an appropriately balanced geographical basis and complies in all other respects with the specifications set out in Annex IV. However, Member States may, for the outermost regions, make specific provisions for the introduction of diesel fuel of a maximum sulphur content of 10 mg/kg. Member States making use of this provision shall inform the Commission accordingly. (e) By no later than 1 January 2009, Member States shall ensure, subject to the provisions of Article 9(1)(a), that diesel fuel may be marketed in their territory only if it complies with the environmental specification set out in Annex IV except for the sulphur content which shall be a maximum of 10 mg/kg."; (b) the following paragraph shall be added: "5. Member States shall ensure that gas oils intended for use by non-road mobile machinery and agricultural and forestry tractors marketed within their territory contain less than 2000 mg/kg of sulphur. By 1 January 2008 at the latest, the maximum permissible sulphur content of gas oils intended for use by non-road mobile machinery and agricultural and forestry tractors shall be 1000 mg/kg. However, Member States may require a lower limit or the same sulphur content for diesel fuels stipulated in this Directive."; 4. in Article 6: (a) paragraph 1 shall be replaced by the following: "1. By way of derogation from Articles 3, 4 and 5 and in accordance with Article 95(10) of the Treaty, a Member State may take measures to require that in specific areas, within its territory, fuels may be marketed only if they comply with more stringent environmental specifications than those provided for in this Directive for all or part of the vehicle fleet with a view to protecting the health of the population in a specific agglomeration or the environment in a specific ecologically or environmentally sensitive area in that Member State, if atmospheric or ground water pollution constitutes, or may reasonably be expected to constitute, a serious and recurrent problem for human health or the environment."; (b) paragraph 3 shall be replaced by the following: "3. The Member States involved shall provide the Commission with relevant environmental data for the agglomeration or area in question as well as the predicted effects on the environment of the measures proposed."; (c) paragraphs 7 and 8 shall be deleted; 5. Article 8 shall be replaced by the following: "Article 8 Monitoring compliance and reporting 1. Member States shall monitor compliance with the requirements of Articles 3 and 4, in respect of petrol and diesel fuels, on the basis of the analytical methods referred to in European standards EN 228:1999 and EN 590:1999 respectively. 2. Member States shall establish a fuel quality monitoring system in accordance with the requirements of the relevant European standard. The use of an alternative fuel quality monitoring system may be permitted provided that such a system ensures results of equivalent confidence. 3. Each year by 30 June, the Member States shall submit a report of national fuel quality data for the preceding calendar year. The first report shall be submitted by 30 June 2002. From 1 January 2004, the format for this report shall be consistent with that described in the relevant European standard. In addition, Member States shall report the total volumes of petrol and diesel fuels marketed in their territories and the volumes of unleaded petrol and diesel fuels marketed with a maximum sulphur content of 10 mg/kg. Furthermore, Member States shall report annually on the availability on an appropriately balanced geographical basis of petrol and diesel fuels with a maximum sulphur content of 10 mg/kg that are marketed within their territory. 4. The Commission shall ensure that the information submitted pursuant to paragraph 3 is promptly made available by appropriate means. The Commission shall publish annually, and for the first time by 31 December 2003, a report on actual fuel quality in the different Member States and geographical coverage of fuels with a maximum sulphur content of 10 mg/kg, aiming to provide an overview of the fuels quality data in the different Member States."; 6. Article 9 shall be replaced by the following: "Article 9 Review process 1. By 31 December 2005 at the latest, the Commission shall review the fuel specifications of Annexes III and IV with the exception of sulphur content and propose amendments, if appropriate, in keeping with current and future requirements of Community vehicle emission and air quality legislation and related objectives. In particular, the Commission shall consider: (a) the necessity of any change to the end date for the full introduction of diesel fuel, with a maximum sulphur content of 10 mg/kg, in order to ensure that there is no overall increase in greenhouse gas emissions. This analysis shall consider developments in refinery processing technologies, expected fuel economy improvements of vehicles and the rate at which new fuel-efficient technologies are introduced into the vehicle fleet; (b) the implications of new Community legislation setting air quality standards for substances such as polycyclic aromatic hydrocarbons; (c) the outcome of the review described in Article 10 of Council Directive 1999/30/EC of 22 April 1999 relating to limit values for sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient air(16); (d) the outcome of the review of the various commitments by the Japanese(17), Korean(18) and European(19) automobile manufacturers to reduce the fuel consumption and carbon dioxide emissions of new passenger cars in the light of the fuel quality changes introduced by this Directive and progress towards the Community target of 120 g/km CO2 emissions for the average vehicle; (e) the outcome of the review required by Article 7 of Directive 1999/96/EC of the European Parliament and of the Council of 13 December 1999 on the approximation of the laws of the Member States relating to measures to be taken against the emission of gaseous and particulate pollutants from compression ignition engines for use in vehicles, and the emission of gaseous pollutants from positive ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles and amending Council Directive 88/77/EEC(20) and the confirmation of the mandatory NOx emission standard for heavy duty engines; (f) the effective functioning of new pollution abatement technologies and the impact of metallic additives and other relevant issues on their performance and developments affecting international fuel markets; (g) the need to encourage the introduction of alternative fuels, including biofuels, as well as the need to introduce modifications to other parameters in the fuel specifications, both for conventional and for alternative fuels, for example the modifications to the maximum volatility limits for petrol contained in this Directive required for their application to blends of bioethanol with petrol and any subsequent necessary changes to EN 228:1999. 2. When considering its proposal for the next stage of emission standards for compression ignition engines in non-road applications, the Commission shall establish in parallel the required fuel quality. In so doing, the Commission shall take into account the importance of the emissions from this sector, the overall environmental and health benefits, the implications in the Member States regarding fuel distribution and the costs and benefits of a more restrictive sulphur level than is currently required for fuel used in compression ignition engines in non-road applications, and shall then align appropriate fuel quality requirements for non-road applications with the on-road sector by a certain date, currently expected to be 1 January 2009, to be confirmed or amended by the Commission in its review in 2005. 3. In addition to the provisions of paragraph 1 the Commission may, inter alia, bring forward: - proposals taking into consideration the particular situation of captive fleets and the need to propose levels of specifications for the special fuels they use, - proposals setting levels of specifications applicable to liquid petroleum gas, natural gas and biofuels."; 7. the following Article shall be inserted: "Article 9a Penalties Member States shall determine the penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties determined must be effective, proportionate and dissuasive."; 8. the first subparagraph of Article 10 shall be replaced by the following: "1. The measurement methods to be applied in relation to the parameters specified in Annexes I and III shall be those analytical methods set out in European standard EN 228:1999. The measurement methods to be applied in relation to the parameters specified in Annexes II and IV shall be those analytical methods set out in European standard EN 590:1999. Member States may adopt the analytical methods specified in replacement EN 228:1999 or EN 590:1999 standards, as appropriate, if they can be shown to give at least the same accuracy and at least the same level of precision as the analytical methods they replace. In the event that adaptation of the permitted analytical methods to technical progress is necessary, amendments may be adopted by the Commission in accordance with the procedure referred to in Article 11(2)."; 9. Article 11 shall be replaced by the following: "Article 11 Committee procedure 1. The Commission shall be assisted by the Committee established in accordance with Article 12 of Directive 96/62/EC(21). 2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down procedures for the exercise of implementing powers conferred upon the Commission(22) shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure."; 10. Annexes I to IV shall be replaced by the text in the Annex to this Directive. Article 2 Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2003. They shall forthwith inform the Commission thereof. Member States shall apply these measures from 1 January 2004. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0023

2003

Commission Directive 2003/23/EC of 25 March 2003 amending Council Directive 91/414/EEC to include imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl and cyazofamid as active substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 2002/81/EC(2), and in particular Article 6(1) thereof, Whereas: (1) In accordance with Article 6(2) of Directive 91/414/EEC France received on 2 December 1997 an application from Cyanamid NV/SA (now BASF AG) for the inclusion of the active substance imazamox in Annex I to Directive 91/414/EEC. Commission Decision 1998/676/EC(3) confirmed that the dossier was "complete" in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. (2) Italy received a similar application on 29 May 1998 from Novartis Protezione Piante SpA (now Syngenta) concerning oxasulfuron. This application was declared complete by Commission Decision 1999/237/EC(4). (3) Italy received a similar application on 3 July 1996 from Hoechst Schering AgrEvo GmbH (now Bayer Crop Science concerning ethoxysulfuron. This application was declared complete by Commission Decision 97/591/EC(5). (4) Germany received a similar application on 30 March 2000 from Aventis Crop Science (now Bayer Crop Science) concerning foramsulfuron. This application was declared complete by Commission Decision 2000/540/EC(6). (5) Italy received a similar application on 16 June 1997 from Rhone-Poulenc Agro SA (now Bayer Crop Science) concerning oxadiargyl. This application was declared complete by Commission Decision 98/398/EC(7). (6) France received a similar application on 16 December 1999 from Ishira Sangyo Kaisha Ltd concerning cyazofamid. This application was declared complete by Commission Decision 2000/412/EC(8). (7) For these active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The nominated rapporteur Member States, submitted a draft assessment report concerning the substance to the Commission on 9 September 1999 (imazamox), 10 May 2000 (oxasulfuron), 20 May 1998 (ethoxysulfuron), 1 June 2001 (foramsulfuron), 20 July 1999 (oxadiargyl) and 27 August 2001 (cyazofamid). (8) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 3 December 2002 in the format of the Commission review reports for imazamox, oxadiargyl, oxasulfuron, ethoxysulfuron, foramsulfuron and cyazofamid. (9) The reviews of imazamox, oxasulfuron foramsulfuron, oxadiargyl and cyazofamid did not reveal any open questions or concern, which would have required a consultation of the Scientific Committee on Plants. (10) The documents and information on ethoxysulfuron were also submitted to the Scientific Committee for Plants for separate consultation. In a first consultation the Scientific Committee was invited to comment on the occurrence of uterine tumours in rats. In its opinion(9) the Committee considered the increase in uterine tumour incidence in rats of no relevance to human risk as it occurred only at a high dose causing marked general toxicity. No additional mechanistic studies were deemed necessary. An additional consultation was made on the potential risk to aquatic organisms. In its second opinion(10) the Committee concluded that assessment of the risk of ethoxysulfuron to aquatic organisms was lacking in several respects, in particular with respect to sediment-dwelling organisms. Also assessment of the risk to aquatic plants and algae from the metabolite Hoe 136086 of ethoxysulfuron was considered incomplete. Additional studies and information were subsequently provided by the applicant and the risk assessment for the active substance and its degradation products was revised by the rapporteur Member State. (11) It has appeared from the various examinations made that plant protection products containing the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive. (12) The Commission review reports are required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Directive 91/414/EEC. It is, therefore, appropriate to provide that the finalised review reports, except for confidential information within the meaning of Article 14 of Directive 91/414/EEC, should be kept available or made available by the Member States for consultation by any interested parties. (13) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl or cyazofamid and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC. (14) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (15) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 31 December 2003 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 January 2004. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall review the authorisation for each plant protection product containing imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl, or cyazofamid to ensure that the conditions relating to this active substance set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw the authorisation in accordance with Directive 91/414/EEC before 31 December 2003. 2. Member States shall, for each authorised plant protection product containing imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl, or cyazofamid as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 June 2003, re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 31 December 2004 at the latest, they shall amend or withdraw the authorisation for each such plant protection product. Article 4 This Directive shall enter into force on 1 July 2003. Article 5 This Directive is addressed to the Member States.

32003L0018

2003

Directive 2003/18/EC of the European Parliament and of the Council of 27 March 2003 amending Council Directive 83/477/EEC on the protection of workers from the risks related to exposure to asbestos at work (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 137(2) thereof, Having regard to the proposal from the Commission(1), drawn up following consultation with social partners and with the Advisory Committee on Safety, Hygiene and Health Protection at Work, Having regard to the opinion of the European Economic and Social Committee(2), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) In its Conclusions of 7 April 1998 on the protection of workers against the risks from exposure to asbestos(4) the Council invited the Commission to bring forward proposals for amending Directive 83/477/EEC(5), considering in particular the merits of refocusing and adapting protective measures for those who are now most at risk, in particular workers who remove asbestos and workers who accidentally come across asbestos at work in the course of servicing and maintenance activities. (2) In those Conclusions, the Commission was also invited to submit proposals to amend Directive 83/477/EEC in the light of the more detailed research on limits for exposure to chrysotile and the methods for measuring airborne asbestos undertaken on the basis of the method adopted by the World Health Organisation (WHO). Similar steps should be taken regarding substitute fibres. (3) The Economic and Social Committee, in its opinion on asbestos(6), called on the Commission to take new measures to reduce the risks to workers. (4) The ban on the marketing and use of chrysotile asbestos introduced by Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations(7) with effect from 1 January 2005, will contribute to a substantial reduction in asbestos exposure of workers. (5) All workers should be protected against the risks associated with exposure to asbestos and the derogations applicable to the sea and air sectors should therefore be removed. (6) In order to ensure clarity in the definition of the fibres, they should be redefined either in mineralogical terms or with regard to their Chemical Abstract Service (CAS) number. (7) Without prejudice to other Community provisions concerning the marketing and use of asbestos, limiting the activities involving exposure to asbestos should play a very important role in preventing the diseases associated with such exposure. (8) The notification system for activities involving exposure to asbestos should be adapted to new work situations. (9) It is important to eliminate activities which expose workers to asbestos fibres during the extraction of asbestos or the manufacture and processing of asbestos products or the manufacture and processing of products containing intentionally added asbestos fibres, in view of their high and unpredictable level of exposure. (10) Taking account of the latest technical expertise, it is necessary to specify more precisely the sampling methodology used to measure the asbestos level in air and the method of counting fibres. (11) Even though it has not yet been possible to identify the exposure threshold below which asbestos does not involve a cancer risk, the limit value for occupational exposure to asbestos should be reduced. (12) Employers should be required to record, before the start of any asbestos removal project, the presence or presumed presence of asbestos in buildings or installations and communicate this information to others who may be exposed to asbestos as a result of its use, of maintenance or of other activities in or on the building. (13) It should be ensured that demolition or asbestos removal work is carried out by undertakings which are familiar with all the precautions to be taken in order to protect workers. (14) Special training for workers exposed or likely to be exposed to asbestos should be provided in order significantly to contribute to reducing the risks related to such exposure. (15) The content of the exposure register and medical records provided for in Directive 83/477/EEC should be brought into line with the records referred to in Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(8). (16) The practical recommendations on the clinical surveillance of exposed workers should be updated in the light of the latest medical expertise, with a view to the early detection of pathologies linked to asbestos. (17) Since the objective of the proposed action, namely improvement in the protection of workers from the risks related to exposure to asbestos at work, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (18) The amendments contained in this Directive constitute a concrete contribution towards creating the social dimension of the internal market. (19) These amendments are limited to the minimum in order not to impose an unnecessary burden on the creation and development of small and medium-sized enterprises. (20) Directive 83/477/EEC should therefore be amended accordingly, Article 1 Directive 83/477/EEC is hereby amended as follows: 1. in Article 1, paragraph 2 shall be deleted; 2. Article 2 shall be replaced by the following: "Article 2 For the purposes of this Directive, 'asbestos' means the following fibrous silicates: - Asbestos actinolite, CAS No 77536-66-4(9), - Asbestos gruenerite (amosite) CAS No 12172-73-5(10), - Asbestos anthophyllite, CAS No 77536-67-5(11), - Chrysotile, CAS No 12001-29-5(12), - Crocidolite, CAS No 12001-28-4(13), - Asbestos tremolite, CAS No 77536-68-6(14)."; 3. in Article 3: (a) paragraph 3 shall be replaced by the following: "3. Provided that worker exposure is sporadic and of low intensity, and when it is clear from the results of the risk assessment referred to in paragraph 2 that the exposure limit for asbestos will not be exceeded in the air of the working area, Articles 4, 15 and 16 may be waived where work involves: (a) short, non-continuous maintenance activities in which only non-friable materials are handled, (b) removal without deterioration of non-degraded materials in which the asbestos fibres are firmly linked in a matrix, (c) encapsulation or sealing of asbestos-containing materials which are in good condition, (d) air monitoring and control, and the collection of samples to ascertain whether a specific material contains asbestos." (b) the following paragraph shall be inserted: "3 bis Member States shall, following consultation with social partners in accordance with national law and practice, lay down practical guidelines for the determination of sporadic and low-intensity exposure, as provided for in paragraph 3."; 4. Article 4 shall be amended as follows: (a) point 2 shall be replaced by the following: "2. The notification shall be submitted by the employer to the responsible authority of the Member States, before the work commences, in accordance with national laws, regulations and administrative provisions. The notification must include at least a brief description of: (a) the location of the work site, (b) the type and quantities of asbestos used or handled, (c) the activities and processes involved, (d) the number of workers involved, (e) the starting date and duration of the work, (f) measures taken to limit the exposure of workers to asbestos."; (b) point 4 shall be replaced by the following: "4. Each time a change in working conditions is likely to result in a significant increase in exposure to dust from asbestos or materials containing asbestos, a new notification must be submitted."; 5. in Article 5 the following paragraph shall be added:"Without prejudice to the application of other Community provisions on marketing and use of asbestos, activities which expose workers to asbestos fibres during the extraction of asbestos or the manufacture and processing of asbestos products or the manufacture and processing of products containing intentionally added asbestos shall be prohibited, with the exception of the treatment and disposal of products resulting from demolition and asbestos removal."; 6. Article 6 shall be replaced by the following: "Article 6 For all activities referred to in Article 3(1), the exposure of workers to dust arising from asbestos or materials containing asbestos at the place of work must be reduced to a minimum and in any case below the limit value laid down in Article 8, in particular through the following measures: 1. the number of workers exposed or likely to be exposed to dust arising from asbestos or materials containing asbestos must be limited to the lowest possible figure; 2. work processes must be designed so as not to produce asbestos dust or, if that proves impossible, to avoid the release of asbestos dust into the air; 3. all premises and equipment involved in the treatment of asbestos must be capable of being regularly and effectively cleaned and maintained; 4. asbestos or dust-generating asbestos-containing material must be stored and transported in suitable sealed packing; 5. waste must be collected and removed from the place of work as soon as possible in suitable sealed packing with labels indicating that it contains asbestos. This measure shall not apply to mining activities. Such waste shall then be dealt with in accordance with Council Directive 91/689/EEC of 12 December 1991 on hazardous waste(15)."; 7. Article 7 shall be replaced by the following: "Article 7 1. Depending on the results of the initial risk assessment, and in order to ensure compliance with the limit value laid down in Article 8, measurement of asbestos fibres in the air at the workplace shall be carried out regularly. 2. Sampling must be representative of the personal exposure of the worker to dust arising from asbestos or materials containing asbestos. 3. Sampling shall be carried out after consultation of the workers and/or their representatives in undertakings. 4. Sampling shall be carried out by suitably qualified personnel. The samples taken shall be subsequently analysed, in accordance with paragraph 6, in laboratories equipped for fibre counting. 5. The duration of sampling must be such that representative exposure can be established for an eight-hour reference period (one shift) by means of measurements or time-weighted calculations. 6. Fibre counting shall be carried out wherever possible by PCM (phase-contrast microscope) in accordance with the 1997 WHO (World Health Organisation) recommended method(16) or any other method giving equivalent results. For the purpose of measuring asbestos in the air, as referred to in the first subparagraph, only fibres with a length of more than five micrometres, a breadth of less than three micrometres and a length/breadth ratio greater than 3:1 shall be taken into consideration."; 8. Article 8 shall be replaced by the following: "Article 8 Employers shall ensure that no worker is exposed to an airborne concentration of asbestos in excess of 0,1 fibres per cm3 as an eight-hour time-weighted average (TWA)."; 9. in Article 9, paragraph 1 shall be deleted; 10. Article 10 shall be amended as follows: (a) in paragraph 1, the first subparagraph shall be replaced by the following:"Where the limit value laid down in Article 8 is exceeded, the reasons for the limit being exceeded must be identified and appropriate measures to remedy the situation must be taken as soon as possible." (b) paragraph 3 shall be replaced by the following: "3. Where exposure cannot be reduced by other means and where compliance with the limit value makes necessary the wearing of individual protective breathing equipment, this may not be permanent and shall be kept to the strict minimum necessary for each worker. During periods of work which require the use of such equipment, provision shall be made for breaks appropriate to the physical and climatological conditions and, where relevant, in consultation with the workers and/or their representatives, in accordance with national laws and practice."; 11. the following Article shall be inserted: "Article 10a Before beginning demolition or maintenance work, employers shall take, if appropriate by obtaining information from the owners of the premises, all necessary steps to identify presumed asbestos-containing materials. If there is any doubt about the presence of asbestos in a material or construction, the applicable provisions of this Directive shall be observed."; 12. in Article 11, paragraph 1 shall be replaced by the following: "1. In the case of certain activities such as demolition, removal, repairing and maintenance in respect of which it is foreseeable that the limit value set out in Article 8 will be exceeded despite the use of technical preventive measures for limiting asbestos in air concentrations, the employer shall determine the measures intended to ensure protection of the workers while they are engaged in such activities, in particular the following: (a) workers shall be issued with suitable respiratory and other personal protective equipment, which must be worn; and (b) warning signs shall be put up indicating that it is foreseeable that the limit value laid down in Article 8 will be exceeded; and (c) the spread of dust arising from asbestos or materials containing asbestos outside the premises or site of action shall be prevented."; 13. in Article 12(2), the first two subparagraphs shall be replaced by the following: "2. The plan referred to in paragraph 1 must prescribe the measures necessary to ensure the safety and health of workers at the place of work. The plan must in particular specify that: - asbestos and/or asbestos-containing products are to be removed before demolition techniques are applied, except where this would cause a greater risk to workers than if the asbestos and/or asbestos-containing products had been left in place; - the personal protective equipment referred to in Article 11(1)(a) shall be provided, where necessary; - when the asbestos demolition or removal work has been completed, the absence of asbestos exposure risks in the workplace shall be verified in compliance with national legislation and practices."; 14. the following Articles shall be inserted: "Article 12a 1. Employers shall provide appropriate training for all workers who are, or are likely to be, exposed to asbestos-containing dust. Such training must be provided at regular intervals and at no cost to the workers. 2. The content of the training must be easily understandable for workers. It must enable them to acquire the necessary knowledge and skills in terms of prevention and safety, particularly as regards: (a) the properties of asbestos and its effects on health, including the synergistic effect of smoking; (b) the types of products or materials likely to contain asbestos; (c) the operations that could result in asbestos exposure and the importance of preventive controls to minimise exposure; (d) safe work practices, controls and protective equipment; (e) the appropriate role, choice, selection, limitations and proper use of respiratory equipment; (f) emergency procedures; (g) decontamination procedures; (h) waste disposal; (i) medical examination requirements. 3. Practical guidelines for the training of asbestos removal workers shall be developed at Community level. Article 12b Before carrying out asbestos demolition or removal work, firms must provide evidence of their ability in this field. The evidence shall be established in accordance with national laws and/or practice."; 15. in Article 14(2), point (b) shall be replaced by the following: "(b) if the results exceed the limit value laid down in Article 8 the workers concerned and their representatives in the undertaking or establishment are informed as quickly as possible of the fact and the reasons for it and the workers and/or their representatives in the undertaking or establishment are consulted on the measures to be taken or, in an emergency, are informed of the measures which have been taken."; 16. in Article 15, point (3) shall be replaced by the following: "3. Information and advice must be given to workers regarding any assessment of their health which they may undergo following the end of exposure. The doctor or authority responsible for the medical surveillance of workers may indicate that medical surveillance must continue after the end of exposure for as long as they consider it necessary to safeguard the health of the person concerned. Such continuing surveillance shall be carried out in accordance with the laws and practices of the individual Member States."; 17. in Article 16, point 2 shall be replaced by the following: "2. The register referred to in point 1 and the medical records referred to in Article 15(1) shall be kept for at least 40 years following the end of exposure, in accordance with national laws and/or practice."; 18. in Article 16 the following point shall be added: "3. The documents referred to in point 2 shall be made available to the responsible authority in cases where the undertaking ceases trading, in accordance with national laws and/or practice."; 19. The following Article shall be inserted: "Article 16a Member States shall provide for adequate sanctions to be applicable in the event of infringement of national legislation adopted pursuant to this Directive. These sanctions must be effective, proportionate and dissuasive."; 20. Annex I shall be deleted; 21. in Annex II, point 3 shall be replaced by the following: "3. Health examination of workers should be carried out in accordance with the principles and practices of occupational medicine. It should include at least the following measures: - keeping records of a worker's medical and occupational history, - a personal interview, - a general clinical examination, with particular reference to the chest, - lung function tests (respiratory flow volumes and rates). The doctor and/or authority responsible for the health surveillance should decide on further examinations, such as sputum cytology tests or a chest X-ray or a tomodensitometry, in the light of the latest occupational health knowledge available." Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 April 2006. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the date of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0026

2003

Commission Directive 2003/26/EC of 3 April 2003 adapting to technical progress Directive 2000/30/EC of the European Parliament and of the Council as regards speed limiters and exhaust emissions of commercial vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2000/30/EC of the European Parliament and of the Council of 6 June 2000 on the technical roadside inspection of the roadworthiness of commercial vehicles circulating in the Community(1), and in particular Article 8 thereof, Whereas: (1) Directive 2000/30/EC concerns a legal framework for the roadside inspection of commercial vehicles, whether carrying passengers or freight. It requires Member States to supplement the annual roadworthiness test with unexpected inspections of a representative proportion of the commercial vehicle fleet on their roads each year. (2) The field of roadworthiness testing is embraced by Council Directive 96/96/EC of 20 December 1996 on the approximation of the laws of the Member States relating to roadworthiness tests for motor vehicles and their trailers(2), as last amended by Commission Directive 2001/11/EC(3), which covers regular roadworthiness testing, and by Directive 2000/30/EC, which applies to the roadside inspections of heavy commercial vehicles for their roadworthiness. Both Directives use the same Committee and the same procedure for technical adaptations. (3) Directive 96/96/EC has been amended by the prescription of stricter emission limits for certain categories of motor vehicle and the functional testing of speed limitation devices on heavy commercial vehicles. In order to be consistent with that Directive, Directive 2000/30/EC also needs to be adapted so as to include the new technical provisions, namely by bringing on-board diagnostic (OBD) monitoring systems and speed limiters within the scope of roadside inspections. Directive 2000/30/EC also needs updating (together with Directive 96/96/EC) to incorporate revised emission testing limit values for certain categories of motor vehicles. (4) The provisions of this Directive are in accordance with the opinion of the Committee on the adaptation to Technical Progress set up pursuant to Article 8 of Directive 96/96/EC, Article 1 Annexes I and II to Directive 2000/30/EC are amended as set out in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2004 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law that they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0027

2003

Commission Directive 2003/27/EC of 3 April 2003 on adapting to technical progress Council Directive 96/96/EC as regards the testing of exhaust emissions from motor vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 96/96/EC of 20 December 1996 on the approximation of the laws of the Member States relating to roadworthiness tests for motor vehicles and their trailers(1), as last amended by Commission Directive 2001/11/EC(2), and in particular Article 7(2) thereof, Whereas: (1) The Auto-Oil programmes, which were initiated in 1992 to provide the analytical foundation for the setting of vehicle emission and fuel quality standards for the year 2000 and beyond, in order to achieve air quality objectives with a particular focus on reducing road transport emissions, identified the standard of motor vehicle maintenance as a key factor in the effect of traffic on air quality. (2) Directive 96/96/EC specifies the tests to be carried out at periodic inspections to check that emissions from both petrol and diesel driven vehicles are still within acceptable limits. (3) A working group of experts from the International Motor Vehicle Inspection Committee (CITA), and from other relevant organisations was established by the Commission and met during year 2000. The group examined the options for amending the limits for the emission tests prescribed in Directive 96/96/EC and in Directive 2000/30/EC of the European Parliament and of the Council of 6 June 2000 on the technical roadside inspection of the roadworthiness of commercial vehicles circulating in the Community(3) to determine whether improved environmental benefits could be realised. The Group concluded that the currently prescribed limits are invariably well above what the vehicle is capable of achieving in practice, provided that it is properly maintained: the current limits are therefore not as effective as they could be in facilitating the detection of gross emitters, i.e. vehicles whose exhaust emissions are at least 50 % more than would be expected from a properly maintained vehicle. (4) The measures provided for in this Directive are in accordance with the opinion of the committee for the adaptation to technical progress of the Directive on roadworthiness tests for motor vehicles and their trailers instituted by Article 8 of Directive 96/96/EC, Article 1 Annex II to Directive 96/96/EC is amended as set out in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2004 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law that they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32003L0028

2003

Commission Directive 2003/28/EC of 7 April 2003 adapting for the fourth time to technical progress Council Directive 94/55/EC on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road(1), as last amended by Commission Directive 2001/7/EC(2), and in particular Article 8 thereof, Whereas: (1) Annexes A and B to Directive 94/55/EC refer to Annexes A and B to the European Agreement concerning the international carriage of dangerous goods by road, generally known as the ADR, as applicable with effect from 1 July 2001. (2) The ADR is updated every two years. Consequently, the amended version will be in force with effect from 1 January 2003, with a transitional period up to 30 June 2003. (3) Annex C contains references to marginals which must become points. (4) It is therefore necessary to amend the Annexes to Directive 94/55/EC. (5) The measures provided for in this Directive are in conformity with the opinion of the Committee for the transport of dangerous goods, Article 1 The Annexes to Directive 94/55/EC are hereby amended as follows: 1. Annex A is replaced by the following: "ANNEX A Provisions of Annex A to the European Agreement on the international carriage of dangerous goods by road (ADR), as applicable with effect from 1 January 2003, it being understood that "contracting party" is replaced by "Member State". The text of the amendments of the 2003 version of Annex A to the ADR will be published as soon as it is available in all official languages of the Community." 2. Annex B is replaced by the following: "ANNEX B Provisions of Annex B to the European Agreement on the International Carriage of Dangerous Goods by Road (ADR), as applicable with effect from 1 January 2003, it being understood that "contracting party" is replaced by "Member State". The text of the amendments of the 2003 version of Annex B to the ADR will be published as soon as it is available in all official languages of the Community." 3. Annex C is amended in conformity with Annex C to this Directive. Article 2 1. The Member States shall bring into force the laws, regulations and administrative provisions needed to conform with this Directive no later than 1 July 2003. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. The Member States shall notify to the Commission the text of the provisions of internal law which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0029

2003

Commission Directive 2003/29/EC of 7 April 2003 adapting for the fourth time to technical progress Council Directive 96/49/EC on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail(1), as last amended by Directive 2001/6/EC(2), and in particular Article 8 thereof, Whereas: (1) The Annex to Directive 96/49/EC refers to the Regulation concerning the international carriage of dangerous goods by rail, generally known as the RID, as applicable with effect from 1 July 2001. (2) The RID is updated every two years. Consequently, the amended version will be in force with effect from 1 January 2003, with a transitional period up to 30 June 2003. (3) It is therefore necessary to amend the Annex to Directive 96/49/EC. (4) The measures provided for in this Directive are in conformity with the opinion of the Committee on the transport of dangerous goods referred to in Article 9 of Directive 96/49/EC, Article 1 The Annex to Directive 96/49/EC is hereby replaced by the following: "ANNEX Regulation concerning the international carriage of dangerous goods by rail (RID) appearing in Annex I to Appendix B to the Convention concerning International Carriage by Rail (COTIF), as applicable with effect from 1 January 2003, it being understood that the terms "contracting party" and "the States or the railways" will be replaced by the term "Member State". The text of the amendments of the 2003 version of the RID will be published as soon as it is available in all official languages of the Community." Article 2 1. The Member States shall bring into force the laws, the regulations and administrative provisions necessary to conform with this Directive no later than 1 July 2003. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. The Member States shall notify to the Commission the text of the provisions of internal law which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0020

2003

Directive 2003/20/EC of the European Parliament and of the Council of 8 April 2003 amending Council Directive 91/671/EEC on the approximation of the laws of the Member States relating to compulsory use of safety belts in vehicles of less than 3,5 tonnes Having regard to the Treaty establishing the European Community, and in particular Article 71(1) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Article 153 of the Treaty requires in particular that, in order to ensure a high level of consumer protection, the Community shall contribute to protecting the health, safety and economic interests of consumers. (2) In its Resolution of 13 March 1984(4), the European Parliament made the compulsory use of safety belts on all roads, whether rural or urban, a priority measure. In its Resolution of 18 February 1986(5), it stressed the need to make the wearing of safety belts compulsory for all passengers, including children, except in public service vehicles. (3) Directive 91/671/EEC(6) provides for the compulsory use of child restraints on seats fitted with safety belts. That Directive does not specify the type of child-restraint system that would be appropriate and allows for the carriage of children without being restrained by an appropriate child restraint where such a restraint is unavailable. (4) Greater stringency in the use of such systems is necessary, thus moving closer to the principle of compulsory use referred to in the second paragraph of Article 2 of the Directive. (5) By Council Decision 97/836/EC(7), the Community acceded to the Agreement of the United Nations Economic Commission for Europe concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or be used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions. (6) By its accession to that Agreement, the Community acceded to a defined list of regulations established pursuant to that Agreement, including that concerning the approval of restraining devices for child occupants of power-driven vehicles (child restraints). (7) Although the number of children fatally injured in car crashes is relatively small compared with child pedestrian or child cyclist fatalities, common child protection rules need to be reinforced. In particular, research has shown that the use of child restraints can make a substantial contribution to reducing the severity of injury in the event of a crash and that the risk of a more severe crash injury is higher for unrestrained children than for restrained children. (8) Member States should nevertheless, with the Commission's agreement, be able to authorise certain exemptions for transport in their territory in the case of very specific situations; Member States should also take the necessary steps in order to avoid abuse. (9) Since it is increasingly common for M2 and M3 vehicles to be fitted with safety belts in accordance with Commission Directives 96/36/EC(8), 96/37/EC(9) and 96/38/EC(10), it is reasonable that seated passengers should be required to use them. Passengers in such vehicles should be informed of the requirement to wear their safety belts when the vehicle is in motion. (10) There are not at present any studies recognised at Community level concerning the use of safety systems by children under three years of age in M2 and M3 vehicles. Accordingly, in view of the importance of protecting children against all types of accident, the Commission should carry out such studies in order to determine the most appropriate Community arrangements to apply to children travelling in such vehicles. Pending the completion of those studies, however, the Member States should be allowed to choose the arrangements to apply. (11) Technical developments are constantly taking place in the field of safety systems; machinery for technical adaptation should therefore be established. (12) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(11), Article 1 Directive 91/671/EEC is hereby amended as follows: 1. the title shall be replaced by the following: "Council Directive of 16 December 1991 relating to the compulsory use of safety belts and child-restraint systems in vehicles"; 2. Article 1 shall be replaced by the following: "Article 1 1. This Directive shall apply to all motor vehicles in categories M1, M2, M3, N1, N2 and N3 as defined in Annex II to Directive 70/156/EEC(12), intended for use on the road, having at least four wheels and a maximum design speed exceeding 25 km/h. 2. For the purposes of this Directive: - the definitions of safety systems, including safety belts and child restraints, with regard to vehicles in categories M1 and N1, and of the components thereof shall be those appearing in Annex I to Directive 77/541/EEC(13), - 'rearward-facing' shall mean facing in the direction opposite to the normal direction of travel of the vehicle. 3. Child restraints shall be classified in five 'mass groups': (a) group 0 for children of a mass of less than 10 kg; (b) group 0+ for children of a mass of less than 13 kg; (c) group I for children of a mass of from 9 kg to 18 kg; (d) group II for children of a mass of from 15 kg to 25 kg; (e) group III for children of a mass of from 22 kg to 36 kg. 4. Child restraints shall be subdivided into two classes: (a) an integral class comprising a combination of straps or flexible components with a securing buckle, adjusting device, attachments and in some cases a supplementary chair and/or impact shield, capable of being anchored by means of its own integral strap or straps; (b) a non-integral class that may comprise a partial restraint which, when used in conjunction with an adult belt which passes around the body of the child or restrains the device in which the child is placed, forms a complete child-restraint system."; 3. Article 2 shall be replaced by the following: "Article 2 1. M1, N1, N2 and N3 vehicles: (a) (i) for M1, NI, N2 and N3 vehicles, Member States shall require that all occupants of vehicles in use shall use the safety systems provided. Children less than 150 cm in height occupying M1, N1, N2 and N3 vehicles fitted with safety systems shall be restrained by an integral or non-integral child-restraint system, within the meaning of Article 1(4)(a) and (b), suitable for the child's mass as defined in Article 1(3); in M1, N1, N2 and N3 vehicles that are not fitted with safety systems: - children under three years of age may not be transported, - without prejudice to point (ii), children aged three and over and less than 150 cm in height shall occupy a seat other than a front seat; (ii) Member States may allow, in their territory, children of less than 150 cm in height and of at least 135 cm in height to be restrained by a safety belt for adults. These height limits shall be re-examined according to the procedure referred to in Article 7b(2); (iii) Member States may, however, allow, in their territory, those children referred to in (i) and (ii) not to be restrained by a child-restraint system when travelling in taxis. However, when the abovementioned children are travelling in taxis not fitted with restraint systems they shall occupy a seat other than a front seat; (b) children may not be transported using a rearward-facing child-restraint system in a passenger seat protected by a front air bag, unless the air bag has been deactivated, even in cases where the air bag is automatically deactivated in a sufficient manner; (c) where a child-restraint system is used, it shall be approved to the standards of UN-ECE Regulation 44/03 or Directive 77/541/EEC, or any other subsequent adaptation thereto; (d) until 9 May 2008 Member States may permit the use of child-restraint systems approved in accordance with the national standards applicable in the Member State on the date of installation of the restraint system or with national standards equivalent to Regulation 44/03 of the United Nations Economic Commission for Europe or Directive 75/541/EEC. 2. M2 and M3 vehicles: (a) Member States shall require that all occupants aged three and over of M2 and M3 vehicles in use shall use the safety systems provided while they are seated. Child restraints shall be approved in accordance with paragraph (1)(c) and (d); (b) passengers in M2 and M3 vehicles shall be informed of the requirement to wear safety belts whenever they are seated and the vehicle is in motion. They shall be informed in one or more of the following ways: - by the driver, - by the conductor, courier or official designated as group leader, - by audio-visual means (e.g. video), - by signs and/or the pictogram established by the Member States in accordance with the Community design in the Annex, prominently displayed at every seating position."; 4. Article 4 shall be deleted; 5. Article 6 shall be replaced by the following: "Article 6 Member States may, for transport in their territory, with the Commission's agreement, grant exemptions other than those laid down in Article 5, in order: - to take account of specific physical conditions, or particular circumstances of limited duration, - to allow certain types of occupation to be carried out effectively, - to ensure that the police, security or emergency services can perform their duties properly, - where two child restraints are fitted in the rear of M1 and N1 vehicles and lack of space prevents the fitting of a third, to allow a third child, aged three or over and less than 150 cm in height, to be restrained by means of a safety belt for adults, - to allow children aged three and over to be restrained by means of an adult safety belt, in seats other than the front seats of M1 and N1 vehicles, for occasional transport over a short distance when no child restraint or an insufficient number of child restraints is available in the vehicle, - to take account of the specific conditions of use of M2 and M3 vehicles for local transport in urban and built-up areas, or in which standing is allowed."; 6. the following Articles shall be added: "Article 6a Member States may, with the Commission's agreement, grant temporary exemptions, other than those provided for in Articles 5 and 6, in order that, subject to compliance with the rules of the Member State concerned, for local transport operations, particularly for school buses, a greater number of seated children may be transported in M2 and M3 vehicles than there are seats available fitted with safety belts. The period of validity of such exemptions, set by the Member State, may not be more than five years from 9 May 2003. Article 6b Member States may, for transport in their territory, grant temporary exemptions, other than those provided for in Articles 5 and 6, in order, subject to compliance with the rules of the Member State concerned, to allow a greater number of persons to be transported in seats other than the front seats of M1 and N1 vehicles than there are seats available fitted with safety belts or restraint systems. The period of validity of such exemptions, set by the Member State, may not be more than six years from 9 May 2003"; 7. the following Articles shall be added: "Article 7a 1. To take account of technical progress, Articles 2 and 6 of this Directive may be adapted in accordance with the procedure referred to in Article 7b(2). 2. The Commission shall continue to carry out studies on the safety systems most suitable for improving the protection of all passengers against all types of accident and shall submit to the European Parliament and the Council a report on the findings of those studies and on the application of this Directive, particularly on the exemptions granted by Member States pursuant to Article 6, in order to assess the advisability of strengthening safety measures and the need for greater harmonisation. Where appropriate, on the basis of this report, the Commission shall submit appropriate proposals. Article 7b 1. The Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC(14) shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure."; 8. the Annex appearing in the Annex to this Directive shall be added. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 9 May 2006. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0031

2003

Commission Directive 2003/31/EC of 11 April 2003 amending Council Directive 91/414/EEC to include 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin as active substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 2003/23/EC(2), and in particular Article 6(1) thereof, Whereas: (1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market(3), as last amended by Regulation (EC) No 2266/2000(4), establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin. (2) For these active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92(5), as last amended by Regulation (EC) No 2230/95(6), the following rapporteur Member States were designated and submitted the relevant assessment reports and recommendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92: 2,4-DB: rapporteur Member State Greece, all relevant information was submitted on 30 April 1996; beta-cyfluthrin: rapporteur Member State Germany, all relevant information was submitted on 4 November 1996; cyfluthrin: rapporteur Member State Germany, all relevant information was submitted on 4 November 1996; iprodione: rapporteur Member State France, all relevant information was submitted on 18 July 1996; linuron: rapporteur Member State United Kingdom, all relevant information was submitted on 31 October 1996; maleic hydrazide: rapporteur Member State Denmark, all relevant information was submitted on 5 September 1997; pendimethalin: rapporteur Member State Spain, all relevant information was submitted on 20 May 1998. (3) These assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. (4) In accordance with Article 6(4) of Directive 91/414/EEC and in view of a possible unfavourable decision for 2,4-DB and for pendimethalin the Commission organised tripartite meetings with the main data submitter and the rapporteur Member State on 7 May 1998 and on 4 June 1999. For both substances the main data submitter provided further data in order to meet the initial concerns. (5) The reviews of all active substances were finalised on 3 December 2002 in the format of the Commission review report for 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin. (6) The reviews of 2,4-DB, linuron, maleic hydrazide and pendimethalin did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants. (7) The report on beta-cyfluthrin and on cyfluthrin and further information concerning both substances were also submitted to the Scientific Committee on Plants for separate consultations. The Committee was asked to comment on the appropriate dietary risk assessment to be used and to confirm that the available ecotoxicological data supports uses only in glasshouses and for seed treatment. In its opinions(7)(8), the Committee suggested that in addition to a long-term dietary intake risk assessment, as routinely carried out for plant protection products, beta-cyfluthrin and cyfluthrin should also undergo a short-term acute dietary risk assessment to evaluate their potential neurotoxicity properties. The Committee confirmed that uses as seed dressing and in greenhouses (except where beneficial arthropods are used) can be considered safe for non-target terrestrial and aquatic organisms, due to the specific circumstances of these applications and the immobility of beta-cyfluthrin and cyfluthrin in soil. The Committee furthermore supports the conclusions reached during the evaluation by the Member States that field spray applications of beta-cyfluthrin and cyfluthrin have not shown to be sufficiently safe under the criteria required by Annex VI to Directive 91/414/EEC. Following the opinion of the Scientific Committee on Plants the short term dietary risk assessment was subsequently provided and discussed with the Member States. It was concluded that the short-term intake of residues is not likely to exceed acceptable limits. (8) The report on iprodione and further information were also submitted to the Scientific Committee on Plants for separate consultation. The Scientific Committee was asked to comment on the predicted environmental concentrations in soil and groundwater, and on the acceptable operator exposure level proposed by the rapporteur. In its opinion(9), the Committee agreed that sufficient information was available to reliably estimate the leaching behaviour of the substance for soils with pH above 6. However, the assessment of leaching in soils with pH below 6 deserves further attention, since, for soils with pH below 6, leaching at concentration levels exceeding 0,1 μg/l may occur in some realistic vulnerable situations. The Committee saw no need to use an additional safety factor for the derivation of the acceptable operator exposure level. The observations of the Scientific Committee were taken into account in this Directive and the review report. (9) It has appeared from the various examinations made that plant protection products containing 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide or pendimethalin may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisation of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive. (10) The Commission review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Directive 91/414/EEC. It is, therefore, appropriate to provide that the finalised review report, except for confidential information, should be kept available or made available by the Member States for consultation by any interested parties. (11) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. (12) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant protection products containing 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide or pendimethalin, and in particular, to review existing authorisations to ensure that the conditions regarding those active substances set out in Annex I to Directive 91/414/EEC are satisfied. A longer period should be provided for the submission and assessment of the complete dossier of each plant protection product in accordance with the uniform principles laid down in Directive 91/414/EEC. (13) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (14) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 30 June 2004 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 July 2004. When Member States adopt this provision, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall review the authorisation for each plant protection product containing 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide or pendimethalin to ensure that the conditions relating to this active substance set out in Annex I to Directive 91/414/EEC are complied with. Where necessary and by 30 June 2004 at the latest, they shall amend or withdraw the authorisation. 2. Member States shall, for each authorised plant protection product containing 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide or pendimethalin as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 December 2003 at the latest, re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 31 December 2007 at the latest, they shall amend or withdraw the authorisation. Article 4 This Directive shall enter into force on 1 January 2004. Article 5 This Directive is addressed to the Member States.

32003L0024

2003

Directive 2003/24/EC of the European Parliament and of the Council of 14 April 2003 amending Council Directive 98/18/EC on safety rules and standards for passenger ships Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(4) introduces a uniform level of safety of life and property on new and existing passenger ships and high-speed passenger craft, when both categories of ships and craft are engaged on domestic voyages, and lays down procedures for negotiation at international level with a view to a harmonisation of the rules for passenger ships engaged on international voyages. (2) The definition of sea areas is crucial to determine the application of Directive 98/18/EC to different classes of passenger ships. The Directive includes a procedure for the publication of lists of sea areas that has proved difficult to implement. It is therefore necessary to establish a functional and transparent procedure, enabling effective monitoring of the implementation of the Directive. (3) With a view to harmonising the level of safety applying to passenger ships across the Community, the derogation given to Greece in relation to the timetable for the application of the safety requirements should be deleted. (4) Directive 2003/25/EC of the European Parliament and of the Council of 14 April 2003 on specific stability requirements for ro-ro passenger ships(5) introduces strengthened stability requirements for ro-ro passenger vessels operating on international services to and from Community ports, and this enhanced measure should also apply to certain categories of such vessels operating on domestic services under the same sea conditions. Failure to apply such stability requirements should be grounds for phasing out ro-ro passenger ships after a certain number of years of operation. (5) In view of the structural modifications that the existing ro-ro passenger ships may need to undergo in order to comply with the specific stability requirements, those requirements should be introduced over a period of years in order to allow to the part of the industry affected sufficient time to comply: to that end, a phasing-in timetable for existing ships should be provided. This phasing-in timetable should not affect the enforcement of the specific stability requirements in the sea areas covered by the Annexes to the Stockholm Agreement of 28 February 1996. (6) It is necessary to take account of changes that have been made to relevant international instruments, such as the International Maritime Organisation (IMO) conventions, protocols, codes and resolutions, and to do so in a flexible and rapid manner. (7) By virtue of Directive 98/18/EC, the International Code for Safety of High-Speed Craft contained in IMO Maritime Safety Committee Resolution MSC 36 (63) of 20 May 1994 applies to all high-speed passenger craft operating on domestic services. The IMO has adopted a new high-speed craft code, the International Code for Safety of High-Speed Craft, 2000 (2000 HSC Code), contained in IMO Maritime Safety Committee Resolution MSC 97(73) of 5 December 2000, applying to all high-speed craft constructed on or after 1 July 2002. It is important to ensure that Directive 98/18/EC can be updated in a flexible manner to apply such developments at the international level, also to high-speed passenger craft operating on domestic services. (8) It is important to apply appropriate measures to ensure the access in safe conditions of persons with reduced mobility to ships and high-speed passenger craft operating on domestic services in the Member States. (9) Directive 98/18/EC should therefore be amended accordingly, Article 1 Directive 98/18/EC is hereby amended as follows: 1. in Article 2 the following points shall be added: "(ea) 'ro-ro passenger ship' means a ship carrying more than 12 passengers, having ro-ro cargo spaces or special category spaces, as defined in regulation II-2/A/2 contained in Annex I." "(ha) 'age' means the age of the ship, expressed in number of years after the date of its delivery." "(w) 'persons with reduced mobility' means anyone who has a particular difficulty when using public transport, including elderly persons, disabled persons, persons with sensory impairments and wheelchair users, pregnant women and persons accompanying small children."; 2. Article 4(2) shall be replaced by the following: "2. Each Member State shall: (a) establish, and update, when necessary, a list of sea areas under its jurisdiction, delimiting the zones for all-year-round operation and, where appropriate, restricted periodical operation of the classes of ships, using the criteria for classes set out in paragraph 1; (b) publish the list in a public database available on the Internet site of the competent maritime authority; (c) notify to the Commission the location of such information, and when modifications are made to the list."; 3. the following Articles shall be inserted: "Article 6a Stability requirements and phasing-out of ro-ro passenger ships 1. All ro-ro passenger ships of Classes A, B, and C, the keel of which is laid or which are at a similar stage of construction on or after 1 October 2004 shall comply with Articles 6, 8 and 9 of Directive 2003/25/EC of the European Parliament and of the Council of 14 April 2003 on specific stability requirements for ro-ro passenger ships(6). 2. All ro-ro passenger ships of Classes A and B, the keel of which is laid or which are at a similar stage of construction before 1 October 2004 shall comply with Articles 6, 8 and 9 of Directive 2003/25/EC by 1 October 2010, unless they are phased out on that date or on a later date on which they reach the age of 30 years but in any case not later than 1 October 2015. Article 6b Safety requirements for persons with reduced mobility 1. Member States shall ensure that appropriate measures are taken, based, where practicable, on the guidelines in Annex III to enable persons with reduced mobility to have safe access to all passenger ships of Classes A, B, C and D and to all high-speed passenger craft, used for public transport, the keel of which is laid or which are at a similar stage of construction on or after 1 October 2004. 2. Member States shall cooperate with and consult organisations representing persons with reduced mobility on the implementation of the guidelines included in Annex III. 3. For the purpose of modification of passenger ships of Classes A, B, C and D and high-speed passenger craft, used for public transport, the keel of which is laid or which are at a similar stage of construction before 1 October 2004, Member States shall apply the guidelines in Annex III as far as reasonable and practicable in economic terms. Member States shall draw up a national action plan on how the guidelines shall be applied to such ships and craft. They shall forward that plan to the Commission not later than 17 May 2005. 4. Member States shall report to the Commission on the implementation of this Article as regards all passenger ships referred to in paragraph 1, passenger ships referred to in paragraph 3 certified to carry more than 400 passengers and all high-speed passenger craft, not later than 17 May 2006." 4. Annex III shall be added, as set out in the Annex. Article 2 Article 6(3)(g) of Directive 98/18/EC shall be deleted with effect from 1 January 2005. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 17 November 2004. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 4 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32003L0025

2003

Directive 2003/25/EC of the European Parliament and of the Council of 14 April 2003 on specific stability requirements for ro-ro passenger ships (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof, Having regard to the proposal from the Commission(1), Having regard to the Opinion of the European Economic and Social Committee(2), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Within the framework of the common transport policy further measures should be taken to improve safety in maritime transport of passengers. (2) The Community wishes to avoid by all appropriate means shipping accidents involving ro-ro passenger ships and resulting in loss of life. (3) The survivability of ro-ro passenger ships following collision damage, as determined by their damage stability standard, is an essential factor for the safety of passengers and crew and is particularly relevant for search and rescue operations; the most dangerous problem for the stability of a ro-ro passenger ship with an enclosed ro-ro deck, following collision damage, is the one posed by the effect of a build up of significant amounts of water on that deck. (4) Persons using ro-ro passenger ships and crew employed on board such vessels throughout the Community should have the right to demand the same high level of safety regardless of the area in which ships operate. (5) In view of the internal market dimension of maritime transport of passengers, action at Community level is the most effective way of establishing a common minimum level of safety for ships throughout the Community. (6) Action at Community level is the best way to ensure the harmonised enforcement of principles agreed on within the International Maritime Organisation (IMO), thus avoiding distortions of competition between the operators of ro-ro passenger ships operating in the Community. (7) General stability requirements for ro-ro passenger ships in damaged condition were established at international level by the 1990 Safety of Life at Sea (SOLAS 90) Conference and were included in Regulation II-1/B/8 of the SOLAS Convention (SOLAS 90 standard). These requirements are applicable in the entire Community owing to the direct application to international voyages of the SOLAS Convention and the application to domestic voyages of Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(4). (8) The SOLAS 90 damage stability standard implicitly includes the effect of water entering the ro-ro deck in a sea state of the order of 1,5 m significant wave height. (9) IMO Resolution 14 of the 1995 SOLAS Conference, allowed IMO members to conclude regional agreements if they consider that prevailing sea conditions and other local conditions require specific stability requirements in a designated area. (10) Eight northern European countries, including seven Member States, agreed in Stockholm on 28 February 1996 to introduce a higher stability standard for ro-ro passenger ships in damaged condition in order to take into account the effect of water accumulation on the ro-ro deck and to enable the ship to survive in more severe states than the SOLAS 90 standard, up to 4 m significant wave heights. (11) Under this agreement, known as the Stockholm Agreement, the specific stability standard is directly related to the sea area in which the vessel operates and more particularly to the significant wave height recorded in the area of operation; the significant wave height of the area where the ship operates determines the height of water on the car deck that would arise following the occurrence of accidental damage. (12) At the conclusion of the Conference at which the Stockholm Agreement was adopted, the Commission noted that the Agreement was not applicable in other parts of the Community and announced its intention to examine the prevailing local conditions under which ro-ro passenger ships sail in all European waters and to take appropriate initiatives. (13) The Council entered a statement in the minutes of the 2074th Council meeting of 17 March 1998 stressing the need to ensure the same level of safety for all passenger ferries operating in similar conditions, whether on international or on domestic voyages. (14) In its Resolution of 5 October 2000 on the sinking of the Greek ferry "Samina"(5), the European Parliament expressly stated that it awaited the evaluation by the Commission of the effectiveness of the Stockholm Agreement and other measures for improving the stability and safety of passenger ships. (15) Following an expert study by the Commission, the wave height conditions in south European waters were found to be similar to those in the north. While meteorological conditions may be generally more favourable in the south, the stability standard determined in the context of the Stockholm Agreement is based solely on the significant wave height parameter and the way this influences the accumulation of water on the ro-ro deck. (16) The application of Community safety standards regarding the stability requirements for ro-ro passenger ships is essential for the safety of these vessels and has to be part of the common maritime safety framework. (17) In the interests of improving safety and avoiding distortion of competition, the common safety standards regarding stability should apply to all ro-ro passenger ships, regardless of the flag that they fly, providing regular services to or from a port in the Member States on international voyages. (18) The safety of ships is primarily the responsibility of flag States and therefore each Member State should ensure compliance with the safety requirements applicable to the ro-ro passenger ships flying the flag of that Member State. (19) Member States should also be addressed in their capacity as host States. The responsibilities exercised in that capacity are based on specific port State responsibilities that are fully in line with the 1982 United Nations Convention on the Law of the Sea (Unclos). (20) The specific stability requirements introduced by this Directive should be based on a method, as set out in the Annexes to the Stockholm Agreement, which calculates the height of water on the ro-ro deck following collision damage in relation to two basic parameters: the ship's residual freeboard and the significant wave height in the sea area where the ship operates. (21) Member States should determine and publicise the significant wave heights in the sea areas crossed by ro-ro passenger ships on regular service to or from their ports. For international routes the significant wave heights should, wherever applicable and possible, be established in agreement between the States at both ends of the route. Significant wave heights for seasonal operation in the same sea areas may also be determined. (22) Every ro-ro passenger ship engaged in voyages within the scope of this Directive should fulfil the stability requirements in relation to the significant wave heights determined for its area of operation. It should carry a certificate of compliance issued by the Administration of the flag State, which should be accepted by all other Member States. (23) The SOLAS 90 Standard provides a level of safety equivalent to the specific stability requirements established by this Directive for ships operating in sea areas where the significant wave height is equal to or less than 1,5 m. (24) In view of the structural modifications that the existing ro-ro passenger ships may need to undergo in order to comply with the specific stability requirements, those requirements should be introduced over a period of years in order to allow to the part of the industry affected sufficient time to comply: to that end, a phasing-in timetable for existing ships should be provided. This phasing-in timetable should not affect the enforcement of the specific stability requirements in the sea areas covered by the Annexes to the Stockholm Agreement. (25) Article 4(1)(e) of Council Directive 1999/35/EC of 29 April 1999 on a system of mandatory surveys for the safe operation of regular ro-ro ferry and high-speed passenger craft services(6) provides that host States are to check that ro-ro passenger ferries and high-speed passenger craft comply with specific stability requirements adopted at regional level and transposed into their national legislation, when these ships operate a service covered by that national legislation in the region concerned. (26) High-speed passenger craft as defined in Regulation 1 of Chapter X of the SOLAS Convention, as amended, should not be required to comply with the provisions of this Directive, provided that they comply entirely with the provisions of the IMO "International code for safety of high-speed craft", as amended. (27) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7). (28) Since the objective of the proposed action, namely to safeguard human life at sea by improving the survivability of ro-ro passenger ships in the event of damage, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective, Article 1 Purpose The purpose of this Directive is to lay down a uniform level of specific stability requirements for ro-ro passenger ships, which will improve the survivability of this type of vessel in case of collision damage and provide a high level of safety for the passengers and the crew. Article 2 Definitions For the purpose of this Directive, the following definitions shall apply: (a) "ro-ro passenger ship" means a ship carrying more than 12 passengers, having ro-ro cargo spaces or special category spaces, as defined in Regulation II-2/3 of the SOLAS Convention, as amended; (b) "new ship" means a ship the keel of which is laid or which is at a similar stage of construction on or after 1 October 2004: a similar stage of construction means the stage at which: (i) construction identifiable with a specific ship begins; and (ii) assembly of that ship has commenced comprising at least 50 tonnes or 1 % of the estimated mass of structural material, whichever is less; (c) "an existing ship" means a ship which is not a new ship; (d) "a passenger" is every person other than the master and the members of the crew or other persons employed or engaged in any capacity on board a ship on the business of that ship and other than a child under one year of age; (e) "international Conventions" means the 1974 International Convention for the Safety of Life at Sea (the SOLAS Convention), and the 1966 International Convention on Load Lines, together with Protocols and amendments thereto in force; (f) "regular service" means a series of ro-ro passenger ship crossings serving traffic between the same two or more ports, which is operated either: (i) according to a published timetable; or (ii) with crossings so regular or frequent that they constitute a recognisable systematic series; (g) "Stockholm Agreement" means the Agreement concluded at Stockholm on 28 February 1996 in pursuance of SOLAS 95 Conference Resolution 14 "Regional agreements on specific stability requirements for ro-ro passenger ships", adopted on 29 November 1995; (h) "administration of flag State" means the competent authorities of the State whose flag the ro-ro passenger ship is entitled to fly; (i) "host State" means a Member State to or from whose ports a ro-ro passenger ship is engaged on a regular service; (j) "international voyage" means a sea voyage from a port of a Member State to a port outside that Member State, or vice versa; (k) "specific stability requirements" means the stability requirements set out in Annex I; (l) "significant wave height" ("hs") is the average height of the highest third of wave heights observed over a given period; (m) "residual freeboard" ("fr") is the minimum distance between the damaged ro-ro deck and the final waterline at the location of the damage, without taking into account the additional effect of the sea water accumulated on the damaged ro-ro deck. Article 3 Scope 1. This Directive shall apply to all ro-ro passenger ships operating to or from a port of a Member State on a regular service, regardless of their flag, when engaged on international voyages. 2. Each Member State, in its capacity as host State, shall ensure that ro-ro passenger ships, flying the flag of a State which is not a Member State, comply fully with the requirements of this Directive before they may be engaged on voyages from or to ports of that Member State in accordance with Article 4 of Directive 1999/35/EC. Article 4 Significant wave heights The significant wave heights (hS) shall be used for determining the height of water on the car deck when applying the specific stability requirements contained in Annex I. The figures of significant wave heights shall be those which are not exceeded by a probability of more than 10 % on a yearly basis. Article 5 Sea areas 1. Host States shall establish, not later than 17 May 2004, a list of sea areas crossed by ro-ro passenger ships operating on regular service to or from their ports as well as the corresponding values of significant wave heights in these areas. 2. The sea areas and the applicable values of the significant wave height in these areas shall be defined by agreement between the Member States or, wherever applicable and possible, between Member States and third countries at both ends of the route. Where the ship's route crosses more than one sea area, the ship shall satisfy the specific stability requirements for the highest value of significant wave height identified for these areas. 3. The list shall be notified to the Commission and published in a public database available in the internet site of the competent maritime authority. The location of such information as well as any updates to the list and the reasons for such updates shall also be notified to the Commission. Article 6 Specific stability requirements 1. Without prejudice to the requirements of Regulation II-I/B/8 of the SOLAS Convention (SOLAS 90 standard) relating to watertight subdivision and stability in damaged condition, all ro-ro passenger ships referred to in Article 3(1) shall comply with the specific stability requirements set out in Annex I to this Directive. 2. For ro-ro passenger ships operating exclusively in sea areas where the significant wave height is equal to or lower than 1,5 metres, compliance with the requirements of the regulation referred to in paragraph 1 shall be considered equivalent to compliance with the specific stability requirements set out in Annex I. 3. In applying the requirements set out in Annex I, Member States shall use the guidelines set out in Annex II, in so far this is practicable and compatible with the design of the ship in question. Article 7 Introduction of the specific stability requirements 1. New ro-ro passenger ships shall comply with the specific stability requirements as set out in Annex I. 2. Existing ro-ro passenger ships, with the exception of those ships to which Article 6(2) applies, shall comply with the specific stability requirements as set out in Annex I not later than 1 October 2010. Existing ro-ro passenger ships which on 17 May 2003 are in compliance with the requirements of the regulation referred to in Article 6(1) shall comply with the specific stability requirements as set out in Annex I not later than 1 October 2015. 3. This Article shall be without prejudice to Article 4(1)(e) of Directive 1999/35/EC. Article 8 Certificates 1. All new and existing ro-ro passenger ships flying the flag of a Member State shall carry a certificate confirming compliance with the specific stability requirements established in Article 6 and Annex I. This certificate, which shall be issued by the administration of the flag State and may be combined with other related certificates, will indicate the significant wave height up to which the ship can satisfy the specific stability requirements. The certificate shall remain valid as long as the ship operates in an area with the same or a lower value of significant wave height. 2. Each Member State acting in its capacity as host State shall recognise certificates issued by another Member State in pursuance of this Directive. 3. Each Member State acting in its capacity as host State shall accept certificates issued by a third country certifying that a ship complies with the specific stability requirements established. Article 9 Seasonal and short-time period operations 1. If a shipping company operating a regular service on a year-round basis wishes to introduce additional ro-ro passenger ships to operate for a shorter period on that service, it shall notify the competent authority of the host State or States not later than one month before the said ships are operated on that service. However, in cases where, following unforeseen circumstances, a replacement ro-ro passenger ship must be introduced rapidly to ensure continuity of service, Directive 1999/35/EC shall apply. 2. If a shipping company wishes to operate seasonally a regular service for a shorter time period not exceeding six months a year, it shall notify the competent authority of the host State or States not later than three months before such operation takes place. 3. Where such operations take place under conditions of lower significant wave height than those established for the same sea area for all-year-round operation, the significant wave height value applicable for this shorter time period may be used by the competent authority for determining the height of water on the deck when applying the specific stability requirements contained in Annex I. The value of the significant wave height applicable for this shorter time period shall be agreed between the Member States or, wherever applicable and possible, between Member States and third countries at both ends of the route. 4. Following agreement of the competent authority of the host State or States for operations within the meaning of paragraphs 1 and 2, the ro-ro passenger ship which undertakes such operations shall be required to carry a certificate confirming compliance with the provisions of this Directive, as provided for in Article 8(1). Article 10 Adaptations In order to take account of developments at international level, in particular, in the International Maritime Organisation (IMO), and to improve the effectiveness of this Directive in the light of experience and of technical progress, the Annexes may be amended in accordance with the procedure referred to in Article 11(2). Article 11 Committee 1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships established pursuant to Article 3 of Regulation (EC) No 2099/2002(8). 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at eight weeks. 3. The Committee shall adopt its Rules of Procedure. Article 12 Penalties Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Article 13 Implementation Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 17 November 2004. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 14 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 15 Addressees This Directive is addressed to the Member States.

32003L0030

2003

Directive 2003/30/EC of the European Parliament and of the Council of 8 May 2003 on the promotion of the use of biofuels or other renewable fuels for transport Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Having regard to the opinion of the Committee of the Regions(3), Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), Whereas: (1) The European Council meeting at Gothenburg on 15 and 16 June 2001 agreed on a Community strategy for sustainable development consisting in a set of measures, which include the development of biofuels. (2) Natural resources, and their prudent and rational utilisation as referred to in Article 174(1) of the Treaty, include oil, natural gas and solid fuels, which are essential sources of energy but also the leading sources of carbon dioxide emissions. (3) However, there is a wide range of biomass that could be used to produce biofuels, deriving from agricultural and forestry products, as well as from residues and waste from forestry and the forestry and agrifoodstuffs industry. (4) The transport sector accounts for more than 30 % of final energy consumption in the Community and is expanding, a trend which is bound to increase, along with carbon dioxide emissions and this expansion will be greater in percentage terms in the candidate countries following their accession to the European Union. (5) The Commission White Paper "European transport policy for 2010: time to decide" expects CO2 emissions from transport to rise by 50 % between 1990 and 2010, to around 1113 million tonnes, the main responsibility resting with road transport, which accounts for 84 % of transport-related CO2 emissions. From an ecological point of view, the White Paper therefore calls for dependence on oil (currently 98 %) in the transport sector to be reduced by using alternative fuels such as biofuels. (6) Greater use of biofuels for transport forms a part of the package of measures needed to comply with the Kyoto Protocol, and of any policy package to meet further commitments in this respect. (7) Increased use of biofuels for transport, without ruling out other possible alternative fuels, including automotive LPG and CNG, is one of the tools by which the Community can reduce its dependence on imported energy and influence the fuel market for transport and hence the security of energy supply in the medium and long term. However, this consideration should not detract in any way from the importance of compliance with Community legislation on fuel quality, vehicle emissions and air quality. (8) As a result of technological advances, most vehicles currently in circulation in the European Union are capable of using a low biofuel blend without any problem. The most recent technological developments make it possible to use higher percentages of biofuel in the blend. Some countries are already using biofuel blends of 10 % and higher. (9) Captive fleets offer the potential of using a higher concentration of biofuels. In some cities captive fleets are already operating on pure biofuels and, in some cases, this has helped to improve air quality in urban areas. Member States could therefore further promote the use of biofuels in public transport modes. (10) Promoting the use of biofuels in transport constitutes a step towards a wider application of biomass which will enable biofuel to be more extensively developed in the future, whilst not excluding other options and, in particular, the hydrogen option. (11) The research policy pursued by the Member States relating to increased use of biofuels should incorporate the hydrogen sector to a significant degree and promote this option, taking into account the relevant Community framework programmes. (12) Pure vegetable oil from oil plants produced through pressing, extraction or comparable procedures, crude or refined but chemically unmodified, can also be used as biofuel in specific cases where its use is compatible with the type of engines involved and the corresponding emission requirements. (13) New types of fuel should conform to recognised technical standards if they are to be accepted to a greater extent by customers and vehicle manufacturers and hence penetrate the market. Technical standards also form the basis for requirements concerning emissions and the monitoring of emissions. Difficulties may be encountered in ensuring that new types of fuel meet current technical standards, which, to a large extent, have been developed for conventional fossil fuels. The Commission and standardisation bodies should monitor developments and adapt and develop actively standards, particularly volatility aspects, so that new types of fuel can be introduced, whilst maintaining environmental performance requirements. (14) Bioethanol and biodiesel, when used for vehicles in pure form or as a blend, should comply with the quality standards laid down to ensure optimum engine performance. It is noted that in the case of biodiesel for diesel engines, where the processing option is esterification, the standard prEN 14214 of the European Committee for Standardisation (CEN) on fatty acid methyl esters (FAME) could be applied. Accordingly, the CEN should establish appropriate standards for other transport biofuel products in the European Union. (15) Promoting the use of biofuels in keeping with sustainable farming and forestry practices laid down in the rules governing the common agricultural policy could create new opportunities for sustainable rural development in a more market-orientated common agriculture policy geared more to the European market and to respect for flourishing country life and multifunctional agriculture, and could open a new market for innovative agricultural products with regard to present and future Member States. (16) In its resolution of 8 June 1998(5), the Council endorsed the Commission's strategy and action plan for renewable energy sources and requested specific measures in the biofuels sector. (17) The Commission Green Paper "Towards a European strategy for the security of energy supply" sets the objective of 20 % substitution of conventional fuels by alternative fuels in the road transport sector by the year 2020. (18) Alternative fuels will only be able to achieve market penetration if they are widely available and competitive. (19) In its resolution of 18 June 1998(6), the European Parliament called for an increase in the market share of biofuels to 2 % over five years through a package of measures, including tax exemption, financial assistance for the processing industry and the establishment of a compulsory rate of biofuels for oil companies. (20) The optimum method for increasing the share of biofuels in the national and Community markets depends on the availability of resources and raw materials, on national and Community policies to promote biofuels and on tax arrangements, and on the appropriate involvement of all stakeholders/parties. (21) National policies to promote the use of biofuels should not lead to prohibition of the free movement of fuels that meet the harmonised environmental specifications as laid down in Community legislation. (22) Promotion of the production and use of biofuels could contribute to a reduction in energy import dependency and in emissions of greenhouse gases. In addition, biofuels, in pure form or as a blend, may in principle be used in existing motor vehicles and use the current motor vehicle fuel distribution system. The blending of biofuel with fossil fuels could facilitate a potential cost reduction in the distribution system in the Community. (23) Since the objective of the proposed action, namely the introduction of general principles providing for a minimum percentage of biofuels to be marketed and distributed, cannot be achieved sufficiently by the Member States by reason of the scale of the action, and can therefore be achieved better at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (24) Research and technological development in the field of the sustainability of biofuels should be promoted. (25) An increase in the use of biofuels should be accompanied by a detailed analysis of the environmental, economic and social impact in order to decide whether it is advisable to increase the proportion of biofuels in relation to conventional fuels. (26) Provision should be made for the possibility of adapting rapidly the list of biofuels, the percentage of renewable contents, and the schedule for introducing biofuels in the transport fuel market, to technical progress and to the results of an environmental impact assessment of the first phase of introduction. (27) Measures should be introduced for developing rapidly the quality standards for the biofuels to be used in the automotive sector, both as pure biofuels and as a blending component in the conventional fuels. Although the biodegradable fraction of waste is a potentially useful source for producing biofuels, the quality standard has to take into account the possible contamination present in the waste to avoid special components damaging the vehicle or causing emissions to deteriorate. (28) Encouragement of the promotion of biofuels should be consistent with security of supply and environmental objectives and related policy objectives and measures within each Member State. In doing so, Member States may consider cost-effective ways of publicising the possibilities of using biofuels. (29) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7), Article 1 This Directive aims at promoting the use of biofuels or other renewable fuels to replace diesel or petrol for transport purposes in each Member State, with a view to contributing to objectives such as meeting climate change commitments, environmentally friendly security of supply and promoting renewable energy sources. Article 2 1. For the purpose of this Directive, the following definitions shall apply: (a) "biofuels" means liquid or gaseous fuel for transport produced from biomass; (b) "biomass" means the biodegradable fraction of products, waste and residues from agriculture (including vegetal and animal substances), forestry and related industries, as well as the biodegradable fraction of industrial and municipal waste; (c) "other renewable fuels" means renewable fuels, other than biofuels, which originate from renewable energy sources as defined in Directive 2001/77/EC(8) and used for transport purposes; (d) "energy content" means the lower calorific value of a fuel. 2. At least the products listed below shall be considered biofuels: (a) "bioethanol": ethanol produced from biomass and/or the biodegradable fraction of waste, to be used as biofuel; (b) "biodiesel": a methyl-ester produced from vegetable or animal oil, of diesel quality, to be used as biofuel; (c) "biogas": a fuel gas produced from biomass and/or from the biodegradable fraction of waste, that can be purified to natural gas quality, to be used as biofuel, or woodgas; (d) "biomethanol": methanol produced from biomass, to be used as biofuel; (e) "biodimethylether": dimethylether produced from biomass, to be used as biofuel; (f) "bio-ETBE (ethyl-tertio-butyl-ether)": ETBE produced on the basis of bioethanol. The percentage by volume of bio-ETBE that is calculated as biofuel is 47 %; (g) "bio-MTBE (methyl-tertio-butyl-ether)": a fuel produced on the basis of biomethanol. The percentage by volume of bio-MTBE that is calculated as biofuel is 36 %; (h) "synthetic biofuels": synthetic hydrocarbons or mixtures of synthetic hydrocarbons, which have been produced from biomass; (i) "biohydrogen": hydrogen produced from biomass, and/or from the biodegradable fraction of waste, to be used as biofuel; (j) "pure vegetable oil": oil produced from oil plants through pressing, extraction or comparable procedures, crude or refined but chemically unmodified, when compatible with the type of engines involved and the corresponding emission requirements. Article 3 1. (a) Member States should ensure that a minimum proportion of biofuels and other renewable fuels is placed on their markets, and, to that effect, shall set national indicative targets. (b) (i) A reference value for these targets shall be 2 %, calculated on the basis of energy content, of all petrol and diesel for transport purposes placed on their markets by 31 December 2005. (ii) A reference value for these targets shall be 5,75 %, calculated on the basis of energy content, of all petrol and diesel for transport purposes placed on their markets by 31 December 2010. 2. Biofuels may be made available in any of the following forms: (a) as pure biofuels or at high concentration in mineral oil derivatives, in accordance with specific quality standards for transport applications; (b) as biofuels blended in mineral oil derivatives, in accordance with the appropriate European norms describing the technical specifications for transport fuels (EN 228 and EN 590); (c) as liquids derived from biofuels, such as ETBE (ethyl-tertio-butyl-ether), where the percentage of biofuel is as specified in Article 2(2). 3. Member States shall monitor the effect of the use of biofuels in diesel blends above 5 % by non-adapted vehicles and shall, where appropriate, take measures to ensure compliance with the relevant Community legislation on emission standards. 4. In the measures that they take, the Member States should consider the overall climate and environmental balance of the various types of biofuels and other renewable fuels and may give priority to the promotion of those fuels showing a very good cost-effective environmental balance, while also taking into account competitiveness and security of supply. 5. Member States shall ensure that information is given to the public on the availability of biofuels and other renewable fuels. For percentages of biofuels, blended in mineral oil derivatives, exceeding the limit value of 5 % of fatty acid methyl ester (FAME) or of 5 % of bioethanol, a specific labelling at the sales points shall be imposed. Article 4 1. Member States shall report to the Commission, before 1 July each year, on: - the measures taken to promote the use of biofuels or other renewable fuels to replace diesel or petrol for transport purposes, - the national resources allocated to the production of biomass for energy uses other than transport, and - the total sales of transport fuel and the share of biofuels, pure or blended, and other renewable fuels placed on the market for the preceding year. Where appropriate, Member States shall report on any exceptional conditions in the supply of crude oil or oil products that have affected the marketing of biofuels and other renewable fuels. In their first report following the entry into force of this Directive, Member States shall indicate the level of their national indicative targets for the first phase. In the report covering the year 2006, Member States shall indicate their national indicative targets for the second phase. In these reports, differentiation of the national targets, as compared to the reference values referred to in Article 3(1)(b), shall be motivated and could be based on the following elements: (a) objective factors such as the limited national potential for production of biofuels from biomass; (b) the amount of resources allocated to the production of biomass for energy uses other than transport and the specific technical or climatic characteristics of the national market for transport fuels; (c) national policies allocating comparable resources to the production of other transport fuels based on renewable energy sources and consistent with the objectives of this Directive. 2. By 31 December 2006 at the latest, and every two years thereafter, the Commission shall draw up an evaluation report for the European Parliament and for the Council on the progress made in the use of biofuels and other renewable fuels in the Member States. This report shall cover at least the following: (a) the cost-effectiveness of the measures taken by Member States in order to promote the use of biofuels and other renewable fuels; (b) the economic aspects and the environmental impact of further increasing the share of biofuels and other renewable fuels; (c) the life-cycle perspective of biofuels and other renewable fuels, with a view to indicating possible measures for the future promotion of those fuels that are climate and environmentally friendly, and that have the potential of becoming competitive and cost-efficient; (d) the sustainability of crops used for the production of biofuels, particularly land use, degree of intensity of cultivation, crop rotation and use of pesticides; (e) the assessment of the use of biofuels and other renewable fuels with respect to their differentiating effects on climate change and their impact on CO2 emissions reduction; (f) a review of further more long-term options concerning energy efficiency measures in transport. On the basis of this report, the Commission shall submit, where appropriate, proposals to the European Parliament and to the Council on the adaptation of the system of targets, as laid down in Article 3(1). If this report concludes that the indicative targets are not likely to be achieved for reasons that are unjustified and/or do not relate to new scientific evidence, these proposals shall address national targets, including possible mandatory targets, in the appropriate form. Article 5 The list contained in Article 2(2) may be adapted to technical progress in accordance with the procedure referred to in Article 6(2). When adapting this list, the environmental impact of biofuels shall be taken into account. Article 6 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. Article 7 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2004 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive. Article 8 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 9 This Directive is addressed to the Member States.

32003L0039

2003

Commission Directive 2003/39/EC of 15 May 2003 amending Council Directive 91/414/EEC to include propineb and propyzamide as active substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant-protection products on the market(1), as last amended by Commission Directive 2003/31/EC(2), and in particular Article 6(1) thereof, Whereas: (1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant-protection products on the market(3), as last amended by Regulation (EC) No 2266/2000(4), establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes propineb and propyzamide. (2) For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. In accordance with Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant-protection products and designating the rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92(5), as last amended by Regulation (EC) No 2230/95(6), the following rapporteur Member States were designated, which in turn submitted the relevant assessment reports and recommendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92: for propineb: rapporteur Member State Italy, all relevant information was submitted on 17 July 1996; for propyzamide: rapporteur Member State Sweden, all relevant information was submitted on 19 May 1998. (3) Those assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. (4) In accordance with Article 6(4) of Directive 91/414/EEC and in view of a possible unfavourable decision for propineb, the Commission organised a tripartite meeting with the main data submitter and the rapporteur Member State on 4 December 1997. The main data submitter provided further data in order to meet the initial concerns. (5) The reviews of all active substances were finalised on 26 February 2003 in the format of the Commission review reports for propineb and propyzamide. (6) The review of propyzamide did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants. (7) The report on propineb and further information were also submitted to the Scientific Committee for Plants for separate consultation. The Scientific Committee was asked to comment on the long-term exposure assessment for birds and on the appropriate animal model to be used for derivation of the acceptable daily intake (ADI) and the acceptable operator exposure level (AOEL). In its opinion(7) the Committee identified a number of respects in which the risks from propineb to birds and from propineb and the metabolite PTU to wild mammals have not been adequately addressed and also indicated ways to improve the risk assessment. Additionally, the Committee emphasised the necessity of a clear expression and justification of all end points, data, assumptions and rationales used for risk assessment. The Committee considered that the rat is the appropriate species for the derivation of ADI and AOEL. The recommendations of the Scientific Committee were taken into account during the further review and in this Directive and in the review report. After the missing information was subsequently delivered by the main notifier and evaluated by the rapporteur Member State, the Member States within the Standing Committee concluded that the risk for birds and wild mammals would be acceptable if appropriate risk-mitigation measures are applied. (8) It has appeared from the various examinations made that plant-protection products containing propineb or propyzamide may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant-protection products containing this active substance can be granted in accordance with the provisions of that Directive. (9) The Commission review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Directive 91/414/EEC. It is, therefore, appropriate to provide that the finalised review report, except for confidential information, should be kept available or made available by the Member States for consultation by any interested parties. (10) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will resulting from the inclusion. (11) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant-protection products containing propineb or propyzamide, and in particular, to review existing authorisations to ensure that the conditions regarding those active substances set out in Annex I to Directive 91/414/EEC are satisfied. A longer period should be provided for the submission and assessment of the complete dossier of each plant-protection product in accordance with the uniform principles laid down in Directive 91/414/EEC. (12) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (13) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 30 September 2004 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 October 2004. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall review the authorisation for each plant-protection product containing propineb or propyzamide to ensure that the conditions relating to those active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary and by 30 September 2004 at the latest, they shall amend or withdraw the authorisation. 2. Member States shall, for each authorised plant-protection product containing propineb or propyzamide as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 March 2004 at the latest, re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 31 March 2008 at the latest, they shall amend or withdraw the authorisation. Article 4 This Directive shall enter into force on 1 April 2004. Article 5 This Directive is addressed to the Member States.

32003L0040

2003

Commission Directive 2003/40/EC of 16 May 2003 establishing the list, concentration limits and labelling requirements for the constituents of natural mineral waters and the conditions for using ozone-enriched air for the treatment of natural mineral waters and spring waters Having regard to the Treaty establishing the European Community, Having regard to Council Directive 80/777/EEC(1), of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters, as last amended by Directive 96/70/EC of the European Parliament and of the Council(2), and in particular Article 11(1) thereof, Whereas: (1) Constituents may be present in the natural state in certain natural mineral waters because of their hydrogeological origin and may present a risk to public health above a certain concentration. It is therefore deemed necessary to establish concentration limits for these constituents in natural mineral waters. (2) Article 11 of Directive 80/777/EEC makes provision for adopting harmonised concentration limits for the constituents of natural mineral waters after consulting the Scientific Committee for Food, and for labelling requirements to indicate, where applicable, the presence of certain constituents at high concentrations. (3) The Scientific Committee for Food issued an opinion(3), on arsenic, barium, fluoride, boron and manganese and, for other constituents of natural mineral waters, validated the limits recommended by the WHO for drinking water. (4) The revised Codex standard for "natural mineral waters"(4), gives, for health purposes, a list of constituents and maximum limits for these constituents. It was adopted on the basis of the most recent international scientific data and affords sufficient public health protection. (5) It is generally acknowledged that a low-level fluoride intake can have a beneficial effect on teeth. By contrast, excessive fluoride intake across the board can have harmful effects on public health. Thus, it is necessary to lay down a harmonised maximum limit for fluoride in natural mineral waters affording sufficient protection for the population as a whole. (6) The World Health Organisation recommended a guide value of 1,5 mg/l for fluoride for drinking water, which was validated for natural mineral waters by the Scientific Committee for Food in the abovementioned opinion. In order to protect infants and young children, who are the most sensitive to the risk of fluorosis, where the fluoride content of a natural mineral water exceeds this guide value, a reference to this fact, which can be seen easily by the consumer, also needs to be made on the label. (7) The Scientific Committee for Food indicated a guide value for boron in natural mineral waters based on the WHO(5), recommendations of 1996. However, the WHO and other internationally recognised scientific organisations have since then made new appraisals of boron's effect on public health and have recommended higher values. The European Food Safety Authority should therefore be consulted about boron in natural mineral waters so that the new scientific appraisals available can be taken into account and a maximum limit for boron should not be set at this stage. (8) The Scientific Committee for Food also indicated in the above opinion the acceptable level for barium, manganese and arsenic in natural mineral waters. For the other undesirable constituents of natural mineral waters which may have a harmful effect on public health, the revised Codex standard lays down maximum limits that afford sufficient protection for public health. However, the limit for nitrates is deemed to be too low in the light of the available data and should be brought into line with that for drinking water(6). (9) The maximum limit for nitrates laid down in the Codex standard affords sufficient protection for public health and should serve as a reference for Community and international trade in natural mineral waters. However, during the procedure for official recognition of natural mineral water sources referred to in Article 1 of the aforementioned Directive, the Member States' competent authorities must be able to take a lower guide value for nitrates in natural mineral waters collected within their territory. (10) Natural mineral waters whose content in certain constituents exceeds the maximum limits for these constituents shall, for public health purposes, be subjected to the separation treatments for these constituents. In order to enable the operators concerned to make the necessary investment to comply with these new standards, sufficient periods should be allowed before the maximum concentration limits for such constituents come into force, in particular with regard to fluoride and nickel for which no separation treatment has yet been assessed or authorised at Community level. (11) For the purposes of official checks on these constituents, a fluctuation margin around the maximum concentration limits is required corresponding to measurement uncertainties. (12) Article 4(1)(b) of Directive 80/777/EEC (as amended) provides for the separation of iron, manganese, sulphur and arsenic from certain natural mineral waters, using ozone-enriched air treatment, subject to an assessment of this treatment by the Scientific Committee for Food and adoption of the conditions for use of this treatment by the Standing Committee on the Food Chain and Animal Health. (13) The Scientific Committee for Food issued an opinion(7), on this treatment which provides for both given methods and results. However, it is deemed appropriate to stipulate only given results, in order to take account of developments in ozone-enriched air treatment techniques and treatment variability depending on the physico-chemical composition of the water to be treated. (14) Moreover, treatment with ozone-enriched air should not modify the composition in terms of characteristic constituents within the meaning of Article 7(2)(a) of Directive 80/777/EEC, or have a disinfectant action within the meaning of Article 4(3) or generate the formation of treatment residues which may have a harmful effect on public health. (15) Pursuant to Article 7(2)(c) of the above Directive, natural mineral waters treated with ozone-enriched air must bear a reference on the label giving customers sufficient information about the treatment carried out. (16) In accordance with the provisions of Article 9(4)(a) fourth indent of Directive 80/777/EEC, the provisions concerning the treatments provided for in Article 4 of the Directive, and in particular treatment with ozone-enriched air, are applicable to spring waters. (17) The measures laid down in this Directive are in accordance with the opinion of the Scientific Committee on the Food Chain and Animal Health, Article 1 This Directive establishes the list of constituents of natural mineral waters which may present a risk to public health, the limits for admissible levels of these constituents, the deadlines for application of these limits and the labelling requirements for certain constituents. These constituents must be present in the water naturally and may not result from contamination at source. It also defines the conditions for using ozone-enriched air for separating compounds of iron, manganese, sulphur and arsenic from natural mineral waters or spring waters, and the labelling requirements for waters which have undergone such treatment. Article 2 1. By 1 January 2006 at the latest, natural mineral waters shall, at the time of packaging, comply with the maximum concentration limits set out in Annex I for the constituents listed in that Annex. 2. However, in the case of fluorides and nickel, the deadline referred to above is extended until 1 January 2008. 3. By way of derogation from paragraph 1, during the procedure for official recognition of natural mineral waters collected within their territory, the competent authorities of the Member States may take a lower reference value for nitrates and nitrites, provided that the same reference value is applied to all applications made to them. Article 3 For the purposes of official controls, the Member States shall comply with the specifications listed in Annex II for analysing the constituents listed in Annex I. Article 4 1. Natural mineral waters with a fluoride concentration exceeding 1,5 mg/l shall bear on the label the words "contains more than 1,5 mg/l of fluoride: not suitable for regular consumption by infants and children under 7 years of age". 2. The label information laid down in paragraph 1 of this Article shall be placed in immediate proximity to the trade name and in clearly visible characters. 3. Natural mineral waters which, under the terms of paragraph 1 of this Article, bear label information, shall indicate the actual fluoride content in relation to the physico-chemical composition in terms of essential constituents, as laid down in Article 7(2)(a) of Directive 80/777/EEC. Article 5 1. Without prejudice to the provisions of Article 4(1)(b) of Directive 80/777/EEC, application of the treatment of natural mineral waters with ozone-enriched air must be notified in advance to the competent authorities, who shall ensure that: (a) use of such treatment is justified by the composition of the water in terms of compounds of iron, manganese, sulphur and arsenic; (b) the operator takes all measures necessary to guarantee that the treatment is effective and safe and to allow it to be checked by the competent authorities. 2. Ozone-enriched air treatment of natural mineral waters must comply with all the following conditions: (a) the physico-chemical composition of the natural mineral waters in terms of essential constituents shall not be modified by the treatment; (b) the natural mineral water before treatment must comply with the microbiological criteria laid down in Article 5(1) and (2) of Directive 80/777/EEC; (c) the treatment shall not lead to the formation of residues with a concentration exceeding the maximum limits laid down in Annex III or residues which could pose a risk to public health. Article 6 Pursuant to Article 7(2)(c) of Directive 80/777/EEC, the labelling of natural mineral waters which have been treated with ozone-enriched air shall bear, in proximity to the analytical composition of characteristic constituents, the words "water subjected to an authorised ozone-enriched air oxidation technique". Article 7 Without prejudice to the provisions of Article 9(4)(b) of Directive 80/777/EEC, the provisions of Articles 5 and 6 of this Directive shall apply to spring waters. Article 8 1. The Member States shall take the necessary measures to permit the marketing of products complying with the present Directive by 1 January 2004 at the latest. 2. Without prejudice to the deadlines set out in Article 2(1) and (2), the Member States shall prohibit the marketing of products not complying with the present Directive from 1 July 2004. However, products packaged and labelled prior to 1 July 2004 may be sold until stocks are exhausted. Article 9 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2003 at the latest. They shall forthwith inform the Commission thereof. The provisions adopted pursuant to this paragraph shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. Member States shall determine how such reference is to be made. Article 10 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 11 This Directive is addressed to the Member States.

32003L0034

2003

Directive 2003/34/EC of the European Parliament and of the Council of 26 May 2003 amending for the 23rd time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (substances classified as carcinogens, mutagens or substances toxic to reproduction — c/m/r) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 17 March 2003, Whereas: (1) Under Article 14 of the Treaty, an area without internal frontiers is to be established in which the free movement of goods, persons, services and capital is ensured. (2) On 29 March 1996 the European Parliament and the Council adopted Decision No 646/96/EC adopting an action plan to combat cancer within the framework for action in the field of public health (1996 to 2000)(4). (3) To improve health protection and consumer safety, substances classified as carcinogenic, mutagenic or toxic to reproduction and preparations containing them should not be placed on the market for use by the general public. The Commission should submit as soon as possible a proposal to prohibit the use of products containing such substances, when there is scientific evidence that they are released from these products leading to exposure of, and risk to, the general public. (4) Directive 94/60/EC of the European Parliament and of the Council of 20 December 1994 amending for the 14th time Directive 76/769/EEC(5) establishes, in the form of an Appendix concerning points 29, 30 and 31 of Annex I to Directive 76/769/EEC(6), a list containing substances classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2. Such substances and preparations containing them should not be placed on the market for use by the general public. (5) Directive 94/60/EC provides that the Commission will submit to the European Parliament and Council a proposal to extend this list not later than six months after publication of an adaptation to technical progress of Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(7), which contains substances classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2. (6) Commission Directive 98/98/EC of 15 December 1998 adapting to technical progress for the 25th time Council Directive 67/548/EEC(8), which in particular adapts Annex I thereto, contains 20 substances newly classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2, and Commission Directive 2000/32/EC of 19 May 2000 adapting to technical progress for the 26th time Council Directive 67/548/EEC(9), which in particular adapts Annex I thereto, contains two substances newly classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2. These substances should be added to points 29, 30 and 31 of the Appendix to Annex I to Directive 76/769/EEC. (7) The risks and advantages of the substances thus newly classified have been taken into account. (8) This Directive is to apply without prejudice to Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(10), and individual directives based thereon, in particular Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work(11), Article 1 The substances listed in the Annex shall be added to those listed in the Appendix, under points 29, 30 and 31 respectively, of Annex I to Directive 76/769/EEC. Article 2 1. Member States shall adopt and publish not later than 15 July 2004 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply these measures from 15 January 2005. 2. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0036

2003

Directive 2003/36/EC of the European Parliament and of the Council of 26 May 2003 amending, for the 25th time, Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (substances classified as carcinogens, mutagens or substances toxic to reproduction — c/m/r) (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Council Directive 76/769/EEC(4), lays down restrictions on the marketing and use of certain dangerous substances and preparations. (2) The measures provided for in this Directive fall within the framework of the action plan in Decision No 646/96/EC of the European Parliament and of the Council of 29 March 1996 adopting an action plan to combat cancer within the framework for action in the field of public health (1996 to 2000)(5). (3) In order to improve health protection and consumer safety, substances classified as carcinogenic, mutagenic or toxic to reproduction, and preparations containing them should not be placed on the market for use by the general public. (4) Directive 94/60/EC of the European Parliament and of the Council of 20 December 1994 amending for the 14th time Directive 76/769/EEC(6), establishes, in the form of an appendix concerning points 29, 30 and 31 of Annex I to Directive 76/769/EEC, a list containing substances classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2. Such substances and preparations containing them should not be placed on the market for use by the general public. (5) Directive 94/60/EC envisaged that the said list would be extended shortly after publication of an adaptation to technical progress of Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(7), which lists substances classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2. (6) Commission Directive 2001/59/EC(8), which adapted to technical progress for the 28th time Council Directive 67/548/EEC, and more particularly Annex I thereto, lists two substances newly classified as carcinogenic category 1, 19 substances newly classified as carcinogenic category 2, five substances newly classified as mutagenic category 2, one substance newly classified as toxic to reproduction category 1 and 16 substances newly classified as toxic to reproduction category 2. (7) Those substances should be added to the list in the appendix to Annex I to Directive 76/769/EEC. (8) The risks and advantages of the substances newly classified, by Directive 2001/59/EC, as carcinogenic, mutagenic and toxic to reproduction of category 1 or 2 have been taken into account. (9) This Directive shall apply without prejudice to Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(9), and individual directives based thereon, in particular Council Directive 90/394/EEC of the 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work(10), Article 1 The substances listed in the Annex to this Directive shall be added to those substances listed in the appendix concerning points 29, 30 and 31 of Annex I to Directive 76/769/EEC. The substances listed in the Annex to this Directive in point 1(c) shall be deleted from list 2 of point 29 of Annex I to Directive 76/769/EEC. Article 2 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 25 June 2004. They shall forthwith inform the Commission thereof. They shall apply those provisions from 25 December 2004. 2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0035

2003

Directive 2003/35/EC of the European Parliament and of the Council of 26 May 2003 providing for public participation in respect of the drawing up of certain plans and programmes relating to the environment and amending with regard to public participation and access to justice Council Directives 85/337/EEC and 96/61/EC - Statement by the Commission Having regard to the Treaty establishing the European Community, and in particular Article 175 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Having regard to the opinion of the Committee of the Regions(3), Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), in the light of the joint text approved by the Conciliation Committee on 15 January 2003, Whereas: (1) Community legislation in the field of the environment aims to contribute to preserving, protecting and improving the quality of the environment and protecting human health. (2) Community environmental legislation includes provisions for public authorities and other bodies to take decisions which may have a significant effect on the environment as well as on personal health and well-being. (3) Effective public participation in the taking of decisions enables the public to express, and the decision-maker to take account of, opinions and concerns which may be relevant to those decisions, thereby increasing the accountability and transparency of the decision-making process and contributing to public awareness of environmental issues and support for the decisions taken. (4) Participation, including participation by associations, organisations and groups, in particular non-governmental organisations promoting environmental protection, should accordingly be fostered, including inter alia by promoting environmental education of the public. (5) On 25 June 1998 the Community signed the UN/ECE Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (the Århus Convention). Community law should be properly aligned with that Convention with a view to its ratification by the Community. (6) Among the objectives of the Århus Convention is the desire to guarantee rights of public participation in decision-making in environmental matters in order to contribute to the protection of the right to live in an environment which is adequate for personal health and well-being. (7) Article 6 of the Århus Convention provides for public participation in decisions on the specific activities listed in Annex I thereto and on activities not so listed which may have a significant effect on the environment. (8) Article 7 of the Århus Convention provides for public participation concerning plans and programmes relating to the environment. (9) Article 9(2) and (4) of the Århus Convention provides for access to judicial or other procedures for challenging the substantive or procedural legality of decisions, acts or omissions subject to the public participation provisions of Article 6 of the Convention. (10) Provision should be made in respect of certain Directives in the environmental area which require Member States to produce plans and programmes relating to the environment but which do not contain sufficient provisions on public participation, so as to ensure public participation consistent with the provisions of the Århus Convention, in particular Article 7 thereof. Other relevant Community legislation already provides for public participation in the preparation of plans and programmes and, for the future, public participation requirements in line with the Århus Convention will be incorporated into the relevant legislation from the outset. (11) Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment(5), and Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control(6) should be amended to ensure that they are fully compatible with the provisions of the Århus Convention, in particular Article 6 and Article 9(2) and (4) thereof. (12) Since the objective of the proposed action, namely to contribute to the implementation of the obligations arising under the Århus Convention, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the action, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective, Article 1 Objective The objective of this Directive is to contribute to the implementation of the obligations arising under the Århus Convention, in particular by: (a) providing for public participation in respect of the drawing up of certain plans and programmes relating to the environment; (b) improving the public participation and providing for provisions on access to justice within Council Directives 85/337/EEC and 96/61/EC. Article 2 Public participation concerning plans and programmes 1. For the purposes of this Article, "the public" shall mean one or more natural or legal persons and, in accordance with national legislation or practice, their associations, organisations or groups. 2. Member States shall ensure that the public is given early and effective opportunities to participate in the preparation and modification or review of the plans or programmes required to be drawn up under the provisions listed in Annex I. To that end, Member States shall ensure that: (a) the public is informed, whether by public notices or other appropriate means such as electronic media where available, about any proposals for such plans or programmes or for their modification or review and that relevant information about such proposals is made available to the public including inter alia information about the right to participate in decision-making and about the competent authority to which comments or questions may be submitted; (b) the public is entitled to express comments and opinions when all options are open before decisions on the plans and programmes are made; (c) in making those decisions, due account shall be taken of the results of the public participation; (d) having examined the comments and opinions expressed by the public, the competent authority makes reasonable efforts to inform the public about the decisions taken and the reasons and considerations upon which those decisions are based, including information about the public participation process. 3. Member States shall identify the public entitled to participate for the purposes of paragraph 2, including relevant non-governmental organisations meeting any requirements imposed under national law, such as those promoting environmental protection. The detailed arrangements for public participation under this Article shall be determined by the Member States so as to enable the public to prepare and participate effectively. Reasonable time-frames shall be provided allowing sufficient time for each of the different stages of public participation required by this Article. 4. This Article shall not apply to plans and programmes designed for the sole purpose of serving national defence or taken in case of civil emergencies. 5. This Article shall not apply to plans and programmes set out in Annex I for which a public participation procedure is carried out under Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment(7) or under Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy(8). Article 3 Amendment of Directive 85/337/EEC Directive 85/337/EEC is hereby amended as follows: 1. in Article 1(2), the following definitions shall be added: "'the public' means: one or more natural or legal persons and, in accordance with national legislation or practice, their associations, organisations or groups; 'the public concerned' means: the public affected or likely to be affected by, or having an interest in, the environmental decision-making procedures referred to in Article 2(2); for the purposes of this definition, non-governmental organisations promoting environmental protection and meeting any requirements under national law shall be deemed to have an interest;" 2. in Article 1, paragraph 4 shall be replaced by the following: "4. Member States may decide, on a case-by-case basis if so provided under national law, not to apply this Directive to projects serving national defence purposes, if they deem that such application would have an adverse effect on these purposes."; 3. in Article 2(3), points (a) and (b) shall be replaced by the following: "(a) consider whether another form of assessment would be appropriate; (b) make available to the public concerned the information obtained under other forms of assessment referred to in point (a), the information relating to the exemption decision and the reasons for granting it."; 4. in Article 6, paragraphs 2 and 3 shall be replaced by the following paragraphs: "2. The public shall be informed, whether by public notices or other appropriate means such as electronic media where available, of the following matters early in the environmental decision-making procedures referred to in Article 2(2) and, at the latest, as soon as information can reasonably be provided: (a) the request for development consent; (b) the fact that the project is subject to an environmental impact assessment procedure and, where relevant, the fact that Article 7 applies; (c) details of the competent authorities responsible for taking the decision, those from which relevant information can be obtained, those to which comments or questions can be submitted, and details of the time schedule for transmitting comments or questions; (d) the nature of possible decisions or, where there is one, the draft decision; (e) an indication of the availability of the information gathered pursuant to Article 5; (f) an indication of the times and places where and means by which the relevant information will be made available; (g) details of the arrangements for public participation made pursuant to paragraph 5 of this Article. 3. Member States shall ensure that, within reasonable time-frames, the following is made available to the public concerned: (a) any information gathered pursuant to Article 5; (b) in accordance with national legislation, the main reports and advice issued to the competent authority or authorities at the time when the public concerned is informed in accordance with paragraph 2 of this Article; (c) in accordance with the provisions of Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information(9), information other than that referred to in paragraph 2 of this Article which is relevant for the decision in accordance with Article 8 and which only becomes available after the time the public concerned was informed in accordance with paragraph 2 of this Article. 4. The public concerned shall be given early and effective opportunities to participate in the environmental decision-making procedures referred to in Article 2(2) and shall, for that purpose, be entitled to express comments and opinions when all options are open to the competent authority or authorities before the decision on the request for development consent is taken. 5. The detailed arrangements for informing the public (for example by bill posting within a certain radius or publication in local newspapers) and for consulting the public concerned (for example by written submissions or by way of a public inquiry) shall be determined by the Member States. 6. Reasonable time-frames for the different phases shall be provided, allowing sufficient time for informing the public and for the public concerned to prepare and participate effectively in environmental decision-making subject to the provisions of this Article." 5. Article 7 shall be amended as follows: (a) paragraphs 1 and 2 shall be replaced by the following: "1. Where a Member State is aware that a project is likely to have significant effects on the environment in another Member State or where a Member State likely to be significantly affected so requests, the Member State in whose territory the project is intended to be carried out shall send to the affected Member State as soon as possible and no later than when informing its own public, inter alia: (a) a description of the project, together with any available information on its possible transboundary impact; (b) information on the nature of the decision which may be taken, and shall give the other Member State a reasonable time in which to indicate whether it wishes to participate in the environmental decision-making procedures referred to in Article 2(2), and may include the information referred to in paragraph 2 of this Article. 2. If a Member State which receives information pursuant to paragraph 1 indicates that it intends to participate in the environmental decision-making procedures referred to in Article 2(2), the Member State in whose territory the project is intended to be carried out shall, if it has not already done so, send to the affected Member State the information required to be given pursuant to Article 6(2) and made available pursuant to Article 6(3)(a) and (b)." (b) paragraph 5 shall be replaced by the following: "5. The detailed arrangements for implementing this Article may be determined by the Member States concerned and shall be such as to enable the public concerned in the territory of the affected Member State to participate effectively in the environmental decision-making procedures referred to in Article 2(2) for the project." 6. Article 9 shall be amended as follows: (a) Paragraph 1 shall be replaced by the following: "1. When a decision to grant or refuse development consent has been taken, the competent authority or authorities shall inform the public thereof in accordance with the appropriate procedures and shall make available to the public the following information: - the content of the decision and any conditions attached thereto, - having examined the concerns and opinions expressed by the public concerned, the main reasons and considerations on which the decision is based, including information about the public participation process, - a description, where necessary, of the main measures to avoid, reduce and, if possible, offset the major adverse effects." (b) Paragraph 2 shall be replaced by the following: "2. The competent authority or authorities shall inform any Member State which has been consulted pursuant to Article 7, forwarding to it the information referred to in paragraph 1 of this Article. The consulted Member States shall ensure that that information is made available in an appropriate manner to the public concerned in their own territory."; 7. the following Article shall be inserted: "Article 10a Member States shall ensure that, in accordance with the relevant national legal system, members of the public concerned: (a) having a sufficient interest, or alternatively, (b) maintaining the impairment of a right, where administrative procedural law of a Member State requires this as a precondition, have access to a review procedure before a court of law or another independent and impartial body established by law to challenge the substantive or procedural legality of decisions, acts or omissions subject to the public participation provisions of this Directive. Member States shall determine at what stage the decisions, acts or omissions may be challenged. What constitutes a sufficient interest and impairment of a right shall be determined by the Member States, consistently with the objective of giving the public concerned wide access to justice. To this end, the interest of any non-governmental organisation meeting the requirements referred to in Article 1(2), shall be deemed sufficient for the purpose of subparagraph (a) of this Article. Such organisations shall also be deemed to have rights capable of being impaired for the purpose of subparagraph (b) of this Article. The provisions of this Article shall not exclude the possibility of a preliminary review procedure before an administrative authority and shall not affect the requirement of exhaustion of administrative review procedures prior to recourse to judicial review procedures, where such a requirement exists under national law. Any such procedure shall be fair, equitable, timely and not prohibitively expensive. In order to further the effectiveness of the provisions of this article, Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures."; 8. in Annex I, the following point shall be added: "22. Any change to or extension of projects listed in this Annex where such a change or extension in itself meets the thresholds, if any, set out in this Annex."; 9. in Annex II, No 13, first indent, the following shall be added at the end: "(change or extension not included in Annex I)". Article 4 Amendment of Directive 96/61/EC Directive 96/61/EC is hereby amended as follows: 1. Article 2 shall be amended as follows: (a) the following sentence shall be added to point 10(b): "For the purposes of this definition, any change to or extension of an operation shall be deemed to be substantial if the change or extension in itself meets the thresholds, if any, set out in Annex I."; (b) the following points shall be added: "13. 'the public' shall mean one or more natural or legal persons and, in accordance with national legislation or practice, their associations, organisations or groups; 14. 'the public concerned' shall mean the public affected or likely to be affected by, or having an interest in, the taking of a decision on the issuing or the updating of a permit or of permit conditions; for the purposes of this definition, non-governmental organisations promoting environmental protection and meeting any requirements under national law shall be deemed to have an interest;" 2. in Article 6(1), first subparagraph, the following indent shall be added: "- the main alternatives, if any, studied by the applicant in outline." 3. Article 15 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: "1. Member States shall ensure that the public concerned are given early and effective opportunities to participate in the procedure for: - issuing a permit for new installations, - issuing a permit for any substantial change in the operation of an installation, - updating of a permit or permit conditions for an installation in accordance with Article 13, paragraph 2, first indent. The procedure set out in Annex V shall apply for the purposes of such participation."; (b) the following paragraph shall be added: "5. When a decision has been taken, the competent authority shall inform the public in accordance with the appropriate procedures and shall make available to the public the following information: (a) the content of the decision, including a copy of the permit and of any conditions and any subsequent updates; and (b) having examined the concerns and opinions expressed by the public concerned, the reasons and considerations on which the decision is based, including information on the public participation process."; 4. the following Article shall be inserted: "Article 15a Access to justice Member States shall ensure that, in accordance with the relevant national legal system, members of the public concerned: (a) having a sufficient interest, or alternatively, (b) maintaining the impairment of a right, where administrative procedural law of a Member State requires this as a precondition; have access to a review procedure before a court of law or another independent and impartial body established by law to challenge the substantive or procedural legality of decisions, acts or omissions subject to the public participation provisions of this Directive. Member States shall determine at what stage the decisions, acts or omissions may be challenged. What constitutes a sufficient interest and impairment of a right shall be determined by the Member States, consistently with the objective of giving the public concerned wide access to justice. To this end, the interest of any non-governmental organisation meeting the requirements referred to in Article 2(14) shall be deemed sufficient for the purpose of subparagraph (a) of this Article. Such organisations shall also be deemed to have rights capable of being impaired for the purpose of subparagraph (b) of this Article. The provisions of this Article shall not exclude the possibility of a preliminary review procedure before an administrative authority and shall not affect the requirement of exhaustion of administrative review procedures prior to recourse to judicial review procedures, where such a requirement exists under national law. Any such procedure shall be fair, equitable, timely and not prohibitively expensive. In order to further the effectiveness of the provisions of this Article, Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures."; 5. Article 17 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: "1. Where a Member State is aware that the operation of an installation is likely to have significant negative effects on the environment of another Member State, or where a Member State likely to be significantly affected so requests, the Member State in whose territory the application for a permit pursuant to Article 4 or Article 12(2) was submitted shall forward to the other Member State any information required to be given or made available pursuant to Annex V at the same time as it makes it available to its own nationals. Such information shall serve as a basis for any consultations necessary in the framework of the bilateral relations between the two Member States on a reciprocal and equivalent basis."; (b) the following paragraphs shall be added: "3. The results of any consultations pursuant to paragraphs 1 and 2 must be taken into consideration when the competent authority reaches a decision on the application. 4. The competent authority shall inform any Member State, which has been consulted pursuant to paragraph 1, of the decision reached on the application and shall forward to it the information referred to in Article 15(5). That Member State shall take the measures necessary to ensure that that information is made available in an appropriate manner to the public concerned in its own territory."; 6. an Annex V shall be added, as set out in Annex II to this Directive. Article 5 Reporting and review By 25 June 2009, the Commission shall send a report on the application and effectiveness of this Directive to the European Parliament and to the Council. With a view to further integrating environmental protection requirements, in accordance with Article 6 of the Treaty, and taking into account the experience acquired in the application of this Directive in the Member States, such a report will be accompanied by proposals for amendment of this Directive, if appropriate. In particular, the Commission will consider the possibility of extending the scope of this Directive to other plans and programmes relating to the environment. Article 6 Implementation Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 25 June 2005 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 7 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 8 Addressees This Directive is addressed to the Member States.

32003L0043

2003

Council Directive 2003/43/EC of 26 May 2003 amending Directive 88/407/EEC laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Parliament(2), Having regard to the opinion of the European Economic and Social Committee(3), After consulting the Committee of the Regions, Whereas: (1) Directive 88/407/EEC(4) lays down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species. (2) In the light of the new scientific data available, it is necessary to amend the animal health conditions applying to entry of bulls into artificial insemination centres, in particular concerning infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV) and bovine viral diarrhoea/mucosal diarrhoea (BVD/MD). (3) The same requirements for storage should apply to all establishments whether or not they are associated with a production unit. (4) The procedure for updating the list of semen collection or storage centres in third countries from which the importation of semen is authorised should be simplified. (5) Necessary measures should be adopted for the implementation of Directive 88/407/EEC in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5), Article 1 Directive 88/407/EEC is hereby amended as follows: 1. the following subparagraph shall be added to Article 1:"This Directive shall not affect Community and/or national zootechnical provisions governing the organisation of artificial insemination in general and the distribution of semen in particular."; 2. Article 2(b) is replaced by the following: "(b) - 'Semen collection centre' means an officially approved and officially supervised establishment situated in the territory of a Member State or third country, in which semen is produced for use in artificial insemination; - 'Semen storage centre' means an officially approved and officially supervised establishment situated in the territory of a Member State or third country in which semen is stored for use in artificial insemination;" 3. Article 3(a) shall be replaced by the following: "(a) it must have been collected and processed and/or stored if need be in a collection or storage centre or centres approved for the purpose in accordance with Article 5(1), with a view to artificial insemination and for the purposes of intra-Community trade;" 4. Article 4(1) and (2) shall be deleted; 5. in Articles 5, 9(2) and 9(3), the words "semen collection centre(s)" shall be replaced by the words "semen collection or storage centre(s)"; 6. Article 9(1) shall be replaced by the following: "1. The lists of semen collection and storage centres from which Member States shall authorise the importation of semen originating in third countries shall be prepared and updated in accordance with this Article. An establishment may be placed on such a list only if the competent authority of the third country of origin guarantees that the conditions referred to in paragraphs 2 and 3(b) to (e) are met. The competent authorities of the third countries appearing on lists drawn up and updated in accordance with Article 8 shall guarantee that lists of semen collection and storage centres from which the semen may be dispatched to the Community are drawn up, kept up-to-date and communicated to the Commission. The Commission shall provide the contact points designated by Member States with regular notifications concerning new or updated lists that it has received from the competent authorities of the third countries concerned in accordance with subparagraph 3. If no Member State objects to the new or updated list within 20 working days of the Commission's notification, imports shall be authorised from establishments appearing on the list 10 working days after the day on which the Commission makes it available to the public. Where written comments are made by at least one Member State or whenever it considers that amendments to a list are necessary in the light of relevant information such as Community inspection reports or the results of the controls carried out under Article 12, the Commission shall inform all Member States and include the matter on the agenda for the relevant sector at the next meeting of the Standing Committee on the Food Chain and Animal Health for decision in accordance with the procedure referred to in Article 18(2). The Commission shall arrange for up-to-date versions of all lists to be made available to the public."; 7. Article 17 shall be replaced by: "Article 17 Annex A shall be amended by the Council, acting by qualified majority on a proposal from the Commission, in particular to adapt it to advances in technology. Annexes B, C and D shall be amended in accordance with the procedure laid down in Article 18(2)."; 8. Article 18 shall be replaced by: "Article 18 1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up by Regulation (EC) No 178/2002(6). 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC(7) shall apply. The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure."; 9. Article 19 shall be deleted; 10. in Articles 5, 8, and 10, the words "the procedure laid down in Article 18" shall be replaced by the words "the procedure referred to in Article 18(2)"; 11. in Articles 8, 11 and 16, the words "the procedure laid down in Article 19" shall be replaced by the words "the procedure referred to in Article 18(2)"; 12. Annexes A, B, C and D to Directive 88/407/EEC shall be replaced by the text in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary in order to comply with this Directive by 1 July 2004. They shall forthwith inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. However, up until 31 December 2004, Member States shall authorise intracommunity trade in and imports of semen that have been collected, processed and stored according to the former provisions of Directive 88/407/EEC and that are accompanied by the former specimen certificate. After that date, Member States shall not authorise intra-Community trade in and imports of semen in accordance with the provisions formerly in force unless it was collected, processed and stored before 31 December 2004. 3. Member States shall inform the Commission of the text of the main provisions of national law which they adopt in the area governed by this Directive. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0033

2003

Directive 2003/33/EC of the European Parliament and of the Council of 26 May 2003 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Articles 47(2), 55 and 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) There are differences between the Member States' laws, regulations and administrative provisions on the advertising of tobacco products and related sponsorship. Such advertising and sponsorship in certain cases crosses the borders of the Member States or involves events organised on an international level, and are activities to which Article 49 of the Treaty applies. The differences in national legislation are likely to give rise to increasing barriers to the free movement between Member States of the products or services that serve as the support for such advertising and sponsorship. In the case of press advertising, certain obstacles have already been encountered. In the case of sponsorship, distortions of the conditions of competition are likely to increase and have already been noted as regards the organisation of certain major sporting and cultural events. (2) Those barriers should be eliminated and, to this end, the rules relating to the advertising of tobacco products and related sponsorship should in specific cases be approximated. In particular, there is a need to specify the extent to which tobacco advertising in certain categories of publications is allowed. (3) Article 95(3) of the Treaty requires the Commission, in its proposals for the establishment and functioning of the Internal Market concerning health, to take as a base a high level of protection. Within their respective powers, the European Parliament and the Council also seek to achieve this objective. The legislation of the Member States to be approximated is intended to protect public health by regulating the promotion of tobacco, an addictive product responsible for over half a million deaths in the Community annually, thereby avoiding a situation where young people begin smoking at an early age as a result of promotion and become addicted. (4) The circulation in the Internal Market of publications such as periodicals, newspapers and magazines is subject to an appreciable risk of obstacles to free movement as a result of Member States' laws, regulations and administrative provisions which prohibit or regulate tobacco advertising in those media. In order to ensure free circulation throughout the Internal Market for all such media, it is necessary to limit tobacco advertising therein to those magazines and periodicals which are not intended for the general public such as publications intended exclusively for professionals in the tobacco trade and to publications printed and published in third countries, that are not principally intended for the Community market. (5) The laws, regulations and administrative provisions of the Member States relating to certain types of sponsorship for the benefit of tobacco products with cross-border effects give rise to an appreciable risk of distortion of the conditions of competition for this activity within the Internal Market. In order to eliminate these distortions, it is necessary to prohibit such sponsorship only for those activities or events with cross-border effects which otherwise may be a means of circumventing the restrictions placed on direct forms of advertising, without regulating sponsorship on a purely national level. (6) Use of information society services is a means of advertising tobacco products which is increasing as public consumption and access to such services increases. Such services, as well as radio broadcasting, which may also be transmitted via information society services, are particularly attractive and accessible to young consumers. Tobacco advertising by both these media has, by its very nature, a cross-border character, and should be regulated at Community level. (7) Free distribution of tobacco products is subject to restriction in several Member States, given its high potential to create addiction. Cases of free distribution have occurred in the context of the sponsorship of events having cross-border effects and should therefore be prohibited. (8) Internationally applicable standards for the advertising of tobacco products and related sponsorship are the subject of negotiations for the drafting of a World Health Organisation Framework Convention on Tobacco Control. These negotiations are intended to create binding international rules complementary to those contained in this Directive. (9) The Commission should draw up a report on the implementation of this Directive. Provision should be made in the relevant Community programmes to monitor the effects of this Directive on public health. (10) Member States should take adequate and effective steps to ensure control of the implementation of measures adopted pursuant to this Directive in compliance with their national legislation, as provided for in Commission Communication to the European Parliament and the Council on the role of penalties in implementing Community Internal Market legislation and in the Council Resolution of 29 June 1995 on the effective uniform application of Community law and on the penalties applicable for breaches of Community law in the Internal Market(4). Such means should include provision for intervention of persons or organisations with legitimate interest in the suppression of activities that are not in conformity with this Directive. (11) The penalties provided for under this Directive should be without prejudice to any other penalty or remedy provided under national law. (12) This Directive regulates the advertising of tobacco products in the media other than television, i.e. in the press and other printed publications, in radio broadcasting and in information society services. It also regulates the sponsorship, by tobacco companies, of radio programmes and of events or activities involving, or taking place in, several Member States or otherwise having cross-border effects, including the free or discounted distribution of tobacco products. Other forms of advertising, such as indirect advertising, as well as the sponsorship of events or activities without cross-border effects, fall outside the scope of this Directive. Subject to the Treaty, Member States retain the competence to regulate these matters as they deem necessary to guarantee the protection of human health. (13) Advertising relating to medicinal products for human use is covered by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(5). Advertising relating to products intended for use in overcoming addiction to tobacco does not fall within the scope of this Directive. (14) This Directive should be without prejudice to Council Directive 89/552/EEC of 3 October 1989 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the pursuit of television broadcasting activities(6), which prohibits all forms of television advertising for cigarettes and other tobacco products. Directive 89/552/EEC provides that television programmes may not be sponsored by undertakings whose principal activity is the manufacture or sale of cigarettes and other tobacco products, or the provision of services, the advertising of which is prohibited by that Directive. Teleshopping for tobacco products is also prohibited by Directive 89/552/EEC. (15) The transnational character of advertising is recognised by Council Directive 84/450/EEC of 10 September 1984 relating to the approximation of the laws, regulations and administrative provisions of the Member States concerning misleading advertising(7). Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products(8), contains provisions on the use of misleading descriptions on the labelling of tobacco products, the cross-border effect of which has also been recognised. (16) Directive 98/43/EC of the European Parliament and of the Council of 6 July 1998 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products(9) was annulled by the Court of Justice in Case C-376/98 Federal Republic of Germany v European Parliament and Council of the European Union(10). References to Directive 98/43/EC should therefore be construed as references to this Directive. (17) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of the proper functioning of the Internal Market to lay down rules on the advertising of tobacco products and related sponsorship. This Directive does not go beyond what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty. (18) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. In particular, this Directive seeks to ensure respect for the fundamental right of freedom of expression, Article 1 Subject-matter and scope 1. The objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States relating to the advertising of tobacco products and their promotion: (a) in the press and other printed publications; (b) in radio broadcasting; (c) in information society services; and (d) through tobacco related sponsorship, including the free distribution of tobacco products. 2. This Directive is intended to ensure the free movement of the media concerned and of related services and to eliminate obstacles to the operation of the Internal Market. Article 2 Definitions For the purposes of this Directive, the following definitions shall apply: (a) "tobacco products" means all products intended to be smoked, sniffed, sucked or chewed inasmuch as they are made, even partly, of tobacco; (b) "advertising" means any form of commercial communications with the aim or direct or indirect effect of promoting a tobacco product; (c) "sponsorship" means any form of public or private contribution to any event, activity or individual with the aim or direct or indirect effect of promoting a tobacco product; (d) "information society services" means services within the meaning of Article 1(2) of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services(11). Article 3 Advertising in printed media and information society services 1. Advertising in the press and other printed publications shall be limited to publications intended exclusively for professionals in the tobacco trade and to publications which are printed and published in third countries, where those publications are not principally intended for the Community market. Other advertising in the press and other printed publications shall be prohibited. 2. Advertising that is not permitted in the press and other printed publications shall not be permitted in information society services. Article 4 Radio advertising and sponsorship 1. All forms of radio advertising for tobacco products shall be prohibited. 2. Radio programmes shall not be sponsored by undertakings whose principal activity is the manufacture or sale of tobacco products. Article 5 Sponsorship of events 1. Sponsorship of events or activities involving or taking place in several Member States or otherwise having cross-border effects shall be prohibited. 2. Any free distribution of tobacco products in the context of the sponsorship of the events referred to in paragraph 1 having the purpose or the direct or indirect effect of promoting such products shall be prohibited. Article 6 Report No later than 20 June 2008, the Commission shall submit a report to the European Parliament, the Council and the European Economic and Social Committee on the implementation of this Directive. That report shall be accompanied by any proposals for amendments to this Directive which the Commission deems necessary. Article 7 Penalties and enforcement Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those rules to the Commission by the date specified in Article 10 at the latest and shall notify it without delay of any subsequent amendment affecting them. Those rules shall include provisions ensuring that persons or organisations which, under national legislation, can justify a legitimate interest in the suppression of advertising, sponsorship or other matters incompatible with this Directive, may take legal action against such advertising or sponsorship or bring such advertising or sponsorship to the attention of an administrative body competent either to pronounce on complaints or to institute the appropriate legal proceedings. Article 8 Free movement of products and services Member States shall not prohibit or restrict the free movement of products or services which comply with this Directive. Article 9 References to Directive 98/43/EC References to the annulled Directive 98/43/EC shall be construed as references to this Directive. Article 10 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 July 2005 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 11 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 12 Addressees This Directive is addressed to the Member States.

32003L0037

2003

Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units and repealing Directive 74/150/EEC (Text with EEA relevance.) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) In connection with the harmonisation of approval procedures, it has become essential to bring the provisions of Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors(4) into line with those of Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(5) and those of Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two- or three-wheel motor vehicles(6). (2) Directive 74/150/EEC currently limits the scope of the Community type-approval procedure to wheeled agricultural or forestry tractors. It is therefore also essential to extend its scope to other categories of agricultural or forestry vehicles. This Directive is therefore a first step towards the regulation of other agricultural motorised vehicles. (3) Account should also be taken of the fact that an exemption procedure should be introduced for certain vehicles built in limited numbers, end-of-series vehicles, or those which take advantage of technical progress not covered by a separate directive. (4) This Directive being based on the principle of total harmonisation, the period before EC type-approval becomes compulsory should be long enough to allow the manufacturers of those vehicles to adjust to the new harmonised procedures. (5) As a result of Council Decision 97/836/EC of 27 November 1997 with a view to accession by the European Community to the Agreement of the United Nations Economic Commission for Europe concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or be used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions (Revised 1958 Agreement)(7), the various international regulations to which the Community has acceded must be complied with. Also, certain tests should be harmonised with those defined by the Organisation for Economic Cooperation and Development (OECD) codes. (6) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(8). (7) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union as general principles of Community law. (8) Directive 74/150/EEC has been variously and substantially amended, and should therefore be recast in the interests of clarity and rationality, Article 1 Scope 1. This Directive applies to the type-approval of vehicles, whether built in one or more stages. It applies to vehicles defined in Article 2(d) having a maximum design speed of not less than 6 km/h. This Directive also applies to the EC type-approval of the systems, components and separate technical units intended for use on such vehicles. 2. This Directive does not apply to: (a) approval of single vehicles; However, this procedure may apply to certain categories of vehicles which fall within the scope of this Directive and for which EC type-approval is obligatory; (b) machinery that has been specially designed for forestry use, such as skidders and forwarders as defined in standard ISO 6814:2000; (c) forestry machinery based on chassis for earthmoving equipment as defined in standard ISO 6165:2001; (d) interchangeable machinery that is fully raised from the ground when the vehicle to which it is attached is in use on a road. Article 2 Definitions For the purposes of this Directive: (a) "EC type-approval" means the procedure whereby a Member State certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant technical requirements of this Directive; the EC type-approval of systems, components and separate technical units may also be referred to as "EC component type-approval"; (b) "multi-stage EC type-approval" means the procedure whereby one or more Member States certify that, depending on the state of completion, an incomplete or completed vehicle type satisfies the relevant technical requirements of this Directive; (c) "approval of single vehicles" means the procedure whereby a Member State certifies that a vehicle approved individually satisfies the national requirements; (d) "vehicle" means any tractor, trailer or interchangeable towed machinery, whether complete, incomplete or completed, which is intended to be used in agriculture or forestry; (e) "vehicle category" means any set of vehicles which have identical design characteristics; (f) "type of vehicle" means vehicles of a particular category which do not differ in the essential respects referred to in Annex II, Chapter A; the different variants and versions of a type of vehicle set out in Annex II, Chapter A are permissible; (g) "base vehicle" means any incomplete vehicle, the vehicle identification number of which is retained during subsequent stages of the multi-stage EC type-approval process; (h) "incomplete vehicle" means any vehicle which still needs completion in at least one further stage in order to meet all the relevant requirements of this Directive; (i) "completed vehicle" means a vehicle resulting from the process of multi-stage EC type-approval which meets all the relevant requirements of this Directive; (j) "tractor" means any motorised, wheeled or tracked agricultural or forestry tractor having at least two axles and a maximum design speed of not less than 6 km/h, the main function of which lies in its tractive power and which has been especially designed to pull, push, carry and actuate certain interchangeable equipment designed to perform agricultural or forestry work, or to tow agricultural or forestry trailers; it may be adapted to carry a load in the context of agricultural or forestry work and/or may be equipped with passenger seats; (k) "trailer" means any towed agricultural or forestry trailer intended mainly to carry loads and designed to be towed by a tractor for agricultural or forestry purposes; trailers of which part of the load is borne by the drawing vehicle fall within this category; any vehicle coupled to a tractor and permanently incorporating an implement shall be assimilated to an agricultural or forestry trailer if the ratio of the technically permissible gross mass to the unladen mass of that vehicle is equal to or greater than 3,0 and if the vehicle has not been designed to process materials; (l) "interchangeable towed machinery" means any instrument used in agriculture or forestry which is designed to be towed by a tractor and changes or adds to its functions; it may include a load platform designed and constructed to receive any tools and appliances needed for those purposes, and to store temporarily any materials produced or needed during work; any vehicle intended to be towed by a tractor and permanently incorporating an implement or designed to process materials shall be considered interchangeable towed machinery if the ratio of the technically permissible gross mass to the unladen mass of that vehicle is less than 3,0; (m) "system" means a set of devices, combined to perform a specific function in a vehicle; (n) "component" means a device, intended to be part of a vehicle, which may be type-approved independently of a vehicle; (o) "separate technical unit" means a device, intended to be part of a vehicle, which may be type-approved separately but only in relation to one or more specified types of vehicles; (p) "manufacturer" means the natural or legal person who is responsible to the EC type-approval authority for all aspects of the type-approval process and for ensuring conformity of production, regardless of whether that person be directly involved in all stages of the construction of a vehicle, system, component or separate technical unit; the following are also considered to be manufacturers: (i) any natural or legal person who, for his own use, designs, has designed, manufactures or has manufactured a vehicle, system, component or separate technical unit; (ii) any natural or legal person who is responsible for ensuring compliance with this Directive at the time a vehicle, system, component or separate technical unit is placed on the market or enters into service; A manufacturer's representative is a natural or legal person established in the Community, duly appointed by the manufacturer to represent him vis-à-vis the competent authority and to act on his behalf, in the field of this Directive. In the following where reference is made to the term "manufacturer" it must be understood as a manufacturer or his representative. (q) "entry into service" means the first use for its intended purpose within the Community of any vehicle which requires no installation or adjustment by the manufacturer or a third party designated by him prior to its first use; the date it is registered or placed for the first time on the market shall be considered the date of entry into service; (r) "EC type-approval authority" means the authority in a Member State which is responsible for all aspects of the approval of a type of vehicle, system, component or separate technical unit, and which issues and, where appropriate, withdraws EC type-approvals, serves as the contact point for the EC type-approval authorities in the other Member States and checks the measures taken by the manufacturer in order to ensure product conformity; (s) "technical service" means the organisation or body that has been appointed as a testing laboratory to carry out tests or inspections on behalf of the EC type-approval authority in a Member State; this function may also be carried out by the EC type-approval authority itself; (t) "separate directives" means the directives listed in Annex II, Chapter B; (u) "EC type-approval certificate" means one of the forms appearing in Annex II, Chapter C, or the corresponding annex to a separate directive, setting out what information is to be supplied by the EC type-approval authority; (v) "information document" means one of the forms appearing in Annex I, or the corresponding annex to a separate directive, setting out what information is to be supplied by the applicant; (w) "information folder" means the complete folder or file containing, in particular, the data, drawings and photographs required as per Annex I and supplied by the applicant to the technical service or EC type-approval authority as required by the information document provided for in a separate directive or in this Directive; (x) "information package" means the information folder plus any test reports or other documents that the technical services or EC type-approval authority has added to the information folder while carrying out its tasks; (y) "index to the information package" means the document setting out the contents of the information package which has been suitably numbered or otherwise marked in order clearly to identify all pages; (z) "certificate of conformity" means the document set out in Annex III, delivered by the manufacturer, in order to certify that a particular vehicle, approved according to this Directive, complies with all applicable regulatory instruments at the time of its production and stating that it may be registered or put into service in all Member States without any additional inspection. Article 3 Application for EC type-approval 1. The manufacturer shall submit an application for vehicle EC type-approval to the approval authority of a Member State. It shall be accompanied by an information folder containing the information required by Annex I. With regard to the EC type-approval of systems, components and separate technical units, the information folder shall also be made available to the EC type-approval authority until EC type-approval is granted or refused. 2. In the case of multi-stage EC type-approval, the information to be supplied shall consist of: (a) at stage one: those parts of the information folder and the EC type-approval certificates required for a complete vehicle which correspond to the state of completion of the base vehicle; (b) at the second and subsequent stages: those parts of the information folder and the EC type-approval certificates which are relevant to the current stage of construction and a copy of the EC type-approval certificate for the incomplete vehicle issued at the previous stage; in addition, the manufacturer shall supply a detailed list of the changes and additions which he has made to the incomplete vehicle. 3. The manufacturer shall submit an application for EC type-approval of a system, component or separate technical unit to the EC type-approval authority in a Member State. It shall be accompanied by an information folder as required by the separate directive. 4. Applications for EC type-approval of a type of vehicle, system, component or separate technical unit may be submitted to only a single Member State. A separate application shall be submitted for each type to be approved. Article 4 The EC type-approval process 1. Each Member State shall grant: (a) the EC type-approval to the vehicle types which conform to the particulars in the information folder and which, according to their category, meet the technical requirements of all the separate directives set out in Annex II, Chapter B; (b) the multi-stage EC type-approval to incomplete or completed base vehicles which conform to the particulars in the information folder and which meet the technical requirements of all the separate directives set out in Annex II, Chapter B; (c) system, component or separate technical unit EC type-approval to all types of systems, components or separate technical units which conform to the particulars in the information folder and which meet the technical requirements contained in the corresponding separate directive listed in Annex II, Chapter B. Where the system, component or separate technical unit to be approved fulfils its function or offers a specific feature only in conjunction with other parts of the vehicle, and where, for this reason, compliance with one or more requirements can be verified only when the system, component or separate technical unit to be approved operates in conjunction with other vehicle parts, whether real or simulated, the scope of the EC type-approval of the system, component or separate technical unit must be restricted accordingly. In this case, the EC type-approval certificate for such a system, component or separate technical unit shall indicate any restrictions on its use and any conditions for fitting it. Observance of these restrictions and conditions shall be verified at the time of EC type-approval of the vehicle. 2. If a Member State finds that a vehicle, system, component or separate technical unit which complies with the provisions of paragraph 1 is nevertheless a serious risk to road safety, the environment or occupational safety, it may refuse to grant EC type-approval. It shall forthwith notify the other Member States and the Commission thereof, stating the reasons on which its decision is based. 3. For each vehicle type in respect of which they have granted, refused to grant or withdrawn EC type-approval, the approval authority in each Member State shall send a copy of the EC type-approval certificate accompanied by the attachments specified in Chapter C of Annex II to the type-approval authorities in the other Member States within one month. 4. Each month, the EC type-approval authority in each Member State shall send a list containing the particulars shown in Annex VI of the EC type-approvals for systems, components or separate technical units which it has granted, refused to grant or withdrawn during the month in question to the EC type-approval authorities in the other Member States. These authorities, on receiving an application from the EC type-approval authority in another Member State, shall immediately send it a copy of the EC type-approval certificate for the system, component or separate technical unit in question and/or an information package for each type of system, component or separate technical unit in respect of which it has issued, refused to issue or withdrawn EC type-approval. Article 5 Amendments to EC type-approvals 1. The Member State which has granted EC type-approval shall take the necessary measures to ensure that it is informed of any change in the particulars appearing in the information package. 2. An application for amendment of an EC type-approval shall be submitted exclusively to the Member State which granted the initial EC type-approval. 3. If, in the case of EC type-approval, any particulars appearing in the information package have changed, the EC type-approval authority in the Member State which granted the initial EC type-approval shall issue revised pages of the information package as necessary, marking each revised page to show clearly the nature of the change and the date of re-issue. A consolidated, updated version of the information package, accompanied by a detailed description of the amendment, shall also be considered to meet this requirement. 4. Each time amended pages or a consolidated, updated version are issued, the index to the information package attached to the EC type-approval certificate shall also be amended to show the most recent dates of amendment, or the date of the consolidated, updated version. 5. The amendment shall be considered to be an "extension" and the type-approval authority in the Member State which granted the initial EC type-approval shall issue a revised EC type-approval certificate bearing an extension number that clearly states the reason for the extension and its date of re-issue in the following cases: (a) if further inspections are required; (b) if any information in the EC type-approval certificate, with the exception of its attachments, has changed; (c) if the requirements of a separate directive which applied on the date from which first entry into service is prohibited have changed since the date which currently appears in the vehicle EC type-approval certificate. 6. If the EC type-approval authority in the Member State which granted the initial EC type-approval finds that an amendment to an information package warrants further inspections or fresh tests or checks, it shall inform the manufacturer accordingly and shall issue the documents referred to in paragraphs 3, 4 and 5 only after carrying out tests or checks which have produced satisfactory results. Article 6 Certificate of conformity and EC type-approval mark 1. In his capacity as holder of a vehicle EC type-approval certificate, the manufacturer shall issue a certificate of conformity. This certificate, specimens of which are given in Annex III, shall accompany each vehicle, whether complete or incomplete, manufactured in conformity with the approved vehicle type. 2. For purposes of vehicle taxation or registration, Member States may, after giving at least three months' notice to the Commission and the other Member States, require particulars not mentioned in Annex III to be added to the certificate of conformity, provided such particulars are explicitly stated in the information package or can be derived from it by a simple calculation. 3. In his capacity as holder of an EC type-approval certificate for a system, component or separate technical unit, the manufacturer shall affix to each component or unit manufactured in conformity with the approved type the trade name or mark, the type and/or, if the separate directive so provides, the EC type-approval mark or number. 4. In his capacity as holder of an EC type-approval certificate which, in accordance with Article 4(1)(c), includes restrictions on the use of the system, component or separate technical unit in question, the manufacturer shall provide with each system, component or separate technical unit detailed information on these restrictions and shall indicate any conditions for fitting it. Article 7 Registration, sale and entry into service 1. Each Member State shall register new type-approved vehicles, permit their sale or permit their entry into service on grounds relating to their construction and functioning only if they are accompanied by a valid certificate of conformity. Each Member State shall permit the sale of incomplete vehicles but may refuse their permanent registration and entry into service until such time as they are completed. 2. Each Member State shall permit the sale or entry into service of systems, components or separate technical units only if these systems, components or separate technical units comply with the requirements of the corresponding separate directives and the requirements referred to in Article 6(3). Article 8 Exemptions 1. The requirements of Article 7(1) shall not apply to vehicles intended for use by the armed forces, civil protection, fire-fighting or public order services or to vehicles type-approved in accordance with paragraph 2 of this Article. 2. Each Member State may, at the request of the manufacturer, exempt the vehicles referred to in Articles 9, 10 and 11 from one or more of the provisions of one or more of the separate directives. Every year, the Member States shall send the Commission and other Member States a list of the exemptions granted. Article 9 Vehicles produced in small series For vehicles produced in small series, the number of vehicles registered, offered for sale or put into service each year in each Member State shall be limited to the maximum number of units indicated in Annex V, Section A. Every year, the Member States shall send the Commission a list of the EC type-approvals of these vehicles. The Member State granting such an EC type-approval shall send a copy of the information documents and the EC type-approval certificate and all its attachments to the approval authorities in the other Member States designated by the manufacturer, stating the nature of the exemptions which have been granted. Within three months, these Member States shall decide whether they accept the EC type-approval for vehicles to be registered within their territory and, if so, for how many vehicles. Article 10 End-of-series vehicles 1. For end-of-series vehicles, Member States may, at the request of the manufacturer, within the quantitative limits set out in Annex V, Section B, and for the limited period specified in the third subparagraph, register and permit the sale or entry into service of new vehicles that conform to a type of vehicle the approval of which is no longer valid. The first subparagraph shall apply solely to vehicles which: (a) are on Community territory, and (b) are accompanied by a valid certificate of conformity issued when the EC type-approval of the vehicle in question was still valid, but which was not registered or placed in service before the said approval lost its validity. This option shall be restricted to a period of 24 months for complete vehicles and 30 months for completed vehicles from the date of expiry of the EC type-approval. 2. In order to apply paragraph 1 to one or more types of vehicles in a specific category, their manufacturer must submit a request to the competent authorities in each Member State affected by the entry into service of that type of vehicle. The request must specify the technical and/or economic grounds on which it is based. Within three months, these Member States shall decide whether or not to authorise the registration of the type of vehicle in question in their territory, and if so for how many vehicles. Each Member State affected by the entry into service of these types of vehicles shall be responsible for ensuring that their manufacturer complies with Annex V, Section B. Article 11 Incompatibility of vehicles, systems, components or separate technical units For vehicles, systems, components or separate technical units designed in accordance with techniques or principles that are incompatible with one or more of the requirements of one or more of the separate directives: (a) a Member State may grant a provisional EC type-approval. In this case, it must, within one month, send a copy of the EC type-approval certificate and its attachments to the approval authorities in the other Member States and to the Commission. At the same time, it shall send the Commission a request for authorisation to grant EC type-approval under this Directive. That request must be accompanied by a file containing the following information: (i) the reasons for which the techniques or principles at issue make the vehicle, system, component or separate technical unit incompatible with the requirements of one or more of the relevant separate directives; (ii) a description of the safety, environmental protection or occupational safety issues raised and of the action taken; (iii) a description of the tests, together with their results, which show that the level of safety, environmental protection and occupational safety guaranteed is at least equivalent to that guaranteed by the requirements of one or more of the relevant separate directives; (b) within three months of receipt of the complete file, the Commission shall submit a draft decision to the committee referred to in Article 20(1). In accordance with the procedure referred to in Article 20(2), the Commission shall decide whether or not to authorise the Member State to grant an EC type-approval under this Directive. Only the request for an authorisation and the draft decision shall be sent to the Member States in their national language(s); (c) if the request is approved, the Member State may grant an EC type-approval under this Directive. In this case, the decision must also state whether restrictions are to be imposed on the validity of such EC type-approvals. In no case shall the period of validity of the EC type-approval be less than 36 months; (d) where the separate directives have been adapted to technical progress in such a way that the types of vehicles, systems, components or separate technical units approved under this Article comply with the amended directives, the Member States shall convert those EC type-approvals into EC type-approvals which comply with this Directive, allowing the time needed for the necessary changes to components or separate technical units, in particular, the removal of any references to restrictions or exemptions; (e) if the action needed to adapt the specific separate directives has not been taken, the validity of the EC type-approvals granted under this Article may be extended, at the request of the Member State having granted the EC type-approval, by means of another Commission decision; (f) an exemption granted for the first time under this Article can serve as a reference for the Committee referred to in Article 20(1) for further, identical requests. Article 12 Equivalence 1. Acting by a qualified majority on a proposal from the Commission, the Council may acknowledge equivalence between the conditions or provisions for EC type-approval of vehicles, systems, components and separate technical units established by this Directive together with the separate directives, and the procedures established by international regulations or regulations of third countries in the framework of multilateral agreements or bilateral agreements between the Community and third countries. 2. The equivalence of EC type-approvals issued on the basis of the separate directives on motor vehicles as defined in Directive 70/156/EEC and set out in Annex II, Chapter B, Part II-A, to this Directive, is acknowledged. 3. The equivalence of type-approvals issued on the basis of the UN/ECE regulations which are annexed to the revised 1958 Agreement set out in Annex II, Chapter B, Part II-B, to this Directive, is acknowledged. 4. The equivalence of the test bulletins issued on the basis of the standardised OECD codes set out in Annex II, Chapter B, Part II-C, to this Directive is acknowledged as an alternative to the test reports drawn up under the separate directives. Article 13 Arrangements to ensure conformity of production 1. A Member State granting an EC type-approval shall take the measures referred to in Annex IV in relation to that approval to verify, where appropriate in cooperation with the EC type-approval authorities in the other Member States, that adequate arrangements have been made to ensure that the vehicles, systems, components or separate technical units produced conform to the approved type. 2. A Member State which has granted an EC type-approval shall take the measures referred to in Annex IV in relation to that approval to verify, where appropriate in cooperation with the EC type-approval authorities in the other Member States, that the arrangements referred to in paragraph 1 continue to be adequate and that the vehicles, systems, components or separate technical units produced continue to conform to the approved type. Verification to ensure that products conform to the approved type shall be limited to the procedures set out in Section 2 of Annex IV. Article 14 Obligation to provide information The competent EC type-approval authorities in the Member States shall inform each other within one month of any withdrawal of EC type-approval and of the reasons for any such measure. Article 15 Safeguard clauses 1. If a Member State establishes that vehicles, systems, components or separate technical units of a particular type pose a serious risk to road safety or occupational safety although they are accompanied by a valid certificate of conformity or are properly marked, it may, for a maximum period of six months, refuse to register such vehicles or prohibit the sale or entry into service in its territory of such vehicles, systems, components or separate technical units. It shall forthwith notify the other Member States and the Commission thereof, stating the reasons on which its decision is based. 2. In the situations described in paragraph 1, the Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultations, the Commission concludes: (a) that the measure is justified, it shall immediately inform the Member State which initiated the action and the other Member States; (b) that the measure is not justified, it shall immediately inform the Member State which initiated the action and the manufacturer. Where the decision described in paragraph 1 is justified because of a gap in one of the separate directives, the decision to maintain it shall be adopted in accordance with the procedure provided for in Article 20(2). Article 16 Failure to conform to the approved type 1. Failure to conform to the approved type occurs where deviations from the particulars in the EC type-approval certificate and/or the information package are found and where these deviations have not been authorised under Article 5(3) by the Member State which granted the EC type-approval. A vehicle is not to be considered to deviate from the approved type where the tolerances permitted by separate directives are met. 2. If a Member State which has granted EC type-approval finds that vehicles, systems, components or separate technical units accompanied by a certificate of conformity or bearing an EC type-approval mark do not conform to the type it has approved, it shall take the necessary measures to ensure that the vehicles, systems, components or separate technical units produced conform to the approved type. The EC type-approval authority in that Member State shall inform those of the other Member States and the Commission of the measures taken, which may extend to withdrawal of EC type-approval. 3. The authority responsible for EC type-approval of the vehicle shall ask the Member State which granted EC type-approval of the system, component, separate technical unit or incomplete vehicle to take the necessary action to ensure that the vehicles produced conform to the approved type in the case of: (a) EC vehicle type-approval where non-conformity of a vehicle arises exclusively from non-conformity of a system, component or separate technical unit, or (b) multi-stage EC type-approval where non-conformity of a completed vehicle arises exclusively from non-conformity of a system, component or separate technical unit forming part of the incomplete vehicle, or of the incomplete vehicle itself. It shall forthwith inform the Commission thereof, and paragraph 2 shall apply. Article 17 Verification of non-conformity If a Member State finds that vehicles, systems, components or separate technical units accompanied by an EC certificate of conformity or bearing an EC type-approval mark do not conform to the approved type, it may ask the Member State which granted the EC type-approval to verify that the vehicles, systems, components or separate technical units produced conform to the approved type. Such action shall be taken as soon as possible, and in any case within six months of the date of the request. Article 18 Notification of decisions and legal remedies available All decisions refusing or withdrawing EC type-approval, refusing registration or prohibiting entry into service or sale taken pursuant to the provisions adopted in implementation of this Directive shall state the grounds on which they are based. All such decisions shall be notified to the party concerned who shall, at the same time, be informed of the remedies available to him under the laws in force in the Member States and of the time limits allowed for the exercise of such remedies. Article 19 Amendment of the Annexes to this Directive or of the separate directives 1. The measures necessary for the implementation of this Directive relating to the subject-matter referred to below shall be adopted in accordance with the procedure set out in Article 20(2): (a) the changes needed to adapt the Annexes to this Directive, or (b) the changes needed to adapt the technical provisions of the separate directives, or (c) the introduction into the separate directives of provisions relating to the EC type-approval of separate technical units. 2. If, pursuant to Decision 97/836/EC, new regulations or amendments to existing regulations which the Community has accepted are introduced, the Commission shall, as a result, adapt the Annexes to this Directive, in accordance with the procedure set out in Article 20(2). Article 20 Committee 1. The Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The committee shall adopt its rules of procedure. Article 21 Notification of the EC type-approval authorities and technical services 1. The Member States shall notify the Commission and the other Member States of the names and addresses of: (a) the EC type-approval authorities and, where appropriate, the fields for which they are responsible, and (b) the technical services which they have appointed, specifying for which test procedures each of these bodies has been appointed. The technical services notified must meet the harmonised standard on the operation of testing laboratories (EN - ISO/IEC 17025:2000) subject to the following conditions: (i) a manufacturer may be appointed as a technical service only where this is expressly provided for by separate directives or alternative regulations; (ii) the use of outside equipment by a technical service, with the agreement of the EC type-approval authority, is authorised. 2. A notified technical service shall be presumed to meet the harmonised standard referred to in paragraph 1(b). However, where appropriate, the Commission may ask the Member States to provide supporting evidence. 3. Services in third countries may be notified as appointed technical services only where this is provided for in a bilateral or multilateral agreement between the Community and the third country in question. Article 22 Implementation 1. The Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2004 at the latest. They shall forthwith inform the Commission thereof. They shall apply these provisions from 1 July 2005. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive. Article 23 Enforcement measures for the EC type-approval 1. As regards vehicles belonging to categories T1, T2 and T3, Member States shall apply this Directive to: (a) new types of vehicles from 1 July 2005; (b) all new vehicles entered into service from 1 July 2009. 2. For vehicle categories other than those referred to in paragraph 1, once all the separate Directives for a vehicle category as defined in Annex II are adopted, Member States shall apply this Directive: (a) three years after the date of entry into force of the last separate directive which must still be adopted for new types of vehicles; (b) six years after the date of entry into force of the last separate directive which must still be adopted for all vehicles entered into service. 3. Member States may, at the request of the manufacturers, apply this Directive to new types of vehicle as from the dates of entry into force of all the related separate directives. Article 24 Repeal 1. Directive 74/150/EEC shall be repealed with effect from 1 July 2005. 2. References to Directive 74/150/EEC shall be construed as references to this Directive and read in accordance with the correlation table set out in Annex VIII to this Directive. Article 25 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 26 Addressees This Directive is addressed to the Member States.

32003L0045

2003

Commission Directive 2003/45/EC of 28 May 2003 amending Council Directive 2002/57/EC on the marketing of seed of oil and fibre plants (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants(1), as amended by Directive 2002/68/EC(2), and in particular Article 2(3a) and Article 24 thereof, Whereas: (1) Directive 2002/57/EC lays out Community provisions for the marketing of seed of oil and fibre plants within the Community. It does not cover, within the definition of the category "basic seed", seed of hybrids other than sunflower; furthermore the Directive does not establish specific conditions to be satisfied by the seed of swede rape and cotton. (2) Commission Decision 95/232/EC of 27 June 1995 on the organisation of a temporary experiment under Council Directive 69/208/EEC in order to establish conditions to be satisfied by the seed of hybrids and varietal associations of swede rape and turnip rape(3), as last amended by Directive 2002/68/EC, aims at, inter alia, establishing the conditions to be satisfied by the seed of hybrids of swede rape for certification and marketing under Community legislation. (3) The results of the temporary experiment provided for in Decision 95/232/EC have confirmed that specific conditions for seed of hybrids of swede rape should be established. Accordingly, Directive 2002/57/EC should be amended in order to include specific conditions. (4) The OECD has established rules for seed for intra- and inter-specific hybrids of cotton (Gossypium hirsutum and Gossypium barbadense). In order to ensure coherence between the OECD and the EU in such an area, Directive 2002/57/EC should be amended to include rules equivalent to those of the OECD. (5) Varietal associations of oil and fibre plants came within the scope of Directive 2002/57/EC. However, the labelling provisions of that Directive do not adequately provide for the labelling of seeds of varietal associations. Accordingly, to provide for a specific labelling of seed of varietal associations, Directive 2002/57/EC should be amended to include adequate labelling requirements for varietal associations. (6) Directive 2002/57/EC should therefore be amended accordingly. (7) The measures contained in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry, Article 1 Directive 2002/57/EC is amended as follows: 1. in Article 2(1)(c), the introductory sentence is replaced by the following: "(c) basic seed: (varieties other than hybrids) means seed"; 2. in Article 2(1)(d), the introductory sentence is replaced by the following: "(d) basic seed (hybrids)"; 3. Annexes I, II, and IV are amended in accordance with the text set out in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 31 December 2003 at the latest. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the main provisions of national law, which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0048

2003

COUNCIL DIRECTIVE 2003/48/EC of 3 June 2003 on taxation of savings income in the form of interest payments Having regard to the Treaty establishing the European Community, and in particular Article 94 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the European Economic and Social Committee (3), Whereas: (1) Articles 56 to 60 of the Treaty guarantee the free movement of capital. (2) Savings income in the form of interest payments from debt claims constitutes taxable income for residents of all Member States. (3) By virtue of Article 58(1) of the Treaty Member States have the right to apply the relevant provisions of their tax law which distinguish between taxpayers who are not in the same situation with regard to their place of residence or with regard to the place where their capital is invested, and to take all requisite measures to prevent infringements of national law and regulations, in particular in the field of taxation. (4) In accordance with Article 58(3) of the Treaty, the provisions of Member States' tax law designed to counter abuse or fraud should not constitute a means of arbitrary discrimination or a disguised restriction on the free movement of capital and payments as established by Article 56 of the Treaty. (5) In the absence of any coordination of national tax systems for taxation of savings income in the form of interest payments, particularly as far as the treatment of interest received by non-residents is concerned, residents of Member States are currently often able to avoid any form of taxation in their Member State of residence on interest they receive in another Member State. (6) This situation is creating distortions in the capital movements between Member States, which are incompatible with the internal market. (7) This Directive builds on the consensus reached at the Santa Maria da Feira European Council of 19 and 20 June 2000 and the subsequent Ecofin Council meetings of 26 and 27 November 2000, 13 December 2001 and 21 January 2003. (8) The ultimate aim of this Directive is to enable savings income in the form of interest payments made in one Member State to beneficial owners who are individuals resident in another Member State to be made subject to effective taxation in accordance with the laws of the latter Member State. (9) The aim of this Directive can best be achieved by targeting interest payments made or secured by economic operators established in the Member States to or for the benefit of beneficial owners who are individuals resident in another Member State. (10) Since the objective of this Directive cannot be sufficiently achieved by the Member States, because of the lack of any coordination of national systems for the taxation of savings income, and can therefore be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive confines itself to the minimum required in order to achieve those objectives and does not go beyond what is necessary for that purpose. (11) The paying agent is the economic operator who pays interest to or secures the payment of interest for the immediate benefit of the beneficial owner. (12) In defining the notion of interest payment and the paying agent mechanism, reference should be made, where appropriate, to Council Directive 85/611/EEC of 20 December 1985 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (4). (13) The scope of this Directive should be limited to taxation of savings income in the form of interest payments on debt claims, to the exclusion, inter alia, of the issues relating to the taxation of pension and insurance benefits. (14) The ultimate aim of bringing about effective taxation of interest payments in the beneficial owner's Member State of residence for tax purposes can be achieved through the exchange of information concerning interest payments between Member States. (15) Council Directive 77/799/EEC of 19 December 1977 concerning mutual assistance by the competent authorities of the Member States in the field of direct and indirect taxation (5) already provides a basis for Member States to exchange information for tax purposes on the income covered by this Directive. It should continue to apply to such exchanges of information in addition to this Directive insofar as this Directive does not derogate from it. (16) The automatic exchange of information between Member States concerning interest payments covered by this Directive makes possible the effective taxation of those payments in the beneficial owner's Member State of residence for tax purposes in accordance with the national laws of that State. It is therefore necessary to stipulate that Member States which exchange information pursuant to this Directive should not be permitted to rely on the limits to the exchange of information as set out in Article 8 of Directive 77/799/EEC. (17) In view of structural differences, Austria, Belgium and Luxembourg cannot apply the automatic exchange of information at the same time as the other Member States. During a transitional period, given that a withholding tax can ensure a minimum level of effective taxation, especially at a rate increasing progressively to 35 %, these three Member States should apply a withholding tax to the savings income covered by this Directive. (18) In order to avoid differences in treatment, Austria, Belgium and Luxembourg should not be obliged to apply automatic exchange of information before the Swiss Confederation, the Principality of Andorra, the Principality of Liechtenstein, the Principality of Monaco and the Republic of San Marino ensure effective exchange of information on request concerning payments of interest. (19) Those Member States should transfer the greater part of their revenue of this withholding tax to the Member State of residence of the beneficial owner of the interest. (20) Those Member States should provide for a procedure allowing beneficial owners resident for tax purposes in other Member States to avoid the imposition of this withholding tax by authorising their paying agent to report the interest payments or by presenting a certificate issued by the competent authority of their Member State of residence for tax purposes. (21) The Member State of residence for tax purposes of the beneficial owner should ensure the elimination of any double taxation of the interest payments which might result from the imposition of this withholding tax in accordance with the procedures laid down in this Directive. It should do so by crediting this withholding tax up to the amount of tax due in its territory and by reimbursing to the beneficial owner any excess amount of tax withheld. It may, however, instead of applying this tax credit mechanism, grant a refund of the withholding tax. (22) In order to avoid market disruption, this Directive should, during the transitional period, not apply to interest payments on certain negotiable debt securities. (23) This Directive should not preclude Member States from levying other types of withholding tax than that referred to in this Directive on interest arising in their territories. (24) So long as the United States of America, Switzerland, Andorra, Liechtenstein, Monaco, San Marino and the relevant dependent or associated territories of the Member States do not all apply measures equivalent to, or the same as, those provided for by this Directive, capital flight towards these countries and territories could imperil the attainment of its objectives. Therefore, it is necessary for the Directive to apply from the same date as that on which all these countries and territories apply such measures. (25) The Commission should report every three years on the operation of this Directive and propose to the Council any amendments that prove necessary in order better to ensure effective taxation of savings income and to remove undesirable distortions of competition. (26) This Directive respects the fundamental rights and principles which are recognised, in particular, by the Charter of Fundamental Rights of the European Union, CHAPTER I INTRODUCTORY PROVISIONS Article 1 Aim 1. The ultimate aim of the Directive is to enable savings income in the form of interest payments made in one Member State to beneficial owners who are individuals resident for tax purposes in another Member State to be made subject to effective taxation in accordance with the laws of the latter Member State. 2. Member States shall take the necessary measures to ensure that the tasks necessary for the implementation of this Directive are carried out by paying agents established within their territory, irrespective of the place of establishment of the debtor of the debt claim producing the interest. Article 2 Definition of beneficial owner 1. For the purposes of this Directive, ‘beneficial owner’ means any individual who receives an interest payment or any individual for whom an interest payment is secured, unless he provides evidence that it was not received or secured for his own benefit, that is to say that: (a) he acts as a paying agent within the meaning of Article 4(1); or (b) he acts on behalf of a legal person, an entity which is taxed on its profits under the general arrangements for business taxation, an UCITS authorised in accordance with Directive 85/611/EEC or an entity referred to in Article 4(2) of this Directive and, in the last mentioned case, discloses the name and address of that entity to the economic operator making the interest payment and the latter communicates such information to the competent authority of its Member State of establishment, or (c) he acts on behalf of another individual who is the beneficial owner and discloses to the paying agent the identity of that beneficial owner in accordance with Article 3(2). 2. Where a paying agent has information suggesting that the individual who receives an interest payment or for whom an interest payment is secured may not be the beneficial owner, and where neither paragraph 1(a) nor 1(b) applies to that individual, it shall take reasonable steps to establish the identity of the beneficial owner in accordance with Article 3(2). If the paying agent is unable to identify the beneficial owner, it shall treat the individual in question as the beneficial owner. Article 3 Identity and residence of beneficial owners 1. Each Member State shall, within its territory, adopt and ensure the application of the procedures necessary to allow the paying agent to identify the beneficial owners and their residence for the purposes of Articles 8 to 12. Such procedures shall comply with the minimum standards established in paragraphs 2 and 3. 2. The paying agent shall establish the identity of the beneficial owner on the basis of minimum standards which vary according to when relations between the paying agent and the recipient of the interest are entered into, as follows: (a) for contractual relations entered into before 1 January 2004, the paying agent shall establish the identity of the beneficial owner, consisting of his name and address, by using the information at its disposal, in particular pursuant to the regulations in force in its State of establishment and to Council Directive 91/308/EEC of 10 June 1991 on prevention of the use of the financial system for the purpose of money laundering (6); (b) for contractual relations entered into, or transactions carried out in the absence of contractual relations, on or after 1 January 2004, the paying agent shall establish the identity of the beneficial owner, consisting of the name, address and, if there is one, the tax identification number allocated by the Member State of residence for tax purposes. These details shall be established on the basis of the passport or of the official identity card presented by the beneficial owner. If it does not appear on that passport or on that official identity card, the address shall be established on the basis of any other documentary proof of identity presented by the beneficial owner. If the tax identification number is not mentioned on the passport, on the official identity card or any other documentary proof of identity, including, possibly, the certificate of residence for tax purposes, presented by the beneficial owner, the identity shall be supplemented by a reference to the latter's date and place of birth established on the basis of his passport or official identification card. 3. The paying agent shall establish the residence of the beneficial owner on the basis of minimum standards which vary according to when relations between the paying agent and the recipient of the interest are entered into. Subject to the conditions set out below, residence shall be considered to be situated in the country where the beneficial owner has his permanent address: (a) for contractual relations entered into before 1 January 2004, the paying agent shall establish the residence of the beneficial owner by using the information at its disposal, in particular pursuant to the regulations in force in its State of establishment and to Directive 91/308/EEC; (b) for contractual relations entered into, or transactions carried out in the absence of contractual relations, on or after 1 January 2004, the paying agent shall establish the residence of the beneficial owner on the basis of the address mentioned on the passport, on the official identity card or, if necessary, on the basis of any documentary proof of identity presented by the beneficial owner and according to the following procedure: for individuals presenting a passport or official identity card issued by a Member State who declare themselves to be resident in a third country, residence shall be established by means of a tax residence certificate issued by the competent authority of the third country in which the individual claims to be resident. Failing the presentation of such a certificate, the Member State which issued the passport or other official identity document shall be considered to be the country of residence. Article 4 Definition of paying agent 1. For the purposes of this Directive, ‘paying agent’ means any economic operator who pays interest to or secures the payment of interest for the immediate benefit of the beneficial owner, whether the operator is the debtor of the debt claim which produces the interest or the operator charged by the debtor or the beneficial owner with paying interest or securing the payment of interest. 2. Any entity established in a Member State to which interest is paid or for which interest is secured for the benefit of the beneficial owner shall also be considered a paying agent upon such payment or securing of such payment. This provision shall not apply if the economic operator has reason to believe, on the basis of official evidence produced by that entity, that: (a) it is a legal person, with the exception of those legal persons referred to in paragraph 5; or (b) its profits are taxed under the general arrangements for business taxation; or (c) it is an UCITS recognised in accordance with Directive 85/611/EEC. An economic operator paying interest to, or securing interest for, such an entity established in another Member State which is considered a paying agent under this paragraph shall communicate the name and address of the entity and the total amount of interest paid to, or secured for, the entity to the competent authority of its Member State of establishment, which shall pass this information on to the competent authority of the Member State where the entity is established. 3. The entity referred to in paragraph 2 shall, however, have the option of being treated for the purposes of this Directive as an UCITS as referred to in 2(c). The exercise of this option shall require a certificate to be issued by the Member State in which the entity is established and presented to the economic operator by that entity. Member States shall lay down the detailed rules for this option for entities established in their territory. 4. Where the economic operator and the entity referred to in paragraph 2 are established in the same Member State, that Member State shall take the necessary measures to ensure that the entity complies with the provisions of this Directive when it acts as a paying agent. 5. The legal persons exempted from paragraph 2(a) are: (a) in Finland: avoin yhtiö (Ay) and kommandiittiyhtiö (Ky)/öppet bolag and kommanditbolag; (b) in Sweden: handelsbolag (HB) and kommanditbolag (KB). Article 5 Definition of competent authority For the purposes of this Directive, ‘competent authority’ means: (a) for Member States, any of the authorities notified by the Member States to the Commission; (b) for third countries, the competent authority for the purposes of bilateral or multilateral tax conventions or, failing that, such other authority as is competent to issue certificates of residence for tax purposes. Article 6 Definition of interest payment 1. For the purposes of this Directive, ‘interest payment’ means: (a) interest paid or credited to an account, relating to debt claims of every kind, whether or not secured by mortgage and whether or not carrying a right to participate in the debtor's profits, and, in particular, income from government securities and income from bonds or debentures, including premiums and prizes attaching to such securities, bonds or debentures; penalty charges for late payments shall not be regarded as interest payments; (b) interest accrued or capitalised at the sale, refund or redemption of the debt claims referred to in (a); (c) income deriving from interest payments either directly or through an entity referred to in Article 4(2), distributed by: (i) an UCITS authorised in accordance with Directive 85/611/EEC, (ii) entities which qualify for the option under Article 4(3), (iii) undertakings for collective investment established outside the territory referred to in Article 7; (d) income realised upon the sale, refund or redemption of shares or units in the following undertakings and entities, if they invest directly or indirectly, via other undertakings for collective investment or entities referred to below, more than 40 % of their assets in debt claims as referred to in (a): (i) an UCITS authorised in accordance with Directive 85/611/EEC, (ii) entities which qualify for the option under Article 4(3), (iii) undertakings for collective investment established outside the territory referred to in Article 7. However, Member States shall have the option of including income mentioned under (d) in the definition of interest only to the extent that such income corresponds to gains directly or indirectly deriving from interest payments within the meaning of (a) and (b). 2. As regards paragraph 1(c) and (d), when a paying agent has no information concerning the proportion of the income which derives from interest payments, the total amount of the income shall be considered an interest payment. 3. As regards paragraph 1(d), when a paying agent has no information concerning the percentage of the assets invested in debt claims or in shares or units as defined in that paragraph, that percentage shall be considered to be above 40 %. Where he cannot determine the amount of income realised by the beneficial owner, the income shall be deemed to correspond to the proceeds of the sale, refund or redemption of the shares or units. 4. When interest, as defined in paragraph 1, is paid to or credited to an account held by an entity referred to in Article 4(2), such entity not having qualified for the option under Article 4(3), it shall be considered an interest payment by such entity. 5. As regards paragraph 1(b) and (d), Member States shall have the option of requiring paying agents in their territory to annualise the interest over a period of time which may not exceed one year, and treating such annualised interest as an interest payment even if no sale, redemption or refund occurs during that period. 6. By way of derogation from paragraphs 1(c) and (d), Member States shall have the option of excluding from the definition of interest payment any income referred to in those provisions from undertakings or entities established within their territory where the investment in debt claims referred to in paragraph 1(a) of such entities has not exceeded 15 % of their assets. Likewise, by way of derogation from paragraph 4, Member States shall have the option of excluding from the definition of interest payment in paragraph 1 interest paid or credited to an account of an entity referred to in Article 4(2) which has not qualified for the option under Article 4(3) and is established within their territory, where the investment of such an entity in debt claims referred to in paragraph 1(a) has not exceeded 15 % of its assets. The exercise of such option by a Member State shall be binding on other Member States. 7. The percentage referred to in paragraph 1(d) and paragraph 3 shall from 1 January 2011 be 25 %. 8. The percentages referred to in paragraph 1(d) and in paragraph 6 shall be determined by reference to the investment policy as laid down in the fund rules or instruments of incorporation of the undertakings or entities concerned and, failing which, by reference to the actual composition of the assets of the undertakings or entities concerned. Article 7 Territorial scope This Directive shall apply to interest paid by a paying agent established within the territory to which the Treaty applies by virtue of Article 299 thereof. CHAPTER II EXCHANGE OF INFORMATION Article 8 Information reporting by the paying agent 1. Where the beneficial owner is resident in a Member State other than that in which the paying agent is established, the minimum amount of information to be reported by the paying agent to the competent authority of its Member State of establishment shall consist of: (a) the identity and residence of the beneficial owner established in accordance with Article 3; (b) the name and address of the paying agent; (c) the account number of the beneficial owner or, where there is none, identification of the debt claim giving rise to the interest; (d) information concerning the interest payment in accordance with paragraph 2. 2. The minimum amount of information concerning interest payment to be reported by the paying agent shall distinguish between the following categories of interest and indicate: (a) in the case of an interest payment within the meaning of Article 6(1)(a): the amount of interest paid or credited; (b) in the case of an interest payment within the meaning of Article 6(1)(b) or (d): either the amount of interest or income referred to in those paragraphs or the full amount of the proceeds from the sale, redemption or refund; (c) in the case of an interest payment within the meaning of Article 6(1)(c): either the amount of income referred to in that paragraph or the full amount of the distribution; (d) in the case of an interest payment within the meaning of Article 6(4): the amount of interest attributable to each of the members of the entity referred to in Article 4(2) who meet the conditions of Articles 1(1) and 2(1); (e) where a Member State exercises the option under Article 6(5): the amount of annualised interest. However, Member States may restrict the minimum amount of information concerning interest payment to be reported by the paying agent to the total amount of interest or income and to the total amount of the proceeds from sale, redemption or refund. Article 9 Automatic exchange of information 1. The competent authority of the Member State of the paying agent shall communicate the information referred to in Article 8 to the competent authority of the Member State of residence of the beneficial owner. 2. The communication of information shall be automatic and shall take place at least once a year, within six months following the end of the tax year of the Member State of the paying agent, for all interest payments made during that year. 3. The provisions of Directive 77/799/EEC shall apply to the exchange of information under this Directive, provided that the provisions of this Directive do not derogate therefrom. However, Article 8 of Directive 77/799/EEC shall not apply to the information to be provided pursuant to this chapter. CHAPTER III TRANSITIONAL PROVISIONS Article 10 Transitional period 1. During a transitional period starting on the date referred to in Article 17(2) and (3) and subject to Article 13(1), Belgium, Luxembourg and Austria shall not be required to apply the provisions of Chapter II. They shall, however, receive information from the other Member States in accordance with Chapter II. During the transitional period, the aim of this Directive shall be to ensure minimum effective taxation of savings in the form of interest payments made in one Member State to beneficial owners who are individuals resident for tax purposes in another Member State. 2. The transitional period shall end at the end of the first full fiscal year following the later of the following dates: — the date of entry into force of an agreement between the European Community, following a unanimous decision of the Council, and the last of the Swiss Confederation, the Principality of Liechtenstein, the Republic of San Marino, the Principality of Monaco and the Principality of Andorra, providing for the exchange of information upon request as defined in the OECD Model Agreement on Exchange of Information on Tax Matters released on 18 April 2002 (hereinafter the ‘OECD Model Agreement’) with respect to interest payments, as defined in this Directive, made by paying agents established within their respective territories to beneficial owners resident in the territory to which the Directive applies, in addition to the simultaneous application by those same countries of a withholding tax on such payments at the rate defined for the corresponding periods referred to in Article 11(1), — the date on which the Council agrees by unanimity that the United States of America is committed to exchange of information upon request as defined in the OECD Model Agreement with respect to interest payments, as defined in this directive, made by paying agents established within its territory to beneficial owners resident in the territory to which the Directive applies. 3. At the end of the transitional period, Belgium, Luxembourg and Austria shall be required to apply the provisions of Chapter II and they shall cease to apply the withholding tax and the revenue sharing provided for in Articles 11 and 12. If, during the transitional period, Belgium, Luxembourg or Austria elects to apply the provisions of Chapter II, it shall no longer apply the withholding tax and the revenue sharing provided for in Articles 11 and 12. Article 11 Withholding tax 1. During the transitional period referred to in Article 10, where the beneficial owner is resident in a Member State other than that in which the paying agent is established, Belgium, Luxembourg and Austria shall levy a withholding tax at a rate of 15 % during the first three years of the transitional period, 20 % for the subsequent three years and 35 % thereafter. 2. The paying agent shall levy withholding tax as follows: (a) in the case of an interest payment within the meaning of Article 6(1)(a): on the amount of interest paid or credited; (b) in the case of an interest payment within the meaning of Article 6(1)(b) or (d): on the amount of interest or income referred to in those paragraphs or by a levy of equivalent effect to be borne by the recipient on the full amount of the proceeds of the sale, redemption or refund; (c) in the case of an interest payment within the meaning of Article 6(1)(c): on the amount of income referred to in that paragraph; (d) in the case of an interest payment within the meaning of Article 6(4): on the amount of interest attributable to each of the members of the entity referred to in Article 4(2) who meet the conditions of Articles 1(1) and 2(1); (e) where a Member State exercises the option under Article 6(5): on the amount of annualised interest. 3. For the purposes of points (a) and (b) of paragraph 2, withholding tax shall be levied pro rata to the period of holding of the debt claim by the beneficial owner. When the paying agent is unable to determine the period of holding on the basis of information in its possession, it shall treat the beneficial owner as having held the debt claim throughout its period of existence unless he provides evidence of the date of acquisition. 4. The imposition of withholding tax by the Member State of the paying agent shall not preclude the Member State of residence for tax purposes of the beneficial owner from taxing the income in accordance with its national law, subject to compliance with the Treaty. 5. During the transitional period, Member States levying withholding tax may provide that an economic operator paying interest to, or securing interest for, an entity referred to in Article 4(2) established in another Member State shall be considered the paying agent in place of the entity and shall levy the withholding tax on that interest, unless the entity has formally agreed to its name, address and the total amount of interest paid to it or secured for it being communicated in accordance with the last subparagraph of Article 4(2). Article 12 Revenue sharing 1. Member States levying withholding tax in accordance with Article 11(1) shall retain 25 % of their revenue and transfer 75 % of the revenue to the Member State of residence of the beneficial owner of the interest. 2. Member States levying withholding tax in accordance with Article 11(5) shall retain 25 % of the revenue and transfer 75 % to the other Member States proportionate to the transfers carried out pursuant to paragraph 1 of this Article. 3. Such transfers shall take place at the latest within a period of six months following the end of the tax year of the Member State of the paying agent in the case of paragraph 1, or that of the Member State of the economic operator in the case of paragraph 2. 4. Member States levying withholding tax shall take the necessary measures to ensure the proper functioning of the revenue-sharing system. Article 13 Exceptions to the withholding tax procedure 1. Member States levying withholding tax in accordance with Article 11 shall provide for one or both of the following procedures in order to ensure that the beneficial owners may request that no tax be withheld: (a) a procedure which allows the beneficial owner expressly to authorise the paying agent to report information in accordance with Chapter II, such authorisation covering all interest paid to the beneficial owner by that paying agent; in such cases, the provisions of Article 9 shall apply; (b) a procedure which ensures that withholding tax shall not be levied where the beneficial owner presents to his paying agent a certificate drawn up in his name by the competent authority of his Member State of residence for tax purposes in accordance with paragraph 2. 2. At the request of the beneficial owner, the competent authority of his Member State of residence for tax purposes shall issue a certificate indicating: (a) the name, address and tax or other identification number or, failing such, the date and place of birth of the beneficial owner; (b) the name and address of the paying agent; (c) the account number of the beneficial owner or, where there is none, the identification of the security. Such certificate shall be valid for a period not exceeding three years. It shall be issued to any beneficial owner who requests it, within two months following such request. Article 14 Elimination of double taxation 1. The Member State of residence for tax purposes of the beneficial owner shall ensure the elimination of any double taxation which might result from the imposition of the withholding tax referred to in Article 11, in accordance with the provisions of paragraphs 2 and 3. 2. If interest received by a beneficial owner has been subject to withholding tax in the Member State of the paying agent, the Member State of residence for tax purposes of the beneficial owner shall grant him a tax credit equal to the amount of the tax withheld in accordance with its national law. Where this amount exceeds the amount of tax due in accordance with its national law, the Member State of residence for tax purposes shall repay the excess amount of tax withheld to the beneficial owner. 3. If, in addition to the withholding tax referred to in Article 11, interest received by a beneficial owner has been subject to any other type of withholding tax and the Member State of residence for tax purposes grants a tax credit for such withholding tax in accordance with its national law or double taxation conventions, such other withholding tax shall be credited before the procedure in paragraph 2 is applied. 4. The Member State of residence for tax purposes of the beneficial owner may replace the tax credit mechanism referred to in paragraphs 2 and 3 by a refund of the withholding tax referred to in Article 11. Article 15 Negotiable debt securities 1. During the transitional period referred to in Article 10, but until 31 December 2010 at the latest, domestic and international bonds and other negotiable debt securities which have been first issued before 1 March 2001 or for which the original issuing prospectuses have been approved before that date by the competent authorities within the meaning of Council Directive 80/390/EEC (7) or by the responsible authorities in third countries shall not be considered as debt claims within the meaning of Article 6(1)(a), provided that no further issues of such negotiable debt securities are made on or after 1 March 2002. However, should the transitional period referred to in Article 10 continue beyond 31 December 2010, the provisions of this Article shall only continue to apply in respect of such negotiable debt securities: — which contain gross-up and early redemption clauses and — where the paying agent as defined in Article 4 is established in a Member State applying the withholding tax referred to in Article 11 and that paying agent pays interest to, or secures the payment of interest for the immediate benefit of, a beneficial owner resident in another Member State. If a further issue is made on or after 1 March 2002 of an aforementioned negotiable debt security issued by a Government or a related entity acting as a public authority or whose role is recognised by an international treaty, as defined in the Annex, the entire issue of such security, consisting of the original issue and any further issue, shall be considered a debt claim within the meaning of Article 6(1)(a). If a further issue is made on or after 1 March 2002 of an aforementioned negotiable debt security issued by any other issuer not covered by the second subparagraph, such further issue shall be considered a debt claim within the meaning of Article 6(1)(a). 2. Nothing in this Article shall prevent Member States from taxing the income from the negotiable debt securities referred to in paragraph 1 in accordance with their national laws. CHAPTER IV MISCELLANEOUS AND FINAL PROVISIONS Article 16 Other withholding taxes This Directive shall not preclude Member States from levying other types of withholding tax than that referred to in Article 11 in accordance with their national laws or double-taxation conventions. Article 17 Transposition 1. Before 1 January 2004 Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. 2. Member States shall apply these provisions from 1 January 2005 provided that: (i) the Swiss Confederation, the Principality of Liechtenstein, the Republic of San Marino, the Principality of Monaco and the Principality of Andorra apply from that same date measures equivalent to those contained in this Directive, in accordance with agreements entered into by them with the European Community, following unanimous decisions of the Council; (ii) all agreements or other arrangements are in place, which provide that all the relevant dependent or associated territories (the Channel Islands, the Isle of Man and the dependent or associated territories in the Caribbean) apply from that same date automatic exchange of information in the same manner as is provided for in Chapter II of this Directive, (or, during the transitional period defined in Article 10, apply a withholding tax on the same terms as are contained in Articles 11 and 12). 3. The Council shall decide, by unanimity, at least six months before 1 January 2005, whether the condition set out in paragraph 2 will be met, having regard to the dates of entry into force of the relevant measures in the third countries and dependent or associated territories concerned. If the Council does not decide that the condition will be met, it shall, acting unanimously on a proposal by the Commission, adopt a new date for the purposes of paragraph 2. 4. When Member States adopt the provisions necessary to comply with this Directive, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 5. Member States shall forthwith inform the Commission thereof and communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive and a correlation table between this Directive and the national provisions adopted. Article 18 Review The Commission shall report to the Council every three years on the operation of this Directive. On the basis of these reports, the Commission shall, where appropriate, propose to the Council any amendments to the Directive that prove necessary in order better to ensure effective taxation of savings income and to remove undesirable distortions of competition. Article 19 Entry into force This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 20 Addressees This Directive is addressed to the Member States.

32003L0049

2003

COUNCIL DIRECTIVE 2003/49/EC of 3 June 2003 on a common system of taxation applicable to interest and royalty payments made between associated companies of different Member States Having regard to the Treaty establishing the European Community, and in particular Article 94 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the European Economic and Social Committee (3), Whereas: (1) In a Single Market having the characteristics of a domestic market, transactions between companies of different Member States should not be subject to less favourable tax conditions than those applicable to the same transactions carried out between companies of the same Member State. (2) This requirement is not currently met as regards interest and royalty payments; national tax laws coupled, where applicable, with bilateral or multilateral agreements may not always ensure that double taxation is eliminated, and their application often entails burdensome administrative formalities and cash-flow problems for the companies concerned. (3) It is necessary to ensure that interest and royalty payments are subject to tax once in a Member State. (4) The abolition of taxation on interest and royalty payments in the Member State where they arise, whether collected by deduction at source or by assessment, is the most appropriate means of eliminating the aforementioned formalities and problems and of ensuring the equality of tax treatment as between national and cross-border transactions; it is particularly necessary to abolish such taxes in respect of such payments made between associated companies of different Member States as well as between permanent establishments of such companies. (5) The arrangements should only apply to the amount, if any, of interest or royalty payments which would have been agreed by the payer and the beneficial owner in the absence of a special relationship. (6) It is moreover necessary not to preclude Member States from taking appropriate measures to combat fraud or abuse. (7) Greece and Portugal should, for budgetary reasons, be allowed a transitional period in order that they can gradually decrease the taxes, whether collected by deduction at source or by assessment, on interest and royalty payments, until they are able to apply the provisions of Article 1. (8) Spain, which has launched a plan for boosting the Spanish technological potential, for budgetary reasons should be allowed during a transitional period not to apply the provisions of Article 1 on royalty payments. (9) It is necessary for the Commission to report to the Council on the operation of the Directive three years after the date by which it must be transposed, in particular with a view to extending its coverage to other companies or undertakings and reviewing the scope of the definition of interest and royalties in pursuance of the necessary convergence of the provisions dealing with interest and royalties in national legislation and in bilateral or multilateral double-taxation treaties. (10) Since the objective of the proposed action, namely setting up a common system of taxation applicable to interest and royalty payments of associated companies of different Member States cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective, Article 1 Scope and procedure 1. Interest or royalty payments arising in a Member State shall be exempt from any taxes imposed on those payments in that State, whether by deduction at source or by assessment, provided that the beneficial owner of the interest or royalties is a company of another Member State or a permanent establishment situated in another Member State of a company of a Member State. 2. A payment made by a company of a Member State or by a permanent establishment situated in another Member State shall be deemed to arise in that Member State, hereafter referred to as the ‘source State’. 3. A permanent establishment shall be treated as the payer of interest or royalties only insofar as those payments represent a tax-deductible expense for the permanent establishment in the Member State in which it is situated. 4. A company of a Member State shall be treated as the beneficial owner of interest or royalties only if it receives those payments for its own benefit and not as an intermediary, such as an agent, trustee or authorised signatory, for some other person. 5. A permanent establishment shall be treated as the beneficial owner of interest or royalties: (a) if the debt-claim, right or use of information in respect of which interest or royalty payments arise is effectively connected with that permanent establishment; and (b) if the interest or royalty payments represent income in respect of which that permanent establishment is subject in the Member State in which it is situated to one of the taxes mentioned in Article 3(a)(iii) or in the case of Belgium to the ‘impôt des non-résidents /belasting der niet-verblijfhouders ’ or in the case of Spain to the ‘Impuesto sobre la Renta de no Residentes’ or to a tax which is identical or substantially similar and which is imposed after the date of entry into force of this Directive in addition to, or in place of, those existing taxes. 6. Where a permanent establishment of a company of a Member State is treated as the payer, or as the beneficial owner, of interest or royalties, no other part of the company shall be treated as the payer, or as the beneficial owner, of that interest or those royalties for the purposes of this Article. 7. This Article shall apply only if the company which is the payer, or the company whose permanent establishment is treated as the payer, of interest or royalties is an associated company of the company which is the beneficial owner, or whose permanent establishment is treated as the beneficial owner, of that interest or those royalties. 8. This Article shall not apply where interest or royalties are paid by or to a permanent establishment situated in a third State of a company of a Member State and the business of the company is wholly or partly carried on through that permanent establishment. 9. Nothing in this Article shall prevent a Member State from taking interest or royalties received by its companies, by permanent establishments of its companies or by permanent establishments situated in that State into account when applying its tax law. 10. A Member State shall have the option of not applying this Directive to a company of another Member State or to a permanent establishment of a company of another Member State in circumstances where the conditions set out in Article 3(b) have not been maintained for an uninterrupted period of at least two years. 11. The source State may require that fulfilment of the requirements laid down in this Article and in Article 3 be substantiated at the time of payment of the interest or royalties by an attestation. If fulfilment of the requirements laid down in this Article has not been attested at the time of payment, the Member State shall be free to require deduction of tax at source. 12. The source State may make it a condition for exemption under this Directive that it has issued a decision currently granting the exemption following an attestation certifying the fulfilment of the requirements laid down in this Article and in Article 3. A decision on exemption shall be given within three months at most after the attestation and such supporting information as the source State may reasonably ask for have been provided, and shall be valid for a period of at least one year after it has been issued. 13. For the purposes of paragraphs 11 and 12, the attestation to be given shall, in respect of each contract for the payment, be valid for at least one year but for not more than three years from the date of issue and shall contain the following information: (a) proof of the receiving company's residence for tax purposes and, where necessary, the existence of a permanent establishment certified by the tax authority of the Member State in which the receiving company is resident for tax purposes or in which the permanent establishment is situated; (b) beneficial ownership by the receiving company in accordance with paragraph 4 or the existence of conditions in accordance with paragraph 5 where a permanent establishment is the recipient of the payment; (c) fulfilment of the requirements in accordance with Article 3(a)(iii) in the case of the receiving company; (d) a minimum holding or the criterion of a minimum holding of voting rights in accordance with Article 3(b); (e) the period for which the holding referred to in (d) has existed. Member States may request in addition the legal justification for the payments under the contract (e.g. loan agreement or licensing contract). 14. If the requirements for exemption cease to be fulfilled, the receiving company or permanent establishment shall immediately inform the paying company or permanent establishment and, if the source State so requires, the competent authority of that State. 15. If the paying company or permanent establishment has withheld tax at source to be exempted under this Article, a claim may be made for repayment of that tax at source. The Member State may require the information specified in paragraph 13. The application for repayment must be submitted within the period laid down. That period shall last for at least two years from the date when the interest or royalties are paid. 16. The source State shall repay the excess tax withheld at source within one year following due receipt of the application and such supporting information as it may reasonably ask for. If the tax withheld at source has not been refunded within that period, the receiving company or permanent establishment shall be entitled on expiry of the year in question to interest on the tax which is refunded at a rate corresponding to the national interest rate to be applied in comparable cases under the domestic law of the source State. Article 2 Definition of interest and royalties For the purposes of this Directive: (a) the term ‘interest’ means income from debt-claims of every kind, whether or not secured by mortgage and whether or not carrying a right to participate in the debtor's profits, and in particular, income from securities and income from bonds or debentures, including premiums and prizes attaching to such securities, bonds or debentures; penalty charges for late payment shall not be regarded as interest; (b) the term ‘royalties’ means payments of any kind received as a consideration for the use of, or the right to use, any copyright of literary, artistic or scientific work, including cinematograph films and software, any patent, trade mark, design or model, plan, secret formula or process, or for information concerning industrial, commercial or scientific experience; payments for the use of, or the right to use, industrial, commercial or scientific equipment shall be regarded as royalties. Article 3 Definition of company, associated company and permanent establishment For the purposes of this Directive: (a) the term ‘company of a Member State’ means any company: (i) taking one of the forms listed in the Annex hereto; and (ii) which in accordance with the tax laws of a Member State is considered to be resident in that Member State and is not, within the meaning of a Double Taxation Convention on Income concluded with a third state, considered to be resident for tax purposes outside the Community; and (iii) which is subject to one of the following taxes without being exempt, or to a tax which is identical or substantially similar and which is imposed after the date of entry into force of this Directive in addition to, or in place of, those existing taxes: — impôt des sociétés /vennootschapsbelasting in Belgium, — selskabsskat in Denmark, — Körperschaftsteuer in Germany, — Φόρος εισοδήματος νομικών προσώπων in Greece, — impuesto sobre sociedades in Spain, — impôt sur les sociétés in France, — corporation tax in Ireland, — imposta sul reddito delle persone giuridiche in Italy, — impôt sur le revenu des collectivités in Luxembourg, — vennootschapsbelasting in the Netherlands, — Körperschaftsteuer in Austria, — imposto sobre o rendimento da pessoas colectivas in Portugal, — yhteisöjen tulovero /inkomstskatten för samfund in Finland, — statlig inkomstskatt in Sweden, — corporation tax in the United Kingdom; (b) a company is an ‘associated company’ of a second company if, at least: (i) the first company has a direct minimum holding of 25 % in the capital of the second company, or (ii) the second company has a direct minimum holding of 25 % in the capital of the first company, or (iii) a third company has a direct minimum holding of 25 % both in the capital of the first company and in the capital of the second company. Holdings must involve only companies resident in Community territory. However, Member States shall have the option of replacing the criterion of a minimum holding in the capital with that of a minimum holding of voting rights; (c) the term ‘permanent establishment’ means a fixed place of business situated in a Member State through which the business of a company of another Member State is wholly or partly carried on. Article 4 Exclusion of payments as interest or royalties 1. The source State shall not be obliged to ensure the benefits of this Directive in the following cases: (a) payments which are treated as a distribution of profits or as a repayment of capital under the law of the source State; (b) payments from debt-claims which carry a right to participate in the debtor's profits; (c) payments from debt-claims which entitle the creditor to exchange his right to interest for a right to participate in the debtor's profits; (d) payments from debt-claims which contain no provision for repayment of the principal amount or where the repayment is due more than 50 years after the date of issue. 2. Where, by reason of a special relationship between the payer and the beneficial owner of interest or royalties, or between one of them and some other person, the amount of the interest or royalties exceeds the amount which would have been agreed by the payer and the beneficial owner in the absence of such a relationship, the provisions of this Directive shall apply only to the latter amount, if any. Article 5 Fraud and abuse 1. This Directive shall not preclude the application of domestic or agreement-based provisions required for the prevention of fraud or abuse. 2. Member States may, in the case of transactions for which the principal motive or one of the principal motives is tax evasion, tax avoidance or abuse, withdraw the benefits of this Directive or refuse to apply this Directive. Article 6 Transitional rules for Greece, Spain and Portugal 1. Greece and Portugal shall be authorised not to apply the provisions of Article 1 until the date of application referred to in Article 17(2) and (3) of Council Directive 2003/48/EC of 3 June 2003 on taxation of savings income in the form of interest payments (4). During a transitional period of eight years starting on the aforementioned date, the rate of tax on payments of interest or royalties made to an associated company of another Member State or to a permanent establishment situated in another Member State of an associated company of a Member State must not exceed 10 % during the first four years and 5 % during the final four years. Spain shall be authorised, for royalty payments only, not to apply the provisions of Article 1 until the date of application referred to in Article 17(2) and (3) of Directive 2003/48/EC. During a transitional period of six years starting on the aforementioned date, the rate of tax on payments of royalties made to an associated company of another Member State or to a permanent establishment situated in another Member State of an associated company of a Member State must not exceed 10 %. These transitional rules shall, however, remain subject to the continued application of any rate of tax lower than those referred to in the first and second subparagraphs provided by bilateral agreements concluded between Greece, Spain or Portugal and other Member States. Before the end of any of the transitional periods mentioned in this paragraph the Council may decide unanimously, on a proposal from the Commission, on a possible extension of the said transitional periods. 2. Where a company of a Member State, or a permanent establishment situated in that Member State of a company of a Member State: — receives interest or royalties from an associated company of Greece or Portugal, — receives royalties from an associated company of Spain, — receives interest or royalties from a permanent establishment situated in Greece or Portugal of an associated company of a Member State, or — receives royalties from a permanent establishment situated in Spain of an associated company of a Member State, the first Member State shall allow an amount equal to the tax paid in Greece, Spain or Portugal in accordance with paragraph 1 on that income as a deduction from the tax on the income of the company or permanent establishment which received that income. 3. The deduction provided for in paragraph 2 need not exceed the lower of: (a) the tax payable in Greece, Spain or Portugal on such income on the basis of paragraph 1, or (b) that part of the tax on the income of the company or permanent establishment which received the interest or royalties, as computed before the deduction is given, which is attributable to those payments under the domestic law of the Member State of which it is a company or in which the permanent establishment is situated. Article 7 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 2004. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive, together with a table showing how the provisions of this Directive correspond to the national provisions adopted. Article 8 Review By 31 December 2006, the Commission shall report to the Council on the operation of this Directive, in particular with a view to extending its coverage to companies or undertakings other than those referred to in Article 3 and the Annex. Article 9 Delimitation clause This Directive shall not affect the application of domestic or agreement-based provisions which go beyond the provisions of this Directive and are designed to eliminate or mitigate the double taxation of interest and royalties. Article 10 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 11 Addressees This Directive is addressed to the Member States.

32003L0041

2003

Directive 2003/41/EC of the European Parliament and of the Council of 3 June 2003 on the activities and supervision of institutions for occupational retirement provision Having regard to the Treaty establishing the European Community, and in particular Article 47(2), Article 55 and Article 95(1) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) A genuine internal market for financial services is crucial for economic growth and job creation in the Community. (2) Major achievements have already been made in the establishment of this internal market, allowing financial institutions to operate in other Member States and ensuring a high level of protection for the consumers of financial services. (3) The communication from the Commission "Implementing the framework for financial markets: action plan" identifies a series of actions that are needed in order to complete the internal market for financial services, and the European Council, at its meeting in Lisbon on 23 and 24 March 2000, called for the implementation of this action plan by 2005. (4) The action plan for financial services stresses as an urgent priority the need to draw up a directive on the prudential supervision of institutions for occupational retirement provision, as these institutions are major financial institutions which have a key role to play in ensuring the integration, efficiency and liquidity of the financial markets, but they are not subject to a coherent Community legislative framework allowing them to benefit fully from the advantages of the internal market. (5) Since social-security systems are coming under increasing pressure, occupational retirement pensions will increasingly be relied on as a complement in future. Occupational retirement pensions should therefore be developed, without, however, calling into question the importance of social-security pension systems in terms of secure, durable and effective social protection, which should guarantee a decent standard of living in old age and should therefore be at the centre of the objective of strengthening the European social model. (6) This Directive thus represents a first step on the way to an internal market for occupational retirement provision organised on a European scale. By setting the "prudent person" rule as the underlying principle for capital investment and making it possible for institutions to operate across borders, the redirection of savings into the sector of occupational retirement provision is encouraged, thus contributing to economic and social progress. (7) The prudential rules laid down in this Directive are intended both to guarantee a high degree of security for future pensioners through the imposition of stringent supervisory standards, and to clear the way for the efficient management of occupational pension schemes. (8) Institutions which are completely separated from any sponsoring undertaking and which operate on a funded basis for the sole purpose of providing retirement benefits should have freedom to provide services and freedom of investment, subject only to coordinated prudential requirements, regardless of whether these institutions are considered as legal entities. (9) In accordance with the principle of subsidiarity, Member States should retain full responsibility for the organisation of their pension systems as well as for the decision on the role of each of the three "pillars" of the retirement system in individual Member States. In the context of the second pillar, they should also retain full responsibility for the role and functions of the various institutions providing occupational retirement benefits, such as industry-wide pension funds, company pension funds and life-assurance companies. This Directive is not intended to call this prerogative into question. (10) National rules concerning the participation of self-employed persons in institutions for occupational retirement provision differ. In some Member States, institutions for occupational retirement provision can operate on the basis of agreements with trade or trade groups whose members act in a self-employed capacity or directly with self-employed and employed persons. In some Member States a self-employed person can also become a member of an institution when the self-employed person acts as employer or provides his professional services to an undertaking. In some Member States self-employed persons cannot join an institution for occupational retirement provision unless certain requirements, including those imposed by social and labour law, are met. (11) Institutions managing social-security schemes, which are already coordinated at Community level, should be excluded from the scope of this Directive. Account should nevertheless be taken of the specificity of institutions which, in a single Member State, manage both social-security schemes and occupational pension schemes. (12) Financial institutions which already benefit from a Community legislative framework should in general be excluded from the scope of this Directive. However, as these institutions may also in some cases offer occupational pension services, it is important to ensure that this Directive does not lead to distortions of competition. Such distortions may be avoided by applying the prudential requirements of this Directive to the occupational pension business of life-assurance companies. The Commission should also carefully monitor the situation in the occupational pensions market and assess the possibility of extending the optional application of this Directive to other regulated financial institutions. (13) When aiming at ensuring financial security in retirement, the benefits paid by institutions for occupational retirement provision should generally provide for the payment of a lifelong pension. Payments for a temporary period or a lump sum should also be possible. (14) It is important to ensure that older and disabled people are not placed at risk of poverty and can enjoy a decent standard of living. Appropriate cover for biometrical risks in occupational pension arrangements is an important aspect of the fight against poverty and insecurity among elderly people. When setting up a pension scheme, employers and employees, or their respective representatives, should consider the possibility of the pension scheme including provisions for the coverage of the longevity risk and occupational disability risks as well as provision for surviving dependants. (15) Giving Member States the possibility to exclude from the scope of national implementing legislation institutions managing schemes which together have less than 100 members in total can facilitate supervision in some Member States, without undermining the proper functioning of the internal market in this field. However, this should not undermine the right of such institutions to appoint for the management of their investment portfolio and the custody of their assets investment managers and custodians established in another Member State and duly authorised. (16) Institutions such as "Unterstützungskassen" in Germany, where the members have no legal rights to benefits of a certain amount and where their interests are protected by a compulsory statutory insolvency insurance, should be excluded from the scope of the Directive. (17) In order to protect members and beneficiaries, institutions for occupational retirement provision should limit their activities to the activities, and those arising therefrom, referred to in this Directive. (18) In the event of the bankruptcy of a sponsoring undertaking, a member faces the risk of losing both his/her job and his/her acquired pension rights. This makes it necessary to ensure that there is a clear separation between that undertaking and the institution and that minimum prudential standards are laid down to protect members. (19) Institutions for occupational retirement provision operate and are supervised with significant differences in Member States. In some Member States, supervision can be exercised not only over the institution itself but also over the entities or companies which are authorised to manage these institutions. Member States should be able to take such specificity into account as long as all the requirements laid down in this Directive are effectively met. Member States should also be able to allow insurance entities and other financial entities to manage institutions for occupational retirement provision. (20) Institutions for occupational retirement provision are financial service providers which bear a heavy responsibility for the provision of occupational retirement benefits and therefore should meet certain minimum prudential standards with respect to their activities and conditions of operation. (21) The huge number of institutions in certain Member States means a pragmatic solution is necessary as regards prior authorisation of institutions. However, if an institution wishes to manage a scheme in another Member State, a prior authorisation granted by the competent authority of the home Member State should be required. (22) Each Member State should require that every institution located in its territory draw up annual accounts and annual reports taking into account each pension scheme operated by the institution and, where applicable, annual accounts and annual reports for each pension scheme. The annual accounts and annual reports, reflecting a true and fair view of the institution's assets, liabilities and financial position, taking into account each pension scheme operated by an institution, and duly approved by an authorised person, are an essential source of information for members and beneficiaries of a scheme and the competent authorities. In particular, they enable the competent authorities to monitor the financial soundness of an institution and assess whether the institution is able to meet all its contractual obligations. (23) Proper information for members and beneficiaries of a pension scheme is crucial. This is of particular relevance for requests for information concerning the financial soundness of the institution, the contractual rules, the benefits and the actual financing of accrued pension entitlements, the investment policy and the management of risks and costs. (24) The investment policy of an institution is a decisive factor for both security and affordability of occupational pensions. The institutions should therefore draw up and, at least every three years, review a statement of investment principles. It should be made available to the competent authorities and on request also to members and beneficiaries of each pension scheme. (25) To fulfil their statutory function, the competent authorities should be provided with adequate rights to information and powers of intervention with respect to institutions and the persons who effectively run them. Where an institution for occupational retirement provision has transferred functions of material importance such as investment management, information technology or accounting to other companies (outsourcing), it should be possible for the rights to information and powers of intervention to be enlarged so as to cover these outsourced functions in order to check whether those activities are carried out in accordance with the supervisory rules. (26) A prudent calculation of technical provisions is an essential condition to ensure that obligations to pay retirement benefits can be met. Technical provisions should be calculated on the basis of recognised actuarial methods and certified by qualified persons. The maximum interest rates should be chosen prudently according to any relevant national rules. The minimum amount of technical provisions should both be sufficient for benefits already in payment to beneficiaries to continue to be paid and reflect the commitments that arise out of members' accrued pension rights. (27) Risks covered by institutions vary significantly from one Member State to another. Home Member States should therefore have the possibility of making the calculation of technical provisions subject to additional and more detailed rules than those laid down in this Directive. (28) Sufficient and appropriate assets to cover the technical provisions protect the interests of members and beneficiaries of the pension scheme if the sponsoring undertaking becomes insolvent. In particular in cases of cross-border activity, the mutual recognition of supervisory principles applied in Member States requires that the technical provisions be fully funded at all times. (29) If the institution does not work on a cross-border basis, Member States should be able to permit underfunding provided that a proper plan is established to restore full funding and without prejudice to the requirements of Council Directive 80/987/EEC of 20 October 1980 on the approximation of the laws of the Member States relating to the protection of employees in the event of the insolvency of their employer(4). (30) In many cases, it could be the sponsoring undertaking and not the institution itself that either covers any biometric risk or guarantees certain benefits or investment performance. However, in some cases, it is the institution itself which provides such cover or guarantees and the sponsor's obligations are generally exhausted by paying the necessary contributions. In these circumstances, the products offered are similar to those of life-assurance companies and the institutions concerned should hold at least the same additional own funds as life-assurance companies. (31) Institutions are very long-term investors. Redemption of the assets held by these institutions cannot, in general, be made for any purpose other than providing retirement benefits. Furthermore, in order to protect adequately the rights of members and beneficiaries, institutions should be able to opt for an asset allocation that suits the precise nature and duration of their liabilities. These aspects call for efficient supervision and an approach towards investment rules allowing institutions sufficient flexibility to decide on the most secure and efficient investment policy and obliging them to act prudently. Compliance with the "prudent person" rule therefore requires an investment policy geared to the membership structure of the individual institution for occupational retirement provision. (32) Supervisory methods and practices vary among Member States. Therefore, Member States should be given some discretion on the precise investment rules that they wish to impose on the institutions located in their territories. However, these rules must not restrict the free movement of capital, unless justified on prudential grounds. (33) As very long-term investors with low liquidity risks, institutions for occupational retirement provision are in a position to invest in non-liquid assets such as shares as well as in risk capital markets within prudent limits. They can also benefit from the advantages of international diversification. Investments in shares, risk capital markets and currencies other than those of the liabilities should therefore not be restricted except on prudential grounds. (34) However, if the institution works on a cross-border basis, it may be asked by the competent authorities of the host Member State to apply limits for investment in shares and similar assets not admitted to trading on a regulated market, in shares and other instruments issued by the same undertaking or in assets denominated in non-matching currencies provided such rules also apply to institutions located in the host Member State. (35) Restrictions regarding the free choice by institutions of approved asset managers and custodians limit competition in the internal market and should therefore be eliminated. (36) Without prejudice to national social and labour legislation on the organisation of pension systems, including compulsory membership and the outcomes of collective bargaining agreements, institutions should have the possibility of providing their services in other Member States. They should be allowed to accept sponsorship from undertakings located in other Member States and to operate pension schemes with members in more than one Member State. This would potentially lead to significant economies of scale for these institutions, improve the competitiveness of the Community industry and facilitate labour mobility. This requires mutual recognition of prudential standards. Proper enforcement of these prudential standards should be supervised by the competent authorities of the home Member State, unless specified otherwise. (37) The exercise of the right of an institution in one Member State to manage an occupational pension scheme contracted in another Member State should fully respect the provisions of the social and labour law in force in the host Member State insofar as it is relevant to occupational pensions, for example the definition and payment of retirement benefits and the conditions for transferability of pension rights. (38) When a scheme is ring-fenced, the provisions of this Directive apply individually to that scheme. (39) It is important to make provision for cooperation between the competent authorities of the Member States for supervisory purposes and between those authorities and the Commission for other purposes. For the purposes of carrying out their duties and of contributing to the consistent and timely implementation of this Directive, competent authorities should provide each other with the information necessary to apply the provisions of the Directive. The Commission has indicated its intention to set up a committee of supervisors in order to encourage cooperation, coordination and exchanges of views between national competent authorities, and to promote the consistent implementation of this Directive. (40) Since the objective of the proposed action, namely to create a Community legal framework covering institutions for occupational retirement provision, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the action, be better achieved by the Community, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective, Article 1 Subject This Directive lays down rules for the taking-up and pursuit of activities carried out by institutions for occupational retirement provision. Article 2 Scope 1. This Directive shall apply to institutions for occupational retirement provision. Where, in accordance with national law, institutions for occupational retirement provision do not have legal personality, Member States shall apply this Directive either to those institutions or, subject to paragraph 2, to those authorised entities responsible for managing them and acting on their behalf. 2. This Directive shall not apply to: (a) institutions managing social-security schemes which are covered by Regulation (EEC) No 1408/71(5) and Regulation (EEC) No 574/72(6); (b) institutions which are covered by Directive 73/239/EEC(7), Directive 85/611/EEC(8), Directive 93/22/EEC(9), Directive 2000/12/EC(10) and Directive 2002/83/EC(11); (c) institutions which operate on a pay-as-you-go basis; (d) institutions where employees of the sponsoring undertakings have no legal rights to benefits and where the sponsoring undertaking can redeem the assets at any time and not necessarily meet its obligations for payment of retirement benefits; (e) companies using book-reserve schemes with a view to paying out retirement benefits to their employees. Article 3 Application to institutions operating social-security schemes Institutions for occupational retirement provision which also operate compulsory employment-related pension schemes which are considered to be social-security schemes covered by Regulations (EEC) No 1408/71 and (EEC) No 574/72 shall be covered by this Directive in respect of their non-compulsory occupational retirement provision business. In that case, the liabilities and the corresponding assets shall be ring-fenced and it shall not be possible to transfer them to the compulsory pension schemes which are considered as social-security schemes or vice versa. Article 4 Optional application to institutions covered by Directive 2002/83/EC Home Member States may choose to apply the provisions of Articles 9 to 16 and Articles 18 to 20 of this Directive to the occupational-retirement-provision business of insurance undertakings which are covered by Directive 2002/83/EC. In that case, all assets and liabilities corresponding to the said business shall be ring-fenced, managed and organised separately from the other activities of the insurance undertakings, without any possibility of transfer. In such case, and only as far as their occupational retirement provision business is concerned, insurance undertakings shall not be subject to Articles 20 to 26, 31 and 36 of Directive 2002/83/EC. The home Member State shall ensure that either the competent authorities, or the authorities responsible for supervision of insurance undertakings covered by Directive 2002/83/EC, as part of their supervisory work, verify the strict separation of the relevant occupational retirement provision business. Article 5 Small pension institutions and statutory schemes With the exception of Article 19, Member States may choose not to apply this Directive, in whole or in part, to any institution located in their territories which operates pension schemes which together have less than 100 members in total. Subject to Article 2(2), such institutions should nevertheless be given the right to apply this Directive on a voluntary basis. Article 20 may be applied only if all the other provisions of this Directive apply. Member States may choose not to apply Articles 9 to 17 to institutions where occupational retirement provision is made under statute, pursuant to legislation, and is guaranteed by a public authority. Article 20 may be applied only if all the other provisions of this Directive apply. Article 6 Definitions For the purposes of this Directive: (a) "institution for occupational retirement provision", or "institution", means an institution, irrespective of its legal form, operating on a funded basis, established separately from any sponsoring undertaking or trade for the purpose of providing retirement benefits in the context of an occupational activity on the basis of an agreement or a contract agreed: - individually or collectively between the employer(s) and the employee(s) or their respective representatives, or - with self-employed persons, in compliance with the legislation of the home and host Member States, and which carries out activities directly arising therefrom; (b) "pension scheme" means a contract, an agreement, a trust deed or rules stipulating which retirement benefits are granted and under which conditions; (c) "sponsoring undertaking" means any undertaking or other body, regardless of whether it includes or consists of one or more legal or natural persons, which acts as an employer or in a self-employed capacity or any combination thereof and which pays contributions into an institution for occupational retirement provision; (d) "retirement benefits" means benefits paid by reference to reaching, or the expectation of reaching, retirement or, where they are supplementary to those benefits and provided on an ancillary basis, in the form of payments on death, disability, or cessation of employment or in the form of support payments or services in case of sickness, indigence or death. In order to facilitate financial security in retirement, these benefits usually take the form of payments for life. They may, however, also be payments made for a temporary period or as a lump sum. (e) "member" means a person whose occupational activities entitle or will entitle him/her to retirement benefits in accordance with the provisions of a pension scheme; (f) "beneficiary" means a person receiving retirement benefits; (g) "competent authorities" means the national authorities designated to carry out the duties provided for in this Directive; (h) "biometrical risks" mean risks linked to death, disability and longevity; (i) "home Member State" means the Member State in which the institution has its registered office and its main administration or, if it does not have a registered office, its main administration; (j) "host Member State" means the Member State whose social and labour law relevant to the field of occupational pension schemes is applicable to the relationship between the sponsoring undertaking and members. Article 7 Activities of an institution Each Member State shall require institutions located within its territory to limit their activities to retirement-benefit related operations and activities arising therefrom. When, in accordance with Article 4, an insurance undertaking manages its occupational retirement provision business by ring-fencing its assets and liabilities, the ring-fenced assets and liabilities shall be restricted to retirement-benefit related operations and activities directly arising therefrom. Article 8 Legal separation between sponsoring undertakings and institutions for occupational retirement provision Each Member State shall ensure that there is a legal separation between a sponsoring undertaking and an institution for occupational retirement provision in order that the assets of the institution are safeguarded in the interests of members and beneficiaries in the event of bankruptcy of the sponsoring undertaking. Article 9 Conditions of operation 1. Each Member State shall, in respect of every institution located in its territory, ensure that: (a) the institution is registered in a national register by the competent supervisory authority or authorised; in the case of cross-border activities referred to in Article 20, the register shall also indicate the Member States in which the institution is operating; (b) the institution is effectively run by persons of good repute who must themselves have appropriate professional qualifications and experience or employ advisers with appropriate professional qualifications and experience; (c) properly constituted rules regarding the functioning of any pension scheme operated by the institution have been implemented and members have been adequately informed of these rules; (d) all technical provisions are computed and certified by an actuary or, if not by an actuary, by another specialist in this field, including an auditor, according to national legislation, on the basis of actuarial methods recognised by the competent authorities of the home Member State; (e) where the sponsoring undertaking guarantees the payment of the retirement benefits, it is committed to regular financing; (f) the members are sufficiently informed of the conditions of the pension scheme, in particular concerning: (i) the rights and obligations of the parties involved in the pension scheme; (ii) the financial, technical and other risks associated with the pension scheme; (iii) the nature and distribution of those risks. 2. In accordance with the principle of subsidiarity and taking due account of the scale of pension benefits offered by the social-security regimes, Member States may provide that the option of longevity and disability cover, provision for surviving dependants and a guarantee of repayment of contributions as additional benefits be offered to members if employers and employees, or their respective representatives, so agree. 3. A Member State may make the conditions of operation of an institution located in its territory subject to other requirements, with a view to ensuring that the interests of members and beneficiaries are adequately protected. 4. A Member State may permit or require institutions located in its territory to entrust management of these institutions, in whole or in part, to other entities operating on behalf of those institutions. 5. In the case of cross-border activity as referred to in Article 20, the conditions of operation of the institution shall be subject to a prior authorisation by the competent authorities of the home Member State. Article 10 Annual accounts and annual reports Each Member State shall require that every institution located in its territory draw up annual accounts and annual reports taking into account each pension scheme operated by the institution and, where applicable, annual accounts and annual reports for each pension scheme. The annual accounts and the annual reports shall give a true and fair view of the institution's assets, liabilities and financial position. The annual accounts and information in the reports shall be consistent, comprehensive, fairly presented and duly approved by authorised persons, according to national law. Article 11 Information to be given to the members and beneficiaries 1. Depending on the nature of the pension scheme established, each Member State shall ensure that every institution located in its territory provides at least the information set out in this Article. 2. Members and beneficiaries and/or, where applicable, their representatives shall receive: (a) on request, the annual accounts and the annual reports referred to in Article 10, and, where an institution is responsible for more than one scheme, those relating to their particular pension scheme; (b) within a reasonable time, any relevant information regarding changes to the pension-scheme rules. 3. The statement of investment policy principles, referred to in Article 12, shall be made available to members and beneficiaries and/or, where applicable, to their representatives on request. 4. Each member shall also receive, on request, detailed and substantial information on: (a) the target level of the retirement benefits, if applicable; (b) the level of benefits in case of cessation of employment; (c) where the member bears the investment risk, the range of investment options, if applicable, and the actual investment portfolio as well as information on risk exposure and costs related to the investments; (d) the arrangements relating to the transfer of pension rights to another institution for occupational retirement provision in the event of termination of the employment relationship. Members shall receive every year brief particulars of the situation of the institution as well as the current level of financing of their accrued individual entitlements. 5. Each beneficiary shall receive, on retirement or when other benefits become due, the appropriate information on the benefits which are due and the corresponding payment options. Article 12 Statement of investment policy principles Each Member State shall ensure that every institution located in its territory prepares and, at least every three years, reviews a written statement of investment-policy principles. This statement is to be revised without delay after any significant change in the investment policy. Member States shall provide that this statement contains, at least, such matters as the investment risk measurement methods, the risk-management processes implemented and the strategic asset allocation with respect to the nature and duration of pension liabilities. Article 13 Information to be provided to the competent authorities Each Member State shall ensure that the competent authorities, in respect of any institution located in its territory, have the necessary powers and means: (a) to require the institution, the members of its board of directors and other managers or directors or persons controlling the institution to supply information about all business matters or forward all business documents; (b) to supervise relationships between the institution and other companies or between institutions, when institutions transfer functions to those other companies or institutions (outsourcing), influencing the financial situation of the institution or being in a material way relevant for effective supervision; (c) to obtain regularly the statement of investment-policy principles, the annual accounts and the annual reports, and all the documents necessary for the purposes of supervision. These may include documents such as: (i) internal interim reports; (ii) actuarial valuations and detailed assumptions; (iii) asset-liability studies; (iv) evidence of consistency with the investment-policy principles; (v) evidence that contributions have been paid in as planned; (vi) reports by the persons responsible for auditing the annual accounts referred to in Article 10; (d) to carry out on-site inspections at the institution's premises and, where appropriate, on outsourced functions to check if activities are carried out in accordance with the supervisory rules. Article 14 Powers of intervention and duties of the competent authorities 1. The competent authorities shall require every institution located in their territories to have sound administrative and accounting procedures and adequate internal control mechanisms. 2. The competent authorities shall have the power to take any measures including, where appropriate, those of an administrative or financial nature, either with regard to any institution located in their territories or against the persons running the institution, which are appropriate and necessary to prevent or remedy any irregularities prejudicial to the interests of the members and beneficiaries. They may also restrict or prohibit the free disposal of the institution's assets when, in particular: (a) the institution has failed to establish sufficient technical provisions in respect of the entire business or has insufficient assets to cover the technical provisions; (b) the institution has failed to hold the regulatory own funds. 3. In order to safeguard the interests of members and beneficiaries, the competent authorities may transfer the powers which the persons running an institution located in their territories hold in accordance with the law of the home Member State wholly or partly to a special representative who is fit to exercise these powers. 4. The competent authorities may prohibit or restrict the activities of an institution located in their territories in particular if: (a) the institution fails to protect adequately the interests of members and beneficiaries; (b) the institution no longer fulfils the conditions of operation; (c) the institution fails seriously in its obligations under the rules to which it is subject; (d) in the case of cross-border activity, the institution does not respect the requirements of social and labour law of the host Member State relevant to the field of occupational pensions. Any decision to prohibit the activities of an institution shall be supported by precise reasons and notified to the institution in question. 5. Member States shall ensure that decisions taken in respect of an institution under laws, regulations and administrative provisions adopted in accordance with this Directive are subject to the right to apply to the courts. Article 15 Technical provisions 1. The home Member State shall ensure that institutions operating occupational pension schemes establish at all times in respect of the total range of their pension schemes an adequate amount of liabilities corresponding to the financial commitments which arise out of their portfolio of existing pension contracts. 2. The home Member State shall ensure that institutions operating occupational pension schemes, where they provide cover against biometric risks and/or guarantee either an investment performance or a given level of benefits, establish sufficient technical provisions in respect of the total range of these schemes. 3. The calculation of technical provisions shall take place every year. However, the home Member State may allow a calculation once every three years if the institution provides members and/or the competent authorities with a certification or a report of adjustments for the intervening years. The certification or the report shall reflect the adjusted development of the technical provisions and changes in risks covered. 4. The calculation of the technical provisions shall be executed and certified by an actuary or, if not by an actuary, by another specialist in this field, including an auditor, according to national legislation, on the basis of actuarial methods recognised by the competent authorities of the home Member State, according to the following principles: (a) the minimum amount of the technical provisions shall be calculated by a sufficiently prudent actuarial valuation, taking account of all commitments for benefits and for contributions in accordance with the pension arrangements of the institution. It must be sufficient both for pensions and benefits already in payment to beneficiaries to continue to be paid, and to reflect the commitments which arise out of members' accrued pension rights. The economic and actuarial assumptions chosen for the valuation of the liabilities shall also be chosen prudently taking account, if applicable, of an appropriate margin for adverse deviation; (b) the maximum rates of interest used shall be chosen prudently and determined in accordance with any relevant rules of the home Member State. These prudent rates of interest shall be determined by taking into account: - the yield on the corresponding assets held by the institution and the future investment returns and/or - the market yields of high-quality or government bonds; (c) the biometric tables used for the calculation of technical provisions shall be based on prudent principles, having regard to the main characteristics of the group of members and the pension schemes, in particular the expected changes in the relevant risks; (d) the method and basis of calculation of technical provisions shall in general remain constant from one financial year to another. However, discontinuities may be justified by a change of legal, demographic or economic circumstances underlying the assumptions. 5. The home Member State may make the calculation of technical provisions subject to additional and more detailed requirements, with a view to ensuring that the interests of members and beneficiaries are adequately protected. 6. With a view to further harmonisation of the rules regarding the calculation of technical provisions which may be justified - in particular the interest rates and other assumptions influencing the level of technical provisions - the Commission shall, every two years or at the request of a Member State, issue a report on the situation concerning the development in cross-border activities. The Commission shall propose any necessary measures to prevent possible distortions caused by different levels of interest rates and to protect the interest of beneficiaries and members of any scheme. Article 16 Funding of technical provisions 1. The home Member State shall require every institution to have at all times sufficient and appropriate assets to cover the technical provisions in respect of the total range of pension schemes operated. 2. The home Member State may allow an institution, for a limited period of time, to have insufficient assets to cover the technical provisions. In this case the competent authorities shall require the institution to adopt a concrete and realisable recovery plan in order to ensure that the requirements of paragraph 1 are met again. The plan shall be subject to the following conditions: (a) the institution shall set up a concrete and realisable plan to re-establish the required amount of assets to cover fully the technical provisions in due time. The plan shall be made available to members or, where applicable, to their representatives and/or shall be subject to approval by the competent authorities of the home Member State; (b) in drawing up the plan, account shall be taken of the specific situation of the institution, in particular the asset/liability structure, risk profile, liquidity plan, the age profile of the members entitled to receive retirement benefits, start-up schemes and schemes changing from non-funding or partial funding to full funding; (c) in the event of termination of a pension scheme during the period referred to above in this paragraph, the institution shall inform the competent authorities of the home Member State. The institution shall establish a procedure in order to transfer the assets and the corresponding liabilities to another financial institution or a similar body. This procedure shall be disclosed to the competent authorities of the home Member State and a general outline of the procedure shall be made available to members or, where applicable, to their representatives in accordance with the principle of confidentiality. 3. In the event of cross-border activity as referred to in Article 20, the technical provisions shall at all times be fully funded in respect of the total range of pension schemes operated. If these conditions are not met, the competent authorities of the home Member State shall intervene in accordance with Article 14. To comply with this requirement the home Member State may require ring-fencing of the assets and liabilities. Article 17 Regulatory own funds 1. The home Member State shall ensure that institutions operating pension schemes, where the institution itself, and not the sponsoring undertaking, underwrites the liability to cover against biometric risk, or guarantees a given investment performance or a given level of benefits, hold on a permanent basis additional assets above the technical provisions to serve as a buffer. The amount thereof shall reflect the type of risk and asset base in respect of the total range of schemes operated. These assets shall be free of all foreseeable liabilities and serve as a safety capital to absorb discrepancies between the anticipated and the actual expenses and profits. 2. For the purposes of calculating the minimum amount of the additional assets, the rules laid down in Articles 27 and 28 of Directive 2002/83/EC shall apply. 3. Paragraph 1 shall, however, not prevent Member States from requiring institutions located in their territory to hold regulatory own funds or from laying down more detailed rules provided that they are prudentially justified. Article 18 Investment rules 1. Member States shall require institutions located in their territories to invest in accordance with the "prudent person" rule and in particular in accordance with the following rules: (a) the assets shall be invested in the best interests of members and beneficiaries. In the case of a potential conflict of interest, the institution, or the entity which manages its portfolio, shall ensure that the investment is made in the sole interest of members and beneficiaries; (b) the assets shall be invested in such a manner as to ensure the security, quality, liquidity and profitability of the portfolio as a whole. Assets held to cover the technical provisions shall also be invested in a manner appropriate to the nature and duration of the expected future retirement benefits; (c) the assets shall be predominantly invested on regulated markets. Investment in assets which are not admitted to trading on a regulated financial market must in any event be kept to prudent levels; (d) investment in derivative instruments shall be possible insofar as they contribute to a reduction of investment risks or facilitate efficient portfolio management. They must be valued on a prudent basis, taking into account the underlying asset, and included in the valuation of the institution's assets. The institution shall also avoid excessive risk exposure to a single counterparty and to other derivative operations; (e) the assets shall be properly diversified in such a way as to avoid excessive reliance on any particular asset, issuer or group of undertakings and accumulations of risk in the portfolio as a whole. Investments in assets issued by the same issuer or by issuers belonging to the same group shall not expose the institution to excessive risk concentration; (f) investment in the sponsoring undertaking shall be no more than 5 % of the portfolio as a whole and, when the sponsoring undertaking belongs to a group, investment in the undertakings belonging to the same group as the sponsoring undertaking shall not be more than 10 % of the portfolio. When the institution is sponsored by a number of undertakings, investment in these sponsoring undertakings shall be made prudently, taking into account the need for proper diversification. Member States may decide not to apply the requirements referred to in points (e) and (f) to investment in government bonds. 2. The home Member State shall prohibit the institution from borrowing or acting as a guarantor on behalf of third parties. However, Member States may authorise institutions to carry out some borrowing only for liquidity purposes and on a temporary basis. 3. Member States shall not require institutions located in their territory to invest in particular categories of assets. 4. Without prejudice to Article 12, Member States shall not subject the investment decisions of an institution located in their territory or its investment manager to any kind of prior approval or systematic notification requirements. 5. In accordance with the provisions of paragraphs 1 to 4, Member States may, for the institutions located in their territories, lay down more detailed rules, including quantitative rules, provided they are prudentially justified, to reflect the total range of pension schemes operated by these institutions. In particular, Member States may apply investment provisions similar to those of Directive 2002/83/EC. However, Member States shall not prevent institutions from: (a) investing up to 70 % of the assets covering the technical provisions or of the whole portfolio for schemes in which the members bear the investment risks in shares, negotiable securities treated as shares and corporate bonds admitted to trading on regulated markets and deciding on the relative weight of these securities in their investment portfolio. Provided it is prudentially justified, Member States may, however, apply a lower limit to institutions which provide retirement products with a long-term interest rate guarantee, bear the investment risk and themselves provide for the guarantee; (b) investing up to 30 % of the assets covering technical provisions in assets denominated in currencies other than those in which the liabilities are expressed; (c) investing in risk capital markets. 6. Paragraph 5 shall not preclude the right for Member States to require the application to institutions located in their territory of more stringent investment rules also on an individual basis provided they are prudentially justified, in particular in the light of the liabilities entered into by the institution. 7. In the event of cross-border activity as referred in Article 20, the competent authorities of each host Member State may require that the rules set out in the second subparagraph apply to the institution in the home Member State. In such case, these rules shall apply only to the part of the assets of the institution that corresponds to the activities carried out in the particular host Member State. Furthermore, they shall only be applied if the same or stricter rules also apply to institutions located in the host Member State. The rules referred to in the first subparagraph are as follows: (a) the institution shall not invest more than 30 % of these assets in shares, other securities treated as shares and debt securities which are not admitted to trading on a regulated market, or the institution shall invest at least 70 % of these assets in shares, other securities treated as shares, and debt securities which are admitted to trading on a regulated market; (b) the institution shall invest no more than 5 % of these assets in shares and other securities treated as shares, bonds, debt securities and other money and capital-market instruments issued by the same undertaking and no more than 10 % of these assets in shares and other securities treated as shares, bonds, debt securities and other money and capital market instruments issued by undertakings belonging to a single group; (c) the institution shall not invest more than 30 % of these assets in assets denominated in currencies other than those in which the liabilities are expressed. To comply with these requirements, the home Member State may require ring-fencing of the assets. Article 19 Management and custody 1. Member States shall not restrict institutions from appointing, for the management of the investment portfolio, investment managers established in another Member State and duly authorised for this activity, in accordance with Directives 85/611/EEC, 93/22/EEC, 2000/12/EC and 2002/83/EC, as well as those referred to in Article 2(1) of this Directive. 2. Member States shall not restrict institutions from appointing, for the custody of their assets, custodians established in another Member State and duly authorised in accordance with Directive 93/22/EEC or Directive 2000/12/EC, or accepted as a depositary for the purposes of Directive 85/611/EEC. The provision referred to in this paragraph shall not prevent the home Member State from making the appointment of a depositary or a custodian compulsory. 3. Each Member State shall take the necessary steps to enable it under its national law to prohibit, in accordance with Article 14, the free disposal of assets held by a depositary or custodian located within its territory at the request of the institution's home Member State. Article 20 Cross-border activities 1. Without prejudice to national social and labour legislation on the organisation of pension systems, including compulsory membership and the outcomes of collective bargaining agreements, Member States shall allow undertakings located within their territories to sponsor institutions for occupational retirement provision authorised in other Member States. They shall also allow institutions for occupational retirement provision authorised in their territories to accept sponsorship by undertakings located within the territories of other Member States. 2. An institution wishing to accept sponsorship from a sponsoring undertaking located within the territory of another Member State shall be subject to a prior authorisation by the competent authorities of its home Member State, as referred to in Article 9(5). It shall notify its intention to accept sponsorship from a sponsoring undertaking located within the territory of another Member State to the competent authorities of the home Member State where it is authorised. 3. Member States shall require institutions located within their territories and proposing to be sponsored by an undertaking located in the territory of another Member State to provide the following information when effecting a notification under paragraph 2: (a) the host Member State(s); (b) the name of the sponsoring undertaking; (c) the main characteristics of the pension scheme to be operated for the sponsoring undertaking. 4. Where a competent authority of the home Member State is notified under paragraph 2, and unless it has reason to doubt that the administrative structure or the financial situation of the institution or the good repute and professional qualifications or experience of the persons running the institution are compatible with the operations proposed in the host Member State, it shall within three months of receiving all the information referred to in paragraph 3 communicate that information to the competent authorities of the host Member State and inform the institution accordingly. 5. Before the institution starts to operate a pension scheme for a sponsoring undertaking in another Member State, the competent authorities of the host Member State shall, within two months of receiving the information referred to in paragraph 3, inform the competent authorities of the home Member State, if appropriate, of the requirements of social and labour law relevant to the field of occupational pensions under which the pension scheme sponsored by an undertaking in the host Member State must be operated and any rules that are to be applied in accordance with Article 18(7) and with paragraph 7 of this Article. The competent authorities of the home Member State shall communicate this information to the institution. 6. On receiving the communication referred to in paragraph 5, or if no communication is received from the competent authorities of the home Member State on expiry of the period provided for in paragraph 5, the institution may start to operate the pension scheme sponsored by an undertaking in the host Member State in accordance with the host Member State's requirements of social and labour law relevant to the field of occupational pensions, and any rules that are to be applied in accordance with Article 18(7) and with paragraph 7 of this Article. 7. In particular, an institution sponsored by an undertaking located in another Member State shall also be subject, in respect of the corresponding members, to any information requirements imposed by the competent authorities of the host Member State on institutions located in that Member State, in accordance with Article 11. 8. The competent authorities of the host Member State shall inform the competent authorities of the home Member State of any significant change in the host Member State's requirements of social and labour law relevant to the field of occupational pension schemes which may affect the characteristics of the pension scheme insofar as it concerns the operation of the pension scheme sponsored by an undertaking in the host Member State and in any rules that have to be applied in accordance with Article 18(7) and with paragraph 7 of this Article. 9. The institution shall be subject to ongoing supervision by the competent authorities of the host Member State as to the compliance of its activities with the host Member State's requirements of labour and social law relevant to the field of occupational pension schemes referred to in paragraph 5 and with the information requirements referred to in paragraph 7. Should this supervision bring irregularities to light, the competent authorities of the host Member State shall inform the competent authorities of the home Member State immediately. The competent authorities of the home Member State shall, in coordination with the competent authorities of the host Member State, take the necessary measures to ensure that the institution puts a stop to the detected breach of social and labour law. 10. If, despite the measures taken by the competent authorities of the home Member State or because appropriate measures are lacking in the home Member State, the institution persists in breaching the applicable provisions of the host Member State's requirements of social and labour law relevant to the field of occupational pension schemes, the competent authorities of the host Member State may, after informing the competent authorities of the home Member State, take appropriate measures to prevent or penalise further irregularities, including, insofar as is strictly necessary, preventing the institution from operating in the host Member State for the sponsoring undertaking. Article 21 Cooperation between Member States and the Commission 1. Member States shall ensure, in an appropriate manner, the uniform application of this Directive through regular exchanges of information and experience with a view to developing best practices in this sphere and closer cooperation, and by so doing, preventing distortions of competition and creating the conditions required for unproblematic cross-border membership. 2. The Commission and the competent authorities of the Member States shall collaborate closely with a view to facilitating supervision of the operations of institutions for occupational retirement provision. 3. Each Member State shall inform the Commission of any major difficulties to which the application of this Directive gives rise. The Commission and the competent authorities of the Member States concerned shall examine such difficulties as quickly as possible in order to find an appropriate solution. 4. Four years after the entry into force of this Directive, the Commission shall issue a report reviewing: (a) the application of Article 18 and the progress achieved in the adaptation of national supervisory systems, and (b) the application of the second subparagraph of Article 19(2), in particular the situation prevailing in Member States regarding the use of depositaries and the role played by them where appropriate. 5. The competent authorities of the host Member State may ask the competent authorities of the home Member State to decide on the ring-fencing of the institution's assets and liabilities, as provided for in Article 16(3) and Article 18(7). Article 22 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 23 September 2005. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive. 3. Member States may postpone until 23 September 2010 the application of Article 17(1) and (2) to institutions located in their territory which at the date specified in paragraph 1 of this Article do not have the minimum level of regulatory own funds required pursuant to Article 17(1) and (2). However, institutions wishing to operate pension schemes on a cross-border basis, within the meaning of Article 20, may not do so until they comply with the rules of this Directive. 4. Member States may postpone until 23 September 2010 the application of Article 18(1)(f) to institutions located in their territory. However, institutions wishing to operate pension schemes on a cross-border basis, within the meaning of Article 20, may not do so until they comply with the rules of this Directive. Article 23 Entry in force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 24 Addressees This Directive is addressed to the Member States.

32003L0047

2003

Commission Directive 2003/47/EC of 4 June 2003 amending Annexes II, IV and V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1), as last amended by Commission Directive 2003/22/EC(2), and in particular point (c) of the second paragraph of Article 14 thereof, Having regard to the agreement of the Member State concerned, Whereas: (1) From information supplied by Portugal based on updated surveys, it appears that the protected zone for Gonipterus scutellatus Gyll. should be modified and restricted to the Azores only. (2) Due to a clerical error in the preparation of Commission Directive 2002/36/EC(3) amending certain annexes to Directive 2000/29/EC, new provisions as regards soil and growing medium, attached to or associated with plants, originating in Cyprus and Malta were unduly adopted. (3) Due to a clerical error in the preparation of Directive 2002/36/EC, the text in point 2 under heading I of Part B of Annex V to Directive 2000/29/EC was replaced without mentioning the relevant plant products concerned. (4) The relevant Annexes to Directive 2000/29/EC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Annexes II, IV and V to Directive 2000/29/EC are amended in accordance with the Annex to this Directive. Article 2 1. Member States shall adopt and publish, by 15 June 2003 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 16 June 2003. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall immediately communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0046

2003

Commission Directive 2003/46/EC of 4 June 2003 amending Directive 2001/32/EC as regards certain protected zones exposed to particular plant health risks in the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1), as last amended by Commission Directive 2003/22/EC(2), and in particular the first subparagraph of Article 2(1)(h) thereof, Having regard to the request made by Greece, Whereas: (1) Since 1993, by Commission Directive 92/76/EEC(3) and then by Commission Directive 2001/32/EC of 8 May 2001 recognising protected zones exposed to particular plant health risks in the Community and repealing Commission Directive 92/76/EEC(4), as last amended by Directive 2003/21/EC(5), Greece was recognised as a protected zone in respect of Gonipterus scutellatus Gyll. (2) Due to a clerical error in the preparation of Commission Directive 2003/21/EC amending Directive 2001/32/EC, the amended text did not refer to Greece in connection with Gonipterus scutellatus Gyll. However, the reasons which led Greece to be recognised as a protected zone in respect of Gonipterus scutellatus Gyll. remain valid. (3) Directive 2001/32/EC should therefore be amended accordingly. (4) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 The Annex to Directive 2001/32/EC is amended in accordance with the Annex to this Directive. Article 2 Member States shall adopt and publish by 15 June 2003 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 16 June 2003. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such a reference is to be made. Article 3 This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0050

2003

Council Directive 2003/50/EC of 11 June 2003 amending Directive 91/68/EEC as regards reinforcement of controls on movements of ovine and caprine animals Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Parliament(2), Having regard to the opinion of the European Economic and Social Committee(3), Whereas: (1) Council Directive 91/68/EEC(4) lays down animal health conditions governing intra-Community trade in ovine and caprine animals. (2) Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine(5) was subsequently amended and updated by Directive 97/12/EC(6) in order to take account of the developments in the livestock sector in the Community. (3) Sheep and goats share with bovine animals and swine not only similar husbandry systems, but also susceptibility to a common range of diseases. (4) Movements of sheep largely contributed to the spread of foot-and-mouth disease in certain parts of the Community during the outbreak in 2001. The animal health conditions for intra-Community trade in sheep and goats have therefore been reinforced by Commission Decision 2001/327/EC of 24 April 2001 concerning restrictions to the movement of animals of susceptible species with regard to foot-and-mouth disease and repealing Decision 2001/263/EC(7). (5) When the foot-and-mouth disease crisis of 2001 came to an end, an International Conference on the Prevention and Control of Foot-and-Mouth Disease was organised jointly by the Belgian Presidency of the Council and the Commission in December 2001 in order to draw the first conclusions from the 2001 outbreak. The Conference called upon the Commission to submit suitable proposals for Community legislation to prevent such outbreaks in the future, and in the event of their occurrence, to minimise the adverse economic effects. Amongst other things, it was requested that the movement of susceptible animals be controlled more efficiently with regard to the health guarantees offered. (6) Therefore, this Directive aims to reinforce the controls on movement of sheep and goats in order to strengthen the health guarantees offered by Member States for intra-Community trade in animals of these species in line with Directive 64/432/EEC. (7) It is necessary to provide for a swift procedure for updating the health certificates. (8) Directive 91/68/EEC should therefore be amended, Article 1 Directive 91/68/EEC is hereby amended as follows: 1. Article 2 shall be replaced by the following: "Article 2 (a) The definitions given in Article 2 of Directive 90/425/EEC and in Article 2 of Directive 91/628/EEC of 19 November 1991 on the protection of animals during transport and amending Directives 90/425/EEC and 91/496/EEC(8) shall apply as far as applicable. (b) In addition, the following definitions apply for the purposes of this Directive: 1. 'ovine or caprine animals for slaughter' means animals of the ovine or caprine species intended to be taken either directly or via an approved assembly centre to a slaughterhouse in order to be slaughtered; 2. 'ovine or caprine animals for breeding' means ovine and caprine animals other than those mentioned in points 1 and 3 intended to be transported to the place of destination, either directly or via an approved assembly centre, for breeding and production purposes; 3. 'ovine or caprine animals for fattening' means ovine and caprine animals other than those mentioned in points 1 and 2 intended to be transported to the place of destination, either directly or via an approved assembly centre, in order to be fattened for subsequent slaughter; 4. 'officially brucellosis-free ovine or caprine holding' means a holding which satisfies the conditions laid down in Section I of Chapter 1 of Annex A; 5. 'brucellosis-free ovine or caprine holding' means a holding which satisfies the conditions laid down in Chapter 2 of Annex A; 6. 'compulsorily notifiable disease' means a disease listed under Section I of Annex B; 7. 'official veterinarian' means a veterinarian designated by the competent central authority of the Member State; 8. 'holding of origin' means any holding on which the ovine and caprine animals have been continuously present as required by this Directive and on which records are maintained demonstrating the residence of the animals which may be audited by the competent authorities; 9. 'assembly centre' means collection centres and markets, at which under the supervision of the official veterinarian ovine and caprine animals originating from different holdings are grouped together to form consignments of animals for national movement; 10. 'approved assembly centre' means premises on which ovine or caprine animals originating from different holdings are grouped together to form consignments of animals intended for intra-Community trade; 11. 'dealer' means any natural or legal person who buys and sells animals commercially either directly or indirectly, who has a turnover of these animals and who within a maximum of 29 days of purchasing animals resells them or relocates them from the first premises to other premises or directly to a slaughterhouse not within his ownership; 12. 'approved dealer's premises' means premises operated by a dealer as defined in point 11 and approved by the competent authorities at which ovine or caprine animals originated from different holdings are grouped together to form consignments of animals intended for intra-Community trade; 13. 'transporter' means any natural or legal person referred to in Article 5 of Directive 91/628/EEC; 14. 'region' means that part of a Member State's territory which is at least 2000 km2 in area and which is subject to inspection by the competent authorities and includes at least one of the following administrative regions: >TABLE>" 2. Article 3 shall be replaced by the following: "Article 3 (1) Ovine and caprine animals for slaughter may be the subject of trade only if they fulfil the conditions laid down in Articles 4, 4a, 4b and 4c. (2) Ovine and caprine animals for fattening may be the subject of trade only if they fulfil the conditions laid down in Articles 4, 4a, 4b and 5, without prejudice to any additional guarantees which may be required pursuant to Articles 7 and 8. (3) Ovine and caprine animals for breeding may be the subject of trade only if they fulfil the conditions laid down in Articles 4, 4a, 4b, 5 and 6, without prejudice to any additional guarantees which may be required pursuant to Articles 7 and 8. (4) By way of derogation from the provisions in paragraphs 2 and 3, the competent authorities of Member States of destination may grant general or limited derogations in respect of movement of ovine and caprine animals for breeding and fattening, intended solely for temporary pasturing near internal borders of the Community. Member States making use of such derogation shall inform the Commission of the content of the derogations granted. (5) Ovine and caprine animals covered by this Directive must at no time between leaving the holding of origin and arriving at destination come into contact with cloven-hoofed animals other than animals that have the same health status." 3. Article 4 shall be replaced by the following: "Article 4 (1) Member States shall ensure that ovine and caprine animals: (a) are identified and registered in accordance with Community legislation; (b) are inspected by an official veterinarian during the 24 hours preceding the loading of the animals, and show no clinical sign of disease; (c) do not come from a holding, nor have been in contact with animals from a holding, which is the subject of a prohibition on animal health grounds; the period of such prohibition shall last after the slaughter and/or the disposal of the last animal suffering from or susceptible to one of the diseases referred to in points (i), (ii) or (iii), for at least: (i) 42 days in the case of brucellosis, (ii) 30 days in the case of rabies, (iii) 15 days in the case of anthrax; (d) do not come from a holding, nor have been in contact with animals from a holding, situated in an area which for health reasons is subject to a prohibition or restriction affecting the species involved in accordance with Community and/or national legislation; (e) are not the subject of animal health restrictions pursuant to Community legislation on foot-and-mouth disease nor have they been vaccinated against foot-and-mouth disease. (2) Member States shall ensure that the following animals are not the subject of trade: (a) ovine and caprine animals which may have to be slaughtered under a national programme for the eradication of diseases not referred to in Annex C to Directive 90/425/EEC or in Chapter I of Annex B to this Directive; (b) ovine and caprine animals which cannot be marketed on their own territory for health or animal health reasons justified by Article 30 of the Treaty. (3) Member States shall ensure that ovine and caprine animals shall: (a) either have been born and reared since birth in the Community, or (b) have been imported from a third country in accordance with Community legislation." 4. The following Articles shall be inserted: "Article 4a (1) Member States shall ensure that ovine and caprine animals for slaughter, breeding and fattening are not dispatched to another Member State, unless the animals: (a) have been continuously resident on the holding of origin for at least 30 days, or since birth if the animals are younger than 30 days of age, (b) do not come from a holding into which ovine or caprine animals have been introduced during the 21 days prior to dispatch, (c) do not come from a holding into which biungulate animals imported from a third country have been introduced during the 30 days prior to dispatch. (2) By way of derogation from paragraphs 1(b) and (c), Member States may authorise the dispatch of ovine and caprine animals to another Member State, if the animals referred to in paragraphs 1(b) and (c) have been completely isolated from all other animals on the holding. Article 4b (1) Member States shall ensure that the conditions set out in paragraphs 2 to 6 are applied to intra-Community trade in all ovine and caprine animals. (2) The animals shall not be outside their holding of origin for more than six days before being last certified for trade to the final destination in another Member State as indicated in the health certificate. Without prejudice to Article 9(1) in the case of transport by sea, the time limit of six days shall be prolonged by the duration of the sea journey. (3) After leaving the holding of origin the animals shall be consigned directly to the destination in another Member State. (4) By way of derogation from paragraph 3, ovine and caprine animals may, after leaving the holding of origin and before arrival at destination in another Member State, transit through only one approved assembly centre situated in the Member State of origin. In the case of ovine and caprine animals for slaughter, the approved assembly centre may be substituted by approved dealer's premises situated in the Member State of origin. (5) Animals for slaughter which have been taken on arrival in the Member State of destination to a slaughterhouse, must be slaughtered there as soon as possible but at least within 72 hours of arrival. (6) Without prejudice to Article 3(5), Member States shall ensure that the animals covered by this Directive at no time, between leaving the holding of origin and their arrival at destination, compromise the health status of ovine and caprine animals not intended for intra-Community trade. Article 4c (1) By way of derogation from Article 4a(1)(a), ovine and caprine animals for slaughter may be subject to trade after they have been continuously resident on the holding of origin for at least 21 days. (2) By way of derogation from Article 4a(1)(b), and without prejudice to paragraph 1 and Article 4b(2), ovine and caprine animals for slaughter may be consigned from a holding of origin into which ovine or caprine animals have been introduced during the 21 days prior to dispatch, if they are transported directly to a slaughterhouse in another Member State for immediate slaughter without passing through an assembly centre or staging point established in accordance with Directive 91/628/EEC. (3) By way of derogation from Article 4b(3) and (4), and without prejudice to the provisions in Article 4b(2), ovine and caprine animals for slaughter may, after leaving the holding of origin, pass through one additional assembly centre under the following alternative conditions: (a) the animals, before passing through the approved assembly centre referred to in Article 4b(4) which is situated in the Member State of origin, comply with the following conditions: (i) after leaving the holding of origin the animals pass through one single assembly centre under official veterinary supervision, which permits at the same time only animals of at least the same health status, (ii) without prejudice to Community legislation on identification of sheep and goats, at the latest at that assembly centre the animals are individually identified so as to enable in each case the tracing of the holding of origin and (iii) from the assembly centre the animals are, accompanied by an official veterinary document, transported to the approved assembly centre referred to in Article 4b(4) to be certified and consigned directly to a slaughterhouse in the Member State of destination; or (b) the animals may after dispatch from the Member State of origin transit through one approved assembly centre before being consigned to the slaughterhouse in the Member State of destination under the following conditions: (i) either the approved assembly centre is situated in the Member State of destination from where the animals must be removed under the responsibility of the official veterinarian directly to a slaughterhouse to be slaughtered within five days of arrival at the approved assembly centre, or (ii) the approved assembly centre is situated in one Member State of transit from where the animals are consigned directly to the slaughterhouse in the Member State of destination indicated in the animal health certificate issued in accordance with Article 9(6)." 5. Article 8a shall be replaced by the following: "Article 8a (1) Member States shall ensure that, in order to be approved by the competent authority, assembly centres must at least: (a) be under the control of an official veterinarian who shall ensure that, in particular, the provisions of Article 3(5) are complied with; (b) be located in an area which is not subject to prohibition or restrictions in accordance with relevant Community legislation and/or national legislation; (c) be cleaned and disinfected before use, as required by the official veterinarian; (d) have, taking into account the animal capacity of the assembly centre: - a facility dedicated exclusively for this purpose when used as an assembly centre, - appropriate facilities for loading, unloading and adequate housing of a suitable standard for the animals, for watering and feeding them, and for giving them any necessary treatment; these facilities must be easy to clean and disinfect, - appropriate inspection facilities, - appropriate isolation facilities, - appropriate equipment for cleaning and disinfecting rooms and trucks, - an appropriate storage area for fodder, litter and manure, - an appropriate system for collecting waste water, - the use of an office for the official veterinarian; (e) admit only animals which are identified in accordance with Community legislation and comply with the animal health conditions set down in this Directive for the category of animals concerned. To this end, when animals are admitted, the owner or person in charge of the centre shall ensure they are accompanied by health documents or appropriate certificates for the species and categories involved; (f) be regularly inspected by the competent authority in order to ascertain that the requirements for approval continue to be fulfilled. (2) The owner or person in charge of the assembly centre shall be required, on the basis either of the accompanying documents for the animals or of the identification numbers or marks of the animals, to record on a register or a database and retain for a minimum period of three years the following information: - the name of the owner, the origin, date of entry and exit, number and identification of the ovine and caprine animals or the registration number of the holding of origin of the animals entering the centre, where applicable the approval or registration number of the assembly centre through which the animals have passed prior to entering the centre and their proposed destination, - the registration number of the transporter and the licence number of the lorry delivering or collecting animals from the centre. (3) The competent authority shall issue an approval number to each approved assembly centre. Such approval may be limited to one or the other species covered by this Directive or to animals for breeding or fattening or to animals for slaughter. The competent authority shall notify the Commission of the list of approved assembly centres and of any updates. The Commission shall present this list to Member States in the framework of the Committee referred to in Article 15(1). (4) The competent authority may suspend or withdraw approval in the event of failure to comply with this Article or other appropriate provisions of this Directive or other directives in respect of health restrictions. Approval may be restored when the competent authority is satisfied that that assembly centre is in full compliance with all the appropriate provisions of this Directive. (5) The competent authority shall ensure that, when operating, assembly centres have sufficient approved veterinarians to carry out all duties. (6) Any detailed rules required for uniform application of this Article shall be adopted in accordance with the procedure referred to in Article 15(2)." 6. The following Articles are inserted: "Article 8b (1) Member States shall ensure that all dealers are registered and, for the purpose of intra-Community trade, approved and issued with an approval number by the competent authority and that approved dealers comply with at least the following conditions: (a) they must deal only in animals which are identified and come from holdings that conform with the conditions set out in Article 3. To this end, the dealer shall ensure that the animals are properly identified and are accompanied by health documents as appropriate in accordance with this Directive; (b) the dealer shall be required, either on the basis of the document accompanying the animals, or on the basis of identification numbers or marks on the animals, to keep a record or database and to store the following data for at least three years: - the name of the owner, origin, date of purchase, categories, number and identification of ovine and caprine animals or registration number of the holding of origin of the animals purchased, where applicable, the approval or registration number of the assembly centre through which the animals have passed prior to purchase and their destination, - the registration number of the transporter and/or the licence number of the lorry delivering and collecting animals, - the name and address of the purchaser and the destination of the animal, - copies of route plans and/or serial number of health certificates as applicable; (c) when the dealer keeps animals on his premises he shall ensure that: - specific training is given to the staff in charge of the animals in applying the requirements of this Directive and in the care and welfare of the animals, - any necessary controls and tests on the animals are carried out regularly by the official veterinarian and that all necessary steps are taken to prevent the spread of disease. (2) Member States shall ensure that all premises used by a dealer in connection with his business are registered and issued with an approval number by the competent authority and that they comply with at least the following conditions: (a) they must be under the control of an official veterinarian; (b) they must be located in an area which is not subject to prohibition or restrictions in accordance with relevant Community or national legislation; (c) they must have: - appropriate facilities of sufficient capacity and, in particular, inspection facilities and isolation facilities so that all animals can be isolated in the event of an outbreak of a contagious disease, - appropriate facilities for unloading and where necessary adequate housing of a suitable standard for the animals, for watering and feeding them, and for giving them any necessary treatment; these facilities must be easy to clean and disinfect, - an appropriate reception area for litter and manure, - an appropriate system for collecting waste water; (d) they must be cleaned and disinfected before use, as required by the official veterinarian. (3) The competent authority may suspend or withdraw approval in the event of failure to comply with this Article or other appropriate provisions of this Directive or other Directives in respect of health restrictions. Approval may be restored when the competent authority is satisfied that the dealer is in full compliance with all the appropriate provisions of this Directive. (4) The competent authority must carry out regular inspections in order to ascertain that the requirements of this Article are fulfilled. Article 8c (1) Member States shall ensure that the transporters referred to in Article 5 of Directive 91/628/EEC meet the following additional conditions: (a) for the carriage of animals they must use means of transport which are: - constructed in such a way that the animal faeces, litter or feed cannot leak or fall out of the vehicle, - cleaned and disinfected immediately after every animal transport or that of any product which could affect animal health and if necessary before any new loading of animals, using disinfectants officially authorised by the competent authority; (b) they must either have appropriate cleaning and disinfection facilities approved by the competent authority, including facilities for storing litter and dung, or they must provide documentary evidence that these operations are performed by a third party approved by the competent authority. (2) The transporter must ensure that for each vehicle used for the transport of animals a register is kept containing at least the following information which shall be kept for a minimum period of three years: (i) places and dates of pick-up, and the name or business name and address of the holding or assembly centre where the animals are picked up, (ii) places and dates of delivery, and the name or business name and address of the consignee(s), (iii) species and number of animals carried, (iv) date and place of disinfection, (v) details of accompanying documentation, number, etc. (3) Transporters shall ensure that the consignment or animals do not at any time, between leaving the holdings or the assembly centre of origin and arriving at their destination, come into contact with animals of a lower health status. (4) Member States shall ensure that transporters give a written undertaking stating in particular that: - all the measures necessary to comply with this Directive shall be taken and in particular the provisions laid down in this Article and relating to the appropriate documentation that must accompany the animals, - the transport of animals is entrusted to staff who possess the necessary ability, professional competence and knowledge. (5) Article 18 of Directive 91/628/EEC shall apply in a like manner in case of infringement of this Article." 7. Article 9 shall be replaced by the following: "Article 9 (1) Ovine and caprine animals must be accompanied during transportation to destination by a health certificate conforming to either model I, II or III set out in Annex E, as appropriate. The certificate shall consist of a single sheet or, where more than one page is required, shall be in such a form that any two or more pages are part of an integrated whole and indivisible and shall contain a serial number. It shall be drawn up on the day of the health inspection, in one of the official languages of the country of destination at least. The certificate shall be valid for 10 days from the date of the health inspection. (2) The health inspection for the issuing of the health certificate, including additional guarantees, for a consignment of animals may be carried out in the holding of origin or in an approved assembly centre or, in the case of animals for slaughter, on approved dealer's premises. For this purpose the competent authority shall ensure that any certificate is drawn up by the official veterinarian after inspections, visits and controls as provided by this Directive. (3) The official veterinarian for the assembly centre shall carry out all necessary checks on animals arriving there. (4) For ovine and caprine animals for fattening and breeding dispatched to another Member State from an approved assembly centre located in the Member State of origin, the health certificate referred to in paragraph 1, conforming to either model II or III set out in Annex E as appropriate, may only be issued on the basis of the checks provided for in paragraph 3 and of an official document containing the necessary information completed by the official veterinarian responsible for the holding of origin. (5) For ovine and caprine animals for slaughter dispatched to another Member State from an approved assembly centre or from an approved dealer's premises located in the Member State of origin, the health certificate referred to in paragraph 1, conforming to model I set out in Annex E, may only be issued on the basis of the checks provided for in paragraph 3 and of an official document containing the necessary information completed by the official veterinarian responsible for the holding of origin or the assembly centre referred to in Article 4c(3)(a)(i). (6) For ovine and caprine animals for slaughter passing through an approved assembly centre in accordance with Article 4c(3)(b)(ii), the official veterinarian responsible for the approved assembly centre in the Member State of transit shall provide certification to the Member State of destination by issuing a second health certificate, conforming to model I set out in Annex E, completing it with the requested data from the original health certificate(s) and attaching to it an officially endorsed copy thereof. In this case, the combined validity of the certificates shall not exceed that provided for in paragraph 1. (7) The official veterinarian issuing a health certificate for intra-Community trade conforming to either model I, II or III set out in Annex E as appropriate, shall ensure that the movement is recorded in the ANIMO system on the day the certificate is issued." 8. Article 13 shall be repealed. 9. Article 14 shall be replaced by the following: "Article 14 (1) Annex A shall be amended by the Council, acting by a qualified majority on a proposal from the Commission. (2) Annexes B, C, D and E shall be amended in accordance with the procedure referred to in Article 15(2). (3) The rules for the implementation of this Directive shall be adopted in accordance with the procedure referred to in Article 15(2)." 10. Article 16 shall be repealed. 11. Annex E shall be replaced by the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 2004. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Union. This Directive is addressed to the Member States.

32003L0044

2003

Directive 2003/44/EC of the European Parliament and of the Council of 16 June 2003 amending Directive 94/25/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3) in the light of the joint text approved by the Conciliation Committee on 9 April 2003, Whereas: (1) Developments since the adoption of Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft(4) have made it necessary to amend that Directive. (2) Directive 94/25/EC does not cover personal watercraft, while since its adoption some Member States have introduced laws, regulations and administrative provisions concerning such craft. (3) The propulsion engines on recreational craft and personal watercraft produce exhaust emissions of carbon monoxide (CO), hydrocarbons (HC), nitrogen oxides (NOx), noise emissions and particle emissions which affect both human health and the environment. (4) Exhaust emissions produced by the engines of such recreational craft and personal watercraft and noise emissions produced by such craft are also not covered by Directive 94/25/EC. (5) It is now necessary to integrate environmental protection requirements into the various Community activities in order to promote sustainable development. Such provisions, which are already the subject of the Council Resolution of 3 December 1992 concerning the relationship between industrial competitiveness and environmental protection(5), were taken up in the conclusions of the Industry Council of 29 April 1999. (6) Laws, regulations and administrative provisions are in force in some Member States limiting noise and exhaust emissions from recreational craft and engines in order to protect human health, the environment and, where appropriate, domestic animal health. Those measures differ and are likely to affect the free movement of such products and constitute barriers to trade within the Community. (7) In the framework of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services(6) Member States have notified draft national regulations aimed at reducing noise and exhaust emissions from the engines of recreational craft. Such technical regulations are considered, like the national provisions already in force, to be likely to affect the free movement of such products or to create obstacles to the proper functioning of the internal market. It is therefore necessary to draw up a binding Community instrument. (8) The harmonisation of national laws is the only way to abolish such barriers to trade and unfair competition found in the internal market. The objective of limiting noise and exhaust emissions cannot be satisfactorily met by the Member States individually. The measures provided for in this Directive lay down only the essential requirements for the free movement of recreational craft, personal watercraft and all the types of engines to which this Directive applies. (9) These measures are in accordance with the principles set out in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards(7), with reference being made to harmonised European standards. (10) The provisions on exhaust and noise emissions laid down in this Directive should apply to all engines, whether inboard, outboard or stern drive with or without integral exhaust, and to personal watercraft in order to ensure optimum effectiveness in the protection of human health and the environment. Engines undergoing major modifications should be included as regards exhaust emissions. Craft with stern drive engines without integral exhausts or inboard propulsion engine installations undergoing major craft conversion should be included as regards noise emissions when placed on the Community market within five years following conversion. (11) Conformity with the essential requirements for emissions from the engines concerned is essential to protect human health and the environment. Maximum authorised levels should be laid down for exhaust emissions of carbon monoxide (CO), hydrocarbons (HC), nitrogen oxide (NOx) and particulate pollutants. As far as noise emissions are concerned, the maximum levels should be broken down as a function of the power of such engines and the number and type of engines on board. These measures should be consistent with all other measures to reduce engine emissions in order to protect human beings and the environment. (12) Member States should consider introducing national support measures to encourage the use of synthetic biodegradable lubrication oils to reduce water pollution by recreational craft. The introduction of measures at Community level should be considered during the review of this Directive. (13) For the two types of emission in question, the data certifying their conformity should always accompany the recreational craft, personal watercraft or engine. (14) Harmonised European standards, in particular as regards the measurement of levels and test methods, make it easier to demonstrate conformity with the essential requirements, also in the case of emissions from the recreational craft and personal watercraft covered by this Directive. (15) In view of the nature of the risks involved, it is necessary to adopt conformity assessment procedures to ensure the necessary level of protection. The manufacturer or his authorised representative or, if they do not fulfil their obligations, the person placing the product on the market and/or putting it into service, should ensure that the products covered by this Directive comply with relevant essential requirements, when they are placed on the market and/or put into service. Adequate procedures should be laid down which provide a choice between procedures with equivalent stringency. Those procedures should comply with Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking which are intended to be used in technical harmonisation Directives(8). (16) As far as exhaust emissions are concerned, all types of engines, including personal watercraft and other similar powered craft, should bear the CE mark affixed by the manufacturer or his authorised representative within the Community, except inboard engines and stern drive engines without integral exhaust, engines type-approved according to stage II of Directive 97/68/EC(9) and engines type-approved according to Directive 88/77/EEC(10) which should be accompanied by the manufacturer's declaration of conformity. As far as noise emissions are concerned, only outboard engines and stern drive engines with integral exhaust must bear the CE mark affixed by the manufacturer or his authorised representative or the person placing the product on the market and/or putting it into service within the Community. For noise emissions and for all types of engines, except outboard engines and of stern drive engines with integral exhaust, the CE mark affixed on the craft demonstrates conformity with the relevant essential requirements. (17) Directive 94/25/EC should be amended also to take account of manufacturing needs, which require a greater choice of certification procedures. (18) For the sake of legal certainty and to ensure the safe use of recreational craft, it is necessary to clarify a number of technical issues relating to the essential construction requirements of recreational craft concerning the boat design categories, the maximum recommended load, the craft identification number, the fuel tanks, the fire fighting equipment and the discharge prevention. (19) The Commission should closely monitor the evolution of engine technology and the need to meet future environmental protection requirements in order to examine the possibility of further reducing emission limit values for noise and exhaust emissions. (20) In order to facilitate the application of measures concerning the efficient functioning of legislation, the procedure establishing a close cooperation between the Commission and Member States in the framework of a Committee should be maintained and reinforced. (21) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(11). (22) It is necessary to provide for a transitional arrangement enabling certain products complying with the national rules in force on the date of entry into force of this Directive to be placed on the market and/or put into service, Article 1 Directive 94/25/EC is hereby amended as follows: 1. Article 1 shall be replaced by the following: "Article 1 Scope and definitions 1. This Directive shall apply: (a) with regard to design and construction, to: (i) recreational craft and partly completed boats; (ii) personal watercraft; (iii) components referred to in Annex II when placed on the Community market separately and when intended for installation; (b) with regard to exhaust emissions, to: (i) propulsion engines which are installed or specifically intended for installation on or in recreational craft and personal watercraft; (ii) propulsion engines installed on or in these craft that are subject to a 'major engine modification'; (c) with regard to noise emissions, to: (i) recreational craft with stern drive engines without integral exhausts or inboard propulsion engine installations; (ii) recreational craft with stern drive engines without integral exhausts or with inboard propulsion installations which are subject to a major craft conversion and subsequently placed on the Community market within five years following conversion; (iii) personal watercraft; (iv) outboard engines and stern drive engines with integral exhausts intended for installation on recreational craft; (d) for products falling under (a)(ii), (b) and (c), the provisions of this Directive shall only apply from the first placing on the market and/or putting into service after the date of entry into force of this Directive. 2. The following shall be excluded from the scope of this Directive: (a) with regard to paragraph 1(a): (i) craft intended solely for racing, including rowing racing boats and training rowing boats, labelled as such by the manufacturer; (ii) canoes and kayaks, gondolas and pedalos; (iii) sailing surfboards; (iv) surfboards, including powered surfboards; (v) original historical craft and individual replicas thereof designed before 1950, built predominantly with the original materials and labelled as such by the manufacturer; (vi) experimental craft, provided that they are not subsequently placed on the Community market; (vii) craft built for own use, provided that they are not subsequently placed on the Community market during a period of five years; (viii) craft specifically intended to be crewed and to carry passengers for commercial purposes, without prejudice to paragraph 3(a), in particular those defined in Council Directive 82/714/EEC of 4 October 1982 laying down technical requirements for inland waterway vessels(12), regardless of the number of passengers; (ix) submersibles; (x) air cushion vehicles; (xi) hydrofoils; (xii) External combustion steam powered craft, fuelled by coal, coke, wood, oil or gas; (b) with regard to paragraph 1(b): (i) propulsion engines installed or specifically intended for installation on the following: - craft intended solely for racing and labelled as such by the manufacturer, - experimental craft, provided that they are not subsequently placed on the Community market, - craft specifically intended to be crewed and to carry passengers for commercial purposes, without prejudice to paragraph 3(a), in particular those defined in Directive 82/714/EEC, regardless of the number of passengers, - submersibles, - air cushion vehicles, - hydrofoils; (ii) original and individual replicas of historical propulsion engines, which are based on a pre-1950 design, not produced in series and fitted on craft referred to in paragraph 2(a)(v) and (vii); (iii) propulsion engines built for own use provided that they are not subsequently placed on the Community market during a period of five years; (c) with regard to paragraph 1(c): - all craft referred to in point (b) of this paragraph, - craft built for own use, provided that they are not subsequently placed on the Community market during a period of five years. 3. For the purposes of this Directive the following definitions shall apply: (a) 'recreational craft': any boat of any type intended for sports and leisure purposes of hull length from 2,5 m to 24 m, measured according to the harmonised standard, regardless of the means of propulsion; the fact that the same boat could be used for charter or for recreational boating training shall not prevent it being covered by this Directive when it is placed on the Community market for recreational purposes; (b) 'personal watercraft': a vessel less than 4 m in length which uses an internal combustion engine having a water jet pump as its primary source of propulsion and designed to be operated by a person or persons sitting, standing or kneeling on, rather than within the confines of, a hull; (c) 'propulsion engine': any spark or compression ignition, internal combustion engine used for propulsion purposes, including two-stroke and four-stroke inboard, stern-drive with or without integral exhaust and outboard engines; (d) 'major engine modification': the modification of an engine which: - could potentially cause the engine to exceed the emission limits set out in Annex I.B. excluding routine replacement of engine components that do not alter the emission characteristics, or - increases the rated power of the engine by more than 15 %; (e) 'major craft conversion': a conversion of a craft which: - changes the means of propulsion of the craft, - involves a major engine modification, - alters the craft to such an extent that it is considered a new craft; (f) 'means of propulsion': the mechanical method by which the craft is driven, in particular marine propellers or waterjet mechanical drive systems; (g) 'engine family': the manufacturer's grouping of engines which, through their design, are expected to have similar exhaust emission characteristics and which comply with the exhaust emissions requirements of this Directive; (h) 'manufacturer': any natural or legal person who designs and manufactures a product covered by this Directive or who has such a product designed and/or manufactured with a view to placing it on the market on his own behalf; (i) 'authorised representative': any natural or legal person established in the Community who has received a written mandate from the manufacturer to act on his behalf with regard to the latter's obligation under this Directive."; 2. Article 4 shall be replaced by the following: "Article 4 Free movement of the products referred to in Article 1(1) 1. Member States shall not prohibit, restrict or impede the placing on the market and/or putting into service in their territory of products referred to in Article 1(1) bearing the CE marking referred to in Annex IV, which indicates their conformity with all the provisions of this Directive, including the conformity procedures set out in Chapter II. 2. Member States shall not prohibit, restrict or impede the placing on the market of partly-completed boats where the builder or his authorised representative established in the Community or the person responsible for the placing on the market declares, in accordance with Annex IIIa, that they are intended to be completed by others. 3. Member States shall not prohibit, restrict or impede the placing on the market and/or putting into service of components referred to in Annex II and bearing the CE marking referred to in Annex IV which indicates their conformity with the relevant essential requirements where these components are accompanied by a written declaration of conformity as provided for in Annex XV and are intended to be incorporated into recreational craft, in accordance with the declaration, referred to in Annex IIIb, of the manufacturer, his authorised representative established in the Community or, in the case of imports from a third country, of any person who places those components on the Community market. 4. Member States shall not prohibit, restrict or impede the placing on the market and/or putting into service of: - inboard engines and stern drive propulsion engines without integral exhaust, - engines type-approved according to Directive 97/68/EC(13) which are in compliance with stage II provided for in section 4.2.3 of Annex I to that Directive and of, - engines type-approved according to Directive 88/77/EEC(14); where the manufacturer or his authorised representative established in the Community declares in accordance with Annex XV.3 that the engine will meet the exhaust emission requirements of this Directive, when installed in a recreational craft or personal watercraft in accordance with the manufacturer's supplied instructions. 5. At trade fairs, exhibitions, demonstrations, etc., Member States shall not create any obstacles to the showing of the products referred to in Article 1(1) which do not comply with this Directive, provided that a visible sign clearly indicates that such products may not be marketed or put into service until they have been made to comply. 6. Where the products referred to in Article 1(1) are subject to other Directives covering other aspects and which provide for the affixing of the CE marking, the latter shall indicate that such products are also presumed to conform to the provisions of those other Directives. The CE marking shall indicate conformity with the applicable Directives or relevant parts thereof. In this case, the particulars of the said Directives applied by the manufacturer, as published in the Official Journal of the European Union, must be given in the documents, declaration of conformity or instructions required by the Directives and accompanying such products."; 3. the following Article shall be inserted: "Article 6a Committee procedure 1. Amendments which are necessary, in the light of evolution of technical knowledge and new scientific evidence, to the requirements of Annex I.B.2 and Annex I.C.1 excluding direct or indirect modifications to exhaust or noise emission values and to the Froude and P/D ratio values shall be adopted by the Commission assisted by the Standing Committee set up pursuant to Article 6(3), acting as a regulatory committee in accordance with the procedure referred to in paragraph 2. Issues to be dealt with shall include the reference fuels and the standards to be used for exhaust and noise emissions testing. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure."; 4. the first subparagraph of Article 7(1) shall be replaced by the following: "1. Where a Member State ascertains that products falling within the scope of Article 1 and bearing the CE marking referred to in Annex IV, when correctly designed, constructed, installed where appropriate, maintained and used in accordance with their intended purpose may endanger the safety and health of persons, property or the environment, it shall take all appropriate interim measures to withdraw them from the market or prohibit or restrict their being placed on the market and/or put into service."; 5. Article 7(3) shall be replaced by the following: "3. Where a non-complying product referred to in Article 1 bears the CE marking, the appropriate measures shall be taken by the Member State which has authority over whomsoever affixed the marking; that Member State shall inform the Commission and the other Member States thereof."; 6. Article 8 shall be replaced by the following: "Article 8 1. Before placing on the market, and/or putting into service, products referred to in Article 1(1) the manufacturer or his authorised representative established within the Community shall apply the procedures referred to in paragraphs 2, 3 and 4 of this Article. In the case of post-construction assessment for recreational craft, if neither the manufacturer nor his authorised representative established within the Community fulfils the responsibilities for the product's conformity to this Directive, these can be assumed by any natural or legal person established within the Community who places the product on the market, and/or puts it into service, under his own responsibility. In such a case, the person who places the product on the market or puts it into service must lodge an application for a post-construction report with a notified body. The person who places the product on the market and/or puts it into service must provide the notified body with any available document and technical file referring to the first placing on the market of the product in the country of origin. The notified body shall examine the individual product and carry out calculations and other assessment to ensure its equivalent conformity with the relevant requirements of the Directive. In this case, the Builder's plate described in Annex I, 2.2 shall include the words ('Post-construction certificate'). The notified body shall draw up a report of conformity concerning the assessment carried out and shall inform the person who places the product on the market and/or puts it into service of his obligations. That person shall draw up a declaration of conformity (see Annex XV) and affix, or cause to be affixed, the CE mark accompanied by the distinguishing number of the relevant notified body on the product. 2. With regard to design and construction of products referred to in Article 1(1)(a), the boat manufacturer or his authorised representative established in the Community shall apply the following procedures for boat design categories A, B, C and D as referred to in section 1 of Annex I.A: (a) for categories A and B: (i) for boats from 2,5 m to 12 m hull length: the internal production control plus tests (module Aa) referred to in Annex VI, or the EC type-examination (module B) as described in Annex VII, supplemented by conformity to type (module C) referred to in Annex VIII, or any of the following modules: B+D, or B+E, or B+F, or G or H; (ii) for boats from 12 m to 24 m hull length: the EC type-examination (module B) referred to in Annex VII supplemented by conformity to type (module C) referred to in Annex VIII, or any of the following modules: B+D, or B+E, or B+F, or G or H; (b) for category C: (i) for boats from 2,5 m to 12 m hull length: - where the harmonised standards relating to Sections 3.2 and 3.3 of Annex I.A are complied with: the internal production control (module A), referred to in Annex V, or internal production control plus tests (module Aa) referred to in Annex VI, or the EC type-examination (module B) as described in Annex VII, supplemented by conformity to type (module C) referred to in Annex VIII, or any of the following modules: B+D, or B+E, or B+F, or G, or H, - where the harmonised standards relating to Sections 3.2 and 3.3 of Annex I.A are not complied with: the internal production control plus tests (module Aa) referred to in Annex VI, or the EC type-examination (module B) as described in Annex VII, supplemented by conformity to type (module C) referred to in Annex VIII, or any of the following modules: B+D, or B+E, or B+F, or G, or H; (ii) for boats from 12 m to 24 m hull length: the EC type-examination (module B) referred to in Annex VII followed by conformity to type (module C) referred to in Annex VIII, or any of the following modules: B+D, or B+E, or B+F, or G or H; (c) for category D: for boats from 2,5 m to 24 m hull length: the internal production control (module A) referred to in Annex V, or the internal production control plus tests (module Aa) referred to in Annex VI, or the EC type-examination (module B) as described in Annex VII, supplemented by conformity to type (module C) referred to in Annex VIII, or any of the following modules: B+D, or B+E, or B+F or G or H; (d) for personal watercraft: the internal production control (module A) referred to in Annex V, or the internal production control plus tests (module Aa) referred to in Annex VI, or the EC type-examination (module B) as described in Annex VII followed by conformity to type (module C) referred to in Annex VIII, or any of the following modules: B+D, or B+E, or B+F, or G or H; (e) for components referred to in Annex II: any of the following modules: B+C, or B+D, or B+F, or G or H. 3. With regard to exhaust emissions: for products referred to in Article 1(1)(b), the engine manufacturer or his authorised representative established in the Community shall apply the EC type-examination (module B) as described in Annex VII followed by conformity to type (module C) referred to in Annex VIII, or any of the following modules: B+D, or B+E, or B+F, or G or H. 4. With regard to noise emissions: (a) for products referred to in Article 1(1)(c)(i) and (ii), the boat manufacturer or his authorised representative established in the Community shall apply: (i) where tests are conducted using the harmonised standard(15) for noise measurement: either internal production control plus tests (module Aa) referred to in Annex VI, or unit verification (module G) referred to in Annex XI, or full quality assurance (module H) referred to in Annex XII; (ii) where the Froude number and power displacement ratio method is used for assessment: either the internal production control (module A) referred to in Annex V, or the internal production control plus tests (module Aa) referred to in Annex VI, or unit verification (module G) referred to in Annex XI, or full quality assurance (module H) referred to in Annex XII; (iii) where certified reference boat data, established in accordance with point (i), is used for assessment: either internal production control (module A) referred to in Annex V, or internal production control plus supplementary requirements (module Aa) referred to in Annex VI, or unit verification (module G) referred to in Annex XI, or full quality assurance (module H) referred to in Annex XII; (b) for products referred to in Article 1(1)(c)(iii) and (iv), the personal watercraft/engine manufacturer or his authorised representative established in the Community shall apply: internal production control plus supplementary requirements referred to in Annex VI (module Aa) or module G or H."; 7. Article 10(1), (2) and (3) shall be replaced by the following: "1. When the following products are placed on the market, they shall bear the CE marking of conformity: (a) recreational craft, personal watercraft and components referred to in Annex II, which are regarded as meeting the corresponding essential requirements set out in Annex I; (b) outboard engines which are regarded as meeting the essential requirements set out in Annex I.B and I.C.; (c) stern drive engines with integral exhaust which are regarded as meeting the essential requirements set out in Annex I.B. and I.C. 2. The CE marking of conformity, as shown in Annex IV, must appear in a visible, legible and indelible form on the craft and the personal watercraft as in point 2.2 of Annex I.A, on components, as referred to in Annex II and/or on their packaging, and on outboard engines and stern drive engines with integral exhaust as in point 1.1 of Annex I.B. The CE marking shall be accompanied by the identification number of the body responsible for implementation of the procedures set out in Annexes IX, X, XI, XII, and XVI. 3. The affixing of markings or inscriptions on products covered by this Directive which are likely to mislead third parties with regard to the meaning or the form of the CE marking shall be prohibited. Any other markings may be affixed to products covered by this Directive and/or on their packaging provided that the visibility and legibility of the CE marking is not thereby reduced."; 8. Annex I is hereby amended as follows: 1. the heading shall be replaced by the following: "ANNEX I ESSENTIAL REQUIREMENTS PRELIMINARY OBSERVATION For the purposes of this Annex the term "craft" shall cover recreational craft and personal watercraft. A. Essential safety requirements for the design and construction of craft."; 2. the table under "1. BOAT DESIGN CATEGORIES" shall be replaced by the following: ">TABLE>" 3. the definition of Boat Design Category A shall be replaced by the following: "A. Ocean: Designed for extended voyages where conditions may exceed wind force 8 (Beaufort scale) and significant wave heights of 4 m and above but excluding abnormal conditions, and vessels largely self-sufficient."; 4. the definition of Boat Design Category D shall be replaced by the following: "D. Sheltered waters - Designed for voyages on sheltered coastal waters, small bays, small lakes, rivers and canals when conditions up to, and including, wind force 4 and significant wave heights up to, and including, 0,3 m may be experienced, with occasional waves of 0,5 m maximum height, for example from passing vessels."; 5. the last subparagraph under section 1. "Boat design categories" shall be replaced by the following: "Craft in each Category must be designed and constructed to withstand these parameters in respect of stability, buoyancy, and other relevant essential requirements listed in Annex I, and to have good handling characteristics."; 6. the text under section 2. "General requirements" shall be replaced by the following: "Products falling under Article 1(1)(a) shall comply with the essential requirements in so far as they apply to them."; 7. in section 2.1: (a) the title should read as follows: "Craft identification"; (b) the introductory wording shall read as follows: "Each craft shall be marked with an identification number including the following information:"; 8. in section 2.2 "Builder's plate", the fourth indent shall read as follows: "- manufacturer's maximum recommended load derived from section 3.6 excluding the weight of the contents of the fixed tanks when full"; 9. in section 3.6 "Manufacturer's maximum recommended load" the following words shall be deleted: "..., as marked on the builder's plate,..."; 10. the following section shall be added in section 5 "Installation requirements": "5.1.5. Personal watercraft running without driver. Personal watercraft shall be designed either with an automatic engine cut-off or with an automatic device to provide reduced speed, circular, forward movement when the driver dismounts deliberately or falls overboard."; 11. section 5.2.2 shall be replaced by the following: "5.2.2. Fuel tanks Fuel tanks, lines and hoses shall be secured and separated or protected from any source of significant heat. The material the tanks are made of and their method of construction shall be according to their capacity and the type of fuel. All tank spaces shall be ventilated. Petrol fuel shall be kept in tanks which do not form part of the hull and are: (a) insulated from the engine compartment and from all other source of ignition; (b) separated from living quarters; Diesel fuel may be kept in tanks that are integral with the hull."; 12. section 5.6.2 shall be replaced by the following: "5.6.2. Fire-fighting equipment Craft shall be supplied with fire-fighting equipment appropriate to the fire hazard, or the position and capacity of fire-fighting equipment appropriate to the fire hazard shall be indicated. The craft shall not be put into service until the appropriate fire-fighting equipment is in place. Petrol engine enclosures shall be protected by a fire extinguishing system that avoids the need to open the enclosure in the event of fire. Where fitted, portable fire extinguishers shall be readily accessible and one shall be so positioned that it can easily be reached from the main steering position of the craft."; 13. section 5.8 shall be replaced by the following: "5.8. Discharge prevention and installations facilitating the delivery ashore of waste Craft shall be constructed so as to prevent the accidental discharge of pollutants (oil, fuel, etc.) overboard. Craft fitted with toilets shall have either: (a) holding tanks, or (b) provision to fit holding tanks. Craft with permanently installed holding tanks shall be fitted with a standard discharge connection to enable pipes of reception facilities to be connected with the craft discharge pipeline. In addition, any through-the-hull pipes for human waste shall be fitted with valves which are capable of being secured in the closed position."; 14. the following parts shall be added: "B. Essential requirements for exhaust emissions from propulsion engines Propulsion engines shall comply with the following essential requirements for exhaust emissions. 1. Engine identification 1.1. Each engine shall be clearly marked with the following information: - engine manufacturer's trademark or trade-name, - engine type, engine family, if applicable, - a unique engine identification number, - CE marking, if required under Article 10. 1.2. These marks must be durable for the normal life of the engine and must be clearly legible and indelible. If labels or plates are used, they must be attached in such a manner that the fixing is durable for the normal life of the engine, and the labels/plates cannot be removed without destroying or defacing them. 1.3. These marks must be secured to an engine part necessary for normal engine operation and not normally requiring replacement during the engine life. 1.4. These marks must be located so as to be readily visible to the average person after the engine has been assembled with all the components necessary for engine operation. 2. Exhaust emission requirements Propulsion engines shall be designed, constructed and assembled so that when correctly installed and in normal use, emissions shall not exceed the limit values obtained from the following table: Table 1 >TABLE> Where A, B and n are constants in accordance with the table, PN is the rated engine power in kW and the exhaust emissions are measured in accordance with the harmonised standard(16). For engines above 130 kW either E3 (IMO) or E5 (recreational marine) duty cycles may be used. The reference fuels to be used for the emissions test for engines fuelled with petrol and diesel shall be as specified in Directive 98/69/EC (Annex IX, Tables 1 and 2), and for those engines fuelled with Liquefied Petroleum Gas as specified in Directive 98/77/EC. 3. Durability The manufacturer of the engine shall supply engine installation and maintenance instructions, which if applied should mean that the engine in normal use will continue to comply with the above limits throughout the normal life of the engine and under normal conditions of use. This information shall be obtained by the engine manufacturer by use of prior endurance testing, based on normal operating cycles, and by calculation of component fatigue so that the necessary maintenance instructions may be prepared by the manufacturer and issued with all new engines when first placed on the market. The normal life of the engine is considered to mean: (a) inboard or stern drive engines with or without integral exhaust: 480 hours or 10 years, whichever occurs first; (b) personal watercraft engines: 350 hours or five years, whichever occurs first; (c) outboard engines: 350 hours or 10 years, whichever occurs first. 4. Owner's manual Each engine shall be provided with an owner's manual in the Community language or languages, which may be determined by the Member State in which the engine is to be marketed. This manual shall: (a) provide instructions for the installation and maintenance needed to assure the proper functioning of the engine to meet the requirements of paragraph 3, (Durability); (b) specify the power of the engine when measured in accordance with the harmonised standard. C. Essential requirements for noise emissions Recreational craft with inboard or stern drive engines without integral exhaust, personal watercraft and outboard engines and stern drive engines with integral exhaust shall comply with the following essential requirements for noise emissions. 1. Noise emission levels 1.1. Recreational craft with inboard or stern drive engines without integral exhaust, personal watercraft and outboard engines and stern drive engines with integral exhaust shall be designed, constructed and assembled so that noise emissions measured in accordance with tests defined in the harmonised standard(17) shall not exceed the limit values in the following table: Table 2 >TABLE> where PN = rated engine power in kW at rated speed and LpASmax = maximum sound pressure level in dB. For twin-engine and multiple-engine units of all engine types an allowance of 3 dB may be applied. 1.2. As an alternative to sound measurement tests, recreational craft with inboard engine configuration or stern drive engine configuration, without integral exhaust, shall be deemed to comply with these noise requirements if they have a Froude number of <= 1,1 and a power displacement ratio of <= 40 and where the engine and exhaust system are installed in accordance with the engine manufacturer's specifications. 1.3. 'Froude number' shall be calculated by dividing the maximum boat speed V (m/s) by the square root of the waterline length lwl (m) multiplied by a given gravitational constant, (g = 9,8 m/s2) >REFERENCE TO A GRAPHIC>. 'Power displacement ratio' shall be calculated by dividing the engine power P (kW) by the boat's displacement >REFERENCE TO A GRAPHIC> 1.4. As a further alternative to sound measurement tests, recreational craft with inboard or stern drive engine configurations without integral exhaust, shall be deemed to comply with these noise requirements if their key design parameters are the same as or compatible with those of a certified reference boat to tolerances specified in the harmonised standard. 1.5. 'Certified reference boat' shall mean a specific combination of hull/inboard engine or stern drive engine without integral exhaust that has been found to comply with the noise emission requirements, when measured in accordance with section 1.1, and for which all appropriate key design parameters and sound level measurements have been included subsequently in the published list of certified reference boats. 2. Owner's Manual For recreational craft with inboard engine or stern drive engines with or without integral exhaust and personal watercraft, the owner's manual required under Annex I.A Section 2.5, shall include information necessary to maintain the craft and exhaust system in a condition that, insofar as is practicable, will ensure compliance with the specified noise limit values when in normal use. For outboard engines, the owner's manual required under Annex I.B.4 shall provide instructions necessary to maintain the outboard engine in a condition, that insofar as is practicable, will ensure compliance with the specified noise limit values when in normal use." 9. Section 4 of Annex II shall read as follows: "4. Fuel tanks intended for fixed installations and fuel hoses."; 10. Annex VI shall be replaced by the following: "ANNEX VI INTERNAL PRODUCTION CONTROL PLUS TESTS (Module Aa, option 1) This module consists of module A, as referred to in Annex V, plus the following supplementary requirements: A. Design and construction On one or several boats representing the production of the manufacturer one or more of the following tests, equivalent calculation or control shall be carried out by the manufacturer or on his behalf: (a) test of stability according to section 3.2 of the Essential Requirements (Annex IA); (b) test of buoyancy characteristics according to section 3.3 of the Essential Requirements (Annex IA). Provisions common to both variations: These tests or calculations or control shall be carried out under the responsibility of a notified body chosen by the manufacturer. B. Noise emissions For recreational craft fitted with inboard or stern drive engines without integral exhaust and for personal watercraft: On one or several craft representing the production of the craft manufacturer, the sound emission tests defined in Annex I.C shall be carried out by the craft manufacturer, or on his behalf, under the responsibility of a notified body chosen by the manufacturer. For outboard engines and stern drive engines with integral exhaust: On one or several engines of each engine family representing the production of the engine manufacturer, the sound emission tests defined in Annex I.C shall be carried out by the engine manufacturer, or on his behalf, under the responsibility of a notified body chosen by the manufacturer. Where more than one engine of an engine family is tested, the statistical method described in Annex XVII shall be applied to ensure conformity of the sample."; 11. the following point shall be added to Annex VIII: "4. With regard to the assessment of conformity with the exhaust emission requirements of this Directive and if the manufacturer is not working under a relevant quality system as described in Annex XII, a notified body chosen by the manufacturer may carry out or have carried out product checks at random intervals. When the quality level appears unsatisfactory or when it seems necessary to verify the validity of the data presented by the manufacturer, the following procedure shall be used: An engine is taken from the series and subjected to the test described in Annex I.B. Test engines shall have been run in, partially or completely, according to the manufacturer's specifications. If the specific exhaust emissions of the engine taken from the series exceed the limit values according to Annex I.B, the manufacturer may ask for measurements to be done on a sample of engines taken from the series and including the engine originally taken. To ensure the conformity of the sample of engines defined above with the requirements of the Directive, the statistical method described in Annex XVII shall be applied."; 12. the following subparagraph shall be added to section 5.3 in Annex X: "For the assessment of conformity with the exhaust emission requirements, the procedure defined in Annex XVII shall be applied."; 13. Annex XIII shall be replaced by the following: "ANNEX XIII TECHNICAL DOCUMENTATION SUPPLIED BY THE MANUFACTURER The technical documentation referred to in Annexes V, VII, VIII, IX, XI and XVI must comprise all relevant data or means used by the manufacturer to ensure that components or craft comply with the essential requirements relating to them. The technical documentation shall enable understanding of the design, manufacture and operation of the product, and shall enable assessment of conformity with the requirements of this Directive. The documentation shall contain so far as relevant for assessment: (a) a general description of the type, (b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc., (c) descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product, (d) a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to fulfil the essential requirements when the standards referred to in Article 5 have not been applied, (e) results of design calculations made, examinations carried out, etc., (f) test reports, or calculations namely on stability according to section 3.2 of the Essential Requirements and on buoyancy according to section 3.3 thereof (Annex I.A), (g) exhaust emissions test reports demonstrating compliance with section 2 of the Essential Requirements (Annex I.B), (h) sound emissions test reports or reference boat data demonstrating compliance with section 1 of the Essential Requirements (Annex I.C)."; 14. point 1 of Annex XIV shall be replaced by the following: "1. The body, its director and the staff responsible for carrying out the verification tests shall not be the designer, manufacturer, supplier or installer of the products referred to in Article 1 which they inspect, nor the authorised representative of any of these parties. They shall not become either involved directly or as authorised representatives in the design, construction, marketing or maintenance of the said products. This does not preclude the possibility of exchanges of technical information between the manufacturer and the body. 1a. A notified body must be independent and must not be controlled by the manufacturers or by suppliers."; 15. Annex XV shall be replaced by the following: "ANNEX XV WRITTEN DECLARATION OF CONFORMITY 1. The written declaration of conformity to the provisions of the Directive must always accompany: (a) the recreational craft and the personal watercraft and must be included with the owner's manual (Annex I.A section 2.5), (b) the components, as referred to in Annex II, (c) propulsion engines and must be included with the owner's manual (Annex I.B.4). 2. The written declaration of conformity shall include the following(1): (a) name and address of the manufacturer or his authorised representative established in the Community(2), (b) description of the product defined in point 1(3), (c) references to the relevant harmonised standards used, or references to the specifications in relation to which conformity is declared, (d) where appropriate, the references of the other Community Directives applied, (e) where appropriate, reference to the EC type-examination certificate issued by a notified body, (f) where appropriate, the name and address of the notified body, (g) identification of the person empowered to sign on behalf of the manufacturer or his authorised representative established within the Community. 3. With regard to: - inboard engines and stern drive propulsion engines without integral exhaust, - engines type-approved according to Directive 97/68/EC which are in compliance with stage II provided for in section 4.2.3 of Annex I of the latter Directive and, - engines type-approved according to Directive 88/77/EEC, the declaration of conformity shall include in addition to the information of point 2, a statement of the manufacturer that the engine will meet the exhaust emission requirements of this Directive, when installed in a recreational craft, in accordance with the manufacturer's supplied instructions and that this engine must not be put into service until the recreational craft into which it is to be installed has been declared in conformity, if so required, with the relevant provision of the Directive; (1) Must be drawn up in the language(s) as provided for under section 2.5 of Annex I.A. (2) Business name and full address; the authorised representative must also give the business name and address of the manufacturer. (3) Description of the product make, type, serial number, where appropriate." 16. the following Annexes shall be added: "ANNEX XVI PRODUCT QUALITY ASSURANCE (MODULE E) 1. This module describes the procedure whereby the manufacturer who satisfies the obligations of point 2 ensures and declares that the products concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of the directive that apply to them. The manufacturer or his authorised representative established within the Community must affix the CE mark to each product and draw up a written declaration of conformity. The CE mark must be accompanied by the identification symbol of the notified body responsible for surveillance as specified in point 4. 2. The manufacturer must operate an approved quality system for final product inspection and testing as specified in point 3 and must be subject to surveillance as specified in point 4. 3. Quality system 3.1. The manufacturer must lodge an application for assessment of his quality system for the products concerned, with a notified body of his choice. The application must include: - all relevant information for the product category envisaged, - the quality system's documentation, - if applicable, the technical documentation of the approved type and a copy of the EC type-examination certificate. 3.2. Under the quality system, each product must be examined and appropriate tests as set out in the relevant standard(s) referred to in Article 5 or equivalent tests shall be carried out in order to ensure its conformity with the relevant requirements of the directive. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must ensure a common understanding of the quality programmes, plans, manuals and records. It must contain in particular an adequate description of: - the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality, - the examinations and tests that will be carried out after manufacture, - the means to monitor the effective operation of the quality system, - quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc. 3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It presumes conformity with these requirements in respect of quality systems that implement the relevant harmonised standard. The auditing team must have at least one member experienced as an assessor in the product technology concerned. The assessment procedure must include an assessment visit to the manufacturer's premises. The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. 3.4. The manufacturer must undertake to fulfil the obligations arising from the quality system as approved and to maintain it in an appropriate and efficient manner. The manufacturer or his authorised representative must keep the notified body which has approved the quality system informed of any intended updating of the quality system. The notified body must evaluate the modifications proposed and decide whether the modified quality system will still satisfy the requirements referred to in point 3.2 or whether a reassessment is required. It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. 4. Surveillance under the responsibility of the notified body 4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer must allow the notified body entrance for inspection purposes to the locations of inspection, testing and storage and shall provide it with all necessary information, in particular: - the quality system documentation, - the technical documentation, - the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc. 4.3. The notified body must periodically carry out audits to ensure that the manufacturer maintains and applies the quality system and must provide an audit report to the manufacturer. 4.4. Additionally, the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality system where necessary; it must provide the manufacturer with a visit report and, if a test has been carried out, with a test report. 5. The manufacturer must, for a period ending at least 10 years after the last product has been manufactured, keep at the disposal of the national authorities: - the documentation referred to in the third indent of the second subparagraph of point 3.1, - the updating referred to in the second subparagraph of point 3.4, - the decisions and reports from the notified body which are referred to in the final subparagraph of point 3.4, points 4.3 and 4.4. 6. Each notified body must forward to the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn. ANNEX XVII CONFORMITY OF PRODUCTION ASSESSMENT FOR EXHAUST AND NOISE EMISSIONS 1. For verifying the conformity of an engine family, a sample of engines is taken from the series. The manufacturer shall decide the size (n) of the sample, in agreement with the notified body. 2. The arithmetical mean X of the results obtained from the sample shall be calculated for each regulated component of the exhaust and noise emission. The production of the series shall be deemed to conform to the requirements (pass decision) if the following condition is met: X + K. S <= L S is standard deviation, where: >REFERENCE TO A GRAPHIC> X= the arithmetical mean of the results x= the individual results of the sample L= the appropriate limit value n= the number of engines in the sample k= statistical factor depending on n (see table) >TABLE> If n >= 20 then k = 0,860/[radic ]n. >REFERENCE TO A GRAPHIC>". Article 2 By 31 December 2006 the Commission shall submit a report on the possibilities of further improving the environmental characteristics of engines and consider inter alia the need to revise the boat design categories. If deemed appropriate, in the light of this report, the Commission shall by 31 December 2007 submit appropriate proposals to the European Parliament and the Council. The Commission shall in the light of the experience gained take account of: (a) the need to further reduce emissions of air pollutants and noise in order to meet environment protection requirements; (b) the possible benefits of a system for "in-use compliance"; (c) the availability of cost efficient techniques for controlling emissions; (d) the need to reduce evaporation and spill of fuel; (e) the possibility of agreeing on international standards for exhaust and noise emissions; (f) possible simplifications of the system for conformity assessment procedures. Article 3 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with the requirements of this Directive by 30 June 2004. They shall immediately inform the Commission thereof. Member States shall apply such measures as from 1 January 2005. 2. Member States shall permit the placing on the market and/or putting into service of products which comply with the rules in force in their territory on the date of entry into force of this Directive, as follows: (a) until 31 December 2005 for the products falling under Article 1(1)(a); (b) until 31 December 2005 for compression ignition and four-stroke spark ignition engines; and, (c) until 31 December 2006 for two-stroke spark ignition engines. 3. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 4. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field governed by this Directive. Article 4 Member States shall determine the penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties shall be effective, proportionate and dissuasive. Article 5 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 6 This Directive is addressed to the Member States.

32003L0057

2003

Commission Directive 2003/57/EC of 17 June 2003 amending Directive 2002/ 32/EC of the European Parliament and of the Council on undesirable substances in animal feedText with EEA relevance Having regard to the Treaty establishing the European Community, Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed(1), and in particular Article 8(1) thereof, Whereas: (1) Council Directive 1999/29/EC on the undesirable substances and products in animal nutrition(2), as amended by Directive 2001/102/EC(3), establishes maximum levels for dioxins in several feed materials and compound feedingstuffs. (2) Directive 2002/32/EC repeals and replaces Directive 1999/29/EC with effect from 1 August 2003. (3) It is of major importance for public and animal health protection that the maximum levels for dioxins established by Directive 1999/29/EC remain in force after 1 August 2003. Directive 2002/32/EC should therefore be amended in order to include the maximum levels for dioxins, established by Directive 1999/29/EC. (4) In order to avoid any confusion it is appropriate to specify that minerals refer to the feed materials in the meaning of the Annex of Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed materials(4) as last amended by Directive 2001/46/EC of the European Parliament and of the Council(5). (5) For greater clarity the rules governing dioxins should be collected in a single text. As a result, it is appropriate to amend Directive 2002/32/EC by inserting as an annex thereto the provisions of Commission Regulation (EC) No 2439/1999 of 17 November 1999 on the conditions for the authorisation of additives belonging to the group "binders, anti-caking agents and coagulants" in feedingstuffs(6), as amended by Regulation (EC) No 739/2000(7), which establishes a provisional maximum limit for kaolinitic clays and other additives authorised for use as binders, anti-caking agents and coagulants. As no or insufficient monitoring data on the presence of dioxins have been provided for calcium sulphate dihydrate, vermiculite, natrolite-phonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin demonstrating the absence of contamination by dioxins or contamination at levels below the limit of quantification, it is therefore appropriate in order to protect animal and human health to establish for these additives a maximum level for dioxins in addition to the maximum level for dioxins in kaolinitic clay. As a result, Regulation (EC) 2439/1999 can be repealed. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 2002/32/EC is hereby amended in accordance with the Annex to this Directive. Article 2 1. With exception of the provisions concerning the entries (c) and (j) in the list of products in the table annexed to this Directive, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 July 2003 at the latest. They shall forthwith inform the Commission thereof. They shall apply these provisions from 1 August 2003. With regard to the provisions concerning the entries (c) and (j) in the list of products in the table annexed to this Directive, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 29 February 2004 at the latest. They shall forthwith inform the Commission thereof. They shall apply these provisions from 1 March 2004. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law, which they adopt in the field covered by this Directive. Article 3 Commission Regulation (EC) No 2439/1999 of 17 November 1999 on the conditions for the authorisation of additives belonging to the group "binders, anti-caking agents and coagulants" in feedingstuffs shall be repealed with effect from 1 March 2004. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32003L0051

2003

Directive 2003/51/EC of the European Parliament and of the Council of 18 June 2003 amending Directives 78/660/EEC, 83/349/EEC, 86/635/EEC and 91/674/EEC on the annual and consolidated accounts of certain types of companies, banks and other financial institutions and insurance undertakings (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 44(1) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) The Lisbon European Council of 23-24 March 2000 emphasised the need to accelerate completion of the internal market for financial services, set the deadline of 2005 for implementation of the Commission's Financial Services Action Plan and urged that steps be taken to enhance the comparability of financial statements prepared by Community companies whose securities are admitted to trading on a regulated market (hereinafter: listed companies). (2) On 13 June 2000, the Commission published its Communication entitled "EU Financial Reporting Strategy: The Way Forward" in which it was proposed that all listed companies prepare their consolidated accounts in accordance with one single set of accounting standards, namely International Accounting Standards (IAS), at the latest by 2005. (3) Regulation (EC) No 1606/2002 of the European Parliament and of the Council of 19 July 2002 on the application of international accounting standards(4) (hereinafter: the IAS Regulation) introduced the requirement that, from 2005 onwards, all listed companies prepare their consolidated accounts in accordance with IAS adopted for application within the Community. It also provided an option for Member States to permit or require the application of adopted IAS in the preparation of annual accounts and to permit or require the application of adopted IAS by unlisted companies. (4) The IAS Regulation provides that, to adopt an international accounting standard for its application in the Community, it is necessary that it meets the basic requirement of the Fourth Council Directive 78/660/EEC of 25 July 1978 on the annual accounts of certain types of companies(5) and of the Seventh Council Directive 83/349/EEC of 13 June 1983 on consolidated accounts(6), that is to say that its application results in a true and fair view of the financial position and performance of an enterprise - this principle being considered in the light of the said Directives without implying a strict conformity with each and every provision of those Directives. (5) As the annual and consolidated accounts of undertakings covered by Directives 78/660/EEC and 83/349/EEC which are not prepared in accordance with the IAS Regulation will continue to have those Directives as the primary source of their Community accounting requirements, it is important that a level playing field exists between Community companies which apply IAS and those which do not. (6) For the purposes both of the adoption of IAS and the application of Directives 78/660/EEC and 83/349/EEC, it is desirable that those Directives reflect developments in international accounting. In this respect, the Communication of the Commission entitled "Accounting Harmonisation: A New Strategy vis-à-vis International Harmonisation" called for the European Union to work to maintain consistency between Community Accounting Directives and developments in international accounting standard setting, in particular within the International Accounting Standards Committee (IASC). (7) Member States should be able to modify the presentation of the profit and loss account and balance sheet in accordance with international developments, as expressed through standards issued by the International Accounting Standards Board (IASB). (8) Member States should be able to permit or require the application of revaluations and of fair value in accordance with international developments, as expressed through standards issued by the IASB. (9) The annual report and the consolidated annual report are important elements of financial reporting. Enhancement, in line with current best practice, of the existing requirement for these to present a fair review of the development of the business and of its position, in a manner consistent with the size and complexity of the business, is necessary to promote greater consistency and give additional guidance concerning the information a "fair review" is expected to contain. The information should not be restricted to the financial aspects of the company's business. It is expected that, where appropriate, this should lead to an analysis of environmental and social aspects necessary for an understanding of the company's development, performance or position. This is consistent also with Commission Recommendation 2001/453/EC of 30 May 2001 on the recognition, measurement and disclosure of environmental issues in the annual accounts and annual reports of companies(7). However, taking into account the evolving nature of this area of financial reporting and having regard to the potential burden placed on undertakings below certain sizes, Member States may choose to waive the obligation to provide non-financial information in the case of the annual report of such undertakings. (10) Differences in the preparation and presentation of the audit report reduce comparability and detract from the user's understanding of this vital aspect of financial reporting. Increased consistency should be achieved by amendments, consistent with current international best practice, to the specific requirements concerning the format and content of an audit report. The fundamental requirement that an audit opinion states whether the annual or consolidated accounts give a true and fair view in accordance with the relevant financial reporting framework does not represent a restriction of the scope of that opinion but clarifies the context in which it is expressed. (11) Directives 78/660/EEC and 83/349/EEC should accordingly be amended. Furthermore, it is also necessary to amend Council Directive 86/635/EEC of 8 December 1986 on the annual accounts and consolidated accounts of banks and other financial institutions(8). (12) The IASB is developing and refining the accounting standards applicable to insurance activities. (13) Insurance undertakings should also be allowed to use fair-value accounting as expressed through appropriate standards issued by the IASB. (14) Consequently Council Directive 91/674/EEC of 19 December 1991 on the annual accounts and consolidated accounts of insurance undertakings(9) should be amended. (15) These amendments will remove all inconsistencies between Directives 78/660/EEC, 83/349/EEC, 86/635/EEC and 91/674/EEC on the one hand and IAS in existence at 1 May 2002, on the other, Article 1 Directive 78/660/EEC is hereby amended as follows: 1. in Article 2(1) the following subparagraph shall be added:"Member States may permit or require the inclusion of other statements in the annual accounts in addition to the documents referred to in the first subparagraph."; 2. in Article 4, the following paragraph shall be added: "6. Member States may permit or require the presentation of amounts within items in the profit and loss account and balance sheet to have regard to the substance of the reported transaction or arrangement. Such permission or requirement may be restricted to certain classes of company and/or to consolidated accounts as defined in the Seventh Council Directive 83/349/EEC of 13 June 1983 on consolidated accounts(10)."; 3. in Article 8 the following paragraph shall be added:"Member States may permit or require companies to adopt the presentation of the balance sheet set out in Article 10a as an alternative to the layouts otherwise prescribed or permitted."; 4. in Article 9, under "Liabilities", in point B, the title "Provisions for liabilities and charges" shall be replaced by "Provisions"; 5. in Article 10, point J, the title "Provisions for liabilities and charges" shall be replaced by "Provisions"; 6. the following Article shall be inserted: "Article 10a Instead of the presentation of balance sheet items in accordance with Articles 9 and 10, Member States may permit or require companies, or certain classes of company, to present those items on the basis of a distinction between current and non-current items provided that the information given is at least equivalent to that otherwise required by Articles 9 and 10."; 7. Article 20 shall be amended as follows: (a) Paragraph 1 shall be replaced by the following: "1. Provisions are intended to cover liabilities the nature of which is clearly defined and which at the date of the balance sheet are either likely to be incurred, or certain to be incurred but uncertain as to amount or as to the date on which they will arise."; (b) Paragraph 3 shall be replaced by the following: "3. Provisions may not be used to adjust the values of assets."; 8. in Article 22, the following paragraph shall be added:"By way of derogation from Article 2(1), Member States may permit or require all companies, or any classes of company, to present a statement of their performance instead of the presentation of profit and loss items in accordance with Articles 23 to 26, provided that the information given is at least equivalent to that otherwise required by those Articles."; 9. Article 31 shall be amended as follows: (a) in paragraph 1(c), point (bb) shall be replaced by the following: "(bb) account must be taken of all liabilities arising in the course of the financial year concerned or of a previous one, even if such liabilities become apparent only between the date of the balance sheet and the date on which it is drawn up,"; (b) the following paragraph shall be inserted: "(1a) In addition to those amounts recorded pursuant to paragraph (1)(c)(bb), Member States may permit or require account to be taken of all foreseeable liabilities and potential losses arising in the course of the financial year concerned or of a previous one, even if such liabilities or losses become apparent only between the date of the balance sheet and the date on which it is drawn up."; 10. in Article 33(1), point (c) shall be replaced by the following: "(c) revaluation of fixed assets"; 11. in Article 42, the first paragraph shall be replaced by the following:"Provisions may not exceed in amount the sums which are necessary."; 12. the following Articles shall be inserted: "Article 42e By way of derogation from Article 32, Member States may permit or require in respect of all companies or any classes of company the valuation of specified categories of assets other than financial instruments at amounts determined by reference to fair value. Such permission or requirement may be restricted to consolidated accounts as defined in Directive 83/349/EEC. Article 42f Notwithstanding Article 31(1)(c), Member States may permit or require in respect of all companies or any classes of company that, where an asset is valued in accordance with Article 42e, a change in the value is included in the profit and loss account."; 13. in Article 43(1)(6) the reference to "Articles 9 and 10" shall be replaced by a reference to "Articles 9, 10 and 10a"; 14. Article 46 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: "1. (a) The annual report shall include at least a fair review of the development and performance of the company's business and of its position, together with a description of the principal risks and uncertainties that it faces. The review shall be a balanced and comprehensive analysis of the development and performance of the company's business and of its position, consistent with the size and complexity of the business; (b) To the extent necessary for an understanding of the company's development, performance or position, the analysis shall include both financial and, where appropriate, non-financial key performance indicators relevant to the particular business, including information relating to environmental and employee matters; (c) In providing its analysis, the annual report shall, where appropriate, include references to and additional explanations of amounts reported in the annual accounts."; (b) the following paragraph shall be added: "4. Member States may choose to exempt companies covered by Article 27 from the obligation in paragraph 1(b) above in so far as it relates to non-financial information."; 15. in Article 48, the third sentence shall be deleted; 16. in Article 49, the third sentence shall be replaced by the following:"The report of the person or persons responsible for auditing the annual accounts (hereinafter: the statutory auditors) shall not accompany this publication, but it shall be disclosed whether an unqualified, qualified or adverse audit opinion was expressed, or whether the statutory auditors were unable to express an audit opinion. It shall also be disclosed whether the report of the statutory auditors included a reference to any matters to which the statutory auditors drew attention by way of emphasis without qualifying the audit opinion."; 17. Article 51(1) shall be replaced by the following: "1. The annual accounts of companies shall be audited by one or more persons approved by Member States to carry out statutory audits on the basis of the Eighth Council Directive 84/253/EEC of 10 April 1984 on the approval of persons responsible for carrying out the statutory audits of accounting documents(11). The statutory auditors shall also express an opinion concerning the consistency or otherwise of the annual report with the annual accounts for the same financial year."; 18. the following Article shall be inserted: "Article 51a 1. The report of the statutory auditors shall include: (a) an introduction which shall at least identify the annual accounts that are the subject of the statutory audit, together with the financial reporting framework that has been applied in their preparation; (b) a description of the scope of the statutory audit which shall at least identify the auditing standards in accordance with which the statutory audit was conducted; (c) an audit opinion which shall state clearly the opinion of the statutory auditors as to whether the annual accounts give a true and fair view in accordance with the relevant financial reporting framework and, where appropriate, whether the annual accounts comply with statutory requirements; the audit opinion shall be either unqualified, qualified, an adverse opinion or, if the statutory auditors are unable to express an audit opinion, a disclaimer of opinion; (d) a reference to any matters to which the statutory auditors draw attention by way of emphasis without qualifying the audit opinion; (e) an opinion concerning the consistency or otherwise of the annual report with the annual accounts for the same financial year. 2. The report shall be signed and dated by the statutory auditors."; 19. Article 53(1) shall be deleted; 20. the following Article shall be inserted: "Article 53a Member States shall not make available the exemptions set out in Articles 11, 27, 46, 47 and 51 in the case of companies whose securities are admitted to trading on a regulated market of any Member State within the meaning of Article 1(13) of Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field(12)."; 21. in Article 56(1) the reference to "Articles 9, 10" shall be replaced by a reference to "Articles 9, 10, 10a"; 22. in Article 60, first paragraph, the words "on the basis of their market value" shall be replaced by "on the basis of their fair value"; 23. in Article 61a, the reference to "Articles 42a to 42d" shall be replaced by a reference to "Articles 42a to 42f". Article 2 Directive 83/349/EEC is hereby amended as follows: 1. in Article 1, paragraph 2 shall be replaced by the following: "2. Apart from the cases mentioned in paragraph 1 the Member States may require any undertaking governed by their national law to draw up consolidated accounts and a consolidated annual report if: (a) that undertaking (a parent undertaking) has the power to exercise, or actually exercises, dominant influence or control over another undertaking (the subsidiary undertaking); or (b) that undertaking (a parent undertaking) and another undertaking (the subsidiary undertaking) are managed on a unified basis by the parent undertaking."; 2. in Article 3(1), the reference to "Articles 13, 14 and 15" shall be replaced by a reference to "Articles 13 and 15"; 3. Article 6 shall be amended as follows: (a) paragraph 4 shall be replaced by the following: "4. This Article shall not apply where one of the undertakings to be consolidated is a company whose securities are admitted to trading on a regulated market of any Member State within the meaning of Article 1(13) of Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field(13)."; (b) paragraph 5 shall be deleted; 4. Article 7 shall be amended as follows: (a) in paragraph 1(b), the second sentence shall be deleted; (b) in paragraph 2(a), the reference to "Articles 13, 14 and 15" shall be replaced by a reference to "Articles 13 and 15"; (c) paragraph 3 shall be replaced by the following: "3. This Article shall not apply to companies whose securities are admitted to trading on a regulated market of any Member State within the meaning of Article 1(13) of Directive 93/22/EEC."; 5. in Article 11(1)(a) the reference to "Articles 13, 14 and 15" shall be replaced by a reference to "Articles 13 and 15"; 6. Article 14 shall be deleted; 7. in Article 16(1) the following subparagraph shall be added:"Member States may permit or require the inclusion of other statements in the consolidated accounts in addition to the documents referred to in the first subparagraph."; 8. in Article 17(1) the reference to "Articles 3 to 10" shall be replaced by a reference to "Articles 3 to 10a"; 9. Article 34 shall be amended as follows: (a) in point (2)(b) the terms "Articles 13 and 14 and, without prejudice to Article 14(3)," shall be replaced by a reference to "Article 13 and"; (b) in point (5) the words "and those excluded pursuant to Article 14" shall be deleted; 10. Article 36 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: "1. The consolidated annual report shall include at least a fair review of the development and performance of the business and of the position of the undertakings included in the consolidation taken as a whole, together with a description of the principal risks and uncertainties that they face. The review shall be a balanced and comprehensive analysis of the development and performance of the business and of the position of the undertakings included in the consolidation taken as a whole, consistent with the size and complexity of the business. To the extent necessary for an understanding of such development, performance or position, the analysis shall include both financial and, where appropriate, non-financial key performance indicators relevant to the particular business, including information relating to environmental and employee matters. In providing its analysis, the consolidated annual report shall, where appropriate, provide references to and additional explanations of amounts reported in the consolidated accounts."; (b) The following paragraph shall be added: "3. Where a consolidated annual report is required in addition to an annual report, the two reports may be presented as a single report. In preparing such a single report, it may be appropriate to give greater emphasis to those matters which are significant to the undertakings included in the consolidation taken as a whole."; 11. Article 37 shall be replaced by the following: "Article 37 1. The consolidated accounts of companies shall be audited by one or more persons approved by the Member State whose laws govern the parent undertaking to carry out statutory audits on the basis of the Eighth Council Directive 84/253/EEC of 10 April 1984 on the approval of persons responsible for carrying out the statutory audits of accounting documents(14). The person or persons responsible for auditing the consolidated accounts (hereinafter: the statutory auditors) shall also express an opinion concerning the consistency or otherwise of the consolidated annual report with the consolidated accounts for the same financial year. 2. The report of the statutory auditors shall include: (a) an introduction which shall at least identify the consolidated accounts which are the subject of the statutory audit, together with the financial reporting framework that has been applied in their preparation; (b) a description of the scope of the statutory audit which shall at least identify the auditing standards in accordance with which the statutory audit was conducted; (c) an audit opinion which shall state clearly the opinion of the statutory auditors as to whether the consolidated accounts give a true and fair view in accordance with the relevant financial reporting framework and, where appropriate, whether the consolidated accounts comply with statutory requirements; the audit opinion shall be either unqualified, qualified, an adverse opinion or, if the statutory auditors are unable to express an audit opinion, a disclaimer of opinion; (d) a reference to any matters to which the statutory auditors draw attention by way of emphasis without qualifying the audit opinion; (e) an opinion concerning the consistency or otherwise of the consolidated annual report with the consolidated accounts for the same financial year. 3. The report shall be signed and dated by the statutory auditors. 4. Where the annual accounts of the parent undertaking are attached to the consolidated accounts, the report of the statutory auditors required by this Article may be combined with any report of the statutory auditors on the annual accounts of the parent undertaking required by Article 51 of Directive 78/660/EEC."; 12. in Article 38, the following paragraph shall be added: "7. Paragraphs 2 and 3 shall not be applied in respect of companies whose securities are admitted to trading on a regulated market of any Member State within the meaning of Article 1(13) of Directive 93/22/EEC." Article 3 Directive 86/635/EEC is hereby amended as follows: 1. in Article 1, paragraphs 1 and 2 shall be replaced by the following: "1. Articles 2, 3, 4(1), (3) to (6), Articles 6, 7, 13, 14, 15(3) and (4), Articles 16 to 21, 29 to 35, 37 to 41, 42 first sentence, 42a to 42f, 45(1), 46(1) and (2), Articles 48 to 50, 50a, 51(1) and 51a, 56 to 59, 61 and 61a of Directive 78/660/EEC shall apply to the institutions mentioned in Article 2 of this Directive, except where this Directive provides otherwise. However, Articles 35(3), 36, 37 and 39(1) to (4) of this Directive shall not apply with respect to assets and liabilities that are valued in accordance with Section 7a of Directive 78/660/EEC. 2. Where reference is made in Directives 78/660/EEC and 83/349/EEC to Articles 9, 10 and 10a (balance sheet) or to Articles 22 to 26 (profit and loss account) of Directive 78/660/EEC, such references shall be deemed to be references to Articles 4 and 4a (balance sheet) or to Articles 26, 27 and 28 (profit and loss account) of this Directive."; 2. Article 4 shall be amended as follows: (a) the first sentence shall be replaced by the following:"The Member States shall prescribe the following layout for the balance sheet. As an alternative, Member States may permit or require credit institutions to adopt the presentation of the balance sheet set out in Article 4a."; (b) under "Liabilities", in point 6, the title "Provisions for liabilities and charges" shall be replaced by "Provisions"; 3. the following Article shall be inserted: "Article 4a Instead of the presentation of balance sheet items in accordance with Article 4, Member States may permit or require credit institutions, or certain classes of credit institution, to present those items classified by their nature and in order of their relative liquidity provided that the information given is at least equivalent to that otherwise required by Article 4."; 4. in Article 26, the following paragraph shall be added:"By way of derogation from Article 2(1) of Directive 78/660/EEC, Member States may permit or require all credit institutions, or any classes of credit institution, to present a statement of their performance instead of the presentation of profit and loss items in accordance with Articles 27 or 28, provided that the information given is at least equivalent to that otherwise required by those Articles."; 5. Article 43(2)(f) shall be deleted. Article 4 Directive 91/674/EEC is hereby amended as follows: 1. in Article 1, paragraphs 1 and 2 shall be replaced by the following: "1. Articles 2, 3, 4(1), (3) to (6), 6, 7, 13, 14, 15(3) and (4), 16 to 21, 29 to 35, 37 to 41, 42, 42a to 42f, 43(1), points 1 to 7 and 9 to 14, 45(1), 46(1) and (2), 48 to 50, 50a, 51(1), 51a, 56 to 59, 61 and 61a of Directive 78/660/EEC shall apply to the undertakings mentioned in Article 2 of this Directive, except where this Directive provides otherwise. Articles 46, 47, 48, 51 and 53 of this Directive shall not apply in respect of assets and liabilities that are valued in accordance with Section 7a of Directive 78/660/EEC. 2. Where reference is made in Directives 78/660/EEC and 83/349/EEC to Articles 9, 10 and 10a (balance sheet) or to Articles 22 to 26 (profit and loss account) of Directive 78/660/EEC, such references shall be deemed to be references to Article 6 (balance sheet) or to Article 34 (profit and loss account) of this Directive as appropriate."; 2. Article 4 shall be replaced by the following: "Article 4 1. This Directive shall apply to the association of underwriters known as Lloyd's. For the purpose of this Directive both Lloyd's and Lloyd's syndicates shall be deemed to be insurance undertakings. 2. By way of derogation from Article 65(1), Lloyd's shall prepare aggregate accounts instead of consolidated accounts required by Directive 83/349/EEC. Aggregate accounts shall be prepared by cumulation of all syndicate accounts."; 3. in Article 6, under "Liabilities", in point E, the title "Provisions for other risks and charges" shall be replaced by "Other provisions"; 4. Article 46 shall be amended as follows: (a) in paragraph 5, the following sentence shall be added:"Member States may permit derogations from this requirement."; (b) paragraph 6 shall be replaced by the following: "6. The method(s) applied to each investment item shall be stated in the notes on the accounts, together with the amounts so determined."; 5. the following Article shall be inserted: "Article 46a 1. Where assets and liabilities are valued in accordance with Section 7a of Directive 78/660/EEC, paragraphs 2 to 6 of this Article shall apply. 2. The investments shown as assets under D shall be shown at their fair value. 3. Where investments are shown at their purchase price, their fair value shall be disclosed in the notes on the accounts. 4. Where investments are shown at their fair value, their purchase price shall be disclosed in the notes on the accounts. 5. The same valuation method shall be applied to all investments included in any item denoted by an arabic numeral or shown as assets under C(I). Member States may permit derogations from this requirement. 6. The method(s) applied to each investment item shall be stated in the notes on the accounts, together with the amounts so determined."; 6. the Annex shall be deleted. Article 5 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2005 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 6 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 7 This Directive is addressed to the Member States.

32003L0052

2003

Directive 2003/52/EC of the European Parliament and of the Council of 18 June 2003 amending Directive 95/2/EC as regards the conditions of use for a food additive E 425 konjac (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners(4) authorises the use of the food additive E 425 konjac in foodstuffs under certain conditions. (2) The Commission has taken measures to suspend temporarily the placing on the market of jelly mini-cups containing E 425 konjac because they have been found to be dangerous as they have caused the death of several children and elderly persons in third countries through choking. (3) Some manufacturers of jelly mini-cups recognise the risk to human health by affixing a warning on the food package, highlighting the risk for children and the elderly. (4) On the basis of the information provided by the Member States which adopted measures at national level, it can be concluded that jelly mini-cups containing E 425 konjac constitute a life-threatening risk. In addition to their shape and size, the chemical and physical properties of konjac are the cause for jelly mini-cups to constitute a serious risk to human health. (5) In the present case, warning through labelling is not sufficient to protect human health, especially with regard to children. (6) It is necessary to modify the conditions of use for E 425 konjac as regards its use in jelly confectionery, including jelly-mini cups. (7) Directive 95/2/EC should therefore be amended accordingly, Article 1 In Annex IV to Directive 95/2/EC in the row for E 425: Konjac: (i) Konjac gum (ii) Konjac glucomannane the text "Foodstuffs in general (except those referred to in Article 2(3))" shall be replaced by the text "Foodstuffs in general (except those referred to in Article 2(3) and jelly confectionery including jelly-mini-cups)". Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 17 January 2004. They shall forthwith inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0053

2003

Directive 2003/53/EC of the European Parliament and of the Council of 18 June 2003 amending for the 26th time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (nonylphenol, nonylphenol ethoxylate and cement) (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) The risks posed to the environment by nonylphenol (NP) and nonylphenol ethoxylate (NPE) have been assessed in accordance with Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances(4). The assessment identified a need to reduce those risks and, in its opinion of 6 and 7 March 2001, the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) confirmed that conclusion. (2) NP is classified as a "priority hazardous substance" in Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy(5). Pursuant to Article 16(6) of that Directive, the Commission is to submit proposals of control for the cessation or phasing-out of discharges, emissions and losses of such substances. (3) Commission Recommendation 2001/838/EC of 7 November 2001 on the results of the risk evaluation and the risk reduction strategies for the substances: acrylaldehyde; dimethyl sulphate; nonylphenol phenol, 4-nonyl-, branched; tert-butyl methyl ether(6), adopted within the framework of Regulation (EEC) No 793/93, proposed a risk limitation strategy for NP and NPE, recommending in particular that restrictions be placed on their marketing and use. (4) In order to protect the environment the Commission is invited to consider an amendment to Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture(7), with a view to establishing a concentration limit value for NP and NPE in sewage sludge that is to be spread on land. (5) In order further to protect the environment, the placing on the market and the use of NP and NPE should be restricted for specific uses which result in discharges, emissions or losses to the environment. However, the restriction concerning co-formulants in pesticides and biocides should be without prejudice to the validity of existing national authorisations of pesticides or biocidal products containing NPE as a co-formulant, which have been granted before the entry into force of this Directive, until they expire. (6) Scientific studies have also shown that cement preparations containing chromium VI may cause allergic reactions in certain circumstances, if there is direct and prolonged contact with the human skin. All uses of cement bear the risk of direct and prolonged contact with the human skin, with the exception of controlled closed and totally automated processes. (7) The CSTEE has confirmed the adverse health effects of chromium VI in cement. (8) Individual protection measures are necessary, but not sufficient to prevent skin contact with cement. Moreover, according to the hierarchy of protection provisions contained in Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (Fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(8), the employer is to ensure as a priority that the level of exposure is reduced to as low a level as possible when substitution is impossible, and apply individual protection measures only where exposure cannot be prevented by other means. (9) In order to protect human health, it therefore appears necessary to restrict the placing on the market and the use of cement. In particular, the placing on the market and the use of cement or cement preparations containing more than 2 ppm chromium VI should be restricted in the case of activities where there is a possibility of contact with the skin. In controlled closed and totally automated processes this is not the case, and they should therefore be exempted. Reducing agents should be used at the earliest possible stage, i.e. at the point of cement production. (10) In order further to protect human health, the Commission is invited to consider an amendment to Annex I to Directive 98/24/EC so as to establish a binding occupational exposure limit value for dust. (11) The use of chromium VI has already been prohibited by Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of-life vehicles(9) and by Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment(10). Other uses of chromium VI are being examined in the framework of a risk assessment, and the Commission is invited to propose as soon as possible the appropriate legislation to address any risks identified. (12) Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations(11) should be amended accordingly. (13) The objective of this Directive is to introduce harmonised provisions with regard to NP, NPE and cement, thus preserving the internal market whilst ensuring a high level of protection for health and the environment, as required by Article 95 of the Treaty. (14) The adoption of a harmonised testing method is desirable for the application of this Directive as regards the content of chromium VI in cement but should not delay the entry into force of this Directive. Therefore, the Commission, in accordance with Article 2a of Directive 76/769/EEC, should establish such a method. The testing method should preferably be developed at European level, if appropriate by the European Committee for Standardisation (CEN). (15) This Directive does not affect the Community legislation laying down minimum requirements for the protection of workers, such as Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(12), and individual directives based thereon, in particular Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(13) and Directive 98/24/EC, Article 1 1. Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive. 2. The validity of existing national authorisations of pesticides or biocidal products containing NPE as a co-formulant, which have been granted before the entry into force of this Directive, shall not be affected by this Directive until they expire. Article 2 A harmonised testing method for the application of point 47, cement, of Annex I to Directive 76/769/EEC shall be adopted by the Commission in accordance with the procedure laid down in Article 2a of that Directive. Article 3 Before 17 July 2004 Member States shall adopt and publish the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply these provisions from 17 January 2005. Where these provisions are adopted by Member States, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 4 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32003L0063

2003

Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating medicinal products for human use(1), as last amended by Directive 2002/98/EC(2), and in particular Article 120 thereof, Whereas: (1) Every medicinal product for human use that is to be placed on the European Community market must be granted a marketing authorisation delivered by a competent authority. With the view to obtaining a marketing authorisation, an application dossier containing particulars and documents relating to the results of tests and trials carried out on this medicinal product must be submitted. (2) The detailed scientific and technical requirements of Annex I to Directive 2001/83/EC need to be adapted to take account of scientific and technical progress and in particular of a large set of new requirements resulting from recent legislation. The presentation and content of the marketing authorisation application dossier have to be improved in order to facilitate the assessment and the better use of certain parts of the dossier which are common to several medicinal products. (3) Within the framework of the International Conference on Harmonisation (ICH) a consensus was reached in 2000 to provide a harmonised format and terminology for a Common Technical Document through which a homogeneous organisation and presentation of a marketing authorisation application dossier for human medicinal products could be achieved. Standardised marketing authorisation dossier requirements should therefore be introduced in order to implement the Common Technical Document without delay. (4) The standardised marketing authorisation dossier requirements (harmonised format) should be applicable to any type of medicinal product for human use, regardless of the procedure for the granting of the marketing authorisation. Some medicinal products present, however, such specific features that all the requirements cannot be fulfilled. To take account of these particular situations, a simplified dossier presentation should be provided for. (5) The safety of biological medicinal products relies on rigorous control of their starting materials. Requirements for the suitability of human donors and the testing of donations of starting materials for plasma-derived medicinal products are laid down by Directive 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. Article 109 of Directive 2001/83/EC has been amended. Plasma-derived medicinal products per se are biological medicinal products, the manufacture of which is based on the careful handling of human plasma as a starting material. To take account of the fact that the same plasma material is used in most cases for several medicinal products and, as a result, that a substantial part of the marketing authorisation dossier may be common to a great number of other dossiers for totally different plasma-derived medicinal products, it is appropriate to establish a new system aimed at simplifying procedures for both the approval of and subsequent changes to human plasma-derived medicinal products. To this end the concept of a plasma master file (PMF) should be introduced, in particular in order to allow the pooling of national expertise and through the coordination by the EMEA of a single evaluation. A PMF should serve as a stand-alone document, which is separate from the marketing authorisation dossier and through which a harmonised control of the relevant information regarding starting material used for the manufacture of plasma-derived medicinal products could be achieved. The PMF system should consist of a two-step assessment: first, an assessment of the PMF carried out at Community level, the result of which, i.e. a certificate of compliance with the Community legislation for each PMF, must be taken into account by any national competent authority, preventing them of any subsequent reassessment; second, an assessment of the finished plasma-derived medicinal product containing the modified part of the PMF (the two essential parts of the content, plasma origin and plasma quality-safety). This should remain the task of the competent authority that granted the marketing authorisation for the plasma-derived medicinal product. (6) In the case of vaccines for human use, the same antigen may be common to several medicinal products (vaccines) and any change to that particular antigen, ipso facto, may impact, therefore, on several vaccines authorised by different procedures. In order to simplify the existing procedures for the assessment of such vaccines, both for the granting of a first marketing authorisation and for subsequent changes to it due to modifications to the manufacturing process and testing of individual antigens involved in combined vaccines, a new system based on the concept of a vaccine antigen master file (VAMF) should be introduced. This VAMF will allow the pooling of national expertise, and through the coordination by the EMEA, a single evaluation of the concerned vaccine antigen. The VAMF should serve as a stand-alone part of the marketing authorisation dossier and provide all relevant information of a biological and chemical nature related to one specific antigen, which constitutes one of the active substances of one or several combined vaccines. (7) The VAMF system should consist of a two-step assessment: first, an assessment of the VAMF carried out at Community level, the result of which, i.e. a certificate of compliance with the Community legislation for each VAMF, must be taken into account by any national competent authority, preventing them from any subsequent reassessment; second, an assessment of the finished medicinal product (combined vaccine) containing the modified antigen which is the task of the competent authority that granted the combined vaccine marketing authorisation. (8) Herbal medicinal products differ substantially from conventional medicinal products in so far as they are intrinsically associated with the very particular notion of herbal substances and herbal preparations. It is therefore appropriate to determine specific requirements in respect of these products with regard to the standardised marketing authorisation requirements. (9) The treatment of various acquired and inherited pathological dysfunctions in humans calls upon novel concept-based approaches based on the development of biotechnology techniques. The latter involve the use of advanced therapy medicinal products based on processes focused on various gene-transfer-produced bio-molecules (gene therapy medicinal products) and manipulated or processed cells (cell therapy medicinal products) as active substances. (10) In so far as they achieve their essential action through metabolic, physiological and immunological means to restore, correct or modify physiological functions in humans, these novel complex therapeutic products representing a new category of biological medicinal products in the sense of Articles 1 and 2 of Directive 2001/83/EC. The general principles already applicable to these products should be specified from a scientific and technical point of view and the specific requirements with regard to the standardised marketing authorisation requirements should be determined. (11) Directive 2001/83/EC should be amended accordingly. (12) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Medicinal Products for Human Use, Article 1 Directive 2001/83/EC is amended as follows: a) in the second paragraph of Article 22 the words "Part 4 (G)" are replaced by the following:"Part II, point 6"; b) Annex I is replaced by the text in the Annex to this Directive. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 October 2003 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. This Directive is applicable as from 1 July 2003. Article 3 This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0054

2003

Directive 2003/54/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in electricity and repealing Directive 96/92/EC - Statements made with regard to decommissioning and waste management activities Having regard to the Treaty establishing the European Community, and in particular Article 47(2), Article 55 and Article 95 thereof, Having regard to the proposals from the Commission(1), Having regard to the Opinion of the European Economic and Social Committee(2), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Directive 96/92/EC of the European Parliament and of the Council of 19 December 1996 concerning common rules for the internal market in electricity(4) has made significant contributions towards the creation of an internal market for electricity. (2) Experience in implementing this Directive shows the benefits that may result from the internal market in electricity, in terms of efficiency gains, price reductions, higher standards of service and increased competitiveness. However, important shortcomings and possibilities for improving the functioning of the market remain, notably concrete provisions are needed to ensure a level playing field in generation and to reduce the risks of market dominance and predatory behaviour, ensuring non-discriminatory transmission and distribution tariffs, through access to the network on the basis of tariffs published prior to their entry into force, and ensuring that the rights of small and vulnerable customers are protected and that information on energy sources for electricity generation is disclosed, as well as reference to sources, where available, giving information on their environmental impact. (3) At its meeting in Lisbon on 23 and 24 March 2000, the European Council called for rapid work to be undertaken to complete the internal market in both electricity and gas sectors and to speed up liberalisation in these sectors with a view to achieving a fully operational internal market. The European Parliament, in its Resolution of 6 July 2000 on the Commission's second report on the state of liberalisation of energy markets, requested the Commission to adopt a detailed timetable for the achievement of accurately defined objectives with a view to gradually but completely liberalising the energy market. (4) The freedoms which the Treaty guarantees European citizens - free movement of goods, freedom to provide services and freedom of establishment - are only possible in a fully open market, which enables all consumers freely to choose their suppliers and all suppliers freely to deliver to their customers. (5) The main obstacles in arriving at a fully operational and competitive internal market relate amongst other things to issues of access to the network, tarification issues and different degrees of market opening between Member States. (6) For competition to function, network access must be non-discriminatory, transparent and fairly priced. (7) In order to complete the internal electricity market, non-discriminatory access to the network of the transmission or the distribution system operator is of paramount importance. A transmission or distribution system operator may comprise one or more undertakings. (8) In order to ensure efficient and non-discriminatory network access it is appropriate that the distribution and transmission systems are operated through legally separate entities where vertically integrated undertakings exist. The Commission should assess measures of equivalent effect, developed by Member States to achieve the aim of this requirement, and, where appropriate, submit proposals to amend this Directive. It is also appropriate that the transmission and distribution system operators have effective decision-making rights with respect to assets necessary to maintain, operate and develop networks when the assets in question are owned and operated by vertically integrated undertakings. It is necessary that the independence of the distribution system operators and the transmission system operators be guaranteed especially with regard to generation and supply interests. Independent management structures must therefore be put in place between the distribution system operators and the transmission system operators and any generation/supply companies. It is important however to distinguish between such legal separation and ownership unbundling. Legal separation does not imply a change of ownership of assets and nothing prevents similar or identical employment conditions applying throughout the whole of the vertically integrated undertakings. However, a non-discriminatory decision-making process should be ensured through organisational measures regarding the independence of the decision-makers responsible. (9) In the case of small systems the provision of ancillary services may have to be ensured by transmission system operators (TSOs) interconnected with small systems. (10) While this Directive is not addressing ownership issues it is recalled that in case of an undertaking performing transmission or distribution and which is separated in its legal form from those undertakings performing generation and/or supply activities, the designated system operators may be the same undertaking owning the infrastructure. (11) To avoid imposing a disproportionate financial and administrative burden on small distribution companies, Member States should be able, where necessary, to exempt such companies from the legal distribution unbundling requirements. (12) Authorisation procedures should not lead to an administrative burden disproportionate to the size and potential impact of electricity producers. (13) Further measures should be taken in order to ensure transparent and non discriminatory tariffs for access to networks. Those tariffs should be applicable to all system users on a non discriminatory basis. (14) In order to facilitate the conclusion of contracts by an electricity undertaking established in a Member State for the supply of electricity to eligible customers in another Member State, Member States and, where appropriate, national regulatory authorities should work towards more homogenous conditions and the same degree of eligibility for the whole of the internal market. (15) The existence of effective regulation, carried out by one or more national regulatory authorities, is an important factor in guaranteeing non-discriminatory access to the network. Member States specify the functions, competences and administrative powers of the regulatory authorities. It is important that the regulatory authorities in all Member States share the same minimum set of competences. Those authorities should have the competence to fix or approve the tariffs, or at least, the methodologies underlying the calculation of transmission and distribution tariffs. In order to avoid uncertainty and costly and time consuming disputes, these tariffs should be published prior to their entry into force. (16) The Commission has indicated its intention to set up a European Regulators Group for Electricity and Gas which would constitute a suitable advisory mechanism for encouraging cooperation and coordination of national regulatory authorities, in order to promote the development of the internal market for electricity and gas, and to contribute to the consistent application, in all Member States, of the provisions set out in this Directive and Directive 2003/55/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in natural gas(5) and in Regulation (EC) No 1228/2003 of the European Parliament and of the Council of 26 June 2003 on conditions for access to the network for cross-border exchanges in electricity(6). (17) In order to ensure effective market access for all market players, including new entrants, non discriminatory and cost-reflective balancing mechanisms are necessary. As soon as the electricity market is sufficiently liquid, this should be achieved through the setting up of transparent market-based mechanisms for the supply and purchase of electricity needed in the framework of balancing requirements. In the absence of such a liquid market, national regulatory authorities should play an active role to ensure that balancing tariffs are non discriminatory and cost-reflective. At the same time, appropriate incentives should be provided to balance in-put and off-take of electricity and not to endanger the system. (18) National regulatory authorities should be able to fix or approve tariffs, or the methodologies underlying the calculation of the tariffs, on the basis of a proposal by the transmission system operator or distribution system operator(s), or on the basis of a proposal agreed between these operator(s) and the users of the network. In carrying out these tasks, national regulatory authorities should ensure that transmission and distribution tariffs are non-discriminatory and cost-reflective, and should take account of the long-term, marginal, avoided network costs from distributed generation and demand-side management measures. (19) All Community industry and commerce, including small and medium-sized enterprises, and all Community citizens that enjoy the economic benefits of the internal market should also be able to enjoy high levels of consumer protection, and in particular households and, where Member States deem it appropriate, small enterprises should also be able to enjoy public service guarantees, in particular with regard to security of supply and reasonable tariffs, for reasons of fairness, competitiveness and indirectly to create employment. (20) Electricity customers should be able to choose their supplier freely. Nonetheless a phased approach should be taken to completing the internal market for electricity to enable industry to adjust and ensure that adequate measures and systems are in place to protect the interests of customers and ensure they have a real and effective right to choose their supplier. (21) Progressive market opening towards full competition should as soon as possible remove differences between Member States. Transparency and certainty in the implementation of this Directive should be ensured. (22) Nearly all Member States have chosen to ensure competition in the electricity generation market through a transparent authorisation procedure. However, Member States should ensure the possibility to contribute to security of supply through the launching of a tendering procedure or an equivalent procedure in the event that sufficient electricity generation capacity is not built on the basis of the authorisation procedure. Member States should have the possibility, in the interests of environmental protection and the promotion of infant new technologies, of tendering for new capacity on the basis of published criteria. New capacity includes inter alia renewables and combined heat and power (CHP). (23) In the interest of security of supply, the supply/demand balance in individual Member States should be monitored, and monitoring should be followed by a report on the situation at Community level, taking account of interconnection capacity between areas. Such monitoring should be carried out sufficiently early to enable appropriate measures to be taken if security of supply is compromised. The construction and maintenance of the necessary network infrastructure, including interconnection capacity, should contribute to ensuring a stable electricity supply. The maintenance and construction of the necessary network infrastructure, including interconnection capacity and decentralised electricity generation, are important elements in ensuring a stable electricity supply. (24) Member States should ensure that household customers and, where Member States deem it appropriate, small enterprises, enjoy the right to be supplied with electricity of a specified quality at clearly comparable, transparent and reasonable prices. In order to ensure the maintenance of the high standards of public service in the Community, all measures taken by Member States to achieve the objectives of this Directive should be regularly notified to the Commission. The Commission should regularly publish a report analysing measures taken at national level to achieve public service objectives and comparing their effectiveness, with a view to making recommendations as regards measures to be taken at national level to achieve high public service standards. Member States should take the necessary measures to protect vulnerable customers in the context of the internal electricity market. Such measures can differ according to the particular circumstances in the Member States in question and may include specific measures relating to the payment of electricity bills, or more general measures taken in the social security system. When universal service is also provided to small enterprises, measures to ensure that this universal service is provided may differ according to households and small enterprises. (25) The Commission has indicated its intention to take initiatives especially as regards the scope of the labelling provision and notably on the manner in which the information on the environmental impact in terms of at least emissions of CO2 and the radioactive waste resulting from electricity production from different energy sources, could be made available in a transparent, easily accessible and comparable manner throughout the European Union and on the manner in which the measures taken in the Member States to control the accuracy of the information provided by suppliers could be streamlined. (26) The respect of the public service requirements is a fundamental requirement of this Directive, and it is important that common minimum standards, respected by all Member States, are specified in this Directive, which take into account the objectives of common protection, security of supply, environmental protection and equivalent levels of competition in all Member States. It is important that the public service requirements can be interpreted on a national basis, taking into account national circumstances and subject to the respect of Community law. (27) Member States may appoint a supplier of last resort. This supplier may be the sales division of a vertically integrated undertaking, that also performs the functions of distribution, provided that it meets the unbundling requirements of this Directive. (28) Measures implemented by Member States to achieve the objectives of social and economic cohesion may include, in particular, the provision of adequate economic incentives, using, where appropriate, all existing national and Community tools. These tools may include liability mechanisms to guarantee the necessary investment. (29) To the extent to which measures taken by Member States to fulfil public service obligations constitute State aid under Article 87(1) of the Treaty, there is an obligation according to Article 88(3) of the Treaty to notify them to the Commission. (30) The requirement to notify the Commission of any refusal to grant authorisation to construct new generation capacity has proven to be an unnecessary administrative burden and should therefore be dispensed with. (31) Since the objective of the proposed action, namely the creation of a fully operational internal electricity market, in which fair competition prevails, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the action, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (32) In the light of the experience gained with the operation of Council Directive 90/547/EEC of 29 October 1990 on the transit of electricity through transmission grids(7), measures should be taken to ensure homogeneous and non-discriminatory access regimes for transmission, including cross-border flows of electricity between Member States. To ensure homogeneity in the treatment of access to the electricity networks, also in the case of transit, that Directive should be repealed. (33) Given the scope of the amendments that are being made to Directive 96/92/EC, it is desirable, for reasons of clarity and rationalisation, that the provisions in question should be recast. (34) This Directive respects the fundamental rights, and observes the principles, recognised in particular by the Charter of Fundamental Rights of the European Union, CHAPTER I SCOPE AND DEFINITIONS Article 1 Scope This Directive establishes common rules for the generation, transmission, distribution and supply of electricity. It lays down the rules relating to the organisation and functioning of the electricity sector, access to the market, the criteria and procedures applicable to calls for tenders and the granting of authorisations and the operation of systems. Article 2 Definitions For the purposes of this Directive: 1. "generation" means the production of electricity; 2. "producer" means a natural or legal person generating electricity; 3. "transmission" means the transport of electricity on the extra high-voltage and high-voltage interconnected system with a view to its delivery to final customers or to distributors, but not including supply; 4. "transmission system operator" means a natural or legal person responsible for operating, ensuring the maintenance of and, if necessary, developing the transmission system in a given area and, where applicable, its interconnections with other systems, and for ensuring the long term ability of the system to meet reasonable demands for the transmission of electricity; 5. "distribution" means the transport of electricity on high-voltage, medium voltage and low voltage distribution systems with a view to its delivery to customers, but not including supply; 6. "distribution system operator" means a natural or legal person responsible for operating, ensuring the maintenance of and, if necessary, developing the distribution system in a given area and, where applicable, its interconnections with other systems and for ensuring the long term ability of the system to meet reasonable demands for the distribution of electricity; 7. "customers" means wholesale and final customers of electricity; 8. "wholesale customers" means any natural or legal persons who purchase electricity for the purpose of resale inside or outside the system where they are established; 9. "final customers" means customers purchasing electricity for their own use; 10. "household customers" means customers purchasing electricity for their own household consumption, excluding commercial or professional activities; 11. "non-household customers" means any natural or legal persons purchasing electricity which is not for their own household use and shall include producers and wholesale customers; 12. "eligible customers" means customers who are free to purchase electricity from the supplier of their choice within the meaning of Article 21 of this Directive; 13. "interconnectors" means equipment used to link electricity systems; 14. "interconnected system" means a number of transmission and distribution systems linked together by means of one or more interconnectors; 15. "direct line" means either an electricity line linking an isolated production site with an isolated customer or an electricity line linking an electricity producer and an electricity supply undertaking to supply directly their own premises, subsidiaries and eligible customers; 16. "economic precedence" means the ranking of sources of electricity supply in accordance with economic criteria; 17. "ancillary services" means all services necessary for the operation of a transmission or distribution system; 18. "system users" means any natural or legal persons supplying to, or being supplied by, a transmission or distribution system; 19. "supply" means the sale, including resale, of electricity to customers; 20. "integrated electricity undertaking" means a vertically or horizontally integrated undertaking; 21. "vertically integrated undertaking" means an undertaking or a group of undertakings whose mutual relationships are defined in Article 3(3) of Council Regulation (EEC) No 4064/89 of 21 December 1989 on the control of concentrations between undertakings(8) and where the undertaking/group concerned is performing at least one of the functions of transmission or distribution and at least one of the functions of generation or supply of electricity; 22. "related undertaking" means affiliated undertakings, within the meaning of Article 41 of the Seventh Council Directive 83/349/EEC of 13 June 1983 based on Article 44(2)(g)(9) of the Treaty on consolidated accounts(10), and/or associated undertakings, within the meaning of Article 33(1) thereof, and/or undertakings which belong to the same shareholders; 23. "horizontally integrated undertaking" means an undertaking performing at least one of the functions of generation for sale, or transmission, or distribution, or supply of electricity, and another non electricity activity; 24. "tendering procedure" means the procedure through which planned additional requirements and replacement capacity are covered by supplies from new or existing generating capacity; 25. "long-term planning" means the planning of the need for investment in generation and transmission and distribution capacity on a long term basis, with a view to meeting the demand of the system for electricity and securing supplies to customers; 26. "small isolated system" means any system with consumption of less than 3000 GWh in the year 1996, where less than 5 % of annual consumption is obtained through interconnection with other systems; 27. "micro isolated system" means any system with consumption less than 500 GWh in the year 1996, where there is no connection with other systems; 28. "security" means both security of supply and provision of electricity, and technical safety; 29. "energy efficiency/demand-side management" means a global or integrated approach aimed at influencing the amount and timing of electricity consumption in order to reduce primary energy consumption and peak loads by giving precedence to investments in energy efficiency measures, or other measures, such as interruptible supply contracts, over investments to increase generation capacity, if the former are the most effective and economical option, taking into account the positive environmental impact of reduced energy consumption and the security of supply and distribution cost aspects related to it; 30. "renewable energy sources" means renewable non-fossil energy sources (wind, solar, geothermal, wave, tidal, hydropower, biomass, landfill gas, sewage treatment plant gas and biogases); 31. "distributed generation" means generation plants connected to the distribution system. CHAPTER II GENERAL RULES FOR THE ORGANISATION OF THE SECTOR Article 3 Public service obligations and customer protection 1. Member States shall ensure, on the basis of their institutional organisation and with due regard to the principle of subsidiarity, that, without prejudice to paragraph 2, electricity undertakings are operated in accordance with the principles of this Directive with a view to achieving a competitive, secure and environmentally sustainable market in electricity, and shall not discriminate between these undertakings as regards either rights or obligations. 2. Having full regard to the relevant provisions of the Treaty, in particular Article 86 thereof, Member States may impose on undertakings operating in the electricity sector, in the general economic interest, public service obligations which may relate to security, including security of supply, regularity, quality and price of supplies and environmental protection, including energy efficiency and climate protection. Such obligations shall be clearly defined, transparent, non discriminatory, verifiable and shall guarantee equality of access for EU electricity companies to national consumers. In relation to security of supply, energy efficiency/demand-side management and for the fulfilment of environmental goals, as referred to in this paragraph, Member States may introduce the implementation of long term planning, taking into account the possibility of third parties seeking access to the system. 3. Member States shall ensure that all household customers, and, where Member States deem it appropriate, small enterprises, (namely enterprises with fewer than 50 occupied persons and an annual turnover or balance sheet not exceeding EUR 10 million), enjoy universal service, that is the right to be supplied with electricity of a specified quality within their territory at reasonable, easily and clearly comparable and transparent prices. To ensure the provision of universal service, Member States may appoint a supplier of last resort. Member States shall impose on distribution companies an obligation to connect customers to their grid under terms, conditions and tariffs set in accordance with the procedure laid down in Article 23(2). Nothing in this Directive shall prevent Member States from strengthening the market position of the domestic, small and medium-sized consumers by promoting the possibilities of voluntary aggregation of representation for this class of consumers. The first subparagraph shall be implemented in a transparent and non-discriminatory way and shall not impede the opening of the market provided for in Article 21. 4. When financial compensation, other forms of compensation and exclusive rights which a Member State grants for the fulfilment of the obligations set out in paragraphs 2 and 3 are provided, this shall be done in a non-discriminatory and transparent way. 5. Member States shall take appropriate measures to protect final customers, and shall in particular ensure that there are adequate safeguards to protect vulnerable customers, including measures to help them avoid disconnection. In this context, Member States may take measures to protect final customers in remote areas. They shall ensure high levels of consumer protection, particularly with respect to transparency regarding contractual terms and conditions, general information and dispute settlement mechanisms. Member States shall ensure that the eligible customer is in fact able to switch to a new supplier. As regards at least household customers, these measures shall include those set out in Annex A. 6. Member States shall ensure that electricity suppliers specify in or with the bills and in promotional materials made available to final customers: (a) the contribution of each energy source to the overall fuel mix of the supplier over the preceding year; (b) at least the reference to existing reference sources, such as web-pages, where information on the environmental impact, in terms of at least emissions of CO2 and the radioactive waste resulting from the electricity produced by the overall fuel mix of the supplier over the preceding year is publicly available. With respect to electricity obtained via an electricity exchange or imported from an undertaking situated outside the Community, aggregate figures provided by the exchange or the undertaking in question over the preceding year may be used. Member States shall take the necessary steps to ensure that the information provided by suppliers to their customers pursuant to this Article is reliable. 7. Member States shall implement appropriate measures to achieve the objectives of social and economic cohesion, environmental protection, which may include energy efficiency/demand-side management measures and means to combat climate change, and security of supply. Such measures may include, in particular, the provision of adequate economic incentives, using, where appropriate, all existing national and Community tools, for the maintenance and construction of the necessary network infrastructure, including interconnection capacity. 8. Member States may decide not to apply the provisions of Articles 6, 7, 20 and 22 insofar as their application would obstruct the performance, in law or in fact, of the obligations imposed on electricity undertakings in the general economic interest and insofar as the development of trade would not be affected to such an extent as would be contrary to the interests of the Community. The interests of the Community include, amongst others, competition with regard to eligiblecustomers in accordance with this Directive and Article 86 of the Treaty. 9. Member States shall, upon implementation of this Directive, inform the Commission of all measures adopted to fulfil universal service and public service obligations, including consumer protection and environmental protection, and their possible effect on national and international competition, whether or not such measures require a derogation from this Directive. They shall inform the Commission subsequently every two years of any changes to such measures, whether or not they require a derogation from this Directive. Article 4 Monitoring of security of supply Member States shall ensure the monitoring of security of supply issues. Where Member States consider it appropriate they may delegate this task to the regulatory authorities referred to in Article 23(1). This monitoring shall, in particular, cover the supply/demand balance on the national market, the level of expected future demand and envisaged additional capacity being planned or under construction, and the quality and level of maintenance of the networks, as well as measures to cover peak demand and to deal with shortfalls of one or more suppliers. The competent authorities shall publish every two years, by 31 July at the latest, a report outlining the findings resulting from the monitoring of these issues, as well as any measures taken or envisaged to address them and shall forward this report to the Commission forthwith. Article 5 Technical rules Member States shall ensure that technical safety criteria are defined and that technical rules establishing the minimum technical design and operational requirements for the connection to the system of generating installations, distribution systems, directly connected consumers' equipment, interconnector circuits and direct lines are developed and made public. These technical rules shall ensure the interoperability of systems and shall be objective and non discriminatory. They shall be notified to the Commission in accordance with Article 8 of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society Services(11). CHAPTER III GENERATION Article 6 Authorisation procedure for new capacity 1. For the construction of new generating capacity, Member States shall adopt an authorisation procedure, which shall be conducted in accordance with objective, transparent and non discriminatory criteria. 2. Member States shall lay down the criteria for the grant of authorisations for the construction of generating capacity in their territory. These criteria may relate to: (a) the safety and security of the electricity system, installations and associated equipment; (b) protection of public health and safety; (c) protection of the environment; (d) land use and siting; (e) use of public ground; (f) energy efficiency; (g) the nature of the primary sources; (h) characteristics particular to the applicant, such as technical, economic and financial capabilities; (i) compliance with measures adopted pursuant to Article 3. 3. Member States shall ensure that authorisation procedures for small and/or distributed generation take into account their limited size and potential impact. 4. The authorisation procedures and criteria shall be made public. Applicants shall be informed of the reasons for any refusal to grant an authorisation. The reasons must be objective, non discriminatory, well founded and duly substantiated. Appeal procedures shall be made available to the applicant. Article 7 Tendering for new capacity 1. Member States shall ensure the possibility, in the interests of security of supply, of providing for new capacity or energy efficiency/demand-side management measures through a tendering procedure or any procedure equivalent in terms of transparency and non-discrimination, on the basis of published criteria. These procedures can, however, only be launched if on the basis of the authorisation procedure the generating capacity being built or the energy efficiency/demand-side management measures being taken are not sufficient to ensure security of supply. 2. Member States may ensure the possibility, in the interests of environmental protection and the promotion of infant new technologies, of tendering for new capacity on the basis of published criteria. This tender may relate to new capacity or energy efficiency/demand-side management measures. A tendering procedure can, however, only be launched if on the basis of the authorisation procedure the generating capacity being built or the measures being taken are not sufficient to achieve these objectives. 3. Details of the tendering procedure for means of generating capacity and energy efficiency/demand-side management measures shall be published in the Official Journal of the European Union at least six months prior to the closing date for tenders. The tender specifications shall be made available to any interested undertaking established in the territory of a Member State so that it has sufficient time in which to submit a tender. With a view to ensuring transparency and non-discrimination the tender specifications shall contain a detailed description of the contract specifications and of the procedure to be followed by all tenderers and an exhaustive list of criteria governing the selection of tenderers and the award of the contract, including incentives, such as subsidies, which are covered by the tender. These specifications may also relate to the fields referred to in Article 6(2). 4. In invitations to tender for the requisite generating capacity, consideration must also be given to electricity supply offers with long term guarantees from existing generating units, provided that additional requirements can be met in this way. 5. Member States shall designate an authority or a public body or a private body independent from electricity generation, transmission, distribution and supply activities, which may be a regulatory authority referred to in Article 23(1), to be responsible for the organisation, monitoring and control of the tendering procedure referred to in paragraphs 1 to 4. Where a transmission system operator is fully independent from other activities not relating to the transmission system in ownership terms, the transmission system operator may be designated as the body responsible for organising, monitoring and controlling the tendering procedure. This authority or body shall take all necessary steps to ensure confidentiality of the information contained in the tenders. CHAPTER IV TRANSMISSION SYSTEM OPERATION Article 8 Designation of Transmission System Operators Member States shall designate, or shall require undertakings which own transmission systems to designate, for a period of time to be determined by Member States having regard to considerations of efficiency and economic balance, one or more transmission system operators. Member States shall ensure that transmission system operators act in accordance with Articles 9 to 12. Article 9 Tasks of Transmission System Operators Each transmission system operator shall be responsible for: (a) ensuring the long-term ability of the system to meet reasonable demands for the transmission of electricity; (b) contributing to security of supply through adequate transmission capacity and system reliability; (c) managing energy flows on the system, taking into account exchanges with other interconnected systems. To that end, the transmission system operator shall be responsible for ensuring a secure, reliable and efficient electricity system and, in that context, for ensuring the availability of all necessary ancillary services insofar as this availability is independent from any other transmission system with which its system is interconnected; (d) providing to the operator of any other system with which its system is interconnected sufficient information to ensure the secure and efficient operation, coordinated development and interoperability of the interconnected system; (e) ensuring non-discrimination as between system users or classes of system users, particularly in favour of its related undertakings; (f) providing system users with the information they need for efficient access to the system. Article 10 Unbundling of Transmission System Operators 1. Where the transmission system operator is part of a vertically integrated undertaking, it shall be independent at least in terms of its legal form, organisation and decision making from other activities not relating to transmission. These rules shall not create an obligation to separate the ownership of assets of the transmission system from the vertically integrated undertaking. 2. In order to ensure the independence of the transmission system operator referred to in paragraph 1, the following minimum criteria shall apply: (a) those persons responsible for the management of the transmission system operator may not participate in company structures of the integrated electricity undertaking responsible, directly or indirectly, for the day-to-day operation of the generation, distribution and supply of electricity; (b) appropriate measures must be taken to ensure that the professional interests of the persons responsible for the management of the transmission system operator are taken into account in a manner that ensures that they are capable of acting independently; (c) the transmission system operator shall have effective decision-making rights, independent from the integrated electricity undertaking, with respect to assets necessary to operate, maintain or develop the network. This should not prevent the existence of appropriate coordination mechanisms to ensure that the economic and management supervision rights of the parent company in respect of return on assets, regulated indirectly in accordance with Article 23(2), in a subsidiary are protected. In particular, this shall enable the parent company to approve the annual financial plan, or any equivalent instrument, of the transmission system operator and to set global limits on the levels of indebtedness of its subsidiary. It shall not permit the parent company to give instructions regarding day-to-day operations, nor with respect to individual decisions concerning the construction or upgrading of transmission lines, that do not exceed the terms of the approved financial plan, or any equivalent instrument; (d) the transmission system operator shall establish a compliance programme, which sets out measures taken to ensure that discriminatory conduct is excluded, and ensure that observance of it is adequately monitored. The programme shall set out the specific obligations of employees to meet this objective. An annual report, setting out the measures taken, shall be submitted by the person or body responsible for monitoring the compliance programme to the regulatory authority referred to in Article 23(1) and shall be published. Article 11 Dispatching and balancing 1. Without prejudice to the supply of electricity on the basis of contractual obligations, including those which derive from the tendering specifications, the transmission system operator shall, where it has this function, be responsible for dispatching the generating installations in its area and for determining the use of interconnectors with other systems. 2. The dispatching of generating installations and the use of interconnectors shall be determined on the basis of criteria which may be approved by the Member State and which must be objective, published and applied in a non discriminatory manner which ensures the proper functioning of the internal market in electricity. They shall take into account the economic precedence of electricity from available generating installations or interconnector transfers and the technical constraints on the system. 3. A Member State may require the system operator, when dispatching generating installations, to give priority to generating installations using renewable energy sources or waste or producing combined heat and power. 4. A Member State may, for reasons of security of supply, direct that priority be given to the dispatch of generating installations using indigenous primary energy fuel sources, to an extent not exceeding in any calendar year 15 % of the overall primary energy necessary to produce the electricity consumed in the Member State concerned. 5. Member States may require transmission system operators to comply with minimum standards for the maintenance and development of the transmission system, including interconnection capacity. 6. Transmission system operators shall procure the energy they use to cover energy losses and reserve capacity in their system according to transparent, non-discriminatory and market-based procedures, whenever they have this function. 7. Rules adopted by transmission system operators for balancing the electricity system shall be objective, transparent and non-discriminatory, including rules for the charging of system users of their networks for energy imbalance. Terms and conditions, including rules and tariffs, for the provision of such services by transmission system operators shall be established pursuant to a methodology compatible with Article 23(2) in a non-discriminatory and cost-reflective way and shall be published. Article 12 Confidentiality for Transmission System Operators Without prejudice to Article 18 or any other legal duty to disclose information, the transmission system operator shall preserve the confidentiality of commercially sensitive information obtained in the course of carrying out its business. Information disclosed regarding its own activities, which may be commercially advantageous, shall be made available in a non-discriminatory manner. CHAPTER V DISTRIBUTION SYSTEM OPERATION Article 13 Designation of Distribution System Operators Member States shall designate or shall require undertakings that own or are responsible for distribution systems to designate, for a period of time to be determined by Member States having regard to considerations of efficiency and economic balance, one or more distribution system operators. Member States shall ensure that distribution system operators act in accordance with Articles 14 to 16. Article 14 Tasks of Distribution System Operators 1. The distribution system operator shall maintain a secure, reliable and efficient electricity distribution system in its area with due regard for the environment. 2. In any event, it must not discriminate between system users or classes of system users, particularly in favour of its related undertakings. 3. The distribution system operator shall provide system users with the information they need for efficient access to the system. 4. A Member State may require the distribution system operator, when dispatching generating installations, to give priority to generating installations using renewable energy sources or waste or producing combined heat and power. 5. Distribution system operators shall procure the energy they use to cover energy losses and reserve capacity in their system according to transparent, non-discriminatory and market based procedures, whenever they have this function. This requirement shall be without prejudice to using electricity acquired under contracts concluded before 1 January 2002. 6. Where distribution system operators are responsible for balancing the electricity distribution system, rules adopted by them for that purpose shall be objective, transparent and non discriminatory, including rules for the charging of system users of their networks for energy imbalance. Terms and conditions, including rules and tariffs, for the provision of such services by distribution system operators shall be established in accordance with Article 23(2) in a non discriminatory and cost-reflective way and shall be published. 7. When planning the development of the distribution network, energy efficiency/demand-side management measures and/or distributed generation that might supplant the need to upgrade or replace electricity capacity shall be considered by the distribution system operator. Article 15 Unbundling of Distribution System Operators 1. Where the distribution system operator is part of a vertically integrated undertaking, it shall be independent at least in terms of its legal form, organisation and decision making from other activities not relating to distribution. These rules shall not create an obligation to separate the ownership of assets of the distribution system operator from the vertically integrated undertaking. 2. In addition to the requirements of paragraph 1, where the distribution system operator is part of a vertically integrated undertaking, it shall be independent in terms of its organisation and decision making from the other activities not related to distribution. In order to achieve this, the following minimum criteria shall apply: (a) those persons responsible for the management of the distribution system operator may not participate in company structures of the integrated electricity undertaking responsible, directly or indirectly, for the day-to-day operation of the generation, transmission or supply of electricity; (b) appropriate measures must be taken to ensure that the professional interests of the persons responsible for the management of the distribution system operator are taken into account in a manner that ensures that they are capable of acting independently; (c) the distribution system operator shall have effective decision-making rights, independent from the integrated electricity undertaking, with respect to assets necessary to operate, maintain or develop the network. This should not prevent the existence of appropriate coordination mechanisms to ensure that the economic and management supervision rights of the parent company in respect of return on assets, regulated indirectly in accordance with Article 23(2), in a subsidiary are protected. In particular, this shall enable the parent company to approve the annual financial plan, or any equivalent instrument, of the distribution system operator and to set global limits on the levels of indebtedness of its subsidiary. It shall not permit the parent company to give instructions regarding day-to-day operations, nor with respect to individual decisions concerning the construction or upgrading of distribution lines, that do not exceed the terms of the approved financial plan, or any equivalent instrument. (d) the distribution system operator shall establish a compliance programme, which sets out measures taken to ensure that discriminatory conduct is excluded, and ensure that observance of it is adequately monitored. The programme shall set out the specific obligations of employees to meet this objective. An annual report, setting out the measures taken, shall be submitted by the person or body responsible for monitoring the compliance programme to the regulatory authority referred to in Article 23(1) and published. Member States may decide not to apply paragraphs 1 and 2 to integrated electricity undertakings serving less than 100000 connected customers, or serving small isolated systems. Article 16 Confidentiality for Distribution System Operators Without prejudice to Article 18 or any other legal duty to disclose information, the distribution system operator must preserve the confidentiality of commercially sensitive information obtained in the course of carrying out its business, and shall prevent information about its own activities which may be commercially advantageous being disclosed in a discriminatory manner. Article 17 Combined operator The rules in Articles 10(1) and 15(1) do not prevent the operation of a combined transmission and distribution system operator, which is independent in terms of its legal form, organisation and decision making from other activities not relating to transmission or distribution system operation and which meets the requirements set out in points (a) to (d). These rules shall not create an obligation to separate the ownership of assets of the combined system from the vertically integrated undertaking: (a) those persons responsible for the management of the combined system operator may not participate in company structures of the integrated electricity undertaking responsible, directly or indirectly, for the day-to-day operation of the generation, or supply of electricity; (b) appropriate measures must be taken to ensure that the professional interests of the persons responsible for the management of the combined system operator are taken into account in a manner that ensures that they are capable of acting independently; (c) the combined system operator shall have effective decision-making rights, independent from the integrated electricity undertaking, with respect to assets necessary to operate, maintain and develop the network. This should not prevent the existence of appropriate coordination mechanisms to ensure that the economic and management supervision rights of the parent company in respect of return on assets, regulated indirectly in accordance with Article 23(2), in a subsidiary are protected. In particular, this shall enable the parent company to approve the annual financial plan, or any equivalent instrument, of the combined system operator and to set global limits on the levels of indebtedness of its subsidiary. It shall not permit the parent company to give instructions regarding day-to-day operations, nor with respect to individual decisions concerning the construction or upgrading of transmission and distribution lines, that do not exceed the terms of the approved financial plan, or any equivalent instrument; (d) the combined system operator shall establish a compliance programme which sets out measures taken to ensure that discriminatory conduct is excluded, and ensure that observance of it is adequately monitored. The programme shall set out the specific obligations of employees to meet this objective. An annual report, setting out the measures taken, shall be submitted by the person or body responsible for monitoring the compliance programme to the regulatory authority referred to in Article 23(1) and published. CHAPTER VI UNBUNDLING AND TRANSPARENCY OF ACCOUNTS Article 18 Right of access to accounts 1. Member States or any competent authority they designate, including the regulatory authorities referred to in Article 23, shall, insofar as necessary to carry out their functions, have right of access to the accounts of electricity undertakings as set out in Article 19. 2. Member States and any designated competent authority, including the regulatory authorities referred to in Article 23, shall preserve the confidentiality of commercially sensitive information. Member States may provide for the disclosure of such information where this is necessary in order for the competent authorities to carry out their functions. Article 19 Unbundling of accounts 1. Member States shall take the necessary steps to ensure that the accounts of electricity undertakings are kept in accordance with paragraphs 2 to 3. 2. Electricity undertakings, whatever their system of ownership or legal form, shall draw up, submit to audit and publish their annual accounts in accordance with the rules of national law concerning the annual accounts of limited liability companies adopted pursuant to the Fourth Council Directive 78/660/EC of 25 July 1978 based on Article 44(2)(g)(12) of the Treaty on the annual accounts of certain types of companies(13). Undertakings which are not legally obliged to publish their annual accounts shall keep a copy of these at the disposal of the public in their head office. 3. Electricity undertakings shall, in their internal accounting, keep separate accounts for each of their transmission and distribution activities as they would be required to do if the activities in question were carried out by separate undertakings, with a view to avoiding discrimination, cross subsidisation and distortion of competition. They shall also keep accounts, which may be consolidated, for other electricity activities not relating to transmission or distribution. Until 1 July 2007, they shall keep separate accounts for supply activities for eligible customers and supply activities for non-eligible customers. Revenue from ownership of the transmission/distribution system shall be specified in the accounts. Where appropriate, they shall keep consolidated accounts for other, non-electricity activities. The internal accounts shall include a balance sheet and a profit and loss account for each activity. 4. The audit referred to in paragraph 2 shall, in particular, verify that the obligation to avoid discrimination and cross-subsidies referred to in paragraph 3, is respected. CHAPTER VII ORGANISATION OF ACCESS TO THE SYSTEM Article 20 Third party access 1. Member States shall ensure the implementation of a system of third party access to the transmission and distribution systems based on published tariffs, applicable to all eligible customers and applied objectively and without discrimination between system users. Member States shall ensure that these tariffs, or the methodologies underlying their calculation, are approved prior to their entry into force in accordance with Article 23 and that these tariffs, and the methodologies - where only methodologies are approved - are published prior to their entry into force. 2. The operator of a transmission or distribution system may refuse access where it lacks the necessary capacity. Duly substantiated reasons must be given for such refusal, in particular having regard to Article 3. Member States shall ensure, where appropriate and when refusal of access takes place, that the transmission or distribution system operator provides relevant information on measures that would be necessary to reinforce the network. The party requesting such information may be charged a reasonable fee reflecting the cost of providing such information. Article 21 Market opening and reciprocity 1. Member States shall ensure that the eligible customers are: (a) until 1 July 2004, the eligible customers as specified in Article 19(1) to (3) of Directive 96/92/EC. Member States shall publish by 31 January each year the criteria for the definition of these eligible customers; (b) from 1 July 2004, at the latest, all non-household customers; (c) from 1 July 2007, all customers. 2. To avoid imbalance in the opening of electricity markets: (a) contracts for the supply of electricity with an eligible customer in the system of another Member State shall not be prohibited if the customer is considered as eligible in both systems involved; (b) in cases where transactions as described in point (a) are refused because of the customer being eligible only in one of the two systems, the Commission may oblige, taking into account the situation in the market and the common interest, the refusing party to execute the requested supply at the request of the Member State where the eligible customer is located. Article 22 Direct lines 1. Member States shall take the measures necessary to enable: (a) all electricity producers and electricity supply undertakings established within their territory to supply their own premises, subsidiaries and eligible customers through a direct line; (b) any eligible customer within their territory to be supplied through a direct line by a producer and supply undertakings. 2. Member States shall lay down the criteria for the grant of authorisations for the construction of direct lines in their territory. These criteria must be objective and non discriminatory. 3. The possibility of supplying electricity through a direct line as referred to in paragraph 1 shall not affect the possibility of contracting electricity in accordance with Article 20. 4. Member States may make authorisation to construct a direct line subject either to the refusal of system access on the basis, as appropriate, of Article 20 or to the opening of a dispute settlement procedure under Article 23. 5. Member States may refuse to authorise a direct line if the granting of such an authorisation would obstruct the provisions of Article 3. Duly substantiated reasons must be given for such refusal. Article 23 Regulatory authorities 1. Member States shall designate one or more competent bodies with the function of regulatory authorities. These authorities shall be wholly independent from the interests of the electricity industry. They shall, through the application of this Article, at least be responsible for ensuring non-discrimination, effective competition and the efficient functioning of the market, monitoring in particular: (a) the rules on the management and allocation of interconnection capacity, in conjunction with the regulatory authority or authorities of those Member States with which interconnection exists; (b) any mechanisms to deal with congested capacity within the national electricity system; (c) the time taken by transmission and distribution undertakings to make connections and repairs; (d) the publication of appropriate information by transmission and distribution system operators concerning interconnectors, grid usage and capacity allocation to interested parties, taking into account the need to treat non-aggregated information as commercially confidential; (e) the effective unbundling of accounts, as referred to in Article 19, to ensure that there are no cross subsidies between generation, transmission, distribution and supply activities; (f) the terms, conditions and tariffs for connecting new producers of electricity to guarantee that these are objective, transparent and non-discriminatory, in particular taking full account of the costs and benefits of the various renewable energy sources technologies, distributed generation and combined heat and power; (g) the extent to which transmission and distribution system operators fulfil their tasks in accordance with Articles 9 and 14; (h) the level of transparency and competition. The authorities established pursuant to this Article shall publish an annual report on the outcome of their monitoring activities referred to in points (a) to (h). 2. The regulatory authorities shall be responsible for fixing or approving, prior to their entry into force, at least the methodologies used to calculate or establish the terms and conditions for: (a) connection and access to national networks, including transmission and distribution tariffs. These tariffs, or methodologies, shall allow the necessary investments in the networks to be carried out in a manner allowing these investments to ensure the viability of the networks; (b) the provision of balancing services. 3. Notwithstanding paragraph 2, Member States may provide that the regulatory authorities shall submit, for formal decision, to the relevant body in the Member State the tariffs or at least the methodologies referred to in that paragraph as well as the modifications in paragraph 4. The relevant body shall, in such a case, have the power to either approve or reject a draft decision submitted by the regulatory authority. These tariffs or the methodologies or modifications thereto shall be published together with the decision on formal adoption. Any formal rejection of a draft decision shall also be published, including its justification. 4. Regulatory authorities shall have the authority to require transmission and distribution system operators, if necessary, to modify the terms and conditions, tariffs, rules, mechanisms and methodologies referred to in paragraphs 1, 2 and 3, to ensure that they are proportionate and applied in a non-discriminatory manner. 5. Any party having a complaint against a transmission or distribution system operator with respect to the issues mentioned in paragraphs 1, 2 and 4 may refer the complaint to the regulatory authority which, acting as dispute settlement authority, shall issue a decision within two months after receipt of the complaint. This period may be extended by two months where additional information is sought by the regulatory authority. This period may be further extended with the agreement of the complainant. Such a decision shall have binding effect unless and until overruled on appeal. Where a complaint concerns connection tariffs for major new generation facilities, the two-month period may be extended by the regulatory authority. 6. Any party who is affected and has a right to complain concerning a decision on methodologies taken pursuant to paragraphs 2, 3 or 4 or, where the regulatory authority has a duty to consult, concerning the proposed methodologies, may, at the latest within two months, or a shorter time period as provided by Member States, following publication of the decision or proposal for a decision, submit a complaint for review. Such a complaint shall not have suspensive effect. 7. Member States shall take measures to ensure that regulatory authorities are able to carry out their duties referred to in paragraphs 1 to 5 in an efficient and expeditious manner. 8. Member States shall create appropriate and efficient mechanisms for regulation, control and transparency so as to avoid any abuse of a dominant position, in particular to the detriment of consumers, and any predatory behaviour. These mechanisms shall take account of the provisions of the Treaty, and in particular Article 82 thereof. Until 2010, the relevant authorities of the Member States shall provide, by 31 July of each year, in conformity with competition law, the Commission with a report on market dominance, predatory and anti competitive behaviour. This report shall, in addition, review the changing ownership patterns and any practical measures taken at national level to ensure a sufficient variety of market actors or practical measures taken to enhance interconnection and competition. From 2010 onwards, the relevant authorities shall provide such a report every two years. 9. Member States shall ensure that the appropriate measures are taken, including administrative action or criminal proceedings in conformity with their national law, against the natural or legal persons responsible where confidentiality rules imposed by this Directive have not been respected. 10. In the event of cross border disputes, the deciding regulatory authority shall be the regulatory authority which has jurisdiction in respect of the system operator which refuses use of, or access to, the system. 11. Complaints referred to in paragraphs 5 and 6 shall be without prejudice to the exercise of rights of appeal under Community and national law. 12. National regulatory authorities shall contribute to the development of the internal market and of a level playing field by cooperating with each other and with the Commission in a transparent manner. CHAPTER VIII FINAL PROVISIONS Article 24 Safeguard measures In the event of a sudden crisis in the energy market and where the physical safety or security of persons, apparatus or installations or system integrity is threatened, a Member State may temporarily take the necessary safeguard measures. Such measures must cause the least possible disturbance in the functioning of the internal market and must not be wider in scope than is strictly necessary to remedy the sudden difficulties which have arisen. The Member State concerned shall without delay notify these measures to the other Member States, and to the Commission, which may decide that the Member State concerned must amend or abolish such measures, insofar as they distort competition and adversely affect trade in a manner which is at variance with the common interest. Article 25 Monitoring of imports of electricity Member States shall inform the Commission every three months of imports of electricity, in terms of physical flows, that have taken place during the previous three months from third countries. Article 26 Derogations 1. Member States which can demonstrate, after the Directive has been brought into force, that there are substantial problems for the operation of their small isolated systems, may apply for derogations from the relevant provisions of Chapters IV, V, VI, VII, as well as Chapter III, in the case of micro isolated systems, as far as refurbishing, upgrading and expansion of existing capacity are concerned, which may be granted to them by the Commission. The latter shall inform the Member States of those applications prior to taking a decision, taking into account respect for confidentiality. This decision shall be published in the Official Journal of the European Union. This Article shall also be applicable to Luxembourg. 2. A Member State which, after the Directive has been brought into force, for reasons of a technical nature has substantial problems in opening its market for certain limited groups of the non-household customers referred to in Article 21(1)(b) may apply for derogation from this provision, which may be granted to it by the Commission for a period not exceeding 18 months after the date referred to in Article 30(1). In any case, such derogation shall end on the date referred to in Article 21(1)(c). Article 27 Review Procedure In the event that the report referred to in Article 28(3) reaches the conclusion whereby, given the effective manner in which network access has been carried out in a Member State - which gives rise to fully effective, non-discriminatory and unhindered network access - the Commission concludes that certain obligations imposed by this Directive on undertakings (including those with respect to legal unbundling for distribution system operators) are not proportionate to the objective pursued, the Member State in question may submit a request to the Commission for exemption from the requirement in question. The request shall be notified, without delay, by the Member State to the Commission, together with all the relevant information necessary to demonstrate that the conclusion reached in the report on effective network access being ensured will be maintained. Within three months of its receipt of a notification, the Commission shall adopt an opinion with respect to the request by the Member State concerned, and where appropriate, submit proposals to the European Parliament and to the Council to amend the relevant provisionsof the Directive. The Commission may propose, in the proposals to amend the Directive, to exempt the Member State concerned from specific requirements, subject to that Member State implementing equally effective measures as appropriate. Article 28 Reporting 1. The Commission shall monitor and review the application of this Directive and submit an overall progress report to the European Parliament and the Council before the end of the first year following the entry into force of this Directive, and thereafter on an annual basis. The report shall cover at least: (a) the experience gained and progress made in creating a complete and fully operational internal market in electricity and the obstacles that remain in this respect, including aspects of market dominance, concentration in the market, predatory or anti-competitive behaviour and the effect of this in terms of market distortion; (b) the extent to which the unbundling and tarification requirements contained in this Directive have been successful in ensuring fair and non-discriminatory access to the Community's electricity system and equivalent levels of competition, as well as the economic, environmental and social consequences of the opening of the electricity market for customers; (c) an examination of issues relating to system capacity levels and security of supply of electricity in the Community, and in particular the existing and projected balance between demand and supply, taking into account the physical capacity for exchanges between areas; (d) special attention will be given to measures taken in Member States to cover peak demand and to deal with shortfalls of one or more suppliers; (e) the implementation of the derogation provided under Article 15(2) with a view to a possible revision of the threshold; (f) a general assessment of the progress achieved with regard to bilateral relations with third countries which produce and export or transport electricity, including progress in market integration, the social and environmental consequences of the trade in electricity and access to the networks of such third countries; (g) the need for possible harmonisation requirements that are not linked to the provisions of this Directive; (h) the manner in which Member States have implemented in practice the requirements regarding energy labelling contained in Article 3(6), and the manner in which any Commission Recommendations on this issue have been taken into account. Where appropriate, this report may include recommendations especially as regards the scope and modalities of labelling provisions including e.g. the way in which reference is made to existing reference sources and the content of these sources, and notably on the manner in which the information on the environmental impact in terms of at least emissions of CO2 and the radioactive waste resulting from the electricity production from different energy sources could be made available in a transparent, easily accessible and comparable manner throughout the European Union and on the manner in which the measures taken by the Member States to control the accuracy of the information provided by suppliers could be streamlined, and measures to counteract negative effects of market dominance and market concentration. 2. Every two years, the report referred to in paragraph 1 shall also cover an analysis of the different measures taken in the Member States to meet public service obligations, together with an examination of the effectiveness of those measures and, in particular, their effects on competition in the electricity market. Where appropriate, this report may include recommendations as to the measures to be taken at national level to achieve high public service standards, or measures intended to prevent market foreclosure. 3. The Commission shall, no later than 1 January 2006, forward to the European Parliament and Council, a detailed report outlining progress in creating the internal electricity market. The report shall, in particular, consider: - the existence of non-discriminatory network access; - effective regulation; - the development of interconnection infrastructure and the security of supply situation in the Community; - the extent to which the full benefits of the opening of markets are accruing to small enterprises and households, notably with respect to public service and universal service standards; - the extent to which markets are in practice open to effective competition, including aspects of market dominance, market concentration and predatory or anti-competitive behaviour; - the extent to which customers are actually switching suppliers and renegotiating tariffs; - price developments, including supply prices, in relation to the degree of the opening of markets; - the experience gained in the application of the Directive as far as the effective independence of system operators in vertically integrated undertakings is concerned and whether other measures in addition to functional independence and separation of accounts have been developed which have effects equivalent to legal unbundling. Where appropriate, the Commission shall submit proposals to the European Parliament and the Council, in particular to guarantee high public service standards. Where appropriate, the Commission shall submit proposals to the European Parliament and the Council, in particular to ensure full and effective independence of distribution system operators before 1 July 2007. When necessary, these proposals shall, in conformity with competition law, also concern measures to address issues of market dominance, market concentration and predatory or anti-competitive behaviour. Article 29 Repeals Directive 90/547/EEC shall be repealed with effect from 1 July 2004. Directive 96/92/EC shall be repealed from 1 July 2004 without prejudice to the obligations of Member States concerning the deadlines for transposition and application of the said Directive. References made to the repealed Directive shall be construed as being made to this Directive and should be read in accordance with the correlation table in Annex B. Article 30 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 2004. They shall forthwith inform the Commission thereof. 2. Member States may postpone the implementation of Article 15(1) until 1 July 2007. This shall be without prejudice to the requirements contained in Article 15(2). 3. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 31 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 32 Addressees This Directive is addressed to the Member States.

32003L0055

2003

Directive 2003/55/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in natural gas and repealing Directive 98/30/EC Having regard to the Treaty establishing the European Community, and in particular Article 47(2), Article 55 and Article 95 thereof, Having regard to the proposals from the Commission(1), Having regard to the Opinion of the European Economic and Social Committee(2), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Directive 98/30/EC of the European Parliament and of the Council of 22 June 1998 concerning common rules for the internal market in natural gas(4) has made significant contributions towards the creation of an internal market for gas. (2) Experience in implementing this Directive shows the benefits that may result from the internal market in gas, in terms of efficiency gains, price reductions, higher standards of service and increased competitiveness. However, significant shortcomings and possibilities for improving the functioning of the market remain, notably concrete provisions are needed to ensure a level playing field and to reduce the risks of market dominance and predatory behaviour, ensuring non-discriminatory transmission and distribution tariffs, through access to the network on the basis of tariffs published prior to their entry into force, and ensuring that the rights of small and vulnerable customers are protected. (3) At its meeting in Lisbon on 23 and 24 March 2000, the European Council called for rapid work to be undertaken to complete the internal market in both electricity and gas sectors and to speed up liberalisation in these sectors with a view to achieving a fully operational internal market. The European Parliament, in its Resolution of 6 July 2000 on the Commission's second report on the state of liberalisation of energy markets, requested the Commission to adopt a detailed timetable for the achievement of accurately defined objectives with a view to gradually but completely liberalising the energy market. (4) The freedoms which the Treaty guarantees European citizens - free movement of goods, freedom to provide services and freedom of establishment - are only possible in a fully open market, which enables all consumers freely to choose their suppliers and all suppliers freely to deliver to their customers. (5) In view of the anticipated increase in dependency as regards natural gas consumption, consideration should be given to initiatives and measures to encourage reciprocal arrangements for access to third-country networks and market integration. (6) The main obstacles in arriving at a fully operational and competitive internal market relate to, amongst other things, issues of access to the network, access to storage, tarification issues, interoperability between systems and different degrees of market opening between Member States. (7) For competition to function, network access must be non-discriminatory, transparent and fairly priced. (8) In order to complete the internal gas market, non-discriminatory access to the network of the transmission and distribution system operators is of paramount importance. A transmission or distribution system operator may consist of one or more undertakings. (9) In case of a gas undertaking performing transmission, distribution, storage or liquefied natural gas (LNG) activities and which is separate in its legal form from those undertakings performing production and/or supply activities, the designated system operators may be the same undertaking owning the infrastructure. (10) In order to ensure efficient and non-discriminatory network access it is appropriate that the transmission and distribution systems are operated through legally separate entities where vertically integrated undertakings exist. The Commission should assess measures of equivalent effect, developed by Member States to achieve the aim of this requirement, and, where appropriate, submit proposals to amend this Directive. It is also appropriate that the transmission and distribution system operators have effective decision making rights with respect to assets necessary to maintain and operate and develop networks when the assets in question are owned and operated by vertically integrated undertakings. It is important however to distinguish between such legal separation and ownership unbundling. Legal separation implies neither a change of ownership of assets and nothing prevents similar or identical employment conditions applying throughout the whole of the vertically integrated undertakings. However, a non-discriminatory decision-making process should be ensured through organisational measures regarding the independence of the decision-makers responsible. (11) To avoid imposing a disproportionate financial and administrative burden on small distribution companies, Member States should be able, where necessary, to exempt such companies from the legal distribution unbundling requirements. (12) In order to facilitate the conclusion of contracts by a gas undertaking established in a Member State for the supply of gas to eligible customers in another Member State, Member States and, where appropriate, national regulatory authorities should work towards more homogenous conditions and the same degree of eligibility for the whole of the internal market. (13) The existence of effective regulation, carried out by one or more national regulatory authorities, is an important factor in guaranteeing non-discriminatory access to the network. Member States specify the functions, competences and administrative powers of the regulatory authorities. It is important that the regulatory authorities in all Member States share the same minimum set of competences. Those authorities should have the competence to fix or approve the tariffs, or at least, the methodologies underlying the calculation of transmission and distribution tariffs and tariffs for access to liquefied natural gas (LNG) facilities. In order to avoid uncertainty and costly and time consuming disputes, these tariffs should be published prior to their entry into force. (14) The Commission has indicated its intention to set up a European Regulators Group for Electricity and Gas which would constitute a suitable advisory mechanism for encouraging cooperation and coordination of national regulatory authorities, in order to promote the development of the internal market for electricity and gas, and to contribute to the consistent application, in all Member States, of the provisions set out in this Directive and Directive 2003/54/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in electricity(5) and in Regulation (EC) No 1228/2003 of the European Parliament and of the Council of 26 June 2003 on conditions for access to the network for cross-border exchanges in electricity(6). (15) In order to ensure effective market access for all market players including new entrants, non discriminatory and cost-reflective balancing mechanisms are necessary. As soon as the gas market is sufficiently liquid, this should be achieved through the setting up of transparent market-based mechanisms for the supply and purchase of gas needed in the framework of balancing requirements. In the absence of such a liquid market, national regulatory authorities should play an active role to ensure that balancing tariffs are non-discriminatory and cost-reflective. At the same time, appropriate incentives should be provided to balance in-put and off-take of gas and not to endanger the system. (16) National regulatory authorities should be able to fix or approve tariffs, or the methodologies underlying the calculation of the tariffs, on the basis of a proposal by the transmission system operator or distribution system operator(s) or LNG system operator, or on the basis of a proposal agreed between these operator(s) and the users of the network. In carrying out these tasks, national regulatory authorities should ensure that transmission and distribution tariffs are non-discriminatory and cost-reflective, and should take account of the long-term, marginal, avoided network costs from demand-side management measures. (17) The benefits resulting from the internal market should be available to all Community industry and commerce, including small and medium-sized enterprises, and to all Community citizens as quickly as possible, for reasons of fairness, competitiveness, and indirectly, to create employment as a result of the efficiency gains that will be enjoyed by enterprises. (18) Gas customers should be able to choose their supplier freely. Nonetheless a phased approach should be taken to completing the internal market for gas, coupled with a specific deadline, to enable industry to adjust and ensure that adequate measures and systems are in place to protect the interests of customers and ensure they have a real and effective right to choose their supplier. (19) Progressive opening of markets towards full competition should as soon as possible remove differences between Member States. Transparency and certainty in the implementation of this Directive should be ensured. (20) Directive 98/30/EC contributes to access to storage as part of the gas system. In the light of the experience gained in implementing the internal market, additional measures should be taken to clarify the provisions for access to storage and ancillary services. (21) Storage facilities are essential means, amongst other things of implementing public service obligations such as security of supply. This should not lead to distortion of competition or discrimination in the access to storage. (22) Further measures should be taken in order to ensure transparent and non discriminatory tariffs for access to transportation. Those tariffs should be applicable to all users on a non discriminatory basis. Where a storage facility, linepack or ancillary service operates in a sufficiently competitive market, access could be allowed on the basis of transparent and non-discriminatory market-based mechanisms. (23) In the interest of security of supply, the supply/demand balance in individual Member States should be monitored, and monitoring should be followed by a report on the situation at Community level, taking account of interconnection capacity between areas. Such monitoring should be carried out sufficiently early to enable appropriate measures to be taken if security of supply is compromised. The construction and maintenance of the necessary network infrastructure, including interconnection capacity, should contribute to ensuring a stable gas supply. (24) Member States should ensure that, taking into account the necessary quality requirements, biogas and gas from biomass or other types of gas are granted non-discriminatory access to the gas system, provided such access is permanently compatible with the relevant technical rules and safety standards. These rules and standards should ensure, that these gases can technically and safely be injected into, and transported through the natural gas system and should also address the chemical characteristics of these gases. (25) Long-term contracts will continue to be an important part of the gas supply of Member States and should be maintained as an option for gas supply undertakings in so far as they do not undermine the objectives of this Directive and are compatible with the Treaty, including competition rules. It is therefore necessary to take them into account in the planning of supply and transportation capacity of gas undertakings. (26) In order to ensure the maintenance of high standards of public service in the Community, all measures taken by Member States to achieve the objectives of this Directive should be regularly notified to the Commission. The Commission should regularly publish a report analysing measures taken at national level to achieve public service objectives and comparing their effectiveness, with a view to making recommendations as regards measures to be taken at national level to achieve high public service standards. Member States should ensure that when they are connected to the gas system customers are informed about their rights to be supplied with natural gas of a specified quality at reasonable prices. Measures taken by Member States to protect final customers may differ according to households and small and medium sized enterprises. (27) The respect of the public service requirements is a fundamental requirement of this Directive, and it is important that common minimum standards, respected by all Member States, are specified in this Directive, which take into account the objectives of consumer protection, security of supply, environmental protection and equivalent levels of competition in all Member States. It is important that the public service requirements can be interpreted on a national basis, taking into account national circumstances and subject to the observance of Community law. (28) Measures implemented by Member States to achieve the objectives of social and economic cohesion may include, in particular, the provision of adequate economic incentives, using, where appropriate, all existing national and Community tools. These tools may include liability mechanisms to guarantee the necessary investment. (29) To the extent to which measures taken by Member States to fulfil public service obligations constitute State aid under Article 87(1) of the Treaty, there is an obligation according to Article 88(3) of the Treaty to notify them to the Commission (30) Since the objective of the proposed action, namely the creation of a fully operational internal gas market, in which fair competition prevails, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the action, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity and proportionality as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (31) In the light of the experience gained with the operation of Council Directive 91/296/EEC of 31 May 1991 on the transit of natural gas through grids(7), measures should be taken to ensure homogeneous and non-discriminatory access regimes for transmission, including cross-border flows of gas between Member States. To ensure homogeneity in the treatment of access to the gas networks, also in the case of transit, that Directive should be repealed, without prejudice to the continuity of contracts concluded under the said Directive. The repeal of Directive 91/296/EEC should not prevent long-term contracts being concluded in the future. (32) Given the scope of the amendments that are being made to Directive 98/30/EC, it is desirable, for reasons of clarity and rationalisation, that the provisions in question should be recast. (33) This Directive respects the fundamental rights, and observes the principles, recognised in particular by the Charter of Fundamental Rights of the European Union. (34) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(8), CHAPTER I SCOPE AND DEFINITIONS Article 1 Scope 1. This Directive establishes common rules for the transmission, distribution, supply and storage of natural gas. It lays down the rules relating to the organisation and functioning of the natural gas sector, access to the market, the criteria and procedures applicable to the granting of authorisations for transmission, distribution, supply and storage of natural gas and the operation of systems. 2. The rules established by this Directive for natural gas, including liquefied natural gas (LNG), shall also apply to biogas and gas from biomass or other types of gas in so far as such gases can technically and safely be injected into, and transported through, the natural gas system. Article 2 Definitions For the purposes of this Directive: 1. "natural gas undertaking" means any natural or legal person carrying out at least one of the following functions: production, transmission, distribution, supply, purchase or storage of natural gas, including LNG, which is responsible for the commercial, technical and/or maintenance tasks related to those functions, but shall not include final customers; 2. "upstream pipeline network" means any pipeline or network of pipelines operated and/or constructed as part of an oil or gas production project, or used to convey natural gas from one or more such projects to a processing plant or terminal or final coastal landing terminal; 3. "transmission" means the transport of natural gas through a high pressure pipeline network other than an upstream pipeline network with a view to its delivery to customers, but not including supply; 4. "transmission system operator" means a natural or legal person who carries out the function of transmission and is responsible for operating, ensuring the maintenance of, and, if necessary, developing the transmission system in a given area and, where applicable, its interconnections with other systems, and for ensuring the long-term ability of the system to meet reasonable demands for the transportation of gas; 5. "distribution" means the transport of natural gas through local or regional pipeline networks with a view to its delivery to customers, but not including supply; 6. "distribution system operator" means a natural or legal person who carries out the function of distribution and is responsible for operating, ensuring the maintenance of, and, if necessary, developing the distribution system in a given area and, where applicable, its interconnections with other systems, and for ensuring the long-term ability of the system to meet reasonable demands for the distribution of gas; 7. "supply" means the sale, including resale, of natural gas, including LNG, to customers; 8. "supply undertaking" means any natural or legal person who carries out the function of supply; 9. "storage facility" means a facility used for the stocking of natural gas and owned and/or operated by a natural gas undertaking, including the part of LNG facilities used for storage but excluding the portion used for production operations, and excluding facilities reserved exclusively for transmission system operators in carrying out their functions; 10. "storage system operator" means a natural or legal person who carries out the function of storage and is responsible for operating a storage facility; 11. "LNG facility" means a terminal which is used for the liquefaction of natural gas or the importation, offloading, and re-gaseification of LNG, and shall include ancillary services and temporary storage necessary for the re-gaseification process and subsequent delivery to the transmission system, but shall not include any part of LNG terminals used for storage; 12. "LNG system operator" means a natural or legal person who carries out the function of liquefaction of natural gas, or the importation, offloading, and re-gaseification of LNG and is responsible for operating a LNG facility; 13. "system" means any transmission networks, distribution networks, LNG facilities and/or storage facilities owned and/or operated by a natural gas undertaking, including linepack and its facilities supplying ancillary services and those of related undertakings necessary for providing access to transmission, distribution and LNG; 14. "ancillary services" means all services necessary for access to and the operation of transmission and/or distribution networks and/or LNG facilities and/or storage facilities including load balancing and blending, but excluding facilities reserved exclusively for transmission system operators carrying out their functions; 15. "linepack" means the storage of gas by compression in gas transmission and distribution systems, but excluding facilities reserved for transmission system operators carrying out their functions; 16. "interconnected system" means a number of systems which are linked with each other; 17. "interconnector" means a transmission line which crosses or spans a border between Member States for the sole purpose of connecting the national transmission systems of these Member States; 18. "direct line" means a natural gas pipeline complementary to the interconnected system; 19. "integrated natural gas undertaking" means a vertically or horizontally integrated undertaking; 20. "vertically integrated undertaking" means a natural gas undertaking or a group of undertakings whose mutual relationships are defined in Article 3(3) of Council Regulation (EEC) No 4064/89 of 21 December 1989 on the control of concentrations between undertakings(9) and where the undertaking/group concerned is performing at least one of the functions of transmission, distribution, LNG or storage, and at least one of the functions of production or supply of natural gas; 21. "horizontally integrated undertaking" means an undertaking performing at least one of the functions of production, transmission, distribution, supply or storage of natural gas, and a non-gas activity; 22. "related undertakings" means affiliated undertakings, within the meaning of Article 41 of the Seventh Council Directive 83/349/EEC of 13 June 1983 based on the Article 44(2)(g)(10) of the Treaty on consolidated accounts(11), and/or associated undertakings, within the meaning of Article 33(1) thereof, and/or undertakings which belong to the same shareholders; 23. "system users" means any natural or legal persons supplying to, or being supplied by, the system; 24. "customers" means wholesale and final customers of natural gas and natural gas undertakings which purchase natural gas; 25. "household customers" means customers purchasing natural gas for their own household consumption; 26. "non-household customers" means customers purchasing natural gas which is not for their own household use; 27. "final customers" means customers purchasing natural gas for their own use; 28. "eligible customers" means customers who are free to purchase gas from the supplier of their choice, within the meaning of Article 23 of this Directive; 29. "wholesale customers" means any natural or legal persons other than transmission system operators and distribution system operators who purchase natural gas for the purpose of resale inside or outside the system where they are established; 30. "long-term planning" means the planning of supply and transportation capacity of natural gas undertakings on a long-term basis with a view to meeting the demand for natural gas of the system, diversification of sources and securing supplies to customers; 31. "emergent market" means a Member State in which the first commercial supply of its first long-term natural gas supply contract was made not more than 10 years earlier; 32. "security" means both security of supply of natural gas and technical safety; 33. "new infrastructure" means an infrastructure not completed by the entry into force of this Directive. CHAPTER II GENERAL RULES FOR THE ORGANISATION OF THE SECTOR Article 3 Public service obligations and customer protection 1. Member States shall ensure, on the basis of their institutional organisation and with due regard to the principle of subsidiarity, that, without prejudice to paragraph 2, natural gas undertakings are operated in accordance with the principles of this Directive with a view to achieving a competitive, secure and environmentally sustainable market in natural gas, and shall not discriminate between these undertakings as regards either rights or obligations. 2. Having full regard to the relevant provisions of the Treaty, in particular Article 86 thereof, Member States may impose on undertakings operating in the gas sector, in the general economic interest, public service obligations which may relate to security, including security of supply, regularity, quality and price of supplies, and environmental protection, including energy efficiency and climate protection. Such obligations shall be clearly defined, transparent, non discriminatory, verifiable and shall guarantee equality of access for EU gas companies to national consumers. In relation to security of supply, energy efficiency/demand-side management and for the fulfilment of environmental goals, as referred to in this paragraph, Member States may introduce the implementation of long term planning, taking into account the possibility of third parties seeking access to the system. 3. Member States shall take appropriate measures to protect final customers and to ensure high levels of consumer protection, and shall, in particular, ensure that there are adequate safeguards to protect vulnerable customers, including appropriate measures to help them avoid disconnection. In this context, they may take appropriate measures to protect customers in remote areas who are connected to the gas system. Member States may appoint a supplier of last resort for customers connected to the gas network. They shall ensure high levels of consumer protection, particularly with respect to transparency regarding general contractual terms and conditions, general information and dispute settlement mechanisms. Member States shall ensure that the eligible customer is effectively able to switch to a new supplier. As regards at least household customers these measures shall include those set out in Annex A. 4. Member States shall implement appropriate measures to achieve the objectives of social and economic cohesion, environmental protection, which may include means to combat climate change, and security of supply. Such measures may include, in particular, the provision of adequate economic incentives, using, where appropriate, all existing national and Community tools, for the maintenance and construction of necessary network infrastructure, including interconnection capacity. 5. Member States may decide not to apply the provisions of Article 4 with respect to distribution insofar as their application would obstruct, in law or in fact, the performance of the obligations imposed on natural gas undertakings in the general economic interest and insofar as the development of trade would not be affected to such an extent as would be contrary to the interests of the Community. The interests of the Community include, inter alia, competition with regard to eligible customers in accordance with this Directive and Article 86 of the Treaty. 6. Member States shall, upon implementation of this Directive, inform the Commission of all measures adopted to fulfil public service obligations, including consumer and environmental protection, and their possible effect on national and international competition, whether or not such measures require a derogation from the provisions of this Directive. They shall notify the Commission subsequently every two years of any changes to such measures, whether or not they require a derogation from this Directive. Article 4 Authorisation procedure 1. In circumstances where an authorisation (e.g. licence, permission, concession, consent or approval) is required for the construction or operation of natural gas facilities, the Member States or any competent authority they designate shall grant authorisations to build and/or operate such facilities, pipelines and associated equipment on their territory, in accordance with paragraphs 2 to 4. Member States or any competent authority they designate may also grant authorisations on the same basis for the supply of natural gas and for wholesale customers. 2. Where Member States have a system of authorisation, they shall lay down objective and non discriminatory criteria which shall be met by an undertaking applying for an authorisation to build and/or operate natural gas facilities or applying for an authorisation to supply natural gas. The non discriminatory criteria and procedures for the granting of authorisations shall be made public. 3. Member States shall ensure that the reasons for any refusal to grant an authorisation are objective and non discriminatory and are given to the applicant. Reasons for such refusals shall be forwarded to the Commission for information. Member States shall establish a procedure enabling the applicant to appeal against such refusals. 4. For the development of newly supplied areas and efficient operation generally, and without prejudice to Article 24, Member States may decline to grant a further authorisation to build and operate distribution pipeline systems in any particular area once such pipeline systems have been or are proposed to be built in that area and if existing or proposed capacity is not saturated. Article 5 Monitoring of security of supply Member States shall ensure the monitoring of security of supply issues. Where Member States consider it appropriate, they may delegate this task to the regulatory authorities referred to in Article 25(1). This monitoring shall, in particular, cover the supply/demand balance on the national market, the level of expected future demand and available supplies, envisaged additional capacity being planned or under construction, and the quality and level of maintenance of the networks, as well as measures to cover peak demand and to deal with shortfalls of one or more suppliers. The competent authorities shall publish, by 31 July each year at the latest a report outlining the findings resulting from the monitoring of these issues, as well as any measures taken or envisaged to address them and shall forward this report to the Commission forthwith. Article 6 Technical rules Member States shall ensure that technical safety criteria are defined and that technical rules establishing the minimum technical design and operational requirements for the connection to the system of LNG facilities, storage facilities, other transmission or distribution systems, and direct lines, are developed and made public. These technical rules shall ensure the interoperability of systems and shall be objective and non-discriminatory. They shall be notified to the Commission in accordance with Article 8 of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society Services(12). CHAPTER III TRANSMISSION, STORAGE AND LNG Article 7 Designation of system operators Member States shall designate or shall require natural gas undertakings which own transmission, storage or LNG facilities to designate, for a period of time to be determined by Member States having regard to considerations of efficiency and economic balance, one or more system operators. Member States shall take the measures necessary to ensure that transmission, storage and LNG system operators act in accordance with Articles 8 to 10. Article 8 Tasks of system operators 1. Each transmission, storage and/or LNG system operator shall: (a) operate, maintain and develop under economic conditions secure, reliable and efficient transmission, storage and/or LNG facilities, with due regard to the environment; (b) refrain from discriminating between system users or classes of system users, particularly in favour of its related undertakings; (c) provide any other transmission system operator, any other storage system operator, any other LNG system operator and/or any distribution system operator, sufficient information to ensure that the transport and storage of natural gas may take place in a manner compatible with the secure and efficient operation of the interconnected system; (d) provide system users with the information they need for efficient access to the system. 2. Rules adopted by transmission system operators for balancing the gas transmission system shall be objective, transparent and non-discriminatory, including rules for the charging of system users of their networks for energy imbalance. Terms and conditions, including rules and tariffs, for the provision of such services by transmission system operators shall be established pursuant to a methodology compatible with Article 25(2) in a non-discriminatory and cost-reflective way and shall be published. 3. Member States may require transmission system operators to comply with minimum requirements for the maintenance and development of the transmission system, including interconnection capacity. 4. Transmission system operators shall procure the energy they use for the carrying out of their functions according to transparent, non-discriminatory and market based procedures. Article 9 Unbundling of transmission system operators 1. Where the transmission system operator is part of a vertically integrated undertaking, it shall be independent at least in terms of its legal form, organisation and decision making from other activities not relating to transmission. These rules shall not create an obligation to separate the ownership of assets of the transmission system from the vertically integrated undertaking. 2. In order to ensure the independence of the transmission system operator referred to in paragraph 1, the following minimum criteria shall apply: (a) those persons responsible for the management of the transmission system operator may not participate in company structures of the integrated natural gas undertaking responsible, directly or indirectly, for the day-to-day operation of the production, distribution and supply of natural gas; (b) appropriate measures must be taken to ensure that the professional interests of persons responsible for the management of the transmission system operator are taken into account in a manner that ensures that they are capable of acting independently; (c) the transmission system operator shall have effective decision-making rights, independent from the integrated gas undertaking, with respect to assets necessary to operate, maintain or develop the network. This should not prevent the existence of appropriate coordination mechanisms to ensure that the economic and management supervision rights of the parent company in respect of return on assets regulated indirectly in accordance with Article 25(2) in a subsidiary are protected. In particular, this shall enable the parent company to approve the annual financial plan, or any equivalent instrument, of the transmission system operator and to set global limits on the levels of indebtedness of its subsidiary. It shall not permit the parent company to give instructions regarding day-to-day operations, nor with respect to individual decisions concerning the construction or upgrading of transmission lines, that do not exceed the terms of the approved financial plan, or any equivalent instrument; (d) the transmission system operator shall establish a compliance programme, which sets out measures taken to ensure that discriminatory conduct is excluded, and ensure that observance of it is adequately monitored. The programme shall set out the specific obligations of employees to meet this objective. An annual report, setting out the measures taken, shall be submitted by the person or body responsible for monitoring the compliance programme to the regulatory authority referred to in Article 25(1) and shall be published. Article 10 Confidentiality for transmission system operators 1. Without prejudice to Article 16 or any other legal duty to disclose information, each transmission, storage and/or LNG system operator shall preserve the confidentiality of commercially sensitive information obtained in the course of carrying out its business, and shall prevent information about its own activities which may be commercially advantageous from being disclosed in a discriminatory manner. 2. Transmission system operators shall not, in the context of sales or purchases of natural gas by related undertakings, abuse commercially sensitive information obtained from third parties in the context of providing or negotiating access to the system. CHAPTER IV DISTRIBUTION AND SUPPLY Article 11 Designation of distribution system operators Member States shall designate, or shall require undertakings which own or are responsible for distribution systems to designate, for a period of time to be determined by Member States, having regard to considerations of efficiency and economic balance, one or more distribution system operators and shall ensure that those operators act in accordance with Articles 12 to 14. Article 12 Tasks of distribution system operators 1. Each distribution system operator shall operate, maintain and develop under economic conditions a secure, reliable and efficient system, with due regard for the environment. 2. In any event, the distribution system operator shall not discriminate between system users or classes of system users, particularly in favour of its related undertakings. 3. Each distribution system operator shall provide any other distribution system operator, and/or any transmission, and/or LNG system operator, and/or storage system operator with sufficient information to ensure that the transport and storage of natural gas takes place in a manner compatible with the secure and efficient operation of the interconnected system. 4. Each distribution system operator shall provide system users with the information they need for efficient access to the system. 5. Where distribution system operators are responsible for balancing the gas distribution system, rules adopted by them for that purpose shall be objective, transparent and non-discriminatory, including rules for the charging of system users for energy imbalance. Terms and conditions, including rules and tariffs, for the provision of such services by system operators shall be established pursuant to a methodology compatible with Article 25(2) in a non-discriminatory and cost-reflective way and shall be published. Article 13 Unbundling of distribution system operators 1. Where the distribution system operator is part of a vertically integrated undertaking, it shall be independent at least in terms of its legal form, organisation and decision making from other activities not relating to distribution. These rules shall not create an obligation to separate the ownership of assets of the distribution system from the vertically integrated undertaking. 2. In addition to the requirements of paragraph 1, where the distribution system operator is part of a vertically integrated undertaking, it shall be independent in terms of its organisation and decision making from the other activities not related to distribution. In order to achieve this, the following minimum criteria shall apply: (a) those persons responsible for the management of the distribution system operator may not participate in company structures of the integrated natural gas undertaking responsible, directly or indirectly, for the day-to-day operation of the production, transmission and supply of natural gas; (b) appropriate measures must be taken to ensure that the professional interests of persons responsible for the management of the distribution system operator are taken into account in a manner that ensures that they are capable of acting independently; (c) the distribution system operator shall have effective decision-making rights, independent from the integrated gas undertaking, with respect to assets necessary to operate, maintain or develop the network. This should not prevent the existence of appropriate coordination mechanisms to ensure that the economic and management supervision rights of the parent company in respect of return on assets, regulated indirectly in accordance with Article 25(2), in a subsidiary are protected. In particular, this shall enable the parent company to approve the annual financial plan, or any equivalent instrument, of the distribution system operator and to set global limits on the levels of indebtedness of its subsidiary. It shall not permit the parent company to give instructions regarding day-to-day operations, nor with respect to individual decisions concerning the construction or upgrading of distribution lines, that do not exceed the terms of the approved financial plan, or any equivalent instrument; (d) the distribution system operator shall establish a compliance programme, which sets out measures taken to ensure that discriminatory conduct is excluded, and ensure that observance of it is adequately monitored. The programme shall set out the specific obligations of employees to meet this objective. An annual report, setting out the measures taken, shall be submitted by the person or body responsible for monitoring the compliance programme to the regulatory authority referred to in Article 25(1) and shall be published. Member States may decide not to apply paragraphs 1 and 2 to integrated natural gas undertakings serving less than 100000 connected customers. Article 14 Confidentiality for distribution system operators 1. Without prejudice to Article 16 or any other legal duty to disclose information, each distribution system operator shall preserve the confidentiality of commercially sensitive information obtained in the course of carrying out its business, and shall prevent information about its own activities which may be commercially advantageous from being disclosed in a discriminatory manner. 2. Distribution system operators shall not, in the context of sales or purchases of natural gas by related undertakings, abuse commercially sensitive information obtained from third parties in the context of providing or negotiating access to the system. Article 15 Combined operator The rules in Articles 9(1) and Article 13(1) shall not prevent the operation of a combined transmission, LNG, storage and distribution system operator, which is independent in terms of its legal form, organisation and decision making from other activities not relating to transmission LNG, storage and distribution system operations and which meets the requirements set out in points (a) to (d). These rules shall not create an obligation to separate the ownership of assets of the combined system from the vertically integrated undertaking: (a) those persons responsible for the management of the combined system operator may not participate in company structures of the integrated natural gas undertaking responsible, directly or indirectly, for the day-to-day operation of the production and supply of natural gas; (b) appropriate measures must be taken to ensure that the professional interests of persons responsible for the management of the combined system operator are taken into account in a manner that ensures that they are capable of acting independently; (c) the combined system operator shall have effective decision-making rights, independent from the integrated gas undertaking, with respect to assets necessary to operate, maintain or develop the network. This should not prevent the existence of appropriate coordination mechanisms to ensure that the economic and management supervision rights of the parent company in respect of return on assets, regulated indirectly in accordance with Article 25(2) in a subsidiary are protected. In particular, this shall enable the parent company to approve the annual financial plan, or any equivalent instrument, of the combined system operator and to set global limits on the levels of indebtedness of its subsidiary. It shall not permit the parent company to give instructions regarding day-to-day operations, nor with respect to individual decisions concerning the construction or upgrading of transmission and distribution lines, that do not exceed the terms of the approved financial plan, or any equivalent instrument; (d) the combined system operator shall establish a compliance programme, which sets out measures taken to ensure that discriminatory conduct is excluded, and ensure that observance of it is adequately monitored. The programme shall set out the specific obligations of employees to meet this objective. An annual report, setting out the measures taken, shall be submitted by the person or body responsible for monitoring the compliance programme to the regulatory authority referred to in Article 25(1) and shall be published. CHAPTER V UNBUNDLING AND TRANSPARENCY OF ACCOUNTS Article 16 Right of access to accounts 1. Member States or any competent authority they designate, including the regulatory authorities referred to in Article 25(1) and the dispute settlement authorities referred to in Article 20(3), shall, insofar as necessary to carry out their functions, have right of access to the accounts of natural gas undertakings as set out in Article 17. 2. Member States and any designated competent authority, including the regulatory authorities referred to in Article 25(1) and the dispute settlement authorities, shall preserve the confidentiality of commercially sensitive information. Member States may provide for the disclosure of such information where this is necessary in order for the competent authorities to carry out their functions. Article 17 Unbundling of accounts 1. Member States shall take the necessary steps to ensure that the accounts of natural gas undertakings are kept in accordance with paragraphs 2 to 5. Where undertakings benefit from a derogation from this provision on the basis of Article 28(2) and (4), they shall at least keep their internal accounts in accordance with this Article. 2. Natural gas undertakings, whatever their system of ownership or legal form, shall draw up, submit to audit and publish their annual accounts in accordance with the rules of national law concerning the annual accounts of limited liability companies adopted pursuant to the Fourth Council Directive 78/660/EEC of 25 July 1978 based on Article 44(2)(g)(13) of the Treaty on the annual accounts of certain types of companies(14). Undertakings which are not legally obliged to publish their annual accounts shall keep a copy of these at the disposal of the public at their head office. 3. Natural gas undertakings shall, in their internal accounting, keep separate accounts for each of their transmission, distribution, LNG and storage activities as they would be required to do if the activities in question were carried out by separate undertakings, with a view to avoiding discrimination, cross-subsidisation and distortion of competition. They shall also keep accounts, which may be consolidated, for other gas activities not relating to transmission, distribution, LNG and storage. Until 1 July 2007, they shall keep separate accounts for supply activities for eligible customers and supply activities for non-eligible customers. Revenue from ownership of the transmission/distribution network shall be specified in the accounts. Where appropriate, they shall keep consolidated accounts for other, non-gas activities. The internal accounts shall include a balance sheet and a profit and loss account for each activity. 4. The audit, referred to in paragraph 2, shall, in particular, verify that the obligation to avoid discrimination and cross-subsidies referred to in paragraph 3, is respected. 5. Undertakings shall specify in their internal accounting the rules for the allocation of assets and liabilities, expenditure and income as well as for depreciation, without prejudice to nationally applicable accounting rules, which they follow in drawing up the separate accounts referred to in paragraph 3. These internal rules may be amended only in exceptional cases. Such amendments shall be mentioned and duly substantiated. 6. The annual accounts shall indicate in notes any transaction of a certain size conducted with related undertakings. CHAPTER VI ORGANISATION OF ACCESS TO THE SYSTEM Article 18 Third party access 1. Member States shall ensure the implementation of a system of third party access to the transmission and distribution system, and LNG facilities based on published tariffs, applicable to all eligible customers, including supply undertakings, and applied objectively and without discrimination between system users. Member States shall ensure that these tariffs, or the methodologies underlying their calculation shall be approved prior to their entry into force by a regulatory authority referred to in Article 25(1) and that these tariffs - and the methodologies, where only methodologies are approved - are published prior to their entry into force. 2. Transmission system operators shall, if necessary for the purpose of carrying out their functions including in relation to cross-border transmission, have access to the network of other transmission system operators. 3. The provisions of this Directive shall not prevent the conclusion of long-term contracts in so far as they comply with Community competition rules Article 19 Access to storage 1. For the organisation of access to storage facilities and linepack when technically and/or economically necessary for providing efficient access to the system for the supply of customers, as well as for the organisation of access to ancillary services, Member States may choose either or both of the procedures referred to in paragraphs 3 and 4. These procedures shall operate in accordance with objective, transparent and non-discriminatory criteria. 2. The provisions of paragraph 1 shall not apply to ancillary services and temporary storage that are related to LNG facilities and are necessary for the re-gaseification process and subsequent delivery to the transmission system. 3. In the case of negotiated access, Member States shall take the necessary measures for natural gas undertakings and eligible customers either inside or outside the territory covered by the interconnected system to be able to negotiate access to storage and linepack, when technically and/or economically necessary for providing efficient access to the system, as well as for the organisation of access to other ancillary services. The parties shall be obliged to negotiate access to storage, linepack and other ancillary services in good faith. Contracts for access to storage, linepack and other ancillary services shall be negotiated with the relevant storage system operator or natural gas undertakings. Member States shall require storage system operators and natural gas undertakings to publish their main commercial conditions for the use of storage, linepack and other ancillary services within the first six months following implementation of this Directive and on an annual basis every year thereafter. 4. In the case of regulated access Member States shall take the necessary measures to give natural gas undertakings and eligible customers either inside or outside the territory covered by the interconnected system a right to access to storage, linepack and other ancillary services, on the basis of published tariffs and/or other terms and obligations for use of that storage and linepack, when technically and/or economically necessary for providing efficient access to the system, as well as for the organisation of access to other ancillary services. This right of access for eligible customers may be given by enabling them to enter into supply contracts with competing natural gas undertakings other than the owner and/or operator of the system or a related undertaking. Article 20 Access to upstream pipeline networks 1. Member States shall take the necessary measures to ensure that natural gas undertakings and eligible customers, wherever they are located, are able to obtain access to upstream pipeline networks, including facilities supplying technical services incidental to such access, in accordance with this Article, except for the parts of such networks and facilities which are used for local production operations at the site of a field where the gas is produced. The measures shall be notified to the Commission in accordance with the provisions of Article 33. 2. The access referred to in paragraph 1 shall be provided in a manner determined by the Member State in accordance with the relevant legal instruments. Member States shall apply the objectives of fair and open access, achieving a competitive market in natural gas and avoiding any abuse of a dominant position, taking into account security and regularity of supplies, capacity which is or can reasonably be made available, and environmental protection. The following may be taken into account: (a) the need to refuse access where there is an incompatibility of technical specifications which cannot be reasonably overcome; (b) the need to avoid difficulties which cannot be reasonably overcome and could prejudice the efficient, current and planned future production of hydrocarbons, including that from fields of marginal economic viability; (c) the need to respect the duly substantiated reasonable needs of the owner or operator of the upstream pipeline network for the transport and processing of gas and the interests of all other users of the upstream pipeline network or relevant processing or handling facilities who may be affected; and (d) the need to apply their laws and administrative procedures, in conformity with Community law, for the grant of authorisation for production or upstream development. 3. Member States shall ensure that they have in place dispute settlement arrangements, including an authority independent of the parties with access to all relevant information, to enable disputes relating to access to upstream pipeline networks to be settled expeditiously, taking into account the criteria in paragraph 2 and the number of parties which may be involved in negotiating access to such networks. 4. In the event of cross border disputes, the dispute settlement arrangements for the Member State having jurisdiction over the upstream pipeline network which refuses access shall be applied. Where, in cross border disputes, more than one Member State covers the network concerned, the Member States concerned shall consult with a view to ensuring that the provisions of this Directive are applied consistently. Article 21 Refusal of access 1. Natural gas undertakings may refuse access to the system on the basis of lack of capacity or where the access to the system would prevent them from carrying out the public service obligations referred to in Article 3(2) which are assigned to them or on the basis of serious economic and financial difficulties with take-or-pay contracts having regard to the criteria and procedures set out in Article 27 and the alternative chosen by the Member State in accordance with paragraph 1 of that Article. Duly substantiated reasons shall be given for such a refusal. 2. Member States may take the measures necessary to ensure that the natural gas undertaking refusing access to the system on the basis of lack of capacity or a lack of connection makes the necessary enhancements as far as it is economic to do so or when a potential customer is willing to pay for them. In circumstances where Member States apply Article 4(4), Member States shall take such measures. Article 22 New infrastructure 1. Major new gas infrastructures, i.e. interconnectors between Member States, LNG and storage facilities, may, upon request, be exempted from the provisions of Articles 18, 19, 20, and 25(2), (3) and (4) under the following conditions: (a) the investment must enhance competition in gas supply and enhance security of supply; (b) the level of risk attached to the investment is such that the investment would not take place unless an exemption was granted; (c) the infrastructure must be owned by a natural or legal person which is separate at least in terms of its legal form from the system operators in whose systems that infrastructure will be built; (d) charges are levied on users of that infrastructure; (e) the exemption is not detrimental to competition or the effective functioning of the internal gas market, or the efficient functioning of the regulated system to which the infrastructure is connected. 2. Paragraph 1 shall apply also to significant increases of capacity in existing infrastructures and to modifications of such infrastructures which enable the development of new sources of gas supply. 3. (a) The regulatory authority referred to in Article 25 may, on a case by case basis, decide on the exemption referred to in paragraphs 1 and 2. However, Member States may provide that the regulatory authorities shall submit, for formal decision, to the relevant body in the Member State its opinion on the request for an exemption. This opinion shall be published together with the decision. (b) (i) The exemption may cover all or parts of, respectively, the new infrastructure, the existing infrastructure with significantly increased capacity or the modification of the existing infrastructure. (ii) In deciding to grant an exemption consideration shall be given, on a case by case basis, to the need to impose conditions regarding the duration of the exemption and non-discriminatory access to the interconnector. (iii) When deciding on the conditions in this subparagraph account shall, in particular, be taken of the duration of contracts, additional capacity to be built or the modification of existing capacity, the time horizon of the project and national circumstances. (c) When granting an exemption the relevant authority may decide upon the rules and mechanisms for management and allocation of capacity insofar as this does not prevent the implementation of long term contracts. (d) The exemption decision, including any conditions referred to in (b), shall be duly reasoned and published. (e) In the case of an interconnector any exemption decision shall be taken after consultation with the other Member States or regulatory authorities concerned. 4. The exemption decision shall be notified, without delay, by the competent authority to the Commission, together with all the relevant information with respect to the decision. This information may be submitted to the Commission in aggregate form, enabling the Commission to reach a well-founded decision. In particular, the information shall contain: (a) the detailed reasons on the basis of which the regulatory authority, or Member State, granted the exemption, including the financial information justifying the need for the exemption; (b) the analysis undertaken of the effect on competition and the effective functioning of the internal gas market resulting from the grant of the exemption; (c) the reasons for the time period and the share of the total capacity of the gas infrastructure in question for which the exemption is granted; (d) in case the exemption relates to an interconnector, the result of the consultation with the Member States concerned or regulatory authorities; (e) the contribution of the infrastructure to the diversification of gas supply. Within two months after receiving a notification, the Commission may request that the regulatory authority or the Member State concerned amend or withdraw the decision to grant an exemption. The two month period may be extended by one additional month where additional information is sought by the Commission. If the regulatory authority or Member State concerned does not comply with the request within a period of four weeks, a final decision shall be taken in accordance with the procedure referred to in Article 30(2). The Commission shall preserve the confidentiality of commercially sensitive information. Article 23 Market opening and reciprocity 1. Member States shall ensure that the eligible customers are: (a) until 1 July 2004, the eligible customers as specified in Article 18 of Directive 98/30/EC. Member States shall publish by 31 January each year the criteria for the definition of these eligible customers; (b) from 1 July 2004, at the latest, all non-household customers; (c) from 1 July 2007, all customers. 2. To avoid imbalance in the opening of gas markets: (a) contracts for the supply with an eligible customer in the system of another Member State shall not be prohibited if the customer is eligible in both systems involved; (b) in cases where transactions as described in point (a) are refused because the customer is eligible in only one of the two systems, the Commission may, taking into account the situation in the market and the common interest, oblige the refusing party to execute the requested supply, at the request of one of the Member States of the two systems. Article 24 Direct lines 1. Member States shall take the necessary measures to enable: (a) natural gas undertakings established within their territory to supply the eligible customers through a direct line; (b) any such eligible customer within their territory to be supplied through a direct line by natural gas undertakings. 2. In circumstances where an authorisation (e.g. licence, permission, concession, consent or approval) is required for the construction or operation of direct lines, the Member States or any competent authority they designate shall lay down the criteria for the grant of authorisations for the construction or operation of such lines in their territory. These criteria shall be objective, transparent and non-discriminatory. 3. Member States may make authorisations to construct a direct line subject either to the refusal of system access on the basis of Article 21 or to the opening of a dispute settlement procedure under Article 25. Article 25 Regulatory authorities 1. Member States shall designate one or more competent bodies with the function of regulatory authorities. These authorities shall be wholly independent of the interests of the gas industry. They shall, through the application of this Article, at least be responsible for ensuring non-discrimination, effective competition and the efficient functioning of the market, monitoring in particular: (a) the rules on the management and allocation of interconnection capacity, in conjunction with the regulatory authority or authorities of those Member States with which interconnection exists; (b) any mechanisms to deal with congested capacity within the national gas system; (c) the time taken by transmission and distribution system operators to make connections and repairs; (d) the publication of appropriate information by transmission and distribution system operators concerning interconnectors, grid usage and capacity allocation to interested parties, taking into account the need to treat non-aggregated information as commercially confidential; (e) the effective unbundling of accounts as referred to in Article 17, to ensure there are no cross subsidies between transmission, distribution, storage, LNG and supply activities; (f) the access conditions to storage, linepack and to other ancillary services as provided for in Article 19; (g) the extent to which transmission and distribution system operators fulfil their tasks in accordance with Articles 8 and 12; (h) the level of transparency and competition. The authorities established pursuant to this Article shall publish an annual report on the outcome of their monitoring activities referred to in points (a) to (h). 2. The regulatory authorities shall be responsible for fixing or approving prior to their entry into force, at least the methodologies used to calculate or establish the terms and conditions for: (a) connection and access to national networks, including transmission and distribution tariffs. These tariffs, or methodologies, shall allow the necessary investments in the networks to be carried out in a manner allowing these investments to ensure the viability of the networks; (b) the provision of balancing services. 3. Notwithstanding paragraph 2, Member States may provide that the regulatory authorities shall submit, for formal decision, to the relevant body in the Member State the tariffs or at least the methodologies referred to in that paragraph as well as the modifications in paragraph 4. The relevant body shall, in such a case, have the power to either approve or reject a draft decision submitted by the regulatory authority. These tariffs or the methodologies or modifications thereto shall be published together with the decision on formal adoption. Any formal rejection of a draft decision shall also be published, including its justification. 4. Regulatory authorities shall have the authority to require transmission, LNG and distribution system operators, if necessary, to modify the terms and conditions, including tariffs and methodologies referred to in paragraphs 1, 2 and 3, to ensure that they are proportionate and applied in a non-discriminatory manner. 5. Any party having a complaint against a transmission, LNG or distribution system operator with respect to the issues mentioned in paragraphs 1, 2 and 4 and in Article 19 may refer the complaint to the regulatory authority which, acting as dispute settlement authority, shall issue a decision within two months after receipt of the complaint. This period may be extended by two months where additional information is sought by the regulatory authorities. This period may be extended with the agreement of the complainant. Such a decision shall have binding effect unless and until overruled on appeal. 6. Any party having a complaint against a transmission, LNG or distribution system operator with respect to the issues mentioned in paragraphs 1, 2 and 4 and in Article 19 may refer the complaint to the regulatory authority which, acting as dispute settlement authority, shall issue a decision within two months after receipt of the complaint. This period may be extended by two months where additional information is sought by the regulatory authorities. This period may be extended with the agreement of the complainant. Such a decision shall have binding effect unless and until overruled on appeal. 7. Member States shall take measures to ensure that regulatory authorities are able to carry out their duties referred to in paragraphs 1 to 5 in an efficient and expeditious manner. 8. Member States shall create appropriate and efficient mechanisms for regulation, control and transparency so as to avoid any abuse of a dominant position, in particular to the detriment of consumers, and any predatory behaviour. These mechanisms shall take account of the provisions of the Treaty, and in particular Article 82 thereof. 9. Member States shall ensure that the appropriate measures are taken, including administrative action or criminal proceedings in conformity with their national law, against the natural or legal persons responsible where confidentiality rules imposed by this Directive have not been respected. 10. In the event of cross border disputes, the deciding regulatory authority shall be the regulatory authority which has jurisdiction in respect of the system operator, which refuses use of, or access to, the system. 11. Complaints referred to in paragraphs 5 and 6 shall be without prejudice to the exercise of rights of appeal under Community and national law. 12. National regulatory authorities shall contribute to the development of the internal market and of a level playing field by cooperating with each other and with the Commission in a transparent manner. CHAPTER VII FINAL PROVISIONS Article 26 Safeguard measures 1. In the event of a sudden crisis in the energy market or where the physical safety or security of persons, apparatus or installations or system integrity is threatened, a Member State may temporarily take the necessary safeguard measures. 2. Such measures shall cause the least possible disturbance to the functioning of the internal market and shall not be wider in scope than is strictly necessary to remedy the sudden difficulties which have arisen. 3. The Member State concerned shall without delay notify these measures to the other Member States, and to the Commission, which may decide that the Member State concerned must amend or abolish such measures, insofar as they distort competition and adversely affect trade in a manner which is at variance with the common interest. Article 27 Derogations in relation to take-or-pay commitments 1. If a natural gas undertaking encounters, or considers it would encounter, serious economic and financial difficulties because of its take-or-pay commitments accepted in one or more gas-purchase contracts, an application for a temporary derogation from Article 18 may be sent to the Member State concerned or the designated competent authority. Applications shall, according to the choice of Member States, be presented on a case-by-case basis either before or after refusal of access to the system. Member States may also give the natural gas undertaking the choice of presenting an application either before or after refusal of access to the system. Where a natural gas undertaking has refused access, the application shall be presented without delay. The applications shall be accompanied by all relevant information on the nature and extent of the problem and on the efforts undertaken by the natural gas undertaking to solve the problem. If alternative solutions are not reasonably available, and taking into account the provisions of paragraph 3, the Member State or the designated competent authority may decide to grant a derogation. 2. The Member State, or the designated competent authority, shall notify the Commission without delay of its decision to grant a derogation, together with all the relevant information with respect to the derogation. This information may be submitted to the Commission in an aggregated form, enabling the Commission to reach a well-founded decision. Within eight weeks of its receipt of this notification, the Commission may request that the Member State or the designated competent authority concerned amend or withdraw the decision to grant a derogation. If the Member State or the designated competent authority concerned does not comply with this request within a period of four weeks, a final decision shall be taken expeditiously in accordance with the procedure referred to in Article 30(2). The Commission shall preserve the confidentiality of commercially sensitive information. 3. When deciding on the derogations referred to in paragraph 1, the Member State, or the designated competent authority, and the Commission shall take into account, in particular, the following criteria: (a) the objective of achieving a competitive gas market; (b) the need to fulfil public service obligations and to ensure security of supply; (c) the position of the natural gas undertaking in the gas market and the actual state of competition in this market; (d) the seriousness of the economic and financial difficulties encountered by natural gas undertakings and transmission undertakings or eligible customers; (e) the dates of signature and terms of the contract or contracts in question, including the extent to which they allow for market changes; (f) the efforts made to find a solution to the problem; (g) the extent to which, when accepting the take-or-pay commitments in question, the undertaking could reasonably have foreseen, having regard to the provisions of this Directive, that serious difficulties were likely to arise; (h) the level of connection of the system with other systems and the degree of interoperability of these systems; and (i) the effects the granting of a derogation would have on the correct application of this Directive as regards the smooth functioning of the internal natural gas market. A decision on a request for a derogation concerning take or pay contracts concluded before the entry into force of this Directive should not lead to a situation in which it is impossible to find economically viable alternative outlets. Serious difficulties shall in any case be deemed not to exist when the sales of natural gas do not fall below the level of minimum offtake guarantees contained in gas purchase take or pay contracts or in so far as the relevant gas purchase take-or-pay contract can be adapted or the natural gas undertaking is able to find alternative outlets. 4. Natural gas undertakings which have not been granted a derogation as referred to in paragraph 1 shall not refuse, or shall no longer refuse, access to the system because of take-or-pay commitments accepted in a gas purchase contract. Member States shall ensure that the relevant provisions of Chapter VI namely Articles 18 to 25 are complied with. 5. Any derogation granted under the above provisions shall be duly substantiated. The Commission shall publish the decision in the Official Journal of the European Union. 6. The Commission shall, within five years of the entry into force of this Directive, submit a review report on the experience gained from the application of this Article, so as to allow the European Parliament and the Council to consider, in due course, the need to adjust it. Article 28 Emergent and isolated markets 1. Member States not directly connected to the interconnected system of any other Member State and having only one main external supplier may derogate from Articles 4, 9, 23 and/or 24 of this Directive. A supply undertaking having a market share of more than 75 % shall be considered to be a main supplier. This derogation shall automatically expire from the moment when at least one of these conditions no longer applies. Any such derogation shall be notified to the Commission. 2. A Member State, qualifying as an emergent market, which because of the implementation of this Directive would experience substantial problems may derogate from Articles 4, 7, 8(1) and (2), 9, 11, 12(5), 13, 17, 18, 23(1) and/or 24 of this Directive. This derogation shall automatically expire from the moment when the Member State no longer qualifies as an emergent market. Any such derogation shall be notified to the Commission. 3. On the date at which the derogation referred to in paragraph 2 expires, the definition of eligible customers shall result in an opening of the market equal to at least 33 % of the total annual gas consumption of the national gas market. Two years thereafter, Article 23(1)(b) shall apply, and three years thereafter, Article 23(1)(c). Until Article 23(1)(b) applies the Member State referred to in paragraph 2 may decide not to apply Article 18 as far as ancillary services and temporary storage for the re-gaseification process and its subsequent delivery to the transmission system are concerned. 4. Where implementation of this Directive would cause substantial problems in a geographically limited area of a Member State, in particular concerning the development of the transmission and major distribution infrastructure, and with a view to encouraging investments, the Member State may apply to the Commission for a temporary derogation from Article 4, Article 7, Article 8(1) and (2), Article 9, Article 11, Article 12(5), Article 13, Article 17, Article 18, Article 23(1) and/or Article 24 for developments within this area. 5. The Commission may grant the derogation referred to in paragraph 4, taking into account, in particular, the following criteria: - the need for infrastructure investments, which would not be economic to operate in a competitive market environment, - the level and pay-back prospects of investments required, - the size and maturity of the gas system in the area concerned, - the prospects for the gas market concerned, - the geographical size and characteristics of the area or region concerned, and socioeconomic and demographic factors. (a) For gas infrastructure other than distribution infrastructure a derogation may be granted only if no gas infrastructure has been established in this area, or has been so established for less than 10 years. The temporary derogation may not exceed 10 years from the time gas is first supplied in the area. (b) For distribution infrastructure a derogation may be granted for a time period which may not exceed 20 years for the distribution infrastructure from the time gas is first supplied through the said system in the area. 6. Luxembourg may benefit from a derogation from Articles 8(3) and 9 for a period of five years from 1 July 2004. Such a derogation shall be reviewed before the end of the five year period and any decision to renew the derogation for another five years shall be taken in accordance with the procedure referred to in Article 30(2). Any such derogation shall be notified to the Commission. 7. The Commission shall inform the Member States of applications made under paragraph 4 prior to taking a decision pursuant to paragraph 5, taking into account respect for confidentiality. This decision, as well as the derogations referred to in paragraphs 1 and 2, shall be published in the Official Journal of the European Union. 8. Greece may derogate from Articles 4, 11, 12, 13, 18, 23 and/or 24 of this Directive for the geographical areas and time periods specified in the licences issued by it, prior to 15 March 2002 and in accordance with Directive 98/30/EC, for the development and exclusive exploitation of distribution networks in certain geographical areas. Article 29 Review Procedure In the event that the report referred to in Article 31(3) reaches the conclusion whereby, given the effective manner in which network access has been carried out in a Member State - which gives rise to fully effective, non-discriminatory and unhindered network access -, the Commission concludes that certain obligations imposed by this Directive on undertakings (including those with respect to legal unbundling for distribution system operators) are not proportionate to the objective pursued, the Member State in question may submit a request to the Commission for exemption from the requirement in question. The request shall be notified, without delay, by the Member State to the Commission, together with all the relevant information necessary to demonstrate that the conclusion reached in the report on effective network access being ensured will be maintained. Within three months of its receipt of a notification, the Commission shall adopt an opinion with respect to the request by the Member State concerned, and where appropriate, submit proposals to the European Parliament and to the Council to amend the relevant provisions of the Directive. The Commission may propose, in the proposals to amend the Directive, to exempt the Member State concerned from specific requirements subject to that Member State implementing equally effective measures as appropriate. Article 30 Committee 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. The Committee shall adopt its rules of procedure. Article 31 Reporting 1. The Commission shall monitor and review the application of this Directive and submit an overall progress report to the European Parliament and the Council before the end of the first year following the entry into force of this Directive, and thereafter on an annual basis. The report shall cover at least: (a) the experience gained and progress made in creating a complete and fully operational internal market in natural gas and the obstacles that remain in this respect including aspects of market dominance, concentration in the market, predatory or anti-competitive behaviour; (b) the derogations granted under this Directive, including implementation of the derogation provided for in Article 13(2) with a view to a possible revision of the threshold; (c) the extent to which the unbundling and tarification requirements contained in this Directive have been successful in ensuring fair and non-discriminatory access to the Community's gas system and equivalent levels of competition, as well as the economic, environmental and social consequences of the opening of the gas market for customers; (d) an examination of issues relating to system capacity levels and security of supply of natural gas in the Community, and in particular the existing and projected balance between demand and supply, taking into account the physical capacity for exchanges between areas and the development of storage (including the question of the proportionality of market regulation in this field); (e) special attention will be given to the measures taken in Member States to cover peak demand and to deal with shortfalls of one or more suppliers; (f) a general assessment of the progress achieved with regard to bilateral relations with third countries which produce and export or transport natural gas, including progress in market integration, trade and access to the networks of such third countries; (g) the need for possible harmonisation requirements which are not linked to the provisions of this Directive. Where appropriate, this report may include recommendations and measures to counteract negative effects of market dominance and market concentration. 2. Every two years, the report referred to in paragraph 1 shall also cover an analysis of the different measures taken in Member States to meet public service obligations, together with an examination of the effectiveness of those measures, and in particular their effects on competition in the gas market. Where appropriate, the report may include recommendations as to the measures to be taken at national level to achieve high public service standards or measures intended to prevent market foreclosure. 3. The Commission shall, no later than 1 January 2006, forward to the European Parliament and Council, a detailed report outlining progress in creating the internal gas market. The report shall, in particular, consider: - the existence of non-discriminatory network access; - effective regulation; - the development of interconnection infrastructure, the conditions of transit, and the security of supply situation in the Community; - the extent to which the full benefits of the opening of the market are accruing to small enterprises and households, notably with respect to public service standards; - the extent to which markets are in practice open to effective competition, including aspects of market dominance, market concentration and predatory or anti-competitive behaviour; - the extent to which customers are actually switching suppliers and renegotiating tariffs; - price developments, including supply prices, in relation to the degree of the opening of markets; - whether effective and non-discriminatory third party access to gas storage exists when technically and/or economically necessary for providing efficient access to the system; - the experience gained in the application of the Directive as far as the effective independence of system operators in vertically integrated undertakings is concerned and whether other measures in addition to functional independence and separation of accounts have been developed which have effects equivalent to legal unbundling. Where appropriate, the Commission shall submit proposals to the European Parliament and the Council, in particular to guarantee high public service standards. Where appropriate, the Commission shall submit proposals to the European Parliament and the Council, in particular to ensure full and effective independence of distribution system operators before 1 July 2007. When necessary, these proposals shall, in conformity with competition law, also concern measures to address issues of market dominance, market concentration and predatory or anti-competitive behaviour. Article 32 Repeals 1. Directive 91/296/EEC shall be repealed with effect from 1 July 2004, without prejudice to contracts concluded pursuant to Article 3(1) of Directive 91/296/EEC, which shall continue to be valid and to be implemented under the terms of the said Directive. 2. Directive 98/30/EC shall be repealed from 1 July 2004, without prejudice to the obligations of Member States concerning the deadlines for transposition and application of the said Directive. References made to the repealed Directive shall be construed as being made to this Directive and should be read in accordance with the correlation table in Annex B. Article 33 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 2004. They shall forthwith inform the Commission thereof. 2. Member States may postpone the implementation of Article 13(1) until 1 July 2007. This shall be without prejudice to the requirements contained in Article 13(2). 3. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 34 Entry into force This Directive shall enter into force on thetwentieth day following that of its publication in the Official Journal of the European Union. Article 35 Addressees This Directive is addressed to the Member States.

32003L0066

2003

Commission Directive 2003/66/EC of 3 July 2003 amending Directive 94/2/EC implementing Council Directive 92/75/EEC with regard to energy labelling of household electric refrigerators, freezers and their combinations (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 92/75/EEC of 22 September 1992 on the indication by labelling and standard product information of the consumption of energy and other resources of household appliances(1), and in particular Articles 9 and 12 thereof, Whereas: (1) Electricity use by refrigerators, freezers and their combinations accounts for a significant part of total Community household energy demand. The further scope for a reduction of energy use by these appliances is substantial. (2) The success of the labelling scheme introduced by Commission Directive 94/2/EC(2), in conjunction with Directive 96/57/EC of the European Parliament and of the Council of 3 September 1996 on energy efficiency requirements for household electric refrigerators, freezers and combinations thereof(3) has led to a rise of the efficiency index of new refrigerators and freezers by over 30 % between 1996 and 2000. (3) About 20 % of the cold appliances sold in 2000 were in the most efficient class A, and in some markets the proportion was more than 50 %. The market shares of A class appliances is rising rapidly. Consequently, there is a need to introduce two additional classes, to be designated as A+ and A++, as an interim arrangement until a comprehensive revision of the energy labelling classes takes place. (4) The effect of labelling on energy efficiency will diminish, or disappear, unless further and more efficient classes are defined. (5) Directive 94/2/EC should therefore be amended accordingly. By the same occasion, it will be possible to align that Directive on similar directives recently adopted, implementing Directive 92/75/EEC. (6) The measures provided for in this Directive are in accordance with the opinion of the Committee set up under Article 10 of Directive 92/75/EEC, Article 1 Directive 94/2/EC is amended as follows: 1. In Article 1, paragraphs 2, 3 and 4 are replaced by the following: "2. The information required by this Directive shall be obtained by measurements made in accordance with harmonised standards adopted by the European Standardisation Bodies (CEN, CENELEC, ETSI) under mandate from the Commission in accordance with Directive 98/34/EC of the European Parliament and of the Council(4), the reference numbers of which have been published in the Official Journal of the European Union and for which Member States have published the reference numbers of the national standards transposing those harmonised standards. 3. The provisions in Annexes I, II and III requiring the giving of information relating to noise shall apply only where that information is required by Member States under Article 3 of Directive 86/594/EEC. This information shall be measured in accordance with that Directive. 4. In this Directive the definitions set out in Article 1(4) of Directive 92/75/EEC shall apply." 2. Article 2 is amended as follows: (a) In paragraph 1, the following subparagraph is added:"Where the information relating to a particular model combination has been obtained by calculation on the basis of design, and/or extrapolation from other combinations, the documentation should include details of such calculations and/or extrapolations, and of tests undertaken to verify the accuracy of the calculations undertaken (details of mathematical model for calculating performance and of measurements taken to verify this model)." (b) Paragraph 5 is replaced by the following: "5. Where the appliances are offered for sale, hire or hire purchase by means of a printed or written communication, or by other means which imply that the potential customer cannot be expected to see the appliance displayed, such as a written offer, a mail order catalogue, advertisements on the Internet or on other electronic media, that communication shall include all the information specified in Annex III." 3. Annexes I, II, III, and V are amended as shown in the Annex to this Directive. 4. Annex VI is deleted. Article 2 Member States shall allow the circulation of labels, fiches and communications referred to in Article 2(5) of Directive 94/2/EC, containing the information as revised by this Directive, no later than 1 July 2004. They shall ensure that all labels, fiches and communications referred to in Article 2(5) of Directive 94/2/EC comply with the revised models, no later than 31 December 2004. Article 3 Member States shall adopt and publish the provisions to comply with this Directive no later than 30 June 2004. They shall immediately inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32003L0068

2003

Commission Directive 2003/68/EC of 11 July 2003 amending Council Directive 91/414/EEC to include trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone and isoxaflutole as active substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 2003/39/EC(2), and in particular Article 6(1) thereof, Whereas: (1) In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 28 January 1998 an application from Novartis Crop Protection UK Ltd for the inclusion of the active substance trifloxystrobin in Annex I to Directive 91/414/EEC. The substance was subsequently transferred to Bayer CropScience, which is now acting as the applicant. Commission Decision 1999/43/EC(3) confirmed that the dossier was "complete" in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. (2) France received an application under Article 6(2) of Directive 91/414/EEC on 14 February 1996 from FMC Europe NV (now FMC Chemical sprl) concerning carfentrazone-ethyl. This application was declared complete by Commission Decision 97/362/EC(4). (3) The United Kingdom received an application under Article 6(2) of Directive 91/414/EEC on 23 April 1998 from Zeneca Agrochemicals UK (now Syngenta) concerning mesotrione. This application was declared complete by Commission Decision 1999/392/EC(5). (4) France received an application under Article 6(2) of Directive 91/414/EEC on 15 September 1999 from Rhone Poulenc Agri SA (now Bayer CropScience) concerning fenamidone. This application was declared complete by Commission Decision 2000/251/EC(6). (5) The Netherlands received an application under Article 6(2) of Directive 91/414/EEC on 6 March 1996 Rhône-Poulenc Agro (now Bayer CropScience) concerning isoxaflutole. This application was declared complete by Commission Decision 96/524/EC(7). (6) For those active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The nominated rapporteur Member States, submitted a draft assessment report concerning the substance to the Commission on 19 April 2000 (trifloxystrobin), 14 May 1998 (carfentrazone-ethyl), 17 December 1999 (mesotrione), 14 May 1998 (fenamidone) and 20 February 1997 (isoxaflutole). (7) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 15 April 2003 in the format of the Commission review reports for mesotrione, trifloxystrobin, carfentrazone-ethyl, fenamidone and isoxaflutole. (8) The review of trifloxystrobin and fenamidone did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee for Plants. (9) For carfentrazone-ethyl the review and information were also submitted to the Scientific Committee for Plants for separate consultation. The Committee was asked to comment on the relevance for humans of the elevated levels of specific porphyrins detected in test animals. The Committee expressed the opinion(8) that the effects of the substance detected in test animals on porphyrin levels are relevant for humans but saw no evidence that humans are more sensitive to the effect than animals. In addition, the Scientific Committee noted that three unknown polar compounds were detected in a lysimeter. The notifier was therefore requested to comment on the relevance of these three compounds. Additional information was subsequently provided by the notifier and evaluated by the Committee. In its assessment of the new data the Committee concluded that those polar compounds will not cause an unacceptable ecotoxicological or toxicological risk. (10) For mesotrione, the Scientific Committee was asked to comment on the suitability of the rat as an animal model for the extrapolation of the toxicological properties of mesotrione in humans and was invited to assess, whether the onset of adverse effects in target organs (in animal models as well as humans) can be linked to a certain threshold concentration of tyrosine in plasma. In its opinion(9), the Committee concluded that due to the similarities in tyrosine kinetics between mice and humans, the mouse can be considered a better animal model than the rat for human risk assessment purposes. The Committee further concluded that no signs or symptoms of adverse effects are to be expected in humans at plasma tyrosine levels below 800 to 1000 nmol/ml. (11) For isoxaflutole the Scientific Committee was asked to comment on the toxicological and ecotoxicological effects of a degradation product of the active substance (RPA 203328); on statistical analyses of tumour incidence in the two-year rat study; and on the observation of developmental effects in laboratory animals. In its opinion(10), the Committee noted that the degradation product RPA 203328 under worst-case conditions might leach into groundwater with expected concentrations exceeding 0,1 ppb. The Committee identified no toxicological or ecotoxiclogical concern with regard to this degradation product. The Committee also identified no concern for humans related to possible carcinogenic or developmental effects. In a second consultation on the same substances the Scientific Committee was asked to comment on the appropriate degradation kinetics to be assumed in model calculations of the leaching behaviour. The Committee found certain parameters used in the modelling were insufficiently justified and the half life time of degradation for the RPA 203328 metabolite may have been under-estimated(11). The model calculations of the leaching behaviour of isoxaflutole and its degradation products were subsequently revised along the lines suggested by the Scientific Committee. (12) It has appeared from the various examinations made that plant protection products containing the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include mesotrione, trifloxystrobin, carfentrazone-ethyl, fenamidone and isoxaflutole in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substance can be granted in accordance with the provisions of that Directive. (13) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone and isoxaflutole and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC. (14) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (15) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 31 March 2004 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 April 2004. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall review the authorisation for each plant protection product containing trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone or isoxaflutole to ensure that the conditions relating to these active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw authorisations in accordance with Directive 91/414/EEC by 31 March 2004 at the latest. 2. For each authorised plant protection product containing trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone or isoxaflutole as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 September 2004 at the latest. Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 31 March 2005 at the latest, they shall amend or withdraw the authorisation for each such plant protection product. Article 4 This Directive shall enter into force on 1 October 2003. Article 5 This Directive is addressed to the Member States.

32003L0058

2003

Directive 2003/58/EC of the European Parliament and of the Council of 15 July 2003 amending Council Directive 68/151/EEC, as regards disclosure requirements in respect of certain types of companies Having regard to the Treaty establishing the European Community and in particular Article 44(2)(g) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Acting in accordance with the procedure referred to in Article 251 of the Treaty(3), Whereas: (1) The First Council Directive 68/151/EEC of 9 March 1968 on coordination of safeguards which, for the protection of the interests of members and others, are required by Member States of companies within the meaning of the second paragraph of Article 58 of the Treaty, with a view to making such safeguards equivalent throughout the Community(4) governs compulsory disclosure of a series of documents and particulars by limited liability companies. (2) In the context of the fourth phase of the Simplification of the Legislation on the Internal Market process (SLIM), launched by the Commission in October 1998, a Company Law Working Group issued in September 1999 a Report on the simplification of the First and Second Company Law Directives which contained certain recommendations. (3) The modernisation of Directive 68/151/EEC along the lines set out in those recommendations should not only help to meet the important objective of making company information more easily and rapidly accessible by interested parties, but should also simplify significantly the disclosure formalities imposed upon companies. (4) The list of companies covered by Directive 68/151/EEC should be updated to take account of the new types of companies created or the types of companies abolished at national level since the adoption of that Directive. (5) Several Directives have been adopted since 1968 with the aim of harmonising the requirements applicable to the accounting documents which must be prepared by companies, namely the Fourth Council Directive 78/660/EEC of 25 July 1978 on the annual accounts of certain types of companies(5), the Seventh Council Directive 83/349/EEC of 13 June 1983 on consolidated accounts(6), Council Directive 86/635/EEC of 8 December 1986 on the annual accounts and consolidated accounts of banks and other financial institutions(7) and Council Directive 91/674/EEC of 19 December 1991 on the annual accounts and consolidated accounts of insurance undertakings(8). The references in Directive 68/151/EEC to the accounting documents which are required to be published in accordance with those Directives should be amended accordingly. (6) In the context of the modernisation pursued, and without prejudice to substantive requisites and formalities established by the national law of the Member States, companies should be able to choose to file their compulsory documents and particulars by paper means or by electronic means. (7) Interested parties should be able to obtain from the register a copy of such documents and particulars by paper means as well as by electronic means. (8) Member States should be allowed to decide to keep the national gazette, appointed for publication of compulsory documents and particulars, in paper form or electronic form, or to provide for disclosure by equally effective means. (9) Cross-border access to company information should be improved by allowing, in addition to the mandatory disclosure made in one of the languages permitted in the company's Member State, voluntary registration in additional languages of the required documents and particulars. Third parties acting in good faith should be able to rely on these translations. (10) It is appropriate to clarify that the statement of the compulsory particulars set out in Article 4 of Directive 68/151/EEC should be included in all company letters and order forms, whether they are in paper form or use any other medium. In the light of technological developments, it is also appropriate to provide that these statements be placed on any company website. (11) Directive 68/151/EEC should be amended accordingly, Article 1 Directive 68/151/EEC is hereby amended as follows: 1. Article 1 shall be amended as follows: (a) the third indent shall be replaced by the following: "- in France: la société anonyme, la société en commandite par actions, la société à responsabilité limitée, la société par actions simplifiée;" (b) the sixth indent shall be replaced by the following: "- in the Netherlands: de naamloze vennootschap, de besloten vennootschap met beperkte aansprakelijkheid;" (c) the ninth indent shall be replaced by the following: "- in Denmark: aktieselskab, kommanditaktieselskab, anpartsselskab;" (d) the 14th indent shall be replaced by the following: "- in Finland: yksityinen osakeyhtiö/privat aktiebolag, julkinen osakeyhtiö/publikt aktiebolag;" 2. Article 2: (a) Article 2(1)(f) shall be replaced by the following: "(f) The accounting documents for each financial year, which are required to be published in accordance with Council Directives 78/660/EEC(9), 83/349/EEC(10), 86/635/EEC(11) and 91/674/EEC(12)."; (b) paragraph 2 shall be deleted. 3. Article 3 shall be replaced by the following: "Article 3 1. In each Member State, a file shall be opened in a central register, commercial register or companies register, for each of the companies registered therein. 2. All documents and particulars which must be disclosed pursuant to Article 2 shall be kept in the file, or entered in the register; the subject matter of the entries in the register must in every case appear in the file. Member States shall ensure that, by 1 January 2007, the filing by companies, as well as by other persons and bodies required to make or assist in making notifications, of all documents and particulars which must be disclosed pursuant to Article 2 will be possible by electronic means. In addition, Member States may require all, or certain categories of, companies to file all, or certain types of, such documents and particulars by electronic means. All documents and particulars referred to in Article 2 which are filed as from 1 January 2007 at the latest, whether by paper means or by electronic means, must be kept in the file, or entered in the register, in electronic form. To this end, Member States shall ensure that all such documents and particulars which are filed by paper means as from 1 January 2007 at the latest are converted by the register to electronic form. The documents and particulars referred to in Article 2 that have been filed by paper means up to 31 December 2006 shall not be required to be converted automatically into electronic form by the register. Member States shall nevertheless ensure that they are converted into electronic form by the register upon receipt of an application for disclosure by electronic means submitted in accordance with the rules adopted to give effect to paragraph 3. 3. A copy of the whole or any part of the documents or particulars referred to in Article 2 must be obtainable on application. As from 1 January 2007 at the latest, applications may be submitted to the register by paper means or by electronic means as the applicant chooses. As from a date to be chosen by each Member State, which shall be no later than 1 January 2007, copies as referred to in the first subparagraph must be obtainable from the register by paper means or by electronic means as the applicant chooses. This shall apply in the case of all documents and particulars, irrespective of whether they were filed before or after the chosen date. However, Member States may decide that all, or certain types of, documents and particulars filed by paper means on or before a date which may not be later than 31 December 2006 shall not be obtainable from the register by electronic means if a specified period has elapsed between the date of filing and the date of the application submitted to the register. Such specified period may not be less than 10 years. The price of obtaining a copy of the whole or any part of the documents or particulars referred to in Article 2, whether by paper means or by electronic means, shall not exceed the administrative cost thereof. Paper copies supplied shall be certified as 'true copies', unless the applicant dispenses with such certification. Electronic copies supplied shall not be certified as 'true copies', unless the applicant explicitly requests such a certification. Member States shall take the necessary measures to ensure that certification of electronic copies guarantees both the authenticity of their origin and the integrity of their contents, by means at least of an advanced electronic signature within the meaning of Article 2(2) of Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a Community framework for electronic signatures(13). 4. Disclosure of the documents and particulars referred to in paragraph 2 shall be effected by publication in the national gazette appointed for that purpose by the Member State, either of the full text or of a partial text, or by means of a reference to the document which has been deposited in the file or entered in the register. The national gazette appointed for that purpose may be kept in electronic form. Member States may decide to replace publication in the national gazette with equally effective means, which shall entail at least the use of a system whereby the information disclosed can be accessed in chronological order through a central electronic platform. 5. The documents and particulars may be relied on by the company as against third parties only after they have been disclosed in accordance with paragraph 4, unless the company proves that the third parties had knowledge thereof. However, with regard to transactions taking place before the 16th day following the disclosure, the documents and particulars shall not be relied on as against third parties who prove that it was impossible for them to have had knowledge thereof. 6. Member States shall take the necessary measures to avoid any discrepancy between what is disclosed in accordance with paragraph 4 and what appears in the register or file. However, in cases of discrepancy, the text disclosed in accordance with paragraph 4 may not be relied on as against third parties; such third parties may nevertheless rely thereon, unless the company proves that they had knowledge of the texts deposited in the file or entered in the register. 7. Third parties may, moreover, always rely on any documents and particulars in respect of which the disclosure formalities have not yet been completed, save where non-disclosure causes them not to have effect. 8. For the purposes of this Article, 'by electronic means' shall mean that the information is sent initially and received at its destination by means of electronic equipment for the processing (including digital compression) and storage of data, and entirely transmitted, conveyed and received in a manner to be determined by Member States by wire, by radio, by optical means or by other electromagnetic means." 4. The following Article shall be inserted: "Article 3a 1. Documents and particulars which must be disclosed pursuant to Article 2 shall be drawn up and filed in one of the languages permitted by the language rules applicable in the Member State in which the file referred to in Article 3(1) is opened. 2. In addition to the mandatory disclosure referred to in Article 3, Member States shall allow documents and particulars referred to in Article 2 to be disclosed voluntarily in accordance with Article 3 in any official language(s) of the Community. Member States may prescribe that the translation of such documents and particulars be certified. Member States shall take the necessary measures to facilitate access by third parties to the translations voluntarily disclosed. 3. In addition to the mandatory disclosure referred to in Article 3, and to the voluntary disclosure provided for under paragraph 2 of this Article, Member States may allow the documents and particulars concerned to be disclosed, in accordance with Article 3, in any other language(s). Member States may stipulate that the translation of such documents and particulars be certified. 4. In cases of discrepancy between the documents and particulars disclosed in the official languages of the register and the translation voluntarily disclosed, the latter may not be relied upon as against third parties. Third parties may nevertheless rely on the translations voluntarily disclosed, unless the company proves that the third parties had knowledge of the version which was the subject of the mandatory disclosure." 5. Article 4 shall be replaced by the following: "Article 4 Member States shall stipulate that letters and order forms, whether they are in paper form or use any other medium, shall state the following particulars: (a) the information necessary to identify the register in which the file mentioned in Article 3 is kept, together with the number of the company in that register; (b) the legal form of the company, the location of its registered office and, where appropriate, the fact that the company is being wound up. Where, in these documents, mention is made of the capital of the company, the reference shall be to the capital subscribed and paid up. Member States shall prescribe that company websites shall contain at least the particulars mentioned in the first paragraph and, if applicable, the reference to the capital subscribed and paid up." 6. Article 6 shall be replaced by the following: "Article 6 Member States shall provide for appropriate penalties at least in the case of: (a) failure to disclose accounting documents as required by Article 2(1)(f); (b) omission from commercial documents or from any company website of the compulsory particulars provided for in Article 4." Article 2 1. Member States shall bring into force before 31 December 2006 the laws, regulations and administrative provisions necessary for them to comply with this Directive. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. 3. The Commission shall present to the European Parliament and to the Council, by 1 January 2012, a report, together with a proposal, if appropriate, for the amendment of this Directive in the light of the experience acquired in applying it, of its aims and of the technological developments observed at the time. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0059

2003

DIRECTIVE 2003/59/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 July 2003 on the initial qualification and periodic training of drivers of certain road vehicles for the carriage of goods or passengers, amending Council Regulation (EEC) No 3820/85 and Council Directive 91/439/EEC and repealing Council Directive 76/914/EEC Having regard to the Treaty establishing the European Community, and in particular Article 71 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Economic and Social Committee (2), After consultation of the Committee of the Regions, Acting in accordance with the procedure referred to in Article 251 of the Treaty (3), Whereas: (1) Article 5(1), (2) and (4) of Regulation (EEC) No 3820/85 (4) provides that certain drivers engaged in the carriage of goods or passengers by road must, depending on their age, on the category of vehicle used and on the distance to be travelled, hold a certificate of professional competence in conformity with Community rules on the minimum level of training for some road transport drivers. That minimum level is determined by Directive 76/914/EEC (5). (2) Given that the provisions of Regulation (EEC) No 3820/85 apply to a very small percentage of drivers and that currently the compulsory training of drivers is only required by a few Member States, the majority of drivers now driving on Community territory are carrying out their profession solely on the basis of a driving licence. (3) To enable drivers to meet the new demands arising from the development of the road transport market, Community rules should be made applicable to all drivers, whether they drive as self-employed or salaried workers, and whether on own account or for hire or reward. (4) The establishment of new Community rules is aimed at ensuring that, by means of his or her qualification, the driver is of a standard to have access to and carry out the activity of driving. (5) More particularly, the obligation to hold an initial qualification and to undergo periodic training is intended to improve road safety and the safety of the driver, including during operations carried out by the driver while the vehicle is stopped. Furthermore, the modern nature of the profession of driver should arouse young people's interest in the profession, contributing to the recruitment of new drivers at a time of shortage. (6) To avoid unequal conditions of competition, this Directive should apply to the activity of driving both by the nationals of a Member State and by nationals of third countries who are employed or used by an undertaking established in a Member State. (7) In order to establish that the driver complies with his or her obligations, Member States should issue the driver with a certificate of professional competence, hereinafter referred to as ‘CPC’, certifying his or her initial qualification or periodic training. (8) Given the differences between current systems in certain Member States, Member States should be able to choose between several options so as to facilitate the implementation of the provisions relating to the initial qualification. (9) In order to maintain their qualification of driver, existing drivers should be obliged to undergo periodic retraining in the skills essential for their profession. (10) The minimum requirements to be met for the initial qualification and the periodic training concern the safety rules to be observed when driving and while the vehicle is stopped. The development of defensive driving — anticipating danger, making allowance for other road users — which goes hand in hand with rational fuel consumption, will have a positive impact both on society and on the road transport sector itself. (11) This Directive should not affect the rights acquired by a driver who has held the driving licence necessary to carry out the activity of driving since before the date laid down for obtaining a CPC certifying the corresponding initial qualification or the periodic training. (12) Only training centres which have been approved by the competent authorities of the Member States should be able to organise the training courses laid down for the initial qualification and the periodic training. To ensure the quality of these approved centres, the competent authorities should set harmonised criteria for their approval including that of a well-established high level of professionalism. (13) Not only the competent authorities of the Member States but also any entity designated by them should be responsible for organising the tests provided for in connection with the initial qualification and the periodic training. Given the importance of this Directive for road safety and for the equality of conditions of competition, the competent authorities of the Member States should supervise such tests. (14) Member States should prescribe that the first session of periodic training is to be completed and should issue the corresponding CPC, within the five years following either the date of issue of the CPC certifying the initial qualification or the expiry date of the time limit set for certain drivers to claim their acquired rights. It should also be possible for these time limits to be shortened or extended. Following the first periodic training, the driver should undergo periodic training every five years. (15) To certify that a driver who is a national of a Member State is the holder of one of the CPCs provided for by this Directive, and to facilitate mutual recognition of the various CPCs, Member States should affix the harmonised Community code laid down for that purpose, together with the code's expiry date, either to the driving licence or to the new driver qualification card, to be mutually recognised by Member States, the harmonised model of which is laid down by this Directive. This card should meet the same security requirements as the driving licence, given the importance of the rights which it confers for road safety and the equality of conditions of competition. The possibility afforded to Member States to affix the Community code on the new card should enable them to lay down a period of validity for driving licences which does not coincide with the date of expiry of the validity of periodic training, given that Directive 91/439/EEC (6) provides that each Member State is to retain the right to determine, on the basis of national criteria, the period of validity of the driving licences which it issues. (16) Annexes I and Ia to Directive 91/439/EEC should be amended so as to add to the list of harmonised codes and sub-codes set out in those Annexes the new Community code determining the date until which a driver fulfils the professional skills requirement, whether this is an initial qualification or periodic training. (17) Special certification provisions should be laid down for drivers covered by this Directive who are nationals of third countries. (18) The Commission should monitor the implementation of this Directive, particularly given the different initial qualification systems which it lays down, and should submit a report on this subject to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. (19) Given the significant number of drivers covered by this Directive, the provisions relating to the initial qualification should be applied in two stages, depending on whether the carriage of passengers or the carriage of goods is involved. The phased application of this Directive as regards the initial qualification for drivers of vehicles engaged in the carriage of goods and passengers should also make it possible for periodic training to be established in a phased manner. (20) The measures necessary to implement this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7). (21) To take account of the application on two different dates of the provisions relating to the initial qualification, the relevant provisions of Regulation (EEC) No 3820/85 as well as Directive 76/914/EEC should be repealed. (22) However, it is desirable, in order to respect the principles of Community law, that drivers of vehicles used to carry out transport where this is considered to have a lesser impact on road safety or where the requirements of this Directive would impose a disproportionate economic or social burden, should be exempted from the application of this Directive. (23) Since the objective of the proposed action, namely the establishment of a Community-wide standard for initial qualification and periodic training, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and the effects of the proposed action, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective, Article 1 Scope This Directive shall apply to the activity of driving carried out by: (a) nationals of a Member State; and (b) nationals of third countries who are employed or used by an undertaking established in a Member State; hereinafter referred to as ‘drivers’, engaged in road transport within the Community, on roads open to the public, using: — vehicles for which a driving licence of category C1, C1+E, C or C+E, as defined in Directive 91/439/EEC, or a driving licence recognised as equivalent, is required, — vehicles for which a driving licence of category D1, D1+E, D or D+E, as defined in Directive 91/439/EEC, or a driving licence recognised as equivalent, is required. Article 2 Exemptions This Directive shall not apply to the drivers of: (a) vehicles with a maximum authorised speed not exceeding 45 km/h; (b) vehicles used by, or under the control of, the armed forces, civil defence, the fire service and forces responsible for maintaining public order; (c) vehicles undergoing road tests for technical development, repair or maintenance purposes, or of new or rebuilt vehicles which have not yet been put into service; (d) vehicles used in states of emergency or assigned to rescue missions; (e) vehicles used in the course of driving lessons for any person wishing to obtain a driving licence or a CPC, as provided for in Article 6 and Article 8(1); (f) vehicles used for non-commercial carriage of passengers or goods, for personal use; (g) vehicles carrying material or equipment to be used by the driver in the course of his or her work, provided that driving the vehicle is not the driver's principal activity. Article 3 Qualification and training 1. The activity of driving as defined in Article 1 shall be subject to a compulsory initial qualification and compulsory periodic training. To this end Member States shall provide for: (a) a system of initial qualification Member States shall choose between the following two options: (i) option combining both course attendance and a test In accordance with section 2(2.1) of Annex I, this type of initial qualification involves compulsory course attendance for a specific period. It shall conclude with a test. Upon successful completion of the test, the qualification shall be certified by a CPC as provided for in Article 6(1)(a); (ii) option involving only tests In accordance with section 2(2.2) of Annex I, this type of initial qualification does not involve compulsory course attendance but only theoretical and practical tests. Upon successful completion of the tests, the qualification shall be certified by a CPC as provided for in Article 6(1)(b). However, a Member State may authorise a driver to drive within its territory before obtaining a CPC, when he or she is undergoing a national vocational training course of at least six months, for a maximum period of three years. In the context of this vocational training course, the tests referred to in points (i) and (ii) may be completed in stages; (b) a system of periodic training In accordance with section 4 of Annex I, periodic training involves compulsory course attendance. It shall be certified by a CPC as provided for in Article 8(1). 2. Member States may also provide for a system of accelerated initial qualification so that a driver may drive in the cases referred to in Article 5(2)(a)(ii) and (b) and in Article 5(3)(a)(i) and (b). In accordance with section 3 of Annex I, the accelerated initial qualification shall involve compulsory course attendance. It shall conclude with a test. Upon successful completion of the test, the qualification shall be certified by a CPC as provided for in Article 6(2). 3. Member States may exempt drivers who have obtained the certificate of professional competence provided for in Directive 96/26/EC (8) from the tests referred to in paragraph 1(a)(i) and (ii) and in paragraph 2 in the subjects covered by the test provided for in that Directive and, where appropriate, from attending the part of the course corresponding thereto. Article 4 Acquired rights The following drivers shall be exempted from the requirement to obtain an initial qualification: (a) drivers who hold a category D1, D1+E, D or D+E licence, or a licence recognised as equivalent, issued no later than two years after the final date for the transposition of this Directive; (b) drivers who hold a category C1, C1+E, C or C+E licence, or a licence recognised as equivalent, issued no later than three years after the final date for the transposition of this Directive. Article 5 Initial qualification 1. Access to an initial qualification shall not require the corresponding driving licence to be obtained beforehand. 2. Drivers of a vehicle intended for the carriage of goods may drive: (a) from the age of 18: (i) a vehicle in licence categories C and C+E, provided they hold a CPC as referred to in Article 6(1); (ii) a vehicle in licence categories C1 and C1+E, provided they hold a CPC as referred to in Article 6(2); (b) from the age of 21, a vehicle in licence categories C and C+E, provided they hold a CPC as referred to in Article 6(2). 3. Drivers of a vehicle intended for the carriage of passengers may drive: (a) from the age of 21: (i) a vehicle in licence categories D and D+E to carry passengers on regular services where the route does not exceed 50 kilometres and a vehicle in licence categories D1 and D1+E, provided they hold a CPC as referred to in Article 6(2). Any Member State may authorise drivers of vehicles in one of the abovementioned categories to drive such vehicles within its territory from the age of 18, provided they hold a CPC as referred to in Article 6(1); (ii) a vehicle in licence categories D and D+E, provided they hold a CPC as referred to in Article 6(1). Any Member State may authorise drivers of vehicles in one of the abovementioned categories to drive such vehicles within its territory from the age of 20, provided they hold a CPC as referred to in Article 6(1). This may be reduced to the age of 18 where the driver drives such vehicles without passengers; (b) from the age of 23, a vehicle in licence categories D and D+E, provided they hold a CPC as referred to in Article 6(2). 4. Without prejudice to the age limits specified in paragraph 2, drivers undertaking carriage of goods who hold a CPC as provided for in Article 6 for one of the categories provided for in paragraph 2 of this Article shall be exempted from obtaining such a CPC for any other of the categories of vehicles referred to in that paragraph. These provisions shall apply under the same conditions to drivers undertaking carriage of passengers in the categories referred to in paragraph 3. 5. Drivers undertaking carriage of goods who broaden or modify their activities in order to carry passengers, or vice versa, and who hold a CPC as provided for in Article 6, shall not be required to repeat the common parts of the initial qualification, but rather only the parts specific to the new qualification. Article 6 CPC certifying the initial qualification 1. CPC certifying an initial qualification (a) CPC awarded on the basis of course attendance and a test In accordance with Article 3(1)(a)(i), Member States shall require trainee drivers to attend courses in a training centre approved by the competent authorities in accordance with section 5 of Annex I, hereinafter referred to as ‘approved training centre’. These courses shall cover all the subjects referred to in section 1 of Annex I. This training shall conclude with successful completion of the test provided for in section 2(2.1) of Annex I. That test shall be organised by the Member States' competent authorities or an entity designated by them and shall serve to check whether, for the aforementioned subjects, the trainee driver has the level of knowledge required in section 1 of Annex I. The said authorities or entities shall supervise the test and, upon successful completion, issue the drivers with a CPC certifying an initial qualification. (b) CPC awarded on the basis of tests In accordance with Article 3(1)(a)(ii), Member States shall require trainee drivers to pass the theoretical and practical tests referred to in section 2(2.2) of Annex I. These tests shall be organised by the Member States' competent authorities or an entity designated by them and shall serve to check whether, for all the aforementioned subjects, the trainee driver has the level of knowledge required in section 1 of Annex I. The said authorities or entities shall supervise the tests and, upon successful completion, issue the drivers with a CPC certifying an initial qualification. 2. CPC certifying an accelerated initial qualification In accordance with Article 3(2), Member States shall require trainee drivers to attend courses in an approved training centre. These courses shall cover all the subjects referred to in section 1 of Annex I. This training shall conclude with the test provided for in section 3 of Annex I. That test shall be organised by the Member States' competent authorities or an entity designated by them and shall serve to check whether, for the aforementioned subjects, the trainee driver has the level of knowledge required in section 1 of Annex I. The said authorities or entities shall supervise the test and, upon successful completion, issue the drivers with a CPC certifying an accelerated initial qualification. Article 7 Periodic training Periodic training shall consist of training to enable holders of a CPC as referred to in Article 6 and the drivers referred to in Article 4 to update the knowledge which is essential for their work, with specific emphasis on road safety and the rationalisation of fuel consumption. This training shall be organised by an approved training centre, in keeping with section 5 of Annex I. If a driver moves to another undertaking, the periodic training already undergone must be taken into account. Periodic training shall be designed to expand on, and to revise, some of the subjects referred in section 1 of Annex I. Article 8 CPC certifying periodic training 1. When a driver has completed the periodic training referred to in Article 7, the Member States' competent authorities or the approved training centre shall issue him or her with a CPC certifying periodic training. 2. The following drivers shall undergo a first course of periodic training: (a) holders of a CPC as referred to in Article 6, within five years of the issue of that CPC; (b) the drivers referred to in Article 4, within five years of the respective dates referred to in Article 14(2), in accordance with a timetable decided on by the Member States. Member States may reduce or extend the periods of time referred to in (a) and (b), inter alia, so that they coincide with the date of expiry of the driving licence or so as to ensure the gradual introduction of periodic training. The period may not, however, be shorter than three years or longer than seven years. 3. A driver who has completed a first course of periodic training as referred to in paragraph 2 shall undergo periodic training every five years, before the end of the period of validity of the CPC certifying periodic training. 4. Holders of the CPC as referred to in Article 6 or the CPC as referred to in paragraph 1 of this Article and the drivers referred to in Article 4 who have ceased pursuit of the occupation and do not meet the requirements of paragraphs 1, 2 and 3, shall undergo a course of periodic training before resuming pursuit of the occupation. 5. Drivers undertaking the carriage of goods or passengers by road who have completed courses of periodic training for one of the licence categories provided for in Article 5(2) and (3) shall be exempt from the obligation to undergo further periodic training for another of the categories provided for in those paragraphs. Article 9 Place of training Drivers referred to in Article 1(a) shall obtain the initial qualification referred to in Article 5 in the Member State in which they have their normal residence, as defined in Article 14 of Regulation (EEC) No 3821/85 (9). Drivers referred to in Article 1(b) shall obtain that qualification in the Member State in which the undertaking is established or in the Member State which issued a work permit to them. Drivers referred to in Article 1(a) and 1(b) shall undergo the periodic training referred to in Article 7 in the Member State in which they have their normal residence or the Member State in which they work. Article 10 Community code 1. On the basis of the CPC referred to in Article 6 and the CPC referred to in Article 8(1), Member States' competent authorities shall mark, taking into account the provisions of Article 5(2) and (3) and Article 8, the Community code provided for in paragraph 2 of this Article alongside the corresponding categories of licence: — either on the driving licence, — or on the driver qualification card drawn up in accordance with the model shown in Annex II. The driver qualification card issued by Member States shall be mutually recognised. When the card is issued, the competent authorities shall check the validity of the driving licence whose number is mentioned on the card. 2. The following Community code shall be added to the list of harmonised Community codes as laid down in Annexes I and Ia to Directive 91/439/EEC: ‘95. Driver holding a CPC complying with the obligation of professional competence referred to in Article 3 until … (e.g. 95. 01.01.2012).’ 3. (a) A driver referred to in Article 1(b) who drives vehicles used for the carriage of goods by road shall prove that he or she has the qualification and training provided for in this Directive by means of the driver's certificate provided for in Regulation (EC) No 484/2002 (10). In addition to the certificate, the Member State may issue him or her with the driver qualification card provided for in Annex II, marked with the relevant Community code. (b) A driver referred to in Article 1(b) who drives vehicles used for the carriage of passengers by road shall prove that he or she has the qualification and training provided for in this Directive by means of: — either the Community code marked on the Community model driving licence, where he or she is the holder of such a licence, or — the driver qualification card provided for in Annex II, marked with the relevant Community code, or — a national certificate whose validity on their territory is mutually recognised by the Member States. Article 11 Adaptation to scientific and technical progress The amendments necessary to adapt Annexes I and II to scientific and technical progress shall be adopted in accordance with the procedure laid down in Article 12(2). Article 12 Committee procedure 1. The Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply having regard to Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. Article 13 Report Before 10 September 2011 the Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report making an initial evaluation of the implementation of this Directive, in particular with regard to the equivalence of the various initial qualification systems provided for in Article 3, and the efficiency thereof in achieving the target level of qualification. The report shall be accompanied by appropriate proposals, if necessary. Article 14 Transposition and implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 10 September 2006. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall apply these measures: — from 10 September 2008 as regards the initial qualification required to drive vehicles in licence categories D1, D1+E, D and D+E; — from 10 September 2009 as regards the initial qualification required to drive vehicles in licence categories C1, C1+E, C and C+E. Member States shall forthwith inform the Commission thereof and shall assist each other in applying these measures. Article 15 Repeal 1. Article 5 of Regulation (EEC) No 3820/85 is hereby amended as follows: (a) paragraph 1 shall be repealed with effect from 10 September 2009. (b) paragraphs 2 and 4 shall be repealed with effect from 10 September 2008. 2. Directive 76/914/EEC shall be repealed with effect from 10 September 2009. 3. The laws, regulations and administrative provisions adopted to comply with Directive 76/914/EEC shall cease to apply: — from 10 September 2008 to drivers of vehicles for the carriage of passengers by road, — from 10 September 2009 to drivers of vehicles for the carriage of goods by road. Article 16 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 17 Addressees This Directive is addressed to the Member States.

32003L0070

2003

Commission Directive 2003/70/EC of 17 July 2003 amending Council Directive 91/414/EEC to include mecoprop, mecoprop-P and propiconazole as active substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 2003/68/EC(2), and in particular Article 6(1) thereof, Whereas: (1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market(3), as last amended by Regulation (EC) No 2266/2000(4), establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes mecoprop, mecoprop-P and propiconazole. (2) For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Regulation (EEC) No 3600/92(5), as last amended by Regulation (EC) No 2230/95(6), the following rapporteur Member States were designated, which in turn submitted the relevant assessment reports and recommendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92: mecoprop: Rapporteur Member State Denmark, all relevant information was submitted on 31 August 1999; mecoprop-P: Rapporteur Member State Denmark, all relevant information was submitted on 7 January 1999; propiconazole: Rapporteur Member State Finland, all relevant information was submitted on 30 November 1998. (3) Those assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. (4) The reviews of all active substances were finalised on 15 April 2003 in the format of the Commission review reports for mecoprop, mecoprop-P and propiconazole. (5) The reviews of mecoprop, mecoprop-P and propiconazole did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants. (6) It has appeared from the various examinations made that plant protection products containing mecoprop, mecoprop-P or propiconazole may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive. (7) The Commission review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Directive 91/414/EEC. It is, therefore, appropriate to provide that the finalised review report, except for confidential information, should be kept available or made available by the Member States for consultation by any interested parties. (8) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. (9) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant protection products containing mecoprop, mecoprop-P or propiconazole, and in particular, to review existing authorisations to ensure that the conditions regarding those active substances set out in Annex I to Directive 91/414/EEC are satisfied. A longer period should be provided for the submission and assessment of the complete dossier of each plant protection product in accordance with the uniform principles laid down in Directive 91/414/EEC. (10) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 30 November 2004 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 December 2004. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall review the authorisation for each plant protection product containing mecoprop, mecoprop-P or propiconazole to ensure that the conditions relating to those active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary and by 30 November 2004 at the latest, they shall amend or withdraw the authorisation. 2. Member States shall, for each authorised plant protection product containing mecoprop, mecoprop-P or propiconazole as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2004 at the latest, re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 31 May 2008 at the latest, they shall amend or withdraw the authorisation. Article 4 This Directive shall enter into force on 1 June 2004. Article 5 This Directive is addressed to the Member States.

32003L0072

2003

Council Directive 2003/72/EC of 22 July 2003 supplementing the Statute for a European Cooperative Society with regard to the involvement of employees Having regard to the Treaty establishing the European Community, and in particular Article 308 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Parliament(2), Having regard to the opinion of the European Economic and Social Committee(3), Whereas: (1) In order to attain the objectives of the Treaty, Council Regulation (EC) No 1435/2003(4) establishes a Statute for a European Cooperative Society (SCE). (2) That Regulation aims at creating a uniform legal framework within which cooperatives and other entities and natural persons from different Member States should be able to plan and carry out the reorganisation of their business in cooperative form on a Community scale. (3) In order to promote the social objectives of the Community, special provisions have to be set, notably in the field of employee involvement, aimed at ensuring that the establishment of an SCE does not entail the disappearance or reduction of practices of employee involvement existing within the entities participating in the establishment of an SCE. This objective should be pursued through the establishment of a set of rules in this field, supplementing the provisions of Regulation (EC) No 1435/2003. (4) Since the objectives of the proposed action, as outlined above, cannot be sufficiently achieved by the Member States, in that the object is to establish a set of rules on employee-involvement applicable to the SCE, and can therefore, by reason of the scale and impact of the proposed action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary to achieve these objectives. (5) The great diversity of rules and practices existing in the Member States as regards the manner in which employees' representatives are involved in decision-making within cooperatives makes it inadvisable to set up a single European model of employee involvement applicable to the SCE. (6) Information and consultation procedures at transnational level should be ensured in all cases of creation of an SCE, with the necessary adaptation for SCEs formed ex novo where this is justified by their size, as measured in terms of employment. (7) If participation rights exist within one or more entities establishing an SCE, they should in principle be preserved through their transfer to the SCE, once established, unless the parties decide otherwise. (8) The concrete procedures of employee transnational information and consultation, as well as, if applicable, participation, to apply to each SCE should be defined primarily by means of an agreement between the parties concerned or, in the absence thereof, through the application of a set of subsidiary rules. (9) Member States should still have the option of not applying the standard rules relating to participation in the case of a merger, given the diversity of national systems for employee involvement. Existing systems and practices of participation where appropriate at the level of participating entities must in that case be maintained by adapting registration rules. (10) The voting rules within the special body representing the employees for negotiation purposes, in particular when concluding agreements providing for a level of participation lower than the one existing within one or more of the participating entities, should be proportionate to the risk of disappearance or reduction of existing systems and practices of participation. That risk is greater in the case of an SCE established by way of transformation or merger than by way of creating an ex novo SCE. (11) In the absence of an agreement subsequent to the negotiation between employees' representatives and the competent organs of the participating entities, provision should be made for certain standard rules to apply to the SCE, once it is established. These standard rules should ensure effective practices of transnational information and consultation of employees, as well as their participation in the relevant organs of the SCE if such participation existed before its establishment within the participating entities. (12) When application of the abovementioned procedures to the entities participating in the ex novo SCE cannot be justified because of their small size as measured in terms of employment, the SCE should be subject to the national rules on the involvement of employees in force in the Member State where it establishes its registered office, or in the Member States where it has subsidiaries or establishments. This should be without prejudice to the obligation placed on an SCE already established to implement these procedures if a significant number of employees so requests. (13) Specific provisions should apply to employee participation in general meetings, in so far as national laws so allow. The application of these provisions does not preclude the application of other forms of participation, as provided for in this Directive. (14) Member States should ensure through appropriate provisions that, in the case of structural changes following the creation of an SCE, the arrangements for the involvement of employees can, where appropriate, be renegotiated. (15) Provision should be made for the employees' representatives acting within the framework of this Directive to enjoy, when exercising their functions, the same protection and guarantees as those provided for employees' representatives by the legislation and/or practice of the country of employment. They should not be subject to any discrimination, including harassment, as a result of the lawful exercise of their activities and should enjoy adequate protection as regards dismissal and other sanctions. (16) The confidentiality of sensitive information should be preserved even after the expiry of the terms of office of the employees' representatives, and provision should be made to allow the competent organ of the SCE to withhold information which would seriously harm, if subject to public disclosure, the functioning of the SCE. (17) Where an SCE and its subsidiaries and establishments are subject to Council Directive 94/45/EC of 22 September 1994 on the establishment of a European Works Council or a procedure in Community-scale undertakings and Community-scale groups of undertakings for the purposes of informing and consulting employees(5), the provisions of that Directive and the provisions transposing it into national legislation should not apply to it nor to its subsidiaries and establishments, unless the special negotiating body decides not to open negotiations or to terminate negotiations already opened. (18) This Directive should not affect other existing rights regarding involvement and need not affect other existing representation structures, provided for by Community and national laws and practices. (19) Member States should take appropriate measures in the event of failure to comply with the obligations laid down in this Directive. (20) The Treaty has not provided the necessary powers for the Community to adopt this Directive, other than those provided for in Article 308. (21) It is a fundamental principle and stated aim of this Directive to secure employees' acquired rights as regards involvement in company decisions. Employee rights in force before the establishment of SCEs should provide the basis for employee rights of involvement in the SCE (the "before and after" principle). Consequently, that approach should apply not only to the initial establishment of an SCE but also to structural changes in an existing SCE and to the entities affected by structural change processes. Therefore, where the registered office of an SCE is transferred from one Member State to another, at least the same level of employee involvement rights should continue to apply. Further, if the threshold concerning employee involvement is reached or exceeded after the registration of an SCE, these rights should apply in the same manner in which they would have applied, had the threshold been reached or exceeded before registration. (22) Member States may provide that representatives of trade unions may be members of a special negotiating body regardless of whether they are employees of an entity participating in the establishment of an SCE. Member States should in this context in particular be able to introduce this right in cases where trade union representatives have the right to be members of, and to vote in, supervisory or administrative company organs in accordance with national legislation. (23) In several Member States, employee involvement and other areas of industrial relations are based on both national legislation and practice which in this context is understood also to cover collective agreements at various national, sectorial and/or company levels, SECTION I GENERAL Article 1 Objective 1. This Directive governs the involvement of employees in the affairs of European Cooperative Societies (hereinafter referred to as SCEs), as referred to in Regulation (EC) No 1435/2003. 2. To this end, arrangements for the involvement of employees shall be established in every SCE in accordance with the negotiating procedure referred to in Articles 3 to 6 or, under the circumstances specified in Articles 7 and 8, in accordance with the Annex. Article 2 Definitions For the purposes of this Directive: (a) "SCE" means any cooperative society established in accordance with Regulation (EC) No 1435/2003; (b) "participating legal entities" means companies and firms within the meaning of the second paragraph of Article 48 of the Treaty, including cooperatives, as well as legal bodies formed under, and governed by, the law of a Member State, directly participating in the establishing of an SCE; (c) "subsidiary" of a participating legal entity or of an SCE means an undertaking over which that legal entity or SCE exercises a dominant influence defined in accordance with Article 3(2) to (7) of Directive 94/45/EC; (d) "concerned subsidiary or establishment" means a subsidiary or establishment of a participating legal entity which is proposed to become a subsidiary or establishment of the SCE upon its formation; (e) "employees' representatives" means the employees' representatives provided for by national law and/or practice; (f) "representative body" means the body representative of the employees set up by the agreements referred to in Article 4 or in accordance with the provisions of the Annex, with the purpose of informing and consulting the employees of an SCE and its subsidiaries and establishments situated in the Community and, where applicable, of exercising participation rights in relation to the SCE; (g) "special negotiating body" means the body established in accordance with Article 3 to negotiate with the competent organ of the participating legal entities regarding the establishment of arrangements for the involvement of employees within the SCE; (h) "involvement of employees" means any mechanism, including information, consultation and participation, through which employees' representatives may exercise an influence on decisions to be taken within an undertaking; (i) "information" means the informing of the body representative of the employees and/or the employees' representatives by the competent organ of the SCE on questions which concern the SCE itself and any of its subsidiaries or establishments situated in another Member State or which exceed the powers of the decision-making organs in a single Member State at a time, in a manner and with a content which allows the employees' representatives to undertake an in-depth assessment of the possible impact and, where appropriate, prepare consultations with the competent organ of the SCE; (j) "consultation" means the establishment of dialogue and exchange of views between the body representative of the employees and/or the employees' representatives and the competent organ of the SCE, at a time, in a manner and with a content which allows the employees' representatives, on the basis of information provided, to express an opinion on measures envisaged by the competent organ which may be taken into account in the decision-making process within the SCE; (k) "participation" means the influence of the body representative of the employees and/or the employees' representatives in the affairs of a legal entity by way of: - the right to elect or appoint some of the members of the legal entity's supervisory or administrative organ, or - the right to recommend and/or oppose the appointment of some or all of the members of the legal entity's supervisory or administrative organ. SECTION II NEGOTIATING PROCEDURE APPLICABLE TO SCEs ESTABLISHED BY AT LEAST TWO LEGAL ENTITIES OR BY TRANSFORMATION Article 3 Creation of a special negotiating body 1. Where the management or administrative organs of participating legal entities draw up a plan for the establishment of an SCE, they shall as soon as possible take the necessary steps, including providing information on the identity of the participating legal entities and subsidiaries or establishments, as well as the number of their employees, to start negotiations with the representatives of the legal entities' employees on arrangements for the involvement of employees in the SCE. 2. For this purpose, a special negotiating body representative of the employees of the participating legal entities and concerned subsidiaries or establishments shall be created in accordance with the following provisions: (a) in electing or appointing members of the special negotiating body, it shall be ensured: (i) that such members are elected or appointed in proportion to the number of employees employed in each Member State by the participating legal entities and concerned subsidiaries or establishments, by allocating in respect of a Member State one seat per each portion of employees employed in that Member State which equals 10 %, or a fraction thereof, of the number of employees employed in all the Member States taken together; (ii) that in the case of an SCE formed by way of merger, there are such further additional members from each Member State as may be necessary in order to ensure that the special negotiating body includes at least one member representing each participating cooperative which is registered and has employees in that Member State and which it is proposed will cease to exist as a separate legal entity following the registration of the SCE, insofar as: - the number of such additional members does not exceed 20 % of the number of members designated by virtue of point (i); and - the composition of the special negotiating body does not entail a double representation of the employees concerned. If the number of such cooperatives is higher than the number of additional seats available pursuant to the first subparagraph, these additional seats shall be allocated to cooperatives in different Member States by decreasing order of the number of employees they employ. (b) Member States shall determine the method to be used for the election or appointment of the members of the special negotiating body who are to be elected or appointed in their territories. They shall take the necessary measures to ensure that, as far as possible, such members shall include at least one member representing each participating legal entity which has employees in the Member State concerned. Such measures must not increase the overall number of members. The methods used to nominate, appoint or elect employee representatives should seek to promote gender balance. Member States may provide that such members may include representatives of trade unions whether or not they are employees of a participating legal entity or concerned subsidiary or establishment. Without prejudice to national legislation and/or practice laying down thresholds for the establishing of a representative body, Member States shall provide that employees in undertakings or establishments in which there are no employees' representatives through no fault of their own have the right to elect or appoint members of the special negotiating body. 3. The special negotiating body and the competent organs of the participating legal entities shall determine, by written agreement, arrangements for the involvement of employees within the SCE. To this end, the competent organs of the participating legal entities shall inform the special negotiating body of the plan and the actual process of establishing the SCE, up to its registration. 4. Subject to paragraph 6, the special negotiating body shall take decisions by an absolute majority of its members, provided that such a majority also represents an absolute majority of the employees. Each member shall have one vote. However, should the result of the negotiations lead to a reduction of participation rights, the majority required for a decision to approve such an agreement shall be the votes of two thirds of the members of the special negotiating body representing at least two thirds of the employees, including the votes of members representing employees employed in at least two Member States, - in the case of an SCE to be established by way of merger, if participation covers at least 25 % of the overall number of employees of the participating cooperatives, or - in the case of an SCE to be established by any other way, if participation covers at least 50 % of the overall number of employees of the participating legal entities. Reduction of participation rights means a proportion of members of the organs of the SCE within the meaning of Article 2(k), which is lower than the highest proportion existing within the participating legal entities. 5. For the purpose of the negotiations, the special negotiating body may request experts of its choice, for example representatives of appropriate Community level trade union organisations, to assist it with its work. Such experts may be present at negotiation meetings in an advisory capacity at the request of the special negotiating body, where appropriate to promote coherence and consistency at Community level. The special negotiating body may decide to inform the representatives of appropriate external organisations, including trade unions, of the start of the negotiations. 6. The special negotiating body may decide by the majority set out in the second subparagraph not to open negotiations or to terminate negotiations already opened, and to rely on the rules on information and consultation of employees in force in the Member States where the SCE has employees. Such a decision shall stop the procedure to conclude the agreement referred to in Article 4. Where such a decision has been taken, none of the provisions of the Annex shall apply. The majority required to decide not to open or to terminate negotiations shall be the votes of two thirds of the members representing at least two thirds of the employees, including the votes of members representing employees employed in at least two Member States. In the case of an SCE established by way of transformation, this paragraph shall not apply if there is participation in the cooperative to be transformed. The special negotiating body shall be reconvened at the written request of at least 10 % of the employees of the SCE, its subsidiaries and establishments, or their representatives, at the earliest two years after the abovementioned decision, unless the parties agree to negotiations being reopened sooner. If the special negotiating body decides to reopen negotiations with the management but no agreement is reached as a result of those negotiations, none of the provisions of the Annex shall apply. 7. Any expenses relating to the functioning of the special negotiating body and, in general, to negotiations shall be borne by the participating legal entities so as to enable the special negotiating body to carry out its task in an appropriate manner. In compliance with this principle, Member States may lay down budgetary rules regarding the operation of the special negotiating body. They may in particular limit the funding to cover one expert only. Article 4 Content of the agreement 1. The competent organs of the participating legal entities and the special negotiating body shall negotiate in a spirit of cooperation with a view to reaching an agreement on arrangements for the involvement of the employees within the SCE. 2. Without prejudice to the autonomy of the parties, and subject to paragraph 4, the agreement referred to in paragraph 1 between the competent organs of the participating legal entities and the special negotiating body shall specify: (a) the scope of the agreement; (b) the composition, number of members and allocation of seats on the representative body which will be the discussion partner of the competent organ of the SCE in connection with arrangements for the information and consultation of the employees of the SCE and its subsidiaries and establishments; (c) the functions and the procedure for the information and consultation of the representative body; (d) the frequency of meetings of the representative body; (e) the financial and material resources to be allocated to the representative body; (f) if, during negotiations, the parties decide to establish one or more information and consultation procedures instead of a representative body, the arrangements for implementing those procedures; (g) if, during negotiations, the parties decide to establish arrangements for participation, the substance of those arrangements including (if applicable) the number of members in the SCE's administrative or supervisory body which the employees will be entitled to elect, appoint, recommend or oppose, the procedures as to how these members may be elected, appointed, recommended or opposed by the employees, and their rights; (h) the date of entry into force of the agreement and its duration, cases where the agreement should be renegotiated and the procedure for its renegotiation, including, where appropriate, in the event of structural changes in the SCE and its subsidiaries and establishments which occur after the creation of the SCE. 3. The agreement shall not, unless provision is made otherwise therein, be subject to the standard rules referred to in the Annex. 4. Without prejudice to Article 15(3)(a), in the case of an SCE established by means of transformation, the agreement shall provide for at least the same level of all elements of employee involvement as the ones existing within the cooperative to be transformed into an SCE. 5. The agreement may specify the arrangements for the entitlement of employees to participate in the general meetings or in the section or sectorial meetings in accordance with Article 9 of this Directive and Article 59(4) of Regulation (EC) No 1435/2003. Article 5 Duration of negotiations 1. Negotiations shall commence as soon as the special negotiating body is established and may continue for six months thereafter. 2. The parties may decide, by joint agreement, to extend negotiations beyond the period referred to in paragraph 1, up to a total of one year from the establishment of the special negotiating body. Article 6 Legislation applicable to the negotiation procedure Except where otherwise provided in this Directive, the legislation applicable to the negotiation procedure provided for in Articles 3, 4 and 5 shall be the legislation of the Member State in which the registered office of the SCE is to be situated. Article 7 Standard rules 1. In order to achieve the objective described in Article 1, Member States shall lay down standard rules on employee involvement which must satisfy the provisions set out in the Annex. The standard rules as laid down by the legislation of the Member State in which the registered office of the SCE is to be situated shall apply from the date of the registration of the SCE where either: (a) the parties so agree; or (b) by the deadline laid down in Article 5, no agreement has been concluded, and: - the competent organ of each of the participating legal entities decides to accept the application of the standard rules in relation to the SCE and so to continue with its registration of the SCE, and - the special negotiating body has not taken the decision provided in Article 3(6). 2. Moreover, the standard rules fixed by the national legislation of the Member State of registration in accordance with part 3 of the Annex shall apply only: (a) in the case of an SCE established by transformation, if the rules of a Member State relating to employee participation in the administrative or supervisory body applied to a cooperative transformed into an SCE; (b) in the case of an SCE established by merger: - if, before registration of the SCE, one or more forms of participation applied in one or more of the participating cooperatives covering at least 25 % of the total number of employees employed by them, or - if, before registration of the SCE, one or more forms of participation applied in one or more of the participating cooperatives covering less than 25 % of the total number of employees employed by them and if the special negotiating body so decides; (c) in the case of an SCE established by any other way; - if, before registration of the SCE, one or more forms of participation applied in one or more of the participating legal entities covering at least 50 % of the total number of employees employed by them; or - if, before registration of the SCE, one or more forms of participation applied in one or more of the participating legal entities covering less than 50 % of the total number of employees employed by them and if the special negotiating body so decides. If there was more than one form of participation within the various participating legal entities, the special negotiating body shall decide which of those forms must be established in the SCE. Member States may fix the rules which are applicable in the absence of any decision on the matter for an SCE registered in their territory. The special negotiating body shall inform the competent organs of the participating legal entities of any decisions taken pursuant to this paragraph. 3. Member States may lay down that the standard rules referred to in Part 3 of the Annex shall not apply in the case provided for in paragraph 2(b). SECTION III RULES APPLICABLE TO SCEs ESTABLISHED EXCLUSIVELY BY NATURAL PERSONS OR BY A SINGLE LEGAL ENTITY AND NATURAL PERSONS Article 8 1. In the case of an SCE established exclusively by natural persons or by a single legal entity and natural persons, which together employ at least 50 employees in at least two Member States, the provisions of Articles 3 to 7 shall apply. 2. In the case of an SCE established exclusively by natural persons or by a single legal entity and natural persons, which together employ fewer than 50 employees, or employ 50 or more employees in only one Member State, employee involvement shall be governed by the following: - in the SCE itself, the provisions of the Member State of the SCE's registered office, which are applicable to other entities of the same type, shall apply, - in its subsidiaries and establishments, the provisions of the Member State where they are situated, and which are applicable to other entities of the same type, shall apply. In the case of transfer from one Member State to another of the registered office of an SCE governed by participation, at least the same level of employee participation rights shall continue to apply. 3. If, after the registration of an SCE referred to in paragraph 2, at least one third of the total number of employees of the SCE and its subsidiaries and establishments in at least two different Member States so requests, or if the total number of employees reaches or exceeds 50 employees in at least two Member States, the provisions of Articles 3 to 7 shall be applied, mutatis mutandis. In this case, the words "participating legal entities" and "concerned subsidiaries or establishments" shall be replaced by the words "SCE" and "subsidiaries or establishments of the SCE" respectively. SECTION IV PARTICIPATION IN THE GENERAL MEETING OR SECTION OR SECTORIAL MEETING Article 9 Subject to the limits laid down in Article 59(4) of Regulation (EC) No 1435/2003, the employees of the SCE and/or their representatives will be entitled to participate in the general meeting or, if it exists, in the section or sectorial meeting, with the right to vote, in the following circumstances: 1. when the parties so decide in the agreement referred to in Article 4, or 2. when a cooperative governed by such a system transforms itself into an SCE, or 3. when, in the case of an SCE established by means other than transformation, a participating cooperative was governed by such a system and: (i) the parties cannot reach agreement, as referred to in Article 4, by the deadline laid down in Article 5; and (ii) Article 7(1)(b) and Part 3 of the Annex apply; and (iii) the participating cooperative governed by such a system has the highest proportion of participation, within the meaning of Article 2(k), in force in the participating cooperatives concerned before registration of the SCE. SECTION V MISCELLANEOUS PROVISIONS Article 10 Reservation and confidentiality 1. Member States shall provide that members of the special negotiating body or the representative body, and experts who assist them, are not authorised to reveal any information which as been given to them in confidence. The same shall apply to employees' representatives in the context of an information and consultation procedure. This obligation shall continue to apply, wherever the persons referred to may be, even after the expiry of their terms of office. 2. Each Member State shall provide, in specific cases and under the conditions and limits laid down by national legislation, that the supervisory or administrative organ of an SCE or of a participating legal entity established in its territory is not obliged to transmit information where its nature is such that, according to objective criteria, to do so would seriously harm the functioning of the SCE (or, as the case may be, a participating legal entity) or its subsidiaries and establishments or would be prejudicial to them. A Member State may make such dispensation subject to prior administrative or judicial authorisation. 3. Each Member State may lay down particular provisions for SCEs in its territory which pursue directly and essentially the aim of ideological guidance with respect to information and the expression of opinions, on condition that, on the date of adoption of this Directive, such provisions already exist in the national legislation. 4. In applying paragraphs 1, 2 and 3, Member States shall make provision for administrative or judicial appeal procedures which the employees' representatives may initiate when the supervisory or administrative organ of an SCE or of a participating legal entity demands confidentiality or does not give information. Such procedures may include arrangements designed to protect the confidentiality of the information in question. Article 11 Operation of the representative body and procedure for the information and consultation of employees The competent organ of the SCE and the representative body shall work together in a spirit of cooperation with due regard for their reciprocal rights and obligations. The same shall apply to cooperation between the supervisory or administrative organ of the SCE and the employees' representatives in conjunction with a procedure for the information and consultation of employees. Article 12 Protection of employees' representatives The members of the special negotiating body, the members of the representative body, any employees' representatives exercising functions under the information and consultation procedure and any employees' representatives in the supervisory or administrative organ of an SCE who are employees of the SCE, its subsidiaries or establishments or of a participating legal entity shall, in the exercise of their functions, enjoy the same protection and guarantees provided for employees' representatives by the national legislation and/or practice in force in their country of employment. This shall apply in particular to attendance at meetings of the special negotiating body or representative body, any other meeting under the agreement referred to in Article 4(2)(f) or any meeting of the administrative or supervisory organ, and to the payment of wages for members employed by a participating legal entity or the SCE or its subsidiaries or establishments during a period of absence necessary for the performance of their duties. Article 13 Misuse of procedures Member States shall take appropriate measures in conformity with Community law with a view to preventing the misuse of an SCE for the purpose of depriving employees of rights to employee involvement or withholding such rights. Article 14 Compliance with this Directive 1. Each Member State shall ensure that the management of establishments of an SCE and the supervisory or administrative organs of subsidiaries and of participating legal entities which are situated within its territory and the employees' representatives or, as the case may be, the employees themselves abide by the obligations laid down by this Directive, regardless of whether or not the SCE has its registered office within its territory. 2. Member States shall provide for appropriate measures in the event of failure to comply with this Directive; in particular they shall ensure that administrative or legal procedures are available to enable the obligations deriving from this Directive to be enforced. Article 15 Link between this Directive and other provisions 1. Where an SCE is a Community-scale undertaking or a controlling undertaking of a Community-scale group of undertakings within the meaning of Directive 94/45/EC or of Council Directive 97/74/EC of 15 December 1997 extending the said Directive to the United Kingdom(6), the provisions of these Directives and the provisions transposing them into national legislation shall not apply to them or to their subsidiaries. However, where the special negotiating body decides in accordance with Article 3(6) not to open negotiations or to terminate negotiations already opened, Directive 94/45/EC or Directive 97/74/EC and the provisions transposing them into national legislation shall apply. 2. Provisions on the participation of employees in company bodies provided for by national legislation and/or practice, other than those implementing this Directive, shall not apply to the SCEs to which Articles 3 to 7 apply. 3. This Directive shall not prejudice: (a) the existing rights to involvement of employees provided for by national legislation and/or practice in the Member States as enjoyed by employees of the SCE and its subsidiaries and establishments, other than participation in the bodies of the SCE; (b) the provisions on participation in the bodies laid down by national legislation and/or practice applicable to the subsidiaries of the SCE or to SCEs to which Articles 3 to 7 do not apply. 4. In order to preserve the rights referred to in paragraph 3, Member States may take the necessary measures to guarantee that the structures of employee representation in participating legal entities which will cease to exist as separate legal entities are maintained after the registration of the SCE. Article 16 Final provisions 1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive no later than 18 August 2006, or shall ensure by that date at the latest that management and labour introduce the required provisions by way of agreement, the Member States being obliged to take all necessary steps enabling them at all times to guarantee the results imposed by this Directive. They shall forthwith inform the Commission thereof. 2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 17 Review by the Commission Not later than 18 August 2009, the Commission shall, in consultation with the Member States and with management and labour at Community level, review the application of applying this Directive, with a view to proposing suitable amendments to the Council where necessary. Article 18 Entry into force This Directive shall enter into force on the date of its publication in the Official Journal of the European Union. Article 19 Addressees This Directive is addressed to the Member States.

32003L0073

2003

Commission Directive 2003/73/EC of 24 July 2003 amending Annex III to Directive 1999/94/EC of the European Parliament and of the Council (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 1999/94/EC of the European Parliament and of the Council of 13 December 1999 relating to the availability of consumer information on fuel economy and CO2 emissions in respect of the marketing of new passenger cars(1), and in particular Article 9 thereof, Whereas: (1) Annex III to Directive 1999/94/EC lays down a format for a poster which has to be exhibited at any point of sale of new passenger cars. (2) Provision should be made for the use of modern communication tools (electronic display), and to prevent the use of poster updating techniques which are less consumer-friendly. (3) Annex III to Directive 1999/94/EC should therefore be amended accordingly. (4) Consumer organisations and interested parties have been consulted. (5) The measures provided for in this Directive are in accordance with the opinion of the Committee established under Article 10 of Directive 1999/94/EC, Article 1 Annex III to Directive 1999/94/EC is replaced by the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within one year of publication in the Official Journal of the European Union. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such a reference shall be adopted by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0078

2003

Commission Directive 2003/78/EC of 11 August 2003 laying down the sampling methods and the methods of analysis for the official control of the levels of patulin in foodstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption(1), and in particular Article 1 thereof, Whereas: (1) Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs(2), as last amended by Commission Regulation (EC) No 1425/2003(3) fixes maximum limits for patulin in certain foodstuffs. (2) Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs(4) introduces a system of quality standards for laboratories entrusted by the Member States with the official control of foodstuffs. (3) It seems necessary to fix general criteria, which the method of analysis has to comply with in order to ensure that laboratories, in charge of the control, use methods of analysis with comparable levels of performance. It is also of major importance that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised enforcement approach across the European Union. These interpretation rules are of application for the analytical result obtained on the sample for official control. In case of analysis for defence or referee purposes, the national rules apply. (4) The provisions for the sampling and methods of analysis have been drawn up on the basis of present knowledge and they may be adapted to take account of advances in scientific and technological knowledge. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Member States shall take all measures necessary to ensure that the sampling for the official control of the levels of patulin in foodstuffs is carried out in accordance with the methods described in Annex I to this Directive. Article 2 The Member States shall take all measures necessary to ensure that sample preparation and methods of analysis used for the official control of the levels of patulin in foodstuffs comply with the criteria described in Annex II to this Directive. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 September 2004 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32003L0077

2003

Commission Directive 2003/77/EC of 11 August 2003 amending Directives 97/24/EC and 2002/24/EC of the European Parliament and of the Council relating to the type-approval of two- or three-wheel motor vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two- and three-wheel motor vehicles and repealing Council Directive 92/61/EEC(1), and in particular Article 17 thereof, Having regard to Directive 97/24/EC of the European Parliament and of the Council of 17 June 1997 on certain components and characteristics of two- or three-wheel motor vehicles(2), as amended by Directive 2002/51/EC(3), and in particular Article 7 thereof, Whereas: (1) Directive 97/24/EC is one of the separate Directives for the purposes of the EC type-approval procedure laid down by Council Directive 92/61/EEC(4), which is to be repealed by Directive 2002/24/EC with effect from 9 November 2003. (2) Directive 2002/51/EC of the European Parliament and of the Council of 19 July 2002 on the reduction of the level of pollutant emissions from two- and three-wheel motor vehicles and amending Directive 97/24/EC introduced new emission limit values for two-wheel motorcycles. Those limit values are applicable in two stages, the first stage with effect from 1 April 2003 for any type of vehicle and the second stage with effect from 1 January 2006 for new types. For the second stage, the measurement of pollutant emissions from two-wheel motorcycles is based on the use of the elementary urban test cycle laid down in UN-ECE Regulation No 40 and the extra-urban driving cycle laid down in Council Directive 70/220/EEC of 20 March 1970 on the approximation of the laws of the Member States on measures to be taken against air pollution by gases from motor vehicles(5), as last amended by Commission Directive 2002/80/EC(6). (3) Directive 97/24/EC, as amended by Directive 2002/51/EC, specified the Type I test cycle for measuring pollutant emissions from two- and three-wheel motor vehicles. That test cycle should be completed by the Commission, through the Committee for Adaptation to Technical Progress established by Article 13 of Directive 70/156/EEC, and should be applicable from 2006. (4) It is necessary to clarify certain aspects of the Type II test data for annual roadworthiness testing, as required by Directive 2002/51/EC, and to provide for the recording of that test data in Annex VII to Directive 2002/24/EC. (5) Directives 97/24/EC and 2002/24/EC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress, Article 1 Annex II to Chapter 5 of Directive 97/24/EC is amended in accordance with Annex I to this Directive. Article 2 Annex VII to Directive 2002/24/EC is amended in accordance with Annex II to this Directive. Article 3 1. Member States shall adopt and publish, by 4 September 2004 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 4 September 2004. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32003L0079

2003

Commission Directive 2003/79/EC of 13 August 2003 amending Council Directive 91/414/EEC to include Coniothyrium minitans as active substance (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 2003/70/EC(2), and in particular Article 6(1) thereof, Whereas: (1) In accordance with Article 6(2) of Directive 91/414/EEC the German authorities received on 10 September 1997 an application from Prophyta GmbH, hereafter referred to as the applicant, for the inclusion of the active substance Coniothyrium minitans in Annex I to the Directive. Commission Decision 98/676/EC(3) confirmed that the dossier was "complete" in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. (2) For this active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The nominated rapporteur Member State submitted a draft assessment report concerning the substance to the Commission on 13 March 2000. (3) The draft assessment report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 4 July 2003 in the format of the Commission review report for Coniothyrium minitans. (4) The review did not reveal any open questions or concerns, which would have required a consultation of the European Food Safety Authority. (5) It has appeared from the various examinations made that plant protection products containing Coniothyrium minitans may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC in the light of Article 5(3) thereof, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include this active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive. (6) Although the Uniform Principles have still to be adopted for micro-organisms, it is appropriate that the Member States should apply the general provisions of Article 4 of the Directive when granting authorisations. It is appropriate to provide that the finalised review report, except for confidential information within the meaning of Article 14 of Directive 91/414/EEC, is kept available or made available by the Member States for consultation by any interested parties. (7) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing Coniothyrium minitans and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC. (8) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 30 June 2004 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 July 2004. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall review the authorisation for each plant protection product containing Coniothyrium minitans to ensure that the conditions relating to this active substance set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw authorisations in accordance with Directive 91/414/EEC by 30 June 2004 at the latest. 2. For each authorised plant protection product containing Coniothyrium minitans as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 December 2004 at the latest, Member States shall re-evaluate the product on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 30 June 2005 at the latest, they shall amend or withdraw the authorisation for each such plant protection product. Article 4 This Directive shall enter into force on 1 January 2004. Article 5 This Directive is addressed to the Member States.

32003L0081

2003

Commission Directive 2003/81/EC of 5 September 2003 amending Council Directive 91/414/EEC to include molinate, thiram and ziram as active substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 2003/79/EC(2), and in particular Article 6(1) thereof, Whereas: (1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market(3), as last amended by Regulation (EC) No 2266/2000(4), establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes molinate, thiram and ziram. (2) For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92(5), as last amended by Regulation (EC) No 2230/95(6), the following rapporteur Member States were designated, which in turn submitted the relevant assessment reports and recommendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92. For molinate the rapporteur Member State was Portugal, and all relevant information was submitted on 30 November 1998. For thiram the Rapporteur Member State was Belgium, and the relevant information was submitted on 15 January 1998. For ziram the rapporteur Member State was Belgium and the relevant information was submitted on 9 June 1998. (3) Those assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. (4) The reviews of all active substances were finalised on 4 July 2003 in the format of the Commission review reports for molinate, thiram and ziram. (5) The reviews of molinate, thiram and ziram did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants. (6) It has appeared from the various examinations made that plant protection products containing molinate, thiram or ziram may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive. (7) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will resulting from the inclusion. (8) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive 91/414/EEC as regards plant protection products containing molinate, thiram or ziram, and in particular, to review existing authorisations to ensure that the conditions regarding those active substances set out in Annex I to Directive 91/414/EEC are satisfied. A longer period should be provided for the submission and assessment of the complete dossier of each plant protection product in accordance with the uniform principles laid down in Directive 91/414/EEC. (9) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 31 January 2005 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 February 2005. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall review the authorisation for each plant protection product containing molinate, thiram or ziram to ensure that the conditions relating to those active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary and by 31 January 2005 at the latest, they shall amend or withdraw the authorisation. 2. Member States shall, for each authorised plant protection product containing molinate, thiram or ziram as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 July 2004 at the latest, re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 31 July 2008 at the latest, they shall amend or withdraw the authorisation. Article 4 This Directive shall enter into force on 1 August 2004. Article 5 This Directive is addressed to the Member States.

32003L0074

2003

Directive 2003/74/EC of the European Parliament and of the Council of 22 September 2003 amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Article 3(a) of Directive 96/22/EC(4) requires Member States to prohibit the administration to farm animals of substances having, inter alia, an oestrogenic, androgenic or gestagenic action. Nevertheless administration of those substances to farm animals may be authorised but only if they are used for therapeutic purposes or zootechnical treatment, in accordance with the provisions of Articles 4, 5 and 7 of that Directive. (2) Article 11(2) of Directive 96/22/EC requires Member States to prohibit the importation from third countries of farm or aquaculture animals to which substances or products referred to in Article 3(a) of that Directive have been administered, unless those products were administered in compliance with the provisions and requirements laid down in Articles 4, 5 and 7 thereof, as well as of meat or products obtained from animals the importation of which is prohibited. (3) In the light of the results of a dispute settlement case brought before the World Trade Organisation (WTO) by the United States of America and by Canada (the Hormones case)(5) and recommendations made in that respect by the WTO Dispute Settlement Body on 13 February 1998, the Commission immediately initiated a complementary risk assessment, in accordance with the requirements of the Agreement on the application of sanitary and phytosanitary measures (WTO-GATT)(6) as interpreted by the appellate body in the Hormones case, of the six hormonal substances (oestradiol 17ß, testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate) whose administration for animal growth promotion purposes is prohibited by Directive 96/22/EC. (4) In parallel, the Commission initiated and funded a number of specific scientific studies and research projects on these six hormones in order to obtain as much as possible of the missing scientific information, as identified in the interpretations and findings of the WTO panel and appellate body reports in the Hormones case. Moreover, the Commission addressed specific requests to the USA, Canada and other third countries, which authorise the use of these six hormones for animal growth promotion, and published an open call for documentation(7) requesting any interested party, including the industry, to provide any relevant and recent scientific data and information in their possession to be taken into account in the complementary risk assessment. (5) On 30 April 1999, as requested by the Commission, the Scientific Committee on Veterinary Measures relating to Public Health (SCVPH) issued an opinion concerning the assessment of potential adverse effects to human health from hormone residues in bovine meat and meat products. The major conclusions of that opinion were, first, that, as concerns excess intake of hormone residues and their metabolites, and in view of the intrinsic properties of hormones and the epidemiological findings, a risk to the consumer has been identified with different levels of conclusive evidence for the six hormones evaluated. Secondly, for the six hormones endocrine, developmental, immunological, neurobiological, immunotoxic, genotoxic and carcinogenic effects could be envisaged and, of the various susceptible risk groups, prepubertal children constitute the group of greatest concern and, third, in view of the intrinsic properties of the hormones and taking into account epidemiological findings, no threshold levels and, therefore, no acceptable daily intake (ADI) can be established for any of the six hormones evaluated when they are administered to bovine animals for growth promotion purposes. (6) As regards, in particular, the use of oestradiol 17ß, with the aim of promoting growth, the SCVPH assessment is that a substantial body of recent evidence suggests that it has to be considered as a complete carcinogen, as it exerts both tumour-initiating and tumour-promoting effects and that the data currently available do not make it possible to give a quantitative estimate of the risk. (7) As regards the other five hormones (testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate), the SCVPH assessment is that, in spite of the individual toxicological and epidemiological data available, which were taken into account, the current state of knowledge does not make it possible to give a quantitative estimate of the risk to consumers. (8) Subsequent to the opinion of the SCVPH of 30 April 1999, new and more recent scientific information on some of the six hormones under consideration was made available to the Commission from the United Kingdom's Veterinary Products Committee, in October 1999, the Committee on Veterinary Medicinal Products of the European Community (CVM), in December 1999, and the Joint FAO/WHO Expert Committee on Food Additives (JECFA), in February 2000. The CVM has noted in particular that oestradiol 17ß has a carcinogenic effect only after prolonged exposure and at levels which are considerably higher than those needed for a physiological (oestrogenic) response. All this latest scientific information was brought to the attention of the SCVPH, which reviewed it and, on 3 May 2000, concluded that it did not provide convincing data and arguments requiring revision of the conclusions drawn in its opinion of 30 April 1999. The SCVPH confirmed in its opinion of 10 April 2002 the validity of its previous opinion, after revising it in the light of the most recent scientific data. (9) As regards, in particular, oestradiol 17ß, this substance can potentially be used in all farm animals and residue intake for all segments of the human population and in particular the susceptible groups at high risk can therefore be especially relevant. The avoidance of such intake is of absolute importance to safeguard human health. Furthermore, the routine use of the above substances for animal growth promotion purposes is likely to lead to increased concentration of those substances in the environment. (10) Taking into account the results of the risk assessment and all other available pertinent information, it has to be concluded that, in order to achieve the chosen level of protection in the Community from the risks posed, in particular to human health, by the routine use of these hormones for growth promotion and the consumption of residues found in meat derived from animals to which these hormones have been administered for growth promotion, it is necessary to maintain the permanent prohibition laid down in Directive 96/22/EC on oestradiol 17ß and to continue provisionally to apply the prohibition to the other five hormones (testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate). Furthermore, according to Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(8), the provisional prohibition of these five hormones should apply while the Community seeks more complete scientific information from any source, which could shed light and clarify the gaps in the present state of knowledge of these substances. (11) However, the use of certain of the above substances, where this is necessary, for therapeutic purposes or zootechnical treatment may continue to be authorised as it is not likely to constitute a hazard for public health owing to the nature and the limited duration of the treatments, the limited quantities administered and the strict conditions laid down in Directive 96/22/EC in order to prevent any possible misuse. (12) However, in the light of the existing information it is appropriate to limit as far the exposure to oestradiol 17ß and only authorise those treatments for which no viable effective alternatives exist. In general, there are alternative treatments or strategies available to replace most of the uses of oestradiol 17ß for therapeutic or zootechnical purposes. Nonetheless, studies appear to show that at present no viable effective alternatives exist in all the Member States for certain treatments which are currently authorised. In order to allow for the necessary adjustments and in particular for the authorisation or the mutual recognition of the pharmaceutical products needed, it is appropriate to phase out the use of oestradiol 17ß for oestrus induction over a given period. It is also appropriate to maintain the possibility of authorising, under strict and verifiable conditions so as to prevent any possible misuse and any unacceptable risk for public health, its use for the treatment of certain conditions (foetus maceration or mummification and pyometra in cattle) which have serious consequences for animal health and welfare. It is necessary to review this possibility within a given time. (13) The proposed amendments to Directive 96/22/EC are necessary to achieve the chosen level of health protection from the residues in meat of farm animals treated with these hormones for growth promotion purposes, whilst respecting the general principles of food law set out in Regulation (EC) No 178/2002 and the international obligations of the Community. Moreover, there is no other means that is reasonably available at present, taking into account technical and economic feasibility, which is significantly less restrictive of trade and can achieve equally effectively the chosen level of health protection. In addition, minor drafting amendments are equally necessary in particular in view of the replacement of a number of Directives by Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(9), Article 1 Directive 96/22/EC is hereby amended as follows: 1. Articles 2 and 3 are replaced by the following: "Article 2 Member States shall prohibit: (a) the placing on the market of the substances listed in Annex II, list A, for administering to animals of all species; (b) the placing on the market of the substances listed in Annex II, list B, for administering to animals, the flesh and products of which are intended for human consumption, for purposes other than those provided for in point 2 of Article 4 and in Article 5a. Article 3 Member States shall prohibit, for substances listed in Annex II, and shall provisionally prohibit, for substances listed in Annex III: (a) the administering of those substances to farm or aquaculture animals, by any means whatsoever; (b) - the holding, except under official control, of animals referred to in point (a) on a farm, and - the placing on the market or the slaughter for human consumption of farm animals, which contain the substances referred to in Annex II and Annex III or in which the presence of such substances has been established, unless proof can be given that the animals in question have been treated in accordance with Articles 4, 5 or 5a; (c) the placing on the market for human consumption of aquaculture animals to which substances referred to above have been administered and of processed products derived from such animals; (d) the placing on the market of meat from animals referred to in point (b); (e) the processing of the meat referred to in (d)." 2. in Article 4, point 1, "oestradiol 17ß" are deleted; 3. in Article 5, first paragraph, the first sentence is replaced by the following:"Notwithstanding Article 3(a) and without prejudice to Article 2, Member States may authorise the administering to farm animals, for the purpose of zootechnical treatment, of veterinary medicinal products having an oestrogenic (other than oestradiol 17ß and its ester-like derivatives), androgenic or gestagenic action which are authorised in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(10)." 4. the following Article is added: "Article 5a 1. Notwithstanding Article 3(a) and without prejudice to Articles 2 and 11a, Member States may authorise the administering to farm animals of veterinary medicinal products containing oestradiol 17ß or its ester-like derivatives for: - the treatment of foetus maceration or mummification in cattle, or - the treatment of pyometra in cattle, in accordance with Directive 2001/82/EC. 2. Notwithstanding Article 3(a) and without prejudice to Article 2, Member States may authorise the administering to farm animals of veterinary medicinal products containing oestradiol 17ß or its ester-like derivatives for oestrus induction in cattle, horses, sheep or goats until 14 October 2006, in accordance with Directive 2001/82/EC. 3. The treatment must be carried out by the veterinarian himself or herself on farm animals which have been clearly identified. This treatment must be registered by the veterinarian responsible. The latter must record at least the following details in a register, which may be that provided for in Directive 2001/82/EC: - the type of product administered, - the nature of the treatment, - the date of treatment, - the identity of the animals treated, - the date of expiry of the withdrawal period. The register must be made available to the competent authority at its request. Stockfarmers shall be prohibited from holding on their farms veterinary medicinal products containing oestradiol 17ß or its ester-like derivatives." 5. Article 6(1) is replaced by the following: "1. Hormonal products and beta-agonists the administration of which to farm animals is authorised in accordance with Articles 4, 5 or 5a must meet the requirements of Directive 2001/82/EC." 6. Article 7(1), first subparagraph, is replaced by the following: "1. For the purpose of trade, Member States may authorise the placing on the market of animals for breeding and breeding animals at the end of their reproductive life which, during the latter period, have undergone a treatment referred to in Articles 4, 5 or 5a and may authorise the affixing of the Community stamp to meat from such animals where the conditions laid down in Articles 4, 5 or 5a and the withdrawal periods provided for in the authorisation to place on the market are complied with." 7. Article 8 is amended as follows: (a) point 1 is replaced by the following: "1. at the time of the import, manufacture, storage, distribution, sale and use of the substances referred to in Articles 2 and 3, their possession is restricted to the persons authorised by national legislation in accordance with Article 68 of Directive 2001/82/EC." (b) in point 2(a), "Article 2" is replaced by "Articles 2 and 3"; (c) in point 2(d), "in Articles 4 and 5" is replaced by "in Articles 4, 5 and 5a"; (d) footnote 2 is deleted and footnote 3 becomes footnote 2; 8. Article 11(2)(a) is amended as follows: (a) in point (i), "point (a) of Article 2" is replaced by "Annex II, List A,"; (b) point (ii) is replaced by the following: "(ii) to which substances referred to in Annex II, List B, and Annex III have been administered, unless those substances were administered in compliance with the provisions and requirements laid down in Articles 4, 5, 5a and 7 and the withdrawal periods allowed in international recommendations have been observed;" 9. the following Article is added: "Article 11a The Commission shall present within two years from 14 October 2003 to the European Parliament and to the Council, a report on the availability of alternative veterinary medicinal products to those containing oestradiol 17ß or its ester-like derivatives for the treatment of foetus maceration or mummification in cattle, and for the treatment of pyometra in cattle, and present to them the following year any necessary proposals intending to replace these substances in due time. Likewise, with regard to the substances listed in Annex III, the Commission shall seek additional information, taking into account recent scientific data from all possible sources, and keep the measures applied under regular review with a view to timely presentation to the European Parliament and to the Council of any necessary proposals." 10. the following Article is added: "Article 14a Notwithstanding Articles 3 and 5a, and without prejudice to Article 2, farm animals for which it can be certified that they have been administered oestradiol 17ß or its ester-like derivatives for therapeutic or zootechnical purposes prior to 14 October 2004 shall be subject to the same provisions as those laid down for the substances authorised in accordance with Article 4(1) as regards therapeutic use and Article 5 as regards zootechnical use." 11. all references to "Directive 81/851/EEC" and "Directive 81/852/EEC" are construed as references to "Directive 2001/82/EC"; 12. the Annex to Directive 96/22/EC become "Annex I", and Annexes II and III in the Annex to this Directive are added. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 14 October 2004 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0084

2003

Commission Directive 2003/84/EC of 25 September 2003 amending Council Directive 91/414/EEC to include flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam as active substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 2003/79/EC(2), and in particular Article 6(1) thereof, Whereas: (1) In accordance with Article 6(2) of Directive 91/414/EEC the authorities of France received on 15 February 1994 an application from Rhône-Poulenc Agro France (now Bayer CropScience) for the inclusion of the active substance flurtamone in Annex I to Directive 91/414/EEC. Commission Decision 1996/341/EC(3) confirmed that the dossier was "complete" in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. (2) France received an application under Article 6(2) of Directive 91/414/EEC on 1 February 1996 an application from Bayer AG (now Bayer CropScience) concerning flufenacet (former name: fluthiamide). This application was declared complete by Commission Decision 97/362/EC(4). (3) Germany received an application under Article 6(2) of Directive 91/414/EEC on 14 December 1998 from Hoechst Schering AgrEvo GmbH (now Bayer CropScience) concerning iodosulfuron (as parent substance of iodosulfuron-methyl-sodium). This application was declared complete by Commission Decision 1999/392/EC(5). (4) Germany received an application under Article 6(2) of Directive 91/414/EEC on 16 April 1999 from BASF AG concerning dimethenamid-p. This application was declared complete by Commission Decision 1999/555/EC(6). (5) Ireland received an application under Article 6(2) of Directive 91/414/EEC on 26 May 1999 from Zeneca Agrochemicals (now Syngenta) concerning picoxystrobin. This application was declared complete also by Commission Decision 1999/555/EC. (6) The United Kingdom received an application under Article 6(2) of Directive 91/414/EEC on 5 March 1996 from ISK Biosciences Europe SA concerning fosthiazate. This application was declared complete by Commission Decision 97/362/EC. (7) Ireland received an application under Article 6(2) of Directive 91/414/EEC on 14 December 1998 from Monsanto Crop Protection concerning silthiofam (former name: silthiopham). This application was declared complete by Commission Decision 1999/392/EC. (8) For those active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The nominated rapporteur Member States submitted a draft assessment report concerning the substance to the Commission on 21 May 1997 (flurtamone), 6 January 1998 (flufenacet), 30 May 2000 (iodosulfuron), 26 September 2000 (dimethenamid-p), 11 June 2001 (picoxystrobin), 18 March 1998 (fosthiazate), and 2 October 2000 (silthiofam). (9) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 4 July 2003 in the format of the Commission review report for flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam. (10) The review of iodosulfuron, dimethenamid-p, picoxystrobin and silthiofam did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants. (11) For flurtamone, the documents and information were also submitted to the Scientific Committee for Plants for separate consultation. The Scientific Committee for Plants was consulted twice, mainly to assess the potential leaching of two metabolites of the active substance, 3-trifluoromethylbenzoic acid (TFMBA) and trifluoroacetic acid (TFAA). In a first opinion(7), the Scientific Committee recommended with respect to TFMBA the inclusion of soils with pH values between 7 and 8 in the sorption studies with this metabolite. As regards the metabolite TFAA, the Committee found the available data insufficient to assess the risk of contamination of groundwater. Subsequently, further studies were undertaken by the applicant for both metabolites. In its second opinion(8) the Scientific Committee concluded that concentrations of TFMBA leaching to groundwater from soils with pH above 5 may exceed 0,1 g/l in a small percentage of cases/situations. The Committee further concluded that the metabolite TFAA does not represent an unacceptable risk to aquatic organisms via groundwater but the toxicological information made available to the Committee was still insufficient. The recommendations of the Scientific Committee were taken into account during the further review and in this Directive and in the Review Report. After the missing information was subsequently delivered by the applicant and evaluated by the rapporteur Member State. The evaluation within the Standing Committee concluded that there would be no unacceptable influence of the metabolites TFMBA and TFAA on the environment if appropriate risk mitigation measures are applied. (12) As regards flufenacet, the Scientific Committee for Plants was asked to comment on two degradation products (M2 and M4) of the active substance, which were detected in lysimeters leachates, and on the exposure of operators. In its opinion(9) the Committee found for the M2 and M4 metabolites that the risk to non-target terrestrial organisms were not yet adequately assessed and also identified other degradation products for which the risk to non-target organisms needed further evaluation. The Committee was of the opinion that operator risk assessment of flufenacet has been adequately addressed but noted that the sensitising potential of the formulation deserves proper attention. The recommendations of the Scientific Committee were taken into account during the further review and in this Directive and in the Review Report. After the missing information was subsequently delivered by the applicant and evaluated by the rapporteur Member State. The evaluation within the Standing Committee concluded that the risk by all identified degradation products for non-target organisms would be acceptable and that the sensitising risk would also be acceptable if appropriate risk mitigation measures are applied. (13) As regards fosthiazate, the Scientific Committee was asked to comment on the potential for leaching to groundwater, on the risk to soil dwelling non-target organisms, on the risk to birds and wild mammals, and on the possible risk of organophosphate-induced delayed polyneuropathy (OPIDP) in humans following severe poisoning incidents. In its opinion(10) the Committee found that based on the available information no safe use scenario could be identified which poses no unacceptable risk to groundwater. The Committee noted that it is possible that lysimeter studies demonstrate lack of leaching for one or more use scenarios but none were reported. Also the risk of the different metabolites to soil organisms had not been sufficiently addressed. The Committee further considered that the potential for exposure of birds and wild mammals by all the routes mentioned above required further consideration. Finally, the Committee was of the opinion that NTE (neuropathy target esterase) inhibition by fosthiazate and its isomers had not been adequately assessed. The recommendations of the Scientific Committee were taken into account during the further review and in this Directive and in the Review Report. After the missing information was subsequently delivered by the applicant and evaluated by the rapporteur Member State and taking into account appropriate measures of risk mitigation measures, the evaluation within the Standing Committee concluded that no harmful effects are to be expected from NTE inhibition by fosthiazate and its isomers. The evaluation within the Standing Committee further concluded that the risk by the parent substances and the identified degradation products for the groundwater, soil organisms, birds and wild mammals would be acceptable if appropriate risk mitigation measures are applied. (14) It has appeared from the various examinations made that plant protection products containing the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive. (15) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC. (16) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (17) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 30 June 2004 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 July 2004. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall review the authorisation for each plant protection product containing flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate or silthiofam to ensure that the conditions relating to these active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw authorisations in accordance with Directive 91/414/EEC by 30 June 2004 at the latest. 2. For each authorised plant protection product containing flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate or silthiofam as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 December 2004 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI, on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 30 June 2005 at the latest, they shall amend or withdraw the authorisation for each such plant protection product. Article 4 This Directive shall enter into force on 1 January 2004. Article 5 This Directive is addressed to the Member States.

32003L0085

2003

Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC (Text with EEA relevance.) Having regard to the Treaty establishing the European Community, and in particular Article 37(3) thereof, Having regard to the proposal from the Commission(1), Having regard to the Opinion of the European Parliament(2), Having regard to the Opinion of the European Economic and Social Committee(3), Having regard to the Opinion of the Committee of the Regions(4), Whereas: (1) One of the Community's tasks in the veterinary field is to improve the state of health of livestock, thereby increasing the profitability of livestock farming and facilitating trade in animals and animal products. At the same time the Community is also a Community of values, and its policies to combat animal diseases must not be based purely on commercial interests but must also take genuine account of ethical principles. (2) Foot-and-mouth disease is a highly contagious viral disease of biungulates. Although foot-and-mouth disease has no public health importance, due to its exceptional economic importance, it is on the top of list A diseases of the Office International des Epizooties (OIE). (3) Foot-and-mouth disease is a compulsorily notifiable disease and outbreaks must be notified by the Member State affected to the Commission and other Member States, in accordance with Council Directive 82/894/EEC of 21 December 1982, on the notification of animal diseases within the Community(5). (4) The Community measures for the control of foot-and-mouth disease are laid down in Council Directive 85/511/EEC of 18 November 1985 introducing Community measures for the control of foot-and-mouth disease(6). That Directive has been significantly amended on many occasions. Now that new amendments are being made to the said Directive, it is desirable, in order to clarify matters, that the provisions in question should be recast. (5) Following the adoption of Council Directive 90/423/EEC of 26 June 1990 amending Directive 85/511/EEC, Directive 64/432/EEC on animal health problems affecting intra-Community trade in bovine animals and swine and Directive 72/462/EEC on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat or meat products from third countries(7), prophylactic vaccination against foot-and-mouth disease was prohibited throughout the Community as of 1 January 1992. (6) Preventive measures are necessary to avoid the incursion of foot-and-mouth disease into the Community and into Community livestock from neighbouring countries or through the introduction into the Community of live animals and products of animal origin. There is no indication that any of the outbreaks of foot-and-mouth disease reported since the prohibition of prophylactic vaccination can be attributed to imports in accordance with Community legislation and subject to veterinary checks at border inspection posts, established in accordance with Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries(8), and Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries(9). (7) Nevertheless, strict application of the Community rules on imports of animal products aimed at reducing risks should be strongly emphasised, if for no other reason than the increase in trade and movement of persons worldwide. The Member States should ensure that this legislation is implemented in its entirety and make enough personnel and resources available to provide strict controls on the external borders. (8) In addition, the European Parliament's Temporary Committee on Foot-and-Mouth Disease found that, in practice, border inspections are failing to prevent significant quantities of meat and meat products from entering the Community illegally. (9) Under the conditions of the single market and the overall satisfactory health status of livestock herds, the exchange of animals and animal products has increased substantially and certain regions of the Community have densely populated livestock areas. (10) The foot-and-mouth disease epidemic in certain Member States in 2001 demonstrated that due to intensive movement of and trade in animals susceptible to foot-and-mouth disease, an outbreak can quickly take on epizootic proportions, causing disturbances on a scale liable to reduce sharply the profitability of farming of animals of susceptible species and other parts of the rural economy and also requiring substantial financial resources to compensate farmers and the application of control measures. (11) During the 2001 foot-and-mouth disease crisis, the Commission reinforced the Community control measures for foot-and-mouth disease laid down in Directive 85/511/EEC by adopting protective measures in accordance with Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market(10), and Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market(11). (12) In 2001, the Commission also adopted Decisions on the conditions for the use of emergency vaccination in accordance with Directive 85/511/EEC. Those conditions were laid down taking account of the recommendations contained in the report of the Scientific Committee on Animal Health and Animal Welfare on the strategy for emergency vaccination against foot-and-mouth disease of 1999. (13) This Directive should take into account the report of expert groups from Member States on a review of Community legislation on foot-and-mouth disease of 1998, which reflects the experience gained by Member States during the classical swine fever epidemic in 1997, and the conclusions of the International Conference on the Prevention and Control of Foot-and-Mouth Disease held in Brussels in December 2001. (14) The Resolution of 17 December 2002 of the European Parliament on the foot-and-mouth disease epidemic in 2001 in the European Union(12), based on the conclusions of the Temporary Committee on Foot-and-Mouth Disease of the European Parliament should be taken into account in this Directive. (15) The recommendations in the Report of the Thirtieth Session of the European Commission for the Control of Foot-and-Mouth Disease of the Food and Agriculture Organisation on minimum standards for laboratories working with foot-and-mouth virus in vitro and in vivo of 1993, should be taken into account. (16) This Directive should also take into account the changes made in the Animal Health Code and the Manual of Standards for Diagnostic Tests and Vaccines of the OIE (OIE Manual). (17) In order to ensure early detection of any possible outbreak of foot-and-mouth disease, legal provisions are necessary to oblige those in contact with animals of susceptible species to notify any suspect case to the competent authorities. Regular inspections should be introduced in the Member States to ensure that farmers are in fact familiar with and are applying the general rules on disease control and biosecurity. (18) It is necessary that action be taken as soon as the presence of the foot-and-mouth disease is suspected so that immediate and effective control measures can be implemented once its presence is confirmed. Such measures should be modulated by the competent authorities depending on the epidemiological situation in the Member State concerned. However, the measures should also be reinforced by specific protection measures established in accordance with Community legislation. (19) A rapid and detailed diagnosis of the disease and identification of the relevant virus should be carried out under the auspices of a network of national laboratories in the Member States. Where necessary, cooperation between the national laboratories should be ensured by a Community reference laboratory designated by the Commission in accordance with the procedure of the Standing Committee on the Food Chain and Animal Health established by Regulation (EC) No 178/2002 of the European Parliament and the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(13). (20) With regard to the differential laboratory diagnosis for foot-and-mouth disease, account should be taken of Commission Decision 2000/428/EC of 4 July 2000 establishing diagnostic procedures, sampling methods and criteria for the evaluation of the results of laboratory tests for the confirmation and differential diagnosis of swine vesicular disease(14). (21) Community measures for the control of foot-and-mouth disease should be based first of all on depopulation of the infected herd. The killing of infected and contaminated animals of susceptible species should be carried out without delay in accordance with Council Directive 93/119/EEC of 22 December 1993 on the protection of animals at the time of slaughter or killing(15). Where possible the processing of the carcasses of dead or killed animals should be carried out in accordance with Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption(16). (22) It is necessary to integrate public health and environment protection aspects in the event of a foot-and-mouth disease outbreak, in particular by establishing close cooperation between the veterinary health and environment competent authorities. Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control(17) requires an integrated environmental permit for installations for the disposal or recycling of animal carcasses and animal waste with a specified treatment capacity. Unnecessary risks from burning animal carcasses on pyres or burying them at mass burial sites should be avoided. (23) It is necessary to prevent any spread of the disease as soon as an outbreak occurs by carefully monitoring movements of animals and the use of products liable to be contaminated, and where appropriate, in particular in densely populated livestock areas, by emergency vaccination. (24) The action taken to control the foot-and-mouth diesease epidemics which struck certain Member States in 2001 has shown that international and Community rules and the ensuing practices have not taken sufficient account of the possibility offered by the use of emergency vaccination and subsequent tests to detect infected animals in a vaccinated population. Too much importance was attached to the trade-policy aspects, with the result that protective vaccination was not carried out even when it had been authorised. (25) Various strategies are available for controlling foot-and-mouth disease. In the event of an epidemic, the choice of strategy to control the disease should likewise take account of which strategy causes the least possible economic damage for non-agricultural sectors of the economy. (26) By means of emergency vaccination without subsequent killing of the vaccinated animals the number of animals to be killed for disease control purposes may be reduced significantly. Appropriate testing should thereafter substantiate the absence of infection. (27) Cleansing and disinfection should be an integral part of the Community control policy for foot-and-mouth disease. The use of disinfectants should be in compliance with Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market(18). (28) Semen, ova and embryos collected from animals of susceptible species infected with the foot-and-mouth disease virus may contribute to the spread of the disease and should therefore be subject to restrictions in addition to those animal health conditions laid down for intra-Community trade in the following Directives: - Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in and imports of deep-frozen semen of domestic animals of the bovine species(19); - Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importations from third countries of embryos of domestic animals of the bovine species(20); - Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC(21). (29) In the event of an outbreak it may be necessary to apply control measures not only to infected animals of susceptible species, but also to contaminated animals of species not susceptible to the disease which may be mechanical vectors for the virus. During the 2001 foot-and-mouth disease epidemic, restrictions were also applied on the movement of equidae coming from holdings keeping animals of susceptible species or neighbouring such holdings and specific certification, in addition to the requirements of Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of equidae(22), was required in order to control trade in equidae from Member States affected by foot-and-mouth disease. (30) With regard to animal health, the conditions governing placing on the market, trade and imports into the Community of animal products intended for human consumption are laid down in the following Directives: - Council Directive 64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat(23); - Council Directive 77/99/EEC of 21 December 1976 on health problems affecting the intra-Community trade of meat products origin(24); - Council Directive 80/215/EEC of 22 January 1980 on animal health problems affecting intra-Community trade in meat products(25); - Council Directive 91/495/EEC of 27 November 1990 concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat(26); - Council Directive 94/65/EC of 14 December 1994 laying down the requirements for the production and placing on the market of minced meat and meat preparations(27), - Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption(28). (31) Those Directives are now in the process of being replaced. In order to ease reference, the treatment of meat and meat products from animals of susceptible species, required to ensure the destruction of possible foot-and-mouth disease virus, is specified in the Annexes VII to IX of this Directive which are based on those Directives and comply with recommendations of the OIE. (32) The animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption are laid down in Council Directive 2002/99/EC of 16 December 2002(29). (33) Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products(30) provides for the treatment of milk from animals kept within the perimeters of surveillance zones established in accordance with Community control measures for foot-and-mouth disease. The requirements of that Directive are not sufficient, as they do not provide for treatment of milk from protection zones and from vaccinated animals. In addition, the treatment for milk for human consumption provided for in that Directive exceeds the requirements of the code of the OIE on destruction of foot-and-mouth disease virus in milk and results in logistic problems in the disposal of substantial quantities of milk refused by dairy plants. More detailed provisions on the collection and transport of milk from animals of susceptible species in areas subject to control measures for foot-and-mouth disease should be included in this Directive. The treatment of milk and milk products specified in Annex IX of this Directive complies with recommendations of the OIE for the destruction of possible foot-and-mouth disease virus in milk and milk products. Directive 92/46/EEC should therefore be amended accordingly. (34) With regard to products of animal origin account should be taken of Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC(31). Certain provisions of Directive 92/118/EEC have been included in Regulation (EC) No 1774/2002. (35) The application of the principle of regionalisation should allow the implementation of strict control measures, including emergency vaccination, in a defined part of the Community without endangering general Community interests. Dairy and meat products from vaccinated animals may be placed on the market in accordance with the relevant Community legislation and this Directive in particular. (36) Directive 64/432/EEC provides for the definition of regions. Commission Decision 2000/807/EC of 11 December 2000 laying down the codified form and the codes for the notification of animal diseases pursuant to Council Directive 82/894/EEC(32) specifies administrative areas in Member States related to disease control measures and disease notification. (37) To guard against emergencies, the Community has, in accordance with Council Decision 91/666/EEC of 11 December 1991 establishing Community reserves of foot-and-mouth disease vaccines(33), established reserves of inactivated foot-and-mouth disease virus antigen stored at designated premises, and the Community antigen and vaccine bank. Transparent and efficient procedures should be established to guarantee access to the antigen without undue delay. In addition, certain Member States have established and maintain national antigen and vaccine banks. (38) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(34) requires that, with only minor exceptions, all veterinary medicinal products that are placed on the market within the Community hold a marketing authorisation. In addition, that Directive lays down the criteria for the granting of a marketing authorisation for veterinary medicinal products, including immunological veterinary medicinal products. That Directive authorises Member States to permit release onto their market of a product without a marketing authorisation in the event of a serious epidemic under certain conditions. Foot-and-mouth disease has the potential for a serious epidemic. Given the rapid variation of antigen required to produce an effective protection of animals of susceptible species in case of emergency, vaccines against foot-and-mouth disease qualify for the derogation provided for in that Directive. (39) The Community Reference Laboratory should advise the Commission and the Member States on the need for vaccines and antigens, in particular where virus strains are detected against which the vaccines produced on the basis of those antigens stored in the Community antigen and vaccine bank do not provide sufficient protection. (40) As a matter of precaution, in relation to the risks of a deliberate release of foot-and-mouth disease virus, it is appropriate to apply specific procedures to the procurement of antigens for the Community antigen and vaccine bank and to the publication of certain details relating to disease control measures. (41) The presence of an entirely non-immune population of susceptible livestock in Member States requires permanent disease-awareness and preparedness. The need for detailed contingency plans has been proven once more during the 2001 foot-and-mouth disease epidemic. At present, all Member States have contingency plans approved by Commission Decision 93/455/EEC of 23 July 1993 approving certain contingency plans for the control of foot-and-mouth-disease(35). Such contingency plans should be reviewed regularly, among other things, in the light of the results of real-time alert exercises carried out in the Member States, the experience of the 2001 epidemic and in order to include measures to protect the environment. Member States should be encouraged to organise and carry out such exercises in close cooperation and across borders. The Commission should be encouraged, in cooperation with the Member States, to make provision for the setting-up of technical assistance which could be made available to Member States affected by an epidemic. (42) In order to protect Community livestock and based on risk assessment, provision should be made to assist neighbouring third countries infected by or at risk of foot-and-mouth disease, in particular as regards the emergency supply of antigen or vaccines. However, such provisions should apply without prejudice to agreements concluded between the third country concerned and the Community on access to the Community antigen and vaccine bank. (43) Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field(36), applies in the event of the occurrence of foot-and-mouth disease and provides for Community aid to be granted to reference laboratories and antigen and vaccine banks. Any Community compensation paid to Member States for financial expenditures relating to control measures in the case of outbreaks of foot-and-mouth disease, should be subject to scrutiny regarding compliance with at least the minimum requirements laid down in this Directive. (44) In order to ensure close cooperation between the Member States and the Commission in controlling foot-and-mouth disease and taking into account the nature of the disease, the Commission should be empowered to modify and adapt certain technical aspects of the control measures. Where necessary, the Commission should base any such modifications or adaptations on the results of a veterinary inspection mission carried out in accordance with Commission Decision 98/139/EC of 4 February 1998 laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in the Member States(37). (45) The Member States should lay down rules on penalties applicable to infringements of the provisions of this Directive and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive. (46) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of maintaining and, in the event of an outbreak, of quick recovery of a foot-and-mouth disease and infection-free status of all Member States, to lay down rules on the measures to increase disease preparedness and to control outbreaks as quickly as possible, if necessary by emergency vaccination, and to limit the adverse effects on the production of and trade in livestock and products of animal origin. This Directive does not go beyond what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty. (47) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(38), CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 Subject matter and scope 1. This Directive sets out: (a) the minimum control measures to be applied in the event of an outbreak of foot-and-mouth disease of whatever type of virus; (b) certain preventative measures aimed at increasing awareness and preparedness of the competent authorities and the farming community for foot-and-mouth disease. 2. Member States shall remain free to take more stringent action in the field covered by this Directive. Article 2 Definitions For the purposes of this Directive the following definitions shall apply: (a) "animal of a susceptible species" means any domestic or wild animal of the suborders Ruminantia, Suina, and Tylopoda of the order Artiodactyla; For specific measures, notably in application of Article 1(2), Article 15 and Article 85(2), other animals, such as for example of the order Rodentia or Proboscidae, may be considered susceptible to foot-and-mouth disease in accordance with scientific evidence. (b) "holding" means any agricultural or other premises, including circuses, located in the national territory of a Member State where animals of susceptible species are being bred or kept on a permanent or temporary basis. However, for the purpose of Article 10(l) this definition does not include living areas for humans on such premises, unless animals of susceptible species, including those referred to in Article 85(2), are kept on a permanent or temporary basis therein, slaughterhouses, means of transport, border inspection posts or fenced areas where animals of susceptible species are kept and may be hunted, if such fenced areas are of a size which makes the measures provided for in Article 10 inapplicable; (c) "herd" means an animal or group of animals kept on a holding as an epidemiological unit; if more than one herd is kept on a holding, each of these herds shall form a distinct unit and shall have the same health status; (d) "owner" means any person or persons, either natural or legal, having ownership of an animal of a susceptible species, or charged with keeping such animals, whether or not for financial reward; (e) "competent authority" means the authority of a Member State competent to carry out veterinary or zootechnical checks or any authority to which it has delegated that competence; (f) "official veterinarian" means the veterinarian designated by the competent authority of the Member State; (g) "authorisation" means a written authorisation given by the competent authorities, of which the necessary copies must be available for subsequent inspections in accordance with the appropriate legislation in the Member State concerned; (h) "incubation period" means the length of the time between infection and the occurrence of clinical signs of foot-and-mouth disease. Namely, for the purposes of this Directive, 14 days for bovine and porcine animals, and 21 days for ovine and caprine animals and any other animal of susceptible species; (i) "animal suspected of being infected" means any animal of a susceptible species exhibiting clinical symptoms or showing post-mortem lesions or reactions to laboratory tests which are such that the presence of foot-and-mouth disease may reasonably be suspected; (j) "animal suspected of being contaminated" means any animal of a susceptible species which, according to the epidemiological information collected, may have been directly or indirectly exposed to the foot-and-mouth disease virus; (k) "case of foot-and-mouth disease" or "animal infected with foot-and-mouth disease" means any animal of a susceptible species or carcass of such animal in which foot-and-mouth disease has been officially confirmed, taking into account the definitions in Annex I: - either on clinical symptoms or post-mortem lesions consistent with foot-and-mouth disease have been officially confirmed, or - as the result of a laboratory examination carried out in accordance with Annex XIII; (l) "outbreak of foot-and-mouth disease" means a holding where animals of susceptible species are kept, which meets one or more of the criteria set out in Annex I; (m) "primary outbreak" means the outbreak within the meaning of Article 2(d) of Directive 82/894/EEC; (n) "killing" means the killing of animals within the meaning of Article 2(6) of Directive 93/119/EEC; (o) "emergency slaughter" means the slaughter in emergency cases within the meaning of Article 2(7) of Directive 93/119/EEC of animals which on the basis of epidemiological data or clinical diagnosis or results of laboratory testing are not considered infected or contaminated with foot-and mouth disease virus, including slaughter for reasons of animal welfare; (p) "processing" means one of the treatments for high risk material laid down in Regulation (EC) No 1774/2002, and any implementing legislation thereof, applied in such a way as to avoid the risk of spread of foot-and-mouth disease virus; (q) "regionalisation" means the delimitation of a restricted zone in which restrictions are applied on the movements of or trade in certain animals or animal products as provided for in Article 45 in order to prevent the spread of foot-and-mouth disease into the free zone where no restrictions are applied in accordance with this Directive; (r) "region" means an area as defined in Article 2(2) (p) of Directive 64/432/EEC; (s) "sub-region" means an area specified in the Annex to Decision 2000/807/EC; (t) "Community antigen and vaccine bank" means appropriate premises designated in accordance with this Directive for the storage of Community reserves of both concentrated inactivated antigen of the foot-and-mouth disease virus for the production of foot-and-mouth disease vaccines and veterinary immunological products (vaccines) reconstituted from such antigens and authorised in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(39); (u) "emergency vaccination" means vaccination in accordance with Article 50(1); (v) "protective vaccination" means emergency vaccination carried out on holdings in a designated area in order to protect animals of susceptible species within this area against airborne spread or spread through fomites of foot-and-mouth disease virus and where the animals are intended to be kept alive following vaccination; (w) "suppressive vaccination" means emergency vaccination which is carried out exclusively in conjunction with a stamping-out policy in a holding or area where there is an urgent need to reduce the amount of foot-and-mouth disease virus circulating and to reduce the risk of it spreading beyond the perimeters of the holding or the area and where the animals are intended to be destroyed following vaccination; (x) "wild animal" means an animal of a susceptible species living outside holdings as defined in Article 2(b) or premises referred to in Articles 15 and 16; (y) "primary case of foot-and-mouth disease in wild animals" means any case of foot-and-mouth disease which is detected in a wild animal in an area in which no measures are in place in accordance with Article 85(3) or (4). CHAPTER II CONTROL OF OUTBREAKS OF FOOT-AND-MOUTH DISEASE SECTION 1 NOTIFICATION Article 3 Foot-and-mouth disease notification 1. Member States shall ensure that: (a) foot-and-mouth disease is listed by the competent authority as a compulsorily notifiable disease; (b) the owner and any person attending animals, accompanying animals during transport or looking after animals shall be obliged to notify without delay to the competent authority or the official veterinarian the presence or suspected presence of foot-and-mouth disease and keep animals infected with foot-and-mouth disease or animals suspected of being infected, away from places where other animals of susceptible species are at risk of being infected or contaminated with the foot-and-mouth disease virus; (c) veterinary practitioners, official veterinarians, senior staff of veterinary or other official or private laboratories and any person with a occupational relation to animals of susceptible species or products derived from such animals shall be obliged to notify without delay to the competent authority any knowledge of the presence or suspected presence of foot-and-mouth disease they have obtained prior to official intervention within the framework of this Directive. 2. Without prejudice to existing Community legislation on notification of outbreaks of animal disease, the Member State on whose territory an outbreak of foot-and-mouth disease or a primary case of foot-and-mouth disease in wild animals is confirmed shall give notification of the disease and provide information and written reports to the Commission and the other Member States in accordance with Annex II. SECTION 2 MEASURES IN CASE OF SUSPICION OF AN OUTBREAK OF FOOT-AND-MOUTH DISEASE Article 4 Measures in case of suspicion of an outbreak of foot-and-mouth disease 1. Member States shall ensure that the measures provided for in paragraphs 2 and 3 are carried out where a holding contains one or more animals suspected of being infected or contaminated. 2. The competent authority shall immediately activate official investigation arrangements under its supervision to confirm or rule out the presence of the foot-and-mouth disease and, in particular, have the necessary samples taken for the laboratory examinations required to confirm an outbreak in accordance with the definition of outbreak in Annex I. 3. The competent authority shall place the holding referred to in paragraph 1 under official surveillance as soon as the suspected infection is notified and shall in particular ensure that: (a) a census is made of all categories of animals on the holding and that, in respect of each category of animals of susceptible species, the number of animals that are already dead and the animals suspected of being infected or of being contaminated, is recorded; (b) the census as referred to in point (a) is kept up to date to take account of those animals of susceptible species born or dying during the period of suspicion. Such information is produced by the owner on request of the competent authority and is checked by that authority at each visit; (c) all stocks of milk, milk products, meat, meat products, carcasses, hides and skins, wool, semen, embryos, ova, slurry, manure as well as animal feed and litter on the holding are recorded and those records are maintained; (d) no animals of susceptible species enter or leave the holding, except in cases of holdings consisting of different epidemiological production units referred to in Article 18, and that all animals of susceptible species on the holding are kept in their living quarters or another place where they can be isolated; (e) appropriate means of disinfection are used at the entrances and exits of buildings or places housing animals of susceptible species and of the holding itself; (f) an epidemiological inquiry is carried out in accordance with Article 13; (g) to facilitate the epidemiological inquiry, the necessary samples shall be taken for laboratory testing in accordance with point 2.1.1.1 of Annex III. Article 5 Movements onto and off a holding in case of suspicion of an outbreak of foot-and-mouth disease 1. Member States shall ensure that in addition to the measures provided for in Article 4, all movement onto and off a holding where there is a suspicion of an outbreak of foot-and-mouth disease is prohibited. That prohibition shall apply in particular to: (a) movement from the holding of meat or carcasses, meat products, milk or milk products, semen, ova or embryos of animals of susceptible species or of animal feed, utensils, objects or other substance, such as wool, hides and skins, bristles or animal waste, slurry, manure or anything liable to transmit foot-and-mouth disease virus; (b) movement of animals of species not susceptible to foot-and-mouth disease; (c) movement of persons onto or out of the holding; (d) movement of vehicles onto or out of the holding. 2. By way of derogation from the prohibition in point (a) of paragraph 1, the competent authority may in the event of difficulties in storing the milk on the holding either order that the milk shall be destroyed on the holding, or authorise the milk to be transported under veterinary supervision and only by means of transport suitably equipped to ensure no risk of spreading foot-and-mouth disease virus from the holding to the nearest possible place for disposal or treatment ensuring destruction of the foot-and-mouth disease virus. 3. By way of derogation from the prohibitions provided for in points (b), (c) and (d) of paragraph 1, the competent authority may authorise such movements onto and off the holding subject to all conditions necessary in order to avoid the spread of foot-and-mouth disease virus. Article 6 Extension of measures to other holdings 1. The competent authority shall extend the measures provided for in Articles 4 and 5 to other holdings where their location, their construction and layout, or contacts with animals from the holding referred to in Article 4, give reason to suspect contamination. 2. The competent authority shall apply at least the measures provided for in Articles 4 and 5(1) to premises or means of transport referred to in Article 16 should the presence of animals of susceptible species give reason to suspect infection or contamination with the foot-and-mouth disease virus. Article 7 Temporary control zone 1. The competent authority may establish a temporary control zone, where required by the epidemiological-situation, and in particular when that situation involves a high density of animals of susceptible species, intensive movement of animals or persons in contact with animals of susceptible species, delays in suspect status notifications, or insufficient information on the possible origin and ways of introduction of the foot-and-mouth disease virus. 2. At least the measures provided for in Article 4(2) and (3)(a), (b) and (d) and in Article 5(1) shall be applied to holdings in the temporary control zone where animals of susceptible species are kept. 3. The measures applied in the temporary control zone may be supplemented by a temporary ban on movements of all animals in a larger area or on the whole of the territory of a Member State. However, the ban on movement of animals of species not susceptible to foot-and-mouth disease shall not exceed 72 hours, unless justified by exceptional circumstances. Article 8 Preventive eradication programme 1. The competent authority may, where epidemiological information or other evidence indicates, implement a preventive eradication programme, including preventive killing of animals of susceptible species likely to be contaminated and, if necessary, of animals from epidemiologically-linked production units or adjoining holdings. 2. In that event, the taking of samples and clinical examinations of animals of susceptible species shall be carried out at least in accordance with point 2.1.1.1 of Annex III. 3. The competent authority shall notify the Commission prior to the implementation of the measures provided for in this Article. Article 9 Maintenance of measures Member States shall not withdraw the measures provided for in Articles 4 to 7 until the suspicion of foot-and-mouth disease has been officially ruled out. SECTION 3 MEASURES IN CASE OF CONFIRMATION Article 10 Measures in case of confirmation of an outbreak of foot-and-mouth disease 1. As soon as an outbreak of foot-and-mouth disease is confirmed, Member States shall ensure that, in addition to the measures provided for in Articles 4 to 6 the following measures are also applied without delay on the holding: (a) All animals of susceptible species shall be killed on-the-spot. In exceptional circumstances the animals of susceptible species may be killed at the nearest suitable place for that purpose under official supervision and in such a way as to avoid the risk of spreading foot-and-mouth disease virus during transport and killing. The Member State concerned shall notify the Commission about the existence of such exceptional circumstances, and the action taken. (b) The official veterinarian shall ensure that before or during the killing of the animals of susceptible species all appropriate samples needed for the epidemiological inquiry referred to in Article 13 have been taken in accordance with point 2.1.1.1 of Annex III, and in sufficient numbers. The competent authority may decide that Article 4(2) shall not apply in cases of appearance of a secondary source which is epidemiologically linked with a primary source for which samples have already been taken in accordance to that Article, provided that appropriate and sufficient numbers of samples needed for the epidemiological inquiry referred to in Article 13 have been taken. (c) The carcasses of animals of susceptible species which have died on the holding and the carcasses of animals which have been killed in accordance with point (a) shall be processed without undue delay under official supervision in such a way that there is no risk of spreading foot-and-mouth disease virus. Where particular circumstances require the carcasses to be buried or burned, on site or off site, such operations shall be carried out in conformity with the instructions prepared in advance in the framework of the contingency plans referred to in Article 72. (d) All products and substances referred to in Article 4(3)(c) shall be isolated until contamination can be ruled out, or treated in accordance with the instructions of the official veterinarian in such a way as to ensure the destruction of any foot-and-mouth disease virus, or processed. 2. After the killing and processing of the animals of susceptible species and the completion of the measures provided for in paragraph 1(d), Member States shall ensure that: (a) the buildings used for housing animals of susceptible species, their surroundings and the vehicles used for their transportation, as well as all other buildings and equipment likely to be contaminated shall be cleaned and disinfected in accordance with Article 11; (b) in addition, where there is a reasonable suspicion that the living area for humans or the office area of the holding are contaminated with the foot-and-mouth disease virus, these areas shall also be disinfected by appropriate means; (c) restocking of animals is carried out in accordance with Annex V. Article 11 Cleansing and disinfection 1. Member States shall ensure that cleansing and disinfection operations, as integral parts of the measures provided for in this Directive, are adequately documented and are carried out under official supervision and in accordance with the instructions given by the official veterinarian, using disinfectants and working concentrations of such disinfectants officially authorised and registered for placing on the market by the competent authority as veterinary hygiene biocidal products in accordance with Directive 98/8/EC, in order to ensure destruction of the foot-and-mouth disease virus. 2. Member States shall ensure that cleansing and disinfection operations, which shall include appropriate pest control, are carried out in a way to reduce as much as possible any adverse environmental impact that may arise from such operations. 3. Member States shall endeavour to ensure that any disinfectants used, in addition to being able to disinfect effectively, also have the lowest possible adverse impacts on the environment and public health in accordance with best available technology. 4. Member States shall ensure that cleansing and disinfection operations are carried out in accordance with Annex IV. Article 12 Tracing and treatment of products and substances derived from or having been in contact with animals of an outbreak of foot-and-mouth disease Member States shall ensure that the products and substances referred to in Article 4(3)(c) of animals of susceptible species collected from a holding where an outbreak of foot-and-mouth disease has been confirmed and semen, ova and embryos collected from animals of susceptible species present on that holding, during the period between the probable introduction of the disease to the holding and the implementation of official measures, shall be traced and processed or, in the case of substances other than semen, ova and embryos, be treated under official supervision and in such a way as to ensure destruction of foot-and-mouth disease virus and to avoid any risk of it spreading further. Article 13 Epidemiological inquiry 1. Member States shall ensure that epidemiological inquiries in relation to outbreaks of foot-and-mouth disease are carried out by specifically trained veterinarians on the basis of questionnaires, prepared within the framework of the contingency plans provided for in Article 72, to ensure standardised, speedy and targeted inquiries. Such inquiries shall deal at least with: (a) the length of time during which the foot-and-mouth disease may have been present on a holding before being suspected or notified; (b) the possible origin of the foot-and-mouth disease virus on a holding and the identification of other holdings where there are animals suspected of being infected or animals suspected of being contaminated from the same source; (c) the possible extent to which animals of susceptible species other than bovine and porcine animals may have been infected or contaminated; (d) the movement of animals, persons, vehicles and the substances referred to in Article 4(3)(c) likely to have carried the foot-and-mouth disease virus to or from the holdings in question. 2. Member States shall inform and regularly update the Commission and the other Member States about the epidemiology and spread of the foot-and-mouth disease virus. Article 14 Additional measures in case of confirmation of outbreaks of foot-and-mouth disease 1. The competent authority may order that, besides the animals of susceptible species, animals of species not susceptible to foot-and-mouth disease on the holding where an outbreak of foot-and-mouth disease has been confirmed shall also be killed and processed of in such a way as to avoid any risk of spreading the foot-and-mouth disease virus. However, the first subparagraph shall not apply to animals of species not susceptible to foot-and-mouth disease which may be isolated, effectively cleansed and disinfected, and provided that they are individually identified, in the case of equidae in accordance with Community legislation, so as to allow the control of their movement. 2. The competent authority may apply the measures provided for in Article 10(1)(a) on epidemiologically-linked production units or adjoining holdings, where epidemiological information or other evidence give reason to suspect a possible contamination of those holdings. The intention to make use of those provisions shall be notified to the Commission, where possible, prior to implementation. In this event, the measures regarding taking of samples and clinical examinations of animals shall be carried out at least as set out in point 2.1.1.1 of Annex III. 3. The competent authority shall, immediately upon confirmation of the first outbreak of foot-and-mouth disease prepare all arrangements necessary for emergency vaccination in an area of at least the size of the surveillance zone established in accordance with Article 21. 4. The competent authority may apply the measures provided for in Articles 7 and 8. SECTION 4 MEASURES TO BE APPLIED IN SPECIAL CASES Article 15 Measures to be applied in case of an outbreak of foot-and-mouth disease in the vicinity or within certain specific premises keeping on a temporary or regular basis animals of susceptible species 1. Where an outbreak of foot-and-mouth disease threatens to infect animals of susceptible species in a laboratory, zoo, wildlife park, and fenced area or in bodies, institutes or centres approved in accordance with Article 13(2) of Directive 92/65/EEC and where animals are kept for scientific purposes or purposes related to conservation of species or farm animal genetic resources, the Member State concerned shall ensure that all appropriate bio-security measures are taken to protect such animals from infection. Those measures may include restricting access to public institutions or making such access subject to special conditions. 2. Where an outbreak of foot-and-mouth disease is confirmed in one of the premises referred to in paragraph 1, the Member State concerned may decide to derogate from Article 10(1)(a), provided that basic Community interests, and in particular the animal health status of other Member States, are not endangered and that all necessary measures are in place to prevent any risk of spreading foot-and-mouth disease virus. 3. The decision referred to in paragraph 2 shall immediately be notified to the Commission. In the case of farm animal genetic resources, this notification shall include a reference to the list of premises established in accordance with Article 77(2)(f), by which the competent authority has identified these premises in advance as breeding nucleus of animals of susceptible species indispensable for the survival of a breed. Article 16 Measures to be applied in slaughterhouses, border inspection posts and means of transportation 1. Where a case of foot-and-mouth disease is confirmed in a slaughterhouse, a border inspection post established in accordance with Directive 91/496/EEC or in a means of transport, the competent authority shall ensure that the following measures are carried out in relation to the affected premises or means of transport: (a) all animals of susceptible species in such premises or means of transport shall be killed without delay; (b) the carcasses of the animals referred to in paragraph (a) shall be processed under official supervision in such a way as to avoid the risk of foot-and-mouth disease virus spreading; (c) other animal waste, including offal, of infected or suspected of being infected and contaminated animals shall be processed under official supervision in such a way as to avoid the risk of foot-and-mouth disease virus spreading; (d) dung, manure and slurry shall be subject to disinfection and shall only be removed for treatment in accordance with point 5 of Section II in Part A of Chapter III of Annex VIII to Regulation (EC) No 1774/2002; (e) cleansing and disinfection of buildings and equipment, including vehicles or means of transport, shall take place under the supervision of the official veterinarian in accordance with Article 11 and with the instructions laid down by the competent authority; (f) an epidemiological inquiry shall be carried out in accordance with Article 13. 2. Member States shall ensure that the measures provided for in Article 19 are applied in contact holdings. 3. Member States shall ensure that no animals are reintroduced for slaughter, inspection or transport in the premises or means of transport referred to in paragraph 1 until at least 24 hours after completion of the cleansing and disinfection operations referred to in paragraph 1(e). 4. Where required by the epidemiological situation, in particular where contamination of animals of susceptible species in holdings adjacent to the premises ore means of transport referred to in paragraph 1 must be suspected, Member States shall ensure that by way of derogation from Article 2(b), second sentence, an outbreak is declared on the premises or means of transport referred to in paragraph 1, and the measures provided for in Articles 10 and 21 are applied. Article 17 Review of measures The Commission shall review the situation regarding the special cases referred to in Article 15 in the Standing Committee on the Food Chain and Animal Health at the earliest possible opportunity. The necessary measures to prevent the spread of the foot-and-mouth disease virus, in particular in relation to regionalisation in accordance with Article 45, and to emergency vaccination in accordance with Article 52, shall be adopted in accordance with the procedure referred to in Article 89(3). SECTION 5 HOLDINGS CONSISTING OF DIFFERENT EPIDEMIOLOGICAL PRODUCTION UNITS AND CONTACT HOLDINGS Article 18 Holdings consisting of different epidemiological production units 1. In the case of holdings which consist of two or more separate production units, the competent authority may, in exceptional cases and after considering the risks, derogate from Article 10(1)(a) as regards production units of such holdings not affected by foot-and-mouth disease. 2. The derogation provided for in paragraph 1 shall only be granted after the official veterinarian has confirmed at the time of the official investigation referred to in Article 4(2), that the following conditions to prevent the spread of foot-and-mouth disease virus between the production units referred to in paragraph 1, have been in place for at least two incubation periods prior to the date the outbreak of foot-and-mouth disease was identified on the holding: (a) the structure, including the administration, and size of the premises allow a complete separation of housing and keeping for the distinct herds of animals of susceptible species, including separate air space; (b) the operations on the different production units, and in particular stable and pasture management, feeding, removal of dung or manure are completely separated and carried out by different personnel; (c) the machinery, working animals of species not susceptible to foot-and-mouth disease, equipment, installations, instruments and disinfection facilities used in the production units are completely separate. 3. In relation to milk, a derogation from Article 10(1)(d) may be granted to a holding producing milk provided that: (a) such holding complies with the conditions set out in paragraph 2, and (b) milking in each unit is carried out separately, and (c) depending on the intended use, the milk is subject to at least one of the treatments described in Part A or Part B of Annex IX. 4. Where a derogation is granted in accordance with paragraph 1, Member States shall lay down in advance detailed rules for applying such derogation. The Member States shall notify the Commission of the derogation and provide details of the measures taken. Article 19 Contact holdings 1. Holdings shall be recognised as contact holdings where the official veterinarian finds, or considers on the basis of confirmed data, that the foot-and-mouth disease virus may have been introduced as a result of the movement of persons, animals, products of animal origin, vehicles or in any other way either from other holdings onto a holding referred to in Articles 4(1) or 10(1) or from a holding referred to in Articles 4(1) or 10(1) to other holdings. 2. Contact holdings shall be subject to the measures provided for in Articles 4(3) and 5 and these measures shall be maintained until the suspected presence of foot-and-mouth disease virus on these contact holdings has been officially ruled out in accordance with the definition in Annex I and the survey requirements provided for in point 2.1.1.1 of Annex III. 3. The competent authority shall prohibit the removal of all animals from contact holdings during a period corresponding to the incubation period specified for the species concerned in Article 2(h). However, the competent authority may, by way of derogation from Article 4(3)(d), authorise the transport of animals of susceptible species under official supervision directly to the closest possible designated slaughterhouse for emergency slaughter. Prior to granting such derogation, the official veterinarian shall at least carry out the clinical examinations provided for in point 1 of Annex III. 4. Where the competent authority considers that the epidemiological situation permits, it may limit the recognition as a contact holding provided for in paragraph 1, to one identified epidemiological production unit of the holding and to the animals contained therein, provided that the epidemiological production unit complies with Article 18. 5. Where an epidemiological link between an outbreak of foot-and-mouth disease and premises or means of transportation referred to in Articles 15 and 16 respectively cannot be excluded, Member States shall ensure that the measures provided for in Article 4(2) and (3) and in Article 5 shall apply to such premises or means of transportation. The competent authority may decide to apply the measures provided for in Article 8. Article 20 Coordination of measures The Commission may review the situation regarding the holdings referred to in Articles 18 and 19 in the Standing Committee on the Food Chain and Animal Health with a view to the adoption, in accordance with the procedure referred to in Article 89(3), of the necessary measures to ensure coordination of the measures implemented by the Member States pursuant to Articles 18 and 19. SECTION 6 PROTECTION AND SURVEILLANCE ZONES Article 21 Establishment of protection and surveillance zones 1. Member States shall ensure that, without prejudice to measures provided for in Article 7, at least the measures laid down in paragraphs 2, 3 and 4 below are taken immediately after an outbreak of foot-and-mouth disease is confirmed. 2. The competent authority shall establish a protection zone based on a minimum radius of 3 km and a surveillance zone based on a minimum radius of 10 km centred on the outbreak of foot-and-mouth disease referred to in paragraph 1. The geographical delimitation of those zones shall take account of administrative boundaries, natural barriers, supervision facilities and technological progress which makes it possible to predict the probable dispersion of the foot-and-mouth disease virus by air or any other means. That delimitation shall be reviewed, if necessary, in the light of such elements. 3. The competent authority shall ensure that the protection and surveillance zones are marked by posting signs of sufficient size on roads entering the zones. 4. In order to ensure full coordination of all measures necessary to eradicate foot-and-mouth disease as quickly as possible, national and local disease control centres as referred to in Articles 74 and 76 shall be established. For the purpose of carrying out the epidemiological inquiry as provided for in Article 13, those centres shall be assisted by an expert group as provided for in Article 78. 5. Member States shall without delay trace animals dispatched from the zones during the period of at least 21 days before the estimated date of earliest infection on a holding in the protection zone and they shall inform the competent authorities in other Member States and the Commission about their results from tracing of animals. 6. Member States shall collaborate in tracing fresh meat, meat products, raw milk and raw milk products derived from animals of susceptible species originating in the protection zone and produced between the date of estimated introduction of the foot-and-mouth disease virus until the date the measures provided for in paragraph 2 come into force. Such fresh meat, meat products, raw milk and raw milk products shall be treated in accordance with Articles 25, 26 and 27 respectively or detained until possible contamination with the foot-and-mouth disease virus is officially ruled out. Article 22 Measures to be applied to holdings in the protection zone 1. Member States shall ensure that at least the following measures are applied in the protection zone without delay: (a) the registration of all holdings with animals of susceptible species and the establishment of a census of all animals present on these holdings shall be carried out as soon as possible and kept up to date; (b) all holdings with animals of susceptible species shall periodically undergo a veterinary inspection, carried out in such a way as to avoid the spread of foot-and-mouth disease virus possibly present on the holdings, which shall include in particular the relevant documentation, notably the records referred to in subparagraph (a) and the measures applied to prevent the introduction or escape of foot-and-mouth disease virus and which may include clinical inspection as described in point 1 of Annex III or taking of samples from animals of susceptible species in accordance with point 2.1.1.1 of Annex III; (c) animals of susceptible species shall not be removed from the holding on which they are kept. 2. By way of derogation from paragraph 1(c), animals of susceptible species may be transported under official supervision for the purpose of emergency slaughter directly to a slaughterhouse situated inside the same protection zone or, if that zone has no slaughterhouse to a slaughterhouse outside the zone designated by the competent authority in means of transport cleansed and disinfected under official control after each transport operation. The movement referred to in the first subparagraph shall only be authorised if the competent authority is satisfied on the basis of a clinical examination in accordance with point 1 of Annex III by the official veterinarian of all the animals of susceptible species present on the holding and after evaluation of epidemiological circumstances that there is no reason to suspect the presence of infected or contaminated animals on the holding. The meat of such animals shall be subject to the measures provided for in Article 25. Article 23 Movement and transport of animals and their products in the protection zone Member States shall ensure that the following activities are prohibited within the protection zone: (a) movement between holdings and transport of animals of susceptible species; (b) fairs, markets, shows and other gatherings of animals including collection and dispersion of susceptible species; (c) itinerant service for breeding of animals of susceptible species; (d) artificial insemination of and collection of ova and embryos from animals of susceptible species. Article 24 Additional measures and derogations 1. The competent authority may extend the prohibitions in Article 23 to: (a) movement or transport of animals of non-susceptible species between holdings situated within the zone or out of or into the protection zone; (b) transit of animals of all species through the protection zone; (c) events with gatherings of people with possible contact with animals of susceptible species, where there is a risk of spreading the foot-and-mouth disease virus; (d) artificial insemination of or collection of ova and embryos from animals of species not susceptible to foot-and-mouth disease; (e) movement of means of transport designed for the transportation of animals; (f) the slaughter on the holding of animals of susceptible species for private consumption; (g) transport of goods referred to in Article 33 to holdings keeping animals of susceptible species. 2. The competent authorities may authorise: (a) the transit of animals of all species through the protection zone undertaken exclusively via major highways or mainline railways; (b) the transport of animals of susceptible species which have been certified by the official veterinarian as coming from holdings outside the protection zone and transported on designated routes directly to designated slaughterhouses for immediate slaughter, provided that the means of transport are cleansed and disinfected after delivery under official supervision at the slaughterhouse and such decontamination of transport is recorded in the logbook of the means of transport; (c) the artificial insemination of animals on a holding carried out by the personnel of that holding by use of semen collected from animals on that holding or semen stored on that holding or semen delivered from a semen collection centre to the outside perimeter of that holding; (d) the movement and transport of equidae taking into account the conditions set out in Annex VI. (e) the transport, under certain conditions, of goods referred to in Article 33 to holdings keeping animals of susceptible species. Article 25 Measures in relation to fresh meat produced in the protection zone 1. Member States shall ensure that the placing on the market of fresh meat, minced meat and meat preparations, derived from animals of susceptible species originating in the protection zone shall be prohibited. 2. Member States shall ensure that the placing on the market of fresh meat, minced meat and meat preparations from animals of susceptible species produced in establishments situated in the protection zone shall be prohibited. 3. Member States shall ensure that fresh meat, minced meat and meat preparations as referred to in paragraph 1, shall be marked in accordance with Directive 2002/99/EC and subsequently transported in sealed containers to an establishment designated by the competent authorities for transformation into meat products treated in accordance with point 1 in Part A of Annex VII of this Directive. 4. By way of derogation, the prohibition provided for in paragraph 1 shall not apply to fresh meat, minced meat and meat preparations which were produced on a date at least 21 days before the estimated date of earliest infection on a holding in the protection zone and which since production have been stored and transported separately from such meats produced after that date. Such meats must be readily distinguished from meats not eligible for dispatch outside the protection zone by means of clear mark established in conformity with Community legislation. 5. By way of derogation, the prohibition provided for in paragraph 2, shall not apply to fresh meat, minced meat or meat preparations obtained from establishments situated in the protection zone under the following conditions: (a) the establishment shall be operated under strict veterinary control; (b) only fresh meat, minced meat or meat preparations as described in paragraph 4, or fresh meat, minced meat or meat preparations obtained from animals reared and slaughtered outside the protection zone or from animals transported to the establishment and slaughtered therein in accordance with the provisions in Article 24(2)(b) shall be processed in the establishment; (c) all such fresh meat, minced meat or meat preparations, must bear the health mark in accordance with Chapter XI of Annex I to Directive 64/433/EEC or in the case of meat from other biungulates the health mark provided for in Chapter III of Annex I to Directive 91/495/EEC, or in the case of minced meat and meat preparations the health mark as provided for in Chapter VI of Annex I to Directive 94/65/EC; (d) during the whole production process all such fresh meat, minced meat or meat preparations must be clearly identified, and transported and stored separately from fresh meat, minced meat or meat preparations which are not eligible for dispatch outside the protection zone in accordance with this Directive. 6. Compliance with the conditions in paragraph 5 shall be certified by the competent authority for fresh meat, minced meat and meat preparations intended for intra-Community trade. The competent authority shall supervise the control of compliance undertaken by the local veterinary authority and, in the case of intra-Community trade, communicate to other Member States and the Commission a list of those establishments which it has approved for the purpose of such certification. 7. Derogation from the prohibition provided for in paragraph 1 may be granted subject to specific conditions adopted in accordance with the procedure referred to in Article 89(3), in particular with regard to the health marking of meat produced from animals of susceptible species originating in protection zones maintained for more than 30 days. Article 26 Measures in relation to meat products produced in the protection zone 1. Member States shall ensure that the placing on the market of meat products produced from meat derived from animals of susceptible species originating in the protection zone shall be prohibited. 2. By way of derogation, the prohibition in paragraph 1 shall not apply to meat products which have either undergone one of the treatments as set out in point 1 in Part A of Annex VII or which have been produced from meats referred to in Article 25(4). Article 27 Measures in relation to milk and milk products produced in the protection zone 1. Member States shall ensure that the placing on the market of milk derived from animals of susceptible species originating in the protection zone and of milk products produced from such milk shall be prohibited. 2. Member States shall ensure that the placing on the market of milk and milk products from animals of susceptible species produced in an establishment situated in the protection zone shall be prohibited. 3. By way of derogation, the prohibition provided for in paragraph 1 shall not apply to milk and milk products derived from animals of susceptible species originating in the protection zone which were produced on a date at least 21 days before the estimated date of earliest infection on a holding in the protection zone and which since production have been stored and transported separately from milk and milk products produced after that date. 4. By way of derogation, the prohibition provided for in paragraph 1 shall not apply to milk derived from animals of susceptible species originating in the protection zone and milk products produced from such milk which have undergone one of the treatments as set out in Parts A or B of Annex IX, depending on the use of the milk or milk products. The treatment shall be carried out under the conditions set out in paragraph 6 in establishments referred to in paragraph 5 or, if there is no establishment situated in the protection zone, in establishments situated outside the protection zone under the conditions set down in paragraph 8. 5. By way of derogation, the prohibition provided for in paragraph 2 shall not apply to milk and milk products which have been prepared in establishments situated in the protection zone under the conditions set out in paragraph 6. 6. Establishments referred to in paragraphs 4 and 5 shall comply with the following conditions: (a) the establishment shall be operated under permanent and strict official control; (b) all milk used in the establishment shall either comply with paragraphs 3 and 4 or the raw milk shall be obtained from animals outside the protection zone; (c) during the whole production process the milk shall be clearly identified and transported and stored separately from raw milk and raw milk products which are not destined for dispatch outside the protection zone; (d) transport of raw milk from holdings situated outside the protection zone to the establishments shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, and which have had no subsequent contact with holdings in the protection zone keeping animals of susceptible species. 7. Compliance with the conditions in paragraph 6 shall be certified by the competent authority for milk intended for intra-Community trade. The competent authority shall supervise the control of compliance undertaken by the local veterinary authority and, in the case of intra-Community trade, communicate to other Member States and the Commission a list of those establishments which it has approved for the purpose of such certification. 8. Transport of raw milk from holdings situated within the protection zone to establishments situated outside the protection zone and the processing of that milk shall be subject to the following conditions: (a) processing in establishments situated outside the protection zone of raw milk produced from animals of susceptible species kept within the protection zone shall be authorised by the competent authorities; (b) the authorisation shall include instructions on and designation of the transport route to the designated establishment; (c) transport shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, which are constructed and maintained in such a way that there is no leakage of milk during transport and which are equipped to avoid aerosol dispersion during the loading and unloading of the milk; (d) before leaving the holding from where milk of animals of susceptible species was collected the connection pipes, tires, wheel cases, the lower parts of the vehicle and any spillage of milk are cleansed and disinfected and after the last disinfection and before leaving the protection zone the vehicle had no subsequent contact with holdings in the protection zone keeping animals of susceptible species; (e) the means of transport are strictly assigned to a defined geographical or administrative area, they are marked accordingly and may only be moved to another area after cleansing and disinfection under official supervision. 9. The collection and transport of samples of raw milk of animals of susceptible species from holdings situated in the protection zone to a laboratory other than a veterinary diagnostic laboratory approved for diagnosis of foot-and-mouth disease and the processing of the milk in such laboratories shall be forbidden. Article 28 Measures in relation to semen, ova and embryos collected from animals of susceptible species in the protection zone 1. Member States shall ensure that the placing on the market of semen, ova and embryos derived from animals of susceptible species originating in the protection zone shall be prohibited. 2. By way of derogation, the prohibition provided for in paragraph 1 shall not apply to frozen semen, ova and embryos collected and stored at least 21 days before the estimated date of earliest infection with the foot-and-mouth disease virus on a holding in the zone. 3. Frozen semen collected in accordance with Community legislation after the date of infection referred to in paragraph 2, shall be stored separately and shall only be released after: (a) all the measures relating to the outbreak of foot-and-mouth disease have been removed in accordance with Article 36, and (b) all animals accommodated in the semen collection centre have undergone a clinical examination, and samples taken in accordance with point 2.2 of Annex III have been subjected to a serological test to substantiate the absence of infection in the semen collection centre concerned, and (c) the donor animal has been subjected with negative result to a serological test for the detection of antibodies against the foot-and-mouth disease virus on a sample taken not earlier than 28 days after the collection of the semen. Article 29 Transport and distribution of dung and manure of animals of susceptible species produced in the protection zone 1. Member States shall ensure that the transport and distribution of dung or manure from holdings and premises or means of transport referred to in Article 16 situated in the protection zone where animals of susceptible species are kept, shall be prohibited within the protection zone. 2. By way of derogation from the prohibition in paragraph 1 the competent authority may authorise the removal of manure of animals of susceptible species from a holding situated in the protection zone to a designated plant for treatment in accordance with point 5 of Section II in Part A of Chapter III of Annex VIII to Regulation (EC) No 1774/2002 or for intermediate storage. 3. By way of derogation from the prohibition in paragraph 1 the competent authority may authorise the removal of manure of animals of susceptible species from holdings situated in the protection zone which are not subject to the measures provided for in Articles 4 or 10 for distribution on designated fields under the following conditions: (a) the entire volume of manure has been produced at least 21 days before the estimated date of earliest infection on a holding in the protection zone and the manure or dung is distributed close to the ground and in sufficient distance from holdings keeping animals of susceptible species and immediately incorporated into the ground, or (b) in the case of manure from bovine animals or pigs: (i) an examination by an official veterinarian of all the animals on the holding has ruled out the presence of animals suspected of being infected with the foot-and-mouth disease virus, and (ii) the entire volume of manure has been produced at least 4 days prior to the examination referred to in point (i), and (iii) the manure is incorporated into the ground on designated fields close to the holding of origin and in sufficient distance to other holdings keeping animals of susceptible species in the protection zone. 4. Member states shall ensure that any authorisation to remove dung or manure from a holding keeping animals of susceptible species is subject to stringent measures to avoid spread of the foot-and-mouth disease virus, in particular by ensuring cleansing and disinfection of the leak-proof transport vehicles after loading and before leaving the holding. Article 30 Measures in relation to hides and skins from animals of susceptible species in the protection zone 1. Member States shall ensure that the placing on the market of hides and skins of animals of susceptible species originating in the protection zone shall be prohibited. 2. By way of derogation, the prohibition as provided for in paragraph 1 shall not apply to hides and skins which either: (a) were produced at least 21 days before the estimated date of infection on the holding referred to in Article 10(1), and that have been stored separately from hides and skins produced after that date; or (b) comply with the requirements laid down in point 2 in Part A of Annex VII. Article 31 Measures in relation to sheep wool, ruminant hair and pig bristles produced in the protection zone 1. Member States shall ensure that the placing on the market of sheep wool, ruminant hair and pig bristles originating in the protection zone shall be prohibited. 2. By way of derogation, the prohibition as provided for in paragraph 1 shall not apply to unprocessed wool, hair and bristles which: (a) were produced at least 21 days before the estimated date of infection on the holding referred to in Article 10(1) and have been stored separately from wool, hair and bristles produced after that date; or (b) comply with the requirements laid down in point 3 in Part A of Annex VII. Article 32 Measures in relation to other animal products produced in the protection zone 1. Member States shall ensure that the placing on the market of animal products derived from animals of susceptible species not referred to in Articles 25 to 31 shall be prohibited. 2. By way of derogation, the prohibitions provided for in paragraph 1 shall not apply to products referred to in paragraph 1 which: (a) either have been produced at least 21 days before the estimated date of infection on the holding referred to in Article 10(1) and have been stored and transported separately from products produced after that date, or (b) have undergone the treatment in accordance with point 4 in Part A of Annex VII, or (c) for specific products, comply with the appropriate requirements in points 5 to 9 in Part A of Annex VII, or (d) are composite products which are not subject to further treatment containing products of animal origin which either have undergone a treatment ensuring destruction of possible foot-and-mouth disease virus or have been obtained from animals not subject to restrictions under the provisions of this Directive, or (e) are packed products intended for use as in-vitro diagnostic or laboratory reagents. Article 33 Measures in relation to feed, forage, hay and straw produced in the protection zone 1. Member State shall ensure that the placing on the market of feed, forage, hay and straw originating in the protection zone shall be prohibited. 2. By way of derogation, the prohibition provided for in paragraph 1 shall not apply to feed, forage, hay and straw: (a) produced at least 21 days before the estimated date of infection on holdings referred to in Article 10(1), and stored and transported separately from feed, forage, hay and straw produced after that date; or (b) intended for use within the protection zone, subject to authorisation by the competent authorities; or (c) produced on premises not keeping animals of susceptible species; or (d) produced in establishments not keeping animals of susceptible species and sourcing the raw material from premises referred to in paragraph (c) or from premises situated outside the protection zone. 3. By way of derogation, the prohibition provided for in paragraph 1 shall not apply to forage and straw produced on holdings keeping animals of susceptible species which comply with the requirements in point 1 in Part B of Annex VII. Article 34 Granting of derogations and additional certification 1. Any derogation from the prohibitions provided for in Articles 24 to 33 shall be granted by a specific decision of the competent authority only after it has satisfied itself that all relevant requirements have been met for a sufficient period before the products leave the protection zone, and that there is no risk of spreading the foot-and-mouth disease virus. 2. Any derogation from the prohibitions provided for in Articles 25 to 33 requires, in the case of intra-Community trade, additional certification by the competent authority. 3. Detailed rules for the implementation of the measures provided for in paragraph 2 may be adopted in accordance with the procedure referred to in Article 89(2). Article 35 Additional measures applied by Member States in the protection zone In addition to the measures applicable in the protection zone in accordance with this Directive, Member States may take additional national measures which are deemed necessary and proportionate to contain the foot-and-mouth disease virus taking into account the particular epidemiological, animal husbandry, commercial and social conditions prevailing in the affected area. Member States shall inform the Commission and the other Member States about such additional measures. Article 36 Removal of measures in the protection zone 1. Member States shall ensure that the measures applied in the protection zone are maintained until the following requirements have been met: (a) at least 15 days have elapsed since the killing and safe disposal of all the animals of susceptible species from the holding referred to in Article 10(1) and the completion of the preliminary cleansing and disinfection on that holding, carried out in accordance with Article 11; (b) a survey has been concluded with negative results in all holdings keeping animals of susceptible species and situated within the protection zone. 2. After the removal of the measures specific to the protection zone, the measures applied in the surveillance zone as provided for in Articles 37 to 42, shall continue to apply for at least 15 days until those measures are removed in accordance with Article 44. 3. The survey referred to in paragraph 1(b) shall be carried out to substantiate the absence of infection and at least in compliance with the criteria of point 1 of Annex III and shall include the measures provided for in point 2.3 of Annex III based on the criteria set out in points 2.1.1. and 2.1.3. of Annex III. Article 37 Measures to be applied to holdings in the surveillance zone 1. Member States shall ensure that the measures provided for in Article 22(1) are applied in the surveillance zone. 2. By way of derogation from the prohibition provided for in Article 22(1)(c) and where there is no or insufficient slaughter capacity available within the surveillance zone, the competent authorities may authorise the removal from holdings situated in the surveillance zone of animals of susceptible species for transporting them directly and under official supervision for slaughter to a slaughterhouse located outside the surveillance zone, subject to the following conditions: (a) the records referred to in Article 22(1) have been subjected to official control, and the epidemiological situation of the holding does not indicate any suspicion of infection or contamination with the foot-and-mouth disease virus, and (b) all the animals of susceptible species on the holding have been subjected with negative result to an inspection by the official veterinarian, and (c) a representative number of animals, taking into account the statistical parameters in point 2.2 of Annex III, has been subjected to thorough clinical examination to rule out the presence or suspicion of clinically infected animals, and (d) the slaughterhouse is designated by the competent authority and located as near to the surveillance zone as possible, and (e) the meat produced from such animals shall be subject to the treatment specified in Article 39. Article 38 Movement of animals of susceptible species within the surveillance zone 1. Member States shall ensure that animals of susceptible species shall not be removed from holdings within the surveillance zone. 2. By way of derogation, the prohibition provided for in paragraph 1 shall not apply to movement of animals for one of the following purposes: (a) for leading them without coming into contact with animals of susceptible species of different holdings to pasture situated within the surveillance zone not earlier than 15 days after the last outbreak of foot-and-mouth disease has been recorded in the protection zone; (b) for transporting them directly and under official supervision for the purpose of slaughter to a slaughterhouse located inside the same zone; (c) for transporting them in accordance with Article 37(2); (d) for transporting them in accordance with Article 24(2)(a) and (b). 3. Movements of animals provided for in paragraph 2(a) shall be authorised by the competent authority only after an examination by an official veterinarian of all the animals of susceptible species on the holding, including testing of samples taken in accordance with point 2.2 of Annex III, has ruled out the presence of animals suspected of being infected or animals suspected of being contaminated. 4. Movements of animals provided for in paragraph 2(b) shall be authorised by the competent authority only after the measures provided for in Article 37(2)(a) and (b) have been completed with satisfactory results. 5. Member States shall without delay trace animals of susceptible species dispatched from the surveillance zone during a period of least 21 days before the estimated date of earliest infection on a holding in the surveillance zone and they shall inform the competent authorities in other Member States about their results from tracing animals. Article 39 Measures to be applied to fresh meat of animals of susceptible species originating in the surveillance zone and meat products produced from such meat 1. Member States shall ensure that the placing on the market of fresh meat, minced meat and meat preparations derived from animals of susceptible species originating in the surveillance zone and of meat products produced from such meats shall be prohibited. 2. Member States shall ensure that the placing on the market of fresh meat, minced meat, meat preparations and meat products from animals of susceptible species produced in establishments situated in the surveillance zone shall be prohibited. 3. By way of derogation, the prohibition provided for in paragraph 1 shall not apply to fresh meat, minced meat and meat preparations which were produced on a date at least 21 days before the estimated date of earliest infection on a holding in the corresponding protection zone and which since production have been stored and transported separately from such meats produced after that date. Such meats must be readily distinguished from meats not eligible for dispatch outside the surveillance zone by means of clear mark established in conformity with Community legislation. 4. By way of derogation, the prohibition provided for in paragraph 1 shall not apply to fresh meat, minced meat and meat preparations which were produced from animals transported to the slaughterhouse under conditions at least as strict as provided for in Article 37(2)(a) to (e) under the condition that the meat is subject to the measures provided for in paragraph 5. 5. By way of derogation, the prohibition provided for in paragraph 2, shall not apply to fresh meat, minced meat or meat preparations obtained from establishments situated in the surveillance zone under the following conditions: (a) the establishment shall be operated under strict veterinary control; (b) only fresh meat, minced meat or meat preparations as described in paragraph 4 and subject to the additional conditions provided for in Part B of Annex VIII or obtained from animals reared and slaughtered outside the surveillance zone or obtained from animals transported in accordance with the provisions in Article 24(2)(b) shall be processed in the establishment; (c) all such fresh meat, minced meat or meat preparations must bear the health mark in accordance with Chapter XI of Annex I to Directive 64/433/EEC or in the case of meat from other biungulates the health mark provided for in Chapter III of Annex I to Directive 91/495/EEC, or in the case of minced meat and meat preparations the health mark as provided for in Chapter VI of Annex I to Directive 95/65/EC; (d) during the whole production process all such fresh meat, minced meat or meat preparations must be clearly identified, and transported and stored separately from fresh meat, minced meat or meat preparations which are not eligible for dispatch outside the surveillance zone in accordance with this Directive. 6. By way of derogation, the prohibition provided for in paragraph 1, shall not apply to meat products produced from fresh meat obtained from animals of susceptible species originating in the surveillance zone which was marked with the health mark provided for Directive 2002/99/EC and transported under official supervision to a designated establishment for treatment in accordance with point 1 in Part A of Annex VII. 7. By way of derogation, the prohibition provided for in paragraph 2, shall not apply to meat products produced in establishments situated in the surveillance zone and either complying with the provisions in paragraph 6, or produced from meat complying with paragraph 5. 8. Compliance with the conditions in paragraphs 5 and 7 shall be certified by the competent authority for fresh meat, minced meat and meat preparations intended for intra-Community trade. The competent authority shall supervise the control of compliance undertaken by the local veterinary authority and in the case of intra-Community trade communicate to other Member States and the Commission a list of those establishments which it has approved for the purpose of such certification. 9. Derogation from the prohibition provided for in paragraph 1 may be granted subject to specific conditions adopted in accordance with the procedure referred to in Article 89(3), in particular with regard to the health marking of meat produced from animals of susceptible species originating in surveillance zone maintained for more than 30 days. Article 40 Measures to be applied to milk and milk products of animals of susceptible species produced in the surveillance zone 1. Member States shall ensure that placing on the market of milk derived from animals of susceptible species originating in the surveillance zone and of milk products produced from such milk shall be prohibited. 2. Member States shall ensure that the placing on the market of milk and milk products from animals of susceptible species produced in the surveillance zone shall be prohibited. 3. By way of derogation, the prohibition provided for in paragraph 1 shall not apply to milk and milk products derived from animals of susceptible species originating in the surveillance zone which were produced on a date at least 21 days before the estimated date of earliest infection on a holding in the corresponding protection zone and which since production have been stored and transported separately from milk and milk products produced after that date. 4. By way of derogation, the prohibition provided for in paragraph 1 shall not apply to milk derived from animals of susceptible species originating in the surveillance zone and milk products produced from such milk which have undergone one of the treatments as set out in Parts A or B of Annex IX depending on the use of the milk or milk products. The treatment shall be carried out under the condition set out in paragraph 6 in establishments referred to in paragraph 5 or, if there is no establishment situated in the surveillance zone, in establishments designated by the competent authorities and situated outside the protection and surveillance zones. 5. By way of derogation, the prohibition provided for in paragraph 2 shall not apply to milk and milk products which have been prepared in establishments situated in the surveillance zone under the conditions set out in paragraph 6. 6. Establishments referred to in paragraphs 4 and 5 shall comply with the following conditions: (a) the establishment shall be operated under strict veterinary control; (b) all milk used in the establishment shall either comply with paragraph 4 or be obtained from animals outside the surveillance and protection zone; (c) throughout the production process the milk shall be clearly identified and transported and stored separately from milk and milk products which are not destined for dispatch outside the surveillance zone; (d) transport of raw milk from holdings situated outside the protection and surveillance zone to the establishments shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, and which have had no subsequent contact with holdings in the protection and surveillance zones keeping animals of susceptible species. 7. Compliance with the conditions in paragraph 6 shall be certified by the competent authority for milk intended for intra-Community trade. The competent authority shall supervise the control of compliance undertaken by the local veterinary authority and, in the case of intra-Community trade, communicate to other Member States and the Commission a list of those establishments which it has approved for the purpose of such certification. 8. Transport of raw milk from holdings situated within the surveillance zone to establishments situated outside the protection and surveillance zones and the processing of that milk shall be subject to the following conditions: (a) processing in establishments situated outside the protection and surveillance zones of raw milk produced from animals of susceptible species kept within the surveillance zone shall be authorised by the competent authorities; (b) the authorisation shall include instructions on and designation of the transport route to the designated establishment; (c) transport shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, which are constructed and maintained in such a way that there is no leakage of milk during transport and which are equipped to avoid aerosol dispersion during the loading and unloading of the milk; (d) before leaving the holding from where milk of animals of susceptible species was collected, the connection pipes, tires, wheel cases, the lower parts of the vehicle and any spillage of milk are cleansed and disinfected and after the last disinfection and before leaving the surveillance zone the vehicle had no subsequent contact with holdings in the protection and surveillance zones keeping animals of susceptible species; (e) the means of transport are strictly assigned to a defined geographical or administrative area, they are marked accordingly and may only be moved to another area after cleansing and disinfection under official supervision. 9. The collection and transport of samples of raw milk of animals of susceptible species from holdings situated in the surveillance zone to a laboratory other than a veterinary diagnostic laboratory approved for diagnosis of foot-and-mouth disease and the processing of the milk in such laboratories shall be subject to official authorisation and measures to avoid any spread of possible foot-and-mouth disease virus. Article 41 Transport and distribution of dung and manure of animals of susceptible species produced in the surveillance zone 1. Member States shall ensure that the transport and distribution of dung or manure from holdings and other premises such as those mentioned in Article 16 situated in the surveillance zone where animals of susceptible species are kept shall be prohibited within and outside that zone. 2. By way of derogation from the prohibition provided for in paragraph 1 the competent authorities may in exceptional circumstances authorise the transport of dung or manure in means of transport thoroughly cleansed and disinfected prior to and after use for distribution in designated areas within the surveillance zone and at sufficient distance to holdings where animals of susceptible species are kept under the following alternative conditions: (a) either an examination by an official veterinarian of all the animals of susceptible species on the holding has ruled out the presence of animals suspected of being infected with the foot-and-mouth disease virus and the manure or dung is distributed close to the ground to avoid the generation of aerosols and immediately ploughed into the ground, or (b) a clinical inspection by an official veterinarian of all the animals of susceptible species on the holding has been carried out with negative result and the manure is injected into ground, or; (c) manure is subject to the provision of Article 29(2). Article 42 Measures in relation to other animal products produced in the surveillance zone Member State shall ensure that the placing on the market of products of animal origin other than those referred to in Articles 39 to 41 shall be subject to the conditions provided for in Articles 28 and 30 to 32. Article 43 Additional measures applied by Member States in the surveillance zone In addition to the measures provided for in Articles 37 to 42, Member States may take additional national measures which are deemed necessary and proportionate to contain foot-and-mouth disease virus taking into account the particular epidemiological, animal husbandry, commercial and social conditions prevailing in the affected area. Where specific measures to restrict the movement of equidae are considered necessary, such measures shall take into account those provided for in Annex VI. Article 44 Removal of measures in the surveillance zone 1. Member states shall ensure that the measures applied in the surveillance zone are maintained until the following requirements have been met: (a) at least 30 days have elapsed since the killing and safe disposal of all animals of susceptible species from the holding referred to in Article 10(1) and the completion of the preliminary cleansing and disinfection on that holding, carried out in accordance with Article 11; (b) the requirements provided for in Article 36 have been met in the protection zone; (c) a survey has been concluded with negative results. 2. The survey referred to in paragraph 1(c) shall be carried out to substantiate the absence of infection in the surveillance zone in compliance with the criteria of point 1 of Annex III and shall include the measures provided for in point 2.4 of Annex III based on the criteria of point 2.1 of Annex III. SECTION 7 REGIONALISATION, MOVEMENT CONTROL AND IDENTIFICATION Article 45 Regionalisation 1. Without prejudice to Directive 90/425/EC, and in particular Article 10 thereof, where the foot-and-mouth disease virus appears to be spreading despite the measures taken in accordance with this Directive and the epizootic becomes extensive and in any case when emergency vaccination is implemented, Member States shall ensure that their territory is regionalised into one or more restricted and free zones. 2. Member States shall notify to the Commission without delay the details of the measures implemented in the restricted zone and the Commission shall review, where necessary amend, and endorse the measures in accordance with the procedure referred to in Article 89(3). 3. Without prejudice to the obligation of Member States to regionalise referred to in paragraph 1, regionalisation, and the measures to be applied within the restricted zone, may be decided in accordance with the procedure referred to in Article 89(3). This decision may extent its effects to neighbouring Member States not infected at the time the measures are taken. 4. Prior to the delimitation of the restricted zone, a thorough epidemiological assessment of the situation shall be carried out, especially with respect to the possible time and probable location of introduction, the possible spread and the probable period of time necessary to eradicate the foot-and-mouth disease virus. 5. The restricted zone shall as far as possible be delimited on the basis of administrative boundaries or geographical barriers. Regionalisation shall take as its starting point larger administrative units rather than regions. The restricted zone may be reduced in the light of the results of the epidemiological inquiry provided for in Article 13, to an area of the size not less than a sub-region, and where necessary the surrounding sub-regions. In the event of the foot-and-mouth disease virus spreading, the restricted zone shall be enlarged by including additional regions or sub-regions. Article 46 Measures applied in a restricted zone of a member state 1. Where regionalisation is applied, Member States shall ensure that at least the following measures are taken: (a) control within the restricted zone of transport and movement of animals of susceptible species, animal products and goods and of the movement of means of transport as potential carriers of foot-and-mouth disease virus; (b) tracing and marking in accordance with Community legislation of fresh meat and raw milk and as far as possible other products in stock not eligible for dispatch outside the restricted zone; (c) specific certification of animals of susceptible species and products derived from such animals and health marking, in accordance with Community legislation, of products for human consumption intended and eligible for dispatch outside the restricted zone. 2. Where regionalisation is applied, Member States shall ensure that at least the animals of susceptible species dispatched from the restricted zone to other Member States during the time between the date of estimated introduction of the foot-and-mouth disease virus until the date regionalisation is implemented shall be traced, and such animals shall be isolated under official veterinary control until possible infection or contamination is officially ruled out. 3. Member States shall collaborate in tracing fresh meat and raw milk and raw milk products derived from animals of susceptible species produced in the restricted zone between the date of estimated introduction of the foot-and-mouth disease virus until the date regionalisation is implemented. Such fresh meat shall be treated in accordance with point 1 in Part A of Annex VII, and raw milk and milk products shall be treated in accordance with Part A or B of Annex IX depending on the use, or detained until possible contamination with the foot-and-mouth disease virus is officially ruled out. 4. Specific measures, in particular in relation to health marking of products derived from animals of susceptible species originating in the restricted zone and not intended for placing on the market outside the restricted zone may be adopted in accordance with Article 4(3) of Directive 2002/99/EC. Article 47 Identification of animals of susceptible species 1. Without prejudice to Community legislation on identification of domestic bovine, ovine and caprine animals and swine, Member States shall ensure that in the event of an outbreak of foot-and-mouth disease on their territory animals of susceptible species shall only leave the holding on which they are kept, if they are identified in such a way as to enable the competent authorities to trace rapidly their movements and their holding of origin, or any holding from which they have come. However, for special cases referred to in Article 15(1) and Article 16(1), the competent authority may, in certain circumstances and having regard to the health situation, authorise other ways of rapidly tracing the movement of those animals and of their holding of origin, or of any holding from which they have come. The arrangements for identifying such animals or for tracing their holdings of origin shall be determined by the competent authority and notified to the Commission. 2. The measures taken by Member States on additional, permanent and indelible marking of animals for the particular purpose of control of the foot-and-mouth disease, and in particular in case of vaccination carried out in accordance with Articles 52 and 53, may be modified in accordance with the procedure referred to in Article 89(3). Article 48 Movement control in case of an outbreak of foot-and-mouth disease 1. Member States shall ensure that in the event of an outbreak of foot-and-mouth disease on their territory the following measures to control movement of animals of susceptible species are applied in the restricted zone established in accordance with Article 45: (a) owners shall supply the competent authority, on request of that authority, with appropriate information concerning animals entering or leaving their holding. That information shall, in relation to all animals of susceptible species, include at least the details required by Article 14 of Directive 64/432/EEC; (b) persons engaged in the transport or marketing of animals of susceptible species shall supply the competent authority, on request of that authority, with appropriate information concerning the movements of such animals which they have transported or marketed. That information shall include at least the details required by Articles 12(2) and 13(1)(b) of Directive 64/432/EEC. 2. Member States may extend some or all the measures provided for in paragraph 1 to a part or the entire free zone. SECTION 8 VACCINATION Article 49 Use, manufacture, sales and controls of foot-and-mouth disease vaccines Member States shall ensure that: (a) the use of foot-and-mouth disease vaccines and the administration of hyperimmune sera against foot-and-mouth disease are prohibited on their territory except as provided for in this Directive; (b) the production, storage, supply, distribution and sale of foot-and-mouth disease vaccines on their territory are carried out under official control; (c) the marketing of foot-and-mouth disease vaccines is under the supervision of the competent authorities in accordance with Community legislation; (d) the use of foot-and-mouth disease vaccines for purposes other than to induce active immunity in animals of susceptible species, notably laboratory investigations, scientific research or testing of vaccines, is authorised by the competent authorities and carried out under appropriate bio-security conditions. Article 50 Decision on introducing emergency vaccination 1. It may be decided to introduce emergency vaccination where at least one of the following conditions applies: (a) outbreaks of foot-and-mouth disease have been confirmed and threaten to become widespread in the Member State where such outbreaks have been confirmed; (b) other Member States are at risk due to the geographical situation of or the prevailing meteorological conditions in relation to reported outbreaks of foot-and-mouth disease in a Member State; (c) other Member States are at risk due to epidemiologically relevant contacts between holdings on their territories and holdings keeping animals of susceptible species in a Member State where there are outbreaks of foot-and-mouth disease; (d) Member States are at risk due to the geographical situation or the prevailing meteorological conditions in a neighbouring third country where there are outbreaks of foot-and-mouth disease. 2. When deciding on the introduction of emergency vaccination, consideration shall be given to the measures provided for in Article 15 and to the criteria listed in Annex X. 3. The decision to introduce emergency vaccination shall be adopted in accordance with the procedure referred to in Article 89(3). 4. The decision referred to in paragraph 3 to introduce emergency vaccination on its own territory may be requested: (a) either by the Member State referred to in paragraph 1(a), or (b) by a Member State referred to in paragraph 1(b), (c) or (d). 5. By way of derogation from paragraph 3, the decision to introduce emergency vaccination may be taken by the Member State concerned and implemented in accordance with this Directive, after a written notification to the Commission which shall include the specifications provided for in Article 51. 6. If a Member State introduces emergency vaccination in accordance with paragraph 5, that decision shall be immediately reviewed in the Standing Committee on the Food Chain and Animal Health and Community measures shall be adopted in accordance with the procedure referred to in Article 89(3). 7. By way of derogation from paragraph 4, a decision to introduce emergency vaccination in a Member State referred to in paragraph (1)(a) may be adopted in concertation with the affected Member State in accordance with the procedure referred to in Article 89(3) on the Commission's own initiative, if the condition in paragraph (1)(a) and paragraph (1)(b) apply. Article 51 Conditions for emergency vaccination 1. The decision to introduce emergency vaccination in accordance with Article 50(3) and (4) shall specify the conditions under which such vaccination shall be carried out and these conditions must specify at least: (a) the delimitation in accordance with Article 45 of the geographical area in which emergency vaccination is to be carried out; (b) the species and the age of the animals to be vaccinated; (c) the duration of the vaccination campaign; (d) a specific prohibition on movements of vaccinated and non-vaccinated animals of susceptible species and their products; (e) the special additional and permanent identification and special registration of the vaccinated animals pursuant to Article 47(2); (f) other matters appropriate to the emergency situation. 2. The conditions for emergency vaccination as provided for in paragraph 1, shall ensure that such vaccination is carried out in accordance with Article 52, irrespective of whether the vaccinated animals are subsequently slaughtered or stay alive. 3. Member States shall ensure that an information programme shall be put in place to inform the public about the safety of meat, milk and dairy products from vaccinated animals for human consumption. Article 52 Protective vaccination 1. Member States applying protective vaccination shall ensure that: (a) the vaccination zone shall be regionalised in accordance with Article 45, where necessary in close cooperation with neighbouring Member States; (b) vaccination shall be carried out swiftly and in conformity with the rules of hygiene and bio-security so as to avoid the spread of foot-and-mouth disease virus; (c) all measures applied in the vaccination zone shall be carried out without prejudice to the measures provided for in Section 7; (d) where the vaccination zone includes parts of or the entire protection or surveillance zone: (i) the measures applicable for the protection zone or surveillance zone in accordance with this Directive shall be maintained within that part of the vaccination zone until such measures have been removed in accordance with Article 36 or Article 44; (ii) after the measures applied in the protection zone and surveillance zone have been removed, the measures applicable for the vaccination zone as provided for in Articles 54 to 58 shall continue to apply. 2. Member States applying protective vaccination shall ensure that the vaccination zone is surrounded by a surveillance area (surveillance zone as defined by OIE) of at least 10 km width from the perimeters of the vaccination zone: (a) in which vaccination is prohibited; (b) in which intensified surveillance is carried out; (c) in which the movement of animals of susceptible species is subject to controls by the competent authorities; (d) which remains in place until the foot-and-mouth disease and infection free status is recovered in accordance with Article 61. Article 53 Suppressive vaccination 1. Member States shall notify the Commission if they decide in accordance with Article 50 and taking into account all relevant circumstances, to introduce suppressive vaccination and shall provide details of the control measures to be taken which shall include at least those provided for in Article 21. 2. Member States shall ensure that suppressive vaccination is carried out: (a) only within a protection zone; (b) only on clearly identified holdings subject to the measures provided for in Article 10(1) and in particular subparagraph (a) thereof. However, for logistical reasons and by way of derogation from Article 10(1)(a), the killing of all animals on such holdings may be delayed as long as necessary to comply with Directive 93/119/EEC and the provisions of Article 10(1)(c) of this Directive. Article 54 Measures applicable in the vaccination zone during the period from the beginning of emergency vaccination until at least 30 days have elapsed following the completion of such vaccination (Phase 1) 1. Member States shall ensure that the measures provided for in paragraphs 2 to 6 are applied in the vaccination zone during the period from the beginning of the emergency vaccination until at least 30 days have elapsed following the completion of such vaccination. 2. Movement of live animals of susceptible species shall be prohibited between holdings within and out of the vaccination zone. By way of derogation from the prohibition provided for in the first subparagraph, and after clinical inspection of such live animals and the herds of origin or dispatch of those animals, the competent authorities may authorise their direct transport for immediate slaughter in a slaughterhouse designated by the competent authority and situated within the vaccination zone or in exceptional cases close to that zone. 3. Fresh meat produced from vaccinated animals slaughtered during the period referred to in paragraph 1 shall: (a) bear the mark provided for in Directive 2002/99/EC; (b) be stored and transported separately from meat not bearing the mark referred to in point (a), and shall subsequently be transported in sealed containers to an establishment designated by the competent authorities for treatment in accordance with point 1 in Part A of Annex VII. 4. Milk and milk products produced from vaccinated animals may be placed on the market within or outside the vaccination zone, provided that, depending on the final use for either human consumption or non-human consumption, it has undergone at least one of the treatments referred to in Parts A and B of Annex IX. The treatment shall be carried out under the conditions set out in paragraph 5 in establishments situated in the vaccination zone or, if there is no establishment in that zone, in establishments situated outside the vaccination zone to which the raw milk is transported under the conditions set down in paragraph 7. 5. Establishments referred to in paragraphs 4 shall comply with the following conditions: (a) the establishment shall be operated under permanent and strict official control; (b) all milk used in the establishment shall either comply with paragraph 4 or the raw milk shall be obtained from animals outside the vaccination zone; (c) during the whole production process the milk shall be clearly identified and transported and stored separately from raw milk and raw milk products which are not destined for dispatch outside the vaccination zone; (d) transport of raw milk from holdings situated outside the vaccination zone to the establishments shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, and which have had no subsequent contact with holdings in a restricted zone keeping animals of susceptible species. 6. Compliance with the conditions in paragraph 5 shall be certified by the competent authority for milk intended for intra-Community trade. The competent authority shall supervise the control of compliance undertaken by the local veterinary authority and in the case of intra-Community trade communicate to other Member States and the Commission a list of those establishments which it has approved for the purpose of such certification. 7. Transport of raw milk from holdings situated within the vaccination zone to establishments situated outside the vaccination zone and the processing of that milk shall be subject to the following conditions: (a) processing in establishments situated outside the vaccination zone of raw milk produced from animals of susceptible species kept within the vaccination zone shall be authorised by the competent authorities; (b) the authorisation shall include instructions on and designation of the transport route to the designated establishment; (c) transport shall be carried out in vehicles which were cleaned and disinfected prior to the transport operation, which are constructed and maintained in such a way that there is no leakage of milk during transport and which are equipped to avoid aerosol dispersion during the loading and unloading of the milk; (d) before leaving the holding from where milk of animals of susceptible species was collected, the connection pipes, tires, wheel cases, the lower parts of the vehicle and any spillage of milk are cleansed and disinfected and after the last disinfection and before leaving the vaccination zone the vehicle had no subsequent contact with holdings in the vaccination zone keeping animals of susceptible species; (e) the means of transport are strictly assigned to a defined geographical or administrative area, they are marked accordingly and may only be moved to another area after cleansing and disinfection under official supervision. 8. The collection and transport of samples of raw milk of animals of susceptible species from holdings situated in the vaccination zone to a laboratory other than a veterinary diagnostic laboratory approved for diagnosis of foot-and-mouth disease and the processing of the milk in such laboratories shall be forbidden. 9. The collection of semen for artificial insemination from donor animals of susceptible species kept in semen collection centres situated within the vaccination zone shall be suspended. By way of derogation from the prohibition provided for in the first subparagraph, the competent authorities may authorise the collection of semen at semen collection centres within the vaccination zone for the production of frozen semen, subject to the following conditions: (a) it is ensured that the semen collected during the period referred to in paragraph 1 is stored separately for at least 30 days, and (b) prior to dispatch of the semen: (1) either the donor animal has not been vaccinated and the conditions of Article 28(3)(b) and (c) apply, or (2) the donor animal has been vaccinated following a negative test for antibodies against foot-and-mouth disease virus carried out prior to vaccination; and (i) a negative result has been achieved in a test for the detection of either virus or viral genome or an approved test for the detection of antibody against non-structural proteins, carried out at the end of the quarantine period for the semen on samples taken from all animals of susceptible species present at that time on the semen collection centre, and (ii) the semen complies with the conditions of Article 4(3) of Chapter II of Directive 88/407/EEC. 10. Collection of ova and embryos from donor animals shall be prohibited. 11. The placing on the market of products of animal origin other than those referred to in paragraphs 9 and 10 shall be subject to the conditions provided for in Articles 30, 31, 32 and 41. Article 55 Measures applicable in the vaccination zone during the period from emergency vaccination until the survey and the classification of holdings are completed (Phase 2) 1. Member States shall ensure that the measures provided for in paragraphs 2 to 5 are applied in the vaccination zone during a period starting not earlier than 30 days from the date of completion of emergency vaccination and terminating with the completion of the measures provided for in Articles 56 and 57. 2. Movement of animals of susceptible species between holdings within and out of the vaccination zone shall be prohibited. 3. By way of derogation from the prohibition provided for in paragraph 2, the competent authorities may authorise direct transport for immediate slaughter of animals of susceptible species from holdings referred to in Article 57(5) to a slaughterhouse situated within or out of the vaccination zone on the following conditions: (a) during transport and in the slaughterhouse those animals shall not come into contact with other animals of susceptible species; (b) the animals shall be accompanied by an official document certifying that all animals of susceptible species on the holding of origin or dispatch have undergone a survey provided for in Article 56(2); (c) the transport vehicles shall be cleansed and disinfected before loading and after the animals have been delivered, with the date and time of the cleaning and disinfection being recorded in the logbook of the means of transport; (d) the animals shall have passed the ante-mortem health inspection at the slaughterhouse during the 24 hours before slaughter and have in particular undergone examination for mouth and feet disease and not shown signs of that disease. 4. Fresh meat, excluding offal, produced from vaccinated large and small ruminants during the period referred to in paragraph 1, may be placed on the market within and outside the vaccination zone under the following conditions: (a) the establishment shall be operated under strict veterinary control; (b) only fresh meat, excluding offal, which was subjected to the treatment described in points 1, 3 and 4 in Part A of Annex VIII or fresh meat obtained from animals reared and slaughtered outside the vaccination zone shall be processed in the establishment; (c) all such fresh meat shall bear the health mark in accordance with Chapter XI of Annex I to Directive 64/433/EEC or, in the case of meat from other biungulates, the health mark provided for in Chapter III of Annex I of Directive 91/495/EEC, or, in the case of minced meat and meat preparations, the health mark provided for in Chapter VI of Annex I of Directive 94/65/EC; (d) throughout the production process the fresh meat shall be clearly identified, and transported and stored separately from meat of different animal health status in accordance with this Directive. 5. Compliance with the conditions in paragraph 4 shall be certified by the competent authority for fresh meat intended for intra-Community trade. The competent authority shall supervise the control of compliance undertaken by the local veterinary authorities and, in the case of intra-Community trade, communicate to other Member States and the Commission a list of those establishments which it has approved for the purpose of such certification. 6. Fresh meat produced from vaccinated porcine animals slaughtered during the period referred to in paragraph 1 shall bear the health mark provided for in Directive 2002/99/EC and shall be stored and transported separately from meat not bearing that mark and subsequently be transported in sealed containers to an establishment designated by the competent authorities for treatment in accordance with point 1 in Part A of Annex VII. 7. Milk and milk products produced from vaccinated animals may be placed on the market within or outside the vaccination zone, provided that depending on the final use for either human consumption or non-human consumption it has undergone at least one of the treatments referred to in Parts A and B of Annex IX. Such treatment shall have been undergone in an establishment located within or outside the vaccination zone in accordance with the provisions in Article 54(4) to (8). 8. For the collection of semen, ova and embryos from animals of susceptible species, the measures provided for in Article 54(9) and (10) shall continue to apply. 9. The placing on the market of products of animal origin other than those referred to in paragraphs 4, 6, 7 and 8 shall be subject to the conditions provided for in Articles 30, 31, 32 and 41. Article 56 Clinical and serological survey in the vaccination zone (Phase 2-A) 1. Member States shall ensure that the measures provided for in paragraphs 2 and 3 are applied in the vaccination zone during a period starting not earlier than 30 days from the date of completion of emergency vaccination and terminating with the completion of a clinical and serological survey. 2. A survey shall be carried out with the aim to identify herds of animals of susceptible species that had contact with the foot-and-mouth disease virus without showing overt clinical signs of the foot-and-mouth disease. That survey shall include a clinical inspection of all animals of susceptible species in all herds in the vaccination zone, and laboratory testing in accordance with paragraph 3. 3. Laboratory testing shall be carried out by use of tests complying with the criteria for diagnostic tests as set out in Annex XIII and approved in accordance with the procedure referred to in Article 89(2), and shall comply with one of the following conditions: (a) testing for infection with the foot-and-mouth disease virus, either by an assay for antibodies against non-structural proteins of the foot-and-mouth disease virus, or by another approved method, shall meet criteria for sampling on holdings set out in point 2.2 of Annex III. Where the competent authorities use in addition sentinel animals, the conditions for restocking of infected holdings in Annex V shall be taken into account; (b) testing for antibodies against non-structural proteins of the foot-and-mouth disease virus shall be carried out on samples taken from all vaccinated animals of susceptible species and their non-vaccinated offspring in all herds in the vaccination zone. Article 57 Classification of herds in the vaccination zone (Phase 2-B) 1. Member States shall ensure that the holdings containing animals of susceptible species: (a) are classified according to the outcome of the survey referred to in Article 56(2) and the criteria set out in Annex I; (b) comply with the measures set out in paragraphs 2 to 4. 2. Holdings containing at least one animal suspected of being infected and where the presence of foot-and-mouth disease virus is confirmed in accordance with the criteria laid down in Annex I shall be subject to the measures provided for in Articles 10 and 21. 3. Holdings containing at least one animal of susceptible species suspected of being infected through previous contact with the foot-and-mouth disease virus but where further testing including all animals of susceptible species present on the holding confirmed the absence of circulating foot-and-mouth disease virus shall be subject to at least the following measures: (a) animals of susceptible species on the holding shall: (1) either be killed and the carcasses processed, or (2) the animals shall be classified and (i) the animals positive to at least one of the approved tests referred to in Article 56(3) shall be killed and their carcasses processed, and (ii) the remaining animals of susceptible species on the holding shall be slaughtered under conditions authorised by the competent authorities; (b) cleansing and disinfection of the holdings in accordance with Article 11; (c) restocking of animals in accordance with Annex V. 4. Member States shall ensure that the following measures are applied to products derived from animals of susceptible species and produced during the period referred to in Article 56(1): (a) fresh meat produced from the animals referred to in paragraph 3(2)(ii) shall be subject to Article 55(4), for meat from ruminants, and (6), for meat from porcine animals, respectively; (b) milk and milk products produced from the animals referred to in paragraph 3(2)(ii) shall undergo at least one of the treatments specified in Parts A and B of Annex IX depending on the intended use and in compliance with the provisions in Article 54(4) to (8). 5. Animals of susceptible species on holdings where the presence of previous or present infection with the foot-and-mouth disease virus has been officially ruled out in accordance with Article 56(3) may be subject to the measures provided for in Article 58. Article 58 Measures applicable in the vaccination zone after the completion of the survey and the classification of holdings until the foot-and-mouth disease and infection free status is recovered (Phase 3) 1. Member States shall ensure that the measures provided for in paragraphs 2 to 6 are applied in the vaccination zone after the completion of the measures laid down in Article 57 and until the foot-and-mouth disease and infection-free status has been recovered in accordance with Article 59. 2. Member States shall ensure that movement of animals of susceptible species between holdings situated in the vaccination zone is subject to authorisation. 3. Movement of animals of susceptible species out of the vaccination zone shall be prohibited. By way of derogation from this prohibition, direct transport to a slaughterhouse for immediate slaughter of animals of susceptible species may be authorised under the conditions provided for in Article 55(3). 4. By way of derogation from the prohibition in paragraph 2, the competent authorities may authorise the transport of unvaccinated animals of susceptible species in accordance with the following provisions: (a) within 24 hours of loading, all animals of susceptible species on the holding have been subjected to clinical examination and have not shown clinical signs of foot-and-mouth disease, and (b) the animals have completed a standstill on the holding of origin of at least 30 days during which no animal of susceptible species has been introduced onto the holding, and (c) the holding of origin is not situated in a protection or surveillance zone, and (d) the animals intended for transport were either individually subjected with negative results to tests for the detection of antibodies against the foot-and-mouth disease virus at the end of the isolation period, or a serological survey was completed on that holding in accordance with point 2.2 of Annex III irrespective of the species concerned; (e) the animals were not exposed to any source of infection during their transportation from the holding of origin to the place of destination. 5. Non-vaccinated offspring of vaccinated dams shall be prohibited from leaving the holding of origin unless being transported to: (a) a holding within the vaccination zone of the same health status as the holding of origin; (b) a slaughterhouse for immediate slaughter; (c) a holding designated by the competent authority, from which the offspring are to be sent directly to the slaughterhouse; (d) any holding, after having obtained a negative result in a serological test for the detection of antibody against the foot-and-mouth disease virus carried out on a sample of blood taken prior to dispatch from the holding of origin. 6. Fresh meat produced from unvaccinated animals of susceptible species may be placed on the market inside and outside the vaccination zone under the following conditions: (a) either the measures provided for in Article 57(3) have been completed in the entire vaccination zone or the animals are transported to the slaughterhouse under the conditions provided for in paragraph 3 or 4(d), and; (b) the establishment shall be operated under strict veterinary control; (c) only fresh meat produced from animals referred to in point (a) or from animals reared and/or slaughtered outside the vaccination zone or fresh meat referred to in paragraph 8 shall be processed in the establishment; (d) all such fresh meat shall bear the health mark in accordance with Chapter XI of Annex I to Directive 64/433/EEC or in the case of meat from other biungulates, the health mark provided for in Chapter III of Annex I of Directive 91/495/EEC, or in the case of minced meat and meat preparations the health mark provided for in Chapter VI of Annex I of Directive 94/65/EC; (e) throughout the production process the fresh meat shall be clearly identified, and transported and stored separately from meat of different animal health status in accordance with this Directive. 7. Fresh meat produced from vaccinated animals of susceptible species or from non-vaccinated seropositive offspring of vaccinated dams slaughtered during the period referred to in paragraph 1 shall bear the health mark provided for in Directive 2002/99/EC and shall be stored and transported separately from meat not bearing that stamp and subsequently be transported in sealed containers to an establishment designated by the competent authorities for treatment in accordance with point 1 in Part A of Annex VII. 8. By way of derogation from paragraph 7, fresh meat and trimmed offal produced from vaccinated large and small ruminants or their non-vaccinated seropositive offspring may be placed on the market within and outside the vaccination zone under the following conditions: (a) the establishment shall be operated under strict veterinary control; (b) only fresh meat excluding offal, which was subjected to the treatment described in point 1, 3 and 4 in Part A of Annex VIII or fresh meat referred to in paragraph 6 or produced from animals reared and/or slaughtered outside the vaccination zone are processed in the establishment; (c) all such fresh meat shall bear the health mark in accordance with Chapter XI of Annex I to Directive 64/433/EEC or in the case of meat from other biungulates the health mark provided for in Chapter III of Annex I to Directive 91/495/EEC, or in the case of minced meat and meat preparations the health mark provided for in Chapter VI of Annex I to Directive 94/65/EC; (d) throughout the production process the fresh meat shall be clearly identified, and transported and stored separately from meat which is of different animal health status in accordance with this Directive. 9. By way of derogation from paragraph 7, fresh meat from vaccinated porcine animals and their non-vaccinated seropositive offspring, produced during the period from the beginning of the survey until the measures provided for in Article 57 have been completed in the entire vaccination zone and until at least 3 months have elapsed after the last outbreak recorded in that zone, may only be placed on the national market of the Member State of origin within and outside the vaccination zone under the following conditions: (a) the establishment shall be operated under strict veterinary control; (b) only fresh meat from animals originating in holdings complying with the conditions in Article 57(5) or fresh meat obtained from animals reared and slaughtered outside the vaccination zone are processed in the establishment; (c) all such fresh meat shall bear a health mark to be decided in accordance with Article 4(3) of Directive 2002/99/EC; (d) throughout the production process the fresh meat shall be clearly identified, and transported and stored separately from meat of different animal health status in accordance with this Directive. 10. A Member State other than the Member State referred to in paragraph 9 may request a decision in accordance with the procedure provided for in Article 89(3) to extend the marketing of the meat referred to in paragraph 9 to its territory or part of its territory under conditions to be laid down under the same procedure. 11. The rules for dispatch from the vaccination zone of fresh meat from vaccinated porcine animals produced after the period referred to in paragraph 9 until free status has been regained in accordance with Article 61, shall be decided in accordance with the procedure provided for in Article 89(3). 12. Compliance with the conditions provided for in paragraph 6, paragraph 8 and where applicable under the provisions of paragraph 10, shall be certified by the competent authority for fresh meat intended for intra-Community trade. The competent authority shall supervise the control of compliance undertaken by the local veterinary authorities and shall in the case of intra-Community trade communicate to other Member States and the Commission a list of those establishments which they have approved for such certification. 13. By way of derogation from paragraph 8 a special health mark which cannot be confused with the health mark referred to in paragraphs 8(c) and 9(c), may be decided in accordance with the procedure referred to in Article 89(3) for fresh meat of ruminants not subjected to the treatment in accordance with Part A of Annex VIII, and minced meat and meat preparations produced from such meat, which are intended for placing on the market in the a specific region of the Member State of origin. 14. Milk and milk products produced from vaccinated animals may be placed on the market within and outside the vaccination zone, provided that depending on the final use for either human consumption or non-human consumption it has undergone at least one of the treatments referred to in Parts A and B of Annex IX. Such treatment shall have been undergone in an establishment located in the vaccination zone or in accordance with the provisions in Article 54(4) to (7). 15. The collection and transport of samples of raw milk of animals of susceptible species, from holdings situated in the surveillance zone to a laboratory other than a veterinary diagnostic laboratory approved for diagnosis of foot-and-mouth disease, and the processing of the milk in such laboratories, shall be subject to official authorisation and to appropriate measures to avoid any possible spread of foot-and-mouth disease virus. 16. The placing on the market of products of animal origin other than those referred to in paragraphs 6 to 11 and 13 to 15 shall be subject to the conditions provided for in Articles 30, 31, 32 and 42. SECTION 9 RECOVERY OF THE FOOT-AND-MOUTH DISEASE AND INFECTION FREE STATUS Article 59 Recovery of the foot-and-mouth disease and infection free status The foot-and-mouth disease and infection free status of a Member State or a region thereof shall be recovered in accordance with the procedure referred to in Article 89(3), taking into account the conditions referred to in Articles 60 and 61. Article 60 Recovery of status following eradication of foot-and-mouth disease without emergency vaccination 1. A Member State or region of a Member State regionalised in accordance with Article 45 shall recover its previous foot-and-mouth disease and infection free status following the control and eradication of one or more outbreaks of foot-and-mouth disease without vaccination under the following conditions: (a) all the measures provided for in Articles 36 and 44 have been completed, and (b) at least one of the following conditions applies: (i) the relevant recommendations in the foot-and-mouth disease Chapter, as last amended, of the Animal Health Code of the OIE are met; (ii) at least three months have elapsed after the last recorded outbreak of foot-and-mouth disease and clinical and laboratory surveillance carried out in accordance with Annex III has confirmed the absence of infection with the foot-and-mouth disease virus in the Member State or region concerned. 2. Decisions on recovering a foot-and-mouth disease and infection-free status shall be adopted in accordance with the procedure referred to Article 89(3). Article 61 Recovery of status following eradication of foot-and-mouth disease with vaccination 1. A Member State or region of a Member State regionalised in accordance with Article 45 shall recover its previous foot-and-mouth disease and infection free status following the control and eradication of one or more outbreaks of foot-and-mouth disease with vaccination under the following conditions: (a) all the measures provided for in Articles 36, 44, 54, 55, 56 and 57 have been completed, and (b) at least one of the following conditions applies: (i) the relevant recommendations in the foot-and-mouth disease Chapter, as last amended, of the Animal Health Code of the OIE are met; (ii) at least three months have elapsed since the slaughter of the last vaccinated animal and serological surveillance has been carried out in accordance with the guidelines established in accordance with Article 70(3); (iii) at least six months have elapsed since the last outbreak of foot-and-mouth disease or the completion of emergency vaccination, what ever event occurred later, and in accordance with the guidelines established in accordance with Article 70(3), a serological survey based on the detection of antibodies against non-structural proteins of the foot-and-mouth disease virus has demonstrated the absence of infection in vaccinated animals. 2. Decisions on recovering a foot-and-mouth and infection-free status shall be adopted in accordance with the procedure referred to Article 89(3). Article 62 Modifications of measures to recover the foot-and-mouth disease and infection-free status 1. By way of derogation from Article 60 it may be decided in accordance with the procedure referred to in Article 89(3), to withdraw the restrictions applied in accordance with this Directive after the requirements provided for in Articles 36 and 44 have been met and the clinical and serological survey has been completed and confirmed the absence of foot-and-mouth disease virus infection. 2. By way of derogation from Article 61 it may be decided in accordance with the procedure referred to in Article 89(3), to withdraw the restrictions applied in accordance with this Directive after the clinical and serological survey provided for in Article 56 and the measures provided for in Article 57 have been completed and confirmed the absence of foot-and-mouth disease virus infection. 3. Without prejudice to paragraphs 1 and 2 it may be decided in accordance with the procedure referred to in Article 89(3) that no animals of a susceptible species shall be removed from the territory or region of the Member State where the outbreak of foot-and-mouth disease has occurred to another Member State until the foot-and-mouth disease and infection free status is recovered in accordance with the conditions of the Animal Health Code of the OIE, unless such animals: (a) have not been vaccinated and are consigned directly to a slaughter house for immediate slaughter; or (b) have been isolated for at least 30 days immediately prior to loading and have undergone a serological test for the detection of antibody against foot-and-mouth disease virus structural proteins, carried out with negative results on samples taken during the 10 days prior to loading. 4. Without prejudice to paragraph 2 it may be decided in accordance with the procedure referred to in Article 89(3) that until the foot-and-mouth disease and infection free status is recovered in accordance with the conditions of the Animal Health Code of the OIE the radius of the surveillance area around the vaccination zone referred to in Article 52(2) shall be reduced after the completion with satisfactory results of the measures provided for in Article 57. Article 63 Certification of animals of susceptible species and products derived from such animals for intra-Community trade Member States shall ensure that additional certification for intra-Community trade in animals of susceptible species or products derived from such animals required in accordance with this Directive shall be continued until the foot-and-mouth disease and infection free status of the Member State or part of the territory of a Member State has been recovered in accordance with Articles 60 and 61. Article 64 Movement of vaccinated animals of susceptible species after the recovery of the foot-and-mouth disease and infection-free status 1. The dispatch from one Member State to another Member State of animals of susceptible species vaccinated against foot-and-mouth disease shall be prohibited. 2. By way of derogation from the prohibition in paragraph 1, it may be decided in accordance with the procedure referred to in Article 89(2) to adopt specific measures with regard to vaccinated animals of susceptible species kept in zoos and included in a programme for wildlife conservation or kept on premises for farm animal resources that have been listed by the competent authorities as breeding nucleus of animals indispensable for the survival of the breed, subject to appropriate provisions in the Animal Health Code of the OIE. CHAPTER III PREVENTATIVE MEASURES SECTION 10 LABORATORIES AND ESTABLISHMENTS HANDLING FOOT-AND-MOUTH DISEASE VIRUS Article 65 Laboratories and establishments handling live foot-and-mouth disease virus Member States shall ensure that: (a) laboratories and establishments in which live foot-and-mouth disease virus, its genome, antigens or vaccines produced from such antigens are handled for research, diagnosis or manufacture are strictly controlled by the competent authorities; (b) the handling of live foot-and-mouth disease virus for research and diagnosis is carried out only in approved laboratories listed in Part A of Annex XI; (c) the handling of live foot-and-mouth disease virus for the manufacturing of either inactivated antigens for the production of vaccines or vaccines and related research is carried out only in the approved establishments and laboratories listed in Part B of Annex XI; (d) the laboratories and establishments referred to in points (b) and (c) are operated at least according to the bio-security standards set out in Annex XII. Article 66 Checks of laboratories and establishments handling live foot-and-mouth disease virus Veterinary experts from the Commission, in collaboration with the competent authorities of the Member States, shall carry out spot-checks to ascertain whether the security systems applied in the establishments and laboratories referred to in Parts A and B of Annex XI comply with the bio-security standards set out in Annex XII. Article 67 Modification of the list of approved laboratories and establishments handling live foot-and-mouth disease virus 1. The list of establishments and laboratories in Part A and B of Annex XI may be amended in accordance with the procedure referred to in Article 89(3), in the light of the spot-checks provided for in Article 66. 2. The list of establishments and laboratories in Part A and B of Annex XI shall be regularly updated based on written information submitted by the Member States, in accordance with the procedure referred to in Article 89(2). Article 68 National Laboratories 1. Member States shall ensure that: (a) laboratory testing for foot-and-mouth disease is carried out in laboratories authorised for such testing by the competent authorities; (b) laboratory testing to confirm the presence of foot-and-mouth disease virus or other vesicular disease viruses is carried out in accordance with Article 71 by one of the laboratories listed in Part A of Annex XI; (c) one of the laboratories listed in Part A of Annex XI shall be designated as the national reference laboratory for the Member State on whose territory it is situated, and it shall be responsible for coordinating standards and methods of diagnosis in that Member State; (d) the national reference laboratory carries out at least the functions and duties set out in Annex XV; (e) the national reference laboratory referred to in point (c) liases with the Community Reference Laboratory provided for in Article 69 and in particular ensures the sending of appropriate samples to the Community Reference Laboratory. 2. The national reference laboratory referred to in paragraph 1(c) of one Member State may provide the services of a national reference laboratory to one or more other Member States. Member States which have no national reference laboratory situated on their territory may use the services of the national reference laboratory in one or more other Member States. That cooperation shall be formalised in a mutual agreement between the competent authorities of the Member States concerned, which shall be notified to the Commission. Such cooperation shall be listed in the special column in the table in Part A of Annex XI. 3. Member States shall ensure that laboratory investigations provided for in this Directive are first of all carried out to confirm or rule out foot-and-mouth disease and to exclude other vesicular diseases. Where an outbreak of foot-and-mouth disease has been confirmed and the serotype of the virus was identified, that virus shall be antigenically characterised in relation to the reference vaccine strains, where necessary with the assistance of the Community Reference Laboratory. Samples from domestic livestock showing signs of vesicular disease which are negative for foot-and-mouth disease virus and, where relevant, Swine Vesicular Disease virus shall be sent to the Community Reference Laboratory for further investigation. 4. Member States shall ensure that the national reference laboratory on their territory is adequately equipped and staffed with the appropriate numbers of trained personnel to carry out the laboratory investigations required in accordance with this Directive. Article 69 Community Reference Laboratory 1. The Community Reference Laboratory shall be designated in agreement with the laboratory concerned and in accordance with the procedure referred to in Article 89(2), for a period to be determined under that procedure. 2. When designating a Community Reference Laboratory, the technical and scientific competence of the laboratory as well as the expertise and excellence of the scientific and technical staff employed shall firstly be taken into account. 3. The Commission shall review the designation of the Community Reference Laboratory by the end of the designated period of operation or earlier in the light of its compliance with the functions and duties of the Community Reference Laboratory specified in Annex XVI. Article 70 Security standards and guidelines for surveillance, code of conduct for approved laboratories and establishments handling live foot-and-mouth disease virus 1. An Operational Manual for Minimum Standards for Laboratories working with the foot-and-mouth disease virus in vitro and in vivo may be adopted in accordance with the procedure referred to in Article 89(2). 2. Guidelines for the surveillance required to recover the foot-and-mouth disease and infection free status may be adopted in accordance with the procedure referred to in Article 89(2). 3. A uniform code of good conduct for the security systems applied in the establishments and laboratories listed in Parts A and B of Annex XI may be adopted in accordance with the procedure referred to in Article 89(2). SECTION 11 DIAGNOSIS OF FOOT-AND-MOUTH DISEASE Article 71 Standards and tests for the diagnosis of foot-and-mouth disease and for the differential diagnosis of other vesicular diseases 1. Member States shall ensure that the national laboratories use the tests and standards for diagnosis set out in Annex XIII. 2. A decision regarding the suitable arrangements for the purchase, storage and supply to national laboratories of sufficient quantities of specific reagents or diagnostic tests in case of an emergency, in particular with regard to the measures provided for in Article 56(3) may be adopted in accordance with the procedure referred to in Article 89(2). 3. An Operational Manual for the diagnosis of foot-and-mouth disease and the differential diagnosis of vesicular diseases other than swine vesicular disease may be adopted in accordance with the procedure referred to in Article 89(2). SECTION 12 CONTINGENCY PLANS AND REAL TIME ALERT EXERCISES Article 72 Contingency plans 1. Member States shall draw up a contingency plan specifying the national measures required to maintain a high level of foot-and-mouth disease awareness and preparedness, and environmental protection and to be implemented in the event of an outbreak of foot-and-mouth disease. 2. The contingency plan shall provide for the access to all facilities, equipment, personnel and other appropriate materials necessary for the rapid and efficient eradication of an outbreak of foot-and-mouth disease, it shall ensure coordination with neighbouring Member States and encourage cooperation with neighbouring third countries. 3. The contingency plan shall provide for measures to be implemented in the event of a worst case scenario as referred to in point 12 of Annex XVII and shall give indications of: (a) the vaccine requirements considered necessary in the event of emergency vaccination, and (b) the regions containing densely populated livestock areas, taking into account the criteria set down in Annex X. 4. The contingency plan shall ensure that all necessary arrangements are made to prevent any avoidable damage to the environment in the event of an outbreak, while ensuring at the same time the highest disease control level, and minimise any damage caused as a result of an outbreak, in particular if it is necessary to bury or burn the carcasses of dead or killed animals on site. 5. The criteria and requirements for drawing up the contingency plan shall be those set out in Annex XVII. Those criteria and requirements may be amended taking into account the specific nature of foot-and-mouth disease and progress made in the development of disease control and environmental protection measures in accordance with the procedure referred to in Article 89(2). 6. The Commission shall examine the contingency plans in order to determine whether they permit the objective provided for in paragraph 1 to be attained and shall suggest to the Member State concerned any amendments required, in particular to ensure that such plans are compatible with those of the other Member States. 7. The contingency plans shall be approved in accordance with the procedure referred to in Article 89(2). 8. Member States shall ensure that significant modifications in their approved contingency plans are notified to the Commission without delay. 9. The revised contingency plans may subsequently be approved in accordance with the procedure referred to in Article 89(2), to take into account developments in the situation. 10. In any case, every five years each Member State shall update its contingency plan in particular in the light of real-time alert exercises referred to in Article 73, and submit it to the Commission for approval in accordance with the procedure referred to in Article 89(2). Article 73 Real-time alert exercises 1. Member States shall ensure that real-time alert exercises are carried out in accordance with their approved contingency plan and Annex XVII. 2. Member States shall ensure that, where possible and practical, real-time alert exercises are carried out in close collaboration with the competent authorities of neighbouring Member States or third countries. 3. Member States shall inform the Commission about the main results of real-time alert exercises. That information shall be submitted to the Commission as part of the information required in Article 8 of Directive 64/432/EEC. SECTION 13 CONTROL CENTRES AND EXPERT GROUPS Article 74 National/Central disease control centres - Functions and duties 1. Member States shall ensure that a fully functional national/central disease control centre may be immediately established in the event of foot-and-mouth disease outbreaks. 2. The national/central disease control centre shall first of all direct and monitor the operations of local disease control centres as provided for in Article 76. Certain functions originally attributed to the national/central disease control centre may subsequently be transferred to the local disease control centre operated at the administrative level provided for in Article 2(2)(p) of Directive 64/432/EEC or higher provided that the tasks of the national disease control centre are not compromised. 3. The national/central disease control centre shall be at least responsible for: (a) designing the necessary control measures; (b) ensuring the prompt and efficient implementation of those measures by the local disease control centres; (c) deploying staff and other resources to local disease control centres; (d) providing information to the Commission, to the competent authorities of other Member States and other national authorities including competent environmental authorities and bodies, as well as veterinary, agricultural and trading organisations and bodies; (e) organising an emergency vaccination campaign and also the delimitation of vaccination zones; (f) liasing with diagnostic laboratories; (g) liasing with competent environmental authorities to coordinate the actions on veterinary and environmental safety; (h) liasing with the media; (i) liasing with the enforcement bodies to ensure adequate implementation of specific legal measures. Article 75 National/Central disease control centres - Technical requirements 1. Member States shall ensure that the national/central disease control centres have all the necessary means including staff, facilities and equipment, to manage an efficient eradication campaign. 2. The means referred to in paragraph 1 shall include at least the following: (a) a herd identifier and animal location system, preferably computerised; (b) all suitable means of communication including telephones, fax and if possible facilities for communication with the media; (c) a communication system allowing exchange of information with the local disease control centres, the laboratories and other relevant organisations, preferably computerised; (d) maps and other sources of information that can be used in directing control measures; (e) a shared daily journal which shall be maintained to record in chronological order all the events associated with an outbreak of foot-and-mouth disease and allowing different activities to be linked and coordinated; (f) lists of national and international organisations and laboratories that are interested in an outbreak of foot-and-mouth and shall be contacted in such an event; (g) lists of staff and other persons who may be called upon immediately to serve at local disease control centres or in expert groups provided for in Article 78 in the event of an outbreak of foot-and-mouth disease; (h) lists of competent environmental protection authorities and bodies to contact in the event of an outbreak of foot-and-mouth disease; (i) maps identifying appropriate processing site areas; (j) lists of treatment and processing undertakings authorised to treat or process animal carcasses and animal waste that could be commissioned in the event of an outbreak of foot-and-mouth disease, in particular, indicating their capacity, address and other contact details; (k) lists of measures to monitor and control disinfectant run-off as well as body tissue and fluid displacement into the surrounding environment as a result of carcass decomposition, particularly into surface waters and groundwaters. Article 76 Local disease control centres - set-up, functions and duties 1. Member States shall ensure that fully functional local disease control centres may be established immediately in the event of outbreaks of foot-and-mouth disease. 2. Member States shall ensure that within the framework of their contingency plans provisions are made for likely locations of local disease control centres, their organisation, staff, accommodation, facilities and equipment, management systems, communication lines as well as information channels. 3. Member States shall ensure the local disease control centres act in close coordination and cooperation with the national/central disease control centre, in particular in relation to the measures provided for in Article 74(3)(b). 4. Member States shall ensure that local disease control centres have the necessary organisation to ensure the prompt implementation of the measures provided for in this Directive to be applied in the event of an outbreak of foot-and-mouth disease. Article 77 Local disease control centres - Technical requirements 1. Member States shall ensure that the local disease control centres have staff, facilities and equipment as required, and a clear management structure and effective management to ensure the prompt implementation of the measures relating to the epidemiological inquiry, environmental protection, processing of carcasses from infected herds, official surveillance of the zones, tracing, welfare and emergency slaughter, cleansing and disinfection and others measures of sanitation, emergency vaccination, and all other policy decisions. 2. The local disease control centres shall have at least: (a) one telephone line reserved for communication with the national disease control centre accessible phone lines where farmers and other rural residents can obtain recent, accurate information about the measures taken; (b) field staff equipped with necessary tools for communication and effective management of all necessary data; (c) a record system, preferably computer-based, connected to the national disease control centre and to all necessary databases, laboratories and other organisations; (d) a shared daily journal which shall be maintained to record in chronological order all the events associated with an outbreak of foot-and-mouth and allowing different activities to be linked and coordinated; (e) up-to-date lists of persons, including private veterinarians, and local organisations in each region who shall be contacted and may be involved in the event of an outbreak of foot-and-mouth disease; (f) up-to-date lists of holdings to which the provisions of Article 15 and 18 may be applied in the case of an outbreak of foot-and-mouth disease; (g) up-to-date inventories of possible burning or burial places for animals killed in accordance with this Directive and to be processed in accordance with Community and national legislation on the protection of the environment; (h) up-to-date list of competent environmental authorities in each region, as well as other environmental bodies who must be contacted and are to be involved in the event of an outbreak of foot-and-mouth disease; (i) maps identifying suitable disposal sites for burial of carcasses that will not present a risk of harm to the environment, in particular to surface waters or groundwaters; (j) list of treatment and disposal undertakings authorised to treat or dispose of animal carcasses and animal waste; (k) list of measures to monitor and control disinfectant run-off as well as body tissue and fluid displacement into the surrounding environment as a result of carcass decomposition, particularly into surface waters and groundwaters. Article 78 Expert Group 1. Member States shall create a permanently operational expert group, which is composed of epidemiologists, veterinary scientists and virologists in a balanced way, to maintain expertise in order to assist the competent authority in ensuring preparedness against an outbreak of foot-and-mouth disease. By way of derogation from the first subparagraph, Member States with a limited number of animals of susceptible species may arrange a formalised agreement with other Member States on mutual assistance in regard of the expert group. These arrangements shall be detailed in the contingency plans referred to in Article 72. 2. In case of a suspicion of an outbreak of foot-and-mouth disease the expert group shall at least: (a) evaluate the clinical picture and the epidemiological situation; (b) give advice regarding the sampling and analyses needed for diagnosing the foot-and-mouth disease together with the additional actions and measures to be taken. 3. In case of an outbreak of foot-and-mouth the expert group shall at least: (a) conduct at least in the index case and if necessary on the spot, an evaluation of the clinical picture and an analysis of the epidemiological inquiry in order to collect the necessary data for determining: (i) the origin of the infection; (ii) the date of introduction of the infectious agent; (iii) the possible spread of the disease; (b) report to the Chief Veterinary Officer and the national disease control centre; (c) give advice on screening, sampling, test procedures, control and the other measures to be applied and on the strategy to be implemented, including advice on bio-security measures on holdings or on premises referred to in Article 16, and in relation to emergency vaccination; (d) follow up and guide the epidemiological inquiry; (e) supplement the epidemiological data with geographical, meteorological and other necessary information; (f) analyse the epidemiological data and perform risk assessments at regular intervals; (g) assist in ensuring that the processing of animal carcasses and animal waste is done with a minimum of detrimental effect on the environment. SECTION 14 ANTIGEN AND VACCINE BANKS Article 79 National antigen and vaccine banks 1. Member States may within the framework of the contingency plan establish or maintain national antigen and vaccine banks for the storage of reserves for emergency vaccination of antigens or vaccines authorised in accordance with Directive 2001/82/EC. 2. Member States may retain establishments for the packaging and storage of vaccines in the case of emergency vaccination. 3. Member States shall ensure that the antigen and formulated vaccine in the national antigen and vaccine banks comply with the minimum standards laid down for the Community antigen and vaccines bank with respect to safety, sterility and content of non-structural proteins. 4. Member States maintaining a national antigen and vaccine bank shall inform the Commission about the antigen and vaccine stocks kept. Such information shall be submitted to the Commission every 12 months as part of the information required by Article 8 of Directive 64/432/EEC. The information on quantities and subtypes of antigens or authorised vaccines stored in the national antigen and vaccine bank shall be treated as classified information and in particular shall not be published. Article 80 Community antigen and vaccine bank 1. A Community antigen and vaccine bank shall be established in accordance with the procedure referred to in Article 89(2). 2. The Commission shall ensure that Community reserves of concentrated inactivated antigens for the production of foot-and-mouth disease vaccines are maintained on the premises of the Community antigen and vaccine bank. For that purpose, the number of doses and the diversity of strains and subtypes of antigen of foot-and-mouth disease virus and, if necessary, of authorised in accordance with Directive 2001/82/EC vaccines stored in the Community antigen and vaccine bank shall be decided in accordance with the procedure referred to in Article 89(2), taking into account the needs as estimated in the context of the contingency plans provided for in Article 72 and the epidemiological situation, where appropriate after consultation with the Community Reference Laboratory. 3. The information on quantities and subtypes of antigens or authorised vaccines stored in the Community antigen and vaccine bank shall be treated as classified information and in particular shall not be published. 4. The conditions for the establishment and maintenance of Community reserves of antigen and authorised vaccines at the premises of preferably at least two manufacturing establishments shall be laid down in contracts concluded between the Commission and the manufacturing establishments. Such contracts shall include at least: (a) conditions for supply of quantities and subtypes of concentrated inactivated antigen; (b) conditions for secure storage of antigen and authorised vaccines; (c) guarantees and conditions of rapid formulation, production, bottling, labelling and distribution of vaccines. 5. The conditions and guarantees referred to in paragraph 4(a) to (c) may be amended in accordance with the procedure referred to in Article 89(3). Article 81 Supply and storage of concentrated inactivated antigen The Commission shall ensure that the contracted manufacturer of the concentrated inactivated antigen supplied to the Community antigen and vaccine bank, guaranties conditions for the supply and storage of concentrated inactivated antigen of the foot-and-mouth disease virus at least equivalent to those laid down in point 1 of Annex XIV. Article 82 Formulation, production, bottling, labelling and distribution of vaccine 1. The Commission shall ensure that the contracted manufacturer of the concentrated inactivated antigen supplied to the Community antigen and vaccine bank guaranties conditions for the formulation, finishing, bottling, labelling and delivery of vaccines reconstituted from antigens referred to in Article 81 at least equivalent to those laid down in point 2 of Annex XIV. 2. In case of emergency and with due regard to the epidemiological situation, the Commission shall be authorised to arrange for the immediate production, bottling, labelling, temporary storage and distribution of necessary quantities of vaccines reconstituted from any suitable antigen. Article 83 Access to the Community antigen and vaccine bank 1. Member States shall have access to the Community antigen and vaccine bank following a request to the Commission. The Commission shall, within the limits of the Community reserves of antigens and vaccines, immediately arrange for the formulation, production, bottling, labelling and distribution of the required quantities and subtypes of vaccines, in particular in application of Article 51. 2. Member States that maintain a national antigen and vaccine bank or Member States that are associated to an international antigen and vaccine bank shall have the same rights and obligations to the Community antigen and vaccine bank as other Member States without such reserves. 3. Where it is in the interest of the Community, the Commission may supply or lend to third countries antigens from the Community reserves or vaccines reconstituted from such antigens. Without prejudice to agreements concluded between the Community and third countries, access of third countries to the Community antigen and vaccine bank shall be authorised in accordance with the procedure referred to in Article 89(2), subject to detailed arrangements between the Commission and the third country concerned on the financial and technical cooperation to be adopted under that procedure. 4. Following the use of the antigen or formulated vaccine from the Community reserves, the Commission shall ensure that the used antigen or vaccine is replaced as soon as possible and according to the epidemiological situation. Article 84 Testing of foot-and-mouth disease vaccines 1. The Commission shall be responsible for arranging independent testing for potency and innocuity of vaccines reconstituted from antigen stored in the Community antigen and vaccine bank, and of vaccines reconstituted from other antigens and intended for use within the framework of Community assistance to control measures against foot-and-mouth disease in third countries in accordance with Articles 82(2) and 83(3). 2. For the purpose of the testing referred to in paragraph 1 the Commission may employ the services of an independent Community Coordinating Institute. If necessary, the Community Coordinating Institute shall be designated, and detailed rules on its functions, responsibilities and Community financial contributions shall be adopted, in accordance with the procedure referred to in Article 89(2). 3. Without prejudice to the standards for potency, safety and production procedures provided for in Community legislation, vaccines reconstituted from antigen stored within the Community antigen and vaccine bank shall meet at least the minimum standards for potency, safety and production procedures laid down in the European Pharmacopoeia and the relevant provisions of the OIE Manual. SECTION 15 FOOT-AND-MOUTH DISEASE IN OTHER SPECIES Article 85 Additional measures to prevent and control foot-and-mouth disease 1. Without prejudice to Regulation (EC) No 1774/2002, and any implementing legislation, Member States shall ensure that the prohibition on swill feeding in accordance with Community and national legislation is applicable to all animals irrespective of their use or the place inhabited by these animals. Detailed rules for the control measures to be applied by Member States may be adopted in accordance with the procedure referred to in Article 89(2). 2. Detailed rules for the control of foot-and-mouth disease in animals referred to in Article 2(a) second sentence may be adopted in accordance with the procedure referred to in Article 89(2). 3. Immediately after the competent authority of a Member State has information that wild animals are suspected of being infected with foot-and-mouth disease, it shall take all appropriate measures to confirm or rule out the presence of the disease by investigations of all wild animals of susceptible species shot or found dead, including laboratory testing. It shall inform owners of animals of susceptible species and hunters on the suspicion. 4. As soon as the competent authority of a Member State has confirmation of a primary case of foot-and-mouth disease in wild animals, it shall immediately apply the measures provided for in Part A of Annex XVIII in order to reduce the spread of disease, and shall draw up a plan for the eradication of foot-and-mouth disease in accordance with Part B of Annex XVIII. It shall inform owners of animals of susceptible species and hunters of the confirmed case. CHAPTER IV IMPLEMENTING MEASURES Article 86 Penalties The Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by the date specified in Article 93(1) at the latest and shall notify it without delay of any subsequent amendment affecting them. Article 87 Procedures for implementing specific articles, for the adoption of further detailed rules for the implementation of this Directive and for amending the Annexes 1. Detailed rules for the implementation of Articles 75(2) and 77(2) may be adopted in accordance with the procedure referred to in Article 89(2). 2. Further detailed rules for the implementation of this Directive may be adopted in accordance with the procedure referred to in Article 89(2). 3. The Annexes to this Directive may be amended in accordance with the procedure referred to in Article 89(2) or, in the case of Annex XI, in accordance with the procedure referred to in Article 89(3). Article 88 Procedure for the adoption of ad hoc epidemiological measures Where, in implementing the measures provided for by this Directive, a Member State determines that a measure is not adapted to the epidemiological situation, or where the foot-and-mouth disease virus appears to be spreading despite the measures taken in accordance with this Directive, a Decision may be adopted on an ad hoc basis in accordance with the procedure referred to in Article 89(3) to authorise that Member State to implement alternative measures with equivalent epidemiological effect for a limited period of time appropriate to the epidemiological situation. Article 89 Committee procedure 1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health established by Regulation (EC) No 178/2002. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, Τhe period laid down in Article 5(6) of that Decision shall be set at 15 days. 4. The Committee shall adopt its Rules of Procedure. CHAPTER V TRANSITIONAL AND FINAL PROVISIONS Article 90 Amendment to Directive 92/46/EEC In point 4(b) of Chapter I of Annex A to Council Directive 92/46/EEC, the second subparagraph is deleted. Article 91 Repeals 1. Directive 85/511/EEC, without prejudice to the obligations of the Member States concerning the time-limits for transposition and application set out in Annex XIX, and Decisions 89/531/EEC of 25 September 1989 designating a reference laboratory for the identification of foot-and-mouth diseasevirus and determining the functions of that laboratory(40) and 91/665/EEC of 11 December 1991 designating a Community Coordinating Institute for foot-and-mouth disease vaccines and laying down its functions(41), adopted in implementation thereof, are hereby repealed as from the date referred to in Article 93. 2. References made to the repealed Directive 85/511/EEC shall be construed as being made to this Directive and should be read in accordance with the correlation table in Annex XX. Article 92 Transitional provisions 1. Transitional provisions may be adopted in accordance with the procedure referred to in Article 89(2) for a period of five years from the date of entry into force of this Directive. 2. Within six months after the date referred to in Article 94, Member States shall submit to the Commission amended contingency plans to take into account the provisions of Article 72. The Commission shall examine those contingency plans against the objectives of this Directive and shall suggest to the Member States concerned any amendments it deems necessary, in particular to ensure that the plans are compatible with those of the other Member States. Those amended contingency plans shall be approved in accordance with the procedure referred to in Article 89(2). Article 93 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2004 at the latest. They shall forthwith inform the Commission thereof. They shall apply these provisions as from 1 July 2004. When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 94 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 95 Addressees This Directive is addressed to the Member States.

32003L0092

2003

Council Directive 2003/92/EC of 7 October 2003 amending Directive 77/388/EEC as regards the rules on the place of supply of gas and electricity Having regard to the Treaty establishing the European Community, and in particular Article 93 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Parliament(2), Having regard to the opinion of the European Economic and Social Committee(3), Whereas: (1) Increasing liberalisation of the gas and electricity sector, aimed at completing the internal market for electricity and natural gas, has revealed a need to review the current VAT rules on the place of supply of those goods, set out in the Sixth Council Directive 77/388/EEC of 17 May 1977 on the harmonisation of the laws of the Member States relating to turnover taxes - Common system of value added tax: uniform basis of assessment(4), in order to modernise and simplify the operation of the VAT system within the context of the internal market, a strategy to which the Commission is committed. (2) Electricity and gas are treated as goods for VAT purposes, and, accordingly, the place of their supply with respect to cross-border transactions has to be determined in accordance with Article 8 of Directive 77/388/EEC. However, since electricity and gas are difficult to track physically it is particularly difficult to determine the place of supply under the current rules. (3) In order to attain a real internal market for electricity and gas without VAT obstacles, the place of supply of gas through the natural gas distribution system and of electricity, before the goods reach the final stage of consumption, should be determined to be the place where the customer has established his business. (4) The supply of electricity and gas in the final stage, from traders and distributors to final consumer, should be taxed at the place where the customer has effective use and consumption of the goods, in order to ensure that taxation takes place in the country where actual consumption takes place. This is normally the place where the meter of the customer is located. (5) Electricity and gas are supplied through distribution networks, to which network operators provide access. In order to avoid double or non-taxation, it is necessary to harmonise the rules governing the place of supply of the transmission and transportation services. Access to and use of the distribution systems and the provision of other services directly linked to these services should therefore be added to the list of specific instances set out in Article 9, paragraph 2(e) of Directive 77/388/EEC. (6) The import of gas through the natural gas distribution system, or of electricity, should be exempted in order to avoid double taxation. (7) Those changes in the rules governing the place of supply of gas through the natural gas distribution system, or of electricity, should be combined with a compulsory reverse charge when the customer is a person identified for VAT purposes. (8) Directive 77/388/EEC should therefore be amended accordingly, Article 1 Directive 77/388/EEC is hereby amended as follows: 1. in Article 8(1), the following points are added: "(d) in the case of the supply of gas through the natural gas distribution system, or of electricity, to a taxable dealer: the place where that taxable dealer has established his business or has a fixed establishment for which the goods are supplied, or, in the absence of such a place of business or fixed establishment, the place where he has his permanent address or usually resides. 'Taxable dealer' for the purposes of this provision means a taxable person whose principal activity in respect of purchases of gas and electricity is reselling such products and whose own consumption of these products is negligible. (e) in the case of the supply of gas through the natural gas distribution system, or of electricity, where such a supply is not covered by point (d): the place where the customer has effective use and consumption of the goods. Where all or part of the goods are not in fact consumed by this customer, these non consumed goods are deemed to have been used and consumed at the place where he has established his business or has a fixed establishment for which the goods are supplied. In the absence of such a place of business or fixed establishment, he is deemed to have used and consumed the goods at the place where he has his permanent address or usually resides."; 2. in Article 9(2)(e), the following indent is inserted after the eighth indent: "- the provision of access to, and of transport or transmission through, natural gas and electricity distribution systems and the provision of other directly linked services."; 3. in Article 14(1), the following point is added: "(k) import of gas through the natural gas distribution system, or of electricity."; 4. Article 21(1)(a), in the version set out in Article 28g, is replaced by the following: "(a) the taxable person carrying out the taxable supply of goods or of services, except for the cases referred to in (b), (c) and (f). Where the taxable supply of goods or of services is effected by a taxable person who is not established within the territory of the country, Member States may, under the conditions determined by them, lay down that the person liable to pay tax is the person for whom the taxable supply of goods or of services is carried out;" 5. in Article 21(1), in the version set out in Article 28g, the following point is added: "(f) persons who are identified for value added tax purposes within the territory of the country and to whom goods are supplied under the conditions set out in Article 8(1)(d) or (e), if the supplies are carried out by a taxable person not established within the territory of the country."; 6. in Article 22(1)(c), in the version set out in Article 28h, the first intent is replaced by the following: "- Every taxable person, with the exception of those referred to in Article 28a(4), who, within the territory of the country, effects supplies of goods or of services giving him the right of deduction, other than supplies of goods or of services for which tax is payable solely by the customer or the recipient in accordance with Article 21(1)(a), (b), (c) or (f). However, Member States need not identify certain taxable persons referred to in article 4(3),"; 7. in Article 28a(5)(b) the following indent is added: "- the supply of gas through the natural gas distribution system, or of electricity, under the conditions set out in Article 8(1)(d) or (e)." Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 January 2005. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0093

2003

Council Directive 2003/93/EC of 7 October 2003 amending Council Directive 77/799/EEC concerning mutual assistance by the competent authorities of the Member States in the field of direct and indirect taxation Having regard to the Treaty establishing the European Community, and in particular Articles 93 and 94 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Parliament(2), Having regard to the opinion of the European Economic and Social Committee(3), Whereas: (1) In order to combat value added tax (VAT) evasion it is necessary to strengthen cooperation between tax administrations within the Community and between the latter and the Commission in accordance with common principles. (2) To that end, Council Regulation (EEC) No 218/92(4), which supplemented, as regards VAT, the system of cooperation established by Council Directive 77/799/EEC of 19 December 1977 concerning mutual assistance by the competent authorities of the Member States in the field of direct and indirect taxation(5), has been replaced by Council Regulation (EC) No 1798/2003 of 7 October 2003 on administrative cooperation in the field of value added tax and repealing Regulation (EEC) No 218/92(6). The latter Regulation sets out all the provisions relating to administrative cooperation in the field of VAT, with the exception of mutual assistance as provided for by Council Directive 76/308/EEC of 15 March 1976 on mutual assistance for the recovery of claims relating to certain levies, duties, taxes and other measures(7). (3) The scope of mutual assistance laid down by Directive 77/799/EEC must be extended to taxation of the insurance premiums referred to in Directive 76/308/EEC so as to better protect the financial interests of the Member States and the neutrality of the internal market. (4) Directive 77/799/EEC should therefore be amended accordingly, Article 1 Directive 77/799/EEC is hereby amended as follows: 1. the title shall be replaced by the following: "Council Directive 77/799/EEC of 19 December 1977 concerning mutual assistance by the competent authorities of the Member States in the field of direct taxation, certain excise duties and taxation of insurance premiums"; 2. in Article 1(1), the first indent shall be replaced by the following: "- taxation of insurance premiums referred to in the sixth indent of Article 3 of Council Directive 76/308/EEC,"; 2(a) in Article 1(5), the wording under the heading "in the United Kingdom" shall be replaced by the following:"The Commissioners of Customs and Excise or an authorised representative for information required concerning taxes on insurance premiums and excise duty. The Commissioners of Inland Revenue or an authorised representative for all other information."; 2(b) in Article 1(5) the wording under "in Italy" shall be replaced by the following:"Il ministro dell'economia e delle finanze or an authorised representative." 3. Article 7(1), shall replaced by the following: "1. All information made known to a Member State under this Directive shall be kept secret in that State in the same manner as information received under its national legislation. In any case, such information: - may be made available only to the persons directly involved in the assessment of the tax or in the administrative control of this assessment, - may be made known only in connection with judicial proceedings or administrative proceedings involving sanctions undertaken with a view to, or relating to, the making or reviewing the tax assessment and only to persons who are directly involved in such proceedings; such information may, however, be disclosed during public hearings or in judgements if the competent authority of the Member State supplying the information raises no objection, - shall in no circumstances be used other than for taxation purposes or in connection with judicial proceedings or administrative proceedings involving sanctions undertaken with a view to, or in relation to, the making or reviewing of the tax assessment. In addition, Member States may provide for the information referred to in the first subparagraph to be used for assessment of other levies, duties and taxes covered by Article 2 of Directive 76/308/EEC(8)." Article 2 References made to Directive 77/799/EEC in relation to value added tax (VAT) shall be construed as references to Regulation (EC) No 1798/2003. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 31 December 2003. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32003L0087

2003

DIRECTIVE 2003/87/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Economic and Social Committee (2), Having regard to the opinion of the Committee of the Regions (3), Acting in accordance with the procedure laid down in Article 251 of the Treaty (4), Whereas: (1) The Green Paper on greenhouse gas emissions trading within the European Union launched a debate across Europe on the suitability and possible functioning of greenhouse gas emissions trading within the European Union. The European Climate Change Programme has considered Community policies and measures through a multi-stakeholder process, including a scheme for greenhouse gas emission allowance trading within the Community (the Community scheme) based on the Green Paper. In its Conclusions of 8 March 2001, the Council recognised the particular importance of the European Climate Change Programme and of work based on the Green Paper, and underlined the urgent need for concrete action at Community level. (2) The Sixth Community Environment Action Programme established by Decision No 1600/2002/EC of the European Parliament and of the Council (5) identifies climate change as a priority for action and provides for the establishment of a Community-wide emissions trading scheme by 2005. That Programme recognises that the Community is committed to achieving an 8 % reduction in emissions of greenhouse gases by 2008 to 2012 compared to 1990 levels, and that, in the longer-term, global emissions of greenhouse gases will need to be reduced by approximately 70 % compared to 1990 levels. (3) The ultimate objective of the United Nations Framework Convention on Climate Change, which was approved by Council Decision 94/69/EC of 15 December 1993 concerning the conclusion of the United Nations Framework Convention on Climate Change (6), is to achieve stabilisation of greenhouse gas concentrations in the atmosphere at a level which prevents dangerous anthropogenic interference with the climate system. (4) Once it enters into force, the Kyoto Protocol, which was approved by Council Decision 2002/358/EC of 25 April 2002 concerning the approval, on behalf of the European Community, of the Kyoto Protocol to the United Nations Framework Convention on Climate Change and the joint fulfilment of commitments thereunder (7), will commit the Community and its Member States to reducing their aggregate anthropogenic emissions of greenhouse gases listed in Annex A to the Protocol by 8 % compared to 1990 levels in the period 2008 to 2012. (5) The Community and its Member States have agreed to fulfil their commitments to reduce anthropogenic greenhouse gas emissions under the Kyoto Protocol jointly, in accordance with Decision 2002/358/EC. This Directive aims to contribute to fulfilling the commitments of the European Community and its Member States more effectively, through an efficient European market in greenhouse gas emission allowances, with the least possible diminution of economic development and employment. (6) Council Decision 93/389/EEC of 24 June 1993 for a monitoring mechanism of Community CO2 and other greenhouse gas emissions (8), established a mechanism for monitoring greenhouse gas emissions and evaluating progress towards meeting commitments in respect of these emissions. This mechanism will assist Member States in determining the total quantity of allowances to allocate. (7) Community provisions relating to allocation of allowances by the Member States are necessary to contribute to preserving the integrity of the internal market and to avoid distortions of competition. (8) Member States should have regard when allocating allowances to the potential for industrial process activities to reduce emissions. (9) Member States may provide that they only issue allowances valid for a five-year period beginning in 2008 to persons in respect of allowances cancelled, corresponding to emission reductions made by those persons on their national territory during a three-year period beginning in 2005. (10) Starting with the said five-year period, transfers of allowances to another Member State will involve corresponding adjustments of assigned amount units under the Kyoto Protocol. (11) Member States should ensure that the operators of certain specified activities hold a greenhouse gas emissions permit and that they monitor and report their emissions of greenhouse gases specified in relation to those activities. (12) Member States should lay down rules on penalties applicable to infringements of this Directive and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive. (13) In order to ensure transparency, the public should have access to information relating to the allocation of allowances and to the results of monitoring of emissions, subject only to restrictions provided for in Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information (9). (14) Member States should submit a report on the implementation of this Directive drawn up on the basis of Council Directive 91/692/EEC of 23 December 1991 standardising and rationalising reports on the implementation of certain Directives relating to the environment (10). (15) The inclusion of additional installations in the Community scheme should be in accordance with the provisions laid down in this Directive, and the coverage of the Community scheme may thereby be extended to emissions of greenhouse gases other than carbon dioxide, inter alia from aluminium and chemicals activities. (16) This Directive should not prevent any Member State from maintaining or establishing national trading schemes regulating emissions of greenhouse gases from activities other than those listed in Annex I or included in the Community scheme, or from installations temporarily excluded from the Community scheme. (17) Member States may participate in international emissions trading as Parties to the Kyoto Protocol with any other Party included in Annex B thereto. (18) Linking the Community scheme to greenhouse gas emission trading schemes in third countries will increase the cost-effectiveness of achieving the Community emission reductions target as laid down in Decision 2002/358/EC on the joint fulfilment of commitments. (19) Project-based mechanisms including Joint Implementation (JI) and the Clean Development Mechanism (CDM) are important to achieve the goals of both reducing global greenhouse gas emissions and increasing the cost-effective functioning of the Community scheme. In accordance with the relevant provisions of the Kyoto Protocol and Marrakech Accords, the use of the mechanisms should be supplemental to domestic action and domestic action will thus constitute a significant element of the effort made. (20) This Directive will encourage the use of more energy-efficient technologies, including combined heat and power technology, producing less emissions per unit of output, while the future directive of the European Parliament and of the Council on the promotion of cogeneration based on useful heat demand in the internal energy market will specifically promote combined heat and power technology. (21) Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (11) establishes a general framework for pollution prevention and control, through which greenhouse gas emissions permits may be issued. Directive 96/61/EC should be amended to ensure that emission limit values are not set for direct emissions of greenhouse gases from an installation subject to this Directive and that Member States may choose not to impose requirements relating to energy efficiency in respect of combustion units or other units emitting carbon dioxide on the site, without prejudice to any other requirements pursuant to Directive 96/61/EC. (22) This Directive is compatible with the United Nations Framework Convention on Climate Change and the Kyoto Protocol. It should be reviewed in the light of developments in that context and to take into account experience in its implementation and progress achieved in monitoring of emissions of greenhouse gases. (23) Emission allowance trading should form part of a comprehensive and coherent package of policies and measures implemented at Member State and Community level. Without prejudice to the application of Articles 87 and 88 of the Treaty, where activities are covered by the Community scheme, Member States may consider the implications of regulatory, fiscal or other policies that pursue the same objectives. The review of the Directive should consider the extent to which these objectives have been attained. (24) The instrument of taxation can be a national policy to limit emissions from installations temporarily excluded. (25) Policies and measures should be implemented at Member State and Community level across all sectors of the European Union economy, and not only within the industry and energy sectors, in order to generate substantial emissions reductions. The Commission should, in particular, consider policies and measures at Community level in order that the transport sector makes a substantial contribution to the Community and its Member States meeting their climate change obligations under the Kyoto Protocol. (26) Notwithstanding the multifaceted potential of market-based mechanisms, the European Union strategy for climate change mitigation should be built on a balance between the Community scheme and other types of Community, domestic and international action. (27) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. (28) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (12). (29) As the criteria (1), (5) and (7) of Annex III cannot be amended through comitology, amendments in respect of periods after 2012 should only be made through codecision. (30) Since the objective of the proposed action, the establishment of a Community scheme, cannot be sufficiently achieved by the Member States acting individually, and can therefore by reason of the scale and effects of the proposed action be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective, Article 1 Subject matter This Directive establishes a scheme for greenhouse gas emission allowance trading within the Community (hereinafter referred to as the ‘Community scheme’) in order to promote reductions of greenhouse gas emissions in a cost-effective and economically efficient manner. Article 2 Scope 1. This Directive shall apply to emissions from the activities listed in Annex I and greenhouse gases listed in Annex II. 2. This Directive shall apply without prejudice to any requirements pursuant to Directive 96/61/EC. Article 3 Definitions For the purposes of this Directive the following definitions shall apply: (a) ‘allowance’ means an allowance to emit one tonne of carbon dioxide equivalent during a specified period, which shall be valid only for the purposes of meeting the requirements of this Directive and shall be transferable in accordance with the provisions of this Directive; (b) ‘emissions’ means the release of greenhouse gases into the atmosphere from sources in an installation; (c) ‘greenhouse gases’ means the gases listed in Annex II; (d) ‘greenhouse gas emissions permit’ means the permit issued in accordance with Articles 5 and 6; (e) ‘installation’ means a stationary technical unit where one or more activities listed in Annex I are carried out and any other directly associated activities which have a technical connection with the activities carried out on that site and which could have an effect on emissions and pollution; (f) ‘operator’ means any person who operates or controls an installation or, where this is provided for in national legislation, to whom decisive economic power over the technical functioning of the installation has been delegated; (g) ‘person’ means any natural or legal person; (h) ‘new entrant’ means any installation carrying out one or more of the activities indicated in Annex I, which has obtained a greenhouse gas emissions permit or an update of its greenhouse gas emissions permit because of a change in the nature or functioning or an extension of the installation, subsequent to the notification to the Commission of the national allocation plan; (i) ‘the public’ means one or more persons and, in accordance with national legislation or practice, associations, organisations or groups of persons; (j) ‘tonne of carbon dioxide equivalent’ means one metric tonne of carbon dioxide (CO2) or an amount of any other greenhouse gas listed in Annex II with an equivalent global-warming potential. Article 4 Greenhouse gas emissions permits Member States shall ensure that, from 1 January 2005, no installation undertakes any activity listed in Annex I resulting in emissions specified in relation to that activity unless its operator holds a permit issued by a competent authority in accordance with Articles 5 and 6, or the installation is temporarily excluded from the Community scheme pursuant to Article 27. Article 5 Applications for greenhouse gas emissions permits An application to the competent authority for a greenhouse gas emissions permit shall include a description of: (a) the installation and its activities including the technology used; (b) the raw and auxiliary materials, the use of which is likely to lead to emissions of gases listed in Annex I; (c) the sources of emissions of gases listed in Annex I from the installation; and (d) the measures planned to monitor and report emissions in accordance with the guidelines adopted pursuant to Article 14. The application shall also include a non-technical summary of the details referred to in the first subparagraph. Article 6 Conditions for and contents of the greenhouse gas emissions permit 1. The competent authority shall issue a greenhouse gas emissions permit granting authorisation to emit greenhouse gases from all or part of an installation if it is satisfied that the operator is capable of monitoring and reporting emissions. A greenhouse gas emissions permit may cover one or more installations on the same site operated by the same operator. 2. Greenhouse gas emissions permits shall contain the following: (a) the name and address of the operator; (b) a description of the activities and emissions from the installation; (c) monitoring requirements, specifying monitoring methodology and frequency; (d) reporting requirements; and (e) an obligation to surrender allowances equal to the total emissions of the installation in each calendar year, as verified in accordance with Article 15, within four months following the end of that year. Article 7 Changes relating to installations The operator shall inform the competent authority of any changes planned in the nature or functioning, or an extension, of the installation which may require updating of the greenhouse gas emissions permit. Where appropriate, the competent authority shall update the permit. Where there is a change in the identity of the installation's operator, the competent authority shall update the permit to include the name and address of the new operator. Article 8 Coordination with Directive 96/61/EC Member States shall take the necessary measures to ensure that, where installations carry out activities that are included in Annex I to Directive 96/61/EC, the conditions of, and procedure for, the issue of a greenhouse gas emissions permit are coordinated with those for the permit provided for in that Directive. The requirements of Articles 5, 6 and 7 of this Directive may be integrated into the procedures provided for in Directive 96/61/EC. Article 9 National allocation plan 1. For each period referred to in Article 11(1) and (2), each Member State shall develop a national plan stating the total quantity of allowances that it intends to allocate for that period and how it proposes to allocate them. The plan shall be based on objective and transparent criteria, including those listed in Annex III, taking due account of comments from the public. The Commission shall, without prejudice to the Treaty, by 31 December 2003 at the latest develop guidance on the implementation of the criteria listed in Annex III. For the period referred to in Article 11(1), the plan shall be published and notified to the Commission and to the other Member States by 31 March 2004 at the latest. For subsequent periods, the plan shall be published and notified to the Commission and to the other Member States at least 18 months before the beginning of the relevant period. 2. National allocation plans shall be considered within the committee referred to in Article 23(1). 3. Within three months of notification of a national allocation plan by a Member State under paragraph 1, the Commission may reject that plan, or any aspect thereof, on the basis that it is incompatible with the criteria listed in Annex III or with Article 10. The Member State shall only take a decision under Article 11(1) or (2) if proposed amendments are accepted by the Commission. Reasons shall be given for any rejection decision by the Commission. Article 10 Method of allocation For the three-year period beginning 1 January 2005 Member States shall allocate at least 95 % of the allowances free of charge. For the five-year period beginning 1 January 2008, Member States shall allocate at least 90 % of the allowances free of charge. Article 11 Allocation and issue of allowances 1. For the three-year period beginning 1 January 2005, each Member State shall decide upon the total quantity of allowances it will allocate for that period and the allocation of those allowances to the operator of each installation. This decision shall be taken at least three months before the beginning of the period and be based on its national allocation plan developed pursuant to Article 9 and in accordance with Article 10, taking due account of comments from the public. 2. For the five-year period beginning 1 January 2008, and for each subsequent five-year period, each Member State shall decide upon the total quantity of allowances it will allocate for that period and initiate the process for the allocation of those allowances to the operator of each installation. This decision shall be taken at least 12 months before the beginning of the relevant period and be based on the Member State's national allocation plan developed pursuant to Article 9 and in accordance with Article 10, taking due account of comments from the public. 3. Decisions taken pursuant to paragraph 1 or 2 shall be in accordance with the requirements of the Treaty, in particular Articles 87 and 88 thereof. When deciding upon allocation, Member States shall take into account the need to provide access to allowances for new entrants. 4. The competent authority shall issue a proportion of the total quantity of allowances each year of the period referred to in paragraph 1 or 2, by 28 February of that year. Article 12 Transfer, surrender and cancellation of allowances 1. Member States shall ensure that allowances can be transferred between: (a) persons within the Community; (b) persons within the Community and persons in third countries, where such allowances are recognised in accordance with the procedure referred to in Article 25 without restrictions other than those contained in, or adopted pursuant to, this Directive. 2. Member States shall ensure that allowances issued by a competent authority of another Member State are recognised for the purpose of meeting an operator's obligations under paragraph 3. 3. Member States shall ensure that, by 30 April each year at the latest, the operator of each installation surrenders a number of allowances equal to the total emissions from that installation during the preceding calendar year as verified in accordance with Article 15, and that these are subsequently cancelled. 4. Member States shall take the necessary steps to ensure that allowances will be cancelled at any time at the request of the person holding them. Article 13 Validity of allowances 1. Allowances shall be valid for emissions during the period referred to in Article 11(1) or (2) for which they are issued. 2. Four months after the beginning of the first five-year period referred to in Article 11(2), allowances which are no longer valid and have not been surrendered and cancelled in accordance with Article 12(3) shall be cancelled by the competent authority. Member States may issue allowances to persons for the current period to replace any allowances held by them which are cancelled in accordance with the first subparagraph. 3. Four months after the beginning of each subsequent five-year period referred to in Article 11(2), allowances which are no longer valid and have not been surrendered and cancelled in accordance with Article 12(3) shall be cancelled by the competent authority. Member States shall issue allowances to persons for the current period to replace any allowances held by them which are cancelled in accordance with the first subparagraph. Article 14 Guidelines for monitoring and reporting of emissions 1. The Commission shall adopt guidelines for monitoring and reporting of emissions resulting from the activities listed in Annex I of greenhouse gases specified in relation to those activities, in accordance with the procedure referred to in Article 23(2), by 30 September 2003. The guidelines shall be based on the principles for monitoring and reporting set out in Annex IV. 2. Member States shall ensure that emissions are monitored in accordance with the guidelines. 3. Member States shall ensure that each operator of an installation reports the emissions from that installation during each calendar year to the competent authority after the end of that year in accordance with the guidelines. Article 15 Verification Member States shall ensure that the reports submitted by operators pursuant to Article 14(3) are verified in accordance with the criteria set out in Annex V, and that the competent authority is informed thereof. Member States shall ensure that an operator whose report has not been verified as satisfactory in accordance with the criteria set out in Annex V by 31 March each year for emissions during the preceding year cannot make further transfers of allowances until a report from that operator has been verified as satisfactory. Article 16 Penalties 1. Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that such rules are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify these provisions to the Commission by 31 December 2003 at the latest, and shall notify it without delay of any subsequent amendment affecting them. 2. Member States shall ensure publication of the names of operators who are in breach of requirements to surrender sufficient allowances under Article 12(3). 3. Member States shall ensure that any operator who does not surrender sufficient allowances by 30 April of each year to cover its emissions during the preceding year shall be held liable for the payment of an excess emissions penalty. The excess emissions penalty shall be EUR 100 for each tonne of carbon dioxide equivalent emitted by that installation for which the operator has not surrendered allowances. Payment of the excess emissions penalty shall not release the operator from the obligation to surrender an amount of allowances equal to those excess emissions when surrendering allowances in relation to the following calendar year. 4. During the three-year period beginning 1 January 2005, Member States shall apply a lower excess emissions penalty of EUR 40 for each tonne of carbon dioxide equivalent emitted by that installation for which the operator has not surrendered allowances. Payment of the excess emissions penalty shall not release the operator from the obligation to surrender an amount of allowances equal to those excess emissions when surrendering allowances in relation to the following calendar year. Article 17 Access to information Decisions relating to the allocation of allowances and the reports of emissions required under the greenhouse gas emissions permit and held by the competent authority shall be made available to the public by that authority subject to the restrictions laid down in Article 3(3) and Article 4 of Directive 2003/4/EC. Article 18 Competent authority Member States shall make the appropriate administrative arrangements, including the designation of the appropriate competent authority or authorities, for the implementation of the rules of this Directive. Where more than one competent authority is designated, the work of these authorities undertaken pursuant to this Directive must be coordinated. Article 19 Registries 1. Member States shall provide for the establishment and maintenance of a registry in order to ensure the accurate accounting of the issue, holding, transfer and cancellation of allowances. Member States may maintain their registries in a consolidated system, together with one or more other Member States. 2. Any person may hold allowances. The registry shall be accessible to the public and shall contain separate accounts to record the allowances held by each person to whom and from whom allowances are issued or transferred. 3. In order to implement this Directive, the Commission shall adopt a Regulation in accordance with the procedure referred to in Article 23(2) for a standardised and secured system of registries in the form of standardised electronic databases containing common data elements to track the issue, holding, transfer and cancellation of allowances, to provide for public access and confidentiality as appropriate and to ensure that there are no transfers incompatible with obligations resulting from the Kyoto Protocol. Article 20 Central Administrator 1. The Commission shall designate a Central Administrator to maintain an independent transaction log recording the issue, transfer and cancellation of allowances. 2. The Central Administrator shall conduct an automated check on each transaction in registries through the independent transaction log to ensure there are no irregularities in the issue, transfer and cancellation of allowances. 3. If irregularities are identified through the automated check, the Central Administrator shall inform the Member State or Member States concerned who shall not register the transactions in question or any further transactions relating to the allowances concerned until the irregularities have been resolved. Article 21 Reporting by Member States 1. Each year the Member States shall submit to the Commission a report on the application of this Directive. This report shall pay particular attention to the arrangements for the allocation of allowances, the operation of registries, the application of the monitoring and reporting guidelines, verification and issues relating to compliance with the Directive and on the fiscal treatment of allowances, if any. The first report shall be sent to the Commission by 30 June 2005. The report shall be drawn up on the basis of a questionnaire or outline drafted by the Commission in accordance with the procedure laid down in Article 6 of Directive 91/692/EEC. The questionnaire or outline shall be sent to Member States at least six months before the deadline for the submission of the first report. 2. On the basis of the reports referred to in paragraph 1, the Commission shall publish a report on the application of this Directive within three months of receiving the reports from the Member States. 3. The Commission shall organise an exchange of information between the competent authorities of the Member States concerning developments relating to issues of allocation, the operation of registries, monitoring, reporting, verification and compliance. Article 22 Amendments to Annex III The Commission may amend Annex III, with the exception of criteria (1), (5) and (7), for the period from 2008 to 2012 in the light of the reports provided for in Article 21 and of the experience of the application of this Directive, in accordance with the procedure referred to in Article 23(2). Article 23 Committee 1. The Commission shall be assisted by the committee instituted by Article 8 of Decision 93/389/EEC. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure. Article 24 Procedures for unilateral inclusion of additional activities and gases 1. From 2008, Member States may apply emission allowance trading in accordance with this Directive to activities, installations and greenhouse gases which are not listed in Annex I, provided that inclusion of such activities, installations and greenhouse gases is approved by the Commission in accordance with the procedure referred to in Article 23(2), taking into account all relevant criteria, in particular effects on the internal market, potential distortions of competition, the environmental integrity of the scheme and reliability of the planned monitoring and reporting system. From 2005 Member States may under the same conditions apply emissions allowance trading to installations carrying out activities listed in Annex I below the capacity limits referred to in that Annex. 2. Allocations made to installations carrying out such activities shall be specified in the national allocation plan referred to in Article 9. 3. The Commission may, on its own initiative, or shall, on request by a Member State, adopt monitoring and reporting guidelines for emissions from activities, installations and greenhouse gases which are not listed in Annex I in accordance with the procedure referred to in Article 23(2), if monitoring and reporting of these emissions can be carried out with sufficient accuracy. 4. In the event that such measures are introduced, reviews carried out pursuant to Article 30 shall also consider whether Annex I should be amended to include emissions from these activities in a harmonised way throughout the Community. Article 25 Links with other greenhouse gas emissions trading schemes 1. Agreements should be concluded with third countries listed in Annex B to the Kyoto Protocol which have ratified the Protocol to provide for the mutual recognition of allowances between the Community scheme and other greenhouse gas emissions trading schemes in accordance with the rules set out in Article 300 of the Treaty. 2. Where an agreement referred to in paragraph 1 has been concluded, the Commission shall draw up any necessary provisions relating to the mutual recognition of allowances under that agreement in accordance with the procedure referred to in Article 23(2). Article 26 Amendment of Directive 96/61/EC In Article 9(3) of Directive 96/61/EC the following subparagraphs shall be added: ‘Where emissions of a greenhouse gas from an installation are specified in Annex I to Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC (13) in relation to an activity carried out in that installation, the permit shall not include an emission limit value for direct emissions of that gas unless it is necessary to ensure that no significant local pollution is caused. For activities listed in Annex I to Directive 2003/87/EC, Member States may choose not to impose requirements relating to energy efficiency in respect of combustion units or other units emitting carbon dioxide on the site. Where necessary, the competent authorities shall amend the permit as appropriate. The three preceding subparagraphs shall not apply to installations temporarily excluded from the scheme for greenhouse gas emission allowance trading within the Community in accordance with Article 27 of Directive 2003/87/EC. Article 27 Temporary exclusion of certain installations 1. Member States may apply to the Commission for installations to be temporarily excluded until 31 December 2007 at the latest from the Community scheme. Any such application shall list each such installation and shall be published. 2. If, having considered any comments made by the public on that application, the Commission decides, in accordance with the procedure referred to in Article 23(2), that the installations will: (a) as a result of national policies, limit their emissions as much as would be the case if they were subject to the provisions of this Directive; (b) be subject to monitoring, reporting and verification requirements which are equivalent to those provided for pursuant to Articles 14 and 15; and (c) be subject to penalties at least equivalent to those referred to in Article 16(1) and (4) in the case of non-fulfilment of national requirements; it shall provide for the temporary exclusion of those installations from the Community scheme. It must be ensured that there will be no distortion of the internal market. Article 28 Pooling 1. Member States may allow operators of installations carrying out one of the activities listed in Annex I to form a pool of installations from the same activity for the period referred to in Article 11(1) and/or the first five-year period referred to in Article 11(2) in accordance with paragraphs 2 to 6 of this Article. 2. Operators carrying out an activity listed in Annex I who wish to form a pool shall apply to the competent authority, specifying the installations and the period for which they want the pool and supplying evidence that a trustee will be able to fulfil the obligations referred to in paragraphs 3 and 4. 3. Operators wishing to form a pool shall nominate a trustee: (a) to be issued with the total quantity of allowances calculated by installation of the operators, by way of derogation from Article 11; (b) to be responsible for surrendering allowances equal to the total emissions from installations in the pool, by way of derogation from Articles 6(2)(e) and 12(3); and (c) to be restricted from making further transfers in the event that an operator's report has not been verified as satisfactory in accordance with the second paragraph of Article 15. 4. The trustee shall be subject to the penalties applicable for breaches of requirements to surrender sufficient allowances to cover the total emissions from installations in the pool, by way of derogation from Article 16(2), (3) and (4). 5. A Member State that wishes to allow one or more pools to be formed shall submit the application referred to in paragraph 2 to the Commission. Without prejudice to the Treaty, the Commission may within three months of receipt reject an application that does not fulfil the requirements of this Directive. Reasons shall be given for any such decision. In the case of rejection the Member State may only allow the pool to be formed if proposed amendments are accepted by the Commission. 6. In the event that the trustee fails to comply with penalties referred to in paragraph 4, each operator of an installation in the pool shall be responsible under Articles 12(3) and 16 in respect of emissions from its own installation. Article 29 Force majeure 1. During the period referred to in Article 11(1), Member States may apply to the Commission for certain installations to be issued with additional allowances in cases of force majeure. The Commission shall determine whether force majeure is demonstrated, in which case it shall authorise the issue of additional and non-transferable allowances by that Member State to the operators of those installations. 2. The Commission shall, without prejudice to the Treaty, develop guidance to describe the circumstances under which force majeure is demonstrated, by 31 December 2003 at the latest. Article 30 Review and further development 1. On the basis of progress achieved in the monitoring of emissions of greenhouse gases, the Commission may make a proposal to the European Parliament and the Council by 31 December 2004 to amend Annex I to include other activities and emissions of other greenhouse gases listed in Annex II. 2. On the basis of experience of the application of this Directive and of progress achieved in the monitoring of emissions of greenhouse gases and in the light of developments in the international context, the Commission shall draw up a report on the application of this Directive, considering: (a) how and whether Annex I should be amended to include other relevant sectors, inter alia the chemicals, aluminium and transport sectors, activities and emissions of other greenhouse gases listed in Annex II, with a view to further improving the economic efficiency of the scheme; (b) the relationship of Community emission allowance trading with the international emissions trading that will start in 2008; (c) further harmonisation of the method of allocation (including auctioning for the time after 2012) and of the criteria for national allocation plans referred to in Annex III; (d) the use of credits from project mechanisms; (e) the relationship of emissions trading with other policies and measures implemented at Member State and Community level, including taxation, that pursue the same objectives; (f) whether it is appropriate for there to be a single Community registry; (g) the level of excess emissions penalties, taking into account, inter alia, inflation; (h) the functioning of the allowance market, covering in particular any possible market disturbances; (i) how to adapt the Community scheme to an enlarged European Union; (j) pooling; (k) the practicality of developing Community-wide benchmarks as a basis for allocation, taking into account the best available techniques and cost-benefit analysis. The Commission shall submit this report to the European Parliament and the Council by 30 June 2006, accompanied by proposals as appropriate. 3. Linking the project-based mechanisms, including Joint Implementation (JI) and the Clean Development Mechanism (CDM), with the Community scheme is desirable and important to achieve the goals of both reducing global greenhouse gas emissions and increasing the cost-effective functioning of the Community scheme. Therefore, the emission credits from the project-based mechanisms will be recognised for their use in this scheme subject to provisions adopted by the European Parliament and the Council on a proposal from the Commission, which should apply in parallel with the Community scheme in 2005. The use of the mechanisms shall be supplemental to domestic action, in accordance with the relevant provisions of the Kyoto Protocol and Marrakesh Accords. Article 31 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2003 at the latest. They shall forthwith inform the Commission thereof. The Commission shall notify the other Member States of these laws, regulations and administrative provisions. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof. Article 32 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 33 Addressees This Directive is addressed to the Member States.

32003L0096

2003

COUNCIL DIRECTIVE 2003/96/EC of 27 October 2003 restructuring the Community framework for the taxation of energy products and electricity (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 93 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament, Having regard to the opinion of the European Economic and Social Committee, Whereas: (1) The scope of Council Directive 92/81/EEC of 19 October 1992 on the harmonisation of the structures of excise duties on mineral oils (1) and of Council Directive 92/82/EEC of 19 October 1992 on the approximation of the rates of excise duties on mineral oils (2) is restricted to mineral oils. (2) The absence of Community provisions imposing a minimum rate of taxation on electricity and energy products other than mineral oils may adversely affect the proper functioning of the internal market. (3) The proper functioning of the internal market and the achievement of the objectives of other Community policies require minimum levels of taxation to be laid down at Community level for most energy products, including electricity, natural gas and coal. (4) Appreciable differences in the national levels of energy taxation applied by Member States could prove detrimental to the proper functioning of the internal market. (5) The establishment of appropriate Community minimum levels of taxation may enable existing differences in the national levels of taxation to be reduced. (6) In accordance with Article 6 of the Treaty, environmental protection requirements must be integrated into the definition and implementation of other Community policies. (7) As a party to the United Nations Framework Convention on Climate Change, the Community has ratified the Kyoto Protocol. The taxation of energy products and, where appropriate, electricity is one of the instruments available for achieving the Kyoto Protocol objectives. (8) The Council needs to examine the exemptions and reductions and the minimum levels of taxation periodically, taking into consideration the proper functioning of the internal market, the real value of the minimum levels of taxation, the competitiveness of Community businesses in the international framework and the wider objectives of the Treaty. (9) Member States should be given the flexibility necessary to define and implement policies appropriate to their national circumstances. (10) Member States wish to introduce or retain different types of taxation on energy products and electricity. To that end, Member States should be permitted to comply with the Community minimum taxation levels by taking into account the total charge levied in respect of all indirect taxes which they have chosen to apply (excluding VAT). (11) Fiscal arrangements made in connection with the implementation of this Community framework for the taxation of energy products and electricity are a matter for each Member State to decide. In this regard, Member States might decide not to increase the overall tax burden if they consider that the implementation of such a principle of tax neutrality could contribute to the restructuring and the modernisation of their tax systems by encouraging behaviour conducive to greater protection of the environment and increased labour use. (12) Energy prices are key elements of Community energy, transport and environment policies. (13) Taxation partly determines the price of energy products and electricity. (14) The minimum levels of taxation should reflect the competitive position of the different energy products and electricity. It would be advisable in this connection to base the calculation of these minimum levels as far as possible on the energy content of the products. However, this method should not be applied to motor fuels. (15) The possibility of applying differentiated national rates of taxation to the same product should be allowed in certain circumstances or permanent conditions, provided that Community minimum levels of taxation and internal market and competition rules are respected. (16) As heat is only subject to very limited intra-Community trade, output taxation of heat should remain outside the scope of this Community framework. (17) It is necessary to establish different Community minimum levels of taxation according to the use of the energy products and electricity. (18) Energy products used as a motor fuel for certain industrial and commercial purposes and those used as heating fuel are normally taxed at lower levels than those applicable to energy products used as a propellant. (19) The taxation of diesel motor fuel used by hauliers, notably those engaging in intra-Community activities, requires a possibility for a specific treatment, including measures to allow for the introduction of a system of road user charges, in order to limit the distortion of competition operators might be confronted with. (20) Member States may need to differentiate between commercial and non-commercial diesel. Member States may use this possibility to reduce the gap between the taxation of non-commercial gas oil used as propellant and petrol. (21) Business use and non-business use of energy products and electricity may be treated differently for tax purposes. (22) Energy products should essentially be subject to a Community framework when used as heating fuel or motor fuel. To that extent, it is in the nature and the logic of the tax system to exclude from the scope of the framework dual uses and non-fuel uses of energy products as well as mineralogical processes. Electricity used in similar ways should be treated on an equal footing. (23) Existing international obligations and the maintaining of the competitive position of Community companies make it advisable to continue the exemptions of energy products supplied for air navigation and sea navigation, other than for private pleasure purposes, while it should be possible for Member States to limit these exemptions. (24) Member States should be permitted to apply certain other exemptions or reduced levels of taxation, where that will not be detrimental to the proper functioning of the internal market and will not result in distortions of competition. (25) In particular, combined heat and power generation and, in order to promote the use of alternative energy sources, renewable forms of energy may qualify for preferential treatment. (26) It is desirable to establish a Community framework to allow Member States to exempt or reduce excise duties so as to promote biofuels, thereby contributing to the better functioning of the internal market and affording Member States and economic operators a sufficient degree of legal certainty. Distortions of competition should be limited and the incentive of a reduction in the basic costs for producers and distributors of biofuels should be maintained through, inter alia, the adjustments by Member States taking into account changes in raw material prices. (27) This Directive shall be without prejudice to the application of the relevant provisions of Council Directive 92/12/EEC of 25 February 1992 on the general arrangements for products subject to excise duty and on the holding, movement and monitoring of such products (3), and Council Directive 92/83/EEC of 19 October 1992 on the harmonization of the structures of excise duties on alcohol and alcoholic beverages (4), when the product intended for use, offered for sale or used as motor fuel or fuel additive is ethyl alcohol as defined in Directive 92/83/EEC. (28) Certain exemptions or reductions in the tax level may prove necessary; notably because of the lack of a stronger harmonisation at Community level, because of the risks of a loss of international competitiveness or because of social or environmental considerations. (29) Businesses entering into agreements to significantly enhance environmental protection and energy efficiency deserve attention; among these businesses, energy intensive ones merit specific treatment. (30) Transitional periods and arrangements may be required in order to allow Member States to smoothly adapt to the new levels of taxation, thus limiting possible negative side effects. (31) It is necessary to provide for a procedure authorising the introduction by Member States, for a set period, of other exemptions or reduced levels of taxation. Such exemptions or reductions should be under regular review. (32) Provision should be made for the Member States to notify the Commission of certain national measures. Such notification does not release Member States from the obligation, laid down in Article 88(3) of the Treaty, to notify certain national measures. This Directive does not prejudice the outcome of any future State aid procedure that may be undertaken in accordance with Articles 87 and 88 of the Treaty. (33) The scope of Directive 92/12/EEC should, where appropriate, be extended to the products and indirect taxes covered by this Directive. (34) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5), Article 1 Member States shall impose taxation on energy products and electricity in accordance with this Directive. Article 2 1. For the purposes of this Directive, the term ‘energy products’ shall apply to products: (a) falling within CN codes 1507 to 1518, if these are intended for use as heating fuel or motor fuel; (b) falling within CN codes 2701, 2702 and 2704 to 2715; (c) falling within CN codes 2901 and 2902; (d) falling within CN code 2905 11 00, which are not of synthetic origin, if these are intended for use as heating fuel or motor fuel; (e) falling within CN code 3403; (f) falling within CN code 3811; (g) falling within CN code 3817; (h) falling within CN code 3824 90 99 if these are intended for use as heating fuel or motor fuel. 2. This Directive shall also apply to: Electricity falling within CN code 2716. 3. When intended for use, offered for sale or used as motor fuel or heating fuel, energy products other than those for which a level of taxation is specified in this Directive shall be taxed according to use, at the rate for the equivalent heating fuel or motor fuel. In addition to the taxable products listed in paragraph 1, any product intended for use, offered for sale or used as motor fuel, or as an additive or extender in motor fuels, shall be taxed at the rate for the equivalent motor fuel. In addition to the taxable products listed in paragraph 1, any other hydrocarbon, except for peat, intended for use, offered for sale or used for heating purposes shall be taxed at the rate for the equivalent energy product. 4. This Directive shall not apply to: (a) output taxation of heat and the taxation of products falling within CN-codes 4401 and 4402; (b) the following uses of energy products and electricity: — energy products used for purposes other than as motor fuels or as heating fuels, — dual use of energy products An energy product has a dual use when it is used both as heating fuel and for purposes other than as motor fuel and heating fuel. The use of energy products for chemical reduction and in electrolytic and metallurgical processes shall be regarded as dual use, — electricity used principally for the purposes of chemical reduction and in electrolytic and metallurgical processes, — electricity, when it accounts for more than 50 % of the cost of a product. ‘Cost of a product’ shall mean the addition of total purchases of goods and services plus personnel costs plus the consumption of fixed capital, at the level of the business, as defined in Article 11. This cost is calculated per unit on average. ‘Cost of electricity’ shall mean the actual purchase value of electricity or the cost of production of electricity if it is generated in the business, — mineralogical processes ‘Mineralogical processes’ shall mean the processes classified in the NACE nomenclature under code DI 26 ‘manufacture of other non-metallic mineral products’ in Council Regulation (EEC) No 3037/90 of 9 October 1990 on the statistical classification of economic activities in the European Community (6). However, Article 20 shall apply to these energy products. 5. References in this Directive to codes of the combined nomenclature shall be to those of Commission Regulation (EC) No 2031/2001 of 6 August 2001, amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (7). A Decision to update the codes of the combined nomenclature for the products referred to in this Directive shall be taken once every year in accordance with the procedure laid down in Article 27. The Decision must not result in any changes in the minimum tax rates applied in this Directive or to the addition or removal of any energy products and electricity. Article 3 References in Directive 92/12/EEC to ‘mineral oils’ and ‘excise duty’, insofar as it applies to mineral oils, shall be interpreted as covering all energy products, electricity and national indirect taxes referred to respectively in Articles 2 and 4(2) of this Directive. Article 4 1. The levels of taxation which Member States shall apply to the energy products and electricity listed in Article 2 may not be less than the minimum levels of taxation prescribed by this Directive. 2. For the purpose of this Directive ‘level of taxation’ is the total charge levied in respect of all indirect taxes (except VAT) calculated directly or indirectly on the quantity of energy products and electricity at the time of release for consumption. Article 5 Provided that they respect the minimum levels of taxation prescribed by this Directive and that they are compatible with Community law, differentiated rates of taxation may be applied by Member States, under fiscal control, in the following cases: — when the differentiated rates are directly linked to product quality; — when the differentiated rates depend on quantitative consumption levels for electricity and energy products used for heating purposes; — for the following uses: local public passenger transport (including taxis), waste collection, armed forces and public administration, disabled people, ambulances; — between business and non-business use, for energy products and electricity referred to in Articles 9 and 10. Article 6 Member States shall be free to give effect to the exemptions or reductions in the level of taxation prescribed by this Directive either: (a) directly, (b) by means of a differentiated rate, or (c) by refunding all or part of the amount of taxation. Article 7 1. As from 1 January 2004 and from 1 January 2010, the minimum levels of taxation applicable to motor fuels shall be fixed as set out in Annex I Table A. Not later than 1 January 2012, the Council, acting unanimously after consulting the European Parliament, shall, on the basis of a report and a proposal from the Commission, decide upon the minimum levels of taxation applicable to gas oil for a further period beginning on 1 January 2013. 2. Member States may differentiate between commercial and non-commercial use of gas oil used as propellant, provided that the Community minimum levels are observed and the rate for commercial gas oil used as propellant does not fall below the national level of taxation in force on 1 January 2003, notwithstanding any derogations for this use laid down in this Directive. 3. ‘Commercial gas oil used as propellant’ shall mean gas oil used as propellant for the following purposes: (a) the carriage of goods for hire or reward, or on own account, by motor vehicles or articulated vehicle combinations intended exclusively for the carriage of goods by road and with a maximum permissible gross laden weight of not less than 7,5 tonnes; (b) the carriage of passengers, whether by regular or occasional service, by a motor vehicle of category M2 or category M3, as defined in Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (8). 4. Notwithstanding paragraph 2, Member States which introduce a system of road user charges for motor vehicles or articulated vehicle combinations intended exclusively for the carriage of goods by road may apply a reduced rate on gas oil used by such vehicles, that goes below the national level of taxation in force on 1 January 2003, as long as the overall tax burden remains broadly equivalent, provided that the Community minimum levels are observed and that the national level of taxation in force on 1 January 2003 for gas oil used as propellant is at least twice as high as the minimum level of taxation applicable on 1 January 2004. Article 8 1. As from 1 January 2004, notwithstanding Article 7, the minimum levels of taxation applicable to products used as motor fuel for the purposes set out in paragraph 2 shall be fixed as set out in Annex I Table B. 2. This Article shall apply to the following industrial and commercial purposes: (a) agricultural, horticultural or piscicultural works, and in forestry; (b) stationary motors; (c) plant and machinery used in construction, civil engineering and public works; (d) vehicles intended for use off the public roadway or which have not been granted authorisation for use mainly on the public roadway. Article 9 1. As from 1 January 2004, the minimum levels of taxation applicable to heating fuels shall be fixed as set out in Annex I Table C. 2. Member States, which on 1 January 2003 are authorised to apply a monitoring charge for heating gas oil, may continue to apply a reduced rate of EUR 10 per 1 000 litres for that product. This authorisation shall be repealed on 1 January 2007 if the Council, acting unanimously on the basis of a report and a proposal from the Commission, so decides, having noted that the level of the reduced rate is too low to avoid problems of trade distortion between the Member States. Article 10 1. As from 1 January 2004, the minimum levels of taxation applicable to electricity shall be fixed as set out in Annex I Table C. 2. Above the minimum levels of taxation referred to in paragraph 1, Member States will have the option of determining the applicable tax base provided that they respect Directive 92/12/EEC. Article 11 1. In this Directive, ‘business use’ shall mean the use by a business entity, identified in accordance with paragraph 2, which independently carries out, in any place, the supply of goods and services, whatever the purpose or results of such economic activities. The economic activities comprise all activities of producers, traders and persons supplying services including mining and agricultural activities and activities of the professions. States, regional and local government authorities and other bodies governed by public law shall not be considered as business entities in respect of the activities or transactions in which they engage as public authorities. However, when they engage in such activities or transactions, they shall be considered as a business in respect of these activities or transactions where treatment as non-business would lead to significant distortions of competition. 2. With respect to this Directive, the business entity cannot be considered as smaller than a part of an enterprise or a legal body that from an organisational point of view constitutes an independent business, that is to say an entity capable of functioning by its own means. 3. Where mixed use takes place, taxation shall apply in proportion to each type of use, although where either the business or non-business use is insignificant, it may be treated as nil. 4. Member States may limit the scope of the reduced level of taxation for business use. Article 12 1. Member States may express their national levels of taxation in units other than those specified in Articles 7 to 10 provided that the corresponding levels of taxation, following conversion into those units, are not below the minimum levels specified in this Directive. 2. For energy products specified in Articles 7, 8 and 9, with levels of taxation based on volumes, the volume shall be measured at a temperature of 15° C. Article 13 1. For Member States that have not adopted the euro, the value of the euro in national currencies to be applied to the value of the levels of taxation shall be fixed once a year. The rates to be applied shall be those obtaining on the first working day of October and published in the Official Journal of the European Union and shall have effect from 1 January of the following calendar year. 2. Member States may maintain the amounts of taxation in force at the time of the annual adjustment provided for in paragraph 1 if the conversion of the amounts of the level of taxation expressed in euro would result in an increase of less than 5 % or EUR 5, whichever is the lower amount, in the level of taxation expressed in national currency. Article 14 1. In addition to the general provisions set out in Directive 92/12/EEC on exempt uses of taxable products, and without prejudice to other Community provisions, Member States shall exempt the following from taxation under conditions which they shall lay down for the purpose of ensuring the correct and straightforward application of such exemptions and of preventing any evasion, avoidance or abuse: (a) energy products and electricity used to produce electricity and electricity used to maintain the ability to produce electricity. However, Member States may, for reasons of environmental policy, subject these products to taxation without having to respect the minimum levels of taxation laid down in this Directive. In such case, the taxation of these products shall not be taken into account for the purpose of satisfying the minimum level of taxation on electricity laid down in Article 10; (b) energy products supplied for use as fuel for the purpose of air navigation other than in private pleasure-flying. For the purposes of this Directive ‘private pleasure-flying’ shall mean the use of an aircraft by its owner or the natural or legal person who enjoys its use either through hire or through any other means, for other than commercial purposes and in particular other than for the carriage of passengers or goods or for the supply of services for consideration or for the purposes of public authorities. Member States may limit the scope of this exemption to supplies of jet fuel (CN code 2710 19 21); (c) energy products supplied for use as fuel for the purposes of navigation within Community waters (including fishing), other than private pleasure craft, and electricity produced on board a craft. For the purposes of this Directive ‘private pleasure craft’ shall mean any craft used by its owner or the natural or legal person who enjoys its use either through hire or through any other means, for other than commercial purposes and in particular other than for the carriage of passengers or goods or for the supply of services for consideration or for the purposes of public authorities. 2. Member States may limit the scope of the exemptions provided for in paragraph 1(b) and (c) to international and intra-Community transport. In addition, where a Member State has entered into a bilateral agreement with another Member State, it may also waive the exemptions provided for in paragraph 1(b) and (c). In such cases, Member States may apply a level of taxation below the minimum level set out in this Directive. Article 15 1. Without prejudice to other Community provisions, Member States may apply under fiscal control total or partial exemptions or reductions in the level of taxation to: (a) taxable products used under fiscal control in the field of pilot projects for the technological development of more environmentally-friendly products or in relation to fuels from renewable resources; (b) electricity: — of solar, wind, wave, tidal or geothermal origin; — of hydraulic origin produced in hydroelectric installations; — generated from biomass or from products produced from biomass; — generated from methane emitted by abandoned coalmines; — generated from fuel cells; (c) energy products and electricity used for combined heat and power generation; (d) electricity produced from combined heat and power generation, provided that the combined generators are environmentally friendly. Member States may apply national definitions of ‘environmentally-friendly’ (or high efficiency) cogeneration production until the Council, on the basis of a report and a proposal from the Commission, unanimously adopts a common definition; (e) energy products and electricity used for the carriage of goods and passengers by rail, metro, tram and trolley bus; (f) energy products supplied for use as fuel for navigation on inland waterways (including fishing) other than in private pleasure craft, and electricity produced on board a craft; (g) natural gas in Member States in which the share of natural gas in final energy consumption was less than 15 % in 2000; The total or partial exemptions or reductions may apply for a maximum period of ten years after the entry into force of this Directive or until the national share of natural gas in final energy consumption reaches 25 %, whichever is the sooner. However, as soon as the national share of natural gas in final energy consumption reaches 20 %, the Member States concerned shall apply a strictly positive level of taxation, which shall increase on a yearly basis in order to reach at least the minimum rate at the end of the period referred to above. The United Kingdom of Great Britain and Northern Ireland may apply the total or partial exemptions or reductions for natural gas separately for Northern Ireland; (h) electricity, natural gas, coal and solid fuels used by households and/or by organisations recognised as charitable by the Member State concerned. In the case of such charitable organisations, Member States may confine the exemption or reduction to use for the purpose of non-business activities. Where mixed use takes place, taxation shall apply in proportion to each type of use. If a use is insignificant, it may be treated as nil; (i) natural gas and LPG used as propellants; (j) motor fuels used in the field of the manufacture, development, testing and maintenance of aircraft and ships; (k) motor fuels used for dredging operations in navigable waterways and in ports; (l) products falling within CN code 2705 used for heating purposes. 2. Member States may also refund to the producer some or all of the amount of tax paid by the consumer on electricity produced from products specified in paragraph 1(b). 3. Member States may apply a level of taxation down to zero to energy products and electricity used for agricultural, horticultural or piscicultural works, and in forestry. On the basis of a proposal from the Commission, the Council shall before 1 January 2008 examine if the possibility of applying a level of taxation down to zero shall be repealed. Article 16 1. Member States may, without prejudice to paragraph 5, apply an exemption or a reduced rate of taxation under fiscal control on the taxable products referred to in Article 2 where such products are made up of, or contain, one or more of the following products: — products falling within CN codes 1507 to 1518; — products falling within CN codes 3824 90 55 and 3824 90 80 to 3824 90 99 for their components produced from biomass; — products falling within CN codes 2207 20 00 and 2905 11 00 which are not of synthetic origin; — products produced from biomass, including products falling within CN codes 4401 and 4402. Member States may also apply a reduced rate of taxation under fiscal control on the taxable products referred to in Article 2 where such products contain water (CN codes 2201 and 2851 00 10). ‘Biomass’ shall mean the biodegradable fraction of products, waste and residues from agriculture (including vegetal and animal substances), forestry and related industries, as well as the biodegradable fraction of industrial and municipal waste. 2. The exemption or reduction in taxation resulting from the application of the reduced rate laid down in paragraph 1 may not be greater than the amount of taxation payable on the volume of the products referred to in paragraph 1 present in the products eligible for the reduction. The levels of taxation applied by Member States on the products made up of or containing the products referred to in paragraph 1 may be lower than the minimum levels specified in Article 4. 3. The exemption or reduction in taxation applied by Member States shall be adjusted to take account of changes in raw material prices to avoid over-compensating for the extra costs involved in the manufacture of the products referred to in paragraph 1. 4. Until 31 December 2003, Member States may exempt or continue to exempt products solely or almost solely made up of the products referred to in paragraph 1. 5. The exemption or reduction provided for the products referred to in paragraph 1 may be granted under a multiannual programme by means of an authorisation issued by an administrative authority to an economic operator for more than one calendar year. The exemption or reduction authorised may not be applied for a period of more than six consecutive years. This period may be renewed. As part of a multiannual programme authorised by an administrative authority prior to 31 December 2012, Member States may apply the exemption or reduction under paragraph 1 after 31 December 2012 and until the end of the multiannual programme. The period may not be renewed. 6. Should Member States be required by Community law to comply with legally binding obligations to place on their markets a minimum proportion of the products referred to in paragraph 1, paragraphs 1 to 5 shall cease to apply as from the date when such obligations become binding on the Member States. 7. Member States shall communicate to the Commission the schedule of tax reductions or exemptions applied in accordance with this Article by 31 December 2004 and every 12 months thereafter. 8. No later than 31 December 2009, the Commission shall report to the Council on the fiscal, economic, agricultural, energy, industrial and environmental aspects of the reductions granted in accordance with this Article. Article 17 1. Provided the minimum levels of taxation prescribed in this Directive are respected on average for each business, Member States may apply tax reductions on the consumption of energy products used for heating purposes or for the purposes of Article 8(2)(b) and (c) and on electricity in the following cases: (a) in favour of energy-intensive business An ‘energy-intensive business’ shall mean a business entity, as referred to in Article 11, where either the purchases of energy products and electricity amount to at least 3,0 % of the production value or the national energy tax payable amounts to at least 0,5 % of the added value. Within this definition, Member States may apply more restrictive concepts, including sales value, process and sector definitions. ‘Purchases of energy products and electricity’ shall mean the actual cost of energy purchased or generated within the business. Only electricity, heat and energy products that are used for heating purposes or for the purposes of Article 8(2)(b) and (c) are included. All taxes are included, except deductible VAT. ‘Production value’ shall mean turnover, including subsidies directly linked to the price of the product, plus or minus the changes in stocks of finished products, work in progress and goods and services purchased for resale, minus the purchases of goods and services for resale. ‘Value added’ shall mean the total turnover liable to VAT including export sales minus the total purchases liable to VAT including imports. Member States, which currently apply national energy tax systems in which energy-intensive businesses are defined according to criteria other than energy costs in comparison with production value and national energy tax payable in comparison with value added, shall be allowed a transitional period until no later than 1 January 2007 to adapt to the definition set out in point (a) first subparagraph; (b) where agreements are concluded with undertakings or associations of undertakings, or where tradable permit schemes or equivalent arrangements are implemented, as far as they lead to the achievement of environmental protection objectives or to improvements in energy efficiency. 2. Notwithstanding Article 4(1), Member States may apply a level of taxation down to zero to energy products and electricity as defined in Article 2, when used by energy-intensive businesses as defined in paragraph 1 of this Article. 3. Notwithstanding Article 4(1), Member States may apply a level of taxation down to 50 % of the minimum levels in this Directive to energy products and electricity as defined in Article 2, when used by business entities as defined in Article 11, which are not energy-intensive as defined in paragraph 1 of this Article. 4. Businesses that benefit from the possibilities referred to in paragraphs 2 and 3 shall enter into the agreements, tradable permit schemes or equivalent arrangements as referred to in paragraph 1(b). The agreements, tradable permit schemes or equivalent arrangements must lead to the achievement of environmental objectives or increased energy efficiency, broadly equivalent to what would have been achieved if the standard Community minimum rates had been observed. Article 18 1. By way of derogation from the provisions of the present directive, Member States are hereby authorised to continue to apply the reductions in the levels of taxation or exemptions set out in Annex II. Subject to a prior review by the Council, on the basis of a proposal from the Commission, this authorisation shall expire on 31 December 2006 or on the date specified in Annex II. 2. Notwithstanding the periods set out in paragraphs 3 to 12 and provided that this does not significantly distort competition, Member States with difficulties in implementing the new minimum levels of taxation will be allowed a transitional period of until 1 January 2007, particularly in order to avoid jeopardising price stability. 3. The Kingdom of Spain may apply a transitional period until 1 January 2007 to adjust its national level of taxation on gas oil used as propellant to the new minimum level of EUR 302 and until 1 January 2012 to reach EUR 330. Until 31 December 2009, it may furthermore apply a special reduced rate on commercial use of gas oil used as propellant, provided that this does not result in taxation at below EUR 287 per 1 000 l and that the national levels of taxation in force on 1 January 2003 are not reduced. From 1 January 2010 until 1 January 2012, it may apply a differentiated rate on commercial use of gas oil used as propellant, provided that it does not result in taxation at below EUR 302 per 1 000 l and that the national levels of taxation in force on 1 January 2010 are not reduced. The special reduced rate on commercial use of gas oil used as propellant may also be applied for taxis until 1 January 2012. With respect to Article 7(3)(a), it may apply, until 1 January 2008, a maximum permissible gross laden weight of not less than 3,5 tonnes in the definition of commercial purposes. 4. The Republic of Austria may apply a transitional period until 1 January 2007 to adjust its national level of taxation on gas oil used as propellant to the new minimum level of EUR 302 and until 1 January 2012 to reach EUR 330. Until 31 December 2009, it may furthermore apply a special reduced rate on commercial use of gas oil used as propellant, provided that this does not result in taxation at below EUR 287 per 1 000 l and that the national levels of taxation in force on 1 January 2003 are not reduced. From 1 January 2010 until 1 January 2012, it may apply a differentiated rate on commercial use of gas oil used as propellant, provided that it does not result in taxation at below EUR 302 per 1 000 l and that the national levels of taxation in force on 1 January 2010 are not reduced. 5. The Kingdom of Belgium may apply a transitional period until 1 January 2007 to adjust its national level of taxation on gas oil used as propellant to the new minimum level of EUR 302 and until 1 January 2012 to reach EUR 330. Until 31 December 2009, it may furthermore apply a special reduced rate on commercial use of gas oil used as propellant, provided that this does not result in taxation at below EUR 287 per 1 000 l and that the national levels of taxation in force on 1 January 2003 are not reduced. From 1 January 2010 until 1 January 2012, it may apply a differentiated rate on commercial use of gas oil used as propellant, provided that it does not result in taxation at below EUR 302 per 1 000 l and that the national levels of taxation in force on 1 January 2010 are not reduced. 6. The Grand Duchy of Luxembourg may apply a transitional period until 1 January 2009 to adjust its national level of taxation on gas oil used as propellant to the new minimum level of EUR 302 and until 1 January 2012 to reach EUR 330. Until 31 December 2009, it may furthermore apply a special reduced rate on commercial use of gas oil used as propellant, provided that this does not result in taxation at below EUR 272 per 1 000 l and that the national levels of taxation in force on 1 January 2003 are not reduced. From 1 January 2010 until 1 January 2012, it may apply a differentiated rate on commercial use of gas oil used as propellant, provided that this does not result in taxation at below EUR 302 per 1 000 l and that the national levels of taxation in force on 1 January 2010 are not reduced. 7. The Portuguese Republic may apply levels of taxation on energy products and electricity consumed in the Autonomous Regions of the Azores and Madeira lower than the minimum levels of taxation laid down in this Directive in order to compensate for the transport costs incurred as a result of the insular and dispersed nature of these regions. The Portuguese Republic may apply a transitional period until 1 January 2009 to adjust its national level of taxation on gas oil used as propellant to the new minimum level of EUR 302 and until 1 January 2012 to reach EUR 330. Until 31 December 2009, it may furthermore apply a differentiated rate on commercial use of gas oil used as propellant, provided that this does not result in taxation at below EUR 272 per 1 000 l and that the national levels of taxation in force on 1 January 2003 are not reduced. From 1 January 2010 until 1 January 2012, it may apply a differentiated rate on commercial use of gas oil used as propellant, provided that this does not result in taxation at below EUR 302 per 1000 l and that the national levels of taxation in force on 1 January 2010 are not reduced. The differentiated rate on commercial use of gas oil used as propellant may also be applied for taxis until 1 January 2012. With respect to Article 7(3)(a) it may apply, until 1 January 2008, a maximum permissible gross laden weight of not less than 3,5 tonnes in the definition of commercial purposes. The Portuguese Republic may apply total or partial exemptions in the level of taxation of electricity until 1 January 2010. 8. The Hellenic Republic may apply levels of taxation up to EUR 22 per 1 000 l lower than the minimum rates laid down in this Directive on gas oil used as propellant and on petrol consumed in the departments of Lesbos, Chios, Samos, the Dodecanese and the Cyclades and on the following islands in the Aegean: Thasos, North Sporades, Samothrace and Skiros. The Hellenic Republic may apply a transitional period until 1 January 2010 to convert its current input electricity taxation system into an output taxation system and to reach the new minimum level of taxation for petrol. The Hellenic Republic may apply a transitional period until 1 January 2010 to adjust its national level of taxation on gas oil used as propellant to the new minimum level of EUR 302 per 1 000 l and until 1 January 2012 to reach EUR 330. Until 31 December 2009 it may furthermore apply a differentiated rate on commercial use of gas oil used as propellant, provided that this does not result in taxation at below EUR 264 per 1 000 l and that the national levels of taxation in force on 1 January 2003 are not reduced. From 1 January 2010 until 1 January 2012, it may apply a differentiated rate on commercial use of gas oil used as propellant, provided that this does not result in taxation at below EUR 302 per 1 000 l and that the national levels of taxation in force on 1 January 2010 are not reduced. The differentiated rate on commercial use of gas oil used as propellant may also be applied for taxis until 1 January 2012. With respect to Article 7(3)(a) it may apply, until 1 January 2008, a maximum permissible gross laden weight of not less than 3,5 tonnes in the definition of commercial purposes. 9. Ireland may apply total or partial exemptions or reductions in the level of taxation of electricity until 1 January 2008. 10. The French Republic may apply total or partial exemptions or reductions for energy products and electricity used by the State, regional and local government authorities or other bodies governed by public law, in respect of the activities or transactions in which they engage as public authorities until 1 January 2009. The French Republic may apply a transitional period until 1 January 2009 to adapt its current electricity taxation system to the provisions set out in this Directive. During this period, the global average level of the current local electricity taxation is to be taken into account to assess whether the minimum rates set out in this Directive are respected. 11. The Italian Republic may apply, until 1 January 2008, a maximum permissible gross laden weight of not less than 3,5 tonnes in the definition of commercial purposes as given in Article 7(3)(a). 12. The Federal Republic of Germany may apply, until 1 January 2008, a maximum permissible gross laden weight of 12 tonnes in the definition of commercial purposes as given in Article 7(3)(a). 13. The Kingdom of the Netherlands may apply, until 1 January 2008, a maximum permissible gross laden weight of 12 tonnes in the definition of commercial purposes as given in Article 7(3)(a). 14. Within the transitional periods established, Member States shall progressively reduce their respective gaps with respect to the new minimum levels of taxation. However, when the difference between the national level and the minimum level does not exceed 3 % of that minimum level, the Member State concerned may wait until the end of the period to adjust its national level. Article 19 1. In addition to the provisions set out in the previous Articles, in particular in Articles 5, 15 and 17, the Council, acting unanimously on a proposal from the Commission, may authorise any Member State to introduce further exemptions or reductions for specific policy considerations. A Member State wishing to introduce such a measure shall inform the Commission accordingly and shall also provide the Commission with all relevant and necessary information. The Commission shall examine the request, taking into account, inter alia, the proper functioning of the internal market, the need to ensure fair competition and Community health, environment, energy and transport policies. Within three months of receiving all relevant and necessary information, the Commission shall either present a proposal for the authorisation of such a measure by the Council or, alternatively, shall inform the Council of the reasons why it has not proposed the authorisation of such a measure. 2. The authorisations referred to in paragraph 1 shall be granted for a maximum period of 6 years, with the possibility of renewal in accordance with the procedure set out in paragraph 1. 3. If the Commission considers that the exemptions or reductions provided for in paragraph 1 are no longer sustainable, particularly in terms of fair competition or distortion of the operation of the internal market, or in terms of Community policy in the areas of health, protection of the environment, energy and transport, it shall submit appropriate proposals to the Council. The Council shall take a unanimous decision on these proposals. Article 20 1. Only the following energy products shall be subject to the control and movement provisions of Directive 92/12/EEC: (a) products falling within CN codes 1507 to 1518, if these are intended for use as heating fuel or motor fuel; (b) products falling within CN codes 2707 10, 2707 20, 2707 30 and 2707 50; (c) products falling within CN codes 2710 11 to 2710 19 69. However, for products falling within CN codes 2710 11 21, 2710 11 25 and 2710 19 29, the control and movement provisions shall only apply to bulk commercial movements; (d) products falling within CN codes 2711 (except 2711 11, 2711 21 and 2711 29); (e) products falling within CN code 2901 10; (f) products falling within CN codes 2902 20, 2902 30, 2902 41, 2902 42, 2902 43 and 2902 44; (g) products falling within CN code 2905 11 00, which are not of synthetic origin, if these are intended for use as heating fuel or motor fuel; (h) products falling within CN code 3824 90 99 if these are intended for use as heating fuel or motor fuel. 2. If a Member State finds that energy products other than those referred to in paragraph 1 are intended for use, offered for sale or used as heating fuel, motor fuel or are otherwise giving rise to evasion, avoidance or abuse, it shall advise the Commission forthwith. This provision shall also apply for electricity. The Commission shall transmit the communication to the other Member States within one month of receipt. A Decision as to whether the products in question should be made subject to the control and movement provisions of Directive 92/12/EEC shall then be taken in accordance with the procedure laid down in Article 27(2). 3. Member States may, pursuant to bilateral arrangements, dispense with some or all of the control measures set out in Directive 92/12/EEC in respect of some or all of the products referred to in paragraph 1, insofar as they are not covered by Articles 7 to 9 of this Directive. Such arrangements shall not affect Member States which are not party to them. All such bilateral arrangements shall be notified to the Commission, which shall inform the other Member States. Article 21 1. In addition to the general provisions defining the chargeable event and the provisions for payment set out in Directive 92/12/EEC, the amount of taxation on energy products shall also become due on the occurrence of one of the chargeable events mentioned in Article 2(3). 2. For the purpose of this Directive, the word ‘production’ in Article 4(c) and 5(1) of Directive 92/12/EEC shall be deemed to include ‘extraction’, when appropriate. 3. The consumption of energy products within the curtilage of an establishment producing energy products shall not be considered as a chargeable event giving rise to taxation, if the consumption consist of energy products produced within the curtilage of the establishment. Member States may also consider the consumption of electricity and other energy products not produced within the curtilage of such an establishment and the consumption of energy products and electricity within the curtilage of an establishment producing fuels to be used for generation of electricity as not giving rise to a chargeable event. Where the consumption is for purposes not related to the production of energy products and in particular for the propulsion of vehicles, this shall be considered a chargeable event, giving rise to taxation. 4. Member States may also provide that taxation on energy products and electricity shall become due when it is established that a final use condition laid down in national rules for the purpose of a reduced level of taxation or exemption is not, or is no longer, fulfilled. 5. For the purpose of applying Articles 5 and 6 of Directive 92/12/EEC, electricity and natural gas shall be subject to taxation and shall become chargeable at the time of supply by the distributor or redistributor. Where the delivery to consumption takes place in a Member State where the distributor or redistributor is not established, the tax of the Member States of delivery shall be chargeable to a company that has to be registered in the Member State of delivery. Tax shall in all cases be levied and collected according to procedures laid down by each Member State. Notwithstanding the first subparagraph, Member States have the right to determine the chargeable event, in the case where there are no connections between their gas pipe lines and those of other Member States. An entity producing electricity for its own use is regarded as a distributor. Notwithstanding Article 14(1)(a), Member States may exempt small producers of electricity provided that they tax the energy products used for the production of that electricity. For the purpose of applying Articles 5 and 6 of Directive 92/12/EEC, coal, coke and lignite shall be subject to taxation and shall become chargeable at the time of delivery by companies, which have to be registered for that purpose by the relevant authorities. Those authorities may allow the producer, trader, importer or fiscal representative to substitute the registered company for the fiscal obligations imposed upon it. Tax shall be levied and collected according to procedures laid down by each Member State. 6. Member States need not treat as ‘production of energy products’: (a) operations during which small quantities of energy products are obtained incidentally; (b) operations by which the user of an energy product makes its reuse possible in his own undertaking provided that the taxation already paid on such product is not less than the taxation which would be due if the reused energy product were again to be liable to taxation; (c) an operation consisting of mixing, outside a production establishment or a tax warehouse, energy products with other energy products or other materials, provided that: (i) taxation on the components has been paid previously; and (ii) the amount paid is not less than the amount of the tax which would be chargeable on the mixture. The condition under (i) shall not apply where the mixture is exempted for a specific use. Article 22 When taxation rates are changed, stocks of energy products already released for consumption may be subject to an increase in, or a reduction of, the tax. Article 23 Member States may refund the amounts of taxation already paid on contaminated or accidentally mixed energy products sent back to a tax warehouse for recycling. Article 24 1. Energy products released for consumption in a Member State, contained in the standard tanks of commercial motor vehicles and intended to be used as fuel by those same vehicles, as well as in special containers, and intended to be used for the operation, during the course of transport, of the systems equipping those same containers shall not be subject to taxation in any other Member State. 2. For the purposes of this Article, ‘standard tanks’ shall mean: — the tanks permanently fixed by the manufacturer to all motor vehicles of the same type as the vehicle in question and whose permanent fitting enables fuel to be used directly, both the purpose of propulsion and, where appropriate, for the operation, during transport, of refrigeration systems and other systems. Gas tanks fitted to motor vehicles designed for the direct use of gas as a fuel and tanks fitted to the other systems with which the vehicle may be equipped shall also be considered to be standard tanks; — the tanks permanently fixed by the manufacturer to all containers of the same type as the container in question and whose permanent fitting enables fuel to be used directly for the operation, during transport, of the refrigeration systems and other systems with which special containers are equipped. ‘Special container’ shall mean any container fitted with specially designed apparatus for refrigeration systems, oxygenation systems, thermal insulation systems or other systems. Article 25 1. Member States shall inform the Commission of the levels of taxation which they apply to the products listed in Article 2 on 1 January each year and following each change in national law. 2. Where the levels of taxation applied by the Member States are expressed in units of measurement other than those specified for each product in Articles 7 to 10, Member States shall also notify the corresponding levels of taxation following conversion into these units. Article 26 1. Member States shall inform the Commission of measures taken pursuant to Articles 5, 14(2), 15 and 17. 2. Measures such as tax exemptions, tax reductions, tax differentiation and tax refunds within the meaning of this Directive might constitute State aid and in those cases have to be notified to the Commission pursuant to Article 88(3) of the Treaty. Information provided to the Commission on the basis of this Directive does not free Member States from the notification obligation pursuant to Article 88(3) of the Treaty. 3. The obligation to inform the Commission pursuant to paragraph 1 of measures taken pursuant to Article 5 does not free Member States from any notification obligations pursuant to Directive 83/189/EEC. Article 27 1. The Commission shall be assisted by the Committee on Excise Duties set up by Article 24(1) of Directive 92/12/EEC. 2. Where reference is made to this paragraph, Article 5 and 7 of Decision 1999/468/EC shall apply. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. Article 28 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 2003. They shall forthwith inform the Commission thereof. 2. They shall apply these provisions from 1 January 2004, except the provisions laid down in Articles 16 and 18(1), which may be applied by the Member States from 1 January 2003. 3. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 4. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 29 The Council, acting on the basis of a report and, where appropriate, a proposal from the Commission, shall periodically examine the exemptions and reductions and the minimum levels of taxation laid down in this Directive and, acting unanimously after consulting the European Parliament, shall adopt the necessary measures. The report by the Commission and the consideration by the Council shall take into account the proper functioning of the internal market, the real value of the minimum levels of taxation and the wider objectives of the Treaty. Article 30 Notwithstanding Article 28(2), Directives 92/81/EEC and 92/82/EEC shall be repealed as from 31 December 2003. Article 31 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 32 This Directive is addressed to the Member States.

32003L0095

2003

Commission Directive 2003/95/EC of 27 October 2003 amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption(1), as amended by Directive 94/34/EC of the European Parliament and of the Council(2), and in particular Article 3(3)(a) thereof, After consulting the Scientific Committee on Food, Whereas: (1) Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners(3), as last amended by Directive 2001/5/EC(4), lays down a list of substances which may be used as additives other than colours and sweeteners in foodstuffs. (2) Commission Directive 96/77/EC(5), as last amended by Directive 2002/82/EC(6), sets out the purity criteria for the additives mentioned in Directive 95/2/EC. (3) The Scientific Committee on Food concluded in its opinion of 6 May 2002 that the presence of ethylene oxide should be brought below the detection limit. Consequently, the relevant criterion of the existing purity criteria set out in Directive 96/77/EC needs to be adapted. (4) It is necessary to adapt to technical progress the existing purity criteria for E 251 sodium nitrate and E 459 beta-cyclodextrin. (5) It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). (6) Directive 96/77/EC should therefore be amended accordingly. (7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Annex to Directive 96/77/EC is amended as set out in the Annex to this Directive. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 November 2004 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 Products put on the market or labelled before 1 November 2004 which do not comply with this Directive may be marketed until stocks are exhausted. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32003L0100

2003

Commission Directive 2003/100/EC of 31 October 2003 amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed(1), as amended by Commission Directive 2003/57/EC(2), and in particular Article 8(1) thereof, Whereas: (1) Directive 2002/32/EC provides that the use of products intended for animal feed which contain levels of undesirable substances exceeding the maximum levels laid down in Annex I thereto is prohibited. (2) When Directive 2002/32/EC was adopted, it was stated that the provisions laid down in Annex I would be reviewed on the basis of updated scientific risk assessments and taking into account the prohibition of any dilution of contaminated non-complying products intended for animal feed. (3) The Scientific Committee for Animal Nutrition (SCAN) was accordingly requested to provide updated scientific risk assessments without delay. SCAN adopted an opinion on undesirable substances in feed on 20 February 2003, which was updated on 25 April 2003. That opinion provides a comprehensive overview of the possible risks for animal and public health as the consequence of the presence of different undesirable substances in animal feed. (4) SCAN nevertheless acknowledged that additional detailed risk assessments are necessary to permit a complete review of Annex I to Directive 2002/32/EC. Since May 2003, the European Food Safety Authority (EFSA) has taken over from the European Commission the responsibility for the scientific assessment of feed and food safety issues. EFSA has been asked to carry out those detailed risk assessments. (5) In the meantime, it has been pointed out that the supply of some essential and valuable feed materials could be endangered because the level of an undesirable substance in some feed materials due to normal background contamination is close to or exceeds the maximum level laid down in the Annex I to Directive 2002/32/EC. Also some inconsistencies have been found between the provisions of the Annex. (6) The Annex should therefore be amended on a provisional basis, pending the detailed scientific risk assessments, maintaining a high level of protection for public and animal health and the environment. (7) With a view to maintaining such a high level of protection for public and animal health and the environment, it is acknowledged that if feed materials are fed directly to the animals or if complementary feedingstuffs are used, their use in a daily ration should not lead to the animal being exposed to a higher level of an undesirable substance than the corresponding maximum levels of exposure where only complete feedingstuffs are used in a daily ration. (8) SCAN confirms that arsenic in its organic forms has a limited toxicity. The determination of total arsenic in feed may, therefore, not always accurately reflect the risk posed by the inorganic forms. However, organic and inorganic forms of arsenic can be distinguished only by a complex method of analysis, which is not readily applicable in the framework of official controls. It is therefore appropriate for the maximum levels to refer to total arsenic with the residual possibility to require more detailed analysis particularly in case of the presence of Hizikia fusiforme. In the absence of a Community method of analysis for the determination of total arsenic, it is necessary to prove the satisfactory performance of the used sample treatment procedure and method of analysis by making use of certified reference materials, containing a significant part of the arsenic in its organic form. (9) It is also necessary to take account of the fact that more than 95 % of the arsenic present in feed materials of marine origin is in the less toxic organic forms and of recent developments in formulating fish feed incorporating higher ratios of fish oil and fishmeal. (10) The current maximum levels for arsenic, lead and fluorine in some mineral feed materials do not reflect the current normal background contamination levels. Given the low bioavailability of these undesirable substances in mineral feedingstuffs, it is appropriate to ensure that those essential and valuable feed materials can be supplied without endangering animal and public health and the environment. (11) Aflatoxin B1 is a genotoxic carcinogen which is detected in milk in the form of its metabolite aflatoxin M1. It is appropriate to keep the maximum levels for aflatoxin as low as reasonably achievable in order to protect public health. Proper handling and drying practices can keep the aflatoxin levels in the different feed materials low, and efficient decontamination procedures exist to reduce levels of the aflatoxin B1. It is appropriate that the same maximum level of aflatoxin B1 should apply to all feed materials. (12) Whole cottonseed contains high levels of free gossypol as natural constituent. It is therefore appropriate to set specific maximum limits for free gossypol in whole cottonseed. (13) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 2002/32/EC is hereby amended in accordance with the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive 12 months after its entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0101

2003

Commission Directive 2003/101/EC of 3 November 2003 amending Council Directive 92/109/EEC on the manufacture and placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 92/109/EEC of 14 December 1992 on the manufacture and placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances(1), as last amended by Commission Directive 2001/8/EC(2), and in particular Article 10(3) thereof, Whereas: (1) With regard to the Community's obligations pursuant to Council Decision 90/611/EEC concerning conclusion, on behalf of the European Economic Community, of the United Nations Convention against illicit traffic in narcotic drugs and psychotropic substances(3), it is necessary to give effect to the decision taken by the United Nations Commission on Narcotic Drugs in March 2001 to add acetic anhydride and potassium permanganate to table 1 of the Annex to the 1988 United Nations Convention. (2) It is also appropriate to bring Directive 92/109/EEC in line with Council Regulation (EEC) No 3677/90 of 13 December 1990 laying down measures to discourage the diversion of certain substances to the illicit manufacture of narcotic drugs and psychotropic substances(4), as last amended by Commission Regulation (EC) No 1232/2002(5). (3) Potassium permanganate should be included among the substances listed in Category 2 of Annex I to Directive 92/109/EEC and deleted from Category 3 in that Annex. (4) In order to ensure that Community trade is not adversely affected, thresholds should be fixed for potassium permanganate as well as for acetic anhydride. (5) Directive 92/109/EEC should be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Committee set up pursuant to Article 10 of Regulation (EEC) No 3677/90, Article 1 The Annexes I and II to Directive 92/109/EEC shall be replaced by the text in the Annex to this Directive. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2004 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0088

2003

Directive 2003/88/EC of the European Parliament and of the Council of 4 November 2003 concerning certain aspects of the organisation of working time Having regard to the Treaty establishing the European Community, and in particular Article 137(2) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee(1), Having consulted the Committee of the Regions, Acting in accordance with the procedure referred to in Article 251 of the Treaty(2), Whereas: (1) Council Directive 93/104/EC of 23 November 1993, concerning certain aspects of the organisation of working time(3), which lays down minimum safety and health requirements for the organisation of working time, in respect of periods of daily rest, breaks, weekly rest, maximum weekly working time, annual leave and aspects of night work, shift work and patterns of work, has been significantly amended. In order to clarify matters, a codification of the provisions in question should be drawn up. (2) Article 137 of the Treaty provides that the Community is to support and complement the activities of the Member States with a view to improving the working environment to protect workers' health and safety. Directives adopted on the basis of that Article are to avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings. (3) The provisions of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(4) remain fully applicable to the areas covered by this Directive without prejudice to more stringent and/or specific provisions contained herein. (4) The improvement of workers' safety, hygiene and health at work is an objective which should not be subordinated to purely economic considerations. (5) All workers should have adequate rest periods. The concept of "rest" must be expressed in units of time, i.e. in days, hours and/or fractions thereof. Community workers must be granted minimum daily, weekly and annual periods of rest and adequate breaks. It is also necessary in this context to place a maximum limit on weekly working hours. (6) Account should be taken of the principles of the International Labour Organisation with regard to the organisation of working time, including those relating to night work. (7) Research has shown that the human body is more sensitive at night to environmental disturbances and also to certain burdensome forms of work organisation and that long periods of night work can be detrimental to the health of workers and can endanger safety at the workplace. (8) There is a need to limit the duration of periods of night work, including overtime, and to provide for employers who regularly use night workers to bring this information to the attention of the competent authorities if they so request. (9) It is important that night workers should be entitled to a free health assessment prior to their assignment and thereafter at regular intervals and that whenever possible they should be transferred to day work for which they are suited if they suffer from health problems. (10) The situation of night and shift workers requires that the level of safety and health protection should be adapted to the nature of their work and that the organisation and functioning of protection and prevention services and resources should be efficient. (11) Specific working conditions may have detrimental effects on the safety and health of workers. The organisation of work according to a certain pattern must take account of the general principle of adapting work to the worker. (12) A European Agreement in respect of the working time of seafarers has been put into effect by means of Council Directive 1999/63/EC of 21 June 1999 concerning the Agreement on the organisation of working time of seafarers concluded by the European Community Shipowners' Association (ECSA) and the Federation of Transport Workers' Unions in the European Union (FST)(5) based on Article 139(2) of the Treaty. Accordingly, the provisions of this Directive should not apply to seafarers. (13) In the case of those "share-fishermen" who are employees, it is for the Member States to determine, pursuant to this Directive, the conditions for entitlement to, and granting of, annual leave, including the arrangements for payments. (14) Specific standards laid down in other Community instruments relating, for example, to rest periods, working time, annual leave and night work for certain categories of workers should take precedence over the provisions of this Directive. (15) In view of the question likely to be raised by the organisation of working time within an undertaking, it appears desirable to provide for flexibility in the application of certain provisions of this Directive, whilst ensuring compliance with the principles of protecting the safety and health of workers. (16) It is necessary to provide that certain provisions may be subject to derogations implemented, according to the case, by the Member States or the two sides of industry. As a general rule, in the event of a derogation, the workers concerned must be given equivalent compensatory rest periods. (17) This Directive should not affect the obligations of the Member States concerning the deadlines for transposition of the Directives set out in Annex I, part B, CHAPTER 1 SCOPE AND DEFINITIONS Article 1 Purpose and scope 1. This Directive lays down minimum safety and health requirements for the organisation of working time. 2. This Directive applies to: (a) minimum periods of daily rest, weekly rest and annual leave, to breaks and maximum weekly working time; and (b) certain aspects of night work, shift work and patterns of work. 3. This Directive shall apply to all sectors of activity, both public and private, within the meaning of Article 2 of Directive 89/391/EEC, without prejudice to Articles 14, 17, 18 and 19 of this Directive. This Directive shall not apply to seafarers, as defined in Directive 1999/63/EC without prejudice to Article 2(8) of this Directive. 4. The provisions of Directive 89/391/EEC are fully applicable to the matters referred to in paragraph 2, without prejudice to more stringent and/or specific provisions contained in this Directive. Article 2 Definitions For the purposes of this Directive, the following definitions shall apply: 1. "working time" means any period during which the worker is working, at the employer's disposal and carrying out his activity or duties, in accordance with national laws and/or practice; 2. "rest period" means any period which is not working time; 3. "night time" means any period of not less than seven hours, as defined by national law, and which must include, in any case, the period between midnight and 5.00; 4. "night worker" means: (a) on the one hand, any worker, who, during night time, works at least three hours of his daily working time as a normal course; and (b) on the other hand, any worker who is likely during night time to work a certain proportion of his annual working time, as defined at the choice of the Member State concerned: (i) by national legislation, following consultation with the two sides of industry; or (ii) by collective agreements or agreements concluded between the two sides of industry at national or regional level; 5. "shift work" means any method of organising work in shifts whereby workers succeed each other at the same work stations according to a certain pattern, including a rotating pattern, and which may be continuous or discontinuous, entailing the need for workers to work at different times over a given period of days or weeks; 6. "shift worker" means any worker whose work schedule is part of shift work; 7. "mobile worker" means any worker employed as a member of travelling or flying personnel by an undertaking which operates transport services for passengers or goods by road, air or inland waterway; 8. "offshore work" means work performed mainly on or from offshore installations (including drilling rigs), directly or indirectly in connection with the exploration, extraction or exploitation of mineral resources, including hydrocarbons, and diving in connection with such activities, whether performed from an offshore installation or a vessel; 9. "adequate rest" means that workers have regular rest periods, the duration of which is expressed in units of time and which are sufficiently long and continuous to ensure that, as a result of fatigue or other irregular working patterns, they do not cause injury to themselves, to fellow workers or to others and that they do not damage their health, either in the short term or in the longer term. CHAPTER 2 MINIMUM REST PERIODS - OTHER ASPECTS OF THE ORGANISATION OF WORKING TIME Article 3 Daily rest Member States shall take the measures necessary to ensure that every worker is entitled to a minimum daily rest period of 11 consecutive hours per 24-hour period. Article 4 Breaks Member States shall take the measures necessary to ensure that, where the working day is longer than six hours, every worker is entitled to a rest break, the details of which, including duration and the terms on which it is granted, shall be laid down in collective agreements or agreements between the two sides of industry or, failing that, by national legislation. Article 5 Weekly rest period Member States shall take the measures necessary to ensure that, per each seven-day period, every worker is entitled to a minimum uninterrupted rest period of 24 hours plus the 11 hours' daily rest referred to in Article 3. If objective, technical or work organisation conditions so justify, a minimum rest period of 24 hours may be applied. Article 6 Maximum weekly working time Member States shall take the measures necessary to ensure that, in keeping with the need to protect the safety and health of workers: (a) the period of weekly working time is limited by means of laws, regulations or administrative provisions or by collective agreements or agreements between the two sides of industry; (b) the average working time for each seven-day period, including overtime, does not exceed 48 hours. Article 7 Annual leave 1. Member States shall take the measures necessary to ensure that every worker is entitled to paid annual leave of at least four weeks in accordance with the conditions for entitlement to, and granting of, such leave laid down by national legislation and/or practice. 2. The minimum period of paid annual leave may not be replaced by an allowance in lieu, except where the employment relationship is terminated. CHAPTER 3 NIGHT WORK - SHIFT WORK - PATTERNS OF WORK Article 8 Length of night work Member States shall take the measures necessary to ensure that: (a) normal hours of work for night workers do not exceed an average of eight hours in any 24-hour period; (b) night workers whose work involves special hazards or heavy physical or mental strain do not work more than eight hours in any period of 24 hours during which they perform night work. For the purposes of point (b), work involving special hazards or heavy physical or mental strain shall be defined by national legislation and/or practice or by collective agreements or agreements concluded between the two sides of industry, taking account of the specific effects and hazards of night work. Article 9 Health assessment and transfer of night workers to day work 1. Member States shall take the measures necessary to ensure that: (a) night workers are entitled to a free health assessment before their assignment and thereafter at regular intervals; (b) night workers suffering from health problems recognised as being connected with the fact that they perform night work are transferred whenever possible to day work to which they are suited. 2. The free health assessment referred to in paragraph 1(a) must comply with medical confidentiality. 3. The free health assessment referred to in paragraph 1(a) may be conducted within the national health system. Article 10 Guarantees for night-time working Member States may make the work of certain categories of night workers subject to certain guarantees, under conditions laid down by national legislation and/or practice, in the case of workers who incur risks to their safety or health linked to night-time working. Article 11 Notification of regular use of night workers Member States shall take the measures necessary to ensure that an employer who regularly uses night workers brings this information to the attention of the competent authorities if they so request. Article 12 Safety and health protection Member States shall take the measures necessary to ensure that: (a) night workers and shift workers have safety and health protection appropriate to the nature of their work; (b) appropriate protection and prevention services or facilities with regard to the safety and health of night workers and shift workers are equivalent to those applicable to other workers and are available at all times. Article 13 Pattern of work Member States shall take the measures necessary to ensure that an employer who intends to organise work according to a certain pattern takes account of the general principle of adapting work to the worker, with a view, in particular, to alleviating monotonous work and work at a predetermined work-rate, depending on the type of activity, and of safety and health requirements, especially as regards breaks during working time. CHAPTER 4 MISCELLANEOUS PROVISIONS Article 14 More specific Community provisions This Directive shall not apply where other Community instruments contain more specific requirements relating to the organisation of working time for certain occupations or occupational activities. Article 15 More favourable provisions This Directive shall not affect Member States' right to apply or introduce laws, regulations or administrative provisions more favourable to the protection of the safety and health of workers or to facilitate or permit the application of collective agreements or agreements concluded between the two sides of industry which are more favourable to the protection of the safety and health of workers. Article 16 Reference periods Member States may lay down: (a) for the application of Article 5 (weekly rest period), a reference period not exceeding 14 days; (b) for the application of Article 6 (maximum weekly working time), a reference period not exceeding four months. The periods of paid annual leave, granted in accordance with Article 7, and the periods of sick leave shall not be included or shall be neutral in the calculation of the average; (c) for the application of Article 8 (length of night work), a reference period defined after consultation of the two sides of industry or by collective agreements or agreements concluded between the two sides of industry at national or regional level. If the minimum weekly rest period of 24 hours required by Article 5 falls within that reference period, it shall not be included in the calculation of the average. CHAPTER 5 DEROGATIONS AND EXCEPTIONS Article 17 Derogations 1. With due regard for the general principles of the protection of the safety and health of workers, Member States may derogate from Articles 3 to 6, 8 and 16 when, on account of the specific characteristics of the activity concerned, the duration of the working time is not measured and/or predetermined or can be determined by the workers themselves, and particularly in the case of: (a) managing executives or other persons with autonomous decision-taking powers; (b) family workers; or (c) workers officiating at religious ceremonies in churches and religious communities. 2. Derogations provided for in paragraphs 3, 4 and 5 may be adopted by means of laws, regulations or administrative provisions or by means of collective agreements or agreements between the two sides of industry provided that the workers concerned are afforded equivalent periods of compensatory rest or that, in exceptional cases in which it is not possible, for objective reasons, to grant such equivalent periods of compensatory rest, the workers concerned are afforded appropriate protection. 3. In accordance with paragraph 2 of this Article derogations may be made from Articles 3, 4, 5, 8 and 16: (a) in the case of activities where the worker's place of work and his place of residence are distant from one another, including offshore work, or where the worker's different places of work are distant from one another; (b) in the case of security and surveillance activities requiring a permanent presence in order to protect property and persons, particularly security guards and caretakers or security firms; (c) in the case of activities involving the need for continuity of service or production, particularly: (i) services relating to the reception, treatment and/or care provided by hospitals or similar establishments, including the activities of doctors in training, residential institutions and prisons; (ii) dock or airport workers; (iii) press, radio, television, cinematographic production, postal and telecommunications services, ambulance, fire and civil protection services; (iv) gas, water and electricity production, transmission and distribution, household refuse collection and incineration plants; (v) industries in which work cannot be interrupted on technical grounds; (vi) research and development activities; (vii) agriculture; (viii) workers concerned with the carriage of passengers on regular urban transport services; (d) where there is a foreseeable surge of activity, particularly in: (i) agriculture; (ii) tourism; (iii) postal services; (e) in the case of persons working in railway transport: (i) whose activities are intermittent; (ii) who spend their working time on board trains; or (iii) whose activities are linked to transport timetables and to ensuring the continuity and regularity of traffic; (f) in the circumstances described in Article 5(4) of Directive 89/391/EEC; (g) in cases of accident or imminent risk of accident. 4. In accordance with paragraph 2 of this Article derogations may be made from Articles 3 and 5: (a) in the case of shift work activities, each time the worker changes shift and cannot take daily and/or weekly rest periods between the end of one shift and the start of the next one; (b) in the case of activities involving periods of work split up over the day, particularly those of cleaning staff. 5. In accordance with paragraph 2 of this Article, derogations may be made from Article 6 and Article 16(b), in the case of doctors in training, in accordance with the provisions set out in the second to the seventh subparagraphs of this paragraph. With respect to Article 6 derogations referred to in the first subparagraph shall be permitted for a transitional period of five years from 1 August 2004. Member States may have up to two more years, if necessary, to take account of difficulties in meeting the working time provisions with respect to their responsibilities for the organisation and delivery of health services and medical care. At least six months before the end of the transitional period, the Member State concerned shall inform the Commission giving its reasons, so that the Commission can give an opinion, after appropriate consultations, within the three months following receipt of such information. If the Member State does not follow the opinion of the Commission, it will justify its decision. The notification and justification of the Member State and the opinion of the Commission shall be published in the Official Journal of the European Union and forwarded to the European Parliament. Member States may have an additional period of up to one year, if necessary, to take account of special difficulties in meeting the responsibilities referred to in the third subparagraph. They shall follow the procedure set out in that subparagraph. Member States shall ensure that in no case will the number of weekly working hours exceed an average of 58 during the first three years of the transitional period, an average of 56 for the following two years and an average of 52 for any remaining period. The employer shall consult the representatives of the employees in good time with a view to reaching an agreement, wherever possible, on the arrangements applying to the transitional period. Within the limits set out in the fifth subparagraph, such an agreement may cover: (a) the average number of weekly hours of work during the transitional period; and (b) the measures to be adopted to reduce weekly working hours to an average of 48 by the end of the transitional period. With respect to Article 16(b) derogations referred to in the first subparagraph shall be permitted provided that the reference period does not exceed 12 months, during the first part of the transitional period specified in the fifth subparagraph, and six months thereafter. Article 18 Derogations by collective agreements Derogations may be made from Articles 3, 4, 5, 8 and 16 by means of collective agreements or agreements concluded between the two sides of industry at national or regional level or, in conformity with the rules laid down by them, by means of collective agreements or agreements concluded between the two sides of industry at a lower level. Member States in which there is no statutory system ensuring the conclusion of collective agreements or agreements concluded between the two sides of industry at national or regional level, on the matters covered by this Directive, or those Member States in which there is a specific legislative framework for this purpose and within the limits thereof, may, in accordance with national legislation and/or practice, allow derogations from Articles 3, 4, 5, 8 and 16 by way of collective agreements or agreements concluded between the two sides of industry at the appropriate collective level. The derogations provided for in the first and second subparagraphs shall be allowed on condition that equivalent compensating rest periods are granted to the workers concerned or, in exceptional cases where it is not possible for objective reasons to grant such periods, the workers concerned are afforded appropriate protection. Member States may lay down rules: (a) for the application of this Article by the two sides of industry; and (b) for the extension of the provisions of collective agreements or agreements concluded in conformity with this Article to other workers in accordance with national legislation and/or practice. Article 19 Limitations to derogations from reference periods The option to derogate from Article 16(b), provided for in Article 17(3) and in Article 18, may not result in the establishment of a reference period exceeding six months. However, Member States shall have the option, subject to compliance with the general principles relating to the protection of the safety and health of workers, of allowing, for objective or technical reasons or reasons concerning the organisation of work, collective agreements or agreements concluded between the two sides of industry to set reference periods in no event exceeding 12 months. Before 23 November 2003, the Council shall, on the basis of a Commission proposal accompanied by an appraisal report, re-examine the provisions of this Article and decide what action to take. Article 20 Mobile workers and offshore work 1. Articles 3, 4, 5 and 8 shall not apply to mobile workers. Member States shall, however, take the necessary measures to ensure that such mobile workers are entitled to adequate rest, except in the circumstances laid down in Article 17(3)(f) and (g). 2. Subject to compliance with the general principles relating to the protection of the safety and health of workers, and provided that there is consultation of representatives of the employer and employees concerned and efforts to encourage all relevant forms of social dialogue, including negotiation if the parties so wish, Member States may, for objective or technical reasons or reasons concerning the organisation of work, extend the reference period referred to in Article 16(b) to 12 months in respect of workers who mainly perform offshore work. 3. Not later than 1 August 2005 the Commission shall, after consulting the Member States and management and labour at European level, review the operation of the provisions with regard to offshore workers from a health and safety perspective with a view to presenting, if need be, the appropriate modifications. Article 21 Workers on board seagoing fishing vessels 1. Articles 3 to 6 and 8 shall not apply to any worker on board a seagoing fishing vessel flying the flag of a Member State. Member States shall, however, take the necessary measures to ensure that any worker on board a seagoing fishing vessel flying the flag of a Member State is entitled to adequate rest and to limit the number of hours of work to 48 hours a week on average calculated over a reference period not exceeding 12 months. 2. Within the limits set out in paragraph 1, second subparagraph, and paragraphs 3 and 4 Member States shall take the necessary measures to ensure that, in keeping with the need to protect the safety and health of such workers: (a) the working hours are limited to a maximum number of hours which shall not be exceeded in a given period of time; or (b) a minimum number of hours of rest are provided within a given period of time. The maximum number of hours of work or minimum number of hours of rest shall be specified by law, regulations, administrative provisions or by collective agreements or agreements between the two sides of the industry. 3. The limits on hours of work or rest shall be either: (a) maximum hours of work which shall not exceed: (i) 14 hours in any 24-hour period; and (ii) 72 hours in any seven-day period; or (b) minimum hours of rest which shall not be less than: (i) 10 hours in any 24-hour period; and (ii) 77 hours in any seven-day period. 4. Hours of rest may be divided into no more than two periods, one of which shall be at least six hours in length, and the interval between consecutive periods of rest shall not exceed 14 hours. 5. In accordance with the general principles of the protection of the health and safety of workers, and for objective or technical reasons or reasons concerning the organisation of work, Member States may allow exceptions, including the establishment of reference periods, to the limits laid down in paragraph 1, second subparagraph, and paragraphs 3 and 4. Such exceptions shall, as far as possible, comply with the standards laid down but may take account of more frequent or longer leave periods or the granting of compensatory leave for the workers. These exceptions may be laid down by means of: (a) laws, regulations or administrative provisions provided there is consultation, where possible, of the representatives of the employers and workers concerned and efforts are made to encourage all relevant forms of social dialogue; or (b) collective agreements or agreements between the two sides of industry. 6. The master of a seagoing fishing vessel shall have the right to require workers on board to perform any hours of work necessary for the immediate safety of the vessel, persons on board or cargo, or for the purpose of giving assistance to other vessels or persons in distress at sea. 7. Members States may provide that workers on board seagoing fishing vessels for which national legislation or practice determines that these vessels are not allowed to operate in a specific period of the calendar year exceeding one month, shall take annual leave in accordance with Article 7 within that period. Article 22 Miscellaneous provisions 1. A Member State shall have the option not to apply Article 6, while respecting the general principles of the protection of the safety and health of workers, and provided it takes the necessary measures to ensure that: (a) no employer requires a worker to work more than 48 hours over a seven-day period, calculated as an average for the reference period referred to in Article 16(b), unless he has first obtained the worker's agreement to perform such work; (b) no worker is subjected to any detriment by his employer because he is not willing to give his agreement to perform such work; (c) the employer keeps up-to-date records of all workers who carry out such work; (d) the records are placed at the disposal of the competent authorities, which may, for reasons connected with the safety and/or health of workers, prohibit or restrict the possibility of exceeding the maximum weekly working hours; (e) the employer provides the competent authorities at their request with information on cases in which agreement has been given by workers to perform work exceeding 48 hours over a period of seven days, calculated as an average for the reference period referred to in Article 16(b). Before 23 November 2003, the Council shall, on the basis of a Commission proposal accompanied by an appraisal report, re-examine the provisions of this paragraph and decide on what action to take. 2. Member States shall have the option, as regards the application of Article 7, of making use of a transitional period of not more than three years from 23 November 1996, provided that during that transitional period: (a) every worker receives three weeks' paid annual leave in accordance with the conditions for the entitlement to, and granting of, such leave laid down by national legislation and/or practice; and (b) the three-week period of paid annual leave may not be replaced by an allowance in lieu, except where the employment relationship is terminated. 3. If Member States avail themselves of the options provided for in this Article, they shall forthwith inform the Commission thereof. CHAPTER 6 FINAL PROVISIONS Article 23 Level of Protection Without prejudice to the right of Member States to develop, in the light of changing circumstances, different legislative, regulatory or contractual provisions in the field of working time, as long as the minimum requirements provided for in this Directive are complied with, implementation of this Directive shall not constitute valid grounds for reducing the general level of protection afforded to workers. Article 24 Reports 1. Member States shall communicate to the Commission the texts of the provisions of national law already adopted or being adopted in the field governed by this Directive. 2. Member States shall report to the Commission every five years on the practical implementation of the provisions of this Directive, indicating the viewpoints of the two sides of industry. The Commission shall inform the European Parliament, the Council, the European Economic and Social Committee and the Advisory Committee on Safety, Hygiene and Health Protection at Work thereof. 3. Every five years from 23 November 1996 the Commission shall submit to the European Parliament, the Council and the European Economic and Social Committee a report on the application of this Directive taking into account Articles 22 and 23 and paragraphs 1 and 2 of this Article. Article 25 Review of the operation of the provisions with regard to workers on board seagoing fishing vessels Not later than 1 August 2009 the Commission shall, after consulting the Member States and management and labour at European level, review the operation of the provisions with regard to workers on board seagoing fishing vessels, and, in particular examine whether these provisions remain appropriate, in particular, as far as health and safety are concerned with a view to proposing suitable amendments, if necessary. Article 26 Review of the operation of the provisions with regard to workers concerned with the carriage of passengers Not later than 1 August 2005 the Commission shall, after consulting the Member States and management and labour at European level, review the operation of the provisions with regard to workers concerned with the carriage of passengers on regular urban transport services, with a view to presenting, if need be, the appropriate modifications to ensure a coherent and suitable approach in the sector. Article 27 Repeal 1. Directive 93/104/EC, as amended by the Directive referred to in Annex I, part A, shall be repealed, without prejudice to the obligations of the Member States in respect of the deadlines for transposition laid down in Annex I, part B. 2. The references made to the said repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex II. Article 28 Entry into force This Directive shall enter into force on 2 August 2004. Article 29 Addressees This Directive is addressed to the Member States.

32003L0089

2003

Directive 2003/89/EC of the European Parliament and of the Council of 10 November 2003 amending Directive 2000/13/EC as regards indication of the ingredients present in foodstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) In order to achieve a high level of health protection for consumers and to guarantee their right to information, it must be ensured that consumers are appropriately informed as regards foodstuffs, inter alia, through the listing of all ingredients on labels. (2) By virtue of Article 6 of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(4), certain substances need not appear in the list of ingredients. (3) When used in the production of foodstuffs and still present, certain ingredients or other substances are the cause of allergies or intolerances in consumers, and some of those allergies or intolerances constitute a danger to the health of those concerned. (4) The Scientific Committee on Food set up by Article 1 of Commission Decision 97/579/EC(5) has stated that the incidence of food allergies is such as to affect the lives of many people, causing conditions ranging from very mild to potentially fatal. (5) The said Committee has acknowledged that common food allergens include cow's milk, fruits, legumes (especially peanuts and soybeans), eggs, crustaceans, tree nuts, fish, vegetables (celery and other foods of the Umbelliferae family), wheat and other cereals. (6) The most common food allergens are found in a wide variety of processed foods. (7) The said Committee has also noted that adverse reactions to food additives may occur and that the avoidance of food additives is often difficult since not all of them are invariably included on the labelling. (8) It is necessary to provide that additives, processing aids and other substances with allergenic effect covered by Article 6(4)(a) of Directive 2000/13/EC are subject to labelling rules, to give appropriate information to consumers suffering from food allergy. (9) Even if labelling, which is intended for consumers in general, is not to be regarded as the only medium of information acting as substitute for the medical establishment, it is nevertheless advisable to assist consumers who have allergies or intolerances as much as possible by providing them with more comprehensive information on the composition of foodstuffs. (10) The list of allergenic substances should include those foodstuffs, ingredients and other substances recognised as causing hypersensitivity. (11) In order to provide all consumers with better information and to protect the health of certain consumers, it should be made obligatory to include in the list of ingredients all ingredients and other substances present in the foodstuff. In the case of alcoholic beverages, it should be mandatory to include in the labelling all ingredients with allergenic effect present in the beverage concerned. (12) In order to take account of the technical constraints involved in the manufacture of foodstuffs, it is necessary to authorise greater flexibility with regard to the listing of ingredients and other substances used in very small quantities. (13) In order to keep up with the development of scientific knowledge and progress as regards technological means of removing the allergenicity in ingredients and other substances and in order to protect consumers against new food allergens and avoid unnecessary obligations on labelling, it is important to be able to revise the list of ingredients rapidly, when necessary by including or deleting certain ingredients or substances. The revision should be based on scientific criteria determined by the European Food Safety Authority set up by Regulation (EC) No 178/2002(6) and take the form of implementing measures of a technical nature, the adoption of which should be entrusted to the Commission in the interest of simplifying and accelerating the procedure. Furthermore, the Commission should, if necessary, draw up technical guidelines for the interpretation of Annex IIIa. (14) Directive 2000/13/EC should therefore be amended accordingly, Article 1 Directive 2000/13/EC is amended as follows: 1. Article 6 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: "1. Ingredients shall be listed in accordance with this Article and Annexes I, II, III and IIIa."; (b) the following paragraph shall be inserted: "3a. Without prejudice to the rules for labelling to be established pursuant to paragraph 3, any ingredient, as defined in paragraph 4(a) and listed in Annex IIIa, shall be indicated on the labelling where it is present in beverages referred to in paragraph 3. This indication shall comprise the word 'contains' followed by the name of the ingredient(s) concerned. However, an indication is not necessary when the ingredient is already included under its specific name in the list of ingredients or in the name under which the beverage is sold. Where necessary, detailed rules for the presentation of the indication referred to in the first subparagraph may be adopted in accordance with the following procedures: (a) as regards the products referred to in Article 1(2) of Council Regulation (EC) No 1493/99 of 17 May 1999 on the common organisation of the market in wine(7), under the procedure laid down in Article 75 of that Regulation; (b) as regards the products referred to in Article 2(1) of Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails(8), under the procedure laid down in Article 13 of that Regulation; (c) as regards the products referred to in Article 1(2) of Council Regulation (EEC) No 1576/89 of 29 May 1989 laying down general rules on the definition, description and presentation of spirit drinks(9), under the procedure laid down in Article 14 of that Regulation; (d) as regards other products, under the procedure laid down in Article 20(2) of this Directive."; (c) the following point shall be added to paragraph 4(c): "(iv) substances which are not additives but are used in the same way and with the same purpose as processing aids and are still present in the finished product, even if in altered form."; (d) the second subparagraph of paragraph 5 shall be amended as follows: (i) the fourth indent shall be replaced by the following: "- where fruit, vegetables or mushrooms, none of which significantly predominates in terms of weight and which are used in proportions that are likely to vary, are used in a mixture as ingredients of a foodstuff, they may be grouped together in the list of ingredients under the designation 'fruit', 'vegetables' or 'mushrooms' followed by the phrase 'in varying proportions', immediately followed by a list of the fruit, vegetables or mushrooms present; in such cases, the mixture shall be included in the list of ingredients in accordance with the first subparagraph, on the basis of the total weight of the fruit, vegetables or mushrooms present,"; (ii) the following indents shall be added: "- ingredients constituting less than 2 % of the finished product may be listed in a different order after the other ingredients, - where ingredients which are similar or mutually substitutable are likely to be used in the manufacture or preparation of a foodstuff without altering its composition, its nature or its perceived value, and in so far as they constitute less than 2 % of the finished product, they may be referred to in the list of ingredients by means of the phrase 'contains ... and/or ...', where at least one of no more than two ingredients is present in the finished product. This provision shall not apply to additives or to ingredients listed in Annex IIIa."; (e) the second subparagraph of paragraph 8 shall be replaced by the following: "The list referred to in the first subparagraph shall not be compulsory: (a) where the composition of the compound ingredient is defined in current Community legislation, and in so far as the compound ingredient constitutes less than 2 % of the finished product; however, this provision shall not apply to additives, subject to paragraph 4(c), (b) for compound ingredients consisting of mixtures of spices and/or herbs that constitute less than 2 % of the finished product, with the exception of additives, subject to paragraph 4(c), (c) where the compound ingredient is a foodstuff for which a list of ingredients is not required under Community legislation."; (f) the following paragraphs shall be added: "10. Notwithstanding paragraph 2, the second subparagraph of paragraph 6 and the second subparagraph of paragraph 8, any ingredient used in production of a foodstuff and still present in the finished product, even if in altered form, and listed in Annex IIIa or originating from an ingredient listed in Annex IIIa shall be indicated on the label with a clear reference to the name of this ingredient. The indication referred to in the first subparagraph shall not be required if the name under which the foodstuff is sold clearly refers to the ingredient concerned. Notwithstanding paragraph 4(c)(ii), (iii) and (iv), any substance used in production of a foodstuff and still present in the finished product, even if in altered form, and originating from ingredients listed in Annex IIIa shall be considered as an ingredient and shall be indicated on the label with a clear reference to the name of the ingredient from which it originates. 11. The list in Annex IIIa shall be systematically re-examined and, where necessary, updated on the basis of the most recent scientific knowledge. The first re-examination shall take place at the latest on 25 November 2005. Updating could also be effected by the deletion from Annex IIIa of ingredients for which it has been scientifically established that it is not possible for them to cause adverse reactions. To this end, the Commission may be notified until 25 August 2004 of the studies currently being conducted to establish whether ingredients or substances, derived from ingredients listed in Annex IIIa are not likely, under specific circumstances, to trigger adverse reactions. The Commission shall, not later than 25 November 2004, after consultation with the European Food Safety Authority, adopt a list of those ingredients or substances, which shall consequently be excluded from Annex IIIa, pending the final results of the notified studies, or at the latest until 25 November 2007. Without prejudice to the second subparagraph, Annex IIIa may be amended, in compliance with the procedure referred to in Article 20(2), after an opinion has been obtained from the European Food Safety Authority issued on the basis of Article 29 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002, laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(10). Where necessary, technical guidelines may be issued for the interpretation of the list in Annex IIIa, in compliance with the procedure referred to in Article 20(2)."; 2. in the second subparagraph of Article 19, "Standing Committee on Foodstuffs set up by Council Decision 69/414/EEC (1)" shall be replaced by "Standing Committee on the Food Chain and Animal Health set up by Regulation (EC) No 178/2002"; 3. the footnote, "OJ L 291, 29.11.1969, p. 9", shall be deleted; 4. in Article 20(1) "Standing Committee on Foodstuffs" shall be replaced by "Standing Committee on the Food Chain and Animal Health"; 5. in Annex I, the designations "crystallised fruit" and "vegetables", and the corresponding definitions, shall be deleted; 6. Annex IIIa, the text of which is set out in the Annex to this Directive, shall be inserted. Article 2 1. Member States shall bring into force, by 25 November 2004 the laws, regulations and administrative provisions necessary to: - permit, as from 25 November 2004, the sale of products that comply with this Directive; - prohibit, as from 25 November 2005, the sale of products that do not comply with this Directive; any products which do not comply with this Directive but which have been placed on the market or labelled prior to this date may, however, be sold while stocks last. They shall forthwith inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0097

2003

Directive 2003/97/EC of the European Parliament and of the Council of 10 November 2003 on the approximation of the laws of the Member States relating to the type-approval of devices for indirect vision and of vehicles equipped with these devices, amending Directive 70/156/EEC and repealing Directive 71/127/EEC (Text with EEA relevance.) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Council Directive 71/127/EEC of 1 March 1971 on the approximation of the laws of the Member States relating to the rear-view mirrors of motor vehicles(4) was adopted as one of the separate directives of the EC type-approval procedure which was established by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(5). Consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to Directive 71/127/EEC. (2) Existing provisions, in particular in the case of categories N2, N3, M2 and M3 have proved inadequate as regards the exterior field of vision to the side, front and rear of the vehicle. In order to remedy this shortcoming, it is necessary to require an extension of the field of vision. (3) In the light of the experience gained and the present state of the art, it is now possible to amplify certain requirements of Directive 71/127/EEC with a view to improving road safety and to permit the use of mirrors to be supplemented by other technologies. (4) Taking into account the nature and the number of changes necessary to the requirements in force today, it is advisable to repeal andreplace Directive 71/127/EEC by this Directive. Since the type-approval and the conformity of production procedures are provided for in Directive 70/156/EEC, it is not necessary to repeat them in this Directive. (5) The Annexes to Directive 70/156/EEC should be amended accordingly, Article 1 The aim of this Directive is to harmonise rules relating to the type-approval of devices for indirect vision and of vehicles equipped with these devices. These rules are contained in the Annexes to this Directive. For the purpose of this Directive "vehicle" means any motor vehicle as defined in Section A of Annex II to Directive 70/156/EEC. Article 2 1. With effect from 26 January 2005, Member States shall not, on grounds relating to devices for indirect vision, - refuse to grant EC type-approval or national type-approval of a vehicle or a device for indirect vision, - prohibit the sale, registration or entry into service of vehicles or devices for indirect vision, if the vehicles or devices for indirect vision comply with the requirements of this Directive. 2. With effect from 26 January 2006, Member States shall refuse to grant EC type-approval for any new type of vehicle on grounds relating to the device for indirect vision or for any new type of device for indirect vision, if the requirements of this Directive are not fulfilled. However, this date shall be postponed by 12 months as regards the requirements concerning a class VI front mirror as a component and its installation on vehicles. 3. With effect from 26 January 2006, Member States shall prohibit the national type-approval for any new type of vehicle on grounds relating to the device for indirect vision if the requirements of this Directive are not fulfilled. However this date shall be postponed by 12 months as regards the requirements concerning a class VI front mirror as a component and its installation on vehicles. 4. With effect from 26 January 2010 for vehicles of categories M1 and N1, and with effect from 26 January 2007 for all vehicles of other categories, Member States: - shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 70/156/EEC to be no longer valid for the purposes of Article 7(1) of that Directive, - shall prohibit the sale, registration or entry into service of vehicles, on grounds relating to the device for indirect vision if the vehicles do not comply with the requirements of this Directive. 5. With effect from 26 January 2010 for vehicles of categories M1 and N1, and with effect from 26 January 2007, for all vehicles of other categories, the requirements of this Directive relating to the device for indirect vision as a component shall apply for the purposes of Article 7(2) of Directive 70/156/EEC. 6. Notwithstanding paragraphs 2 and 5, for the purposes of replacement parts, Member States shall continue to grant EC type-approval and to permit the sale and entry into service of components or separate technical units intended for use on vehicle types which have been approved before 26 January 2007, pursuant to Directive 71/127/EEC and, where applicable, subsequent extensions to those approvals. 7. Notwithstanding paragraph 3, Member States may continue to grant national type-approval for any new type of articulated vehicle of category M2 and M3, class I, as defined in Annex I, point 2.1.1.1 to Directive 2001/85/EC(6), composed of at least three articulated rigid parts, which do not comply with the provisions of this Directive, provided that the requirements for the driver's field of vision are respected as referred in Annex III, point 5 to this Directive. 8. The provisions laid down in this Directive shall also contribute to establishing a high level of protection in the context of the international harmonisation of legislation in this area. Therefore, as soon as possible after the adoption of this Directive, the Commission shall submit a proposal to the United Nations Economic Commission for Europe with the aim of aligning the provisions of UNECE Regulation 46 with the provisions of this Directive. Article 3 By 26 January 2010, the Commission shall carry out a detailed study to ascertain whether the amendments introduced by this Directive are having a positive effect on road safety, in particular as regards pedestrians, cyclists and other vulnerable road users. On the basis of those findings, the Commission shall, if necessary, propose additional legislative measures for further improvement of the field of indirect vision. Article 4 Directive 70/156/EEC is hereby amended as follows: 1. in Annex I, point 9.9 is replaced by the following: ">TABLE>" 2. in Annex III, point 9.9 is replaced by the following: ">TABLE>" 3. Annex IV is hereby amended as follows: - Part I, point 8 of the table shall be replaced by the following: ">TABLE>" - in point 8 of Part I, the term "rear-view mirrors" shall be replaced by "devices for indirect vision", - in point 8 of Part II, the term "rear-view mirrors" shall be replaced by "devices for indirect vision"; 4. in point 8 of Appendices 1 and 2 to Annex XI, the term "rear-view mirrors" shall be replaced by "devices for indirect vision". Article 5 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 24 January 2005. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 6 Directive 71/127/EEC shall be repealed with effect from 24 January 2010. References to the repealed Directive shall be construed as being made to this Directive and shall be read in accordance with the correlation table set out in Annex IV. Article 7 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 8 This Directive is addressed to the Member States.

32003L0104

2003

Commission Directive 2003/104/EC of 12 November 2003 authorising isopropyl ester of the hydroxylated analogue of methionine Having regard to the Treaty establishing the European Community, Having regard to Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition(1), as last amended by Directive 1999/20/EC(2), and in particular Article 6 thereof, Whereas: (1) Directive 82/471/EEC provides that amendments to be made to the Annex to that Directive as a result of developments in scientific or technical knowledge shall be adopted by the procedure laid down in Article 13. (2) An application for authorisation has been submitted for isopropyl ester of the hydroxylated analogue of methionine which belongs to the group "analogues of aminoacids" referred to in the Annex to Directive 82/471/EEC. (3) The Scientific Committee on Animal Nutrition (SCAN) delivered an opinion on the use of this product in feedingstuffs on 25 April 2003, which concludes that the isopropyl ester of the hydroxylated analogue of methionine does not present a risk on human health, animal health or the environment. (4) The assessment of the request for authorisation submitted in respect of the isopropyl ester of the hydroxylated analogue of methionine shows that this product meets the requirements laid down in Article 6(2) of Directive 82/471/EEC, under the conditions set out in the Annex to this Directive. This product should therefore be authorised. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Annex to Directive 82/471/EEC is amended as provided in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 May 2004 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. 2. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 3. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the seventh day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32003L0099

2003

Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Live animals and food of animal origin appear on the list in Annex I to the Treaty. Livestock farming and the placing on the market of food of animal origin constitute an important source of income for farmers. The implementation of veterinary measures aimed at raising the level of public and animal health in the Community assists the rational development of the farming sector. (2) The protection of human health against diseases and infections transmissible directly or indirectly between animals and humans (zoonoses) is of paramount importance. (3) Zoonoses transmissible through food may cause human suffering, as well as economic losses to food production and the food industry. (4) Zoonoses transmitted through sources other than food, especially from wild animal and pet animal populations, are also a matter of concern. (5) Council Directive 92/117/EEC of 17 December 1992 concerning measures for protection against specified zoonoses and specified zoonotic agents in animals and products of animal origin in order to prevent outbreaks of food-borne infections and intoxications(4) provided for the establishment of a monitoring system for certain zoonoses both at the level of Member States and at Community level. (6) With the assistance of the Community reference laboratory for the epidemiology of zoonoses, the Commission collects the results of monitoring yearly from Member States and compiles them. Publication of the results has taken place yearly since 1995. They provide a basis for the evaluation of the current situation concerning zoonoses and zoonotic agents. However, the data collection systems are not harmonised and therefore do not permit comparisons between Member States. (7) Other Community legislation provides for the monitoring and control of certain zoonoses in animal populations. In particular, Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine(5) deals with bovine tuberculosis and bovine brucellosis. Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals(6) deals with ovine and caprine brucellosis. This Directive should not create any unnecessary duplication of those existing requirements. (8) Moreover, a future regulation of the European Parliament and of the Council on the hygiene of foodstuffs should cover specific elements necessary for prevention, control and monitoring of zoonoses and zoonotic agents and include specific requirements for the microbiological quality of food. (9) Directive 92/117/EEC provides for collection of data on human cases of zoonoses. The aim of Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community(7) is to reinforce the collection of such data and to contribute to improving the prevention and control, in the Community, of communicable diseases. (10) The collection of data on the occurrence of zoonoses and zoonotic agents in animals, food, feed and humans is necessary to determine the trends and sources of zoonoses. (11) In its opinion on zoonoses adopted on 12 April 2000, the Scientific Committee on Veterinary Measures relating to Public Health considered that the measures in place at that time to control food-borne zoonotic infections were insufficient. It further considered that the epidemiological data that Member States were collecting were incomplete and not fully comparable. As a consequence, the Committee recommended improved monitoring arrangements and identified risk-management options. In particular, the Committee identified Salmonella spp., Campylobacter spp., verotoxigenic Escherichia coli (VTEC), Listeria monocytogenes, Cryptosporidium spp., Echinococcus granulosus/multilocularis and Trichinella spiralis as public health priorities. (12) It is therefore necessary to improve the existing monitoring and data collection systems established by Directive 92/117/EEC. Simultaneously, Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents(8) will replace the specific control measures established by Directive 92/117/EEC. Directive 92/117/EEC should therefore be repealed. (13) The new framework for scientific advice and scientific support in matters of food safety set up by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(9) should be used to collect and analyse the relevant data. (14) Where necessary to make data easier to compile and compare, monitoring should take place on a harmonised basis. This would make it possible to evaluate trends and sources of zoonoses and zoonotic agents within the Community. The data collected, together with data from other sources, should form the basis for risk assessment of zoonotic organisms. (15) Priority should be given to those zoonoses posing the greatest risk to human health. However, the monitoring systems should also facilitate the detection of emerging or newly emerging zoonotic diseases and new strains of zoonotic organisms. (16) The alarming emergence of resistance to antimicrobial agents (such as antimicrobial medicinal products and antimicrobial feed additives) is a characteristic that should be monitored. Provision should be made for such monitoring to cover not only zoonotic agents but also, in so far as they present a threat to public health, other agents. In particular, the monitoring of indicator organisms might be appropriate. Such organisms constitute a reservoir of resistance genes, which they can transfer to pathogenic bacteria. (17) In addition to general monitoring, specific needs may be recognised which may necessitate the establishment of coordinated monitoring programmes. Attention should be paid in particular to zoonoses listed in Annex I to Regulation (EC) No 2160/2003. (18) If thoroughly investigated, food-borne outbreaks of zoonoses provide the opportunity to identify the pathogen, the food vehicle involved and the factors in the food preparation and handling that contributed to the outbreak. It is therefore appropriate to make provision for such investigations and for close cooperation between the various authorities. (19) Transmissible spongiform encephalopathies are covered by Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(10). (20) To ensure that information collected on zoonoses and zoonotic agents can be used effectively, appropriate rules should be laid down concerning the exchange of all relevant information. That information should be collected in Member States and transmitted to the Commission in the form of reports, which should be forwarded to the European Food Safety Authority and made available to the public in an appropriate way without delay. (21) The reports should be submitted on an annual basis. However, additional reports may be appropriate, when warranted by circumstances. (22) It may be appropriate to designate national and Community reference laboratories for giving guidance and assistance for analysis and testing in relation to zoonoses and zoonotic agents falling within the scope of this Directive. (23) Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field(11) should be amended in so far as concerns the detailed rules governing the Community's financial contribution towards certain actions relating to the monitoring and control of zoonoses and zoonotic agents. (24) Appropriate procedures should be laid down for amending certain provisions of this Directive to take account of technical and scientific progress and for the adoption of implementing and transitional measures. (25) To take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Committee set up by Regulation (EC) No 178/2002. (26) Member States cannot, acting alone, collect comparable data to provide a basis for risk assessment of zoonotic organisms of significance at Community level. The collection of such data can better be achieved at Community level. The Community may therefore adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. The responsibility for establishing and maintaining monitoring systems should lie with Member States. (27) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(12), CHAPTER I INTRODUCTORY PROVISIONS Article 1 Subject matter and scope 1. The purpose of this Directive is to ensure that zoonoses, zoonotic agents and related antimicrobial resistance are properly monitored, and that food-borne outbreaks receive proper epidemiological investigation, to enable the collection in the Community of the information necessary to evaluate relevant trends and sources. 2. This Directive covers: (a) the monitoring of zoonoses and zoonotic agents; (b) the monitoring of related antimicrobial resistance; (c) the epidemiological investigation of food-borne outbreaks; and (d) the exchange of information related to zoonoses and zoonotic agents. 3. This Directive shall apply without prejudice to more specific Community provisions on animal health, animal nutrition, food hygiene, communicable human diseases, health and safety in the workplace, gene technology and transmissible spongiform encephalopathies. Article 2 Definitions For the purposes of this Directive, the following definitions shall apply: 1. the definitions laid down in Regulation (EC) No 178/2002, and 2. the following definitions: (a) "zoonosis" means any disease and/or infection which is naturally transmissible directly or indirectly between animals and humans; (b) "zoonotic agent" means any virus, bacterium, fungus, parasite or other biological entity which is likely to cause a zoonosis; (c) "antimicrobial resistance" means the ability of micro-organisms of certain species to survive or even to grow in the presence of a given concentration of an antimicrobial agent, that is usually sufficient to inhibit or kill micro-organisms of the same species; (d) "food-borne outbreak" means an incidence, observed under given circumstances, of two or more human cases of the same disease and/or infection, or a situation in which the observed number of cases exceeds the expected number and where the cases are linked, or are probably linked, to the same food source; (e) "monitoring" means a system of collecting, analysing and disseminating data on the occurrence of zoonoses, zoonotic agents and antimicrobial resistance related thereto. Article 3 General obligations 1. Member States shall ensure that data on the occurrence of zoonoses and zoonotic agents and antimicrobial resistance related thereto are collected, analysed and published without delay in accordance with the requirements of this Directive and of any provisions adopted pursuant to it. 2. Each Member State shall designate a competent authority or competent authorities for the purposes of this Directive and notify the Commission thereof. If a Member State designates more than one competent authority, it shall: (a) notify the Commission of the competent authority that will act as a contact point for contacts with the Commission; and (b) ensure that the competent authorities cooperate so as to guarantee the proper implementation of the requirements of this Directive. 3. Each Member State shall ensure that effective and continuous cooperation based on free exchange of general information and, where necessary, of specific data, is established between the competent authority or authorities designated for the purposes of this Directive and: (a) the competent authorities for the purposes of Community legislation on animal health; (b) the competent authorities for the purposes of Community legislation on feed; (c) the competent authorities for the purposes of Community legislation on food hygiene; (d) the structures and/or authorities referred to in Article 1 of Decision No 2119/98/EC; (e) other authorities and organisations concerned. 4. Each Member State shall ensure that the relevant officials of the competent authority or competent authorities referred to in paragraph 2 undertake suitable initial and ongoing training in veterinary science, microbiology or epidemiology, as necessary. CHAPTER II MONITORING OF ZOONOSES AND ZOONOTIC AGENTS Article 4 General rules on monitoring of zoonoses and zoonotic agents 1. Member States shall collect relevant and comparable data in order to identify and characterise hazards, to assess exposures and to characterise risks related to zoonoses and zoonotic agents. 2. Monitoring shall take place at the stage or stages of the food chain most appropriate to the zoonosis or zoonotic agent concerned, that is: (a) at the level of primary production; and/or (b) at other stages of the food chain, including in food and feed. 3. Monitoring shall cover zoonoses and zoonotic agents listed in Annex I, Part A. Where the epidemiological situation in a Member State so warrants, zoonoses and zoonotic agents listed in Annex I, Part B shall also be monitored. 4. Annex I may be amended in accordance with the procedure referred to in Article 12(2) to add zoonoses or zoonotic agents to, or delete them from, the lists therein, taking account in particular of the following criteria: (a) their occurrence in animal and human populations, feed and food; (b) the gravity of their effects for humans; (c) their economic consequences for animal and human health care and for feed and food businesses; (d) epidemiological trends in animal and human populations, feed and food. 5. Monitoring shall be based on the systems in place in Member States. However, where necessary to make data easier to compile and compare, detailed rules for the monitoring of zoonoses and zoonotic agents listed in Annex I may be laid down in accordance with the procedure referred to in Article 12(2) and taking into consideration other Community rules laid down in the fields of animal health, food hygiene and communicable human diseases. Such detailed rules shall lay down minimum requirements for the monitoring of certain zoonoses or zoonotic agents. They may, in particular, specify: (a) the animal population or subpopulations or stages in the food chain to be covered by monitoring; (b) the nature and type of data to be collected; (c) case definitions; (d) sampling schemes to be used; (e) laboratory methods to be used in testing; and (f) the frequency of reporting, including guidelines for reporting between local, regional and central authorities. 6. When considering whether to propose detailed rules in accordance with paragraph 5 to harmonise the routine monitoring of zoonoses and zoonotic agents, the Commission shall give priority to zoonoses and zoonotic agents listed in Part A of Annex I. Article 5 Coordinated monitoring programmes 1. If data collected through routine monitoring in accordance with Article 4 are not sufficient, coordinated monitoring programmes concerning one or more zoonoses and/or zoonotic agents may be established in accordance with the procedure referred to in Article 12(2). Coordinated monitoring programmes may be established, especially when specific needs are identified, to assess risks or to establish base-line values related to zoonoses or zoonotic agents at the level of Member States or at Community level. 2. Where a coordinated monitoring programme is established, special reference shall be made to zoonoses and zoonotic agents in animal populations referred to in Annex I to Regulation (EC) No 2160/2003. 3. Minimum rules concerning the establishment of coordinated monitoring programmes are laid down in Annex III. Article 6 Food business operators' duties 1. Member States shall ensure that, when food business operators carry out examinations for the presence of zoonoses and zoonotic agents subject to monitoring under Article 4(2), they: (a) keep the results and arrange for the preservation of any relevant isolate for a period to be specified by the competent authority; and (b) communicate results or provide isolates to the competent authority on request. 2. Detailed rules for the implementation of this Article may be laid down in accordance with the procedure referred to in Article 12(2). CHAPTER III ANTIMICROBIAL RESISTANCE Article 7 Monitoring of antimicrobial resistance 1. Member States shall ensure, in accordance with the requirements set out in Annex II, that monitoring provides comparable data on the occurrence of antimicrobial resistance in zoonotic agents and, in so far as they present a threat to public health, other agents. 2. Such monitoring shall supplement the monitoring of human isolates conducted in accordance with Decision No 2119/98/EC. 3. Detailed rules for the implementation of this Article shall be laid down in accordance with the procedure referred to in Article 12(2). CHAPTER IV FOOD-BORNE OUTBREAKS Article 8 Epidemiological investigation of food-borne outbreaks 1. Member States shall ensure that, when a food business operator provides information to the competent authority pursuant to Article 19(3) of Regulation (EC) No 178/2002, the foodstuff involved, or an appropriate sample of it, is preserved in order not to impede its investigation in a laboratory or the investigation of any food-borne outbreak. 2. The competent authority shall investigate food-borne outbreaks in cooperation with the authorities referred to in Article 1 of Decision No 2119/98/EC. The investigation shall provide data on the epidemiological profile, the foodstuffs potentially implicated and the potential causes of the outbreak. The investigation shall include, as far as possible, adequate epidemiological and microbiological studies. The competent authority shall transmit to the Commission (which shall send it to the European Food Safety Authority) a summary report of the results of the investigations carried out, containing the information referred to in Part E of Annex IV. 3. Detailed rules concerning the investigation of food-borne outbreaks may be laid down in accordance with the procedure referred to in Article 12(2). 4. Paragraphs 1 and 2 shall apply without prejudice to Community provisions on product safety, early warning and response systems for the prevention and control of communicable human diseases, food hygiene and the general requirements of food law, in particular those concerning emergency measures and procedures for withdrawing food and feed from the market. CHAPTER V EXCHANGE OF INFORMATION Article 9 Assessment of trends and sources of zoonoses, zoonotic agents and antimicrobial resistance 1. Member States shall assess trends and sources of zoonoses, zoonotic agents and antimicrobial resistance in their territory. Each Member State shall transmit to the Commission every year by the end of May a report on trends and sources of zoonoses, zoonotic agents and antimicrobial resistance, covering the data collected pursuant to Articles 4, 7 and 8 during the previous year. Reports, and any summaries of them, shall be made publicly available. Reports shall also contain the information referred to in Article 3(2)(b) of Regulation (EC) No 2160/2003. Minimum requirements concerning the reports are laid down in Annex IV. Detailed rules concerning the assessment of those reports, including the formats and the minimum information that they must include, may be laid down in accordance with the procedure referred to in Article 12(2). Where the circumstances warrant it, the Commission may request specific additional information and the Member States shall submit reports to the Commission upon such request, or on their own initiative. 2. The Commission shall send the reports referred to in paragraph 1 to the European Food Safety Authority, which shall examine them and publish by the end of November a summary report on the trends and sources of zoonoses, zoonotic agents and antimicrobial resistance in the Community. When preparing the summary report, the European Food Safety Authority may take into consideration other data provided for in the framework of Community legislation, such as: - Article 8 of Directive 64/432/EEC, - Article 14(2) of Directive 89/397/EEC(13), - Article 24 of Decision 90/424/EEC, - Article 4 of Decision No 2119/98/EC. 3. Member States shall provide the Commission with the results of coordinated monitoring programmes established in accordance with Article 5. The Commission shall send the results to the European Food Safety Authority. The results, and any summaries of them, shall be made publicly available. CHAPTER VI LABORATORIES Article 10 Community and national reference laboratories 1. One or more Community reference laboratories for the analysis and testing of zoonoses and zoonotic agents and antimicrobial resistance related thereto may be designated in accordance with the procedure referred to in Article 12(2). 2. Without prejudice to the relevant provisions of Decision 90/424/EEC, the responsibilities and tasks of the Community reference laboratories, in particular with regard to coordination of their activities and those of the national reference laboratories, shall be laid down in accordance with the procedure referred to in Article 12(2). 3. Member States shall designate national reference laboratories for each field where a Community reference laboratory has been established and inform the Commission thereof. 4. Certain responsibilities and tasks of the national reference laboratories, in particular with regard to coordination of their activities and those of relevant laboratories in the Member States, may be laid down in accordance with the procedure referred to in Article 12(2). CHAPTER VII IMPLEMENTATION Article 11 Amendments to the Annexes and transitional or implementing measures Annexes II, III and IV may be amended and any appropriate transitional or implementing measures adopted in accordance with the procedure referred to in Article 12(2). Article 12 Committee procedure 1. The Commission shall be assisted by the Committee on the Food Chain and Animal Health instituted by Regulation (EC) No 178/2002 or, where appropriate, by the Committee set up under Decision No 2119/98/EC. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. Article 13 Consultation of the European Food Safety Authority The Commission shall consult the European Food Safety Authority on any matter within the scope of this Directive that could have a significant impact on public health, in particular before proposing any amendment to Annexes I or II or before establishing any coordinated monitoring programme in accordance with Article 5. Article 14 Transposition 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 12 April 2004. They shall forthwith inform the Commission thereof. They shall apply those measures by 12 June 2004. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the provisions of national law that they adopt in the field covered by this Directive. CHAPTER VIII FINAL PROVISIONS Article 15 Repeal Directive 92/117/EEC shall be repealed with effect from 12 June 2004. However, measures which Member States have adopted pursuant to Article 8(1) of Directive 92/117/EEC and those implemented in accordance with Article 10(1) thereof and plans approved in accordance with Article 8(3) thereof shall remain in force until corresponding control programmes have been approved in accordance with Article 5 of Regulation (EC) No 2160/2003. Article 16 Amendment of Decision 90/424/EEC Decision 90/424/EEC is hereby amended as follows: 1. Article 29 is replaced by the following: "Article 29 1. Member States may seek a Community financial contribution for the monitoring and control of the zoonoses specified in the Annex, Group 2, in the framework of the provisions referred to in Article 24(2) to (11). 2. As regards control of zoonoses, the Community financial contribution shall be introduced as part of a national control programme referred to in Article 5 of Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents(14). The level of Community financial participation shall be fixed at a maximum of 50 % of costs incurred for the implementation of mandatory control measures." 2. the following Article is inserted: "Article 29a Member States may seek from the Community the financial contribution referred to in Article 29(2) for a national plan which was approved on the basis of Directive 92/117/EEC, until the date on which corresponding control programmes have been approved in accordance with Article 6 of Regulation (EC) No 2160/2003." 3. In the Annex, the following indents shall be added to the list under Group 2: "- Campylobacteriosis and agents thereof - Listeriosis and agents thereof - Salmonellosis (zoonotic salmonella) and agents thereof - Trichinellosis and agents thereof - Verotoxigenic Escherichia coli." Article 17 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 18 Addressees This Directive is addressed to the Member States.

32003L0102

2003

Directive 2003/102/EC of the European Parliament and of the Council of 17 November 2003 relating to the protection of pedestrians and other vulnerable road users before and in the event of a collision with a motor vehicle and amending Council Directive 70/156/EEC Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee(1), Acting in accordance with the procedure laid down in Article 251 of the Treaty(2), Whereas: (1) In order to reduce the number of road accident casualties in the Community, it is necessary to introduce measures so as to improve the protection of pedestrians and other vulnerable road users before and in the event of a collision with the front of a motor vehicle. (2) A package of passive and active measures for improving safety (avoidance of accidents and reduction of secondary effects by traffic calming and infrastructure improvements) for vulnerable road users, such as pedestrians, cyclists and motorcyclists, is urgently needed in the framework of the road safety action programme. (3) The internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital must be ensured and to that end a Community type-approval system for motor vehicles is in place; the technical requirements for the type-approval of motor vehicles with regard to pedestrian protection should be harmonised to avoid the adoption of requirements that differ from one Member State to another and to ensure the proper functioning of the internal market. (4) Pedestrian protection objectives can be achieved by a combination of active and passive safety measures; the recommendations by the European Enhanced Vehicle-Safety Committee (EEVC) of June 1999 are the subject of a wide consensus in this area; those recommendations propose performance requirements for the frontal structures of certain categories of motor vehicles to reduce their aggressiveness; this Directive presents tests and limit values based on the EEVC recommendations. (5) The Commission should examine the feasibility of extending the scope of this Directive to vehicles with a maximum mass of up to 3,5 tonnes, and report its findings to the European Parliament and to the Council. (6) This Directive should be considered as one element of a broader package of measures, to be undertaken by the Community, the industry and the relevant authorities of the Member States, on the basis of exchanges in best practice, in order to address pre-crash (active), in-crash (passive), and post-crash safety of pedestrians and other vulnerable road users, with respect to road users, vehicles and infrastructure. (7) In view of the speed of technological development in this area, alternative measures at least equivalent in terms of actual effectiveness to the requirements of this Directive - either passive or a combination of active and passive measures - may be proposed by the industry and shall be assessed following a feasibility study carried out by independent experts by 1 July 2004; the introduction of alternative measures at least equivalent in terms of actual effectiveness would require adapting or amending this Directive. (8) Because of the ongoing research and technical progress in the area of pedestrian protection, it is appropriate to introduce a degree of flexibility in this field. Accordingly, this Directive should establish the fundamental provisions regarding pedestrian protection in the form of tests to be complied with by new types of vehicles and by new vehicles. The technical prescriptions for the application of such tests should be adopted by Commission decision. (9) The rapidly advancing technology in active safety means that collision mitigation and avoidance systems could provide major safety benefits, for example in reducing collision speed and adjusting impact direction. The development of such technologies should be encouraged by this Directive. (10) The associations representing the European, Japanese and Korean motor vehicle manufacturers have made commitments to start applying the EEVC recommendations concerning limit values and tests, or agreed alternative measures of at least equivalent effect, as from 2010, and a first set of limit values and tests as from 2005 to new types of vehicles and to apply the first set of tests to 80 % of all new vehicles as from 1 July 2010, to 90 % of all new vehicles as from 1 July 2011 and to all new vehicles as from 31 December 2012. (11) This Directive should also contribute to establishing a high level of protection in the context of the international harmonisation of legislation in this area, which started under the 1998 Agreement of the UN/ECE concerning the establishment of global technical regulations for wheeled vehicles, equipment and parts which can be fitted and/or be used on wheeled vehicles. (12) This Directive is one of the separate Directives which have to be complied with in order to conform to the EC type-approval procedure established by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(3). (13) Directive 70/156/EEC should therefore be amended accordingly, Article 1 1. This Directive shall apply to the frontal surfaces of vehicles. For the purpose of this Directive, "vehicle" means any motor vehicle as defined in Article 2 of and Annex II to Directive 70/156/EEC, of category M1, of a maximum mass not exceeding 2,5 tonnes, and N1 derived from M1, of a maximum mass not exceeding 2,5 tonnes. 2. The purpose of this Directive is to reduce injuries to pedestrians and other vulnerable road users who are hit by the frontal surfaces of the vehicles defined in paragraph 1. Article 2 1. With effect from 1 January 2004 no Member State may, on grounds relating to pedestrian protection: - refuse, in respect of a type of vehicle, to grant EC type-approval, or national type-approval, or - prohibit the registration, sale or entry into service of vehicles, provided that the vehicles comply with the technical provisions set out in section 3.1. or 3.2. of Annex I. 2. With effect from 1 October 2005, Member States shall no longer grant: - EC type-approval, or - national type-approval, except where the provisions of Article 8(2) of Directive 70/156/EEC are invoked, for any type of vehicle on grounds relating to pedestrian protection if the technical provisions set out in section 3.1. or 3.2. of Annex I are not complied with. 3. Paragraph 2 shall not apply to vehicles which do not differ with respect to their essential aspects of bodywork construction and design forward of the A pillars from vehicle types which have been granted EC type-approval or national type-approval before 1 October 2005 and which have not already been approved under this Directive. 4. With effect from 1 September 2010, Member States shall no longer grant: - EC type-approval, or - national type-approval, except where the provisions of Article 8(2) of Directive 70/156/EEC are invoked, for any type of vehicle on grounds relating to pedestrian protection if the technical provisions set out in section 3.2. of Annex I to this Directive are not complied with. 5. With effect from 31 December 2012, Member States shall: - consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 70/156/EEC to be no longer valid for the purposes of Article 7(1) of that Directive, and - prohibit the registration, sale and entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 70/156/EEC, on grounds relating to pedestrian protection if the technical provisions set out in section 3.1. or 3.2. of Annex I are not complied with. 6. With effect from 1 September 2015, Member States shall: - consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 70/156/EEC to be no longer valid for the purposes of Article 7(1) of that Directive, and - prohibit the registration, sale and entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 70/156/EEC, on grounds relating to pedestrian protection if the technical provisions set out in section 3.2. of Annex I are not complied with. Article 3 Subject to the provisions of Article 2, Member States shall ensure that the tests laid down in section 3.1. or 3.2. of Annex I are carried out in accordance with the technical prescriptions to be specified by Commission decision. Article 4 Every month the approval authorities of the Member States shall each send to the Commission a copy of the type-approval certificate, the model for which is set out in Appendix 2 to Annex II, in respect of each vehicle they have approved in accordance with this Directive during that month. Article 5 1. The Commission, acting on the basis of relevant information communicated by the approval authorities and interested parties as well as of independent studies, shall monitor the progress made by the industry in the area of pedestrian protection, and shall carry out, by 1 July 2004, an independent feasibility assessment concerning the provisions of Annex I, section 3.2, and in particular alternative measures - either passive or a combination of active and passive measures - which are at least equivalent in terms of actual effectiveness. The feasibility study shall be based, inter alia, on practical tests and independent scientific studies. 2. If, as a result of the feasibility assessment referred to in paragraph 1, it is considered necessary to adapt the provisions of Annex I, section 3.2, to include a combination of passive and active measures which afford at least the same level of protection as the existing provisions of Annex I, section 3.2, the Commission shall submit a proposal to the European Parliament and the Council to amend this Directive accordingly. 3. As long as adaptation of this Directive is restricted to the introduction of alternative passive measures which afford at least the same level of protection as the existing provisions of Annex I, section 3.2, such adaptation may be carried out by the Committee for Adaptation to Technical Progress, in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC. 4. Before 1 April 2006, and every two years thereafter, the Commission shall report to the European Parliament and the Council on the results of the monitoring referred to in paragraph 1. Article 6 Directive 70/156/EEC is hereby amended as follows: 1. The following points shall be inserted in Annex I: "9.23. Pedestrian protection 9.23.1. A detailed description, including photographs and/or drawings, of the vehicle with respect to the structure, the dimensions, the relevant reference lines and the constituent materials of the frontal part of the vehicle (interior and exterior) shall be provided. This description should include detail of any active protection system installed." 2. The following points shall be inserted in Section A of Annex III: "9.23. Pedestrian protection 9.23.1. A detailed description, including photographs and/or drawings, of the vehicle with respect to the structure, the dimensions, the relevant reference lines and the constituent materials of the frontal part of the vehicle (interior and exterior) shall be provided. This description should include detail of any active protection system installed." 3. The following item 58 and footnotes shall be inserted in Part I of Annex IV: ">TABLE>" 4. Annex XI shall be amended as follows: - the following item 58 shall be inserted in Appendix 1: ">TABLE>" - the following item 58 shall be inserted in Appendix 2: ">TABLE>" - the following item 58 shall be inserted in Appendix 3: ">TABLE>" Article 7 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2003 at the latest. They shall forthwith inform the Commission thereof. They shall apply these measures with effect from 1 January 2004. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 8 This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Union. Article 9 This Directive is addressed to the Member States.

32003L0098

2003

Directive 2003/98/EC of the European Parliament and of the Council of 17 November 2003 on the re-use of public sector information Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Having regard to the opinion of the Committee of the Regions(3), Acting in accordance with the procedure set out in Article 251 of the Treaty(4), Whereas: (1) The Treaty provides for the establishment of an internal market and of a system ensuring that competition in the internal market is not distorted. Harmonisation of the rules and practices in the Member States relating to the exploitation of public sector information contributes to the achievement of these objectives. (2) The evolution towards an information and knowledge society influences the life of every citizen in the Community, inter alia, by enabling them to gain new ways of accessing and acquiring knowledge. (3) Digital content plays an important role in this evolution. Content production has given rise to rapid job creation in recent years and continues to do so. Most of these jobs are created in small emerging companies. (4) The public sector collects, produces, reproduces and disseminates a wide range of information in many areas of activity, such as social, economic, geographical, weather, tourist, business, patent and educational information. (5) One of the principal aims of the establishment of an internal market is the creation of conditions conducive to the development of Community-wide services. Public sector information is an important primary material for digital content products and services and will become an even more important content resource with the development of wireless content services. Broad cross-border geographical coverage will also be essential in this context. Wider possibilities of re-using public sector information should inter alia allow European companies to exploit its potential and contribute to economic growth and job creation. (6) There are considerable differences in the rules and practices in the Member States relating to the exploitation of public sector information resources, which constitute barriers to bringing out the full economic potential of this key document resource. Traditional practice in public sector bodies in exploiting public sector information has developed in very disparate ways. That should be taken into account. Minimum harmonisation of national rules and practices on the re-use of public sector documents should therefore be undertaken, in cases where the differences in national regulations and practices or the absence of clarity hinder the smooth functioning of the internal market and the proper development of the information society in the Community. (7) Moreover, without minimum harmonisation at Community level, legislative activities at national level, which have already been initiated in a number of Member States in order to respond to the technological challenges, might result in even more significant differences. The impact of such legislative differences and uncertainties will become more significant with the further development of the information society, which has already greatly increased cross-border exploitation of information. (8) A general framework for the conditions governing re-use of public sector documents is needed in order to ensure fair, proportionate and non-discriminatory conditions for the re-use of such information. Public sector bodies collect, produce, reproduce and disseminate documents to fulfil their public tasks. Use of such documents for other reasons constitutes a re-use. Member States' policies can go beyond the minimum standards established in this Directive, thus allowing for more extensive re-use. (9) This Directive does not contain an obligation to allow re-use of documents. The decision whether or not to authorise re-use will remain with the Member States or the public sector body concerned. This Directive should apply to documents that are made accessible for re-use when public sector bodies license, sell, disseminate, exchange or give out information. To avoid cross-subsidies, re-use should include further use of documents within the organisation itself for activities falling outside the scope of its public tasks. Activities falling outside the public task will typically include supply of documents that are produced and charged for exclusively on a commercial basis and in competition with others in the market. The definition of "document" is not intended to cover computer programmes. The Directive builds on the existing access regimes in the Member States and does not change the national rules for access to documents. It does not apply in cases in which citizens or companies can, under the relevant access regime, only obtain a document if they can prove a particular interest. At Community level, Articles 41 (right to good administration) and 42 of the Charter of Fundamental Rights of the European Union recognise the right of any citizen of the Union and any natural or legal person residing or having its registered office in a Member State to have access to European Parliament, Council and Commission documents. Public sector bodies should be encouraged to make available for re-use any documents held by them. Public sector bodies should promote and encourage re-use of documents, including official texts of a legislative and administrative nature in those cases where the public sector body has the right to authorise their re-use. (10) The definitions of "public sector body" and "body governed by public law" are taken from the public procurement Directives (92/50/EEC(5), 93/36/EEC(6) and 93/37/EEC(7) and 98/4/EC(8)). Public undertakings are not covered by these definitions. (11) This Directive lays down a generic definition of the term "document", in line with developments in the information society. It covers any representation of acts, facts or information - and any compilation of such acts, facts or information - whatever its medium (written on paper, or stored in electronic form or as a sound, visual or audiovisual recording), held by public sector bodies. A document held by a public sector body is a document where the public sector body has the right to authorise re-use. (12) The time limit for replying to requests for re-use should be reasonable and in line with the equivalent time for requests to access the document under the relevant access regimes. Reasonable time limits throughout the Union will stimulate the creation of new aggregated information products and services at pan-European level. Once a request for re-use has been granted, public sector bodies should make the documents available in a timeframe that allows their full economic potential to be exploited. This is particularly important for dynamic content (e.g. traffic data), the economic value of which depends on the immediate availability of the information and of regular updates. Should a licence be used, the timely availability of documents may be a part of the terms of the licence. (13) The possibilities for re-use can be improved by limiting the need to digitise paper-based documents or to process digital files to make them mutually compatible. Therefore, public sector bodies should make documents available in any pre-existing format or language, through electronic means where possible and appropriate. Public sector bodies should view requests for extracts from existing documents favourably when to grant such a request would involve only a simple operation. Public sector bodies should not, however, be obliged to provide an extract from a document where this involves disproportionate effort. To facilitate re-use, public sector bodies should make their own documents available in a format which, as far as possible and appropriate, is not dependent on the use of specific software. Where possible and appropriate, public sector bodies should take into account the possibilities for the re-use of documents by and for people with disabilities. (14) Where charges are made, the total income should not exceed the total costs of collecting, producing, reproducing and disseminating documents, together with a reasonable return on investment, having due regard to the self-financing requirements of the public sector body concerned, where applicable. Production includes creation and collation, and dissemination may also include user support. Recovery of costs, together with a reasonable return on investment, consistent with applicable accounting principles and the relevant cost calculation method of the public sector body concerned, constitutes an upper limit to the charges, as any excessive prices should be precluded. The upper limit for charges set in this Directive is without prejudice to the right of Member States or public sector bodies to apply lower charges or no charges at all, and Member States should encourage public sector bodies to make documents available at charges that do not exceed the marginal costs for reproducing and disseminating the documents. (15) Ensuring that the conditions for re-use of public sector documents are clear and publicly available is a pre-condition for the development of a Community-wide information market. Therefore all applicable conditions for the re-use of the documents should be made clear to the potential re-users. Member States should encourage the creation of indices accessible on line, where appropriate, of available documents so as to promote and facilitate requests for re-use. Applicants for re-use of documents should be informed of available means of redress relating to decisions or practices affecting them. This will be particularly important for SMEs which may not be familiar with interactions with public sector bodies from other Member States and corresponding means of redress. (16) Making public all generally available documents held by the public sector - concerning not only the political process but also the legal and administrative process - is a fundamental instrument for extending the right to knowledge, which is a basic principle of democracy. This objective is applicable to institutions at every level, be it local, national or international. (17) In some cases the re-use of documents will take place without a licence being agreed. In other cases a licence will be issued imposing conditions on the re-use by the licensee dealing with issues such as liability, the proper use of documents, guaranteeing non-alteration and the acknowledgement of source. If public sector bodies license documents for re-use, the licence conditions should be fair and transparent. Standard licences that are available online may also play an important role in this respect. Therefore Member States should provide for the availability of standard licences. (18) If the competent authority decides to no longer make available certain documents for re-use, or to cease updating these documents, it should make these decisions publicly known, at the earliest opportunity, via electronic means whenever possible. (19) Conditions for re-use should be non-discriminatory for comparable categories of re-use. This should, for example, not prevent the exchange of information between public sector bodies free of charge for the exercise of public tasks, whilst other parties are charged for the re-use of the same documents. Neither should it prevent the adoption of a differentiated charging policy for commercial and non-commercial re-use. (20) Public sector bodies should respect competition rules when establishing the principles for re-use of documents avoiding as far as possible exclusive agreements between themselves and private partners. However, in order to provide a service of general economic interest, an exclusive right to re-use specific public sector documents may sometimes be necessary. This may be the case if no commercial publisher would publish the information without such an exclusive right. (21) This Directive should be implemented and applied in full compliance with the principles relating to the protection of personal data in accordance with Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and of the free movement of such data(9). (22) The intellectual property rights of third parties are not affected by this Directive. For the avoidance of doubt, the term "intellectual property rights" refers to copyright and related rights only (including sui generis forms of protection). This Directive does not apply to documents covered by industrial property rights, such as patents, registered designs and trademarks. The Directive does not affect the existence or ownership of intellectual property rights of public sector bodies, nor does it limit the exercise of these rights in any way beyond the boundaries set by this Directive. The obligations imposed by this Directive should apply only insofar as they are compatible with the provisions of international agreements on the protection of intellectual property rights, in particular the Berne Convention for the Protection of Literary and Artistic Works (the Berne Convention) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement). Public sector bodies should, however, exercise their copyright in a way that facilitates re-use. (23) Tools that help potential re-users to find documents available for re-use and the conditions for re-use can facilitate considerably the cross-border use of public sector documents. Member States should therefore ensure that practical arrangements are in place that help re-users in their search for documents available for re-use. Assets lists, accessible preferably online, of main documents (documents that are extensively re-used or that have the potential to be extensively re-used), and portal sites that are linked to decentralised assets lists are examples of such practical arrangements. (24) This Directive is without prejudice to Directive 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society(10) and Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases(11). It spells out the conditions within which public sector bodies can exercise their intellectual property rights in the internal information market when allowing re-use of documents. (25) Since the objectives of the proposed action, namely to facilitate the creation of Community-wide information products and services based on public sector documents, to enhance an effective cross-border use of public sector documents by private companies for added-value information products and services and to limit distortions of competition on the Community market, cannot be sufficiently achieved by the Member States and can therefore, in view of the intrinsic Community scope and impact of the said action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. This Directive should achieve minimum harmonisation, thereby avoiding further disparities between the Member States in dealing with the re-use of public sector documents, CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope 1. This Directive establishes a minimum set of rules governing the re-use and the practical means of facilitating re-use of existing documents held by public sector bodies of the Member States. 2. This Directive shall not apply to: (a) documents the supply of which is an activity falling outside the scope of the public task of the public sector bodies concerned as defined by law or by other binding rules in the Member State, or in the absence of such rules as defined in line with common administrative practice in the Member State in question; (b) documents for which third parties hold intellectual property rights; (c) documents which are excluded from access by virtue of the access regimes in the Member States, including on the grounds of: - the protection of national security (i.e. State security), defence, or public security, - statistical or commercial confidentiality; (d) documents held by public service broadcasters and their subsidiaries, and by other bodies or their subsidiaries for the fulfilment of a public service broadcasting remit; (e) documents held by educational and research establishments, such as schools, universities, archives, libraries and research facilities including, where relevant, organisations established for the transfer of research results; (f) documents held by cultural establishments, such as museums, libraries, archives, orchestras, operas, ballets and theatres. 3. This Directive builds on and is without prejudice to the existing access regimes in the Member States. This Directive shall not apply in cases in which citizens or companies have to prove a particular interest under the access regime to obtain access to the documents. 4. This Directive leaves intact and in no way affects the level of protection of individuals with regard to the processing of personal data under the provisions of Community and national law, and in particular does not alter the obligations and rights set out in Directive 95/46/EC. 5. The obligations imposed by this Directive shall apply only insofar as they are compatible with the provisions of international agreements on the protection of intellectual property rights, in particular the Berne Convention and the TRIPS Agreement. Article 2 Definitions For the purpose of this Directive the following definitions shall apply: 1. "public sector body" means the State, regional or local authorities, bodies governed by public law and associations formed by one or several such authorities or one or several such bodies governed by public law; 2. "body governed by public law" means any body: (a) established for the specific purpose of meeting needs in the general interest, not having an industrial or commercial character; and (b) having legal personality; and (c) financed, for the most part by the State, or regional or local authorities, or other bodies governed by public law; or subject to management supervision by those bodies; or having an administrative, managerial or supervisory board, more than half of whose members are appointed by the State, regional or local authorities or by other bodies governed by public law; 3. "document" means: (a) any content whatever its medium (written on paper or stored in electronic form or as a sound, visual or audiovisual recording); (b) any part of such content; 4. "re-use" means the use by persons or legal entities of documents held by public sector bodies, for commercial or non-commercial purposes other than the initial purpose within the public task for which the documents were produced. Exchange of documents between public sector bodies purely in pursuit of their public tasks does not constitute re-use; 5. "personal data" means data as defined in Article 2(a) of Directive 95/46/EC. Article 3 General principle Member States shall ensure that, where the re-use of documents held by public sector bodies is allowed, these documents shall be re-usable for commercial or non-commercial purposes in accordance with the conditions set out in Chapters III and IV. Where possible, documents shall be made available through electronic means. CHAPTER II REQUESTS FOR RE-USE Article 4 Requirements applicable to the processing of requests for re-use 1. Public sector bodies shall, through electronic means where possible and appropriate, process requests for re-use and shall make the document available for re-use to the applicant or, if a licence is needed, finalise the licence offer to the applicant within a reasonable time that is consistent with the time-frames laid down for the processing of requests for access to documents. 2. Where no time limits or other rules regulating the timely provision of documents have been established, public sector bodies shall process the request and shall deliver the documents for re-use to the applicant or, if a licence is needed, finalise the licence offer to the applicant within a timeframe of not more than 20 working days after its receipt. This timeframe may be extended by another 20 working days for extensive or complex requests. In such cases the applicant shall be notified within three weeks after the initial request that more time is needed to process it. 3. In the event of a negative decision, the public sector bodies shall communicate the grounds for refusal to the applicant on the basis of the relevant provisions of the access regime in that Member State or of the national provisions adopted pursuant to this Directive, in particular Article 1(2)(a), (b) and (c), or Article 3. Where a negative decision is based on Article 1(2)(b), the public sector body shall include a reference to the natural or legal person who is the rightholder, where known, or alternatively to the licensor from which the public sector body has obtained the relevant material. 4. Any negative decision shall contain a reference to the means of redress in case the applicant wishes to appeal the decision. 5. Public sector bodies covered under Article 1(2)(d), (e) and (f) shall not be required to comply with the requirements of this Article. CHAPTER III CONDITIONS FOR RE-USE Article 5 Available formats 1. Public sector bodies shall make their documents available in any pre-existing format or language, through electronic means where possible and appropriate. This shall not imply an obligation for public sector bodies to create or adapt documents in order to comply with the request, nor shall it imply an obligation to provide extracts from documents where this would involve disproportionate effort, going beyond a simple operation. 2. On the basis of this Directive, public sector bodies cannot be required to continue the production of a certain type of documents with a view to the re-use of such documents by a private or public sector organisation. Article 6 Principles governing charging Where charges are made, the total income from supplying and allowing re-use of documents shall not exceed the cost of collection, production, reproduction and dissemination, together with a reasonable return on investment. Charges should be cost-oriented over the appropriate accounting period and calculated in line with the accounting principles applicable to the public sector bodies involved. Article 7 Transparency Any applicable conditions and standard charges for the re-use of documents held by public sector bodies shall be pre-established and published, through electronic means where possible and appropriate. On request, the public sector body shall indicate the calculation basis for the published charge. The public sector body in question shall also indicate which factors will be taken into account in the calculation of charges for atypical cases. Public sector bodies shall ensure that applicants for re-use of documents are informed of available means of redress relating to decisions or practices affecting them. Article 8 Licences 1. Public sector bodies may allow for re-use of documents without conditions or may impose conditions, where appropriate through a licence, dealing with relevant issues. These conditions shall not unnecessarily restrict possibilities for re-use and shall not be used to restrict competition. 2. In Member States where licences are used, Member States shall ensure that standard licences for the re-use of public sector documents, which can be adapted to meet particular licence applications, are available in digital format and can be processed electronically. Member States shall encourage all public sector bodies to use the standard licences. Article 9 Practical arrangements Member States shall ensure that practical arrangements are in place that facilitate the search for documents available for re-use, such as assets lists, accessible preferably online, of main documents, and portal sites that are linked to decentralised assets lists. CHAPTER IV NON-DISCRIMINATION AND FAIR TRADING Article 10 Non-discrimination 1. Any applicable conditions for the re-use of documents shall be non-discriminatory for comparable categories of re-use. 2. If documents are re-used by a public sector body as input for its commercial activities which fall outside the scope of its public tasks, the same charges and other conditions shall apply to the supply of the documents for those activities as apply to other users. Article 11 Prohibition of exclusive arrangements 1. The re-use of documents shall be open to all potential actors in the market, even if one or more market players already exploit added-value products based on these documents. Contracts or other arrangements between the public sector bodies holding the documents and third parties shall not grant exclusive rights. 2. However, where an exclusive right is necessary for the provision of a service in the public interest, the validity of the reason for granting such an exclusive right shall be subject to regular review, and shall, in any event, be reviewed every three years. The exclusive arrangements established after the entry into force of this Directive shall be transparent and made public. 3. Existing exclusive arrangements that do not qualify for the exception under paragraph 2 shall be terminated at the end of the contract or in any case not later than 31 December 2008. CHAPTER V FINAL PROVISIONS Article 12 Implementation Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 2005. They shall forthwith inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 13 Review 1. The Commission shall carry out a review of the application of this Directive before 1 July 2008 and shall communicate the results of this review, together with any proposals for modifications of the Directive, to the European Parliament and the Council. 2. The review shall in particular address the scope and impact of this Directive, including the extent of the increase in re-use of public sector documents, the effects of the principles applied to charging and the re-use of official texts of a legislative and administrative nature, as well as further possibilities of improving the proper functioning of the internal market and the development of the European content industry. Article 14 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 15 Addressees This Directive is addressed to the Member States.