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eu_regulatory_ir

like 3

32001L0002

2001

Commission Directive 2001/2/EC of 4 January 2001 adapting to technical progress Council Directive 1999/36/EC on transportable pressure equipment (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 1999/36/EC of 29 April 1999 on transportable pressure equipment(1), and in particular Article 14 thereof, Whereas: (1) Article 3(1) of Directive 1999/36/EC stipulates that new receptacles and new tanks shall meet the relevant provisions of 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(2), as last amended by Directive 2000/61/EC of the European Parliament and of the Council(3), and also that they shall meet the relevant provisions of 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(4), as last amended by Directive 2000/62/EC of the European Parliament and of the Council(5). (2) The provisions of the European Agreement on the International Carriage of Dangerous Goods by Road (hereinafter referred to as the ADR) and of the regulation on the international carriage of dangerous goods by Rail (hereinafter referred to as the RID)(6), together with their amendments, are annexed to Directives 94/55/EC and 96/49/EC respectively. A new version of the ADR and RID will enter into force on 1 July 2001. (3) Annex V to Directive 1999/36/EC lays down the modules to be followed for the conformity assessment of the new receptacles and new tanks. These provisions no longer comply with the new version of the ADR and the RID. Consequently, this Annex should be amended. (4) The amendments necessary for adapting the Annexes to Directive 1999/36/EC shall be adopted pursuant to Article 14 of the Directive, in accordance with the procedure laid down in Article 15 thereof. (5) The measures provided for in this Directive are in accordance with the opinion of the Committee referred to in Article 15 of Directive 1999/36/EC, Article 1 The text of the Annex to Directive 1999/36/EC is replaced by the text of 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 July 2001 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 a reference shall be laid down by the Member States. 2. Member States shall comunicate to the Commission the text of the main provisions of domestic law that they adopt in the field governed 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 Communities. Article 4 This Directive is addressed to the Member States.

32001L0003

2001

Commission Directive 2001/3/EC of 8 January 2001 adapting to technical progress Council Directive 74/150/EEC relating to the type-approval of wheeled agricultural or forestry tractors and Council Directive 75/322/EEC relating to the suppression of radio interference produced by spark-ignition engines fitted to wheeled agricultural or forestry tractors (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to 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(1), as last amended by European Parliament and Council Directive 2000/25/EC(2), and in particular Article 11 thereof, Whereas: (1) It is necessary to clarify certain Articles of Directive 74/150/EEC and to align the Annexes thereto with the Annexes 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(3), as last amended by European Parliament and Council Directive 2000/40/EC(4), and with the Annexes to Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two- or three-wheel motor vehicles(5), as last amended by European Parliament and Council Directive 2000/7/EC(6). (2) Council Directive 75/322(EEC)(7), as last amended by Commission Directive 2000/2/EC(8), contains an information document which needs to the renumbered to take account of the numbering scheme introduced by this Directive. (3) Directives 74/150/EEC and 75/322/EEC should be adapted accordingly. (4) The provisions of this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Article 12 of Directive 74/150/EEC, Article 1 Directive 74/150/EEC is hereby amended as follows: 1. In Article 2(b), the words words "special Directives" are replaced by the words "special Directives listed in Annex II". 2. In Article 3, the second sentence is replaced by the following:"An application shall be accompanied by an exhaustive list of information or an information document, the models of which are given in Annex I, and by the documents referred to therein." 3. In Article 4(1), the introductory wording is replaced by the following:"A Member State shall approve all tractor types (defined in Annex II, along with the category to which it belongs) which satisfy the following conditions:". 4. The Annexes are replaced by the text shown in Annex I to this Directive. Article 2 Annex IIA (other than its appendices) to Directive 75/322/EEC is replaced by the text shown in Annex II to this Directive. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 June 2002. 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 its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32000L0084

2001

Directive 2000/84/EC of the European Parliament and of the Council of 19 January 2001 on summer-time arrangements 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), Whereas: (1) The eighth Directive, 97/44/EC, of the European Parliament and of the Council of 22 July 1997 on summer-time arrangements(4) introduced a common date and time in all Member States, for the beginning and end of summer time in 1998, 1999, 2000 and 2001. (2) Given that the Member States apply summer-time arrangements, it is important for the functioning of the internal market that a common date and time for the beginning and end of the summer-time period be fixed throughout the Community. (3) Since the summer-time period considered most appropriate by the Member States runs from the end of March to the end of October, it is appropriate that that period therefore be maintained. (4) The proper functioning of certain sectors, not only transport and communications, but also other sectors of industry, requires stable, long-term planning. Provisions concerning summer time should therefore be laid down for an unspecified period. Article 4 of Directive 97/44/EC provides, in that respect, that the European Parliament and the Council are to adopt, by 1 January 2001, the arrangements to apply from 2002 onwards. (5) For reasons of clarity and accuracy of information, a timetable for the implementation of the summer-time period for the following five years should be published every five years. (6) Implementation of this Directive should, moreover, be monitored by means of a report, to be presented by the Commission to the European Parliament, the Council and the Economic and Social Committee, on the impact of these provisions in all of the areas concerned. That report should be based on the information made available to the Commission by the Member States in sufficient time to enable the report to be presented at the specified time. (7) Given that the complete harmonisation of the timetable for the summer-time period with a view to facilitating transport and communications cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may take measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. This Directive does not go beyond what is necessary to achieve those objectives. (8) For geographical reasons, the common summer-time arrangements should not apply to the overseas territories of the Member States, Article 1 For the purposes of this Directive "summer-time period" shall mean the period of the year during which clocks are put forward by 60 minutes compared with the rest of the year. Article 2 From 2002 onwards, the summer-time period shall begin, in every Member State, at 1.00 a.m., Greenwich Mean Time, on the last Sunday in March. Article 3 From 2002 onwards, the summer-time period shall end, in every Member State, at 1.00 a.m., Greenwich Mean Time, on the last Sunday in October. Article 4 The Commission shall publish a communication in the Official Journal of the European Communities(5), for the first time on the occasion of the publication of this Directive, and every five years thereafter, containing the timetable showing the dates on which the summer-time period will begin and end for the following five years. Article 5 The Commission shall report to the European Parliament, the Council and the Economic and Social Committee on the impact of the provisions of this Directive on the sectors concerned by 31 December 2007 at the latest. That report shall be drawn up on the basis of the information made available to the Commission by each Member State by 30 April 2007 at the latest. The Commission shall, if necessary and following the conclusions of the report, make appropriate proposals. Article 6 This Directive shall not apply to the overseas territories of the Member States. Article 7 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2001 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. Member States shall determine how such reference is to be made. Article 8 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 9 This Directive is addressed to the Member States.

32001L0001

2001

Directive 2001/1/EC of the European Parliament and of the Council of 22 January 2001 amending Council Directive 70/220/EEC concerning measures to be taken against air pollution by emissions from motor vehicles 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), Whereas: (1) 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(4), is one of the separate directives under the type-approval procedure laid down 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). (2) Directive 70/220/EEC lays down the specifications for the testing of emissions of the motor vehicles falling within its scope. In view of the recent experience gained and the rapidly developing state of the art of on-board diagnostic systems, it is appropriate to adapt those specifications accordingly. (3) On-board diagnostics (OBD) is at a less developed stage for vehicles equipped with positive-ignition engines which run permanently or part-time on liquefied petroleum gas (LPG) or natural gas (NG) and cannot be required on such new types of vehicles before 2003. (4) Directive 70/220/EEC should be amended accordingly, Article 1 In Annex I to Directive 70/220/EEC Section 8.1 shall be replaced by the following: "8.1. Vehicles with positive-ignition engines 8.1.1. Petrol fuelled engines With effect from 1 January 2000 for new types and from 1 January 2001 for all types, vehicles of category M1 - except vehicles the maximum mass of which exceeds 2500 kg - and vehicles of category N1 class I, must be fitted with an OBD system for emission control in accordance with Annex XI. With effect from 1 January 2001 for new types and from 1 January 2002 for all types, vehicles of category N1 classes II and III and vehicles of category M1, the maximum mass of which exceeds 2500 kg, must be fitted with an OBD system for emission control in accordance with Annex XI. 8.1.2. LPG and natural gas fuelled vehicles With effect from 1 January 2003 for new types and from 1 January 2004 for all types, vehicles of category M1 - except vehicles the maximum mass of which exceeds 2500 kg - and vehicles of category N1 class I, running permanently or part-time on either LPG or natural gas fuel, must be fitted with an OBD system for emission control in accordance with Annex XI. With effect from 1 January 2006 for new types and from 1 January 2007 for all types, vehicles of category N1 classes II and III and vehicles of category M1, the maximum mass of which exceeds 2500 kg, running permanently or part-time on either LPG or natural gas fuel, must be fitted with an OBD system for emission control in accordance with Annex XI.". Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 6 February 2002. 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 text of the main provisions of domestic 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 This Directive is addressed to the Member States.

32001L0006

2001

Commission Directive 2001/6/EC of 29 January 2001 adapting for the third 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 European Parliament and Council Directive 2000/62/EC(2), and in particular Article 8 thereof, Whereas: (1) The Annex to Directive 96/49/EC contains the Regulations concerning the international carriage of dangerous goods by rail, usually known as "the RID", as applicable from 1 July 1999. (2) The RID is updated every two years and therefore an amended version will be in force as from 1 July 2001 with a transitory period until 31 December 2002, except of dangerous goods of class 7 (radioactive material), for which the transitory period will end on 31 December 2001. (3) It is therefore necessary to amend the Annex to Directive 96/49/EC. (4) The measures provided for in this Directive are in accordance with the opinion of the Committee on the transport of dangerous goods provided by Article 9 of Directive 96/49/EC, Article 1 The Annex to Directive 96/49/EC is replaced by the following: "ANNEX Regulations concerning the international carriage of dangerous goods by rail (RID), appearing as Annex I to Appendix B to COTIF, as applicable with effect from 1 July 2001, on the understanding that "Contracting Party" and "the States or the railways" will be replaced by "Member State" NB: The consolidated text of the 2001 version of the RID will be published as soon as the text is available in all the official languages of the Community." Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive concerning dangerous goods of class 7 by 31 December 2001 and concerning dangerous goods of other classes 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. 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 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32001L0007

2001

Commission Directive 2001/7/EC of 29 January 2001 adapting for the third 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 European Parliament and Council Directive 2000/61/EC(2), and in particular Article 8 thereof, Whereas: (1) The Annexes A and B to Directive 94/55/EC contain the Annexes A and B to the European Agreement concerning the international carriage of dangerous goods by road, usually known as "the ADR" as applicable from 1 July 1999. (2) The ADR is updated every two years and therefore an amended version will be in force as from 1 July 2001 with a transitory period until 31 December 2002, except of dangerous goods of class 7 (radioactive material), for which the transitory period will end on 31 December 2001. (3) It is therefore necessary to amend the Annexes to Directive 94/55/EC. (4) The measures provided for in this Directive are in accordance with the opinion of the Committee on the transport of dangerous goods, Article 1 Annexes to Directive 94/55/EC are amended as follows: 1. Annex A is replaced by the following: "ANNEX A Provisions of Annex A to the European Agreement concerning the international carriage of dangerous goods by road (ADR) as in force from 1 July 2001, "Member State" being substituted for "Contracting Party" NB: The consolidated text of the 2001 version of Annex A to the ADR will be published as soon as the text is available in all the official languages of the Community." 2. Annex B is replaced by the following: "ANNEX B Provisions of Annex B to the European Agreement concerning the international carriage of dangerous goods by road (ADR) as in force from 1 July 2001, "Member State" being substituted for "Contracting Party" NB: The consolidated text of the 2001 version of Annex B to the ADR will be published as soon as the text is available in all the official languages of the Community." Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive concerning dangerous goods of class 7 by 31 December 2001 and concerning dangerous goods of other classes 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. 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 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32001L0008

2001

Commission Directive 2001/8/EC of 8 February 2001 replacing Annex I to 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 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 amended by Commission Directive 93/46/EEC(2), and in particular Article 10(3) thereof, Whereas: (1) It is necessary to give effect to the decision taken by the United Nations Commission on Narcotic Drugs in March 2000 to include the substance norephedrine in Table I of the Annex to the 1988 UN Convention. (2) It is necessary to amend Category 1 of the Annex I to the basic Directive to comply with this. (3) Such inclusion will continue the process of aligning the Directive 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(3), as implemented and last amended by Commission Regulation (EEC) No 3769/92(4). (4) 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 Annex I to Directive 92/109/EEC is replaced by 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 March 2001 at the latest. They shall forthwith inform the Commission thereof. When adopted by the Member States, those provisions 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 its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32001L0009

2001

Commission Directive 2001/9/EC of 12 February 2001 adapting to technical progress Council Directive 96/96/EC on the approximation of the laws of the Member States relating to roadworthiness tests for motor vehicles and their trailers (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 amended by Commission Directive 1999/52/EC(2), and in particular Article 8 thereof, Whereas: (1) The auto-oil programmes, which were initiated in 1992 to provide the analytical foundation for the setting of vehicle emisison 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 inspection to check that emissions from both petrol and diesel driven vehicles are still within acceptable limits. (3) The carbon monixide content of the exhaust emissions of petrol driven vehicles equipped with certain exhaust after-treatment systems (Euro 1 standard) need to be tested at both low and high engine speeds. (4) Directive 98/69/EC of the European Parliament and of the Council of 13 October 1998 relating to measures to be taken against air pollution by emissions from motor vehicles and amending Council Directive 70/220/EEC(3) requires the introduction, from 2000, of on-board diagnostic (OBD) systems for petrol driven cars and light commercial vehicles to monitor the functioning of the vehicle's emission control system in service. Similarly, OBD systems will be required for new diesel vehicles from 2003. (5) The development of OBDs capable of monitoring and recording vehicle faults during operation should narrow the gap between test conditions and actual operation in the future. (6) This Directive abolishes the need to test petrol driven vehicles at low idle speed thus reducing the complexity of the test, but increasing accuracy through monitoring the functioning of the vehicle's OBD system. (7) 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 Directive 96/96/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 one year after the entry into force of the Directive 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. 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 its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32001L0005

2001

Directive 2001/5/EC of the European Parliament and of the Council of 12 February 2001 amending Directive 95/2/EC on food additives other than colours and sweeteners Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, 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), and in particular Articles 3(2) and 5(3) thereof, Having regard to the proposal from the Commission(2), Having regard to the opinion of the Economic and Social Committee(3), Acting in accordance with the procedure referred to in Article 251 of the Treaty(4), 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(5) lays down a list of food additives that may be used in the Community and the conditions for their use. (2) There have been technical developments in the field of food additives since the adoption of Directive 95/2/EC. (3) Directive 95/2/EC should be adapted to take account of these developments. (4) Food additives may be approved for use in foodstuffs only if they comply with the general criteria laid down in Annex II to Directive 89/107/EEC. (5) According to Article 5(1) of Directive 89/107/EEC, a Member State may authorise the use of a new food additive for a two-year period in its territory. (6) In accordance with requests from Member States, the following nationally authorised additives should be approved at Community level: propane, butane and iso-butane; these products should be labelled according to Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers(6). (7) The Scientific Committee on Food, established under Commission Decision 97/579/EC(7), has been consulted on the adoption of provisions liable to have an effect on public health, pursuant to Article 6 of Directive 89/107/EEC, Article 1 The Annexes to Directive 95/2/EC are hereby amended as follows: 1. Annex I shall be amended as follows: (a) the following additive shall be inserted in the table: "E 949 Hydrogen *" (b) in point 3 of the note, the following shall be inserted in the text corresponding to the symbol *: "E 949" 2. in Annex IV (a) the following shall be added in the third and fourth columns to the row for "E 445: Glycerol esters of wood rosin": "" (b) The following rows shall be added: ">TABLE>" 3. in Annex V the first row shall be replaced by the following: ">TABLE>" Article 2 1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive by 24 August 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 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 domestic 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 This Directive is addressed to the Member States.

32001L0011

2001

Commission Directive 2001/11/EC of 14 February 2001 adapting to technical progress Council Directive 96/96/EC on the approximation of the laws of the Member States relating to roadworthiness tests for motor vehicles and their trailers — functional testing of commercial vehicles' speed limitation device (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 amended by Commission Directive 1999/52/EC(2), and in particular Article 8 thereof, Whereas: (1) The fitting of road speed limiter (RSL) systems to certain vehicles in categories M3 and N3 was mandated through Council Directive 92/6/EEC of 10 February 1992 on the installation and use of speed limitation devices for certain categories of motor vehicles in the Community(3) for safety, environmental and competitive equalisation reasons. The installation to the vehicles within the scope of the Directive was implemented by 1 January 1996. (2) Directive 96/96/EC does not include a requirement to carry out functional checking of RSL systems, i.e. the ability for the device to effectively control the vehicle's maximum speed. (3) This amending Directive requires the authorities to carry out a test that will ensure that the RSL functions correctly. (4) Today simple, common diagnostic systems are available that can be used by testing organisations to test the vast majority of the speed limiters equipped. For those vehicles that are not accessible by such readily available diagnostic tools, the authorities will need to either make use of available equipment from the original vehicle manufacturer or provide for the acceptance of appropriate test certification from the vehicle manufacturer or their franchise organisation. (5) In the future, periodic verification of the correct functioning of the speed limiter will be facilitated for the vehicles that are fitted with the new recording equipment (digital tachograph) according to Council Regulation (EC) No 2135/98 of 24 September 1998 amending Regulation (EEC) No 3821/85 on recording equipment in road transport and Directive 88/599/EEC concerning the application of Regulations (EEC) No 3820/85 and (EEC) No 3821/85(4). New vehicles will be fitted with such equipment from the year 2003. (6) The provisions of this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of the Directive on motor vehicle roadworthiness testing established under Article 8 of Directive 96/96/EC, Article 1 A fourth indent is added to point 7.10 of Annex II to Directive 96/96/EC as follows: "- check wherever practical that the set speed of the speed limitation device conforms to the limits according to Articles 2 and 3 of Directive 92/6/EEC and that the speed limitation device prevents vehicles mentioned in those same Articles from exceeding those pre-set values." Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive two years after the entry into force of the Directive 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. 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 its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32001L0015

2001

Commission Directive 2001/15/EC of 15 February 2001 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses (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 European Parliament and Council Directive 1999/41/EC(2), and in particular Article 4(2) thereof, After consulting the Scientific Committee for Food, Whereas: (1) A number of nutritional substances such as vitamins, minerals, amino acids and others may be added to foods for particular nutritional uses in order to ensure that the particular nutritional requirements of the persons for whom those foods are intended are fulfilled and/or in order to satisfy legal requirements laid down in specific directives adopted pursuant to Article 4(1) of Directive 89/398/EEC. (2) It is not possible to define nutritional substances as a distinct group for the purpose of this Directive nor to draw up at this stage an exhaustive list of all categories of nutritional substances that may be added in foods for particular nutritional uses. (3) The range of foods for particular nutritional uses is very wide and diversified and the technological processes used for their manufacture are varied. For this reason, the widest possible choice of substances that can be safely used in the manufacture of foods for particular nutritional uses should be available for the categories of nutritional substances to be listed in this Directive. (4) The choice of substances should be based primarily on their safety and subsequently on their availability for use by humans and their organoleptic and technological properties. The inclusion of substances in the list of those that may be used in the manufacture of foods for particular nutritional uses does not mean that their addition to those foods is necessary or desirable. (5) Where the addition of a nutritional substance has been judged necessary, this has been stipulated by specific rules in the relevant specific directives together with the appropriate quantitative conditions, as the case may be. (6) In the absence of any specific rules or in the case of foods for particular nutritional uses not covered by specific directives, nutritional substances should be used in order to manufacture products that are in conformity with the definition of such products and fulfil the particular nutritional requirements of the persons for whom they are intended. The products in question must also be safe when used as instructed by the manufacturer. (7) The provisions concerning the list of the nutritional substances that may be used in the manufacture of infant formulae and follow-on formulae and of processed cereal-based foods and baby foods for infants and young children are laid down in Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae(3), as last amended by Directive 1999/50/EC(4), and Commission Directive 96/5/EC of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children(5), as last amended by Directive 1999/39/EC(6). Therefore those provisions need not be repeated in this Directive. (8) A number of the nutritional substances may also be used in foodstuffs as food additives. In this context purity criteria have been or are to be adopted for them at Community level in accordance with 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(7), as amended by European Parliament and Council Directive 94/34/EC(8). Those purity criteria should be applicable for those substances whatever the purpose of their use in foodstuffs. (9) Pending the adoption of purity criteria for the rest of the substances at Community Ievel, and in order to ensure a high level of protection for public health, generally acceptable purity criteria recommended by international organisations or agencies including but not limited to the Joint FAO/WHO Expert Committee on Food Additives (JECFA), EUP (European Pharmacopoeia) should apply. Member States should be permitted to maintain national rules setting stricter purity criteria, without prejudice to the rules set out in the Treaty. (10) Some specific nutrients or their derivatives have been identified as specifically necessary for the manufacture of some foods belonging to the group of foods for special medical purposes and their potential use should be reserved to the manufacture of these products. (11) The measures provided in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 1. For the categories of substances added for specific nutritional purposes in foods for particular nutritional uses listed in the Annex to this Directive only the chemical substances mentioned under each category may be used in the manufacture of foodstuffs for particular nutritional uses covered by Directive 89/398/EEC. The use of those substances shall be in conformity with any specific provisions concerning those substances that may be laid down in specific directives provided for in Article 4(1) of Directive 89/398/EEC. 2. Without prejudice to European Parliament and Council Regulation (EC) No 258/97(9), other substances added for specific nutritional purposes, not belonging to one of the categories listed in the Annex to this Directive, may be used in the manufacture of foods for particular nutritional uses. 3. The use of nutritional substances in foods for particular nutritional uses shall result in the manufacture of safe products that fulfil the particular nutritional requirements of the persons for whom they are intended as established by generally accepted scientific data. 4. The competent authorities of Member States, referred to in Article 9 of Directive 89/398/EEC, shall be empowered to require the manufacturer or, where appropriate, the importer to produce the scientific work and the data establishing the use of substances added for specific nutritional purposes in compliance with paragraph 3. If such work is contained in a readily available publication, a mere reference to this publication shall suffice. Article 2 1. Purity criteria for substances listed in the Annex, specified by Community legislation for their use in the manufacture of foodstuffs for purposes other than those covered by this Directive, shall apply. 2. For those substances listed in the Annex for which purity criteria are not specified by Community legislation, and until the adoption of such specifications, generally acceptable purity criteria recommended by international bodies shall apply. National rules setting stricter purity criteria may be maintained. Article 3 Member States shall adopt and publish the provisions necessary to comply with this Directive by 31 March 2002 at the latest. They shall forthwith inform the Commission thereof. They shall apply those provisions in such a way as to: (a) permit trade in products complying with this Directive with effect from 1 April 2002; (b) prohibit trade in products which do not comply with this Directive with effect from 1 April 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 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32001L0013

2001

Directive 2001/13/EC of the European Parliament and of the Council of 26 February 2001 amending Council Directive 95/18/EC on the licensing of railway undertakings 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), 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 on 22 November 2000 by the Conciliation Committee, Whereas: (1) Council Directive 91/440/EEC of 29 July 1991 on the development of the Community's railways(5) provides for certain access rights in international rail transport for railway undertakings and international groupings of railway undertakings. (2) To ensure dependable and adequate services, a common licensing scheme is necessary to ensure that all railway undertakings meet at any time certain requirements in relation to good repute, financial fitness and professional competence in order to protect customers and third parties and offer services observing a high standard of safety. (3) In order to ensure that access rights to railway infrastructure are applied throughout the Community on a uniform and non-discriminatory basis, Council Directive 95/18/EC(6) introduced a licence for railway undertakings providing the services referred to in Article 10 of Directive 91/440/EEC, this licence being obligatory for the operation of such services and valid throughout the Community. (4) Since some Member States have extended access rights going beyond Directive 91/440/EEC, it seems necessary to ensure fair, transparent and non-discriminatory treatment of all railway undertakings that may operate in this market by extending the licensing principles laid down by Directive 95/18/EC to all companies active in the sector. (5) In order better to fulfil the information obligations, Member States and the Commission should ensure better information for all Member States and the Commission. Following common practice and a logical interpretation of Directive 95/18/EC, the information to be given by Member States and the Commission should also cover licenses issued. (6) It is desirable to ensure that licensed railway undertakings that operate international goods transport respect the relevant customs and tax provisions applicable, in particular regarding customs transit. (7) In accordance with the principles of subsidiarity and proportionality as set out in Article 5 of the Treaty, the objectives of this Directive, namely to set out broad principles for the licensing of railway undertakings and the mutual recognition of such licences throughout the Community, cannot be sufficiently achieved by the Member States on account of the manifestly international dimension of issuing such licences and can therefore, by reason of its trans-national implications, be better achieved by the Community. This Directive does not go beyond what is necessary to achieve those objectives. (8) Directive 95/18/EC should be amended accordingly, Article 1 Directive 95/18/EC is hereby amended as follows: 1) Article 1 shall be replaced by the following: "Article 1 1. This Directive concerns the criteria applicable to the issue, renewal or amendment of licences by a Member State intended for railway undertakings which are or will be established in the Community. 2. Member States may exclude from the scope of this Directive: a) undertakings which only operate rail passenger services on local and regional stand-alone railway infrastructure; b) railway undertakings which only operate urban or suburban rail passenger services; c) railway undertakings whose activity is limited to the provision of regional rail freight services that are not covered by the scope of Directive 91/440/EEC; d) undertakings which only carry out freight operations on privately owned railway infrastructure that exists solely for use by the infrastructure owner for its own freight operations. 3. Undertakings the business of which is limited to providing shuttle services for road vehicles through the Channel Tunnel are excluded from the scope of this Directive." 2) Article 2(a) shall be replaced by the following: "a) 'railway undertaking' shall mean any public or private undertaking the principal business of which is to provide services for the transport of goods and/or passengers by rail with a requirement that the undertaking must ensure traction; this also includes undertakings which provide traction only"; 3. Article 3 shall be replaced by the following: "Article 3 Each Member State shall designate the body responsible for issuing licences and for carrying out the obligations imposed by this Directive. The task of issuing licences shall be carried out by a body which does not provide rail transport services itself and is independent of bodies or undertakings that do so." 4) The following paragraph shall be added to Article 4: "5. A licence shall be valid throughout the territory of the Community." 5) Article 6, fourth indent shall be replaced by the following: "- has/have not been convicted of serious or repeated failure to fulfil social- or labour-law obligations, including obligations under occupational safety and health legislation, and customs-law obligations in case of a company seeking to operate cross-border goods transport subject to customs procedures"; 6) Article 11(8) shall be replaced by the following: "8. When a licensing authority issues, suspends, revokes or amends a licence, the Member State concerned shall immediately inform the Commission accordingly. The Commission shall inform the other Member States forthwith". 7) Articles 12 and 13 shall be replaced by the following: "Article 12 1. In addition to the requirements of this Directive, a railway undertaking shall also comply with national law and regulatory provisions which are compatible with Community law and are applied in a non-discriminatory manner, in particular: a) specific technical and operational requirements for rail services; b) safety requirements applying to staff, rolling stock and the internal organisation of the undertaking; c) provisions on health, safety, social conditions and the rights of workers and consumers; d) requirements applying to all undertakings in the relevant railway sector designed to offer benefits or protection to consumers. 2. A railway undertaking may at any time refer to the Commission the question of the compatibility of the requirements of national law with Community law and also the question of whether such requirements are applied in a non-discriminatory manner. If the Commission considers that the provisions of this Directive have not been fulfilled, it shall deliver an opinion on the correct interpretation of the Directive without prejudice to Article 226 of the Treaty. Article 13 Railway undertakings shall respect the agreements applicable to international rail transport in force in the Member States in which they operate. They also shall observe the relevant customs and tax provisions." Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 March 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 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 Communities. Article 4 This Directive is addressed to the Member States.

32001L0012

2001

Directive 2001/12/EC of the European Parliament and of the Council of 26 February 2001 amending Council Directive 91/440/EEC on the development of the Community's railways Having regard to the Treaty establishing the European Community, and in particular Article 71 thereof, Having regard to the proposal of 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(4) of the Treaty in the light of the joint text approved on 22 November 2000 by the Conciliation Committee, Whereas: (1) Council Directive 91/440/EEC of 29 July 1991 on the development of the Community's railways(5) should be amended to take account of experience with its implementation and of developments in the railway sector since its adoption, in order to ensure that its objectives are achieved. (2) Fair and non-discriminatory access to the infastructure needs to be guaranteed through the separation of certain essential functions and/or the creation of a rail regulator fulfilling the control and implementation functions as well as through the separation of profit and loss accounts and the balance sheets. (3) Fair and non-discriminatory access to the infrastructure needs to be guaranteed also through the separation of safety related functions and/or the creation of a rail regulator fulfilling the control and implementation functions. In any case railway undertakings may be involved in a non-discriminatory way in enforcement and monitoring of safety standards. (4) Extension of access rights should, as with other modes of transport, proceed in conjunction with the parallel implementation of the necessary accompanying harmonisation measures. (5) In accordance with the objective of completing the internal market, which will include the possibility for all licensed railway undertakings meeting the safety conditions to provide services, access rights should, for a transitional period of up to seven years, be extended to licensed railway undertakings for the international transport of goods on a defined network, called the Trans European Rail Freight Network, including access to, and supply of, services in major terminals and ports. After this transitional period, the Trans-European Rail Freight Network should cover the entire European rail network and the railway undertakings should be granted rights of access thereto for international freight transport. (6) Access right is guaranteed to the licensed railway undertaking meeting the safety conditions and seeking access, whatever the mode of operation. (7) Member States remain free to grant access rights that are more extensive than access for railway undertakings operating international combined transport to international groupings operating international services and to railway undertakings operating international freight services within the Trans-European Rail Freight Network. The use of these more extensive access rights may be limited to railway undertakings licensed in Member States where access rights of a similar nature are granted, provided that this limitation is compatible with the Treaty. (8) To promote efficient management of infrastructure in the public interest, infrastructure managers should be given a status independent of the State, and freedom to manage their internal affairs, while Member States should take the necessary measures for the development and the safe use of railway infrastructure. (9) To promote the efficient operation of passenger and freight transport services and to ensure transparency in their finances, including all financial compensation or aid paid by the State, it is necessary to separate the accounts of passenger and of freight transport services. (10) It is necessary to implement a number of measures in order better to monitor the development of the railway sector and the evolution of the market, assess the effect of the measures adopted and analyse the impact of the measures envisaged by the Commission. (11) Bodies should be established with a sufficient degree of independence to regulate competition on the rail services market where there are no entities performing that function. (12) The Commission should report on the implementation of this Directive and make appropriate proposals. (13) 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(6). (14) Specific measures are required to take account of the specific geopolitical and geographical situations of certain Member States as well as a specific organisation of the railway sector in various Member States while ensuring the integrity of the internal market. (15) In accordance with the principles of subsidiarity and proportionality as set out in Article 5 of the Treaty, the objectives of this Directive, namely to develop the Community's railways, cannot be sufficiently achieved by the Member States in view of the need to ensure fair and non-discriminatory terms for access to the infrastructure as well as to take account of the manifestly international dimensions involved in the operation of significant elements of the railway networks, and can therefore, by reason of the need for coordinated trans-national action, be better achieved by the Community. This Directive does not go beyond what is necessary to achieve those objectives. (16) Directive 91/440/EEC should be amended accordingly, Article 1 Directive 91/440/EEC is hereby amended as follows: 1) the title of Section I shall be replaced by the following: "Scope and Definitions"; 2) Article 1 shall be repealed; 3) the following paragraph shall be added to Article 2: "3. Undertakings the train operations of which are limited to providing solely shuttle services for road vehicles through the Channel Tunnel are excluded from the scope of this Directive except Articles 6(1), 10 and 10a."; 4) Article 3 shall be amended as follows: a) the first and second indents shall be replaced by the following: "- 'railway undertaking' shall mean any public or private undertaking licensed according to applicable Community legislation, the principal business of which is to provide services for the transport of goods and/or passengers by rail with a requirement that the undertaking must ensure traction; this also includes undertakings which provide traction only; - 'infrastructure manager' shall mean any body or undertaking responsible in particular for establishing and maintaining railway infrastructure. This may also include the management of infrastructure control and safety systems. The functions of the infrastructure manager on a network or part of a network may be allocated to different bodies or undertakings"; b) the following indent shall be inserted after the fourth indent: "- 'international freight service' shall mean transport services where the train crosses at least one border of a Member State; the train may be joined and/or split and the different sections may have different origins and destinations, provided that all wagons cross at least one border"; 5) the title of Section II shall be replaced by the following: "Management independence"; 6) Article 4 shall be replaced by the following: "Article 4 1. Member States shall take the measures necessary to ensure that as regards management, administration and internal control over administrative, economic and accounting matters railway undertakings have independent status in accordance with which they will hold, in particular, assets, budgets and accounts which are separate from those of the State. 2. While respecting the framework and specific charging and allocation rules established by the Member States, the infrastructure manager shall have responsibilities for its own management, administration and internal control"; 7) Article 6 shall be replaced by the following: "Article 6 1. Member States shall take the measures necessary to ensure that separate profit and loss accounts and balance sheets are kept and published, on the one hand, for business relating to the provision of transport services by railway undertakings and, on the other, for business relating to the management of railway infrastructure. Public funds paid to one of these two areas of activity may not be transferred to the other. The accounts for the two areas of activity shall be kept in a way that reflects this prohibition. 2. Member States may also provide that this separation shall require the organisation of distinct divisions within a single undertaking or that the infrastructure shall be managed by a separate entity. 3. Member States shall take the measures necessary to ensure that the functions determining equitable and non-discriminatory access to infrastructure, listed in Annex II, are entrusted to bodies or firms that do not themselves provide any rail transport services. Regardless of the organisational structures, this objective must be shown to have been achieved. Member States may, however, assign to railway undertakings or any other body the collecting of the charges and the responsibility for managing the railway infrastructure, such as investment, maintenance and funding. 4. The application of paragraph 3 shall be subject to a report by the Commission in accordance with Article 10b, to be submitted by 15 March 2006."; 8) Article 7 shall be replaced by the following: "Article 7 1. Member States shall take the necessary measures for the development of their national railway infrastructure taking into account, where necessary, the general needs of the Community. 2. Member States shall ensure that safety standards and rules are laid down, rolling stock and railway undertakings are certified accordingly and accidents investigated. These tasks shall be accomplished by bodies or undertakings that do not provide rail transport services themselves and are independent of bodies or undertakings that do so, in such a way as to guarantee equitable and non-discriminatory access to infrastructure. Railway undertakings shall apply these safety standards and rules. Unless Member States mandate independent bodies with enforcement and monitoring, they may require or allow railway undertakings to be involved in ensuring the enforcement and monitoring of the safety standards and rules while guaranteeing the neutral and non-discriminatory execution of these functions. 3. Member States may also accord the infrastructure manager, having due regard to Articles 73, 87 and 88 of the Treaty, financing consistent with the tasks, size and financial requirements, in particular in order to cover new investments. 4. Within the framework of general policy determined by the State, the infrastructure manager shall draw up a business plan including investment and financial programmes. The plan shall be designed to ensure optimal and efficient use and development of the infrastructure while ensuring financial balance and providing means for these objectives to be achieved."; 9) Article 9(3) shall be replaced by the following: "3. Aid accorded by Member States to cancel the debts referred to in this Article shall be granted in accordance with Articles 73, 87 and 88 of the Treaty."; 10) the following paragraph shall be added to Article 9: "4. In the case of railway undertakings profit and loss accounts and either balance sheets or annual statement of assets and liabilities shall be kept and published for business relating to the provision of rail freight-transport services. Funds paid for activities relating to the provision of passenger-transport services as public-service remits must be shown separately in the relevant accounts and may not be transferred to activities relating to the provision of other transport services or any other business."; 11) Article 10 shall be replaced by the following: "Article 10 1. International groupings shall be granted access and transit rights in the Member States of establishment of their constituent railway undertakings, as well as transit rights in other Member States, for international services between the Member States where the undertakings constituting the said groupings are established. 2. Railway undertakings within the scope of Article 2 shall be granted, on equitable conditions, access to the infrastructure in other Member States for the purpose of operating international combined transport goods services. 3. Whatever the mode of operation, railway undertakings within the scope of Article 2 shall be granted, on equitable conditions, the access that they are seeking to the Trans-European Rail Freight Network defined in Article 10(a) and in Annex I after 15 March 2008, to the entire rail network, for the purpose of operating international freight services. 4. At the request of a Member State or on its own initiative the Commission shall, in a specific case, examine the application and enforcement of this Article, and within two months of receipt of such a request and after consulting the Committee referred to in Article 11a(2), decide whether the related measure may continue to be applied. The Commission shall communicate its decision to the European Parliament, the Council and to the Member States. Without prejudice to Article 226 of the Treaty, any Member State may refer the Commission's decision to the Council within a time limit of one month. The Council, acting by a qualified majority, may in exceptional circumstances take a different decision within a period of one month. 5. Any railway undertaking engaged in rail transport services under paragraphs 1, 2 and 3 shall conclude the necessary administrative, technical and financial agreements on the basis of public or private law with the infrastructure managers of the railway infrastructure used with a view to regulating traffic control and safety issues concerning that transport. The conditions governing such agreements shall be non-discriminatory and, if applicable, in conformity with the provisions of Directive 2000/14/EC of the European Parliament and of the Council of 26 February 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification(7). 6. Track access to, and supply of, services in the terminals and ports linked to rail activities referred to in paragraphs 1, 2 and 3, serving or potentially serving more than one final customer, shall be provided to all railway undertakings in a non-discriminatory manner, and requests by railway undertakings may be subject to restrictions only if viable alternatives under market conditions exist. 7. Without prejudice to Community and national regulations concerning competition policy and the institutions with responsibility in that area, the regulatory body established pursuant to Article 30 of Directive 2000/14/EC, or any other body enjoying the same degree of independence shall monitor the competition in the rail services markets, including the rail freight transport market. That body shall be set up in accordance with the rules in Article 30(1) of the said Directive. Any applicant or interested party may lodge a complaint with this body if it feels that it has been treated unjustly, has been the subject of discrimination or has been injured in any other way. On the basis of the complaint and, where appropriate, on its own initiative, the regulatory body shall decide at the earliest opportunity on appropriate measures to correct undesirable developments in these markets. In order to ensure the necessary possibility of judicial control and the requisite cooperation between national regulatory bodies, Article 30(6) and Article 31 of the said Directive shall apply in this context. 8. In accordance with Article 14 which provides for a report on the implementation of this Directive, accompanied by suitable proposals on continuing Community action to develop the railway market and the legal framework governing it, and in any case seven years after 15 March 2008, the Trans-European Rail Freight Network defined in Article 10a and Annex I, granting access for the international transport of goods to the railway undertakings defined in Article 3, shall be extended to cover the entire European rail network. The railway undertakings shall be granted, over that entire network and on fair conditions, guaranteed access and transit for the international transport of goods."; 12) in Section V "Access to railway infrastructure" the following Article shall be added: "Article 10a 1. The Trans-European Rail Freight Network consists of the following elements: a) Railway lines as indicated in the maps in Annex I. b) Diversionary routes, where appropriate, particularly around congested infrastructure within the meaning of Directive 2000/14/EC. When these routes are offered, overall journey times shall be safeguarded as far as this is feasible. c) Track access to terminals serving or potentially serving more than one final customer and to other sites and facilities, including feeder lines to and from these. d) Track access to and from ports as listed in Annex I, including feeder lines. 2. The feeder lines mentioned in paragraph 1(c) and (d) cover at either end of the journey 50 km or 20 % of the length of the journey on the railway lines referred to in paragraph 1(a), whichever is greater. Belgium and Luxembourg, as Member States with a relatively small or concentrated network, may limit the length of the feeder lines in the first year after 15 March 2003 to at least 20 km and until the end of the second year to at least 40 km."; 13) after Section V "Access to railway infrastructure", the following section shall be added: "SECTION Va Monitoring tasks of the Commission Article 10b 1. Not later than 15 September 2001 the Commission shall make the necessary arrangements to monitor technical and economic conditions and market developments of European rail transport. The Commission shall ensure that adequate resources are made available to enable the effective monitoring of this sector. 2. In this context, the Commission shall closely involve representatives of the Member States and of the sectors concerned in its work, including users, so that they are able better to monitor the development of the railway sector and the evolution of the market, assess the effect of the measures adopted and analyse the impact of the measures planned by the Commission. 3. The Commission shall monitor the use of the networks and the evolution of the framework conditions in the rail sector, in particular infrastructure charging, capacity allocation, safety regulation and licensing and the degree of harmonisation that evolves. It shall ensure an active cooperation between the appropriate regulatory bodies in the Member States. 4. The Commission shall report to the European Parliament and the Council on: a) the evolution of the internal market in rail services b) the framework conditions c) the state of the Trans-European Rail Freight Network d) the utilisation of access rights e) barriers to more effective rail services f) infrastructure limitations, and g) the need for legislation." 14) Article 11 shall be replaced by the following: "Article 11 1. Member States may bring any question concerning the implementation of this Directive to the attention of the Commission. Appropriate decisions shall be adopted by use of the advisory procedure referred to in Article 11a(2). 2. The amendments necessary to adapt the Annexes shall be adopted by use of the regulatory procedure referred to in Article 11a(3)."; 15) the following Article shall be inserted: "Article 11a 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. 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. 4. The Committee shall adopt its rules of procedure."; 16) Article 14 shall be replaced by the following: "Article 14 By 15 March 2005 the Commission shall submit to the European Parliament, the Economic and Social Committee, the Committee of the Regions and the Council a report on the implementation of this Directive accompanied by suitable proposals on continuing Community action to develop the railway market and the legal framework governing it."; 17) the following Article shall be inserted: "Article 14a 1. For a period of five years from 15 March 2003, the following Member States: - Ireland, as a Member State located on an island with a rail link to only one other Member State - the United Kingdom, in respect of Northern Ireland, on the same basis, and - Greece, as a Member State that does not have any direct rail link to any other Member State, do not need to apply the requirement to entrust to an independent body the functions determining equitable and non-discriminatory access to infrastructure, as provided for in Article 6(3), first subparagraph and the tasks set out in Article 7(2), first subparagraph, in so far as those Articles oblige Member States to establish independent bodies performing the tasks referred to in the said Articles. 2. However, where: a) more than one railway undertaking licensed in accordance with Article 4 of Directive 95/18/EC, or, in the case of Ireland and of Northern Ireland, a railway company so licensed elsewhere, submits an official application to operate competing railway services in, to or from Ireland, Northern Ireland or Greece, the continued applicability of this derogation will be decided upon in accordance with the advisory procedure referred to out in Article 11a(2); or b) a railway undertaking operating railway services in Ireland, Northern Ireland or Greece submits an official application to operate railway services on, to or from the territory of another Member State (in the case of Ireland, or the United Kingdom, in respect of Northern Ireland, or both, another Member State outside their territories), the derogation referred to in paragraph 1 shall not apply. Within one year from the receipt of either the decision referred to in point (a) adopted in accordance with the advisory procedure referred to in Article 11a(2), or notification of the official application referred to in point (b), the Member State or States concerned (Ireland, the United Kingdom with respect to Northern Ireland, or Greece) shall put in place legislation to implement the Articles referred to in paragraph 1. 3. A derogation referred to in paragraph 1, may be renewed for periods not longer than five years. Not later than 12 months before the expiry date of the derogation a Member State availing itself of such derogation may address a request to the Commission for a renewed derogation. Any such request must be substantiated. The Commission shall examine such a request and adopt a decision in accordance with the advisory procedure referred to in Article 11a (2). The said advisory procedure shall apply to any decision related to the request. When adopting its decision the Commission shall take into account any development in the geopolitical situation and the development of the rail market in, from and to the Member State having requested the renewed derogation. 4. Luxembourg as a Member State with a relatively small rail network does not need to apply until 31 August 2004 the requirement to award to an independent body the functions determining equitable and non-discriminatory access to infrastructure, as provided for in Article 6(3), first subparagraph, in so far as it obliges Member States to establish independent bodies performing the tasks referred to in that Article." Article 2 Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive by 15 March 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 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 date of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32001L0022

2001

Commission Directive 2001/22/EC of 8 March 2001 laying down the sampling methods and the methods of analysis for the official control of the levels of lead, cadmium, mercury and 3-MCPD 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) Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food(2) provides that maximum levels must be set for certain contaminants in foodstuffs in order to protect public health. (2) Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs(3) establishes, besides others, maximum levels for lead, cadmium, mercury and 3-monochloropropane-1,2-diol (3-MCPD) in foodstuffs and makes reference to the measures laying down the sampling and analysis methods to be used. (3) Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs(4) 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(5) introduces a system of quality standards for laboratories entrusted by the Member States with the official control of foodstuffs. (4) Sampling plays a crucial role in obtaining representative results for the determination of the levels of the contaminants which may be heterogeneously distributed in a lot. (5) Directive 85/591/EEC has fixed general criteria for methods of sampling and analysis but in certain cases more specific criteria become necessary in order to ensure that laboratories, in charge of the control, use methods of analysis with comparable levels of performance. (6) 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. (7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Foodstuffs, Article 1 The Member States shall take all measures necessary to ensure that the sampling for the official control of the levels of lead, cadmium, mercury and 3-MCPD 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 analyses used for the official control of the levels of lead, cadmium, mercury and 3-MCPD in foodstuffs comply with the criteria described in Annex II to this Directive. Article 3 The Member States shall, not later than 5 April 2003, bring into force the laws, regulations or administrative provisions necessary to comply with the provisions of this Directive. They shall forthwith notify the Commission thereof. When Member States adopt these provisions, the provisions 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 reference shall be adopted by Member States. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. This Directive is addressed to the Member States.

32001L0018

2001

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC - Commission Declaration 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, in the light of the joint text approved by the Conciliation Committee on 20 December 2000(3), Whereas: (1) The Report of the Commission on the Review of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(4), adopted on 10 December 1996, identified a number of areas where improvement is needed. (2) There is a need for clarification of the scope of Directive 90/220/EEC and of the definitions therein. (3) Directive 90/220/EEC has been amended. Now that new amendments are being made to the Directive, it is desirable, for reasons of clarity and rationalisation, that the provisions in question should be recast. (4) Living organisms, whether released into the environment in large or small amounts for experimental purposes or as commercial products, may reproduce in the environment and cross national frontiers thereby affecting other Member States. The effects of such releases on the environment may be irreversible. (5) The protection of human health and the environment requires that due attention be given to controlling risks from the deliberate release into the environment of genetically modified organisms (GMOs). (6) Under the Treaty, action by the Community relating to the environment should be based on the principle that preventive action should be taken. (7) It is necessary to approximate the laws of the Member States concerning the deliberate release into the environment of GMOs and to ensure the safe development of industrial products utilising GMOs. (8) The precautionary principle has been taken into account in the drafting of this Directive and must be taken into account when implementing it. (9) Respect for ethical principles recognised in a Member State is particularly important. Member States may take into consideration ethical aspects when GMOs are deliberately released or placed on the market as or in products. (10) For a comprehensive and transparent legislative framework, it is necessary to ensure that the public is consulted by either the Commission or the Member States during the preparation of measures and that they are informed of the measures taken during the implementation of this Directive. (11) Placing on the market also covers import. Products containing and/or consisting of GMOs covered by this Directive cannot be imported into the Community if they do not comply with its provisions. (12) Making GMOs available to be imported or handled in bulk quantities, such as agricultural commodities, should be regarded as placing on the market for the purpose of this Directive. (13) The content of this Directive duly takes into account international experience in this field and international trade commitments and should respect the requirements of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. As soon as possible, and in any case before July 2001, the Commission should, in the context of the ratification of the Protocol, submit the appropriate proposals for its implementation. (14) Guidance on the implementation of provisions related to the definition of the placing on the market in this Directive should be provided by the Regulatory Committee. (15) When defining "genetically modified organism" for the purpose of this Directive, human beings should not be considered as organisms. (16) The provisions of this Directive should be without prejudice to national legislation in the field of environmental liability, while Community legislation in this field needs to be complemented by rules covering liability for different types of environmental damage in all areas of the European Union. To this end the Commission has undertaken to bring forward a legislative proposal on environmental liability before the end of 2001, which will also cover damage from GMOs. (17) This Directive should not apply to organisms obtained through certain techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record. (18) It is necessary to establish harmonised procedures and criteria for the case-by-case evaluation of the potential risks arising from the deliberate release of GMOs into the environment. (19) A case-by-case environmental risk assessment should always be carried out prior to a release. It should also take due account of potential cumulative long-term effects associated with the interaction with other GMOs and the environment. (20) It is necessary to establish a common methodology to carry out the environmental risk assessment based on independent scientific advice. It is also necessary to establish common objectives for the monitoring of GMOs after their deliberate release or placing on the market as or in products. Monitoring of potential cumulative long-term effects should be considered as a compulsory part of the monitoring plan. (21) Member States and the Commission should ensure that systematic and independent research on the potential risks involved in the deliberate release or the placing on the market of GMOs is conducted. The necessary resources should be secured for such research by Member States and the Community in accordance with their budgetary procedures and independent researchers should be given access to all relevant material, while respecting intellectual property rights. (22) The issue of antibiotic-resistance genes should be taken into particular consideration when conducting the risk assessment of GMOs containing such genes. (23) The deliberate release of GMOs at the research stage is in most cases a necessary step in the development of new products derived from, or containing GMOs. (24) The introduction of GMOs into the environment should be carried out according to the "step by step" principle. This means that the containment of GMOs is reduced and the scale of release increased gradually, step by step, but only if evaluation of the earlier steps in terms of protection of human health and the environment indicates that the next step can be taken. (25) No GMOs, as or in products, intended for deliberate release are to be considered for placing on the market without first having been subjected to satisfactory field testing at the research and development stage in ecosystems which could be affected by their use. (26) The implementation of this Directive should be carried out in close liaison with the implementation of other relevant instruments such as Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(5). In this context the competent authorities concerned with the implementation of this Directive and of those instruments, within the Commission and at national level, should coordinate their action as far as possible. (27) Concerning the environmental risk assessment for part C, risk management, labelling, monitoring, information to the public and safeguard clause, this Directive should be a point of reference for GMOs as or in products authorised by other Community legislation which should therefore provide for a specific environmental risk assessment, to be carried out in accordance with the principles set out in Annex II and on the basis of information specified in Annex III without prejudice to additional requirements laid down by the Community legislation mentioned above, and for requirements as regards risk management, labelling, monitoring as appropriate, information to the public and safeguard clause at least equivalent to that laid down in this Directive. To this end it is necessary to provide for cooperation with the Community and Member State bodies mentioned in this Directive for the purpose of its implementation. (28) It is necessary to establish a Community authorisation procedure for the placing on the market of GMOs, as or in products, where the intended use of the product involves the deliberate release of the organism(s) into the environment. (29) The Commission is invited to conduct a study which should contain an assessment of various options to improve further the consistency and efficiency of this framework, particularly focusing on a centralised authorisation procedure for the placing on the market of GMOs within the Community. (30) For sectoral legislation, monitoring requirements may have to be adapted to the product concerned. (31) Part C of this Directive does not apply to products covered by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(6), provided that it includes an environmental risk assessment equivalent to that provided for by this Directive. (32) Any person, before undertaking a deliberate release into the environment of a GMO, or the placing on the market of GMOs, as or in products, where the intended use of the product involves its deliberate release into the environment, is to submit a notification to the national competent authority. (33) That notification should contain a technical dossier of information including a full environmental risk assessment, appropriate safety and emergency response, and, in the case of products, precise instructions and conditions for use, and proposed labelling and packaging. (34) After notification, no deliberate release of GMOs should be carried out unless the consent of the competent authority has been obtained. (35) A notifier should be able to withdraw his dossier at any stage of the administrative procedures laid down in this Directive. The administrative procedure should come to an end when a dossier is withdrawn. (36) Rejection of a notification for the placing on the market of a GMO as or in products by a competent authority should be without prejudice to the submission of a notification of the same GMO to another competent authority. (37) An agreement should be reached at the end of the mediation period when no objections remain. (38) Rejection of a notification following a confirmed negative assessment report should be without prejudice to future decisions based on the notification of the same GMO to another competent authority. (39) In the interests of the smooth functioning of this Directive, Member States should be able to avail themselves of the various provisions for the exchange of information and experience before having recourse to the safeguard clause in this Directive. (40) In order to ensure that the presence of GMOs in products containing, or consisting of, genetically modified organisms is appropriately identified, the words "This product contains genetically modified organisms" should appear clearly either on a label or in an accompanying document. (41) A system should be designed using the appropriate committee procedure, for the assignment of a unique identifier to GMOs, taking into account relevant developments in international fora. (42) It is necessary to ensure traceability at all stages of the placing on the market of GMOs as or in products authorised under part C of this Directive. (43) It is necessary to introduce into this Directive an obligation to implement a monitoring plan in order to trace and identify any direct or indirect, immediate, delayed or unforeseen effects on human health or the environment of GMOs as or in products after they have been placed on the market. (44) Member States should be able, in accordance with the Treaty, to take further measures for monitoring and inspection, for example by official services, of the GMOs as or in products placed on the market. (45) Means should be sought for providing possibilities for facilitating the control of GMOs or their retrieval in the event of severe risk. (46) Comments by the public should be taken into consideration in the drafts of measures submitted to the Regulatory Committee. (47) The competent authority should give its consent only after it has been satisfied that the release will be safe for human health and the environment. (48) The administrative procedure for granting consents for the placing on the market of GMOs as or in products should be made more efficient and more transparent and first-time consent should be granted for a fixed period. (49) For products for which consent has been granted for a fixed period a streamlined procedure should apply as regards the renewal of consent. (50) The existing consents granted under Directive 90/220/EEC have to be renewed in order to avoid disparities between consents granted under that Directive and those pursuant to this Directive and in order to take full account of the conditions of consent under this Directive. (51) Such renewal requires a transitional period during which existing consents granted under Directive 90/220/EEC remain unaffected. (52) When a consent is renewed, it should be possible to revise all the conditions of the original consent, including those related to monitoring and the time limitation of the consent. (53) Provision should be made for consultation of the relevant Scientific Committee(s) established by Commission Decision 97/579/EC(7) on matters which are likely to have an impact on human health and/or the environment. (54) The system of exchange of information contained in notifications, established under Directive 90/220/EEC, has been useful and should be continued. (55) It is important to follow closely the development and use of GMOs. (56) When a product containing a GMO, as or in products, is placed on the market, and where such a product has been properly authorised under this Directive, a Member State may not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of this Directive. A safeguard procedure should be provided in case of risk to human health or the environment. (57) The Commission's European Group on Ethics in Science and New Technologies should be consulted with a view to obtaining advice on ethical issues of a general nature regarding the deliberate release or placing on the market of GMOs. Such consultations should be without prejudice to the competence of Member States as regards ethical issues. (58) Member States should be able to consult any committee they have established with a view to obtaining advice on the ethical implications of biotechnology. (59) The measures necessary for the implementation of this Directive are to 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). (60) The information exchange set up under this Directive should also cover experience gained with the consideration of ethical aspects. (61) 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, including in the event of release or placing on the market contrary to the provisions of this Directive, particularly as a result of negligence. (62) A report to be issued every three years by the Commission, taking into account the information provided by Member States, should contain a separate chapter regarding the socioeconomic advantages and disadvantages of each category of GMOs authorised for placing on the market, which will take due account of the interest of farmers and consumers. (63) The regulatory framework for biotechnology should be reviewed so as to identify the feasibility of improving further the consistency and efficiency of that framework. Procedures may need to be adapted so as to optimise efficiency, and all options which might achieve that should be considered, PART A GENERAL PROVISIONS Article 1 Objective In accordance with the precautionary principle, the objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when: - carrying out the deliberate release into the environment of genetically modified organisms for any other purposes than placing on the market within the Community, - placing on the market genetically modified organisms as or in products within the Community. Article 2 Definitions For the purposes of this Directive: (1) "organism" means any biological entity capable of replication or of transferring genetic material; (2) "genetically modified organism (GMO)" means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination; Within the terms of this definition: (a) genetic modification occurs at least through the use of the techniques listed in Annex I A, part 1; (b) the techniques listed in Annex I A, part 2, are not considered to result in genetic modification; (3) "deliberate release" means any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment; (4) "placing on the market" means making available to third parties, whether in return for payment or free of charge; The following operations shall not be regarded as placing on the market: - making available genetically modified microorganisms for activities regulated under Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified microorganisms(9) including culture collections, - making available GMOs other than microorganisms referred to in the first indent, to be used exclusively for activities where appropriate stringent containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment, the measures should be based on the same principles of containment as laid down in Directive 90/219/EEC, - making available GMOs to be used exclusively for deliberate releases complying with the requirements laid down in part B of this Directive; (5) "notification" means the submission of the information required under this Directive to the competent authority of a Member State; (6) "notifier" means the person submitting the notification; (7) "product" means a preparation consisting of, or containing, a GMO or a combination of GMOs, which is placed on the market; (8) "environmental risk assessment" means the evaluation of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose and carried out in accordance with Annex II. Article 3 Exemptions 1. This Directive shall not apply to organisms obtained through the techniques of genetic modification listed in Annex I B. 2. This Directive shall not apply to the carriage of genetically modified organisms by rail, road, inland waterway, sea or air. Article 4 General obligations 1. Member States shall, in accordance with the precautionary principle, ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs. GMOs may only be deliberately released or placed on the market in conformity with part B or part C respectively. 2. Any person shall, before submitting a notification under part B or part C, carry out an environmental risk assessment. The information which may be necessary to carry out the environmental risk assessment is laid down in Annex III. Member States and the Commission shall ensure that GMOs which contain genes expressing resistance to antibiotics in use for medical or veterinary treatment are taken into particular consideration when carrying out an environmental risk assessment, with a view to identifying and phasing out antibiotic resistance markers in GMOs which may have adverse effects on human health and the environment. This phasing out shall take place by the 31 December 2004 in the case of GMOs placed on the market according to part C and by 31 December 2008 in the case of GMOs authorised under part B. 3. Member States and where appropriate the Commission shall ensure that potential adverse effects on human health and the environment, which may occur directly or indirectly through gene transfer from GMOs to other organisms, are accurately assessed on a case-by-case basis. This assessment shall be conducted in accordance with Annex II taking into account the environmental impact according to the nature of the organism introduced and the receiving environment. 4. Member States shall designate the competent authority or authorities responsible for complying with the requirements of this Directive. The competent authority shall examine notifications under part B and part C for compliance with the requirements of this Directive and whether the assessment provided for in paragraph 2 is appropriate. 5. Member States shall ensure that the competent authority organises inspections and other control measures as appropriate, to ensure compliance with this Directive. In the event of a release of GMO(s) or placing on the market as or in products for which no authorisation was given, the Member State concerned shall ensure that necessary measures are taken to terminate the release or placing on the market, to initiate remedial action if necessary, and to inform its public, the Commission and other Member States. 6. Member States shall take measures to ensure traceability, in line with the requirements laid down in Annex IV, at all stages of the placing on the market of GMOs authorised under part C. PART B DELIBERATE RELASE OF GMOs FOR ANY OTHER PURPOSE THAN FOR PLACING ON THE MARKET Article 5 1. Articles 6 to 11 shall not apply to medicinal substances and compunds for human use consisting of, or containing, a GMO or combination of GMOs provided that their deliberate release for any purpose other than that of being placed on the market is authorised by Community legislation which provides: (a) for a specific environmental risk assessment in accordance with Annex II and on the basis of the type of information specified in Annex III without prejudice to additional requirements provided for by the said legislation; (b) for explicit consent prior to release; (c) for a monitoring plan in accordance with the relevant parts of Annex III, with a view to detecting the effects of the GMO or GMOs on human health or the environment; (d) in an appropriate manner for requirements relating to treatment of new items of information, information to the public, information on the results of releases, and exchanges of information at least equivalent to those contained in this Directive and in the measures taken in accordance therewith. 2. Assessment of the risks to the environment presented by such substances and compounds shall be carried out in coordination with the national and Community authorities mentioned in this Directive. 3. Procedures ensuring conformity of the specific environmental risk assessment and equivalence with the provisions of this Directive must be provided for by the said legislation, which must refer to this Directive. Article 6 Standard authorisation procedure 1. Without prejudice to Article 5, any person must, before undertaking a deliberate release of a GMO or of a combination of GMOs, submit a notification to the competent authority of the Member State within whose territory the release is to take place. 2. The notification referred to in paragraph 1 shall include: (a) a technical dossier supplying the information specified in Annex III necessary for carrying out the environmental risk assessment of the deliberate release of a GMO or combination of GMOs, in particular: (i) general information including information on personnel and training, (ii) information relating to the GMO(s), (iii) information relating to the conditions of release and the potential receiving environment, (iv) information on the interactions between the GMO(s) and the environment, (v) a plan for monitoring in accordance with the relevant parts of Annex III in order to identify effects of the GMO(s) on human health or the environment, (vi) information on control, remediation methods, waste treatment and emergency response plans, (vii) a summary of the dossier; (b) the environmental risk assessment and the conclusions required in Annex II, section D, together with any bibliographic reference and indications of the methods used. 3. The notifier may refer to data or results from notifications previously submitted by other notifiers, provided that the information, data and results are non confidential or these notifiers have given their agreement in writing, or may submit additional information he considers relevant. 4. The competent authority may accept that releases of the same GMO or of a combination of GMOs on the same site or on different sites for the same purpose and within a defined period may be notified in a single notification. 5. The competent authority shall acknowledge the date of receipt of the notification and, having considered, where appropriate, any observations by other Member States made in accordance with Article 11, shall respond in writing to the notifier within 90 days of receipt of the notification by either: (a) indicating that it is satisfied that the notification is in compliance with this Directive and that the release may proceed; or (b) indicating that the release does not fulfil the conditions of this Directive and that notification is therefore rejected. 6. For the purpose of calculating the 90 day period referred to in paragraph 5, no account shall be taken of any periods of time during which the competent authority: (a) is awaiting further information which it may have requested from the notifier, or (b) is carrying out a public inquiry or consultation in accordance with Article 9; this public inquiry or consultation shall not prolong the 90 day period referred to in paragraph 5 by more than 30 days. 7. If the competent authority requests new information it must simultaneously give its reasons for so doing. 8. The notifier may proceed with the release only when he has received the written consent of the competent authority, and in conformity with any conditions required in this consent. 9. Member States shall ensure that no material derived from GMOs which are deliberately released in accordance with part B is placed on the market, unless in accordance with part C. Article 7 Differentiated procedures 1. If sufficient experience has been obtained of releases of certain GMOs in certain ecosystems and the GMOs concerned meet the criteria set out in Annex V, a competent authority may submit to the Commission a reasoned proposal for the application of differentiated procedures to such types of GMOs. 2. Following its own initiative or at the latest 30 days following the receipt of a competent authority's proposal, the Commission shall, (a) forward the proposal to the competent authorities, which may, within 60 days, present observations and at the same time; (b) make available the proposal to the public which may, within 60 days, make comments; and (c) consult the relevant Scientific Committee(s) which may, within 60 days give an opinion. 3. A decision shall be taken on each proposal in accordance with the procedure laid down in Article 30(2). This decision shall establish the minimum amount of technical information from Annex III necessary for evaluating any foreseeable risks from the release, in particular: (a) information relating to the GMO(s); (b) information relating to the conditions of release and the potential receiving environment; (c) information on the interactions between the GMO(s) and the environment; (d) the environmental risk assessment. 4. This decision shall be taken within 90 days of the date of the Commission's proposal or of receipt of the competent authority's proposal. This 90 day period shall not take into account the period of time during which the Commission is awaiting the observations of competent authorities, the comments of the public or the opinion of Scientific Committees, as provided for in paragraph 2. 5. The decision taken under paragraphs 3 and 4 shall provide that the notifier may proceed with the release only when he has received the written consent of the competent authority. The notifier shall proceed with the release in conformity with any conditions required in this consent. The decision taken under paragraphs 3 and 4 may provide that releases of a GMO or of a combination of GMOs on the same site or on different sites for the same purpose and within a defined period may be notified in a single notification. 6. Without prejudice to paragraphs 1 to 5, Commission Decision 94/730/EC of 4 November 1994 establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants pursuant to Article 6(5) of Council Directive 90/220/EEC(10) shall continue to apply. 7. Where a Member State decides to make use or not of a procedure established in a decision taken in accordance with paragraphs 3 and 4 for releases of GMOs within its territory, it shall inform the Commission thereof. Article 8 Handling of modifications and new information 1. In the event of any modification of, or unintended change to, the deliberate release of a GMO or of a combination of GMOs which could have consequences with regard to risks for human health and the environment after the competent authority has given its written consent, or if new information has become available on such risks, either while the notification is being examined by the competent authority of a Member State or after that authority has given its written consent, the notifier shall immediately: (a) take the measures necessary to protect human health and the environment; (b) inform the competent authority in advance of any modification or as soon as the unintended change is known or the new information is available; (c) revise the measures specified in the notification. 2. If information becomes available to the competent authority referred to in paragraph 1 which could have significant consequences with regard to risks for human health and the environment or under the circumstances described in paragraph 1, the competent authority shall evaluate such information and make it available to the public. It may require the notifier to modify the conditions of, suspend or terminate the deliberate release and shall inform the public thereof. Article 9 Consultation of and information to the public 1. Member States shall, without prejudice to the provisions of Articles 7 and 25, consult the public and, where appropriate, groups on the proposed deliberate release. In doing so, Member States shall lay down arrangements for this consultation, including a reasonable time-period, in order to give the public or groups the opportunity to express an opinion. 2. Without prejudice to the provisions of Article 25: - Member States shall make available to the public information on all part B releases of GMOs in their territory; - the Commission shall make available to the public the information contained in the system of exchange of information pursuant to Article 11. Article 10 Reporting by notifiers on releases After completion of a release, and thereafter, at any intervals laid down in the consent on the basis of the results of the environmental risk assessment, the notifier shall send to the competent authority the result of the release in respect of any risk to human health or the environment, with, where appropriate, particular reference to any kind of product that the notifier intends to notify at a later stage. The format for the presentation of this result shall be established in accordance with the procedure laid down in Article 30(2). Article 11 Exchange of information between competent authorities and the Commission 1. The Commission shall set up a system of exchange of the information contained in the notifications. The competent authorities shall send to the Commission, within 30 days of its receipt, a summary of each notification received under Article 6. The format of this summary shall be established and modified if appropriate in accordance with the procedure laid down in Article 30(2). 2. The Commission shall, at the latest 30 days following their receipt, forward these summaries to the other Member States, which may, within 30 days, present observations through the Commission or directly. At its request, a Member State shall be permitted to receive a copy of the full notification from the competent authority of the relevant Member State. 3. The competent authorities shall inform the Commission of the final decisions taken in compliance with Article 6(5), including where relevant the reasons for rejecting a notification, and of the results of the releases received in accordance with Article 10. 4. For the releases of GMOs referred to in Article 7, once a year Member States shall send a list of GMOs which have been released on their territory and a list of notifications that were rejected to the Commission, which shall forward them to the competent authorities of the other Member States. PART C PLACING ON THE MARKET OF GMOs AS OR IN PRODUCTS Article 12 Sectoral legislation 1. Articles 13 to 24 shall not apply to any GMO as or in products as far as they are authorised by Community legislation which provides for a specific environmental risk assessment carried out in accordance with the principles set out in Annex II and on the basis of information specified in Annex III without prejudice to additional requirements provided for by the Community legislation mentioned above, and for requirements as regards risk management, labelling, monitoring as appropriate, information to the public and safeguard clause at least equivalent to that laid down in this Directive. 2. As far as Council Regulation (EEC) No 2309/93 is concerned, Articles 13 to 24 of this Directive shall not apply to any GMO as or in products as far as they are authorised by that Regulation provided that a specific environmental risk assessment is carried out in accordance with the principles set out in Annex II to this Directive and on the basis of the type of information specified in Annex III to this Directive without prejudice to other relevant requirements as regards risk assessment, risk management, labelling, monitoring as appropriate, information to the public and safeguard clause provided by Community legislation concerning medicinal products for human and veterinary use. 3. Procedures ensuring that the risk assessment, requirements regarding risk management, labelling, monitoring as appropriate, information to the public and safeguard clause are equivalent to those laid down in this Directive shall be introduced, in a Regulation of the European Parliament and of the Council. Future sectoral legislation based on the provisions of that Regulation shall make a reference to this Directive. Until the Regulation enters into force, any GMO as or in products as far as they are authorised by other Community legislation shall only be placed on the market after having been accepted for placing on the market in accordance with this Directive. 4. During evaluation of the requests for the placing on the market of the GMOs referred to in paragraph 1, the bodies established by the Community under this Directive and by Member States for the purpose of implementing this Directive shall be consulted. Article 13 Notification procedure 1. Before a GMO or a combination of GMOs as or in products is placed on the market, a notification shall be submitted to the competent authority of the Member State where such a GMO is to be placed on the market for the first time. The competent authority shall acknowledge the date of receipt of the notification and immediately forward the summary of the dossier referred to in paragraph 2(h) to the competent authorities of the other Member States and the Commission. The competent authority shall without delay examine whether the notification is in accordance with paragraph 2 and shall, if necessary, ask the notifier for additional information. When the notification is in accordance with paragraph 2, and at the latest when it sends its assessment report in accordance with Article 14(2), the competent authority shall forward a copy of the notification to the Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States. 2. The notification shall contain: (a) the information required in Annexes III and IV. This information shall take into account the diversity of sites of use of the GMO as or in a product and shall include information on data and results obtained from research and developmental releases concerning the impact of the release on human health and the environment; (b) the environmental risk assessment and the conclusions required in Annex II, section D; (c) the conditions for the placing on the market of the product, including specific conditions of use and handling; (d) with reference to Article 15(4), a proposed period for the consent which should not exceed ten years; (e) a plan for monitoring in accordance with Annex VII, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent; (f) a proposal for labelling which shall comply with the requirements laid down in Annex IV. The labelling shall clearly state that a GMO is present. The words "this product contains genetically modified organisms" shall appear either on a label or in an accompanying document; (g) a proposal for packaging which shall comprise the requirements laid down in Annex IV; (h) a summary of the dossier. The format of the summary shall be established in accordance with the procedure laid down in Article 30(2). If on the basis of the results of any release notified under part B, or on other substantive, reasoned scientific grounds, a notifier considers that the placing on the market and use of a GMO as or in a product do not pose a risk to human health and the environment, he may propose to the competent authority not to provide part or all of the information required in Annex IV, section B. 3. The notifier shall include in this notification information on data or results from releases of the same GMOs or the same combination of GMOs previously or currently notified and/or carried out by the notifier either inside or outside the Community. 4. The notifier may also refer to data or results from notifications previously submitted by other notifiers or submit additional information he considers relevant, provided that the information, data and results are non-confidential or these notifiers have given their agreement in writing. 5. In order for a GMO or combination of GMOs to be used for a purpose different from that already specified in a notification, a separate notification shall be submitted. 6. If new information has become available with regard to the risks of the GMO to human health or the environment, before the written consent is granted, the notifier shall immediately take the measures necessary to protect human health and the environment, and inform the competent authority thereof. In addition, the notifier shall revise the information and conditions specified in the notification. Article 14 Assessment report 1. On receipt and after acknowledgement of the notification in accordance with Article 13(2), the competent authority shall examine it for compliance with this Directive. 2. Within 90 days after receipt of the notification the competent authority shall: - prepare an assessment report and send it to the notifier. A subsequent withdrawal by the notifier shall be without prejudice to any further submission of the notification to another competent authority; - in the case referred to in paragraph 3(a), send its report, together with the information referred to in paragraph 4 and any other information on which it has based its report, to the Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States. In the case referred to paragraph 3(b), the competent authority shall send its report, together with the information referred to in paragraph 4 and any other information on which it has based its report, to the Commission no earlier than 15 days after sending the assessment report to the notifier and no later than 105 days after receipt of the notification. The Commission shall, within 30 days of its receipt, forward the report to the competent authorities of the other Member States. 3. The assessment report shall indicate whether: (a) the GMO(s) in question should be placed on the market and under which conditions; or (b) the GMO(s) in question should not be placed on the market. The assessment reports shall be established in accordance with the guidelines laid down in Annex VI. 4. For the purpose of calculating the 90 day period referred to in paragraph 2, any periods of time during which the competent authority is awaiting further information which it may have requested from the notifier shall not be taken into account. The competent authority shall state the reasons in any request for further information. Article 15 Standard procedure 1. In the cases referred to in Article 14(3), a competent authority or the Commission may ask for further information, make comments or present reasoned objections to the placing on the market of the GMO(s) in question within a period of 60 days from the date of circulation of the assessment report. Comments or reasoned objections and replies shall be forwarded to the Commission which shall immediately circulate them to all competent authorities. The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 105 days from the date of circulation of the assessment report. Any periods of time during which further information from the notifier is awaited shall not be taken into account for the purpose of calculating the final 45 day period for arriving at an agreement. Reasons shall be stated in any request for further information. 2. In the case referred to in Article 14(3)(b), if the competent authority which prepared the report decides that the GMO(s) should not be placed on the market, the notification shall be rejected. This decision shall state the reasons. 3. If the competent authority which prepared the report decides that the product may be placed on the market, in the absence of any reasoned objection from a Member State or the Commission within 60 days following the date of circulation of the assessment report referred to in Article 14(3)(a) or if outstanding issues are resolved within the 105 day period referred to in paragraph 1, the competent authority which prepared the report shall give consent in writing for placing on the market, shall transmit it to the notifier and shall inform the other Member States and the Commission thereof within 30 days. 4. The consent shall be given for a maximum period of ten years starting from the date on which the consent is issued. For the purpose of approval of a GMO or a progeny of that GMO intended only for the marketing of their seeds under the relevant Community provisions, the period of the first consent shall end at the latest ten years after the date of the first inclusion of the first plant variety containing the GMO on an official national catalogue of plant varieties in accordance with Council Directives 70/457/EEC(11) and 70/458/EEC(12). In the case of forest reproductive material, the period of the first consent shall end at the latest ten years after the date of the first inclusion of basic material containing the GMO on an official national register of basic material in accordance with Council Directive 1999/105/EC(13). Article 16 Criteria and information for specified GMOs 1. A competent authority, or the Commission on its own initiative, may make a proposal on criteria and information requirements to be met for the notification, by way of derogation from Article 13, for the placing on the market of certain types of GMOs as or in products. 2. These criteria and information requirements as well as any appropriate requirements for a summary shall be adopted, after consultation of the relevant Scientific Committee(s), in accordance with the procedure laid down in Article 30(2). The criteria and the information requirements shall be such as to ensure a high level of safety to human health and the environment and be based on the scientific evidence available on such safety and on the experience gained from the release of comparable GMOs. The requirements set out in Article 13(2) shall be replaced by those adopted above, and the procedure set out in Article 13(3), (4), (5) and (6) and Articles 14 and 15 shall apply. 3. Before the procedure laid down in Article 30(2) for a decision on criteria and information requirements referred to in paragraph 1 is initiated, the Commission shall make the proposal available to the public. The public may make comments to the Commission within 60 days. The Commission shall forward any such comments, together with an analysis, to the Committee set up pursuant to Article 30. Article 17 Renewal of consent 1. By way of derogation from Articles 13, 14 and 15, the procedure set out in paragraphs 2 to 9 shall be applied to the renewal of: (a) consents granted under part C; and (b) before 17 October 2006 of consents granted under Directive 90/220/EEC for placing on the market of GMOs as or in products before 17 October 2002, 2. At the latest nine months before the expiry of the consent, for the consents referred to in paragraph 1(a), and before 17 October 2006, for the consents referred to in paragraph 1(b), the notifier under this Article shall submit a notification to the competent authority which received the original notification, which shall contain: (a) a copy of the consent to the placing on the market of the GMOs; (b) a report on the results of the monitoring which was carried out according to Article 20. In the case of consents referred to in paragraph 1(b), this report shall be submitted when the monitoring was carried out; (c) any other new information which has become available with regard to the risks of the product to human health and/or the environment; and (d) as appropriate, a proposal for amending or complementing the conditions of the original consent, inter alia the conditions concerning future monitoring and the time limitation of the consent. The competent authority shall acknowledge the date of receipt of the notification and when the notification is in accordance with this paragraph it shall without delay forward a copy of the notification and its assessment report to the Commission, which shall, within 30 days of their receipt, forward them to the competent authorities of the other Member States. It shall also send its assessment report to the notifier. 3. The assessment report shall indicate whether: (a) the GMO(s) should remain on the market and under which conditions; or (b) the GMO(s) should not remain on the market. 4. The other competent authorities or the Commission may ask for further information, make comments, or present reasoned objections within a period of 60 days from the date of circulation of the assessment report. 5. All comments, reasoned objections and replies shall be forwarded to the Commission which shall immediately circulate them to all competent authorities. 6. In the case of paragraph 3(a) and in the absence of any reasoned objection from a Member State or the Commission within 60 days from the date of circulation of the assessment report, the competent authority which prepared the report shall transmit to the notifier the final decision in writing and shall inform the other Member States and the Commission thereof within 30 days. The validity of the consent should not, as a general rule, exceed ten years and may be limited or extended as appropriate for specific reasons. 7. The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 75 days from the date of circulation of the assessment report. 8. If outstanding issues are resolved within the 75 day period referred to in paragraph 7, the competent authority which prepared the report shall transmit to the notifier its final decision in writing and shall inform the other Member States and the Commission thereof within 30 days. The validity of the consent may be limited as appropriate. 9. Following a notification for the renewal of a consent in accordance with paragraph 2, the notifier may continue to place the GMOs on the market under the conditions specified in that consent until a final decision has been taken on the notification. Article 18 Community procedure in case of objections 1. In cases where an objection is raised and maintained by a competent authority or the Commission in accordance with Articles 15, 17 and 20, a decision shall be adopted and published within 120 days in accordance with the procedure laid down in Article 30(2). This decision shall contain the same information as in Article 19(3). For the purpose of calculating the 120 day period, any period of time during which the Commission is awaiting further information which it may have requested from the notifier or is seeking the opinion of the Scientific Committee which has been consulted in accordance with Article 28 shall not be taken into account. The Commission shall state reasons in any request for further information and inform the competent authorities of its requests to the notifier. The period of time during which the Commission is awaiting the opinion of the Scientific Committee shall not exceed 90 days. The period of time that the Council takes to act in accordance with the procedure laid down in Article 30(2) shall not be taken into account. 2. Where a favourable decision has been taken, the competent authority which prepared the report shall give consent in writing to the placing on the market or to the renewal of the consent, shall transmit it to the notifier and shall inform the other Member States and the Commission thereof within 30 days following the publication or notification of the decision. Article 19 Consent 1. Without prejudice to requirements under other Community legislation, only if a written consent has been given for the placing on the market of a GMO as or in a product may that product be used without further notification throughout the Community in so far as the specific conditions of use and the environments and/or geographical areas stipulated in these conditions are strictly adhered to. 2. The notifier may proceed with the placing on the market only when he has received the written consent of the competent authority in accordance with Articles 15, 17 and 18, and in conformity with any conditions required in that consent. 3. The written consent referred to in Articles 15, 17 and 18 shall, in all cases, explicitly specify: (a) the scope of the consent, including the identity of the GMO(s) to be placed on the market as or in products, and their unique identifier; (b) the period of validity of the consent; (c) the conditions for the placing on the market of the product, including any specific condition of use, handling and packaging of the GMO(s) as or in products, and conditions for the protection of particular ecosystems/environments and/or geographical areas; (d) that, without prejudice to Article 25, the notifier shall make control samples available to the competent authority on request; (e) the labelling requirements, in compliance with the requirements laid down in Annex IV. The labelling shall clearly state that a GMO is present. The words "This product contains genetically modified organisms" shall appear either on a label or in a document accompanying the product or other products containing the GMO(s); (f) monitoring requirements in accordance with Annex VII, including obligations to report to the Commission and competent authorities, the time period of the monitoring plan and, where appropriate, any obligations on any person selling the product or any user of it, inter alia, in the case of GMOs grown, concerning a level of information deemed appropriate on their location. 4. Member States shall take all necessary measures to ensure that the written consent and the decision referred to in Article 18, where applicable, are made accessible to the public and that the conditions specified in the written consent and the decision, where applicable, are complied with. Article 20 Monitoring and handling of new information 1. Following the placing on the market of a GMO as or in a product, the notifier shall ensure that monitoring and reporting on it are carried out according to the conditions specified in the consent. The reports of this monitoring shall be submitted to the Commission and the competent authorities of the Member States. On the basis of these reports, in accordance with the consent and within the framework for the monitoring plan specified in the consent, the competent authority which received the original notification may adapt the monitoring plan after the first monitoring period. 2. If new information has become available, from the users or other sources, with regard to the risks of the GMO(s) to human health or the environment after the written consent has been given, the notifier shall immediately take the measures necessary to protect human health and the environment, and inform the competent authority thereof. In addition, the notifier shall revise the information and conditions specified in the notification. 3. If information becomes available to the competent authority which could have consequences for the risks of the GMO(s) to human health or the environment, or under the circumstances described in paragraph 2, it shall immediately forward the information to the Commission and the competent authorities of the other Member States and may avail itself of the provisions in Articles 15(1) and 17(7) where appropriate, when the information has become available before the written consent. When the information has become available after the consent has been given, the competent authority shall within 60 days after receipt of the new information, forward its assessment report indicating whether and how the conditions of the consent should be amended or the consent should be terminated to the Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States. Comments or reasoned objections to further placing on the market of the GMO or on the proposal for amending the conditions of the consent shall, within 60 days following the circulation of the assessment report, be forwarded to the Commission which shall immediately forward them to all competent authorities. The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 75 days from the date of circulation of the assessment report. In the absence of any reasoned objection from a Member State or the Commission within 60 days following the date of circulation of the new information or if outstanding issues are resolved within 75 days, the competent authority which prepared the report shall amend the consent as proposed, shall transmit the amended consent to the notifier and shall inform the other Member States and the Commission thereof within 30 days. 4. So as to ensure its transparency, the results of the monitoring carried out under part C of the Directive shall be made publicly available. Article 21 Labelling 1. Member States shall take all necessary measures to ensure that at all stages of the placing on the market, the labelling and packaging of GMOs placed on the market as or in products comply with the relevant requirements specified in the written consent referred to in Articles 15(3), 17(5) and (8), 18(2) and 19(3). 2. For products where adventitious or technically unavoidable traces of authorised GMOs cannot be excluded, a minimum threshold may be established below which these products shall not have to be labelled according to the provision in paragraph 1. The threshold levels shall be established according to the product concerned, under the procedure laid down in Article 30(2). Article 22 Free circulation Without prejudice to Article 23, Member States may not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of this Directive. Article 23 Safeguard clause 1. Where a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a GMO as or in a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory. The Member State shall ensure that in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public. The Member State shall immediately inform the Commission and the other Member States of actions taken under this Article and give reasons for its decision, supplying its review of the environmental risk assessment, indicating whether and how the conditions of the consent should be amended or the consent should be terminated, and, where appropriate, the new or additional information on which its decision is based. 2. A decision shall be taken on the matter within 60 days in accordance with the procedure laid down in Article 30(2). For the purpose of calculating the 60 day period, any period of time during which the Commission is awaiting further information which it may have requested from the notifier or is seeking the opinion of the Scientific Committee(s) which has/have been consulted shall not be taken into account. The period of time during which the Commission is awaiting the opinion of the Scientific Committee(s) consulted shall not exceed 60 days. Likewise, the period of time the Council takes to act in accordance with the procedure laid down in Article 30(2) shall not be taken into account. Article 24 Information to the public 1. Without prejudice to Article 25, upon receipt of a notification in accordance with Article 13(1), the Commission shall immediately make available to the public the summary referred to in Article 13(2)(h). The Commission shall also make available to the public assessment reports in the case referred to in Article 14(3)(a). The public may make comments to the Commission within 30 days. The Commission shall immediately forward the comments to the competent authorities. 2. Without prejudice to Article 25, for all GMOs which have received written consent for placing on the market or whose placing on the market was rejected as or in products under this Directive, the assessment reports carried out for these GMOs and the opinion(s) of the Scientific Committees consulted shall be made available to the public. For each product, the GMO or GMOs contained therein and the use or uses shall be clearly specified. PART D FINAL PROVISIONS Article 25 Confidentiality 1. The Commission and the competent authorities shall not divulge to third parties any confidential information notified or exchanged under this Directive and shall protect intellectual property rights relating to the data received. 2. The notifier may indicate the information in the notification submitted under this Directive, the disclosure of which might harm his competitive positionand which should therefore be treated as confidential. Verifiable justification must be given in such cases. 3. The competent authority shall, after consultation with the notifier, decide which information will be kept confidential and shall inform the notifier of its decisions. 4. In no case may the following information when submitted according to Articles 6, 7, 8, 13, 17, 20 or 23 be kept confidential: - general description of the GMO or GMOs, name and address of the notifier, purpose of the release, location of release and intended uses; - methods and plans for monitoring of the GMO or GMOs and for emergency response; - environmental risk assessment. 5. If, for whatever reasons, the notifier withdraws the notification, the competent authorities and the Commission must respect the confidentiality of the information supplied. Article 26 Labelling of GMOs referred to in Article 2(4), second subparagraph 1. The GMOs to be made available for operations referred to under Article 2(4), second subparagraph, shall be subject to adequate labelling requirements in accordance with the relevant sections of Annex IV in order to provide for clear information, on a label or in an accompanying document, on the presence of GMOs. To that effect the words "This product contains genetically modified organisms" shall appear either on a label or in an accompanying document. 2. The conditions for the implementation of paragraph 1 shall, without duplicating or creating inconsistencies with existing labelling provisions laid down in existing Community legislation, be determined in accordance with the procedure laid down in Article 30(2). In doing so, account should be taken, as appropriate, of labelling provisions established by Member States in accordance with Community legislation. Article 27 Adaptation of Annexes to technical progress Sections C and D of Annex II, Annexes III to VI, and section C of Annex VII shall be adapted to technical progress in accordance with the procedure laid down in Article 30(2). Article 28 Consultation of Scientific Committee(s) 1. In cases where an objection as regards the risks of GMOs to human health or to the environment is raised by a competent authority or the Commission and maintained in accordance with Article 15(1), 17(4), 20(3) or 23, or where the assessment report referred to in Article 14 indicates that the GMO should not be placed on the market, the relevant Scientific Committee(s) shall be consulted by the Commission, on its own initiative or at the request of a Member State, on the objection. 2. The relevant Scientific Committee(s) may also be consulted by the Commission, on its own initiative or at the request of a Member State, on any matter under this Directive that may have an adverse effect on human health and the environment. 3. The administrative procedures laid down in this Directive shall not be affected by paragraph 2. Article 29 Consultation of Committee(s) on Ethics 1. Without prejudice to the competence of Member States as regards ethical issues, the Commission shall, on its own initiative or at the request of the European Parliament or the Council, consult any committee it has created with a view to obtaining its advice on the ethical implications of biotechnology, such as the European Group on Ethics in Science and New Technologies, on ethical issues of a general nature. This consultation may also take place at the request of a Member State. 2. This consultation is conducted under clear rules of openness, transparency and public accessibility. Its outcome shall be accessible to the public. 3. The administrative procedures provided for in this Directive shall not be affected by paragraph 1. Article 30 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 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 own rules of procedure. Article 31 Exchange of information and reporting 1. Member States and the Commission shall meet regularly and exchange information on the experience acquired with regard to the prevention of risks related to the release and the placing on the market of GMOs. This information exchange shall also cover experience gained from the implementation of Article 2(4), second subparagraph, environmental risk assessment, monitoring and the issue of consultation and information of the public. Where necessary, guidance on the implementation of Article 2(4), second subparagraph, may be provided by the committee established under Article 30(1). 2. The Commission shall establish one or several register(s) for the purpose of recording the information on genetic modifications in GMOs mentioned in point A No 7 of Annex IV. Without prejudice to Article 25, the register(s) shall include a part which is accessible to the public. The detailed arrangements for the operation of the register(s) shall be decided in accordance with the procedure laid down in Article 30(2). 3. Without prejudice to paragraph 2 and point A No 7 of Annex IV, (a) Member States shall establish public registers in which the location of the release of the GMOs under part B is recorded. (b) Member States shall also establish registers for recording the location of GMOs grown under part C, inter alia so that the possible effects of such GMOs on the environment may be monitored in accordance with the provisions of Articles 19(3)(f) and 20(1). Without prejudice to such provisions in Articles 19 and 20, the said locations shall: - be notified to the competent authorities, and - be made known to the public in the manner deemed appropriate by the competent authorities and in accordance with national provisions. 4. Every three years, Member States shall send the Commission a report on the measures taken to implement the provisions of this Directive. This report shall include a brief factual report on their experience with GMOs placed on the market in or as products under this Directive. 5. Every three years, the Commission shall publish a summary based on the reports referred to in paragraph 4. 6. The Commission shall send to the European Parliament and the Council, in 2003 and thereafter every three years, a report on the experience of Member States with GMOs placed on the market under this Directive. 7. When submitting this report in 2003, the Commission shall at the same time submit a specific report on the operation of part B and part C including an assessment of: (a) all its implications, particularly to take account of the diversity of European ecosystems and the need to complement the regulatory framework in this field; (b) the feasibility of various options to improve further the consistency and efficiency of this framework, including a centralised Community authorisation procedure and the arrangements for the final decision making by the Commission; (c) whether sufficient experience has accumulated on the implementation of part B differentiated procedures to justify a provision on implicit consent in these procedures and on part C to justify the application of differentiated procedures; and (d) the socioeconomic implications of deliberate releases and placing on the market of GMOs. 8. The Commission shall send to the European Parliament and the Council every year, a report on the ethical issues referred to in Article 29(1); this report may be accompanied, if appropriate, by a proposal with a view to amending this Directive. Article 32 Implementation of the Cartagena Protocol on biosafety 1. The Commission is invited to bring forward as soon as possible and in any case before July 2001 a legislative proposal for implementing in detail the Cartagena Protocol on biosafety. The proposal shall complement and, if necessary, amend the provisions of this Directive. 2. This proposal shall, in particular, include appropriate measures to implement the procedures laid down in the Cartagena Protocol and, in accordance with the Protocol, require Community exporters to ensure that all requirements of the Advance Informed Agreement Procedure, as set out in Articles 7 to 10, 12 and 14 of the Cartagena Protocol, are fulfilled. Article 33 Penalties Member States shall determine the penalties applicable to breaches of the national provisions adopted pursuant to this Directive. Those penalties shall be effective, proportionate and dissuasive. Article 34 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 17 October 2002. 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 texts of the main provisions of domestic law which they adopt in the field covered by this Directive. Article 35 Pending notifications 1. Notifications concerning placing on the market of GMOs as or in products received pursuant to Directive 90/220/EEC, and in respect of which the procedures of that Directive have not been completed by 17 October 2002 shall be subject to the provisions of this Directive. 2. By 17 January 2003 notifiers shall have complemented their notification in accordance with this Directive. Article 36 Repeal 1. Directive 90/220/EEC shall be repealed on 17 October 2002. 2. 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 VIII. Article 37 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 38 This Directive is addressed to the Member States.

32001L0017

2001

Directive 2001/17/EC of the European Parliament and of the Council of 19 March 2001 on the reorganisation and winding-up of insurance undertakings Having regard to the Treaty establishing the European Community, and in particular Articles 47(2) and 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 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(4), as supplemented by Directive 92/49/EEC(5), and the 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(6), as supplemented by Directive 92/96/EEC(7), provide for a single authorisation of the insurance undertakings granted by the home Member State supervisory authority. This single authorisation allows the insurance undertaking to carry out its activities in the Community by means of establishment or free provision of services without any further authorisation by the host Member State and under the sole prudential supervision of the home Member State supervisory authorities. (2) The insurance directives providing a single authorisation with a Community scope for the insurance undertakings do not contain coordination rules in the event of winding-up proceedings. Insurance undertakings as well as other financial institutions are expressly excluded from the scope of Council Regulation (EC) No 1346/2000 of 29 May 2000 on insolvency proceedings(8). It is in the interest of the proper functioning of the internal market and of the protection of creditors that coordinated rules are established at Community level for winding-up proceedings in respect of insurance undertakings. (3) Coordination rules should also be established to ensure that the reorganisation measures, adopted by the competent authority of a Member State in order to preserve or restore the financial soundness of an insurance undertaking and to prevent as much as possible a winding-up situation, produce full effects throughout the Community. The reorganisation measures covered by this Directive are those affecting pre-existing rights of parties other than the insurance undertaking itself. The measures provided for in Article 20 of Directive 73/239/EEC and Article 24 of Directive 79/267/EEC should be included within the scope of this Directive provided that they comply with the conditions contained in the definition of reorganisation measures. (4) This Directive has a Community scope which affects insurance undertakings as defined in Directives 73/239/EEC and 79/267/EEC which have their head office in the Community, Community branches of insurance undertakings which have their head office in third countries and creditors resident in the Community. This Directive should not regulate the effects of the reorganisation measures and winding-up proceedings vis-à-vis third countries. (5) This Directive should concern winding-up proceedings whether or not they are founded on insolvency and whether they are voluntary or compulsory. It should apply to collective proceedings as defined by the home Member State's legislation in accordance with Article 9 involving the realisation of the assets of an insurance undertaking and the distribution of their proceeds. Winding-up proceedings which, without being founded on insolvency, involve for the payment of insurance claims a priority order in accordance with Article 10 should also be included in the scope of this Directive. Claims by the employees of an insurance undertaking arising from employment contracts and employment relationships should be capable of being subrogated to a national wage guarantee scheme; such subrogated claims should benefit from the treatment determined by the home Member State's law (lex concursus) according to the principles of this Directive. The provisions of this Directive should apply to the different cases of winding-up proceedings as appropriate. (6) The adoption of reorganisation measures does not preclude the opening of winding-up proceedings. Winding-up proceedings may be opened in the absence of, or following, the adoption of reorganisation measures and they may terminate with composition or other analogous measures, including reorganisation measures. (7) The definition of branch, in accordance with existing insolvency principles, should take account of the single legal personality of the insurance undertaking. The home Member State's legislation should determine the way in which the assets and liabilities held by independent persons who have a permanent authority to act as agent for an insurance undertaking should be treated in the winding-up of an insurance undertaking. (8) A distinction should be made between the competent authorities for the purposes of reorganisation measures and winding-up proceedings and the supervisory authorities of the insurance undertakings. The competent authorities may be administrative or judicial authorities depending on the Member State's legislation. This Directive does not purport to harmonise national legislation concerning the allocation of competences between such authorities. (9) This Directive does not seek to harmonise national legislation concerning reorganisation measures and winding-up proceedings but aims at ensuring mutual recognition of Member States' reorganisation measures and winding-up legislation concerning insurance undertakings as well as the necessary cooperation. Such mutual recognition is implemented in this Directive through the principles of unity, universality, coordination, publicity, equivalent treatment and protection of insurance creditors. (10) Only the competent authorities of the home Member State should be empowered to take decisions on winding-up proceedings concerning insurance undertakings (principle of unity). These proceedings should produce their effects throughout the Community and should be recognised by all Member States. All the assets and liabilities of the insurance undertaking should, as a general rule, be taken into consideration in the winding-up proceedings (principle of universality). (11) The home Member State's law should govern the winding-up decision concerning an insurance undertaking, the winding-up proceedings themselves and their effects, both substantive and procedural, on the persons and legal relations concerned, except where this Directive provides otherwise. Therefore all the conditions for the opening, conduct and closure of winding-up proceedings should in general be governed by the home Member State's law. In order to facilitate its application this Directive should include a non-exhaustive list of aspects which, in particular, are subject to the general rule of the home Member State's legislation. (12) The supervisory authorities of the home Member State and those of all the other Member States should be informed as a matter of urgency of the opening of winding-up proceedings (principle of coordination). (13) It is of utmost importance that insured persons, policy-holders, beneficiaries and any injured party having a direct right of action against the insurance undertaking on a claim arising from insurance operations be protected in winding-up proceedings. Such protection should not include claims which arise not from obligations under insurance contracts or insurance perations but from civil liability caused by an agent in negotiations for which, according to the law applicable to the insurance contract or operation, the agent himself is not responsible under such insurance contract or operation. In order to achieve this objective Member States should ensure special treatment for insurance creditors according to one of two optional methods provided for in this Directive. Member States may choose between granting insurance claims absolute precedence over any other claim with respect to assets representing the technical provisions or granting insurance claims a special rank which may only be preceded by claims on salaries, social security, taxes and rights "in rem" over the whole assets of the insurance undertaking. Neither of the two methods provided for in this Directive impedes a Member State from establishing a ranking between different categories of insurance claims. (14) This Directive should ensure an appropriate balance between the protection of insurance creditors and other privileged creditors protected by the Member State's legislation and not harmonise the different systems of privileged creditors existing in the Member States. (15) The two optional methods for treatment of insurance claims are considered substantially equivalent. The first method ensures the affectation of assets representing the technical provisions to insurance claims, the second method ensures insurance claims a position in the ranking of creditors which not only affects the assets representing the technical provisions but all the assets of the insurance undertaking. (16) Member States which, in order to protect insurance creditors, opt for the method of granting insurance claims absolute precedence with respect to the assets representing the technical provisions should require their insurance undertakings to establish and keep up to date a special register of such assets. Such a register is a useful instrument for identifying the assets affected to such claims. (17) In order to strengthen equivalence between both methods of treatment of insurance claims, this Directive should oblige the Member States which apply the method set out in Article 10(1)(b) to require every insurance undertaking to represent, at any moment and independently of a possible winding-up, claims, which according to that method may have precedence over insurance claims and which are registered in the insurance undertaking's accounts, by assets allowed by the insurance directives in force to represent the technical provisions. (18) The home Member State should be able to provide that, where the rights of insurance creditors have been subrogated to a guarantee scheme established in such home Member State, claims by that scheme should not benefit from the treatment of insurance claims under this Directive. (19) The opening of winding-up proceedings should involve the withdrawal of the authorisation to conduct business granted to the insurance undertaking unless such authorisation has previously been withdrawn. (20) The decision to open winding-up proceedings, which may produce effects throughout the Community according to the principle of universality, should have appropriate publicity within the Community. In order to protect interested parties, the decision should be published in accordance with the home Member State's procedures and in the Official Journal of the European Communities and, further, by any other means decided by the other Member States' supervisory authorities within their respective territories. In addition to publication of the decision, known creditors who are resident in the Community should be individually informed of the decision and this information should contain at least the elements specified in this Directive. Liquidators should also keep creditors regularly informed of the progress of the winding-up proceedings. (21) Creditors should have the right to lodge claims or to submit written observations in winding-up proceedings. Claims by creditors resident in a Member State other than the home Member State should be treated in the same way as equivalent claims in the home Member State without any discrimination on the grounds of nationality or residence (principle of equivalent treatment). (22) This Directive should apply to reorganisation measures adopted by a competent authority of a Member State principles which are similar "mutatis mutandis" to those provided for in winding-up proceedings. The publication of such reorganisation measures should be limited to the case in which an appeal in the home Member State is possible by parties other than the insurance undertaking itself. When reorganisation measures affect exclusively the rights of shareholders, members or employees of the insurance undertaking considered in those capacities, the competent authorities should determine the manner in which the parties affected should be informed in accordance with relevant legislation. (23) This Directive provides for coordinated rules to determine the law applicable to reorganisation measures and winding-up proceedings of insurance undertakings. This Directive does not seek to establish rules of private international law determining the law applicable to contracts and other legal relations. In particular, this Directive does not seek to govern the applicable rules on the existence of a contract, the rights and obligations of parties and the evaluation of debts. (24) The general rule of this Directive, according to which reorganisation measures and the winding-up proceedings are governed by the law of the home Member State, should have a series of exceptions in order to protect legitimate expectations and the certainty of certain transactions in Member States other than the home Member State. Such exceptions should concern the effects of such reorganisation measures or winding-up proceedings on certain contracts and rights, third parties' rights in rem, reservations of title, set-off, regulated markets, detrimental acts, third party purchasers and lawsuits pending. (25) The exception concerning the effects of reorganisation measures and winding-up proceedings on certain contracts and rights provided for in Article 19 should be limited to the effects specified therein and should not include any other issues related to reorganisation measures and winding-up proceedings such as the lodging, verification, admission and ranking of claims regarding such contracts and rights, which should be governed by the home Member State's legislation. (26) The effects of reorganisation measures or winding-up proceedings on a lawsuit pending should be governed by the law of the Member States in which the lawsuit is pending concerning an asset or a right of which the insurance undertaking has been divested as an exception to the application of the law of the home Member State. The effects of such measures and proceedings on individual enforcement actions arising from these lawsuits should be governed by the home Member State's legislation, according to the general rule of this Directive. (27) All persons required to receive or divulge information connected with the procedures of communication provided for in this Directive should be bound by professional secrecy in the same manner as that established in Article 16 of Directive 92/49/EEC and Article 15 of Directive 92/96/EEC, with the exception of any judicial authority to which specific national legislation applies. (28) For the sole purpose of applying the provisions of this Directive to reorganisation measures and winding-up proceedings concerning branches situated in the Community of an insurance undertaking whose head office is located in a third country the home Member State should be defined as the Member State in which the branch is located and the supervisory authorities and competent authorities as the authorities of that Member State. (29) Where there are branches in more than one Member State of an insurance undertaking whose head office is located outside the Community, each branch should be treated independently with regard to the application of this Directive. In that case the competent authorities, supervisory authorities, administrators and liquidators should endeavour to coordinate their actions, TITLE I SCOPE AND DEFINITIONS Article 1 Scope 1. This Directive applies to reorganisation measures and winding-up proceedings concerning insurance undertakings. 2. This Directive also applies, to the extent provided for in Article 30, to reorganisation measures and winding-up proceedings concerning branches in the territory of the Community of insurance undertakings having their head office outside the Community. Article 2 Definitions For the purpose of this Directive: (a) "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; (b) "branch" means any permanent presence of an insurance undertaking in the territory of a Member State other than the home Member State which carries out insurance business; (c) "reorganisation measures" means measures involving any intervention by administrative bodies or judicial authorities which are intended to preserve or restore the financial situation of an insurance undertaking and which affect pre-existing rights of parties other than the insurance undertaking itself, including but not limited to measures involving the possibility of a suspension of payments, suspension of enforcement measures or reduction of claims; (d) "winding-up proceedings" means collective proceedings involving realising the assets of an insurance undertaking and distributing the proceeds among the creditors, shareholders or members as appropriate, which necessarily involve any intervention by the administrative or the judicial authorities of a Member State, including where the collective proceedings are terminated by a composition or other analogous measure, whether or not they are founded on insolvency or are voluntary or compulsory; (e) "home Member State" means the Member State in which an insurance undertaking has been authorised in accordance with Article 6 of Directive 73/239/EEC or Article 6 of Directive 79/267/EEC; (f) "host Member State" means the Member State other than the home Member State in which an insurance undertaking has a branch; (g) "competent authorities" means the administrative or judicial authorities of the Member States which are competent for the purposes of the reorganisation measures or the winding-up proceedings; (h) "supervisory authorities" means the competent authorities within the meaning of Article 1(k) of Directive 92/49/EEC and of Article 1(l) of Directive 92/96/EEC; (i) "administrator" means any person or body appointed by the competent authorities for the purpose of administering reorganisation measures; (j) "liquidator" means any person or body appointed by the competent authorities or by the governing bodies of an insurance undertaking, as appropriate, for the purpose of administering winding-up proceedings; (k) "insurance claims" means any amount which is owed by an insurance undertaking to insured persons, policy holders, beneficiaries or to any injured party having direct right of action against the insurance undertaking and which arises from an insurance contract or from any operation provided for in Article 1(2) and (3), of Directive 79/267/EEC in direct insurance business, including amounts set aside for the aforementioned persons, when some elements of the debt are not yet known. The premiums owed by an insurance undertaking as a result of the non-conclusion or cancellation of these insurance contracts and operations in accordance with the law applicable to such contracts or operations before the opening of the winding-up proceedings shall also be considered insurance claims. TITLE II REORGANISATION MEASURES Article 3 Scope This Title applies to the reorganisation measures defined in Article 2(c). Article 4 Adoption of reorganisation measures - Applicable law 1. Only the competent authorities of the home Member State shall be entitled to decide on the reorganisation measures with respect to an insurance undertaking, including its branches in other Member States. The reorganisation measures shall not preclude the opening of winding-up proceedings by the home Member State. 2. The reorganisation measures shall be governed by the laws, regulations and procedures applicable in the home Member State, unless otherwise provided in Articles 19 to 26. 3. The reorganisation measures shall be fully effective throughout the Community in accordance with the legislation of the home Member State without any further formalities, including against third parties in other Member States, even if the legislation of those other Member States does not provide for such reorganisation measures or alternatively makes their implementation subject to conditions which are not fulfilled. 4. The reorganisation measures shall be effective throughout the Community once they become effective in the Member State where they have been taken. Article 5 Information to the supervisory authorities The competent authorities of the home Member State shall inform as a matter or urgency the home Member State's supervisory authorities of their decision on any reorganisation measure, where possible before the adoption of such a measure and failing that immediately thereafter. The supervisory authorities of the home Member State shall inform as a matter of urgency the supervisory authorities of all other Member States of the decision to adopt reorganisation measures including the possible practical effects of such measures. Article 6 Publication 1. Where an appeal is possible in the home Member State against a reorganisation measure, the competent authorities of the home Member State, the administrator or any person entitled to do so in the home Member State shall make public its decision on a reorganisation measure in accordance with the publication procedures provided for in the home Member State and, furthermore, publish in the Official Journal of the European Communities at the earliest opportunity an extract from the document establishing the reorganisation measure. The supervisory authorities of all the other Member States which have been informed of the decision on a reorganisation measure pursuant to Article 5 may ensure the publication of such decision within their territory in the manner they consider appropriate. 2. The publications provided for in paragraph 1 shall also specify the competent authority of the home Member State, the applicable law as provided in Article 4(2) and the administrator appointed, if any. They shall be carried out in the official language or in one of the official languages of the Member State in which the information is published. 3. The reorganisation measures shall apply regardless of the provisions concerning publication set out in paragraphs 1 and 2 and shall be fully effective as against creditors, unless the competent authorities of the home Member State or the law of that State provide otherwise. 4. When reorganisation measures affect exclusively the rights of shareholders, members or employees of an insurance undertaking, considered in those capacities, this Article shall not apply unless the law applicable to these reorganisation measures provides otherwise. The competent authorities shall determine the manner in which the interested parties affected by such reorganisation measures shall be informed in accordance with the relevant legislation. Article 7 Information to known creditors - Right to lodge claims 1. Where the legislation of the home Member State requires lodgement of a claim with a view to its recognition or provides for compulsory notification of a reorganisation measure to creditors who have their normal place of residence, domicile or head office in that State, the competent authorities of the home Member State or the administrator shall also inform known creditors who have their normal place of residence, domicile or head office in another Member State, in accordance with the procedures laid down in Articles 15 and 17(1). 2. Where the legislation of the home Member State provides for the right of creditors who have their normal place of residence, domicile or head office in that State to lodge claims or to submit observations concerning their claims, creditors who have their normal place of residence, domicile or head office in another Member State shall have the same right to lodge claims or submit observations in accordance with the procedures laid down in Articles 16 and 17(2). TITLE III WINDING-UP PROCEEDINGS Article 8 Opening of winding-up proceedings - Information to the supervisory authorities 1. Only the competent authorities of the home Member State shall be entitled to take a decision concerning the opening of winding-up proceedings with regard to an insurance undertaking, including its branches in other Member States. This decision may be taken in the absence, or following the adoption, of reorganisation measures. 2. A decision adopted according to the home Member State's legislation concerning the opening of winding-up proceedings of an insurance undertaking, including its branches in other Member States, shall be recognised without further formality within the territory of all other Member States and shall be effective there as soon as the decision is effective in the Member State in which the proceedings are opened. 3. The supervisory authorities of the home Member State shall be informed as a matter of urgency of the decision to open winding-up proceedings, if possible before the proceedings are opened and failing that immediately thereafter. The supervisory authorities of the home Member State shall inform as a matter of urgency the supervisory authorities of all other Member States of the decision to open winding-up proceedings including the possible practical effects of such proceedings. Article 9 Applicable law 1. The decision to open winding-up proceedings with regard to an insurance undertaking, the winding-up proceedings and their effects shall be governed by the laws, regulations and administrative provisions applicable in its home Member State unless otherwise provided in Articles 19 to 26. 2. The law of the home Member State shall determine in particular: (a) the assets which form part of the estate and the treatment of assets acquired by, or devolving on, the insurance undertaking after the opening of the winding-up proceedings; (b) the respective powers of the insurance undertaking and the liquidator; (c) the conditions under which set-off may be invoked; (d) the effects of the winding-up proceedings on current contracts to which the insurance undertaking is party; (e) the effects of the winding-up proceedings on proceedings brought by individual creditors, with the exception of lawsuits pending as provided for in Article 26; (f) the claims which are to be lodged against the insurance undertaking's estate and the treatment of claims arising after the opening of winding-up proceedings; (g) the rules governing the lodging, verification and admission of claims; (h) the rules governing the distribution of proceeds from the realisation of assets, the ranking of claims, and the rights of creditors who have obtained partial satisfaction after the opening of winding-up proceedings by virtue of a right in rem or through a set-off; (i) the conditions for and the effects of closure of winding-up proceedings, in particular by composition; (j) creditors' rights after the closure of winding-up proceedings; (k) who is to bear the cost and expenses incurred in the winding-up proceedings; (l) the rules relating to the voidness, voidability or unenforceability of legal acts detrimental to all the creditors. Article 10 Treatment of insurance claims 1. Member States shall ensure that insurance claims take precedence over other claims on the insurance undertaking according to one or both of the following methods: (a) insurance claims shall, with respect to assets representing the technical provisions, take absolute precedence over any other claim on the insurance undertaking; (b) insurance claims shall, with respect to the whole of the insurance undertaking's assets, take precedence over any other claim on the insurance undertaking with the only possible exception of: (i) claims by employees arising from employment contracts and employment relationships, (ii) claims by public bodies on taxes, (iii) claims by social security systems, (iv) claims on assets subject to rights in rem. 2. Without prejudice to paragraph 1, Member States may provide that the whole or a part of the expenses arising from the winding-up procedure, as defined by their national legislation, shall take precedence over insurance claims. 3. Member States which have opted for the method provided for in paragraph 1(a) shall require that insurance undertakings establish and keep up to date a special register in line with the provisions set out in the Annex. Article 11 Subrogation to a guarantee scheme The home Member State may provide that, where the rights of insurance creditors have been subrogated to a guarantee scheme established in that Member State, claims by that scheme shall not benefit from the provisions of Article 10(1). Article 12 Representation of preferential claims by assets By way of derogation from Article 18 of Directive 73/239/EEC and Article 21 of Directive 79/267/EEC, Member States which apply the method set out in Article 10(1)(b) of this Directive shall require every insurance undertaking to represent, at any moment and independently from a possible winding-up, the claims which may take precedence over insurance claims pursuant to Article 10(1)(b) and which are registered in the insurance undertaking's accounts, by assets mentioned in Article 21 of Directive 92/49/EEC and Article 21 of Directive 92/96/EEC. Article 13 Withdrawal of the authorisation 1. Where the opening of winding-up proceedings is decided in respect of an insurance undertaking, the authorisation of the insurance undertaking shall be withdrawn, except to the extent necessary for the purposes of paragraph 2, in accordance with the procedure laid down in Article 22 of Directive 73/239/EEC and Article 26 of Directive 79/267/EEC, if the authorisation has not been previously withdrawn. 2. The withdrawal of authorisation pursuant to paragraph 1 shall not prevent the liquidator or any other person entrusted by the competent authorities from carrying on some of the insurance undertakings' activities in so far as that is necessary or appropriate for the purposes of winding-up. The home Member State may provide that such activities shall be carried on with the consent and under the supervision of the supervisory authorities of the home Member State. Article 14 Publication 1. The competent authority, the liquidator or any person appointed for that purpose by the competent authority shall publish the decision to open winding-up proceedings in accordance with the publication procedures provided for in the home Member State and also publish an extract from the winding-up decision in the Official Journal of the European Communities. The supervisory authorities of all the other Member States which have been informed of the decision to open winding-up proceedings in accordance with Article 8(3) may ensure the publication of such decision within their territories in the manner they consider appropriate. 2. The publication of the decision to open winding-up proceedings provided for in paragraph 1 shall also specify the competent authority of the home Member State, the applicable law and the liquidator appointed. It shall be in the official language or in one of the official languages of the Member State in which the information is published. Article 15 Information to known creditors 1. When winding-up proceedings are opened, the competent authorities of the home Member State, the liquidator or any person appointed for that purpose by the competent authorities shall without delay individually inform by written notice each known creditor who has his normal place of residence, domicile or head office in another Member State thereof. 2. The notice referred to in paragraph 1 shall in particular deal with time limits, the penalties laid down with regard to those time limits, the body or authority empowered to accept the lodgement of claims or observations relating to claims and the other measures laid down. The notice shall also indicate whether creditors whose claims are preferential or secured in rem need to lodge their claims. In the case of insurance claims, the notice shall further indicate the general effects of the winding-up proceedings on the insurance contracts, in particular, the date on which the insurance contracts or the operations will cease to produce effects and the rights and duties of insured persons with regard to the contract or operation. Article 16 Right to lodge claims 1. Any creditor who has his normal place of residence, domicile or head office in a Member State other than the home Member State, including Member States' public authorities, shall have the right to lodge claims or to submit written observations relating to claims. 2. The claims of all creditors who have their normal place of residence, domicile or head office in a Member State other than the home Member State, including the aforementioned authorities, shall be treated in the same way and accorded the same ranking as claims of an equivalent nature lodgeable by creditors who have their normal place of residence, domicile or head office in the home Member State. 3. Except in cases where the law of the home Member State allows otherwise, a creditor shall send copies of supporting documents, if any, and shall indicate the nature of the claim, the date on which it arose and the amount, whether he alleges preference, security in rem or reservation of title in respect of the claim and what assets are covered by his security. The precedence granted to insurance claims by Article 10 need not be indicated. Article 17 Languages and form 1. The information in the notice referred to in Article 15 shall be provided in the official language or one of the official languages of the home Member State. For that purpose a form shall be used bearing the heading "Invitation to lodge a claim; time limits to be observed" or, where the law of the home Member State provides for the submission of observations relating to claims, "Invitation to submit observations relating to a claim; time limits to be observed", in all the official languages of the European Union. However, where a known creditor is a holder of an insurance claim, the information in the notice referred to in Article 15 shall be provided in the official language or one of the official languages of the Member State in which the creditor has his normal place of residence, domicile or head office. 2. Any creditor who has his normal place of residence, domicile or head office in a Member State other than the home Member State may lodge his claim or submit observations relating to his claim in the official language or one of the official languages of that other Member State. However, in that event the lodgement of his claim or the submission of observations on his claim, as appropriate, shall bear the heading "Lodgement of claim" or "Submission of observations relating to claims", as appropriate, in the official language or one of the official languages of the home Member State. Article 18 Regular information to the creditors 1. Liquidators shall keep creditors regularly informed, in an appropriate manner, in particular regarding the progress of the winding-up. 2. The supervisory authorities of the Member States may request information on developments in the winding-up procedure from the supervisory authorities of the home Member State. TITLE IV PROVISIONS COMMON TO REORGANISATION MEASURES AND WINDING-UP PROCEEDINGS Article 19 Effects on certain contracts and rights By way of derogation from Articles 4 and 9, the effects of the opening of reorganisation measures or of winding-up proceedings on the contracts and rights specified below shall be governed by the following rules: (a) employment contracts and employment relationships shall be governed solely by the law of the Member State applicable to the employment contract or employment relationship; (b) a contract conferring the right to make use of or acquire immovable property shall be governed solely by the law of the Member State in whose territory the immovable property is situated; (c) rights of the insurance undertaking with respect to immovable property, a ship or an aircraft subject to registration in a public register shall be governed by the law of the Member State under whose authority the register is kept. Article 20 Third parties' rights in rem 1. The opening of reorganisation measures or winding-up proceedings shall not affect the rights in rem of creditors or third parties in respect of tangible or intangible, movable or immovable assets - both specific assets and collections of indefinite assets as a whole which change from time to time - belonging to the insurance undertaking which are situated within the territory of another Member State at the time of the opening of such measures or proceedings. 2. The rights referred to in paragraph 1 shall in particular mean: (a) the right to dispose of assets or have them disposed of and to obtain satisfaction from the proceeds of or income from those assets, in particular by virtue of a lien or a mortgage; (b) the exclusive right to have a claim met, in particular a right guaranteed by a lien in respect of the claim or by assignment of the claim by way of a guarantee; (c) the right to demand the assets from, and/or to require restitution by, anyone having possession or use of them contrary to the wishes of the party so entitled; (d) a right in rem to the beneficial use of assets. 3. The right, recorded in a public register and enforceable against third parties, under which a right in rem within the meaning of paragraph 1 may be obtained, shall be considered a right in rem. 4. Paragraph 1 shall not preclude actions for voidness, voidability or unenforceability referred to in Article 9(2)(l). Article 21 Reservation of title 1. The opening of reorganisation measures or winding-up proceedings against an insurance undertaking purchasing an asset shall not affect the seller's rights based on a reservation of title where at the time of the opening of such measures or proceedings the asset is situated within the territory of a Member State other than the State in which such measures or proceedings were opened. 2. The opening of reorganisation measures or winding-up proceedings against an insurance undertaking selling an asset, after delivery of the asset, shall not constitute grounds for rescinding or terminating the sale and shall not prevent the purchaser from acquiring title where at the time of the opening of such measures or proceedings the asset sold is situated within the territory of a Member State other than the State in which such measures or proceedings were opened. 3. Paragraphs 1 and 2 shall not preclude actions for voidness, voidability or unenforceability referred to in Article 9(2)(l). Article 22 Set-off 1. The opening of reorganisation measures or winding-up proceedings shall not affect the right of creditors to demand the set-off of their claims against the claims of the insurance undertaking, where such a set-off is permitted by the law applicable to the insurance undertaking's claim. 2. Paragraph 1 shall not preclude actions for voidness, voidability or unenforceability referred to in Article 9(2)(l). Article 23 Regulated markets 1. Without prejudice to Article 20 the effects of a reorganisation measure or the opening of winding-up proceedings on the rights and obligations of the parties to a regulated market shall be governed solely by the law applicable to that market. 2. Paragraph 1 shall not preclude any action for voidness, voidability, or unenforceability referred to in Article 9(2)(l) which may be taken to set aside payments or transactions under the law applicable to that market. Article 24 Detrimental acts Article 9(2)(l) shall not apply, where a person who has benefited from a legal act detrimental to all the creditors provides proof that: (a) the said act is subject to the law of a Member State other than the home Member State, and (b) that law does not allow any means of challenging that act in the relevant case. Article 25 Protection of third-party purchasers Where, by an act concluded after the adoption of a reorganisation measure or the opening of winding-up proceedings, an insurance undertaking disposes, for a consideration, of: (a) an immovable asset, (b) a ship or an aircraft subject to registration in a public register, or (c) transferable or other securities whose existence or transfer presupposes entry in a register or account laid down by law or which are placed in a central deposit system governed by the law of a Member State, the validity of that act shall be governed by the law of the Member State within whose territory the immovable asset is situated or under whose authority the register, account or system is kept. Article 26 Lawsuits pending The effects of reorganisation measures or winding-up proceedings on a pending lawsuit concerning an asset or a right of which the insurance undertaking has been divested shall be governed solely by the law of the Member State in which the lawsuit is pending. Article 27 Administrators and liquidators 1. The administrator's or liquidator's appointment shall be evidenced by a certified copy of the original decision appointing him or by any other certificate issued by the competent authorities of the home Member State. A translation into the official language or one of the official languages of the Member State within the territory of which the administrator or liquidator wishes to act may be required. No legalisation or other similar formality shall be required. 2. Administrators and liquidators shall be entitled to exercise within the territory of all the Member States all the powers which they are entitled to exercise within the territory of the home Member State. Persons to assist or, where appropriate, represent administrators and liquidators may be appointed, according to the home Member State's legislation, in the course of the reorganisation measure or winding-up proceedings, in particular in host Member States and, specifically, in order to help overcome any difficulties encountered by creditors in the host Member State. 3. In exercising his powers according to the home Member State's legislation, an administrator or liquidator shall comply with the law of the Member States within whose territory he wishes to take action, in particular with regard to procedures for the realisation of assets and the informing of employees. Those powers may not include the use of force or the right to rule on legal proceedings or disputes. Article 28 Registration in a public register 1. The administrator, liquidator or any other authority or person duly empowered in the home Member State may request that a reorganisation measure or the decision to open winding-up proceedings be registered in the land register, the trade register and any other public register kept in the other Member States. However, if a Member State prescribes mandatory registration, the authority or person referred to in subparagraph 1 shall take all the measures necessary to ensure such registration. 2. The costs of registration shall be regarded as costs and expenses incurred in the proceedings. Article 29 Professional secrecy All persons required to receive or divulge information in connection with the procedures of communication laid down in Articles 5, 8 and 30 shall be bound by professional secrecy, in the same manner as laid down in Article 16 of Directive 92/49/EEC and Article 15 of Directive 92/96/EEC, with the exception of any judicial authorities to which existing national provisions apply. Article 30 Branches of third country insurance undertakings 1. Notwithstanding the definitions laid down in Article 2(e), (f) and (g) and for the purpose of applying the provisions of this Directive to the reorganisation measures and winding-up proceedings concerning a branch situated in a Member State of an insurance undertaking whose head office is located outside the Community: (a) "home Member State" means the Member State in which the branch has been granted authorisation according to Article 23 of Directive 73/239/EEC and Article 27 of Directive 79/267/EEC, and (b) "supervisory authorities" and "competent authorities" mean such authorities of the Member State in which the branch was authorised. 2. When an insurance undertaking whose head office is outside the Community has branches established in more than one Member State, each branch shall be treated independently with regard to the application of this Directive. The competent authorities and the supervisory authorities of these Member States shall endeavour to coordinate their actions. Any administrators or liquidators shall likewise endeavour to coordinate their actions. Article 31 Implementation of this Directive 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 20 April 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 reference shall be laid down by Member States. 2. National provisions adopted in application of this Directive shall apply only to reorganisation measures or winding-up proceedings adopted or opened after the date referred to in paragraph 1. Reorganisation measures adopted or winding up proceedings opened before that date shall continue to be governed by the law that was applicable to them at the time of adoption or opening. 3. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 32 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 33 Addressees This Directive is addressed to the Member States.

32001L0024

2001

Directive 2001/24/EC of the European Parliament and of the Council of 4 April 2001 on the reorganisation and winding up of credit institutions 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), Having regard to the opinion of the European Monetary Institute(3), Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), Whereas: (1) In accordance with the objectives of the Treaty, the harmonious and balanced development of economic activities throughout the Community should be promoted through the elimination of any obstacles to the freedom of establishment and the freedom to provide services within the Community. (2) At the same time as those obstacles are eliminated, consideration should be given to the situation which might arise if a credit institution runs into difficulties, particularly where that institution has branches in other Member States. (3) This Directive forms part of the Community legislative framework set up by 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(5). It follows therefrom that, while they are in operation, a credit institution and its branches form a single entity subject to the supervision of the competent authorities of the State where authorisation valid throughout the Community was granted. (4) It would be particularly undesirable to relinquish such unity between an institution and its branches where it is necessary to adopt reorganisation measures or open winding-up proceedings. (5) The adoption of Directive 94/19/EC of the European Parliament and of the Council of 30 May 1994 on deposit-guarantee schemes(6), which introduced the principle of compulsory membership by credit institutions of a guarantee scheme in their home Member State, brings out even more clearly the need for mutual recognition of reorganisation measures and winding-up proceedings. (6) The administrative or judicial authorities of the home Member State must have sole power to decide upon and to implement the reorganisation measures provided for in the law and practices in force in that Member State. Owing to the difficulty of harmonising Member States' laws and practices, it is necessary to establish mutual recognition by the Member States of the measures taken by each of them to restore to viability the credit institutions which it has authorised. (7) It is essential to guarantee that the reorganisation measures adopted by the administrative or judicial authorities of the home Member State and the measures adopted by persons or bodies appointed by those authorities to administer those reorganisation measures, including measures involving the possibility of a suspension of payments, suspension of enforcement measures or reduction of claims and any other measure which could affect third parties' existing rights, are effective in all Member States. (8) Certain measures, in particular those affecting the functioning of the internal structure of credit institutions or managers' or shareholders' rights, need not be covered by this Directive to be effective in Member States insofar as, pursuant to the rules of private international law, the applicable law is that of the home State. (9) Certain measures, in particular those connected with the continued fulfilment of conditions of authorisation, are already the subject of mutual recognition pursuant to Directive 2000/12/EC insofar as they do not affect the rights of third parties existing before their adoption. (10) Persons participating in the operation of the internal structures of credit institutions as well as managers and shareholders of such institutions, considered in those capacities, are not to be regarded as third parties for the purposes of this Directive. (11) It is necessary to notify third parties of the implementation of reorganisation measures in Member States where branches are situated when such measures could hinder the exercise of some of their rights. (12) The principle of equal treatment between creditors, as regards the opportunities open to them to take action, requires the administrative or judicial authorities of the home Member State to adopt such measures as are necessary for the creditors in the host Member State to be able to exercise their rights to take action within the time limit laid down. (13) There must be some coordination of the role of the administrative or judicial authorities in reorganisation measures and winding-up proceedings for branches of credit institutions having head offices outside the Community and situated in different Member States. (14) In the absence of reorganisation measures, or in the event of such measures failing, the credit institutions in difficulty must be wound up. Provision should be made in such cases for mutual recognition of winding-up proceedings and of their effects in the Community. (15) The important role played by the competent authorities of the home Member State before winding-up proceedings are opened may continue during the process of winding up so that these proceedings can be properly carried out. (16) Equal treatment of creditors requires that the credit institution is wound up according to the principles of unity and universality, which require the administrative or judicial authorities of the home Member State to have sole jurisdiction and their decisions to be recognised and to be capable of producing in all the other Member States, without any formality, the effects ascribed to them by the law of the home Member State, except where this Directive provides otherwise. (17) The exemption concerning the effects of reorganisation measures and winding-up proceedings on certain contracts and rights is limited to those effects and does not cover other questions concerning reorganisation measures and winding-up proceedings such as the lodging, verification, admission and ranking of claims concerning those contracts and rights and the rules governing the distribution of the proceeds of the realisation of the assets, which are governed by the law of the home Member State. (18) Voluntary winding up is possible when a credit institution is solvent. The administrative or judicial authorities of the home Member State may nevertheless, where appropriate, decide on a reorganisation measure or winding-up proceedings, even after voluntary winding up has commenced. (19) Withdrawal of authorisation to pursue the business of banking is one of the consequences which winding up a credit institution necessarily entails. Withdrawal should not, however, prevent certain activities of the institution from continuing insofar as is necessary or appropriate for the purposes of winding up. Such a continuation of activity may nonetheless be made subject by the home Member State to the consent of, and supervision by, its competent authorities. (20) Provision of information to known creditors on an individual basis is as essential as publication to enable them, where necessary, to lodge their claims or submit observations relating to their claims within the prescribed time limits. This should take place without discrimination against creditors domiciled in a Member State other than the home Member State, based on their place of residence or the nature of their claims. Creditors must be kept regularly informed in an appropriate manner throughout winding-up proceedings. (21) For the sole purpose of applying the provisions of this Directive to reorganisation measures and winding-up proceedings involving branches located in the Community of a credit institution of which the head office is situated in a third country, the definitions of "home Member State", "competent authorities" and "administrative or judicial authorities" should be those of the Member State in which the branch is located. (22) Where a credit institution which has its head office outside the Community possesses branches in more than one Member State, each branch should receive individual treatment in regard to the application of this Directive. In such a case, the administrative or judicial authorities and the competent authorities as well as the administrators and liquidators should endeavour to coordinate their activities. (23) Although it is important to follow the principle that the law of the home Member State determines all the effects of reorganisation measures or winding-up proceedings, both procedural and substantive, it is also necessary to bear in mind that those effects may conflict with the rules normally applicable in the context of the economic and financial activity of the credit institution in question and its branches in other Member States. In some cases reference to the law of another Member State represents an unavoidable qualification of the principle that the law of the home Member State is to apply. (24) That qualification is especially necessary to protect employees having a contract of employment with a credit institution, ensure the security of transactions in respect of certain types of property and protect the integrity of regulated markets functioning in accordance with the law of a Member State on which financial instruments are traded. (25) Transactions carried out in the framework of a payment and settlement system are covered by Directive 98/26/EC of the European Parliament and of the Council of 19 May 1998 on settlement finality in payment and securities settlement systems(7). (26) The adoption of this Directive does not call into question the provisions of Directive 98/26/EC according to which insolvency proceedings must not have any effect on the enforceability of orders validly entered into a system, or on collateral provided for a system. (27) Some reorganisation measures or winding-up proceedings involve the appointment of a person to administer them. The recognition of his appointment and his powers in all other Member States is therefore an essential factor in the implementation of decisions taken in the home Member State. However, the limits within which he may exercise his powers when he acts outside the home Member State should be specified. (28) Creditors who have entered into contracts with a credit institution before a reorganisation measure is adopted or winding-up proceedings are opened should be protected against provisions relating to voidness, voidability or unenforceability laid down in the law of the home Member State, where the beneficiary of the transaction produces evidence that in the law applicable to that transaction there is no available means of contesting the act concerned in the case in point. (29) The confidence of third-party purchasers in the content of the registers or accounts regarding certain assets entered in those registers or accounts and by extension of the purchasers of immovable property should be safeguarded, even after winding-up proceedings have been opened or a reorganisation measure adopted. The only means of safeguarding that confidence is to make the validity of the purchase subject to the law of the place where the immovable asset is situated or of the State under whose authority the register or account is kept. (30) The effects of reorganisation measures or winding-up proceedings on a lawsuit pending are governed by the law of the Member State in which the lawsuit is pending, by way of exception to the application of the lex concursus. The effects of those measures and procedures on individual enforcement actions arising from such lawsuits are governed by the legislation of the home Member State, in accordance with the general rule established by this Directive. (31) Provision should be made for the administrative or judicial authorities in the home Member State to notify immediately the competent authorities of the host Member State of the adoption of any reorganisation measure or the opening of any winding-up proceedings, if possible before the adoption of the measure or the opening of the proceedings, or, if not, immediately afterwards. (32) Professional secrecy as defined in Article 30 of Directive 2000/12/EC is an essential factor in all information or consultation procedures. For that reason it should be respected by all the administrative authorities taking part in such procedures, whereas the judicial authorities remain, in this respect, subject to the national provisions relating to them, TITLE I SCOPE AND DEFINITIONS Article 1 Scope 1. This Directive shall apply to credit institutions and their branches set up in Member States other than those in which they have their head offices, as defined in points (1) and (3) of Article 1 of Directive 2000/12/EC, subject to the conditions and exemptions laid down in Article 2(3) of that Directive. 2. The provisions of this Directive concerning the branches of a credit institution having a head office outside the Community shall apply only where that institution has branches in at least two Member States of the Community. Article 2 Definitions For the purposes of this Directive: - "home Member State" shall mean the Member State of origin within the meaning of Article 1, point (6) of Directive 2000/12/EC; - "host Member State" shall mean the host Member State within the meaning of Article 1, point (7) of Directive 2000/12/EC; - "branch" shall mean a branch within the meaning of Article 1, point (3) of Directive 2000/12/EC; - "competent authorities" shall mean the competent authorities within the meaning of Article 1, point (4) of Directive 2000/12/EC; - "administrator" shall mean any person or body appointed by the administrative or judicial authorities whose task is to administer reorganisation measures; - "administrative or judicial authorities" shall mean such administrative or judicial authorities of the Member States as are competent for the purposes of reorganisation measures or winding-up proceedings; - "reorganisation measures" shall mean measures which are intended to preserve or restore the financial situation of a credit institution and which could affect third parties' pre-existing rights, including measures involving the possibility of a suspension of payments, suspension of enforcement measures or reduction of claims; - "liquidator" shall mean any person or body appointed by the administrative or judicial authorities whose task is to administer winding-up proceedings; - "winding-up proceedings" shall mean collective proceedings opened and monitored by the administrative or judicial authorities of a Member State with the aim of realising assets under the supervision of those authorities, including where the proceedings are terminated by a composition or other, similar measure; - "regulated market" shall mean a regulated market within the meaning of Article 1, point (13) of Directive 93/22/EEC; - "instruments" shall mean all the instruments referred to in Section B of the Annex to Directive 93/22/EEC. TITLE II REORGANISATION MEASURES A. Credit institutions having their head offices within the Community Article 3 Adoption of reorganisation measures - applicable law 1. The administrative or judicial authorities of the home Member State shall alone be empowered to decide on the implementation of one or more reorganisation measures in a credit institution, including branches established in other Member States. 2. The reorganisation measures shall be applied in accordance with the laws, regulations and procedures applicable in the home Member State, unless otherwise provided in this Directive. They shall be fully effective in accordance with the legislation of that Member State throughout the Community without any further formalities, including as against third parties in other Member States, even where the rules of the host Member State applicable to them do not provide for such measures or make their implementation subject to conditions which are not fulfilled. The reorganisation measures shall be effective throughout the Community once they become effective in the Member State where they have been taken. Article 4 Information for the competent authorities of the host Member State The administrative or judicial authorities of the home Member State shall without delay inform, by any available means, the competent authorities of the host Member State of their decision to adopt any reorganisation measure, including the practical effects which such a measure may have, if possible before it is adopted or otherwise immediately thereafter. Information shall be communicated by the competent authorities of the home Member State. Article 5 Information for the supervisory authorities of the home Member State Where the administrative or judicial authorities of the host Member State deem it necessary to implement within their territory one or more reorganisation measures, they shall inform the competent authorities of the home Member State accordingly. Information shall be communicated by the host Member State's competent authorities. Article 6 Publication 1. Where implementation of the reorganisation measures decided on pursuant to Article 3(1) and (2) is likely to affect the rights of third parties in a host Member State and where an appeal may be brought in the home Member State against the decision ordering the measure, the administrative or judicial authorities of the home Member State, the administrator or any person empowered to do so in the home Member State shall publish an extract from the decision in the Official Journal of the European Communities and in two national newspapers in each host Member State, in order in particular to facilitate the exercise of the right of appeal in good time. 2. The extract from the decision provided for in paragraph 1 shall be forwarded at the earliest opportunity, by the most appropriate route, to the Office for Official Publications of the European Communities and to the two national newspapers in each host Member State. 3. The Office for Official Publications of the European Communities shall publish the extract at the latest within twelve days of its dispatch. 4. The extract from the decision to be published shall specify, in the official language or languages of the Member States concerned, in particular the purpose and legal basis of the decision taken, the time limits for lodging appeals, specifically a clearly understandable indication of the date of expiry of the time limits, and the full address of the authorities or court competent to hear an appeal. 5. The reorganisation measures shall apply irrespective of the measures prescribed in paragraphs 1 to 3 and shall be fully effective as against creditors, unless the administrative or judicial authorities of the home Member State or the law of that State governing such measures provide otherwise. Article 7 Duty to inform known creditors and right to lodge claims 1. Where the legislation of the home Member State requires lodgement of a claim with a view to its recognition or provides for compulsory notification of the measure to creditors who have their domiciles, normal places of residence or head offices in that State, the administrative or judicial authorities of the home Member State or the administrator shall also inform known creditors who have their domiciles, normal places of residence or head offices in other Member States, in accordance with the procedures laid down in Articles 14 and 17(1). 2. Where the legislation of the home Member State provides for the right of creditors who have their domiciles, normal places of residence or head offices in that State to lodge claims or to submit observations concerning their claims, creditors who have their domiciles, normal places of residence or head offices in other Member States shall also have that right in accordance with the procedures laid down in Article 16 and Article 17(2). B. Credit institutions having their head offices outside the Community Article 8 Branches of third-country credit institutions 1. The administrative or judicial authorities of the host Member State of a branch of a credit institution having its head office outside the Community shall without delay inform, by any available means, the competent authorities of the other host Member States in which the institution has set up branches which are included on the list referred to in Article 11 of Directive 2000/12/EC and published each year in the Official Journal of the European Communities, of their decision to adopt any reorganisation measure, including the practical effects which that measure may have, if possible before it is adopted or otherwise immediately thereafter. Information shall be communicated by the competent authorities of the host Member State whose administrative or judicial authorities decide to apply the measure. 2. The administrative or judicial authorities referred to in paragraph 1 shall endeavour to coordinate their actions. TITLE III WINDING-UP PROCEEDINGS A. Credit institutions having their head offices within the Community Article 9 Opening of winding-up proceedings - Information to be communicated to other competent authorities 1. The administrative or judicial authorities of the home Member State which are responsible for winding up shall alone be empowered to decide on the opening of winding-up proceedings concerning a credit institution, including branches established in other Member States. A decision to open winding-up proceedings taken by the administrative or judicial authority of the home Member State shall be recognised, without further formality, within the territory of all other Member States and shall be effective there when the decision is effective in the Member State in which the proceedings are opened. 2. The administrative or judicial authorities of the home Member State shall without delay inform, by any available means, the competent authorities of the host Member State of their decision to open winding-up proceedings, including the practical effects which such proceedings may have, if possible before they open or otherwise immediately thereafter. Information shall be communicated by the competent authorities of the home Member State. Article 10 Law applicable 1. A credit institution shall be wound up in accordance with the laws, regulations and procedures applicable in its home Member State insofar as this Directive does not provide otherwise. 2. The law of the home Member State shall determine in particular: (a) the goods subject to administration and the treatment of goods acquired by the credit institution after the opening of winding-up proceedings; (b) the respective powers of the credit institution and the liquidator; (c) the conditions under which set-offs may be invoked; (d) the effects of winding-up proceedings on current contracts to which the credit institution is party; (e) the effects of winding-up proceedings on proceedings brought by individual creditors, with the exception of lawsuits pending, as provided for in Article 32; (f) the claims which are to be lodged against the credit institution and the treatment of claims arising after the opening of winding-up proceedings; (g) the rules governing the lodging, verification and admission of claims; (h) the rules governing the distribution of the proceeds of the realisation of assets, the ranking of claims and the rights of creditors who have obtained partial satisfaction after the opening of insolvency proceedings by virtue of a right in re or through a set-off; (i) the conditions for, and the effects of, the closure of insolvency proceedings, in particular by composition; (j) creditors' rights after the closure of winding-up proceedings; (k) who is to bear the costs and expenses incurred in the winding-up proceedings; (l) the rules relating to the voidness, voidability or unenforceability of legal acts detrimental to all the creditors. Article 11 Consultation of competent authorities before voluntary winding up 1. The competent authorities of the home Member State shall be consulted in the most appropriate form before any voluntary winding-up decision is taken by the governing bodies of a credit institution. 2. The voluntary winding up of a credit institution shall not preclude the adoption of a reorganisation measure or the opening of winding-up proceedings. Article 12 Withdrawal of a credit institution's authorisation 1. Where the opening of winding-up proceedings is decided on in respect of a credit institution in the absence, or following the failure, of reorganisation measures, the authorisation of the institution shall be withdrawn in accordance with, in particular, the procedure laid down in Article 22(9) of Directive 2000/12/EC. 2. The withdrawal of authorisation provided for in paragraph 1 shall not prevent the person or persons entrusted with the winding up from carrying on some of the credit institution's activities insofar as that is necessary or appropriate for the purposes of winding up. The home Member State may provide that such activities shall be carried on with the consent, and under the supervision, of the competent authorities of that Member State. Article 13 Publication The liquidators or any administrative or judicial authority shall announce the decision to open winding-up proceedings through publication of an extract from the winding-up decision in the Official Journal of the European Communities and at least two national newspapers in each of the host Member States. Article 14 Provision of information to known creditors 1. When winding-up proceedings are opened, the administrative or judicial authority of the home Member State or the liquidator shall without delay individually inform known creditors who have their domiciles, normal places of residence or head offices in other Member States, except in cases where the legislation of the home State does not require lodgement of the claim with a view to its recognition. 2. That information, provided by the dispatch of a notice, shall in particular deal with time limits, the penalties laid down in regard to those time limits, the body or authority empowered to accept the lodgement of claims or observations relating to claims and the other measures laid down. Such a notice shall also indicate whether creditors whose claims are preferential or secured in re need lodge their claims. Article 15 Honouring of obligations Where an obligation has been honoured for the benefit of a credit institution which is not a legal person and which is the subject of winding-up proceedings opened in another Member State, when it should have been honoured for the benefit of the liquidator in those proceedings, the person honouring the obligation shall be deemed to have discharged it if he was unaware of the opening of proceedings. Where such an obligation is honoured before the publication provided for in Article 13 has been effected, the person honouring the obligation shall be presumed, in the absence of proof to the contrary, to have been unaware of the opening of winding-up proceedings; where the obligation is honoured after the publication provided for in Article 13 has been effected, the person honouring the obligation shall be presumed, in the absence of proof to the contrary, to have been aware of the opening of proceedings. Article 16 Right to lodge claims 1. Any creditor who has his domicile, normal place of residence or head office in a Member State other than the home Member State, including Member States' public authorities, shall have the right to lodge claims or to submit written observations relating to claims. 2. The claims of all creditors whose domiciles, normal places of residence or head offices are in Member States other than the home Member State shall be treated in the same way and accorded the same ranking as claims of an equivalent nature which may be lodged by creditors having their domiciles, normal places of residence, or head offices in the home Member State 3. Except in cases where the law of the home Member State provides for the submission of observations relating to claims, a creditor shall send copies of supporting documents, if any, and shall indicate the nature of the claim, the date on which it arose and its amount, as well as whether he alleges preference, security in re or reservation of title in respect of the claim and what assets are covered by his security. Article 17 Languages 1. The information provided for in Articles 13 and 14 shall be provided in the official language or one of the official languages of the home Member State. For that purpose a form shall be used bearing, in all the official languages of the European Union, the heading "Invitation to lodge a claim. Time limits to be observed" or, where the law of the home Member State provides for the submission of observations relating to claims, the heading "Invitation to submit observations relating to a claim. Time limits to be observed". 2. Any creditor who has his domicile, normal place of residence or head office in a Member State other than the home Member State may lodge his claim or submit observations relating to his claim in the official language or one of the official languages of that other Member State. In that event, however, the lodgement of his claim or the submission of observations on his claim shall bear the heading "Lodgement of claim" or "Submission of observations relating to claims" in the official language or one of the official languages of the home Member State. In addition, he may be required to provide a translation into that language of the lodgement of claim or submission of observations relating to claims. Article 18 Regular provision of information to creditors Liquidators shall keep creditors regularly informed, in an appropriate manner, particularly with regard to progress in the winding up. B. Credit institutions the head offices of which are outside the Community Article 19 Branches of third-country credit institutions 1. The administrative or judicial authorities of the host Member State of the branch of a credit institution the head office of which is outside the Community shall without delay inform, by any available means, the competent authorities of the other host Member States in which the credit institution has set up branches on the list referred to in Article 11 of Directive 2000/12/EC and published each year in the Official Journal of the European Communities, of their decision to open winding-up proceedings, including the practical effects which these proceedings may have, if possible before they open or otherwise immediately thereafter. Information shall be communicated by the competent authorities of the first abovementioned host Member State. 2. Administrative or judicial authorities which decide to open proceedings to wind up a branch of a credit institution the head office of which is outside the Community shall inform the competent authorities of the other host Member States that winding-up proceedings have been opened and authorisation withdrawn. Information shall be communicated by the competent authorities in the host Member State which has decided to open the proceedings. 3. The administrative or judicial authorities referred to in paragraph 1 shall endeavour to coordinate their actions. Any liquidators shall likewise endeavour to coordinate their actions. TITLE IV PROVISIONS COMMON TO REORGANISATION MEASURES AND WINDING-UP PROCEEDINGS Article 20 Effects on certain contracts and rights The effects of a reorganisation measure or the opening of winding-up proceedings on: (a) employment contracts and relationships shall be governed solely by the law of the Member State applicable to the employment contract; (b) a contract conferring the right to make use of or acquire immovable property shall be governed solely by the law of the Member State within the territory of which the immovable property is situated. That law shall determine whether property is movable or immovable; (c) rights in respect of immovable property, a ship or an aircraft subject to registration in a public register shall be governed solely by the law of the Member State under the authority of which the register is kept. Article 21 Third parties' rights in re 1. The adoption of reorganisation measures or the opening of winding-up proceedings shall not affect the rights in re of creditors or third parties in respect of tangible or intangible, movable or immovable assets - both specific assets and collections of indefinite assets as a whole which change from time to time - belonging to the credit institution which are situated within the territory of another Member State at the time of the adoption of such measures or the opening of such proceedings. 2. The rights referred to in paragraph 1 shall in particular mean: (a) the right to dispose of assets or have them disposed of and to obtain satisfaction from the proceeds of or income from those assets, in particular by virtue of a lien or a mortgage; (b) the exclusive right to have a claim met, in particular a right guaranteed by a lien in respect of the claim or by assignment of the claim by way of a guarantee; (c) the right to demand the assets from, and/or to require restitution by, anyone having possession or use of them contrary to the wishes of the party so entitled; (d) a right in re to the beneficial use of assets. 3. The right, recorded in a public register and enforceable against third parties, under which a right in re within the meaning of paragraph 1 may be obtained, shall be considered a right in re. 4. Paragraph 1 shall not preclude the actions for voidness, voidability or unenforceability laid down in Article 10(2)(l). Article 22 Reservation of title 1. The adoption of reorganisation measures or the opening of winding-up proceedings concerning a credit institution purchasing an asset shall not affect the seller's rights based on a reservation of title where at the time of the adoption of such measures or opening of such proceedings the asset is situated within the territory of a Member State other than the State in which the said measures were adopted or the said proceedings were opened. 2. The adoption of reorganisation measures or the opening of winding-up proceedings concerning a credit institution selling an asset, after delivery of the asset, shall not constitute grounds for rescinding or terminating the sale and shall not prevent the purchaser from acquiring title where at the time of the adoption of such measures or the opening of such proceedings the asset sold is situated within the territory of a Member State other than the State in which such measures were adopted or such proceedings were opened. 3. Paragraphs 1 and 2 shall not preclude the actions for voidness, voidability or unenforceability laid down in Article 10(2)(l). Article 23 Set-off 1. The adoption of reorganisation measures or the opening of winding-up proceedings shall not affect the right of creditors to demand the set-off of their claims against the claims of the credit institution, where such a set-off is permitted by the law applicable to the credit institution's claim. 2. Paragraph 1 shall not preclude the actions for voidness, voidability or unenforceability laid down in Article 10(2)(l). Article 24 Lex rei sitae The enforcement of proprietary rights in instruments or other rights in such instruments the existence or transfer of which presupposes their recording in a register, an account or a centralised deposit system held or located in a Member State shall be governed by the law of the Member State where the register, account, or centralised deposit system in which those rights are recorded is held or located. Article 25 Netting agreements Netting agreements shall be governed solely by the law of the contract which governs such agreements. Article 26 Repurchase agreements Without prejudice to Article 24, repurchase agreements shall be governed solely by the law of the contract which governs such agreements. Article 27 Regulated markets Without prejudice to Article 24, transactions carried out in the context of a regulated market shall be governed solely by the law of the contract which governs such transactions. Article 28 Proof of liquidators' appointment 1. The administrator or liquidator's appointment shall be evidenced by a certified copy of the original decision appointing him or by any other certificate issued by the administrative or judicial authority of the home Member State. A translation into the official language or one of the official languages of the Member State within the territory of which the administrator or liquidator wishes to act may be required. No legalisation or other similar formality shall be required. 2. Administrators and liquidators shall be entitled to exercise within the territory of all the Member States all the powers which they are entitled to exercise within the territory of the home Member State. They may also appoint persons to assist or, where appropriate, represent them in the course of the reorganisation measure or winding-up proceedings, in particular in host Member States and, specifically, in order to help overcome any difficulties encountered by creditors in the host Member State. 3. In exercising his powers, an administrator or liquidator shall comply with the law of the Member States within the territory of which he wishes to take action, in particular with regard to procedures for the realisation of assets and the provision of information to employees. Those powers may not include the use of force or the right to rule on legal proceedings or disputes. Article 29 Registration in a public register 1. The administrator, liquidator or any administrative or judicial authority of the home Member State may request that a reorganisation measure or the decision to open winding-up proceedings be registered in the land register, the trade register and any other public register kept in the other Member States. A Member State may, however, prescribe mandatory registration. In that event, the person or authority referred to in the preceding subparagraph shall take all the measures necessary to ensure such registration. 2. The costs of registration shall be regarded as costs and expenses incurred in the proceedings. Article 30 Detrimental acts 1. Article 10 shall not apply as regards the rules relating to the voidness, voidability or unenforceability of legal acts detrimental to the creditors as a whole, where the beneficiary of these acts provides proof that: - the act detrimental to the creditors as a whole is subject to the law of a Member State other than the home Member State, and - that law does not allow any means of challenging that act in the case in point. 2. Where a reorganisation measure decided on by a judicial authority provides for rules relating to the voidness, voidability or unenforceability of legal acts detrimental to the creditors as a whole performed before adoption of the measure, Article 3(2) shall not apply in the cases provided for in paragraph 1 of this Article. Article 31 Protection of third parties Where, by an act concluded after the adoption of a reorganisation measure or the opening of winding-up proceedings, a credit institution disposes, for consideration, of: - an immovable asset, - a ship or an aircraft subject to registration in a public register, or - instruments or rights in such instruments the existence or transfer of which presupposes their being recorded in a register, an account or a centralised deposit system held or located in a Member State, the validity of that act shall be governed by the law of the Member State within the territory of which the immovable asset is situated or under the authority of which that register, account or deposit system is kept. Article 32 Lawsuits pending The effects of reorganisation measures or winding-up proceedings on a pending lawsuit concerning an asset or a right of which the credit institution has been divested shall be governed solely by the law of the Member State in which the lawsuit is pending. Article 33 Professional secrecy All persons required to receive or divulge information in connection with the information or consultation procedures laid down in Articles 4, 5, 8, 9, 11 and 19 shall be bound by professional secrecy, in accordance with the rules and conditions laid down in Article 30 of Directive 2000/12/EC, with the exception of any judicial authorities to which existing national provisions apply. TITLE V FINAL PROVISIONS Article 34 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 5 May 2004. They shall forthwith inform the Commission thereof. National provisions adopted in application of this Directive shall apply only to reorganisation measures or winding-up proceedings adopted or opened after the date referred to in the first subparagraph. Measures adopted or proceedings opened before that date shall continue to be governed by the law that was applicable to them at the time of adoption or opening. 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. 3. 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 35 Entry into force This Directive shall enter into force on the date of its publication. Article 36 Addressees This Directive is addressed to the Member States.

32001L0020

2001

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use 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), Whereas: (1) Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(4) requires that applications for authorisation to place a medicinal product on the market should be accompanied by a dossier containing particulars and documents relating to the results of tests and clinical trials carried out on the product. Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of medicinal products(5) lays down uniform rules on the compilation of dossiers including their presentation. (2) The accepted basis for the conduct of clinical trials in humans is founded in the protection of human rights and the dignity of the human being with regard to the application of biology and medicine, as for instance reflected in the 1996 version of the Helsinki Declaration. The clinical trial subject's protection is safeguarded through risk assessment based on the results of toxicological experiments prior to any clinical trial, screening by ethics committees and Member States' competent authorities, and rules on the protection of personal data. (3) Persons who are incapable of giving legal consent to clinical trials should be given special protection. It is incumbent on the Member States to lay down rules to this effect. Such persons may not be included in clinical trials if the same results can be obtained using persons capable of giving consent. Normally these persons should be included in clinical trials only when there are grounds for expecting that the administering of the medicinal product would be of direct benefit to the patient, thereby outweighing the risks. However, there is a need for clinical trials involving children to improve the treatment available to them. Children represent a vulnerable population with developmental, physiological and psychological differences from adults, which make age- and development- related research important for their benefit. Medicinal products, including vaccines, for children need to be tested scientifically before widespread use. This can only be achieved by ensuring that medicinal products which are likely to be of significant clinical value for children are fully studied. The clinical trials required for this purpose should be carried out under conditions affording the best possible protection for the subjects. Criteria for the protection of children in clinical trials therefore need to be laid down. (4) In the case of other persons incapable of giving their consent, such as persons with dementia, psychiatric patients, etc., inclusion in clinical trials in such cases should be on an even more restrictive basis. Medicinal products for trial may be administered to all such individuals only when there are grounds for assuming that the direct benefit to the patient outweighs the risks. Moreover, in such cases the written consent of the patient's legal representative, given in cooperation with the treating doctor, is necessary before participation in any such clinical trial. (5) The notion of legal representative refers back to existing national law and consequently may include natural or legal persons, an authority and/or a body provided for by national law. (6) In order to achieve optimum protection of health, obsolete or repetitive tests will not be carried out, whether within the Community or in third countries. The harmonisation of technical requirements for the development of medicinal products should therefore be pursued through the appropriate fora, in particular the International Conference on Harmonisation. (7) For medicinal products falling within the scope of Part A of the Annex to Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(6), which include products intended for gene therapy or cell therapy, prior scientific evaluation by the European Agency for the Evaluation of Medicinal Products (hereinafter referred to as the "Agency"), assisted by the Committee for Proprietary Medicinal Products, is mandatory before the Commission grants marketing authorisation. In the course of this evaluation, the said Committee may request full details of the results of the clinical trials on which the application for marketing authorisation is based and, consequently, on the manner in which these trials were conducted and the same Committee may go so far as to require the applicant for such authorisation to conduct further clinical trials. Provision must therefore be made to allow the Agency to have full information on the conduct of any clinical trial for such medicinal products. (8) A single opinion for each Member State concerned reduces delay in the commencement of a trial without jeopardising the well-being of the people participating in the trial or excluding the possibility of rejecting it in specific sites. (9) Information on the content, commencement and termination of a clinical trial should be available to the Member States where the trial takes place and all the other Member States should have access to the same information. A European database bringing together this information should therefore be set up, with due regard for the rules of confidentiality. (10) Clinical trials are a complex operation, generally lasting one or more years, usually involving numerous participants and several trial sites, often in different Member States. Member States' current practices diverge considerably on the rules on commencement and conduct of the clinical trials and the requirements for carrying them out vary widely. This therefore results in delays and complications detrimental to effective conduct of such trials in the Community. It is therefore necessary to simplify and harmonise the administrative provisions governing such trials by establishing a clear, transparent procedure and creating conditions conducive to effective coordination of such clinical trials in the Community by the authorities concerned. (11) As a rule, authorisation should be implicit, i.e. if there has been a vote in favour by the Ethics Committee and the competent authority has not objected within a given period, it should be possible to begin the clinical trials. In exceptional cases raising especially complex problems, explicit written authorisation should, however, be required. (12) The principles of good manufacturing practice should be applied to investigational medicinal products. (13) Special provisions should be laid down for the labelling of these products. (14) Non-commercial clinical trials conducted by researchers without the participation of the pharmaceuticals industry may be of great benefit to the patients concerned. The Directive should therefore take account of the special position of trials whose planning does not require particular manufacturing or packaging processes, if these trials are carried out with medicinal products with a marketing authorisation within the meaning of Directive 65/65/EEC, manufactured or imported in accordance with the provisions of Directives 75/319/EEC and 91/356/EEC, and on patients with the same characteristics as those covered by the indication specified in this marketing authorisation. Labelling of the investigational medicinal products intended for trials of this nature should be subject to simplified provisions laid down in the good manufacturing practice guidelines on investigational products and in Directive 91/356/EEC. (15) The verification of compliance with the standards of good clinical practice and the need to subject data, information and documents to inspection in order to confirm that they have been properly generated, recorded and reported are essential in order to justify the involvement of human subjects in clinical trials. (16) The person participating in a trial must consent to the scrutiny of personal information during inspection by competent authorities and properly authorised persons, provided that such personal information is treated as strictly confidential and is not made publicly available. (17) This Directive is to apply without prejudice to Directive 95/46/EEC 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(7). (18) It is also necessary to make provision for the monitoring of adverse reactions occurring in clinical trials using Community surveillance (pharmacovigilance) procedures in order to ensure the immediate cessation of any clinical trial in which there is an unacceptable level of risk. (19) 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 Scope 1. This Directive establishes specific provisions regarding the conduct of clinical trials, including multi-centre trials, on human subjects involving medicinal products as defined in Article 1 of Directive 65/65/EEC, in particular relating to the implementation of good clinical practice. This Directive does not apply to non-interventional trials. 2. Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. 3. The principles of good clinical practice and detailed guidelines in line with those principles shall be adopted and, if necessary, revised to take account of technical and scientific progress in accordance with the procedure referred to in Article 21(2). These detailed guidelines shall be published by the Commission. 4. All clinical trials, including bioavailability and bioequivalence studies, shall be designed, conducted and reported in accordance with the principles of good clinical practice. Article 2 Definitions For the purposes of this Directive the following definitions shall apply: (a) "clinical trial": any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy; This includes clinical trials carried out in either one site or multiple sites, whether in one or more than one Member State; (b) "multi-centre clinical trial": a clinical trial conducted according to a single protocol but at more than one site, and therefore by more than one investigator, in which the trial sites may be located in a single Member State, in a number of Member States and/or in Member States and third countries; (c) "non-interventional trial": a study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data; (d) "investigational medicinal product": a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form; (e) "sponsor": an individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial; (f) "investigator": a doctor or a person following a profession agreed in the Member State for investigations because of the scientific background and the experience in patient care it requires. The investigator is responsible for the conduct of a clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the leader responsible for the team and may be called the principal investigator; (g) "investigator's brochure": a compilation of the clinical and non-clinical data on the investigational medicinal product or products which are relevant to the study of the product or products in human subjects; (h) "protocol": a document that describes the objective(s), design, methodology, statistical considerations and organisation of a trial. The term protocol refers to the protocol, successive versions of the protocol and protocol amendments; (i) "subject": an individual who participates in a clinical trial as either a recipient of the investigational medicinal product or a control; (j) "informed consent": decision, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of its nature, significance, implications and risks and appropriately documented, by any person capable of giving consent or, where the person is not capable of giving consent, by his or her legal representative; if the person concerned is unable to write, oral consent in the presence of at least one witness may be given in exceptional cases, as provided for in national legislation. (k) "ethics committee": an independent body in a Member State, consisting of healthcare professionals and non-medical members, whose responsibility it is to protect the rights, safety and wellbeing of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, expressing an opinion on the trial protocol, the suitability of the investigators and the adequacy of facilities, and on the methods and documents to be used to inform trial subjects and obtain their informed consent; (l) "inspection": the act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by the competent authority to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organisation's facilities, or at other establishments which the competent authority sees fit to inspect; (m) "adverse event": any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment; (n) "adverse reaction": all untoward and unintended responses to an investigational medicinal product related to any dose administered; (o) "serious adverse event or serious adverse reaction": any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect; (p) "unexpected adverse reaction": an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. investigator's brochure for an unauthorised investigational product or summary of product characteristics for an authorised product). Article 3 Protection of clinical trial subjects 1. This Directive shall apply without prejudice to the national provisions on the protection of clinical trial subjects if they are more comprehensive than the provisions of this Directive and consistent with the procedures and time-scales specified therein. Member States shall, insofar as they have not already done so, adopt detailed rules to protect from abuse individuals who are incapable of giving their informed consent. 2. A clinical trial may be undertaken only if, in particular: (a) the foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial subject and other present and future patients. A clinical trial may be initiated only if the Ethics Committee and/or the competent authority comes to the conclusion that the anticipated therapeutic and public health benefits justify the risks and may be continued only if compliance with this requirement is permanently monitored; (b) the trial subject or, when the person is not able to give informed consent, his legal representative has had the opportunity, in a prior interview with the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the trial, and the conditions under which it is to be conducted and has also been informed of his right to withdraw from the trial at any time; (c) the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him in accordance with Directive 95/46/EC are safeguarded; (d) the trial subject or, when the person is not able to give informed consent, his legal representative has given his written consent after being informed of the nature, significance, implications and risks of the clinical trial; if the individual is unable to write, oral consent in the presence of at least one witness may be given in exceptional cases, as provided for in national legislation; (e) the subject may without any resulting detriment withdraw from the clinical trial at any time by revoking his informed consent; (f) provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor. 3. The medical care given to, and medical decisions made on behalf of, subjects shall be the responsibility of an appropriately qualified doctor or, where appropriate, of a qualified dentist. 4. The subject shall be provided with a contact point where he may obtain further information. Article 4 Clinical trials on minors In addition to any other relevant restriction, a clinical trial on minors may be undertaken only if: (a) the informed consent of the parents or legal representative has been obtained; consent must represent the minor's presumed will and may be revoked at any time, without detriment to the minor; (b) the minor has received information according to its capacity of understanding, from staff with experience with minors, regarding the trial, the risks and the benefits; (c) the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation or to be withdrawn from the clinical trial at any time is considered by the investigator or where appropriate the principal investigator; (d) no incentives or financial inducements are given except compensation; (e) some direct benefit for the group of patients is obtained from the clinical trial and only where such research is essential to validate data obtained in clinical trials on persons able to give informed consent or by other research methods; additionally, such research should either relate directly to a clinical condition from which the minor concerned suffers or be of such a nature that it can only be carried out on minors; (f) the corresponding scientific guidelines of the Agency have been followed; (g) clinical trials have been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and developmental stage; both the risk threshold and the degree of distress have to be specially defined and constantly monitored; (h) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol; and (i) the interests of the patient always prevail over those of science and society. Article 5 Clinical trials on incapacitated adults not able to give informed legal consent In the case of other persons incapable of giving informed legal consent, all relevant requirements listed for persons capable of giving such consent shall apply. In addition to these requirements, inclusion in clinical trials of incapacitated adults who have not given or not refused informed consent before the onset of their incapacity shall be allowed only if: (a) the informed consent of the legal representative has been obtained; consent must represent the subject's presumed will and may be revoked at any time, without detriment to the subject; (b) the person not able to give informed legal consent has received information according to his/her capacity of understanding regarding the trial, the risks and the benefits; (c) the explicit wish of a subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is considered by the investigator or where appropriate the principal investigator; (d) no incentives or financial inducements are given except compensation; (e) such research is essential to validate data obtained in clinical trials on persons able to give informed consent or by other research methods and relates directly to a life-threatening or debilitating clinical condition from which the incapacitated adult concerned suffers; (f) clinical trials have been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and developmental stage; both the risk threshold and the degree of distress shall be specially defined and constantly monitored; (g) the Ethics Committee, with expertise in the relevant disease and the patient population concerned or after taking advice in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol; (h) the interests of the patient always prevail over those of science and society; and (i) there are grounds for expecting that administering the medicinal product to be tested will produce a benefit to the patient outweighing the risks or produce no risk at all. Article 6 Ethics Committee 1. For the purposes of implementation of the clinical trials, Member States shall take the measures necessary for establishment and operation of Ethics Committees. 2. The Ethics Committee shall give its opinion, before a clinical trial commences, on any issue requested. 3. In preparing its opinion, the Ethics Committee shall consider, in particular: (a) the relevance of the clinical trial and the trial design; (b) whether the evaluation of the anticipated benefits and risks as required under Article 3(2)(a) is satisfactory and whether the conclusions are justified; (c) the protocol; (d) the suitability of the investigator and supporting staff; (e) the investigator's brochure; (f) the quality of the facilities; (g) the adequacy and completeness of the written information to be given and the procedure to be followed for the purpose of obtaining informed consent and the justification for the research on persons incapable of giving informed consent as regards the specific restrictions laid down in Article 3; (h) provision for indemnity or compensation in the event of injury or death attributable to a clinical trial; (i) any insurance or indemnity to cover the liability of the investigator and sponsor; (j) the amounts and, where appropriate, the arrangements for rewarding or compensating investigators and trial subjects and the relevant aspects of any agreement between the sponsor and the site; (k) the arrangements for the recruitment of subjects. 4. Notwithstanding the provisions of this Article, a Member State may decide that the competent authority it has designated for the purpose of Article 9 shall be responsible for the consideration of, and the giving of an opinion on, the matters referred to in paragraph 3(h), (i) and (j) of this Article. When a Member State avails itself of this provision, it shall notify the Commission, the other Member States and the Agency. 5. The Ethics Committee shall have a maximum of 60 days from the date of receipt of a valid application to give its reasoned opinion to the applicant and the competent authority in the Member State concerned. 6. Within the period of examination of the application for an opinion, the Ethics Committee may send a single request for information supplementary to that already supplied by the applicant. The period laid down in paragraph 5 shall be suspended until receipt of the supplementary information. 7. No extension to the 60-day period referred to in paragraph 5 shall be permissible except in the case of trials involving medicinal products for gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms. In this case, an extension of a maximum of 30 days shall be permitted. For these products, this 90-day period may be extended by a further 90 days in the event of consultation of a group or a committee in accordance with the regulations and procedures of the Member States concerned. In the case of xenogenic cell therapy, there shall be no time limit to the authorisation period. Article 7 Single opinion For multi-centre clinical trials limited to the territory of a single Member State, Member States shall establish a procedure providing, notwithstanding the number of Ethics Committees, for the adoption of a single opinion for that Member State. In the case of multi-centre clinical trials carried out in more than one Member State simultaneously, a single opinion shall be given for each Member State concerned by the clinical trial. Article 8 Detailed guidance The Commission, in consultation with Member States and interested parties, shall draw up and publish detailed guidance on the application format and documentation to be submitted in an application for an ethics committee opinion, in particular regarding the information that is given to subjects, and on the appropriate safeguards for the protection of personal data. Article 9 Commencement of a clinical trial 1. Member States shall take the measures necessary to ensure that the procedure described in this Article is followed for commencement of a clinical trial. The sponsor may not start a clinical trial until the Ethics Committee has issued a favourable opinion and inasmuch as the competent authority of the Member State concerned has not informed the sponsor of any grounds for non-acceptance. The procedures to reach these decisions can be run in parallel or not, depending on the sponsor. 2. Before commencing any clinical trial, the sponsor shall be required to submit a valid request for authorisation to the competent authority of the Member State in which the sponsor plans to conduct the clinical trial. 3. If the competent authority of the Member State notifies the sponsor of grounds for non-acceptance, the sponsor may, on one occasion only, amend the content of the request referred to in paragraph 2 in order to take due account of the grounds given. If the sponsor fails to amend the request accordingly, the request shall be considered rejected and the clinical trial may not commence. 4. Consideration of a valid request for authorisation by the competent authority as stated in paragraph 2 shall be carried out as rapidly as possible and may not exceed 60 days. The Member States may lay down a shorter period than 60 days within their area of responsibility if that is in compliance with current practice. The competent authority can nevertheless notify the sponsor before the end of this period that it has no grounds for non-acceptance. No further extensions to the period referred to in the first subparagraph shall be permissible except in the case of trials involving the medicinal products listed in paragraph 6, for which an extension of a maximum of 30 days shall be permitted. For these products, this 90-day period may be extended by a further 90 days in the event of consultation of a group or a committee in accordance with the regulations and procedures of the Member States concerned. In the case of xenogenic cell therapy there shall be no time limit to the authorisation period. 5. Without prejudice to paragraph 6, written authorisation may be required before the commencement of clinical trials for such trials on medicinal products which do not have a marketing authorisation within the meaning of Directive 65/65/EEC and are referred to in Part A of the Annex to Regulation (EEC) No 2309/93, and other medicinal products with special characteristics, such as medicinal products the active ingredient or active ingredients of which is or are a biological product or biological products of human or animal origin, or contains biological components of human or animal origin, or the manufacturing of which requires such components. 6. Written authorisation shall be required before commencing clinical trials involving medicinal products for gene therapy, somatic cell therapy including xenogenic cell therapy and all medicinal products containing genetically modified organisms. No gene therapy trials may be carried out which result in modifications to the subject's germ line genetic identity. 7. This authorisation shall be issued without prejudice to the application of Council Directives 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms(9) and 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(10). 8. In consultation with Member States, the Commission shall draw up and publish detailed guidance on: (a) the format and contents of the request referred to in paragraph 2 as well as the documentation to be submitted to support that request, on the quality and manufacture of the investigational medicinal product, any toxicological and pharmacological tests, the protocol and clinical information on the investigational medicinal product including the investigator's brochure; (b) the presentation and content of the proposed amendment referred to in point (a) of Article 10 on substantial amendments made to the protocol; (c) the declaration of the end of the clinical trial. Article 10 Conduct of a clinical trial Amendments may be made to the conduct of a clinical trial following the procedure described hereinafter: (a) after the commencement of the clinical trial, the sponsor may make amendments to the protocol. If those amendments are substantial and are likely to have an impact on the safety of the trial subjects or to change the interpretation of the scientific documents in support of the conduct of the trial, or if they are otherwise significant, the sponsor shall notify the competent authorities of the Member State or Member States concerned of the reasons for, and content of, these amendments and shall inform the ethics committee or committees concerned in accordance with Articles 6 and 9. On the basis of the details referred to in Article 6(3) and in accordance with Article 7, the Ethics Committee shall give an opinion within a maximum of 35 days of the date of receipt of the proposed amendment in good and due form. If this opinion is unfavourable, the sponsor may not implement the amendment to the protocol. If the opinion of the Ethics Committee is favourable and the competent authorities of the Member States have raised no grounds for non-acceptance of the abovementioned substantial amendments, the sponsor shall proceed to conduct the clinical trial following the amended protocol. Should this not be the case, the sponsor shall either take account of the grounds for non-acceptance and adapt the proposed amendment to the protocol accordingly or withdraw the proposed amendment; (b) without prejudice to point (a), in the light of the circumstances, notably the occurrence of any new event relating to the conduct of the trial or the development of the investigational medicinal product where that new event is likely to affect the safety of the subjects, the sponsor and the investigator shall take appropriate urgent safety measures to protect the subjects against any immediate hazard. The sponsor shall forthwith inform the competent authorities of those new events and the measures taken and shall ensure that the Ethics Committee is notified at the same time; (c) within 90 days of the end of a clinical trial the sponsor shall notify the competent authorities of the Member State or Member States concerned and the Ethics Committee that the clinical trial has ended. If the trial has to be terminated early, this period shall be reduced to 15 days and the reasons clearly explained. Article 11 Exchange of information 1. Member States in whose territory the clinical trial takes place shall enter in a European database, accessible only to the competent authorities of the Member States, the Agency and the Commission: (a) extracts from the request for authorisation referred to in Article 9(2); (b) any amendments made to the request, as provided for in Article 9(3); (c) any amendments made to the protocol, as provided for in point a of Article 10; (d) the favourable opinion of the Ethics Committee; (e) the declaration of the end of the clinical trial; and (f) a reference to the inspections carried out on conformity with good clinical practice. 2. At the substantiated request of any Member State, the Agency or the Commission, the competent authority to which the request for authorisation was submitted shall supply all further information concerning the clinical trial in question other than the data already in the European database. 3. In consultation with the Member States, the Commission shall draw up and publish detailed guidance on the relevant data to be included in this European database, which it operates with the assistance of the Agency, as well as the methods for electronic communication of the data. The detailed guidance thus drawn up shall ensure that the confidentiality of the data is strictly observed. Article 12 Suspension of the trial or infringements 1. Where a Member State has objective grounds for considering that the conditions in the request for authorisation referred to in Article 9(2) are no longer met or has information raising doubts about the safety or scientific validity of the clinical trial, it may suspend or prohibit the clinical trial and shall notify the sponsor thereof. Before the Member State reaches its decision it shall, except where there is imminent risk, ask the sponsor and/or the investigator for their opinion, to be delivered within one week. In this case, the competent authority concerned shall forthwith inform the other competent authorities, the Ethics Committee concerned, the Agency and the Commission of its decision to suspend or prohibit the trial and of the reasons for the decision. 2. Where a competent authority has objective grounds for considering that the sponsor or the investigator or any other person involved in the conduct of the trial no longer meets the obligations laid down, it shall forthwith inform him thereof, indicating the course of action which he must take to remedy this state of affairs. The competent authority concerned shall forthwith inform the Ethics Committee, the other competent authorities and the Commission of this course of action. Article 13 Manufacture and import of investigational medicinal products 1. Member States shall take all appropriate measures to ensure that the manufacture or importation of investigational medicinal products is subject to the holding of authorisation. In order to obtain the authorisation, the applicant and, subsequently, the holder of the authorisation, shall meet at least the requirements defined in accordance with the procedure referred to in Article 21(2). 2. Member States shall take all appropriate measures to ensure that the holder of the authorisation referred to in paragraph 1 has permanently and continuously at his disposal the services of at least one qualified person who, in accordance with the conditions laid down in Article 23 of the second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products(11), is responsible in particular for carrying out the duties specified in paragraph 3 of this Article. 3. Member States shall take all appropriate measures to ensure that the qualified person referred to in Article 21 of Directive 75/319/EEC, without prejudice to his relationship with the manufacturer or importer, is responsible, in the context of the procedures referred to in Article 25 of the said Directive, for ensuring: (a) in the case of investigational medicinal products manufactured in the Member State concerned, that each batch of medicinal products has been manufactured and checked in compliance with the requirements of Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use(12), the product specification file and the information notified pursuant to Article 9(2) of this Directive; (b) in the case of investigational medicinal products manufactured in a third country, that each production batch has been manufactured and checked in accordance with standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 91/356/EEC, in accordance with the product specification file, and that each production batch has been checked in accordance with the information notified pursuant to Article 9(2) of this Directive; (c) in the case of an investigational medicinal product which is a comparator product from a third country, and which has a marketing authorisation, where the documentation certifying that each production batch has been manufactured in conditions at least equivalent to the standards of good manufacturing practice referred to above cannot be obtained, that each production batch has undergone all relevant analyses, tests or checks necessary to confirm its quality in accordance with the information notified pursuant to Article 9(2) of this Directive. Detailed guidance on the elements to be taken into account when evaluating products with the object of releasing batches within the Community shall be drawn up pursuant to the good manufacturing practice guidelines, and in particular Annex 13 to the said guidelines. Such guidelines will be adopted in accordance with the procedure referred to in Article 21(2) of this Directive and published in accordance with Article 19a of Directive 75/319/EEC. Insofar as the provisions laid down in (a), (b) or (c) are complied with, investigational medicinal products shall not have to undergo any further checks if they are imported into another Member State together with batch release certification signed by the qualified person. 4. In all cases, the qualified person must certify in a register or equivalent document that each production batch satisfies the provisions of this Article. The said register or equivalent document shall be kept up to date as operations are carried out and shall remain at the disposal of the agents of the competent authority for the period specified in the provisions of the Member States concerned. This period shall in any event be not less than five years. 5. Any person engaging in activities as the qualified person referred to in Article 21 of Directive 75/319/EEC as regards investigational medicinal products at the time when this Directive is applied in the Member State where that person is, but without complying with the conditions laid down in Articles 23 and 24 of that Directive, shall be authorised to continue those activities in the Member State concerned. Article 14 Labelling The particulars to appear in at least the official language(s) of the Member State on the outer packaging of investigational medicinal products or, where there is no outer packaging, on the immediate packaging, shall be published by the Commission in the good manufacturing practice guidelines on investigational medicinal products adopted in accordance with Article 19a of Directive 75/319/EEC. In addition, these guidelines shall lay down adapted provisions relating to labelling for investigational medicinal products intended for clinical trials with the following characteristics: - the planning of the trial does not require particular manufacturing or packaging processes; - the trial is conducted with medicinal products with, in the Member States concerned by the study, a marketing authorisation within the meaning of Directive 65/65/EEC, manufactured or imported in accordance with the provisions of Directive 75/319/EEC; - the patients participating in the trial have the same characteristics as those covered by the indication specified in the abovementioned authorisation. Article 15 Verification of compliance of investigational medicinal products with good clinical and manufacturing practice 1. To verify compliance with the provisions on good clinical and manufacturing practice, Member States shall appoint inspectors to inspect the sites concerned by any clinical trial conducted, particularly the trial site or sites, the manufacturing site of the investigational medicinal product, any laboratory used for analyses in the clinical trial and/or the sponsor's premises. The inspections shall be conducted by the competent authority of the Member State concerned, which shall inform the Agency; they shall be carried out on behalf of the Community and the results shall be recognised by all the other Member States. These inspections shall be coordinated by the Agency, within the framework of its powers as provided for in Regulation (EEC) No 2309/93. A Member State may request assistance from another Member State in this matter. 2. Following inspection, an inspection report shall be prepared. It must be made available to the sponsor while safeguarding confidential aspects. It may be made available to the other Member States, to the Ethics Committee and to the Agency, at their reasoned request. 3. At the request of the Agency, within the framework of its powers as provided for in Regulation (EEC) No 2309/93, or of one of the Member States concerned, and following consultation with the Member States concerned, the Commission may request a new inspection should verification of compliance with this Directive reveal differences between Member States. 4. Subject to any arrangements which may have been concluded between the Community and third countries, the Commission, upon receipt of a reasoned request from a Member State or on its own initiative, or a Member State may propose that the trial site and/or the sponsor's premises and/or the manufacturer established in a third country undergo an inspection. The inspection shall be carried out by duly qualified Community inspectors. 5. The detailed guidelines on the documentation relating to the clinical trial, which shall constitute the master file on the trial, archiving, qualifications of inspectors and inspection procedures to verify compliance of the clinical trial in question with this Directive shall be adopted and revised in accordance with the procedure referred to in Article 21(2). Article 16 Notification of adverse events 1. The investigator shall report all serious adverse events immediately to the sponsor except for those that the protocol or investigator's brochure identifies as not requiring immediate reporting. The immediate report shall be followed by detailed, written reports. The immediate and follow-up reports shall identify subjects by unique code numbers assigned to the latter. 2. Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations shall be reported to the sponsor according to the reporting requirements and within the time periods specified in the protocol. 3. For reported deaths of a subject, the investigator shall supply the sponsor and the Ethics Committee with any additional information requested. 4. The sponsor shall keep detailed records of all adverse events which are reported to him by the investigator or investigators. These records shall be submitted to the Member States in whose territory the clinical trial is being conducted, if they so request. Article 17 Notification of serious adverse reactions 1. (a) The sponsor shall ensure that all relevant information about suspected serious unexpected adverse reactions that are fatal or life-threatening is recorded and reported as soon as possible to the competent authorities in all the Member States concerned, and to the Ethics Committee, and in any case no later than seven days after knowledge by the sponsor of such a case, and that relevant follow-up information is subsequently communicated within an additional eight days. (b) All other suspected serious unexpected adverse reactions shall be reported to the competent authorities concerned and to the Ethics Committee concerned as soon as possible but within a maximum of fifteen days of first knowledge by the sponsor. (c) Each Member State shall ensure that all suspected unexpected serious adverse reactions to an investigational medicinal product which are brought to its attention are recorded. (d) The sponsor shall also inform all investigators. 2. Once a year throughout the clinical trial, the sponsor shall provide the Member States in whose territory the clinical trial is being conducted and the Ethics Committee with a listing of all suspected serious adverse reactions which have occurred over this period and a report of the subjects' safety. 3. (a) Each Member State shall see to it that all suspected unexpected serious adverse reactions to an investigational medicinal product which are brought to its attention are immediately entered in a European database to which, in accordance with Article 11(1), only the competent authorities of the Member States, the Agency and the Commission shall have access. (b) The Agency shall make the information notified by the sponsor available to the competent authorities of the Member States. Article 18 Guidance concerning reports The Commission, in consultation with the Agency, Member States and interested parties, shall draw up and publish detailed guidance on the collection, verification and presentation of adverse event/reaction reports, together with decoding procedures for unexpected serious adverse reactions. Article 19 General provisions This Directive is without prejudice to the civil and criminal liability of the sponsor or the investigator. To this end, the sponsor or a legal representative of the sponsor must be established in the Community. Unless Member States have established precise conditions for exceptional circumstances, investigational medicinal products and, as the case may be, the devices used for their administration shall be made available free of charge by the sponsor. The Member States shall inform the Commission of such conditions. Article 20 Adaptation to scientific and technical progress This Directive shall be adapted to take account of scientific and technical progress in accordance with the procedure referred to in Article 21(2). Article 21 Committee procedure 1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use, set up by Article 2b of Directive 75/318/EEC (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 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 22 Application 1. Member States shall adopt and publish before 1 May 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 at the latest with effect from 1 May 2004. When Member States adopt these provisions, 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 provisions of national law which they adopt in the field governed by this Directive. Article 23 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 24 Addressees This Directive is addressed to the Member States.

32001L0030

2001

Commission Directive 2001/30/EC of 2 May 2001 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 Scientific Committee on Food, Whereas: (1) It is necessary to establish purity criteria for all additives other than colours and sweeteners mentioned in 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). (2) Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners(5), as last amended by Directive 2000/63/EC(6) set out purity criteria for a number of food additives. This Directive should now be completed with purity criteria for the remaining food additives mentioned in Directive 95/2/EC. (3) 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). (4) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Foodstuffs, Article 1 Directive 96/77/EC is hereby amended as follows: In the Annex, the text of the Annex to this Directive shall be added. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 June 2002 at the latest. They shall forthwith inform the Commission thereof. 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. Products put on the market or labelled before 1 June 2002 which do not comply with this Directive may be marketed until stocks are exhausted. 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.

32001L0033

2001

Commission Directive 2001/33/EC of 8 May 2001 amending certain annexes 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), and in particular Article 14(c) thereof, Having regard to the requests made by Denmark, France, Ireland, Italy, Austria, Portugal and the United Kingdom, Whereas: (1) From information supplied by United Kingdom and Sweden it appears that following local government reorganisation, the current descriptin of the respective protected zones in respect of Dendroctonus micans Kugelan and Leptinotarsa decemlineata Say should be modified. (2) Certain provisions on protective measures in Denmark against Bemisia tabaci Genn. (European populations) and tomato spotted wilt virus, in Portugal against Gonipterus scutellatus Gyll., in the United Kingdom and in Ireland against Pissodes spp. (European), and in France, Italy and Austria against Erwinia amylovora (Burr.) Winsl. et al. should be modified to take into account the present distribution of these organisms in the respective countries. (3) The amendments are in agreement with the requests of the Member States concerned. (4) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Annexes I to IV to Directive 2000/29/EC shall be amended in accordance with 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 21 May 2001. They shall apply them from 22 May 2001. They shall immediately 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 procedure for such a reference shall be adopted by Member States. Member States shall immediately communicate to the Commission the essential provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. It shall apply from 22 May 2001. Article 4 This Directive is addressed to the Member States.

32001L0032

2001

Commission Directive 2001/32/EC of 8 May 2001 recognising protected zones exposed to particular plant health risks in the Community and repealing Directive 92/76/EEC 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), and in particular the first subparagraph of Article 2(1)(h) thereof, Having regard to the requests made by Denmark, Greece, Spain, France, Ireland, Italy, Austria, Portugal, Finland, Sweden and the United Kingdom, Whereas: (1) Under the provisions of Directive 2000/29/EC, "protected zones" exposed to particular plant health risks may be defined and therefore may be accorded special protection under conditions compatible with the internal market. Such zones were defined in Commission Directive 92/76/EEC of 6 October 1992, recognising protected zones exposed to particular plant health risks in the Community(2) as last amended by Directive 2000/23/EC(3). (2) Since then, there have been significant developments in the plant health status of some of these zones initially recognised as protected zones in respect of the relevant harmful organisms. (3) From information supplied by Denmark it appears that it is no longer appropriate to maintain the protected zone recognised for Denmark in respect of Bemisia tabaci Genn. (European populations) and tomato spotted wilt virus. (4) Certain provisions on protective measures in Portugal against Gonipterus scutellatus Gyll. and in the United Kingdom and in Ireland against Pissodes spp. (European) should be modified to take into account the present distribution of these organisms in the respective countries. (5) From information supplied by United Kingdom and Sweden it appears that following local government reorganisation, the current description of the respective protected zones in respect of Dendroctonus micans Kugelan and Leptinotarsa decemlineata Say should be modified. (6) Under Directive 92/76/EEC, Austria, Ireland and the regions of Apulia, Emilia-Romagna, Lombardia and Veneto in Italy were provisionally recognised as protected zone in respect of Erwinia amylovora (Burr.) Winsl. et al. for a period expiring on 31 March 2001. (7) From information supplied by Ireland it appears that the provisional recognition of the protected zones for Ireland in respect of Erwinia amylovora (Burr.) Winsl. et al. should be extended for a further limited period. (8) From information supplied by Austria and Italy it appears that some areas within Austria and Italy should not longer be recognised as protected zones in respect of Erwinia amylovora (Burr.) Winsl. et al., whilst other areas should be recognised as protected zones in respect of Erwinia amylovora (Burr.) Winsl. et al. for a further limited period. (9) From information supplied by France it appears that some areas within France should not longer be recognised as protected zones in respect of Erwinia amylovora (Burr.) Winsl. et al. (10) From information supplied by United Kingdom it appears that the provisional recognition of the protected zone for United Kingdom in respect of beet necrotic yellow vein virus should be extended for a further limited period. (11) It is therefore necessary to modify the existing designation of protected zones. In the interest of clarity, a new list of such zones should be adopted. Directive 92/76/EEC should therefore be repealed. In view of the continuing plant health problems, this Directive should enter into force and be transposed as soon as possible. (12) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 The zones in the Community listed in the Annex are hereby recognised as "protected zones" referred to in the first subparagraph of Article 2(1)(h) of Directive 2000/29/EC, in respect of the harmful organism(s) listed against their names in the Annex. In the case of point 2 of (b), for Ireland, for Italy (Emilia-Romagna: provinces of Forlí-Cesena, Parma, Piacenza and Rimini; Lombardia; Trentino-Alto Adige: autonomous province of Bolzano; Veneto), and for Austria (Burgenland, Kärnten, Niederösterreich, Osttirol, Steiermark, Wien), the said zones are recognised until 31 March 2002. In the case of point 1 of (d), the said zone in United Kingdom is recognised until 31 March 2002. Article 2 The extension of the recognition beyond the dates referred to in Article 1, and any amendment to the list of protected zones referred to in Article 1, shall be made in accordance with the procedure laid down in Article 18 of Directive 2000/29/EC, taking into account the results of appropriate surveys based on Community conditions and monitored by Commission experts. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 21 May 2001 at the latest. They shall apply them from 22 May 2001. 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 procedure for such a reference shall be adopted by Member States. 2. Member States shall immediately communicate to the Commission the essential provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 4 Directive 92/76/EEC is hereby repealed with effect from 22 May 2001. Article 5 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. It shall apply from 22 May 2001. Article 6 This Directive is addressed to the Member States.

32001L0031

2001

Commission Directive 2001/31/EC of 8 May 2001 adapting to technical progress Council Directive 70/387/EEC relating to the doors of motor vehicles and their trailers (Text with EEA relevance) 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 type-approval of motor vehicles and their trailers(1), as last amended by Directive 2000/40/EC of the European Parliament and of the Council(2), and in particular Article 13(2) thereof, Having regard to Council Directive 70/387/EEC of 27 July 1970 on the approximation of the laws of the Member States relating to the doors of motor vehicle and their trailers(3), as last amended by Commission Directive 98/90/EC(4), and in particular Article 3 thereof, Whereas: (1) Directive 70/387/EEC is one of the separate Directives of the EC type-approval procedure 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 this Directive. (2) Directive 98/90/EC has introduced design requirements for the steps and handholds of cabs in order to improve the safety of persons entering and leaving the driver's compartment of certain heavy goods vehicles. (3) Certain cab designs already on the market cannot comply with the specific requirements introduced by Directive 98/90/EC, although their level of safety is considered equivalent. It is therefore necessary to further refine the technical requirements in order to allow such cab designs. (4) The measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress established by Directive 70/156/EEC, Article 1 Annex III to Directive 70/387/EEC is amended in accordance with the Annex to this Directive. Article 2 1. With effect from 1 October 2001, Member States may not on grounds relating to vehicle doors: - refuse, in respect of a type of vehicle, to grant EC type-approval or national type-approval, or - prohibit the sale, registration, or entry into service of vehicles, if the vehicles comply with the requirements of Directive 70/387/EEC, as amended by this Directive. 2. With effect from 1 December 2001, Member States: - shall no longer grant EC type-approval, and - may refuse to grant national type-approval, for a new type of vehicle on grounds relating to vehicle doors if the requirements of Directive 70/387/EEC, as amended by this Directive, are not fulfilled. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 2001 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 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 twentieth day following that of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32001L0035

2001

Commission Directive 2001/35/EC of 11 May 2001 amending the Annexes to Council Directive 90/642/EEC on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables Having regard to the Treaty establishing the European Community, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables(1), as last amended by Commission Directive 2000/82/EC(2), and in particular Article 7 thereof, Whereas: (1) Commission Directive 2000/42/EC(3) fixed maximum residue levels (MRLs) in relation to pesticide/food combinations that were left open in Council Directives 94/29/EC(4), 94/30/EC(5), 95/38/EC(6), 95/39/EC(7), 96/32/EC(8), 96/33/EC(9) and Commission Directive 98/82/EC(10). The above entries in the Annexes to the Directives were left "open", or were fixed on a temporary basis, because there was insufficient data available, at the dates of their adoption, to justify the fixing of maximum residue limits at Community level by 1 July 2000. The objective of fixing the said deadline was to provide interested parties with sufficient time to provide the necessary data enabling, where appropriate and justified, the adoption of maximum residue levels at Community level above the lower limit of analytical determination. In the period preceding the expiry of the deadline, the available data was evaluated and in some cases not considered adequate to justify fixing maximum residue levels higher than the limit of analytical determination. (2) Following publication of Directive 2000/42/EC, the Commission received requests, supported by further data, to review the levels at which MRLs for certain pesticide/food combinations had been fixed by virtue of Directive 2000/42/EC. The applications and data were reviewed, and for some combinations, the data was sufficient to justify the fixing of an MRL above the lower limit of analytical determination. For other combinations the information available remains inadequate and it is appropriate to fix maximum residue levels at the lower limit of analytical determination. For other combinations the information now available is sufficient to demonstrate 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, the maximum residue levels should remain fixed at the lower limit of analytical determination. (3) The lifetime exposure of consumers to these pesticides via food products that may contain residues of these pesticides arising from their uses in plant protection and, where applicable, in veterinary medicine has been assessed and evaluated in accordance with the procedures and practices used within the European Community taking account of guidelines published by the World Health Organisation(11) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceeding of the acceptable daily intakes. (4) 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 the procedures and practices used within the European Community, taking account of guidelines published by the World Health Organisation. It has been calculated that the maximum residue levels fixed for open positions in the present Directive do not give rise to acute toxic effects. (5) The Community's trading partners will be consulted about the levels set out in this Directive through the World Trade Organisation and their comments on these levels will be considered. (6) The opinions of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account. The methodology described by the World Health Organisation, referred to above, as applied by rapporteur Member States, checked and evaluated by the Commission in the framework of the Standing Committee on Plant Health, is in agreement with the guidance given by the Scientifc Committee of Plants(12). (7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 The maximum levels for residues listed in the Annex to this Directive shall replace those listed in Annex II to Directive 90/642/EEC for the pesticides in question. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2001 at the latest. They shall forthwith inform the Commission thereof. They shall apply these measures as of 1 July 2001. Article 3 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 first day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32001L0019

2001

Directive 2001/19/EC of the European Parliament and of the Council of 14 May 2001 amending Council Directives 89/48/EEC and 92/51/EEC on the general system for the recognition of professional qualifications and Council Directives 77/452/EEC, 77/453/EEC, 78/686/EEC, 78/687/EEC, 78/1026/EEC, 78/1027/EEC, 80/154/EEC, 80/155/EEC, 85/384/EEC, 85/432/EEC, 85/433/EEC and 93/16/EEC concerning the professions of nurse responsible for general care, dental practitioner, veterinary surgeon, midwife, architect, pharmacist and doctor (Text with EEA relevance.) - Statements Having regard to the Treaty establishing the European Community, and in particular Articles 40, 47(1), the first and third sentences of 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), in the light of the joint text approved by the Conciliation Committee on 15 January 2001, Whereas: (1) On 16 February 1996 the Commission gave the European Parliament and the Council its Report on the state of application of the general system for the recognition of higher-education diplomas made in accordance with Article 13 of Council Directive 89/48/EEC of 21 December 1988 on a general system for the recognition of higher-education diplomas awarded on completion of professional education and training of at least three years' duration(4). In this Report the Commission undertook to examine the possibility of incorporating into that Directive the obligation to take into consideration, when examining applications for recognition, experience gained following the award of the qualification in question, the possibility of introducing the concept of "regulated education and training". The Commission also undertook to examine the arrangements whereby the role of the Coordinating Group set up by Article 9(2) of Directive 89/48/EEC could be developed in order to ensure more uniform application and interpretation of the Directive. (2) The concept of regulated education and training, introduced by Council Directive 92/51/EEC of 18 June 1992 on a second general system for the recognition of professional education and training to supplement Directive 89/48/EEC(5) (both Directives being hereinafter referred to as the "general system Directives"), should be extended to the initial general system and should be based on the same principles by applying to it the same rules; it should be left to the individual Member States to choose the means of defining professions covered by regulated education and training. (3) The general system Directives permit the host Member State to require, subject to certain conditions, the applicant to take compensation steps, notably where substantial differences exist between the theoretical and/or practical education and training undergone and that covered by the qualification required in the host Member State; under Articles 39 and 43 of the Treaty, as interpreted by the Court of Justice of the European Communities(6), the host Member State must assess whether professional experience is sufficient in order to prove possession of the knowledge which is lacking; in the interests of clarity and legal certainty for individuals wishing to practise their profession in another Member State, it is desirable to incorporate into the general system Directives the requirement that the host Member State has to examine whether the professional experience gained by the applicant since obtaining his qualification(s) covers the subjects referred to above. (4) The coordination procedure provided for by the general system Directives should be improved and simplified by enabling the Coordinating Group to adopt and publish opinions on questions referred to it by the Commission that relate to the practical application of the general system. (5) In its Communication to the European Parliament and the Council on the SLIM initiative, the Commission undertook to present proposals aimed at simplifying the updating of the lists of qualifications eligible for automatic recognition. Council Directive 93/16/EEC of 5 April 1993 to facilitate the free movement of doctors and the mutual recognition of their diplomas, certificates and other evidence of formal qualifications(7) provides for a simple procedure in the case of general practitioners' qualifications; experience has shown that the procedure affords sufficient legal certainty; it is desirable to extend it to qualifications held by nurses responsible for general care, dental practitioners, veterinary surgeons, midwives, pharmacists and doctors as referred to in Council Directives 77/452/EEC(8), 77/453/EEC(9), 78/686/EEC(10), 78/687/EEC(11), 78/1026/EEC(12), 78/1027/EEC(13), 80/154/EEC(14), 80/155/EEC(15), 85/432/EEC(16), 85/433/EEC(17) and 93/16/EEC (hereinafter referred to as the "sectoral Directives") respectively. (6) According to the case-law of the Court of Justice of the European Communities, Member States are not required to recognise diplomas, certificates and other evidence of formal qualifications which do not testify to training acquired in one of the Member States of the Community(18). However, Member States should take into account professional experience gained by the person concerned in another Member State(19). That being so, it should be stipulated in the sectoral Directives that recognition by a Member State of a diploma, certificate or other evidence of formal qualification awarded to a nurse responsible for general care, dental practitioner, veterinary surgeon, midwife, architect, pharmacist or doctor on completion of education and training in a third country and professional experience gained by the person concerned in a Member State constitute Community elements which the other Member States should examine. (7) The period within which Member States are to reach a decision on applications for recognition of diplomas, certificates and other evidence of formal qualifications obtained by nurses responsible for general care, dental practitioners, veterinary surgeons, midwives, architects, pharmacists or doctors in a third country should be stipulated. (8) Lifelong learning has been made especially important in the area of medicine by the rapid advances in technical and scientific progress. It is up to the Member States to decide how to ensure, by suitable continuing training after completion of studies, that doctors maintain their knowledge of progress in medicine. The present system of mutual recognition of professional qualifications remains unchanged. (9) The applicant must have right of appeal under national law if his application is rejected or if a decision is not reached within the stipulated period. Member States are to state their reasons for such decisions taken regarding the recognition of diplomas, certificates and other evidence of formal qualifications held by nurses responsible for general care, dental practitioners, veterinary surgeons, midwives, architects, pharmacists or doctors; where a Member State decides to recognise a diploma, certificate or other evidence of formal qualifications, it should be free to choose whether or not to state the reasons. (10) For reasons of fairness, transitional measures should be taken in respect of certain dental practitioners in Italy who hold diplomas, certificates or other evidence of formal qualifications in medicine awarded in Italy but on completion of medical training begun after the deadline stipulated in Article 19 of Directive 78/686/EEC. (11) Article 15 of Directive 85/384/EEC(20) provides for a derogation during a transitional period that has now expired, that provision should be deleted. (12) There should be a clear distinction in Article 24 of Directive 85/384/EEC between the formalities to be completed in the case of establishment and those to be completed in the case of provision of services, thereby rendering more effective the exercise of the freedom to provide services as an architect. (13) For reasons of equality of treatment, transitional measures should be provided for in respect of certain holders of diplomas, certificates and other evidence of formal qualifications in pharmacy awarded in Italy on completion of training that does not fully comply with Directive 85/432/EEC. (14) It is desirable to extend the scope of mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy in order to facilitate effective exercise of the right of establishment between Greece and the other Member States. Therefore, the derogation provided for in Article 3 of Directive 85/433/EEC should be deleted. (15) In its Report on specific training in general medical practice provided for by Title IV of Directive 93/16/EEC, the Commission recommended that the requirements applying to part-time training in general medical practice should be brought into line with those applying to other medical specialists. (16) The general system Directives and the sectoral Directives, should be amended, SECTION 1 AMENDMENTS TO THE GENERAL SYSTEM DIRECTIVES Article 1 Directive 89/48/EEC is hereby amended as follows: 1) Article 1 shall be amended as follows: (a) the second indent of point (a) shall be replaced by the following: "- which shows that the holder has successfully completed a post-secondary course of at least three years' duration, or of an equivalent duration part-time, at a university or establishment of higher education or another establishment of equivalent level and, where appropriate, that he has successfully completed the professional training required in addition to the post-secondary course, and" (b) the following point shall be inserted: "(d) a regulated education and training: any education and training which: - is directly geared to the practice of a defined profession, and - comprises a post-secondary course of at least three years' duration, or an equivalent duration part-time, at a university or higher education establishment or in another establishment of equivalent level and, where appropriate, the professional training, professional traineeship or professional practice required in addition to the post-secondary course; the structure and level of the professional training, professional traineeship or professional practice shall be determined by the laws, regulations or administrative provisions of the Member State concerned or monitored or approved by the authority designated for that purpose."; 2) in Article 3(b), the following subparagraph shall be inserted after the first subparagraph: "However, the two years' of professional experience referred to in the first subparagraph may not be required where the qualification or qualifications held by the applicant and referred to in this point were awarded on completion of regulated education and training."; 3) in Article 4(1)(b), the following subparagraph shall be inserted after the first subparagraph: "If the host Member State intends to require the applicant to complete an adaptation period or take an aptitude test, it must first examine whether the knowledge acquired by the applicant in the course of his professional experience is such that it fully or partly covers the substantial difference referred to in the first subparagraph."; 4) the following paragraphs shall be added to Article 6: "5. Where proof of financial standing is required in order to take up or pursue a regulated profession in the host Member State, that Member State shall regard certificates issued by banks in the Member State of origin or in the Member State from where the foreign national comes as equivalent to those issued in its own territory. 6. Where the competent authority of the host Member State requires of its own nationals wishing to take up or pursue a regulated profession proof that they are insured against the financial risks arising from their professional liability, that Member State shall accept certificates issued by insurance undertakings of other Member States as equivalent to those issued in its own territory. Such certificates shall state that the insurer has complied with the laws and regulations in force in the host Member State regarding the terms and extent of cover. They may not be presented more than three months after their date of issue."; 5. in Article 9(2), the first indent of the second subparagraph shall be replaced by: "- to facilitate the implementation of this Directive, in particular by adopting and publishing opinions on the questions referred to it by the Commission,". Article 2 Directive 92/51/EEC is hereby amended as follows: 1) in Article 4(1)(b), the following subparagraph shall be inserted after the first subparagraph: "If the host Member State intends to require the applicant to complete an adaptation period or take an aptitude test, it must examine first whether the knowledge acquired by the applicant in the course of his professional experience is such that it fully or partly covers the substantial difference referred to in the first subparagraph."; 2) in Article 5, the following paragraph shall be inserted after the second paragraph: "If the host Member State intends to require the applicant to complete an adaptation period or take an aptitude test, it must first examine whether knowledge acquired by the applicant in the course of his professional experience is such that it fully or partly covers the substantial difference between the diploma and the certificate."; 3) in Article 7(a) the following subparagraph shall be inserted after the first subparagraph: "If the host Member State intends to require the applicant to complete an adaptation period or take an aptitude test, it must first examine whether knowledge acquired by the applicant in the course of his professional experience is such that it fully or partly covers the substantial difference referred to in the first subparagraph."; 4) the following paragraphs shall be added to Article 10: "5. Where proof of financial standing is required in order to take up or pursue a regulated profession in the host Member State, that Member State shall regard certificates issued by banks in the Member State of origin or in the Member State from where the foreign national comes as equivalent to those issued in its own territory. 6. Where the competent authority of the host Member State requires of its own nationals wishing to take up or pursue a regulated profession proof that they are insured against the financial risks arising from their professional liability, that Member State shall accept certificates issued by insurance undertakings of other Member States as equivalent to those issued in its own territory. Such certificates shall state that the insurer has complied with the laws and regulations in force in the host Member State regarding the terms and extent of cover. They may not be presented more than three months after their date of issue."; 5) in Article 13(2), the first indent of the second subparagraph shall be replaced by: "- facilitate the implementation of this Directive, in particular by adopting and publishing opinions on the questions referred to it by the Commission,"; 6) the following paragraph shall be added to Article 15: "8. Amendments made to the lists of education and training courses set out in Annexes C and D on the basis of the procedure laid down above shall apply immediately on the date set by the Commission.". SECTION 2 AMENDMENTS TO THE SECTORAL DIRECTIVES Section 2.1 Nurses responsible for general care Article 3 Directive 77/452/EEC is hereby amended as follows: 1) (concerns only the Greek version); 2) In Article 2, the words "listed in Article 3" shall be replaced by "listed in the Annex"; 3) Article 3 shall be deleted; 4) references made to Article 3 shall be understood as made to the Annex; 5) (concerns only the Greek version). 6) the following Articles shall be inserted: "Article 18a Member States shall notify the Commission of the laws, regulations or administrative provisions they adopt as regards the award of diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive. The Commission shall publish an appropriate notice in the Official Journal of the European Communities, listing the names adopted by the Member States for the training qualification concerned and, where applicable, for the corresponding professional title. Article 18b Each Member State shall recognise as sufficient proof, in respect of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive do not correspond to the names listed for that Member State in this Directive, the diplomas, certificates and other evidence of formal qualifications awarded by those Member States and accompanied by a certificate issued by the competent authorities or bodies. The certificate shall state that the diplomas, certificates and other evidence of formal qualifications in question have been awarded on completion of education and training that complies with the provisions of this Directive and are treated by the awarding Member State as equivalent to those whose names are listed therein. Article 18c Member States shall examine diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive obtained by the holder outside the European Union in cases where those diplomas, certificates and other evidence of formal qualifications have been recognised in a Member State, as well as of training undergone and/or professional experience gained in a Member State. The Member State shall give its decision within three months of the date on which the applicant submits his application together with full supporting documentation. Article 18d Where the application is rejected, Member States shall duly give the reasons for decisions on applications for recognition of diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive. Applicants shall have a right of appeal before the courts under national law. That right of appeal shall likewise apply in the event of failure to reach a decision within the stipulated period."; 7) the Annex as it appears in Annex I to this Directive shall be added. Article 4 In Article 1(1) of Directive 77/453/EEC, the words "as specified in Article 3 of Directive 77/452/EEC" shall be replaced by "as specified in the Annex to Directive 77/452/EEC". Section 2.2 Dental practitioners Article 5 Directive 78/686/EEC is hereby amended as follows: 1) in Article 2, the words "listed in Article 3" shall be replaced by "listed in Annex A"; 2) Article 3 shall be deleted; 3) the title of Chapter III shall be replaced by: "Diplomas, certificates and other evidence of formal qualifications in specialised dentistry."; 4) Article 4 shall be replaced by: "Article 4 Each Member State with provisions in this field laid down by law, regulation or administrative action shall recognise the diplomas, certificates and other evidence of formal qualifications of dental practitioners specialising in orthodontics and oral surgery awarded to nationals of Member States by other Member States in accordance with Articles 2 and 3 of Directive 78/687/EEC and which are listed in Annex B, by granting such qualifications the same effect in its territory as the diplomas, certificates and other evidence of formal qualifications which it itself awards."; 5) Article 5 shall be deleted; 6) Article 6 shall be amended as follows: (a) the following subparagraph shall be added to paragraph 2: "It shall also take into account any professional experience, additional training and continuing dental education they possess."; (b) paragraph 3 shall be replaced by: "3. The competent authorities or bodies of the host Member State, having assessed the content and duration of the training of the person concerned on the basis of the diplomas, certificates and other evidence of formal qualifications submitted, and taking into account any professional experience, additional training and continuing dental education that he possesses, shall inform him of the period of additional training required and of the fields to be covered by it."; (c) the following paragraph shall be added: "4. The Member State shall give its decision within four months of the date on which the applicant submits his application together with full supporting documentation."; 7) in Article 19 the existing two subparagraphs shall become paragraph 1 and the following paragraph shall be added: "2. Member States shall recognise the diplomas, certificates and other evidence of formal qualifications in medicine awarded in Italy to persons who commenced their university medical training between 28 January 1980 and 31 December 1984 and accompanied by a certificate issued by the Italian competent authorities stating: - that the persons concerned have passed the specialist aptitude test set by the Italian competent authorities in order to ascertain that they possess a level of knowledge and skills comparable to those of persons holding the qualification listed for Italy in Annex A; - that they have effectively, lawfully and principally been engaged in Italy in the activities specified in Article 5 of Directive 78/687/EEC for at least three consecutive years during the five years prior to the issue of the certificate; - and that they are authorised to engage in, or are effectively, lawfully and principally engaged in, the activities referred to in Article 5 of Directive 78/687/EEC, subject to the same conditions as holders of the qualification listed for Italy in Annex A to this Directive. The requirement to take the aptitude test referred to in the first subparagraph shall be waived in the case of persons who have successfully completed at least three years' of study which are certified by the competent authorities as being equivalent to the training referred to in Article 1 of Directive 78/687/EEC."; 8) references made to Articles 3 and 5 shall be understood as being made to Annexes A and B respectively; 9) the following Articles shall be inserted: "Article 23a Member States shall notify the Commission of the laws, regulations or administrative provisions they adopt as regards the award of diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive. The Commission shall publish an appropriate notice in the Official Journal of the European Communities, listing the names adopted by the Member States for the training qualifications concerned and, where applicable, for the corresponding professional title. Article 23b Each Member State shall recognise as sufficient proof, in respect of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive do not correspond to the names listed for that Member State in this Directive, the diplomas, certificates and other evidence of formal qualifications awarded by those Member States and accompanied by a certificate issued by the competent authorities or bodies. The certificate shall state that the diplomas, certificates and other evidence of formal qualifications in question have been awarded on completion of education and training that complies with the provisions of this Directive and are treated by the awarding Member State as equivalent to those whose names are listed therein. Article 23c Member States shall examine diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive obtained by the holder outside the European Union in cases where those diplomas, certificates and other evidence of formal qualifications have been recognised in a Member State, as well as of training undergone and/or professional experience gained in a Member State. The Member State shall give its decision within three months of the date on which the applicant submits his application together with full supporting documentation. Article 23d Where the application is rejected, Member States shall duly give the reasons for decisions on applications for recognition of diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive. Applicants shall have a right of appeal before the courts under national law. That right of appeal shall likewise apply in the event of failure to reach a decision within the stipulated period."; 10) Annexes A and B as they appear in Annex II to this Directive shall be added. Article 6 In Article 1(1) of Directive 78/687/EEC, the words "referred to in Article 3 of the same Directive" shall be replaced by "referred to in Annex A to that Directive". Section 2.3 Veterinary surgeons Article 7 Directive 78/1026/EEC is hereby amended as follows: 1) in Article 2, the words "in Article 3" shall be replaced by "in the Annex"; 2) Article 3 shall be deleted; 3) references made to Article 3 shall be understood as being made to the Annex; 4) the following Articles shall be inserted: "Article 17a Member States shall notify the Commission of the laws, regulations or administrative provisions they adopt as regards the award of diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive. The Commission shall publish an appropriate notice in the Official Journal of the European Communities, listing the names adopted by the Member States for the training qualifications concerned and, where applicable, for the corresponding professional title. Article 17b Each Member State shall recognise as sufficient proof, in respect of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive do not correspond to the names listed for that Member State in this Directive, the diplomas, certificates and other evidence of formal qualifications awarded by those Member States and accompanied by a certificate issued by the competent authorities or bodies. The certificate shall state that the diplomas, certificates and other evidence of formal qualifications in question have been awarded on completion of education and training that complies with the provisions of this Directive and are treated by the awarding Member State as equivalent to those whose names are listed therein. Article 17c Member States shall examine diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive obtained by the holder outside the European Union in cases where those diplomas, certificates and other evidence of formal qualifications have been recognised in a Member State, as well as of training undergone and/or professional experience gained in a Member State. The Member State shall give its decision within three months of the date on which the applicant submits his application together with full supporting documentation. Article 17d Where the application is rejected, Member States shall duly give the reasons for decisions on applications for recognition of diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive. Applicants shall have a right of appeal before the courts under national law. That right of appeal shall likewise apply in the event of failure to reach a decision within the stipulated period."; 5) the Annex as it appears in Annex III to this Directive shall be added. Article 8 In Article 1(1) of Directive 78/1027/EEC, the words "referred to in Article 3 of Directive 78/1026/EEC" shall be replaced by "referred to in the Annex to Directive 78/1026/EEC". Section 2.4 Midwives Article 9 Directive 80/154/EEC is hereby amended as follows: 1) in Article 2(1), the words "listed in Article 3" shall be replaced by "listed in the Annex"; 2) in the fourth and fifth indents of Article 2(1), the words "referred to in Article 3 of Directive 77/452/EEC" shall be replaced by "referred to in the Annex to Directive 77/452/EEC"; 3) Article 3 shall be deleted; 4) references made to Article 3 shall be understood as being made to the Annex; 5) the following Articles shall be inserted: "Article 19a Member States shall notify the Commission of the laws, regulations or administrative provisions they adopt as regards the award of diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive. The Commission shall publish an appropriate notice in the Official Journal of the European Communities, listing the names adopted by the Member States for the training qualifications concerned and, where applicable, for the corresponding professional title. Article 19b Each Member State shall recognise as sufficient proof, in respect of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive do not correspond to the names listed for that Member State in this Directive, the diplomas, certificates and other evidence of formal qualifications awarded by those Member States and accompanied by a certificate issued by the competent authorities or bodies. The certificate shall state that the diplomas, certificates and other evidence of formal qualifications in question have been awarded on completion of education and training that complies with the provisions of this Directive and are treated by the awarding Member State as equivalent to those whose names are listed therein. Article 19c Member States shall examine diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive obtained by the holder outside the European Union in cases where those diplomas, certificates and other evidence of formal qualifications have been recognised in a Member State, as well as of training undergone and/or professional experience gained in a Member State. The Member State shall give its decision within three months of the date on which the applicant submits his application together with full supporting documentation. Article 19d Where the application is rejected, Member States shall duly give the reasons for decisions on applications for recognition of diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive. Applicants shall have a right of appeal before the courts under national law. That right of appeal shall likewise apply in the event of failure to reach a decision within the stipulated period."; 6) the Annex as it appears in Annex IV to this Directive shall be added. Article 10 Directive 80/155/EEC is hereby amended as follows: 1) in Article 1(1), the words "referred to in Article 3" shall be replaced by "referred to in the Annex"; 2. in the second indent of Article 1(2), the words "referred to in Article 3 of Directive 77/452/EEC" shall be replaced by "referred to in the Annex to Directive 77/452/EEC". Section 2.5 Architects Article 11 Directive 85/384/EEC is hereby amended as follows: 1) the following Articles shall be inserted: "Article 6 Member States shall examine diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive obtained by the holder outside the European Union in cases where those diplomas, certificates and other evidence of formal qualifications have been recognised in a Member State, as well as of training undergone and/or professional experience gained in a Member State. The Member State shall give its decision within three months of the date on which the applicant submits his application together with full supporting documentation. Article 6a Where the application is rejected, Member States shall duly give the reasons for decisions on applications for recognition of diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive. Applicants shall have a right of appeal before the courts under national law. That right of appeal shall likewise apply in the event of failure to reach a decision within the stipulated period."; 2) Article 15 shall be deleted; 3) in Article 24(1), the words "pursuant to Articles 17 and 18" shall be replaced by "pursuant to Articles 17 and 18 in the case of establishment and pursuant to Article 22 in the case of provision of services". Section 2.6 Pharmacists Article 12 In Article 2 of Directive 85/432/EEC, the following point shall be added: "6. As a transitional measure and by way of derogation from paragraphs 3 and 5, Italy, whose laws, regulations and administrative provisions prescribed training which was not brought fully into line with the training requirements laid down in this Article by the deadline stipulated in Article 5, may continue to apply those provisions to persons who commenced their training in pharmacy before 1 November 1993 and concluded it before 1 November 2003. Each host Member State shall be authorised to require that holders of diplomas, certificates and other evidence of formal qualifications in pharmacy awarded in Italy on completion of training commenced before 1 November 1993 and concluded before 1 November 2003 produce, together with their qualifications, a certificate stating that, for at least three consecutive years during the five years prior to the issue of the certificate, they were effectively and lawfully engaged in one of the activities referred to in Article 1(2) in so far as such activity is regulated in Italy.". Article 13 Directive 85/433/EEC is hereby amended as follows: 1) in Article 1, the words "referred to in Article 4" shall be replaced by "referred to in the Annex"; 2) Article 3 shall be deleted; 3) Article 4 shall be deleted; 4) references made to Article 4 shall be understood as being made to the Annex; 5) the following Articles shall be inserted: "Article 18a Member States shall notify the Commission of the laws, regulations or administrative provisions they adopt as regards the award of diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive. The Commission shall publish an appropriate notice in the Official Journal of the European Communities, listing the names adopted by the Member States for the training qualifications concerned and, where applicable, for the corresponding professional title. Article 18b Each Member State shall recognise as sufficient proof, in respect of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive do not correspond to the names listed for that Member State in this Directive, the diplomas, certificates and other evidence of formal qualifications awarded by those Member States and accompanied by a certificate issued by the competent authorities or bodies. The certificate shall state that the diplomas, certificates and other evidence of formal qualifications in question have been awarded on completion of education and training that complies with the provisions of this Directive and are treated by the awarding Member State as equivalent to those whose names are listed therein. Article 18c Member States shall examine diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive obtained by the holder outside the European Union in cases where those diplomas, certificates and other evidence of formal qualifications have been recognised in a Member State, as well as of training undergone and/or professional experience gained in a Member State. The Member State shall give its decision within three months of the date on which the applicant submits his application together with full supporting documentation. Article 18d Where the application is rejected, Member States shall duly give the reasons for decisions on applications for recognition of diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive. Applicants shall have a right of appeal before the courts under national law. That right of appeal shall likewise apply in the event of failure to reach a decision within the stipulated period."; 6) the Annex as it appears in Annex V to this Directive shall be added. Section 2.7 Doctors Article 14 Directive 93/16/EEC is hereby amended as follows: 1) in Article 2, the words "listed in Article 3" shall be replaced by "listed in Annex A"; 2) Article 3 shall be deleted; 3) the title of Chapter II shall be replaced by the following: "Diplomas, certificates and other evidence of formal qualifications in specialised medicine."; 4) Article 4 shall be replaced by the following: "Article 4 Each Member State with provisions in this field laid down by law, regulation or administrative action shall recognise the diplomas, certificates and other evidence of formal qualifications in specialised medicine awarded to nationals of Member States by the other Member States in accordance with Articles 24, 25, 26 and 29 and which are listed in Annexes B and C, by giving such qualifications the same effect in its territory as those which the Member State itself awards."; 5) Article 5 shall be replaced by the following: "Article 5 The diplomas, certificates and other evidence of formal qualifications referred to in Article 4 shall be those which, having been awarded by the competent authorities or bodies listed in Annex B, correspond, for the purposes of the specialised training in question, to the qualifications listed in Annex C in respect of those Member States where such training exists."; 6) the title of Chapter III and Articles 6 and 7 shall be deleted; 7) in Article 8: (a) the following subparagraph shall be added to paragraph 2: "It shall also take into account their professional experience, additional training and continuing medical education."; (b) paragraph 3 shall be replaced by the following: "3. The competent authorities or bodies of the host Member State, having assessed the content and duration of the training of the person concerned on the basis of the diplomas, certificates and other evidence of formal qualifications submitted, and taking into account his professional experience, additional training and continuing medical education, shall inform him of the period of additional training required and of the fields to be covered by it."; (c) the following paragraph shall be added: "4. The Member State shall deliver its decision within four months of the date on which the applicant submits his application together with full supporting documentation."; 8) in Article 9, the following paragraph shall be added: "2a Member States shall recognise evidence of formal qualifications in specialised medicine awarded in Spain to doctors who completed specialised training before 1 January 1995 which did not comply with the formal training requirements laid down in Articles 24 to 27, if the evidence is accompanied by a certificate awarded by the competent Spanish authorities attesting to the fact that the person concerned has passed the test of specific professional competence organised in the context of the special regularisation measures contained in Royal Decree 1497/99 with the aim of verifying that the person concerned has a level of knowledge and competence comparable to that of doctors holding the specialist doctors' qualifications which, in the case of Spain, are referred to in Articles 5(3) and 7(2)."; 9) the following paragraph shall be added to Article 23: "6. Continuing training shall ensure, in accordance with the arrangements prevailing in each Member State, that the persons who have completed their studies can keep up with progress in medicine."; 10) in Article 24(1), point (a) shall be replaced by the following: "(a) it shall entail the successful completion of six years' study within the framework of the training course referred to in Article 23, during which appropriate knowledge of general medicine shall have been acquired;"; 11) Articles 26 and 27 shall be replaced by the following: "Article 26 Member States with provisions in this field laid down by law, regulation or administrative action shall ensure that the minimum length of the specialised training courses may not be not less than the course lengths stipulated in Annex C in respect of each training course. Such minimum course lengths shall be amended pursuant to the procedure laid down in Article 44a(3)."; 12) Article 30 shall be replaced by the following: "Article 30 Each Member State which dispenses the complete training referred to in Article 23 within its territory shall institute specific training in general medical practice meeting requirements at least as stringent as those laid down in Articles 31 and 32, in such a manner that the first diplomas, certificates or other evidence of formal qualifications awarded on completion of the course are issued not later than 1 January 2006." 13) in Article 31, paragraph 1(b) shall be replaced by the following: "(b) it shall be a full-time course lasting at least three years, and shall be supervised by the competent authorities or bodies."; 14) Article 31(2) shall be replaced by the following: "2. Where the training course referred to in Article 23 involves practical training given in an approved hospital or clinic with suitable equipment and services in general medicine or in an approved general medical practice or in an approved centre where doctors provide primary care, the duration of that training may be included, subject to a maximum of one year, in the period laid down in paragraph 1(b). This option shall be available only to Member States in which, on 1 January 2001, the duration of specific training in general medical practice is two years. Should the Commission note, when this paragraph is being applied, that major difficulties arise for a Member State with regard to the level of training indicated in paragraph 1(b), it shall take the opinion of the Committee of Senior Officials on Public Health established by Council Decision 75/365/EEC(21) and shall inform the European Parliament and the Council. The Commission shall submit to the European Parliament and the Council, where appropriate, proposals directed towards greater coordination of the duration of specific training in general medicine.". 15) in the second indent of Article 34(1), "60 %" shall be replaced by "50 %"; 16) references made to Articles 3, 6, 7 and 27 shall be understood as being made to Annex A, Article 4, Article 5 and Article 26 respectively; 17) the following Articles shall be inserted: "Article 42a Member States shall notify the Commission of the laws, regulations or administrative provisions they adopt as regards the award of diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive. The Commission shall publish an appropriate notice in the Official Journal of the European Communities, listing the names adopted by the Member States for the training qualifications concerned and, where applicable, for the corresponding professional title. Article 42b Each Member State shall recognise as sufficient proof, in respect of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive do not correspond to the names listed for that Member State in this Directive, the diplomas, certificates and other evidence of formal qualifications awarded by those Member States and accompanied by a certificate issued by the competent authorities or bodies. The certificate shall state that the diplomas, certificates and other evidence of formal qualifications in question have been awarded on completion of education and training that complies with the provisions of this Directive and are treated by the awarding Member State as equivalent to those whose names are listed therein. Article 42c Member States shall examine diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive obtained by the holder outside the European Union in cases where those diplomas, certificates and other evidence of formal qualifications have been recognised in a Member State, as well as of training undergone and/or professional experience gained in a Member State. The Member State shall give its decision within three months of the date on which the applicant submits his application together with full supporting documentation. Article 42d Where the application is rejected, Member States shall duly give the reasons for decisions on applications for recognition of diplomas, certificates and other evidence of formal qualifications in the field covered by this Directive. Applicants shall have a right of appeal before the courts under national law. That right of appeal shall likewise apply in the event of failure to reach a decision within the stipulated period."; 18) Article 44a shall be amended as follows: (a) does not affect the English text; (b) paragraph 2 shall be deleted; 19) Annexes A, B and C as they appear in Annex VI to this Directive shall be added; SECTION 3 FINAL PROVISIONS Article 15 Not later than 1 January 2008, the Commission shall report to the European Parliament and the Council on the state of application of Article 1 points (1) and (2) in the Member States. After undertaking all the necessary hearings, the Commission shall submit its conclusions regarding any changes to the existing arrangement in Article 1 points (1) and (2). If necessary, the Commission shall also submit proposals for improving the existing arrangement. Article 16 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 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 reference shall be laid down by 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 17 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 18 This Directive is addressed to the Member States.

32001L0010

2001

Directive 2001/10/EC of the European Parliament and of the Council of 22 May 2001 amending Council Directive 91/68/EEC as regards scrapie 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) The animal health conditions for scrapie, covering placing on the market of animals, are laid down in Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals(4). (2) The Commission has obtained scientific opinions, in particular from the Scientific Steering Committee, on several aspects of transmissible spongiform encephalopathies (TSEs). The rules laid down in Directive 91/68/EEC should be reviewed in the light of those opinions. (3) Provisions should be laid down for all matters concerning TSEs to apply, in particular, to the production and placing on the market of live animals and products of animal origin referred to in Article 1(1) of Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down the rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(5). (4) This Directive concerns public health directly and relates to the operation of the internal market. It is consequently appropriate to take Article 152(4)(b) of the Treaty as the legal basis for the adoption of rules for the prevention and control of certain transmissible spongiform encephalopathies. (5) Directive 91/68/EEC should therefore be amended accordingly, Article 1 Directive 91/68/EEC is hereby amended as follows: 1. In Article 2(7), "as listed under Sections I and II of Annex B" shall be replaced by "as listed under Section I of Annex B". 2. Article 6(b) shall be deleted. 3. In Article 7(1), "referred to in Annex B, Sections II and III" shall be replaced by "referred to in Annex B, Section III". 4. In Article 8(1), "listed in Annex B, Sections II and III" shall be replaced by "listed in Annex B, Section III". 5. Section II of Annex B shall be deleted. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 June 2001. They shall immediately inform the Commission thereof. They shall apply these provisions from 1 July 2001. 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. The Member States shall communicate to the Commission the provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. 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.

32001L0029

2001

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 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 Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) The Treaty provides for the establishment of an internal market and the institution of a system ensuring that competition in the internal market is not distorted. Harmonisation of the laws of the Member States on copyright and related rights contributes to the achievement of these objectives. (2) The European Council, meeting at Corfu on 24 and 25 June 1994, stressed the need to create a general and flexible legal framework at Community level in order to foster the development of the information society in Europe. This requires, inter alia, the existence of an internal market for new products and services. Important Community legislation to ensure such a regulatory framework is already in place or its adoption is well under way. Copyright and related rights play an important role in this context as they protect and stimulate the development and marketing of new products and services and the creation and exploitation of their creative content. (3) The proposed harmonisation will help to implement the four freedoms of the internal market and relates to compliance with the fundamental principles of law and especially of property, including intellectual property, and freedom of expression and the public interest. (4) A harmonised legal framework on copyright and related rights, through increased legal certainty and while providing for a high level of protection of intellectual property, will foster substantial investment in creativity and innovation, including network infrastructure, and lead in turn to growth and increased competitiveness of European industry, both in the area of content provision and information technology and more generally across a wide range of industrial and cultural sectors. This will safeguard employment and encourage new job creation. (5) Technological development has multiplied and diversified the vectors for creation, production and exploitation. While no new concepts for the protection of intellectual property are needed, the current law on copyright and related rights should be adapted and supplemented to respond adequately to economic realities such as new forms of exploitation. (6) Without 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 significant differences in protection and thereby in restrictions on the free movement of services and products incorporating, or based on, intellectual property, leading to a refragmentation of the internal market and legislative inconsistency. 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 transborder exploitation of intellectual property. This development will and should further increase. Significant legal differences and uncertainties in protection may hinder economies of scale for new products and services containing copyright and related rights. (7) The Community legal framework for the protection of copyright and related rights must, therefore, also be adapted and supplemented as far as is necessary for the smooth functioning of the internal market. To that end, those national provisions on copyright and related rights which vary considerably from one Member State to another or which cause legal uncertainties hindering the smooth functioning of the internal market and the proper development of the information society in Europe should be adjusted, and inconsistent national responses to the technological developments should be avoided, whilst differences not adversely affecting the functioning of the internal market need not be removed or prevented. (8) The various social, societal and cultural implications of the information society require that account be taken of the specific features of the content of products and services. (9) Any harmonisation of copyright and related rights must take as a basis a high level of protection, since such rights are crucial to intellectual creation. Their protection helps to ensure the maintenance and development of creativity in the interests of authors, performers, producers, consumers, culture, industry and the public at large. Intellectual property has therefore been recognised as an integral part of property. (10) If authors or performers are to continue their creative and artistic work, they have to receive an appropriate reward for the use of their work, as must producers in order to be able to finance this work. The investment required to produce products such as phonograms, films or multimedia products, and services such as "on-demand" services, is considerable. Adequate legal protection of intellectual property rights is necessary in order to guarantee the availability of such a reward and provide the opportunity for satisfactory returns on this investment. (11) A rigorous, effective system for the protection of copyright and related rights is one of the main ways of ensuring that European cultural creativity and production receive the necessary resources and of safeguarding the independence and dignity of artistic creators and performers. (12) Adequate protection of copyright works and subject-matter of related rights is also of great importance from a cultural standpoint. Article 151 of the Treaty requires the Community to take cultural aspects into account in its action. (13) A common search for, and consistent application at European level of, technical measures to protect works and other subject-matter and to provide the necessary information on rights are essential insofar as the ultimate aim of these measures is to give effect to the principles and guarantees laid down in law. (14) This Directive should seek to promote learning and culture by protecting works and other subject-matter while permitting exceptions or limitations in the public interest for the purpose of education and teaching. (15) The Diplomatic Conference held under the auspices of the World Intellectual Property Organisation (WIPO) in December 1996 led to the adoption of two new Treaties, the "WIPO Copyright Treaty" and the "WIPO Performances and Phonograms Treaty", dealing respectively with the protection of authors and the protection of performers and phonogram producers. Those Treaties update the international protection for copyright and related rights significantly, not least with regard to the so-called "digital agenda", and improve the means to fight piracy world-wide. The Community and a majority of Member States have already signed the Treaties and the process of making arrangements for the ratification of the Treaties by the Community and the Member States is under way. This Directive also serves to implement a number of the new international obligations. (16) Liability for activities in the network environment concerns not only copyright and related rights but also other areas, such as defamation, misleading advertising, or infringement of trademarks, and is addressed horizontally in 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")(4), which clarifies and harmonises various legal issues relating to information society services including electronic commerce. This Directive should be implemented within a timescale similar to that for the implementation of the Directive on electronic commerce, since that Directive provides a harmonised framework of principles and provisions relevant inter alia to important parts of this Directive. This Directive is without prejudice to provisions relating to liability in that Directive. (17) It is necessary, especially in the light of the requirements arising out of the digital environment, to ensure that collecting societies achieve a higher level of rationalisation and transparency with regard to compliance with competition rules. (18) This Directive is without prejudice to the arrangements in the Member States concerning the management of rights such as extended collective licences. (19) The moral rights of rightholders should be exercised according to the legislation of the Member States and the provisions of the Berne Convention for the Protection of Literary and Artistic Works, of the WIPO Copyright Treaty and of the WIPO Performances and Phonograms Treaty. Such moral rights remain outside the scope of this Directive. (20) This Directive is based on principles and rules already laid down in the Directives currently in force in this area, in particular Directives 91/250/EEC(5), 92/100/EEC(6), 93/83/EEC(7), 93/98/EEC(8) and 96/9/EC(9), and it develops those principles and rules and places them in the context of the information society. The provisions of this Directive should be without prejudice to the provisions of those Directives, unless otherwise provided in this Directive. (21) This Directive should define the scope of the acts covered by the reproduction right with regard to the different beneficiaries. This should be done in conformity with the acquis communautaire. A broad definition of these acts is needed to ensure legal certainty within the internal market. (22) The objective of proper support for the dissemination of culture must not be achieved by sacrificing strict protection of rights or by tolerating illegal forms of distribution of counterfeited or pirated works. (23) This Directive should harmonise further the author's right of communication to the public. This right should be understood in a broad sense covering all communication to the public not present at the place where the communication originates. This right should cover any such transmission or retransmission of a work to the public by wire or wireless means, including broadcasting. This right should not cover any other acts. (24) The right to make available to the public subject-matter referred to in Article 3(2) should be understood as covering all acts of making available such subject-matter to members of the public not present at the place where the act of making available originates, and as not covering any other acts. (25) The legal uncertainty regarding the nature and the level of protection of acts of on-demand transmission of copyright works and subject-matter protected by related rights over networks should be overcome by providing for harmonised protection at Community level. It should be made clear that all rightholders recognised by this Directive should have an exclusive right to make available to the public copyright works or any other subject-matter by way of interactive on-demand transmissions. Such interactive on-demand transmissions are characterised by the fact that members of the public may access them from a place and at a time individually chosen by them. (26) With regard to the making available in on-demand services by broadcasters of their radio or television productions incorporating music from commercial phonograms as an integral part thereof, collective licensing arrangements are to be encouraged in order to facilitate the clearance of the rights concerned. (27) The mere provision of physical facilities for enabling or making a communication does not in itself amount to communication within the meaning of this Directive. (28) Copyright protection under this Directive includes the exclusive right to control distribution of the work incorporated in a tangible article. The first sale in the Community of the original of a work or copies thereof by the rightholder or with his consent exhausts the right to control resale of that object in the Community. This right should not be exhausted in respect of the original or of copies thereof sold by the rightholder or with his consent outside the Community. Rental and lending rights for authors have been established in Directive 92/100/EEC. The distribution right provided for in this Directive is without prejudice to the provisions relating to the rental and lending rights contained in Chapter I of that Directive. (29) The question of exhaustion does not arise in the case of services and on-line services in particular. This also applies with regard to a material copy of a work or other subject-matter made by a user of such a service with the consent of the rightholder. Therefore, the same applies to rental and lending of the original and copies of works or other subject-matter which are services by nature. Unlike CD-ROM or CD-I, where the intellectual property is incorporated in a material medium, namely an item of goods, every on-line service is in fact an act which should be subject to authorisation where the copyright or related right so provides. (30) The rights referred to in this Directive may be transferred, assigned or subject to the granting of contractual licences, without prejudice to the relevant national legislation on copyright and related rights. (31) A fair balance of rights and interests between the different categories of rightholders, as well as between the different categories of rightholders and users of protected subject-matter must be safeguarded. The existing exceptions and limitations to the rights as set out by the Member States have to be reassessed in the light of the new electronic environment. Existing differences in the exceptions and limitations to certain restricted acts have direct negative effects on the functioning of the internal market of copyright and related rights. Such differences could well become more pronounced in view of the further development of transborder exploitation of works and cross-border activities. In order to ensure the proper functioning of the internal market, such exceptions and limitations should be defined more harmoniously. The degree of their harmonisation should be based on their impact on the smooth functioning of the internal market. (32) This Directive provides for an exhaustive enumeration of exceptions and limitations to the reproduction right and the right of communication to the public. Some exceptions or limitations only apply to the reproduction right, where appropriate. This list takes due account of the different legal traditions in Member States, while, at the same time, aiming to ensure a functioning internal market. Member States should arrive at a coherent application of these exceptions and limitations, which will be assessed when reviewing implementing legislation in the future. (33) The exclusive right of reproduction should be subject to an exception to allow certain acts of temporary reproduction, which are transient or incidental reproductions, forming an integral and essential part of a technological process and carried out for the sole purpose of enabling either efficient transmission in a network between third parties by an intermediary, or a lawful use of a work or other subject-matter to be made. The acts of reproduction concerned should have no separate economic value on their own. To the extent that they meet these conditions, this exception should include acts which enable browsing as well as acts of caching to take place, including those which enable transmission systems to function efficiently, provided that the intermediary does not modify the information and does not interfere with the lawful use of technology, widely recognised and used by industry, to obtain data on the use of the information. A use should be considered lawful where it is authorised by the rightholder or not restricted by law. (34) Member States should be given the option of providing for certain exceptions or limitations for cases such as educational and scientific purposes, for the benefit of public institutions such as libraries and archives, for purposes of news reporting, for quotations, for use by people with disabilities, for public security uses and for uses in administrative and judicial proceedings. (35) In certain cases of exceptions or limitations, rightholders should receive fair compensation to compensate them adequately for the use made of their protected works or other subject-matter. When determining the form, detailed arrangements and possible level of such fair compensation, account should be taken of the particular circumstances of each case. When evaluating these circumstances, a valuable criterion would be the possible harm to the rightholders resulting from the act in question. In cases where rightholders have already received payment in some other form, for instance as part of a licence fee, no specific or separate payment may be due. The level of fair compensation should take full account of the degree of use of technological protection measures referred to in this Directive. In certain situations where the prejudice to the rightholder would be minimal, no obligation for payment may arise. (36) The Member States may provide for fair compensation for rightholders also when applying the optional provisions on exceptions or limitations which do not require such compensation. (37) Existing national schemes on reprography, where they exist, do not create major barriers to the internal market. Member States should be allowed to provide for an exception or limitation in respect of reprography. (38) Member States should be allowed to provide for an exception or limitation to the reproduction right for certain types of reproduction of audio, visual and audio-visual material for private use, accompanied by fair compensation. This may include the introduction or continuation of remuneration schemes to compensate for the prejudice to rightholders. Although differences between those remuneration schemes affect the functioning of the internal market, those differences, with respect to analogue private reproduction, should not have a significant impact on the development of the information society. Digital private copying is likely to be more widespread and have a greater economic impact. Due account should therefore be taken of the differences between digital and analogue private copying and a distinction should be made in certain respects between them. (39) When applying the exception or limitation on private copying, Member States should take due account of technological and economic developments, in particular with respect to digital private copying and remuneration schemes, when effective technological protection measures are available. Such exceptions or limitations should not inhibit the use of technological measures or their enforcement against circumvention. (40) Member States may provide for an exception or limitation for the benefit of certain non-profit making establishments, such as publicly accessible libraries and equivalent institutions, as well as archives. However, this should be limited to certain special cases covered by the reproduction right. Such an exception or limitation should not cover uses made in the context of on-line delivery of protected works or other subject-matter. This Directive should be without prejudice to the Member States' option to derogate from the exclusive public lending right in accordance with Article 5 of Directive 92/100/EEC. Therefore, specific contracts or licences should be promoted which, without creating imbalances, favour such establishments and the disseminative purposes they serve. (41) When applying the exception or limitation in respect of ephemeral recordings made by broadcasting organisations it is understood that a broadcaster's own facilities include those of a person acting on behalf of and under the responsibility of the broadcasting organisation. (42) When applying the exception or limitation for non-commercial educational and scientific research purposes, including distance learning, the non-commercial nature of the activity in question should be determined by that activity as such. The organisational structure and the means of funding of the establishment concerned are not the decisive factors in this respect. (43) It is in any case important for the Member States to adopt all necessary measures to facilitate access to works by persons suffering from a disability which constitutes an obstacle to the use of the works themselves, and to pay particular attention to accessible formats. (44) When applying the exceptions and limitations provided for in this Directive, they should be exercised in accordance with international obligations. Such exceptions and limitations may not be applied in a way which prejudices the legitimate interests of the rightholder or which conflicts with the normal exploitation of his work or other subject-matter. The provision of such exceptions or limitations by Member States should, in particular, duly reflect the increased economic impact that such exceptions or limitations may have in the context of the new electronic environment. Therefore, the scope of certain exceptions or limitations may have to be even more limited when it comes to certain new uses of copyright works and other subject-matter. (45) The exceptions and limitations referred to in Article 5(2), (3) and (4) should not, however, prevent the definition of contractual relations designed to ensure fair compensation for the rightholders insofar as permitted by national law. (46) Recourse to mediation could help users and rightholders to settle disputes. The Commission, in cooperation with the Member States within the Contact Committee, should undertake a study to consider new legal ways of settling disputes concerning copyright and related rights. (47) Technological development will allow rightholders to make use of technological measures designed to prevent or restrict acts not authorised by the rightholders of any copyright, rights related to copyright or the sui generis right in databases. The danger, however, exists that illegal activities might be carried out in order to enable or facilitate the circumvention of the technical protection provided by these measures. In order to avoid fragmented legal approaches that could potentially hinder the functioning of the internal market, there is a need to provide for harmonised legal protection against circumvention of effective technological measures and against provision of devices and products or services to this effect. (48) Such legal protection should be provided in respect of technological measures that effectively restrict acts not authorised by the rightholders of any copyright, rights related to copyright or the sui generis right in databases without, however, preventing the normal operation of electronic equipment and its technological development. Such legal protection implies no obligation to design devices, products, components or services to correspond to technological measures, so long as such device, product, component or service does not otherwise fall under the prohibition of Article 6. Such legal protection should respect proportionality and should not prohibit those devices or activities which have a commercially significant purpose or use other than to circumvent the technical protection. In particular, this protection should not hinder research into cryptography. (49) The legal protection of technological measures is without prejudice to the application of any national provisions which may prohibit the private possession of devices, products or components for the circumvention of technological measures. (50) Such a harmonised legal protection does not affect the specific provisions on protection provided for by Directive 91/250/EEC. In particular, it should not apply to the protection of technological measures used in connection with computer programs, which is exclusively addressed in that Directive. It should neither inhibit nor prevent the development or use of any means of circumventing a technological measure that is necessary to enable acts to be undertaken in accordance with the terms of Article 5(3) or Article 6 of Directive 91/250/EEC. Articles 5 and 6 of that Directive exclusively determine exceptions to the exclusive rights applicable to computer programs. (51) The legal protection of technological measures applies without prejudice to public policy, as reflected in Article 5, or public security. Member States should promote voluntary measures taken by rightholders, including the conclusion and implementation of agreements between rightholders and other parties concerned, to accommodate achieving the objectives of certain exceptions or limitations provided for in national law in accordance with this Directive. In the absence of such voluntary measures or agreements within a reasonable period of time, Member States should take appropriate measures to ensure that rightholders provide beneficiaries of such exceptions or limitations with appropriate means of benefiting from them, by modifying an implemented technological measure or by other means. However, in order to prevent abuse of such measures taken by rightholders, including within the framework of agreements, or taken by a Member State, any technological measures applied in implementation of such measures should enjoy legal protection. (52) When implementing an exception or limitation for private copying in accordance with Article 5(2)(b), Member States should likewise promote the use of voluntary measures to accommodate achieving the objectives of such exception or limitation. If, within a reasonable period of time, no such voluntary measures to make reproduction for private use possible have been taken, Member States may take measures to enable beneficiaries of the exception or limitation concerned to benefit from it. Voluntary measures taken by rightholders, including agreements between rightholders and other parties concerned, as well as measures taken by Member States, do not prevent rightholders from using technological measures which are consistent with the exceptions or limitations on private copying in national law in accordance with Article 5(2)(b), taking account of the condition of fair compensation under that provision and the possible differentiation between various conditions of use in accordance with Article 5(5), such as controlling the number of reproductions. In order to prevent abuse of such measures, any technological measures applied in their implementation should enjoy legal protection. (53) The protection of technological measures should ensure a secure environment for the provision of interactive on-demand services, in such a way that members of the public may access works or other subject-matter from a place and at a time individually chosen by them. Where such services are governed by contractual arrangements, the first and second subparagraphs of Article 6(4) should not apply. Non-interactive forms of online use should remain subject to those provisions. (54) Important progress has been made in the international standardisation of technical systems of identification of works and protected subject-matter in digital format. In an increasingly networked environment, differences between technological measures could lead to an incompatibility of systems within the Community. Compatibility and interoperability of the different systems should be encouraged. It would be highly desirable to encourage the development of global systems. (55) Technological development will facilitate the distribution of works, notably on networks, and this will entail the need for rightholders to identify better the work or other subject-matter, the author or any other rightholder, and to provide information about the terms and conditions of use of the work or other subject-matter in order to render easier the management of rights attached to them. Rightholders should be encouraged to use markings indicating, in addition to the information referred to above, inter alia their authorisation when putting works or other subject-matter on networks. (56) There is, however, the danger that illegal activities might be carried out in order to remove or alter the electronic copyright-management information attached to it, or otherwise to distribute, import for distribution, broadcast, communicate to the public or make available to the public works or other protected subject-matter from which such information has been removed without authority. In order to avoid fragmented legal approaches that could potentially hinder the functioning of the internal market, there is a need to provide for harmonised legal protection against any of these activities. (57) Any such rights-management information systems referred to above may, depending on their design, at the same time process personal data about the consumption patterns of protected subject-matter by individuals and allow for tracing of on-line behaviour. These technical means, in their technical functions, should incorporate privacy safeguards 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 the free movement of such data(10). (58) Member States should provide for effective sanctions and remedies for infringements of rights and obligations as set out in this Directive. They should take all the measures necessary to ensure that those sanctions and remedies are applied. The sanctions thus provided for should be effective, proportionate and dissuasive and should include the possibility of seeking damages and/or injunctive relief and, where appropriate, of applying for seizure of infringing material. (59) In the digital environment, in particular, the services of intermediaries may increasingly be used by third parties for infringing activities. In many cases such intermediaries are best placed to bring such infringing activities to an end. Therefore, without prejudice to any other sanctions and remedies available, rightholders should have the possibility of applying for an injunction against an intermediary who carries a third party's infringement of a protected work or other subject-matter in a network. This possibility should be available even where the acts carried out by the intermediary are exempted under Article 5. The conditions and modalities relating to such injunctions should be left to the national law of the Member States. (60) The protection provided under this Directive should be without prejudice to national or Community legal provisions in other areas, such as industrial property, data protection, conditional access, access to public documents, and the rule of media exploitation chronology, which may affect the protection of copyright or related rights. (61) In order to comply with the WIPO Performances and Phonograms Treaty, Directives 92/100/EEC and 93/98/EEC should be amended, CHAPTER I OBJECTIVE AND SCOPE Article 1 Scope 1. This Directive concerns the legal protection of copyright and related rights in the framework of the internal market, with particular emphasis on the information society. 2. Except in the cases referred to in Article 11, this Directive shall leave intact and shall in no way affect existing Community provisions relating to: (a) the legal protection of computer programs; (b) rental right, lending right and certain rights related to copyright in the field of intellectual property; (c) copyright and related rights applicable to broadcasting of programmes by satellite and cable retransmission; (d) the term of protection of copyright and certain related rights; (e) the legal protection of databases. CHAPTER II RIGHTS AND EXCEPTIONS Article 2 Reproduction right Member States shall provide for the exclusive right to authorise or prohibit direct or indirect, temporary or permanent reproduction by any means and in any form, in whole or in part: (a) for authors, of their works; (b) for performers, of fixations of their performances; (c) for phonogram producers, of their phonograms; (d) for the producers of the first fixations of films, in respect of the original and copies of their films; (e) for broadcasting organisations, of fixations of their broadcasts, whether those broadcasts are transmitted by wire or over the air, including by cable or satellite. Article 3 Right of communication to the public of works and right of making available to the public other subject-matter 1. Member States shall provide authors with the exclusive right to authorise or prohibit any communication to the public of their works, by wire or wireless means, including the making available to the public of their works in such a way that members of the public may access them from a place and at a time individually chosen by them. 2. Member States shall provide for the exclusive right to authorise or prohibit the making available to the public, by wire or wireless means, in such a way that members of the public may access them from a place and at a time individually chosen by them: (a) for performers, of fixations of their performances; (b) for phonogram producers, of their phonograms; (c) for the producers of the first fixations of films, of the original and copies of their films; (d) for broadcasting organisations, of fixations of their broadcasts, whether these broadcasts are transmitted by wire or over the air, including by cable or satellite. 3. The rights referred to in paragraphs 1 and 2 shall not be exhausted by any act of communication to the public or making available to the public as set out in this Article. Article 4 Distribution right 1. Member States shall provide for authors, in respect of the original of their works or of copies thereof, the exclusive right to authorise or prohibit any form of distribution to the public by sale or otherwise. 2. The distribution right shall not be exhausted within the Community in respect of the original or copies of the work, except where the first sale or other transfer of ownership in the Community of that object is made by the rightholder or with his consent. Article 5 Exceptions and limitations 1. Temporary acts of reproduction referred to in Article 2, which are transient or incidental [and] an integral and essential part of a technological process and whose sole purpose is to enable: (a) a transmission in a network between third parties by an intermediary, or (b) a lawful use of a work or other subject-matter to be made, and which have no independent economic significance, shall be exempted from the reproduction right provided for in Article 2. 2. Member States may provide for exceptions or limitations to the reproduction right provided for in Article 2 in the following cases: (a) in respect of reproductions on paper or any similar medium, effected by the use of any kind of photographic technique or by some other process having similar effects, with the exception of sheet music, provided that the rightholders receive fair compensation; (b) in respect of reproductions on any medium made by a natural person for private use and for ends that are neither directly nor indirectly commercial, on condition that the rightholders receive fair compensation which takes account of the application or non-application of technological measures referred to in Article 6 to the work or subject-matter concerned; (c) in respect of specific acts of reproduction made by publicly accessible libraries, educational establishments or museums, or by archives, which are not for direct or indirect economic or commercial advantage; (d) in respect of ephemeral recordings of works made by broadcasting organisations by means of their own facilities and for their own broadcasts; the preservation of these recordings in official archives may, on the grounds of their exceptional documentary character, be permitted; (e) in respect of reproductions of broadcasts made by social institutions pursuing non-commercial purposes, such as hospitals or prisons, on condition that the rightholders receive fair compensation. 3. Member States may provide for exceptions or limitations to the rights provided for in Articles 2 and 3 in the following cases: (a) use for the sole purpose of illustration for teaching or scientific research, as long as the source, including the author's name, is indicated, unless this turns out to be impossible and to the extent justified by the non-commercial purpose to be achieved; (b) uses, for the benefit of people with a disability, which are directly related to the disability and of a non-commercial nature, to the extent required by the specific disability; (c) reproduction by the press, communication to the public or making available of published articles on current economic, political or religious topics or of broadcast works or other subject-matter of the same character, in cases where such use is not expressly reserved, and as long as the source, including the author's name, is indicated, or use of works or other subject-matter in connection with the reporting of current events, to the extent justified by the informatory purpose and as long as the source, including the author's name, is indicated, unless this turns out to be impossible; (d) quotations for purposes such as criticism or review, provided that they relate to a work or other subject-matter which has already been lawfully made available to the public, that, unless this turns out to be impossible, the source, including the author's name, is indicated, and that their use is in accordance with fair practice, and to the extent required by the specific purpose; (e) use for the purposes of public security or to ensure the proper performance or reporting of administrative, parliamentary or judicial proceedings; (f) use of political speeches as well as extracts of public lectures or similar works or subject-matter to the extent justified by the informatory purpose and provided that the source, including the author's name, is indicated, except where this turns out to be impossible; (g) use during religious celebrations or official celebrations organised by a public authority; (h) use of works, such as works of architecture or sculpture, made to be located permanently in public places; (i) incidental inclusion of a work or other subject-matter in other material; (j) use for the purpose of advertising the public exhibition or sale of artistic works, to the extent necessary to promote the event, excluding any other commercial use; (k) use for the purpose of caricature, parody or pastiche; (l) use in connection with the demonstration or repair of equipment; (m) use of an artistic work in the form of a building or a drawing or plan of a building for the purposes of reconstructing the building; (n) use by communication or making available, for the purpose of research or private study, to individual members of the public by dedicated terminals on the premises of establishments referred to in paragraph 2(c) of works and other subject-matter not subject to purchase or licensing terms which are contained in their collections; (o) use in certain other cases of minor importance where exceptions or limitations already exist under national law, provided that they only concern analogue uses and do not affect the free circulation of goods and services within the Community, without prejudice to the other exceptions and limitations contained in this Article. 4. Where the Member States may provide for an exception or limitation to the right of reproduction pursuant to paragraphs 2 and 3, they may provide similarly for an exception or limitation to the right of distribution as referred to in Article 4 to the extent justified by the purpose of the authorised act of reproduction. 5. The exceptions and limitations provided for in paragraphs 1, 2, 3 and 4 shall only be applied in certain special cases which do not conflict with a normal exploitation of the work or other subject-matter and do not unreasonably prejudice the legitimate interests of the rightholder. CHAPTER III PROTECTION OF TECHNOLOGICAL MEASURES AND RIGHTS-MANAGEMENT INFORMATION Article 6 Obligations as to technological measures 1. Member States shall provide adequate legal protection against the circumvention of any effective technological measures, which the person concerned carries out in the knowledge, or with reasonable grounds to know, that he or she is pursuing that objective. 2. Member States shall provide adequate legal protection against the manufacture, import, distribution, sale, rental, advertisement for sale or rental, or possession for commercial purposes of devices, products or components or the provision of services which: (a) are promoted, advertised or marketed for the purpose of circumvention of, or (b) have only a limited commercially significant purpose or use other than to circumvent, or (c) are primarily designed, produced, adapted or performed for the purpose of enabling or facilitating the circumvention of, any effective technological measures. 3. For the purposes of this Directive, the expression "technological measures" means any technology, device or component that, in the normal course of its operation, is designed to prevent or restrict acts, in respect of works or other subject-matter, which are not authorised by the rightholder of any copyright or any right related to copyright as provided for by law or the sui generis right provided for in Chapter III of Directive 96/9/EC. Technological measures shall be deemed "effective" where the use of a protected work or other subject-matter is controlled by the rightholders through application of an access control or protection process, such as encryption, scrambling or other transformation of the work or other subject-matter or a copy control mechanism, which achieves the protection objective. 4. Notwithstanding the legal protection provided for in paragraph 1, in the absence of voluntary measures taken by rightholders, including agreements between rightholders and other parties concerned, Member States shall take appropriate measures to ensure that rightholders make available to the beneficiary of an exception or limitation provided for in national law in accordance with Article 5(2)(a), (2)(c), (2)(d), (2)(e), (3)(a), (3)(b) or (3)(e) the means of benefiting from that exception or limitation, to the extent necessary to benefit from that exception or limitation and where that beneficiary has legal access to the protected work or subject-matter concerned. A Member State may also take such measures in respect of a beneficiary of an exception or limitation provided for in accordance with Article 5(2)(b), unless reproduction for private use has already been made possible by rightholders to the extent necessary to benefit from the exception or limitation concerned and in accordance with the provisions of Article 5(2)(b) and (5), without preventing rightholders from adopting adequate measures regarding the number of reproductions in accordance with these provisions. The technological measures applied voluntarily by rightholders, including those applied in implementation of voluntary agreements, and technological measures applied in implementation of the measures taken by Member States, shall enjoy the legal protection provided for in paragraph 1. The provisions of the first and second subparagraphs shall not apply to works or other subject-matter made available to the public on agreed contractual terms in such a way that members of the public may access them from a place and at a time individually chosen by them. When this Article is applied in the context of Directives 92/100/EEC and 96/9/EC, this paragraph shall apply mutatis mutandis. Article 7 Obligations concerning rights-management information 1. Member States shall provide for adequate legal protection against any person knowingly performing without authority any of the following acts: (a) the removal or alteration of any electronic rights-management information; (b) the distribution, importation for distribution, broadcasting, communication or making available to the public of works or other subject-matter protected under this Directive or under Chapter III of Directive 96/9/EC from which electronic rights-management information has been removed or altered without authority, if such person knows, or has reasonable grounds to know, that by so doing he is inducing, enabling, facilitating or concealing an infringement of any copyright or any rights related to copyright as provided by law, or of the sui generis right provided for in Chapter III of Directive 96/9/EC. 2. For the purposes of this Directive, the expression "rights-management information" means any information provided by rightholders which identifies the work or other subject-matter referred to in this Directive or covered by the sui generis right provided for in Chapter III of Directive 96/9/EC, the author or any other rightholder, or information about the terms and conditions of use of the work or other subject-matter, and any numbers or codes that represent such information. The first subparagraph shall apply when any of these items of information is associated with a copy of, or appears in connection with the communication to the public of, a work or other subjectmatter referred to in this Directive or covered by the sui generis right provided for in Chapter III of Directive 96/9/EC. CHAPTER IV COMMON PROVISIONS Article 8 Sanctions and remedies 1. Member States shall provide appropriate sanctions and remedies in respect of infringements of the rights and obligations set out in this Directive and shall take all the measures necessary to ensure that those sanctions and remedies are applied. The sanctions thus provided for shall be effective, proportionate and dissuasive. 2. Each Member State shall take the measures necessary to ensure that rightholders whose interests are affected by an infringing activity carried out on its territory can bring an action for damages and/or apply for an injunction and, where appropriate, for the seizure of infringing material as well as of devices, products or components referred to in Article 6(2). 3. Member States shall ensure that rightholders are in a position to apply for an injunction against intermediaries whose services are used by a third party to infringe a copyright or related right. Article 9 Continued application of other legal provisions This Directive shall be without prejudice to provisions concerning in particular patent rights, trade marks, design rights, utility models, topographies of semi-conductor products, type faces, conditional access, access to cable of broadcasting services, protection of national treasures, legal deposit requirements, laws on restrictive practices and unfair competition, trade secrets, security, confidentiality, data protection and privacy, access to public documents, the law of contract. Article 10 Application over time 1. The provisions of this Directive shall apply in respect of all works and other subject-matter referred to in this Directive which are, on 22 December 2002, protected by the Member States' legislation in the field of copyright and related rights, or which meet the criteria for protection under the provisions of this Directive or the provisions referred to in Article 1(2). 2. This Directive shall apply without prejudice to any acts concluded and rights acquired before 22 December 2002. Article 11 Technical adaptations 1. Directive 92/100/EEC is hereby amended as follows: (a) Article 7 shall be deleted; (b) Article 10(3) shall be replaced by the following: "3. The limitations shall only be applied in certain special cases which do not conflict with a normal exploitation of the subject-matter and do not unreasonably prejudice the legitimate interests of the rightholder." 2. Article 3(2) of Directive 93/98/EEC shall be replaced by the following: "2. The rights of producers of phonograms shall expire 50 years after the fixation is made. However, if the phonogram has been lawfully published within this period, the said rights shall expire 50 years from the date of the first lawful publication. If no lawful publication has taken place within the period mentioned in the first sentence, and if the phonogram has been lawfully communicated to the public within this period, the said rights shall expire 50 years from the date of the first lawful communication to the public. However, where through the expiry of the term of protection granted pursuant to this paragraph in its version before amendment by 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(11) the rights of producers of phonograms are no longer protected on 22 December 2002, this paragraph shall not have the effect of protecting those rights anew." Article 12 Final provisions 1. Not later than 22 December 2004 and every three years thereafter, the Commission shall submit to the European Parliament, the Council and the Economic and Social Committee a report on the application of this Directive, in which, inter alia, on the basis of specific information supplied by the Member States, it shall examine in particular the application of Articles 5, 6 and 8 in the light of the development of the digital market. In the case of Article 6, it shall examine in particular whether that Article confers a sufficient level of protection and whether acts which are permitted by law are being adversely affected by the use of effective technological measures. Where necessary, in particular to ensure the functioning of the internal market pursuant to Article 14 of the Treaty, it shall submit proposals for amendments to this Directive. 2. Protection of rights related to copyright under this Directive shall leave intact and shall in no way affect the protection of copyright. 3. A contact committee is hereby established. It shall be composed of representatives of the competent authorities of the Member States. It shall be chaired by a representative of the Commission and shall meet either on the initiative of the chairman or at the request of the delegation of a Member State. 4. The tasks of the committee shall be as follows: (a) to examine the impact of this Directive on the functioning of the internal market, and to highlight any difficulties; (b) to organise consultations on all questions deriving from the application of this Directive; (c) to facilitate the exchange of information on relevant developments in legislation and case-law, as well as relevant economic, social, cultural and technological developments; (d) to act as a forum for the assessment of the digital market in works and other items, including private copying and the use of technological measures. Article 13 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 22 December 2002. 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 provisions of domestic 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.

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2001

Commission Directive 2001/39/EC of 23 May 2001 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively 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 2000/82/EC(2), 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(3), as last amended by Directive 2000/82/EC, 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(4), as last amended by Directive 2000/82/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(5), as last amended by Commission Directive 2001/21/EC(6), and in particular Article 4(1)(f) thereof, Whereas: (1) The new active substances, azimsulfuron, and prohexadione calcium were included in Annex I to Directive 91/414/EEC by Commission Directives 1999/80/EC(7) and 2000/50/EC(8), respectively, for use as a pre-emergence herbicide on rice, and as a plant growth regulator respectively. (2) The substances were included in Annex I to Directive 91/414/EEC based on assessment of the information submitted concerning the proposed uses. (3) Prior to the inclusion of the substances in Annex I to Directive 91/414/EEC, their use had been provisionally authorised in certain Member States in accordance with Article 8(1) of the Directive. Following inclusion of the substances in Annex I, those Member States authorised a number of plant protection products containing them in accordance with Article 4 of the Directive, and established provisional maximum residue levels as required by Article 4(1)(f). As required by the Directive, those levels, and the information on which they were based, have been notified to the Commission. This information together with data available from other sources has been reviewed and is sufficient to fix certain maximum residue levels (MRLS). Where no Community maximum residue level or provisional MRL exists, Member States must establish a national provisional maximum residue level in accordance with Article 4(1)(f) of the Directive before the authorisation may be granted. In view of Article 5 of Directive 86/363/EEC, this also applies for provisional MRLs for animal products where commodities containing residues of an active substance may be expected to be used as animal feeds. (4) At their inclusion in Annex I to Directive 91/414/EEC, the technical and scientific evaluations of azimsulfuron, and prohexadione calcium were finalised on 2 July 1999, and 16 June 2000, respectively in the Commission review reports for azimsulfuron and prohexadione calcium. In these review reports the acceptable daily intake (ADI) for azimsulfuron was set at 0,1 mg/kg bw/day, and for prohexadione calcium at 0,2 mg/kg bw/day. The lifetime exposure of consumers of food products treated with azimsulfuron, and prohexadione calcium has been assessed and evaluated in accordance with the procedures and practices used within the Community, taking account of guidelines published by the World Health Organisation(9) and the opinion of the Scientific Committee for Plants(10) on this methodology. It has been calculated that the maximum residue levels provided for in this Directive do not result in these ADIs being exceeded. (5) Acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluations and discussions that preceded the inclusion of azimsulfuron, and prohexadione calcium in Annex I to Directive 91/414/EEC. (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 provisional maximum residue levels at the lower limit of analytical determination for all those products covered by Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. The setting at Community level of such provisional maximum residue levels does not prevent the Member States from establishing provisional maximum residue levels for azimsulfuron and prohexadione calcium in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. Four years is considered a sufficient period of time during which to establish most further uses of azimsulfuron and prohexadione calcium. After that period these provisional maximum residue levels should become definitive. (7) The measures provided for in this Directive were communicated to the World Trade Organisation and the comments received were taken into consideration. The possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the Commission on the basis of the submission of acceptable data. (8) The opinions of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account. (9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 In part A of Annex II to Directive 86/362/EEC the following rows are added: >TABLE> Article 2 In part B of Annex II to Directive 86/363/EEC the following row is added: >TABLE> Article 3 In Annex II to Directive 90/642/EEC the columns headed "Azimsulfuron", and "Prohexadione (prohexadione and its salts expressed as prohexadione)" set out in the Annex to this Directive are added. Article 4 Member States shall adopt and publish the provisions necessary to comply with this Directive by 31 December 2001 at the latest. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 January 2002. 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 its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.

32001L0037

2001

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 - Commission statement Having regard to the Treaty establishing the European Community, and in particular Articles 95 and 133 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 5 April 2001, Whereas: (1) Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use(5) was amended substantially by Directive 92/41/EEC(6). Since further amendments are to be made to that Directive, as well as to Council Directive 90/239/EEC of 17 May 1990 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the maximum tar yield of cigarettes(7), those Directives should be recast in the interests of clarity. (2) There are still substantial differences between the Member States' laws, regulations and administrative provisions on the manufacture, presentation, and sale of tobacco products which impede the functioning of the internal market. (3) Those barriers should be eliminated and, to this end, the rules relating to the manufacture, presentation and sale of tobacco products should be approximated, while leaving Member States the possibility of introducing, under certain conditions, such requirements as they consider necessary in order to guarantee the protection of the health of individuals. (4) In accordance with Article 95(3) of the Treaty, a high level of protection in terms of health, safety, environmental protection and consumer protection should be taken as a basis, regard being had, in particular, to any new developments based on scientific facts; in view of the particularly harmful effects of tobacco, health protection should be given priority in this context. (5) Directive 90/239/EEC established maximum limits for the tar yield of cigarettes marketed in the Member States with effect from 31 December 1992. The carcinogenic nature of tar makes it necessary to reduce further the levels of tar in cigarettes. (6) Directive 89/622/EEC established a general warning to be carried on the unit packaging of all tobacco products, together with additional warnings exclusively for cigarettes and, from 1992, extended the requirement for additional warnings to other tobacco products. (7) Several Member States have indicated that, if measures establishing maximum carbon monoxide yields for cigarettes are not adopted at Community level, they will adopt such measures at national level. Differences in rules concerning carbon monoxide are likely to constitute barriers to trade and to impede the smooth operation of the internal market. In addition, cigarettes have been shown to produce amounts of carbon monoxide which are hazardous to human health and capable of contributing to heart disease and other ailments. (8) A revision of the regulatory framework needs to evaluate evidence-based claims for tobacco products designed and/or marketed to "reduce risk", or for which harm reduction is claimed by the manufacturers. (9) There are differences between the laws, regulations and administrative provisions of the Member States on the limitation of the maximum nicotine yield of cigarettes. Such differences are liable to constitute barriers to trade and to impede the smooth operation of the internal market. Member States and scientific authorities have raised specific problems of public health in a field which has already been the subject of prior harmonisation measures, which the Commission has examined. (10) Those obstacles should accordingly be eliminated and to that end the release for free circulation, marketing and manufacture of cigarettes should be made subject to common rules not only concerning tar but also concerning maximum nicotine and carbon monoxide levels. (11) This Directive will also have consequences for tobacco products which are exported from the European Community. The export regime is part of the common commercial policy. Health requirements are, pursuant to Article 152(1) of the Treaty and the case law of the Court of Justice of the European Communities, to form a constituent part of the Community's other policies. Rules should be adopted in order to ensure that the internal market provisions are not undermined. (12) The provisions of this Directive are without prejudice to Community legislation governing the use and labelling of genetically modified organisms. (13) Internationally applicable standards for tobacco products are one of the subjects of the negotiations for the drafting of a World Health Organisation Framework Convention on Tobacco Control. (14) For measuring the tar, nicotine and carbon monoxide yields of cigarettes, reference should be made to ISO standards 4387, 10315 and 8454, which are the only internationally recognised standards, it being understood that subsequent research and technological progress to be promoted should make it possible to develop and use more precise and reliable measurement methods for cigarette yields and to develop measurement methods for the other tobacco products. (15) There are no internationally agreed standards or tests for quantifying and assessing the yields of constituents in cigarette smoke other than tar, nicotine and carbon monoxide. A procedure for development of such standards, in consultation with the International Standards Organisation, is therefore necessary. (16) In Directive 90/239/EEC, in view of particular socioeconomic problems, Greece was granted a derogation from the time limits for the implementation of maximum tar yields. That derogation should be maintained for the period stipulated. (17) The application of tar, nicotine and carbon monoxide ceilings to exported cigarettes should be subject to transitional arrangements in order to allow more time to change product specifications and to allow for the establishment of internationally agreed standards. (18) Transitional periods should also be provided for in relation to other provisions of this Directive in order to allow the necessary modifications in production to take place and for disposal of stocks, particularly for products other than cigarettes. Use of irremovable labels should be allowed to facilitate the introduction of the labelling requirements of this Directive. (19) The presentation of warning labels and yields has continued to remain variable in the different Member States. As a consequence, consumers in one Member State may be better informed as to the risks of tobacco products than in another. Such differences are unacceptable and are liable to constitute a barrier to trade and to impede the operation of the internal market in tobacco products, and should therefore be eliminated. It is necessary to that end that the existing legislation be strengthened and clarified, while ensuring a high level of health protection. (20) Provision should be made for batches of tobacco products to be marked so that those products are traceable for the purposes of monitoring compliance with this Directive. (21) The direct and indirect socioeconomic costs of active and passive tobacco use should be regularly evaluated and made available to the public in the context of the appropriate Community programmes. (22) The situation varies in the different Member States regarding the ingredients and additives used in the manufacture of tobacco products. A number of Member States have neither existing legislation nor voluntary agreements in place on those substances. Several Member States in which such legislation or voluntary agreements exist receive no information from tobacco manufacturers on the quantities of such ingredients and additives present in particular tobacco products on a brand name by brand name basis. An approximation of the measures applicable in this field should be introduced, resulting in greater transparency. (23) The lack of information together with the lack of toxicological data prevents the relevant authorities in the Member States from assessing in any meaningful manner the toxicity of, and hazards posed to the health of the consumer by, tobacco products. This is inconsistent with the obligation placed on the Community to ensure a high level of protection for human health. (24) Member States should be able to adopt more stringent rules concerning tobacco products which they deem necessary to protect public health, in so far as the rules in the Directive are not prejudiced, and subject to the provisions of the Treaty. (25) Pending the establishment of the common list of ingredients referred to in Article 12, Member States may provide for the prohibition of the use of ingredients which have the effect of increasing the addictive properties of tobacco products, since the use of such ingredients may undermine the limits on nicotine levels laid down in this Directive. (26) Tobacco products have been shown to contain and emit many noxious substances and known carcinogens hazardous to human health when burnt. In recent years it has also been shown that passive smoking is dangerous in particular to unborn children and infants and that it can cause or aggravate respiratory problems in persons inhaling smoke. Moreover, 80 % of new smokers in the Community are below the age of 18. The greatest possible transparency of product information should be ensured, while ensuring that appropriate account is taken of the commercial and intellectual property rights of the tobacco manufacturers. (27) The use on tobacco product packaging of certain texts, such as "low-tar", "light", "ultra-light", "mild", names, pictures and figurative or other signs, may mislead the consumer into the belief that such products are less harmful and give rise to changes in consumption. Smoking behaviour and addiction, and not only the content of certain substances contained in the product before consumption, also determine the level of inhaled substances. This fact is not reflected in the use of such terms and so may undermine the labelling requirements set in this Directive. In order to ensure the proper functioning of the internal market, and given the development of proposed international rules, the prohibition of such use should be provided for at Community level, giving sufficient time for introduction of this rule. (28) Directive 89/622/EEC prohibited the sale in the Member States of certain types of tobacco for oral use. Article 151 of the Act of Accession of Austria, Finland and Sweden grants the Kingdom of Sweden a derogation from the provisions of that Directive in this regard. (29) Technical and scientific progress in the field of tobacco products calls for regular re-evaluation of the provisions and the application of this Directive in Member States. To that end provision should be made for a procedure for the Commission to draw up regular reports supported by scientific and technical data. Certain data ought to be examined with particular attention in this context. (30) In connection with the fixing of maximum yields, it ought to be considered whether, on the one hand, it is advisable at a later date to reduce the yields fixed and in particular how, if at all, they are connected and, on the other hand, whether standards on these matters should be developed for products other than cigarettes, in particular rolling tobacco. (31) As regards tobacco products other than cigarettes, standards and measurement methodologies need to be developed at Community level, and to this end the Commission should be requested to submit appropriate proposals. (32) As regards the other ingredients, including additives, the drawing up of a common list ought to be considered, with a view to subsequent harmonisation. (33) The size of the internal market in tobacco products and the increasing tendency of tobacco manufacturers to concentrate production for the whole of the Community in only a small number of production plants within the Member States, calls for legislative action to achieve the smooth operation of the internal market in tobacco products to be carried out at Community rather than national level. (34) The functioning of the common organisation of the market in raw tobacco is to be the subject of a Commission report to the European Parliament and Council in 2002(8). The Commission has indicated that such report will also examine the issue of integration of public health considerations, including the standards established in this Directive, in other Community policies, as required under Article 152 of the Treaty. (35) In applying this Directive, provision should be made for establishing time limits which allow, on the one hand, completion to a maximum degree of efficiency of the process of conversion already begun by Directive 90/239/EEC, and, on the other, consumers and manufacturers to adapt to products with a lower tar, nicotine and carbon monoxide yield. (36) 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(9). (37) This Directive should be without prejudice to the time limits within which the Member States must transpose and apply the Directives set out in Annex II, Article 1 Aim The aim of this Directive is to approximate the laws, regulations and administrative provisions of the Member States concerning the maximum tar, nicotine and carbon monoxide yields of cigarettes and the warnings regarding health and other information to appear on unit packets of tobacco products, together with certain measures concerning the ingredients and the descriptions of tobacco products, taking as a basis a high level of health protection. Article 2 Definitions For the purposes of this Directive: 1. "tobacco products" means products for the purposes of smoking, sniffing, sucking or chewing, inasmuch as they are, even partly, made of tobacco, whether genetically modified or not; 2. "tar" means the raw anhydrous nicotine-free condensate of smoke; 3. "nicotine" means nicotinic alkaloids; 4. "tobacco for oral use" means all products for oral use, except those intended to be smoked or chewed, made wholly or partly of tobacco, in powder or in particulate form or in any combination of those forms, particularly those presented in sachet portions or porous sachets, or in a form resembling a food product; 5. "ingredient" means any substance or any constituent except for tobacco leaf and other natural or unprocessed tobacco plant parts used in the manufacture or preparation of a tobacco product and still present in the finished product, even if in altered form, including paper, filter, inks and adhesives. Article 3 Cigarettes: maximum tar, nicotine and carbon monoxide yields 1. From 1 January 2004, the yield of cigarettes released for free circulation, marketed or manufactured in the Member States shall not be greater than: - 10 mg per cigarette for tar, - 1 mg per cigarette for nicotine, - 10 mg per cigarette for carbon monoxide. 2. By way of derogation from the date referred to in paragraph 1, as regards cigarettes manufactured within, but exported from, the European Community, Member States may apply the yield limits laid down in this Article as from 1 January 2005 but shall in any event do so by 1 January 2007 at the latest. 3. For Greece, as a temporary derogation, the date of application of the maximum tar yield of cigarettes manufactured and marketed within its territory, as referred to in paragraph 1, shall be 1 January 2007. Article 4 Measurement methods 1. The tar, nicotine and carbon monoxide yields of cigarettes shall be measured on the basis of ISO standards 4387 for tar, 10315 for nicotine, and 8454 for carbon monoxide. The accuracy of the tar and nicotine indications on packets shall be verified in accordance with ISO standard 8243. 2. The tests referred to in paragraph 1 shall be carried out or verified by testing laboratories which are approved and monitored by the competent authorities of the Member States. Member States shall send the Commission a list of approved laboratories, specifying the criteria used for approval and the methods of monitoring applied, by 30 September 2002, and whenever any change is made. 3. Member States may also require tobacco manufacturers or importers to carry out any other tests as may be laid down by the competent national authorities in order to assess the yield of other substances produced by their tobacco products on a brand-name-by-brand-name basis and type-by-type-basis and in order to assess the effects of those other substances on health, taking into account, inter alia, their addictiveness. Member States may also require that such tests be carried out or verified in approved testing laboratories as laid down in paragraph 2. 4. The results of tests carried out in accordance with paragraph 3 shall be submitted to the relevant national authorities on an annual basis. Member States may provide for less frequent disclosure of test results in cases where the product specifications have not varied. Member States shall be informed of changes in such product specifications Member States shall ensure the dissemination, by any appropriate means, of information submitted in accordance with this Article with a view to informing consumers and in so doing shall take account, where appropriate, of any information which constitutes a trade secret. 5. Each year Member States shall communicate all data and information submitted pursuant to this Article to the Commission, which shall take account thereof when drawing up the report referred to in Article 11. Article 5 Labelling 1. The tar, nicotine and carbon monoxide yields of cigarettes measured in accordance with Article 4 shall be printed on one side of the cigarette packet in the official language or languages of the Member State where the product is placed on the market, so that at least 10 % of the corresponding surface is covered. That percentage shall be raised to 12 % for Member States with two official languages and to 15 % for Member States with three official languages. 2. Each unit packet of tobacco products, except for tobacco for oral use and other smokeless tobacco products must carry the following warnings: (a) general warnings: 1. "Smoking kills/Smoking can kill," or 2. "Smoking seriously harms you and others around you." The general warnings indicated above shall be rotated in such a way as to guarantee their regular appearance. The warning shall be printed on the most visible surface of the unit packet, and on any outside packaging, with the exception of additional transparent wrappers, used in the retail sale of the product; and (b) an additional warning taken from the list set out in Annex I. The additional warnings referred to above shall be rotated in such a way as to guarantee their regular appearance. That warning shall be printed on the other most visible surface of the unit packet, and on any outside packaging, with the exception of additional transparent wrappers, used in the retail sale of the product. Member States may determine the positioning of the warnings on those surfaces in order to accommodate language requirements. 3. The Commission shall, as soon as practicable and in any event not later than 31 December 2002, in accordance with the procedure laid down in Article 10(2), adopt rules for the use of colour photographs or other illustrations to depict and explain the health consequences of smoking, with a view to ensuring that internal market provisions are not undermined. Where Member States require additional warnings in the form of colour photographs or other illustrations, these shall be in accordance with the abovementioned rules. 4. Tobacco products for oral use, where their marketing is permitted under Article 8, and smokeless tobacco products shall carry the following warning: "This tobacco product can damage your health and is addictive." This warning shall be printed on the most visible surface of the unit packet and on any outside packaging, with the exception of additional transparent wrappers, used in the retail sale of the product. Member States may determine the positioning of the warning on that surface in order to accommodate language requirements. 5. The general warning required pursuant to paragraph 2(a) and the warning for smokeless and oral tobacco products referred to in paragraph 4 shall cover not less than 30 % of the external area of the corresponding surface of the unit packet of tobacco on which it is printed. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with three official languages. The additional warning required pursuant to paragraph 2(b) shall cover not less than 40 % of the external area of the corresponding surface of the unit packet of tobacco on which it is printed. That proportion shall be increased to 45 % for Member States with two official languages and 50 % for Member States with three official languages. However, in the case of unit packets intended for products other than cigarettes, the most visible surface of which exceeds 75 cm2, the warnings referred to in paragraph 2 shall cover an area of at least 22,5 cm2 on each surface. That area shall be increased to 24 cm2 for Member States with two official languages and 26,25 cm2 for Member States with three official languages. 6. The text of warnings and yield indications required under this Article shall be: (a) printed in black Helvetica bold type on a white background. In order to accommodate language requirements, Member States shall have the right to determine the point size of the font, provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required; (b) in lower-case type, except for the first letter of the message and where required by grammar usage; (c) centred in the area in which the text is required to be printed, parallel to the top edge of the packet; (d) for products other than those referred to in paragraph 4, surrounded by a black border not less than 3 mm and not more than 4 mm in width which in no way interferes with the text of the warning or information given; (e) in the official language or languages of the Member State where the product is placed on the market. 7. The printing of the texts required by this Article on the tax stamps of unit packets shall be prohibited. The texts shall be irremovably printed, indelible and shall in no way be hidden, obscured or interrupted by other written or pictorial matter or by the opening of the packet. In the case of tobacco products other than cigarettes, the texts may be affixed by means of stickers, provided that such stickers are irremovable. 8. Member States may stipulate that the warnings referred to in paragraphs 2 and 4 are to be accompanied by a reference, outside the box for warnings, to the issuing authority. 9. To ensure product identification and traceability, the tobacco product shall be marked in any appropriate manner, by batch numbering or equivalent, on the unit packet enabling the place and time of manufacture to be determined. The technical measures to apply this provision shall be adopted in accordance with the procedure laid down in Article 10(2). Article 6 Further product information 1. Member States shall require manufacturers and importers of tobacco products to submit to them a list of all ingredients, and quantities thereof, used in the manufacture of those tobacco products by brand name and type. This list shall be accompanied by a statement setting out the reasons for the inclusion of such ingredients in those tobacco products. It shall indicate their function and category. The list shall also be accompanied by the toxicological data available to the manufacturer or importer regarding these ingredients in burnt or unburnt form as appropriate, referring in particular to their effects on health and taking into account, inter alia, any addictive effects. The list shall be established in descending order of the weight of each ingredient included in the product. The information referred to in the first subparagraph shall be provided on a yearly basis and for the first time by 31 December 2002 at the latest. 2. Member States shall ensure the dissemination of the information provided in accordance with this article by any appropriate means, with a view to informing consumers. Due account shall nevertheless be taken of protection of any information on specific product formulae which constitutes a trade secret. 3. Member States shall ensure that the list of ingredients for each product, indicating tar, nicotine and carbon monoxide yields, is made public. 4. Each year Member States shall communicate all data and information submitted pursuant to this Article to the Commission, which shall take account thereof when drawing up the report referred to in Article 11. Article 7 Product descriptions With effect from 30 September 2003, and without prejudice to Article 5(1), texts, names, trade marks and figurative or other signs suggesting that a particular tobacco product is less harmful than others shall not be used on the packaging of tobacco products. Article 8 Tobacco for oral use Member States shall prohibit the placing on the market of tobacco for oral use, without prejudice to Article 151 of the Act of Accession of Austria, Finland and Sweden. Article 9 Adaptations The Commission shall, in accordance with the procedure laid down in Article 10(2), adapt to scientific and technical progress: (a) the measurement methods laid down in Article 4 and the definitions relating thereto; (b) the health warnings to be shown on unit packets of tobacco products as set out in Annex I and the frequency of rotation of the health warnings; (c) the marking for identification and tracing purposes of tobacco products. Article 10 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 11 Report No later than 31 December 2004, and every two years thereafter, the Commission shall submit to the European Parliament, the Council and the Economic and Social Committee a report on the application of this Directive. With a view to drafting the report referred to in the first paragraph, the Commission shall be assisted by scientific and technical experts in order to have all the necessary information available. On submission of the first report, the Commission shall indicate in particular the features which should be reviewed or developed in the light of developments in scientific and technical knowledge, including the development of internationally agreed rules and standards on products, and shall pay special heed to: - subsequent reduction of the maximum yields laid down in Article 3(1), - possible links between these yields, - improvements in health warnings, in terms of size, position and wording, - new scientific and technical information regarding labelling and the printing on cigarette packets of photographs or other illustrations to depict and explain the health consequences of smoking, - methodologies for more realistically assessing and regulating toxic exposure and harm, - evaluation of the addictive effects of those ingredients which encourage addiction, - evaluation of tobacco products which may have the potential to reduce harm, - development of standardised testing methods to measure the yields of constituents in cigarette smoke other than tar, nicotine and carbon monoxide, - toxicological data to be required from manufacturers on ingredients and the manner in which they should be tested in order to allow public health authorities to assess their use, - development of standards concerning products other than cigarettes, in particular rolling tobacco. The report shall also examine the links between the labelling requirements laid down in Article 5 and consumer behaviour. That report shall be accompanied by any proposals for amendments to this Directive which the Commission deems necessary to adapt it to developments in the field of tobacco products, to the extent necessary for the establishment and operation of the internal market, and to take into account any new development based on scientific facts and developments on internationally agreed product standards. Article 12 Common list of ingredients In the framework of the first report referred to in Article 11, at the latest by 31 December 2004, and with a view to the proper functioning of the internal market, the Commission is invited to submit, on the basis of the information provided under Article 6, a proposal providing for a common list of ingredients authorised for tobacco products, taking into account, inter alia, their addictiveness. Article 13 Import, sale and consumption of tobacco products 1. Member States may not, for considerations relating to the limitation of the tar, nicotine or carbon monoxide yields of cigarettes, to health warnings and other indications or to other requirements of this Directive, prohibit or restrict the import, sale or consumption of tobacco products which comply with this Directive, with the exception of measures taken for the purposes of verifying the data provided under Article 4. 2. This Directive shall not affect the right of Member States to keep or introduce, in accordance with the Treaty, more stringent rules concerning the manufacture, import, sale and consumption of tobacco products which they deem necessary in order to protect public health, in-so-far as such rules do not prejudice the rules laid down in this Directive. 3. In particular, Member States may provide for the prohibition, pending the establishment of the common list of ingredients referred to in Article 12, of the use of ingredients which have the effect of increasing the addictive properties of tobacco products. Article 14 Implementation 1. Without prejudice to the first paragraph of Article 15, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 2002 at the latest. 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 on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Products which do not comply with the provisions of this Directive may continue to be marketed for one year after the date referred to in paragraph 1. 3. By way of derogation from paragraph 2, products other than cigarettes which do not comply with the provisions of this Directive may continue to be marketed for two years after the date referred to in paragraph 1. 4. Member States shall communicate to the Commission the text of the provisions of domestic law which they adopt in the field governed by this Directive. Article 15 Repeal Directives 89/622/EEC and 90/239/EEC are hereby repealed, without prejudice to the obligations of Member States concerning the time limits for transposition and application of the Directives listed in Annex II. References to the Directives repealed shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III. 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.

32001L0041

2001

Directive 2001/41/EC of the European Parliament and of the Council of 19 June 2001 amending, for the twenty-first 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, as regards substances classified as carcinogens, mutagens or substances toxic to reproduction 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), Whereas: (1) Article 14 of the Treaty provides for the establishment of an area without internal frontiers 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 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) 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 fourteenth 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 in category 1 or 2. Such substances and preparations 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 relating to the classification, packaging and labelling of dangerous substances(7), which contains substances classified as carcinogenic, mutagenic or toxic to reproduction in category 1 or 2. (6) Commission Directive 97/69/EC of 5 December 1997 adapting for the twenty-third time Directive 67/548/EEC, and more particularly Annex I thereto, to technical progress, contains one substance newly classified as carcinogenic in category 2 and Commission Directive 98/73/EC(8) of 18 September 1998 adapting for the twenty-fourth time Directive 67/548/EEC(9), and more particularly Annex 1 thereto, to technical progress, contains one substance newly classified as carcinogenic in category 2 and one substance newly classified as toxic to reproduction in category 2. These substances should be added to the Appendix concerning points 29 and 31 of Annex I to Directive 76/769/EEC. (7) The risks and advantages of the substances newly classified, by Directives 97/69/EC and 98/73/EC, as carcinogenic in category 2 or toxic to reproduction in category 2 have been taken into account. (8) This Directive applies 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 (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(11), Article 1 The Appendix to Annex I to Directive 76/769/EEC shall be amended as follows: 1. In the introduction, the Note R below shall be added: ">TABLE> Note R: The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter, less two standard errors, greater than 6μm." 2. The substances listed in the Annex to this Directive shall be added to those substances listed in the Appendix concerning points 29 and 31. Article 2 1. The Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 18 July 2002. They shall forthwith inform the Commission thereof. They shall apply those provisions from 18 January 2003. 2. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. Member Sates shall determine how such reference is to be made. Article 3 This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32001L0045

2001

Directive 2001/45/EC of the European Parliament and of the Council of 27 June 2001 amending Council Directive 89/655/EEC concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (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, submitted after consulting the Advisory Committee on Safety, Hygiene and Health Protection at Work(1), Having regard to the opinion of the Economic and Social Committee(2), After consulting the Committee of the Regions, Acting in accordance with the procedure referred to in Article 251 of the Treaty(3), Whereas: (1) Article 137(2) of the Treaty provides that the Council may adopt, by means of Directives, minimum requirements for encouraging improvements, especially in the working environment, to ensure a better level of protection of the safety and health of workers. (2) Pursuant to the said Article, such Directives must avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized enterprises. (3) The improvement of occupational safety, hygiene and health is an objective which may not be subordinated to purely economic considerations. (4) Compliance with the minimum requirements designed to ensure a better standard of health and safety in the use of work equipment provided for temporary work at a height is essential to ensure the health and safety of workers. (5) The provisions adopted pursuant to Article 137(2) of the Treaty do not prevent any Member State from maintaining or introducing such more stringent measures for the protection of working conditions as are compatible with the Treaty. (6) Work at a height may expose workers to particularly severe risks to their health and safety, notably to the risks of falls from a height and other serious occupational accidents, which account for a large proportion of all accidents, especially of fatal accidents. (7) Self-employed persons and employers, where they themselves pursue an occupational activity and personally use work equipment intended for carrying out temporary work at a height, may affect employees' health and safety. (8) Council Directive 92/57/EEC of 24 June 1992 on the implementation of minimum safety and health requirements at temporary or mobile construction sites (eighth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(4), imposes on these categories of persons the obligation to respect inter alia Article 4 and Annex I of Directive 89/655/EEC(5). (9) Any employer who intends to have temporary work carried out at a height must select equipment affording adequate protection against the risks of falls from a height. (10) In general collective protection measures to prevent falls offer better protection than personal protection measures. The selection and use of equipment appropriate to each specific site for preventing and eliminating risks should be accompanied by specific training and supplementary investigations where appropriate. (11) Ladders, scaffolding and ropes are the equipment most commonly used in performing temporary work at a height and the safety and health of workers engaged in this type of work therefore depend to a significant extent on their correct use; the manner in which such equipment can most safely be used by workers must therefore be specified; adequate specific training of the workers is therefore required. (12) This Directive is the most appropriate means of achieving the desired objectives and does not go beyond what is necessary for that purpose. (13) This Directive is a practical contribution towards creating the social dimension of the internal market. (14) Member States should be given the opportunity to make use of a transitional period to take account of the particular problems which SMEs have to face, Article 1 The text annexed to this Directive shall be added to Annex II to Directive 89/655/EEC. Article 2 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 19 July 2004. They shall forthwith inform the Commission thereof. Member States shall have the right, as regards the implementation of section 4 of the Annex, to make use of a transitional period of not more than two years from the date mentioned in the first subparagraph, in order to take account of the various situations which might arise from the practical implementation of this Directive in particular by small and medium-sized enterprises. 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. 3. Member States shall notify the Commission of the provisions of national law which they have already adopted or 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 This Directive is addressed to the Member States.

32001L0042

2001

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 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), in the light of the joint text approved by the Conciliation Committee on 21 March 2001, Whereas: (1) Article 174 of the Treaty provides that Community policy on the environment is to contribute to, inter alia, the preservation, protection and improvement of the quality of the environment, the protection of human health and the prudent and rational utilisation of natural resources and that it is to be based on the precautionary principle. Article 6 of the Treaty provides that environmental protection requirements are to be integrated into the definition of Community policies and activities, in particular with a view to promoting sustainable development. (2) The Fifth Environment Action Programme: Towards sustainability - A European Community programme of policy and action in relation to the environment and sustainable development(5), supplemented by Council Decision No 2179/98/EC(6) on its review, affirms the importance of assessing the likely environmental effects of plans and programmes. (3) The Convention on Biological Diversity requires Parties to integrate as far as possible and as appropriate the conservation and sustainable use of biological diversity into relevant sectoral or cross-sectoral plans and programmes. (4) Environmental assessment is an important tool for integrating environmental considerations into the preparation and adoption of certain plans and programmes which are likely to have significant effects on the environment in the Member States, because it ensures that such effects of implementing plans and programmes are taken into account during their preparation and before their adoption. (5) The adoption of environmental assessment procedures at the planning and programming level should benefit undertakings by providing a more consistent framework in which to operate by the inclusion of the relevant environmental information into decision making. The inclusion of a wider set of factors in decision making should contribute to more sustainable and effective solutions. (6) The different environmental assessment systems operating within Member States should contain a set of common procedural requirements necessary to contribute to a high level of protection of the environment. (7) The United Nations/Economic Commission for Europe Convention on Environmental Impact Assessment in a Transboundary Context of 25 February 1991, which applies to both Member States and other States, encourages the parties to the Convention to apply its principles to plans and programmes as well; at the second meeting of the Parties to the Convention in Sofia on 26 and 27 February 2001, it was decided to prepare a legally binding protocol on strategic environmental assessment which would supplement the existing provisions on environmental impact assessment in a transboundary context, with a view to its possible adoption on the occasion of the 5th Ministerial Conference "Environment for Europe" at an extraordinary meeting of the Parties to the Convention, scheduled for May 2003 in Kiev, Ukraine. The systems operating within the Community for environmental assessment of plans and programmes should ensure that there are adequate transboundary consultations where the implementation of a plan or programme being prepared in one Member State is likely to have significant effects on the environment of another Member State. The information on plans and programmes having significant effects on the environment of other States should be forwarded on a reciprocal and equivalent basis within an appropriate legal framework between Member States and these other States. (8) Action is therefore required at Community level to lay down a minimum environmental assessment framework, which would set out the broad principles of the environmental assessment system and leave the details to the Member States, having regard to the principle of subsidiarity. Action by the Community should not go beyond what is necessary to achieve the objectives set out in the Treaty. (9) This Directive is of a procedural nature, and its requirements should either be integrated into existing procedures in Member States or incorporated in specifically established procedures. With a view to avoiding duplication of the assessment, Member States should take account, where appropriate, of the fact that assessments will be carried out at different levels of a hierarchy of plans and programmes. (10) All plans and programmes which are prepared for a number of sectors and which set a framework for future development consent of projects listed in Annexes I and II to Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment(7), and all plans and programmes which have been determined to require assessment pursuant to Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild flora and fauna(8), are likely to have significant effects on the environment, and should as a rule be made subject to systematic environmental assessment. When they determine the use of small areas at local level or are minor modifications to the above plans or programmes, they should be assessed only where Member States determine that they are likely to have significant effects on the environment. (11) Other plans and programmes which set the framework for future development consent of projects may not have significant effects on the environment in all cases and should be assessed only where Member States determine that they are likely to have such effects. (12) When Member States make such determinations, they should take into account the relevant criteria set out in this Directive. (13) Some plans or programmes are not subject to this Directive because of their particular characteristics. (14) Where an assessment is required by this Directive, an environmental report should be prepared containing relevant information as set out in this Directive, identifying, describing and evaluating the likely significant environmental effects of implementing the plan or programme, and reasonable alternatives taking into account the objectives and the geographical scope of the plan or programme; Member States should communicate to the Commission any measures they take concerning the quality of environmental reports. (15) In order to contribute to more transparent decision making and with the aim of ensuring that the information supplied for the assessment is comprehensive and reliable, it is necessary to provide that authorities with relevant environmental responsibilities and the public are to be consulted during the assessment of plans and programmes, and that appropriate time frames are set, allowing sufficient time for consultations, including the expression of opinion. (16) Where the implementation of a plan or programme prepared in one Member State is likely to have a significant effect on the environment of other Member States, provision should be made for the Member States concerned to enter into consultations and for the relevant authorities and the public to be informed and enabled to express their opinion. (17) The environmental report and the opinions expressed by the relevant authorities and the public, as well as the results of any transboundary consultation, should be taken into account during the preparation of the plan or programme and before its adoption or submission to the legislative procedure. (18) Member States should ensure that, when a plan or programme is adopted, the relevant authorities and the public are informed and relevant information is made available to them. (19) Where the obligation to carry out assessments of the effects on the environment arises simultaneously from this Directive and other Community legislation, such as Council Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds(9), Directive 92/43/EEC, or Directive 2000/60/EC of the European Parliament and the Council of 23 October 2000 establishing a framework for Community action in the field of water policy(10), in order to avoid duplication of the assessment, Member States may provide for coordinated or joint procedures fulfilling the requirements of the relevant Community legislation. (20) A first report on the application and effectiveness of this Directive should be carried out by the Commission five years after its entry into force, and at seven-year intervals thereafter. With a view to further integrating environmental protection requirements, and taking into account the experience acquired, the first report should, if appropriate, be accompanied by proposals for amendment of this Directive, in particular as regards the possibility of extending its scope to other areas/sectors and other types of plans and programmes, Article 1 Objectives The objective of this Directive is to provide for a high level of protection of the environment and to contribute to the integration of environmental considerations into the preparation and adoption of plans and programmes with a view to promoting sustainable development, by ensuring that, in accordance with this Directive, an environmental assessment is carried out of certain plans and programmes which are likely to have significant effects on the environment. Article 2 Definitions For the purposes of this Directive: (a) "plans and programmes" shall mean plans and programmes, including those co-financed by the European Community, as well as any modifications to them: - which are subject to preparation and/or adoption by an authority at national, regional or local level or which are prepared by an authority for adoption, through a legislative procedure by Parliament or Government, and - which are required by legislative, regulatory or administrative provisions; (b) "environmental assessment" shall mean the preparation of an environmental report, the carrying out of consultations, the taking into account of the environmental report and the results of the consultations in decision-making and the provision of information on the decision in accordance with Articles 4 to 9; (c) "environmental report" shall mean the part of the plan or programme documentation containing the information required in Article 5 and Annex I; (d) "The 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 Scope 1. An environmental assessment, in accordance with Articles 4 to 9, shall be carried out for plans and programmes referred to in paragraphs 2 to 4 which are likely to have significant environmental effects. 2. Subject to paragraph 3, an environmental assessment shall be carried out for all plans and programmes, (a) which are prepared for agriculture, forestry, fisheries, energy, industry, transport, waste management, water management, telecommunications, tourism, town and country planning or land use and which set the framework for future development consent of projects listed in Annexes I and II to Directive 85/337/EEC, or (b) which, in view of the likely effect on sites, have been determined to require an assessment pursuant to Article 6 or 7 of Directive 92/43/EEC. 3. Plans and programmes referred to in paragraph 2 which determine the use of small areas at local level and minor modifications to plans and programmes referred to in paragraph 2 shall require an environmental assessment only where the Member States determine that they are likely to have significant environmental effects. 4. Member States shall determine whether plans and programmes, other than those referred to in paragraph 2, which set the framework for future development consent of projects, are likely to have significant environmental effects. 5. Member States shall determine whether plans or programmes referred to in paragraphs 3 and 4 are likely to have significant environmental effects either through case-by-case examination or by specifying types of plans and programmes or by combining both approaches. For this purpose Member States shall in all cases take into account relevant criteria set out in Annex II, in order to ensure that plans and programmes with likely significant effects on the environment are covered by this Directive. 6. In the case-by-case examination and in specifying types of plans and programmes in accordance with paragraph 5, the authorities referred to in Article 6(3) shall be consulted. 7. Member States shall ensure that their conclusions pursuant to paragraph 5, including the reasons for not requiring an environmental assessment pursuant to Articles 4 to 9, are made available to the public. 8. The following plans and programmes are not subject to this Directive: - plans and programmes the sole purpose of which is to serve national defence or civil emergency, - financial or budget plans and programmes. 9. This Directive does not apply to plans and programmes co-financed under the current respective programming periods(11) for Council Regulations (EC) No 1260/1999(12) and (EC) No 1257/1999(13). Article 4 General obligations 1. The environmental assessment referred to in Article 3 shall be carried out during the preparation of a plan or programme and before its adoption or submission to the legislative procedure. 2. The requirements of this Directive shall either be integrated into existing procedures in Member States for the adoption of plans and programmes or incorporated in procedures established to comply with this Directive. 3. Where plans and programmes form part of a hierarchy, Member States shall, with a view to avoiding duplication of the assessment, take into account the fact that the assessment will be carried out, in accordance with this Directive, at different levels of the hierarchy. For the purpose of, inter alia, avoiding duplication of assessment, Member States shall apply Article 5(2) and (3). Article 5 Environmental report 1. Where an environmental assessment is required under Article 3(1), an environmental report shall be prepared in which the likely significant effects on the environment of implementing the plan or programme, and reasonable alternatives taking into account the objectives and the geographical scope of the plan or programme, are identified, described and evaluated. The information to be given for this purpose is referred to in Annex I. 2. The environmental report prepared pursuant to paragraph 1 shall include the information that may reasonably be required taking into account current knowledge and methods of assessment, the contents and level of detail in the plan or programme, its stage in the decision-making process and the extent to which certain matters are more appropriately assessed at different levels in that process in order to avoid duplication of the assessment. 3. Relevant information available on environmental effects of the plans and programmes and obtained at other levels of decision-making or through other Community legislation may be used for providing the information referred to in Annex I. 4. The authorities referred to in Article 6(3) shall be consulted when deciding on the scope and level of detail of the information which must be included in the environmental report. Article 6 Consultations 1. The draft plan or programme and the environmental report prepared in accordance with Article 5 shall be made available to the authorities referred to in paragraph 3 of this Article and the public. 2. The authorities referred to in paragraph 3 and the public referred to in paragraph 4 shall be given an early and effective opportunity within appropriate time frames to express their opinion on the draft plan or programme and the accompanying environmental report before the adoption of the plan or programme or its submission to the legislative procedure. 3. Member States shall designate the authorities to be consulted which, by reason of their specific environmental responsibilities, are likely to be concerned by the environmental effects of implementing plans and programmes. 4. Member States shall identify the public for the purposes of paragraph 2, including the public affected or likely to be affected by, or having an interest in, the decision-making subject to this Directive, including relevant non-governmental organisations, such as those promoting environmental protection and other organisations concerned. 5. The detailed arrangements for the information and consultation of the authorities and the public shall be determined by the Member States. Article 7 Transboundary consultations 1. Where a Member State considers that the implementation of a plan or programme being prepared in relation to its territory 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 plan or programme is being prepared shall, before its adoption or submission to the legislative procedure, forward a copy of the draft plan or programme and the relevant environmental report to the other Member State. 2. Where a Member State is sent a copy of a draft plan or programme and an environmental report under paragraph 1, it shall indicate to the other Member State whether it wishes to enter into consultations before the adoption of the plan or programme or its submission to the legislative procedure and, if it so indicates, the Member States concerned shall enter into consultations concerning the likely transboundary environmental effects of implementing the plan or programme and the measures envisaged to reduce or eliminate such effects. Where such consultations take place, the Member States concerned shall agree on detailed arrangements to ensure that the authorities referred to in Article 6(3) and the public referred to in Article 6(4) in the Member State likely to be significantly affected are informed and given an opportunity to forward their opinion within a reasonable time-frame. 3. Where Member States are required under this Article to enter into consultations, they shall agree, at the beginning of such consultations, on a reasonable timeframe for the duration of the consultations. Article 8 Decision making The environmental report prepared pursuant to Article 5, the opinions expressed pursuant to Article 6 and the results of any transboundary consultations entered into pursuant to Article 7 shall be taken into account during the preparation of the plan or programme and before its adoption or submission to the legislative procedure. Article 9 Information on the decision 1. Member States shall ensure that, when a plan or programme is adopted, the authorities referred to in Article 6(3), the public and any Member State consulted under Article 7 are informed and the following items are made available to those so informed: (a) the plan or programme as adopted; (b) a statement summarising how environmental considerations have been integrated into the plan or programme and how the environmental report prepared pursuant to Article 5, the opinions expressed pursuant to Article 6 and the results of consultations entered into pursuant to Article 7 have been taken into account in accordance with Article 8 and the reasons for choosing the plan or programme as adopted, in the light of the other reasonable alternatives dealt with, and (c) the measures decided concerning monitoring in accordance with Article 10. 2. The detailed arrangements concerning the information referred to in paragraph 1 shall be determined by the Member States. Article 10 Monitoring 1. Member States shall monitor the significant environmental effects of the implementation of plans and programmes in order, inter alia, to identify at an early stage unforeseen adverse effects, and to be able to undertake appropriate remedial action. 2. In order to comply with paragraph 1, existing monitoring arrangements may be used if appropriate, with a view to avoiding duplication of monitoring. Article 11 Relationship with other Community legislation 1. An environmental assessment carried out under this Directive shall be without prejudice to any requirements under Directive 85/337/EEC and to any other Community law requirements. 2. For plans and programmes for which the obligation to carry out assessments of the effects on the environment arises simultaneously from this Directive and other Community legislation, Member States may provide for coordinated or joint procedures fulfilling the requirements of the relevant Community legislation in order, inter alia, to avoid duplication of assessment. 3. For plans and programmes co-financed by the European Community, the environmental assessment in accordance with this Directive shall be carried out in conformity with the specific provisions in relevant Community legislation. Article 12 Information, reporting and review 1. Member States and the Commission shall exchange information on the experience gained in applying this Directive. 2. Member States shall ensure that environmental reports are of a sufficient quality to meet the requirements of this Directive and shall communicate to the Commission any measures they take concerning the quality of these reports. 3. Before 21 July 2006 the Commission shall send a first report on the application and effectiveness of this Directive to the European Parliament and to the Council. With a view further to 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 areas/sectors and other types of plans and programmes. A new evaluation report shall follow at seven-year intervals. 4. The Commission shall report on the relationship between this Directive and Regulations (EC) No 1260/1999 and (EC) No 1257/1999 well ahead of the expiry of the programming periods provided for in those Regulations, with a view to ensuring a coherent approach with regard to this Directive and subsequent Community Regulations. Article 13 Implementation of the Directive 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 21 July 2004. They shall forthwith inform the Commission thereof. 2. When Member States adopt the 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. 3. The obligation referred to in Article 4(1) shall apply to the plans and programmes of which the first formal preparatory act is subsequent to the date referred to in paragraph 1. Plans and programmes of which the first formal preparatory act is before that date and which are adopted or submitted to the legislative procedure more than 24 months thereafter, shall be made subject to the obligation referred to in Article 4(1) unless Member States decide on a case by case basis that this is not feasible and inform the public of their decision. 4. Before 21 July 2004, Member States shall communicate to the Commission, in addition to the measures referred to in paragraph 1, separate information on the types of plans and programmes which, in accordance with Article 3, would be subject to an environmental assessment pursuant to this Directive. The Commission shall make this information available to the Member States. The information will be updated on a regular basis. 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.

32001L0048

2001

Commission Directive 2001/48/EC of 28 June 2001 amending the Annexes to Council Directives 86/362/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals and certain products of plant origin, including fruit and vegetables respectively (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 2001/39/EC(2), and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November1990 on the 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 2001/39/EC, and in particular Article 7 thereof, Having regard to Council Directive 91/414/EEC of 15 July 1991 on the placing of plant protection products on the market(4), as last amended by Commission Directive 2001/47/EC(5), and in particular Article 4(1)(f) thereof, Whereas: (1) The new active substances, azoxystrobin and kresoxim methyl, were included in Annex I to Directive 91/414/EEC by Commission Directives 98/47/EC(6) and 1999/1/EC(7), respectively, for use as fungicides only, without specifying particular conditions having an impact on crops which may be treated with plant protection products containing these active ingredients. (2) Maximum residue levels in and on all commodities covered by Directives 86/362/EEC and 90/642/EEC were fixed by Commission Directives 1999/71/EC(8) and 2000/48/EC(9) for azoxystrobin residues, and by Commission Directive 2000/58/EC(10) for kresoxim methyl residues. (3) In fixing the said maximum residue levels, it was recognised that these levels should be kept under review and should be changed to take account of new information and data. Directives 1999/71/EC, 2000/48/EC and 2000/58/EC acknowledged that national provisional maximum residue levels for other cereals and fruit and vegetables should be fixed by Member States as a part of their authorisation of plant protection products containing azoxystrobin or kresoxim methyl and should be notified to the Commission under the requirements of Article 4(1)(f) to Directive 91/414/EEC. To facilitate this eventuality, some of the levels set in Directives 1999/71/EC and 2000/48/EC and all of the levels set in Directive 2000/58/EC were fixed on a provisional basis, enabling Member States to grant further authorisations for new uses and to notify the Commission under the procedure described by the said Article. This Article provides that where a provisional Community maximum residue level exists and where the new authorised use would lead to higher levels, the authorising Member State shall establish a national provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC before the authorisation may be granted. (4) To ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it was considered prudent, in adopting Directives 1999/71/EC, 2000/48/EC and 2000/58/EC, to set provisional maximum residue levels at the lower level of analytical determination for such products. The setting at Community level of such provisional maximum residue levels is without prejudice to the granting of provisional authorisations by the Member States for uses of azoxystrobin and/or kresoxim methyl on such products in accordance with Article 4(1)(f) of Directive 91/414/EEC. (5) In order to authorise a plant protection product, Member States must apply the uniform principles provided for in Annex VI to Directive 91/414/EEC in evaluating, in particular, a dossier conforming to the requirements of Annex III to Directive 91/414/EEC, submitted by the applicant for authorisation. Annex III, Part A, section 8 of Directive 91/414/EEC requires applicants to submit certain information including proposed maximum residue levels together with full justification and estimations of the potential and actual exposure through diet and other means. Annex VI, part B, section 2.4.2 and Part C, section 2.5 of Directive 91/414/EEC requires Member States to evaluate the information submitted concerning impact on human or animal health arising from residues and the impact on the environment and to take decisions on authorisations which ensure that residues occurring reflect the minimum quantities of the plant protection product necessary to achieve adequate control corresponding to good agricultural practice, applied in such a manner that the residues at harvest, slaughter or after storage, as appropriate, are reduced to a minimum. (6) New data has been provided for uses of azoxystrobin on aubergines, peppers, oats, hops, peas (fresh and dry) and for uses of kresoxim methyl on asparagus, strawberries and other small fruits and berries. This new data has been evaluated and it is considered appropriate to revise the provisional maximum residue levels fixed for these products in Directives 1999/71/EC, 2000/48/EC and 2000/58/EC. (7) At the inclusion in Annex I to Directive 91/414/EEC the technical and scientific evaluation of azoxystrobin has been finalised on 22 April 1998 in the format of the Commission review report for azoxystrobin. In this review report the acceptable daily intake (ADI) for azoxystrobin was set at 0,1 mg/kg bw/day. At the inclusion in Annex I to Directive 91/414/EEC the technical and scientific evaluation of kresoxim methyl has been finalised on 16 October 1998 in the format of the Commission review report for kresoxim methyl. In this review report the acceptable daily intake (ADI) for kresoxim methyl was set at 0,4 mg/kg bw/day. The lifetime exposure of consumers of food products treated with azoxystrobin or kresoxim methyl has been assessed and evaluated in accordance with the procedures and practices used within the European Community, taking account of guidelines published by the World Health Organisation(11) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceedence of these ADIs. (8) Acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluation and discussion that preceded the inclusion of azoxystrobin and kresoxim methyl in Annex I to Directive 91/414/EEC. (9) The Community's trading partners have been consulted about the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered. The possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the Commission on the basis of the submission of acceptable data. (10) The advice and recommendations of the Scientific Committee for Plants, in particular concerning the protection of consumers of food products treated with pesticides, have been taken into account. (11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 In part A of Annex II to Directive 86/362/EEC the following entry shall be added in respect of azoxystrobin: ">TABLE>" Article 2 In Annex II to Directive 90/642/EEC the columns headed "azoxystrobin", and "kresoxim methyl" are replaced by those set out in the Annex to this Directive. Article 3 The provision in Article 3(2) of Directive 2000/42/EC where "The maximum level for residues of acephate on peaches shall be fixed at 0,02(*) mg/kg" shall be applied by the Member States as of 1 December 2001. Article 4 1. This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Communities. 2. Member States shall adopt and publish the legislative, regulatory or administrative measures to comply with this Directive by 28 February 2002 at the latest. They shall forthwith inform the Commission thereof. 3. They shall apply these measures as from 1 March 2002. 4. 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 is addressed to the Member States.

32001L0050

2001

Commission Directive 2001/50/EC of 3 July 2001 amending Directive 95/45/EC laying down specific purity criteria concerning colours for use in foodstuffs (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 for Food, Whereas: (1) Council Directive 94/36/EC of the European Parliament and of Council of 30 June 1994 on colours for use in foodstuffs(3) lists those substances which may be used as colours in foodstuffs. (2) Commission Directive 94/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs(4), as amended by Directive 1999/75/EC(5), sets out the purity criteria for the colours mentioned in Directive 94/36/EC. (3) It is necessary, in the light of technical progress, to amend the purity criteria set out in Directive 95/45/EC for mixed carotenes (E160a(i)) and beta-carotene (E160a(ii)). (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) It is consequently necessary to adapt Directive 95/45/EC. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 In part B of the Annex to Directive 95/45/EC, the text concerning mixed carotenes (E160a(i)) and beta-carotene (E160a(ii)) is replaced by the text of 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 before 30 June 2002. They shall immediately 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 time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32001L0054

2001

Commission Directive 2001/54/EC of 11 July 2001 repealing Directive 79/1066/EEC laying down Community methods of analysis for testing coffee extracts and chicory extracts (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 1999/4/EC of the European Parliament and of the Council of 22 February 1999 relating to coffee extracts and chicory extracts(1), and in particular Article 4 thereof, Whereas: (1) The analysis methods contained in Commission Directive 79/1066/EEC(2), which is based on Council Directive 77/436/EEC(3), are obsolete. (2) Council Directives 89/397/EEC of 14 June 1989 on the official control of foodstuffs(4) and Council Directive 93/1999/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs(5) provide for analyses to be carried out on the conformity of foodstuffs with legal provisions. To that end, Member States must assure themselves that the methods used are validated as often as possible, in particular taking account of standardisation within the ISO. (3) The importance of checks on the authenticity of coffee extracts as a means of combating fraud and adulteration has resulted in international standardisation work undertaken by the ISO. The Community is participating in this work, which has resulted in ISO standards for soluble coffee. (4) As a result it is not necessary, within the meaning of 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(6), to maintain official Community analysis methods for coffee extracts and chicory extracts. For that reason Directive 79/1066/EEC should be repealed in accordance with the procedure laid down in Article 4 of Directive 1999/4/EC. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 Directive 79/1066/EEC is repealed. Article 2 Member States must take the necessary measures to comply with this Directive by 1 February 2001 at the latest. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. Article 3 This Directive is addressed to the Member States.

32001L0055

2001

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 Having regard to the Treaty establishing the European Community, and in particular point 2(a) and (b) 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) The preparation of a common policy on asylum, including common European arrangements for asylum, is a constituent part of the European Union's objective of establishing progressively an area of freedom, security and justice open to those who, forced by circumstances, legitimately seek protection in the European Union. (2) Cases of mass influx of displaced persons who cannot return to their country of origin have become more substantial in Europe in recent years. In these cases it may be necessary to set up exceptional schemes to offer them immediate temporary protection. (3) In the conclusions relating to persons displaced by the conflict in the former Yugoslavia adopted by the Ministers responsible for immigration at their meetings in London on 30 November and 1 December 1992 and Copenhagen on 1 and 2 June 1993, the Member States and the Community institutions expressed their concern at the situation of displaced persons. (4) On 25 September 1995 the Council adopted a Resolution on burden-sharing with regard to the admission and residence of displaced persons on a temporary basis(5), and, on 4 March 1996, adopted Decision 96/198/JHA on an alert and emergency procedure for burden-sharing with regard to the admission and residence of displaced persons on a temporary basis(6). (5) The Action Plan of the Council and the Commission of 3 December 1998(7) provides for the rapid adoption, in accordance with the Treaty of Amsterdam, of minimum standards for giving temporary protection to displaced persons from third countries who cannot return to their country of origin and of measures promoting a balance of effort between Member States in receiving and bearing the consequences of receiving displaced persons. (6) On 27 May 1999 the Council adopted conclusions on displaced persons from Kosovo. These conclusions call on the Commission and the Member States to learn the lessons of their response to the Kosovo crisis in order to establish the measures in accordance with the Treaty. (7) The European Council, at its special meeting in Tampere on 15 and 16 October 1999, acknowledged the need to reach agreement on the issue of temporary protection for displaced persons on the basis of solidarity between Member States. (8) It is therefore necessary to establish minimum standards for giving temporary protection in the event of a mass influx of displaced persons and to take measures to promote a balance of efforts between the Member States in receiving and bearing the consequences of receiving such persons. (9) Those standards and measures are linked and interdependent for reasons of effectiveness, coherence and solidarity and in order, in particular, to avert the risk of secondary movements. They should therefore be enacted in a single legal instrument. (10) This temporary protection should be compatible with the Member States' international obligations as regards refugees. In particular, it must not prejudge the recognition of refugee status pursuant to the Geneva Convention of 28 July 1951 on the status of refugees, as amended by the New York Protocol of 31 January 1967, ratified by all the Member States. (11) The mandate of the United Nations High Commissioner for Refugees regarding refugees and other persons in need of international protection should be respected, and effect should be given to Declaration No 17, annexed to the Final Act to the Treaty of Amsterdam, on Article 63 of the Treaty establishing the European Community which provides that consultations are to be established with the United Nations High Commissioner for Refugees and other relevant international organisations on matters relating to asylum policy. (12) It is in the very nature of minimum standards that Member States have the power to introduce or maintain more favourable provisions for persons enjoying temporary protection in the event of a mass influx of displaced persons. (13) Given the exceptional character of the provisions established by this Directive in order to deal with a mass influx or imminent mass influx of displaced persons from third countries who are unable to return to their country of origin, the protection offered should be of limited duration. (14) The existence of a mass influx of displaced persons should be established by a Council Decision, which should be binding in all Member States in relation to the displaced persons to whom the Decision applies. The conditions for the expiry of the Decision should also be established. (15) The Member States' obligations as to the conditions of reception and residence of persons enjoying temporary protection in the event of a mass influx of displaced persons should be determined. These obligations should be fair and offer an adequate level of protection to those concerned. (16) With respect to the treatment of persons enjoying temporary protection under this Directive, the Member States are bound by obligations under instruments of international law to which they are party and which prohibit discrimination. (17) Member States should, in concert with the Commission, enforce adequate measures so that the processing of personal data respects the standard of protection of 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 on the free movement of such data(8). (18) Rules should be laid down to govern access to the asylum procedure in the context of temporary protection in the event of a mass influx of displaced persons, in conformity with the Member States' international obligations and with the Treaty. (19) Provision should be made for principles and measures governing the return to the country of origin and the measures to be taken by Member States in respect of persons whose temporary protection has ended. (20) Provision should be made for a solidarity mechanism intended to contribute to the attainment of a balance of effort between Member States in receiving and bearing the consequences of receiving displaced persons in the event of a mass influx. The mechanism should consist of two components. The first is financial and the second concerns the actual reception of persons in the Member States. (21) The implementation of temporary protection should be accompanied by administrative cooperation between the Member States in liaison with the Commission. (22) It is necessary to determine criteria for the exclusion of certain persons from temporary protection in the event of a mass influx of displaced persons. (23) Since the objectives of the proposed action, namely to establish minimum standards for giving temporary protection in the event of a mass influx of displaced persons and measures promoting a balance of efforts between the Member States in receiving and bearing the consequences of receiving such persons, cannot be sufficiently attained by the Member States and can therefore, by reason of the scale or 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 those objectives. (24) 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 27 September 2000, of its wish to take part in the adoption and application of this Directive. (25) Pursuant to 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. (26) 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 not bound by it nor subject to its application, CHAPTER I General provisions Article 1 The purpose of this Directive is to establish minimum standards for giving temporary protection in the event of a mass influx of displaced persons from third countries who are unable to return to their country of origin and to promote a balance of effort between Member States in receiving and bearing the consequences of receiving such persons. Article 2 For the purposes of this Directive: (a) "temporary protection" means a procedure of exceptional character to provide, in the event of a mass influx or imminent mass influx of displaced persons from third countries who are unable to return to their country of origin, immediate and temporary protection to such persons, in particular if there is also a risk that the asylum system will be unable to process this influx without adverse effects for its efficient operation, in the interests of the persons concerned and other persons requesting protection; (b) "Geneva Convention" means the Convention of 28 July 1951 relating to the status of refugees, as amended by the New York Protocol of 31 January 1967; (c) "displaced persons" means third-country nationals or stateless persons who have had to leave their country or region of origin, or have been evacuated, in particular in response to an appeal by international organisations, and are unable to return in safe and durable conditions because of the situation prevailing in that country, who may fall within the scope of Article 1A of the Geneva Convention or other international or national instruments giving international protection, in particular: (i) persons who have fled areas of armed conflict or endemic violence; (ii) persons at serious risk of, or who have been the victims of, systematic or generalised violations of their human rights; (d) "mass influx" means arrival in the Community of a large number of displaced persons, who come from a specific country or geographical area, whether their arrival in the Community was spontaneous or aided, for example through an evacuation programme; (e) "refugees" means third-country nationals or stateless persons within the meaning of Article 1A of the Geneva Convention; (f) "unaccompanied minors" means third-country nationals or stateless persons below the age of eighteen, who arrive on the territory of the Member States unaccompanied by an adult responsible for them whether by law or custom, and for as long as they are not effectively taken into the care of such a person, or minors who are left unaccompanied after they have entered the territory of the Member States; (g) "residence permit" means any permit or authorisation issued by the authorities of a Member State and taking the form provided for in that State's legislation, allowing a third country national or a stateless person to reside on its territory; (h) "sponsor" means a third-country national enjoying temporary protection in a Member State in accordance with a decision taken under Article 5 and who wants to be joined by members of his or her family. Article 3 1. Temporary protection shall not prejudge recognition of refugee status under the Geneva Convention. 2. Member States shall apply temporary protection with due respect for human rights and fundamental freedoms and their obligations regarding non-refoulement. 3. The establishment, implementation and termination of temporary protection shall be the subject of regular consultations with the Office of the United Nations High Commissioner for Refugees (UNHCR) and other relevant international organisations. 4. This Directive shall not apply to persons who have been accepted under temporary protection schemes prior to its entry into force. 5. This Directive shall not affect the prerogative of the Member States to adopt or retain more favourable conditions for persons covered by temporary protection. CHAPTER II Duration and implementation of temporary protection Article 4 1. Without prejudice to Article 6, the duration of temporary protection shall be one year. Unless terminated under the terms of Article 6(1)(b), it may be extended automatically by six monthly periods for a maximum of one year. 2. Where reasons for temporary protection persist, the Council may decide by qualified majority, on a proposal from the Commission, which shall also examine any request by a Member State that it submit a proposal to the Council, to extend that temporary protection by up to one year. Article 5 1. The existence of a mass influx of displaced persons shall be established by a Council Decision adopted by a qualified majority on a proposal from the Commission, which shall also examine any request by a Member State that it submit a proposal to the Council. 2. The Commission proposal shall include at least: (a) a description of the specific groups of persons to whom the temporary protection will apply; (b) the date on which the temporary protection will take effect; (c) an estimation of the scale of the movements of displaced persons. 3. The Council Decision shall have the effect of introducing temporary protection for the displaced persons to which it refers, in all the Member States, in accordance with the provisions of this Directive. The Decision shall include at least: (a) a description of the specific groups of persons to whom the temporary protection applies; (b) the date on which the temporary protection will take effect; (c) information received from Member States on their reception capacity; (d) information from the Commission, UNHCR and other relevant international organisations. 4. The Council Decision shall be based on: (a) an examination of the situation and the scale of the movements of displaced persons; (b) an assessment of the advisability of establishing temporary protection, taking into account the potential for emergency aid and action on the ground or the inadequacy of such measures; (c) information received from the Member States, the Commission, UNHCR and other relevant international organisations. 5. The European Parliament shall be informed of the Council Decision. Article 6 1. Temporary protection shall come to an end: (a) when the maximum duration has been reached; or (b) at any time, by Council Decision adopted by a qualified majority on a proposal from the Commission, which shall also examine any request by a Member State that it submit a proposal to the Council. 2. The Council Decision shall be based on the establishment of the fact that the situation in the country of origin is such as to permit the safe and durable return of those granted temporary protection with due respect for human rights and fundamental freedoms and Member States' obligations regarding non-refoulement. The European Parliament shall be informed of the Council Decision. Article 7 1. Member States may extend temporary protection as provided for in this Directive to additional categories of displaced persons over and above those to whom the Council Decision provided for in Article 5 applies, where they are displaced for the same reasons and from the same country or region of origin. They shall notify the Council and the Commission immediately. 2. The provisions of Articles 24, 25 and 26 shall not apply to the use of the possibility referred to in paragraph 1, with the exception of the structural support included in the European Refugee Fund set up by Decision 2000/596/EC(9), under the conditions laid down in that Decision. CHAPTER III Obligations of the Member States towards persons enjoying temporary protection Article 8 1. The Member States shall adopt the necessary measures to provide persons enjoying temporary protection with residence permits for the entire duration of the protection. Documents or other equivalent evidence shall be issued for that purpose. 2. Whatever the period of validity of the residence permits referred to in paragraph 1, the treatment granted by the Member States to persons enjoying temporary protection may not be less favourable than that set out in Articles 9 to 16. 3. The Member States shall, if necessary, provide persons to be admitted to their territory for the purposes of temporary protection with every facility for obtaining the necessary visas, including transit visas. Formalities must be reduced to a minimum because of the urgency of the situation. Visas should be free of charge or their cost reduced to a minimum. Article 9 The Member States shall provide persons enjoying temporary protection with a document, in a language likely to be understood by them, in which the provisions relating to temporary protection and which are relevant to them are clearly set out. Article 10 To enable the effective application of the Council Decision referred to in Article 5, Member States shall register the personal data referred to in Annex II, point (a), with respect to the persons enjoying temporary protection on their territory. Article 11 A Member State shall take back a person enjoying temporary protection on its territory, if the said person remains on, or, seeks to enter without authorisation onto, the territory of another Member State during the period covered by the Council Decision referred to in Article 5. Member States may, on the basis of a bilateral agreement, decide that this Article should not apply. Article 12 The Member States shall authorise, for a period not exceeding that of temporary protection, persons enjoying temporary protection to engage in employed or self-employed activities, subject to rules applicable to the profession, as well as in activities such as educational opportunities for adults, vocational training and practical workplace experience. For reasons of labour market policies, Member States may give priority to EU citizens and citizens of States bound by the Agreement on the European Economic Area and also to legally resident third-country nationals who receive unemployment benefit. The general law in force in the Member States applicable to remuneration, access to social security systems relating to employed or self-employed activities and other conditions of employment shall apply. Article 13 1. The Member States shall ensure that persons enjoying temporary protection have access to suitable accommodation or, if necessary, receive the means to obtain housing. 2. The Member States shall make provision for persons enjoying temporary protection to receive necessary assistance in terms of social welfare and means of subsistence, if they do not have sufficient resources, as well as for medical care. Without prejudice to paragraph 4, the assistance necessary for medical care shall include at least emergency care and essential treatment of illness. 3. Where persons enjoying temporary protection are engaged in employed or self-employed activities, account shall be taken, when fixing the proposed level of aid, of their ability to meet their own needs. 4. The Member States shall provide necessary medical or other assistance to persons enjoying temporary protection who have special needs, such as unaccompanied minors or persons who have undergone torture, rape or other serious forms of psychological, physical or sexual violence. Article 14 1. The Member States shall grant to persons under 18 years of age enjoying temporary protection access to the education system under the same conditions as nationals of the host Member State The Member States may stipulate that such access must be confined to the state education system. 2. The Member States may allow adults enjoying temporary protection access to the general education system. Article 15 1. For the purpose of this Article, in cases where families already existed in the country of origin and were separated due to circumstances surrounding the mass influx, the following persons shall be considered to be part of a family: (a) the spouse of the sponsor or his/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; the minor unmarried children of the sponsor or of his/her spouse, without distinction as to whether they were born in or out of wedlock or adopted; (b) other close relatives who lived together as part of the family unit at the time of the events leading to the mass influx, and who were wholly or mainly dependent on the sponsor at the time. 2. In cases where the separate family members enjoy temporary protection in different Member States, Member States shall reunite family members where they are satisfied that the family members fall under the description of paragraph 1(a), taking into account the wish of the said family members. Member States may reunite family members where they are satisfied that the family members fall under the description of paragraph 1(b), taking into account on a case by case basis the extreme hardship they would face if the reunification did not take place. 3. Where the sponsor enjoys temporary protection in one Member State and one or some family members are not yet in a Member State, the Member State where the sponsor enjoys temporary protection shall reunite family members, who are in need of protection, with the sponsor in the case of family members where it is satisfied that they fall under the description of paragraph 1(a). The Member State may reunite family members, who are in need of protection, with the sponsor in the case of family members where it is satisfied that they fall under the description of paragraph 1(b), taking into account on a case by case basis the extreme hardship which they would face if the reunification did not take place. 4. When applying this Article, the Member States shall taken into consideration the best interests of the child. 5. The Member States concerned shall decide, taking account of Articles 25 and 26, in which Member State the reunification shall take place. 6. Reunited family members shall be granted residence permits under temporary protection. Documents or other equivalent evidence shall be issued for that purpose. Transfers of family members onto the territory of another Member State for the purposes of reunification under paragraph 2, shall result in the withdrawal of the residence permits issued, and the termination of the obligations towards the persons concerned relating to temporary protection, in the Member State of departure. 7. The practical implementation of this Article may involve cooperation with the international organisations concerned. 8. A Member State shall, at the request of another Member State, provide information, as set out in Annex II, on a person receiving temporary protection which is needed to process a matter under this Article. Article 16 1. The Member States shall as soon as possible take measures to ensure the necessary representation of unaccompanied minors enjoying temporary protection 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. 2. During the period of temporary protection Member States shall provide for unaccompanied minors to be placed: (a) with adult relatives; (b) with a foster-family; (c) in reception centres with special provisions for minors, or in other accommodation suitable for minors; (d) with the person who looked after the child when fleeing. The Member States shall take the necessary steps to enable the placement. Agreement by the adult person or persons concerned shall be established by the Member States. The views of the child shall be taken into account in accordance with the age and maturity of the child. CHAPTER IV Access to the asylum procedure in the context of temporary protection Article 17 1. Persons enjoying temporary protection must be able to lodge an application for asylum at any time. 2. The examination of any asylum application not processed before the end of the period of temporary protection shall be completed after the end of that period. Article 18 The criteria and mechanisms for deciding which Member State is responsible for considering an asylum application shall apply. In particular, the Member State responsible for examining an asylum application submitted by a person enjoying temporary protection pursuant to this Directive, shall be the Member State which has accepted his transfer onto its territory. Article 19 1. The Member States may provide that temporary protection may not be enjoyed concurrently with the status of asylum seeker while applications are under consideration. 2. Where, after an asylum application has been examined, refugee status or, where applicable, other kind of protection is not granted to a person eligible for or enjoying temporary protection, the Member States shall, without prejudice to Article 28, provide for that person to enjoy or to continue to enjoy temporary protection for the remainder of the period of protection. CHAPTER V Return and measures after temporary protection has ended Article 20 When the temporary protection ends, the general laws on protection and on aliens in the Member States shall apply, without prejudice to Articles 21, 22 and 23. Article 21 1. The Member States shall take the measures necessary to make possible the voluntary return of persons enjoying temporary protection or whose temporary protection has ended. The Member States shall ensure that the provisions governing voluntary return of persons enjoying temporary protection facilitate their return with respect for human dignity. The Member State shall ensure that the decision of those persons to return is taken in full knowledge of the facts. The Member States may provide for exploratory visits. 2. For such time as the temporary protection has not ended, the Member States shall, on the basis of the circumstances prevailing in the country of origin, give favourable consideration to requests for return to the host Member State from persons who have enjoyed temporary protection and exercised their right to a voluntary return. 3. At the end of the temporary protection, the Member States may provide for the obligations laid down in CHAPTER III to be extended individually to persons who have been covered by temporary protection and are benefiting from a voluntary return programme. The extension shall have effect until the date of return. Article 22 1. The Member States shall take the measures necessary to ensure that the enforced return of persons whose temporary protection has ended and who are not eligible for admission is conducted with due respect for human dignity. 2. In cases of enforced return, Member States shall consider any compelling humanitarian reasons which may make return impossible or unreasonable in specific cases. Article 23 1. The Member States shall take the necessary measures concerning the conditions of residence of persons who have enjoyed temporary protection and who cannot, in view of their state of health, reasonably be expected to travel; where for example they would suffer serious negative effects if their treatment was interrupted. They shall not be expelled so long as that situation continues. 2. The Member States may allow families whose children are minors and attend school in a Member State to benefit from residence conditions allowing the children concerned to complete the current school period. CHAPTER VI Solidarity Article 24 The measures provided for in this Directive shall benefit from the European Refugee Fund set up by Decision 2000/596/EC, under the terms laid down in that Decision. Article 25 1. The Member States shall receive persons who are eligible for temporary protection in a spirit of Community solidarity. They shall indicate - in figures or in general terms - their capacity to receive such persons. This information shall be set out in the Council Decision referred to in Article 5. After that Decision has been adopted, the Member States may indicate additional reception capacity by notifying the Council and the Commission. This information shall be passed on swiftly to UNHCR. 2. The Member States concerned, acting in cooperation with the competent international organisations, shall ensure that the eligible persons defined in the Council Decision referred to in Article 5, who have not yet arrived in the Community have expressed their will to be received onto their territory. 3. When the number of those who are eligible for temporary protection following a sudden and massive influx exceeds the reception capacity referred to in paragraph 1, the Council shall, as a matter of urgency, examine the situation and take appropriate action, including recommending additional support for Member States affected. Article 26 1. For the duration of the temporary protection, the Member States shall cooperate with each other with regard to transferral of the residence of persons enjoying temporary protection from one Member State to another, subject to the consent of the persons concerned to such transferral. 2. A Member State shall communicate requests for transfers to the other Member States and notify the Commission and UNHCR. The Member States shall inform the requesting Member State of their capacity for receiving transferees. 3. A Member State shall, at the request of another Member State, provide information, as set out in Annex II, on a person enjoying temporary protection which is needed to process a matter under this Article. 4. Where a transfer is made from one Member State to another, the residence permit in the Member State of departure shall expire and the obligations towards the persons concerned relating to temporary protection in the Member State of departure shall come to an end. The new host Member State shall grant temporary protection to the persons concerned. 5. The Member States shall use the model pass set out in Annex I for transfers between Member States of persons enjoying temporary protection. CHAPTER VII Administrative cooperation Article 27 1. For the purposes of the administrative cooperation required to implement temporary protection, the Member States shall each appoint a national contact point, whose address they shall communicate to each other and to the Commission. The Member States shall, in liaison with the Commission, take all the appropriate measures to establish direct cooperation and an exchange of information between the competent authorities. 2. The Member States shall, regularly and as quickly as possible, communicate data concerning the number of persons enjoying temporary protection and full information on the national laws, regulations and administrative provisions relating to the implementation of temporary protection. CHAPTER VIII Special provisions Article 28 1. The Member States may exclude a person from temporary protection if: (a) there are serious reasons for considering that: (i) he or she has committed a crime against peace, a war crime, or a crime against humanity, as defined in the international instruments drawn up to make provision in respect of such crimes; (ii) he or she has committed a serious non-political crime outside the Member State of reception prior to his or her admission to that Member State as a person enjoying temporary protection. The severity of the expected persecution is to be weighed against the nature of the criminal offence of which the person concerned is suspected. Particularly cruel actions, even if committed with an allegedly political objective, may be classified as serious non-political crimes. This applies both to the participants in the crime and to its instigators; (iii) he or she has been guilty of acts contrary to the purposes and principles of the United Nations; (b) there are reasonable grounds for regarding him or her as a danger to the security of the host Member State or, having been convicted by a final judgment of a particularly serious crime, he or she is a danger to the community of the host Member State. 2. The grounds for exclusion referred to in paragraph 1 shall be based solely on the personal conduct of the person concerned. Exclusion decisions or measures shall be based on the principle of proportionality. CHAPTER IX Final provisions Article 29 Persons who have been excluded from the benefit of temporary protection or family reunification by a Member State shall be entitled to mount a legal challenge in the Member State concerned. Article 30 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. Article 31 1. Not later than two years after the date specified in Article 32, the Commission shall report to the European Parliament and the Council on the application of this Directive in the Member States and shall propose any amendments that are necessary. The Member States shall send the Commission all the information that is appropriate for drawing up this report. 2. After presenting the report referred to at paragraph 1, the Commission shall report to the European Parliament and the Council on the application of this Directive in the Member States at least every five years. Article 32 1. The 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. 2. When the 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. Article 33 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 34 This Directive is addressed to the Member States in accordance with the Treaty establishing the European Community.

32001L0046

2001

Directive 2001/46/EC of the European Parliament and of the Council of 23 July 2001 amending Council Directive 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition and Directives 70/524/EEC, 96/25/EC and 1999/29/EC on animal nutrition 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) The safety of products destined for animal nutrition is of primary concern and it is necessary to ensure that products put into circulation in the Community for the purposes of animal nutrition are safe. Council Directive 95/53/EC of 25 October 1995 fixing the principles governing the organisation of official inspections in the field of animal nutrition(4) contributes to the achievement of that objective. (2) Council Directive 74/63/EEC has been repealed by Article 16 of Council Directive 1999/29/EC of 22 April 1999 on undesirable substances and products in animal nutrition(5). Therefore, references to Directive 74/63/EEC have to be amended pursuant to the Table in Annex IV to Directive 1999/29/EC. (3) As regards the reference to the circulation of products to be used in animal nutrition, it is necessary to harmonise the definitions used by Directives 70/524/EEC(6), 95/53/EC and 96/25/EC(7) in the animal nutrition sector. (4) Serious dioxin contamination recently occurred twice in products to be used in animal nutrition. Taking into account the experience gained from these incidents, it is necessary to improve the procedures applicable to cases where a product for animal nutrition poses a serious risk to human or animal health or to the environment or where certain infringements of Directive 1999/29/EC are detected. The aim is in this way to improve the management of risks which would preclude the level of protection of human or animal health and of the environment provided for in the Community Regulation on animal nutrition while not trivialising those special procedures by systematically applying them to minor problems. (5) A Commission inspection carried out following dioxin contamination of the feed and food chain revealed that Member States had had difficulty in managing such an unusual crisis. In the light of the experience gained, and in order to ensure that serious risks involving a product for animal nutrition are managed with equivalent guarantees of efficiency throughout the Community, it is necessary to introduce provisions requiring the Members States to have in place contingency operational plans to deal with emergencies in the animal nutrition sector. (6) Where a serious risk to human or animal health or to the environment arises in a Member State due to products for animal nutrition, and where that risk cannot be contained satisfactorily by the Member State(s) concerned, it is indispensable for the Commission to be able to take all the necessary precautionary measures and to have in particular the authority to suspend trade in, and exports of, products for animal nutrition from all or part of the Member State concerned or to establish special conditions for the relevant products or substances. (7) Directive 1999/29/EC establishes the maximum permitted levels for certain undesirable substances and products in feed materials and feeding stuffs. (8) A system has already been established to enable the Member States to be informed by operators, at all stages of the feed producing chain, of certain cases of non compliance with the rules on undesirable products and substances. In view of both the experience gained and the similar arrangements provided for in the Community rules on general product safety, that system should be improved and extended to render it applicable to all cases where an operator finds that a product for animal nutrition poses a serious risk to human or animal health or to the environment. (9) At present there is an obligation to inform the other Member States and the Commission when a consignment of feed materials or feeding stuffs which is not in compliance with the maximum levels for undesirable substances or products is likely to be sent to other Member States. (10) It is necessary to incorporate this rapid information exchange system into Directive 95/53/EC and set standard procedures for its operation, so that it can be applied in future in all cases where a product endangers human health, animal health or the environment and for the purpose of improving the inspection system as a whole. For reasons of simplicity and efficiency, the system should also apply where a Member State refuses a product from a third country when checking it upon importation. These standard procedures could, subject to certain amendments, be the same as those laid down for exchanging information in emergencies pursuant to Council Directive 92/59/EEC of 29 June 1992 on general product safety(8). (11) It is not possible to list all potentially dangerous contaminations of biological or chemical origin, which may happen by accident or by illegal action, and may affect a product to be used in animal nutrition. (12) The risk of hazards deriving from mislabeling or from handling, transport, storage or processing should be taken into consideration. (13) To improve the efficiency of the inspection system and the relevant inspection measures, where there is a suspicion of contamination posing a serious risk to human health, animal health or to the environment, Member States should be required to verify the nature and extent of the contamination and to make every effort to identify its origin in order to detect any other possible contamination. (14) Directive 95/53/EC requires Member States to submit to the Commission information on the results of inspections carried out each year, before 1 April 2000 for the first time. It is also laid down that those reports will be used by the Commission to prepare and submit an overall summary report on inspections carried out at Community level together with a proposal for a coordinated inspection programme for the following year. Information concerning contamination affecting the safety of a product to be used in animal nutrition shall be considered by the Member States and the Commission in fixing the priorities for annual coordinated inspection programmes. All the information gathered on risks to human health, animal health or to the environment, relating to the circulation and use of products for animal nutrition, can be better analysed when provided in harmonised and standardised form. (15) Taking into account the foregoing, Directives 95/53/EC, 70/524/EEC, 96/25/EC and 1999/29/EC should be amended, Article 1 Council Directive 95/53/EC is amended as follows: 1. Article 2(1) is amended as follows: (a) in point (a), the second indent shall be replaced by the following: "- Council Directive 1999/29/EC of 22 April 1999 on undesirable substances and products in animal nutrition(9)." (b) point (e) shall be replaced by the following: "(e) 'product intended for animal nutrition' or 'product': animal feed or any substance used in animal nutrition;" (c) point (h) shall be replaced by the following: "(h) 'putting into circulation' or 'circulation': the holding of any product intended for animal nutrition for the purposes of sale, including offering for sale, or any other form of transfer, whether free or not, to third parties, and the sale and other forms of transfer themselves."; 2. the following Article shall be added after Article 4: "Article 4a 1. Member States shall draw up contingency operational plans setting out measures to be implemented without delay where a product for animal nutrition has been found to pose a serious risk to human health, animal health or to the environment and specifying powers and responsibilities as well as channels for transmitting information. Member States shall review these plans as appropriate, particularly in the light of changes in the organisation of the inspection services and of the experience gained, including that gained in any simulation exercises. 2. Member States shall forward to the Commission the contingency operational plans drawn up by them and also any amendments thereto. 3. The Commission shall examine the plans and suggest to the Member States concerned any amendment which would help to ensure that Member States' contingency operation plans offer equivalent guarantees of efficiency. Where necessary in order to achieve that objective the Commission, acting in accordance with the procedure provided for in Article 23, may issue guidelines to harmonise the contingency operational plans."; 3. Article 12(1) shall be replaced by the following: "1. The competent authority of the Member State of destination may, at places of destination, check the compliance of products with the provisions of Article 2(1)(a) by means of non-discriminatory random checks. In particular, and only to the extent necessary for carrying out these random checks, Member States may ask operators to report the arrival of the products to that competent authority. Member States shall inform the Commission when they avail themselves of this action."; 4. in Article 13(1), the second indent shall be replaced by the following: "- rendering the products harmless where appropriate,"; 5. in Article 14, the first paragraph shall be replaced by the following: "In the event of the destruction, use for other purposes, re-dispatch to the country of origin or rendering harmless of the products as provided for in Article 13(1), the Member State of destination shall contact the Member State of dispatch without delay. The Member State of dispatch shall take all necessary measures and notify the Member State of destination of the nature and outcome of the checks carried out, the decisions taken and the reasons for such decisions."; 6. the following Section shall be added after Article 15: "Section 3a Safeguard clause Article 15a 1. Where a problem due to a product to be used in animal nutrition, likely to pose a serious risk to human health, animal health or to the environment, appears in one or more Member States and cannot be contained satisfactorily by means of the measures taken by the Member State(s) concerned, the Commission, acting in accordance with the procedure provided for in Article 23a on its own initiative or at the request of a Member State, shall immediately, depending on the seriousness of the situation adopt the following measures: - suspend the putting into circulation within the Community, the use in animal nutrition or exports to third countries of products from all or part of the Member State(s) concerned or from one or more establishments situated in Community territory, or - lay down special conditions for the putting into circulation in the Community, the use in animal nutrition or exports to third countries of products from all or part of the Member State(s) concerned or from one or more establishments situated in Community territory. 2. However, in emergencies, the Commission may provisionally adopt the measures referred to in paragraph 1 after consulting the Member State(s) concerned and informing the other Member States. It shall submit the matter to the Standing Committee for Feeding stuffs set up by Article 1 of Decision 70/372/EEC(10) within ten working days for its opinion, in accordance with the procedure laid down in Article 23a, with a view to the extension, amendment or repeal of those measures. Where a Member State officially informs the Commission of the need to take protective measures and where the Commission has not had recourse to the measures referred to in paragraph 1, that Member State may adopt temporary protective measures with regard to use or putting into circulation. Where a Member State adopts such measures, it shall immediately inform the other Member States and the Commission. The Commission shall submit the question to the Standing Committee for Feeding stuffs within ten working days for its opinion in accordance with the procedure laid down in Article 23a with a view to the extension, amendment or repeal of the temporary protective measures taken by that Member State. Article 15b The Commission shall inform the European Parliament of the measures taken under Articles 9a and 15a." 7. the following Chapter shall be added after Article 16: "CHAPTER IIIA INFORMATION SYSTEM FOR HAZARDS FROM FEEDING STUFFS Article 16a Member States shall prescribe that the persons responsible for the establishments must immediately inform the Member States' competent authorities if they have evidence that a consignment of products for animal nutrition which they have brought into Community territory from a third country or put into circulation, and which they are holding or own: - exceeds the maximum levels laid down in Section A of Annex II to Directive 1999/29/EC beyond which the product must not be fed as such to animals or mixed with other products for animal nutrition, or - does not comply with one of the other provisions referred to in Article 2(1)(a) of this Directive and, owing to that non-compliance and, in view of the purpose for which it is intended, poses a serious risk to human health, animal health or to the environment. The persons responsible for the establishments shall provide all details enabling precise identification of the relevant product or consignment of products and as full as possible a description of the risk posed by the product or products concerned, as well as all available information useful in tracing the product or products. They shall also inform the competent authorities of the Member States of action taken to prevent risks to human health, animal health or to the environment, describing that action. The Member States shall lay down the same information requirements concerning the risks posed by products for animal nutrition for persons carrying out health monitoring of holdings such as those referred to in Article 10 of Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products(11), and for persons responsible for laboratories carrying out analyses. Where appropriate, the competent authorities shall apply the provisions of Articles 8, 11 or 13. Article 16b 1. Where the competent authorities of the Member States have information indicating, on the basis of the risk assessment factors available, that a consignment of products for animal nutrition poses a serious risk to human health, animal health or to the environment they shall verify the information received and, where appropriate, ensure that the necessary measures are taken so that the consignment is not used in animal nutrition, put the consignment under restriction and investigate immediately: - the nature of the hazard and where appropriate the level of undesirable substances, - the possible origin of the undesirable substances or of the hazard, in order to assess the risk more closely. Where appropriate, the risk assessment shall be extended to other consignments of the same product or to other products in the feed or food chain which might contain undesirable substances or in respect of which such a hazard might exist, taking into account any admixture of the undesirable substances in other products for animal nutrition and possible recycling of dangerous products into the feed chain. 2. Where the existence of a serious risk is confirmed in accordance with paragraph 1, Member States shall ensure that the final destination of the consignment containing undesirable substances, including possible decontamination, further action to render the products harmless, reprocessing or destruction, cannot have harmful effects on human or animal health or on the environment and where it is possible that the undesirable substances or the risk of such substances being present has extended to other consignments or to the feed or food chain they shall immediately identify and put under control other consignments of the products deemed hazardous and also, where appropriate, identify live animals fed with hazardous products and implement the measures provided for in Directive 96/23/EC or in other relevant Community provisions relating to animal health or to the food safety of products of animal origin ensuring coordination between the relevant control services, in order to avoid the hazardous products being put into circulation and to ensure the enforcement of recall procedures for the products already in circulation. Article 16c 1. Where a Member State finds that a product for animal nutrition which has been put into circulation in its own territory and in that of other Member States, or a product originating in a third country which has been brought into Community territory in order to be put into circulation in one or more Member States: - exceeds the maximum levels laid down in Section A of Annex II to Directive 1999/29/EC beyond which the product must not be fed as such to animals or mixed with other products for animal nutrition, or - does not comply with one of the other provisions referred to in Article 2(1)(a) of this Directive and, owing to that non-compliance and the purpose for which it is intended, poses a serious risk to human health, animal health or to the environment, that Member State shall forthwith alert the Commission by way of notification. It shall provide sufficient information to identify the products concerned, trace and put them under control and, where appropriate, the live animals fed with them, and shall specify safeguard measures envisaged or already taken, in order to enable the Commission properly to inform the other Member States. 2. Any Member State concerned shall immediately alert the Commission of any follow up measure taken in respect of the notified hazards, including information concerning the end of the risk situation. 3. The Commission and the Member States shall set up and operate a system for rapid exchange of information under conditions set in accordance with the procedure provided for in Article 23, with a view to expediting transmission and dissemination of the alerts referred to in paragraph 1 and the information referred to in Article 8(1). 4. The Commission shall inform the European Parliament of measures taken to expedite the transmission and dissemination of alerts." 8. Article 17(2) shall be replaced by the following: "2. Member States shall provide that officials responsible for inspection are subject to professional confidentiality. However, this provision shall not affect the possibility for the competent authorities of the Member States of disseminating information necessary to prevent a serious risk to human health, animal health or to the environment."; 9. Article 17a shall be replaced by the following: "Article 17a 1. Without prejudice to Article 15, experts from the Commission may, insofar as is necessary for the uniform application of this Directive, make on-the-spot inspections in cooperation with the competent authorities of the Member States. The Member State on whose territory inspections are made shall afford the experts all the assistance necessary for carrying out their duties. The Commission shall inform the competent authorities, the Member States and the European Parliament of the results of the inspections made. 2. The detailed rules for the application of this Article, and in particular those governing the arrangements for cooperation with the national authorities, shall be adopted in accordance with the procedure referred to in Article 23."; 10. Article 22 shall be amended as follows: (a) the following sentence shall be added at the end of paragraph 2: "This information shall be presented in the form of annual reports in accordance with a specimen to be drawn up pursuant to Article 23." (b) the following subparagraph shall be added at the end of paragraph 3: "The overall summary report referred to in the first subparagraph shall be communicated to the European Parliament." Article 2 In Directive 70/524/EEC, Article 2(k) shall be replaced by the following: "(k) 'putting into circulation' or 'circulation': the holding of any product intended for animal nutrition for the purposes of sale, including offering for sale, or any other form of transfer, whether free or not, to third parties, and the sale and other forms of transfer themselves;" Article 3 In Directive 96/25/EC, Article 2(b) shall be replaced by the following: "(b) 'putting into circulation' or 'circulation': the holding of any product intended for animal nutrition for the purposes of sale, including offering for sale, or any other form of transfer, whether free or not, to third parties, and the sale and other forms of transfer themselves." Article 4 Article 12(3) and (4) of Directive 1999/29/EC are hereby repealed. Article 5 1. Member States shall adopt and publish, not later than 1 September 2002 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 1 May 2003. 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 main provisions of national law which they adopt in the field covered by this Directive. Article 6 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 7 This Directive is addressed to the Member States.

32001L0057

2001

Commission Directive 2001/57/EC of 25 July 2001 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively (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 2001/48/EC(2), 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(3), as last amended by Commission Directive 2001/39/EC(4), 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 certain products of plant origin including fruit and vegetables(5), as last amended by Directive 2001/48/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(6), as last amended by Commission Directive 2001/49/EC(7), and in particular Article 4(1)(f) thereof, Whereas: (1) The existing active substance, fluroxypyr, was included in Annex I to Directive 91/414/EEC by Commission Directive 2000/10/EC(8). No harmonised maximum residue levels for this active substance have yet been set by the Commission. The harmonisation of maximum residue levels is desirable both from the public health and from the trade point of view. (2) Following inclusion of the substance in Annex I, Member States authorised a number of plant protection products containing it in accordance with Article 4 of Directive 91/414/EEC, and established provisional maximum residue levels as required by Article 4(1)(f) thereof. These authorisations concern uses as a herbicide in orchards or as a post emergence herbicide on apples, olives, onions, cereals, meadows and pastures. As required by that Directive, those levels, and the information on which they were based, have been notified to the Commission. This information together with data available from other sources has been reviewed and is sufficient to provisionally fix certain maximum residue levels. (3) Article 5 of Directive 86/363/EEC requires that provisional maximum residue levels for animal products established pursuant to Article 4(1)(f) of Directive 91/414/EEC be indicated in Annex II to Directive 86/363/EEC. (4) At the inclusion in Annex I to Directive 91/414/EEC the technical and scientific evaluation of fluroxypyr was finalised on 30 November 1999 in the format of the Commission review report for fluroxypyr. In this review report the acceptable daily intake (ADI) for fluroxypyr was set at 0,8 mg/kg bw/day. The lifetime exposure of consumers of food products treated with fluroxypyr has been assessed and evaluated in accordance with the procedures and practices used within the European Community, taking account of guidelines published by the World Health Organisation(9) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceeding of this ADI. (5) Acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluation and discussion that preceded the inclusion of fluroxypyr in Annex I to Directive 91/414/EEC. (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. The setting at Community level of provisional maximum residue levels does not prevent Member States from establishing provisional maximum residue levels for fluroxypyr in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. (7) Four years is considered a sufficient period of time during which to establish most further uses of fluroxypyr. After that period, provisional maximum residue levels should become definitive. (8) The Community's trading partners have been consulted about the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered. No CODEX maximum residue levels are defined for fluroxypyr. The possibility of fixing maximum residue levels for specific pesticide/crop combinations other than those listed herein will be examined by the Commission on the basis of the submission of acceptable data. (9) The opinions of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account. (10) This Directive is in accordance with the opinion of the Standing Committee on Plant Health, Article 1 In part A of Annex II to Directive 86/362/EEC, the following rows are added: ">TABLE>" Article 2 The following row shall be added to part B of Annex II to Directive 86/363/EEC: ">TABLE>" Article 3 In Annex II to Directive 90/642/EEC the column headed "Fluroxypyr including its esters expressed as fluroxypyr", set out in the Annex to this Directive, is added. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 February 2002 at the latest. They shall forthwith inform the Commission thereof. They shall apply these provisions as of 1 March 2002. 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 is addressed to the Member States.

32001L0058

2001

Commission Directive 2001/58/EC of 27 July 2001 amending for the second time Directive 91/155/EEC defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 14 of European Parliament and Council Directive 1999/45/EC and relating to dangerous substances in implementation of Article 27 of Council Directive 67/548/EEC (safety data sheets) (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(1), and in particular Article 14 thereof, Having regard 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(2), as last amended by Commission Directive 2000/33/EC(3), and in particular Article 27 thereof, Whereas: (1) Article 14 of Directive 1999/45/EC provides that the person responsible for placing on the market certain specified preparations must provide a safety data sheet. (2) Article 27 of Directive 67/548/EEC provides that the person responsible for placing dangerous substances on the market must also provide a safety data sheet. (3) Safety data sheet information is principally intended for use by professional users and must enable them to take the necessary measures as regards the protection of health, safety and the environment at the place of work. (4) Safety data sheets for dangerous substances and certain preparations, and their supply must comply with the provisions of Commission Directive 91/155/EEC(4), as amended by Directive 93/112/EC(5). (5) Article 14(2.1)(b) of Directive 1999/45/EC introduces a new requirement for persons responsible for placing preparations on the market to provide on the request of professional users a safety data sheet containing proportionate information for preparations not classified as dangerous within the meaning of Articles 5, 6 and 7 of Directive 1999/45/EC, but which contain in an individual concentration of >= 1 % by weight for non-gaseous preparations and >= 0,2 % by volume for gaseous preparations at least one substance posing health or environmental hazards, or one substance for which there are Community workplace exposure limits. (6) Directive 1999/45/EC also introduces a requirement for preparations to be classified and labelled for their effects on the environment. (7) It is therefore necessary to amend Directive 91/155/EEC accordingly, as specified in Article 14(2.3) of Directive 1999/45/EC, before 30 July 2002. (8) Article 4 of Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risk related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(6) requires employers to determine whether any hazardous chemical agents are present at the workplace, and to assess any risk to the health and safety of workers arising from the presence of those chemical agents, taking into consideration the information provided by the supplier via safety data sheets; it is therefore opportune to amend the Annex to Directive 91/155/EEC accordingly. (9) It is known from recent enforcement activities and studies in the Member States that many safety data sheets are of poor quality and do not provide adequate information for the user; one way of improving the quality of safety data sheets is to improve the guidance given to compilers of safety data sheets set out in the Annex to Directive 91/155/EEC; it is therefore opportune to amend the Annex to Directive 91/155/EEC accordingly; the Commission and the Member States will consider other means by which the quality of safety data sheets can be improved further in future. (10) The measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of the Directives on the removal of technical barriers to trade in dangerous substances and preparations established under Article 20 of Directive 1999/45/EC, Article 1 Directive 91/155/EEC is amended as follows: 1. Article 1(1) is replaced by the following: "1. (a) The person who is responsible for placing a chemical substance or preparation on the market, whether the manufacturer, importer or distributor, shall supply the recipient, who is a professional user of the substance or preparation, with a safety data sheet containing the information set out in Article 3 and the Annex to this Directive, if the substance or preparation is classified as dangerous according to Directive 67/548/EEC or European Parliament and Council Directive 1999/45/EC(7). (b) Any person who is responsible for placing a preparation on the market, whether the manufacturer, importer or distributor, shall supply, on request of a professional user, a safety data sheet providing proportionate information as set out in Article 3 and the Annex to this Directive, if the preparation is not classified as dangerous according to Articles 5, 6 and 7 of Directive 1999/45/EC, but the preparation contains in an individual concentration of >= 1 % by weight for non-gaseous preparations and >= 0,2 % by volume for gaseous preparations at least one substance posing health or environmental hazards, or one substance for which there are Community workplace exposure limits." 2. The Annex referred to in Article 3 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 by 30 July 2002 at the latest. They shall forthwith inform the Commission thereof. 2. Member States shall apply the laws, regulations and administrative provisions referred to in paragraph 1: (a) to preparations not within the scope of Council Directive 91/414/EEC(8) on the placing of plant protection products on the market, or Council Directive 98/8/EC(9) on the placing of biocidal products on the market as from 30 July 2002; (b) and to preparations within the scope of Directive 91/414/EEC or Directive 98/8/EC as from 30 July 2004. 3. 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 its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32001L0059

2001

Commission Directive 2001/59/EC of 6 August 2001 adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Text with EEA relevance.) Having regard to the Treaty establishing the European Community, Having regard 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(1), as last amended by Commission Directive 2000/33/EC(2), and in particular Article 28 thereof, Whereas: (1) Annex I to Directive 67/548/EEC contains a list of dangerous substances, together with particulars of the classification and labelling of each substance. Present scientific and technical knowledge has shown that the list of dangerous substances in that Annex should be adapted to technical progress. Specifically, Tables A and B in the Foreword to Annex I require inclusion of the Finnish and Swedish nomenclature. Certain language versions of the Directive require technical corrections in specific sections of the Foreword to Annex I. It is useful to publish an updated and recast version of the Foreword to Annex I. Furthermore, the list itself should be updated to include notified new substances and further existing substances; the identity, nomenclature, classification, labelling and/or concentration limits for certain substances should be amended to reflect increased technical knowledge; the entries for three substances should be deleted from the list, since they are covered by other entries. (2) Annex II to Directive 67/548/EEC contains a list of symbols and indications of danger for dangerous substances and preparations. Annex III to Directive 67/548/EEC contains a list of phrases indicating the nature of special risks attributed to dangerous substances and preparations. Annex IV to Directive 67/548/EEC contains a list of the phrases indicating the safety advice concerning dangerous substances and preparations. Annexes II, III and IV require inclusion of the Finnish and Swedish wordings. Certain language versions of the Directive require technical corrections in specific sections of Annexes II, III and IV. It is useful to publish updated and recast versions of Annexes II, III and IV. (3) Article 1 of European Parliament and Council Directive 1999/33/EC(3) permitted Sweden from 1 January 1999 until 31 December 2000 to require the use of the additional R-phrase R340, not listed in Annex III, for substances classified as carcinogenic, category 3, instead of R-phrase R40. Member State experts have agreed to revise the text of R-phrase R40 to refer to carcinogenic, category 3 substances. A new R-phrase R-68 should be added to Annex III, containing the original text of R-phrase R40 for classification and labelling of mutagenic category 3 and harmful substances listed in Annex I. The classification and labelling and concentration limit references in Annex I that include R40 should therefore be revised for such mutagenic category 3 and harmful substances. (4) Annex V to Directive 67/548/EEC lays down the methods for the determination of the physicochemical properties, toxicity and ecotoxicity of substances and preparations. It is necessary to adapt that Annex to technical progress. It is appropriate to reduce to a minimum the number of animals used for experimental purposes, in accordance with Council Directive 86/609/EEC(4). Chapter B.1 should therefore be deleted, since alternative methods, using fewer animals, are available. Due regard should be given to methods recognised and recommended by competent international organisations. The methods for subchronic oral toxicity in Chapters B.26 and B.27 should be revised accordingly and Chapters C.14 to C.20, on environmental toxicity should be added to Annex V. Certain language versions require technical corrections to specific sections of Annex V. (5) Annex VI to Directive 67/548/EEC contains a guide to the classification and labelling of dangerous substances and preparations. It is necessary to adapt that Annex to technical progress. Certain language versions of the Directive require technical corrections in specific sections of Annex VI. Specific sections require publication in Finnish and Swedish. It is useful to publish an updated and recast version of Annex VI, particularly including reference to Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(5). (6) In accordance with the provisions of Directive 67/548/EEC, any new substance placed on the market should be notified to the competent authorities of the Member States by means of a notification containing certain information including a technical dossier. For new substances supplied and then consumed in a chemical reaction which are strictly controlled (intermediates with limited exposure), it is technically justifiable and appropriate to define a reduced test package (RTP). Current technical progress can guarantee minimum exposure for man and the environment through rigorous containment of the process. (7) The technical dossier should contain a test package for intermediates with limited exposure which would supply the information necessary to evaluate their foreseeable risk for man and the environment. Annex VII should specify the content of this technical dossier and Annex VIII should detail additional tests and studies that may be required for intermediates with limited exposure marketed in higher volumes. (8) The criteria for the notification of intermediates with limited exposure may need to be revised in the light of technical progress and experience gained with such notifications made in accordance with the new specific requirements laid down in this Directive. (9) The measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Elimination of Technical Barriers to Trade in Dangerous Substances and Preparations, Article 1 Directive 67/548/EEC is hereby amended as follows: 1. Annex I is amended as follows: (a) Tables A and B in the foreword to Annex I shall include the Finnish and Swedish nomenclature. Certain language versions of the Directive shall include technical corrections in specific sections of the Foreword and Tables A and B. The Foreword including Tables A and B is replaced by Annex 1A to this Directive. (b) The corresponding entries are replaced by the entries in Annex 1B to this Directive. (c) The entries in Annex 1C to this Directive are inserted. (d) The entries in Annex 1D to this Directive are deleted. (e) The entries shown in Annex 1E to this Directive are amended by replacing classification references to "Muta. Cat. 3; R40" by "Muta. Cat. 3; R68" and by replacing labelling references to R40 by R68. (f) The entries shown in Annex 1F to this Directive are amended by replacing classification references to "Xn; R40" by "Xn; R68" and by replacing labelling references to R40 by R68. (g) The entry shown in Annex 1G to this Directive is amended by replacing concentration limit references to "Xn; R40/20/21/22" by "Xn; R68/20/21/22". (h) The entry shown in Annex 1H to this Directive is amended by replacing concentration limit references to "Xn; R20/21/22-40/20/21/22" by "Xn; R20/21/22-68/20/21/22". (i) The entries shown in Annex 1I to this Directive are amended by replacing classification references to "Muta. Cat. 3; R40" by "Muta. Cat. 3; R68". (j) The entries shown in Annex 1J to this Directive are amended by replacing classification references to "Muta. Cat. 3; R40" by "Muta. Cat. 3; R68" and by adding R68 to the label. 2. Annex II shall include the Swedish and Finnish versions and technical corrections to certain language versions. Annex II is therefore replaced by Annex 2 to this Directive. 3. Annex III shall include the Swedish and Finnish versions and technical corrections to certain language versions. Annex III is therefore replaced by Annex 3 to this Directive. 4. Annex IV shall include the Swedish and Finnish versions and technical corrections to certain language versions. Annex IV is therefore replaced by Annex 4 to this Directive. 5. Annex V is amended as follows: (a) Chapter B.1 is deleted. (b) The title of the English version of Chapter B13/14 is replaced by the text in Annex 5A. (c) The last sentence of the French version of paragraph 1.4.2.2 of Chapter B.39 is replaced by the text in Annex 5B. (d) The equation in the last sentence of section 1.7.1.6 of the English version of Chapter B.41 is replaced by the text in Annex 5C. (e) The test method for subchronic oral toxicity tests in rodents is amended in accordance with Annex 5D to this Directive, which replaces Chapter B.26. (f) The test method for subchronic oral toxicity tests in non-rodents is amended in accordance with Annex 5E to this Directive, which replaces Chapter B.27. (g) The seven new test methods for environmental toxicity in Annex 5F to this Directive are included in Part C. 6. Annex VI shall include the Swedish and Finnish versions, technical corrections to certain language versions and further detailed technical updates. Annex VI is therefore replaced by Annex 6 to this Directive. 7. Annex VII.A shall include a technical dossier containing a test package for intermediates with limited exposure, supplying the information necessary to evaluate their foreseeable risk for man and the environment. Annex VII.A is therefore amended as follows: (a) the text in Annex 7A to this Directive is inserted before section 0 of Annex VII.A; (b) the text in Annex 7B to this Directive is inserted at the end of Annex VII.A. 8. Annex VIII shall include additional tests and studies that may be required for intermediates with limited exposure marketed in higher volumes. Annex VIII is therefore amended as follows: (a) the text in Annex 8A to this Directive is inserted between "Level 1" and "Physicochemical studies" of Annex VIII; (b) the text in Annex 8B to this Directive is inserted between "Level 2" and "Toxicological studies" of Annex VIII. Article 2 1. Member States shall adopt and publish before 30 July 2002 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. 2. Member States shall apply the laws, regulations and administrative provisions referred to in paragraph 1: (a) as from 30 July 2002 or an earlier date for dangerous substances; (b) as from 30 July 2002 for preparations not within the scope of Council Directive 91/414/EEC(6) or European Parliament and Council Directive 98/8/EC(7); (c) as from 30 July 2004 for preparations within the scope of Directive 91/414/EEC or Directive 98/8/EC. 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. 3. Member States shall 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 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32001L0060

2001

Commission Directive 2001/60/EC of 7 August 2001 adapting to technical progress Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(1), and in particular Article 20 thereof, Whereas: (1) Commission Directive 98/98/EC(2) adapting to technical progress for the 25th time Council Directive 67/548/EEC(3), as last amended by Directive 2000/33/EC(4), provides for new criteria and a new R phrase (R67) for vapours which may cause drowsiness and dizziness. The provisions set out in Annex V to Directive 1999/45/EC should therefore be supplemented. (2) Commission Directive 2001/59/EC(5) introduces new wording for R phrase R40 when it is assigned to carcinogens of category 3. Consequently, the old wording of R phrase R40 will now be referred to as R68 and will continue to be used for mutagens of category 3 and for certain substances with non-lethal irreversible effects. It is therefore necessary to amend the references to R40 in Annex II to Directive 1999/45/EC. (3) Directive 2001/59/EC introduces into Annex VI to Directive 67/548/EEC clearer advice on the classification of substances and preparations for corrosive effects. It is therefore necessary to supplement Annex II to Directive 1999/45/EC accordingly. (4) It is known that cement preparations containing chromium (VI) may cause allergic reactions in certain circumstances. It is therefore desirable to require such preparations to display a warning label by supplementing Annex V to Directive 1999/45/EC. (5) The measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of the Directives on the removal of technical barriers to trade in dangerous substances and preparations established under Article 20 of Directive 1999/45/EC, Article 1 Directive 1999/45/EC is amended as follows: 1. In Annex II, Part A: - in paragraph 3.3, the term "R40" is replaced by "R68", - in paragraph 8.2, the term "R40" is replaced by "R68" each time it occurs. 2. In Annex II, Part B: - in paragraph 2.1 (including Table II), the term "R40" is replaced by "R68" each time it occurs, - in paragraph 2.2 (including Table II A), the term "R40" is replaced by "R68" each time it occurs, - in paragraph 6.1, the term "R40" is replaced by "R68" the second time it occurs (i.e. in relation to mutagenic category 3), - in Table VI, the term "R40" is replaced by "R68" in the fourth row, columns 1 and 3 (i.e. in relation with mutagenic category 3), - in paragraph 6.2, the term "R40" is replaced by "R68" the second time it occurs (i.e. in relation to mutagenic category 3), - in Table VI A, the term "R40" is replaced by "R68" in the fourth row, columns 1 and 3 (i.e. in relation with mutagenic category 3). 3. In Annex II, Part B, Tables IV and IV A are supplemented with the following note: ">TABLE> NB: Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI to Directive 67/548/EEC and in the second and third indents of Article 6(3), of this Directive." Article 2 Annex V(B) to Directive 1999/45/EC is supplemented by the addition of new paragraphs 11 and 12 as in Annex I 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 30 July 2002 at the latest. They shall forthwith inform the Commission thereof. 2. Member States shall apply the laws, regulations and administrative provisions referred to in paragraph 1: (a) to preparations not within the scope of Council Directive 91/414/EEC(6) on the placing of plant protection products on the market, or European Parliament and Council Directive 98/8/EC(7) on the placing of biocidal products on the market as from 30 July 2002; (b) and to preparations within the scope of Directive 91/414/EEC or Directive 98/8/EC as from 30 July 2004. 3. 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.

32001L0062

2001

Commission Directive 2001/62/EC of 9 August 2001 amending Directive 90/128/EEC 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) Silicones should be regarded as elastomeric materials rather than plastic materials and therefore should be deleted from the definition of plastics. (2) 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. (3) 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. (4) Recent collaborative tests indicate that there is greater variability in the results of analysis for the determination of overall migration of substances used in plastics when aqueous food simulants as well as volatile media such as isooctane, ethanol and other similar solutions are used. (5) 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, use of which may be continued pending their evaluation by the Scientific Committee on Food and the decision on their inclusion in the Community list. (6) On the basis of the new information available to the Scientific Committee on Food, certain monomers provisionally admitted at national level as well as other monomers requested for use following the adoption of 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 1999/91/EC(3), may be included in the Community list of approved substances. (7) For certain substances, the restrictions already established at Community level should be amended on the basis of the information available. (8) The current total 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 only pending a decision on inclusion in the Community list. (9) This Directive establishes specifications for only a few substances, and therefore the other substances, which may require specifications remain regulated in this respect by national laws only pending a decision at Community level. (10) 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. (11) 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 admitted 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. (12) Directive 90/128/EEC should therefore be amended accordingly. (13) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 Directive 90/128/EEC is amended as follows: 1. In Article 1, paragraph 3 is replaced by the following: "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 macromoles. Other substances or matter may be added to such macromolecular compounds. However, the following shall not be regarded as 'plastics': (i) varnished or unvarnished regenerated cellulose film, covered by Commission Directive 93/10/EEC(4); (ii) elastomers and natural and synthetic rubber; (iii) paper and paperboard, whether modified or not by the addition of plastics; (iv) 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; (v) ion-exchange resins; (vi) silicones." 2. In Article 3, paragraphs 4 and 5 are replaced by the following: "4. Only those monomers and other starting substances listed in Annex II, Section A, shall be used for the manufacture of plastic materials and articles, subject to the restrictions specified therein. By way of derogation from the first subparagraph, the monomers and other starting substances listed in Annex II, Section B, may continue to be used until 31 December 2004 at the latest, pending their evaluation by the Scientific Committee on Food. 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." 3. Article 3a is replaced by the following: "Article 3a An incomplete list of additives which may be used for the manufacture of plastic materials and articles, together with 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." 4. In Article 3c, paragraph 1 is replaced by the following: "1. General specifications related to plastics 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." 5. In Article 5, the following paragraph 4 is added: "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." 6. Annexes I, II, III, V and VI are amended as set out in Annexes I to V to this Directive. Article 2 The requirements introduced by this Directive shall not apply to materials and articles containing the substances regulated by the Directive which have been put into free circulation in the Community before 1 December 2002. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 November 2002 at latest. They shall forthwith inform the Commission thereof. When Member States adopt these 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 its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32001L0064

2001

Council Directive 2001/64/EC of 31 August 2001 amending Directive 66/401/EEC on the marketing of fodder plant seed and Directive 66/402/EEC on the marketing of cereal seed 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) For the reasons set out below, Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed(4) and Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seeds(5) should be amended. (2) Commission Decision 94/650/EC(6) organised a temporary experiment under specified conditions, with the aim of assessing whether the marketing of seed in bulk to the final consumer would have no adverse effect on the quality of the seed compared with the level of quality achieved under the present system under Directives 66/401/EEC and 66/402/EEC. (3) Following that temporary experiment, it is appropriate to permit the marketing of seed in bulk to the final consumer on a permanent basis, subject to the observance of specific conditions, and Directives 66/401/EEC and 66/402/EEC should be amended accordingly. (4) The measures necessary for the implementation of Directives 66/401/EEC and 66/402/EEC 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 Directive 66/401/EEC is hereby amended as follows: 1. The following Article shall be inserted: "Article 10d 1. Member States may, by way of derogation from Articles 8, 9 and 10, provide a simplification of the provisions relating to the closing device and the marking of packages in the case of marketing of seed of the category 'certified seed' in bulk to the final consumer. 2. Conditions for the application of the derogation under paragraph 1 above shall be determined in accordance with the procedure referred to in Article 21(2). Until such measures are adopted, the conditions set out in Article 2 of Commission Decision 94/650/EC(8) shall apply." 2. Article 21 shall be replaced by the following: "Article 21 1. The Commission shall be assisted by the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry established by Article 1 of Council Decision 66/399/EEC (hereinafter 'the Committee'). 2. Where reference is made to this paragraph, Articles 4 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(9) shall apply. The period provided for in Article 4(3) of Decision 1999/468/EC shall be set at one month. 3. The Committee shall adopt its rules of procedures." Article 2 Directive 66/402/EEC is hereby amended as follows: 1. The following Article shall be inserted: "Article 10a 1. Member States may, by way of derogation from Articles 8, 9 and 10, provide a simplification of the provisions relating to the closing device and the marking of packages in the case of marketing of seed of the category 'certified seed' in bulk to the final consumer. 2. Conditions for the application of the derogation under paragraph 1 above shall be determined in accordance with the procedure referred to in Article 21(2). Until such measures are adopted, the conditions set out in Article 2 of Commission Decision 94/650/EC(10) shall apply." 2. Article 21 shall be replaced by the following: "Article 21 1. The Commission shall be assisted by the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry established by Article 1 of Decision 66/399/EEC (hereinafter 'the Committee'). 2. Where reference is made to this paragraph, Articles 4 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(11) shall apply. The period provided for in Article 4(3) of Decision 1999/468/EC shall be set at one month. 3. The Committee shall adopt its rules of procedures." Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 March 2002. 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 domestic law they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32001L0078

2001

Commission Directive 2001/78/EC of 13 September 2001 amending Annex IV to Council Directive 93/36/EEC, Annexes IV, V and VI to Council Directive 93/37/EEC, Annexes III and IV to Council Directive 92/50/EEC, as amended by Directive 97/52/EC, and Annexes XII to XV, XVII and XVIII to Council Directive 93/38/EEC, as amended by Directive 98/4/EC (Directive on the use of standard forms in the publication of public contract notices) (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 92/50/EEC of 18 June 1992 relating to the coordination of procedures for the award of public service contracts(1) as amended by Directive 97/52/EC(2), and in particular Article 22 thereof, Council Directive 93/36/EEC of 14 June 1993 coordinating procedures for the award of public supply contracts(3) as amended by Directive 97/52/EC, and in particular Article 14 thereof, Council Directive 93/37/EEC of 14 June 1993, concerning the coordination of procedures for the award of public works contracts(4) as amended by Directive 97/52/EC, and in particular Article 35(2) thereof and Council Directive 93/38/EEC of 14 June 1993, coordinating the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors(5) as amended by Directive 98/4/EC(6), and in particular Article 39(2) and Article 40(2) and (3) thereof, Whereas: (1) Directives 92/50/EEC, 93/36/EEC, 93/37/EEC and 93/38/EEC stipulate that contracts to which they apply must be published in the Official Journal of the European Communities and specify the information they must contain; these Directives also establish models in accordance with which notices must be drawn up; this obligation arises from article 9(4) of Directive 93/36/EEC, Article 11(6) of Directive 93/37/EEC, Article 17(1) of Directive 92/50/EEC and Article 21(1) and (4), Article 22(2) and Article 24(1) of Directive 93/38/EEC. (2) The Commission adopted a recommendation (91/561/EEC) on 24 October 1991(7) and a communication on 30 December 1992(8); the use of certain model notices for supplies and works contracts is therefore recommended. These models differ from the model notices in the annexes to the Directives. (3) The models laid down in the Directives now need to be modified in order to contribute to simplifying the implementation of the advertising rules while adapting them to the electronic means developed as part of the information system for public procurement (SIMAP), launched by the Commission in collaboration with the Member States. Moreover, the use of standard forms and the possible use of the common procurement vocabulary (CPV) will contribute to greater transparency in the market. For clarification purposes, it is suitable to replace the abovementioned annexes by the standard form. (4) The measures provided for in this Directive are in accordance with the opinions of both the Advisory Committee on Public Procurement and the Advisory Committee on Telecommunications Procurement, Article 1 1. Annex IV to Directive 93/36/EEC shall be replaced by Annex I to this Directive. 2. Annexes IV, V and VI to Directive 93/37/EEC shall be replaced by the text of Annexes II, III and IV respectively to this Directive. 3. Annexes III and IV to Directive 92/50/EEC shall be replaced by Annexes V and VI respectively to this Directive. 4. Annexes XII to XV, XVII and XVIII to Directive 93/38/EEC shall be replaced by Annexes VII to XII respectively to this directive. Article 2 1. Member States shall take the measures necessary to comply with this Directive not later than 1 May 2002. They shall immediately inform the Commission. 2. When Member States adopt the measures referred to in article 1, these shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods for making such a reference shall be laid down by the Member States. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32001L0084

2001

Directive 2001/84/EC of the European Parliament and of the Council of 27 September 2001 on the resale right for the benefit of the author of an original work of art 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), and in the light of the joint text approved by the Conciliation Committee on 6 June 2001, Whereas: (1) In the field of copyright, the resale right is an unassignable and inalienable right, enjoyed by the author of an original work of graphic or plastic art, to an economic interest in successive sales of the work concerned. (2) The resale right is a right of a productive character which enables the author/artist to receive consideration for successive transfers of the work. The subject-matter of the resale right is the physical work, namely the medium in which the protected work is incorporated. (3) The resale right is intended to ensure that authors of graphic and plastic works of art share in the economic success of their original works of art. It helps to redress the balance between the economic situation of authors of graphic and plastic works of art and that of other creators who benefit from successive exploitations of their works. (4) The resale right forms an integral part of copyright and is an essential prerogative for authors. The imposition of such a right in all Member States meets the need for providing creators with an adequate and standard level of protection. (5) Under Article 151(4) of the Treaty the Community is to take cultural aspects into account in its action under other provisions of the Treaty. (6) The Berne Convention for the Protection of Literary and Artistic Works provides that the resale right is available only if legislation in the country to which the author belongs so permits. The right is therefore optional and subject to the rule of reciprocity. It follows from the case-law of the Court of Justice of the European Communities on the application of the principle of non-discrimination laid down in Article 12 of the Treaty, as shown in the judgment of 20 October 1993 in Joined Cases C-92/92 and C-326/92 Phil Collins and Others(4), that domestic provisions containing reciprocity clauses cannot be relied upon in order to deny nationals of other Member States rights conferred on national authors. The application of such clauses in the Community context runs counter to the principle of equal treatment resulting from the prohibition of any discrimination on grounds of nationality. (7) The process of internationalisation of the Community market in modern and contemporary art, which is now being speeded up by the effects of the new economy, in a regulatory context in which few States outside the EU recognise the resale right, makes it essential for the European Community, in the external sphere, to open negotiations with a view to making Article 14b of the Berne Convention compulsory. (8) The fact that this international market exists, combined with the lack of a resale right in several Member States and the current disparity as regards national systems which recognise that right, make it essential to lay down transitional provisions as regards both entry into force and the substantive regulation of the right, which will preserve the competitiveness of the European market. (9) The resale right is currently provided for by the domestic legislation of a majority of Member States. Such laws, where they exist, display certain differences, notably as regards the works covered, those entitled to receive royalties, the rate applied, the transactions subject to payment of a royalty, and the basis on which these are calculated. The application or non-application of such a right has a significant impact on the competitive environment within the internal market, since the existence or absence of an obligation to pay on the basis of the resale right is an element which must be taken into account by each individual wishing to sell a work of art. This right is therefore a factor which contributes to the creation of distortions of competition as well as displacement of sales within the Community. (10) Such disparities with regard to the existence of the resale right and its application by the Member States have a direct negative impact on the proper functioning of the internal market in works of art as provided for by Article 14 of the Treaty. In such a situation Article 95 of the Treaty constitutes the appropriate legal basis. (11) The objectives of the Community as set out in the Treaty include laying the foundations of an ever closer union among the peoples of Europe, promoting closer relations between the Member States belonging to the Community, and ensuring their economic and social progress by common action to eliminate the barriers which divide Europe. To that end the Treaty provides for the establishment of an internal market which presupposes the abolition of obstacles to the free movement of goods, freedom to provide services and freedom of establishment, and for the introduction of a system ensuring that competition in the common market is not distorted. Harmonisation of Member States' laws on the resale right contributes to the attainment of these objectives. (12) 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(5), progressively introduces a Community system of taxation applicable inter alia to works of art. Measures confined to the tax field are not sufficient to guarantee the harmonious functioning of the art market. This objective cannot be attained without harmonisation in the field of the resale right. (13) Existing differences between laws should be eliminated where they have a distorting effect on the functioning of the internal market, and the emergence of any new differences of that kind should be prevented. There is no need to eliminate, or prevent the emergence of, differences which cannot be expected to affect the functioning of the internal market. (14) A precondition of the proper functioning of the internal market is the existence of conditions of competition which are not distorted. The existence of differences between national provisions on the resale right creates distortions of competition and displacement of sales within the Community and leads to unequal treatment between artists depending on where their works are sold. The issue under consideration has therefore transnational aspects which cannot be satisfactorily regulated by action by Member States. A lack of Community action would conflict with the requirement of the Treaty to correct distortions of competition and unequal treatment. (15) In view of the scale of divergences between national provisions it is therefore necessary to adopt harmonising measures to deal with disparities between the laws of the Member States in areas where such disparities are liable to create or maintain distorted conditions of competition. It is not however necessary to harmonise every provision of the Member States' laws on the resale right and, in order to leave as much scope for national decision as possible, it is sufficient to limit the harmonisation exercise to those domestic provisions that have the most direct impact on the functioning of the internal market. (16) This Directive complies therefore, in its entirety, with the principles of subsidiarity and proportionality as laid down in Article 5 of the Treaty. (17) Pursuant to Council Directive 93/98/EEC of 29 October 1993 harmonising the term of protection of copyright and certain related rights(6), the term of copyright runs for 70 years after the author's death. The same period should be laid down for the resale right. Consequently, only the originals of works of modern and contemporary art may fall within the scope of the resale right. However, in order to allow the legal systems of Member States which do not, at the time of the adoption of this Directive, apply a resale right for the benefit of artists to incorporate this right into their respective legal systems and, moreover, to enable the economic operators in those Member States to adapt gradually to the aforementioned right whilst maintaining their economic viability, the Member States concerned should be allowed a limited transitional period during which they may choose not to apply the resale right for the benefit of those entitled under the artist after his death. (18) The scope of the resale right should be extended to all acts of resale, with the exception of those effected directly between persons acting in their private capacity without the participation of an art market professional. This right should not extend to acts of resale by persons acting in their private capacity to museums which are not for profit and which are open to the public. With regard to the particular situation of art galleries which acquire works directly from the author, Member States should be allowed the option of exempting from the resale right acts of resale of those works which take place within three years of that acquisition. The interests of the artist should also be taken into account by limiting this exemption to such acts of resale where the resale price does not exceed EUR 10000. (19) It should be made clear that the harmonisation brought about by this Directive does not apply to original manuscripts of writers and composers. (20) Effective rules should be laid down based on experience already gained at national level with the resale right. It is appropriate to calculate the royalty as a percentage of the sale price and not of the increase in value of works whose original value has increased. (21) The categories of works of art subject to the resale right should be harmonised. (22) The non-application of royalties below the minimum threshold may help to avoid disproportionately high collection and administration costs compared with the profit for the artist. However, in accordance with the principle of subsidiarity, the Member States should be allowed to establish national thresholds lower than the Community threshold, so as to promote the interests of new artists. Given the small amounts involved, this derogation is not likely to have a significant effect on the proper functioning of the internal market. (23) The rates set by the different Member States for the application of the resale right vary considerably at present. The effective functioning of the internal market in works of modern and contemporary art requires the fixing of uniform rates to the widest possible extent. (24) It is desirable to establish, with the intention of reconciling the various interests involved in the market for original works of art, a system consisting of a tapering scale of rates for several price bands. It is important to reduce the risk of sales relocating and of the circumvention of the Community rules on the resale right. (25) The person by whom the royalty is payable should, in principle, be the seller. Member States should be given the option to provide for derogations from this principle in respect of liability for payment. The seller is the person or undertaking on whose behalf the sale is concluded. (26) Provision should be made for the possibility of periodic adjustment of the threshold and rates. To this end, it is appropriate to entrust to the Commission the task of drawing up periodic reports on the actual application of the resale right in the Member States and on the impact on the art market in the Community and, where appropriate, of making proposals relating to the amendment of this Directive. (27) The persons entitled to receive royalties must be specified, due regard being had to the principle of subsidiarity. It is not appropriate to take action through this Directive in relation to Member States' laws of succession. However, those entitled under the author must be able to benefit fully from the resale right after his death, at least following the expiry of the transitional period referred to above. (28) The Member States are responsible for regulating the exercise of the resale right, particularly with regard to the way this is managed. In this respect management by a collecting society is one possibility. Member States should ensure that collecting societies operate in a transparent and efficient manner. Member States must also ensure that amounts intended for authors who are nationals of other Member States are in fact collected and distributed. This Directive is without prejudice to arrangements in Member States for collection and distribution. (29) Enjoyment of the resale right should be restricted to Community nationals as well as to foreign authors whose countries afford such protection to authors who are nationals of Member States. A Member State should have the option of extending enjoyment of this right to foreign authors who have their habitual residence in that Member State. (30) Appropriate procedures for monitoring transactions should be introduced so as to ensure by practical means that the resale right is effectively applied by Member States. This implies also a right on the part of the author or his authorised representative to obtain any necessary information from the natural or legal person liable for payment of royalties. Member States which provide for collective management of the resale right may also provide that the bodies responsible for that collective management should alone be entitled to obtain information, CHAPTER I SCOPE Article 1 Subject matter of the resale right 1. Member States shall provide, for the benefit of the author of an original work of art, a resale right, to be defined as an inalienable right, which cannot be waived, even in advance, to receive a royalty based on the sale price obtained for any resale of the work, subsequent to the first transfer of the work by the author. 2. The right referred to in paragraph 1 shall apply to all acts of resale involving as sellers, buyers or intermediaries art market professionals, such as salesrooms, art galleries and, in general, any dealers in works of art. 3. Member States may provide that the right referred to in paragraph 1 shall not apply to acts of resale where the seller has acquired the work directly from the author less than three years before that resale and where the resale price does not exceed EUR 10000. 4. The royalty shall be payable by the seller. Member States may provide that one of the natural or legal persons referred to in paragraph 2 other than the seller shall alone be liable or shall share liability with the seller for payment of the royalty. Article 2 Works of art to which the resale right relates 1. For the purposes of this Directive, "original work of art" means works of graphic or plastic art such as pictures, collages, paintings, drawings, engravings, prints, lithographs, sculptures, tapestries, ceramics, glassware and photographs, provided they are made by the artist himself or are copies considered to be original works of art. 2. Copies of works of art covered by this Directive, which have been made in limited numbers by the artist himself or under his authority, shall be considered to be original works of art for the purposes of this Directive. Such copies will normally have been numbered, signed or otherwise duly authorised by the artist. CHAPTER II PARTICULAR PROVISIONS Article 3 Threshold 1. It shall be for the Member States to set a minimum sale price from which the sales referred to in Article 1 shall be subject to resale right. 2. This minimum sale price may not under any circumstances exceed EUR 3000. Article 4 Rates 1. The royalty provided for in Article 1 shall be set at the following rates: (a) 4 % for the portion of the sale price up to EUR 50000; (b) 3 % for the portion of the sale price from EUR 50000,01 to EUR 200000; (c) 1 % for the portion of the sale price from EUR 200000,01 to EUR 350000; (d) 0,5 % for the portion of the sale price from EUR 350000,01 to EUR 500000; (e) 0,25 % for the portion of the sale price exceeding EUR 500000. However, the total amount of the royalty may not exceed EUR 12500. 2. By way of derogation from paragraph 1, Member States may apply a rate of 5 % for the portion of the sale price referred to in paragraph 1(a). 3. If the minimum sale price set should be lower than EUR 3000, the Member State shall also determine the rate applicable to the portion of the sale price up to EUR 3000; this rate may not be lower than 4 %. Article 5 Calculation basis The sale prices referred to in Articles 3 and 4 are net of tax. Article 6 Persons entitled to receive royalties 1. The royalty provided for under Article 1 shall be payable to the author of the work and, subject to Article 8(2), after his death to those entitled under him/her. 2. Member States may provide for compulsory or optional collective management of the royalty provided for under Article 1. Article 7 Third-country nationals entitled to receive royalties 1. Member States shall provide that authors who are nationals of third countries and, subject to Article 8(2), their successors in title shall enjoy the resale right in accordance with this Directive and the legislation of the Member State concerned only if legislation in the country of which the author or his/her successor in title is a national permits resale right protection in that country for authors from the Member States and their successors in title. 2. On the basis of information provided by the Member States, the Commission shall publish as soon as possible an indicative list of those third countries which fulfil the condition set out in paragraph 1. This list shall be kept up to date. 3. Any Member State may treat authors who are not nationals of a Member State but who have their habitual residence in that Member State in the same way as its own nationals for the purpose of resale right protection. Article 8 Term of protection of the resale right 1. The term of protection of the resale right shall correspond to that laid down in Article 1 of Directive 93/98/EEC. 2. By way of derogation from paragraph 1, those Member States which do not apply the resale right on (the entry into force date referred to in Article 13), shall not be required, for a period expiring not later than 1 January 2010, to apply the resale right for the benefit of those entitled under the artist after his/her death. 3. A Member State to which paragraph 2 applies may have up to two more years, if necessary to enable the economic operators in that Member State to adapt gradually to the resale right system while maintaining their economic viability, before it is required to apply the resale right for the benefit of those entitled under the artist after his/her death. At least 12 months before the end of the period referred to in paragraph 2, the Member State concerned shall inform the Commission giving its reasons, so that the Commission can give an opinion, after appropriate consultations, within three months following the receipt of such information. If the Member State does not follow the opinion of the Commission, it shall within one month inform the Commission and 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 Communities and forwarded to the European Parliament. 4. In the event of the successful conclusion, within the periods referred to in Article 8(2) and (3), of international negotiations aimed at extending the resale right at international level, the Commission shall submit appropriate proposals. Article 9 Right to obtain information The Member States shall provide that for a period of three years after the resale, the persons entitled under Article 6 may require from any art market professional mentioned in Article 1(2) to furnish any information that may be necessary in order to secure payment of royalties in respect of the resale. CHAPTER III FINAL PROVISIONS Article 10 Application in time This Directive shall apply in respect of all original works of art as defined in Article 2 which, on 1 January 2006, are still protected by the legislation of the Member States in the field of copyright or meet the criteria for protection under the provisions of this Directive at that date. Article 11 Revision clause 1. The Commission shall submit to the European Parliament, the Council and the Economic and Social Committee not later than 1 January 2009 and every four years thereafter a report on the implementation and the effect of this Directive, paying particular attention to the competitiveness of the market in modern and contemporary art in the Community, especially as regards the position of the Community in relation to relevant markets that do not apply the resale right and the fostering of artistic creativity and the management procedures in the Member States. It shall examine in particular its impact on the internal market and the effect of the introduction of the resale right in those Member States that did not apply the right in national law prior to the entry into force of this Directive. Where appropriate, the Commission shall submit proposals for adapting the minimum threshold and the rates of royalty to take account of changes in the sector, proposals relating to the maximum amount laid down in Article 4(1) and any other proposal it may deem necessary in order to enhance the effectiveness of this Directive. 2. A Contact Committee is hereby established. It shall be composed of representatives of the competent authorities of the Member States. It shall be chaired by a representative of the Commission and shall meet either on the initiative of the Chairman or at the request of the delegation of a Member State. 3. The task of the Committee shall be as follows: - to organise consultations on all questions deriving from application of this Directive, - to facilitate the exchange of information between the Commission and the Member States on relevant developments in the art market in the Community. Article 12 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 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. 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 13 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 14 Addressees This Directive is addressed to the Member States.

32001L0077

2001

Directive 2001/77/EC of the European Parliament and of the Council of 27 September 2001 on the promotion of electricity produced from renewable energy sources in the internal electricity market 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) The potential for the exploitation of renewable energy sources is underused in the Community at present. The Community recognises the need to promote renewable energy sources as a priority measure given that their exploitation contributes to environmental protection and sustainable development. In addition this can also create local employment, have a positive impact on social cohesion, contribute to security of supply and make it possible to meet Kyoto targets more quickly. It is therefore necessary to ensure that this potential is better exploited within the framework of the internal electricity market. (2) The promotion of electricity produced from renewable energy sources is a high Community priority as outlined in the White Paper on Renewable Energy Sources (hereinafter referred to as "the White Paper") for reasons of security and diversification of energy supply, of environmental protection and of social and economic cohesion. That was endorsed by the Council in its resolution of 8 June 1998 on renewable sources of energy(5), and by the European Parliament in its resolution on the White Paper.(6) (3) The increased use of electricity produced from renewable energy sources constitutes an important part of the package of measures needed to comply with the Kyoto Protocol to the United Nations Framework Convention on Climate Change, and of any policy package to meet further commitments. (4) The Council in its conclusions of 11 May 1999 and the European Parliament in its resolution of 17 June 1998 on electricity from renewable energy sources(7) have invited the Commission to submit a concrete proposal for a Community framework on access for electricity produced from renewable energy sources to the internal market. Furthermore, the European Parliament in its resolution of 30 March 2000 on electricity from renewable energy sources and the internal electricity market(8) underlined that binding and ambitious renewable energy targets at the national level are essential for obtaining results and achieving the Community targets. (5) To ensure increased market penetration of electricity produced from renewable energy sources in the medium term, all Member States should be required to set national indicative targets for the consumption of electricity produced from renewable sources. (6) These national indicative targets should be consistent with any national commitment made as part of the climate change commitments accepted by the Community under the Kyoto Protocol. (7) The Commission should assess to what extent Member States have made progress towards achieving their national indicative targets, and to what extent the national indicative targets are consistent with the global indicative target of 12 % of gross domestic energy consumption by 2010, considering that the White Paper's indicative target of 12 % for the Community as a whole by 2010 provides useful guidance for increased efforts at Community level as well as in Member States, bearing in mind the need to reflect differing national circumstances. If necessary for the achievement of the targets, the Commission should submit proposals to the European Parliament and the Council which may include mandatory targets. (8) Where they use waste as an energy source, Member States must comply with current Community legislation on waste management. The application of this Directive is without prejudice to the definitions set out in Annex 2a and 2b to Council Directive 75/442/EEC of 15 July 1975 on waste(9). Support for renewable energy sources should be consistent with other Community objectives, in particular respect for the waste treatment hierarchy. Therefore, the incineration of non-separated municipal waste should not be promoted under a future support system for renewable energy sources, if such promotion were to undermine the hierarchy. (9) The definition of biomass used in this Directive does not prejudge the use of a different definition in national legislation, for purposes other than those set out in this Directive. (10) This Directive does not require Member States to recognise the purchase of a guarantee of origin from other Member States or the corresponding purchase of electricity as a contribution to the fulfilment of a national quota obligation. However, to facilitate trade in electricity produced from renewable energy sources and to increase transparency for the consumer's choice between electricity produced from non-renewable and electricity produced from renewable energy sources, the guarantee of origin of such electricity is necessary. Schemes for the guarantee of origin do not by themselves imply a right to benefit from national support mechanisms established in different Member States. It is important that all forms of electricity produced from renewable energy sources are covered by such guarantees of origin. (11) It is important to distinguish guarantees of origin clearly from exchangeable green certificates. (12) The need for public support in favour of renewable energy sources is recognised in the Community guidelines for State aid for environmental protection(10), which, amongst other options, take account of the need to internalise external costs of electricity generation. However, the rules of the Treaty, and in particular Articles 87 and 88 thereof, will continue to apply to such public support. (13) A legislative framework for the market in renewable energy sources needs to be established. (14) Member States operate different mechanisms of support for renewable energy sources at the national level, including green certificates, investment aid, tax exemptions or reductions, tax refunds and direct price support schemes. One important means to achieve the aim of this Directive is to guarantee the proper functioning of these mechanisms, until a Community framework is put into operation, in order to maintain investor confidence. (15) It is too early to decide on a Community-wide framework regarding support schemes, in view of the limited experience with national schemes and the current relatively low share of price supported electricity produced from renewable energy sources in the Community. (16) It is, however necessary to adapt, after a sufficient transitional period, support schemes to the developing internal electricity market. It is therefore appropriate that the Commission monitor the situation and present a report on experience gained with the application of national schemes. If necessary, the Commission should, in the light of the conclusions of this report, make a proposal for a Community framework with regard to support schemes for electricity produced from renewable energy sources. That proposal should contribute to the achievement of the national indicative targets, be compatible with the principles of the internal electricity market and take into account the characteristics of the different sources of renewable energy, together with the different technologies and geographical differences. It should also promote the use of renewable energy sources in an effective way, and be simple and at the same time as efficient as possible, particularly in terms of cost, and include sufficient transitional periods of at least seven years, maintain investors' confidence and avoid stranded costs. This framework would enable electricity from renewable energy sources to compete with electricity produced from non-renewable energy sources and limit the cost to the consumer, while, in the medium term, reduce the need for public support. (17) Increased market penetration of electricity produced from renewable energy sources will allow for economies of scale, thereby reducing costs. (18) It is important to utilise the strength of the market forces and the internal market and make electricity produced from renewable energy sources competitive and attractive to European citizens. (19) When favouring the development of a market for renewable energy sources, it is necessary to take into account the positive impact on regional and local development opportunities, export prospects, social cohesion and employment opportunities, especially as concerns small and medium-sized undertakings as well as independent power producers. (20) The specific structure of the renewable energy sources sector should be taken into account, especially when reviewing the administrative procedures for obtaining permission to construct plants producing electricity from renewable energy sources. (21) In certain circumstances it is not possible to ensure fully transmission and distribution of electricity produced from renewable energy sources without affecting the reliability and safety of the grid system and guarantees in this context may therefore include financial compensation. (22) The costs of connecting new producers of electricity from renewable energy sources should be objective, transparent and non-discriminatory and due account should be taken of the benefit embedded generators bring to the grid. (23) Since the general objectives of the proposed action 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. Their detailed implementation should, however, be left to the Member States, thus allowing each Member State to choose the regime which corresponds best to its particular situation. 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, Article 1 Purpose The purpose of this Directive is to promote an increase in the contribution of renewable energy sources to electricity production in the internal market for electricity and to create a basis for a future Community framework thereof. Article 2 Definitions For the purposes of this Directive, the following definitions shall apply: (a) "renewable energy sources" shall mean renewable non-fossil energy sources (wind, solar, geothermal, wave, tidal, hydropower, biomass, landfill gas, sewage treatment plant gas and biogases); (b) "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; (c) "electricity produced from renewable energy sources" shall mean electricity produced by plants using only renewable energy sources, as well as the proportion of electricity produced from renewable energy sources in hybrid plants also using conventional energy sources and including renewable electricity used for filling storage systems, and excluding electricity produced as a result of storage systems; (d) "consumption of electricity" shall mean national electricity production, including autoproduction, plus imports, minus exports (gross national electricity consumption). In addition, the definitions in Directive 96/92/EC of the European Parliament and of the Council of 19 December 1996 concerning common rules for the internal market of electricity(11) shall apply. Article 3 National indicative targets 1. Member States shall take appropriate steps to encourage greater consumption of electricity produced from renewable energy sources in conformity with the national indicative targets referred to in paragraph 2. These steps must be in proportion to the objective to be attained. 2. Not later than 27 October 2002 and every five years thereafter, Member States shall adopt and publish a report setting national indicative targets for future consumption of electricity produced from renewable energy sources in terms of a percentage of electricity consumption for the next 10 years. The report shall also outline the measures taken or planned, at national level, to achieve these national indicative targets. To set these targets until the year 2010, the Member States shall: - take account of the reference values in the Annex, - ensure that the targets are compatible with any national commitments accepted in the context of the climate change commitments accepted by the Community pursuant to the Kyoto Protocol to the United Nations Framework Convention on Climate Change. 3. Member States shall publish, for the first time not later than 27 October 2003 and thereafter every two years, a report which includes an analysis of success in meeting the national indicative targets taking account, in particular, of climatic factors likely to affect the achievement of those targets and which indicates to what extent the measures taken are consistent with the national climate change commitment. 4. On the basis of the Member States' reports referred to in paragraphs 2 and 3, the Commission shall assess to what extent: - Member States have made progress towards achieving their national indicative targets, - the national indicative targets are consistent with the global indicative target of 12 % of gross national energy consumption by 2010 and in particular with the 22,1 % indicative share of electricity produced from renewable energy sources in total Community electricity consumption by 2010. The Commission shall publish its conclusions in a report, for the first time not later than 27 October 2004 and thereafter every two years. This report shall be accompanied, as appropriate, by proposals to the European Parliament and to the Council. If the report referred to in the second subparagraph concludes that the national indicative targets are likely to be inconsistent, for reasons that are unjustified and/or do not relate to new scientific evidence, with the global indicative target, these proposals shall address national targets, including possible mandatory targets, in the appropriate form. Article 4 Support schemes 1. Without prejudice to Articles 87 and 88 of the Treaty, the Commission shall evaluate the application of mechanisms used in Member States according to which a producer of electricity, on the basis of regulations issued by the public authorities, receives direct or indirect support, and which could have the effect of restricting trade, on the basis that these contribute to the objectives set out in Articles 6 and 174 of the Treaty. 2. The Commission shall, not later than 27 October 2005, present a well-documented report on experience gained with the application and coexistence of the different mechanisms referred to in paragraph 1. The report shall assess the success, including cost-effectiveness, of the support systems referred to in paragraph 1 in promoting the consumption of electricity produced from renewable energy sources in conformity with the national indicative targets referred to in Article 3(2). This report shall, if necessary, be accompanied by a proposal for a Community framework with regard to support schemes for electricity produced from renewable energy sources. Any proposal for a framework should: (a) contribute to the achievement of the national indicative targets; (b) be compatible with the principles of the internal electricity market; (c) take into account the characteristics of different sources of renewable energy, together with the different technologies, and geographical differences; (d) promote the use of renewable energy sources in an effective way, and be simple and, at the same time, as efficient as possible, particularly in terms of cost; (e) include sufficient transitional periods for national support systems of at least seven years and maintain investor confidence. Article 5 Guarantee of origin of electricity produced from renewable energy sources 1. Member States shall, not later than 27 October 2003, ensure that the origin of electricity produced from renewable energy sources can be guaranteed as such within the meaning of this Directive according to objective, transparent and non-discriminatory criteria laid down by each Member State. They shall ensure that a guarantee of origin is issued to this effect in response to a request. 2. Member States may designate one or more competent bodies, independent of generation and distribution activities, to supervise the issue of such guarantees of origin. 3. A guarantee of origin shall: - specify the energy source from which the electricity was produced, specifying the dates and places of production, and in the case of hydroelectric installations, indicate the capacity; - serve to enable producers of electricity from renewable energy sources to demonstrate that the electricity they sell is produced from renewable energy sources within the meaning of this Directive. 4. Such guarantees of origin, issued according to paragraph 2, should be mutually recognised by the Member States, exclusively as proof of the elements referred to in paragraph 3. Any refusal to recognise a guarantee of origin as such proof, in particular for reasons relating to the prevention of fraud, must be based on objective, transparent and non-discriminatory criteria. In the event of refusal to recognise a guarantee of origin, the Commission may compel the refusing party to recognise it, particularly with regard to objective, transparent and non-discriminatory criteria on which such recognition is based. 5. Member States or the competent bodies shall put in place appropriate mechanisms to ensure that guarantees of origin are both accurate and reliable and they shall outline in the report referred to in Article 3(3) the measures taken to ensure the reliability of the guarantee system. 6. After having consulted the Member States, the Commission shall, in the report referred to in Article 8, consider the form and methods that Member States could follow in order to guarantee the origin of electricity produced from renewable energy sources. If necessary, the Commission shall propose to the European Parliament and the Council the adoption of common rules in this respect. Article 6 Administrative procedures 1. Member States or the competent bodies appointed by the Member States shall evaluate the existing legislative and regulatory framework with regard to authorisation procedures or the other procedures laid down in Article 4 of Directive 96/92/EC, which are applicable to production plants for electricity produced from renewable energy sources, with a view to: - reducing the regulatory and non-regulatory barriers to the increase in electricity production from renewable energy sources, - streamlining and expediting procedures at the appropriate administrative level, and - ensuring that the rules are objective, transparent and non-discriminatory, and take fully into account the particularities of the various renewable energy source technologies. 2. Member States shall publish, not later than 27 October 2003, a report on the evaluation referred to in paragraph 1, indicating, where appropriate, the actions taken. The purpose of this report is to provide, where this is appropriate in the context of national legislation, an indication of the stage reached specifically in: - coordination between the different administrative bodies as regards deadlines, reception and treatment of applications for authorisations, - drawing up possible guidelines for the activities referred to in paragraph 1, and the feasibility of a fast-track planning procedure for producers of electricity from renewable energy sources, and - the designation of authorities to act as mediators in disputes between authorities responsible for issuing authorisations and applicants for authorisations. 3. The Commission shall, in the report referred to in Article 8 and on the basis of the Member States' reports referred to in paragraph 2 of this Article, assess best practices with a view to achieving the objectives referred to in paragraph 1. Article 7 Grid system issues 1. Without prejudice to the maintenance of the reliability and safety of the grid, Member States shall take the necessary measures to ensure that transmission system operators and distribution system operators in their territory guarantee the transmission and distribution of electricity produced from renewable energy sources. They may also provide for priority access to the grid system of electricity produced from renewable energy sources. When dispatching generating installations, transmission system operators shall give priority to generating installations using renewable energy sources insofar as the operation of the national electricity system permits. 2. Member States shall put into place a legal framework or require transmission system operators and distribution system operators to set up and publish their standard rules relating to the bearing of costs of technical adaptations, such as grid connections and grid reinforcements, which are necessary in order to integrate new producers feeding electricity produced from renewable energy sources into the interconnected grid. These rules shall be based on objective, transparent and non-discriminatory criteria taking particular account of all the costs and benefits associated with the connection of these producers to the grid. The rules may provide for different types of connection. 3. Where appropriate, Member States may require transmission system operators and distribution system operators to bear, in full or in part, the costs referred to in paragraph 2. 4. Transmission system operators and distribution system operators shall be required to provide any new producer wishing to be connected with a comprehensive and detailed estimate of the costs associated with the connection. Member States may allow producers of electricity from renewable energy sources wishing to be connected to the grid to issue a call for tender for the connection work. 5. Member States shall put into place a legal framework or require transmission system operators and distribution system operators to set up and publish their standard rules relating to the sharing of costs of system installations, such as grid connections and reinforcements, between all producers benefiting from them. The sharing shall be enforced by a mechanism based on objective, transparent and non-discriminatory criteria taking into account the benefits which initially and subsequently connected producers as well as transmission system operators and distribution system operators derive from the connections. 6. Member States shall ensure that the charging of transmission and distribution fees does not discriminate against electricity from renewable energy sources, including in particular electricity from renewable energy sources produced in peripheral regions, such as island regions and regions of low population density. Where appropriate, Member States shall put in place a legal framework or require transmission system operators and distribution system operators to ensure that fees charged for the transmission and distribution of electricity from plants using renewable energy sources reflect realisable cost benefits resulting from the plant's connection to the network. Such cost benefits could arise from the direct use of the low-voltage grid. 7. Member States shall, in the report referred to in Article 6(2), also consider the measures to be taken to facilitate access to the grid system of electricity produced from renewable energy sources. That report shall examine, inter alia, the feasibility of introducing two-way metering. Article 8 Summary report On the basis of the reports by Member States pursuant to Article 3(3) and Article 6(2), the Commission shall present to the European Parliament and the Council, no later than 31 December 2005 and thereafter every five years, a summary report on the implementation of this Directive. This report shall: - consider the progress made in reflecting the external costs of electricity produced from non-renewable energy sources and the impact of public support granted to electricity production, - take into account the possibility for Member States to meet the national indicative targets established in Article 3(2), the global indicative target referred to in Article 3(4) and the existence of discrimination between different energy sources. If appropriate, the Commission shall submit with the report further proposals to the European Parliament and the Council. Article 9 Transposition Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 27 October 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 a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 10 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 11 Addressees This Directive is addressed to the Member States.

32001L0087

2001

Commission Directive 2001/87/EC of 12 October 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen-ethyl as active substances 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 2001/49/EC(2), and in particular Article 6(1) thereof, Whereas: (1) In accordance with Article 6(2) of Directive 91/414/EEC (hereinafter referred to as "the Directive") France received on 15 October 1996 an application from Novartis (now Syngenta) for the inclusion of the active substance acibenzolar-s-methyl (CGA 245704) in Annex I to the Directive. By Commission Decision 97/865/EC(3) it was confirmed that the dossier was "complete" i.e. it could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to the Directive. (2) Greece received a similar application on 27 March 1996 from Rhône Poulenc Agrochimie SA (now Aventis CropScience), concerning cyclanilide (RPA 090946). This application was declared complete by Commission Decision 97/137/EC(4). (3) On 27 August 1998, Germany received an application from W. Neudorff GmbH KG, concerning ferric phosphate. This application was declared complete by Commission Decision 1999/43/EC(5). (4) Germany also received on 4 September 1996 an application from Novartis concerning pymetrozine (CGA 215944). By Commission Decision 97/865/EC this application was declared complete. (5) On 16 June 1997, Belgium received an application from Nihon Nohyaku Co. Ltd, concerning pyraflufen-ethyl. This application was declared complete by Commission Decision 98/242/EC(6). (6) For these five 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 the Directive, for the uses proposed by the respective applicant. The nominated rapporteur Member States, submitted draft assessment reports concerning the substances to the Commission on 17 December 1998 (acibenzolar-s-methyl), 11 February 1998 (cyclanilide), 30 July 1999 (ferric phosphate), 28 May 1998 (pymethrozine) and 8 July 1999 (pyraflufen-ethyl), respectively. (7) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on Plant Health. The reviews were finalised on 29 June 2001 in the format of the individual Commission review reports for acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymethrozine and pyraflufen-ethyl. (8) The dossier and the information from each of the reviews were submitted to the Scientific Committee for Plants. As regards acibenzolar-s-methyl and ferric phosphate, no specific questions were addressed to the Committee. The Committee considered that there were no issues that it wished to raise regarding the active substances in the context of a possible inclusion in Annex I to the Directive(7). The Committee noted that absence of comment should only be interpreted as an indication of no obvious reasons necessitating comment. (9) In its opinion(8) concerning cyclanilide the Committee provided its interpretation of certain effects observed in mice and rabbits and recommended a reassessment of the degradation of the soil metabolite 2,4-dichloraniline. The recommendations of the Committee have been taken into consideration. (10) In its opinion(9) on pymetrozine the Committee assessed certain effects in the context of deriving an acceptable daily intake and an acute reference dose for consumers. (11) In its opinion(10) on pyraflufen-ethyl the Committee concluded that there is generally negligible risk of groundwater contamination for the parent compound and its breakdown products. However, under extreme conditions the fate of certain breakdown products should be assessed carefully. (12) It has appeared from the various examinations made that plant protection products containing any of the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a), (b) and (3) of the Directive, in particular with regard to the uses which were examined and detailed in the respective 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 the active substances concerned can be granted in accordance with the provisions of the said Directive. (13) After inclusion, a reasonable period is necessary to permit Member States to implement the provisions of the Directive on plant protection products containing acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine or pyraflufen-ethyl and in particular to review, within this period, existing provisional authorisations or to grant, by the end of this period at the latest, new authorisations in accordance with the provisions of the Directive. A longer period may also be required for plant protection products containing any of the active substances concerned and other active substances included in Annex I. (14) The review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Annex VI to the Directive, where those principles refer to the evaluation of the data which were submitted for the purpose of the inclusion of the active substance in Annex I to the Directive. It is, therefore, appropriate to provide that the finalised review reports (except for confidential information in the meaning of Article 14 of the Directive) are kept available or made available by the Member States for consultation by any interested parties. If a review report has to be updated to take account of technical and scientific developments, the conditions for the inclusion of the active substance concerned in Annex I to the Directive should also be amended in accordance with the Directive. (15) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 The table in Annex I to Directive 91/414/EEC shall be amended as set out in the Annex hereto. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, at the latest by 31 March 2002. 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. However, with regard to evaluation and decision-making pursuant to 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, the period laid down in the first paragraph is extended for existing provisional authorisations of plant protection products containing acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine or pyraflufen-ethyl to 31 March 2003. 3. However for plant protection products containing acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine or pyraflufen-ethyl together with another active substance which is in Annex I to Directive 91/414/EEC, the period referred to in paragraph 1 is extended to the extent that a longer implementation period is provided for by the provisions laid down in the Directive amending Annex I to Directive 91/414/EEC to include the substance in the Annex. 4. Member States shall keep available the review reports for acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen-ethyl (except for confidential information within the meaning of Article 14 of the Directive) for consultation by any interested parties or shall make it available to them on specific request. Article 3 This Directive shall enter into force on 1 November 2001. Article 4 This Directive is addressed to the Member States.

32001L0080

2001

Directive 2001/80/EC of the European Parliament and of the Council of 23 October 2001 on the limitation of emissions of certain pollutants into the air from large combustion plants 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 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 2 August 2001, Whereas: (1) Council Directive 88/609/EEC of 24 November 1988 on the limitation of emissions of certain pollutants into the air from large combustion plants(4) has contributed to the reduction and control of atmospheric emissions from large combustion plants. It should be recast in the interests of clarity. (2) The Fifth Environmental Action Programme(5) sets as objectives that the critical loads and levels of certain acidifying pollutants such as sulphur dioxide (SO2) and nitrogen oxides (NOx) should not be exceeded at any time and, as regards air quality, that all people should be effectively protected against recognised health risks from air pollution. (3) All Member States have signed the Gothenburg Protocol of 1 December 1999 to the 1979 Convention of the United Nations Economic Commission for Europe (UNECE) on long-range transboundary air pollution to abate acidification, eutrophication and ground-level ozone, which includes, inter alia, commitments to reduce emissions of sulphur dioxide and oxides of nitrogen. (4) The Commission has published a Communication on a Community strategy to combat acidification in which the revision of Directive 88/609/EEC was identified as being an integral component of that strategy with the long term aim of reducing emissions of sulphur dioxide and nitrogen oxides sufficiently to bring depositions and concentrations down to levels below the critical loads and levels. (5) In accordance with the principle of subsidiarity as set out in Article 5 of the Treaty, the objective of reducing acidifying emissions from large combustion plants cannot be sufficiently achieved by the Member States acting individually and unconcerted action offers no guarantee of achieving the desired objective; in view of the need to reduce acidifying emissions across the Community, it is more effective to take action at Community level. (6) Existing large combustion plants are significant contributors to emissions of sulphur dioxide and nitrogen oxides in the Community and it is necessary to reduce these emissions. It is therefore necessary to adapt the approach to the different characteristics of the large combustion plant sector in the Member States. (7) Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control(6) sets out an integrated approach to pollution prevention and control in which all the aspects of an installation's environmental performance are considered in an integrated manner; combustion installations with a rated thermal input exceeding 50 MW are included within the scope of that Directive; pursuant to Article 15(3) of that Directive an inventory of the principal emissions and sources responsible is to be published every three years by the Commission on the basis of data supplied by the Member States. Pursuant to Article 18 of that Directive, acting on a proposal from the Commission, the Council will set emission limit values in accordance with the procedures laid down in the Treaty for which the need for Community action has been identified, on the basis, in particular, of the exchange of information provided for in Article 16 of that Directive. (8) Compliance with the emission limit values laid down by this Directive should be regarded as a necessary but not sufficient condition for compliance with the requirements of Directive 96/61/EC regarding the use of best available techniques. Such compliance may involve more stringent emission limit values, emission limit values for other substances and other media, and other appropriate conditions. (9) Industrial experience in the implementation of techniques for the reduction of polluting emissions from large combustion plants has been acquired over a period of 15 years. (10) The Protocol on heavy metals to the UNECE Convention on long-range transboundary air pollution recommends the adoption of measures to reduce heavy metals emitted by certain installations. It is known that benefits from reducing dust emissions by dust abatement equipment will provide benefits on reducing particle-bound heavy metal emissions. (11) Installations for the production of electricity represent an important part of the large combustion plant sector. (12) 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(7) is intended inter alia to have the effect of distributing new production capacity among new arrivals in the sector. (13) The Community is committed to a reduction of carbon dioxide emissions. Where it is feasible the combined production of heat and electricity represents a valuable opportunity for significantly improving overall efficiency in fuel use. (14) A significant increase in the use of natural gas for producing electricity is already underway and is likely to continue, in particular through the use of gas turbines. (15) In view of the increase in energy production from biomass, specific emission standards for this fuel are justified. (16) The Council Resolution of 24 February 1997 on a Community strategy for waste management(8) emphasises the need for promoting waste recovery and states that appropriate emission standards should apply to the operation of facilities in which waste is incinerated in order to ensure a high level of protection for the environment. (17) Industrial experience has been gained concerning techniques and equipment for the measurement of the principal pollutants emitted by large combustion plants; the European Committee for Standardisation (CEN) has undertaken work with the aim of providing a framework securing comparable measurement results within the Community and guaranteeing a high level of quality of such measurements. (18) There is a need to improve knowledge concerning the emission of the principal pollutants from large combustion plants. In order to be genuinely representative of the level of pollution of an installation, such information should also be associated with knowledge concerning its energy consumption. (19) This Directive is without prejudice to the time limits within which the Member States must transpose and implement Directive 88/609/EEC, Article 1 This Directive shall apply to combustion plants, the rated thermal input of which is equal to or greater than 50 MW, irrespective of the type of fuel used (solid, liquid or gaseous). Article 2 For the purpose of this Directive: (1) "emission" means the discharge of substances from the combustion plant into the air; (2) "waste gases" means gaseous discharges containing solid, liquid or gaseous emissions; their volumetric flow rates shall be expressed in cubic metres per hour at standard temperature (273 K) and pressure (101,3 kPa) after correction for the water vapour content, hereinafter referred to as (Nm3/h); (3) "emission limit value" means the permissible quantity of a substance contained in the waste gases from the combustion plant which may be discharged into the air during a given period; it shall be calculated in terms of mass per volume of the waste gases expressed in mg/Nm3, assuming an oxygen content by volume in the waste gas of 3 % in the case of liquid and gaseous fuels, 6 % in the case of solid fuels and 15 % in the case of gas turbines; (4) "rate of desulphurisation" means the ratio of the quantity of sulphur which is not emitted into the air at the combustion plant site over a given period to the quantity of sulphur contained in the fuel which is introduced into the combustion plant facilities and which is used over the same period; (5) "operator" means any natural or legal person who operates the combustion plant, or who has or has been delegated decisive economic power over it; (6) "fuel" means any solid, liquid or gaseous combustible material used to fire the combustion plant with the exception of waste covered by Council Directive 89/369/EEC of 8 June 1989 on the prevention of air pollution from new municipal waste incineration plants(9), Council Directive 89/429/EEC of 21 June 1989 on the reduction of air pollution from existing municipal waste incineration plants(10), and Council Directive 94/67/EC of 16 December 1994 concerning the incineration of hazardous waste(11) or any subsequent Community act repealing and replacing one or more of these Directives; (7) "combustion plant" means any technical apparatus in which fuels are oxidised in order to use the heat thus generated. This Directive shall apply only to combustion plants designed for production of energy with the exception of those which make direct use of the products of combustion in manufacturing processes. In particular, this Directive shall not apply to the following combustion plants: (a) plants in which the products of combustion are used for the direct heating, drying, or any other treatment of objects or materials e.g. reheating furnaces, furnaces for heat treatment; (b) post-combustion plants i.e. any technical apparatus designed to purify the waste gases by combustion which is not operated as an independent combustion plant; (c) facilities for the regeneration of catalytic cracking catalysts; (d) facilities for the conversion of hydrogen sulphide into sulphur; (e) reactors used in the chemical industry; (f) coke battery furnaces; (g) cowpers; (h) any technical apparatus used in the propulsion of a vehicle, ship or aircraft; (i) gas turbines used on offshore platforms; (j) gas turbines licensed before 27 November 2002 or which in the view of the competent authority are the subject of a full request for a licence before 27 November 2002 provided that the plant is put into operation no later than 27 November 2003 without prejudice to Article 7(1) and Annex VIII(A) and (B); Plants powered by diesel, petrol and gas engines shall not be covered by this Directive. Where two or more separate new plants are installed in such a way that, taking technical and economic factors into account, their waste gases could, in the judgement of the competent authorities, be discharged through a common stack, the combination formed by such plants shall be regarded as a single unit; (8) "multi-fuel firing unit" means any combustion plant which may be fired simultaneously or alternately by two or more types of fuel; (9) "new plant" means any combustion plant for which the original construction licence or, in the absence of such a procedure, the original operating licence was granted on or after 1 July 1987; (10) "existing plant" means any combustion plant for which the original construction licence or, in the absence of such a procedure, the original operating licence was granted before 1 July 1987; (11) "biomass" means products consisting of any whole or part of a vegetable matter from agriculture or forestry which can be used as a fuel for the purpose of recovering its energy content and the following waste used as a fuel: (a) vegetable waste from agriculture and forestry; (b) vegetable waste from the food processing industry, if the heat generated is recovered; (c) fibrous vegetable waste from virgin pulp production and from production of paper from pulp, if it is co-incinerated at the place of production and the heat generated is recovered; (d) cork waste; (e) wood waste with the exception of wood waste which may contain halogenated organic compounds or heavy metals as a result of treatment with wood preservatives or coating, and which includes in particular such wood waste originating from construction and demolition waste; (12) "gas turbine" means any rotating machine which converts thermal energy into mechanical work, consisting mainly of a compressor, a thermal device in which fuel is oxidised in order to heat the working fluid, and a turbine. (13) "Outermost Regions" means the French Overseas Departments with regard to France, the Azores and Madeira with regard to Portugal and the Canary Islands with regard to Spain. Article 3 1. Not later than 1 July 1990 Member States shall draw up appropriate programmes for the progressive reduction of total annual emissions from existing plants. The programmes shall set out the timetables and the implementing procedures. 2. In accordance with the programmes mentioned in paragraph 1, Member States shall continue to comply with the emission ceilings and with the corresponding percentage reductions laid down for sulphur dioxide in Annex I, columns 1 to 6, and for oxides of nitrogen in Annex II, columns 1 to 4, by the dates specified in those Annexes, until the implementation of the provisions of Article 4 that apply to existing plants. 3. When the programmes are being carried out, Member States shall also determine the total annual emissions in accordance with Annex VIII(C). 4. 4. If a substantial and unexpected change in energy demand or in the availability of certain fuels or certain generating installations creates serious technical difficulties for the implementation by a Member State of its programme drawn up under paragraph 1, the Commission shall, at the request of the Member State concerned and taking into account the terms of the request, take a decision to modify, for that Member State, the emission ceilings and/or the dates set out in Annexes I and II and communicate its decision to the Council and to the Member States. Any Member State may within three months refer the decision of the Commission to the Council. The Council, acting by a qualified majority, may within three months take a different decision. Article 4 1. Without prejudice to Article 17 Member States shall take appropriate measures to ensure that all licences for the construction or, in the absence of such a procedure, for the operation of new plants which in the view of the competent authority are the subject of a full request for a licence before 27 November 2002, provided that the plant is put into operation no later than 27 November 2003 contain conditions relating to compliance with the emission limit values laid down in part A of Annexes III to VII in respect of sulphur dioxide, nitrogen oxides and dust. 2. Member States shall take appropriate measures to ensure that all licences for the construction or, in the absence of such a procedure, for the operation of new plants, other than those covered by paragraph 1, contain conditions relating to compliance with the emission limit values laid down in part B of Annexes III to VII in respect of sulphur dioxide, nitrogen oxides and dust. 3. Without prejudice to Directive 96/61/EC and Council Directive 96/62/EC of 27 September 1996 on ambient air quality assessment and management(12), Member States shall, by 1 January 2008 at the latest, achieve significant emission reductions by: (a) taking appropriate measures to ensure that all licences for the operation of existing plants contain conditions relating to compliance with the emission limit values established for new plants referred to in paragraph 1; or (b) ensuring that existing plants are subject to the national emission reduction plan referred to in paragraph 6; and, where appropriate, applying Articles 5, 7 and 8. 4. Without prejudice to Directives 96/61/EC and 96/62/EC, existing plants may be exempted from compliance with the emission limit values referred to in paragraph 3 and from their inclusion in the national emission reduction plan on the following conditions: (a) the operator of an existing plant undertakes, in a written declaration submitted by 30 June 2004 at the latest to the competent authority, not to operate the plant for more than 20000 operational hours starting from 1 January 2008 and ending no later than 31 December 2015; (b) the operator is required to submit each year to the competent authority a record of the used and unused time allowed for the plants' remaining operational life. 5. Member States may require compliance with emission limit values and time limits for implementation which are more stringent than those set out in paragraphs 1, 2, 3 and 4 and in Article 10. They may include other pollutants, and they may impose additional requirements or adaptation of plant to technical progress. 6. Member States may, without prejudice to this Directive and Directive 96/61/EC, and taking into consideration the costs and benefits as well as their obligations under Directive 2001/81/EC of the European Parliament and of the Council of 23 October 2001 on national emission ceilings for certain atmospheric pollutants(13) and Directive 96/62/EC, define and implement a national emission reduction plan for existing plants, taking into account, inter alia, compliance with the ceilings as set out in Annexes I and II. The national emission reduction plan shall reduce the total annual emissions of nitrogen oxides (NOx), sulphur dioxide (SO2) and dust from existing plants to the levels that would have been achieved by applying the emission limit values referred to in paragraph 3 to the existing plants in operation in the year 2000, (including those existing plants undergoing a rehabilitation plan in 2000, approved by the competent authority, to meet emission reductions required by national legislation) on the basis of each plant's actual annual operating time, fuel used and thermal input, averaged over the last five years of operation up to and including 2000. The closure of a plant included in the national emission reduction plan shall not result in an increase in the total annual emissions from the remaining plants covered by the plan. The national emission reduction plan may under no circumstances exempt a plant from the provisions laid down in relevant Community legislation, including inter alia Directive 96/61/EC. The following conditions shall apply to national emission reduction plans: (a) the plan shall comprise objectives and related targets, measures and timetables for reaching these objectives and targets, and a monitoring mechanism; (b) Member States shall communicate their national emission reduction plan to the Commission no later than 27 November 2003; (c) within six months of the communication referred to in point (b) the Commission shall evaluate whether or not the plan meets the requirements of this paragraph. When the Commission considers that this is not the case, it shall inform the Member State and within the subsequent three months the Member State shall communicate any measures it has taken in order to ensure that the requirements of this paragraph are met; (d) the Commission shall, no later than 27 November 2002, develop guidelines to assist Member States in the preparation of their plans. 7. Not later than 31 December 2004 and in the light of progress towards protecting human health and attaining the Community's environmental objectives for acidification and for air quality pursuant to Directive 96/62/EC, the Commission shall submit a report to the European Parliament and the Council in which it shall assess: (a) the need for further measures; (b) the amounts of heavy metals emitted by large combustion plants; (c) the cost-effectiveness and costs and advantages of further emission reductions in the combustion plants sector in Member States compared to other sectors; (d) the technical and economic feasibility of such emission reductions; (e) the effects of both the standards set for the large combustion plants sector including the provisions for indigenous solid fuels, and the competition situation in the energy market, on the environment and the internal market; (f) any national emission reduction plans provided by Member States in accordance with paragraph 6. The Commission shall include in its report an appropriate proposal of possible end dates or of lower limit values for the derogation contained in footnote 2 to Annex VI A. 8. The report referred to in paragraph 7 shall, as appropriate, be accompanied by related proposals, having regard to Directive 96/61/EC. Article 5 By way of derogation from Annex III: (1) Plants, of a rated thermal input equal to or greater than 400 MW, which do not operate more than the following numbers of hours a year (rolling average over a period of five years), - until 31 December 2015, 2000 hours; - from 1 January 2016, 1500 hours; shall be subject to a limit value for sulphur dioxide emissions of 800 mg/Nm3. This provision shall not apply to new plants for which the licence is granted pursuant to Article 4(2). (2) Until 31 December 1999, the Kingdom of Spain may authorise new power plants with a rated thermal input equal to or greater than 500 MW burning indigenous or imported solid fuels, commissioned before the end of 2005 and complying with the following requirements: (a) in the case of imported solid fuels, a sulphur dioxide emission limit value of 800 mg/Nm3; (b) in the case of indigenous solid fuels, at least a 60 % rate of desulphurisation, provided that the total authorised capacity of such plants to which this derogation applies does not exceed: - 2000 MWe in the case of plants burning indigenous solid fuels; - in the case of plants burning imported solid fuels either 7500 or 50 % of all the new capacity of all plants burning solid fuels authorised up to 31 December 1999, whichever is the lower. Article 6 In the case of new plants for which the licence is granted pursuant to Article 4(2) or plants covered by Article 10, Member States shall ensure that the technical and economic feasibility of providing for the combined generation of heat and power is examined. Where this feasibility is confirmed, bearing in mind the market and the distribution situation, installations shall be developed accordingly. Article 7 1. Member States shall ensure that provision is made in the licences or permits referred to in Article 4 for procedures relating to malfunction or breakdown of the abatement equipment. In case of a breakdown the competent authority shall in particular require the operator to reduce or close down operations if a return to normal operation is not achieved within 24 hours, or to operate the plant using low polluting fuels. In any case the competent authority shall be notified within 48 hours. In no circumstances shall the cumulative duration of unabated operation in any twelve-month period exceed 120 hours. The competent authority may allow exceptions to the limits of 24 hours and 120 hours above in cases where, in their judgement: (a) there is an overriding need to maintain energy supplies, or (b) the plant with the breakdown would be replaced for a limited period by another plant which would cause an overall increase in emissions. 2. The competent authority may allow a suspension for a maximum of six months from the obligation to comply with the emission limit values provided for in Article 4 for sulphur dioxide in respect of a plant which to this end normally uses low-sulphur fuel, in cases where the operator is unable to comply with these limit values because of an interruption in the supply of low-sulphur fuel resulting from a serious shortage. The Commission shall immediately be informed of such cases. 3. The competent authority may allow a derogation from the obligation to comply with the emission limit values provided for in Article 4 in cases where a plant which normally uses only gaseous fuel, and which would otherwise need to be equipped with a waste gas purification facility, has to resort exceptionally, and for a period not exceeding 10 days except where there is an overriding need to maintain energy supplies, to the use of other fuels because of a sudden interruption in the supply of gas. The competent authority shall immediately be informed of each specific case as it arises. Member States shall inform the Commission immediately of the cases referred to in this paragraph. Article 8 1. In the case of plants with a multi-firing unit involving the simultaneous use of two or more fuels, when granting the licence referred to in Articles 4(1) or 4(2), and in the case of such plants covered by Articles 4(3) or 10, the competent authority shall set the emission limit values as follows: (a) firstly by taking the emission limit value relevant for each individual fuel and pollutant corresponding to the rated thermal input of the combustion plant as given in Annexes III to VII, (b) secondly by determining fuel-weighted emission limit values, which are obtained by multiplying the above individual emission limit value by the thermal input delivered by each fuel, the product of multiplication being divided by the sum of the thermal inputs delivered by all fuels, (c) thirdly by aggregating the fuel-weighted limit values. 2. In multi-firing units using the distillation and conversion residues from crude-oil refining for own consumption, alone or with other fuels, the provisions for the fuel with the highest emission limit value (determinative fuel) shall apply, notwithstanding paragraph 1 above, if during the operation of the combustion plant the proportion contributed by that fuel to the sum of the thermal inputs delivered by all fuels is at least 50 %. Where the proportion of the determinative fuel is lower than 50 %, the emission limit value is determined on a pro rata basis of the heat input supplied by the individual fuels in relation to the sum of the thermal inputs delivered by all fuels as follows: (a) firstly by taking the emission limit value relevant for each individual fuel and pollutant corresponding to the rated heat input of the combustion plant as given in Annexes III to VII, (b) secondly by calculating the emission limit value of the determinative fuel (fuel with the highest emission limit value according to Annexes III to VII and, in the case of two fuels having the same emission limit value, the fuel with the higher thermal input); this value is obtained by multiplying the emission limit value laid down in Annexes III to VII for that fuel by a factor of two, and subtracting from this product the emission limit value of the fuel with the lowest emission limit value, (c) thirdly by determining the fuel-weighted emission limit values, which are obtained by multiplying the calculated fuel emission limit value by the thermal input of the determinative fuel and the other individual emission limit values by the thermal input delivered by each fuel, the product of multiplication being divided by the sum of the thermal inputs delivered by all fuels, (d) fourthly by aggregating the fuel-weighted emission limit values. 3. As an alternative to paragraph 2, the following average emission limit values for sulphur dioxide may be applied (irrespective of the fuel combination used): (a) for plants referred to in Article 4(1) and (3): 1000 mg/Nm3, averaged over all such plants within the refinery; (b) for new plants referred to in Article 4(2): 600 mg/Nm3, averaged over all such plants within the refinery, with the exception of gas turbines. The competent authorities shall ensure that the application of this provision does not lead to an increase in emissions from existing plants. 4. In the case of plants with a multi-firing unit involving the alternative use of two or more fuels, when granting the licence referred to in Article 4(1) and (2), and in the case of such plants covered by Articles 4(3) or 10, the emission limit values set out in Annexes III to VII corresponding to each fuel used shall be applied. Article 9 Waste gases from combustion plants shall be discharged in controlled fashion by means of a stack. The licence referred to in Article 4 and licences for combustion plants covered by Article 10 shall lay down the discharge conditions. The competent authority shall in particular ensure that the stack height is calculated in such a way as to safeguard health and the environment. Article 10 Where a combustion plant is extended by at least 50 MW, the emission limit values as set in part B of Annexes III to VII shall apply to the new part of the plant and shall be fixed in relation to the thermal capacity of the entire plant. This provision shall not apply in the cases referred to in Article 8(2) and (3). Where the operator of a combustion plant is envisaging a change according to Articles 2(10)(b) and 12(2) of Directive 96/61/EC, the emission limit values as set out in part B of Annexes III to VII in respect of sulphur dioxide, nitrogen oxides and dust shall apply. Article 11 In the case of construction of combustion plants which are likely to have significant effects on the environment in another Member State, the Member States shall ensure that all appropriate information and consultation takes place, in accordance with Article 7 of Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment(14). Article 12 Member States shall take the necessary measures to ensure the monitoring, in accordance with Annex VIII(A), of emissions from the combustion plants covered by this Directive and of all other values required for the implementation of this Directive. Member States may require that such monitoring shall be carried out at the operator's expense. Article 13 Member States shall take appropriate measures to ensure that the operator informs the competent authorities within reasonable time limits about the results of the continuous measurements, the checking of the measuring equipment, the individual measurements and all other measurements carried out in order to assess compliance with this Directive. Article 14 1. In the event of continuous measurements, the emission limit values set out in part A of Annexes III to VII shall be regarded as having been complied with if the evaluation of the results indicates, for operating hours within a calendar year, that: (a) none of the calendar monthly mean values exceeds the emission limit values; and (b) in the case of: (i) sulphur dioxide and dust: 97 % of all the 48 hourly mean values do not exceed 110 % of the emission limit values, (ii) nitrogen oxides: 95 % of all the 48 hourly mean values do not exceed 110 % of the emission limit values. The periods referred to in Article 7 as well as start-up and shut-down periods shall be disregarded. 2. In cases where only discontinuous measurements or other appropriate procedures for determination are required, the emission limit values set out in Annexes III to VII shall be regarded as having been complied with if the results of each of the series of measurements or of the other procedures defined and determined according to the rules laid down by the competent authorities do not exceed the emission limit values. 3. In the cases referred to in Article 5(2) and (3), the rates of desulphurisation shall be regarded as having been complied with if the evaluation of measurements carried out pursuant to Annex VIII, point A.3, indicates that all of the calendar monthly mean values or all of the rolling monthly mean values achieve the required desulphurisation rates. The periods referred to in Article 7 as well as start-up and shut-down periods shall be disregarded. 4. For new plants for which the licence is granted pursuant to Article 4(2), the emission limit values shall be regarded, for operating hours within a calendar year, as complied with if: (a) no validated daily average value exceeds the relevant figures set out in part B of Annexes III to VII, and (b) 95 % of all the validated hourly average values over the year do not exceed 200 % of the relevant figures set out in part B of Annexes III to VII. The "validated average values" are determined as set out in point A.6 of Annex VIII. The periods referred to in Article 7 as well as start up and shut down periods shall be disregarded. Article 15 1. Member States shall, not later than 31 December 1990, inform the Commission of the programmes drawn up in accordance with Article 3(1). At the latest one year after the end of the different phases for reduction of emissions from existing plants, the Member States shall forward to the Commission a summary report on the results of the implementation of the programmes. An intermediate report is required as well in the middle of each phase. 2. The reports referred to in paragraph 1 shall provide an overall view of: (a) all the combustion plants covered by this Directive, (b) emissions of sulphur dioxide, and oxides of nitrogen expressed in tonnes per annum and as concentrations of these substances in the waste gases, (c) measures already taken or envisaged with a view to reducing emissions, and of changes in the choice of fuel used, (d) changes in the method of operation already made or envisaged, (e) definitive closures of combustion plants already effected or envisaged, and (f) where appropriate, the emission limit values imposed in the programmes in respect of existing plants. When determining the annual emissions and concentrations of pollutants in the waste gases, Member States shall take account of Articles 12, 13 and 14. 3. Member States applying Article 5 or the provisions of the Nota Bene in Annex III or the footnotes in Annex VI.A shall report thereon annually to the Commission. Article 16 The Member States shall determine the 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 17 1. Directive 88/609/EEC shall be repealed with effect from 27 November 2002, without prejudice to paragraph 2 or to the obligations of Member States concerning the time limits for transposition and application of that Directive listed in Annex IX hereto. 2. In the case of new plants licensed before 27 November 2002 Article 4(1) of this Directive, Article 4(1), Article 5(2), Article 6, Article 15(3), Annexes III, VI, VIII and point A.2 of Annex IX to Directive 88/609/EEC as amended by Directive 94/66/EC shall remain in effect until 1 January 2008 after which they shall be repealed. 3. References to Directive 88/609/EEC shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex X hereto. Article 18 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 27 November 2002. 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 on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. For existing plant, and for new plant for which a licence is granted pursuant to Article 4(1), the provisions of point A.2 of Annex VIII shall be applied from 27 November 2004. 3. 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 19 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 20 This Directive is addressed to the Member States.

32001L0088

2001

Council Directive 2001/88/EC of 23 October 2001 amending Directive 91/630/EEC laying down minimum standards for the protection of pigs 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), After consulting the Committee of the Regions, Whereas: (1) The Protocol on protection and welfare of animals annexed to the Treaty requires that in formulating and implementing the Community agriculture policy, the Community and the Member States shall pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage. (2) Pursuant to Article 6 of Council Directive 91/630/EEC(4), the Commission submitted a report on intensive pig-rearing systems taking into account in particular the welfare of sows reared in varying degrees of confinement and in groups and has made proposals for adjustments to the rules. (3) Pigs, being live animals, are included in the list of products set out in Annex I to the Treaty. (4) The opinion of the Scientific Veterinary Committee of 30 September 1997 concluded that pigs should benefit from an environment corresponding to their needs for exercise and investigatory behaviour and that the welfare of pigs appeared to be compromised by severe restrictions of space. (5) Sows prefer to have social interactions with other pigs when provided with freedom of movement and environmental complexity. The current practice of keeping sows in continuous close confinement should therefore be prohibited. It is however appropriate to allow producers sufficient time to make the necessary structural changes to their production facilities. (6) A balance must be kept between the various aspects to be taken into consideration, as regarding welfare including health, economic and social considerations, and also environmental impact. (7) It is appropriate for the Commission to submit a new report taking into account further research and practical experience in order to improve further the welfare of pigs, in particular as regards aspects not covered by Directive 91/630/EEC. (8) The measures necessary for the implementation of Directive 91/630/EEC 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 91/630/EEC is hereby amended as follows: 1. Article 3 shall be replaced by the following: "Article 3 Member States shall ensure as follows: 1. all holdings shall comply with the following requirements: (a) the unobstructed floor area available to each weaner or rearing pig kept in a group, excluding gilts after service and sows, must be at least: >TABLE> (b) the total unobstructed floor area available to each gilt after service and to each sow when gilts and/or sows are kept in groups must be at least 1,64 m2 and 2,25 m2 respectively. When these animals are kept in groups of less than 6 individuals the unobstructed floor area must be increased by 10 %. When these animals are kept in groups of 40 or more individuals the unobstructed floor area may be decreased by 10 %; 2. flooring surfaces shall comply with the following requirements: (a) for gilts after service and pregnant sows: a part of the area required in 1(b), equal to at least 0,95 m2 per gilt and at least 1,3 m2 per sow, must be of continuous solid floor of which a maximum of 15 % is reserved for drainage openings; (b) when concrete slatted floors are used for pigs kept in groups: (i) the maximum width of the openings must be: - 11 mm for piglets, - 14 mm for weaners, - 18 mm for rearing pigs, - 20 mm for gilts after service and sows; (ii) the minimum slat width must be: - 50 mm for piglets and weaners, and - 80 mm for rearing pigs, gilts after service and sows; 3. the construction of or conversion to installations in which sows and gilts are tethered is prohibited. From 1 January 2006 the use of tethers for sows and gilts shall be prohibited; 4. (a) sows and gilts shall be kept in groups during a period starting from 4 weeks after the service to 1 week before the expected time of farrowing. The pen where the group is kept must have sides greater than 2,8 m in length. When less than 6 individuals are kept in a group the pen where the group is kept must have sides greater than 2,4 m in length; (b) by way of derogation from the provisions of (a), sows and gilts raised on holdings of fewer than 10 sows may be kept individually during the period mentioned in (a), provided that they can turn around easily in their boxes; 5. without prejudice to the requirements laid down in the Annex, sows and gilts shall have permanent access to manipulable material at least complying with the relevant requirements of that Annex; 6. sows and gilts kept in groups must be fed using a system which ensures that each individual can obtain sufficient food even when competitors for the food are present; 7. to satisfy their hunger and given the need to chew, all dry pregnant sows and gilts must be given a sufficient quantity of bulky or high-fibre food as well as high-energy food; 8. pigs which have to be kept in groups, which are particular aggressors, which have been attacked by other pigs or which are sick or injured, may temporarily be kept in individual pens. In this case the individual pen used shall allow the animal to turn around easily if this is not in contradiction with specific veterinary advice; 9. from 1 January 2003 provisions laid down in points 1(b), 2, 4, 5 and the last sentence of point 8 shall apply to all holdings newly built or rebuilt or brought into use for the first time after that date. From 1 January 2013 those provisions shall apply to all holdings. The provisions laid down in point 4(a) shall not apply to holdings with fewer than ten sows." 2. The following Article shall be inserted: "Article 5a Member States shall ensure that: 1. any person who employs or engages persons to attend to pigs ensures that the person attending to the animals has received instructions and guidance on the relevant provisions of Article 3 and the Annex; 2. appropriate training courses are available. In particular such training courses must focus on welfare aspects." 3. Article 6 shall be replaced by the following: "Article 6 1. Preferably before 1 January 2005 and in any event by 1 July 2005, the Commission shall submit to the Council a report, drawn up on the basis of an opinion from the Scientific Committee on Animal Health and Welfare. The report shall be drawn up taking into account the socio-economic consequences, the sanitary consequences, the environmental effects and different climatic conditions. It shall also take into account the development of techniques and systems of pig production and meat processing which would be likely to reduce the need to resort to surgical castration. If need be, the report shall be accompanied by appropriate legislative proposals on the effects of different space allowances and floor types applicable to the welfare of weaners and rearing pigs. The Council shall act on these proposals by a qualified majority. 2. Not later than 1 January 2008 the Commission shall submit to the Council a report, drawn up on the basis of an opinion from the Scientific Committee on Animal Health and Welfare. The report shall cover in particular: (a) the effects of stocking density, including group size and methods of grouping the animals, in different farming systems on the welfare, including health, of pigs; (b) the impact of stall design and different flooring types on the welfare, including health, of pigs, taking into account different climatic conditions; (c) the risk factors associated with tail biting and recommendations to reduce the need for tail docking; (d) further developments of group-housing systems for pregnant sows, taking account both of pathological, zootechnical, physiological and ethological aspects of the various systems and of their health and environmental impact and of the different climatic conditions; (e) the determination of space requirements, including the service area for individually housed adult breeding boars; (f) further developments of loose-house systems for sows in the service area and for farrowing sows, which meet the needs of the sow without compromising piglet survival; (g) consumers' attitudes and behaviour towards pigmeat in the event of different levels of improvement in the welfare of the animals; (h) socio-economic implications of the various systems of rearing pigs and their effects on the Community's economic partners. The report may, if necessary, be accompanied by appropriate legislative proposals." 4. Article 10 shall be replaced by the following: "Article 10 1. The Commission shall be assisted by the Standing Veterinary Committee established by Decision 68/361/EEC(6) (hereinafter referred to as 'the Committee'). 2. Where reference is made to this Article, Articles 5 and 7 of Council 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.". Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2003 at the latest. They shall forthwith inform the Commission thereof. 2. 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. 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.

32001L0081

2001

Directive 2001/81/EC of the European Parliament and of the Council of 23 October 2001 on national emission ceilings for certain atmospheric pollutants 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), in the light of the joint text approved by the Conciliation Committee on 2 August 2001, Whereas: (1) The general approach and strategy of the Fifth Environmental Action Programme was approved by the Resolution of 1 February 1993 of the Council and the Representatives of the Governments of the Member States meeting within the Council on a Community programme of policy and action in relation to the environment and sustainable development(5) and it sets as objectives that critical loads and levels for acidification in the Community are not to be exceeded. The programme requires that all people should be effectively protected against health risks from air pollution and that permitted levels of pollution should take account of the protection of the environment. The programme also requires that guideline values from the World Health Organisation (WHO) should become mandatory at Community level. (2) The Member States have signed the Gothenburg Protocol of 1 December 1999 to the United Nations Economic Commission for Europe (UNECE) Convention on long-range transboundary air pollution to abate acidification, eutrophication and ground-level ozone. (3) Decision No 2179/98/EC of the European Parliament and of the Council of 24 September 1998 on the review of the European Community programme of policy and action in relation to the environment and sustainable development "Towards sustainability"(6) specified that particular attention should be given to developing and implementing a strategy with the goal of ensuring that critical loads, in relation to exposure to acidifying, eutrophying and photochemical air pollutants, are not exceeded. (4) Council Directive 92/72/EEC of 21 September 1992 on air pollution by ozone(7) requires the Commission to submit to the Council a report on the evaluation of photochemical pollution in the Community, accompanied by any proposals the Commission deems appropriate on the control of air pollution by ground-level ozone and, if necessary, on reducing emissions of ozone precursors. (5) Significant areas of the Community are exposed to depositions of acidifying and eutrophying substances at levels which have adverse effects on the environment. The WHO guideline values for the protection of human health and vegetation from photochemical pollution are substantially exceeded in all Member States. (6) The exceedance of critical loads should therefore be gradually eliminated and guideline levels respected. (7) At present it is not technically feasible to meet the long-term objectives of eliminating the adverse effects of acidification and reducing exposure to ground-level ozone of man and the environment to the guideline values established by the WHO. It is therefore necessary to provide for interim environmental objectives for acidification and ground-level ozone pollution, on which the necessary measures to reduce such pollution are to be based. (8) Interim environmental objectives and the measures to meet them should take account of technical feasibility and the associated costs and benefits. Such measures should ensure that any action taken is cost-effective for the Community as a whole and should take account of the need to avoid excessive costs for any individual Member State. (9) Transboundary pollution contributes to acidification, soil eutrophication and ground-level ozone formation, the abatement of which requires coordinated Community action. (10) Reducing emissions of the pollutants causing acidification and exposure to ground-level ozone will also reduce soil eutrophication. (11) A set of national ceilings for each Member State for emissions of sulphur dioxide, nitrogen oxides, volatile organic compounds and ammonia is a cost-effective way of meeting interim environmental objectives. Such emission ceilings will allow the Community and the Member States flexibility in determining how to comply with them. (12) Member States should be responsible for implementing measures to comply with national emission ceilings. It will be necessary to evaluate progress towards compliance with the emission ceilings. National programmes for the reduction of emissions should therefore be drawn up and reported on to the Commission and should include information on the measures adopted or envisaged to comply with the emission ceilings. (13) In accordance with the principle of subsidiarity as set out in Article 5 of the Treaty and taking account, in particular, of the precautionary principle, the objective of this Directive, namely limitation of emissions of acidifying and eutrophying pollutants and ozone precursors, cannot be sufficiently achieved by the Member States because of the transboundary nature of the pollution and can therefore be better achieved by the Community; in accordance with the principle of proportionality this Directive does not go beyond what is necessary to achieve that purpose. (14) There should be a timely review of the progress made by Member States towards the emission ceilings, as well as a review of the extent to which implementing the ceilings is likely to meet interim environmental objectives, for the Community as a whole. Such review should consider also scientific and technical progress, developments in Community legislation and emission reductions outside the Community with special regard to progress made inter alia by the accession candidate countries. In that review, the Commission should undertake a further examination of the costs and benefits of the emission ceilings, including their cost-effectiveness, marginal costs and benefits and socio-economic impact and any impact on competitiveness. The review should also consider the limitations on the scope of this Directive. (15) The Commission should for this purpose prepare a report to the European Parliament and the Council and, if it considers it necessary, propose appropriate amendments to this Directive taking account of the effects of any relevant Community legislation inter alia setting emission limits and product standards for relevant sources of emissions and international regulations concerning ship and aircraft emissions. (16) Sea transport is a significant contributor to emissions of sulphur dioxide and nitrogen oxides and also to concentrations and depositions of air pollutants in the Community. Such emissions should therefore be reduced. Article 7(3) of Council Directive 1999/32/EC of 26 April 1999 relating to a reduction in the sulphur content of certain liquid fuels and amending Directive 93/12/EEC(8) requires the Commission to consider which measures could be taken to reduce the contribution to acidification of the combustion of marine fuels other than those specified in Article 2(3) of that Directive. (17) Member States should seek to ratify Annex VI to the International Convention for the Prevention of Pollution from Ships (MARPOL) as soon as possible. (18) Owing to the transboundary nature of acidification and ozone pollution, the Commission should continue to examine further the need to develop harmonised Community measures, without prejudice to Article 18 of Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control(9), with the aim of avoiding distortion of competition, and taking into account the balance between benefits and cost of action. (19) The provisions of this Directive should apply without prejudice to the Community legislation regulating emissions of those pollutants from specific sources and to the provisions of Council Directive 96/61/EC in relation to emission limit values and use of best available techniques. (20) Emission inventories are necessary to monitor progress towards compliance with the emission ceilings and must be calculated in accordance with internationally agreed methodology and reported on regularly to the Commission and the European Environment Agency (EEA). (21) Member States should lay down rules on penalties applicable to infringements of the provisions of this Directive and ensure that they are implemented. The penalties should be effective, proportionate and dissuasive. (22) 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). (23) The Commission and Members States should cooperate internationally with a view to achieving the objectives of this Directive, Article 1 Objective The aim of this Directive is to limit emissions of acidifying and eutrophying pollutants and ozone precursors in order to improve the protection in the Community of the environment and human health against risks of adverse effects from acidification, soil eutrophication and ground-level ozone and to move towards the long-term objectives of not exceeding critical levels and loads and of effective protection of all people against recognised health risks from air pollution by establishing national emission ceilings, taking the years 2010 and 2020 as benchmarks, and by means of successive reviews as set out in Articles 4 and 10. Article 2 Scope This Directive covers emissions in the territory of the Member States and their exclusive economic zones from all sources of the pollutants referred to in Article 4 which arise as a result of human activities. It does not cover: (a) emissions from international maritime traffic; (b) aircraft emissions beyond the landing and take-off cycle; (c) for Spain, emissions in the Canary Islands; (d) for France, emissions in the overseas departments; (e) for Portugal, emissions in Madeira and the Azores. Article 3 Definitions For the purposes of this Directive: (a) "AOT 40" means the sum of the difference between hourly concentrations of ground-level ozone greater than 80 μg/m3 (= 40 ppb) and 80 μg/m3 during daylight hours accumulated from May to July each year; (b) "AOT 60" means the sum of the difference between hourly concentrations of ground-level ozone greater than 120 μg/m3 (=60 ppb) and 120 μg/m3 accumulated throughout the year; (c) "critical load" means a quantitative estimate of an exposure to one or more pollutants below which significant adverse effects on specified sensitive elements of the environment do not occur, according to present knowledge; (d) "critical level" means the concentration of pollutants in the atmosphere above which direct adverse effects on receptors, such as human beings, plants, ecosystems or materials, may occur, according to present knowledge; (e) "emission" means the release of a substance from a point or diffuse source into the atmosphere; (f) "grid cell" means a square 150 km x 150 km, which is the resolution used when mapping critical loads on a European scale, and also when monitoring emissions and depositions of air pollutants under the Cooperative Programme for Monitoring and Evaluation of the long-range Transmission of Air Pollutants in Europe (EMEP); (g) "landing and take-off cycle" means a cycle represented by the following time in each operating mode: approach 4,0 minutes; taxi/ground idle 26,0 minutes, take-off 0,7 minutes; climb 2,2 minutes; (h) "national emission ceiling" means the maximum amount of a substance expressed in kilotonnes, which may be emitted from a Member State in a calendar year; (i) "nitrogen oxides" and "NOx" mean nitric oxide and nitrogen dioxide, expressed as nitrogen dioxide; (j) "ground-level ozone" means ozone in the lowermost part of the troposphere; (k) "volatile organic compounds" and "VOC" mean all organic compounds arising from human activities, other than methane, which are capable of producing photochemical oxidants by reactions with nitrogen oxides in the presence of sunlight. Article 4 National emission ceilings 1. By the year 2010 at the latest, Member States shall limit their annual national emissions of the pollutants sulphur dioxide (SO2), nitrogen oxides (NOx), volatile organic compounds (VOC) and ammonia (NH3) to amounts not greater than the emission ceilings laid down in Annex I, taking into account any modifications made by Community measures adopted following the reports referred to in Article 9. 2. Member States shall ensure that the emission ceilings laid down in Annex I are not exceeded in any year after 2010. Article 5 Interim environmental objectives The national emission ceilings in Annex I shall have as their purpose to meet broadly the following interim environmental objectives, for the Community as a whole, by 2010: (a) Acidification The areas where critical loads are exceeded shall be reduced by at least 50 % (in each grid cell) compared with the 1990 situation. (b) Health-related ground-level ozone exposure The ground-level ozone load above the critical level for human health (AOT60=0) shall be reduced by two-thirds in all grid cells compared with the 1990 situation. In addition, the ground-level ozone load shall not exceed an absolute limit of 2,9 ppm.h in any grid cell. (c) Vegetation-related ground-level ozone exposure The ground-level ozone load above the critical level for crops and semi-natural vegetation (AOT40=3 ppm.h) shall be reduced by one-third in all grid cells compared with the 1990 situation. In addition, the ground-level ozone load shall not exceed an absolute limit of 10 ppm.h, expressed as an exceedance of the critical level of 3 ppm.h in any grid cell. Article 6 National programmes 1. Member States shall, by 1 October 2002 at the latest, draw up programmes for the progressive reduction of national emissions of the pollutants referred to in Article 4 with the aim of complying at least with the national emission ceilings laid down in Annex I by 2010 at the latest. 2. The national programmes shall include information on adopted and envisaged policies and measures and quantified estimates of the effect of these policies and measures on emissions of the pollutants in 2010. Anticipated significant changes in the geographical distribution of national emissions shall be indicated. 3. Member States shall update and revise the national programmes as necessary by 1 October 2006. 4. Member States shall make available to the public and to appropriate organisations such as environmental organisations the programmes drawn up in accordance with paragraphs 1, 2 and 3. Information made available to the public and to organisations under this paragraph shall be clear, comprehensible and easily accessible. Article 7 Emission inventories and projections 1. Member States shall prepare and annually update national emission inventories and emission projections for 2010 for the pollutants referred to in Article 4. 2. Member States shall establish their emission inventories and projections using the methodologies specified in Annex III. 3. The Commission, assisted by the European Environment Agency, shall, in cooperation with the Member States and on the basis of the information provided by them, establish inventories and projections of the pollutants referred to in Article 4. The inventories and projections shall be made publicly available. 4. Any updating of the methodologies to be used in accordance with Annex III, shall be made in accordance with the procedure set out in Article 13(2). Article 8 Reports by the Member States 1. Member States shall each year, by 31 December at the latest, report their national emission inventories and their emission projections for 2010 established in accordance with Article 7 to the Commission and the European Environment Agency. They shall report their final emission inventories for the previous year but one and their provisional emission inventories for the previous year. Emission projections shall include information to enable a quantitative understanding of the key socioeconomic assumptions used in their preparation. 2. Member States shall, by 31 December 2002 at the latest, inform the Commission of the programmes drawn up in accordance with Article 6(1) and (2). Member States shall, by 31 December 2006 at the latest, inform the Commission of the updated programmes drawn up in accordance with Article 6(3). 3. The Commission shall forward the national programmes received to the other Member States within one month of their reception. 4. The Commission shall, in accordance with the procedure set out in Article 13(2), establish provisions to ensure consistent and transparent reporting of national programmes. Article 9 Reports by the Commission 1. In 2004 and 2008 the Commission shall report to the European Parliament and the Council on progress on the implementation of the national emission ceilings laid down in Annex I and on the extent to which the interim environmental objectives set out in Article 5 are likely to be met by 2010 and on the extent to which the long-term objectives set out in Article 1 could be met by 2020. The reports shall include an economic assessment, including cost-effectiveness, benefits, an assessment of marginal costs and benefits and the socioeconomic impact of the implementation of the national emission ceilings on particular Member States and sectors. They shall also include a review of the limitations of the scope of this Directive as defined in Article 2 and an evaluation of the extent to which further emission reductions might be necessary in order to meet the interim environmental objectives set out in Article 5. They shall take into account the reports made by Member States pursuant to Article 8(1) and (2), as well as, inter alia: (a) any new Community legislation which may have been adopted setting emission limits and product standards for relevant sources of emissions; (b) developments of best available techniques in the framework of the exchange of information under Article 16 of Directive 96/61/EC; (c) emission reduction objectives for 2008 for emissions of sulphur dioxide and nitrogen oxides from existing large combustion plants, reported by Member States pursuant to Directive 2001/80/EC of the European Parliament and of the Council of 23 October 2001 on the limitation of emissions of certain pollutants into the air from large combustion plants(11); (d) emission reductions and reduction commitments by third countries, with particular focus on measures to be taken in the accession candidate countries, and the possibility for further emission reductions in regions in the vicinity of the Community; (e) any new Community legislation and any international regulations concerning ship and aircraft emissions; (f) the development of transport and any further action to control transport emissions; (g) developments in the field of agriculture, new livestock projections and improvements in emission reduction methods in the agricultural sector; (h) any major changes in the energy supply market within a Member State and new forecasts reflecting the actions taken by Member States to comply with their international obligations in relation to climate change; (i) assessment of the current and projected exceedances of critical loads and the WHO's guideline values for ground-level ozone; (j) the possibility of identification of a proposed interim objective for reducing soil eutrophication; (k) new technical and scientific data including an assessment of the uncertainties in: (i) national emission inventories; (ii) input reference data; (iii) knowledge of the transboundary transport and deposition of pollutants; (iv) critical loads and levels; (v) the model used; and an assessment of the resulting uncertainty in the national emission ceilings required to meet the interim environmental objectives mentioned in Article 5. (l) whether there is a need to avoid excessive costs for any individual Member State; (m) a comparison of model calculations with observations of acidification, eutrophication and ground-level ozone with a view to improving models; (n) the possible use, where appropriate, of relevant economic instruments. 2. In 2012 the Commission shall report to the European Parliament and the Council on compliance with the ceilings in Annex I and on progress in relation to the interim environmental objectives in Article 5 and the long-term objectives set out in Article 1. Its report shall take account of the reports made by Member States pursuant to Article 8(1) and (2) as well as the matters listed in points (a) to (n) of paragraph 1. Article 10 Review 1. The reports referred to in Article 9 shall take into account the factors listed in Article 9(1). In the light of these factors, of progress towards attaining the emission ceilings by the year 2010, of scientific and technical progress, and of the situation regarding progress towards attaining the interim objectives of this Directive and the long-term objectives of no exceedance of critical loads and levels and of WHO air quality guidelines for ozone, the Commission shall carry out a review of this Directive in preparation for each report. 2. In the review to be completed in 2004 an evaluation will be carried out of the indicative emission ceilings for the Community as a whole set out in Annex II. The evaluation of these indicative ceilings shall be a factor for consideration during analysis of further cost-effective actions that might be taken in order to reduce emissions of all relevant pollutants, with the aim of attaining the interim environmental objectives set out in Article 5, for the Community as a whole by 2010. 3. All reviews shall include a further investigation of the estimated costs and benefits of national emission ceilings, computed with state-of-the-art models and making use of the best available data to achieve the least possible uncertainty and taking also into account progress in the enlargement of the European Union, and of the merits of alternative methodologies, in the light of the factors listed in Article 9. 4. Without prejudice to Article 18 of Directive 96/61/EC, with the aim of avoiding distortion of competition, and taking into account the balance between benefits and costs of action, the Commission shall examine further the need to develop harmonised Community measures, for the most relevant economic sectors and products contributing to acidification, eutrophication and formation of ground-level ozone. 5. The reports referred to in Article 9 will, if appropriate, be accompanied by proposals for: (a) modifications of the national ceilings in Annex I with the aim of meeting the interim environmental objectives of Article 5 and/or for modifications to those interim environmental objectives; (b) possible further emission reductions with the aim of meeting, preferably by 2020, the long-term objectives of this Directive; (c) measures to ensure compliance with the ceilings. Article 11 Cooperation with third countries To promote the achievement of the objective set out in Article 1, the Commission and Member States, as appropriate, shall, without prejudice to Article 300 of the Treaty, pursue bilateral and multilateral cooperation with third countries and relevant international organisations such as the United Nations Economic Commission for Europe (UNECE), the International Maritime Organization (IMO) and the International Civil Aviation Organization (ICAO), including through the exchange of information, concerning technical and scientific research and development and with the aim of improving the basis for the facilitation of emission reductions. Article 12 Reports concerning ship and aircraft emission 1. By the end of 2002 the Commission shall report to the European Parliament and Council on the extent to which emissions from international maritime traffic contribute to acidification, eutrophication and the formation of ground-level ozone within the Community. 2. By the end of 2004 the Commission shall report to the European Parliament and Council on the extent to which emissions from aircraft beyond the landing and take-off cycle contribute to acidification, eutrophication and the formation of ground-level ozone within the Community. 3. Each report shall specify a programme of actions which could be taken at international and Community level as appropriate to reduce emissions from the sector concerned, as a basis for further consideration by the European Parliament and Council. Article 13 Committee 1. The Commission shall be assisted by the Committee set up by Article 12 of Directive 96/62/EC, hereinafter referred to as "the Committee". 2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period referred to in Article 4(3) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure. Article 14 Penalties 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 15 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 27 November 2002. 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 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 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.

32001L0090

2001

Commission Directive 2001/90/EC of 26 October 2001 adapting to technical progress for the seventh time Annex I to 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 (creosote) (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 Directive 2001/41/EC of the European Parliament and of the Council(2), and in particular Article 2a thereof, introduced by Council Directive 89/678/EEC(3), Whereas: (1) 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 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) places certain restrictions on the marketing and use of creosote. (2) A recent study(5) has concluded that creosote has a greater potential to cause cancer than previously thought. (3) The study was referred to the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) for peer review(6) and the CSTEE concluded that the study was well designed and that there is scientific evidence to support the opinion and there is a cancer risk to consumers from creosote with a benzo-a-pyrene (BaP) content of less than 0,005 % by mass and/or from wood containing such creosote, and that the magnitude of the risk gives clear reasons for concern. (4) An analysis of the advantages and drawbacks of further restrictions on the marketing and use of creosote(7) has concluded among other things, that the majority of industrial use creosote within the Community already contains less than 0,005 % BaP by mass and has indicated that the health risks from such creosote and/or wood containing such creosote are likely to be low in industrial applications. (5) 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(8) will harmonise the authorisation of biocides at a European 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(9) requires wood preservatives to be evaluated as a priority in the review programme established under Directive 98/8/EC. Pending harmonisation of rules under Directive 98/8/EC the restrictions on creosote need to be adapted to technical progress. (6) This Directive is without prejudice to 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) laying down minimum requirements for the protection of workers and its individual Directives within the meaning of Article 16(1) of that Directive, 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) and 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(12). (7) 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 adapted to technical progress at set out in the Annex hereto. Article 2 1. Member States shall adopt and publish the 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 by at the latest 30 June 2003. 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. 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.

32001L0091

2001

Commission Directive 2001/91/EC of 29 October 2001 adapting to technical progress for the eighth time Annex I to 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 (hexachloroethane) (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 dangerous substances and preparations(1), as last amended by Commission Directive 2001/90/EC(2), and in particular Article 2a thereof, introduced by Council Directive 89/678/EEC(3), and Directive 97/16/EC of the European Parliament and of the Council of 10 April 1997, amending for the 15th time Directive 76/769/EEC on restrictions on the marketing and use of certain dangerous substances and preparations(4), Whereas: (1) Directive 97/16/EC prohibited the use of hexachloroethane in the manufacturing and processing of non-ferrous metals whilst permitting, by way of derogation, Member States to allow on their territories continued use, under specified conditions, in non-integrated aluminium foundries and in the production of certain magnesium alloys. (2) There is no longer a need for derogations and Annex I to Directive 76/769/EEC should be adapted to technical progress for hexachloroethane by deleting the derogations. (3) The restrictions on the use of hexachloroethane laid down by this Directive take into account the current state of knowledge and techniques regarding suitable alternatives. (4) This Directive does not affect 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), as last amended by Directive 1999/38/EC(7). (5) The measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of the 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 adapted to technical progress 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 December 2002 at the latest. They shall forthwith inform the Commission thereof. They shall apply these provisions as from 30 June 2003. When Member States adopt those provisions, these 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 Regulation 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.

32001L0083

2001

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 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 Economic and Social Committee(1), Acting in accordance with the procedure laid down in Article 251 of the Treaty(2), Whereas: (1) Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(3), Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products(4), Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products(5), Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens(6), Council Directive 89/343/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for radiopharmaceuticals(7), Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down special provisions for proprietary medicinal products derived from human blood or human plasma(8), Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use(9), Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use(10), Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets(11), Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use(12), Council Directive 92/73/EEC of 22 September 1992 widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down additional provisions on homeopathic medicinal products(13) have been frequently and substantially amended. In the interests of clarity and rationality, the said Directives should therefore be codified by assembling them in a single text. (2) The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health. (3) However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community. (4) Trade in medicinal products within the Community is hindered by disparities between certain national provisions, in particular between provisions relating to medicinal products (excluding substances or combinations of substances which are foods, animal feeding-stuffs or toilet preparations), and such disparities directly affect the functioning of the internal market. (5) Such hindrances must accordingly be removed; whereas this entails approximation of the relevant provisions. (6) In order to reduce the disparities which remain, rules should be laid down on the control of medicinal products and the duties incumbent upon the Member States' competent authorities should be specified with a view to ensuring compliance with legal requirements. (7) The concepts of harmfulness and therapeutic efficacy can only be examined in relation to each other and have only a relative significance depending on the progress of scientific knowledge and the use for which the medicinal product is intended. The particulars and documents which must accompany an application for marketing authorization for a medicinal product demonstrate that potential risks are outweighed by the therapeutic efficacy of the product. (8) Standards and protocols for the performance of tests and trials on medicinal products are an effective means of control of these products and hence of protecting public health and can facilitate the movement of these products by laying down uniform rules applicable to tests and trials, the compilation of dossiers and the examination of applications. (9) Experience has shown that it is advisable to stipulate more precisely the cases in which the results of toxicological and pharmacological tests or clinical trials do not have to be provided with a view to obtaining authorization for a medicinal product which is essentially similar to an authorized product, while ensuring that innovative firms are not placed at a disadvantage. (10) However, there are reasons of public policy for not conducting repetitive tests on humans or animals without over-riding cause. (11) The adoption of the same standards and protocols by all the Member States will enable the competent authorities to arrive at their decisions on the basis of uniform tests and by reference to uniform criteria and will therefore help to avoid differences in evaluation. (12) With the exception of those medicinal products which are subject to the centralized Community authorization procedure established by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(14) a marketing authorization for a medicinal product granted by a competent authority in one Member State ought to be recognized by the competent authorities of the other Member States unless there are serious grounds for supposing that the authorization of the medicinal product concerned may present a risk to public health. In the event of a disagreement between Member States about the quality, the safety or the efficacy of a medicinal product, a scientific evaluation of the matter should be undertaken according to a Community standard, leading to a single decision on the area of disagreement binding on the Member States concerned. Whereas this decision should be adopted by a rapid procedure ensuring close cooperation between the Commission and the Member States. (13) For this purpose, a Committee for Proprietary Medicinal Products should be set up attached to the European Agency for the Evaluation of Medicinal Products established in the abovementioned Regulation (EEC) No 2309/93. (14) This Directive represents an important step towards achievement of the objective of the free movement of medicinal products. Further measures may abolish any remaining barriers to the free movement of proprietary medicinal products will be necessary in the light of experience gained, particularly in the abovementioned Committee for Proprietary Medicinal Products. (15) In order better to protect public health and avoid any unnecessary duplication of effort during the examination of application for a marketing authorization for medicinal products, Member States should systematically prepare assessment reports in respect of each medicinal product which is authorized by them, and exchange the reports upon request. Furthermore, a Member State should be able to suspend the examination of an application for authorization to place a medicinal product on the market which is currently under active consideration in another Member State with a view to recognizing the decision reached by the latter Member State. (16) Following the establishment of the internal market, specific controls to guarantee the quality of medicinal products imported from third countries can be waived only if appropriate arrangements have been made by the Community to ensure that the necessary controls are carried out in the exporting country. (17) It is necessary to adopt specific provisions for immunological medicinal products, homeopathic medicinal products, radiopharmaceuticals, and medicinal products based on human blood or human plasma. (18) Any rules governing radiopharmaceuticals must take into account the provisions of Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the radiation protection of persons undergoing medical examination or treatment(15). Account should also be taken of Council Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation(16), the objective of which is to prevent the exposure of workers or patients to excessive or unnecessarily high levels of ionizing radiation, and in particular of Article 5c thereof, which requires prior authorization for the addition of radioactive substances to medicinal products as well as for the importation of such medicinal products. (19) The Community entirely supports the efforts of the Council of Europe to promote voluntary unpaid blood and plasma donation to attain self-sufficiency throughout the Community in the supply of blood products, and to ensure respect for ethical principles in trade in therapeutic substances of human origin. (20) The rules designed to guarantee the quality, safety and efficacy of medicinal products derived from human blood or human plasma must be applied in the same manner to both public and private establishments, and to blood and plasma imported from third countries. (21) Having regard to the particular characteristics of these homeopathic medicinal products, such as the very low level of active principles they contain and the difficulty of applying to them the conventional statistical methods relating to clinical trials, it is desirable to provide a special, simplified registration procedure for those homeopathic medicinal products which are placed on the market without therapeutic indications in a pharmaceutical form and dosage which do not present a risk for the patient. (22) The anthroposophic medicinal products described in an official pharmacopoeia and prepared by a homeopathic method are to be treated, as regards registration and marketing authorization, in the same way as homeopathic medicinal products. (23) It is desirable in the first instance to provide users of these homeopathic medicinal products with a very clear indication of their homeopathic character and with sufficient guarantees of their quality and safety. (24) The rules relating to the manufacture, control and inspection of homeopathic medicinal products must be harmonized to permit the circulation throughout the Community of medicinal products which are safe and of good quality. (25) The usual rules governing the authorization to market medicinal products should be applied to homeopathic medicinal products placed on the market with therapeutic indications or in a form which may present risks which must be balanced against the desired therapeutic effect. In particular, those Member States which have a homeopathic tradition should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products provided that they notify them to the Commission. (26) In order to facilitate the movement of medicinal products and to prevent the controls carried out in one Member State from being repeated in another, minimum requirements should be laid down for manufacture and imports coming from third countries and for the grant of the authorization relating thereto. (27) It should be ensured that, in the Member States, the supervision and control of the manufacture of medicinal products is carried out by a person who fulfils minimum conditions of qualification. (28) Before an authorization to market an immunological medicinal product or derived from human blood or human plasma can be granted, the manufacturer must demonstrate his ability to attain batch-to-batch consistency. Before an authorization to market a medicinal product derived from human blood or human plasma can be granted, the manufacturer must also demonstrate the absence of specific viral contamination, to the extent that the state of technology permits. (29) The conditions governing the supply of medicinal products to the public should be harmonized. (30) In this connection persons moving around within the Community have the right to carry a reasonable quantity of medicinal products lawfully obtained for their personal use. It must also be possible for a person established in one Member State to receive from another Member State a reasonable quantity of medicinal products intended for his personal use. (31) In addition, by virtue of Regulation (EC) No 2309/93, certain medicinal products are the subject of a Community marketing authorization. In this context, the classification for the supply of medicinal products covered by a Community marketing authorization needs to be established. It is therefore important to set the criteria on the basis of which Community decisions will be taken. (32) It is therefore appropriate, as an initial step, to harmonize the basic principles applicable to the classification for the supply of medicinal products in the Community or in the Member State concerned, while taking as a starting point the principles already established on this subject by the Council of Europe as well as the work of harmonization completed within the framework of the United Nations, concerning narcotic and psychotropic substances. (33) The provisions dealing with the classification of medicinal products for the purpose of supply do not infringe the national social security arrangements for reimbursement or payment for medicinal products on prescription. (34) Many operations involving the wholesale distribution of medicinal products for human use may cover several Member States simultaneously. (35) It is necessary to exercise control over the entire chain of distribution of medicinal products, from their manufacture or import into the Community through to supply to the public, so as to guarantee that such products are stored, transported and handled in suitable conditions. The requirements which must be adopted for this purpose will considerably facilitate the withdrawal of defective products from the market and allow more effective efforts against counterfeit products. (36) Any person involved in the wholesale distribution of medicinal products should be in possession of a special authorization. Pharmacists and persons authorized to supply medicinal products to the public, and who confine themselves to this activity, should be exempt from obtaining this authorization. It is however necessary, in order to control the complete chain of distribution of medicinal products, that pharmacists and persons authorized to supply medicinal products to the public keep records showing transactions in products received. (37) Authorization must be subject to certain essential conditions and it is the responsibility of the Member State concerned to ensure that such conditions are met; whereas each Member State must recognize authorizations granted by other Member States. (38) Certain Member States impose on wholesalers who supply medicinal products to pharmacists and on persons authorized to supply medicinal products to the public certain public service obligations. Those Member States must be able to continue to impose those obligations on wholesalers established within their territory. They must also be able to impose them on wholesalers in other Member States on condition that they do not impose any obligation more stringent than those which they impose on their own wholesalers and provided that such obligations may be regarded as warranted on grounds of public health protection and are proportionate in relation to the objective of such protection. (39) Rules should be laid down as to how the labelling and package leaflets are to be presented. (40) The provisions governing the information supplied to users should provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information. (41) The marketing of medicinal products whose labelling and package leaflets comply with this Directive should not be prohibited or impeded on grounds connected with the labelling or package leaflet. (42) This Directive is without prejudice to the application of measures adopted pursuant to 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(17). (43) All Member States have adopted further specific measures concerning the advertising of medicinal products. There are disparities between these measures. These disparities are likely to have an impact on the functioning of the internal market, since advertising disseminated in one Member State is likely to have effects in other Member States. (44) 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(18) prohibits the television advertising of medicinal products which are available only on medical prescription in the Member State within whose jurisdiction the television broadcaster is located. This principle should be made of general application by extending it to other media. (45) Advertising to the general public, even of non-prescription medicinal products, could affect public health, were it to be excessive and ill-considered. Advertising of medicinal products to the general public, where it is permitted, ought therefore to satisfy certain essential criteria which ought to be defined. (46) Furthermore, distribution of samples free of charge to the general public for promotional ends must be prohibited. (47) The advertising of medicinal products to persons qualified to prescribe or supply them contributes to the information available to such persons. Nevertheless, this advertising should be subject to strict conditions and effective monitoring, referring in particular to the work carried out within the framework of the Council of Europe. (48) Advertising of medicinal products should be subject to effective, adequate monitoring. Reference in this regard should be made to the monitoring mechanisms set up by Directive 84/450/EEC. (49) Medical sales representatives have an important role in the promotion of medicinal products. Therefore, certain obligations should be imposed upon them, in particular the obligation to supply the person visited with a summary of product characteristics. (50) Persons qualified to prescribe medicinal products must be able to carry out these functions objectively without being influenced by direct or indirect financial inducements. (51) It should be possible within certain restrictive conditions to provide samples of medicinal products free of charge to persons qualified to prescribe or supply them so that they can familiarize themselves with new products and acquire experience in dealing with them. (52) Persons qualified to prescribe or supply medicinal products must have access to a neutral, objective source of information about products available on the market. Whereas it is nevertheless for the Member States to take all measures necessary to this end, in the light of their own particular situation. (53) Each undertaking which manufactures or imports medicinal products should set up a mechanism to ensure that all information supplied about a medicinal product conforms with the approved conditions of use. (54) In order to ensure the continued safety of medicinal products in use, it is necessary to ensure that pharmacovigilance systems in the Community are continually adapted to take account of scientific and technical progress. (55) It is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance. (56) The increasing use of electronic networks for communication of information on adverse reactions to medicinal products marketed in the Community is intended to allow competent authorities to share the information at the same time. (57) It is the interest of the Community to ensure that the pharmacovigilance systems for centrally authorised medicinal products and those authorised by other procedures are consistent. (58) Holders of marketing authorisations should be proactively responsible for on-going pharmacovigilance of the medicinal products they place on the market. (59) 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(19). (60) The Commission should be empowered to adopt any necessary changes to Annex I in order to take into account scientific and technical progress. (61) This Directive should be without prejudice to the obligations of the Member States concerning the time-limits for transposition of the Directives set out in Annex II, Part B. TITLE I DEFINITIONS Article 1 For the purposes of this Directive, the following terms shall bear the following meanings: 1. Proprietary medicinal product: Any ready-prepared medicinal product placed on the market under a special name and in a special pack. 2. Medicinal product: Any substance or combination of substances presented for treating or preventing disease in human beings. Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product. 3. Substance: Any matter irrespective of origin which may be: - human, e.g. human blood and human blood products; - animal, e.g. micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products; - vegetable, e.g. micro-organisms, plants, parts of plants, vegetable secretions, extracts; - chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis. 4. Immunological medicinal product: Any medicinal product consisting of vaccines, toxins, serums or allergen products: (a) vaccines, toxins and serums shall cover in particular: (i) agents used to produce active immunity, such as cholera vaccine, BCG, polio vaccines, smallpox vaccine; (ii) agents used to diagnose the state of immunity, including in particular tuberculin and tuberculin PPD, toxins for the Schick and Dick Tests, brucellin; (iii) agents used to produce passive immunity, such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin; (b) "allergen product" shall mean any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent. 5. Homeopathic medicinal product: Any medicinal product prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may also contain a number of principles. 6. Radiopharmaceutical: Any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose. 7. Radionuclide generator: Any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be obtained by elution or by any other method and used in a radiopharmaceutical. 8. Radionuclide kit: Any preparation to be reconsitituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration. 9. Radionuclide precursor: Any other radionuclide produced for the radio-labelling of another substance prior to administration. 10. Medicinal products derived from human blood or human plasma: Medicinal products based on blood constitutents which are prepared industrially by public or private establishments, such medicinal products including, in particular, albumin, coagulating factors and immunoglobulins of human origin. 11. Adverse reaction: A response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function. 12. Serious adverse reaction: An adverse reaction which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect. 13. Unexpected adverse reaction: An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics. 14. Periodic safety update reports: The periodical reports containing the records referred to in Article 104. 15. Post-authorisation safety study: A pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying or quantifying a safety hazard relating to an authorised medicinal product. 16. Abuse of medicinal products: Persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effets. 17. Wholesale distribution of medicinal products: All activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned. 18. Public service obligation: The obligation placed on wholesalers to guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question. 19. Medicinal Prescription: Any medicinal prescription issued by a professional person qualified to do so. 20. Name of the medicinal product: The name given to a medicinal product, which may be either an invented name or a common or scientific name, together with a trade mark or the name of the manufacturer; the invented name shall not be liable to confusion with the common name. 21. Common name: The international non-proprietary name recommended by the World Health Organization, or, if one does not exist, the usual common name. 22. Strength of the medicinal product: The content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form. 23. Immediate packaging: The container or other form of packaging immediately in contact with the medicinal product. 24. Outer packaging: The packaging into which is placed the immediate packaging. 25. Labelling: Information on the immediate or outer packaging. 26. Package leaflet: A leaflet containing information for the user which accompanies the medicinal product. 27. Agency: The European Agency for the Evaluation of Medicinal Products established by Regulation (EEC) No 2309/93. 28. Risk to public health: All risks with regard to the quality, safety and efficacy of the medicinal product. TITLE II SCOPE Article 2 The provisions of this Directive shall apply to industrially produced medicinal products for human use intended to be placed on the market in Member States. Article 3 This Directive shall not apply to: 1. Any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient (commonly known as the magistral formula). 2. Any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question (commonly known as the official formula). 3. Medicinal products intended for research and development trials. 4. Intermediate products intended for further processing by an authorized manufacturer. 5. Any radionuclides in the form of sealed sources. 6. Whole blood, plasma or blood cells of human origin. Article 4 1. Nothing in this Directive shall in any way derogate from the Community rules for the radiation protection of persons undergoing medical examination or treatment, or from the Community rules laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation. 2. This Directive shall be without prejudice to Council Decision 86/346/EEC of 25 June 1986 accepting on behalf of the Community the European Agreement on the Exchange of Therapeutic Substances of Human Origin(20). 3. The provisions of this Directive shall not affect the powers of the Member States' authorities either as regards the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes, on the basis of health, economic and social conditions. 4. This Directive shall not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products as contraceptives or abortifacients. The Member States shall communicate the national legislation concerned to the Commission. Article 5 A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorized health care professional and for use by his individual patients on his direct personal responsibility. TITLE III PLACING ON THE MARKET CHAPTER 1 Marketing authorization Article 6 1. No medicinal product may be placed on the market of a Member State unless a marketing authorization has been issued by the competent authorities of that Member State in accordance with this Directive or an authorization has been granted in accordance with Regulation (EEC) No 2309/93. 2. The authorisation referred to in paragraph 1 shall also be required for radionuclide generators, radionuclide kits, radionuclide precursor radiopharmaceuticals and industrially prepared radiopharmaceuticals. Article 7 A marketing authorization shall not be required for a radiopharmaceutical prepared at the time of use by a person or by an establishment authorized, according to national legislation, to use such medicinal products in an approved health care establishment exclusively from authorized radionuclide generators, radionuclide kits or radionuclide precursors in accordance with the manufacturer's instructions. Article 8 1. In order to obtain an authorization to place a medicinal product on the market regardless of the procedure established by Regulation (EEC) No 2309/93, an application shall be made to the competent authority of the Member State concerned. 2. A marketing authorization may only be granted to an applicant established in the Community. 3. The application shall be accompanied by the following particulars and documents, submitted in accordance with Annex I: (a) Name or corporate name and permanent address of the applicant and, where applicable, of the manufacturer. (b) Name of the medicinal product. (c) Qualitative and quantitative particulars of all the constituents of the medicinal product in usual terminology, but excluding empirical chemical formulae, with mention of the international non-proprietary name recommended by the World Health Organization where such name exists. (d) Description of the manufacturing method. (e) Therapeutic indications, contra-indications and adverse reactions. (f) Posology, pharmaceutical form, method and route of administration and expected shelf life. (g) If applicable, reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, its administration to patients and for the disposal of waste products, together with an indication of any potential risks presented by the medicinal product for the environment. (h) Description of the control methods employed by the manufacturer (qualitative and quantitative analysis of the constituents and of the finished product, special tests, e.g. sterility tests, tests for the presence of pyrogenic substances, the presence of heavy metals, stability tests, biological and toxicity tests, controls carried out at an intermediate stage of the manufacturing process). (i) Results of: - physico-chemical, biological or microbiological tests, - toxicological and pharmacological tests, - clinical trials. (j) A summary, in accordance with Article 11, of the product characteristics, one or more specimens or mock-ups of the outer packaging and the immediate packaging of the medicinal product, together with a package leaflet. (k) A document showing that the manufacturer is authorised in his own country to produce medicinal products. (l) Copies of any authorisation obtained in another Member State or in a third country to place the medicinal product on the market, together with a list of those Member States in which an application for authorisation submitted in accordance with this Directive is under examination. Copies of the summary of the product characteristics proposed by the applicant in accordance with Article 11 or approved by the competent authorities of the Member State in accordance with Article 21. Copies of the package leaflet proposed in accordance with Article 59 or approved by the competent authorities of the Member State in accordance with Article 61. Details of any decision to refuse authorization, whether in the Community or in a third country, and the reasons for such a decision. This information shall be updated on a regular basis. Article 9 In addition to the requirements set out in Articles 8 and 10(1), an application for authorization to market a radionuclide generator shall also contain the following information and particulars: - a general description of the system together with a detailed description of the components of the system which may affect the composition or quality of the daughter nucleid preparation, - qualitative and quantitative particulars of the eluate or the sublimate. Article 10 1. In derogation of Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property: (a) The applicant shall not be required to provide the results of toxicological and pharmacological tests or the results of clinical trials if he can demonstrate: (i) either that the medicinal product is essentially similar to a medicinal product authorized in the Member State concerned by the application and that the holder of the marketing authorization for the original medicinal product has consented to the toxicological, pharmacological and/or clinical references contained in the file on the original medicinal product being used for the purpose of examining the application in question; (ii) or that the constituent or constituents of the medicinal product have a well established medicinal use, with recognized efficacy and an acceptable level of safety, by means of a detailed scientific bibliography; (iii) or that the medicinal product is essentially similar to a medicinal product which has been authorized within the Community, in accordance with Community provisions in force, for not less than six years and is marketed in the Member State for which the application is made. This period shall be extended to 10 years in the case of high-technology medicinal products having been authorised according to the procedure laid down in Article 2(5) of Council Directive 87/22/EEC(21). Furthermore, a Member State may also extend this period to 10 years by a single Decision covering all the medicinal products marketed on its territory where it considers this necessary in the interest of public health. Member States are at liberty not to apply the six-year period beyond the date of expiry of a patent protecting the original medicinal product. However, where the medicinal product is intended for a different therapeutic use from that of the other medicinal products marketed or is to be administered by different routes or in different doses, the results of appropriate toxicological and pharmacological tests and/or of appropriate clinical trials must be provided. (b) In the case of new medicinal products containing known constituents not hitherto used in combination for therapeutic purposes, the results of toxicological and pharmacological tests and of clinical trials relating to that combination must be provided, but it shall not be necessary to provide references relating to each individual constituent. 2. Annex I shall apply by analogy where, pursuant to point (ii) of paragraph 1, (a), bibliographic references to published data are submitted. Article 11 The summary of the product characteristics shall contain the following information: 1. Name of the medicinal product. 2. Qualitative and quantitative composition in terms of the active substances and constituents of the excipient, knowledge of which is essential for proper administration of the medicinal product. The usual common name or chemical description shall be used. 3. Pharmaceutical form. 4. Pharmacological properties and, in so far as this information is useful for therapeutic purposes, pharmacokinetic particulars. 5. Clinical particulars: 5.1. therapeutic indications, 5.2. contra-indications, 5.3. adverse reactions (frequency and seriousness), 5.4. special precautions for use and, in the case of immunological medicinal products, any special precautions to be taken by persons handling such products and administering them to patients, together with any precautions to be taken by the patient, 5.5. use during pregnancy and lactation, 5.6. interaction with other medicaments and other forms of interaction, 5.7. posology and method of administration for adults and, where necessary, for children, 5.8. overdose (symptoms, emergency procedures, antidotes), 5.9. special warnings, 5.10. effects on ability to drive and to use machines. 6. Pharmaceutical particulars: 6.1. major incompatibilities, 6.2. shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time, 6.3. special precautions for storage, 6.4. nature and contents of the immediate packaging, 6.5. special precautions for disposal of unused medicinal products or waste materials derived from such medicinal products, if appropriate. 7. Name or corporate name and permanent address of the marketing authorization holder. 8. For radiopharmaceuticals, full details of internal radiation dosimetry. 9. For radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality control of such preparation and, where appropriate, maximum storage time during which any intermediate preparation such as an eluate or the ready-to-use pharmaceutical will conform with its specifications. Article 12 1. Member States shall take all appropriate measures to ensure that the documents and particulars listed in Article 8(3)(h) and (i), and Article 10(1)(a)(ii) are drawn up by experts with the necessary technical or professional qualifications before they are submitted to the competent authorities. These documents and particulars shall be signed by the experts. 2. The duties of the experts according to their respective qualifications shall be: (a) to perform tasks falling within their respective disciplines (analysis, pharmacology and similar experimental sciences, clinical trials) and to describe objectively the results obtained (qualitatively and quantitatively); (b) to describe their observations in accordance with Annex I, and to state, in particular: - in the case of the analyst, whether the medicinal product is consistent with the declared composition, giving any substantiation of the control methods employed by the manufacturer; - in the case of the pharmacologist or the specialist with similar experimental competence, the toxicity of the medicinal product and the pharmacological properties observed; - in the case of the clinician, whether he has been able to ascertain effects on persons treated with the medicinal product which correspond to the particulars given by the applicant in accordance with Articles 8 and 10, whether the patient tolerates the medicinal product well, the posology the clinician advises and any contra-indications and adverse reactions; (c) where applicable, to state the grounds for using the bibliography mentioned in point (a)(ii) of Article 10(1). 3. Detailed reports by the experts shall form part of the particulars accompanying the application which the applicant submits to the competent authorities. CHAPTER 2 Specific provisions applicable to homeopathic medicinal products Article 13 1. Member States shall ensure that homeopathic medicinal products manufactured and placed on the market within the Community are registered or authorized in accordance with Articles 14, 15 and 16, except where the products are covered by a registration or authorization which was granted under national law on or before 31 December 1993 (and whether or not that registration or authorization has been renewed after that date). Each Member State shall take due account of registrations and authorizations previously granted by another Member State. 2. A Member State may refrain from establishing a special, simplified registration procedure for the homeopathic medicinal products referred to in Article 14. A Member State shall inform the Commission accordingly. The Member State concerned shall allow the use in its territory of homeopathic medicinal products registered by other Member States in accordance with Articles 14 and 15. Article 14 1. Only homeopathic medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure: - they are administered orally or externally, - no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto, - there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product may not contain either more than one part per 10000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy with regard to active substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor's prescription. At the time of registration, Member States shall determine the classification for the dispensing of the medicinal product. 2. The criteria and rules of procedure provided for in Article 4(4), Article 17(1) and Articles 22 to 26, 112, 116 and 125 shall apply by analogy to the special, simplified registration procedure for homeopathic medicinal products, with the exception of the proof of therapeutic efficacy. 3. The proof of therapeutic efficacy shall not be required for homeopathic medicinal products registered in accordance with paragraph 1 of this Article, or, where appropriate, admitted in accordance with Article 13(2). Article 15 An application for special, simplified registration may cover a series of medicinal products derived from the same homeopathic stock or stocks. The following documents shall be included with the application in order to demonstrate, in particular, the pharmaceutical quality and the batch-to-batch homogeneity of the products concerned: - scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered, - dossier describing how the homeopathic stock or stocks is/are obtained and controlled, and justifying its/their homeopathic nature, on the basis of an adequate bibliography, - manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentization, - manufacturing authorization for the medicinal product concerned, - copies of any registrations or authorizations obtained for the same medicinal product in other Member States, - one or more specimens or mock-ups of the outer packaging and the immediate packaging of the medicinal products to be registered, - data concerning the stability of the medicinal product. Article 16 1. Homeopathic medicinal products other than those referred to in Article 14(1) shall be authorized and labelled in accordance with Articles 8, 10 and 11. 2. A Member State may introduce or retain in its territory specific rules for the toxicological and pharmacological tests and clinical trials of homeopathic medicinal products other than those referred to in Article 14(1) in accordance with the principles and characteristics of homeopathy as practised in that Member State. In this case, the Member State concerned shall notify the Commission of the specific rules in force. 3. Title IX shall apply to homeopathic medicinal products, with the exception of those referred to in Article 14(1). CHAPTER 3 Procedures relevant to the marketing authorization Article 17 1. Member States shall take all appropriate measures to ensure that the procedure for granting an authorization to place a medicinal product on the market is completed within 210 days of the submission of a valid application. 2. Where a Member State notes that an application for authorization is already under active examination in another Member State in respect of that medicinal product, the Member State concerned may decide to suspend the detailed examination of the application in order to await the assessment report prepared by the other Member State in accordance with Article 21(4). The Member State concerned shall inform the other Member State and the applicant of its decision to suspend detailed examination of the application in question. As soon as it has completed the examination of the application and reached a decision, the other Member State shall forward a copy of its assessment report to the Member State concerned. Article 18 Where a Member State is informed in accordance with Article 8(3)(l) that another Member State has authorized a medicinal product which is the subject of an application for authorization in the Member State concerned, that Member State shall forthwith request the authorities of the Member State which has granted the authorization to forward to it the assessment report referred to in Article 21(4). Within 90 days of the receipt of the assessment report, the Member State concerned shall either recognize the decision of the first Member State and the summary of the product characteristics as approved by it or, if it considers that there are grounds for supposing that the authorization of the medicinal product concerned may present a risk to public health, it shall apply the procedures set out in Articles 29 to 34. Article 19 In order to examine the application submitted in accordance with Articles 8 and 10(1), the competent authority of the Member State: 1. must verify whether the particulars submitted in support of the application comply with the said Articles 8 and 10(1) and examine whether the conditions for issuing an authorization to place medicinal products on the market (marketing authorization) are complied with. 2. may submit the medicinal product, its starting materials and, if need be, its intermediate products or other constituent materials, for testing by a State laboratory or by a laboratory designated for that purpose in order to ensure that the control methods employed by the manufacturer and described in the particulars accompanying the application in accordance with Article 8(3)(h) are satisfactory. 3. may, where appropriate, require the applicant to supplement the particulars accompanying the application in respect of the items listed in the Articles 8(3) and 10(1). Where the competent authority avails itself of this option, the time limits laid down in Article 17 shall be suspended until such time as the supplementary information required has been provided. Likewise, these time limits shall be suspended for the time allowed the applicant, where appropriate, for giving oral or written explanation. Article 20 Member States shall take all appropriate measures to ensure that: (a) the competent authorities verify that manufacturers and importers of medicinal products coming from third countries are able to carry out manufacture in compliance with the particulars supplied pursuant to Article 8(3)(d), and/or to carry out controls according to the methods described in the particulars accompanying the application in accordance with Article 8(3)(h); (b) the competent authorities may allow manufacturers and importers of medicinal products coming from third countries, in exceptional and justifiable cases, to have certain stages of manufacture and/or certain of the controls referred to in (a) carried out by third parties; in such cases, the verifications by the competent authorities shall also be made in the establishment designated. Article 21 1. When the marketing authorization is issued, the holder shall be informed, by the competent authorities of the Member State concerned, of the summary of the product characteristics as approved by it. 2. The competent authorities shall take all necessary measures to ensure that the information given in the summary is in conformity with that accepted when the marketing authorization is issued or subsequently. 3. The competent authorities shall forward to the Agency a copy of the authorization together with the summary of the product characteristics. 4. The competent authorities shall draw up an assessment report and comments on the dossier as regards the results of the analytical and pharmacotoxicological tests and the clinical trials of the medicinal product concerned. The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the medicinal product concerned. Article 22 In exceptional circumstances, and following consultation with the applicant, an authorization may be granted subject to certain specific obligations, including: - the carrying out of further studies following the granting of authorization, - the notification of adverse reactions to the medicinal product. These exceptional decisions may be adopted only for objective and verifiable reasons and shall be based on one of the causes referred to in Part 4 (G) of Annex I. Article 23 After an authorization has been issued, the authorization holder must, in respect of the methods of manufacture and control provided for in Article 8(3)(d) and (h), take account of scientific and technical progress and introduce any changes that may be required to enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods. These changes shall be subject to the approval of the competent authority of the Member State concerned. Article 24 Authorization shall be valid for five years and shall be renewable for five-year periods, on application by the holder at least three months before the expiry date and after consideration by the competent authority of a dossier containing in particular details of the data on pharmacovigilance and other information relevant to the monitoring of the medicinal product. Article 25 Authorization shall not affect the civil and criminal liability of the manufacturer and, where applicable, of the marketing authorization holder. Article 26 The marketing authorisation shall be refused if, after verification of the particulars and documents listed in Articles 8 and 10(1), it proves that: (a) the medicinal product is harmful in the normal conditions of use, or (b) that its therapeutic efficacy is lacking or is insufficiently substantiated by the applicant, or (c) that its qualitative and quantitative composition is not as declared. Authorisation shall likewise be refused if the particulars and documents submitted in support of the application do not comply with Articles 8 and 10(1). CHAPTER 4 Mutual recognition of authorizations Article 27 1. In order to facilitate the adoption of common decisions by Member States on the authorization of medicinal products on the basis of the scientific criteria of quality, safety and efficacy, and to achieve thereby the free movement of medicinal products within the Community, a Committee for Proprietary Medicinal Products, hereinafter referred to as "the Committee", is hereby set up. The Committee shall be part of the Agency. 2. In addition to the other responsibilities conferred upon it by Community law, the Committee shall examine any question relating to the granting, variation, suspension or withdrawal of marketing authorization which is submitted to it in accordance with this Directive. 3. The Committee shall draw up its own Rules of Prodecure. Article 28 1. Before submitting the application for recognition of a marketing authorization, the holder of the authorization shall inform the Member State which granted the authorization on which the application is based (hereinafter "reference Member State"), that an application is to be made in accordance with this Directive and shall notify it of any additions to the original dossier; that Member State may require the applicant to provide it with all the particulars and documents necessary to enable it to check that the dossiers filed are identical. In addition the holder of the authorization shall request the reference Member State to prepare an assessment report in respect of the medicinal product concerned, or, if necessary, to update any existing assessment report. That Member State shall prepare the assessment report, or update it, within 90 days of the receipt of the request. At the same time as the application is submitted in accordance with paragraph 2, the reference Member State shall forward the assessment report to the Member State or Member States concerned by the application. 2. In order to obtain the recognition according to the procedures laid down in this Chapter in one or more of the Member States of a marketing authorization issued by a Member State, the holder of the authorization shall submit an application to the competent authorities of the Member State or Member States concerned, together with the information and particulars referred to in Articles 8, 10(1) and 11. He shall testify that the dossier is identical to that accepted by the reference Member State, or shall identify any additions or amendments it may contain. In the latter case, he shall certify that the summary of the product characteristics proposed by him in accordance with Article 11 is identical to that accepted by the reference Member State in accordance with Article 21. Moreover, he shall certify that all the dossiers filed as part of the procedure are identical. 3. The holder of the marketing authorization shall communicate the application to the Agency, inform it of the Member States concerned and of the dates of submission of the application and send it a copy of the authorization granted by the reference Member State. He shall also send the Agency copies of any such authorization which may have been granted by the other Member States in respect of the medicinal product concerned, and shall indicate whether any application for authorization is currently under consideration in any Member State. 4. Save in the exceptional case provided for in Article 29(1), each Member State shall recognize the marketing authorization granted by the reference Member State within 90 days of receipt of the application and the assessment report. It shall inform the reference Member State which granted the initial authorization, the other Member States concerned by the application, the Agency, and the marketing authorization holder. Article 29 1. Where a Member State considers that there are grounds for supposing that the marketing authorization of the medicinal product concerned may present a risk to public health, it shall forthwith inform the applicant, the reference Member State which granted the initial authorization, any other Member States concerned by the application and the Agency. The Member State shall state its reasons in detail and shall indicate what action may be necessary to correct any defect in the application. 2. All the Member States concerned shall use their best endeavours to reach agreement on the action to be taken in respect of the application. They shall provide the applicant with the opportunity to make his point of view known orally or in writing. However, if the Member States have not reached agreement within the time limit referred to in Article 28(4) they shall forthwith refer the matter to the Agency with regard to the Committee's reference for the application of the procedure laid down in Article 32. 3. Within the time limit referred to in Article 28(4), the Member States concerned shall provide the Committee with a detailed statement of the matters on which they have been unable to reach agreement and the reasons for their disagreement. The applicant shall be provided with a copy of this information. 4. As soon as he is informed that the matter has been referred to the Committee, the applicant shall forthwith forward to the Committee a copy of the information and particulars referred to in Article 28(2). Article 30 If several applications submitted in accordance with Articles 8, 10(1) and Article 11 have been made for marketing authorization for a particular medicinal product, and Member States have adopted divergent decisions concerning the authorization of the medicinal product or its suspension or withdrawal, a Member State, or the Commission, or the marketing authorization holder may refer the matter to the Committee for application of the procedure laid down in Article 32. The Member State concerned, the marketing authorization holder or the Commission shall clearly identify the question which is referred to the Committee for consideration and, where appropriate, shall inform the holder. The Member State and the marketing authorization holder shall forward to the Committee all available information relating to the matter in question. Article 31 The Member States or the Commission or the applicant or holder of the marketing authorization may, in specific cases where the interests of the Community are involved, refer the matter to the Committee for the application of the procedure laid down in Article 32 before reaching a decision on a request for a marketing authorization or on the suspension or withdrawal of an authorization, or on any other variation to the terms of a marketing authorization which appears necessary, in particular to take account of the information collected in accordance with Title IX. The Member State concerned or the Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the marketing authorization holder. The Member States and the marketing authorization holder shall forward to the Committee all available information relating to the matter in question. Article 32 1. When reference is made to the procedure described in this Article, the Committee shall consider the matter concerned and issue a reasoned opinion within 90 days of the date on which the matter was referred to it. However, in cases submitted to the Committee in accordance with Articles 30 and 31, this period may be extended by 90 days. In case of urgency, on a proposal from its Chairman, the Committee may agree to a shorter deadline. 2. In order to consider the matter, the Committee may appoint one of its members to act as rapporteur. The Committee may also appoint individual experts to advise it on specific questions. When appointing experts, the Committee shall define their tasks and specify the time-limit for the completion of these tasks. 3. In the cases referred to in Articles 29 and 30, before issuing its opinion, the Committee shall provide the marketing authorization holder with an opportunity to present written or oral explanations. In the case referred to in Article 31, the marketing authorization holder may be asked to explain himself orally or in writing. If it considers it appropriate, the Committee may invite any other person to provide information relating to the matter before it. The Committee may suspend the time limit referred to in paragraph 1 in order to allow the marketing authorization holder to prepare explanations. 4. The Agency shall forthwith inform the marketing authorization holder where the opinion of the Committee is that: - the application does not satisfy the criteria for authorization, or - the summary of the product characteristics proposed by the applicant in accordance with Article 11 should be amended, or - the authorization should be granted subject to conditions, with regard to conditions considered essential for the safe and effective use of the medicinal product including pharmacovigilance, or - a marketing authorization should be suspended, varied or withdrawn. Within 15 days of the receipt of the opinion, the marketing authorization holder may notify the Agency in writing of his intention to appeal. In that case, he shall forward the detailed grounds for appeal to the Agency within 60 days of receipt of the opinion. Within 60 days of receipt of the grounds for appeal, the Committee shall consider whether its opinion should be revised, and the conclusions reached on the appeal shall be annexed to the assessment report referred to in paragraph 5. 5. Within 30 days of its adoption, the Agency shall forward the final opinion of the Committee to the Member States, the Commission and the marketing authorization holder together with a report describing the assessment of the medicinal product and stating the reasons for its conclusions. In the event of an opinion in favour of granting or maintaining an authorization to place the medicinal product concerned on the market, the following documents shall be annexed to the opinion. (a) a draft summary of the product characteristics, as referred to in Article 11; (b) any conditions affecting the authorization within the meaning of paragraph 4. Article 33 Within 30 days of the receipt of the opinion, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account Community law. In the event of a draft decision which envisages the granting of marketing authorization, the documents referred to in Article 32(5)(a) and (b) shall be annexed. Where, exceptionally, the draft decision is not in accordance with the opinion of the Agency, the Commission shall also annex a detailed explanation of the reasons for the differences. The draft decision shall be forwarded to the Member States and the applicant. Article 34 1. A final decision on the application shall be adopted in accordance with the procedure referred to in Article 121(2). 2. The rules of procedure of the Standing Committee established by Article 121(1) shall be adjusted to take account of the tasks incumbent upon it in accordance with this Chapter. These adjustments shall involve the following: - except in cases referred to in the third paragraph of Article 33, the opinion of the Standing Committee shall be obtained in writing, - each Member State is allowed at least 28 days to forward written observations on the draft decision to the Commission, - each Member State is able to require in writing that the draft decision be discussed by the Standing Committee, giving its reasons in detail. Where, in the opinion of the Commission, the written observations of a Member State raise important new questions of a scientific or technical nature which have not been addressed in the opinion of the Agency, the Chairman shall suspend the procedure and refer the application back to the Agency for further consideration. The provisions necessary for the implementation of this paragraph shall be adopted by the Commission in accordance with the procedure referred to in Article 121(2). 3. A decision as referred to in paragraph 1 shall be addressed to the Member States concerned by the matter and reported to the marketing authorization holder. The Member States shall either grant or withdraw marketing authorization, or vary the terms of a marketing authorization as necessary to comply with the decision within 30 days of its notification. They shall inform the Commission and the Agency thereof. Article 35 1. Any application by the marketing authorization holder to vary a marketing authorization which has been granted in accordance with the provisions of this Chapter shall be submitted to all the Member States which have previously authorized the medicinal product concerned. The Commission shall, in consultation with the Agency, adopt appropriate arrangements for the examination of variations to the terms of a marketing authorization. These arrangements shall include a notification system or administration procedures concerning minor variations and define precisely the concept of "a minor variation". These arrangements shall be adopted by the Commission in the form of an implementing Regulation in accordance with the procedure referred to in Article 121(2). 2. In case of arbitration submitted to the Commission, the procedure laid down in Articles 32, 33 and 34 shall apply by analogy to variations made to marketing authorizations. Article 36 1. Where a Member State considers that the variation of a marketing authorization which has been granted in accordance with the provisions of this Chapter or its suspension or withdrawal is necessary for the protection of public health, the Member State concerned shall forthwith refer the matter to the Agency for the application of the procedures laid down in Articles 32, 33 and 34. 2. Without prejudice to the provisions of Article 31, in exceptional cases, where urgent action is essential to protect public health, until a definitive decision is adopted a Member State may suspend the marketing and the use of the medicinal product concerned on its territory. It shall inform the Commission and the other Member States no later than the following working day of the reasons for its action. Article 37 Articles 35 and 36 shall apply by analogy to medicinal products authorized by Member States following an opinion of the Committee given in accordance with Article 4 of Directive 87/22/EEC before 1 January 1995. Article 38 1. The Agency shall publish an annual report on the operation of the procedures laid down in this Chapter and shall forward that report to the European Parliament and the Council for information. 2. By 1 January 2001, the Commission shall publish a detailed review of the operation of the procedures laid down in this Chapter and shall propose any amendments which may be necessary to improve these procedures. The Council shall decide, under the conditions provided for in the Treaty, on the Commission proposal within one year of its submission. Article 39 The provisions referred to in Articles 27 to 34 shall not apply to the homeopathic medicinal products referred to in Article 16(2). TITLE IV MANUFACTURE AND IMPORTATION Article 40 1. Member States shall take all appropriate measures to ensure that the manufacture of the medicinal products within their territory is subject to the holding of an authorization. This manufacturing authorization shall be required nothwithstanding that the medicinal products manufactured are intended for export. 2. The authorization referred to in paragraph 1 shall be required for both total and partial manufacture, and for the various processes of dividing up, packaging or presentation. However, such authorization shall not be required for preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail supply, by pharmacists in dispensing pharmacies or by persons legally authorized in the Member States to carry out such processes. 3. Authorization referred to in paragraph 1 shall also be required for imports coming from third countries into a Member State; this Title and Article 118 shall have corresponding application to such imports as they have to manufacture. Article 41 In order to obtain the manufacturing authorization, the applicant shall meet at least the following requirements: (a) specify the medicinal products and pharmaceutical forms which are to be manufactured or imported and also the place where they are to be manufactured and/or controlled; (b) have at his disposal, for the manufacture or import of the above, suitable and sufficient premises, technical equipment and control facilities complying with the legal requirements which the Member State concerned lays down as regards both manufacture and control and the storage of medicinal products, in accordance with Article 20; (c) have at his disposal the services of at least one qualified person within the meaning of Article 48. The applicant shall provide particulars in support of the above in his application. Article 42 1. The competent authority of the Member State shall issue the manufacturing authorization only after having made sure of the accuracy of the particulars supplied pursuant to Article 41, by means of an inquiry carried out by its agents. 2. In order to ensure that the requirements referred to in Article 41 are complied with, authorization may be made conditional on the carrying out of certain obligations imposed either when authorization is granted or at a later date. 3. The authorization shall apply only to the premises specified in the application and to the medicinal products and pharmaceutical forms specified in that same application. Article 43 The Member States shall take all appropriate measures to ensure that the time taken for the procedure for granting the manufacturing authorization does not exceed 90 days from the day on which the competent authority receives the application. Article 44 If the holder of the manufacturing authorization requests a change in any of the particulars referred to in points (a) and (b) of the first paragraph of Article 41, the time taken for the procedure relating to this request shall not exceed 30 days. In exceptional cases this period of time may be extended to 90 days. Article 45 The competent authority of the Member State may require from the applicant further information concerning the particulars supplied pursuant to Article 41 and concerning the qualified person referred to in Article 48; where the competent authority concerned exercises this right, application of the time-limits referred to in Article 43 and 44 shall be suspended until the additional data required have been supplied. Article 46 The holder of a manufacturing authorization shall at least be obliged: (a) to have at his disposal the services of staff who comply with the legal requirements existing in the Member State concerned both as regards manufacture and controls; (b) to dispose of the authorized medicinal products only in accordance with the legislation of the Member States concerned; (c) to give prior notice to the competent authority of any changes he may wish to make to any of the particulars supplied pursuant to Article 41; the competent authority shall, in any event, be immediately informed if the qualified person referred to in Article 48 is replaced unexpectedly; (d) to allow the agents of the competent authority of the Member State concerned access to his premises at any time; (e) to enable the qualified person referred to in Article 48 to carry out his duties, for example by placing at his disposal all the necessary facilities; (f) to comply with the principles and guidelines of good manufacturing practice for medicinal products as laid down by Community law. Article 47 The principles and guidelines of good manufacturing practices for medicinal products referred to in Article 46(f) shall be adopted in the form of a directive, in accordance with the procedure referred to in Article 121(2). Detailed guidelines in line with those principles will be published by the Commission and revised necessary to take account of technical and scientific progress. Article 48 1. Member States shall take all appropriate measures to ensure that the holder of the manufacturing authorization has permanently and continuously at his disposal the services of at least one qualified person, in accordance with the conditions laid down in Article 49, responsible in particular for carrying out the duties specified in Article 51. 2. If he personally fulfils the conditions laid down in Article 49, the holder of the authorization may himself assume the responsibility referred to in paragraph 1. Article 49 1. Member States shall ensure that the qualified person referred to in Article 48 fulfils the minimum conditions of qualification set out in paragraphs 2 and 3. 2. A qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology. However, the minimum duration of the university course may be three and a half years where the course is followed by a period of theoretical and practical training of a minimum duration of one year and including a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level. Where two university courses or two courses recognized by the State as equivalent co-exist in a Member State and where one of these extends over four years and the other over three years, the three-year course leading to a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course or its recognized equivalent shall be considered to fulfil the condition of duration referred to in the second subparagraph in so far as the diplomas, certificates or other evidence of formal qualifications awarded on completion of both courses are recognized as equivalent by the State in question. The course shall include theoretical and practical study bearing upon at least the following basic subjects: - Applied physics - General and inorganic chemistry - Organic chemistry - Analytical chemistry - Pharmaceutical chemistry, including analysis of medicinal products - General and applied biochemistry (medical) - Physiology - Microbiology - Pharmacology - Pharmaceutical technology - Toxicology - Pharmacognosy (study of the composition and effects of the natural active substances of plant and animal origin). Studies in these subjects should be so balanced as to enable the person concerned to fulfil the obligations specified in Article 51. In so far as certain diplomas, certificates or other evidence of formal qualifications mentioned in the first subparagraph do not fulfil the criteria laid down in this paragraph, the competent authority of the Member State shall ensure that the person concerned provides evidence of adequate knowledge of the subjects involved. 3. The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products. The duration of practical experience may be reduced by one year where a university course lasts for at least five years and by a year and a half where the course lasts for at least six years. Article 50 1. A person engaging in the activities of the person referred to in Article 48 from the time of the application of Directive 75/319/EEC, in a Member State without complying with the provisions of Article 49 shall be eligible to continue to engage in those activities in the State concerned. 2. The holder of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course - or a course recognized as equivalent by the Member State concerned - in a scientific discipline allowing him to engage in the activities of the person referred to in Article 48 in accordance with the laws of that State may - if he began his course prior to 21 May 1975 - be considered as qualified to carry out in that State the duties of the person referred to in Article 48 provided that he has previously engaged in the following activities for at least two years before 21 May 1985 following notification of this directive in one or more undertakings authorized to manufacture: production supervision and/or qualitative and quantitative analysis of active substances, and the necessary testing and checking under the direct authority of the person referred to in Article 48 to ensure the quality of the medicinal products. If the person concerned has acquired the practical experience referred to in the first subparagraph before 21 May 1965, a further one year's practical experience in accordance with the conditions referred to in the first subparagraph will be required to be completed immediately before he engages in such activities. Article 51 1. Member States shall take all appropriate measures to ensure that the qualified person referred to in Article 48, without prejudice to his relationship with the holder of the manufacturing authorization, is responsible, in the context of the procedures referred to in Article 52, for securing: (a) in the case of medicinal products manufactured within the Member States concerned, that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that Member State and in accordance with the requirements of the marketing authorization; (b) in the case of medicinal products coming from third countries, that each production batch has undergone in the importing Member State a full qualitative analysis, a quantitative analysis of at least all the active constituents and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorization. The batches of medicinal products which have undergone such controls in a Member State shall be exempt from the controls if they are marketed in another Member State, accompanied by the control reports signed by the qualified person. 2. In the case of medicinal products imported from a third country, where appropriate arrangements have been made by the Community with the exporting country to ensure that the manufacturer of the medicinal product applies standards of good manufacturing practice at least equivalent to those laid down by the Community, and to ensure that the controls referred to under point (b) of the first subparagraph of paragraph 1 have been carried out in the exporting country, the qualified person may be relieved of responsibility for carrying out those controls. 3. In all cases and particularly where the medicinal products are released for sale, the qualified person must certify in a register or equivalent document provided for that purpose, that each production batch satisfies the provisions of this Article; the said register or equivalent document must be kept up to date as operations are carried out and must remain at the disposal of the agents of the competent authority for the period specified in the provisions of the Member State concerned and in any event for at least five years. Article 52 Member States shall ensure that the duties of qualified persons referred to in Article 48 are fulfilled, either by means of appropriate administrative measures or by making such persons subject to a professional code of conduct. Member States may provide for the temporary suspension of such a person upon the commencement of administrative or disciplinary procedures against him for failure to fulfil his obligations. Article 53 The provisions of this Title shall also apply to homeopathic medicinal products. TITLE V LABELLING AND PACKAGE LEAFLET Article 54 The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging: (a) the name of the medicinal product followed by the common name where the product contains only one active substance and if its name is an invented name; where a medicinal product is available in several pharmaceutical forms and/or several strengths, the pharmaceutical form and/or the strength (baby, child or adult as appropriate) must be included in the name of the medicinal product; (b) a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names; (c) the pharmaceutical form and the contents by weight, by volume or by number of doses of the product; (d) a list of those excipients known to have a recognized action or effect and included in the guidelines published pursuant to Article 65. However, if the product is injectable, or a topical or eye preparation, all excipients must be stated; (e) the method and, if necessary, the route of administration; (f) a special warning that the medicinal product must be stored out of reach of children; (g) a special warning, if this is necessary for the medicinal product; (h) the expiry date in clear terms (month/year); (i) special storage precautions, if any; (j) special precautions for disposal of unused medicinal products or waste materials from medicinal products, if appropriate; (k) the name and address of the holder of the authorization for placing the medicinal product on the market; (l) the number of the authorization for placing the medicinal product on the market; (m) the manufacturer's batch number; (n) in the case of self-medication, instructions on the use of the medicinal products. Article 55 1. The particulars laid down in Articles 54 and 62 shall appear on immediate packagings other than those referred to in paragraphs 2 and 3. 2. The following particulars at least shall appear on immediate packagings which take the form of blister packs and are placed in an outer packaging that complies with the requirements laid down in Articles 54 and 62. - the name of the medicinal product as laid down in Article 54(a), - the name of the holder of the authorization for placing the product on the market, - the expiry date, - the batch number. 3. The following particulars at least shall appear on small immediate packaging units on which the particulars laid down in Articles 54 and 62 cannot be displayed: - the name of the medicinal product and, if necessary, the strength and the route of administration, - the method of administration, - the expiry date, - the batch number, - the contents by weight, by volume or by unit. Article 56 The particulars referred to in Articles 54, 55 and 62 shall be easily legible, clearly comprehensible and indelible. Article 57 Notwithstanding Article 60, Member States may require the use of certain forms of labelling of the medicinal product making it possible to ascertain: - the price of the medicinal product, - the reimbursement conditions of social security organizations, - the legal status for supply to the patient, in accordance with Title VI, - identification and authenticity. Article 58 The inclusion in the packaging of all medicinal products of a package leaflet shall be obligatory unless all the information required by Articles 59 and 62 is directly conveyed on the outer packaging or on the immediate packaging. Article 59 1. The package leaflet shall be drawn up in accordance with the summary of the product characteristics; it shall include, in the following order: (a) for the identification of the medicinal product: - the name of the medicinal product, followed by the common name if the product contains only one active substance and if its name is an invented name; where a medicinal product is available in several pharmaceutical forms and/or several strengths, the pharmaceutical form and/or the strength (for example, baby, child, adult) must be included in the name of the medicinal product, - a full statement of the active substances and excipients expressed qualitatively and a statement of the active substances expressed quantitatively, using their common names, in the case of each presentation of the medicinal product, - the pharmaceutical form and the contents by weight, by volume or by number of doses of the product, in the case of each presentation of the product, - the pharmaco-therapeutic group, or type of activity in terms easily comprehensible for the patient, - the name and address of the holder of the authorization for placing the medicinal product on the market and of the manufacturer; (b) the therapeutic indications; (c) list of information which is necessary before taking the medicinal product: - contra-indications, - appropriate precautions for use, - forms of interaction with other medicinal products and other forms of interaction (e.g. alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product, - special warnings; this list must: - take into account the particular condition of certain categories of users (e.g. children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions), - mention, if appropriate, potential effects on the ability to drive vehicles or to operate machinery, - detail those excipients, knowledge of which is important for the safe and effective use of the medicinal product and included in the guidelines published pursuant to Article 65; (d) the necessary and usual instructions for proper use, in particular: - the dosage, - the method and, if necessary, route of administration, - the frequency of administration, specifying if necessary, the appropriate time at which the medicinal product may or must be administered, and, as appropriate, depending on the nature of the product: - the duration of treatment, where it should be limited, - the action to be taken in the case of an overdose (e.g., symptoms, emergency procedures), - the course of action to take when one or more doses have not been taken, - indication, if necessary, of the risk of withdrawal effects; (e) a description of the undesirable effects which can occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case; the patient should be expressly invited to communicate any undesirable effect which is not mentioned in the leaflet to his doctor or to his pharmacist; (f) a reference to the expiry date indicated on the label, with: - a warning against using the product after this date, - where appropriate, special storage precautions, - if necessary, a warning against certain visible signs of deterioration; (g) the date on which the package leaflet was last revised. 2. Notwithstanding paragraph 1(b), the authority competent may decide that certain therapeutic indications shall not be mentioned in the package leaflet, where the dissemination of such information might have serious disadvantages for the patient. Article 60 Member States may not prohibit or impede the placing on the market of medicinal products within their territory on grounds connected with labelling or the package leaflet where these comply with the requirements of this Title. Article 61 1. One or more specimens or mock-ups of the outer packaging and the immediate packaging of a medicinal product, together with the draft package leaflet, shall be submitted to the authorities competent for authorizing marketing when the marketing authorization is requested. 2. The competent authority shall refuse the marketing authorization if the labelling or the package leaflet do not comply with the provisions of this Title or if they are not in accordance with the particulars listed in the summary of product characteristics. 3. All proposed changes to an aspect of the labelling or the package leaflet covered by this Title and not connected with the summary of product characteristics shall be submitted to the authorities competent for authorizing marketing. If the competent authorities have not opposed a proposed change within 90 days following the introduction of the request, the applicant may put the change into effect. 4. The fact that the competent authority do not refuse a marketing authorization pursuant to paragraph 2 or a change to the labelling or the package leaflet pursuant to paragraph 3 does not alter the general legal liability of the manufacturer or as appropriate the marketing authorization holder. Article 62 The outer packaging and the package leaflet may include symbols or pictograms designed to clarify certain information mentioned in Articles 54 and 59(1) and other information compatible with the summary of the product characteristics which is useful for health education, to the exclusion of any element of a promotional nature. Article 63 1. The particulars for labelling listed in Articles 54, 59 and 62 shall appear in the official language or languages of the Member State where the product is placed on the market. The first subparagraph shall not prevent these particulars from being indicated in several languages, provided that the same particulars appear in all the languages used. 2. The package leaflet must be written in clear and understandable terms for the users and be clearly legible in the official language or languages of the Member State where the medicinal product is placed on the market. The first subparagraph shall not prevent the package leaflet being printed in several languages, provided that the same information is given in all the languages used. 3. The competent authorities may exempt labels and package leaflets for specific medicinal products from the obligation that certain particulars shall appear and that the leaflet must be in the official language or languages of the Member State where the product is placed on the market, when the product is not intended to be delivered to the patient for self-administration. Article 64 Where the provisions of this Title are not complied with, and a notice served on the person concerned has remained without effect, the competent authorities of the Member States may suspend the marketing authorization, until the labelling and the package leaflet of the medicinal product in question have been made to comply with the requirements of this Title. Article 65 As necessary, the Commission shall publish guidelines concerning in particular: - the formulation of certain special warnings for certain categories of medicinal products, - the particular information needs relating to self-medication, - the legibility of particulars on the labelling and package leaflet, - methods for the identification and authentication of medicinal products, - the list of excipients which must feature on the labelling of medicinal products and the way these excipients must be indicated. These guidelines shall be adopted in the form of a Directive, in accordance with the procedure referred to in Article 121(2). Article 66 1. The outer carton and the container of medicinal products containing radionuclides shall be labelled in accordance with the regulations for the safe transport of radioactive materials laid down by the International Atomic Energy Agency. Moreover, the labelling shall comply with the provisions set out in paragraphs 2 and 3. 2. The label on the shielding shall include the particulars mentioned in Article 54. In addition, the labelling on the shielding shall explain in full, the codings used on the vial and shall indicate, where necessary, for a given time and date, the amount of radioactivity per dose or per vial and the number of capsules, or, for liquids, the number of millilitres in the container. 3. The vial shall be labelled with the following information: - the name or code of the medicinal product, including the name or chemical symbol of the radionuclide, - the batch identification and expiry date, - the international symbol for radioactivity, - the name of the manufacturer, - the amount of radioactivity as specified in paragraph 2. Article 67 The competent authority shall ensure that a detailed instruction leaflet is enclosed with the packaging of radiopharmaceuticals, radionuclide generators, radionuclide kits or radionuclide precursors. The text of this leaflet shall be established in accordance with the provisions of Article 59. In addition, the leaflet shall include any precautions to be taken by the user and the patient during the preparation and administration of the medicinal product and special precautions for the disposal of the packaging and its unused contents. Article 68 Without prejudice to the provisions of Article 69, homeopathic medicinal products shall be labelled in accordance with the provisions of this title and shall be identified by a reference on their labels, in clear and legible form, to their homeopathic nature. Article 69 1. In addition to the clear mention of the words "homeopathic medicinal product", the labelling and, where appropriate, the package insert for the medicinal products referred to in Article 14(1) shall bear the following, and no other, information: - the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in accordance with Article 1(5), - name and address of the registration holder and, where appropriate, of the manufacturer, - method of administration and, if necessary, route, - expiry date, in clear terms (month, year), - pharmaceutical form, - contents of the sales presentation, - special storage precautions, if any, - a special warning if necessary for the medicinal product, - manufacturer's batch number, - registration number, - "homeopathic medicinal product without approved therapeutic indications", - a warning advising the user to consult a doctor if the symptoms persist during the use of the medicinal product. 2. Notwithstanding paragraph 1, Member States may require the use of certain types of labelling in order to show: - the price of the medicinal product, - the conditions for refunds by social security bodies. TITLE VI CLASSIFICATION OF MEDICINAL PRODUCTS Article 70 1. When a marketing authorization is granted, the competent authorities shall specify the classification of the medicinal product into: - a medicinal product subject to medical prescription, - a medicinal product not subject to medical prescription. To this end, the criteria laid down in Article 71(1) shall apply. 2. The competent authorities may fix sub-categories for medicinal products which are available on medical prescription only. In that case, they shall refer to the following classification: (a) medicinal products on renewable or non-renewable medical prescription; (b) medicinal products subject to special medical prescription; (c) medicinal products on restricted medical prescription, reserved for use in certain specialized areas. Article 71 1. Medicinal products shall be subject to medical prescription where they: - are likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision, or - are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or - contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation, or - are normally prescribed by a doctor to be administered parenterally. 2. Where Member States provide for the sub-category of medicinal products subject to special medical prescription, they shall take account of the following factors: - the medicinal product contains, in a non-exempt quantity, a substance classified as a narcotic or a psychotropic substance within the meaning of the international conventions in force, such as the United Nations Conventions of 1961 and 1971, or - the medicinal product is likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes, or - the medicinal product contains a substance which, by reason of its novelty or properties, could be considered as belonging to the group envisaged in the second indent as a precautionary measure. 3. Where Member States provide for the sub-category of medicinal products subject to restricted prescription, they shall take account of the following factors: - the medicinal product, because of its pharmaceutical characteristics or novelty or in the interests of public health, is reserved for treatments which can only be followed in a hospital environment, - the medicinal product is used in the treatment of conditions which must be diagnosed in a hospital environment or in institutions with adequate diagnostic facilities, although administration and follow-up may be carried out elsewhere, or - the medicinal product is intended for outpatients but its use may produce very serious adverse reactions requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment. 4. A competent authority may waive application of paragraphs 1, 2 and 3 having regard to: (a) the maximum single dose, the maximum daily dose, the strength, the pharmaceutical form, certain types of packaging; and/or (b) other circumstances of use which it has specified. 5. If a competent authority does not designate medicinal products into sub-categories referred to in Article 70(2), it shall nevertheless take into account the criteria referred to in paragraphs 2 and 3 of this Article in determining whether any medicinal product shall be classified as a prescription-only medicine. Article 72 Medicinal products not subject to prescription shall be those which do not meet the criteria listed in Article 71. Article 73 The competent authorities shall draw up a list of the medicinal products subject, on their territory, to medical prescription, specifying, if necessary, the category of classification. They shall update this list annually. Article 74 On the occasion of the five-yearly renewal of the marketing authorization or when new facts are brought to their notice, the competent authorities shall examine and, as appropriate, amend the classification of a medicinal product, by applying the criteria listed in Article 71. Article 75 Each year, Member States shall communicate to the Commission and to the other Member States, the changes that have been made to the list referred to in Article 73. TITLE VII WHOLESALE DISTRIBUTION OF MEDICINAL PRODUCTS Article 76 Without prejudice to Article 6, Member States shall take all appropriate action to ensure that only medicinal products in respect of which a marketing authorization has been granted in accordance with Community law are distributed on their territory. Article 77 1. Member States shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to the possession of an authorization to engage in activity as a wholesaler in medicinal products, stating the place for which it is valid. 2. Where persons authorized or entitled to supply medicinal products to the public may also, under national law, engage in wholesale business, such persons shall be subject to the authorization provided for in paragraph 1. 3. Possession of a manufacturing authorization shall include authorization to distribute by wholesale the medicinal products covered by that authorization. Possession of an authorization to engage in activity as a wholesaler in medicinal products shall not give dispensation from the obligation to possess a manufacturing authorization and to comply with the conditions set out in that respect, even where the manufacturing or import business is secondary. 4. At the request of the Commission or any Member State, Member States shall supply all appropriate information concerning the individual authorizations which they have granted under paragraph 1. 5. Checks on the persons authorized to engage in the activity of wholesaler in medicinal products and the inspection of their premises, shall be carried out under the responsibility of the Member State which granted the authorization. 6. The Member State which granted the authorization referred to in paragraph 1 shall suspend or revoke that authorization if the conditions of authorization cease to be met. It shall forthwith inform the other Member States and the Commission thereof. 7. Should a Member State consider that, in respect of a person holding an authorization granted by another Member State under the terms of paragraph 1, the conditions of authorization are not, or are no longer met, it shall forthwith inform the Commission and the other Member State involved. The latter shall take the measures necessary and shall inform the Commission and the first Member State of the decisions taken and the reasons for those decisions. Article 78 Member States shall ensure that the time taken for the procedure for examining the application for the distribution authorization does not exceed 90 days from the day on which the competent authority of the Member State concerned receives the application. The competent authority may, if need be, require the applicant to supply all necessary information concerning the conditions of authorization. Where the authority exercises this option, the period laid down in the first paragraph shall be suspended until the requisite additional data have been supplied. Article 79 In order to obtain the distribution authorization, applicants must fulfil the following minimum requirements: (a) they must have suitable and adequate premises, installations and equipment, so as to ensure proper conservation and distribution of the medicinal products; (b) they must have staff, and in particular, a qualified person designated as responsible, meeting the conditions provided for by the legislation of the Member State concerned; (c) they must undertake to fulfil the obligations incumbent on them under the terms of Article 80. Article 80 Holders of the distribution authorization must fulfil the following minimum requirements: (a) they must make the premises, installations and equipment referred to in Article 79(a) accessible at all times to the persons responsible for inspecting them; (b) they must obtain their supplies of medicinal products only from persons who are themselves in possession of the distribution authorization or who are exempt from obtaining such authorization under the terms of Article 77(3); (c) they must supply medicinal products only to persons who are themselves in possession of the distribution authorization or who are authorized or entitled to supply medicinal products to the public in the Member State concerned; (d) they must have an emergency plan which ensures effective implementation of any recall from the market ordered by the competent authorities or carried out in cooperation with the manufacturer or marketing authorization holder for the medicinal product concerned; (e) they must keep records either in the form of purchase/sales invoices, or on computer, or in any other form, giving for any transaction in medicinal products received or dispatched at least the following information: - date, - name of the medicinal product, - quantity received or supplied, - name and address of the supplier or consignee, as appropriate; (f) they must keep the records referred to under (e) available to the competent authorities, for inspection purposes, for a period of five years; (g) they must comply with the principles and guidelines of good distribution practice for medicinal products as laid down in Article 84. Article 81 With regard to the supply of medicinal products to pharmacists and persons authorized or entitled to supply medicinal products to the public, Member States shall not impose upon the holder of a distribution authorization which has been granted by another Member State, any obligation, in particular public service obligations, more stringent than those they impose on persons whom they have themselves authorized to engage in equivalent activities. The said obligations should, moreover, be justified, in keeping with the Treaty, on grounds of public health protection and be proportionate in relation to the objective of such protection. Article 82 For all supplies of medicinal products to a person authorized or entitled to supply medicinal products to the public in the Member State concerned, the authorized wholesaler must enclose a document that makes it possible to ascertain: - the date, - the name and pharmaceutical form of the medicinal product, - the quantity supplied, - the name and address of the supplier and consignor. Member States shall take all appropriate measures to ensure that persons authorized or entitled to supply medicinal products to the public are able to provide information that makes it possible to trace the distribution path of every medicinal product. Article 83 The provisions of this Title shall not prevent the application of more stringent requirements laid down by Member States in respect of the wholesale distribution of: - narcotic or psychotropic substances within their territory, - medicinal products derived from blood, - immunological medicinal products, - radiopharmaceuticals. Article 84 The Commission shall publish guidelines on good distribution practice. To this end, it shall consult the Committee for Proprietary Medicinal Products and the Pharmaceutical Committee established by Council Decision 75/320/EEC(22). Article 85 The provisions of this Title shall apply to homeopathic medicinal products, with the exception of those referred to in Article 14(1). TITLE VIII ADVERTISING Article 86 1. For the purposes of this Title, "advertising of medicinal products" shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products; it shall include in particular: - the advertising of medicinal products to the general public, - advertising of medicinal products to persons qualified to prescribe or supply them, - visits by medical sales representatives to persons qualified to prescribe medicinal products, - the supply of samples, - the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal, - sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products, - sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith. 2. The following are not covered by this Title: - the labelling and the accompanying package leaflets, which are subject to the provisions of Title V, - correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product, - factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims, - statements relating to human health or diseases, provided there is no reference, even indirect, to medicinal products. Article 87 1. Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorization has not been granted in accordance with Community law. 2. All parts of the advertising of a medicinal product must comply with the particulars listed in the summary of product characteristics. 3. The advertising of a medicinal product: - shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties, - shall not be misleading. Article 88 1. Member States shall prohibit the advertising to the general public of medicinal products which: - are available on medical prescription only, in accordance with Title VI, - contain psychotropic or narcotic substances, such as the United Nations Conventions of 1961 and 1971, - may not be advertised to the general public in accordance with the second subparagraph of paragraph 2. 2. Medicinal products may be advertised to the general public which, by virtue of their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary. Member States shall prohibit the mentioning in advertising to the general public of therapeutic indications such as: - tuberculosis, - sexually transmitted diseases, - other serious infectious diseases, - cancer and other tumoral diseases, - chronic insomnia, - diabetes and other metabolic illnesses. 3. Member States shall be able to ban, on their territory, advertising to the general public of medicinal products the cost of which may be reimbursed. 4. The prohibition referred to in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States. 5. The prohibition referred to in paragraph 1 shall apply without prejudice to Article 14 of Directive 89/552/EEC. 6. Member States shall prohibit the direct distribution of medicinal products to the public by the industry for promotional purposes; they may, however, authorize such distribution in special cases for other purposes. Article 89 1. Without prejudice to Article 88, all advertising to the general public of a medicinal product shall: (a) be set out in such a way that it is clear that the message is an advertisement and that the product is clearly identified as a medicinal product; (b) include the following minimum information: - the name of the medicinal product, as well as the common name if the medicinal product contains only one active substance, - the information necessary for correct use of the medicinal product, - an express, legible invitation to read carefully the instructions on the package leaflet or on the outer packaging, as the case may be. 2. Member States may decide that the advertising of a medicinal product to the general public may, notwithstanding paragraph 1, include only the name of the medicinal product if it is intended solely as a reminder. Article 90 The advertising of a medicinal product to the general public shall not contain any material which: (a) gives the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail; (b) suggests that the effects of taking the medicine are guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or medicinal product; (c) suggests that the health of the subject can be enhanced by taking the medicine; (d) suggests that the health of the subject could be affected by not taking the medicine; this prohibition shall not apply to the vaccination campaigns referred to in Article 88(4); (e) is directed exclusively or principally at children; (f) refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medicinal products; (g) suggests that the medicinal product is a foodstuff, cosmetic or other consumer product; (h) suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural; (i) could, by a description or detailed representation of a case history, lead to erroneous self-diagnosis; (j) refers, in improper, alarming or misleading terms, to claims of recovery; (k) uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts thereof; (l) mentions that the medicinal product has been granted a marketing authorization. Article 91 1. Any advertising of a medicinal product to persons qualified to prescribe or supply such products shall include: - essential information compatible with the summary of product characteristics; - the supply classification of the medicinal product. Member States may also require such advertising to include the selling price or indicative price of the various presentations and the conditions for reimbursement by social security bodies. 2. Member States may decide that the advertising of a medicinal product to persons qualified to prescribe or supply such products may, notwithstanding paragraph 1, include only the name of the medicinal product, if it is intended solely as a reminder. Article 92 1. Any documentation relating to a medicinal product which is transmitted as part of the promotion of that product to persons qualified to prescribe or supply it shall include, as a minimum, the particulars listed in Article 91(1) and shall state the date on which it was drawn up or last revised. 2. All the information contained in the documentation referred to in paragraph 1 shall be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned. 3. Quotations as well as tables and other illustrative matter taken from medical journals or other scientific works for use in the documentation referred to in paragraph 1 shall be faithfully reproduced and the precise sources indicated. Article 93 1. Medical sales representatives shall be given adequate training by the firm which employs them and shall have sufficient scientific knowledge to be able to provide information which is precise and as complete as possible about the medicinal products which they promote. 2. During each visit, medical sales representatives shall give the persons visited, or have available for them, summaries of the product characteristics of each medicinal product they present together, if the legislation of the Member State so permits, with details of the price and conditions for reimbursement referred to in Article 91(1). 3. Medical sales representatives shall transmit to the scientific service referred to in Article 98(1) any information about the use of the medicinal products they advertise, with particular reference to any adverse reactions reported to them by the persons they visit. Article 94 1. Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy. 2. Hospitality at sales promotion shall always be reasonable in level and secondary to the main purpose of the meeting and must not be extended to other than health professionals. 3. Persons qualified to prescribe or supply medicinal products shall not solicit or accept any inducement prohibited under paragraph 1 or contrary to paragraph 2. 4. Existing measures or trade practices in Member States relating to prices, margins and discounts shall not be affected by paragraphs 1, 2 and 3. Article 95 The provisions of Article 94(1) shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes; such hospitality shall always be reasonable in level and remain subordinate to the main scientific objective of the meeting; it must not be extended to persons other than health professionals. Article 96 1. Free samples shall be provided on an exceptional basis only to persons qualified to prescribe them and on the following conditions: (a) the number of samples for each medicinal product each year on prescription shall be limited; (b) any supply of samples shall be in response to a written request, signed and dated, from the prescribing agent; (c) those supplying samples shall maintain an adequate system of control and accountability; (d) each sample shall be identical with the smallest presentation on the market; (e) each sample shall be marked "free medical sample - not for sale" or shall show some other wording having the same meaning; (f) each sample shall be accompanied by a copy of the summary of product characteristics; (g) no samples of medicinal products containing psychotropic or narcotic substances within the meaning of international conventions, such as the United Nations Conventions of 1961 and 1971, may be supplied. 2. Member States may also place further restrictions on the distribution of samples of certain medicinal products. Article 97 1. Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods, which may be based on a system of prior vetting, shall in any event include legal provisions under which persons or organizations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Title, may take legal action against such advertisement, or bring such advertisement before an administrative authority competent either to decide on complaints or to initiate appropriate legal proceedings. 2. Under the legal provisions referred to in paragraph 1, Member States shall confer upon the courts or administrative authorities powers enabling them, in cases where they deem such measures to be necessary, taking into account all the interests involved, and in particular the public interest: - to order the cessation of, or to institute appropriate legal proceedings for an order for the cessation of, misleading advertising, or - if misleading advertising has not yet been published but publication is imminent, to order the prohibition of, or to institute appropriate legal proceedings for an order for the prohibition of, such publication, even without proof of actual loss or damage or of intention or negligence on the part of the advertiser. 3. Member States shall make provision for the measures referred to in the second subparagraph to be taken under an accelerated procedure, either with interim effect or with definitive effect. It shall be for each Member State to decide which of the two options set out in the first subparagraph to select. 4. Member States may confer upon the courts or administrative authorities powers enabling them, with a view to eliminating the continuing effects of misleading advertising the cessation of which has been ordered by a final decision: - to require publication of that decision in full or in part and in such form as they deem adequate, - to require in addition the publication of a corrective statement. 5. Paragraphs 1 to 4 shall not exclude the voluntary control of advertising of medicinal products by self-regulatory bodies and recourse to such bodies, if proceedings before such bodies are possible in addition to the judicial or administrative proceedings referred to in paragraph 1. Article 98 1. The marketing authorization holder shall establish, within his undertaking, a scientific service in charge of information about the medicinal products which he places on the market. 2. The marketing authorization holder shall: - keep available for, or communicate to, the authorities or bodies responsible for monitoring advertising of medicinal products, a sample of all advertisements emanating from his undertaking together with a statement indicating the persons to whom it is addressed, the method of dissemination and the date of first dissemination, - ensure that advertising of medicinal products by his undertaking conforms to the requirements of this Title, - verify that medical sales representatives employed by his undertaking have been adequately trained and fulfill the obligations imposed upon them by Article 93(2) and (3), - supply the authorities or bodies responsible for monitoring advertising of medicinal products with the information and assistance they require to carry out their responsibilities, - ensure that the decisions taken by the authorities or bodies responsible for monitoring advertising of medicinal products are immediately and fully complied with. Article 99 Member States shall take the appropriate measures to ensure that the provisions of this Title are applied and shall determine in particular what penalties shall be imposed should the provisions adopted in the execution of Title be infringed. Article 100 Advertising of the homeopathic medicinal products referred to in Article 13(2) and Article 14(1) shall be subject to the provisions of this Title with the exception of Article 87(1). However, only the information specified in Article 69(1) may be used in the advertising of such medicinal products. Moreover, each Member State may prohibit in its territory any advertising of the homeopathic medicinal products referred to in Article 13(2) and Article 14(1). TITLE IX PHARMACOVIGILANCE Article 101 The Member States shall take all appropriate measures to encourage doctors and other health care professionals to report suspected adverse reactions to the competent authorities. The Member States may impose specific requirements on doctors and other health care professionals, in respect of the reporting of suspected serious or unexpected adverse reactions, in particular where such reporting is a condition of the marketing authorization. Article 102 In order to ensure the adoption of appropriate regulatory decisions concerning the medicinal products authorized within the Community, having regard to information obtained about adverse reactions to medicinal products under normal conditions of use, the Member States shall establish a pharmacovigilance system. This system shall be used to collect information useful in the surveillance of medicinal products, with particular reference to adverse reactions in human beings, and to evaluate such information scientifically. Such information shall be collated with data on consumption of medicinal products. This system shall also take into account any available information on misuse and abuse of medicinal products which may have an impact on the evaluation of their benefits and risks. Article 103 The marketing authorization holder shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance. That qualified person shall be responsible for the following: (a) the establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the company, and to medical representatives, is collected and collated in order to be accessible at least at one point within the Community; (b) the preparation for the competent authorities of the reports referred to in Article 104, in such form as may be laid down by those authorities, in accordance with the guidance referred to in Article 106(1); (c) ensuring that any request from the competent authorities for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions of the medicinal product concerned; (d) the provision to the competent authorities, of any other information relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on post-authorization safety studies. Article 104 1. The marketing authorization holder shall be required to maintain detailed records of all suspected adverse reactions occurring either in the Community or in a third country. 2. The marketing authorization holder shall be required to record and to report all suspected serious adverse reactions which are brought to his attention by a health care professional immediately to the competent authority of the Member State in whose territory the incident occurred, and in no case later than 15 calendar days following the receipt of the information. 3. The marketing authorization holder shall be required to record and report all other suspected serious adverse reactions which meet the reporting criteria in accordance with the guidance referred to in Article 106(1) of which he can reasonably be expected to have knowledge immediately to the competent authority of the Member State in whose territory the incident occurred, and in no case later than 15 calendar days following the receipt of the information. 4. The marketing authorization holder shall ensure that all suspected serious and unexpected adverse reactions occurring in the territory of a third country and brought to his attention by a health care professional are reported immediately in accordance with the guidance referred to in Article 106(1), so that they are available to the Agency and to the competent authorities of the Member States where the medicinal product is authorised, and in no case later than 15 calendar days following the receipt of the information. 5. In the case of medicinal products which have been considered within the scope of Directive 87/22/EEC, or which have benefited from the procedures of mutual recognition foreseen in Articles 17 and 18 of this Directive, Article 28(4) of this Directive, and medicinal products for which there has been a referral to the procedures foreseen by Articles 32, 33 and 34 of this Directive, the marketing authorisation holder shall additionally ensure that all suspected serious adverse reactions occurring in the Community are reported in the format and at intervals to be agreed with the reference Member State, or a competent authority acting as the reference Member State, in such a way so as to be accessible to the reference Member State. 6. Unless other requirements have been laid down as a condition of the granting of authorisation, or subsequently as indicated in the guidance referred to in Article 106(1), records of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety update report, either immediately upon request or periodically as follows: six monthly for the first two years after authorisation, annually for the subsequent two years, and at the time of the first renewal. Thereafter the periodic safety update reports shall be submitted at five-yearly intervals together with the application for renewal of the authorisation. The periodic safety update reports shall include a scientific evaluation of the benefit and risks afforded by the medicinal products. 7. Following the granting of a marketing authorisation, the marketing authorisation holder may request the amendment of the periods referred to in this article according to the procedure laid down by Commission Regulation (EC) No 541/95(23). Article 105 1. The Agency, in collaboration with the Member States and the Commission shall set up a data-processing network to facilitate the exchange of pharmacovigilance information regarding medicinal products marketed in the Community intended to allow all competent authorities to share the information at the same time. 2. Making use of the network foreseen in paragraph 1, Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are immediately made available to the Agency and the other Member States, and in any case within 15 calendar days of their notification, at the latest. 3. The Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are immediately made available to the marketing authorisation holder, and in any case within 15 calendar days of their notification, at the latest. Article 106 1. In order to facilitate the exchange of information about pharmacovigilance within the Community, the Commission, in consultation with the Agency, Member States and interested parties, shall draw up guidance on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of pharmacovigilance information in accordance with internationally agreed formats and shall publish a reference to an internationally agreed medical terminology. This guidance shall be published in Volume 9 of The rules governing medicinal products in the European Community and shall take account of international harmonisation work carried out in the field of pharmacovigilance. 2. For the interpretation of the definitions referred to in Article 1 points 11 to 16 and the principles outlined in this Title, the marketing authorisation holder and the competent authorities shall refer to the guidance referred to in paragraph 1. Article 107 1. Where, as a result of the evaluation of pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, withdrawn or varied in accordance with the guidance referred to in Article 106(1), it shall forthwith inform the Agency, the other Member States and the marketing authorisation holder. 2. In case of urgency, the Member State concerned may suspend the marketing authorisation of a medicinal product, provided the Agency, the Commission and the other Member States are informed at the latest on the following working day. Article 108 Any amendments which may be necessary to update provisions of Articles 101 to 107 to take account of scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 121(2). TITLE X SPECIAL PROVISIONS ON MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD AND PLASMA Article 109 1. In respect of the use of human blood or human plasma as a starting material for the manufacture of medicinal products, Member States shall take the necessary measures to prevent the transmission of infectious diseases. In so far as this is covered by the amendments referred to in Article 121(1), as well as the application of the monographs of the European Pharmacopoeia regarding blood and plasma, these measures shall comprise those recommended by the Council of Europe and the World Health Organization, particularly with reference to the selection and testing of blood and plasma donors. 2. Member States shall take the necessary measures to ensure that human blood and human plasma donors and donation centres are always clearly identifiable. 3. All the safety guarantees referred to in paragraphs 1 and 2 must also be given by importers of human blood or human plasma from third countries. Article 110 Member States shall take the necessary measures to promote Community self-sufficiency in human blood or human plasma. For this purpose, they shall encourage the voluntary unpaid donation of blood and plasma and shall take the necessary measures to develop the production and use of products derived from human blood or human plasma coming from voluntary unpaid donations. They shall notify the Commission of such measures. TITLE XI SUPERVISION AND SANCTIONS Article 111 1. The competent authority of the Member State concerned shall ensure, by means of repeated inspections, that the legal requirements governing medicinal products are complied with. Such inspections shall be carried out by officials representing the competent authority who shall be empowered to: (a) inspect manufacturing or commercial establishments and any laboratories entrusted by the holder of the manufacturing authorization with the task of carrying out checks pursuant to Article 20; (b) take samples; (c) examine any documents relating to the object of the inspection, subject to the provisions in force in the Member States on 21 May 1975 and which place restrictions on these powers with regard to the descriptions of the method of preparation. 2. Member States shall take all appropriate steps to ensure that the manufacturing processes used in the manufacture of immunological products are properly validated and attain batch-to-batch consistency. 3. After every inspection as referred to in paragraph 1, the officials representing the competent authority shall report on whether the manufacturer complies with the principles and guidelines of good manufacturing practice laid down in Article 47. The content of such reports shall be communicated to the manufacturer who has to undergo the inspection. Article 112 Member States shall take all appropriate measures to ensure that the holder of the marketing authorization for a medicinal product and, where appropriate, the holder of the manufacturing authorization, furnish proof of the controls carried out on the medicinal product and/or the ingredients and of the controls carried out at an intermediate stage of the manufacturing process, in accordance with the methods laid down in Article 8(3)(h). Article 113 For the purpose of implementing Article 112, Member States may require manufacturers of immunological products to submit to a competent authority copies of all the control reports signed by the qualified person in accordance with Article 51. Article 114 1. Where it considers it necessary in the interests of public health, a Member State may require the holder of an authorization for marketing: - live vaccines, - immunological medicinal products used in the primary immunization of infants or of other groups at risk, - immunological medicinal products used in public health immunization programmes, - new immunological medicinal products or immunological medicinal products manufactured using new or altered kinds of technology or new for a particular manufacturer, during a transitional period normally specified in the marketing authorization, to submit samples from each batch of the bulk and/or the medicinal product for examination by a State laboratory or a laboratory designated for that purpose before release on to the market unless, in the case of a batch manufactured in another Member State, the competent authority of that Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications. Member States shall ensure that any such examination is completed within 60 days of the receipt of the samples. 2. Where, in the interests of public health, the laws of a Member State so provide, the competent authorities may require the marketing authorization holder for medicinal products derived from human blood or human plasma to submit samples from each batch of the bulk and/or the medicinal product for testing by a State laboratory or a laboratory designated for that purpose before being released into free circulation, unless the competent authorities of another Member State have previously examined the batch in question and declared it to be in conformity with the approved specifications. Member States shall ensure that any such examination is completed within 60 days of the receipt of the samples. Article 115 Member States shall take all necessary measures to ensure that the manufacturing and purifying processes used in the preparation of medicinal products derived from human blood or human plasma are properly validated, attain batch-to-batch consistency and guarantee, insofar as the state of technology permits, the absence of specific viral contamination. To this end manufacturers shall notify the competent authorities of the method used to reduce or eliminate pathogenic viruses liable to be transmitted by medicinal products derived from human blood or human plasma. The competent authority may submit samples of the bulk and/or the medicinal product for testing by a State laboratory or a laboratory designated for that purpose, either during the examination of the application pursuant to Article 19, or after a marketing authorization has been granted. Article 116 The competent authorities of the Member States shall suspend or revoke an authorization to place a medicinal product on the market where that product proves to be harmful in the normal conditions of use, or where its therapeutic efficacy is lacking, or where its qualitative and quantitative composition is not as declared. Therapeutic efficacy is lacking when it is established that therapeutic results cannot be obtained with the medicinal product. An authorization shall also be suspended or revoked where the particulars supporting the application as provided for in Articles 8, 10(1) and 11 are incorrect or have not been amended in accordance with Article 23, or where the controls referred to in Article 112 have not been carried out. Article 117 1. Notwithstanding the measures provided for in Article 116, Member States shall take all appropriate measures to ensure that the supply of the medicinal product shall be prohibited and the medicinal product withdrawn from the market if: (a) the medicinal product proves to be harmful under normal conditions of use, or (b) it is lacking in therapeutic efficacy, or (c) its qualitative and quantitative composition is not as declared, or (d) the controls on the medicinal product and/or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out or if some other requirement or obligation relating to the grant of the manufacturing authorization has not been fulfilled. 2. The competent authority may limit the prohibition to supply the product, or its withdrawal from the market, to those batches which are the subject of dispute. Article 118 1. The competent authority shall suspend or revoke the marketing authorization for a category of preparations or all preparations where any one of the requirements laid down in Article 41 is no longer met. 2. In addition to the measures specified in Article 117, the competent authority may suspend manufacture or imports of medicinal products coming from third countries, or suspend or revoke the manufacturing authorization for a category of preparations or all preparations where Articles 42, 46, 51 and 112 are not complied with. Article 119 The provisions of this Title shall apply to homeopathic medicinal products, subject to the provisions of Article 14(3). TITLE XII STANDING COMMITTEE Article 120 Any changes which are necessary in order to adapt Annex I to take account of scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 121(2). Article 121 1. The Commission shall be assisted by a Standing Committee on Medicinal Products for Human Use on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Medicinal Products Sector, (hereinafter referred to as the "Standing 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 provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Standing Committee shall adopt its rules of procedure. TITLE XIII GENERAL PROVISIONS Article 122 Member States shall take all appropriate measures to ensure that the competent authorities concerned communicate to each other such information as is appropriate to guarantee that the requirements for the manufacturing authorizations or marketing authorizations are fulfilled. Upon reasoned request, Member States shall forthwith communicate the reports referred to in Article 111(3) to the competent authorities of another Member State. If, after considering the reports, the Member State receiving the reports considers that it cannot accept the conclusions reached by the competent authorities of the Member State in which the report was established, it shall inform the competent authorities concerned of its reasons and may request further information. The Member States concerned shall use their best endeavours to reach agreement. If necessary, in the case of serious differences of opinion, the Commission shall be informed by one of the Member States concerned. Article 123 1. Each Member State shall take all the appropriate measures to ensure that decisions authorizing marketing, refusing or revoking a marketing authorization, cancelling a decision refusing or revoking a marketing authorization, prohibiting supply, or withdrawing a product from the market, together with the reasons on which such decisions are based, are brought to the attention of the Agency forthwith. 2. The marketing authorization holder shall be obliged to notify the Member States concerned forthwith of any action taken by him to suspend the marketing of a medicinal product or to withdraw a medicinal product from the market, together with the reasons for such action if the latter concerns the efficacy of the medicinal product or the protection of public health. Member States shall ensure that this information is brought to the attention of the Agency. 3. Member States shall ensure that appropriate information about action taken pursuant to paragraphs 1 and 2 which may affect the protection of public health in third countries is forthwith brought to the attention of the World Health Organization, with a copy to the Agency. 4. The Commission shall publish annually a list of the medicinal products which are prohibited in the Community. Article 124 Member States shall communicate to each other all the information necessary to guarantee the quality and safety of homeopathic medicinal products manufactured and marketed within the Community, and in particular the information referred to in Articles 122 and 123. Article 125 Every decision referred to in this Directive which is taken by the competent authority of a Member State shall state in detail the reasons on which it is based. Such decision shall be notified to the party concerned, together with information as to the redress available to him under the laws in force and of the time-limit allowed for access to such redress. Marketing authorizations, and decisions to revoke such authorizations, shall be published by each Member State in the appropriate official publication. Article 126 An authorization to market a medicinal product shall not be refused, suspended or revoked except on the grounds set out in this Directive. No decision concerning suspension of manufacture or of importation of medicinal products coming from third countries, prohibition of supply or withdrawal from the market of a medicinal product may be taken except on the grounds set out in Articles 117 and 118. Article 127 1. At the request of the manufacturer, the exporter or the authorities of an importing third country, Member States shall certify that a manufacturer of medicinal products is in possession of the manufacturing authorization. When issuing such certificates Member States shall comply with the following conditions: (a) they shall have regard to the prevailing administrative arrangements of the World Health Organization; (b) for medicinal products intended for export which are already authorized on their territory, they shall supply the summary of the product characteristics as approved in accordance with Article 21. 2. When the manufacturer is not in possession of a marketing authorization he shall provide the authorities responsible for establishing the certificate referred to in paragraph 1, with a declaration explaining why no marketing authorization is available. TITLE XIV FINAL PROVISIONS Article 128 Directives 65/65/EEC, 75/318/EEC, 75/319/EEC, 89/342/EEC, 89/343/EEC, 89/381/EEC, 92/25/EEC, 92/26/EEC, 92/27/EEC, 92/28/EEC and 92/73/EEC, amended by the Directives referred to in Annex II, Part A, are repealed, without prejudice to the obligations of the Member States concerning the time-limits for implementation set out in Annex II, Part B. 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 III. Article 129 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities. Article 130 This Directive is addressed to the Member States.

32001L0093

2001

Commission Directive 2001/93/EC of 9 November 2001 amending Directive 91/630/EEC laying down minimum standards for the protection of pigs Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/630/EEC of 19 November 1991 laying down minimum standards for the protection of pigs(1) as amended, and in particular Article 5 thereof, Whereas: (1) Pursuant to Article 6 of Directive 91/630/EEC the Scientific Veterinary Committee adopted on 30 September 1997 an opinion regarding the welfare of intensively kept pigs. (2) Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes(2), drawn up on the basis of the European Convention for the protection of animals kept for farming purposes, establishes Community provisions applying to all farmed animals in relation to construction requirements for animal housing, insulation, heating and ventilation conditions, equipment inspection and inspection of livestock. It is therefore necessary to deal with these matters in the Annex to Directive 91/630/EEC when more detailed requirements have to be established. (3) When pigs are kept in groups, appropriate management measures for their protection should be taken to improve their welfare. (4) Tail docking, tooth clipping and tooth grinding are likely to cause immediate pain and some prolonged pain to pigs. Castration is likely to cause prolonged pain which is worse if there is tearing of the tissues. Those practices are therefore detrimental to the welfare of pigs, especially when carried out by incompetent and inexperienced persons. As consequence, rules should be laid down to ensure better practices. (5) The abovementioned report of the Scientific Veterinary Committee recommended that, in the interests of their welfare, piglets should not be weaned from the sow aged less than 28 days, unless the health of either the sow or her piglets would otherwise be adversely affected or advantages for the health of the piglets justify an earlier weaning. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Veterinary Committee, Article 1 The Annex to Directive 91/630/EEC 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 1 January 2003 at the latest. They shall forthwith communicate to the Commission the text of those provisions. 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.

32001L0102

2001

Council Directive 2001/102/EC of 27 November 2001 amending Directive 1999/29/EC on the undesirable substances and products in animal nutrition (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 1999/29/EC of 22 April 1999 on the undesirable substances and products in animal nutrition(1), and in particular Article 10 point (a) thereof, Having regard to the proposal from the Commission, Whereas: (1) Directive 1999/29/EC provides that feed materials may only be put into circulation in the Community if they are sound, genuine and of merchantable quality. (2) The term "dioxins" covers a group of 75 polychlorinated dibenzo-p-dioxin ("PCDD") and 135 polychlorinated dibenzofuran ("PCDF") congeners, of which 17 are of toxicological concern. The most toxic congener is 2,3,7,8-tetrachlordibenzo-p-dioxin (TCDD) classified by the International Agency for Research on Cancer and other reputable international organisations as a known human carcinogen. The Scientific Committee for Food ("SCF"), in line with the World Health Organisation ("WHO"), concluded that the carcinogenic effect of dioxins does not occur at levels below a certain threshold. Other adverse effects, such as endometriosis, neurobehavioural and immunosuppressive effects occur at much lower levels and are therefore considered relevant for the determination of a tolerable intake. (3) Polychlorinated biphenyls, ("PCBs"), are a group of 209 different congeners which can be divided into two groups according to their toxicological properties: 12 congeners exhibit toxicological properties similar to dioxins and are therefore often termed "dioxin-like PCBs". The other PCBs do not exhibit dioxin-like toxicity but have a different toxicological profile. (4) Each congener of dioxins or dioxin-like PCBs presents a different level of toxicity. In order to be able to sum up the toxicity of these different congeners, the concept of toxic equivalency factors ("TEFs") has been introduced to facilitate risk assessment and regulatory control. This means that the analytical results relating to all 17 individual dioxin congeners and to the 12 dioxin-like PCB congeners are expressed in terms of a single quantifiable unit: "TCDD toxic equivalent concentration" ("TEQ"). (5) Dioxins and PCBs are extremely resistant to chemical and biological degradation and therefore persist in the environment and accumulate in the feed and food chain. (6) The distribution of dioxins, PCBs and dioxin-like PCBs throughout the environment causes background contamination affecting all terrestrial plants directly grazed or used as feed materials for animal feed as well as the aquatic feed chain. The same applies to the soil that might contaminate feed materials or be directly ingested by animals. In addition to background contamination, direct accidental pollution of feed materials may occur due to localised discharge of dioxins from industrial activities, contamination of feed materials during their production, processing and transportation, and illegal practices or management failures during feed production. (7) More than 90 % of human dioxin exposure derives from foodstuffs. Foodstuffs of animal origin normally contribute to approximately 80 % of overall exposure. The dioxin burden in animals derives mainly from feedingstuffs. Therefore feedingstuffs, and in some cases soil, are of concern as potential sources of dioxins. (8) The SCF adopted an opinion on the Risk Assessment of Dioxins and Dioxin-like PCBs in Food on 30 May 2001. This is an update based on new scientific information available since the adoption of the SCF opinion on this matter on 22 November 2000. The SCF fixed a tolerable weekly intake ("TWI") for dioxins and dioxin-like PCBs of 14 pg WHO-TEQ/kg body weight. Exposure estimates indicate that a considerable proportion of the Community population has a dietary intake in excess of the tolerable intake. (9) The reduction of human exposure to dioxins through food consumption is therefore important and necessary to ensure consumer protection. As food contamination is directly related to feed contamination, an integrated approach must be adopted to reduce dioxin incidence throughout the food chain, i.e. from feed materials through food-producing animals to humans. The introduction of measures relating to feed materials and feedingstuffs is therefore a crucial step towards reducing dioxin intake by humans. (10) The Scientific Committee for Animal Nutrition ("SCAN") has been asked to advise on the sources of contamination of feedingstuffs with dioxins and PCBs, including dioxin-like PCBs, the exposure of food-producing animals to dioxins and PCBs, the carry-over of these compounds to food products of animal origin, and any impact on animal health of dioxins and PCBs present in feedingstuffs. The SCAN adopted an opinion on 6 November 2000. It identified fish meal and fish oil as the most heavily contaminated feed materials, with products of European origin being more heavily contaminated. Animal fat was identified as the next most seriously contaminated material. All other feed materials of animal and plant origin had relatively low levels of dioxin contamination. Roughages presented a wide range of dioxin contamination depending on location, degree of contamination with soil and exposure to sources of aerial pollution. (11) Measures should be implemented with the aim of reducing the presence and release of dioxin contamination of the environment in order to reduce the impact of environmental pollution on the contamination of feed materials. The SCAN recommended, inter alia, that emphasis should be placed on reducing the impact of the most contaminated feed materials on overall diet contamination. (12) Maximum levels for dioxins and dioxin like PCBs should be an appropriate tool to prevent unacceptably high exposure of animals and to prevent the distribution of feedingstuffs with an unacceptably high level of contamination, e.g. in cases of accidental pollution and exposure. Furthermore, the setting of maximum levels is indispensable for the implementation of a regulatory control system and to ensure uniform application. (13) Measures based solely on establishing maximum levels for dioxins and dioxin-like PCBs in feedingstuffs would not be sufficiently effective in reducing human exposure to dioxins unless the levels were set so low that a large part of the feed supply would have to be declared unfit for animal consumption. It is generally recognised that, in order to actively reduce the presence of dioxins in feedingstuffs, maximum levels should be accompanied by measures stimulating an active approach, including action levels and target levels for feedingstuffs in combination with measures to limit emissions. Target levels indicate the levels to be achieved in order to ultimately bring human exposure for the majority of the population down to the TWI set by the SCF. Action levels are a tool for competent authorities and operators to identify those cases where it is appropriate to identify a source of contamination and to take measures for its reduction or elimination, not only in the event of non-compliance with this Directive but also where significant levels of dioxins above normal background levels are found. This will result in a gradual reduction of dioxin levels in feedingstuffs, and the target levels will ultimately be achieved. A recommendation from the Commission on this issue is therefore being addressed to the Member States. (14) Although, from a toxicological point of view, any level should apply to dioxins, furans and dioxin-like PCBs, for the time being the maximum levels are set only for dioxins and furans and not for dioxin-like PCBs, given the very limited data available on the prevalence of the latter. However, monitoring will continue, in particular on the presence of dioxin-like PCBs with a view to including these substances in the maximum levels. (15) The unacceptability of the dioxin content of feedingstuffs should be assessed in the light of the current background levels of contamination, which differ from feed material to feed material. The maximum level should be fixed, taking account of background contamination, at a strict but feasible level. (16) In order to ensure that all operators in the food and feed chain continue to make all possible efforts and do all that is necessary to limit the presence of dioxins in feed and food, the maximum levels applicable should be reviewed within a defined period with a view to setting lower maximum levels. An overall reduction of at least 25 % in human exposure to dioxins should be achieved by 2006. (17) Compound feedingstuffs and feed materials of plant origin do not normally contain high levels of dioxins. Since feed materials of plant origin are by far the largest component in the diet of many species of animals, it is appropriate to set a maximum level also for these feed materials. The more sensitive the method of analysis, the more expensive and time-consuming the analysis to check for dioxin. As it is important that as many samples as possible be analysed, the maximum levels proposed are somewhat higher than normal background levels given that they constitute upper-bound levels. (18) It is of utmost importance to reduce that overall levels of dioxin contamination in feedingstuffs be reduced. It is therefore absolutely necessary to prohibit the mixing of feed materials and feedingstuffs complying with the maximum levels with feed materials/feedingstuffs exceeding these maximum levels. (19) Directive 1999/29/EC should therefore be amended accordingly. (20) The Standing Committee for Feedingstuffs did not deliver a favourable opinion. The Commission has been therefore unable to adopt the provisions it envisaged according to the procedure laid down in Article 13 of Directive 1999/29/EC, Article 1 Annexes I and II to Directive 1999/29/EC are hereby amended in accordance with the Annex to this Directive. Article 2 1. Member States shall adopt and publish, before 1 July 2002 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 1 July 2002. When the 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 texts of the provisions of national law, which they adopt in the field covered by this Directive. Article 3 1. The provisions referred to in Article 1 shall be reviewed for the first time by 31 December 2004 at the latest in the light of new data on the presence of dioxins and dioxin-like PCBs, in particular with a view to the inclusion of dioxin-like PCBs in the levels to be set. 2. The provisions referred to in Article 1 shall be further reviewed by 31 December 2006 at the latest with the aim of significantly reducing the maximum levels. 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.

32001L0095

2001

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (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 Economic and Social Committee(2), Acting in accordance with the procedure referred to in Article 251 of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 2 August 2001, Whereas: (1) Under Article 16 of Council Directive 92/59/EEC of 29 June 1992 on general product safety(4), the Council was to decide, four years after the date set for the implementation of the said Directive, on the basis of a report of the Commission on the experience acquired, together with appropriate proposals, whether to adjust Directive 92/59/EEC. It is necessary to amend Directive 92/59/EEC in several respects, in order to complete, reinforce or clarify some of its provisions in the light of experience as well as new and relevant developments on consumer product safety, together with the changes made to the Treaty, especially in Articles 152 concerning public health and 153 concerning consumer protection, and in the light of the precautionary principle. Directive 92/59/EEC should therefore be recast in the interest of clarity. This recasting leaves the safety of services outside the scope of this Directive, since the Commission intends to identify the needs, possibilities and priorities for Community action on the safety of services and liability of service providers, with a view to presenting appropriate proposals. (2) It is important to adopt measures with the aim of improving the functioning of the internal market, comprising an area without internal frontiers in which the free movement of goods, persons, services and capital is assured. (3) In the absence of Community provisions, horizontal legislation of the Member States on product safety, imposing in particular a general obligation on economic operators to market only safe products, might differ in the level of protection afforded to consumers. Such disparities, and the absence of horizontal legislation in some Member States, would be liable to create barriers to trade and distortion of competition within the internal market. (4) In order to ensure a high level of consumer protection, the Community must contribute to protecting the health and safety of consumers. Horizontal Community legislation introducing a general product safety requirement, and containing provisions on the general obligations of producers and distributors, on the enforcement of Community product safety requirements and on rapid exchange of information and action at Community level in certain cases, should contribute to that aim. (5) It is very difficult to adopt Community legislation for every product which exists or which may be developed; there is a need for a broad-based, legislative framework of a horizontal nature to deal with such products, and also to cover lacunae, in particular pending revision of the existing specific legislation, and to complement provisions in existing or forthcoming specific legislation, in particular with a view to ensuring a high level of protection of safety and health of consumers, as required by Article 95 of the Treaty. (6) It is therefore necessary to establish at Community level a general safety requirement for any product placed on the market, or otherwise supplied or made available to consumers, intended for consumers, or likely to be used by consumers under reasonably foreseeable conditions even if not intended for them. In all these cases the products under consideration can pose risks for the health and safety of consumers which must be prevented. Certain second-hand goods should nevertheless be excluded by their very nature. (7) This Directive should apply to products irrespective of the selling techniques, including distance and electronic selling. (8) The safety of products should be assessed taking into account all the relevant aspects, in particular the categories of consumers which can be particularly vulnerable to the risks posed by the products under consideration, in particular children and the elderly. (9) This Directive does not cover services, but in order to secure the attainment of the protection objectives in question, its provisions should also apply to products that are supplied or made available to consumers in the context of service provision for use by them. The safety of the equipment used by service providers themselves to supply a service to consumers does not come within the scope of this Directive since it has to be dealt with in conjunction with the safety of the service provided. In particular, equipment on which consumers ride or travel which is operated by a service provider is excluded from the scope of this Directive. (10) Products which are designed exclusively for professional use but have subsequently migrated to the consumer market should be subject to the requirements of this Directive because they can pose risks to consumer health and safety when used under reasonably foreseeable conditions. (11) In the absence of more specific provisions, within the framework of Community legislation covering safety of the products concerned, all the provisions of this Directive should apply in order to ensure consumer health and safety. (12) If specific Community legislation sets out safety requirements covering only certain risks or categories of risks, with regard to the products concerned the obligations of economic operators in respect of these risks are those determined by the provisions of the specific legislation, while the general safety requirement of this Directive should apply to the other risks. (13) The provisions of this Directive relating to the other obligations of producers and distributors, the obligations and powers of the Member States, the exchanges of information and rapid intervention situations and dissemination of information and confidentiality apply in the case of products covered by specific rules of Community law, if those rules do not already contain such obligations. (14) In order to facilitate the effective and consistent application of the general safety requirement of this Directive, it is important to establish European voluntary standards covering certain products and risks in such a way that a product which conforms to a national standard transposing a European standard is to be presumed to be in compliance with the said requirement. (15) With regard to the aims of this Directive, European standards should be established by European standardisation bodies, under mandates set by the Commission assisted by appropriate Committees. In order to ensure that products in compliance with the standards fulfil the general safety requirement, the Commission assisted by a committee composed of representatives of the Member States, should fix the requirements that the standards must meet. These requirements should be included in the mandates to the standardisation bodies. (16) In the absence of specific regulations and when the European standards established under mandates set by the Commission are not available or recourse is not made to such standards, the safety of products should be assessed taking into account in particular national standards transposing any other relevant European or international standards, Commission recommendations or national standards, international standards, codes of good practice, the state of the art and the safety which consumers may reasonably expect. In this context, the Commission's recommendations may facilitate the consistent and effective application of this Directive pending the introduction of European standards or as regards the risks and/or products for which such standards are deemed not to be possible or appropriate. (17) Appropriate independent certification recognised by the competent authorities may facilitate proof of compliance with the applicable product safety criteria. (18) It is appropriate to supplement the duty to observe the general safety requirement by other obligations on economic operators because action by such operators is necessary to prevent risks to consumers under certain circumstances. (19) The additional obligations on producers should include the duty to adopt measures commensurate with the characteristics of the products, enabling them to be informed of the risks that these products may present, to supply consumers with information enabling them to assess and prevent risks, to warn consumers of the risks posed by dangerous products already supplied to them, to withdraw those products from the market and, as a last resort, to recall them when necessary, which may involve, depending on the provisions applicable in the Member States, an appropriate form of compensation, for example exchange or reimbursement. (20) Distributors should help in ensuring compliance with the applicable safety requirements. The obligations placed on distributors apply in proportion to their respective responsibilities. In particular, it may prove impossible, in the context of charitable activities, to provide the competent authorities with information and documentation on possible risks and origin of the product in the case of isolated used objects provided by private individuals. (21) Both producers and distributors should cooperate with the competent authorities in action aimed at preventing risks and inform them when they conclude that certain products supplied are dangerous. The conditions regarding the provision of such information should be set in this Directive to facilitate its effective application, while avoiding an excessive burden for economic operators and the authorities. (22) In order to ensure the effective enforcement of the obligations incumbent on producers and distributors, the Member States should establish or designate authorities which are responsible for monitoring product safety and have powers to take appropriate measures, including the power to impose effective, proportionate and dissuasive penalties, and ensure appropriate coordination between the various designated authorities. (23) It is necessary in particular for the appropriate measures to include the power for Member States to order or organise, immediately and efficiently, the withdrawal of dangerous products already placed on the market and as a last resort to order, coordinate or organise the recall from consumers of dangerous products already supplied to them. Those powers should be applied when producers and distributors fail to prevent risks to consumers in accordance with their obligations. Where necessary, the appropriate powers and procedures should be available to the authorities to decide and apply any necessary measures rapidly. (24) The safety of consumers depends to a great extent on the active enforcement of Community product safety requirements. The Member States should, therefore, establish systematic approaches to ensure the effectiveness of market surveillance and other enforcement activities and should ensure their openness to the public and interested parties. (25) Collaboration between the enforcement authorities of the Member States is necessary in ensuring the attainment of the protection objectives of this Directive. It is, therefore, appropriate to promote the operation of a European network of the enforcement authorities of the Member States to facilitate, in a coordinated manner with other Community procedures, in particular the Community Rapid Information System (RAPEX), improved collaboration at operational level on market surveillance and other enforcement activities, in particular risk assessment, testing of products, exchange of expertise and scientific knowledge, execution of joint surveillance projects and tracing, withdrawing or recalling dangerous products. (26) It is necessary, for the purpose of ensuring a consistent, high level of consumer health and safety protection and preserving the unity of the internal market, that the Commission be informed of any measure restricting the placing on the market of a product or requiring its withdrawal or recall from the market. Such measures should be taken in compliance with the provisions of the Treaty, and in particular Articles 28, 29 and 30 thereof. (27) Effective supervision of product safety requires the setting-up at national and Community levels of a system of rapid exchange of information in situations of serious risk requiring rapid intervention in respect of the safety of a product. It is also appropriate in this Directive to set out detailed procedures for the operation of the system and to give the Commission, assisted by an advisory committee, power to adapt them. (28) This Directive provides for the establishment of non-binding guidelines aimed at indicating simple and clear criteria and practical rules which may change, in particular for the purpose of allowing efficient notification of measures restricting the placing on the market of products in the cases referred to in this Directive, whilst taking into account the range of situations dealt with by Member States and economic operators. The guidelines should in particular include criteria for the application of the definition of serious risks in order to facilitate consistent implementation of the relevant provisions in case of such risks. (29) It is primarily for Member States, in compliance with the Treaty and in particular with Articles 28, 29 and 30 thereof, to take appropriate measures with regard to dangerous products located within their territory. (30) However, if the Member States differ as regards the approach to dealing with the risk posed by certain products, such differences could entail unacceptable disparities in consumer protection and constitute a barrier to intra-Community trade. (31) It may be necessary to deal with serious product-safety problems requiring rapid intervention which affect or could affect, in the immediate future, all or a significant part of the Community and which, in view of the nature of the safety problem posed by the product, cannot be dealt with effectively in a manner commensurate with the degree of urgency, under the procedures laid down in the specific rules of Community law applicable to the products or category of products in question. (32) It is therefore necessary to provide for an adequate mechanism allowing, as a last resort, for the adoption of measures applicable throughout the Community, in the form of a decision addressed to the Member States, to cope with situations created by products presenting a serious risk. Such a decision should entail a ban on the export of the product in question, unless in the case in point exceptional circumstances allow a partial ban or even no ban to be decided upon, particularly when a system of prior consent is established. In addition, the banning of exports should be examined with a view to preventing risks to the health and safety of consumers. Since such a decision is not directly applicable to economic operators, Member States should take all necessary measures for its implementation. Measures adopted under such a procedure are interim measures, save when they apply to individually identified products or batches of products. In order to ensure the appropriate assessment of the need for, and the best preparation of such measures, they should be taken by the Commission, assisted by a committee, in the light of consultations with the Member States, and, if scientific questions are involved falling within the competence of a Community scientific committee, with the scientific committee competent for the risk concerned. (33) 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). (34) In order to facilitate effective and consistent application of this Directive, the various aspects of its application may need to be discussed within a committee. (35) Public access to the information available to the authorities on product safety should be ensured. However, professional secrecy, as referred to in Article 287 of the Treaty, must be protected in a way which is compatible with the need to ensure the effectiveness of market surveillance activities and of protection measures. (36) This Directive should not affect victims' rights within the meaning of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products(6). (37) It is necessary for Member States to provide for appropriate means of redress before the competent courts in respect of measures taken by the competent authorities which restrict the placing on the market of a product or require its withdrawal or recall. (38) In addition, the adoption of measures concerning imported products, like those concerning the banning of exports, with a view to preventing risks to the safety and health of consumers must comply with the Community's international obligations. (39) The Commission should periodically examine the manner in which this Directive is applied and the results obtained, in particular in relation to the functioning of market surveillance systems, the rapid exchange of information and measures adopted at Community level, together with other issues relevant for consumer product safety in the Community, and submit regular reports to the European Parliament and the Council on the subject. (40) This Directive should not affect the obligations of Member States concerning the deadline for transposition and application of Directive 92/59/EEC, CHAPTER I Objective - Scope - Definitions Article 1 1. The purpose of this Directive is to ensure that products placed on the market are safe. 2. This Directive shall apply to all the products defined in Article 2(a). Each of its provisions shall apply in so far as there are no specific provisions with the same objective in rules of Community law governing the safety of the products concerned. Where products are subject to specific safety requirements imposed by Community legislation, this Directive shall apply only to the aspects and risks or categories of risks not covered by those requirements. This means that: (a) Articles 2(b) and (c), 3 and 4 shall not apply to those products insofar as concerns the risks or categories of risks covered by the specific legislation; (b) Articles 5 to 18 shall apply except where there are specific provisions governing the aspects covered by the said Articles with the same objective. Article 2 For the purposes of this Directive: (a) "product" shall mean any product - including in the context of providing a service - which is intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them, and is supplied or made available, whether for consideration or not, in the course of a commercial activity, and whether new, used or reconditioned. This definition shall not apply to second-hand products supplied as antiques or as products to be repaired or reconditioned prior to being used, provided that the supplier clearly informs the person to whom he supplies the product to that effect; (b) "safe product" shall mean any product which, under normal or reasonably foreseeable conditions of use including duration and, where applicable, putting into service, installation and maintenance requirements, does not present any risk or only the minimum risks compatible with the product's use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons, taking into account the following points in particular: (i) the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance; (ii) the effect on other products, where it is reasonably foreseeable that it will be used with other products; (iii) the presentation of the product, the labelling, any warnings and instructions for its use and disposal and any other indication or information regarding the product; (iv) the categories of consumers at risk when using the product, in particular children and the elderly. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to be "dangerous"; (c) "dangerous product" shall mean any product which does not meet the definition of "safe product" in (b); (d) "serious risk" shall mean any serious risk, including those the effects of which are not immediate, requiring rapid intervention by the public authorities; (e) "producer" shall mean: (i) the manufacturer of the product, when he is established in the Community, and any other person presenting himself as the manufacturer by affixing to the product his name, trade mark or other distinctive mark, or the person who reconditions the product; (ii) the manufacturer's representative, when the manufacturer is not established in the Community or, if there is no representative established in the Community, the importer of the product; (iii) other professionals in the supply chain, insofar as their activities may affect the safety properties of a product; (f) "distributor" shall mean any professional in the supply chain whose activity does not affect the safety properties of a product; (g) "recall" shall mean any measure aimed at achieving the return of a dangerous product that has already been supplied or made available to consumers by the producer or distributor; (h) "withdrawal" shall mean any measure aimed at preventing the distribution, display and offer of a product dangerous to the consumer. CHAPTER II General safety requirement, conformity assessment criteria and European standards Article 3 1. Producers shall be obliged to place only safe products on the market. 2. A product shall be deemed safe, as far as the aspects covered by the relevant national legislation are concerned, when, in the absence of specific Community provisions governing the safety of the product in question, it conforms to the specific rules of national law of the Member State in whose territory the product is marketed, such rules being drawn up in conformity with the Treaty, and in particular Articles 28 and 30 thereof, and laying down the health and safety requirements which the product must satisfy in order to be marketed. A product shall be presumed safe as far as the risks and risk categories covered by relevant national standards are concerned when it conforms to voluntary national standards transposing European standards, the references of which have been published by the Commission in the Official Journal of the European Communities in accordance with Article 4. The Member States shall publish the references of such national standards. 3. In circumstances other than those referred to in paragraph 2, the conformity of a product to the general safety requirement shall be assessed by taking into account the following elements in particular, where they exist: (a) voluntary national standards transposing relevant European standards other than those referred to in paragraph 2; (b) the standards drawn up in the Member State in which the product is marketed; (c) Commission recommendations setting guidelines on product safety assessment; (d) product safety codes of good practice in force in the sector concerned; (e) the state of the art and technology; (f) reasonable consumer expectations concerning safety. 4. Conformity of a product with the criteria designed to ensure the general safety requirement, in particular the provisions mentioned in paragraphs 2 or 3, shall not bar the competent authorities of the Member States from taking appropriate measures to impose restrictions on its being placed on the market or to require its withdrawal from the market or recall where there is evidence that, despite such conformity, it is dangerous. Article 4 1. For the purposes of this Directive, the European standards referred to in the second subparagraph of Article 3(2) shall be drawn up as follows: (a) the requirements intended to ensure that products which conform to these standards satisfy the general safety requirement shall be determined in accordance with the procedure laid down in Article 15(2); (b) on the basis of those requirements, the Commission shall, in accordance with 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) call on the European standardisation bodies to draw up standards which satisfy these requirements; (c) on the basis of those mandates, the European standardisation bodies shall adopt the standards in accordance with the principles contained in the general guidelines for cooperation between the Commission and those bodies; (d) the Commission shall report every three years to the European Parliament and the Council, within the framework of the report referred to in Article 19(2), on its programmes for setting the requirements and the mandates for standardisation provided for in subparagraphs (a) and (b) above. This report will, in particular, include an analysis of the decisions taken regarding requirements and mandates for standardisation referred to in subparagraphs (a) and (b) and regarding the standards referred to in subparagraph (c). It will also include information on the products for which the Commission intends to set the requirements and the mandates in question, the product risks to be considered and the results of any preparatory work launched in this area. 2. The Commission shall publish in the Official Journal of the European Communities the references of the European standards adopted in this way and drawn up in accordance with the requirements referred to in paragraph 1. If a standard adopted by the European standardisation bodies before the entry into force of this Directive ensures compliance with the general safety requirement, the Commission shall decide to publish its references in the Official Journal of the European Communities. If a standard does not ensure compliance with the general safety requirement, the Commission shall withdraw reference to the standard from publication in whole or in part. In the cases referred to in the second and third subparagraphs, the Commission shall, on its own initiative or at the request of a Member State, decide in accordance with the procedure laid down in Article 15(2) whether the standard in question meets the general safety requirement. The Commission shall decide to publish or withdraw after consulting the Committee established by Article 5 of Directive 98/34/EC. The Commission shall notify the Member States of its decision. CHAPTER III Other obligations of producers and obligations of distributors Article 5 1. Within the limits of their respective activities, producers shall provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use, where such risks are not immediately obvious without adequate warnings, and to take precautions against those risks. The presence of warnings does not exempt any person from compliance with the other requirements laid down in this Directive. Within the limits of their respective activities, producers shall adopt measures commensurate with the characteristics of the products which they supply, enabling them to: (a) be informed of risks which these products might pose; (b) choose to take appropriate action including, if necessary to avoid these risks, withdrawal from the market, adequately and effectively warning consumers or recall from consumers. The measures referred to in the third subparagraph shall include, for example: (a) an indication, by means of the product or its packaging, of the identity and details of the producer and the product reference or, where applicable, the batch of products to which it belongs, except where not to give such indication is justified and (b) in all cases where appropriate, the carrying out of sample testing of marketed products, investigating and, if necessary, keeping a register of complaints and keeping distributors informed of such monitoring. Action such as that referred to in (b) of the third subparagraph shall be undertaken on a voluntary basis or at the request of the competent authorities in accordance with Article 8(1)(f). Recall shall take place as a last resort, where other measures would not suffice to prevent the risks involved, in instances where the producers consider it necessary or where they are obliged to do so further to a measure taken by the competent authority. It may be effected within the framework of codes of good practice on the matter in the Member State concerned, where such codes exist. 2. Distributors shall be required to act with due care to help to ensure compliance with the applicable safety requirements, in particular by not supplying products which they know or should have presumed, on the basis of the information in their possession and as professionals, do not comply with those requirements. Moreover, within the limits of their respective activities, they shall participate in monitoring the safety of products placed on the market, especially by passing on information on product risks, keeping and providing the documentation necessary for tracing the origin of products, and cooperating in the action taken by producers and competent authorities to avoid the risks. Within the limits of their respective activities they shall take measures enabling them to cooperate efficiently. 3. Where producers and distributors know or ought to know, on the basis of the information in their possession and as professionals, that a product that they have placed on the market poses risks to the consumer that are incompatible with the general safety requirement, they shall immediately inform the competent authorities of the Member States thereof under the conditions laid down in Annex I, giving details, in particular, of action taken to prevent risk to the consumer. The Commission shall, in accordance with the procedure referred to in Article 15(3), adapt the specific requirements relating to the obligation to provide information laid down in Annex I. 4. Producers and distributors shall, within the limits of their respective activities, cooperate with the competent authorities, at the request of the latter, on action taken to avoid the risks posed by products which they supply or have supplied. The procedures for such cooperation, including procedures for dialogue with the producers and distributors concerned on issues related to product safety, shall be established by the competent authorities. CHAPTER IV Specific obligations and powers of the Member States Article 6 1. Member States shall ensure that producers and distributors comply with their obligations under this Directive in such a way that products placed on the market are safe. 2. Member States shall establish or nominate authorities competent to monitor the compliance of products with the general safety requirements and arrange for such authorities to have and use the necessary powers to take the appropriate measures incumbent upon them under this Directive. 3. Member States shall define the tasks, powers, organisation and cooperation arrangements of the competent authorities. They shall keep the Commission informed, and the Commission shall pass on such information to the other Member States. Article 7 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 shall be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 15 January 2004 and shall also notify it, without delay, of any amendment affecting them. Article 8 1. For the purposes of this Directive, and in particular of Article 6 thereof, the competent authorities of the Member States shall be entitled to take, inter alia, the measures in (a) and in (b) to (f) below, where appropriate: (a) for any product: (i) to organise, even after its being placed on the market as being safe, appropriate checks on its safety properties, on an adequate scale, up to the final stage of use or consumption; (ii) to require all necessary information from the parties concerned; (iii) to take samples of products and subject them to safety checks; (b) for any product that could pose risks in certain conditions: (i) to require that it be marked with suitable, clearly worded and easily comprehensible warnings, in the official languages of the Member State in which the product is marketed, on the risks it may present; (ii) to make its marketing subject to prior conditions so as to make it safe; (c) for any product that could pose risks for certain persons: to order that they be given warning of the risk in good time and in an appropriate form, including the publication of special warnings; (d) for any product that could be dangerous: for the period needed for the various safety evaluations, checks and controls, temporarily to ban its supply, the offer to supply it or its display; (e) for any dangerous product: to ban its marketing and introduce the accompanying measures required to ensure the ban is complied with; (f) for any dangerous product already on the market: (i) to order or organise its actual and immediate withdrawal, and alert consumers to the risks it presents; (ii) to order or coordinate or, if appropriate, to organise together with producers and distributors its recall from consumers and its destruction in suitable conditions. 2. When the competent authorities of the Member States take measures such as those provided for in paragraph 1, in particular those referred to in (d) to (f), they shall act in accordance with the Treaty, and in particular Articles 28 and 30 thereof, in such a way as to implement the measures in a manner proportional to the seriousness of the risk, and taking due account of the precautionary principle. In this context, they shall encourage and promote voluntary action by producers and distributors, in accordance with the obligations incumbent on them under this Directive, and in particular Chapter III thereof, including where applicable by the development of codes of good practice. If necessary, they shall organise or order the measures provided for in paragraph 1(f) if the action undertaken by the producers and distributors in fulfilment of their obligations is unsatisfactory or insufficient. Recall shall take place as a last resort. It may be effected within the framework of codes of good practice on the matter in the Member State concerned, where such codes exist. 3. In particular, the competent authorities shall have the power to take the necessary action to apply with due dispatch appropriate measures such as those mentioned in paragraph 1, (b) to (f), in the case of products posing a serious risk. These circumstances shall be determined by the Member States, assessing each individual case on its merits, taking into account the guidelines referred to in point 8 of Annex II. 4. The measures to be taken by the competent authorities under this Article shall be addressed, as appropriate, to: (a) the producer; (b) within the limits of their respective activities, distributors and in particular the party responsible for the first stage of distribution on the national market; (c) any other person, where necessary, with a view to cooperation in action taken to avoid risks arising from a product. Article 9 1. In order to ensure effective market surveillance, aimed at guaranteeing a high level of consumer health and safety protection, which entails cooperation between their competent authorities, Member States shall ensure that approaches employing appropriate means and procedures are put in place, which may include in particular: (a) establishment, periodical updating and implementation of sectoral surveillance programmes by categories of products or risks and the monitoring of surveillance activities, findings and results; (b) follow-up and updating of scientific and technical knowledge concerning the safety of products; (c) periodical review and assessment of the functioning of the control activities and their effectiveness and, if necessary, revision of the surveillance approach and organisation put in place. 2. Member States shall ensure that consumers and other interested parties are given an opportunity to submit complaints to the competent authorities on product safety and on surveillance and control activities and that these complaints are followed up as appropriate. Member States shall actively inform consumers and other interested parties of the procedures established to that end. Article 10 1. The Commission shall promote and take part in the operation in a European network of the authorities of the Member States competent for product safety, in particular in the form of administrative cooperation. 2. This network operation shall develop in a coordinated manner with the other existing Community procedures, particularly RAPEX. Its objective shall be, in particular, to facilitate: (a) the exchange of information on risk assessment, dangerous products, test methods and results, recent scientific developments as well as other aspects relevant for control activities; (b) the establishment and execution of joint surveillance and testing projects; (c) the exchange of expertise and best practices and cooperation in training activities; (d) improved cooperation at Community level with regard to the tracing, withdrawal and recall of dangerous products. CHAPTER V Exchanges of information and rapid intervention situations Article 11 1. Where a Member State takes measures which restrict the placing on the market of products - or require their withdrawal or recall - such as those provided for in Article 8(1)(b) to (f), the Member State shall, to the extent that such notification is not required under Article 12 or any specific Community legislation, inform the Commission of the measures, specifying its reasons for adopting them. It shall also inform the Commission of any modification or lifting of such measures. If the notifying Member State considers that the effects of the risk do not or cannot go beyond its territory, it shall notify the measures concerned insofar as they involve information likely to be of interest to Member States from the product safety standpoint, and in particular if they are in response to a new risk which has not yet been reported in other notifications. In accordance with the procedure laid down in Article 15(3) of this Directive, the Commission shall, while ensuring the effectiveness and proper functioning of the system, adopt the guidelines referred to in point 8 of Annex II. These shall propose the content and standard form for the notifications provided for in this Article, and, in particular, shall provide precise criteria for determining the conditions for which notification is relevant for the purposes of the second subparagraph. 2. The Commission shall forward the notification to the other Member States, unless it concludes, after examination on the basis of the information contained in the notification, that the measure does not comply with Community law. In such a case, it shall immediately inform the Member State which initiated the action. Article 12 1. Where a Member State adopts or decides to adopt, recommend or agree with producers and distributors, whether on a compulsory or voluntary basis, measures or actions to prevent, restrict or impose specific conditions on the possible marketing or use, within its own territory, of products by reason of a serious risk, it shall immediately notify the Commission thereof through RAPEX. It shall also inform the Commission without delay of modification or withdrawal of any such measure or action. If the notifying Member State considers that the effects of the risk do not or cannot go beyond its territory, it shall follow the procedure laid down in Article 11, taking into account the relevant criteria proposed in the guidelines referred to in point 8 of Annex II. Without prejudice to the first subparagraph, before deciding to adopt such measures or to take such action, Member States may pass on to the Commission any information in their possession regarding the existence of a serious risk. In the case of a serious risk, they shall notify the Commission of the voluntary measures laid down in Article 5 of this Directive taken by producers and distributors. 2. On receiving such notifications, the Commission shall check whether they comply with this Article and with the requirements applicable to the functioning of RAPEX, and shall forward them to the other Member States, which, in turn, shall immediately inform the Commission of any measures adopted. 3. Detailed procedures for RAPEX are set out in Annex II. They shall be adapted by the Commission in accordance with the procedure referred to in Article 15(3). 4. Access to RAPEX shall be open to applicant countries, third countries or international organisations, within the framework of agreements between the Community and those countries or international organisations, according to arrangements defined in these agreements. Any such agreements shall be based on reciprocity and include provisions on confidentiality corresponding to those applicable in the Community. Article 13 1. If the Commission becomes aware of a serious risk from certain products to the health and safety of consumers in various Member States, it may, after consulting the Member States, and, if scientific questions arise which fall within the competence of a Community Scientific Committee, the Scientific Committee competent to deal with the risk concerned, adopt a decision in the light of the result of those consultations, in accordance with the procedure laid down in Article 15(2), requiring Member States to take measures from among those listed in Article 8(1)(b) to (f) if, at one and the same time: (a) it emerges from prior consultations with the Member States that they differ significantly on the approach adopted or to be adopted to deal with the risk; and (b) the risk cannot be dealt with, in view of the nature of the safety issue posed by the product, in a manner compatible with the degree of urgency of the case, under other procedures laid down by the specific Community legislation applicable to the products concerned; and (c) the risk can be eliminated effectively only by adopting appropriate measures applicable at Community level, in order to ensure a consistent and high level of protection of the health and safety of consumers and the proper functioning of the internal market. 2. The decisions referred to in paragraph 1 shall be valid for a period not exceeding one year and may be confirmed, under the same procedure, for additional periods none of which shall exceed one year. However, decisions concerning specific, individually identified products or batches of products shall be valid without a time limit. 3. Export from the Community of dangerous products which have been the subject of a decision referred to in paragraph 1 shall be prohibited unless the decision provides otherwise. 4. Member States shall take all necessary measures to implement the decisions referred to in paragraph 1 within less than 20 days, unless a different period is specified in those decisions. 5. The competent authorities responsible for carrying out the measures referred to in paragraph 1 shall, within one month, give the parties concerned an opportunity to submit their views and shall inform the Commission accordingly. CHAPTER VI Committee procedures Article 14 1. The measures necessary for the implementation of this Directive relating to the matters referred to below shall be adopted in accordance with the regulatory procedure provided for in Article 15(2): (a) the measures referred to in Article 4 concerning standards adopted by the European standardisation bodies; (b) the decisions referred to in Article 13 requiring Member States to take measures as listed in Article 8(1)(b) to (f). 2. The measures necessary for the implementation of this Directive in respect of all other matters shall be adopted in accordance with the advisory procedure provided for in Article 15(3). Article 15 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 15 days. 3. 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. 4. The Committee shall adopt its rules of procedure. CHAPTER VII Final provisions Article 16 1. Information available to the authorities of the Member States or the Commission relating to risks to consumer health and safety posed by products shall in general be available to the public, in accordance with the requirements of transparency and without prejudice to the restrictions required for monitoring and investigation activities. In particular the public shall have access to information on product identification, the nature of the risk and the measures taken. However, Member States and the Commission shall take the steps necessary to ensure that their officials and agents are required not to disclose information obtained for the purposes of this Directive which, by its nature, is covered by professional secrecy in duly justified cases, except for information relating to the safety properties of products which must be made public if circumstances so require, in order to protect the health and safety of consumers. 2. Protection of professional secrecy shall not prevent the dissemination to the competent authorities of information relevant for ensuring the effectiveness of market monitoring and surveillance activities. The authorities receiving information covered by professional secrecy shall ensure its protection. Article 17 This Directive shall be without prejudice to the application of Directive 85/374/EEC. Article 18 1. Any measure adopted under this Directive and involving restrictions on the placing of a product on the market or requiring its withdrawal or recall must state the appropriate reasons on which it is based. It shall be notified as soon as possible to the party concerned and shall indicate the remedies available under the provisions in force in the Member State in question and the time limits applying to such remedies. The parties concerned shall, whenever feasible, be given an opportunity to submit their views before the adoption of the measure. If this has not been done in advance because of the urgency of the measures to be taken, they shall be given such opportunity in due course after the measure has been implemented. Measures requiring the withdrawal of a product or its recall shall take into consideration the need to encourage distributors, users and consumers to contribute to the implementation of such measures. 2. Member States shall ensure that any measure taken by the competent authorities involving restrictions on the placing of a product on the market or requiring its withdrawal or recall can be challenged before the competent courts. 3. Any decision taken by virtue of this Directive and involving restrictions on the placing of a product on the market or requiring its withdrawal or its recall shall be without prejudice to assessment of the liability of the party concerned, in the light of the national criminal law applying in the case in question. Article 19 1. The Commission may bring before the Committee referred to in Article 15 any matter concerning the application of this Directive and particularly those relating to market monitoring and surveillance activities. 2. Every three years, following 15 January 2004, the Commission shall submit a report on the implementation of this Directive to the European Parliament and the Council. The report shall in particular include information on the safety of consumer products, in particular on improved traceability of products, the functioning of market surveillance, standardisation work, the functioning of RAPEX and Community measures taken on the basis of Article 13. To this end the Commission shall conduct assessments of the relevant issues, in particular the approaches, systems and practices put in place in the Member States, in the light of the requirements of this Directive and the other Community legislation relating to product safety. The Member States shall provide the Commission with all the necessary assistance and information for carrying out the assessments and preparing the reports. Article 20 The Commission shall identify the needs, possibilities and priorities for Community action on the safety of services and submit to the European Parliament and the Council, before 1 January 2003, a report, accompanied by proposals on the subject as appropriate. Article 21 1. Member States shall bring into force the laws, regulations and administrative provisions necessary in order to comply with this Directive with effect from 15 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 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 provisions of national law which they adopt in the field covered by this Directive. Article 22 Directive 92/59/EEC is hereby repealed from 15 January 2004, without prejudice to the obligations of Member States concerning the deadlines for transposition and application of the said Directive as indicated in Annex III. References to Directive 92/59/EEC shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IV. Article 23 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 24 This Directive is addressed to the Member States.

32001L0106

2001

Directive 2001/106/EC of the European Parliament and of the Council of 19 December 2001 amending Council Directive 95/21/EC concerning the enforcement, in respect of shipping using Community ports and sailing in the waters under the jurisdiction of the Member States, of international standards for ship safety, pollution prevention and shipboard living and working conditions (port State control) 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), in the light of the joint text approved by the Conciliation Committee on 13 November 2001, Whereas: (1) Council Directive 95/21/EC(5) establishes a system of port State control of shipping in the European Community based on uniform inspection and detention procedures. (2) It is necessary to take account of the changes that have been made to the International Maritime Organisation (IMO) conventions, protocols, codes and resolutions and of developments in the framework of the Paris Memorandum of Understanding (MOU). (3) It is understood that nothing in this Directive has the effect of transferring to port States the responsibilities of flag States including those of the recognised organisations acting on behalf of the flag States. (4) Some ships pose a manifest risk to maritime safety and the marine environment because of their poor condition, flag and history; among which in particular, ships flying the flag of a State described as "very high risk" or "high risk" in the black list as published in the annual report of the MOU. They should therefore be refused access to Community ports, unless it can be demonstrated that they can be operated safely in Community waters. Guidelines must be established setting out the procedures applicable in the event of the imposition of such an access ban and of the lifting of the ban. In the interests of transparency, the list of ships refused access to Community ports should be made public. (5) Ships with a high target factor present a particularly serious accident or pollution risk, justifying the need to inspect them frequently at Community ports of call. (6) The categories of ships listed in Annex V to Directive 95/21/EC also present a major accident or pollution hazard when they reach a certain age. The broad discretionary power of the inspection authority as to whether to select such ships for expanded inspection prevents the achievement of uniform practices within the Community. It is therefore necessary to make inspection of these ships mandatory. In particular, given the risks of major pollution caused by oil tankers and in view of the fact that the great majority of deficiencies leading to detention concern ships older than 15 years, the expanded inspection regime should be applied to oil tankers from the age of 15 years. (7) The content of the expanded inspections for which guidelines have been laid down may vary considerably at the discretion of the inspection authority. In order to achieve uniform practices within the Community, these guidelines should therefore be made mandatory. However, there should be provision for making an exception when the conduct of an inspection of such ships, in particular in view of the state of the ship's cargo tanks or of operational constraints relating to loading or unloading activities, is impossible or would involve excessive risks for the safety of the ship, its crew, the inspector or the safety of the port area. (8) Member States should be entitled to organise the mandatory inspections efficiently so as to achieve the highest value added from a strengthened inspection regime, taking into account the various operational conditions and making use of cooperation between ports and Member States, while adhering to the overall quantitative inspection targets. (9) As the recruitment and training of qualified inspectors requires some time, the Member States should be allowed to build up their inspection service gradually; given the characteristics of the port of Rotterdam, particularly the volume of traffic calling there, provision should be made for the possibility of extending slightly the period for recruiting and training inspectors for this port. (10) Structural defects in a ship are likely to increase the risk of an accident at sea. In the case of a ship carrying a bulk cargo of oil, such accidents can have disastrous consequences for the environment. The inspection authority should carry out a visual examination of the accessible parts of the ship in order to detect any serious corrosion and take whatever follow-up action may be necessary, in particular vis-à-vis the classification societies responsible for the structural quality of ships. (11) Expanded inspection based on mandatory verification of certain aspects of the ship takes a considerable amount of time and organisation. The task of preparing the inspection should be facilitated, which in turn will improve its effectiveness. To this end, the master or operator of any ship entering a Community port should notify certain information of an operational nature. (12) The growing importance of port State control in the battle against sub-standard practices is resulting in an overall increase in inspectors' tasks. A particular effort should therefore be made to avoid redundant inspections and to improve the information available to inspectors on the content of inspections performed in previous ports. Consequently, the inspection report produced by the inspector on completion of an inspection, a more detailed inspection or an expanded inspection should state which parts of the ship have already been inspected; the inspector at the following port of call will thus be able, where appropriate, to decide to refrain from inspecting a part of the ship if no deficiency was detected during the previous inspection. (13) Essential technological progress has been made in the field of on-board equipment, which enables voyage data to be recorded (by means of voyage data recorder (VDR system) or "black boxes") in order to facilitate post-accident investigations. In view of the importance of such equipment for maritime safety and in parallel with the efforts being made on this subject within the IMO, it should be made mandatory after a period of up to five years after the entry into force of this Directive for cargo ships built before 1 July 2002 calling at Community ports and, when compulsory, its absence or failure should warrant detention. (14) The administration of the flag State of a ship inspected or the classification society concerned should be informed of the result of inspection in order to ensure more effective monitoring of the development and, where appropriate, the deterioration in the state of the ship in order to take the necessary remedial action while there is still time. (15) Accidental pollution by oil is likely to cause considerable damage to the environment and the economy of the region concerned. It is therefore necessary to verify whether oil tankers calling at European Community ports have appropriate cover for such risks. (16) The transparency of information relating to ships inspected and detained is a key element of any policy designed to deter the use of ships that fall short of the safety standards. It is necessary in this context to include the identity of the ship's charterer in the list of information published. The public should also be given fuller and clearer information on the inspections and detentions carried out in Community ports. This concerns in particular information on the more extensive inspections performed on-board ships, both by the port State authorities and by the classification societies, and an explanation of the measures taken by the port State authorities or the classification societies concerned following a detention order under the Directive. (17) It is essential to monitor the application of the Directive in order to avoid the risk of varying levels of safety and distortion of competition between ports and regions of the European Community. The Commission should therefore have more detailed information, particularly on the movements of ships in ports, in order to be able to carry out a detailed examination of the conditions under which the Directive is being applied. Such information should be provided to the Commission sufficiently frequently to enable it to intervene more rapidly whenever anomalies are found in the application of the Directive. (18) The measures necessary for the implementation of Directive 95/21/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(6), Article 1 Directive 95/21/EC is hereby amended as follows: 1. the title shall be replaced by the following: "Directive 95/21/EC of the Council of 19 June 1995 on port State control of shipping;" 2. Article 2(1) and (2) shall be replaced by the following: "1. 'Conventions' means: - the International Convention on Load Lines, 1966 (LL 66), - the International Convention for the Safety of Life at Sea, 1974 (SOLAS 74), - the International Convention for the Prevention of Pollution from Ships, 1973, and the 1978 Protocol relating thereto (Marpol 73/78), - the International Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978 (STCW 78), - the Convention on the International Regulations for Preventing Collisions at Sea, 1972 (Colreg 72), - the International Convention on Tonnage Measurement of Ships, 1969 (ITC 69), - the Merchant Shipping (Minimum Standards) Convention, 1976 (ILO No 147), - the International Convention on Civil Liability for Oil Pollution Damage, 1992 (CLC 92), together with the Protocols and amendments to these Conventions and related codes of mandatory status, in force on 19 December 2001. 2. 'MOU' means the Memorandum of Understanding on Port State Control, signed in Paris on 26 January 1982, as it stands on 19 December 2001;" 3. Article 4 shall be replaced by the following: "Article 4 Inspection body Member States shall maintain appropriate national maritime administrations with the requisite number of staff, in particular qualified inspectors, hereinafter called 'competent authorities', for the inspection of ships and shall take whatever measures are appropriate to ensure that their competent authorities perform their duties as laid down in this Directive."; 4. Article 5(1), (2) and (3) shall be replaced by the following: "1. The total number of inspections of the ships referred to in paragraph (2) and Article 7 to be carried out annually by the competent authority of each Member State shall correspond to at least 25 % of the average annual number of individual ships which entered its ports, calculated on the basis of the three most recent calendar years for which statistics are available. 2. (a) The competent authority shall, subject to the provisions of Article 7a, ensure that an inspection in accordance with Article 6 is carried out on any ship not subject to an expanded inspection with a target factor greater than 50 in the Sirenac information system, provided that a period of at least one month has elapsed since the last inspection carried out in a port in the MOU region. (b) In selecting other ships for inspection, the competent authorities shall determine the order of priority as follows: - the first ships to be selected for inspection shall be those listed in Annex I, Part I, irrespective of their target factor, - the ships listed in Annex I, Part II shall be selected in decreasing order, depending on the order of priority resulting from the value of their target factor ranges as referred to in the Sirenac information system. 3. Member States shall refrain from inspecting ships which have been inspected by any Member State within the previous six months, provided that: - the ship is not listed in Annex I, - no deficiencies have been reported, following a previous inspection, - no clear grounds exist for carrying out an inspection, - the ship is not covered by paragraph 2(a)."; 5. Article 7 shall be replaced by the following: "Article 7 Mandatory expanded inspection of certain ships 1. A ship in one of the categories in Annex V, section A, is liable to an expanded inspection after a period of 12 months since the last expanded inspection carried out in a port of a State signatory of the MOU. 2. If such a ship is selected for inspection in accordance with Article 5(2)(b), an expanded inspection shall be carried out. However an inspection in accordance with Article 6 may be carried out in the period between two expanded inspections. 3. (a) The operator or master of a ship to which paragraph 1 applies shall communicate all the information listed in Annex V, section B, to the competent authority of the Member State of each port visited after a period of 12 months since the last expanded inspection. This information shall be provided at least three days before the expected time of arrival in the port or before leaving the previous port if the voyage is expected to take fewer than three days. (b) Any ship not complying with subparagraph (a) shall be subject to an expanded inspection at the port of destination. 4. Member States shall, subject to Article 7a, ensure that an expanded inspection is carried out on a ship to which paragraph 3 applies and which has a target factor of 7 or more at its first port visited after a period of 12 months since the last expanded inspection. In cases where the Member States are unable to increase their capacity in time to carry out all the additional inspections required, particularly because of problems connected with the recruitment and training of inspectors, they shall be allowed until 1 January 2003 to build up their inspection service gradually. This period may be extended by six months for the port of Rotterdam. The Commission shall notify the Member States and the European Parliament of any such extension. 5. Expanded inspection shall be carried out in accordance with the procedures in Annex V, section C. 6. Where there is a risk that an amendment or draft amendment to the MOU may weaken the scope of the obligation for expanded inspection under this Article, the Commission shall submit without delay to the Committee established by Article 18, draft measures with a view to reintroducing target factor values complying with the objectives of this Directive."; 6. the following Article 7a shall be inserted: "Article 7a Procedure in case certain ships cannot be inspected 1. In cases where, for operational reasons, a Member State is unable to carry out an inspection of a ship with a target factor of more than 50 as referred to in Article 5(2)(a) or a mandatory expanded inspection as referred to in Article 7(4), the Member State shall, without delay, inform the Sirenac system that such inspection did not take place. 2. Such cases shall be notified, at intervals of six months, to the Commission together with the reasons for not inspecting the ships concerned. 3. During any calendar year, such non-inspections shall not exceed 5 % of the average annual number of individual ships eligible for the inspections referred to in paragraph 1 calling at the ports of the Member State, calculated on the basis of the three most recent calendar years for which statistics are available. 4. Ships referred to in paragraph 1 shall be subject to an inspection, as provided for in Article 5(2)(a) or a mandatory expanded inspection as referred to in Article 7(4), as appropriate, in the next port of call in the Community. 5. By 22 July 2008 the figure of 5 % referred to in paragraph 3 shall be amended on the basis of an assessment by the Commission, if it is considered appropriate, in accordance with the procedure laid down in Article 19."; 7. the following Article 7b shall be inserted: "Article 7b Access refusal measures concerning certain ships 1. A Member State shall ensure that a ship in one of the categories of Annex XI, section A, is refused access to its ports, except in the situations described in Article 11(6), if the ship: either - flies the flag of a State appearing in the black list as published in the annual report of the MOU, and - has been detained more than twice in the course of the preceding 24 months in a port of a State signatory of the MOU, or - flies the flag of a State described as 'very high risk' or 'high risk' in the black list as published in the annual report of the MOU, and - has been detained more than once in the course of the preceding 36 months in a port of a State signatory of the MOU. The refusal of access shall become applicable immediately the ship has been authorised to leave the port where it has been the subject of a second or third detention as appropriate. 2. For the purposes of paragraph 1, Member States shall comply with the procedures laid down in Annex XI, section B. 3. The Commission shall publish every six months the information relating to ships that have been refused access to Community ports in application of this Article."; 8. Article 8 shall be replaced by the following: "Article 8 Report of inspection to the master On completion of an inspection, a more detailed inspection or an expanded inspection, the inspector shall draw up a report in accordance with Annex IX. A copy of the inspection report shall be provided to the ship's master."; 9. in Article 9: (a) paragraph 1 shall be replaced by the following: "1. The competent authority shall be satisfied that any deficiencies confirmed or revealed by the inspection referred to in Article 5(2) and Article 7 are or will be rectified in accordance with the Conventions."; (b) paragraph 3 shall be replaced by the following: "3. When exercising his professional judgment as to whether or not a ship should be detained, the inspector shall apply the criteria set out in Annex VI. In this respect, the ship shall be detained, if not equipped with a functioning voyage data recorder system, when its use is compulsory in accordance with Annex XII. If this deficiency cannot be readily rectified in the port of detention, the competent authority may allow the ship to proceed to the nearest appropriate port where it shall be readily rectified or require that the deficiency is rectified within a maximum period of 30 days. For these purposes, the procedures laid down in Article 11 shall apply."; (c) paragraph 5 shall be replaced as follows: "5. In the event that the inspections referred to in Article 5(2) and Article 7 give rise to detention, the competent authority shall immediately inform, in writing and including the report of inspection, the administration of the State whose flag the ship is entitled to fly (hereinafter called 'flag administration') or, when this is not possible, the Consul or, in his absence, the nearest diplomatic representative of that State, of all the circumstances in which intervention was deemed necessary. In addition, nominated surveyors or recognised organisations responsible for the issue of class certificates or certificates issued on behalf of the flag State in accordance with the international conventions shall also be notified where relevant."; 10. Article 10(1) shall be replaced by the following: "1. The owner or the operator of a ship or his representative in the Member State shall have a right of appeal against a detention decision or refusal of access taken by the competent authority. An appeal shall not cause the detention or refusal of access to be suspended."; 11. Article 14(2) shall be replaced by the following: "2. Member States shall maintain provisions for the exchange of information and cooperation between their competent authority and the competent authorities of all other Member States and maintain the established operational link between their competent authority, the Commission and the Sirenac information system set up in St Malo, France. For the purposes of carrying out the inspections referred to in Article 5(2) and Article 7, inspectors shall consult the public and private databases relating to ship inspection accessible through the Equasis information system."; 12. Article 15(2) shall be replaced by the following: "2. The information listed in Annex VIII, Parts I and II, and the information on changes, suspensions and withdrawals of class referred to in Article 15(3) of Directive 94/57/EC, shall be available in the Sirenac system. It shall be made public through the Equasis information system, as soon as possible after the inspection has been completed or the detention has been lifted."; 13. in Article 15 the following paragraph shall be added: "5. The provisions of this Article do not affect national legislation on liability."; 14. in Article 16 the following paragraph shall be inserted: "2a. In the case of detention of a vessel for deficiencies or lack of valid certificates as laid down in Article 9 and Annex VI, all costs relating to the detention in port shall be borne by the owner or operator of the ship."; 15. Articles 17 and 18 shall be replaced by the following: "Article 17 Data to monitor implementation Member States shall provide the Commission with the information listed in Annex X at the intervals stated therein in that Annex. Article 18 Regulatory Committee 1. The Commission shall be assisted by the Committee set up pursuant to Article 12 of Directive 93/75/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."; 16. in Article 19, the introductory phrase and subparagraph (a) shall be replaced by the following: "This Directive may, without broadening its scope, be amended in accordance with the procedure laid down in Article 18(2), in order to: (a) adapt the obligations referred to in Article 5, except the figure of 25 % referred to in paragraph 1 thereof, in Articles 6, 7, 7a, 7b, 8, 15 and 17, and in the Annexes to which these Articles refer, on the basis of the experience gained from the implementation of this Directive and taking into account developments in the MOU;" 17. the following Article 19a shall be inserted: "Article 19a Penalties Member States shall lay down a system of penalties for the breach of national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that those penalties are applied. The penalties thus provided shall be effective, proportionate and dissuasive."; 18. the following paragraph shall be added to Article 20: "4. In addition, the Commission shall inform the European Parliament and the Council on a regular basis of progress in the implementation of the Directive within the Member States."; 19. Annex I, Part II shall be replaced by the text in Annex I to this Directive; 20. in Annex II: (a) item 10 shall be replaced by the following items: "10. Minimum Safe Manning Document; 10a Certificates issued in accordance with the STCW Convention."; (b) the following item 35 shall be added: "35. Certificate of insurance or any other financial security in respect of civil liability for oil pollution damage (International Convention on Civil Liability for Oil Pollution Damage, 1992)."; 21. in Annex III, item 1, the words "II-8 and II-11" shall be replaced by the words "and II-8"; 22. Annex V shall be replaced by the text in Annex II to this Directive; 23. Annex VI shall be amended as follows: (a) the following shall be added to item 2 ("Application of main criteria"): "14. provide the maximum of information in case of accident."; (b) in item 3.1 the words "The lack of valid certificates" are replaced by the words "The lack of valid certificates and documents"; (c) the following shall be added to item 3.2: "15. Failure to carry out the enhanced survey programme in accordance with SOLAS 74, Chapter XI, Regulation 2. 16. Absence or failure of a VDR, when its use is compulsory."; (d) the following point shall be added to item 3.6: "5. Survey report file missing or not in conformity with Regulation 13G(3)(b) of the Marpol Convention."; 24. Annex VIII shall be replaced by the text in Annex III to this Directive; 25. Annexes IX, X, XI and XII shall be added, the text of which is in Annex IV to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 22 July 2003. They shall forthwith inform the Commission thereof. 2. 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. The methods of making such a reference shall be laid down by the Member States. 3. Member States shall communicate to the Commission the text of the provisions of national law which they have adopted in the field governed by this Directive. Article 3 The Commission shall review the implementation of this Directive no later than 22 July 2006. The review will examine, inter alia, the number of port State control inspectors in each Member State and the number of inspections carried out, including mandatory expanded inspections. The Commission shall communicate the findings of the review to the European Parliament and the Council and shall determine on the basis of the review whether it is necessary to propose an amending Directive or further legislation in this area. 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.

32001L0112

2001

Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended 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 Economic and Social Committee(3), Whereas: (1) Certain vertical Directives relating to foodstuffs should be simplified in order to take account only of the essential requirements to be met by the products they cover in order that those products may move freely within the internal market, in accordance with the conclusions of the Edinburgh European Council on 11 and 12 December 1992, as confirmed by those of the Brussels European Council on 10 and 11 December 1993. (2) Council Directive 93/77/EEC of 21 September 1993 relating to fruit juices and certain similar products(4) was intended to codify Directive 75/726/EEC(5) on the same subject. (3) Directives 75/726/EEC and 93/77/EEC had been justified by the fact that differences between national laws concerning fruit juices and nectars intended for human consumption could result in conditions of unfair competition likely to mislead consumers, and thereby have a direct effect on the establishment and functioning of the common market. (4) The said Directives had consequently laid down common rules governing the composition, use of reserved descriptions, manufacturing specifications and labelling of the products concerned, in order to ensure their free movement within the Community. (5) For the sake of clarity, Directive 93/77/EEC should be recast in order to make the rules on manufacturing and marketing conditions for fruit juices and certain similar products more accessible. (6) Directive 93/77/EEC should also be brought into line with general Community legislation on foodstuffs, particularly legislation on labelling, colouring matter, sweeteners and other authorised additives. (7) 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(6), and in particular Article 7(2) and (5) thereof, should apply subject to certain conditions. It should be clearly indicated when a product is a mixture of fruit juice and fruit juice from concentrate, and, for fruit nectar, when it is obtained entirely or partly from a concentrated product. The list of ingredients in the labelling bears the names of both the fruit juices and fruit juices from concentrate used. (8) Subject to Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs(7), the addition of vitamins to the products defined by this Directive is permitted in some Member States. However, the extension of this possibility to the whole of the Community is not envisaged. Therefore, Member States are free to authorise or prohibit the addition of vitamins and also minerals as part of the manufacturing process. In all circumstances, however, the principle of the free movement of products within the Community should be observed in accordance with the rules and principles laid down in the Treaty. (9) In accordance with the principles of subsidiarity and proportionality established by Article 5 of the Treaty, the objective of laying down common definitions and rules for the products concerned and bringing the provisions into line with general Community legislation on foodstuffs cannot be sufficiently achieved by the Member States and can therefore, by reason of the nature of this Directive, be better achieved by the Community. This Directive does not go beyond what is necessary in order to achieve the said objective. (10) 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). (11) To avoid creating new barriers to free movement, Member States should refrain from adopting, for the products in question, national provisions not provided for by this Directive, Article 1 This Directive shall apply to the products defined in Annex I. Article 2 Member States may, subject to Directive 90/496/EEC, authorise the addition of vitamins and minerals to the products defined in part I of Annex I hereto. Article 3 Directive 2000/13/EC shall apply to the products defined in Annex I, subject to the following conditions: 1. (a) The product names listed in Annex I shall apply only to the products referred to therein and shall, without prejudice to subparagraph (b), be used in trade to designate them. (b) As an alternative to the product names referred to in subparagraph (a), Annex III provides a list of particular designations. These designations may be used in the language and under the conditions laid down in Annex III. 2. If the product comes from a single kind of fruit, the name of the latter shall be substituted for the word "fruit". 3. For products manufactured from two or more fruits, except where lemon juice is used under the conditions laid down in part II.1 of Annex I, the product names shall be supplemented by a list of the fruits used, in descending order of the volume of the fruit juices or purées included. However, in the case of products manufactured from three or more fruits, the indication of the fruits used may be replaced by the words "several fruits" or a similar wording, or by the number of fruits used. 4. For fruit juices which have been sweetened by the addition of sugars, the sales name shall include the word "sweetened" or "with added sugar", followed by an indication of the maximum quantity of sugar added, calculated as dry matter and expressed in grams per litre. 5. The restoration of the products defined in part I of Annex I to their original state, by means of the substances strictly necessary for this operation, shall not entail an obligation to enter on the labels a list of the ingredients used for this purpose. The addition to fruit juice of extra pulp or cells as defined in Annex II shall be indicated on the labelling. 6. Without prejudice to Article 7(2) and (5) of Directive 2000/13/EC for mixtures of fruit juice and fruit juice from concentrate, and for fruit nectar obtained entirely or partly from one or more concentrated products, the labelling shall bear the words "made with concentrate(s)" or "partially made with concentrate(s)", as appropriate. That information shall be entered close to the product name, standing out well from any background, in clearly visible characters. 7. For fruit nectars, the labelling shall indicate the minimum content of fruit juice, fruit purée or any mixture of those ingredients, by the declaration "fruit content: ... % minimum". That information shall be located in the same field of vision as the product name. Article 4 The labelling of concentrated fruit juice referred to in part I point 2 of Annex I not intended for delivery to the final consumer shall bear a reference indicating the presence and quantity of added sugars, or added lemon juice or acidifying agents as permitted by Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners(9). This reference shall appear on the packaging, on a label attached to the packaging or on an accompanying document. Article 5 For the products defined in Annex I, Member States shall not adopt national provisions not provided for by this Directive. Article 6 Without prejudice 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(10), only the treatments and substances listed in part II of Annex I and the raw materials complying with Annex II may be used to manufacture the products defined in part I of Annex I. Moreover, fruit nectars shall comply with the provisions of Annex IV. Article 7 The measures necessary for the implementation of this Directive relating to the matters referred to below shall be adopted in accordance with the regulatory procedure referred to in Article 8(2): - bringing this Directive into line with general Community legislation on foodstuffs, - adaptations to technical progress. Article 8 1. The Commission shall be assisted by the Standing Committee on Foodstuffs (hereinafter referred to as "the Committee") set up by Article 1 of Decision 69/414/EEC(11). 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 9 Directive 93/77/EEC is hereby repealed with effect from 12 July 2003. References to the repealed Directive shall be construed as references to this Directive. Article 10 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 12 July 2003. They shall forthwith inform the Commission thereof. The measures shall be applied so as to: - authorise the marketing of the products defined in Annex I if they comply with the definitions and rules laid down in this Directive, with effect from 12 July 2003, - prohibit the marketing of products which fail to comply with this Directive, with effect from 12 July 2004. However, the marketing of products which fail to comply with this Directive but which were labelled before 12 July 2004 in accordance with Directive 93/77/EEC may continue until stocks run out. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time 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.

32001L0115

2001

Council Directive 2001/115/EC of 20 December 2001 amending Directive 77/388/EEC with a view to simplifying, modernising and harmonising the conditions laid down for invoicing in respect of value added tax 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 Economic and Social Committee(3), Whereas: (1) The current conditions laid down for invoicing and listed under Article 22(3), in the version given in Article 28h of 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), are relatively few in number, thus leaving it to the Member States to define the most important such conditions. At the same time, the conditions are no longer appropriate given the development of new invoicing technologies and methods. (2) The Commission report on the second phase of the SLIM exercise (Simpler Legislation for the Single Market) recommended that a study be carried out to determine what details should be required for VAT purposes when drawing up an invoice and what the legal and technical requirements are as regards electronic invoicing. (3) The conclusions of the Ecofin Council of June 1998 underlined the fact that the development of electronic commerce has made it necessary to establish a legal framework for the use of electronic invoicing to enable tax administrations to continue to perform their controls. (4) It is therefore necessary, in order to ensure that the internal market functions properly, to draw up a list, harmonised at Community level, of the particulars that must appear on invoices for the purposes of value added tax and to establish a number of common arrangements governing the use of electronic invoicing and the electronic storage of invoices, as well as for self-billing and the outsourcing of invoicing operations. (5) Lastly, the storage of invoices should comply with the conditions laid down by 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). (6) Since the introduction of the transitional VAT arrangements in 1993, Greece has adopted the prefix EL rather than the prefix GR laid down in the ISO International Standard No 3166 - alpha 2 referred to in Article 22(1)(d). Given the consequences of amending the prefix in all the Member States, it is important to lay down an exception for Greece providing that the ISO Standard does not apply in Greece. (7) Directive 77/388/EEC should therefore be amended accordingly, Article 1 Directive 77/388/EEC is hereby amended in accordance with the following Articles. Article 2 At Article 28h (which replaces Article 22 of the same Directive), Article 22 shall be amended as follows: 1. The following sentence shall be added to paragraph 1(d): "Nevertheless, the Hellenic Republic shall be authorised to use the prefix 'EL'." 2. Paragraph 3 shall be replaced by the following: "3. (a) Every taxable person shall ensure that an invoice is issued, either by himself or by his customer or, in his name and on his behalf, by a third party, in respect of goods or services which he has supplied or rendered to another taxable person or to a non-taxable legal person. Every taxable person shall also ensure that an invoice is issued, either by himself or by his customer or, in his name and on his behalf, by a third party, in respect of the supplies of goods referred to in Article 28b(B)(1) and in respect of goods supplied under the conditions laid down in Article 28c(A). Every taxable person shall likewise ensure that an invoice is issued, either by himself or by his customer or, in his name and on his behalf, by a third party, in respect of any payment on account made to him before any supplies of goods referred to in the first subparagraph and in respect of any payment on account made to him by another taxable person or non-taxable legal person before the provision of services is completed. Member States may impose on taxable persons an obligation to issue an invoice in respect of goods or services other than those referred to in the preceding subparagraphs which they have supplied or rendered on their territory. When they do so, Member States may impose fewer obligations in respect of these invoices than those listed under points (b), (c) and (d). The Member States may release taxable persons from the obligation to issue an invoice in respect of goods or services which they have supplied or rendered in their territory and which are exempt, with or without refund of the tax paid at the preceding stage, pursuant to Article 13, Article 28(2)(a) and Article 28(3)(b). Any document or message that amends and refers specifically and unambiguously to the initial invoice is to be treated as an invoice. Member States in whose territory goods or services are supplied or rendered may allow some of the obligatory details to be left out of such documents or messages. Member States may impose time limits for the issue of invoices on taxable persons supplying goods and services in their territory. Under conditions to be laid down by the Member States in whose territory goods or services are supplied or rendered, a summary invoice may be drawn up for several separate supplies of goods or services. Invoices may be drawn up by the customer of a taxable person in respect of goods or services supplied or rendered to him by that taxable person, on condition that there is at the outset an agreement between the two parties, and on condition that a procedure exists for the acceptance of each invoice by the taxable person supplying the goods or services. The Member States in whose territory the goods or services are supplied or rendered shall determine the terms and conditions of the agreement and of the acceptance procedures between the taxable person and his customer. Member States may impose further conditions on the issue of invoices by the customers of taxable persons supplying goods or services on their territory. For example, they may require that such invoices be issued in the name and on behalf of the taxable person. Such conditions must always be the same wherever the customer is established. Member States may also lay down specific conditions for taxable persons supplying goods or services in their territory in cases where the third party, or the customer, who issues invoices is established in a country with which no legal instrument exists relating to mutual assistance similar in scope to that laid down 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(6), 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(7) and by Council Regulation (EEC) No 218/92 of 27 January 1992 on administrative cooperation in the field of indirect taxation (VAT)(8). (b) Without prejudice to the specific arrangements laid down by this Directive, only the following details are required for VAT purposes on invoices issued under the first, second and third subparagraphs of point (a): - the date of issue; - a sequential number, based on one or more series, which uniquely identifies the invoice, - the VAT identification number referred to in paragraph 1(c) under which the taxable person supplied the goods or services; - where the customer is liable to pay tax on goods supplied or services rendered or has been supplied with goods as referred to in Article 28c(A), the VAT identification number as referred to in paragraph 1(c) under which the goods were supplied or the services rendered to him; - the full name and address of the taxable person and of his customer; - the quantity and nature of the goods supplied or the extent and nature of the services rendered; - the date on which the supply of goods or of services was made or completed or the date on which the payment on account referred to in the second subparagraph of point (a) was made, insofar as that a date can be determined and differs from the date of issue of the invoice; - the taxable amount per rate or exemption, the unit price exclusive of tax and any discounts or rebates if they are not included in the unit price; - the VAT rate applied; - the VAT amount payable, except where a specific arrangement is applied for which this Directive excludes such a detail; - where an exemption is involved or where the customer is liable to pay the tax, reference to the appropriate provision of this directive, to the corresponding national provision, or to any indication that the supply is exempt or subject to the reverse charge procedure; - where the intra-Community supply of a new means of transport is involved, the particulars specified in Article 28a(2); - where the margin scheme is applied, reference to Article 26 or 26a, to the corresponding national provisions, or to any other indication that the margin scheme has been applied; - where the person liable to pay the tax is a tax representative within the meaning of Article 21(2), the VAT identification number referred to in paragraph 1(c) of that tax representative, together with his full name and address. Member States may require taxable persons established on their territory and supplying goods or services on their territory to indicate the VAT identification number referred to in paragraph 1(c) of their customer in cases other than those referred to in the fourth indent of the first subparagraph. Member States shall not require invoices to be signed. The amounts which appear on the invoice may be expressed in any currency, provided that the amount of tax to be paid is expressed in the national currency of the Member State where the supply of goods or services takes place, using the conversion mechanism laid down in Article 11 C(2). Where necessary for control purposes, Member States may require invoices in respect of goods supplied or services rendered in their territory and invoices received by taxable persons in their territory to be translated into their national languages. (c) Invoices issued pursuant to point (a) may be sent either on paper or, subject to an acceptance by the customer, by electronic means. Invoices sent by electronic means shall be accepted by Member States provided that the authenticity of the origin and integrity of the contents are guaranteed: - by means 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(9); Member States may however ask for the advanced electronic signature to be based on a qualified certificate and created by a secure-signature-creation device, within the meaning of Article 2(6) and (10) of the aforementioned Directive; - or by means of electronic data interchange (EDI) as defined in Article 2 of Commission Recommendation 1994/820/EC of 19 October 1994 relating to the legal aspects of electronic data interchange(10) when the agreement relating to the exchange provides for the use of procedures guaranteeing the authenticity of the origin and integrity of the data; however Member States may, subject to conditions which they lay down, require that an additional summary document on paper is necessary. Invoices may, however, be sent by other electronic means subject to acceptance by the Member State(s) concerned. The Commission will present, at the latest on 31 December 2008, a report, together with a proposal, if appropriate, amending the conditions on electronic invoicing in order to take account of possible future technological developments in this field. Member States may not impose on taxable persons supplying goods or services in their territory any other obligations or formalities relating to the transmission of invoices by electronic means. However, they may provide, until 31 December 2005, that the use of such a system is to be subject to prior notification. Member States may lay down specific conditions for invoices issued by electronic means for goods or services supplied in their territory from a country with which no legal instrument exists relating to mutual assistance similar in scope to that laid down by Directives 76/308/EEC and 77/799/EEC and by Regulation (EEC) No 218/92. When batches containing several invoices are sent to the same recipient by electronic means, the details that are common to the individual invoices may be mentioned only once if, for each invoice, all the information is accessible. (d) Every taxable person shall ensure that copies of invoices issued by himself, by his customer or, in his name and on his behalf, by a third party, and all the invoices which he has received are stored. For the purposes of this Directive, the taxable person may decide the place of storage provided that he makes the invoices or information stored there available without undue delay to the competent authorities whenever they so request. Member States may, however, require taxable persons established in their territory to notify them of the place of storage, if it is outside their territory. Member States may, in addition, require taxable persons established in their territory to store within the country invoices issued by themselves or by their customers or, in their name and on their behalf, by a third party, as well as all the invoices which they have received, when the storage is not by electronic means guaranteeing full on-line access to the data concerned. The authenticity of the origin and integrity of the content of the invoices, as well as their readability, must be guaranteed throughout the storage period. As regards the invoices referred to in the third subparagraph of point (c), the information they contain may not be altered; it must remain legible throughout the aforementioned period. The Member States shall determine the period for which taxable persons must store invoices relating to goods or services supplied in their territory and invoices received by taxable persons established in their territory. In order to ensure that the conditions laid down in the third subparagraph are met, Member States referred to in the fourth subparagraph may require that invoices be stored in the original form in which they were sent, whether paper or electronic. They may also require that when invoices are stored by electronic means, the data guaranteeing the authenticity of the origin and integrity of the content also be stored. Member States referred to in the fourth subparagraph may impose specific conditions prohibiting or restricting the storage of invoices in a country with which no legal instrument exists relating to mutual assistance similar in scope to that laid down by Directives 76/308/EEC, 77/799/EEC and by Regulation (EEC) No 218/92 and to the right of access by electronic means, download and use referred to in Article 22a. Member States may, subject to conditions which they lay down, require the storage of invoices received by non-taxable persons. (e) For the purposes of points (c) and (d), transmission and storage of invoices 'by electronic means' shall mean transmission or making available to the recipient and storage using electronic equipment for processing (including digital compression) and storage of data, and employing wires, radio transmission, optical technologies or other electromagnetic means. For the purposes of this Directive, Member States shall accept documents or messages in paper or electronic form as invoices if they meet the conditions laid down in this paragraph." 3. The following subparagraph shall be added to paragraph 8: "The option provided for in the first subparagraph cannot be used to impose additional obligations over and above those laid down in paragraph 3." 4. The following subparagraph shall be added to paragraph 9(a): "Without prejudice to the provisions laid down in point (d), Member States may not, however, release the taxable persons referred to in the third indent from the obligations referred to in Article 22(3)." 5. The following point shall be added to paragraph 9: "(d) Subject to consultation of the Committee provided for in Article 29 and under the conditions which they may lay down, Member States may provide that invoices in respect of goods supplied or services rendered in their territory do not have to fulfil some of the conditions laid down in paragraph 3(b) in the following cases: - when the amount of the invoice is minor, or - when commercial or administrative practice in the business sector concerned or the technical conditions under which the invoices are issued make it difficult to comply with all the requirements referred to in paragraph 3(b). In any case, these invoices must contain the following: - the date of issue, - identification of the taxable person, - identification of the type of goods supplied or services rendered, - the tax due or the information needed to calculate it. The simplified arrangements provided for in this point may not be applied to transactions referred to in paragraph 4(c)." 6. The following point shall be added to paragraph 9: "(e) In cases where Member States make use of the option provided for in the third indent of point (a) to refrain from allocating a number as referred to in paragraph 1(c) to taxable persons who do not carry out any of the transactions referred to in paragraph 4(c), and where the supplier or the customer have not been allocated an identification number of this type, the invoice should feature instead another number called the tax reference number, as defined by the Member States concerned. When the taxable person has been allocated an identification number as referred to in paragraph 1(c), the Member States referred to in the first subparagraph may also require the invoice to show: - for services rendered referred to in Article 28b(C), (D), (E) and (F) and for supplies of goods referred to in Article 28c(A) and (E) point 3, the number referred to in paragraph 1(c) and the tax reference number of the supplier; - for other supplies of goods and services, only the tax reference number of the supplier or only the number referred to in paragraph 1(c)." Article 3 The following Article shall be inserted: "Article 22a Right of access to invoices stored by electronic means in another Member State When a taxable person stores invoices which he issues or receives by an electronic means guaranteeing on-line access to the data and when the place of storage is in a Member State other than that in which he is established, the competent authorities in the Member State in which he is established shall have a right, for the purpose of this directive, to access by electronic means, download and use these invoices within the limits set by the regulations of the Member State where the taxable person is established and as far as that State requires for control purposes." Article 4 1. The words "or of the document serving as invoice" shall be deleted from the first and third indents of the third subparagraph of Article 10(2). 2. The words "or on any other documents serving as invoices" shall be deleted from Article 24(5) and the words "or on any other document serving as an invoice" shall be deleted from Article 26a(B), point 9. 3. The words "or a document in lieu" shall be deleted from point 4 of Article 26a(C). 4. The words "or other document serving as invoice" and "or document" shall be deleted from Article 28d(3) and from the second subparagraph of Article 28d(4). 5. In Article 28g (which replaces Article 21 of the same Directive), Article 21 shall be amended as follows: - The words "or other document serving as invoice" shall be deleted from paragraph 1(d). 6. The words "or on any other document in lieu" shall be deleted from Article 28o(1)(e). Article 5 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 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 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 6 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 7 This Directive is addressed to the Member States.

32001L0111

2001

Council Directive 2001/111/EC of 20 December 2001 relating to certain sugars intended 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 Economic and Social Committee(3), Whereas: (1) Certain vertical Directives relating to foodstuffs should be simplified in order to take account only of the essential requirements to be met by the products they cover in order that those products may move freely within the internal market, in accordance with the conclusions of the European Council held in Edinburgh on 11 and 12 December 1992, as confirmed by those of the European Council in Brussels on 10 and 11 December 1993. (2) Council Directive 73/437/EEC of 11 December 1973 on the approximation of the laws of the Member States concerning certain sugars intended for human consumption(4) was justified by the fact that differences between national laws on certain categories of sugar could result in conditions of unfair competition likely to mislead consumers, and thereby have a direct effect on the establishment and functioning of the common market. (3) Directive 73/437/EEC was consequently designed to lay down definitions and common rules on the manufacturing characteristics, packaging and labelling of the products concerned so as to ensure their free movement within the Community. (4) The Commission intends to propose, as quickly as possible, and at all events before 1 July 2000, the inclusion in Council Directive 80/232/EEC of 15 January 1980 on the approximation of the laws of the Member States relating to the ranges of nominal quantities and nominal capacities permitted for certain prepackaged products(5) of a range of nominal weights of the products covered by this Directive. (5) Directive 73/437/EEC should be recast in order to make the rules on manufacturing and marketing conditions relating to certain sugars intended for human consumption more accessible and, furthermore, in order to bring it into line with general Community legislation on foodstuffs, particularly legislation on labelling, colouring matter and other authorised additives, extraction solvents and methods of analysis. (6) The general food-labelling rules laid down in Directive 2000/13/EC of the European Parliament and of the Council(6) should apply subject to certain conditions. (7) In accordance with the principles of subsidiarity and proportionality established by Article 5 of the Treaty, the objective of laying down common definitions and rules for the products concerned and bringing the provisions into line with general Community legislation on foodstuffs cannot be sufficiently achieved by the Member States and can therefore, by reason of the nature of this Directive, be better achieved by the Community. This Directive does not go beyond what is necessary in order to achieve the said objective. (8) 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). (9) To avoid creating new barriers to free movement, Member States should refrain from adopting, for the products in question, national provisions not provided for by this Directive, Article 1 This Directive shall apply to the products defined in Part A of the Annex. However, this Directive shall not apply to the products defined in Part A of the Annex when they take the following forms: icing sugars, candy sugars, sugars in loaf form. Article 2 Directive 2000/13/EC shall apply to the products defined in Part A of the Annex hereto subject to the following conditions and derogations: 1. Without prejudice to point 5 below, the product names listed in Part A of the Annex shall apply only to the products referred to therein and shall be used in trade to designate them. The product name referred to in point 2 of Part A of the Annex may also be used to designate the product referred to in point 3 thereof. However, - the products defined in Part A of the Annex may, in addition to the compulsory product name, also bear qualifying terms commonly used in the various Member States; - the product names may also be used in product names made up to designate other products, in accordance with custom, provided that such names are not liable to mislead the consumer. 2. For pre-packaged products weighing less than 20 g, the net weight need not be indicated on the labelling. 3. The labelling shall indicate the dry matter and invert sugar content of sugar solution, invert sugar solution and invert sugar syrup. 4. The labelling shall include the qualifying term "crystallised" for invert sugar syrup incorporating crystals in the solution. 5. Where the products referred to in points 7 and 8 of Part A of the Annex contain fructose in proportions greater than 5 % on a dry matter basis, they shall, in respect of their product name and as ingredients, be labelled as "glucose-fructose syrup" or "fructose-glucose syrup" and "dried glucose-fructose syrup" or "dried fructose-glucose syrup", respectively, to reflect whether the glucose component or the fructose component is in greater proportion. Article 3 For the products defined in the Annex, Member States shall not adopt national provisions not provided for by this Directive. Article 4 The measures necessary for the implementation of this Directive relating to the matters referred to below shall be adopted in accordance with the regulatory procedure set out in Article 5(2): - bringing this Directive into line with general Community legislation on foodstuffs, - adaptations to technical progress. Article 5 1. The Commission shall be assisted by the Standing Committee on Foodstuffs (hereinafter referred to as "the Committee") set up by Article 1 of Decision 69/414/EEC(8). 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 6 Directive 73/437/EEC is hereby repealed with effect from 12 July 2003. References to the repealed Directive shall be construed as references to this Directive. Article 7 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 12 July 2003. They shall forthwith inform the Commission thereof. The measures shall be applied so as to: - authorise the marketing of the products defined in Part A of the Annex if they conform to the definitions and rules laid down in this Directive, with effect from 12 July 2003; - prohibit the marketing of products which fail to conform to this Directive, with effect from 12 July 2004; However, the marketing of products which fail to conform to this Directive but which were labelled before 12 July 2004 in accordance with Directive 73/437/EEC shall be permitted until stocks run out. When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such reference shall be adopted by Member States. Article 8 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 9 This Directive is addressed to the Member States.

32001L0113

2001

COUNCIL DIRECTIVE 2001/113/EC of 20 December 2001 relating to fruit jams, jellies and marmalades and sweetened chestnut purée intended 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 Economic and Social Committee (3), Whereas: (1) Certain vertical Directives relating to foodstuffs should be simplified in order to take account only of the essential requirements to be met by the products they cover so that those products may move freely within the internal market, in accordance with the conclusions of the European Council meeting in Edinburgh on 11 and 12 December 1992, as confirmed by those of the European Council meeting in Brussels on 10 and 11 December 1993. (2) Council Directive 79/693/EEC of 24 July 1979 on the approximation of the laws of the Member States relating to fruit jams, jellies and marmalades and chestnut purée (4) was justified by the fact that differences between national laws relating to the products concerned could result in conditions of unfair competition likely to mislead consumers, and thereby have a direct effect on the establishment and functioning of the common market. (3) Directive 79/693/EEC was consequently designed to lay down definitions and common rules governing composition, manufacturing specifications and labelling of the products concerned, so as to ensure their free movement within the Community. (4) Directive 79/693/EEC should be brought into line with general Community legislation on foodstuffs, and in particular legislation on labelling, colouring agents, sweeteners and other authorised additives and, for the sake of clarity, should be recast in order to make the rules on the conditions for the production and marketing of fruit jams, jellies and marmalades and sweetened chestnut purée intended for human consumption more accessible. (5) The general food-labelling rules laid down in Directive 2000/13/EC of the European Parliament and of the Council (5) should apply subject to certain conditions. (6) In order to take account of existing national traditions in the making of fruit jams, jellies and marmalades and sweetened chestnut purée, it is necessary to maintain existing national regulations authorising the marketing of such products with a reduced sugar content. (7) In accordance with the principles of subsidiarity and proportionality established by Article 5 of the Treaty, the objective of laying down common definitions and rules for the products concerned and bringing the provisions into line with general Community legislation on foodstuffs cannot be sufficiently achieved by the Member States and can therefore, by reason of the nature of this Directive, be better achieved by the Community. This Directive does not go beyond what is necessary in order to achieve the said objective. (8) 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 (6). (9) To avoid creating new barriers to free movement, Member States should refrain from adopting, for the products in question, national provisions not provided for by this Directive, Article 1 This Directive shall apply to the products defined in Annex I. It shall not apply to products intended for the manufacture of fine bakery wares, pastries or biscuits. Article 2 Directive 2000/13/EC shall apply to the products defined in Annex I hereto, subject to the following conditions: 1. The product names listed in Annex I shall apply only to the products referred to therein and shall be used in trade to designate them. The product names used in Annex I may, however, be used in addition to the name and in accordance with practices used to designate other products which cannot be confused with those defined in Annex I. 2. The product names shall be supplemented by an indication of the fruit or fruits used, in descending order of weight of the raw materials used. However, for products manufactured from three or more fruits, the indication of the fruits used may be replaced by the words ‘mixed fruit’ or a similar wording, or by the number of fruits used. 3. The labelling shall indicate the fruit content by including the words ‘prepared with … g of fruit per 100 g’ of the finished product, after deduction of the weight of water used in preparing the aqueous extracts, if appropriate. 4. The labelling shall indicate the total sugar content by the words ‘total sugar content … g per 100 g’, the figure indicated representing the value determined by refractometer at 20 °C for the finished product, subject to a tolerance of ± 3 refractometric degrees. The sugar content need not, however, be indicated where a nutrition claim is made for sugars on the labelling pursuant to Directive 90/496/EEC (7). 5. The particulars referred to in point 3 and the first subparagraph of point 4 shall appear in the same visual field as the product name and in clearly visible characters. 6. Where the residual content of sulphur dioxide is more than 10 mg/kg, its presence shall be indicated on the list of ingredients by way of derogation from Article 6(4) of Directive 2000/13/EC. Article 3 For the products defined in Annex I, Member States shall not adopt national provisions not provided for by this Directive. Article 4 Without prejudice to Directive 89/107/EEC (8) or to provisions adopted in order to give it effect, only the ingredients listed in Annex II hereto and raw materials which comply with Annex III hereto may be used in the manufacture of the products defined in Annex I hereto. Article 5 The measures necessary for the implementation of this Directive relating to the matters referred to below shall be adopted in accordance with the regulatory procedure referred to in Article 6(2): — bringing this Directive into line with general Community legislation on foodstuffs, — adaptations to technical progress. Article 6 1. The Commission shall be assisted by the Standing Committee on Foodstuffs (hereinafter referred to as ‘the Committee’) set up by Article 1 of Decision 69/414/EEC (9). 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 7 Directive 79/693/EEC is hereby repealed with effect from 12 July 2003. References to the repealed Directive shall be construed as references to this Directive. Article 8 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 12 July 2003. They shall forthwith inform the Commission thereof. The measures shall be applied so as to: — authorise the marketing of the products defined in Annex I if they comply with the definitions and rules laid down in this Directive, with effect from 12 July 2003, — prohibit the marketing of products which do not comply with this Directive, with effect from 12 July 2004. However, the marketing of products which fail to conform to this Directive but which were labelled before 12 July 2004 in accordance with Directive 79/693/EEC shall be permitted until stocks run out. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such reference shall be adopted by Member States. Article 9 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 10 This Directive is addressed to the Member States.

32001L0110

2001

Council Directive 2001/110/EC of 20 December 2001 relating to honey 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) Certain vertical directives relating to foods should be simplified in order to take account only of the essential requirements to be met by the products they cover in order that those products may move freely within the internal market, in accordance with the conclusions of the European Council held in Edinburgh on 11 and 12 December 1992, confirmed by those of the European Council in Brussels on 10 and 11 December 1993. (2) Council Directive 74/409/EEC of 22 July 1974 on the harmonisation of the laws of the Member States relating to honey(4) was justified by the fact that differences between national laws on the definition of honey, the various types of honey and the characteristics required of it could result in conditions of unfair competition likely to mislead consumers, and thereby have a direct effect on the establishment and functioning of the common market. (3) Directive 74/409/EEC and its subsequent amendments consequently established definitions, specified the different types of honey which could be placed on the market under appropriate names, laid down common rules on composition and determined the main labelling information so as to ensure the free movement of these products within the Community. (4) For the sake of clarity Directive 74/409/EEC should be recast, in order to make rules on the conditions for the production and marketing of honey more accessible and to bring it into line with general Community legislation on foodstuffs, particularly legislation on labelling, contaminants and methods of analysis. (5) The general food-labelling rules laid down in Directive 2000/13/EC of the European Parliament and of the Council(5) should apply subject to certain conditions. In view of the close link between the quality of honey and its origin, it is indispensable that full information on those matters be available so that the consumer is not misled regarding the quality of the product. The particular consumer interests as regards the geographical characteristics of honey and full transparency in this regard necessitate that the country of origin where the honey has been harvested should be included in the labelling. (6) No pollen or other individual ingredient of honey is to be removed, unless that is inevitable when organic and inorganic foreign materials are removed. That process may be carried out by filtering. Where such filtering leads to the removal of a significant quantity of pollen, the consumer must be correctly informed to that effect by means of an appropriate indication on the label. (7) Honey the name of which includes indications concerning floral, vegetable, regional, territorial or topographical origin or specific quality criteria may not have filtered honey added to it. So that the transparency of the market may be improved, the labelling of filtered honeys and baker's honeys must be mandatory for every transaction on the bulk market. (8) As the Commission stressed in its communication to the European Parliament and the Council of 24 June 1994 on European apiculture, the Commission may adopt methods of analysis to ensure compliance with the compositional characteristics and additional specific statements for all honey marketed in the Community. (9) It is desirable to take account of the work achieved on a new Codex standard for honey, adjusted, as appropriate, to the specific requirements of the Community. (10) In accordance with the principles of subsidiarity and proportionality established by Article 5 of the Treaty, the objective of laying down common definitions and rules for the products concerned and bringing the provisions into line with general Community legislation on foodstuffs cannot be sufficiently achieved by the Member States and can therefore, by reason of the nature of this Directive, be better achieved by the Community. This Directive does not go beyond what is necessary to achieve the said objective. (11) 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(6). (12) To avoid creating new barriers to free movement, Member States should refrain from adopting, for the products in question, national provisions not provided for by this Directive, Article 1 This Directive shall apply to the products defined in Annex I. These products shall meet the requirements set out in Annex II. Article 2 Directive 2000/13/EC shall apply to the products defined in Annex I, subject to the following conditions: 1. the term "honey" shall be applied only to the product defined in Annex I, point 1, and shall be used in trade to designate that product; 2. the product names referred to in Annex I, points 2 and 3, shall apply only to the products defined therein and shall be used in trade to designate them. These names may be replaced by the simple product name "honey", except in the case of filtered honey, comb honey, chunk honey or cut comb in honey and baker's honey. However, (a) in the case of baker's honey, the words "intended for cooking only" shall appear on the label in close proximity to the product name; (b) except in the case of filtered honey and baker's honey, the product names may be supplemented by information referring to: - floral or vegetable origin, if the product comes wholly or mainly from the indicated source and possesses the organoleptic, physico-chemical and microscopic characteristics of the source, - regional, territorial or topographical origin, if the product comes entirely from the indicated source, - specific quality criteria; 3. where baker's honey has been used as an ingredient in a compound foodstuff, the term "honey" may be used in the product name of the compound food instead of the term "baker's honey". However, in the list of ingredients, the term as referred to in Annex I, point 3, shall be used; 4. (a) the country or countries of origin where the honey has been harvested shall be indicated on the label. However, if the honey originates in more than one Member State or third country that indication may be replaced with one of the following, as appropriate: - "blend of EC honeys", - "blend of non-EC honeys", - "blend of EC and non-EC honeys". (b) For the purpose of Directive 2000/13/EC and in particular Articles 13, 14, 16 and 17 thereof, the particulars to be indicated according to subparagraph (a) shall be considered as indications according to Article 3 of that Directive. Article 3 In the case of filtered honey and baker's honey, bulk containers, packs and trade documents shall clearly indicate the full product name, as referred to in Annex I, point 2(b)(viii), and point 3. Article 4 The Commission may adopt methods to permit verification of compliance of honey with the provisions of this Directive. These methods shall be adopted in accordance with the procedure laid down in Article 7(2). Until the adoption of such methods, Member States shall, whenever possible, use internationally recognised validated methods such as those approved by Codex Alimentarius to verify compliance with the provisions of this Directive. Article 5 For the products defined in Annex I, Member States shall not adopt national provisions not provided for by this Directive. Article 6 The measures necessary for the implementation of this Directive relating to the matters referred to below shall be adopted in accordance with the procedure set out in Article 7(2): - bringing this Directive into line with general Community legislation on foodstuffs, - adaptations to technical progress. Article 7 1. The Commission shall be assisted by the Standing Committee on Foodstuffs (hereinafter referred to as "the Committee") set up by Article 1 of Decision 69/414/EEC(7). 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 8 Directive 74/409/EEC is hereby repealed with effect from 1 August 2003. References to the repealed Directive shall be construed as references to this Directive. Article 9 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 August 2003. They shall forthwith inform the Commission thereof. The measures shall be applied so as to: - authorise the marketing of the products defined in Annex I if they conform to the definitions and rules laid down in this Directive, with effect from 1 August 2003; - prohibit the marketing of products which fail to conform to this Directive, with effect from 1 August 2004. However, the marketing of products which fail to conform to this Directive and labelled before 1 August 2004 in accordance with Directive 74/409/EEC shall be permitted until stocks run out. When Member States adopt these measures, these 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 10 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 11 This Directive is addressed to the Member States.

32001L0114

2001

Council Directive 2001/114/EC of 20 December 2001 relating to certain partly or wholly dehydrated preserved milk 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 Economic and Social Committee(3), Whereas: (1) Certain vertical Directives relating to foodstuffs should be simplified to take account only of the essential requirements to be met by the products they cover so as to allow those products to move freely within the internal market, in accordance with the conclusions of the European Council held in Edinburgh on 11 and 12 December 1992, as confirmed by those of the European Council in Brussels on 10 and 11 December 1993. (2) Council Directive 76/118/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to certain partly or wholly dehydrated preserved milk for human consumption(4) was justified by the fact that differences between national laws concerning preserved milk could result in conditions of unfair competition likely to mislead consumers, and thereby have a direct effect on the establishment and functioning of the common market. (3) Directive 76/118/EEC was consequently designed to lay down definitions and common rules governing the composition, manufacturing specifications and labelling of certain preserved milk, so as to ensure its free movement within the Community. (4) Directive 76/118/EEC should be brought into line with general Community legislation on foodstuffs, particularly legislation on labelling, authorised additives, hygiene and the health rules laid down in Council Directive 92/46/EEC(5). (5) For the sake of clarity, Directive 76/118/EEC should be recast in order to make the rules on the conditions for the production and marketing of certain partly or wholly dehydrated preserved milk for human consumption more accessible. (6) The general food-labelling rules laid down in Directive 2000/13/EC of the European Parliament and of the Council(6) should apply subject to certain conditions. (7) Subject to Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs(7), the addition of vitamins to the products defined in this Directive is authorised in certain Member States. However, no decision can be taken to extend such authorisation to the Community as a whole. Member States are therefore free to authorise or prohibit the addition of vitamins to their national products although the free movement of goods within the Community is, in any case, to be guaranteed in accordance with the rules and principles deriving from the Treaty. (8) For products intended for infants, Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae(8) applies. (9) In accordance with the principles of subsidiarity and proportionality established by Article 5 of the Treaty, the objective of laying down common definitions and rules for the products concerned and bringing the provisions into line with general Community legislation on foodstuffs cannot be sufficiently achieved by the Member States and can therefore, by reason of the nature of this Directive, be better achieved by the Community. This Directive does not go beyond what is necessary in order to achieve the said objective. (10) 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(9). (11) To avoid creating new barriers to free movement, Member States should refrain from adopting, for the products in question, national provisions not provided for by this Directive, Article 1 This Directive shall apply to partly or wholly dehydrated preserved milk defined in Annex I. Article 2 Member States may, subject to Directive 90/496/EEC, authorise the addition of vitamins to the products defined in Annex I hereto. Article 3 Directive 2000/13/EC shall apply to the products defined in Annex I, subject to the following conditions. 1. (a) The product names listed in Annex I shall apply only to the products referred to therein and shall, without prejudice to subparagraph (b), be used in trade to designate them; (b) as an alternative to the product names referred to in subparagraph (a), Annex II provides a list of particular designations. These designations may be used in the language and under the conditions laid down in Annex II. 2. The labelling must state the percentage of milk fat, expressed by weight in relation to the finished product, except in the case of the products defined in Annex I(1)(d) and (g) and Annex I(2)(d), and the percentage of fat-free dried milk extract in the case of the products defined in Annex I(1). These particulars shall appear near the trade name. 3. In the case of the products defined in Annex I(2), the label must state the recommendations as to the method of dilution or reconstitution, including details of the fat content of the product thus diluted or reconstituted. 4. Where products weighing less than 20 g per unit are packed in an outer packaging, the particulars required by this Article need appear on the outer packaging only, except for the designation required by point 1(a). 5. The labelling of the products defined in Annex I(2) shall state that the product is "not intended as a food for infants under 12 months". Article 4 For the products defined in Annexes I and II, Member States shall not adopt national provisions not provided for by this Directive. Article 5 The measures necessary for the implementation of this Directive relating to the matters referred to below shall be adopted in accordance with the regulatory procedure referred to in Article 6(2): - bringing this Directive into line with general Community legislation on foodstuffs, - adaptations to technical progress. Article 6 1. The Commission shall be assisted by the Standing Committee on Foodstuffs (hereinafter referred to as "the Committee") set up by Article 1 of Decision 69/414/EEC(10). 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 7 Directive 76/118/EEC is hereby repealed with effect from 17 July 2003. References to the repealed Directive shall be construed as references to this Directive. Article 8 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 17 July 2003. They shall forthwith inform the Commission thereof. The measures shall be applied so as to: - authorise the marketing of the products defined in Annex I if they conform to the definitions and rules laid down in this Directive, with effect from 17 July 2003, - prohibit the marketing of products which fail to conform to this Directive, with effect from 17 July 2004. However, the marketing of products which fail to conform to this Directive but which were labelled before 17 July 2004 in accordance with Directive 76/118/EEC shall be permitted until stocks run out. When Member States adopt these measures these 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 reference shall be adopted by Member States. Article 9 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 10 This Directive is addressed to the Member States.

32002L0001

2002

Commission Directive 2002/1/EC of 7 January 2002 amending Directive 94/39/EC as regards animal feedingstuffs for the support of liver function in case of chronic liver insufficiency (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes(1), as last amended by Directive 1999/29/EC(2), and in particular Article 6(c) thereof, Whereas: (1) By Directive 94/39/EC(3), as amended by Directive 95/9/EC(4), the Commission has adopted a list of intended uses of animal feedingstuffs for particular nutritional purposes. (2) Further scientific research has demonstrated that there is no necessity to lower or moderate the level of fat in feedingstuffs intended to support liver function in chronic liver insufficiency for cats and dogs. It has however shown that it would be beneficial to indicate on the label the need for water to be available to animals fed with such feeds at all times. (3) Directive 94/39/EC should therefore be adapted accordingly. (4) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 The Annex to Directive 94/39/EC is amended in accordance with 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 20 November 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 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32001L0107

2002

Directive 2001/107/EC of the European Parliament and of the Council of 21 January 2002 amending Council Directive 85/611/EEC on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) with a view to regulating management companies and simplified prospectuses 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), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Council Directive 85/611/EEC of 20 December 1985 on undertakings for collective investment in transferable securities (UCITS)(4), has already contributed significantly to the achievement of the Single Market in this field, laying down - for the first time in the financial services sector - the principle of mutual recognition of authorisation and other provisions which facilitate the free circulation within the European Union of the units of the collective investment undertakings (unit trusts/common funds or as investment companies) covered by that Directive. (2) However, Directive 85/611/EEC does not regulate to a great extent the companies which manage collective investment undertakings (so-called "management companies"). In particular, Directive 85/611/EEC does not lay down provisions ensuring in all Member States equivalent market access rules and operating conditions for such companies. Directive 85/611/EEC does not lay down provisions regulating the establishment of branches and the free provision of services by such companies in Member States other than their home Member State. (3) Authorisation granted in the management company's home Member State should ensure investor protection and the solvency of management companies, with a view to contributing to the stability of the financial system. The approach adopted is to ensure the essential harmonisation necessary and sufficient to secure the mutual recognition of authorisation and of prudential supervision systems, making possible the grant of a single authorisation valid throughout the European Union and the application of the home Member State supervision. (4) It is necessary, for the protection of investors, to guarantee the internal overview of every management company in particular by means of a two-man management and by adequate internal control mechanisms. (5) In order to ensure that the management company will be able to fulfil the obligations arising from its activities and thus to ensure its stability, initial capital and an additional amount of own funds are required. To take account of developments, particularly those pertaining to capital charges on operational risk within the European Union and other international fora, these requirements, including the use of guarantees, will have to be reviewed within three years. (6) By virtue of mutual recognition, management companies authorised in their home Member States should be permitted to carry on the services for which they have received authorisation throughout the European Union by establishing branches or under the freedom to provide services. The approval of the fund rules of common funds/unit trusts falls within the competence of the management company's home Member State. (7) With regard to collective portfolio management (management of unit trusts/common funds and investment companies), the authorisation granted to a management company authorised in its home Member State should permit the company to carry on in host Member States the following activities: to distribute the units of the harmonised unit trusts/common funds managed by the company in its home Member State; to distribute the shares of the harmonised investment companies, managed by such a company; to perform all the other functions and tasks included in the activity of collective portfolio management; to manage the assets of investment companies incorporated in Member States other than its home Member State; to perform, on the basis of mandates, on behalf of management companies incorporated in Member States other than its home Member State, the functions included in the activity of collective portfolio management. (8) The principles of mutual recognition and of home Member State supervision require that the Member States' competent authorities should not grant or should withdraw authorisation where factors, such as the content of programmes of operations, the geographical distribution or the activities actually carried on indicate clearly that a management company 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 the territory of which it intends to carry on or does carry on the greater part of its activities. For the purpose of this Directive, a management company should be authorised in the Member State in which it has its registered office. In accordance with the principle of the home country control, only the Member State in which the management company has its registered office can be considered competent to approve the fund rules of unit trusts/common funds set up by such a company and the choice of the depositary. In order to prevent supervisory arbitrage and to promote confidence in the effectiveness of supervision by the home Member State authorities, a requirement for authorisation of a UCITS should be that it should not be prevented in any legal way from being marketed in its home Member State. This does not affect the free decision, once the UCITS has been authorised, to choose the Member State(s) where the units of the UCITS are to be marketed in accordance with this Directive. (9) Directive 85/611/EEC limits the scope of management companies to the sole activity of management of unit trusts/common funds and of investment companies (collective portfolio management). In order to take into account recent developments in national legislation of Member States and to permit such companies to achieve important economies of scale, it is desirable to revise this restriction. It is therefore desirable to permit such companies to carry out also the activity of management of portfolios of investments on a client-by-client basis (individual portfolio management) including the management of pension funds as well as some specific non-core activities linked to the main business. Such an extension of the scope of the activity of the management company would not prejudge the stability of such companies. However, specific rules should be introduced preventing conflicts of interest when management companies are authorised to carry on both the business of collective and individual portfolio management. (10) The activity of management of portfolios of investments is an investment service already covered by Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field(5). In order to ensure a homogeneous regulatory framework in this area, it is desirable to subject management companies, the authorisation of which also covers that service, to the operating conditions laid down in that Directive. (11) A home Member State may, as a general rule, establish rules stricter than those laid down in this Directive, in particular as regards authorisation conditions, prudential requirements and the rules on reporting and the full prospectus. (12) It is desirable to lay down rules defining the preconditions under which a management company may delegate, on the basis of mandates, specific tasks and functions to third parties so as to increase the efficiency of the conduct of its business. In order to ensure the correct functioning of the principles of mutual recognition of the authorisation and of the home country control, Member States permitting such delegations should ensure that the management company to which they granted an authorisation does not delegate globally its functions to one or more third parties, so as to become a letter box entity, and the existence of mandates does not hinder an effective supervision over the management company. However, the fact that the management company has delegated its own functions should in no case affect the liabilities of that company and of the depositary vis-à-vis the unit holders and the competent authorities. (13) To safeguard shareholders' interests and to secure a level playing field in the market for harmonised collective investment undertakings, an initial capital is required for investment companies. However, investment companies which have designated a management company will be covered through the management company's additional amount of own funds. (14) Articles 5g and 5h should always be complied with by authorised investment companies, either by the company directly according to Article 13b or indirectly, due to the fact that if an authorised investment company chooses to designate a management company, that management company should be authorised in accordance with the Directive and thus obliged to comply with Articles 5g and 5h. (15) To take into account developments of information techniques, it is desirable to revise the current information framework provided for in Directive 85/611/EEC. In particular, it is desirable to introduce, in addition to the existing full prospectus, a new type of prospectus for UCITS (simplified prospectus). Such a new prospectus should be designed to be investor-friendly and should therefore represent a source of valuable information for the average investor. Such a prospectus should give key information about the UCITS in a clear, concise and easily understandable way. However, the investor should always be informed, by an appropriate statement to be included in the simplified prospectus, that more detailed information is contained in the full prospectus and in the UCITS' yearly and half-yearly report, which can be obtained free of charge at his/her request. The simplified prospectus should always be offered free of charge to subscribers before the conclusion of the contract. This should be a sufficient precondition to meet the legal obligation under this Directive to provide information to subscribers before the conclusion of the contract. (16) There is a need to ensure a level playing field among intermediaries in the financial services area when providing the same services and to ensure a harmonised minimum degree of investor protection. A harmonised minimum degree of harmonisation of the conditions for taking up business and operating conditions represents the essential precondition for achieving the internal market for these operators. Therefore, only a binding Community Directive laying down agreed minimum standards in this respect can achieve the desired objectives. This Directive effects only the minimum harmonisation required, and 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. (17) The Commission may consider proposing codification in due time after adoption of the proposals, Article 1 Directive 85/611/EEC is hereby amended as follows: 1. the following Article 1a shall be inserted: "Article 1a For the purposes of this Directive: 1. 'depositary' shall mean any institution entrusted with the duties mentioned in Articles 7 and 14 and subject to the other provisions laid down in Sections IIIa and IVa; 2. 'management company' shall mean any company, the regular business of which is the management of UCITS in the form of unit trusts/common funds and/or of investment companies (collective portfolio management of UCITS); this includes the functions mentioned in Annex II; 3. a 'management company's home Member State' shall mean the Member State, in which the management company's registered office is situated; 4. a 'management company's host Member State' shall mean the Member State, other than the home Member State, within the territory of which a management company has a branch or provides services; 5. a 'UCITS home Member State' shall mean: (a) with regard to a UCITS constituted as unit trust/common fund, the Member State in which the management company's registered office is situated, (b) with regard to a UCITS constituted as investment company, the Member State in which the investment company's registered office is situated; 6. a 'UCITS host Member State' shall mean the Member State, other than the UCITS home Member State, in which the units of the common fund/unit trust or of the investment company are marketed; 7. 'branch' shall mean a place of business which is a part of the management company, which has no legal personality and which provides the services for which the management company has been authorised; all the places of business set up in the same Member State by a management company with headquarters in another Member State shall be regarded as a single branch; 8. 'competent authorities' shall mean the authorities which each Member State designates under Article 49 of this Directive; 9. 'close links' shall mean a situation as defined in Article 2(1) of Directive 95/26/EC(6); 10. 'qualifying holdings' shall mean any direct or indirect holding in a management company 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 management company in which that holding subsists. For the purpose of this definition, the voting rights referred to in Article 7 of Directive 88/627/EEC(7) shall be taken into account; 11. 'ISD' shall mean Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field(8); 12. 'parent undertaking' shall mean a parent undertaking as defined in Articles 1 and 2 of Directive 83/349/EEC(9); 13. '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 parent undertaking which is the ultimate parent of those undertakings; 14. 'initial capital' shall mean capital as defined in items 1 and 2 of Article 34(2) of Directive 2000/12/EC(10); 15. 'own funds' shall mean own funds as defined in Title V, Chapter 2, Section 1 of Directive 2000/12/EC; this definition may, however, be amended in the circumstances described in Annex V of Directive 93/6/EEC(11)."; 2. Article 4(3) shall be replaced by the following: "3. The competent authorities may not authorise a UCITS if the management company or the investment company do not comply with the preconditions laid down in this Directive, in Sections III and IV respectively. Moreover the competent authorities may not authorise a UCITS if the directors of the depositary are not of sufficiently good repute or are not sufficiently experienced also in relation to the type of UCITS to be managed. To that end, the names of the directors of the depositary and of every person succeeding them in office must be communicated forthwith to the competent authorities. Directors shall mean those persons who, under the law or the instruments of incorporation, represent the depositary, or who effectively determine the policy of the depositary. 3a. The competent authorities shall not grant authorisation if the UCITS is legally prevented (e.g. through a provision in the fund rules or instruments of incorporation) from marketing its units or shares in its home Member State."; 3. the title of Section III and Articles 5 and 6 shall be replaced by the following: "SECTION III Obligations regarding management companies Title A Conditions for taking up business Article 5 1. Access to the business of management companies is subject to prior official authorisation to be granted by the home Member State's competent authorities. Authorisation granted under this Directive to a management company shall be valid for all Member States. 2. No management company may engage in activities other than the management of UCITS authorised according to this Directive except the additional management of other collective investment undertakings which are not covered by this Directive and for which the management company is subject to prudential supervision but which cannot be marketed in other Member States under this Directive. The activity of management of unit trusts/common funds and of investment companies includes, for the purpose of this Directive, the functions mentioned in Annex II which are not exhaustive. 3. By way of derogation from paragraph 2, Member States may authorise management companies to provide, in addition to the management of unit trusts/common funds and of investment companies, the following services: (a) management of portfolios of investments, including those owned by pension funds, in accordance with mandates given by investors on a discretionary, client-by-client basis, where such portfolios include one or more of the instruments listed in Section B of the Annex to the ISD, (b) as non-core services: - investment advice concerning one or more of the instruments listed in Section B of the Annex to the ISD, - safekeeping and administration in relation to units of collective investment undertakings. Management companies may in no case be authorised under this Directive to provide only the services mentioned in this paragraph or to provide non-core services without being authorised for the service referred to in point (a). 4. Article 2(4), Article 8(2), Articles 10, 11 and 13 of the ISD shall apply to the provision of the services mentioned in paragraph 3 of this Article by management companies. Article 5a 1. Without prejudice to other conditions of general application laid down by national law, the competent authorities shall not grant authorisation to a management company unless: (a) the management company has an initial capital of at least EUR 125000: - When the value of the portfolios of the management company, exceeds EUR 250000000, the management company shall be required to provide an additional amount of own funds. This additional amount of own funds shall be equal to 0,02 % of the amount by which the value of the portfolios of the management company exceeds EUR 250000000. The required total of the initial capital and the additional amount shall not, however, exceed EUR 10000000. - For the purpose of this paragraph, the following portfolios shall be deemed to be the portfolios of the management company: (i) unit trusts/common funds managed by the management company including portfolios for which it has delegated the management function but excluding portfolios that it is managing under delegation; (ii) investment companies for which the management company is the designated management company; (iii) other collective investment undertakings managed by the management company including portfolios for which it has delegated the management function but excluding portfolios that it is managing under delegation. - Irrespective of the amount of these requirements, the own funds of the management company shall never be less than the amount prescribed in Annex IV of Directive 93/6/EEC. - Member States may authorise management companies not to provide up to 50 % of the additional amount of own funds referred to in the first indent if they benefit from a guarantee of the same amount given by a credit institution or an insurance undertaking. The credit institution or insurance undertaking must have its registered office in a Member State, or in a non-Member State provided that it is subject to prudential rules considered by the competent authorities as equivalent to those laid down in Community law. - No later than 13 February 2005, the Commission shall present a report to the European Parliament and the Council on the application of this capital requirement, accompanied where appropriate by proposals for its revision; (b) the persons who effectively conduct the business of a management company are of sufficiently good repute and are sufficiently experienced also in relation to the type of UCITS managed by the management company. To that end, the names of these persons and of every person succeeding them in office must be communicated forthwith to the competent authorities. The conduct of a management company's business must be decided by at least two persons meeting such conditions; (c) the application for authorisation is accompanied by a programme of activity setting out, inter alia, the organisational structure ofhe management company; (d) both its head office and its registered office are located in the same Member State. 2. Moreover where close links exist between the management company and other natural or legal persons, the competent authorities shall grant authorisation only if those 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 management company has close links, or difficulties involved in their enforcement, prevent the effective exercise of their supervisory functions. The competent authorities shall require management companies to provide them with the information they require to monitor compliance with the conditions referred to in this paragraph on a continuous basis. 3. An applicant shall be informed, within six months of the submission of a complete application, whether or not authorisation has been granted. Reasons shall be given whenever an authorisation is refused. 4. A management company may start business as soon as authorisation has been granted. 5. The competent authorities may withdraw the authorisation issued to a management company subject to this Directive only where that company: (a) does not make use of the authorisation within 12 months, expressly renounces the authorisation or has ceased the activity covered by this Directive more than six months previously unless the Member State concerned has provided for authorisation to lapse in such cases; (b) has obtained the authorisation by making false statements or by any other irregular means; (c) no longer fulfils the conditions under which authorisation was granted; (d) no longer complies with Directive 93/6/EEC if its authorisation also covers the discretionary portfolio management service referred to in Article 5(3)(a) of this Directive; (e) has seriously and/or systematically infringed the provisions adopted pursuant to this Directive; or (f) falls within any of the cases where national law provides for withdrawal. Article 5b 1. The competent authorities shall not grant authorisation to take up the business of management companies until they have been informed of the identities of the shareholders or members, whether direct or indirect, natural or legal persons, that have qualifying holdings and of the amounts of those holdings. The competent authorities shall refuse authorisation if, taking into account the need to ensure the sound and prudent management of a management company, they are not satisfied as to the suitability of the aforementioned shareholders or members. 2. In the case of branches of management companies that have registered offices outside the European Union and are starting or carrying on business, the Member States shall not apply provisions that result in treatment more favourable than that accorded to branches of management companies that have registered offices in Member States. 3. The competent authorities of the other Member State involved shall be consulted beforehand on the authorisation of any management company which is: (a) a subsidiary of another management company, an investment firm, a credit institution or an insurance undertaking authorised in another Member State, (b) a subsidiary of the parent undertaking of another management company, an investment firm, a credit institution or an insurance undertaking authorised in another Member State, or (c) controlled by the same natural or legal persons as control another management company, an investment firm, a credit institution or an insurance undertaking authorised in another Member State. Title B Relations with third countries Article 5c 1. Relations with third countries shall be regulated in accordance with the relevant rules laid down in Article 7 of the ISD. For the purpose of this Directive, the expressions 'firm/investment firm' and 'investment firms' contained in Article 7 of the ISD shall be construed respectively as 'management company' and 'management companies'; the expression 'providing investment services' in Article 7(2) of the ISD shall be construed as 'providing services'. 2. The Member States shall also inform the Commission of any general difficulties which UCITS encounter in marketing their units in any third country. Title C Operating conditions Article 5d 1. The competent authorities of the management company's home Member State shall require that the management company which they have authorised complies at all times with the conditions laid down in Article 5 and Article 5a(1) and (2) of this Directive. The own funds of a management company may not fall below the level specified in Article 5a(1)(a). If they do, however, the competent authorities may, where the circumstances justify it, allow such firms a limited period in which to rectify their situations or cease their activities. 2. The prudential supervision of a management company shall be the responsibility of the competent authorities of the home Member State, whether the management company establishes a branch or provides services in another Member State or not, without prejudice to those provisions of this Directive which give responsibility to the authorities of the host country. Article 5e 1. Qualifying holdings in management companies shall be subject to the same rules as those laid down in Article 9 of the ISD. 2. For the purpose of this Directive, the expressions 'firm/investment firm' and 'investment firms' contained in Article 9 of the ISD shall be construed respectively as 'management company' and 'management companies'. Article 5f 1. Each home Member State shall draw up prudential rules which management companies, with regard to the activity of management of UCITS authorised according to this Directive, shall observe at all times. In particular, the competent authorities of the home Member State having regard also to the nature of the UCITS managed by a management company, shall require that each such company: (a) has sound administrative and accounting procedures, control and safeguard arrangements for electronic data processing and adequate internal control mechanisms including, in particular, rules for personal transactions by its employees or for the holding or management of investments in financial instruments in order to invest own funds and ensuring, inter alia, that each transaction involving the fund may be reconstructed according to its origin, the parties to it, its nature, and the time and place at which it was effected and that the assets of the unit trusts/common funds or of the investment companies managed by the management company are invested according to the fund rules or the instruments of incorporation and the legal provisions in force; (b) is structured and organised in such a way as to minimise the risk of UCITS' or clients' interests being prejudiced by conflicts of interest between the company and its clients, between one of its clients and another, between one of its clients and a UCITS or between two UCITS. Nevertheless, where a branch is set up, the organisational arrangements may not conflict with the rules of conduct laid down by the host Member State to cover conflicts of interest. 2. Each management company the authorisation of which also covers the discretionary portfolio management service mentioned in Article 5(3)(a): - shall not be permitted to invest all or a part of the investor's portfolio in units of unit trusts/common funds or of investment companies it manages, unless it receives prior general approval from the client, - shall be subject with regard to the services referred to in Article 5(3) to the provisions laid down in Directive 97/9/EC of the European Parliament and of the Council of 3 March 1997 on investor-compensation schemes(12). Article 5g 1. If Member States permit management companies to delegate to third parties for the purpose of a more efficient conduct of the companies' business to carry out on their behalf one or more of their own functions the following preconditions have to be complied with: (a) the competent authority must be informed in an appropriate manner; (b) the mandate shall not prevent the effectiveness of supervision over the management company, and in particular it must not prevent the management company from acting, or the UCITS from being managed, in the best interests of its investors; (c) when the delegation concerns the investment management, the mandate may only be given to undertakings which are authorised or registered for the purpose of asset management and subject to prudential supervision; the delegation must be in accordance with investment-allocation criteria periodically laid down by the management companies; (d) where the mandate concerns the investment management and is given to a third-country undertaking, cooperation between the supervisory authorities concerned must be ensured; (e) a mandate with regard to the core function of investment management shall not be given to the depositary or to any other undertaking whose interests may conflict with those of the management company or the unit-holders; (f) measures shall exist which enable the persons who conduct the business of the management company to monitor effectively at any time the activity of the undertaking to which the mandate is given; (g) the mandate shall not prevent the persons who conduct the business of the management company to give at any time further instructions to the undertaking to which functions are delegated and to withdraw the mandate with immediate effect when this is in the interest of investors; (h) having regard to the nature of the functions to be delegated, the undertaking to which functions will be delegated must be qualified and capable of undertaking the functions in question, and (i) the UCITS' prospectuses list the functions which the management company has been permitted to delegate. 2. In no case shall the management company's and the depositary's liability be affected by the fact that the management company delegated any functions to third parties, nor shall the management company delegate its functions to the extent that it becomes a letter box entity. Article 5h Each Member State shall draw up rules of conduct which management companies authorised in that Member State shall observe at all times. Such rules must implement at least the principles set out in the following indents. These principles shall ensure that a management company: (a) acts honestly and fairly in conducting its business activities in the best interests of the UCITS it manages and the integrity of the market; (b) acts with due skill, care and diligence, in the best interests of the UCITS it manages and the integrity of the market; (c) has and employs effectively the resources and procedures that are necessary for the proper performance of its business activities; (d) tries to avoid conflicts of interests and, when they cannot be avoided, ensures that the UCITS it manages are fairly treated, and (e) complies with all regulatory requirements applicable to the conduct of its business activities so as to promote the best interests of its investors and the integrity of the market. Title D The right of establishment and the freedom to provide services Article 6 1. Member States shall ensure that a management company, authorised in accordance with this Directive by the competent authorities of another Member State, may carry on within their territories the activity for which it has been authorised, either by the establishment of a branch or under the freedom to provide services. 2. Member States may not make the establishment of a branch or the provision of the services subject to any authorisation requirement, to any requirement to provide endowment capital or to any other measure having equivalent effect. Article 6a 1. In addition to meeting the conditions imposed in Articles 5 and 5a, any management company wishing to establish a branch within the territory of another Member State shall notify the competent authorities of its home Member State. 2. Member States shall require every management company wishing to establish a branch within the territory of another Member State to provide the following information and documents, when effecting the notification provided for in paragraph 1: (a) the Member State within the territory of which the management company plans to establish a branch; (b) a programme of operations setting out the activities and services according to Article 5(2) and (3) envisaged and the organisational structure of the branch; (c) the address in the host Member State from which documents may be obtained; (d) the names of those responsible for the management of the branch. 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 a management company, taking into account the activities envisaged, they shall, within three months of receiving all the information referred to in paragraph 2, communicate that information to the competent authorities of the host Member State and shall inform the management company accordingly. They shall also communicate details of any compensation scheme intended to protect investors. 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 host Member State, they shall give reasons for their refusal to the management company concerned within two months of receiving all the information. That refusal or failure to reply shall be subject to the right to apply to the courts in the home Member State. 4. Before the branch of a management company starts business, the competent authorities of the host Member State shall, within two months of receiving the information referred to in paragraph 2, prepare for the supervision of the management company and, if necessary, indicate the conditions, including the rules mentioned in Articles 44 and 45 in force in the host Member State and the rules of conduct to be respected in the case of provision of the portfolio management service mentioned in Article 5(3) and of investment advisory services and custody, under which, in the interest of the general good, that business must be carried on in the host Member State. 5. On receipt of a communication from the competent authorities of the host Member State or on the expiry of the period provided for in paragraph 4 without receipt of any communication from those authorities, the branch may be established and start business. From that moment the management company may also begin distributing the units of the unit trusts/common funds and of the investment companies subject to this Directive which it manages, unless the competent authorities of the host Member State establish, in a reasoned decision taken before the expiry of that period of two months - to be communicated to the competent authorities of the home Member State - that the arrangements made for the marketing of the units do not comply with the provisions referred to in Article 44(1) and Article 45. 6. In the event of change of any particulars communicated in accordance with paragraphs 2(b), (c) or (d), a management company shall give written notice of that change to the competent authorities of the home and host Member States at least one month before implementing the change so that the competent authorities of the home Member State may take a decision on the change under paragraph 3 and the competent authorities of the host Member State may do so under paragraph 4. 7. In the event of a change in the particulars communicated in accordance with the first subparagraph of paragraph 3, the authorities of the home Member State shall inform the authorities of the host Member State accordingly. Article 6b 1. Any management company wishing to carry on business within the territory of another Member State for the first time under the freedom to provide services shall communicate the following information to the competent authorities of its home Member State: (a) the Member State within the territory of which the management company intends to operate; (b) a programme of operations stating the activities and services referred to in Article 5(2) and (3) envisaged. 2. The competent authorities of the home Member State shall, within one month of receiving the information referred to in paragraph 1, forward it to the competent authorities of the host Member State. They shall also communicate details of any applicable compensation scheme intended to protect investors. 3. The management company may then start business in the host Member State notwithstanding the provisions of Article 46. When appropriate, the competent authorities of the host Member State shall, on receipt of the information referred to in paragraph 1, indicate to the management company the conditions, including the rules of conduct to be respected in the case of provision of the portfolio management service mentioned in Article 5(3) and of investment advisory services and custody, with which, in the interest of the general good, the management company must comply in the host Member State. 4. Should the content of the information communicated in accordance with paragraph 1(b) be amended, the management company shall give notice of the amendment in writing to the competent authorities of the home Member State and of the host Member State before implementing the change, so that the competent authorities of the host Member State may, if necessary, inform the company of any change or addition to be made to the information communicated under paragraph 3. 5. A management company shall also be subject to the notification procedure laid down in this Article in cases where it entrusts a third party with the marketing of the units in a host Member State. Article 6c 1. Host Member States may, for statistical purposes, require all management companies with branches within their territories to report periodically on their activities in those host Member States to the competent authorities of those host Member States. 2. In discharging their responsibilities under this Directive, host Member States may require branches of management companies to provide the same particulars as national management companies for that purpose. Host Member States may require management companies, carrying on business within their territories under the freedom to provide services, to provide the information necessary for the monitoring of their compliance with the standards set by the host Member State that apply to them, although those requirements may not be more stringent than those which the same Member State imposes on established management companies for the monitoring of their compliance with the same standards. 3. Where the competent authorities of a host Member State ascertain that a management company that has a branch or provides services within its territory is in breach of the legal or regulatory provisions adopted in that State pursuant to those provisions of this Directive which confer powers on the host Member State's competent authorities, those authorities shall require the management company concerned to put an end to its irregular situation. 4. If the management company concerned fails to take the necessary steps, the competent authorities of the host Member State shall inform the competent authorities of the home Member State accordingly. The latter shall, at the earliest opportunity, take all appropriate measures to ensure that the management company concerned puts an end to its irregular situation. The nature of those measures shall be communicated to the competent authorities of the host Member State. 5. If, despite the measures taken by the home Member State or because such measures prove inadequate or are not available in the Member State in question, the management company persists in breaching the legal or regulatory provisions referred to in paragraph 2 in force in the host Member State, the latter may, after informing the competent authorities of the home Member State, take appropriate measures to prevent or to penalise further irregularities and, insofar as necessary, to prevent that management company from initiating any further transaction within its territory. The Member States shall ensure that within their territories it is possible to serve the legal documents necessary for those measures on management companies. 6. The foregoing provisions shall not affect the powers of 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 management companies from initiating any further transactions within their territories. 7. Any measure adopted pursuant to paragraphs 4, 5 or 6 involving penalties or restrictions on the activities of a management company must be properly justified and communicated to the management company concerned. Every such measure shall be subject to the right to apply to the courts in the Member State which adopted it. 8. Before following the procedure laid down in paragraphs 3, 4 or 5 the competent authorities of the host Member State may, in emergencies, take any precautionary measures necessary to protect the interests of investors and others for whom services are provided. The Commission and the competent authorities of the other Member States concerned must be informed of such measures at the earliest opportunity. After consulting the competent authorities of the Member States concerned, the Commission may decide that the Member State in question must amend or abolish those measures. 9. In the event of the withdrawal of authorisation, the competent authorities of the host Member State shall be informed and shall take appropriate measures to prevent the management company concerned from initiating any further transactions within its territory and to safeguard investors' interests. Every two years the Commission shall submit a report on such cases to the Contact Committee set up under Article 53. 10. The Member States shall inform the Commission of the number and type of cases in which there have been refusals pursuant to Article 6a or measures have been taken in accordance with paragraph 5. Every two years the Commission shall submit a report on such cases to the Contact Committee set up under Article 53."; 4. the following shall be inserted before Article 7: "SECTION IIIa Obligations regarding the depositary"; 5. the title of Section IV and Article 12 shall be replaced by the following: "SECTION IV Obligations regarding investment companies Title A Conditions for taking up business Article 12 Access to the business of investment companies shall be subject to prior official authorisation to be granted by the home Member States competent authorities. The Member States shall determine the legal form which an investment company must take."; 6. the following Articles shall be inserted after Article 13: "Article 13a 1. Without prejudice to other conditions of general application laid down by national law, the competent authorities shall not grant authorisation to an investment company that has not designated a management company unless the investment company has a sufficient initial capital of at least EUR 300000. In addition, when an investment company has not designated a management company authorised pursuant to this Directive: - the authorisation shall not be granted unless the application for authorisation is accompanied by a programme of activity setting out, inter alia, the organisational structure of the investment company; - the directors of the investment company shall be of sufficiently good repute and be sufficiently experienced also in relation to the type of business carried out by the investment company. To that end, the names of the directors and of every person succeeding them in office must be communicated forthwith to the competent authorities. The conduct of an investment company's business must be decided by at least two persons meeting such conditions. Directors shall mean those persons who, under the law or the instruments of incorporation, represent the investment company, or who effectively determine the policy of the company; - moreover, where close links exist between the investment company and other natural or legal persons, the competent authorities shall grant authorisation only if those 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 investment company has close links, or difficulties involved in their enforcement, prevent the effective exercise of their supervisory functions. The competent authorities shall require investment companies to provide them with the information they require. 2. An applicant shall be informed, within six months of the submission of a complete application, whether or not authorisation has been granted. Reasons shall be given whenever an authorisation is refused. 3. An investment company may start business as soon as authorisation has been granted. 4. The competent authorities may withdraw the authorisation issued to an investment company subject to this Directive only where that company: (a) does not make use of the authorisation within 12 months, expressly renounces the authorisation or has ceased the activity covered by this Directive more than 6 months previously unless the Member State concerned has provided for authorisation to lapse in such cases; (b) has obtained the authorisation by making false statements or by any other irregular means; (c) no longer fulfils the conditions under which authorisation was granted; (d) has seriously and/or systematically infringed the provisions adopted pursuant to this Directive; or (e) falls within any of the cases where national law provides for withdrawal. Title B Operating conditions Article 13b Articles 5g and 5h shall apply to investment companies that have not designated a management company authorised pursuant to this Directive. For the purpose of this Article 'management company' shall be construed as 'investment company'. Investment companies may only manage assets of their own portfolio and may not, under any circumstances, receive any mandate to manage assets on behalf of a third party. Article 13c Each home Member State shall draw up prudential rules which shall be observed at all times by investment companies that have not designated a management company authorised pursuant to this Directive. In particular, the competent authorities of the home Member State, having regard also to the nature of the investment company, shall require that the company has sound administrative and accounting procedures, control and safeguard arrangements for electronic data processing and adequate internal control mechanisms including, in particular, rules for personal transactions by its employees or for the holding or management of investments in financial instruments in order to invest its initial capital and ensuring, inter alia, that each transaction involving the company may be reconstructed according to its origin, the parties to it, its nature, and the time and place at which it was effected and that the assets of the investment company are invested according to the instruments of incorporation and the legal provisions in force."; 7. the following shall be inserted before Article 14: "SECTION IVa Obligations regarding the depositary"; 8. Article 27(1) shall be replaced by the following: "1. An investment company and, for each of the unit trusts and common funds it manages, a management company, must publish: - a simplified prospectus, - a full prospectus, - an annual report for each financial year, and - a half-yearly report covering the first six months of the financial year."; 9. Article 28 shall be replaced by the following: "Article 28 1. Both the simplified and the full prospectuses must include the information necessary for investors to be able to make an informed judgement of the investment proposed to them, and, in particular, of the risks attached thereto. The latter shall include, independent of the instruments invested in, a clear and easily understandable explanation of the fund's risk profile. 2. The full prospectus shall contain at least the information provided for in Schedule A, Annex I to this Directive, in so far as that information does not already appear in the fund rules or instruments of incorporation annexed to the full prospectus in accordance with Article 29(1). 3. The simplified prospectus shall contain in summary form the key information provided for in Schedule C, Annex I to this Directive. It shall be structured and written in such a way that it can be easily understood by the average investor. Member States may permit that the simplified prospectus be attached to the full prospectus as a removable part of it. The simplified prospectus can be used as a marketing tool designed to be used in all Member States without alterations except translation. Member States may therefore not require any further documents or additional information to be added. 4. Both the full and the simplified prospectus may be incorporated in a written document or in any durable medium having an equivalent legal status approved by the competent authorities. 5. The annual report must include a balance-sheet or a statement of assets and liabilities, a detailed income and expenditure account for the financial year, a report on the activities of the financial year and the other information provided for in Schedule B, Annex I to this Directive, as well as any significant information which will enable investors to make an informed judgment on the development of the activities of the UCITS and its results. 6. The half-yearly report must include at least the information provided for in Chapters I to IV of Schedule B, Annex I to this Directive; where a UCITS has paid or proposes to pay an interim dividend, the figures must indicate the results after tax for the half-year concerned and the interim dividend paid or proposed."; 10. Article 29 shall be replaced by the following: "Article 29 1. The fund rules or an investment company's instruments of incorporation shall form an integral part of the full prospectus and must be annexed thereto. 2. The documents referred to in paragraph 1 need not, however, be annexed to the full prospectus provided that the unit-holder is informed that on request he or she will be sent those documents or be apprised of the place where, in each Member State in which the units are placed on the market, he or she may consult them."; 11. Article 30 shall be replaced by the following: "Article 30 The essential elements of the simplified and the full prospectuses must be kept up to date."; 12. Article 32 shall be replaced by the following: "Article 32 UCITS must send their simplified and full prospectuses and any amendments thereto, as well as their annual and half-yearly reports, to the competent authorities."; 13. Article 33 shall be replaced by the following: "Article 33 1. The simplified prospectus must be offered to subscribers free of charge before the conclusion of the contract. In addition, the full prospectus and the latest published annual and half-yearly reports shall be supplied to subscribers free of charge on request. 2. The annual and half-yearly reports shall be supplied to unit-holders free of charge on request. 3. The annual and half-yearly reports must be available to the public at the places, or through other means approved by the competent authorities, specified in the full and simplified prospectus."; 14. Article 35 shall be replaced by the following: "Article 35 All publicity comprising an invitation to purchase the units of UCITS must indicate that prospectuses exist and the places where they may be obtained by the public or how the public may have access to them."; 15. Article 46 shall be replaced by the following: "Article 46 If a UCITS proposes to market its units in a Member State other than that in which it is situated, it must first inform the competent authorities of that other Member State accordingly. It must simultaneously send the latter authorities: - an attestation by the competent authorities to the effect that it fulfils the conditions imposed by this Directive, - its fund rules or its instruments of incorporation, - its full and simplified prospectuses, - where appropriate, its latest annual report and any subsequent half-yearly report, and - details of the arrangements made of the marketing of its units in that other Member State. An investment company or a management company may begin to market its units in that other Member State two months after such communication, unless the authorities of the Member States concerned establish, in a reasoned decision taken before the expiry of that period of two months, that the arrangements made for the marketing of units do not comply with the provisions referred to in Article 44(1) and Article 45."; 16. Article 47 shall be replaced by the following: "Article 47 If a UCITS markets its units in a Member State other than that in which it is situated, it must distribute in that other Member State, in accordance with the same procedures as those provided for in the home Member State, the full and simplified prospectuses, the annual and half-yearly reports and the other information provided for in Articles 29 and 30. These documents shall be provided in the or one of the official languages of the host Member State or in a language approved by the competent authorities of the host Member State."; 17. the following Articles shall be added after Article 52: "Article 52a 1. Where, through the provision of services or by the establishment of branches, a management company operates in one or more host Member States, the competent authorities of all the Member States concerned shall collaborate closely. They shall supply one another on request with all the information concerning the management and ownership of such management companies that is likely to facilitate their supervision and all information likely to facilitate the monitoring of such companies. In particular, the authorities of the home Member State shall cooperate to ensure that the authorities of the host Member State collect the particulars referred to in Article 6c(2). 2. Insofar as it is necessary for the purpose of exercising their powers of supervision, the competent authorities of the home Member State shall be informed by the competent authorities of the host Member State of any measures taken by the host Member State pursuant to Article 6c(6) which involve penalties imposed on a management company or restrictions on a management company's activities. Article 52b 1. Each host Member State shall ensure that, where a management company authorised in another Member State carries on business within its territory through a branch, the competent authorities of the management company's home Member State may, after informing the competent authorities of the host Member State, themselves or through the intermediary of persons they instruct for the purpose, carry out on-the-spot verification of the information referred to in Article 52a. 2. The competent authorities of the management company's home Member State may also ask the competent authorities of the management company's host Member State to have such verification carried out. Authorities which receive such requests must, within the framework of their powers, act upon them by carrying out the verifications themselves, by allowing the authorities who have requested them to carry them out or by allowing auditors or experts to do so. 3. This Article shall not affect the right of the competent authorities of the host Member State, in discharging their responsibilities under this Directive, to carry out on-the-spot verifications of branches established within their territory."; 18. the Annex to Directive 85/611/EEC shall be re-numbered as Annex I; 19. Schedule A of Annex I shall be amended as follows: 1. Under the column "Information concerning the investment company", after paragraph 1.2, the following shall be added: "1.3. In the case of investment companies having different investment compartments, the indication of the compartments." 2. Under the column "Information concerning the investment company", in paragraph 1.13, the following sentence shall be added: "In the case of investment companies having different investment compartments, information on how a unit-holder may pass from one compartment into another and the charges applicable in such cases." 3. The following paragraphs shall be added after paragraph 4: "5. Other investment information 5.1. Historical performance of the unit trust/common fund or of the investment company (where applicable) - such information may be either included in or attached to the prospectus; 5.2. Profile of the typical investor for whom the unit trust/common fund or the investment company is designed. 6. Economic information 6.1. Possible expenses or fees, other than the charges mentioned in paragraph 1.17, distinguishing between those to be paid by the unit-holder and those to be paid out of the unit trust's/common fund's or of the investment company's assets."; 20. the text of Annex I to this Directive shall be added to Annex I to Directive 85/611/EEC; 21. Annex II to this Directive shall be added as Annex II to Directive 85/611/EEC. Transitional and final provisions Article 2 1. Investment firms, as defined in Article 1(2) of Directive 93/22/EEC, authorised to carry out only the services provided for in Section A(3) and in Section C(1) and (6) of the Annex to that Directive, may obtain authorisation under this Directive to manage unit trusts/common funds and investment companies and to qualify themselves as "management companies". In that case, such investment firms must give up the authorisation obtained under Directive 93/22/EEC. 2. Management companies already authorised before 13 February 2004 in their home Member State under Directive 85/611/EEC to manage UCITS in the form of unit trusts/common funds and investment companies shall be deemed to be authorised for the purposes of this Directive if the laws of those Member States provide that to take up such activity they must comply with conditions equivalent to those imposed in Articles 5a and 5b. 3. Management companies, already authorised before 13 February 2004, which are not included among those referred to in paragraph 2 may continue such activity provided that, no later than 13 February 2007 and pursuant to the provisions of their home Member State, they obtain authorisation to continue such activity in accordance with the provisions adopted in implementation of this Directive. Only the grant of such authorisation shall enable such management companies to qualify under the provisions of this Directive on the right of establishment and the freedom to provide services. Article 3 No later than 13 August 2003 Member States shall adopt the laws, regulations and administrative provisions necessary for them to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply these measures no later than 13 February 2004. 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. Article 4 This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32001L0108

2002

Directive 2001/108/EC of the European Parliament and of the Council of 21 January 2002 amending Council Directive 85/611/EEC on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS), with regard to investments of UCITS 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), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) The scope of Council Directive 85/611/EEC(4) was confined initially to collective investment undertakings of the open-ended type which promote the sale of their units to the public in the Community and the sole object of which is investment in transferable securities (UCITS). It was envisaged in the preamble to Directive 85/611/EEC that collective investment undertakings falling outside its scope would be the subject of coordination at a later stage. (2) Taking into account market developments, it is desirable that the investment objective of UCITS be widened in order to permit them to invest in financial instruments, other than transferable securities, which are sufficiently liquid. The financial instruments which are eligible to be investment assets of the portfolio of the UCITS are listed in this Directive. The selection of investments for a portfolio by means of an index is a management technique. (3) The definition of transferable securities included in this Directive is valid only for this Directive and in no way affects the various definitions used in national legislation for other purposes such as taxation. Consequently, shares and other securities equivalent to shares issued by bodies such as building societies and industrial and provident societies, the ownership of which cannot in practice be transferred except by the issuing body buying them back, are not covered by this definition. (4) Money market instruments cover those transferable instruments which are normally not traded on regulated markets but dealt in on the money market, for example treasury and local authority bills, certificates of deposit, commercial paper, medium-term notes and bankers' acceptances. (5) It is useful to ensure that the concept of regulated market in this Directive corresponds to that in Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field(5). (6) It is desirable to permit a UCITS to invest its assets in units of UCITS and/or other collective investment undertakings of the open-ended type which also invest in liquid financial assets mentioned in this Directive and which operate on the principle of risk spreading. It is necessary that UCITS or other collective investment undertakings in which a UCITS invests be subject to effective supervision. (7) The development of opportunities for a UCITS to invest in UCITS and in other collective investment undertakings should be facilitated. It is therefore essential to ensure that such investment activity does not diminish investor protection. Owing to the enhanced possibilities for UCITS to invest in the units of other UCITS and/or collective investment undertakings, it is necessary to lay down certain rules on quantitative limits, the disclosure of information and prevention of the cascade phenomenon. (8) To take market developments into account and in consideration of the completion of economic and monetary union it is desirable to permit UCITS to invest in bank deposits. To ensure adequate liquidity of investments in deposits, these deposits are to be repayable on demand or have the right to be withdrawn. If the deposits are made with a credit institution the registered office of which is located in a non-Member State, the credit institution should be subject to prudential rules equivalent to those laid down in Community legislation. (9) In addition to the case in which a UCITS invests in bank deposits according to its fund rules or instruments of incorporation, it may be necessary to allow all UCITS to hold ancillary liquid assets, such as bank deposits at sight. The holding of such ancillary liquid assets may be justified, for example, in the following cases: in order to cover current or exceptional payments; in the case of sales, for the time necessary to reinvest in transferable securities, money market instruments and/or in other financial assets provided for in this Directive; for a period of time strictly necessary when, because of unfavourable market conditions, the investment in transferable securities, money market instruments and in other financial assets must be suspended. (10) For prudential reasons it is necessary to avoid excessive concentration by a UCITS in investments which expose them to counterparty risk to the same entity or to entities belonging to the same group. (11) UCITS should be explicitly permitted, as part of their general investment policy and/or for hedging purposes in order to reach a set financial target or the risk profile indicated in the prospectus, to invest in financial derivative instruments. In order to ensure investor protection, it is necessary to limit the maximum potential exposure relating to derivative instruments so that it does not exceed the total net value of the UCITS's portfolio. In order to ensure constant awareness of the risks and commitments arising from derivative transactions and to check compliance with investment limits, these risks and commitments will have to be measured and monitored on an ongoing basis. Finally, in order to ensure investor protection through disclosure, UCITS should describe their strategies, techniques and investment limits governing their derivative operations. (12) With regard to over-the-counter (OTC) derivatives, additional requirements should be set in terms of the eligibility of counterparties and instruments, liquidity and ongoing assessment of the position. The purpose of such additional requirements is to ensure an adequate level of investor protection, close to that which they obtain when they acquire derivatives dealt in on regulated markets. (13) Operations in derivatives may never be used to circumvent the principles and rules set out in this Directive. With regard to OTC derivatives, additional risk-spreading rules should apply to exposures to a single counterparty or group of counterparties. (14) Some portfolio management techniques for collective investment undertakings investing primarily in shares and/or debt securities are based on the replication of stock indices and/or debt-security indices. It is desirable to permit UCITS to replicate well-known and recognised stock indices and/or debt-security indices. It may therefore be necessary to introduce more flexible risk-spreading rules for UCITS investing in shares and/or debt securities to this end. (15) Collective investment undertakings falling within the scope of this Directive should not be used for purposes other than the collective investment of the money raised from the public according to the rules laid down in this Directive. In the cases identified by this Directive a UCITS may have subsidiaries only when necessary to carry out effectively on behalf of that UCITS certain activities, also defined in this Directive. It is necessary to ensure an effective supervision of UCITS. Therefore the establishment of a subsidiary of a UCITS in a third country should be permitted only in the cases and under the conditions identified in the Directive. The general obligation to act solely in the interests of unit-holders and, in particular, the objective of increasing cost efficiencies, never justify a UCITS undertaking measures which may hinder the competent authorities from exercising effectively their supervisory functions. (16) There is a need to ensure the free cross-border marketing of the units of a wider range of collective investment undertakings, while providing a uniform minimum level of investor protection. Therefore, only a binding Community Directive laying down agreed minimum standards can achieve the desired objectives. This Directive effects only the minimum harmonisation required and 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. (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(6). (18) The Commission may consider proposing codification in due course after the adoption of the proposals, Article 1 Directive 85/611/EEC is hereby amended as follows: 1. in Article 1(2), the first indent shall be replaced by the following: "- the sole object of which is the collective investment in transferable securities and/or in other liquid financial assets referred to in Article 19(1) of capital raised from the public and which operates on the principle of risk-spreading and"; 2. in Article 1 the following paragraphs shall be added: "8. For the purposes of this Directive, 'transferable securities' shall mean: - shares in companies and other securities equivalent to shares in companies ('shares'), - bonds and other forms of securitised debt ('debt securities'), - any other negotiable securities which carry the right to acquire any such transferable securities by subscription or exchange, excluding the techniques and instruments referred to in Article 21. 9. For the purposes of this Directive 'money market instruments' shall mean instruments normally dealt in on the money market which are liquid, and have a value which can be accurately determined at any time."; 3. Article 19(1)(a) shall be replaced by the following: "(a) transferable securities and money market instruments admitted to or dealt in on a regulated market within the meaning of Article 1(13) of the ISD, and/or"; 4. in Article 19(1)(b) and (c), the words "and money market instruments" shall be added after the words "transferable securities"; 5. in Article 19(1): - the terms "and/or" shall be added to the end of point (d), - the following points shall be added: "(e) units of UCITS authorised according to this Directive and/or other collective investment undertakings within the meaning of the first and second indent of Article 1(2), should they be situated in a Member State or not, provided that: - such other collective investment undertakings are authorised under laws which provide that they are subject to supervision considered by the UCITS' competent authorities to be equivalent to that laid down in Community law, and that cooperation between authorities is sufficiently ensured, - the level of protection for unit-holders in the other collective investment undertakings is equivalent to that provided for unit-holders in a UCITS, and in particular that the rules on assets segregation, borrowing, lending, and uncovered sales of transferable securities and money market instruments are equivalent to the requirements of this Directive, - the business of the other collective investment undertakings is reported in half-yearly and annual reports to enable an assessment to be made of the assets and liabilities, income and operations over the reporting period, - no more than 10 % of the UCITS' or the other collective investment undertakings' assets, whose acquisition is contemplated, can, according to their fund rules or instruments of incorporation, be invested in aggregate in units of other UCITS or other collective investment undertakings, and/or (f) deposits with credit institutions which are repayable on demand or have the right to be withdrawn, and maturing in no more than 12 months, provided that the credit institution has its registered office in a Member State or, if the registered office of the credit institution is situated in a non-Member State, provided that it is subject to prudential rules considered by the UCITS' competent authorities as equivalent to those laid down in Community law, and/or (g) financial derivative instruments, including equivalent cash-settled instruments, dealt in on a regulated market referred to in subparagraphs (a), (b) and (c); and/or financial derivative instruments dealt in over-the-counter ('OTC derivatives'), provided that: - the underlying consists of instruments covered by this paragraph, financial indices, interest rates, foreign exchange rates or currencies, in which the UCITS may invest according to its investment objectives as stated in the UCITS' fund rules or instruments of incorporation, - the counterparties to OTC derivative transactions are institutions subject to prudential supervision, and belonging to the categories approved by the UCITS' competent authorities, and - the OTC derivatives are subject to reliable and verifiable valuation on a daily basis and can be sold, liquidated or closed by an offsetting transaction at any time at their fair value at the UCITS' initiative, and/or (h) money market instruments other than those dealt in on a regulated market, which fall under Article 1(9), if the issue or issuer of such instruments is itself regulated for the purpose of protecting investors and savings, and provided that they are: - issued or guaranteed by a central, regional or local authority or central bank of a Member State, the European Central Bank, the European Union or the European Investment Bank, a non-Member State or, in the case of a Federal State, by one of the members making up the federation, or by a public international body to which one or more Member States belong, or - issued by an undertaking any securities of which are dealt in on regulated markets referred to in subparagraphs (a), (b) or (c), or - issued or guaranteed by an establishment subject to prudential supervision, in accordance with criteria defined by Community law, or by an establishment which is subject to and complies with prudential rules considered by the competent authorities to be at least as stringent as those laid down by Community law; or - issued by other bodies belonging to the categories approved by the UCITS' competent authorities provided that investments in such instruments are subject to investor protection equivalent to that laid down in the first, the second or the third indent and provided that the issuer is a company whose capital and reserves amount to at least EUR 10 million and which presents and publishes its annual accounts in accordance with Directive 78/660/EEC(7), is an entity which, within a group of companies which includes one or several listed companies, is dedicated to the financing of the group or is an entity which is dedicated to the financing of securitisation vehicles which benefit from a banking liquidity line."; 6. in Article 19(2)(a), the words "and money market instruments" shall be added after the words "transferable securities"; 7. Article 19(2)(b) and (3) shall be deleted; 8. Article 20 shall be deleted; 9. Article 21 shall be replaced by the following: "Article 21 1. The management or investment company must employ a risk-management process which enables it to monitor and measure at any time the risk of the positions and their contribution to the overall risk profile of the portfolio; it must employ a process for accurate and independent assessment of the value of OTC derivative instruments. It must communicate to the competent authorities regularly and in accordance with the detailed rules they shall define, the types of derivative instruments, the underlying risks, the quantitative limits and the methods which are chosen in order to estimate the risks associated with transactions in derivative instruments regarding each managed UCITS. 2. The Member States may authorise UCITS to employ techniques and instruments relating to transferable securities and money market instruments under the conditions and within the limits which they lay down provided that such techniques and instruments are used for the purpose of efficient portfolio management. When these operations concern the use of derivative instruments, these conditions and limits shall conform to the provisions laid down in this Directive. Under no circumstances shall these operations cause the UCITS to diverge from its investment objectives as laid down in the UCITS' fund rules, instruments of incorporation or prospectus. 3. A UCITS shall ensure that its global exposure relating to derivative instruments does not exceed the total net value of its portfolio. The exposure is calculated taking into account the current value of the underlying assets, the counterparty risk, future market movements and the time available to liquidate the positions. This shall also apply to the following subparagraphs. A UCITS may invest, as a part of its investment policy and within the limit laid down in Article 22(5), in financial derivative instruments provided that the exposure to the underlying assets does not exceed in aggregate the investment limits laid down in Article 22. The Member States may allow that, when a UCITS invests in index-based financial derivative instruments, these investments do not have to be combined to the limits laid down in Article 22. When a transferable security or money market instrument embeds a derivative, the latter must be taken into account when complying with the requirements of this Article. 4. The Member States shall send the Commission full information and any subsequent changes in their regulation concerning the methods used to calculate the risk exposures mentioned in paragraph 3, including the risk exposure to a counterparty in OTC derivative transactions, no later than 13 February 2004. The Commission shall forward that information to the other Member States. Such information will be the subject of exchanges of views within the Contact Committee in accordance with the procedure laid down in Article 53(4)."; 10. Article 22 shall be replaced by the following: "Article 22 1. A UCITS may invest no more than 5 % of its assets in transferable securities or money market instruments issued by the same body. A UCITS may not invest more than 20 % of its assets in deposits made with the same body. The risk exposure to a counterparty of the UCITS in an OTC derivative transaction may not exceed: - 10 % of its assets when the counterpart is a credit institution referred to in Article 19(1)(f), or - 5 % of its assets, in other cases. 2. Member States may raise the 5 % limit laid down in the first sentence of paragraph 1 to a maximum of 10 %. However, the total value of the transferable securities and the money market instruments held by the UCITS in the issuing bodies in each of which it invests more than 5 % of its assets must not then exceed 40 % of the value of its assets. This limitation does not apply to deposits and OTC derivative transactions made with financial institutions subject to prudential supervision. Notwithstanding the individual limits laid down in paragraph 1, a UCITS may not combine: - investments in transferable securities or money market instruments issued by, - deposits made with, and/or - exposures arising from OTC derivative transactions undertaken with a single body in excess of 20 % of its assets. 3. The Member States may raise the 5 % limit laid down in the first sentence of paragraph 1 to a maximum of 35 % if the transferable securities or money market instruments are issued or guaranteed by a Member State, by its local authorities, by a non-member State or by public international bodies to which one or more Member States belong. 4. Member States may raise the 5 % limit laid down in the first sentence of paragraph 1 to a maximum of 25 % in the case of certain bonds when these are issued by a credit institution which has its registered office in a Member State and is subject by law to special public supervision designed to protect bond-holders. In particular, sums deriving from the issue of these bonds must be invested in conformity with the law in assets which, during the whole period of validity of the bonds, are capable of covering claims attaching to the bonds 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. When a UCITS invests more than 5 % of its assets in the bonds referred to in the first subparagraph and issued by one issuer, the total value of these investments may not exceed 80 % of the value of the assets of the UCITS. The Member States shall send the Commission a list of the aforementioned categories of bonds together with the categories of issuers authorised, in accordance with the laws and supervisory arrangements mentioned in the first subparagraph, to issue bonds complying with the criteria set out above. A notice specifying the status of the guarantees offered shall be attached to these lists. The Commission shall immediately forward that information to the other Member States together with any comments which it considers appropriate, and shall make the information available to the public. Such communications may be the subject of exchanges of views within the Contact Committee in accordance with the procedure laid down in Article 53(4). 5. The transferable securities and money market instruments referred to in paragraphs 3 and 4 shall not be taken into account for the purpose of applying the limit of 40 % referred to in paragraph 2. The limits provided for in paragraphs 1, 2, 3 and 4 may not be combined, and thus investments in transferable securities or money market instruments issued by the same body or in deposits or derivative instruments made with this body carried out in accordance with paragraphs 1, 2, 3 and 4 shall under no circumstances exceed in total 35 % of the assets of the UCITS. Companies which are included in the same group for the purposes of consolidated accounts, as defined in accordance with Directive 83/349/EEC(8) or in accordance with recognised international accounting rules, are regarded as a single body for the purpose of calculating the limits contained in this Article. Member States may allow cumulative investment in transferable securities and money market instruments within the same group up to a limit of 20 %."; 11. the following Article shall be inserted: "Article 22a 1. Without prejudice to the limits laid down in Article 25, the Member States may raise the limits laid down in Article 22 to a maximum of 20 % for investment in shares and/or debt securities issued by the same body when, according to the fund rules or instruments of incorporation, the aim of the UCITS' investment policy is to replicate the composition of a certain stock or debt securities index which is recognised by the competent authorities, on the following basis: - its composition is sufficiently diversified, - the index represents an adequate benchmark for the market to which it refers, - it is published in an appropriate manner. 2. Member States may raise the limit laid down in paragraph 1 to a maximum of 35 % where that proves to be justified by exceptional market conditions in particular in regulated markets where certain transferable securities or money market instruments are highly dominant. The investment up to this limit is only permitted for a single issuer."; 12. in Article 23(1), the words "and money market instruments" shall be added after the words "transferable securities"; 13. Article 24 shall be replaced by the following: "Article 24 1. A UCITS may acquire the units of UCITS and/or other collective investment undertakings referred to in Article 19(1)(e), provided that no more than 10 % of its assets are invested in units of a single UCITS or other collective investment undertaking. The Member States may raise the limit to a maximum of 20 %. 2. Investments made in units of collective investment undertakings other than UCITS may not exceed, in aggregate, 30 % of the assets of the UCITS. The Member States may allow that, when a UCITS has acquired units of UCITS and/or other collective investment undertakings, the assets of the respective UCITS or other collective investment undertakings do not have to be combined for the purposes of the limits laid down in Article 22. 3. When a UCITS invests in the units of other UCITS and/or other collective investment undertakings that are managed, directly or by delegation, by the same management company or by any other company with which the management company is linked by common management or control, or by a substantial direct or indirect holding, that management company or other company may not charge subscription or redemption fees on account of the UCITS's investment in the units of such other UCITS and/or collective investment undertakings. A UCITS that invests a substantial proportion of its assets in other UCITS and/or collective investment undertakings shall disclose in its prospectus the maximum level of the management fees that may be charged both to the UCITS itself and to the other UCITS and/or collective investment undertakings in which it intends to invest. In its annual report it shall indicate the maximum proportion of management fees charged both to the UCITS itself and to the UCITS and/or other collective investment undertaking in which it invests."; 14. the following Article shall be inserted: "Article 24a 1. The prospectus shall indicate in which categories of assets a UCITS is authorised to invest. It shall mention if transactions in financial derivative instruments are authorised; in this event, it must include a prominent statement indicating if these operations may be carried out for the purpose of hedging or with the aim of meeting investment goals, and the possible outcome of the use of financial derivative instruments on the risk profile. 2. When a UCITS invests principally in any category of assets defined in Article 19 other than transferable securities and money market instruments or replicates a stock or debt securities index in accordance with Article 22a, its prospectus and, where necessary, any other promotional literature must include a prominent statement drawing attention to the investment policy. 3. When the net asset value of a UCITS is likely to have a high volatility due to its portfolio composition or the portfolio management techniques that may be used, its prospectus and, where necessary, any other promotional literature must include a prominent statement drawing attention to this characteristic. 4. Upon request of an investor, the management company must also provide supplementary information relating to the quantitative limits that apply in the risk management of the UCITS, to the methods chosen to this end and to the recent evolution of the main instrument categories' risks and yields."; 15. in Article 25(2): 1. the third indent shall be replaced by the following: "- 25 % of the units of any single UCITS and/or other collective investment undertaking within the meaning of the first and second indent of Article 1(2),"; 2. the following indent shall be added: "- 10 % of the money market instruments of any single issuing body,"; 16. in Article 25(2), the second sentence shall be replaced by the following: "The limits laid down in the second, third and fourth indents may be disregarded at the time of acquisition if at that time the gross amount of the debt securities or of the money market instruments, or the net amount of the securities in issue, cannot be calculated."; 17. in Article 25(3)(a), (b) and (c) the words "and money market instruments" shall be added after the words "transferable securities"; 18. Article 25(3)(e) shall be replaced by the following: "(e) shares held by an investment company or investment companies in the capital of subsidiary companies carrying on only the business of management, advice or marketing in the country where the subsidiary is located, in regard to the repurchase of units at unit-holders' request exclusively on its or their behalf."; 19. Article 26(1) shall be replaced by the following: "1. UCITS need not comply with the limits laid down in this section when exercising subscription rights attaching to transferable securities or money market instruments which form part of their assets. While ensuring observance of the principle of risk spreading, the Member States may allow recently authorised UCITS to derogate from Articles 22, 22a, 23 and 24 for six months following the date of their authorisation."; 20. Article 41(2) shall be replaced by the following: "2. Paragraph 1 shall not prevent such undertakings from acquiring transferable securities, money market instruments or other financial instruments referred to in Article 19(1)(e), (g) and (h) which are not fully paid."; 21. Article 42 shall be replaced by the following: "Article 42 Neither: - an investment company, nor - a management company or depositary acting on behalf of a unit trust may carry out uncovered sales of transferable securities, money market instruments or other financial instruments referred to in Article 19(1)(e), (g) and (h)."; 22. after Article 53 the following Article shall be inserted: "Article 53a 1. In addition to its functions provided for in Article 53(1), the Contact Committee may also meet as a Regulatory Committee within the meaning of Article 5 of Decision 1999/468/EC(9) to assist the Commission in regard to the technical modifications to be made to this Directive in the following areas: - clarification of the definitions in order to ensure uniform application of this Directive throughout the Community, - alignment of terminology and the framing of definitions in accordance with subsequent acts on UCITS and related matters. 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 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 2 1. No later than 13 February 2005, the Commission shall forward to the European Parliament and the Council a report on the application of Directive 85/611/EEC as amended and proposals for amendments, where appropriate. The report shall in particular: (a) analyse how to deepen and broaden the single market for UCITS, in particular with regard to cross-border marketing of UCITS (including third-party funds), the functioning of the passport for management companies, the functioning of the simplified prospectus as an information and marketing tool, the review of the scope of ancillary activities and the possibilities for improved collaboration of supervisory authorities with respect to common interpretation and application of the Directive; (b) review the scope of the Directive in terms of how it applies to different types of products (e.g. institutional funds, real-estate funds, master-feeder funds and hedge funds); the study should in particular focus on the size of the market for such funds, the regulation, where applicable, of these funds in the Member States and an evaluation of the need for further harmonisation of these funds; (c) evaluate the organisation of funds, including the delegation rules and practices and the relationship between fund manager and depositary; (d) review the investment rules for UCITS, for example the use of derivatives and other instruments and techniques relating to securities, the regulation of index funds, the regulation of money market instruments, deposits, the regulation of "fund of fund" investments, as well as the various investment limits; (e) analyse the competitive situation between funds managed by management companies and "self-managed" investment companies. In preparing its report, the Commission shall consult as widely as possible with the various industries concerned and with consumer groups and supervisory bodies. 2. Member States may grant UCITS existing on the date of entry into force of this Directive a period of not more than 60 months from that date in order to comply with the new national legislation. Article 3 No later than 13 August 2003 Member States shall adopt the laws, regulations and administrative provisions necessary for them to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply these measures no later than 13 February 2004. 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. Article 4 This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32002L0002

2002

Directive 2002/2/EC of the European Parliament and of the Council of 28 January 2002 amending Council Directive 79/373/EEC on the circulation of compound feedingstuffs and repealing Commission Directive 91/357/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 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), and in the light of the joint text approved by the Conciliation Committee on 20 November 2001, Whereas: (1) Council Directive 79/373/EEC(4) lays down rules for the circulation of compound feedingstuffs within the Community. (2) As regards labelling, the purpose of Directive 79/373/EEC is to ensure that stock farmers are informed objectively and as accurately as possible as to the composition and use of feedingstuffs. (3) Hitherto, Directive 79/373/EEC provided for a flexible declaration confined to the indication of the feed materials without stating their quantity in feedingstuffs for production animals, while retaining the possibility of declaring categories of feed materials instead of declaring the feed materials themselves. (4) Nonetheless, the bovine spongiform encephalopathy crisis and the recent dioxin crisis have demonstrated the inadequacy of the current provisions and the need for more detailed qualitative and quantitative information on the composition of compound feedingstuffs for production animals. (5) Detailed quantitative information may help to ensure that potentially contaminated feed materials can be traced to specific batches, which will be beneficial to public health and avoid the destruction of products which do not present a significant risk to public health. (6) Accordingly, it is appropriate, at this stage, to impose a compulsory declaration for all the feed materials as well as their amount in compound feedingstuffs for production animals. (7) For practical reasons, it is appropriate that declarations of the feed materials included in compound feedingstuffs for production animals be provided on an ad hoc label or accompanying document. (8) The declaration of the feed materials in feedingstuffs constitutes, in certain cases, an important item of information for stock farmers. It is therefore appropriate that the person responsible for labelling supply, at the customers' request, a detailed list of all the feed materials used and their exact percentages by weight. (9) It is also important to see to it that the accuracy of the declarations made can be officially verified at all stages of the circulation of the feedingstuffs. It is therefore appropriate that, in accordance with Council Directive 95/53/EC of 25 October 1995 fixing the principles governing the organisation of official inspections in the field of animal nutrition(5), the competent authorities monitor the accuracy of the information given by the labelling of compound feedingstuffs and that, in order to ensure the effectiveness of such monitoring, the manufacturers of compound feedingstuffs be obliged to make available to the competent authorities any document concerning the composition of feedingstuffs intended to be put into circulation. (10) On the basis of a feasibility study, the Commission will submit a report to the European Parliament and the Council by 31 December 2002, accompanied by an appropriate proposal for the establishment of a positive list, taking account of the conclusions of the report. (11) Special provisions are also needed for the labelling of feedingstuffs for pets to allow for the special character of this kind of feedingstuffs. (12) Since it will no longer be possible in the future to declare categories of feed materials instead of declaring the feed materials themselves in the case of compound feedingstuffs for production animals, Commission Directive 91/357/EEC of 13 June 1991 laying down the categories of feed materials which may be used for the purposes of labelling compound feedingstuffs for animals other than pet animals(6) should be repealed, Article 1 Council Directive 79/373/EEC is hereby amended as follows: 1. Article 5(1) is hereby amended as follows: (a) point (j) shall be replaced by the following: "(j) the batch reference number;" (b) the following point shall be added: "(k) in the case of compound feedingstuffs other than those intended for pets, the indication 'the exact percentages by weight of feed materials used in this feedingstuff may be obtained from: ...' (name or trade name, address or registered office, telephone number and e-mail address of the person responsible for the particulars referred to in this paragraph). This information shall be provided at the customer's request."; 2. Article 5(3) is hereby amended as follows: (a) point (c) shall be deleted; (b) point (g) shall be deleted; 3. in Article 5(5), point (d) shall be replaced by the following: "(d) the minimum storage life, the net quantity, the batch reference number and the approval or registration number may be marked outside the space reserved for the labelling particulars referred to in paragraph 1; in this case, these details shall be accompanied by an indication of where the information appears."; 4. Article 5c shall be replaced by the following: "Article 5c 1. All feed materials used in the compound feedingstuff shall be listed by their specific names. 2. The listing of feed materials for feedingstuffs shall be subject to the following rules: (a) compound feedingstuffs intended for animals other than pets: (i) listing of feed materials for feedingstuffs with an indication, in descending order, of the percentages by weight present in the compound feedingstuff; (ii) as regards the above percentages, a tolerance of ± 15 % of the declared value shall be permitted; (b) compound feedingstuffs intended for pets: listing of feed materials for feedingstuffs either indicating the amount contained or naming them in descending order by weight. 3. In the case of compound feedingstuffs intended for pets, the indication of the specific name of the feed material for feedingstuffs may be replaced by the name of the category to which the feed material for feedingstuffs belongs, with reference to the categories grouping several feed materials established in accordance with Article 10(a). Use of one of these two forms of declaration shall exclude use of the other save where one of the feed materials for feedingstuffs used belongs to none of the categories which have been defined; in that case, the feed material for feedingstuffs, designated by its specific name, shall be mentioned in descending order by weight in relation to the categories. 4. The labelling of compound feedingstuffs for pets may also draw attention by a specific declaration to the presence or low content of one or more feed materials for feedingstuffs, which are essential for characterising a feedingstuff. In such a case, the minimum or maximum content, expressed in terms of percentage by weight of the feed material(s) incorporated, shall be clearly indicated either opposite the declaration drawing special attention to the feed material(s) or in the list of feed materials by mentioning the feed material(s) and the percentage(s) by weight concerned opposite the corresponding category of feed materials."; 5. the following subparagraph shall be added to Article 12: "They shall stipulate that the manufacturers of compound feedingstuffs are obliged to make available to the authorities responsible for carrying out official inspections, on request, any document concerning the composition of feedingstuffs intended to be put into circulation which enables the accuracy of the information given by the labelling to be verified."; 6. the following Article shall be inserted: "Article 15a At the latest on 6 November 2006, the Commission shall submit a report to the European Parliament and the Council, on the basis of the information received from Member States, on the implementation of the measures introduced by Article 5(1)(j) and (l), and (5)(d) and Article 5c and the second subparagraph of Article 12, particularly as regards the indication of quantities, in the form of percentage by weight, of feed materials on the labelling of compound feedingstuffs, including the permitted tolerance, accompanied by any proposals designed to improve these measures." Article 2 Commission Directive 91/357/EEC shall be repealed as from 6 November 2003. Article 3 1. Member States shall adopt and publish not later than 6 March 2003, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply these measures as from 6 November 2003. 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 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 Communities. Article 5 This Directive is addressed to the Member States.

32002L0005

2002

Commission Directive 2002/5/EC of 30 January 2002 amending Annex II to Council Directive 90/642/EEC as regards the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables Having regard to the Treaty establishing the European Community, 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(1), as last amended by Commission Directive 2001/57/EC(2), and in particular Article 7 thereof, Whereas: (1) For 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 practicable and toxicologically acceptable, having regard in particular to the protection of the environment and to the protection of the consumers notably in terms of the estimated dietary intake by consumers. Community maximum residue levels (MRLs) represent the upper limit to the amounts of such residues that might be found in commodities when good agricultural practices have been respected by producers. (2) MRLs for pesticides should be kept under review and may be changed to take account of new information and data. Maximum residue levels 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) Following publication of Commission Directive 2000/42/EC(3), the Commission received requests, supported by further data, to review the MRLs for lambda-cyhalothrin and amitraz on certain food commodities fixed by Directive 2000/42/EC. The applications and data were reviewed, and for some combinations, the data was sufficient to justify the fixing of an MRL above the lower limit of analytical determination. For other combinations the information available remains inadequate and it is appropriate to fix MRLs at the lower limit of analytical determination. For yet other combinations the information now available is sufficient to demonstrate that the setting of an MRL 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, the MRLs should remain fixed at the lower limit of analytical determination. (4) Information on new or changed uses of cypermetrin on asparagus, ethephon on pineapple, fenbutatinoxyde on peppers, metalaxyl on spring onions, acephate on peaches and chlorothalonil on celeriac has been notified to the Commission and evaluated. In the light of that information it is appropriate to modify the existing MRLs specified in the Annex to the Directive. (5) The lifetime exposure of consumers to each of the pesticides in this Directive via food products has been assessed and evaluated in accordance with the procedures and practices used within the European Union taking account of guidelines published by the World Health Organisation(4) and it is calculated that the MRLs fixed in this Directive will not lead to the acceptable daily intakes being exceeded. (6) 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 the procedures and practices used within the European Union, taking account of guidelines published by the World Health Organisation. It is calculated that the maximum residue levels fixed in the present Directive do not cause acute toxic effects. (7) Through the World Trade Organisation, the Community's trading partners were consulted about the levels fixed 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 protection of consumers of food products treated with pesticides. The methodology described by the World Health Organisation, referred to above, as applied by rapporteur Member States, and monitored and evaluated by the Commission through the Standing Committee on Plant Health, is consistent with the guidance given by the Scientific Committee for Plants. (9) Directive 90/642/EEC should therefore be amended accordingly and should enter into force immediately. (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 The maximum residue levels listed in the Annex to this Directive are to replace those listed in Annex II to Directive 90/642/EEC for the pesticides in question. Article 2 The maximum residue levels listed in Annex II to Directive 90/642/EEC are in respect of the pesticide commodity combinations referred to in this provision, to be replaced by the following: cypermetrin on asparagus: 0,1 mg/kg, ethephon on pineapples: 2 mg/kg, fenbutatinoxyde on peppers: 1 mg/kg, metalaxyl on spring onions: 0,2 mg/kg, metalaxyl on "scarole (broad-leaf endive)" and herbs: 1 mg/kg, chlorothalonil on "celeriac": 1 mg/kg, acephate on "Peaches": 0,2 mg/kg(5). Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 August 2002 at the latest. They shall forthwith inform the Commission thereof. They shall apply these measures as of 1 September 2002. 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. Article 4 This Directive shall enter into force on the first day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32002L0004

2002

Commission Directive 2002/4/EC of 30 January 2002 on the registration of establishments keeping laying hens, covered by Council Directive 1999/74/EC Having regard to the Treaty establishing the European Community, Having regard to Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens(1), and in particular Article 7 thereof, Whereas: (1) Directive 1999/74/EC lays down specific requirements for the protection of laying hens in various systems of farming and allow the Member States to choose the most appropriate system or systems. (2) Article 7 of Directive 1999/74/EC requires that every establishment covered by the scope of that Directive shall be registered by the competent authority of the Member State and given a distinguishing number, which will be the medium for tracing eggs placed on the market for human consumption. (3) Council Regulation (EEC) No 1907/90 of 26 June 1990 on certain marketing standards for eggs(2), as last amended by Regulation (EC) No 5/2001(3), makes it compulsory to stamp eggs with a code designating the producer's distinguishing number and permitting the farming method to be identified. (4) The farming methods are defined by Commission Regulation (EEC) No 1274/91 of 15 May 1991 introducing detailed rules for implementing Regulation (EEC) No 1907/90 on certain marketing standards for eggs(4), as last amended by Regulation (EC) No 1651/2001(5), and also by Council Regulation (EEC) No 2092/91 of 24 June 1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs(6), as last amended by Commission Regulation (EC) No 2491/2001(7), as far as organic production is concerned. (5) A registration of the establishments under distinguishing numbers is a condition for tracing eggs placed on the market for human consumption. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Veterinary Committee, Article 1 1. Member States shall: (a) establish a system for registering every production site (hereafter: establishment) covered by the scope of Directive 1999/74/EC, allocating a distinguishing number to it, in conformity with the Annex to this Directive; (b) ensure that for each such establishment at least the information set out in point 1 of the Annex is supplied to the competent authority of the Member State, by a date determined by the Member State; this date shall be such as to allow sufficient time for registration of those establishments in accordance with point (c); (c) ensure that each establishment for which the required information is supplied by the date determined pursuant to point (b) is registered and allocated a distinguishing number by 31 May 2003. 2. Member States shall provide that, from 1 June 2003 (a) no establishment for which the information required pursuant to paragraph 1(b) has not been supplied by the date determined there may continue to be used; and (b) no new establishment is brought into use prior to completion of registration and receipt of the distinguishing number. 3. Member States shall ensure that the register of establishments established pursuant to paragraph 1 is accessible to the competent authority of the Member State for the purpose of tracing eggs put on the market for human consumption. 4. Member States shall ensure that changes concerning registered data are notified to the competent authority without delay and that the register is updated immediately when such information is received. Article 2 Member States shall bring into force the laws, regulations and administrative provisions to comply with this Directive by 31 March 2003. They shall forthwith communicate to the Commission the text of those provisions. 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.

32002L0006

2002

Directive 2002/6/EC of the European Parliament and of the Council of 18 February 2002 on reporting formalities for ships arriving in and/or departing from ports of the Member States of the Community (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 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 has an established policy to encourage sustainable transport, such as shipping, and, in particular, to promote short sea shipping. (2) Facilitation of maritime transport is an essential objective for the Community to further strengthen the position of shipping in the transport system as an alternative and complement to other transport modes in a door-to-door transport chain. (3) The documentary procedures required in maritime transport have caused concern and have been considered to hamper the development of the mode to its full potential. (4) The International Maritime Organisation's Convention on Facilitation of International Maritime Traffic adopted by the International Conference on Facilitation of Maritime Travel and Transport on 9 April 1965, as subsequently amended (hereinafter "the IMO FAL Convention"), has provided a set of models for standardised facilitation forms for ships to fulfil certain reporting formalities when they arrive in or depart from a port. (5) Most Member States use these facilitation forms but do not apply the models provided under the auspices of the IMO in a uniform manner. (6) Uniformity in the format of the forms required for a ship arriving in and departing from a port should facilitate the documentary procedures for port calls and be beneficial to the development of Community shipping. (7) Consequently, it is opportune to introduce the recognition of the IMO facilitation forms (hereinafter "IMO FAL forms") at Community level. The Member States should recognise the IMO FAL forms and the categories of information in them as sufficient proof that a ship has fulfilled the reporting formalities these forms are intended for. (8) However, the recognition of certain IMO FAL forms, in particular the cargo declaration and - for passenger ships - the passenger list, would add to the complexity of reporting formalities either because those forms cannot contain all necessary information or because well-established facilitation practices already exist. Consequently, obligatory recognition of those forms should not be introduced. (9) Maritime transport is a global activity and the introduction of the IMO FAL forms in the Community could pave the way towards their intensified application around the world. (10) Since the objectives of the proposed action, namely to facilitate maritime transport, 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 those objectives. (11) 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(4), Article 1 Purpose The purpose of this Directive is to facilitate maritime transport by providing for standardisation of reporting formalities. Article 2 Scope This Directive shall apply to the reporting formalities on arrival in and/or departure from ports of the Member States of the Community, as set out in Annex I, Part A, relating to a ship, its stores, its crew's effects, its crew list and, in the case of a ship certified to carry 12 passengers or fewer, its passenger list. Article 3 Definitions For the purposes of this Directive, the following definitions shall apply: (a) "IMO FAL Convention" means the International Maritime Organisation's Convention on Facilitation of International Maritime Traffic adopted by the International Conference on Facilitation of Maritime Travel and Transport on 9 April 1965; (b) "IMO FAL forms" means A4 size standardised IMO model facilitation forms provided for under the IMO FAL Convention; (c) "reporting formality" means the information that, when required by a Member State, must be provided for administrative and procedural purposes when a ship arrives in or departs from a port; (d) "ship" means a seagoing vessel of any type operating in the marine environment; (e) "ship's stores" means goods for use in the ship, including consumable goods, goods carried for sale to passengers and crew members, fuel and lubricants, but excluding ship's equipment and spare parts; (f) "ship's equipment" means articles other than ship's spare parts which are on board a ship for use thereon and are removable but not of a consumable nature, including accessories, such as lifeboats, life-saving devices, furniture, ship's apparel and similar items; (g) "ship's spare parts" means articles of a repair or replacement nature for incorporation into the ship in which they are carried; (h) "crew's effects" means clothing, items in everyday use and other articles, which may include currency, belonging to the crew and carried on the ship; (i) "crew member" means any person actually employed for duties on board during a voyage in the working or service of a ship and included in the crew list. Article 4 Acceptance of forms Member States shall accept that the reporting formalities referred to in Article 2 are satisfied when the information submitted is in accordance with: (a) the respective specifications set out in Annex I, Parts B and C, and (b) the corresponding model forms set out in Annex II with their categories of data. Article 5 Amendment procedure Any amendments of Annexes I and II to this Directive and references to IMO instruments in order to bring them into line with Community or IMO measures which have entered into force shall be adopted in accordance with the regulatory procedure referred to in Article 6(2), in so far as such amendments do not broaden the scope of this Directive. Article 6 Committee 1. The Commission shall be assisted by the committee set up pursuant to Article 12(1) of Council Directive 93/75/EEC(5). 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 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 9 September 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 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 8 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 9 Addressees This Directive is addressed to the Member States.

32002L0016

2002

Commission Directive 2002/16/EC of 20 February 2002 on the use of certain epoxy derivatives in 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) The use and/or presence of 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether ("BADGE"), bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers ("BFDGE") and novolac glycidyl ethers ("NOGE") in materials and articles intended to come into contact with foodstuffs has led to questions about their safety, mainly when they are used as an additive. (2) Test results have shown significant levels of these substances and certain derivatives thereof in some foodstuffs. (3) The Scientific Committee on Food has given an opinion that the specific migration limit for BADGE and some of its derivatives can be extended for another three years pending the submission of further toxicological data for evaluation. (4) Acceptance of the use and/or presence of BADGE may therefore be provisionally extended. (5) The Scientific Committee on Food has examined the data available on BFDGE, which are very similar to the corresponding data obtained for BADGE. (6) Acceptance of the use and/or presence of BFDGE and some of its derivatives may therefore also be continued pending the submission and evaluation of further toxicological data, under certain conditions. (7) The Scientific Committee on Food has stated that, in the absence of information about the potential exposure and toxicological profile of NOGE components with more than two aromatic rings and their derivatives, it is not in a position to evaluate the safety of use and/or the presence of corresponding products. The Committee is therefore of the opinion that at present, it is not appropriate to use NOGE as an additive in materials and articles intended to come into contact with foodstuffs due to its tendency to migrate in this application. (8) The use and/or presence of NOGE components with more than two aromatic rings and their derivatives in plastic materials and articles, surface coatings and adhesives intended to come into contact with foodstuffs should be regulated through the establishment of a strict limit, which should, in practice, provisionally rule out their use as additives. This provisional limit should apply pending the submission of adequate data for a more complete scientific risk assessment, in accordance with Article 5(7) of the World Trade Organisation Agreement on the Application of Sanitary and Phytosanitary Measures, and the development of adequate methods for the determination of their levels in foodstuffs. (9) The use and/or presence of NOGE and BFDGE as starting substances for the preparation of special coatings used to cover the surfaces of very big containers should provisionally be allowed to continue, pending the submission of further technical data. The large volume/surface area ratio of these containers, their repeated use over their long lifetime which reduces migration, and their contact with foodstuffs at ambient temperature in the majority of the applications suggest that it is not necessary to set a migration limit for NOGE and BFDGE in such containers. (10) Member States which have not yet authorised the use and/or the presence of BADGE and/or BFDGE and/or NOGE in materials and articles intended to come into contact with foodstuffs should be able to maintain their prohibition. (11) The use and/or presence of BADGE, BFDGE and NOGE in plastic materials and articles, surface coatings such as varnishes, lacquers and paints, as well as adhesives, should be regulated at Community level to avoid risks to human health and barriers to the free movement of goods. (12) Errors due to the presence of other chemical substances may occur during analysis. Validated methods of analysis are, therefore, necessary for correct verification of compliance with the restrictions set out in the Directive. (13) A transitional period should be provided for in respect of materials and articles which are brought into contact with foodstuffs before the deadline for implementation of this Directive. (14) This transitional period should also take into account the requirements 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(2), as amended by Commission Directive 2001/101/EC(3). (15) In view of the new technical requirements, Commission Directive 2001/61/EC of 8 August 2001 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs(4) should be repealed for reasons of clarity. (16) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 1. This Directive shall apply to materials and articles which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs and are intended for that purpose and which are manufactured with or contain one or more of the following substances: (a) 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (hereinafter "BADGE"), and some of its derivatives; (b) bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers (hereinafter "BFDGE"), and some of their derivatives; (c) other novolac glycidyl ethers (hereinafter "NOGE"), and some of their derivatives. For the purposes of this Directive, "materials and articles" are: (a) materials and articles made of any type of plastics; (b) materials and articles covered by surface coatings; (c) adhesives. 2. This Directive shall not apply to containers or storage tanks having a capacity greater than 10000 litres or to pipelines belonging to or connected with them, covered by special coatings called "heavy-duty coatings". Article 2 The materials and articles referred to in Article 1(1) shall not release the substances listed in Annex I in a quantity exceeding the limit laid down in that Annex. The use and/or presence of BADGE in the manufacture of those materials and articles may only be continued until 31 December 2004. Article 3 The materials and articles referred to in Article 1(1) shall not release the substances listed in Annex II in a quantity which, when added, to the sum of BADGE and its derivatives listed in Annex I, exceeds the limit laid down in Annex II. The use and/or presence of BFDGE in the manufacture of those materials and articles may only be continued until 31 December 2004. Article 4 As from 1 March 2003, the quantity of NOGE components with more than two aromatic rings and at least one epoxy group as well as their derivatives containing chlorohydrin functions and having a molecular mass less than 1000 daltons shall not be detectable in the materials and articles referred to in Article 1(1) at the detection limit of 0,2 mg/6 dm2, including analytical tolerance. For the purpose of this Directive, the detection limit specified in the first paragraph should be verified by a validated method of analysis. If such a method does not exist, an analytical method with appropriate performance characteristics may be used, pending the development of a validated method. The use and/or presence of NOGE in the manufacture of those materials and articles may only be continued until 31 December 2004. Article 5 The requirements of this Directive shall not apply to materials and articles covered by surface coatings, and adhesives, referred to in points (b) and (c) of the second subparagraph of Article 1(1), which are brought into contact with foodstuffs before 1 March 2003. These materials and articles may continue to be placed on the market provided that the date of filling appears on the materials and articles, taking into account the requirements of Directive 2000/13/EC. Article 6 Directive 2001/61/EC is hereby repealed. References to the repealed Directive shall be construed as references to this Directive and be read in accordance with the correlation table set out in Annex III. Article 7 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 February 2003 at 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 8 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 9 This Directive is addressed to the Member States.

32002L0017

2002

Commission Directive 2002/17/EC of 21 February 2002 amending Directive 90/128/EEC 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) On the basis of the new information available to the Scientific Committee on Food, certain monomers provisionally permitted at national level as well as other monomers requested for use following the adoption of 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 2001/62/EC(3), may be included in the Community list of permitted substances in Annex II to Directive 90/128/EEC. (2) Annex III to Directive 90/128/EEC contains an incomplete list of additives which may be used in the manufacture of plastics materials and articles. That list should be amended so as to include other additives evaluated by the Scientific Committee on Food. (3) For certain substances, the restrictions already established at Community level should be amended on the basis of the information available. (4) 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 only pending a decision on inclusion in the Community list. (5) 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 only pending a decision at Community level. (6) Directive 90/128/EEC should therefore be amended accordingly. (7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 Annexes II, III, V and VI to Directive 90/128/EEC are amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish, by 28 February 2003 at the latest, the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions in such a way as to: (a) permit the trade in and use of plastic materials and articles intended to come into contact with foodstuffs and complying with this Directive, from 1 March 2003; (b) prohibit the manufacture and importation into the Community of plastic materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive, from 1 March 2004. However, for materials and articles which contain divinylbenzene and do not comply with the restriction set in this Directive, Member States shall prohibit their manufacture and importation into the Community as from 1 March 2003. When Member States adopt these 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 its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32002L0023

2002

Commission Directive 2002/23/EC of 26 February 2002 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively 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 2001/57/EC(2), 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(3), as last amended by Directive 2001/57/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 certain products of plant origin, including fruit and vegetables(4), as last amended by Commission Directive 2002/5/EC(5), 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(6), as last amended by Commission Directive 2001/103/EC(7), and in particular Article 4(1)(f) thereof, Whereas: (1) The new active substances flupyrsulfuron-methyl, pymetrozine, azoxystrobin and kresoxim-methyl (the active substances concerned) were included in Annex I to Directive 91/414/EEC by Commission Directives 2001/49/EC(8), 2001/87/EC(9), 98/47/EC(10) and 1999/1/EC(11), for use, respectively as a herbicide on cereals, insecticide on cereals, fruits, vegetables, pulses, oil seeds and hops, a fungicide without uses specified and a fungicide on cereals, pome fruit and vines. (2) The inclusion in Annex I of the active substances concerned was based on the assessment of the information submitted concerning the proposed uses. Information relating to these uses 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 these active substances may be authorised. (4) With respect to the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned, the related technical and scientific evaluations were finalised in the form of Commission review reports. The reports were finalised on 16 October 1998, 27 April 2001, 22 April 1998, 27 July 2001 in the case of kresoxim-methyl, flupyrsulfuron-methyl, azoxystrobin and pymetrozine, respectively. They fixed the acceptable daily intake (ADI) for kresoxim-methyl at 0,4 mg/kg bw/day, for flupyrsulfuron-methyl at 0,035 mg/kg bw/day, for azoxystrobin at 0,1 mg/kg bw/day and for pymetrozine at 0,03 mg/kg bw/day. The lifetime exposure of consumers of food products treated with the active substances concerned has been assessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation(12) and the opinion of the Scientific Committee for Plants(13) on the methodology employed and it is calculated that MRL accordingly proposed will not lead to those ADIs being exceeded. (5) No acute toxic effects requiring the setting of an acute reference dose were noted during the evaluations and discussions preceding the inclusion of flupyrsulfuron-methyl, azoxystrobin and kresoxim-methyl in Annex I to Directive 91/414/EEC. The acute reference dose for pymetrozine was established at 0,1 mg/kg bw/day. According to the exposure assessment, the MRLs proposed will not lead to an unacceptable acute exposure of consumers. (6) In order to ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisation has been granted, it is prudent to set provisional MRL at the lower limit of analytical determination for all such products covered by Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. The setting at Community level of such provisional MRL does not prevent the Member States from establishing provisional maximum residue levels for flupyrsulfuron-methyl, pymetrozine, azoxystrobin and kresoxim-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 enable most further uses of the active substances concerned. The provisional MRL should then become definitive. (7) The Community notified the draft Commission Directive to the World Trade Organisation and the comments received have been considered in finalising the Directive. MRLs for specific pesticide/crop combinations used in third countries could be examined by the Commission on the basis of the acceptable data submitted. (8) Account has been taken of the opinions of the Scientific Committee for Plants, in particular of its advice and recommendations concerning the protection of consumers of food products treated with pesticides. (9) This Directive is in accordance with the opinion of the Standing Committee on Plant Health, Article 1 The following pesticide maximum residue levels are added to part A of Annex II to Directive 86/362/EEC: >TABLE> By 1 December 2005, provisional maximum residue levels for flupyrsulfuron-methyl and pymetrozine shall cease to be provisional and shall become definitive in the sense of Article 4(1) of Directive 86/362/EEC. Article 2 The following pesticide residues are added to part B of Annex II to Directive 86/363/EEC: >TABLE> By 1 December 2005, provisional maximum residue levels for pymetrozine shall cease to be provisional and shall become definitive in the sense of Article 4(1) of Directive 86/363/EEC. Article 3 The maximum pesticide residue levels for flupyrsulfuron-methyl and pymetrozine in the Annex to this Directive shall be added to Annex II to Directive 90/642/EEC. The maximum pesticide residue levels for azoxystrobin in the Annex to this Directive shall replace those in Annex II to Directive 90/642/EEC. Article 4 The provisional maximum pesticide residue levels for kresoxim-methyl in Annex II to Directive 90/642/EEC shall be modified to 0,2 mg/kg (p) for strawberries. (p) indicates provisional maximum residue level. For kresoxim-methyl provisional MRLs shall become definitive with effect of 19 October 2004. Article 5 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 August 2002 at the latest. They shall forthwith inform the Commission thereof. 2. They shall apply these provisions as of 1 September 2002. 3. 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 20th day following its publication in the Official Journal of the European Communities. This Directive is addressed to the Member States.

32002L0025

2002

Commission Directive 2002/25/EC of 5 March 2002 amending Council Directive 98/18/EC on safety rules and standards for passenger ships Having regard to the Treaty establishing the European Community, Having regard to Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(1), and in particular Article 8, point (b) thereof, Whereas: (1) For the purpose of Directive 98/18/EC, the international conventions, including the 1974 International Convention for the Safety of Life at Sea (SOLAS Convention) and other international codes and resolutions, for the safety rules and standards for passenger vessels, were in force on the date of the adoption of that Directive. (2) Amendments to the SOLAS Convention and to other international codes and resolutions have entered into force since the date of adoption of Directive 98/18/EC, or will enter into force shortly. (3) Account should be taken of these new international instruments in Annex I to Directive 98/18/EC. (4) Directive 98/18/EC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 12(1) of Council Directive 93/75/EEC(2), as last amended by Commission Directive 98/74/EC(3), Article 1 Annex I to Directive 98/18/EC is 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 to comply with this Directive by 15 October 2002 at the latest. They shall forthwith notify 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 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. It shall apply from 1 January 2003, unless otherwise specified in the Annex. Article 4 This Directive is addressed to the Member States.

32002L0021

2002

Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive) 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), Whereas: (1) The current regulatory framework for telecommunications has been successful in creating the conditions for effective competition in the telecommunications sector during the transition from monopoly to full competition. (2) On 10 November 1999, the Commission presented a communication to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions entitled "Towards a new framework for electronic communications infrastructure and associated services - the 1999 communications review". In that communication, the Commission reviewed the existing regulatory framework for telecommunications, in accordance with its obligation under Article 8 of Council Directive 90/387/EEC of 28 June 1990 on the establishment of the internal market for telecommunications services through the implementation of open network provision(4). It also presented a series of policy proposals for a new regulatory framework for electronic communications infrastructure and associated services for public consultation. (3) On 26 April 2000 the Commission presented a communication to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions on the results of the public consultation on the 1999 communications review and orientations for the new regulatory framework. The communication summarised the public consultation and set out certain key orientations for the preparation of a new framework for electronic communications infrastructure and associated services. (4) The Lisbon European Council of 23 and 24 March 2000 highlighted the potential for growth, competitiveness and job creation of the shift to a digital, knowledge-based economy. In particular, it emphasised the importance for Europe's businesses and citizens of access to an inexpensive, world-class communications infrastructure and a wide range of services. (5) The convergence of the telecommunications, media and information technology sectors means all transmission networks and services should be covered by a single regulatory framework. That regulatory framework consists of this Directive and four specific Directives: Directive 2002/20/EC of the European Parliament and of the Council of 7 March 2002 on the authorisation of electronic communications networks and services (Authorisation Directive)(5), Directive 2002/19/EC of the European Parliament and of the Council of 7 March 2002 on access to, and interconnection of, electronic communications networks and associated facilities (Access Directive)(6), Directive 2002/22/EC of the European Parliament and of the Council of 7 March 2002 on universal service and users' rights relating to electronic communications networks and services (Universal Service Directive)(7), 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(8), (hereinafter referred to as "the Specific Directives"). It is necessary to separate the regulation of transmission from the regulation of content. This framework does not therefore cover the content of services delivered over electronic communications networks using electronic communications services, such as broadcasting content, financial services and certain information society services, and is therefore without prejudice to measures taken at Community or national level in respect of such services, in compliance with Community law, in order to promote cultural and linguistic diversity and to ensure the defence of media pluralism. The content of television programmes is covered by 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(9). The separation between the regulation of transmission and the regulation of content does not prejudice the taking into account of the links existing between them, in particular in order to guarantee media pluralism, cultural diversity and consumer protection. (6) Audiovisual policy and content regulation are undertaken in pursuit of general interest objectives, such as freedom of expression, media pluralism, impartiality, cultural and linguistic diversity, social inclusion, consumer protection and the protection of minors. The Commission communication "Principles and guidelines for the Community's audio-visual policy in the digital age", and the Council conclusions of 6 June 2000 welcoming this communication, set out the key actions to be taken by the Community to implement its audio-visual policy. (7) The provisions of this Directive and the Specific Directives are without prejudice to the possibility for each Member State to take the necessary measures to ensure the protection of its essential security interests, to safeguard public policy and public security, and to permit the investigation, detection and prosecution of criminal offences, including the establishment by national regulatory authorities of specific and proportional obligations applicable to providers of electronic communications services. (8) This Directive does not cover equipment within the scope of Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity(10), but does cover consumer equipment used for digital television. It is important for regulators to encourage network operators and terminal equipment manufacturers to cooperate in order to facilitate access by disabled users to electronic communications services. (9) Information society services are covered by 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)(11). (10) The definition of "information society service" in Article 1 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 of information society services(12) spans a wide range of economic activities which take place on-line. Most of these activities are not covered by the scope of this Directive because they do not consist wholly or mainly in the conveyance of signals on electronic communications networks. Voice telephony and electronic mail conveyance services are covered by this Directive. The same undertaking, for example an Internet service provider, can offer both an electronic communications service, such as access to the Internet, and services not covered under this Directive, such as the provision of web-based content. (11) In accordance with the principle of the separation of regulatory and operational functions, Member States should guarantee the independence of the national regulatory authority or authorities with a view to ensuring the impartiality of their decisions. This requirement of independence is without prejudice to the institutional autonomy and constitutional obligations of the Member States or to the principle of neutrality with regard to the rules in Member States governing the system of property ownership laid down in Article 295 of the Treaty. National regulatory authorities should be in possession of all the necessary resources, in terms of staffing, expertise, and financial means, for the performance of their tasks. (12) Any party who is the subject of a decision by a national regulatory authority should have the right to appeal to a body that is independent of the parties involved. This body may be a court. Furthermore, any undertaking which considers that its applications for the granting of rights to install facilities have not been dealt with in accordance with the principles set out in this Directive should be entitled to appeal against such decisions. This appeal procedure is without prejudice to the division of competences within national judicial systems and to the rights of legal entities or natural persons under national law. (13) National regulatory authorities need to gather information from market players in order to carry out their tasks effectively. Such information may also need to be gathered on behalf of the Commission, to allow it to fulfil its obligations under Community law. Requests for information should be proportionate and not impose an undue burden on undertakings. Information gathered by national regulatory authorities should be publicly available, except in so far as it is confidential in accordance with national rules on public access to information and subject to Community and national law on business confidentiality. (14) Information that is considered confidential by a national regulatory authority, in accordance with Community and national rules on business confidentiality, may only be exchanged with the Commission and other national regulatory authorities where such exchange is strictly necessary for the application of the provisions of this Directive or the Specific Directives. The information exchanged should be limited to that which is relevant and proportionate to the purpose of such an exchange. (15) It is important that national regulatory authorities consult all interested parties on proposed decisions and take account of their comments before adopting a final decision. In order to ensure that decisions at national level do not have an adverse effect on the single market or other Treaty objectives, national regulatory authorities should also notify certain draft decisions to the Commission and other national regulatory authorities to give them the opportunity to comment. It is appropriate for national regulatory authorities to consult interested parties on all draft measures which have an effect on trade between Member States. The cases where the procedures referred to in Articles 6 and 7 apply are defined in this Directive and in the Specific Directives. The Commission should be able, after consulting the Communications Committee, to require a national regulatory authority to withdraw a draft measure where it concerns definition of relevant markets or the designation or not of undertakings with significant market power, and where such decisions would create a barrier to the single market or would be incompatible with Community law and in particular the policy objectives that national regulatory authorities should follow. This procedure is without prejudice to the notification procedure provided for in Directive 98/34/EC and the Commission's prerogatives under the Treaty in respect of infringements of Community law. (16) National regulatory authorities should have a harmonised set of objectives and principles to underpin, and should, where necessary, coordinate their actions with the regulatory authorities of other Member States in carrying out their tasks under this regulatory framework. (17) The activities of national regulatory authorities established under this Directive and the Specific Directives contribute to the fulfilment of broader policies in the areas of culture, employment, the environment, social cohesion and town and country planning. (18) The requirement for Member States to ensure that national regulatory authorities take the utmost account of the desirability of making regulation technologically neutral, that is to say that it neither imposes nor discriminates in favour of the use of a particular type of technology, does not preclude the taking of proportionate steps to promote certain specific services where this is justified, for example digital television as a means for increasing spectrum efficiency. (19) Radio frequencies are an essential input for radio-based electronic communications services and, in so far as they relate to such services, should therefore be allocated and assigned by national regulatory authorities according to a set of harmonised objectives and principles governing their action as well as to objective, transparent and non-discriminatory criteria, taking into account the democratic, social, linguistic and cultural interests related to the use of frequency. It is important that the allocation and assignment of radio frequencies is managed as efficiently as possible. Transfer of radio frequencies can be an effective means of increasing efficient use of spectrum, as long as there are sufficient safeguards in place to protect the public interest, in particular the need to ensure transparency and regulatory supervision of such transfers. Decision No 676/2002/EC of the European Parliament and of the Council of 7 March 2002 on a regulatory framework for radio spectrum policy in the European Community (Radio Spectrum Decision)(13) establishes a framework for harmonisation of radio frequencies, and action taken under this Directive should seek to facilitate the work under that Decision. (20) Access to numbering resources on the basis of transparent, objective and non-discriminatory criteria is essential for undertakings to compete in the electronic communications sector. All elements of national numbering plans should be managed by national regulatory authorities, including point codes used in network addressing. Where there is a need for harmonisation of numbering resources in the Community to support the development of pan-European services, the Commission may take technical implementing measures using its executive powers. Where this is appropriate to ensure full global interoperability of services, Member States should coordinate their national positions in accordance with the Treaty in international organisations and fora where numbering decisions are taken. The provisions of this Directive do not establish any new areas of responsibility for the national regulatory authorities in the field of Internet naming and addressing. (21) Member States may use, inter alia, competitive or comparative selection procedures for the assignment of radio frequencies as well as numbers with exceptional economic value. In administering such schemes, national regulatory authorities should take into account the provisions of Article 8. (22) It should be ensured that procedures exist for the granting of rights to install facilities that are timely, non-discriminatory and transparent, in order to guarantee the conditions for fair and effective competition. This Directive is without prejudice to national provisions governing the expropriation or use of property, the normal exercise of property rights, the normal use of the public domain, or to the principle of neutrality with regard to the rules in Member States governing the system of property ownership. (23) Facility sharing can be of benefit for town planning, public health or environmental reasons, and should be encouraged by national regulatory authorities on the basis of voluntary agreements. In cases where undertakings are deprived of access to viable alternatives, compulsory facility or property sharing may be appropriate. It covers inter alia: physical co-location and duct, building, mast, antenna or antenna system sharing. Compulsory facility or property sharing should be imposed on undertakings only after full public consultation. (24) Where mobile operators are required to share towers or masts for environmental reasons, such mandated sharing may lead to a reduction in the maximum transmitted power levels allowed for each operator for reasons of public health, and this in turn may require operators to install more transmission sites to ensure national coverage. (25) There is a need for ex ante obligations in certain circumstances in order to ensure the development of a competitive market. The definition of significant market power in the Directive 97/33/EC of the European Parliament and of the Council of 30 June 1997 on interconnection in telecommunications with regard to ensuring universal service and interoperability through application of the principles of open network provision (ONP)(14) has proved effective in the initial stages of market opening as the threshold for ex ante obligations, but now needs to be adapted to suit more complex and dynamic markets. For this reason, the definition used in this Directive is equivalent to the concept of dominance as defined in the case law of the Court of Justice and the Court of First Instance of the European Communities. (26) Two or more undertakings can be found to enjoy a joint dominant position not only where there exist structural or other links between them but also where the structure of the relevant market is conducive to coordinated effects, that is, it encourages parallel or aligned anti-competitive behaviour on the market. (27) It is essential that ex ante regulatory obligations should only be imposed where there is not effective competition, i.e. in markets where there are one or more undertakings with significant market power, and where national and Community competition law remedies are not sufficient to address the problem. It is necessary therefore for the Commission to draw up guidelines at Community level in accordance with the principles of competition law for national regulatory authorities to follow in assessing whether competition is effective in a given market and in assessing significant market power. National regulatory authorities should analyse whether a given product or service market is effectively competitive in a given geographical area, which could be the whole or a part of the territory of the Member State concerned or neighbouring parts of territories of Member States considered together. An analysis of effective competition should include an analysis as to whether the market is prospectively competitive, and thus whether any lack of effective competition is durable. Those guidelines will also address the issue of newly emerging markets, where de facto the market leader is likely to have a substantial market share but should not be subjected to inappropriate obligations. The Commission should review the guidelines regularly to ensure that they remain appropriate in a rapidly developing market. National regulatory authorities will need to cooperate with each other where the relevant market is found to be transnational. (28) In determining whether an undertaking has significant market power in a specific market, national regulatory authorities should act in accordance with Community law and take into the utmost account the Commission guidelines. (29) The Community and the Member States have entered into commitments in relation to standards and the regulatory framework of telecommunications networks and services in the World Trade Organisation. (30) Standardisation should remain primarily a market-driven process. However there may still be situations where it is appropriate to require compliance with specified standards at Community level to ensure interoperability in the single market. At national level, Member States are subject to the provisions of Directive 98/34/EC. Directive 95/47/EC of the European Parliament and of the Council of 24 October 1995 on the use of standards for the transmission of television signals(15) did not mandate any specific digital television transmission system or service requirement. Through the Digital Video Broadcasting Group, European market players have developed a family of television transmission systems that have been standardised by the European Telecommunications Standards Institute (ETSI) and have become International Telecommunication Union recommendations. Any decision to make the implementation of such standards mandatory should follow a full public consultation. Standardisation procedures under this Directive are without prejudice to the provisions of Directive 1999/5/EC, Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits(16) and Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility(17). (31) Interoperability of digital interactive television services and enhanced digital television equipment, at the level of the consumer, should be encouraged in order to ensure the free flow of information, media pluralism and cultural diversity. It is desirable for consumers to have the capability of receiving, regardless of the transmission mode, all digital interactive television services, having regard to technological neutrality, future technological progress, the need to promote the take-up of digital television, and the state of competition in the markets for digital television services. Digital interactive television platform operators should strive to implement an open application program interface (API) which conforms to standards or specifications adopted by a European standards organisation. Migration from existing APIs to new open APIs should be encouraged and organised, for example by Memoranda of Understanding between all relevant market players. Open APIs facilitate interoperability, i.e. the portability of interactive content between delivery mechanisms, and full functionality of this content on enhanced digital television equipment. However, the need not to hinder the functioning of the receiving equipment and to protect it from malicious attacks, for example from viruses, should be taken into account. (32) In the event of a dispute between undertakings in the same Member State in an area covered by this Directive or the Specific Directives, for example relating to obligations for access and interconnection or to the means of transferring subscriber lists, an aggrieved party that has negotiated in good faith but failed to reach agreement should be able to call on the national regulatory authority to resolve the dispute. National regulatory authorities should be able to impose a solution on the parties. The intervention of a national regulatory authority in the resolution of a dispute between undertakings providing electronic communications networks or services in a Member State should seek to ensure compliance with the obligations arising under this Directive or the Specific Directives. (33) In addition to the rights of recourse granted under national or Community law, there is a need for a simple procedure to be initiated at the request of either party in a dispute, to resolve cross-border disputes which lie outside the competence of a single national regulatory authority. (34) A single Committee should replace the "ONP Committee" instituted by Article 9 of Directive 90/387/EEC and the Licensing Committee instituted by Article 14 of Directive 97/13/EC of the European Parliament and of the Council of 10 April 1997 on a common framework for general authorisations and individual licences in the field of telecommunications services(18). (35) National regulatory authorities and national competition authorities should provide each other with the information necessary to apply the provisions of this Directive and the Specific Directives, in order to allow them to cooperate fully together. In respect of the information exchanged, the receiving authority should ensure the same level of confidentiality as the originating authority. (36) The Commission has indicated its intention to set up a European regulators group for electronic communications networks and services which would constitute a suitable mechanism for encouraging cooperation and coordination of national regulatory authorities, in order to promote the development of the internal market for electronic communications networks and services, and to seek to achieve consistent application, in all Member States, of the provisions set out in this Directive and the Specific Directives, in particular in areas where national law implementing Community law gives national regulatory authorities considerable discretionary powers in application of the relevant rules. (37) National regulatory authorities should be required to cooperate with each other and with the Commission in a transparent manner to ensure consistent application, in all Member States, of the provisions of this Directive and the Specific Directives. This cooperation could take place, inter alia, in the Communications Committee or in a group comprising European regulators. Member States should decide which bodies are national regulatory authorities for the purposes of this Directive and the Specific Directives. (38) Measures that could affect trade between Member States are measures that may have an influence, direct or indirect, actual or potential, on the pattern of trade between Member States in a manner which might create a barrier to the single market. They comprise measures that have a significant impact on operators or users in other Member States, which include, inter alia: measures which affect prices for users in other Member States; measures which affect the ability of an undertaking established in another Member State to provide an electronic communications service, and in particular measures which affect the ability to offer services on a transnational basis; and measures which affect market structure or access, leading to repercussions for undertakings in other Member States. (39) The provisions of this Directive should be reviewed periodically, in particular with a view to determining the need for modification in the light of changing technological or market conditions. (40) 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(19). (41) Since the objectives of the proposed action, namely achieving a harmonised framework for the regulation of electronic communications services, electronic communications networks, associated facilities and associated services 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 for those objectives. (42) Certain directives and decisions in this field should be repealed. (43) The Commission should monitor the transition from the existing framework to the new framework, and may in particular, at an appropriate time, bring forward a proposal to repeal Regulation (EC) No 2887/2000 of the European Parliament and of the Council of 18 December 2000 on unbundled access to the local loop(20), CHAPTER I SCOPE, AIM AND DEFINITIONS Article 1 Scope and aim 1. This Directive establishes a harmonised framework for the regulation of electronic communications services, electronic communications networks, associated facilities and associated services. It lays down tasks of national regulatory authorities and establishes a set of procedures to ensure the harmonised application of the regulatory framework throughout the Community. 2. This Directive as well as the Specific Directives are without prejudice to obligations imposed by national law in accordance with Community law or by Community law in respect of services provided using electronic communications networks and services. 3. This Directive as well as the Specific Directives are without prejudice to measures taken at Community or national level, in compliance with Community law, to pursue general interest objectives, in particular relating to content regulation and audio-visual policy. 4. This Directive and the Specific Directives are without prejudice to the provisions of Directive 1999/5/EC. Article 2 Definitions For the purposes of this Directive: (a) "electronic communications network" means transmission systems and, where applicable, switching or routing equipment and other resources which permit the conveyance of signals by wire, by radio, by optical or by other electromagnetic means, including satellite networks, fixed (circuit- and packet-switched, including Internet) and mobile terrestrial networks, electricity cable systems, to the extent that they are used for the purpose of transmitting signals, networks used for radio and television broadcasting, and cable television networks, irrespective of the type of information conveyed; (b) "transnational markets" means markets identified in accordance with Article 15(4) covering the Community or a substantial part thereof; (c) "electronic communications service" means a service normally provided for remuneration which consists wholly or mainly in the conveyance of signals on electronic communications networks, including telecommunications services and transmission services in networks used for broadcasting, but exclude services providing, or exercising editorial control over, content transmitted using electronic communications networks and services; it does not include information society services, as defined in Article 1 of Directive 98/34/EC, which do not consist wholly or mainly in the conveyance of signals on electronic communications networks; (d) "public communications network" means an electronic communications network used wholly or mainly for the provision of publicly available electronic communications services; (e) "associated facilities" means those facilities associated with an electronic communications network and/or an electronic communications service which enable and/or support the provision of services via that network and/or service. It includes conditional access systems and electronic programme guides; (f) "conditional access system" means any technical measure and/or arrangement whereby access to a protected radio or television broadcasting service in intelligible form is made conditional upon subscription or other form of prior individual authorisation; (g) "national regulatory authority" means the body or bodies charged by a Member State with any of the regulatory tasks assigned in this Directive and the Specific Directives; (h) "user" means a legal entity or natural person using or requesting a publicly available electronic communications service; (i) "consumer" means any natural person who uses or requests a publicly available electronic communications service for purposes which are outside his or her trade, business or profession; (j) "universal service" means the minimum set of services, defined in Directive 2002/22/EC (Universal Service Directive), of specified quality which is available to all users regardless of their geographical location and, in the light of specific national conditions, at an affordable price; (k) "subscriber" means any natural person or legal entity who or which is party to a contract with the provider of publicly available electronic communications services for the supply of such services; (l) "Specific Directives" means Directive 2002/20/EC (Authorisation Directive), Directive 2002/19/EC (Access Directive), Directive 2002/22/EC (Universal Service Directive) and Directive 97/66/EC; (m) "provision of an electronic communications network" means the establishment, operation, control or making available of such a network; (n) "end-user" means a user not providing public communications networks or publicly available electronic communications services. (o) "enhanced digital television equipment" means set-top boxes intended for connection to television sets or integrated digital television sets, able to receive digital interactive television services; (p) "application program interface (API)" means the software interfaces between applications, made available by broadcasters or service providers, and the resources in the enhanced digital television equipment for digital television and radio services. CHAPTER II NATIONAL REGULATORY AUTHORITIES Article 3 National regulatory authorities 1. Member States shall ensure that each of the tasks assigned to national regulatory authorities in this Directive and the Specific Directives is undertaken by a competent body. 2. Member States shall guarantee the independence of national regulatory authorities by ensuring that they are legally distinct from and functionally independent of all organisations providing electronic communications networks, equipment or services. Member States that retain ownership or control of undertakings providing electronic communications networks and/or services shall ensure effective structural separation of the regulatory function from activities associated with ownership or control. 3. Member States shall ensure that national regulatory authorities exercise their powers impartially and transparently. 4. Member States shall publish the tasks to be undertaken by national regulatory authorities in an easily accessible form, in particular where those tasks are assigned to more than one body. Member States shall ensure, where appropriate, consultation and cooperation between those authorities, and between those authorities and national authorities entrusted with the implementation of competition law and national authorities entrusted with the implementation of consumer law, on matters of common interest. Where more than one authority has competence to address such matters, Member States shall ensure that the respective tasks of each authority are published in an easily accessible form. 5. National regulatory authorities and national competition authorities shall provide each other with the information necessary for the application of the provisions of this Directive and the Specific Directives. In respect of the information exchanged, the receiving authority shall ensure the same level of confidentiality as the originating authority. 6. Member States shall notify to the Commission all national regulatory authorities assigned tasks under this Directive and the Specific Directives, and their respective responsibilities. Article 4 Right of appeal 1. Member States shall ensure that effective mechanisms exist at national level under which any user or undertaking providing electronic communications networks and/or services who is affected by a decision of a national regulatory authority has the right of appeal against the decision to an appeal body that is independent of the parties involved. This body, which may be a court, shall have the appropriate expertise available to it to enable it to carry out its functions. Member States shall ensure that the merits of the case are duly taken into account and that there is an effective appeal mechanism. Pending the outcome of any such appeal, the decision of the national regulatory authority shall stand, unless the appeal body decides otherwise. 2. Where the appeal body referred to in paragraph 1 is not judicial in character, written reasons for its decision shall always be given. Furthermore, in such a case, its decision shall be subject to review by a court or tribunal within the meaning of Article 234 of the Treaty. Article 5 Provision of information 1. Member States shall ensure that undertakings providing electronic communications networks and services provide all the information, including financial information, necessary for national regulatory authorities to ensure conformity with the provisions of, or decisions made in accordance with, this Directive and the Specific Directives. These undertakings shall provide such information promptly on request and to the timescales and level of detail required by the national regulatory authority. The information requested by the national regulatory authority shall be proportionate to the performance of that task. The national regulatory authority shall give the reasons justifying its request for information. 2. Member States shall ensure that national regulatory authorities provide the Commission, after a reasoned request, with the information necessary for it to carry out its tasks under the Treaty. The information requested by the Commission shall be proportionate to the performance of those tasks. Where the information provided refers to information previously provided by undertakings at the request of the national regulatory authority, such undertakings shall be informed thereof. To the extent necessary, and unless the authority that provides the information has made an explicit and reasoned request to the contrary, the Commission shall make the information provided available to another such authority in another Member State. Subject to the requirements of paragraph 3, Member States shall ensure that the information submitted to one national regulatory authority can be made available to another such authority in the same or different Member State, after a substantiated request, where necessary to allow either authority to fulfil its responsibilities under Community law. 3. Where information is considered confidential by a national regulatory authority in accordance with Community and national rules on business confidentiality, the Commission and the national regulatory authorities concerned shall ensure such confidentiality. 4. Member States shall ensure that, acting in accordance with national rules on public access to information and subject to Community and national rules on business confidentiality, national regulatory authorities publish such information as would contribute to an open and competitive market. 5. National regulatory authorities shall publish the terms of public access to information as referred to in paragraph 4, including procedures for obtaining such access. Article 6 Consultation and transparency mechanism Except in cases falling within Articles 7(6), 20 or 21 Member States shall ensure that where national regulatory authorities intend to take measures in accordance with this Directive or the Specific Directives which have a significant impact on the relevant market, they give interested parties the opportunity to comment on the draft measure within a reasonable period. National regulatory authorities shall publish their national consultation procedures. Member States shall ensure the establishment of a single information point through which all current consultations can be accessed. The results of the consultation procedure shall be made publicly available by the national regulatory authority, except in the case of confidential information in accordance with Community and national law on business confidentiality. Article 7 Consolidating the internal market for electronic communications 1. In carrying out their tasks under this Directive and the Specific Directives, national regulatory authorities shall take the utmost account of the objectives set out in Article 8, including in so far as they relate to the functioning of the internal market. 2. National regulatory authorities shall contribute to the development of the internal market by cooperating with each other and with the Commission in a transparent manner to ensure the consistent application, in all Member States, of the provisions of this Directive and the Specific Directives. To this end, they shall, in particular, seek to agree on the types of instruments and remedies best suited to address particular types of situations in the market place. 3. In addition to the consultation referred to in Article 6, where a national regulatory authority intends to take a measure which: (a) falls within the scope of Articles 15 or 16 of this Directive, Articles 5 or 8 of Directive 2002/19/EC (Access Directive) or Article 16 of Directive 2002/22/EC (Universal Service Directive), and (b) would affect trade between Member States, it shall at the same time make the draft measure accessible to the Commission and the national regulatory authorities in other Member States, together with the reasoning on which the measure is based, in accordance with Article 5(3), and inform the Commission and other national regulatory authorities thereof. National regulatory authorities and the Commission may make comments to the national regulatory authority concerned only within one month or within the period referred to in Article 6 if that period is longer. The one-month period may not be extended. 4. Where an intended measure covered by paragraph 3 aims at: (a) defining a relevant market which differs from those defined in the recommendation in accordance with Article 15(1), or (b) deciding whether or not to designate an undertaking as having, either individually or jointly with others, significant market power, under Article 16(3), (4) or (5), and would affect trade between Member States and the Commission has indicated to the national regulatory authority that it considers that the draft measure would create a barrier to the single market or if it has serious doubts as to its compatibility with Community law and in particular the objectives referred to in Article 8, then the draft measure shall not be adopted for a further two months. This period may not be extended. Within this period the Commission may, in accordance with the procedure referred to in Article 22(2), take a decision requiring the national regulatory authority concerned to withdraw the draft measure. This decision shall be accompanied by a detailed and objective analysis of why the Commission considers that the draft measure should not be adopted together with specific proposals for amending the draft measure. 5. The national regulatory authority concerned shall take the utmost account of comments of other national regulatory authorities and the Commission and may, except in cases covered by paragraph 4, adopt the resulting draft measure and, where it does so, shall communicate it to the Commission. 6. In exceptional circumstances, where a national regulatory authority considers that there is an urgent need to act, by way of derogation from the procedure set out in paragraphs 3 and 4, in order to safeguard competition and protect the interests of users, it may immediately adopt proportionate and provisional measures. It shall, without delay, communicate those measures, with full reasons, to the Commission and the other national regulatory authorities. A decision by the national regulatory authority to render such measures permanent or extend the time for which they are applicable shall be subject to the provisions of paragraphs 3 and 4. CHAPTER III TASKS OF NATIONAL REGULATORY AUTHORITIES Article 8 Policy objectives and regulatory principles 1. Member States shall ensure that in carrying out the regulatory tasks specified in this Directive and the Specific Directives, the national regulatory authorities take all reasonable measures which are aimed at achieving the objectives set out in paragraphs 2, 3 and 4. Such measures shall be proportionate to those objectives. Member States shall ensure that in carrying out the regulatory tasks specified in this Directive and the Specific Directives, in particular those designed to ensure effective competition, national regulatory authorities take the utmost account of the desirability of making regulations technologically neutral. National regulatory authorities may contribute within their competencies to ensuring the implementation of policies aimed at the promotion of cultural and linguistic diversity, as well as media pluralism. 2. The national regulatory authorities shall promote competition in the provision of electronic communications networks, electronic communications services and associated facilities and services by inter alia: (a) ensuring that users, including disabled users, derive maximum benefit in terms of choice, price, and quality; (b) ensuring that there is no distortion or restriction of competition in the electronic communications sector; (c) encouraging efficient investment in infrastructure, and promoting innovation; and (d) encouraging efficient use and ensuring the effective management of radio frequencies and numbering resources. 3. The national regulatory authorities shall contribute to the development of the internal market by inter alia: (a) removing remaining obstacles to the provision of electronic communications networks, associated facilities and services and electronic communications services at European level; (b) encouraging the establishment and development of trans-European networks and the interoperability of pan-European services, and end-to-end connectivity; (c) ensuring that, in similar circumstances, there is no discrimination in the treatment of undertakings providing electronic communications networks and services; (d) cooperating with each other and with the Commission in a transparent manner to ensure the development of consistent regulatory practice and the consistent application of this Directive and the Specific Directives. 4. The national regulatory authorities shall promote the interests of the citizens of the European Union by inter alia: (a) ensuring all citizens have access to a universal service specified in Directive 2002/22/EC (Universal Service Directive); (b) ensuring a high level of protection for consumers in their dealings with suppliers, in particular by ensuring the availability of simple and inexpensive dispute resolution procedures carried out by a body that is independent of the parties involved; (c) contributing to ensuring a high level of protection of personal data and privacy; (d) promoting the provision of clear information, in particular requiring transparency of tariffs and conditions for using publicly available electronic communications services; (e) addressing the needs of specific social groups, in particular disabled users; and (f) ensuring that the integrity and security of public communications networks are maintained. Article 9 Management of radio frequencies for electronic communications services 1. Member States shall ensure the effective management of radio frequencies for electronic communication services in their territory in accordance with Article 8. They shall ensure that the allocation and assignment of such radio frequencies by national regulatory authorities are based on objective, transparent, non-discriminatory and proportionate criteria. 2. Member States shall promote the harmonisation of use of radio frequencies across the Community, consistent with the need to ensure effective and efficient use thereof and in accordance with the Decision No 676/2002/EC (Radio Spectrum Decision). 3. Member States may make provision for undertakings to transfer rights to use radio frequencies with other undertakings. 4. Member States shall ensure that an undertaking's intention to transfer rights to use radio frequencies is notified to the national regulatory authority responsible for spectrum assignment and that any transfer takes place in accordance with procedures laid down by the national regulatory authority and is made public. National regulatory authorities shall ensure that competition is not distorted as a result of any such transaction. Where radio frequency use has been harmonised through the application of Decision No 676/2002/EC (Radio Spectrum Decision) or other Community measures, any such transfer shall not result in change of use of that radio frequency. Article 10 Numbering, naming and addressing 1. Member States shall ensure that national regulatory authorities control the assignment of all national numbering resources and the management of the national numbering plans. Member States shall ensure that adequate numbers and numbering ranges are provided for all publicly available electronic communications services. National regulatory authorities shall establish objective, transparent and non-discriminatory assigning procedures for national numbering resources. 2. National regulatory authorities shall ensure that numbering plans and procedures are applied in a manner that gives equal treatment to all providers of publicly available electronic communications services. In particular, Member States shall ensure that an undertaking allocated a range of numbers does not discriminate against other providers of electronic communications services as regards the number sequences used to give access to their services. 3. Member States shall ensure that the national numbering plans, and all subsequent additions or amendments thereto, are published, subject only to limitations imposed on the grounds of national security. 4. Member States shall support the harmonisation of numbering resources within the Community where that is necessary to support the development of pan European services. The Commission may, in accordance with the procedure referred to in Article 22(3), take the appropriate technical implementing measures on this matter. 5. Where this is appropriate in order to ensure full global interoperability of services, Member States shall coordinate their positions in international organisations and forums in which decisions are taken on issues relating to the numbering, naming and addressing of electronic communications networks and services. Article 11 Rights of way 1. Member States shall ensure that when a competent authority considers: - an application for the granting of rights to install facilities on, over or under public or private property to an undertaking authorised to provide public communications networks, or - an application for the granting of rights to install facilities on, over or under public property to an undertaking authorised to provide electronic communications networks other than to the public, the competent authority: - acts on the basis of transparent and publicly available procedures, applied without discrimination and without delay, and - follows the principles of transparency and non-discrimination in attaching conditions to any such rights. The abovementioned procedures can differ depending on whether the applicant is providing public communications networks or not. 2. Member States shall ensure that where public or local authorities retain ownership or control of undertakings operating electronic communications networks and/or services, there is effective structural separation of the function responsible for granting the rights referred to in paragraph 1 from activities associated with ownership or control. 3. Member States shall ensure that effective mechanisms exist to allow undertakings to appeal against decisions on the granting of rights to install facilities to a body that is independent of the parties involved. Article 12 Co-location and facility sharing 1. Where an undertaking providing electronic communications networks has the right under national legislation to install facilities on, over or under public or private property, or may take advantage of a procedure for the expropriation or use of property, national regulatory authorities shall encourage the sharing of such facilities or property. 2. In particular where undertakings are deprived of access to viable alternatives because of the need to protect the environment, public health, public security or to meet town and country planning objectives, Member States may impose the sharing of facilities or property (including physical co-location) on an undertaking operating an electronic communications network or take measures to facilitate the coordination of public works only after an appropriate period of public consultation during which all interested parties must be given an opportunity to express their views. Such sharing or coordination arrangements may include rules for apportioning the costs of facility or property sharing. Article 13 Accounting separation and financial reports 1. Member States shall require undertakings providing public communications networks or publicly available electronic communications services which have special or exclusive rights for the provision of services in other sectors in the same or another Member State to: (a) keep separate accounts for the activities associated with the provision of electronic communications networks or services, to the extent that would be required if these activities were carried out by legally independent companies, so as to identify all elements of cost and revenue, with the basis of their calculation and the detailed attribution methods used, related to their activities associated with the provision of electronic communications networks or services including an itemised breakdown of fixed asset and structural costs, or (b) have structural separation for the activities associated with the provision of electronic communications networks or services. Member States may choose not to apply the requirements referred to in the first subparagraph to undertakings the annual turnover of which in activities associated with electronic communications networks or services in the Member States is less than EUR 50 million. 2. Where undertakings providing public communications networks or publicly available electronic communications services are not subject to the requirements of company law and do not satisfy the small and medium-sized enterprise criteria of Community law accounting rules, their financial reports shall be drawn up and submitted to independent audit and published. The audit shall be carried out in accordance with the relevant Community and national rules. This requirement shall also apply to the separate accounts required under paragraph 1(a). CHAPTER IV GENERAL PROVISIONS Article 14 Undertakings with significant market power 1. Where the Specific Directives require national regulatory authorities to determine whether operators have significant market power in accordance with the procedure referred to in Article 16, paragraphs 2 and 3 of this Article shall apply. 2. An undertaking shall be deemed to have significant market power if, either individually or jointly with others, it enjoys a position equivalent to dominance, that is to say a position of economic strength affording it the power to behave to an appreciable extent independently of competitors, customers and ultimately consumers. In particular, national regulatory authorities shall, when assessing whether two or more undertakings are in a joint dominant position in a market, act in accordance with Community law and take into the utmost account the guidelines on market analysis and the assessment of significant market power published by the Commission pursuant to Article 15. Criteria to be used in making such an assessment are set out in Annex II. 3. Where an undertaking has significant market power on a specific market, it may also be deemed to have significant market power on a closely related market, where the links between the two markets are such as to allow the market power held in one market to be leveraged into the other market, thereby strengthening the market power of the undertaking. Article 15 Market definition procedure 1. After public consultation and consultation with national regulatory authorities the Commission shall adopt a recommendation on relevant product and service markets (hereinafter "the recommendation"). The recommendation shall identify in accordance with Annex I hereto those product and service markets within the electronic communications sector, the characteristics of which may be such as to justify the imposition of regulatory obligations set out in the Specific Directives, without prejudice to markets that may be defined in specific cases under competition law. The Commission shall define markets in accordance with the principles of competition law. The Commission shall regularly review the recommendation. 2. The Commission shall publish, at the latest on the date of entry into force of this Directive, guidelines for market analysis and the assessment of significant market power (hereinafter "the guidelines") which shall be in accordance with the principles of competition law. 3. National regulatory authorities shall, taking the utmost account of the recommendation and the guidelines, define relevant markets appropriate to national circumstances, in particular relevant geographic markets within their territory, in accordance with the principles of competition law. National regulatory authorities shall follow the procedures referred to in Articles 6 and 7 before defining the markets that differ from those defined in the recommendation. 4. After consultation with national regulatory authorities the Commission may, acting in accordance with the procedure referred to in Article 22(3), adopt a Decision identifying transnational markets. Article 16 Market analysis procedure 1. As soon as possible after the adoption of the recommendation or any updating thereof, national regulatory authorities shall carry out an analysis of the relevant markets, taking the utmost account of the guidelines. Member States shall ensure that this analysis is carried out, where appropriate, in collaboration with the national competition authorities. 2. Where a national regulatory authority is required under Articles 16, 17, 18 or 19 of Directive 2002/22/EC (Universal Service Directive), or Articles 7 or 8 of Directive 2002/19/EC (Access Directive) to determine whether to impose, maintain, amend or withdraw obligations on undertakings, it shall determine on the basis of its market analysis referred to in paragraph 1 of this Article whether a relevant market is effectively competitive. 3. Where a national regulatory authority concludes that the market is effectively competitive, it shall not impose or maintain any of the specific regulatory obligations referred to in paragraph 2 of this Article. In cases where sector specific regulatory obligations already exist, it shall withdraw such obligations placed on undertakings in that relevant market. An appropriate period of notice shall be given to parties affected by such a withdrawal of obligations. 4. Where a national regulatory authority determines that a relevant market is not effectively competitive, it shall identify undertakings with significant market power on that market in accordance with Article 14 and the national regulatory authority shall on such undertakings impose appropriate specific regulatory obligations referred to in paragraph 2 of this Article or maintain or amend such obligations where they already exist. 5. In the case of transnational markets identified in the Decision referred to in Article 15(4), the national regulatory authorities concerned shall jointly conduct the market analysis taking the utmost account of the guidelines and decide on any imposition, maintenance, amendment or withdrawal of regulatory obligations referred to in paragraph 2 of this Article in a concerted fashion. 6. Measures taken according to the provisions of paragraphs 3, 4 and 5 of this Article shall be subject to the procedures referred to in Articles 6 and 7. Article 17 Standardisation 1. The Commission, acting in accordance with the procedure referred to in Article 22(2), shall draw up and publish in the Official Journal of the European Communities a list of standards and/or specifications to serve as a basis for encouraging the harmonised provision of electronic communications networks, electronic communications services and associated facilities and services. Where necessary, the Commission may, acting in accordance with the procedure referred to in Article 22(2) and following consultation of the Committee established by Directive 98/34/EC, request that standards be drawn up by the European standards organisations (European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardisation (CENELEC), and European Telecommunications Standards Institute (ETSI)). 2. Member States shall encourage the use of the standards and/or specifications referred to in paragraph 1, for the provision of services, technical interfaces and/or network functions, to the extent strictly necessary to ensure interoperability of services and to improve freedom of choice for users. As long as standards and/or specifications have not been published in accordance with paragraph 1, Member States shall encourage the implementation of standards and/or specifications adopted by the European standards organisations. In the absence of such standards and/or specifications, Member States shall encourage the implementation of international standards or recommendations adopted by the International Telecommunication Union (ITU), the International Organisation for Standardisation (ISO) or the International Electrotechnical Commission (IEC). Where international standards exist, Member States shall encourage the European standards organisations to use them, or the relevant parts of them, as a basis for the standards they develop, except where such international standards or relevant parts would be ineffective. 3. If the standards and/or specifications referred to in paragraph 1 have not been adequately implemented so that interoperability of services in one or more Member States cannot be ensured, the implementation of such standards and/or specifications may be made compulsory under the procedure laid down in paragraph 4, to the extent strictly necessary to ensure such interoperability and to improve freedom of choice for users. 4. Where the Commission intends to make the implementation of certain standards and/or specifications compulsory, it shall publish a notice in the Official Journal of the European Communities and invite public comment by all parties concerned. The Commission, acting in accordance with the procedure referred to in Article 22(3), shall make implementation of the relevant standards compulsory by making reference to them as compulsory standards in the list of standards and/or specifications published in the Official Journal of the European Communities. 5. Where the Commission considers that standards and/or specifications referred to in paragraph 1 no longer contribute to the provision of harmonised electronic communications services, or that they no longer meet consumers' needs or are hampering technological development, it shall, acting in accordance with the procedure referred to in Article 22(2), remove them from the list of standards and/or specifications referred to in paragraph 1. 6. Where the Commission considers that standards and/or specifications referred to in paragraph 4 no longer contribute to the provision of harmonised electronic communications services, or that they no longer meet consumers' needs or are hampering technological development, it shall, acting in accordance with the procedure referred to in Article 22(3), remove them from this list of standards and/or specifications referred to in paragraph 1. 7. This Article does not apply in respect of any of the essential requirements, interface specifications or harmonised standards to which the provisions of Directive 1999/5/EC apply. Article 18 Interoperability of digital interactive television services 1. In order to promote the free flow of information, media pluralism and cultural diversity, Member States shall encourage, in accordance with the provisions of Article 17(2): (a) providers of digital interactive television services for distribution to the public in the Community on digital interactive television platforms, regardless of the transmission mode, to use an open API; (b) providers of all enhanced digital television equipment deployed for the reception of digital interactive television services on interactive digital television platforms to comply with an open API in accordance with the minimum requirements of the relevant standards or specifications. 2. Without prejudice to Article 5(1)(b) of Directive 2002/19/ EC (Access Directive), Member States shall encourage proprietors of APIs to make available on fair, reasonable and non-discriminatory terms, and against appropriate remuneration, all such information as is necessary to enable providers of digital interactive television services to provide all services supported by the API in a fully functional form. 3. Within one year after the date of application referred to in Article 28(1), second subparagraph, the Commission shall examine the effects of this Article. If interoperability and freedom of choice for users have not been adequately achieved in one or more Member States, the Commission may take action in accordance with the procedure laid down in Article 17(3) and (4). Article 19 Harmonisation procedures 1. Where the Commission, acting in accordance with the procedure referred to in Article 22(2), issues recommendations to Member States on the harmonised application of the provisions in this Directive and the Specific Directives in order to further the achievement of the objectives set out in Article 8, Member States shall ensure that national regulatory authorities take the utmost account of those recommendations in carrying out their tasks. Where a national regulatory authority chooses not to follow a recommendation, it shall inform the Commission giving the reasoning for its position. 2. Where the Commission finds that divergence at national level in regulations aimed at implementing Article 10(4) creates a barrier to the single market, the Commission may, acting in accordance with the procedure referred to in Article 22(3), take the appropriate technical implementing measures. Article 20 Dispute resolution between undertakings 1. In the event of a dispute arising in connection with obligations arising under this Directive or the Specific Directives between undertakings providing electronic communications networks or services in a Member State, the national regulatory authority concerned shall, at the request of either party, and without prejudice to the provisions of paragraph 2, issue a binding decision to resolve the dispute in the shortest possible time frame and in any case within four months except in exceptional circumstances. The Member State concerned shall require that all parties cooperate fully with the national regulatory authority. 2. Member States may make provision for national regulatory authorities to decline to resolve a dispute through a binding decision where other mechanisms, including mediation, exist and would better contribute to resolution of the dispute in a timely manner in accordance with the provisions of Article 8. The national regulatory authority shall inform the parties without delay. If after four months the dispute is not resolved, and if the dispute has not been brought before the courts by the party seeking redress, the national regulatory authority shall issue, at the request of either party, a binding decision to resolve the dispute in the shortest possible time frame and in any case within four months. 3. In resolving a dispute, the national regulatory authority shall take decisions aimed at achieving the objectives set out in Article 8. Any obligations imposed on an undertaking by the national regulatory authority in resolving a dispute shall respect the provisions of this Directive or the Specific Directives. 4. The decision of the national regulatory authority shall be made available to the public, having regard to the requirements of business confidentiality. The parties concerned shall be given a full statement of the reasons on which it is based. 5. The procedure referred to in paragraphs 1, 3 and 4 shall not preclude either party from bringing an action before the courts. Article 21 Resolution of cross-border disputes 1. In the event of a cross-border dispute arising under this Directive or the Specific Directives between parties in different Member States, where the dispute lies within the competence of national regulatory authorities from more than one Member State, the procedure set out in paragraphs 2, 3 and 4 shall be applicable. 2. Any party may refer the dispute to the national regulatory authorities concerned. The national regulatory authorities shall coordinate their efforts in order to bring about a resolution of the dispute, in accordance with the objectives set out in Article 8. Any obligations imposed on an undertaking by the national regulatory authority in resolving a dispute shall respect the provisions of this Directive or the Specific Directives. 3. Member States may make provision for national regulatory authorities jointly to decline to resolve a dispute where other mechanisms, including mediation, exist and would better contribute to resolution of the dispute in a timely manner in accordance with the provisions of Article 8. They shall inform the parties without delay. If after four months the dispute is not resolved, if the dispute has not been brought before the courts by the party seeking redress, and if either party requests it, the national regulatory authorities shall coordinate their efforts in order to bring about a resolution of the dispute, in accordance with the provisions set out in Article 8. 4. The procedure referred to in paragraph 2 shall not preclude either party from bringing an action before the courts. Article 22 Committee 1. The Commission shall be assisted by a Committee ("the Communications 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. 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 three months. 4. The Committee shall adopt its rules of procedure. Article 23 Exchange of information 1. The Commission shall provide all relevant information to the Communications Committee on the outcome of regular consultations with the representatives of network operators, service providers, users, consumers, manufacturers and trade unions, as well as third countries and international organisations. 2. The Communications Committee shall, taking account of the Community's electronic communications policy, foster the exchange of information between the Member States and between the Member States and the Commission on the situation and the development of regulatory activities regarding electronic communications networks and services. Article 24 Publication of information 1. Member States shall ensure that up-to-date information pertaining to the application of this Directive and the Specific Directives is made publicly available in a manner that guarantees all interested parties easy access to that information. They shall publish a notice in their national official gazette describing how and where the information is published. The first such notice shall be published before the date of application referred to in Article 28(1), second subparagraph, and thereafter a notice shall be published whenever there is any change in the information contained therein. 2. Member States shall send to the Commission a copy of all such notices at the time of publication. The Commission shall distribute the information to the Communications Committee as appropriate. Article 25 Review procedures 1. The Commission shall periodically review the functioning of this Directive and report to the European Parliament and to the Council, on the first occasion not later than three years after the date of application referred to in Article 28(1), second subparagraph. For this purpose, the Commission may request information from the Member States, which shall be supplied without undue delay. CHAPTER V FINAL PROVISIONS Article 26 Repeal The following Directives and Decisions are hereby repealed with effect from the date of application referred to in Article 28(1), second subparagraph: - Directive 90/387/EEC, - Council Decision 91/396/EEC of 29 July 1991 on the introduction of a single European emergency call number(21), - Council Directive 92/44/EEC of 5 June 1992 on the application of open network provision to leased lines(22), - Council Decision 92/264/EEC of 11 May 1992 on the introduction of a standard international telephone access code in the Community(23), - Directive 95/47/EC, - Directive 97/13/EC, - Directive 97/33/EC, - Directive 98/10/EC of the European Parliament and of the Council of 26 February 1998 on the application of open network provision (ONP) to voice telephony and on universal service for telecommunications in a competitive environment(24). Article 27 Transitional measures Member States shall maintain all obligations under national law referred to in Article 7 of Directive 2002/19/EC (Access Directive) and Article 16 of Directive 2002/22/EC (Universal Service Directive) until such time as a determination is made in respect of those obligations by a national regulatory authority in accordance with Article 16 of this Directive. Operators of fixed public telephone networks that were designated by their national regulatory authority as having significant market power in the provision of fixed public telephone networks and services under Annex I, Part 1 of Directive 97/33/EC or Directive 98/10/EC shall continue to be considered "notified operators" for the purposes of Regulation (EC) No 2887/2000 until such a time as the market analysis procedure referred to in Article 16 has been completed. Thereafter they shall cease to be considered "notified operators" for the purposes of the Regulation. Article 28 Transposition 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 24 July 2003. They shall forthwith inform the Commission thereof. They shall apply those measures from 25 July 2003. 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 a reference shall be laid down by the Member States. 3. 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 and of any subsequent amendments to those provisions. Article 29 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 30 Addressees This Directive is addressed to the Member States.

32002L0020

2002

Directive 2002/20/EC of the European Parliament and of the Council of 7 March 2002 on the authorisation of electronic communications networks and services (Authorisation Directive) 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), Whereas: (1) The outcome of the public consultation on the 1999 review of the regulatory framework for electronic communications, as reflected in the Commission communication of 26 April 2000, and the findings reported by the Commission in its communications on the fifth and sixth reports on the implementation of the telecommunications regulatory package, has confirmed the need for a more harmonised and less onerous market access regulation for electronic communications networks and services throughout the Community. (2) Convergence between different electronic communications networks and services and their technologies requires the establishment of an authorisation system covering all comparable services in a similar way regardless of the technologies used. (3) The objective of this Directive is to create a legal framework to ensure the freedom to provide electronic communications networks and services, subject only to the conditions laid down in this Directive and to any restrictions in conformity with Article 46(1) of the Treaty, in particular measures regarding public policy, public security and public health. (4) This Directive covers authorisation of all electronic communications networks and services whether they are provided to the public or not. This is important to ensure that both categories of providers may benefit from objective, transparent, non-discriminatory and proportionate rights, conditions and procedures. (5) This Directive only applies to the granting of rights to use radio frequencies where such use involves the provision of an electronic communications network or service, normally for remuneration. The self-use of radio terminal equipment, based on the non-exclusive use of specific radio frequencies by a user and not related to an economic activity, such as use of a citizen's band by radio amateurs, does not consist of the provision of an electronic communications network or service and is therefore not covered by this Directive. Such use is covered by the Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity(4). (6) Provisions regarding the free movement of conditional access systems and the free provision of protected services based on such systems are laid down in Directive 98/84/EC of the European Parliament and of the Council of 20 November 1998 on the legal protection of services based on, or consisting of, conditional access(5). The authorisation of such systems and services therefore does not need to be covered by this Directive. (7) The least onerous authorisation system possible should be used to allow the provision of electronic communications networks and services in order to stimulate the development of new electronic communications services and pan-European communications networks and services and to allow service providers and consumers to benefit from the economies of scale of the single market. (8) Those aims can be best achieved by general authorisation of all electronic communications networks and services without requiring any explicit decision or administrative act by the national regulatory authority and by limiting any procedural requirements to notification only. Where Member States require notification by providers of electronic communication networks or services when they start their activities, they may also require proof of such notification having been made by means of any legally recognised postal or electronic acknowledgement of receipt of the notification. Such acknowledgement should in any case not consist of or require an administrative act by the national regulatory authority to which the notification must be made. (9) It is necessary to include the rights and obligations of undertakings under general authorisations explicitly in such authorisations in order to ensure a level playing field throughout the Community and to facilitate cross-border negotiation of interconnection between public communications networks. (10) The general authorisation entitles undertakings providing electronic communications networks and services to the public to negotiate interconnection under the conditions of Directive 2002/19/EC of the European Parliament and of the Council of 7 March 2002 on access to, and interconnection of, electronic communication networks and associated facilities (Access Directive)(6). Undertakings providing electronic communications networks and services other than to the public can negotiate interconnection on commercial terms. (11) The granting of specific rights may continue to be necessary for the use of radio frequencies and numbers, including short codes, from the national numbering plan. Rights to numbers may also be allocated from a European numbering plan, including for example the virtual country code "3883" which has been attributed to member countries of the European Conference of Post and Telecommunications (CEPT). Those rights of use should not be restricted except where this is unavoidable in view of the scarcity of radio frequencies and the need to ensure the efficient use thereof. (12) This Directive does not prejudice whether radio frequencies are assigned directly to providers of electronic communication networks or services or to entities that use these networks or services. Such entities may be radio or television broadcast content providers. Without prejudice to specific criteria and procedures adopted by Member States to grant rights of use for radio frequencies to providers of radio or television broadcast content services, to pursue general interest objectives in conformity with Community law, the procedure for assignment of radio frequencies should in any event be objective, transparent, non-discriminatory and proportionate. In accordance with case law of the Court of Justice, any national restrictions on the rights guaranteed by Article 49 of the Treaty should be objectively justified, proportionate and not exceed what is necessary to achieve general interest objectives as defined by Member States in conformity with Community law. The responsibility for compliance with the conditions attached to the right to use a radio frequency and the relevant conditions attached to the general authorisation should in any case lie with the undertaking to whom the right of use for the radio frequency has been granted. (13) As part of the application procedure for granting rights to use a radio frequency, Member States may verify whether the applicant will be able to comply with the conditions attached to such rights. For this purpose the applicant may be requested to submit the necessary information to prove his ability to comply with these conditions. Where such information is not provided, the application for the right to use a radio frequency may be rejected. (14) Member States are neither obliged to grant nor prevented from granting rights to use numbers from the national numbering plan or rights to install facilities to undertakings other than providers of electronic communications networks or services. (15) The conditions, which may be attached to the general authorisation and to the specific rights of use, should be limited to what is strictly necessary to ensure compliance with requirements and obligations under Community law and national law in accordance with Community law. (16) In the case of electronic communications networks and services not provided to the public it is appropriate to impose fewer and lighter conditions than are justified for electronic communications networks and services provided to the public. (17) Specific obligations which may be imposed on providers of electronic communications networks and services in accordance with Community law by virtue of their significant market power as defined in Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive)(7) should be imposed separately from the general rights and obligations under the general authorisation. (18) The general authorisation should only contain conditions which are specific to the electronic communications sector. It should not be made subject to conditions which are already applicable by virtue of other existing national law which is not specific to the electronic communications sector. Nevertheless, the national regulatory authorities may inform network operators and service providers about other legislation concerning their business, for instance through references on their websites. (19) The requirement to publish decisions on the granting of rights to use frequencies or numbers may be fulfilled by making these decisions publicly accessible via a website. (20) The same undertaking, for example a cable operator, can offer both an electronic communications service, such as the conveyance of television signals, and services not covered under this Directive, such as the commercialisation of an offer of sound or television broadcasting content services, and therefore additional obligations can be imposed on this undertaking in relation to its activity as a content provider or distributor, according to provisions other than those of this Directive, without prejudice to the list of conditions laid in the Annex to this Directive. (21) When granting rights of use for radio frequencies, numbers or rights to install facilities, the relevant authorities may inform the undertakings to whom they grant such rights of the relevant conditions in the general authorisation. (22) Where the demand for radio frequencies in a specific range exceeds their availability, appropriate and transparent procedures should be followed for the assignment of such frequencies in order to avoid any discrimination and optimise use of those scarce resources. (23) National regulatory authorities should ensure, in establishing criteria for competitive or comparative selection procedures, that the objectives in Article 8 of Directive 2002/21/EC (Framework Directive) are met. It would therefore not be contrary to this Directive if the application of objective, non-discriminatory and proportionate selection criteria to promote the development of competition would have the effect of excluding certain undertakings from a competitive or comparative selection procedure for a particular radio frequency. (24) Where the harmonised assignment of radio frequencies to particular undertakings has been agreed at European level, Member States should strictly implement such agreements in the granting of rights of use of radio frequencies from the national frequency usage plan. (25) Providers of electronic communications networks and services may need a confirmation of their rights under the general authorisation with respect to interconnection and rights of way, in particular to facilitate negotiations with other, regional or local, levels of government or with service providers in other Member States. For this purpose the national regulatory authorities should provide declarations to undertakings either upon request or alternatively as an automatic response to a notification under the general authorisation. Such declarations should not by themselves constitute entitlements to rights nor should any rights under the general authorisation or rights of use or the exercise of such rights depend upon a declaration. (26) Where undertakings find that their applications for rights to install facilities have not been dealt with in accordance with the principles set out in Directive 2002/21/EC (Framework Directive) or where such decisions are unduly delayed, they should have the right to appeal against decisions or delays in such decisions in accordance with that Directive. (27) The penalties for non-compliance with conditions under the general authorisation should be commensurate with the infringement. Save in exceptional circumstances, it would not be proportionate to suspend or withdraw the right to provide electronic communications services or the right to use radio frequencies or numbers where an undertaking did not comply with one or more of the conditions under the general authorisation. This is without prejudice to urgent measures which the relevant authorities of the Member States may need to take in case of serious threats to public safety, security or health or to economic and operational interests of other undertakings. This Directive should also be without prejudice to any claims between undertakings for compensation for damages under national law. (28) Subjecting service providers to reporting and information obligations can be cumbersome, both for the undertaking and for the national regulatory authority concerned. Such obligations should therefore be proportionate, objectively justified and limited to what is strictly necessary. It is not necessary to require systematic and regular proof of compliance with all conditions under the general authorisation or attached to rights of use. Undertakings have a right to know the purposes for which the information they should provide will be used. The provision of information should not be a condition for market access. For statistical purposes a notification may be required from providers of electronic communication networks or services when they cease activities. (29) This Directive should be without prejudice to Member States' obligations to provide any information necessary for the defence of Community interests within the context of international agreements. This Directive should also be without prejudice to any reporting obligations under legislation which is not specific to the electronic communications sector such as competition law. (30) Administrative charges may be imposed on providers of electronic communications services in order to finance the activities of the national regulatory authority in managing the authorisation system and for the granting of rights of use. Such charges should be limited to cover the actual administrative costs for those activities. For this purpose transparency should be created in the income and expenditure of national regulatory authorities by means of annual reporting about the total sum of charges collected and the administrative costs incurred. This will allow undertakings to verify that administrative costs and charges are in balance. (31) Systems for administrative charges should not distort competition or create barriers for entry into the market. With a general authorisation system it will no longer be possible to attribute administrative costs and hence charges to individual undertakings except for the granting of rights to use numbers, radio frequencies and for rights to install facilities. Any applicable administrative charges should be in line with the principles of a general authorisation system. An example of a fair, simple and transparent alternative for these charge attribution criteria could be a turnover related distribution key. Where administrative charges are very low, flat rate charges, or charges combining a flat rate basis with a turnover related element could also be appropriate. (32) In addition to administrative charges, usage fees may be levied for the use of radio frequencies and numbers as an instrument to ensure the optimal use of such resources. Such fees should not hinder the development of innovative services and competition in the market. This Directive is without prejudice to the purpose for which fees for rights of use are employed. Such fees may for instance be used to finance activities of national regulatory authorities that cannot be covered by administrative charges. Where, in the case of competitive or comparative selection procedures, fees for rights of use for radio frequencies consist entirely or partly of a one-off amount, payment arrangements should ensure that such fees do not in practice lead to selection on the basis of criteria unrelated to the objective of ensuring optimal use of radio frequencies. The Commission may publish on a regular basis benchmark studies with regard to best practices for the assignment of radio frequencies, the assignment of numbers or the granting of rights of way. (33) Member States may need to amend rights, conditions, procedures, charges and fees relating to general authorisations and rights of use where this is objectively justified. Such changes should be duly notified to all interested parties in good time, giving them adequate opportunity to express their views on any such amendments. (34) The objective of transparency requires that service providers, consumers and other interested parties have easy access to any information regarding rights, conditions, procedures, charges, fees and decisions concerning the provision of electronic communications services, rights of use of radio frequencies and numbers, rights to install facilities, national frequency usage plans and national numbering plans. The national regulatory authorities have an important task in providing such information and keeping it up to date. Where such rights are administered by other levels of government the national regulatory authorities should endeavour to create a user-friendly instrument for access to information regarding such rights. (35) The proper functioning of the single market on the basis of the national authorisation regimes under this Directive should be monitored by the Commission. (36) In order to arrive at a single date of application of all elements of the new regulatory framework for the electronic communications sector, it is important that the process of national transposition of this Directive and of alignment of the existing licences with the new rules take place in parallel. However, in specific cases where the replacement of authorisations existing on the date of entry into force of this Directive by the general authorisation and the individual rights of use in accordance with this Directive would lead to an increase in the obligations for service providers operating under an existing authorisation or to a reduction of their rights, Member States may avail themselves of an additional nine months after the date of application of this Directive for alignment of such licences, unless this would have a negative effect on the rights and obligations of other undertakings. (37) There may be circumstances under which the abolition of an authorisation condition regarding access to electronic communications networks would create serious hardship for one or more undertakings that have benefited from the condition. In such cases further transitional arrangements may be granted by the Commission, upon request by a Member State. (38) Since the objectives of the proposed action, namely the harmonisation and simplification of electronic communications rules and conditions for the authorisation of networks and services 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 for those objectives, Article 1 Objective and scope 1. The aim of this Directive is to implement an internal market in electronic communications networks and services through the harmonisation and simplification of authorisation rules and conditions in order to facilitate their provision throughout the Community. 2. This Directive shall apply to authorisations for the provision of electronic communications networks and services. Article 2 Definitions 1. For the purposes of this Directive, the definitions set out in Article 2 of Directive 2002/21/EC (Framework Directive) shall apply. 2. The following definitions shall also apply: (a) "general authorisation" means a legal framework established by the Member State ensuring rights for the provision of electronic communications networks or services and laying down sector specific obligations that may apply to all or to specific types of electronic communications networks and services, in accordance with this Directive; (b) "harmful interference" means interference which endangers the functioning of a radionavigation service or of other safety services or which otherwise seriously degrades, obstructs or repeatedly interrupts a radiocommunications service operating in accordance with the applicable Community or national regulations. Article 3 General authorisation of electronic communications networks and services 1. Member States shall ensure the freedom to provide electronic communications networks and services, subject to the conditions set out in this Directive. To this end, Member States shall not prevent an undertaking from providing electronic communications networks or services, except where this is necessary for the reasons set out in Article 46(1) of the Treaty. 2. The provision of electronic communications networks or the provision of electronic communications services may, without prejudice to the specific obligations referred to in Article 6(2) or rights of use referred to in Article 5, only be subject to a general authorisation. The undertaking concerned may be required to submit a notification but may not be required to obtain an explicit decision or any other administrative act by the national regulatory authority before exercising the rights stemming from the authorisation. Upon notification, when required, an undertaking may begin activity, where necessary subject to the provisions on rights of use in Articles 5, 6 and 7. 3. The notification referred to in paragraph 2 shall not entail more than a declaration by a legal or natural person to the national regulatory authority of the intention to commence the provision of electronic communication networks or services and the submission of the minimal information which is required to allow the national regulatory authority to keep a register or list of providers of electronic communications networks and services. This information must be limited to what is necessary for the identification of the provider, such as company registration numbers, and the provider's contact persons, the provider's address, a short description of the network or service, and an estimated date for starting the activity. Article 4 Minimum list of rights derived from the general authorisation 1. Undertakings authorised pursuant to Article 3, shall have the right to: (a) provide electronic communications networks and services; (b) have their application for the necessary rights to install facilities considered in accordance with Article 11 of Directive 2002/21/EC (Framework Directive). 2. When such undertakings provide electronic communications networks or services to the public the general authorisation shall also give them the right to: (a) negotiate interconnection with and where applicable obtain access to or interconnection from other providers of publicly available communications networks and services covered by a general authorisation anywhere in the Community under the conditions of and in accordance with Directive 2002/19/EC (Access Directive); (b) be given an opportunity to be designated to provide different elements of a universal service and/or to cover different parts of the national territory in accordance with Directive 2002/22/EC of the European Parliament and of the Council of 7 March 2002 on universal service and users' rights relating to electronic communications networks and services (Universal Service Directive)(8). Article 5 Rights of use for radio frequencies and numbers 1. Member States shall, where possible, in particular where the risk of harmful interference is negligible, not make the use of radio frequencies subject to the grant of individual rights of use but shall include the conditions for usage of such radio frequencies in the general authorisation. 2. Where it is necessary to grant individual rights of use for radio frequencies and numbers, Member States shall grant such rights, upon request, to any undertaking providing or using networks or services under the general authorisation, subject to the provisions of Articles 6, 7 and 11(1)(c) of this Directive and any other rules ensuring the efficient use of those resources in accordance with Directive 2002/21/EC (Framework Directive). Without prejudice to specific criteria and procedures adopted by Member States to grant rights of use of radio frequencies to providers of radio or television broadcast content services with a view to pursuing general interest objectives in conformity with Community law, such rights of use shall be granted through open, transparent and non-discriminatory procedures. When granting rights of use, Member States shall specify whether those rights can be transferred at the initiative of the right holder, and under which conditions, in the case of radio frequencies, in accordance with Article 9 of Directive 2002/21/EC (Framework Directive). Where Member States grant rights of use for a limited period of time, the duration shall be appropriate for the service concerned. 3. Decisions on rights of use shall be taken, communicated and made public as soon as possible after receipt of the complete application by the national regulatory authority, within three weeks in the case of numbers that have been allocated for specific purposes within the national numbering plan and within six weeks in the case of radio frequencies that have been allocated for specific purposes within the national frequency plan. The latter time limit shall be without prejudice to any applicable international agreements relating to the use of radio frequencies or of orbital positions. 4. Where it has been decided, after consultation with interested parties in accordance with Article 6 of Directive 2002/21/EC (Framework Directive), that rights for use of numbers of exceptional economic value are to be granted through competitive or comparative selection procedures, Member States may extend the maximum period of three weeks by up to three weeks. With regard to competitive or comparative selection procedures for radio frequencies Article 7 shall apply. 5. Member States shall not limit the number of rights of use to be granted except where this is necessary to ensure the efficient use of radio frequencies in accordance with Article 7. Article 6 Conditions attached to the general authorisation and to the rights of use for radio frequencies and for numbers, and specific obligations 1. The general authorisation for the provision of electronic communications networks or services and the rights of use for radio frequencies and rights of use for numbers may be subject only to the conditions listed respectively in parts A, B and C of the Annex. Such conditions shall be objectively justified in relation to the network or service concerned, non-discriminatory, proportionate and transparent. 2. Specific obligations which may be imposed on providers of electronic communications networks and services under Articles 5(1), 5(2), 6 and 8 of Directive 2002/19/EC (Access Directive) and Articles 16, 17, 18 and 19 of Directive 2002/22/EC (Universal Service Directive) or on those designated to provide universal service under the said Directive shall be legally separate from the rights and obligations under the general authorisation. In order to achieve transparency for undertakings, the criteria and procedures for imposing such specific obligations on individual undertakings shall be referred to in the general authorisation. 3. The general authorisation shall only contain conditions which are specific for that sector and are set out in Part A of the Annex and shall not duplicate conditions which are applicable to undertakings by virtue of other national legislation. 4. Member States shall not duplicate the conditions of the general authorisation where they grant the right of use for radio frequencies or numbers. Article 7 Procedure for limiting the number of rights of use to be granted for radio frequencies 1. Where a Member State is considering whether to limit the number of rights of use to be granted for radio frequencies, it shall inter alia: (a) give due weight to the need to maximise benefits for users and to facilitate the development of competition; (b) give all interested parties, including users and consumers, the opportunity to express their views on any limitation in accordance with Article 6 of Directive 2002/21/EC (Framework Directive); (c) publish any decision to limit the granting of rights of use, stating the reasons therefor; (d) after having determined the procedure, invite applications for rights of use; and (e) review the limitation at reasonable intervals or at the reasonable request of affected undertakings. 2. Where a Member State concludes that further rights of use for radio frequencies can be granted, it shall publish that conclusion and invite applications for such rights. 3. Where the granting of rights of use for radio frequencies needs to be limited, Member States shall grant such rights on the basis of selection criteria which must be objective, transparent, non-discriminatory and proportionate. Any such selection criteria must give due weight to the achievement of the objectives of Article 8 of Directive 2002/21/EC (Framework Directive). 4. Where competitive or comparative selection procedures are to be used, Member States may extend the maximum period of six weeks referred to in Article 5(3) for as long as necessary to ensure that such procedures are fair, reasonable, open and transparent to all interested parties, but by no longer than eight months. These time limits shall be without prejudice to any applicable international agreements relating to the use of radio frequencies and satellite coordination. 5. This Article is without prejudice to the transfer of rights of use for radio frequencies in accordance with Article 9 of Directive 2002/21/EC (Framework Directive). Article 8 Harmonised assignment of radio frequencies Where the usage of radio frequencies has been harmonised, access conditions and procedures have been agreed, and undertakings to which the radio frequencies shall be assigned have been selected in accordance with international agreements and Community rules, Member States shall grant the right of use for such radio frequencies in accordance therewith. Provided that all national conditions attached to the right to use the radio frequencies concerned have been satisfied in the case of a common selection procedure, Member States shall not impose any further conditions, additional criteria or procedures which would restrict, alter or delay the correct implementation of the common assignment of such radio frequencies. Article 9 Declarations to facilitate the exercise of rights to install facilities and rights of interconnection At the request of an undertaking, national regulatory authorities shall, within one week, issue standardised declarations, confirming, where applicable, that the undertaking has submitted a notification under Article 3(2) and detailing under what circumstances any undertaking providing electronic communications networks or services under the general authorisation has the right to apply for rights to install facilities, negotiate interconnection, and/or obtain access or interconnection in order to facilitate the exercise of those rights for instance at other levels of government or in relation to other undertakings. Where appropriate such declarations may also be issued as an automatic reply following the notification referred to in Article 3(2). Article 10 Compliance with the conditions of the general authorisation or of rights of use and with specific obligations 1. National regulatory authorities may require undertakings providing electronic communications networks or services covered by the general authorisation or enjoying rights of use for radio frequencies or numbers to provide information necessary to verify compliance with the conditions of the general authorisation or of rights of use or with the specific obligations referred to in Article 6(2), in accordance with Article 11. 2. Where a national regulatory authority finds that an undertaking does not comply with one or more of the conditions of the general authorisation, or of rights of use or with the specific obligations referred to in Article 6(2), it shall notify the undertaking of those findings and give the undertaking a reasonable opportunity to state its views or remedy any breaches within: - one month after notification, or - a shorter period agreed by the undertaking or stipulated by the national regulatory authority in case of repeated breaches, or - a longer period decided by the national regulatory authority. 3. If the undertaking concerned does not remedy the breaches within the period as referred to in paragraph 2, the relevant authority shall take appropriate and proportionate measures aimed at ensuring compliance. In this regard, Member States may empower the relevant authorities to impose financial penalties where appropriate. The measures and the reasons on which they are based shall be communicated to the undertaking concerned within one week of their adoption and shall stipulate a reasonable period for the undertaking to comply with the measure. 4. Notwithstanding the provisions of paragraphs 2 and 3, Member States may empower the relevant authority to impose financial penalties where appropriate on undertakings for failure to provide information in accordance with obligations imposed under Article 11(1)(a) or (b) of this Directive or Article 9 of Directive 2002/19/EC (Access Directive) within a reasonable period stipulated by the national regulatory authority. 5. In cases of serious and repeated breaches of the conditions of the general authorisation, the rights of use or specific obligations referred to in Article 6(2), where measures aimed at ensuring compliance as referred to in paragraph 3 of this Article have failed, national regulatory authorities may prevent an undertaking from continuing to provide electronic communications networks or services or suspend or withdraw rights of use. 6. Irrespective of the provisions of paragraphs 2, 3 and 5, where the relevant authority has evidence of a breach of the conditions of the general authorisation, rights of use or specific obligations referred to in Article 6(2) that represents an immediate and serious threat to public safety, public security or public health or will create serious economic or operational problems for other providers or users of electronic communications networks or services, it may take urgent interim measures to remedy the situation in advance of reaching a final decision. The undertaking concerned shall thereafter be given a reasonable opportunity to state its view and propose any remedies. Where appropriate, the relevant authority may confirm the interim measures. 7. Undertakings shall have the right to appeal against measures taken under this Article in accordance with the procedure referred to in Article 4 of Directive 2002/21/EC (Framework Directive). Article 11 Information required under the general authorisation, for rights of use and for the specific obligations 1. Without prejudice to information and reporting obligations under national legislation other than the general authorisation, national regulatory authorities may only require undertakings to provide information under the general authorisation, for rights of use or the specific obligations referred to in Article 6(2) that is proportionate and objectively justified for: (a) systematic or case-by-case verification of compliance with conditions 1 and 2 of Part A, condition 6 of Part B and condition 7 of Part C of the Annex and of compliance with obligations as referred to in Article 6(2); (b) case-by-case verification of compliance with conditions as set out in the Annex where a complaint has been received or where the national regulatory authority has other reasons to believe that a condition is not complied with or in case of an investigation by the national regulatory authority on its own initiative; (c) procedures for and assessment of requests for granting rights of use; (d) publication of comparative overviews of quality and price of services for the benefit of consumers; (e) clearly defined statistical purposes; (f) market analysis for the purposes of Directive 2002/19/EC (Access Directive) or Directive 2002/22/EC (Universal Service Directive). The information referred to in points (a), (b), (d), (e) and (f) of the first subparagraph may not be required prior to or as a condition for market access. 2. Where national regulatory authorities require undertakings to provide information as referred to in paragraph 1, they shall inform them of the specific purpose for which this information is to be used. Article 12 Administrative charges 1. Any administrative charges imposed on undertakings providing a service or a network under the general authorisation or to whom a right of use has been granted shall: (a) in total, cover only the administrative costs which will be incurred in the management, control and enforcement of the general authorisation scheme and of rights of use and of specific obligations as referred to in Article 6(2), which may include costs for international cooperation, harmonisation and standardisation, market analysis, monitoring compliance and other market control, as well as regulatory work involving preparation and enforcement of secondary legislation and administrative decisions, such as decisions on access and interconnection; and (b) be imposed upon the individual undertakings in an objective, transparent and proportionate manner which minimises additional administrative costs and attendant charges. 2. Where national regulatory authorities impose administrative charges, they shall publish a yearly overview of their administrative costs and of the total sum of the charges collected. In the light of the difference between the total sum of the charges and the administrative costs, appropriate adjustments shall be made. Article 13 Fees for rights of use and rights to install facilities Member States may allow the relevant authority to impose fees for the rights of use for radio frequencies or numbers or rights to install facilities on, over or under public or private property which reflect the need to ensure the optimal use of these resources. Member States shall ensure that such fees shall be objectively justified, transparent, non-discriminatory and proportionate in relation to their intended purpose and shall take into account the objectives in Article 8 of Directive 2002/21/EC (Framework Directive). Article 14 Amendment of rights and obligations 1. Member States shall ensure that the rights, conditions and procedures concerning general authorisations and rights of use or rights to install facilities may only be amended in objectively justified cases and in a proportionate manner. Notice shall be given in an appropriate manner of the intention to make such amendments and interested parties, including users and consumers, shall be allowed a sufficient period of time to express their views on the proposed amendments, which shall be no less than four weeks except in exceptional circumstances. 2. Member States shall not restrict or withdraw rights to install facilities before expiry of the period for which they were granted except where justified and where applicable in conformity with relevant national provisions regarding compensation for withdrawal of rights. Article 15 Publication of information 1. Member States shall ensure that all relevant information on rights, conditions, procedures, charges, fees and decisions concerning general authorisations and rights of use is published and kept up to date in an appropriate manner so as to provide easy access to that information for all interested parties. 2. Where information as referred to in paragraph 1 is held at different levels of government, in particular information regarding procedures and conditions on rights to install facilities, the national regulatory authority shall make all reasonable efforts, bearing in mind the costs involved, to create a user-friendly overview of all such information, including information on the relevant levels of government and the responsible authorities, in order to facilitate applications for rights to install facilities. Article 16 Review procedures The Commission shall periodically review the functioning of the national authorisation systems and the development of cross-border service provision within the Community and report to the European Parliament and to the Council on the first occasion not later than three years after the date of application of this Directive referred to in Article 18(1), second subparagraph. For this purpose, the Commission may request from the Member States information, which shall be supplied without undue delay. Article 17 Existing authorisations 1. Member States shall bring authorisations already in existence on the date of entry into force of this Directive into line with the provisions of this Directive by at the latest the date of application referred to in Article 18(1), second subparagraph. 2. Where application of paragraph 1 results in a reduction of the rights or an extension of the obligations under authorisations already in existence, Member States may extend the validity of those rights and obligations until at the latest nine months after the date of application referred to in Article 18(1), second subparagraph, provided that the rights of other undertakings under Community law are not affected thereby. Member States shall notify such extensions to the Commission and state the reasons therefor. 3. Where the Member State concerned can prove that the abolition of an authorisation condition regarding access to electronic communications networks, which was in force before the date of entry into force of this Directive, creates excessive difficulties for undertakings that have benefited from mandated access to another network, and where it is not possible for these undertakings to negotiate new agreements on reasonable commercial terms before the date of application referred to in Article 18(1), second subparagraph, Member States may request a temporary prolongation of the relevant condition(s). Such requests shall be submitted by the date of application referred to in Article 18(1), second subparagraph, at the latest, and shall specify the condition(s) and period for which the temporary prolongation is requested. The Member State shall inform the Commission of the reasons for requesting a prolongation. The Commission shall consider such a request, taking into account the particular situation in that Member State and of the undertaking(s) concerned, and the need to ensure a coherent regulatory environment at a Community level. It shall take a decision on whether to grant or reject the request, and where it decides to grant the request, on the scope and duration of the prolongation to be granted. The Commission shall communicate its decision to the Member State concerned within six months after receipt of the application for a prolongation. Such decisions shall be published in the Official Journal of the European Communities. Article 18 Transposition 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 24 July 2003 at the latest. They shall forthwith inform the Commission thereof. They shall apply those measures from 25 July 2003. 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 Member States. 2. 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 and of any subsequent amendments to those provisions. Article 19 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 20 Addressees This Directive is addressed to the Member States.

32002L0022

2002

Directive 2002/22/EC of the European Parliament and of the Council of 7 March 2002 on universal service and users' rights relating to electronic communications networks and services (Universal Service Directive) 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 the Regions(3), Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), Whereas: (1) The liberalisation of the telecommunications sector and increasing competition and choice for communications services go hand in hand with parallel action to create a harmonised regulatory framework which secures the delivery of universal service. The concept of universal service should evolve to reflect advances in technology, market developments and changes in user demand. The regulatory framework established for the full liberalisation of the telecommunications market in 1998 in the Community defined the minimum scope of universal service obligations and established rules for its costing and financing. (2) Under Article 153 of the Treaty, the Community is to contribute to the protection of consumers. (3) The Community and its Member States have undertaken commitments on the regulatory framework of telecommunications networks and services in the context of the World Trade Organisation (WTO) agreement on basic telecommunications. Any member of the WTO has the right to define the kind of universal service obligation it wishes to maintain. Such obligations will not be regarded as anti-competitive per se, provided they are administered in a transparent, non-discriminatory and competitively neutral manner and are not more burdensome than necessary for the kind of universal service defined by the member. (4) Ensuring universal service (that is to say, the provision of a defined minimum set of services to all end-users at an affordable price) may involve the provision of some services to some end-users at prices that depart from those resulting from normal market conditions. However, compensating undertakings designated to provide such services in such circumstances need not result in any distortion of competition, provided that designated undertakings are compensated for the specific net cost involved and provided that the net cost burden is recovered in a competitively neutral way. (5) In a competitive market, certain obligations should apply to all undertakings providing publicly available telephone services at fixed locations and others should apply only to undertakings enjoying significant market power or which have been designated as a universal service operator. (6) The network termination point represents a boundary for regulatory purposes between the regulatory framework for electronic communication networks and services and the regulation of telecommunication terminal equipment. Defining the location of the network termination point is the responsibility of the national regulatory authority, where necessary on the basis of a proposal by the relevant undertakings. (7) Member States should continue to ensure that the services set out in Chapter II are made available with the quality specified to all end-users in their territory, irrespective of their geographical location, and, in the light of specific national conditions, at an affordable price. Member States may, in the context of universal service obligations and in the light of national conditions, take specific measures for consumers in rural or geographically isolated areas to ensure their access to the services set out in the Chapter II and the affordability of those services, as well as ensure under the same conditions this access, in particular for the elderly, the disabled and for people with special social needs. Such measures may also include measures directly targeted at consumers with special social needs providing support to identified consumers, for example by means of specific measures, taken after the examination of individual requests, such as the paying off of debts. (8) A fundamental requirement of universal service is to provide users on request with a connection to the public telephone network at a fixed location, at an affordable price. The requirement is limited to a single narrowband network connection, the provision of which may be restricted by Member States to the end-user's primary location/residence, and does not extend to the Integrated Services Digital Network (ISDN) which provides two or more connections capable of being used simultaneously. There should be no constraints on the technical means by which the connection is provided, allowing for wired or wireless technologies, nor any constraints on which operators provide part or all of universal service obligations. Connections to the public telephone network at a fixed location should be capable of supporting speech and data communications at rates sufficient for access to online services such as those provided via the public Internet. The speed of Internet access experienced by a given user may depend on a number of factors including the provider(s) of Internet connectivity as well as the given application for which a connection is being used. The data rate that can be supported by a single narrowband connection to the public telephone network depends on the capabilities of the subscriber's terminal equipment as well as the connection. For this reason it is not appropriate to mandate a specific data or bit rate at Community level. Currently available voice band modems typically offer a data rate of 56 kbit/s and employ automatic data rate adaptation to cater for variable line quality, with the result that the achieved data rate may be lower than 56 kbit/s. Flexibility is required on the one hand to allow Member States to take measures where necessary to ensure that connections are capable of supporting such a data rate, and on the other hand to allow Member States where relevant to permit data rates below this upper limit of 56 kbits/s in order, for example, to exploit the capabilities of wireless technologies (including cellular wireless networks) to deliver universal service to a higher proportion of the population. This may be of particular importance in some accession countries where household penetration of traditional telephone connections remains relatively low. In specific cases where the connection to the public telephony network at a fixed location is clearly insufficient to support satisfactory Internet access, Member States should be able to require the connection to be brought up to the level enjoyed by the majority of subscribers so that it supports data rates sufficient for access to the Internet. Where such specific measures produce a net cost burden for those consumers concerned, the net effect may be included in any net cost calculation of universal service obligations. (9) The provisions of this Directive do not preclude Member States from designating different undertakings to provide the network and service elements of universal service. Designated undertakings providing network elements may be required to ensure such construction and maintenance as are necessary and proportionate to meet all reasonable requests for connection at a fixed location to the public telephone network and for access to publicly available telephone services at a fixed location. (10) Affordable price means a price defined by Member States at national level in the light of specific national conditions, and may involve setting common tariffs irrespective of location or special tariff options to deal with the needs of low-income users. Affordability for individual consumers is related to their ability to monitor and control their expenditure. (11) Directory information and a directory enquiry service constitute an essential access tool for publicly available telephone services and form part of the universal service obligation. Users and consumers desire comprehensive directories and a directory enquiry service covering all listed telephone subscribers and their numbers (including fixed and mobile numbers) and want this information to be presented in a non-preferential fashion. 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(5) ensures the subscribers' right to privacy with regard to the inclusion of their personal information in a public directory. (12) For the citizen, it is important for there to be adequate provision of public pay telephones, and for users to be able to call emergency telephone numbers and, in particular, the single European emergency call number ("112") free of charge from any telephone, including public pay telephones, without the use of any means of payment. Insufficient information about the existence of "112" deprives citizens of the additional safety ensured by the existence of this number at European level especially during their travel in other Member States. (13) Member States should take suitable measures in order to guarantee access to and affordability of all publicly available telephone services at a fixed location for disabled users and users with special social needs. Specific measures for disabled users could include, as appropriate, making available accessible public telephones, public text telephones or equivalent measures for deaf or speech-impaired people, providing services such as directory enquiry services or equivalent measures free of charge for blind or partially sighted people, and providing itemised bills in alternative format on request for blind or partially sighted people. Specific measures may also need to be taken to enable disabled users and users with special social needs to access emergency services "112" and to give them a similar possibility to choose between different operators or service providers as other consumers. Quality of service standards have been developed for a range of parameters to assess the quality of services received by subscribers and how well undertakings designated with universal service obligations perform in achieving these standards. Quality of service standards do not yet exist in respect of disabled users. Performance standards and relevant parameters should be developed for disabled users and are provided for in Article 11 of this Directive. Moreover, national regulatory authorities should be enabled to require publication of quality of service performance data if and when such standards and parameters are developed. The provider of universal service should not take measures to prevent users from benefiting fully from services offered by different operators or service providers, in combination with its own services offered as part of universal service. (14) The importance of access to and use of the public telephone network at a fixed location is such that it should be available to anyone reasonably requesting it. In accordance with the principle of subsidiarity, it is for Member States to decide on the basis of objective criteria which undertakings have universal service obligations for the purposes of this Directive, where appropriate taking into account the ability and the willingness of undertakings to accept all or part of the universal service obligations. It is important that universal service obligations are fulfilled in the most efficient fashion so that users generally pay prices that correspond to efficient cost provision. It is likewise important that universal service operators maintain the integrity of the network as well as service continuity and quality. The development of greater competition and choice provide more possibilities for all or part of the universal service obligations to be provided by undertakings other than those with significant market power. Therefore, universal service obligations could in some cases be allocated to operators demonstrating the most cost-effective means of delivering access and services, including by competitive or comparative selection procedures. Corresponding obligations could be included as conditions in authorisations to provide publicly available services. (15) Member States should monitor the situation of consumers with respect to their use of publicly available telephone services and in particular with respect to affordability. The affordability of telephone service is related to the information which users receive regarding telephone usage expenses as well as the relative cost of telephone usage compared to other services, and is also related to their ability to control expenditure. Affordability therefore means giving power to consumers through obligations imposed on undertakings designated as having universal service obligations. These obligations include a specified level of itemised billing, the possibility for consumers selectively to block certain calls (such as high-priced calls to premium services), the possibility for consumers to control expenditure via pre-payment means and the possibility for consumers to offset up-front connection fees. Such measures may need to be reviewed and changed in the light of market developments. Current conditions do not warrant a requirement for operators with universal service obligations to alert subscribers where a predetermined limit of expenditure is exceeded or an abnormal calling pattern occurs. Review of the relevant legislative provisions in future should consider whether there is a possible need to alert subscribers for these reasons. (16) Except in cases of persistent late payment or non-payment of bills, consumers should be protected from immediate disconnection from the network on the grounds of an unpaid bill and, particularly in the case of disputes over high bills for premium rate services, should continue to have access to essential telephone services pending resolution of the dispute. Member States may decide that such access may continue to be provided only if the subscriber continues to pay line rental charges. (17) Quality and price are key factors in a competitive market and national regulatory authorities should be able to monitor achieved quality of service for undertakings which have been designated as having universal service obligations. In relation to the quality of service attained by such undertakings, national regulatory authorities should be able to take appropriate measures where they deem it necessary. National regulatory authorities should also be able to monitor the achieved quality of services of other undertakings providing public telephone networks and/or publicly available telephone services to users at fixed locations. (18) Member States should, where necessary, establish mechanisms for financing the net cost of universal service obligations in cases where it is demonstrated that the obligations can only be provided at a loss or at a net cost which falls outside normal commercial standards. It is important to ensure that the net cost of universal service obligations is properly calculated and that any financing is undertaken with minimum distortion to the market and to undertakings, and is compatible with the provisions of Articles 87 and 88 of the Treaty. (19) Any calculation of the net cost of universal service should take due account of costs and revenues, as well as the intangible benefits resulting from providing universal service, but should not hinder the general aim of ensuring that pricing structures reflect costs. Any net costs of universal service obligations should be calculated on the basis of transparent procedures. (20) Taking into account intangible benefits means that an estimate in monetary terms, of the indirect benefits that an undertaking derives by virtue of its position as provider of universal service, should be deducted from the direct net cost of universal service obligations in order to determine the overall cost burden. (21) When a universal service obligation represents an unfair burden on an undertaking, it is appropriate to allow Member States to establish mechanisms for efficiently recovering net costs. Recovery via public funds constitutes one method of recovering the net costs of universal service obligations. It is also reasonable for established net costs to be recovered from all users in a transparent fashion by means of levies on undertakings. Member States should be able to finance the net costs of different elements of universal service through different mechanisms, and/or to finance the net costs of some or all elements from either of the mechanisms or a combination of both. In the case of cost recovery by means of levies on undertakings, Member States should ensure that that the method of allocation amongst them is based on objective and non-discriminatory criteria and is in accordance with the principle of proportionality. This principle does not prevent Member States from exempting new entrants which have not yet achieved any significant market presence. Any funding mechanism should ensure that market participants only contribute to the financing of universal service obligations and not to other activities which are not directly linked to the provision of the universal service obligations. Recovery mechanisms should in all cases respect the principles of Community law, and in particular in the case of sharing mechanisms those of non-discrimination and proportionality. Any funding mechanism should ensure that users in one Member State do not contribute to universal service costs in another Member State, for example when making calls from one Member State to another. (22) Where Member States decide to finance the net cost of universal service obligations from public funds, this should be understood to comprise funding from general government budgets including other public financing sources such as state lotteries. (23) The net cost of universal service obligations may be shared between all or certain specified classes of undertaking. Member States should ensure that the sharing mechanism respects the principles of transparency, least market distortion, non-discrimination and proportionality. Least market distortion means that contributions should be recovered in a way that as far as possible minimises the impact of the financial burden falling on end-users, for example by spreading contributions as widely as possible. (24) National regulatory authorities should satisfy themselves that those undertakings benefiting from universal service funding provide a sufficient level of detail of the specific elements requiring such funding in order to justify their request. Member States' schemes for the costing and financing of universal service obligations should be communicated to the Commission for verification of compatibility with the Treaty. There are incentives for designated operators to raise the assessed net cost of universal service obligations. Therefore Member States should ensure effective transparency and control of amounts charged to finance universal service obligations. (25) Communications markets continue to evolve in terms of the services used and the technical means used to deliver them to users. The universal service obligations, which are defined at a Community level, should be periodically reviewed with a view to proposing that the scope be changed or redefined. Such a review should take account of evolving social, commercial and technological conditions and the fact that any change of scope should be subject to the twin test of services that become available to a substantial majority of the population, with a consequent risk of social exclusion for those who can not afford them. Care should be taken in any change of the scope of universal service obligations to ensure that certain technological choices are not artificially promoted above others, that a disproportionate financial burden is not imposed on sector undertakings (thereby endangering market developments and innovation) and that any financing burden does not fall unfairly on consumers with lower incomes. Any change of scope automatically means that any net cost can be financed via the methods permitted in this Directive. Member States are not permitted to impose on market players financial contributions which relate to measures which are not part of universal service obligations. Individual Member States remain free to impose special measures (outside the scope of universal service obligations) and finance them in conformity with Community law but not by means of contributions from market players. (26) More effective competition across all access and service markets will give greater choice for users. The extent of effective competition and choice varies across the Community and varies within Member States between geographical areas and between access and service markets. Some users may be entirely dependent on the provision of access and services by an undertaking with significant market power. In general, for reasons of efficiency and to encourage effective competition, it is important that the services provided by an undertaking with significant market power reflect costs. For reasons of efficiency and social reasons, end-user tariffs should reflect demand conditions as well as cost conditions, provided that this does not result in distortions of competition. There is a risk that an undertaking with significant market power may act in various ways to inhibit entry or distort competition, for example by charging excessive prices, setting predatory prices, compulsory bundling of retail services or showing undue preference to certain customers. Therefore, national regulatory authorities should have powers to impose, as a last resort and after due consideration, retail regulation on an undertaking with significant market power. Price cap regulation, geographical averaging or similar instruments, as well as non-regulatory measures such as publicly available comparisons of retail tariffs, may be used to achieve the twin objectives of promoting effective competition whilst pursuing public interest needs, such as maintaining the affordability of publicly available telephone services for some consumers. Access to appropriate cost accounting information is necessary, in order for national regulatory authorities to fulfil their regulatory duties in this area, including the imposition of any tariff controls. However, regulatory controls on retail services should only be imposed where national regulatory authorities consider that relevant wholesale measures or measures regarding carrier selection or pre-selection would fail to achieve the objective of ensuring effective competition and public interest. (27) Where a national regulatory authority imposes obligations to implement a cost accounting system in order to support price controls, it may itself undertake an annual audit to ensure compliance with that cost accounting system, provided that it has the necessary qualified staff, or it may require the audit to be carried out by another qualified body, independent of the operator concerned. (28) It is considered necessary to ensure the continued application of the existing provisions relating to the minimum set of leased line services in Community telecommunications legislation, in particular in Council Directive 92/44/EEC of 5 June 1992 on the application of open network provision to leased lines(6), until such time as national regulatory authorities determine, in accordance with the market analysis procedures laid down in Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive)(7), that such provisions are no longer needed because a sufficiently competitive market has developed in their territory. The degree of competition is likely to vary between different markets of leased lines in the minimum set, and in different parts of the territory. In undertaking the market analysis, national regulatory authorities should make separate assessments for each market of leased lines in the minimum set, taking into account their geographic dimension. Leased lines services constitute mandatory services to be provided without recourse to any compensation mechanisms. The provision of leased lines outside of the minimum set of leased lines should be covered by general retail regulatory provisions rather than specific requirements covering the supply of the minimum set. (29) National regulatory authorities may also, in the light of an analysis of the relevant market, require mobile operators with significant market power to enable their subscribers to access the services of any interconnected provider of publicly available telephone services on a call-by-call basis or by means of pre-selection. (30) Contracts are an important tool for users and consumers to ensure a minimum level of transparency of information and legal security. Most service providers in a competitive environment will conclude contracts with their customers for reasons of commercial desirability. In addition to the provisions of this Directive, the requirements of existing Community consumer protection legislation relating to contracts, in particular Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts(8) and 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), apply to consumer transactions relating to electronic networks and services. Specifically, consumers should enjoy a minimum level of legal certainty in respect of their contractual relations with their direct telephone service provider, such that the contractual terms, conditions, quality of service, condition for termination of the contract and the service, compensation measures and dispute resolution are specified in their contracts. Where service providers other than direct telephone service providers conclude contracts with consumers, the same information should be included in those contracts as well. The measures to ensure transparency on prices, tariffs, terms and conditions will increase the ability of consumers to optimise their choices and thus to benefit fully from competition. (31) End-users should have access to publicly available information on communications services. Member States should be able to monitor the quality of services which are offered in their territories. National regulatory authorities should be able systematically to collect information on the quality of services offered in their territories on the basis of criteria which allow comparability between service providers and between Member States. Undertakings providing communications services, operating in a competitive environment, are likely to make adequate and up-to-date information on their services publicly available for reasons of commercial advantage. National regulatory authorities should nonetheless be able to require publication of such information where it is demonstrated that such information is not effectively available to the public. (32) End-users should be able to enjoy a guarantee of interoperability in respect of all equipment sold in the Community for the reception of digital television. Member States should be able to require minimum harmonised standards in respect of such equipment. Such standards could be adapted from time to time in the light of technological and market developments. (33) It is desirable to enable consumers to achieve the fullest connectivity possible to digital television sets. Interoperability is an evolving concept in dynamic markets. Standards bodies should do their utmost to ensure that appropriate standards evolve along with the technologies concerned. It is likewise important to ensure that connectors are available on television sets that are capable of passing all the necessary elements of a digital signal, including the audio and video streams, conditional access information, service information, application program interface (API) information and copy protection information. This Directive therefore ensures that the functionality of the open interface for digital television sets is not limited by network operators, service providers or equipment manufacturers and continues to evolve in line with technological developments. For display and presentation of digital interactive television services, the realisation of a common standard through a market-driven mechanism is recognised as a consumer benefit. Member States and the Commission may take policy initiatives, consistent with the Treaty, to encourage this development. (34) All end-users should continue to enjoy access to operator assistance services whatever organisation provides access to the public telephone network. (35) The provision of directory enquiry services and directories is already open to competition. The provisions of this Directive complement the provisions of Directive 97/66/EC by giving subscribers a right to have their personal data included in a printed or electronic directory. All service providers which assign telephone numbers to their subscribers are obliged to make relevant information available in a fair, cost-oriented and non-discriminatory manner. (36) It is important that users should be able to call the single European emergency number "112", and any other national emergency telephone numbers, free of charge, from any telephone, including public pay telephones, without the use of any means of payment. Member States should have already made the necessary organisational arrangements best suited to the national organisation of the emergency systems, in order to ensure that calls to this number are adequately answered and handled. Caller location information, to be made available to the emergency services, will improve the level of protection and the security of users of "112" services and assist the emergency services, to the extent technically feasible, in the discharge of their duties, provided that the transfer of calls and associated data to the emergency services concerned is guaranteed. The reception and use of such information should comply with relevant Community law on the processing of personal data. Steady information technology improvements will progressively support the simultaneous handling of several languages over the networks at a reasonable cost. This in turn will ensure additional safety for European citizens using the "112" emergency call number. (37) Easy access to international telephone services is vital for European citizens and European businesses. "00" has already been established as the standard international telephone access code for the Community. Special arrangements for making calls between adjacent locations across borders between Member States may be established or continued. The ITU has assigned, in accordance with ITU Recommendation E.164, code "3883" to the European Telephony Numbering Space (ETNS). In order to ensure connection of calls to the ETNS, undertakings operating public telephone networks should ensure that calls using "3883" are directly or indirectly interconnected to ETNS serving networks specified in the relevant European Telecommunications Standards Institute (ETSI) standards. Such interconnection arrangements should be governed by the provisions of Directive 2002/19/EC of the European Parliament and of the Council of 7 March 2002 on access to, and interconnection of, electronic communications networks and associated facilities (Access Directive)(10). (38) Access by end-users to all numbering resources in the Community is a vital pre-condition for a single market. It should include freephone, premium rate, and other non-geographic numbers, except where the called subscriber has chosen, for commercial reasons, to limit access from certain geographical areas. Tariffs charged to parties calling from outside the Member State concerned need not be the same as for those parties calling from inside that Member State. (39) Tone dialling and calling line identification facilities are normally available on modern telephone exchanges and can therefore increasingly be provided at little or no expense. Tone dialling is increasingly being used for user interaction with special services and facilities, including value added services, and the absence of this facility can prevent the user from making use of these services. Member States are not required to impose obligations to provide these facilities when they are already available. Directive 97/66/EC safeguards the privacy of users with regard to itemised billing, by giving them the means to protect their right to privacy when calling line identification is implemented. The development of these services on a pan-European basis would benefit consumers and is encouraged by this Directive. (40) Number portability is a key facilitator of consumer choice and effective competition in a competitive telecommunications environment such that end-users who so request should be able to retain their number(s) on the public telephone network independently of the organisation providing service. The provision of this facility between connections to the public telephone network at fixed and non-fixed locations is not covered by this Directive. However, Member States may apply provisions for porting numbers between networks providing services at a fixed location and mobile networks. (41) The impact of number portability is considerably strengthened when there is transparent tariff information, both for end-users who port their numbers and also for end-users who call those who have ported their numbers. National regulatory authorities should, where feasible, facilitate appropriate tariff transparency as part of the implementation of number portability. (42) When ensuring that pricing for interconnection related to the provision of number portability is cost-oriented, national regulatory authorities may also take account of prices available in comparable markets. (43) Currently, Member States impose certain "must carry" obligations on networks for the distribution of radio or television broadcasts to the public. Member States should be able to lay down proportionate obligations on undertakings under their jurisdiction, in the interest of legitimate public policy considerations, but such obligations should only be imposed where they are necessary to meet general interest objectives clearly defined by Member States in conformity with Community law and should be proportionate, transparent and subject to periodical review. "Must carry" obligations imposed by Member States should be reasonable, that is they should be proportionate and transparent in the light of clearly defined general interest objectives, and could, where appropriate, entail a provision for proportionate remuneration. Such "must carry" obligations may include the transmission of services specifically designed to enable appropriate access by disabled users. (44) Networks used for the distribution of radio or television broadcasts to the public include cable, satellite and terrestrial broadcasting networks. They might also include other networks to the extent that a significant number of end-users use such networks as their principal means to receive radio and television broadcasts. (45) Services providing content such as the offer for sale of a package of sound or television broadcasting content are not covered by the common regulatory framework for electronic communications networks and services. Providers of such services should not be subject to universal service obligations in respect of these activities. This Directive is without prejudice to measures taken at national level, in compliance with Community law, in respect of such services. (46) Where a Member State seeks to ensure the provision of other specific services throughout its national territory, such obligations should be implemented on a cost efficient basis and outside the scope of universal service obligations. Accordingly, Member States may undertake additional measures (such as facilitating the development of infrastructure or services in circumstances where the market does not satisfactorily address the requirements of end-users or consumers), in conformity with Community law. As a reaction to the Commission's e-Europe initiative, the Lisbon European Council of 23 and 24 March 2000 called on Member States to ensure that all schools have access to the Internet and to multimedia resources. (47) In the context of a competitive environment, the views of interested parties, including users and consumers, should be taken into account by national regulatory authorities when dealing with issues related to end-users' rights. Effective procedures should be available to deal with disputes between consumers, on the one hand, and undertakings providing publicly available communications services, on the other. Member States should take full account of 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(11). (48) Co-regulation could be an appropriate way of stimulating enhanced quality standards and improved service performance. Co-regulation should be guided by the same principles as formal regulation, i.e. it should be objective, justified, proportional, non-discriminatory and transparent. (49) This Directive should provide for elements of consumer protection, including clear contract terms and dispute resolution, and tariff transparency for consumers. It should also encourage the extension of such benefits to other categories of end-users, in particular small and medium-sized enterprises. (50) The provisions of this Directive do not prevent a Member State from taking measures justified on grounds set out in Articles 30 and 46 of the Treaty, and in particular on grounds of public security, public policy and public morality. (51) Since the objectives of the proposed action, namely setting a common level of universal service for telecommunications for all European users and of harmonising conditions for access to and use of public telephone networks at a fixed location and related publicly available telephone services and also achieving a harmonised framework for the regulation of electronic communications services, electronic communications networks and associated facilities, 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 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. (52) 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 SCOPE, AIMS AND DEFINITIONS Article 1 Scope and aims 1. Within the framework of Directive 2002/21/EC (Framework Directive), this Directive concerns the provision of electronic communications networks and services to end-users. The aim is to ensure the availability throughout the Community of good quality publicly available services through effective competition and choice and to deal with circumstances in which the needs of end-users are not satisfactorily met by the market. 2. This Directive establishes the rights of end-users and the corresponding obligations on undertakings providing publicly available electronic communications networks and services. With regard to ensuring provision of universal service within an environment of open and competitive markets, this Directive defines the minimum set of services of specified quality to which all end-users have access, at an affordable price in the light of specific national conditions, without distorting competition. This Directive also sets out obligations with regard to the provision of certain mandatory services such as the retail provision of leased lines. Article 2 Definitions For the purposes of this Directive, the definitions set out in Article 2 of Directive 2002/21/EC (Framework Directive) shall apply. The following definitions shall also apply: (a) "public pay telephone" means a telephone available to the general public, for the use of which the means of payment may include coins and/or credit/debit cards and/or pre-payment cards, including cards for use with dialling codes; (b) "public telephone network" means an electronic communications network which is used to provide publicly available telephone services; it supports the transfer between network termination points of speech communications, and also other forms of communication, such as facsimile and data; (c) "publicly available telephone service" means a service available to the public for originating and receiving national and international calls and access to emergency services through a number or numbers in a national or international telephone numbering plan, and in addition may, where relevant, include one or more of the following services: the provision of operator assistance, directory enquiry services, directories, provision of public pay phones, provision of service under special terms, provision of special facilities for customers with disabilities or with special social needs and/or the provision of non-geographic services; (d) "geographic number" means a number from the national numbering plan where part of its digit structure contains geographic significance used for routing calls to the physical location of the network termination point (NTP); (e) "network termination point" (NTP) means the physical point at which a subscriber is provided with access to a public communications network; in the case of networks involving switching or routing, the NTP is identified by means of a specific network address, which may be linked to a subscriber number or name; (f) "non-geographic numbers" means a number from the national numbering plan that is not a geographic number. It includes inter alia mobile, freephone and premium rate numbers. CHAPTER II UNIVERSAL SERVICE OBLIGATIONS INCLUDING SOCIAL OBLIGATIONS Article 3 Availability of universal service 1. Member States shall ensure that the services set out in this Chapter are made available at the quality specified to all end-users in their territory, independently of geographical location, and, in the light of specific national conditions, at an affordable price. 2. Member States shall determine the most efficient and appropriate approach for ensuring the implementation of universal service, whilst respecting the principles of objectivity, transparency, non-discrimination and proportionality. They shall seek to minimise market distortions, in particular the provision of services at prices or subject to other terms and conditions which depart from normal commercial conditions, whilst safeguarding the public interest. Article 4 Provision of access at a fixed location 1. Member States shall ensure that all reasonable requests for connection at a fixed location to the public telephone network and for access to publicly available telephone services at a fixed location are met by at least one undertaking. 2. The connection provided shall be capable of allowing end-users to make and receive local, national and international telephone calls, facsimile communications and data communications, at data rates that are sufficient to permit functional Internet access, taking into account prevailing technologies used by the majority of subscribers and technological feasibility. Article 5 Directory enquiry services and directories 1. Member States shall ensure that: (a) at least one comprehensive directory is available to end-users in a form approved by the relevant authority, whether printed or electronic, or both, and is updated on a regular basis, and at least once a year; (b) at least one comprehensive telephone directory enquiry service is available to all end-users, including users of public pay telephones. 2. The directories in paragraph 1 shall comprise, subject to the provisions of Article 11 of Directive 97/66/EC, all subscribers of publicly available telephone services. 3. Member States shall ensure that the undertaking(s) providing the services referred to in paragraph 1 apply the principle of non-discrimination to the treatment of information that has been provided to them by other undertakings. Article 6 Public pay telephones 1. Member States shall ensure that national regulatory authorities can impose obligations on undertakings in order to ensure that public pay telephones are provided to meet the reasonable needs of end-users in terms of the geographical coverage, the number of telephones, the accessibility of such telephones to disabled users and the quality of services. 2. A Member State shall ensure that its national regulatory authority can decide not to impose obligations under paragraph 1 in all or part of its territory, if it is satisfied that these facilities or comparable services are widely available, on the basis of a consultation of interested parties as referred to in Article 33. 3. Member States shall ensure that it is possible to make emergency calls from public pay telephones using the single European emergency call number "112" and other national emergency numbers, all free of charge and without having to use any means of payment. Article 7 Special measures for disabled users 1. Member States shall, where appropriate, take specific measures for disabled end-users in order to ensure access to and affordability of publicly available telephone services, including access to emergency services, directory enquiry services and directories, equivalent to that enjoyed by other end-users. 2. Member States may take specific measures, in the light of national conditions, to ensure that disabled end-users can also take advantage of the choice of undertakings and service providers available to the majority of end-users. Article 8 Designation of undertakings 1. Member States may designate one or more undertakings to guarantee the provision of universal service as identified in Articles 4, 5, 6 and 7 and, where applicable, Article 9(2) so that the whole of the national territory can be covered. Member States may designate different undertakings or sets of undertakings to provide different elements of universal service and/or to cover different parts of the national territory. 2. When Member States designate undertakings in part or all of the national territory as having universal service obligations, they shall do so using an efficient, objective, transparent and non-discriminatory designation mechanism, whereby no undertaking is a priori excluded from being designated. Such designation methods shall ensure that universal service is provided in a cost-effective manner and may be used as a means of determining the net cost of the universal service obligation in accordance with Article 12. Article 9 Affordability of tariffs 1. National regulatory authorities shall monitor the evolution and level of retail tariffs of the services identified in Articles 4, 5, 6 and 7 as falling under the universal service obligations and provided by designated undertakings, in particular in relation to national consumer prices and income. 2. Member States may, in the light of national conditions, require that designated undertakings provide tariff options or packages to consumers which depart from those provided under normal commercial conditions, in particular to ensure that those on low incomes or with special social needs are not prevented from accessing or using the publicly available telephone service. 3. Member States may, besides any provision for designated undertakings to provide special tariff options or to comply with price caps or geographical averaging or other similar schemes, ensure that support is provided to consumers identified as having low incomes or special social needs. 4. Member States may require undertakings with obligations under Articles 4, 5, 6 and 7 to apply common tariffs, including geographical averaging, throughout the territory, in the light of national conditions or to comply with price caps. 5. National regulatory authorities shall ensure that, where a designated undertaking has an obligation to provide special tariff options, common tariffs, including geographical averaging, or to comply with price caps, the conditions are fully transparent and are published and applied in accordance with the principle of non-discrimination. National regulatory authorities may require that specific schemes be modified or withdrawn. Article 10 Control of expenditure 1. Member States shall ensure that designated undertakings, in providing facilities and services additional to those referred to in Articles 4, 5, 6, 7 and 9(2), establish terms and conditions in such a way that the subscriber is not obliged to pay for facilities or services which are not necessary or not required for the service requested. 2. Member States shall ensure that designated undertakings with obligations under Articles 4, 5, 6, 7 and 9(2) provide the specific facilities and services set out in Annex I, Part A, in order that subscribers can monitor and control expenditure and avoid unwarranted disconnection of service. 3. Member States shall ensure that the relevant authority is able to waive the requirements of paragraph 2 in all or part of its national territory if it is satisfied that the facility is widely available. Article 11 Quality of service of designated undertakings 1. National regulatory authorities shall ensure that all designated undertakings with obligations under Articles 4, 5, 6, 7 and 9(2) publish adequate and up-to-date information concerning their performance in the provision of universal service, based on the quality of service parameters, definitions and measurement methods set out in Annex III. The published information shall also be supplied to the national regulatory authority. 2. National regulatory authorities may specify, inter alia, additional quality of service standards, where relevant parameters have been developed, to assess the performance of undertakings in the provision of services to disabled end-users and disabled consumers. National regulatory authorities shall ensure that information concerning the performance of undertakings in relation to these parameters is also published and made available to the national regulatory authority. 3. National regulatory authorities may, in addition, specify the content, form and manner of information to be published, in order to ensure that end-users and consumers have access to comprehensive, comparable and user-friendly information. 4. National regulatory authorities shall be able to set performance targets for those undertakings with universal service obligations at least under Article 4. In so doing, national regulatory authorities shall take account of views of interested parties, in particular as referred to in Article 33. 5. Member States shall ensure that national regulatory authorities are able to monitor compliance with these performance targets by designated undertakings. 6. Persistent failure by an undertaking to meet performance targets may result in specific measures being taken in accordance with Directive 2002/20/EC of the European Parliament and of the Council of 7 March 2002 on the authorisation of electronic communications networks and services (Authorisation Directive)(13). National regulatory authorities shall be able to order independent audits or similar reviews of the performance data, paid for by the undertaking concerned, in order to ensure the accuracy and comparability of the data made available by undertakings with universal service obligations. Article 12 Costing of universal service obligations 1. Where national regulatory authorities consider that the provision of universal service as set out in Articles 3 to 10 may represent an unfair burden on undertakings designated to provide universal service, they shall calculate the net costs of its provision. For that purpose, national regulatory authorities shall: (a) calculate the net cost of the universal service obligation, taking into account any market benefit which accrues to an undertaking designated to provide universal service, in accordance with Annex IV, Part A; or (b) make use of the net costs of providing universal service identified by a designation mechanism in accordance with Article 8(2). 2. The accounts and/or other information serving as the basis for the calculation of the net cost of universal service obligations under paragraph 1(a) shall be audited or verified by the national regulatory authority or a body independent of the relevant parties and approved by the national regulatory authority. The results of the cost calculation and the conclusions of the audit shall be publicly available. Article 13 Financing of universal service obligations 1. Where, on the basis of the net cost calculation referred to in Article 12, national regulatory authorities find that an undertaking is subject to an unfair burden, Member States shall, upon request from a designated undertaking, decide: (a) to introduce a mechanism to compensate that undertaking for the determined net costs under transparent conditions from public funds; and/or (b) to share the net cost of universal service obligations between providers of electronic communications networks and services. 2. Where the net cost is shared under paragraph 1(b), Member States shall establish a sharing mechanism administered by the national regulatory authority or a body independent from the beneficiaries under the supervision of the national regulatory authority. Only the net cost, as determined in accordance with Article 12, of the obligations laid down in Articles 3 to 10 may be financed. 3. A sharing mechanism shall respect the principles of transparency, least market distortion, non-discrimination and proportionality, in accordance with the principles of Annex IV, Part B. Member States may choose not to require contributions from undertakings whose national turnover is less than a set limit. 4. Any charges related to the sharing of the cost of universal service obligations shall be unbundled and identified separately for each undertaking. Such charges shall not be imposed or collected from undertakings that are not providing services in the territory of the Member State that has established the sharing mechanism. Article 14 Transparency 1. Where a mechanism for sharing the net cost of universal service obligations as referred to in Article 13 is established, national regulatory authorities shall ensure that the principles for cost sharing, and details of the mechanism used, are publicly available. 2. Subject to Community and national rules on business confidentiality, national regulatory authorities shall ensure that an annual report is published giving the calculated cost of universal service obligations, identifying the contributions made by all the undertakings involved, and identifying any market benefits, that may have accrued to the undertaking(s) designated to provide universal service, where a fund is actually in place and working. Article 15 Review of the scope of universal service 1. The Commission shall periodically review the scope of universal service, in particular with a view to proposing to the European Parliament and the Council that the scope be changed or redefined. A review shall be carried out, on the first occasion within two years after the date of application referred to in Article 38(1), second subparagraph, and subsequently every three years. 2. This review shall be undertaken in the light of social, economic and technological developments, taking into account, inter alia, mobility and data rates in the light of the prevailing technologies used by the majority of subscribers. The review process shall be undertaken in accordance with Annex V. The Commission shall submit a report to the European Parliament and the Council regarding the outcome of the review. CHAPTER III REGULATORY CONTROLS ON UNDERTAKINGS WITH SIGNIFICANT MARKET POWER IN SPECIFIC MARKETS Article 16 Review of obligations 1. Member States shall maintain all obligations relating to: (a) retail tariffs for the provision of access to and use of the public telephone network, imposed under Article 17 of Directive 98/10/EC of the European Parliament and of the Council of 26 February 1998 on the application of open network provision (ONP) to voice telephony and on universal service for telecommunications in a competitive environment(14); (b) carrier selection or pre-selection, imposed under Directive 97/33/EC of the European Parliament and of the Council of 30 June 1997 on interconnection in telecommunications with regard to ensuring universal service and interoperability through application of the principles of open network provision (ONP)(15); (c) leased lines, imposed under Articles 3, 4, 6, 7, 8 and 10 of Directive 92/44/EEC, until a review has been carried out and a determination made in accordance with the procedure in paragraph 3 of this Article. 2. The Commission shall indicate relevant markets for the obligations relating to retail markets in the initial recommendation on relevant product and service markets and the Decision identifying transnational markets to be adopted in accordance with Article 15 of Directive 2002/21/EC (Framework Directive). 3. Member States shall ensure that, as soon as possible after the entry into force of this Directive, and periodically thereafter, national regulatory authorities undertake a market analysis, in accordance with the procedure set out in Article 16 of Directive 2002/21/EC (Framework Directive) to determine whether to maintain, amend or withdraw the obligations relating to retail markets. Measures taken shall be subject to the procedure referred to in Article 7 of Directive 2002/21/EC (Framework Directive). Article 17 Regulatory controls on retail services 1. Member States shall ensure that, where: (a) as a result of a market analysis carried out in accordance with Article 16(3) a national regulatory authority determines that a given retail market identified in accordance with Article 15 of Directive 2002/21/EC (Framework Directive) is not effectively competitive, and (b) the national regulatory authority concludes that obligations imposed under Directive 2002/19/EC (Access Directive), or Article 19 of this Directive would not result in the achievement of the objectives set out in Article 8 of Directive 2002/21/EC (Framework Directive), national regulatory authorities shall impose appropriate regulatory obligations on undertakings identified as having significant market power on a given retail market in accordance with Article 14 of Directive 2002/21/EC (Framework Directive). 2. Obligations imposed under paragraph 1 shall be based on the nature of the problem identified and be proportionate and justified in the light of the objectives laid down in Article 8 of Directive 2002/21/EC (Framework Directive). The obligations imposed may include requirements that the identified undertakings do not charge excessive prices, inhibit market entry or restrict competition by setting predatory prices, show undue preference to specific end-users or unreasonably bundle services. National regulatory authorities may apply to such undertakings appropriate retail price cap measures, measures to control individual tariffs, or measures to orient tariffs towards costs or prices on comparable markets, in order to protect end-user interests whilst promoting effective competition. 3. National regulatory authorities shall, on request, submit information to the Commission concerning the retail controls applied and, where appropriate, the cost accounting systems used by the undertakings concerned. 4. National regulatory authorities shall ensure that, where an undertaking is subject to retail tariff regulation or other relevant retail controls, the necessary and appropriate cost accounting systems are implemented. National regulatory authorities may specify the format and accounting methodology to be used. Compliance with the cost accounting system shall be verified by a qualified independent body. National regulatory authorities shall ensure that a statement concerning compliance is published annually. 5. Without prejudice to Article 9(2) and Article 10, national regulatory authorities shall not apply retail control mechanisms under paragraph 1 of this Article to geographical or user markets where they are satisfied that there is effective competition. Article 18 Regulatory controls on the minimum set of leased lines 1. Where, as a result of the market analysis carried out in accordance with Article 16(3), a national regulatory authority determines that the market for the provision of part or all of the minimum set of leased lines is not effectively competitive, it shall identify undertakings with significant market power in the provision of those specific elements of the minimum set of leased lines services in all or part of its territory in accordance with Article 14 of Directive 2002/21/EC (Framework Directive). The national regulatory authority shall impose obligations regarding the provision of the minimum set of leased lines, as identified in the list of standards published in the Official Journal of the European Communities in accordance with Article 17 of Directive 2002/21/EC (Framework Directive), and the conditions for such provision set out in Annex VII to this Directive, on such undertakings in relation to those specific leased line markets. 2. Where as a result of the market analysis carried out in accordance with Article 16(3), a national regulatory authority determines that a relevant market for the provision of leased lines in the minimum set is effectively competitive, it shall withdraw the obligations referred to in paragraph 1 in relation to this specific leased line market. 3. The minimum set of leased lines with harmonised characteristics, and associated standards, shall be published in the Official Journal of the European Communities as part of the list of standards referred to in Article 17 of Directive 2002/21/EC (Framework Directive). The Commission may adopt amendments necessary to adapt the minimum set of leased lines to new technical developments and to changes in market demand, including the possible deletion of certain types of leased line from the minimum set, acting in accordance with the procedure referred to in Article 37(2) of this Directive. Article 19 Carrier selection and carrier pre-selection 1. National regulatory authorities shall require undertakings notified as having significant market power for the provision of connection to and use of the public telephone network at a fixed location in accordance with Article 16(3) to enable their subscribers to access the services of any interconnected provider of publicly available telephone services: (a) on a call-by-call basis by dialling a carrier selection code; and (b) by means of pre-selection, with a facility to override any pre-selected choice on a call-by-call basis by dialling a carrier selection code. 2. User requirements for these facilities to be implemented on other networks or in other ways shall be assessed in accordance with the market analysis procedure laid down in Article 16 of Directive 2002/21/EC (Framework Directive) and implemented in accordance with Article 12 of Directive 2002/19/EC (Access Directive). 3. National regulatory authorities shall ensure that pricing for access and interconnection related to the provision of the facilities in paragraph 1 is cost oriented and that direct charges to subscribers, if any, do not act as a disincentive for the use of these facilities. CHAPTER IV END-USER INTERESTS AND RIGHTS Article 20 Contracts 1. Paragraphs 2, 3 and 4 apply without prejudice to Community rules on consumer protection, in particular Directives 97/7/EC and 93/13/EC, and national rules in conformity with Community law. 2. Member States shall ensure that, where subscribing to services providing connection and/or access to the public telephone network, consumers have a right to a contract with an undertaking or undertakings providing such services. The contract shall specify at least: (a) the identity and address of the supplier; (b) services provided, the service quality levels offered, as well as the time for the initial connection; (c) the types of maintenance service offered; (d) particulars of prices and tariffs and the means by which up-to-date information on all applicable tariffs and maintenance charges may be obtained; (e) the duration of the contract, the conditions for renewal and termination of services and of the contract; (f) any compensation and the refund arrangements which apply if contracted service quality levels are not met; and (g) the method of initiating procedures for settlement of disputes in accordance with Article 34. Member States may extend these obligations to cover other end-users. 3. Where contracts are concluded between consumers and electronic communications services providers other than those providing connection and/or access to the public telephone network, the information in paragraph 2 shall also be included in such contracts. Member States may extend this obligation to cover other end-users. 4. Subscribers shall have a right to withdraw from their contracts without penalty upon notice of proposed modifications in the contractual conditions. Subscribers shall be given adequate notice, not shorter than one month, ahead of any such modifications and shall be informed at the same time of their right to withdraw, without penalty, from such contracts, if they do not accept the new conditions. Article 21 Transparency and publication of information 1. Member States shall ensure that transparent and up-to-date information on applicable prices and tariffs, and on standard terms and conditions, in respect of access to and use of publicly available telephone services is available to end-users and consumers, in accordance with the provisions of Annex II. 2. National regulatory authorities shall encourage the provision of information to enable end-users, as far as appropriate, and consumers to make an independent evaluation of the cost of alternative usage patterns, by means of, for instance, interactive guides. Article 22 Quality of service 1. Member States shall ensure that national regulatory authorities are, after taking account of the views of interested parties, able to require undertakings that provide publicly available electronic communications services to publish comparable, adequate and up-to-date information for end-users on the quality of their services. The information shall, on request, also be supplied to the national regulatory authority in advance of its publication. 2. National regulatory authorities may specify, inter alia, the quality of service parameters to be measured, and the content, form and manner of information to be published, in order to ensure that end-users have access to comprehensive, comparable and user-friendly information. Where appropriate, the parameters, definitions and measurement methods given in Annex III could be used. Article 23 Integrity of the network Member States shall take all necessary steps to ensure the integrity of the public telephone network at fixed locations and, in the event of catastrophic network breakdown or in cases of force majeure, the availability of the public telephone network and publicly available telephone services at fixed locations. Member States shall ensure that undertakings providing publicly available telephone services at fixed locations take all reasonable steps to ensure uninterrupted access to emergency services. Article 24 Interoperability of consumer digital television equipment In accordance with the provisions of Annex VI, Member States shall ensure the interoperability of the consumer digital television equipment referred to therein. Article 25 Operator assistance and directory enquiry services 1. Member States shall ensure that subscribers to publicly available telephone services have the right to have an entry in the publicly available directory referred to in Article 5(1)(a). 2. Member States shall ensure that all undertakings which assign telephone numbers to subscribers meet all reasonable requests to make available, for the purposes of the provision of publicly available directory enquiry services and directories, the relevant information in an agreed format on terms which are fair, objective, cost oriented and non-discriminatory. 3. Member States shall ensure that all end-users provided with a connection to the public telephone network can access operator assistance services and directory enquiry services in accordance with Article 5(1)(b). 4. Member States shall not maintain any regulatory restrictions which prevent end-users in one Member State from accessing directly the directory enquiry service in another Member State. 5. Paragraphs 1, 2, 3 and 4 apply subject to the requirements of Community legislation on the protection of personal data and privacy and, in particular, Article 11 of Directive 97/66/EC. Article 26 Single European emergency call number 1. Member States shall ensure that, in addition to any other national emergency call numbers specified by the national regulatory authorities, all end-users of publicly available telephone services, including users of public pay telephones, are able to call the emergency services free of charge, by using the single European emergency call number "112". 2. Member States shall ensure that calls to the single European emergency call number "112" are appropriately answered and handled in a manner best suited to the national organisation of emergency systems and within the technological possibilities of the networks. 3. Member States shall ensure that undertakings which operate public telephone networks make caller location information available to authorities handling emergencies, to the extent technically feasible, for all calls to the single European emergency call number "112". 4. Member States shall ensure that citizens are adequately informed about the existence and use of the single European emergency call number "112". Article 27 European telephone access codes 1. Member States shall ensure that the "00" code is the standard international access code. Special arrangements for making calls between adjacent locations across borders between Member States may be established or continued. The end-users of publicly available telephone services in the locations concerned shall be fully informed of such arrangements. 2. Member States shall ensure that all undertakings that operate public telephone networks handle all calls to the European telephony numbering space, without prejudice to the need for an undertaking that operates a public telephone network to recover the cost of the conveyance of calls on its network. Article 28 Non-geographic numbers Member States shall ensure that end-users from other Member States are able to access non-geographic numbers within their territory where technically and economically feasible, except where a called subscriber has chosen for commercial reasons to limit access by calling parties located in specific geographical areas. Article 29 Provision of additional facilities 1. Member States shall ensure that national regulatory authorities are able to require all undertakings that operate public telephone networks to make available to end-users the facilities listed in Annex I, Part B, subject to technical feasibility and economic viability. 2. A Member State may decide to waive paragraph 1 in all or part of its territory if it considers, after taking into account the views of interested parties, that there is sufficient access to these facilities. 3. Without prejudice to Article 10(2), Member States may impose the obligations in Annex I, Part A, point (e), concerning disconnection as a general requirement on all undertakings. Article 30 Number portability 1. Member States shall ensure that all subscribers of publicly available telephone services, including mobile services, who so request can retain their number(s) independently of the undertaking providing the service: (a) in the case of geographic numbers, at a specific location; and (b) in the case of non-geographic numbers, at any location. This paragraph does not apply to the porting of numbers between networks providing services at a fixed location and mobile networks. 2. National regulatory authorities shall ensure that pricing for interconnection related to the provision of number portability is cost oriented and that direct charges to subscribers, if any, do not act as a disincentive for the use of these facilities. 3. National regulatory authorities shall not impose retail tariffs for the porting of numbers in a manner that would distort competition, such as by setting specific or common retail tariffs. Article 31 "Must carry" obligations 1. Member States may impose reasonable "must carry" obligations, for the transmission of specified radio and television broadcast channels and services, on undertakings under their jurisdiction providing electronic communications networks used for the distribution of radio or television broadcasts to the public where a significant number of end-users of such networks use them as their principal means to receive radio and television broadcasts. Such obligations shall only be imposed where they are necessary to meet clearly defined general interest objectives and shall be proportionate and transparent. The obligations shall be subject to periodical review. 2. Neither paragraph 1 of this Article nor Article 3(2) of Directive 2002/19/EC (Access Directive) shall prejudice the ability of Member States to determine appropriate remuneration, if any, in respect of measures taken in accordance with this Article while ensuring that, in similar circumstances, there is no discrimination in the treatment of undertakings providing electronic communications networks. Where remuneration is provided for, Member States shall ensure that it is applied in a proportionate and transparent manner. CHAPTER V GENERAL AND FINAL PROVISIONS Article 32 Additional mandatory services Member States may decide to make additional services, apart from services within the universal service obligations as defined in Chapter II, publicly available in its own territory but, in such circumstances, no compensation mechanism involving specific undertakings may be imposed. Article 33 Consultation with interested parties 1. Member States shall ensure as far as appropriate that national regulatory authorities take account of the views of end-users, and consumers (including, in particular, disabled users), manufacturers, undertakings that provide electronic communications networks and/or services on issues related to all end-user and consumer rights concerning publicly available electronic communications services, in particular where they have a significant impact on the market. 2. Where appropriate, interested parties may develop, with the guidance of national regulatory authorities, mechanisms, involving consumers, user groups and service providers, to improve the general quality of service provision by, inter alia, developing and monitoring codes of conduct and operating standards. Article 34 Out-of-court dispute resolution 1. Member States shall ensure that transparent, simple and inexpensive out-of-court procedures are available for dealing with unresolved disputes, involving consumers, relating to issues covered by this Directive. Member States shall adopt measures to ensure that such procedures enable disputes to be settled fairly and promptly and may, where warranted, adopt a system of reimbursement and/or compensation. Member States may extend these obligations to cover disputes involving other end-users. 2. Member States shall ensure that their legislation does not hamper the establishment of complaints offices and the provision of on-line services at the appropriate territorial level to facilitate access to dispute resolution by consumers and end-users. 3. Where such disputes involve parties in different Member States, Member States shall coordinate their efforts with a view to bringing about a resolution of the dispute. 4. This Article is without prejudice to national court procedures. Article 35 Technical adjustment Amendments necessary to adapt Annexes I, II, III, VI and VII to technological developments or to changes in market demand shall be adopted by the Commission, acting in accordance with the procedure referred to in Article 37(2). Article 36 Notification, monitoring and review procedures 1. National regulatory authorities shall notify to the Commission by at the latest the date of application referred to in Article 38(1), second subparagraph, and immediately in the event of any change thereafter in the names of undertakings designated as having universal service obligations under Article 8(1). The Commission shall make the information available in a readily accessible form, and shall distribute it to the Communications Committee referred to in Article 37. 2. National regulatory authorities shall notify to the Commission the names of operators deemed to have significant market power for the purposes of this Directive, and the obligations imposed upon them under this Directive. Any changes affecting the obligations imposed upon undertakings or of the undertakings affected under the provisions of this Directive shall be notified to the Commission without delay. 3. The Commission shall periodically review the functioning of this Directive and report to the European Parliament and to the Council, on the first occasion not later than three years after the date of application referred to in Article 38(1), second subparagraph. The Member States and national regulatory authorities shall supply the necessary information to the Commission for this purpose. Article 37 Committee 1. The Commission shall be assisted by the Communications Committee, set up by Article 22 of Directive 2002/21/EC (Framework Directive). 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 three months. 3. The Committee shall adopt its rules of procedure. Article 38 Transposition 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 24 July 2003 at the latest. They shall forthwith inform the Commission thereof. They shall apply those measures from 25 July 2003. 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 a reference shall be laid down by the Member States. 3. 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 and of any subsequent modifications to those provisions. Article 39 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 40 Addressees This Directive is addressed to the Member States.

32002L0019

2002

Directive 2002/19/EC of the European Parliament and of the Council of 7 March 2002 on access to, and interconnection of, electronic communications networks and associated facilities (Access Directive) 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), Whereas: (1) Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive)(4) lays down the objectives of a regulatory framework to cover electronic communications networks and services in the Community, including fixed and mobile telecommunications networks, cable television networks, networks used for terrestrial broadcasting, satellite networks and Internet networks, whether used for voice, fax, data or images. Such networks may have been authorised by Member States under Directive 2002/20/EC of the European Parliament and of the Council of 7 March 2002 on the authorisation of electronic communications networks and services (Authorisation Directive)(5) or have been authorised under previous regulatory measures. The provisions of this Directive apply to those networks that are used for the provision of publicly available electronic communications services. This Directive covers access and interconnection arrangements between service suppliers. Non-public networks do not have obligations under this Directive except where, in benefiting from access to public networks, they may be subject to conditions laid down by Member States. (2) Services providing content such as the offer for sale of a package of sound or television broadcasting content are not covered by the common regulatory framework for electronic communications networks and services. (3) The term "access" has a wide range of meanings, and it is therefore necessary to define precisely how that term is used in this Directive, without prejudice to how it may be used in other Community measures. An operator may own the underlying network or facilities or may rent some or all of them. (4) Directive 95/47/EC of the European Parliament and of the Council of 24 October 1995 on the use of standards for the transmission of television signals(6) did not mandate any specific digital television transmission system or service requirement, and this opened up an opportunity for the market actors to take the initiative and develop suitable systems. Through the Digital Video Broadcasting Group, European market actors have developed a family of television transmission systems that have been adopted by broadcasters throughout the world. These transmissions systems have been standardised by the European Telecommunications Standards Institute (ETSI) and have become International Telecommunication Union recommendations. In relation to wide-screen digital television, the 16:9 aspect ratio is the reference format for wide-format television services and programmes, and is now established in Member States' markets as a result of Council Decision 93/424/EEC of 22 July 1993 on an action plan for the introduction of advanced television services in Europe(7). (5) In an open and competitive market, there should be no restrictions that prevent undertakings from negotiating access and interconnection arrangements between themselves, in particular on cross-border agreements, subject to the competition rules of the Treaty. In the context of achieving a more efficient, truly pan-European market, with effective competition, more choice and competitive services to consumers, undertakings which receive requests for access or interconnection should in principle conclude such agreements on a commercial basis, and negotiate in good faith. (6) In markets where there continue to be large differences in negotiating power between undertakings, and where some undertakings rely on infrastructure provided by others for delivery of their services, it is appropriate to establish a framework to ensure that the market functions effectively. National regulatory authorities should have the power to secure, where commercial negotiation fails, adequate access and interconnection and interoperability of services in the interest of end-users. In particular, they may ensure end-to-end connectivity by imposing proportionate obligations on undertakings that control access to end-users. Control of means of access may entail ownership or control of the physical link to the end-user (either fixed or mobile), and/or the ability to change or withdraw the national number or numbers needed to access an end-user's network termination point. This would be the case for example if network operators were to restrict unreasonably end-user choice for access to Internet portals and services. (7) National legal or administrative measures that link the terms and conditions for access or interconnection to the activities of the party seeking interconnection, and specifically to the degree of its investment in network infrastructure, and not to the interconnection or access services provided, may cause market distortion and may therefore not be compatible with competition rules. (8) Network operators who control access to their own customers do so on the basis of unique numbers or addresses from a published numbering or addressing range. Other network operators need to be able to deliver traffic to those customers, and so need to be able to interconnect directly or indirectly to each other. The existing rights and obligations to negotiate interconnection should therefore be maintained. It is also appropriate to maintain the obligations formerly laid down in Directive 95/47/EC requiring fully digital electronic communications networks used for the distribution of television services and open to the public to be capable of distributing wide-screen television services and programmes, so that users are able to receive such programmes in the format in which they were transmitted. (9) Interoperability is of benefit to end-users and is an important aim of this regulatory framework. Encouraging interoperability is one of the objectives for national regulatory authorities as set out in this framework, which also provides for the Commission to publish a list of standards and/or specifications covering the provision of services, technical interfaces and/or network functions, as the basis for encouraging harmonisation in electronic communications. Member States should encourage the use of published standards and/or specifications to the extent strictly necessary to ensure interoperability of services and to improve freedom of choice for users. (10) Competition rules alone may not be sufficient to ensure cultural diversity and media pluralism in the area of digital television. Directive 95/47/EC provided an initial regulatory framework for the nascent digital television industry which should be maintained, including in particular the obligation to provide conditional access on fair, reasonable and non-discriminatory terms, in order to make sure that a wide variety of programming and services is available. Technological and market developments make it necessary to review these obligations on a regular basis, either by a Member State for its national market or the Commission for the Community, in particular to determine whether there is justification for extending obligations to new gateways, such as electronic programme guides (EPGs) and application program interfaces (APIs), to the extent that is necessary to ensure accessibility for end-users to specified digital broadcasting services. Member States may specify the digital broadcasting services to which access by end-users must be ensured by any legislative, regulatory or administrative means that they deem necessary. (11) Member States may also permit their national regulatory authority to review obligations in relation to conditional access to digital broadcasting services in order to assess through a market analysis whether to withdraw or amend conditions for operators that do not have significant market power on the relevant market. Such withdrawal or amendment should not adversely affect access for end-users to such services or the prospects for effective competition. (12) In order to ensure continuity of existing agreements and to avoid a legal vacuum, it is necessary to ensure that obligations for access and interconnection imposed under Articles 4, 6, 7, 8, 11, 12, and 14 of Directive 97/33/EC of the European Parliament and of the Council of 30 June 1997 on interconnection in telecommunications with regard to ensuring universal service and interoperability through application of the principles of open network provision (ONP)(8), obligations on special access imposed under Article 16 of Directive 98/10/EC of the European Parliament and of the Council of 26 February 1998 on the application of open network provision (ONP) to voice telephony and on universal service for telecommunications in a competitive environment(9), and obligations concerning the provision of leased line transmission capacity under Council Directive 92/44/EEC of 5 June 1992 on the application of open network provision to leased lines(10), are initially carried over into the new regulatory framework, but are subject to immediate review in the light of prevailing market conditions. Such a review should also extend to those organisations covered by Regulation (EC) No 2887/2000 of the European Parliament and of the Council of 18 December 2000 on unbundled access to the local loop(11). (13) The review should be carried out using an economic market analysis based on competition law methodology. The aim is to reduce ex ante sector specific rules progressively as competition in the market develops. However the procedure also takes account of transitional problems in the market such as those related to international roaming and of the possibility of new bottlenecks arising as a result of technological development, which may require ex ante regulation, for example in the area of broadband access networks. It may well be the case that competition develops at different speeds in different market segments and in different Member States, and national regulatory authorities should be able to relax regulatory obligations in those markets where competition is delivering the desired results. In order to ensure that market players in similar circumstances are treated in similar ways in different Member States, the Commission should be able to ensure harmonised application of the provisions of this Directive. National regulatory authorities and national authorities entrusted with the implementation of competition law should, where appropriate, coordinate their actions to ensure that the most appropriate remedy is applied. The Community and its Member States have entered into commitments on interconnection of telecommunications networks in the context of the World Trade Organisation agreement on basic telecommunications and these commitments need to be respected. (14) Directive 97/33/EC laid down a range of obligations to be imposed on undertakings with significant market power, namely transparency, non-discrimination, accounting separation, access, and price control including cost orientation. This range of possible obligations should be maintained but, in addition, they should be established as a set of maximum obligations that can be applied to undertakings, in order to avoid over-regulation. Exceptionally, in order to comply with international commitments or Community law, it may be appropriate to impose obligations for access or interconnection on all market players, as is currently the case for conditional access systems for digital television services. (15) The imposition of a specific obligation on an undertaking with significant market power does not require an additional market analysis but a justification that the obligation in question is appropriate and proportionate in relation to the nature of the problem identified. (16) Transparency of terms and conditions for access and interconnection, including prices, serve to speed-up negotiation, avoid disputes and give confidence to market players that a service is not being provided on discriminatory terms. Openness and transparency of technical interfaces can be particularly important in ensuring interoperability. Where a national regulatory authority imposes obligations to make information public, it may also specify the manner in which the information is to be made available, covering for example the type of publication (paper and/or electronic) and whether or not it is free of charge, taking into account the nature and purpose of the information concerned. (17) The principle of non-discrimination ensures that undertakings with market power do not distort competition, in particular where they are vertically integrated undertakings that supply services to undertakings with whom they compete on downstream markets. (18) Accounting separation allows internal price transfers to be rendered visible, and allows national regulatory authorities to check compliance with obligations for non-discrimination where applicable. In this regard the Commission published Recommendation 98/322/EC of 8 April 1998 on interconnection in a liberalised telecommunications market (Part 2 - accounting separation and cost accounting)(12). (19) Mandating access to network infrastructure can be justified as a means of increasing competition, but national regulatory authorities need to balance the rights of an infrastructure owner to exploit its infrastructure forits own benefit, and the rights of other service providers to access facilities that are essential for the provision of competing services. Where obligations are imposed on operators that require them to meet reasonable requests for access to and use of networks elements and associated facilities, such requests should only be refused on the basis of objective criteria such as technical feasibility or the need to maintain network integrity. Where access is refused, the aggrieved party may submit the case to the dispute resolutions procedure referred to in Articles 20 and 21 of Directive 2002/21/EC (Framework Directive). An operator with mandated access obligations cannot be required to provide types of access which are not within its powers to provide. The imposition by national regulatory authorities of mandated access that increases competition in the short-term should not reduce incentives for competitors to invest in alternative facilities that will secure more competition in the long-term. The Commission has published a Notice on the application of the competition rules to access agreements in the telecommunications sector(13) which addresses these issues. National regulatory authorities may impose technical and operational conditions on the provider and/or beneficiaries of mandated access in accordance with Community law. In particular the imposition of technical standards should comply with 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 of Information Society Services(14). (20) Price control may be necessary when market analysis in a particular market reveals inefficient competition. The regulatory intervention may be relatively light, such as an obligation that prices for carrier selection are reasonable as laid down in Directive 97/33/EC, or much heavier such as an obligation that prices are cost oriented to provide full justification for those prices where competition is not sufficiently strong to prevent excessive pricing. In particular, operators with significant market power should avoid a price squeeze whereby the difference between their retail prices and the interconnection prices charged to competitors who provide similar retail services is not adequate to ensure sustainable competition. When a national regulatory authority calculates costs incurred in establishing a service mandated under this Directive, it is appropriate to allow a reasonable return on the capital employed including appropriate labour and building costs, with the value of capital adjusted where necessary to reflect the current valuation of assets and efficiency of operations. The method of cost recovery should be appropriate to the circumstances taking account of the need to promote efficiency and sustainable competition and maximise consumer benefits. (21) Where a national regulatory authority imposes obligations to implement a cost accounting system in order to support price controls, it may itself undertake an annual audit to ensure compliance with that cost accounting system, provided that it has the necessary qualified staff, or it may require the audit to be carried out by another qualified body, independent of the operator concerned. (22) Publication of information by Member States will ensure that market players and potential market entrants understand their rights and obligations, and know where to find the relevant detailed information. Publication in the national gazette helps interested parties in other Member States to find the relevant information. (23) In order to ensure that the pan-European electronic communications market is effective and efficient, the Commission should monitor and publish information on charges which contribute to determining prices to end-users. (24) The development of the electronic communications market, with its associated infrastructure, could have adverse effects on the environment and the landscape. Member States should therefore monitor this process and, if necessary, take action to minimise any such effects by means of appropriate agreements and other arrangements with the relevant authorities. (25) In order to determine the correct application of Community law, the Commission needs to know which undertakings have been designated as having significant market power and what obligations have been placed upon market players by national regulatory authorities. In addition to national publication of this information, it is therefore necessary for Member States to send this information to the Commission. Where Member States are required to send information to the Commission, this may be in electronic form, subject to appropriate authentication procedures being agreed. (26) Given the pace of technological and market developments, the implementation of this Directive should be reviewed within three years of its date of application to determine if it is meeting its objectives. (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(15). (28) Since the objectives of the proposed action, namely establishing a harmonised framework for the regulation of access to and interconnection of electronic communications networks and associated facilities, 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 those objectives, CHAPTER I SCOPE, AIM AND DEFINITIONS Article 1 Scope and aim 1. Within the framework set out in Directive 2002/21/EC (Framework Directive), this Directive harmonises the way in which Member States regulate access to, and interconnection of, electronic communications networks and associated facilities. The aim is to establish a regulatory framework, in accordance with internal market principles, for the relationships between suppliers of networks and services that will result in sustainable competition, interoperability of electronic communications services and consumer benefits. 2. This Directive establishes rights and obligations for operators and for undertakings seeking interconnection and/or access to their networks or associated facilities. It sets out objectives for national regulatory authorities with regard to access and interconnection, and lays down procedures to ensure that obligations imposed by national regulatory authorities are reviewed and, where appropriate, withdrawn once the desired objectives have been achieved. Access in this Directive does not refer to access by end-users. Article 2 Definitions For the purposes of this Directive the definitions set out in Article 2 of Directive 2002/21/EC (Framework Directive) shall apply. The following definitions shall also apply: (a) "access" means the making available of facilities and/or services, to another undertaking, under defined conditions, on either an exclusive or non-exclusive basis, for the purpose of providing electronic communications services. It covers inter alia: access to network elements and associated facilities, which may involve the connection of equipment, by fixed or non-fixed means (in particular this includes access to the local loop and to facilities and services necessary to provide services over the local loop), access to physical infrastructure including buildings, ducts and masts; access to relevant software systems including operational support systems, access to number translation or systems offering equivalent functionality, access to fixed and mobile networks, in particular for roaming, access to conditional access systems for digital television services; access to virtual network services; (b) "interconnection" means the physical and logical linking of public communications networks used by the same or a different undertaking in order to allow the users of one undertaking to communicate with users of the same or another undertaking, or to access services provided by another undertaking. Services may be provided by the parties involved or other parties who have access to the network. Interconnection is a specific type of access implemented between public network operators; (c) "operator" means an undertaking providing or authorised to provide a public communications network or an associated facility; (d) "wide-screen television service" means a television service that consists wholly or partially of programmes produced and edited to be displayed in a full height wide-screen format. The 16:9 format is the reference format for wide-screen television services; (e) "local loop" means the physical circuit connecting the network termination point at the subscriber's premises to the main distribution frame or equivalent facility in the fixed public telephone network. CHAPTER II GENERAL PROVISIONS Article 3 General framework for access and interconnection 1. Member States shall ensure that there are no restrictions which prevent undertakings in the same Member State or in different Member States from negotiating between themselves agreements on technical and commercial arrangements for access and/or interconnection, in accordance with Community law. The undertaking requesting access or interconnection does not need to be authorised to operate in the Member State where access or interconnection is requested, if it is not providing services and does not operate a network in that Member State. 2. Without prejudice to Article 31 of Directive 2002/22/EC of the European Parliament and of the Council of 7 March 2002 on universal service and users' rights relating to electronic communications networks and services (Universal Service Directive)(16), Member States shall not maintain legal or administrative measures which oblige operators, when granting access or interconnection, to offer different terms and conditions to different undertakings for equivalent services and/or imposing obligations that are not related to the actual access and interconnection services provided without prejudice to the conditions fixed in the Annex of Directive 2002/20/EC (Authorisation Directive). Article 4 Rights and obligations for undertakings 1. Operators of public communications networks shall have a right and, when requested by other undertakings so authorised, an obligation to negotiate interconnection with each other for the purpose of providing publicly available electronic communications services, in order to ensure provision and interoperability of services throughout the Community. Operators shall offer access and interconnection to other undertakings on terms and conditions consistent with obligations imposed by the national regulatory authority pursuant to Articles 5, 6, 7 and 8. 2. Public electronic communications networks established for the distribution of digital television services shall be capable of distributing wide-screen television services and programmes. Network operators that receive and redistribute wide-screen television services or programmes shall maintain that wide-screen format. 3. Without prejudice to Article 11 of Directive 2002/20/EC (Authorisation Directive), Member States shall require that undertakings which acquire information from another undertaking before, during or after the process of negotiating access or interconnection arrangements use that information solely for the purpose for which it was supplied and respect at all times the confidentiality of information transmitted or stored. The received information shall not be passed on to any other party, in particular other departments, subsidiaries or partners, for whom such information could provide a competitive advantage. Article 5 Powers and responsibilities of the national regulatory authorities with regard to access and interconnection 1. National regulatory authorities shall, acting in pursuit of the objectives set out in Article 8 of Directive 2002/21/EC (Framework Directive), encourage and where appropriate ensure, in accordance with the provisions of this Directive, adequate access and interconnection, and interoperability of services, exercising their responsibility in a way that promotes efficiency, sustainable competition, and gives the maximum benefit to end-users. In particular, without prejudice to measures that may be taken regarding undertakings with significant market power in accordance with Article 8, national regulatory authorities shall be able to impose: (a) to the extent that is necessary to ensure end-to-end connectivity, obligations on undertakings that control access to end-users, including in justified cases the obligation to interconnect their networks where this is not already the case; (b) to the extent that is necessary to ensure accessibility for end-users to digital radio and television broadcasting services specified by the Member State, obligations on operators to provide access to the other facilities referred to in Annex I, Part II on fair, reasonable and non-discriminatory terms. 2. When imposing obligations on an operator to provide access in accordance with Article 12, national regulatory authorities may lay down technical or operational conditions to be met by the provider and/or beneficiaries of such access, in accordance with Community law, where necessary to ensure normal operation of the network. Conditions that refer to implementation of specific technical standards or specifications shall respect Article 17 of Directive 2002/21/EC (Framework Directive). 3. Obligations and conditions imposed in accordance with paragraphs 1 and 2 shall be objective, transparent, proportionate and non-discriminatory, and shall be implemented in accordance with the procedures referred to in Articles 6 and 7 of Directive 2002/21/EC (Framework Directive). 4. With regard to access and interconnection, Member States shall ensure that the national regulatory authority is empowered to intervene at its own initiative where justified or, in the absence of agreement between undertakings, at the request of either of the parties involved, in order to secure the policy objectives of Article 8 of Directive 2002/21/EC (Framework Directive), in accordance with the provisions of this Directive and the procedures referred to in Articles 6 and 7, 20 and 21 of Directive 2002/21/EC (Framework Directive). CHAPTER III OBLIGATIONS ON OPERATORS AND MARKET REVIEW PROCEDURES Article 6 Conditional access systems and other facilities 1. Member States shall ensure that, in relation to conditional access to digital television and radio services broadcast to viewers and listeners in the Community, irrespective of the means of transmission, the conditions laid down in Annex I, Part I apply. 2. In the light of market and technological developments, Annex I may be amended in accordance with the procedure referred to in Article 14(3). 3. Notwithstanding the provisions of paragraph 1, Member States may permit their national regulatory authority, as soon as possible after the entry into force of this Directive and periodically thereafter, to review the conditions applied in accordance with this Article, by undertaking a market analysis in accordance with the first paragraph of Article 16 of Directive 2002/21/EC (Framework Directive) to determine whether to maintain, amend or withdraw the conditions applied. Where, as a result of this market analysis, a national regulatory authority finds that one or more operators do not have significant market power on the relevant market, it may amend or withdraw the conditions with respect to those operators, in accordance with the procedures referred to in Articles 6 and 7 of Directive 2002/21/EC (Framework Directive), only to the extent that: (a) accessibility for end-users to radio and television broadcasts and broadcasting channels and services specified in accordance with Article 31 of Directive 2002/22/EC (Universal Service Directive) would not be adversely affected by such amendment or withdrawal, and (b) the prospects for effective competition in the markets for: (i) retail digital television and radio broadcasting services, and (ii) conditional access systems and other associated facilities, would not be adversely affected by such amendment or withdrawal. An appropriate period of notice shall be given to parties affected by such amendment or withdrawal of conditions. 4. Conditions applied in accordance with this Article are without prejudice to the ability of Member States to impose obligations in relation to the presentational aspect of electronic programme guides and similar listing and navigation facilities. Article 7 Review of former obligations for access and interconnection 1. Member States shall maintain all obligations on undertakings providing public communications networks and/or services concerning access and interconnection that were in force prior to the date of entry into force of this Directive under Articles 4, 6, 7, 8, 11, 12, and 14 of Directive 97/33/EC, Article 16 of Directive 98/10/EC, and Articles 7 and 8 of Directive 92/44/EC, until such time as these obligations have been reviewed and a determination made in accordance with paragraph 3. 2. The Commission will indicate relevant markets for the obligations referred to in paragraph 1 in the initial recommendation on relevant product and service markets and the Decision identifying transnational markets to be adopted in accordance with Article 15 of Directive 2002/21/EC (Framework Directive). 3. Member States shall ensure that, as soon as possible after the entry into force of this Directive, and periodically thereafter, national regulatory authorities undertake a market analysis, in accordance with Article 16 of Directive 2002/21/EC (Framework Directive) to determine whether to maintain, amend or withdraw these obligations. An appropriate period of notice shall be given to parties affected by such amendment or withdrawal of obligations. Article 8 Imposition, amendment or withdrawal of obligations 1. Member States shall ensure that national regulatory authorities are empowered to impose the obligations identified in Articles 9 to 13. 2. Where an operator is designated as having significant market power on a specific market as a result of a market analysis carried out in accordance with Article 16 of Directive 2002/21/EC (Framework Directive), national regulatory authorities shall impose the obligations set out in Articles 9 to 13 of this Directive as appropriate. 3. Without prejudice to: - the provisions of Articles 5(1), 5(2) and 6, - the provisions of Articles 12 and 13 of Directive 2002/21/EC (Framework Directive), Condition 7 in Part B of the Annex to Directive 2002/20/EC (Authorisation Directive) as applied by virtue of Article 6(1) of that Directive, Articles 27, 28 and 30 of Directive 2002/22/EC (Universal Service Directive) and the relevant provisions of 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(17) containing obligations on undertakings other than those designated as having significant market power, or - the need to comply with international commitments, national regulatory authorities shall not impose the obligations set out in Articles 9 to 13 on operators that have not been designated in accordance with paragraph 2. In exceptional circumstances, when a national regulatory authority intends to impose on operators with significant market power other obligations for access or interconnection than those set out in Articles 9 to 13 in this Directive it shall submit this request to the Commission. The Commission, acting in accordance with Article 14(2), shall take a decision authorising or preventing the national regulatory authority from taking such measures. 4. Obligations imposed in accordance with this Article shall be based on the nature of the problem identified, proportionate and justified in the light of the objectives laid down in Article 8 of Directive 2002/21/EC (Framework Directive). Such obligations shall only be imposed following consultation in accordance with Articles 6 and 7 of that Directive. 5. In relation to the third indent of the first subparagraph of paragraph 3, national regulatory authorities shall notify decisions to impose, amend or withdraw obligations on market players to the Commission, in accordance with the procedure referred to in Article 7 of Directive 2002/21/EC (Framework Directive). Article 9 Obligation of transparency 1. National regulatory authorities may, in accordance with the provisions of Article 8, impose obligations for transparency in relation to interconnection and/or access, requiring operators to make public specified information, such as accounting information, technical specifications, network characteristics, terms and conditions for supply and use, and prices. 2. In particular where an operator has obligations of non-discrimination, national regulatory authorities may require that operator to publish a reference offer, which shall be sufficiently unbundled to ensure that undertakings are not required to pay for facilities which are not necessary for the service requested, giving a description of the relevant offerings broken down into components according to market needs, and the associated terms and conditions including prices. The national regulatory authority shall, inter alia, be able to impose changes to reference offers to give effect to obligations imposed under this Directive. 3. National regulatory authorities may specify the precise information to be made available, the level of detail required and the manner of publication. 4. Notwithstanding paragraph 3, where an operator has obligations under Article 12 concerning unbundled access to the twisted metallic pair local loop, national regulatory authorities shall ensure the publication of a reference offer containing at least the elements set out in Annex II. 5. In the light of market and technological developments, Annex II may be amended in accordance with the procedure referred to in Article 14(3). Article 10 Obligation of non-discrimination 1. A national regulatory authority may, in accordance with the provisions of Article 8, impose obligations of non-discrimination, in relation to interconnection and/or access. 2. Obligations of non-discrimination shall ensure, in particular, that the operator applies equivalent conditions in equivalent circumstances to other undertakings providing equivalent services, and provides services and information to others under the same conditions and of the same quality as it provides for its own services, or those of it subsidiaries or partners. Article 11 Obligation of accounting separation 1. A national regulatory authority may, in accordance with the provisions of Article 8, impose obligations for accounting separation in relation to specified activities related to interconnection and/or access. In particular, a national regulatory authority may require a vertically integrated company to make transparent its wholesale prices and its internal transfer prices inter alia to ensure compliance where there is a requirement for non-discrimination under Article 10 or, where necessary, to prevent unfair cross-subsidy. National regulatory authorities may specify the format and accounting methodology to be used. 2. Without prejudice to Article 5 of Directive 2002/21/EC (Framework Directive), to facilitate the verification of compliance with obligations of transparency and non-discrimination, national regulatory authorities shall have the power to require that accounting records, including data on revenues received from third parties, are provided on request. National regulatory authorities may publish such information as would contribute to an open and competitive market, while respecting national and Community rules on commercial confidentiality. Article 12 Obligations of access to, and use of, specific network facilities 1. A national regulatory authority may, in accordance with the provisions of Article 8, impose obligations on operators to meet reasonable requests for access to, and use of, specific network elements and associated facilities, inter alia in situations where the national regulatory authority considers that denial of access or unreasonable terms and conditions having a similar effect would hinder the emergence of a sustainable competitive market at the retail level, or would not be in the end-user's interest. Operators may be required inter alia: (a) to give third parties access to specified network elements and/or facilities, including unbundled access to the local loop; (b) to negotiate in good faith with undertakings requesting access; (c) not to withdraw access to facilities already granted; (d) to provide specified services on a wholesale basis for resale by third parties; (e) to grant open access to technical interfaces, protocols or other key technologies that are indispensable for the interoperability of services or virtual network services; (f) to provide co-location or other forms of facility sharing, including duct, building or mast sharing; (g) to provide specified services needed to ensure interoperability of end-to-end services to users, including facilities for intelligent network services or roaming on mobile networks; (h) to provide access to operational support systems or similar software systems necessary to ensure fair competition in the provision of services; (i) to interconnect networks or network facilities. National regulatory authorities may attach to those obligations conditions covering fairness, reasonableness and timeliness. 2. When national regulatory authorities are considering whether to impose the obligations referred in paragraph 1, and in particular when assessing whether such obligations would be proportionate to the objectives set out in Article 8 of Directive 2002/21/EC (Framework Directive), they shall take account in particular of the following factors: (a) the technical and economic viability of using or installing competing facilities, in the light of the rate of market development, taking into account the nature and type of interconnection and access involved; (b) the feasibility of providing the access proposed, in relation to the capacity available; (c) the initial investment by the facility owner, bearing in mind the risks involved in making the investment; (d) the need to safeguard competition in the long term; (e) where appropriate, any relevant intellectual property rights; (f) the provision of pan-European services. Article 13 Price control and cost accounting obligations 1. A national regulatory authority may, in accordance with the provisions of Article 8, impose obligations relating to cost recovery and price controls, including obligations for cost orientation of prices and obligations concerning cost accounting systems, for the provision of specific types of interconnection and/or access, in situations where a market analysis indicates that a lack of effective competition means that the operator concerned might sustain prices at an excessively high level, or apply a price squeeze, to the detriment of end-users. National regulatory authorities shall take into account the investment made by the operator and allow him a reasonable rate of return on adequate capital employed, taking into account the risks involved. 2. National regulatory authorities shall ensure that any cost recovery mechanism or pricing methodology that is mandated serves to promote efficiency and sustainable competition and maximise consumer benefits. In this regard national regulatory authorities may also take account of prices available in comparable competitive markets. 3. Where an operator has an obligation regarding the cost orientation of its prices, the burden of proof that charges are derived from costs including a reasonable rate of return on investment shall lie with the operator concerned. For the purpose of calculating the cost of efficient provision of services, national regulatory authorities may use cost accounting methods independent of those used by the undertaking. National regulatory authorities may require an operator to provide full justification for its prices, and may, where appropriate, require prices to be adjusted. 4. National regulatory authorities shall ensure that, where implementation of a cost accounting system is mandated in order to support price controls, a description of the cost accounting system is made publicly available, showing at least the main categories under which costs are grouped and the rules used for the allocation of costs. Compliance with the cost accounting system shall be verified by a qualified independent body. A statement concerning compliance shall be published annually. CHAPTER IV PROCEDURAL PROVISIONS Article 14 Committee 1. The Commission shall be assisted by the Communications Committee set up by Article 22 of Directive 2002/21/EC (Framework Directive). 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. 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. 4. The Committee shall adopt its rules of procedure. Article 15 Publication of, and access to, information 1. Member States shall ensure that the specific obligations imposed on undertakings under this Directive are published and that the specific product/service and geographical markets are identified. They shall ensure that up-to-date information, provided that the information is not confidential and, in particular, does not comprise business secrets, is made publicly available in a manner that guarantees all interested parties easy access to that information. 2. Member States shall send to the Commission a copy of all such information published. The Commission shall make this information available in a readily accessible form, and shall distribute the information to the Communications Committee as appropriate. Article 16 Notification 1. Member States shall notify to the Commission by at the latest the date of application referred to in Article 18(1) second subparagraph the national regulatory authorities responsible for the tasks set out in this Directive. 2. National regulatory authorities shall notify to the Commission the names of operators deemed to have significant market power for the purposes of this Directive, and the obligations imposed upon them under this Directive. Any changes affecting the obligations imposed upon undertakings or of the undertakings affected under the provisions of this Directive shall be notified to the Commission without delay. Article 17 Review procedures The Commission shall periodically review the functioning of this Directive and report to the European Parliament and to the Council, on the first occasion not later than three years after the date of application referred to in Article 18(1), second subparagraph. For this purpose, the Commission may request from the Member States information, which shall be supplied without undue delay. Article 18 Transposition 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by not later than 24 July 2003. They shall forthwith inform the Commission thereof. They shall apply those measures from 25 July 2003. 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 governed by this Directive and of any subsequent amendments to those provisions. Article 19 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 20 Addressees This Directive is addressed to the Member States.

32002L0014

2002

Directive 2002/14/EC of the European Parliament and of the Council of 11 March 2002 establishing a general framework for informing and consulting employees in the European Community - Joint declaration of the European Parliament, the Council and the Commission on employee representation 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 regard to the opinion of the Committee of the Regions(3), Acting in accordance with the procedure referred to in Article 251(4), and in the light of the joint text approved by the Conciliation Committee on 23 January 2002, Whereas: (1) Pursuant to Article 136 of the Treaty, a particular objective of the Community and the Member States is to promote social dialogue between management and labour. (2) Point 17 of the Community Charter of Fundamental Social Rights of Workers provides, inter alia, that information, consultation and participation for workers must be developed along appropriate lines, taking account of the practices in force in different Member States. (3) The Commission consulted management and labour at Community level on the possible direction of Community action on the information and consultation of employees in undertakings within the Community. (4) Following this consultation, the Commission considered that Community action was advisable and again consulted management and labour on the contents of the planned proposal; management and labour have presented their opinions to the Commission. (5) Having completed this second stage of consultation, management and labour have not informed the Commission of their wish to initiate the process potentially leading to the conclusion of an agreement. (6) The existence of legal frameworks at national and Community level intended to ensure that employees are involved in the affairs of the undertaking employing them and in decisions which affect them has not always prevented serious decisions affecting employees from being taken and made public without adequate procedures having been implemented beforehand to inform and consult them. (7) There is a need to strengthen dialogue and promote mutual trust within undertakings in order to improve risk anticipation, make work organisation more flexible and facilitate employee access to training within the undertaking while maintaining security, make employees aware of adaptation needs, increase employees' availability to undertake measures and activities to increase their employability, promote employee involvement in the operation and future of the undertaking and increase its competitiveness. (8) There is a need, in particular, to promote and enhance information and consultation on the situation and likely development of employment within the undertaking and, where the employer's evaluation suggests that employment within the undertaking may be under threat, the possible anticipatory measures envisaged, in particular in terms of employee training and skill development, with a view to offsetting the negative developments or their consequences and increasing the employability and adaptability of the employees likely to be affected. (9) Timely information and consultation is a prerequisite for the success of the restructuring and adaptation of undertakings to the new conditions created by globalisation of the economy, particularly through the development of new forms of organisation of work. (10) The Community has drawn up and implemented an employment strategy based on the concepts of "anticipation", "prevention" and "employability", which are to be incorporated as key elements into all public policies likely to benefit employment, including the policies of individual undertakings, by strengthening the social dialogue with a view to promoting change compatible with preserving the priority objective of employment. (11) Further development of the internal market must be properly balanced, maintaining the essential values on which our societies are based and ensuring that all citizens benefit from economic development. (12) Entry into the third stage of economic and monetary union has extended and accelerated the competitive pressures at European level. This means that more supportive measures are needed at national level. (13) The existing legal frameworks for employee information and consultation at Community and national level tend to adopt an excessively a posteriori approach to the process of change, neglect the economic aspects of decisions taken and do not contribute either to genuine anticipation of employment developments within the undertaking or to risk prevention. (14) All of these political, economic, social and legal developments call for changes to the existing legal framework providing for the legal and practical instruments enabling the right to be informed and consulted to be exercised. (15) This Directive is without prejudice to national systems regarding the exercise of this right in practice where those entitled to exercise it are required to indicate their wishes collectively. (16) This Directive is without prejudice to those systems which provide for the direct involvement of employees, as long as they are always free to exercise the right to be informed and consulted through their representatives. (17) Since the objectives of the proposed action, as outlined above, cannot be adequately achieved by the Member States, in that the object is to establish a framework for employee information and consultation appropriate for the new European context described above, and can therefore, in view 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 in order to achieve these objectives. (18) The purpose of this general framework is to establish minimum requirements applicable throughout the Community while not preventing Member States from laying down provisions more favourable to employees. (19) The purpose of this general framework is also to avoid any administrative, financial or legal constraints which would hinder the creation and development of small and medium-sized undertakings. To this end, the scope of this Directive should be restricted, according to the choice made by Member States, to undertakings with at least 50 employees or establishments employing at least 20 employees. (20) This takes into account and is without prejudice to other national measures and practices aimed at fostering social dialogue within companies not covered by this Directive and within public administrations. (21) However, on a transitional basis, Member States in which there is no established statutory system of information and consultation of employees or employee representation should have the possibility of further restricting the scope of the Directive as regards the numbers of employees. (22) A Community framework for informing and consulting employees should keep to a minimum the burden on undertakings or establishments while ensuring the effective exercise of the rights granted. (23) The objective of this Directive is to be achieved through the establishment of a general framework comprising the principles, definitions and arrangements for information and consultation, which it will be for the Member States to comply with and adapt to their own national situation, ensuring, where appropriate, that management and labour have a leading role by allowing them to define freely, by agreement, the arrangements for informing and consulting employees which they consider to be best suited to their needs and wishes. (24) Care should be taken to avoid affecting some specific rules in the field of employee information and consultation existing in some national laws, addressed to undertakings or establishments which pursue political, professional, organisational, religious, charitable, educational, scientific or artistic aims, as well as aims involving information and the expression of opinions. (25) Undertakings and establishments should be protected against disclosure of certain particularly sensitive information. (26) The employer should be allowed not to inform and consult where this would seriously damage the undertaking or the establishment or where he has to comply immediately with an order issued to him by a regulatory or supervisory body. (27) Information and consultation imply both rights and obligations for management and labour at undertaking or establishment level. (28) Administrative or judicial procedures, as well as sanctions that are effective, dissuasive and proportionate in relation to the seriousness of the offence, should be applicable in cases of infringement of the obligations based on this Directive. (29) This Directive should not affect the provisions, where these are more specific, of Council Directive 98/59/EC of 20 July 1998 on the approximation of the laws of the Member States relating to collective redundancies(5) and of Council Directive 2001/23/EC of 12 March 2001 on the approximation of the laws of the Member States relating to the safeguarding of employees' rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses(6). (30) Other rights of information and consultation, including those arising from Council Directive 94/45/EEC 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(7), should not be affected by this Directive. (31) Implementation of this Directive should not be sufficient grounds for a reduction in the general level of protection of workers in the areas to which it applies, Article 1 Object and principles 1. The purpose of this Directive is to establish a general framework setting out minimum requirements for the right to information and consultation of employees in undertakings or establishments within the Community. 2. The practical arrangements for information and consultation shall be defined and implemented in accordance with national law and industrial relations practices in individual Member States in such a way as to ensure their effectiveness. 3. When defining or implementing practical arrangements for information and consultation, the employer and the employees' representatives shall work in a spirit of cooperation and with due regard for their reciprocal rights and obligations, taking into account the interests both of the undertaking or establishment and of the employees. Article 2 Definitions For the purposes of this Directive: (a) "undertaking" means a public or private undertaking carrying out an economic activity, whether or not operating for gain, which is located within the territory of the Member States; (b) "establishment" means a unit of business defined in accordance with national law and practice, and located within the territory of a Member State, where an economic activity is carried out on an ongoing basis with human and material resources; (c) "employer" means the natural or legal person party to employment contracts or employment relationships with employees, in accordance with national law and practice; (d) "employee" means any person who, in the Member State concerned, is protected as an employee under national employment law and in accordance with national practice; (e) "employees' representatives" means the employees' representatives provided for by national laws and/or practices; (f) "information" means transmission by the employer to the employees' representatives of data in order to enable them to acquaint themselves with the subject matter and to examine it; (g) "consultation" means the exchange of views and establishment of dialogue between the employees' representatives and the employer. Article 3 Scope 1. This Directive shall apply, according to the choice made by Member States, to: (a) undertakings employing at least 50 employees in any one Member State, or (b) establishments employing at least 20 employees in any one Member State. Member States shall determine the method for calculating the thresholds of employees employed. 2. In conformity with the principles and objectives of this Directive, Member States may lay down particular provisions applicable to undertakings or establishments which pursue directly and essentially political, professional organisational, religious, charitable, educational, scientific or artistic aims, as well as aims involving information and the expression of opinions, on condition that, at the date of entry into force of this Directive, provisions of that nature already exist in national legislation. 3. Member States may derogate from this Directive through particular provisions applicable to the crews of vessels plying the high seas. Article 4 Practical arrangements for information and consultation 1. In accordance with the principles set out in Article 1 and without prejudice to any provisions and/or practices in force more favourable to employees, the Member States shall determine the practical arrangements for exercising the right to information and consultation at the appropriate level in accordance with this Article. 2. Information and consultation shall cover: (a) information on the recent and probable development of the undertaking's or the establishment's activities and economic situation; (b) information and consultation on the situation, structure and probable development of employment within the undertaking or establishment and on any anticipatory measures envisaged, in particular where there is a threat to employment; (c) information and consultation on decisions likely to lead to substantial changes in work organisation or in contractual relations, including those covered by the Community provisions referred to in Article 9(1). 3. Information shall be given at such time, in such fashion and with such content as are appropriate to enable, in particular, employees' representatives to conduct an adequate study and, where necessary, prepare for consultation. 4. Consultation shall take place: (a) while ensuring that the timing, method and content thereof are appropriate; (b) at the relevant level of management and representation, depending on the subject under discussion; (c) on the basis of information supplied by the employer in accordance with Article 2(f) and of the opinion which the employees' representatives are entitled to formulate; (d) in such a way as to enable employees' representatives to meet the employer and obtain a response, and the reasons for that response, to any opinion they might formulate; (e) with a view to reaching an agreement on decisions within the scope of the employer's powers referred to in paragraph 2(c). Article 5 Information and consultation deriving from an agreement Member States may entrust management and labour at the appropriate level, including at undertaking or establishment level, with defining freely and at any time through negotiated agreement the practical arrangements for informing and consulting employees. These agreements, and agreements existing on the date laid down in Article 11, as well as any subsequent renewals of such agreements, may establish, while respecting the principles set out in Article 1 and subject to conditions and limitations laid down by the Member States, provisions which are different from those referred to in Article 4. Article 6 Confidential information 1. Member States shall provide that, within the conditions and limits laid down by national legislation, the employees' representatives, and any experts who assist them, are not authorised to reveal to employees or to third parties, any information which, in the legitimate interest of the undertaking or establishment, has expressly been provided to them in confidence. This obligation shall continue to apply, wherever the said representatives or experts are, even after expiry of their terms of office. However, a Member State may authorise the employees' representatives and anyone assisting them to pass on confidential information to employees and to third parties bound by an obligation of confidentiality. 2. Member States shall provide, in specific cases and within the conditions and limits laid down by national legislation, that the employer is not obliged to communicate information or undertake consultation when the nature of that information or consultation is such that, according to objective criteria, it would seriously harm the functioning of the undertaking or establishment or would be prejudicial to it. 3. Without prejudice to existing national procedures, Member States shall provide for administrative or judicial review procedures for the case where the employer requires confidentiality or does not provide the information in accordance with paragraphs 1 and 2. They may also provide for procedures intended to safeguard the confidentiality of the information in question. Article 7 Protection of employees' representatives Member States shall ensure that employees' representatives, when carrying out their functions, enjoy adequate protection and guarantees to enable them to perform properly the duties which have been assigned to them. Article 8 Protection of rights 1. Member States shall provide for appropriate measures in the event of non-compliance with this Directive by the employer or the employees' representatives. In particular, they shall ensure that adequate administrative or judicial procedures are available to enable the obligations deriving from this Directive to be enforced. 2. Member States shall provide for adequate sanctions to be applicable in the event of infringement of this Directive by the employer or the employees' representatives. These sanctions must be effective, proportionate and dissuasive. Article 9 Link between this Directive and other Community and national provisions 1. This Directive shall be without prejudice to the specific information and consultation procedures set out in Article 2 of Directive 98/59/EC and Article 7 of Directive 2001/23/EC. 2. This Directive shall be without prejudice to provisions adopted in accordance with Directives 94/45/EC and 97/74/EC. 3. This Directive shall be without prejudice to other rights to information, consultation and participation under national law. 4. Implementation of this Directive shall not be sufficient grounds for any regression in relation to the situation which already prevails in each Member State and in relation to the general level of protection of workers in the areas to which it applies. Article 10 Transitional provisions Notwithstanding Article 3, a Member State in which there is, at the date of entry into force of this Directive, no general, permanent and statutory system of information and consultation of employees, nor a general, permanent and statutory system of employee representation at the workplace allowing employees to be represented for that purpose, may limit the application of the national provisions implementing this Directive to: (a) undertakings employing at least 150 employees or establishments employing at least 100 employees until 23 March 2007, and (b) undertakings employing at least 100 employees or establishments employing at least 50 employees during the year following the date in point (a). Article 11 Transposition 1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive not later than 23 March 2005 or shall ensure that management and labour introduce by that date the required provisions by way of agreement, the Member States being obliged to take all necessary steps enabling them to guarantee the results imposed by this Directive at all times. They shall forthwith inform the Commission thereof. 2. Where 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 12 Review by the Commission Not later than 23 March 2007, the Commission shall, in consultation with the Member States and the social partners at Community level, review the application of this Directive with a view to proposing any necessary amendments. Article 13 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 14 Addresses This Directive is addressed to the Member States.

32002L0015

2002

Directive 2002/15/EC of the European Parliament and of the Council of 11 March 2002 on the organisation of the working time of persons performing mobile road transport activities Having regard to the Treaty establishing the European Community, and in particular Article 71 and 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), Following consultation of the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), and in the light of the joint text approved by the Conciliation Committee on 16 January 2002, Whereas: (1) Council Regulation (EEC) No 3820/85 of 20 December 1985 on the harmonisation of certain social legislation relating to road transport(4) laid down common rules on driving times and rest periods for drivers; that Regulation does not cover other aspects of working time for road transport. (2) Council Directive 93/104/EC of 23 November 1993 concerning certain aspects of the organisation of working time(5) makes it possible to adopt more specific requirements for the organisation of working time. Bearing in mind the sectoral nature of this Directive, the provisions thereof take precedence over Directive 93/104/EC by virtue of Article 14 thereof. (3) Despite intensive negotiations between the social partners, it has not been possible to reach agreement on the subject of mobile workers in road transport. (4) It is therefore necessary to lay down a series of more specific provisions concerning the hours of work in road transport intended to ensure the safety of transport and the health and safety of the persons involved. (5) Since the objectives of the proposed action 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 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. (6) The scope of this Directive covers only mobile workers employed by transport undertakings established in a Member State participating in mobile road transport activities covered by Regulation (EEC) No 3820/85 or, failing that, by the European agreement concerning the work of crews of vehicles engaged in international road transport (AETR). (7) It should be made clear that mobile workers excluded from the scope of this Directive, other than self-employed drivers, benefit from the basic protection provided for in Directive 93/104/EC. That basic protection includes the existing rules on adequate rest, the maximum average working week, annual leave and certain basic provisions for night workers including health assessment. (8) As self-employed drivers are included within the scope of Regulation (EEC) No 3820/85 but excluded from that of Directive 93/104/EC, they should be excluded temporarily from the scope of this Directive in accordance with the provisions of Article 2(1). (9) The definitions used in this Directive are not to constitute a precedent for other Community regulations on working time. (10) In order to improve road safety, prevent the distortion of competition and guarantee the safety and health of the mobile workers covered by this Directive, the latter should know exactly which periods devoted to road transport activities constitute working time and which do not and are thus deemed to be break times, rest times or periods of availability. These workers should be granted minimum daily and weekly periods of rest, and adequate breaks. It is also necessary to place a maximum limit on the number of weekly working hours. (11) Research has shown that the human body is more sensitive at night to environmental disturbances and also to certain burdensome forms of organisation and that long periods of night work can be detrimental to the health of workers and can endanger their safety and also road safety in general. (12) As a consequence, there is a need to limit the duration of periods of night work and to provide that professional drivers who work at night should receive appropriate compensation for their activity and should not be disadvantaged as regards training opportunities. (13) Employers should keep records of instances when the maximum average working week applicable to mobile workers is exceeded. (14) The provisions of Regulation (EEC) No 3820/85 on driving time in international and national passenger transport, other than regular services, should continue to apply. (15) The Commission should monitor the implementation of this Directive and developments in this field in the Member States and submit to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions a report on the application of the rules and the consequences of the provisions on night work. (16) It is necessary to provide that certain provisions may be subject to derogations adopted, according to the circumstances, 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 compensatory rest periods, Article 1 Purpose The purpose of this Directive shall be to establish minimum requirements in relation to the organisation of working time in order to improve the health and safety protection of persons performing mobile road transport activities and to improve road safety and align conditions of competition. Article 2 Scope 1. This Directive shall apply to mobile workers employed by undertakings established in a Member State, participating in road transport activities covered by Regulation (EEC) No 3820/85 or, failing that, by the AETR Agreement. Without prejudice to the provisions of following subparagraph, this Directive shall apply to self-employed drivers from 23 March 2009. At the latest two years before this date, the Commission shall present a report to the European Parliament and the Council. This report shall analyse the consequences of the exclusion of self-employed drivers from the scope of the Directive in respect of road safety, conditions of competition, the structure of the profession as well as social aspects. The circumstances in each Member State relating to the structure of the transport industry and to the working environment of the road transport profession shall be taken into account. On the basis of this report, the Commission shall submit a proposal, the aim of which may be either, as appropriate - to set out the modalities for the inclusion of the self-employed drivers within the scope of the Directive in respect of certain self-employed drivers who are not participating in road transport activities in other Member States and who are subject to local constraints for objective reasons, such as peripheral location, long internal distances and a particular competitive environment, or - not to include self-employed drivers within the scope of the Directive. 2. The provisions of Directive 93/104/EC shall apply to mobile workers excluded from the scope of this Directive. 3. In so far as this Directive contains more specific provisions as regards mobile workers performing road transport activities it shall, pursuant to Article 14 of Directive 93/104/EC, take precedence over the relevant provisions of that Directive. 4. This Directive shall supplement the provisions of Regulation (EEC) No 3820/85 and, where necessary, of the AETR Agreement, which take precedence over the provisions of this Directive. Article 3 Definitions For the purposes of this Directive: (a) "working time" shall mean: 1. in the case of mobile workers: the time from the beginning to the end of work, during which the mobile worker is at his workstation, at the disposal of the employer and exercising his functions or activities, that is to say: - the time devoted to all road transport activities. These activities are, in particular, the following: (i) driving; (ii) loading and unloading; (iii) assisting passengers boarding and disembarking from the vehicle; (iv) cleaning and technical maintenance; (v) all other work intended to ensure the safety of the vehicle, its cargo and passengers or to fulfil the legal or regulatory obligations directly linked to the specific transport operation under way, including monitoring of loading and unloading, administrative formalities with police, customs, immigration officers etc., - the times during which he cannot dispose freely of his time and is required to be at his workstation, ready to take up normal work, with certain tasks associated with being on duty, in particular during periods awaiting loading or unloading where their foreseeable duration is not known in advance, that is to say either before departure or just before the actual start of the period in question, or under the general conditions negotiated between the social partners and/or under the terms of the legislation of the Member States; 2. in the case of self-employed drivers, the same definition shall apply to the time from the beginning to the end of work, during which the self employed driver is at his workstation, at the disposal of the client and exercising his functions or activities other than general administrative work that is not directly linked to the specific transport operation under way. The break times referred to in Article 5, the rest times referred to in Article 6 and, without prejudice to the legislation of Member States or agreements between the social partners providing that such periods should be compensated or limited, the periods of availability referred to in (b) of this Article, shall be excluded from working time; (b) "periods of availability" shall mean: - periods other than those relating to break times and rest times during which the mobile worker is not required to remain at his workstation, but must be available to answer any calls to start or resume driving or to carry out other work. In particular such periods of availability shall include periods during which the mobile worker is accompanying a vehicle being transported by ferryboat or by train as well as periods of waiting at frontiers and those due to traffic prohibitions. These periods and their foreseeable duration shall be known in advance by the mobile worker, that is to say either before departure or just before the actual start of the period in question, or under the general conditions negotiated between the social partners and/or under the terms of the legislation of the Member States, - for mobile workers driving in a team, the time spent sitting next to the driver or on the couchette while the vehicle is in motion; (c) "workstation" shall mean: - the location of the main place of business of the undertaking for which the person performing mobile road transport activities carries out duties, together with its various subsidiary places of business, regardless of whether they are located in the same place as its head office or main place of business, - the vehicle which the person performing mobile road transport activities uses when he carries out duties, and - any other place in which activities connected with transportation are carried out; (d) "mobile worker" shall mean any worker forming part of the travelling staff, including trainees and apprentices, who is in the service of an undertaking which operates transport services for passengers or goods by road for hire or reward or on its own account; (e) "self-employed driver" shall mean anyone whose main occupation is to transport passengers or goods by road for hire or reward within the meaning of Community legislation under cover of a Community licence or any other professional authorisation to carry out the aforementioned transport, who is entitled to work for himself and who is not tied to an employer by an employment contract or by any other type of working hierarchical relationship, who is free to organise the relevant working activities, whose income depends directly on the profits made and who has the freedom to, individually or through a cooperation between self-employed drivers, have commercial relations with several customers. For the purposes of this Directive, those drivers who do not satisfy these criteria shall be subject to the same obligations and benefit from the same rights as those provided for mobile workers by this Directive; (f) "person performing mobile road transport activities" shall mean any mobile worker or self-employed driver who performs such activities; (g) "week" shall mean the period between 00.00 hours on Monday and 24.00 hours on Sunday; (h) "night time" shall mean a period of at least four hours, as defined by national law, between 00.00 hours and 07.00 hours; (i) "night work" shall mean any work performed during night time. Article 4 Maximum weekly working time Member States shall take the measures necessary to ensure that: (a) the average weekly working time may not exceed 48 hours. The maximum weekly working time may be extended to 60 hours only if, over four months, an average of 48 hours a week is not exceeded. The fourth and fifth subparagraphs of Article 6(1) of Regulation (EEC) No 3820/85 or, where necessary, the fourth subparagraph of Article 6(1) of the AETR Agreement shall take precedence over this Directive, in so far as the drivers concerned do not exceed an average working time of 48 hours a week over four months; (b) working time for different employers is the sum of the working hours. The employer shall ask the mobile worker concerned in writing for an account of time worked for another employer. The mobile worker shall provide such information in writing. Article 5 Breaks 1. Member States shall take the measures necessary to ensure that, without prejudice to the level of protection provided by Regulation (EEC) No 3820/85 or, failing that, by the AETR Agreement, persons performing mobile road transport activities, without prejudice to Article 2(1), in no circumstances work for more than six consecutive hours without a break. Working time shall be interrupted by a break of at least 30 minutes, if working hours total between six and nine hours, and of at least 45 minutes, if working hours total more than nine hours. 2. Breaks may be subdivided into periods of at least 15 minutes each. Article 6 Rest periods For the purposes of this Directive, apprentices and trainees shall be covered by the same provisions on rest time as other mobile workers in pursuance of Regulation (EEC) No 3820/85 or, failing that, of the AETR Agreement. Article 7 Night work 1. Member States shall take the measures necessary to ensure that: - if night work is performed, the daily working time does not exceed ten hours in each 24 period, - compensation for night work is given in accordance with national legislative measures, collective agreements, agreements between the two sides of industry and/or national practice, on condition that such compensation is not liable to endanger road safety. 2. By 23 March 2007, the Commission shall, within the framework of the report which it draws up in accordance with Article 13(2), assess the consequences of the provisions laid down in paragraph 1 above. The Commission shall, if necessary, submit appropriate proposals along with that report. 3. The Commission shall present a proposal for a Directive containing provisions relating to the training of professional drivers, including those who perform night work, and laying down the general principles of such training. Article 8 Derogations 1. Derogations from Articles 4 and 7 may, for objective or technical reasons or reasons concerning the organisation of work, be adopted by means of collective agreements, agreements between the social partners, or if this is not possible, by laws, regulations or administrative provisions provided there is consultation of the representatives of the employers and workers concerned and efforts are made to encourage all relevant forms of social dialogue. 2. The option to derogate from Article 4 may not result in the establishment of a reference period exceeding six months, for calculation of the average maximum weekly working time of forty-eight hours. Article 9 Information and records Member States shall ensure that: (a) mobile workers are informed of the relevant national requirements, the internal rules of the undertaking and agreements between the two sides of industry, in particular collective agreements and any company agreements, reached on the basis of this Directive, without prejudice to Council Directive 91/533/EEC of 14 October 1991 on an employer's obligation to inform employees of the conditions applicable to the contract or employment relationship(6); (b) without prejudice to Article 2(1), the working time of persons performing mobile road transport activities is recorded. Records shall be kept for at least two years after the end of the period covered. Employers shall be responsible for recording the working time of mobile workers. Employers shall upon request provide mobile workers with copies of the records of hours worked. Article 10 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 health and safety of persons performing mobile road transport activities, or their right to facilitate or permit the application of collective agreements or other agreements concluded between the two sides of industry which are more favourable to the protection of the health and safety of mobile workers. Implementation of this Directive shall not constitute valid grounds for reducing the general level of protection afforded to workers referred to in Article 2(1). Article 11 Penalties Member States shall lay down a system of penalties for breaches of the national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that these penalties are applied. The penalties thus provided for shall be effective, proportional and dissuasive. Article 12 Negotiations with third countries Once this Directive has entered into force, the Community shall begin negotiations with the relevant third countries with a view to the application of rules equivalent to those laid down in this Directive to mobile workers employed by undertakings established in a third country. Article 13 Reports 1. Member States shall report to the Commission every two years on the implementation of this Directive, indicating the views of the two sides of industry. The report must reach the Commission no later than 30 September following the date on which the two-year period covered by the report expires. The two-year period shall be the same as that referred to in Article 16(2) of Regulation (EEC) No 3820/85. 2. The Commission shall produce a report every two years on the implementation of this Directive by Member States and developments in the field in question. The Commission shall forward this report to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions. Article 14 Final provisions 1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive by 23 March 2005 or shall ensure by that date that the two sides of industry have established the necessary measures by agreement, the Member States being obliged to take any steps to allow them to be able at any time to guarantee the results required by this Directive. When Member States adopt the measures referred to in the first subparagraph, 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 provisions of national law which they have already adopted or which they adopt in the field covered by this Directive. 3. Member States shall take care that consignors, freight forwarders, prime contractors, subcontractors and enterprises which employ mobile workers comply with the relevant provisions of this Directive. Article 15 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 16 Addressees This Directive is addressed to the Member States.

32002L0026

2002

Commission Directive 2002/26/EC of 13 March 2002 laying down the sampling methods and the methods of analysis for the official control of the levels of ochratoxin A in foodstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food(1), and in particular Article 2 thereof, 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(2), 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(3), as last amended by Regulation (EC) No 472/2002(4), fixes maximum limits for ochratoxin A 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(5) introduces a system of quality standards for laboratories entrusted by the Member States with the official control of foodstuffs. (3) Sampling plays a crucial part in the precision of the determination of the levels of ochratoxin A, which are very heterogeneously distributed in a lot. (4) 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. (5) 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. (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 Member States shall take all measures necessary to ensure that the sampling for the official control of the levels of ochratoxin A 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 analyses used for the official control of the levels of ochratoxin A in foodstuffs comply with the criteria described in Annex II to this Directive. 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 its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32002L0027

2002

Commission Directive 2002/27/EC of 13 March 2002 amending Directive 98/53/EC laying down the sampling methods and the methods of analysis for the official control of the levels for certain contaminants 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 Regulation (EC) No 472/2002(3), fixes maximum limits for aflatoxins in spices. (2) Sampling plays a crucial part in the precision of the determination of the levels of aflatoxins, which are very heterogeneously distributed in a lot. Commission Directive 98/53/EC of 16 July 1998 laying down the sampling methods of analysis and the methods of analysis for the official control of the levels for certain contaminants in foodstuffs(4) should be amended to include spices. (3) It is appropriate to rectify minor errors in Directive 98/53/EC. (4) 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 98/53/EC is amended as set out in the Annex of this Directive. Article 2 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 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32002L0024

2002

Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles and repealing Council Directive 92/61/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 Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles(4), laid down the procedure for Community type-approval of two or three-wheel motor vehicles, of components and of separate technical units produced in conformity with the technical requirements set out in separate directives. (2) All the separate directives, provided for in the exhaustive list of systems, components and separate technical units to be regulated at Community level, have been adopted. (3) The commencement of the application of 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) allows the type-approval procedure to be applied in full. (4) It is clearly necessary, in order that the type-approval system may work properly, to clarify certain administrative instructions and to supplement the norms contained in the annexes to Directive 92/61/EEC. With this in view, it is necessary to introduce harmonised norms concerning, in particular, the numbering of type-approval certificates as well as exemptions for end-of-series vehicles and for vehicles, components and separate technical units incorporating technologies which are not yet covered by Community arrangements, in the manner of the analogous norms 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(6). (5) Account being taken of currently established technologies, examination of the components and characteristics of the said vehicles has resulted in the retention only of those set out in Annex I to this Directive since all others are inappropriate for regulatory purposes. However, in view of progress and developments in technology, it will be appropriate to examine any further components and characteristics, in particular those relating to secondary safety, to be added to those already listed in the said Annex I. (6) The Community approval procedure is intended to enable each Member State to confirm that each type of vehicle has undergone the checks provided for in the separate directives and has been issued with a type-approval certificate. It is also intended to enable manufacturers to prepare a certificate of conformity for all vehicles conforming to the type that has been approved. When a vehicle is accompanied by this certificate it may be placed on the market, sold and registered for use throughout the Community. (7) Since the objectives of improving the functioning of the system of Community vehicle approval according to type cannot be sufficiently achieved by the Member States individually and can therefore, given the scale and the impact of the measures proposed, 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 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). (9) For reasons of clarity it is advisable to repeal Council Directive 92/61/EEC and replace it by this Directive, CHAPTER I Scope and definitions Article 1 1. This Directive applies to all two or three-wheel motor vehicles, whether twin-wheeled or otherwise, intended to travel on the road, and to the components or separate technical units of such vehicles. This Directive does not apply to the following vehicles: (a) vehicles with a maximum design speed not exceeding 6 km/h; (b) vehicles intended for pedestrian control; (c) vehicles intended for use by the physically handicapped; (d) vehicles intended for use in competition, on roads or in off-road conditions; (e) vehicles already in use before the application date of Directive 92/61/EEC; (f) tractors and machines, used for agricultural or similar purposes; (g) vehicles designed primarily for off-road leisure use having wheels arranged symmetrically with one wheel at the front of the vehicle and two at the rear; (h) cycles with pedal assistance which are equipped with an auxiliary electric motor having a maximum continuous rated power of 0,25 kW, of which the output is progressively reduced and finally cut off as the vehicle reaches a speed of 25 km/h, or sooner, if the cyclist stops pedalling, nor to the components or technical units thereof unless they are intended to be fitted to vehicles covered by this Directive. It does not apply to the approval of single vehicles except that Member States granting such approvals shall accept any type-approval of components and separate technical units granted under this Directive instead of under the relevant national requirements. 2. The vehicles referred to in paragraph 1 shall be subdivided into: (a) mopeds, i.e. two-wheel vehicles (category L1e) or three-wheel vehicles (category L2e) with a maximum design speed of not more than 45 km/h and characterised by: (i) in the case of the two-wheel type, an engine whose: - cylinder capacity does not exceed 50 cm3 in the case of the internal combustion type, or - maximum continuous rated power is no more than 4 kW in the case of an electric motor; (ii) in the case of the three-wheel type, an engine whose: - cylinder capacity does not exceed 50 cm3 if of the spark (positive) ignition type, or - maximum net power output does not exceed 4 kW in the case of other internal combustion engines, or - maximum continuous rated power does not exceed 4 kW in the case of an electric motor; (b) motorcycles, i.e. two-wheel vehicles without a sidecar (category L3e) or with a sidecar (category L4e), fitted with an engine having a cylinder capacity of more than 50 cm3 if of the internal combustion type and/or having a maximum design speed of more than 45 km/h, (c) motor tricycles, i.e. vehicles with three symmetrically arranged wheels (category L5e) fitted with an engine having a cylinder capacity of more than 50 cm3 if of the internal combustion type and/or a maximum design speed of more than 45 km/h. 3. This Directive shall also apply to quadricycles, i.e. motor vehicles with four wheels having the following characteristics: (a) light quadricycles whose unladen mass is not more than 350 kg (category L6e), not including the mass of the batteries in case of electric vehicles, whose maximum design speed is not more than 45 km/h, and (i) whose engine cylinder capacity does not exceed 50 cm3 for spark (positive) ignition engines, or (ii) whose maximum net power output does not exceed 4 kW in the case of other internal combustion engines, or (iii) whose maximum continuous rated power does not exceed 4 kW in the case of an electric motor. These vehicles shall fulfil the technical requirements applicable to three-wheel mopeds of category L2e unless specified differently in any of the separate directives; (b) quadricycles, other than those referred to in (a), whose unladen mass is not more than 400 kg (category L7e) (550 kg for vehicles intended for carrying goods), not including the mass of batteries in the case of electric vehicles, and whose maximum net engine power does not exceed 15 kW. These vehicles shall be considered to be motor tricycles and shall fulfil the technical requirements applicable to motor tricycles of category L5e unless specified differently in any of the separate Directives. Article 2 For the purposes of this Directive: 1. "type of vehicle" means either a vehicle or a group of vehicles (variants) which: (a) belong to a single category (two-wheel moped L1e, three-wheel moped L2e, etc., as defined in Article 1); (b) are constructed by the same manufacturer; (c) have the same chassis, frame, sub-frame, floor pan or structure to which major components are attached; (d) have a power unit with the same principle of operation (internal combustion, electric, hybrid, etc.); (e) have the same type designation given by the manufacturer. A type of vehicle may include variants and versions; 2. "variant" means either a vehicle or a group of vehicles (versions) being of the same type where: (a) they have the same shape of the bodywork (basic characteristics); (b) within the group of vehicles (versions) the difference in the mass in running order between the lowest value and the highest value does not exceed 20 % of the lowest value; (c) within the group of vehicles (versions) the difference in the maximum permissible mass between the lowest value and the highest value does not exceed 20 % of the lowest value; (d) they have the same operating cycle (two or four stroke, spark ignition or compression ignition); (e) within the group of vehicles (versions) the difference in the cylinder capacity of the power unit (in the case of an internal combustion unit) between the lowest value and the highest value does not exceed 30 % of the lowest value; (f) have the same number and arrangement of cylinders; (g) within the group of vehicles (versions) the difference in the power output of the power unit between the lowest value and the highest value does not exceed 30 % of the lowest value; (h) have the same operating mode (of electric motors); (i) have the same type of gearbox (manual, automatic, etc.); 3. "version" means a vehicle of the same typeand variant but which may incorporate any of the equipment, components or systems listed in the information document in Annex II provided that there is only: (a) one value quoted for: (i) the mass in running order; (ii) the maximum permissible mass; (iii) the power output of the power unit; (iv) the cylinder capacity of the power unit; and (b) one set of test results quoted in accordance with Annex VII; 4. "system" means any vehicle system such as brakes, emission control equipment, etc. which is subject to the requirements laid down in any of the separate directives; 5. "separate technical unit" means a device, such as a replacement exhaust system silencer, subject to the requirements of a separate directive, 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, where the separate directive makes express provision for so doing; 6. "component" means a device, such as a lamp, subject to the requirements of a separate directive, intended to be part of a vehicle, which may be type-approved independently of a vehicle, where the separate directive makes express provision for so doing; 7. "type-approval" means the procedure whereby a Member State certifies that a type of vehicle, system, separate technical unit or component satisfies the technical requirements set out in this Directive or the separate directives and the checks on the correctness of the manufacturer's data, as provided for in the exhaustive list set out in Annex I; 8. "twinned wheels" means two wheels mounted on the same axle, the distance between the centres of their areas of contact with the ground being less than 460 mm. Twinned wheels shall be considered as one wheel; 9. "twin-propulsion vehicles" means vehicles with two different systems of propulsion, for example an electric system and a thermic system; 10. "manufacturer" means the person or body responsible to the approval authority for all aspects of the type-approval process and for ensuring conformity of production. It is not essential that the person or body is directly involved in all stages of the construction of the vehicle, component or separate technical unit covered by the approval process; 11. "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 approval authority of a Member State. This function may also be carried out by the approval authority itself. CHAPTER II Procedures for granting type-approval Article 3 Applications for type-approval shall be submitted by the manufacturer to the approval authority of a Member State. They shall be accompanied by an information document, a model of which, for vehicle type-approval purposes, is set out in Annex II and, for type-approval purposes of systems, separate technical units or components, is contained in an annex or appendix to the relevant system, separate technical unit or component directive, and also by the other documents referred to in the information document. Applications for a given type of vehicle, system, separate technical unit or component may be submitted to one Member State only. Article 4 1. Each Member State shall grant type-approval to all types of vehicle, systems, separate technical units or components if these meet the following conditions: (a) the type of vehicle meets the technical requirements of the separate directives and is as described by the manufacturer in accordance with the data provided for in the exhaustive list set out in Annex I; (b) the system, separate technical unit or component meets the technical requirements of the relevant separate directive and is as described by the manufacturer in accordance with the data provided for in the exhaustive list set out in Annex I. 2. Before conducting type-approval, the competent authorities in the Member State which carry out these operations shall take all necessary steps to ensure, if necessary in cooperation with the competent authorities in the Member State where manufacturing takes place or the product is brought into the Community, that there is compliance with the provisions of Annex VI in order that the new vehicles, systems, separate technical units or components manufactured, placed on the market, offered for sale or put into service, conform to the approved type. 3. The competent authorities referred to in paragraph 2 shall ensure, if necessary in cooperation with the competent authorities in the Member State where manufacturing takes place or the product is brought into the Community, that the provisions of Annex VI continue to be observed. 4. Where an application for type-approval for a type of vehicle is accompanied by one or more type-approval certificates of a system, separate technical or component unit issued by one or more Member States, the Member State conducting type-approval for a type of vehicle shall be obliged to accept them and shall not perform, in respect of the systems, separate technical units and/or components which have been type-approved, the checks required by paragraph 1(b). 5. Each Member State shall be responsible for the type-approval of a system, separate technical unit or component that it grants. The competent authorities in the Member State which grant type-approval for a type of vehicle shall check conformity of production, where necessary in cooperation with those competent authorities in the other Member States which have issued type-approval certificates for systems, separate technical unit or components. 6. However, if a Member State finds that a vehicle, system, separate technical unit or component which complies with the provisions of paragraph 1 is nevertheless a serious risk to road safety, it may refuse to grant the type-approval. It shall forthwith inform the other Member States and the Commission thereof, stating the reasons on which its decision is based. Article 5 1. The competent authority in a Member State shall complete the type-approval form contained in Annex III for all types of vehicles in respect of which it conducts type-approval, and in addition shall enter the test results under the relevant headings on the form attached to the vehicle approval form, the model for which is given in Annex VII. 2. The competent authority in a Member State shall complete the type-approval form contained in an annex or an appendix to each relevant separate Directive, for each type of system, separate technical unit or component in respect of which it conducts type-approval. 3. Type-approval certificates of a system, separate technical unit or component shall be numbered in accordance with the method described in Annex V, Part A. Article 6 1. The competent authority in each Member State shall forward to those of the other Member States, within one month, a copy of the type-approval certificate, together with the annexes for each type of vehicle that they type-approve or refuse to type-approve. 2. The competent authority in each Member State shall send monthly to the competent authorities of the other Member States, a list of the type-approvals of a system, separate technical unit or component, which it has granted or refused to grant during that month. In addition, at the request of a competent authority of another Member State, it shall send forthwith a copy of the type-approval certificate together with the annexes for each type of system, separate technical unit or component. Article 7 1. A certificate of conformity, a model of which is shown in Annex IV-A, shall be completed by the manufacturer for each vehicle produced in conformity with the type that has been approved. Such a certificate shall accompany each vehicle. However, Member States may request, after giving at least three months' notice to the Commission and other Member States, for reasons of vehicle taxation or in order to draw up the vehicle registration document, that the certificate of conformity shall contain details other than those mentioned in Annex IV-A, provided that those details are explicitly included in the information document. The certificate of conformity shall be made in such a way as to prevent any forgery. For this purpose, the printing shall be made on paper protected either by coloured graphics or watermarked with the vehicle manufacturer's identification mark. 2. A certificate of conformity, a model of which is shown in Annex IV-B, shall be completed by the manufacturer for each non-original separate technical unit or component manufactured in conformity with the approved type. That certificate is not required for original separate technical units or components. 3. Where the separate technical unit or component to be type-approved performs its function or displays a specific characteristic only in conjunction with other components of the vehicle and for this reason compliance with one or more requirements can be verified only when that separate technical unit or component to be approved functions in conjunction with other vehicle components whether real or simulated, the scope of the type-approval of that separate technical unit or component must be restricted accordingly. The type-approval certificate for a separate technical unit or component shall then set out any restrictions on use and any instructions for fitting it. Compliance with these restrictions and requirements shall be verified when the vehicle is type-approved. 4. Without prejudice to paragraph 2, the holder of a type-approval for a separate technical unit or component that has been granted under Article 4 shall be obliged to affix to each such separate technical unit or component manufactured in conformity with the approved type, his factory or trade mark, a statement of the type and, if the separate directive so requires, the type-approval mark referred to in Article 8. In this latter case, he is not required to complete the certificate provided for in paragraph 2. 5. Any holder of a type-approval certificate for a separate technical unit or component which, under paragraph 3, contains restrictions on use, must supply detailed information on those restrictions and must give fitting instructions, where appropriate, with each separate technical unit or component manufactured. 6. Any holder of a type-approval certificate for a separate technical unit of non-original equipment, issued in connection with one or more types of vehicle, must with each such unit supply detailed information allowing those vehicles to be identified. Article 8 1. Any vehicle produced in conformity with the type which has been type-approved shall bear a type-approval mark composed in accordance with Section 1, Section 3 and Section 4 of the type-approval number, set out in Annex V, Part A. 2. Any separate technical unit and any component produced in conformity with the type having been type-approved shall include, if the relevant separate directive so provides, a type-approval mark which meets the requirements set out in Annex V, Part B. The type-approval number listed in Annex V, Part B, paragraph 1.2 shall be composed in accordance with Section 4 of the type-approval number set out in Annex V, Part A. The information contained in the type-approval mark may be supplemented by further information enabling certain characteristics which are specific to the separate technical unit or component at issue to be identified. That further information shall, where appropriate, be specified in the separate directives on those separate technical units or components. Article 9 1. The manufacturer shall be responsible for the manufacture of each vehicle or the production of each system, separate technical unit or component in compliance with the approved type. The final cessation of production or any changes to the information contained in the information document must be notified by the type-approval holder to the competent authorities in the Member State which issued that type-approval. 2. If the competent authorities of the Member State referred to in paragraph 1 consider that a change of this type does not involve any change to the existing type-approval certificate, or the drawing up of a new type-approval certificate, they shall inform the manufacturer accordingly. 3. If the competent authorities in the Member State referred to in paragraph 1 confirm that a change in the information set out in the information document justifies new checks or new tests, they shall inform the manufacturer accordingly and shall perform those tests. Should the checks or tests involve amendments to the existing type-approval certificate or the drawing up of a new certificate, the authorities shall inform the competent authorities of the other Member States in accordance with Article 6. 4. Where the particulars appearing in the information document for vehicle approval have changed, the manufacturer shall issue revised pages to the approval authority showing clearly the nature of the change and the date of re-issue. Only where the changes made to the information document necessitate the amendment of one or more of the entries given in the certificate of conformity in Annex IV (except items 19.1 and 45 to 51 inclusive), shall the reference number on the information document be changed. 5. Where a type-approval certificate ceases to have effect as a result of final cessation of production of the type of vehicle which has been approved or of the system or of the separate technical unit or component which has been type-approved, the competent authorities in the Member State which have carried out that type-approval shall inform the competent authorities in the other Member States within one month. Article 10 1. If the Member State which has conducted type-approval finds that vehicles, systems, separate technical units or components do not conform to the approved type, it shall take the necessary measures to ensure that the production of any item that has been type-approved is again in conformity. The competent authorities in that Member State shall inform the authorities in the other Member States of the measures taken which may, where necessary, extend to the withdrawal of type-approval. 2. If a Member State finds that vehicles, systems, separate technical units or components do not conform to the approved type, it may request the Member State which has conducted the type-approval to verify the irregularities found. Any Member State which has conducted type-approval shall conduct the necessary check within six months following the date of receipt of that request. Should a failure to conform be established, the competent authorities in the Member State which has conducted type-approval shall take the measures set out in paragraph 1. 3. The competent authorities in the Member States shall inform each other, within one month, of the withdrawal of any type-approval granted and of the reasons for such measure. 4. If the Member State which has granted type-approval disputes the failure to conform notified to it, the Member States involved shall endeavour to resolve the matter. The Commission shall be kept informed and, where necessary, shall hold appropriate consultations in order to reach a settlement. Article 11 Acting by a qualified majority on a proposal from the Commission, the Council may acknowledge equivalence between the conditions or provisions for type-approval of vehicles, systems, separate technical units and components 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. Article 12 If a Member State finds that vehicles, systems, separate technical units or components constitute a road safety hazard, even though they are of an approved type, it may, for a maximum period of six months, prohibit on its territory the sale, entry into service or use thereof. It shall forthwith inform the other Member States and the Commission, giving reasons for its decision. Article 13 Any decision concerning the refusal or withdrawal of type-approval, a ban on the sale or use of a vehicle, separate technical unit or component taken in pursuance of the provisions adopted in implementation of this Directive shall state in detail the reasons on which it is based. It shall be notified to the party concerned, who shall, at the same time, be informed of the remedies available under the laws in force in the Member States and of the time limits allowed for the exercise of such remedies. Article 14 1. Member States shall notify the Commission and the other Member States of the names and addresses of: (a) the type-approval authorities and, if applicable, the disciplines for which the authorities are responsible; (b) the technical services which they have approved, specifying for which test procedures each of these services has been approved. The notified services must satisfy the harmonised standards on the operation of testing laboratories (EN 45001) subject to the following provisos: (i) a manufacturer may not be approved as a technical service except where the separate Directive makes express provisions for doing so; (ii) for the purpose of this Directive it is not considered exceptional for a technical service to use equipment from an outside source, subject to the agreement of the approval authority. 2. A notified service shall be presumed to satisfy the harmonised standard but, where appropriate, the Commission may ask Member States to provide supporting evidence. Third country services may not be notified as approved technical services other than in the framework of bilateral agreements or multilateral agreements between the Community and third countries. CHAPTER III Conditions attached to free movement, provisional arrangements, exemptions and alternative procedures. Article 15 1. Member States shall not prohibit the placing on the market, sale, entry into service or use of new vehicles complying with this Directive. Only vehicles complying with this Directive may be presented for initial registration. 2. Member States shall not prohibit the placing on the market, sale or use of new separate technical units or new components complying with this Directive. Only separate technical units and components complying with this Directive may be placed on the market and sold for the first time for use in the Member States. 3. By way of derogation from paragraphs 1 and 2: (a) Member States may exempt vehicles, systems, separate technical units and components intended: (i) either for production in small series of up to a maximum of 200 units a year per type of vehicle, per system, per component or per separate technical unit; (ii) or for the armed forces, law enforcement agencies, civil defence services, fire brigades or public-works bodies, from compliance with any of the requirements of the separate directives. The other Member States shall be informed of these exemptions within one month of their being granted. Within three months these Member States shall decide whether they accept the type-approval for vehicles to be registered within their territory. The certificate of such type-approval may not bear the heading "EC type-approval certificate"; (b) type-approval certificates issued at national level before 17 June 1999 shall remain valid within the Member States issuing them for a period of four years from the date on which national laws are required to comply with the relevant directives. The same period is also extended to types of vehicles, systems, components or technical entities conforming to national requirements of Member States applying other legislative systems than those for type-approval in force before the implementation of the relevant directives. Vehicles covered by the latter exemption may be placed on the market, sold and entered into service during this period with no time limit on their use. The placing on the market, sale and use of systems, separate technical units and components for these vehicles shall carry no time limit. 4. This Directive shall not affect the right of the Member States to lay down - in accordance with the Treaty - the requirements which they consider necessary to ensure the protection of users during the use of the vehicles in question, provided that this does not entail modification to the vehicles. Article 16 1. By way of derogation from Article 15(1) and (2), and within the limits set out in Annex VIII, Member States may, for a limited period, register and permit the sale or entry into service of new vehicles conforming to a type of vehicle whose type-approval is no longer valid. This option shall be limited to a period of 12 months as from the date on which the type-approval lost its validity. The first subparagraph shall apply only to vehicles which were in the territory of the Community and were accompanied by a valid certificate of conformity which had been issued when the type-approval of the vehicle in question was still valid, but which had not been registered or put into service before the said type-approval lost its validity. 2. Before paragraph 1 may be applied to one or more types of a given category, the manufacturer shall submit a request to the competent authority of each Member State concerned by the entry into service of such types of vehicle. The request shall specify the technical and/or economic reasons justifying it. Within three months such Member States shall decide whether, and for how many units, they will accept the vehicle type concerned for registration in their territory. Each Member State concerned by the entry into service of such types of vehicle shall be responsible for ensuring that the manufacturer complies with the provisions of Annex VIII. Member States shall send the Commission every year a list of exemptions granted. 3. As regards vehicles, components or separate technical units incorporating technologies or concepts which cannot, due to their specific nature, comply with one or more of the requirements of one or more of the separate Directives, point (c) of Article 8(2) of Directive 70/156/EEC shall apply. CHAPTER IV Procedure for adaptation to technical progress Article 17 Any amendments needed for the purposes of adapting to technical progress the Annexes to this Directive or the provisions of the separate directives referred to in Annex I shall be adopted in accordance with the procedure set out in Article 18(2). Article 18 1. The Commission shall be assisted by the Committee for Adaptation to Technical Progress, set up by Article 13 of Directive 70/156/EEC (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 is set at three months. 3. The Committee shall adopt its rules of procedure. CHAPTER V Final provisions Article 19 Council Directive 92/61/EEC shall be repealed with effect from 9 November 2003. References made to Directive 92/61/EEC shall be construed as references to this Directive and read according to the table of correspondance in Annex IX. Article 20 1. Member States shall bring into force before 9 May 2003 the laws, regulations and administrative provisions necessary 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 be accompanied by such reference on the occasion of their official publication. Methods of making such reference shall be laid down by Member States. 2. Member States shall apply the provisions referred to in paragraph 1, first subparagraph, as from 9 November 2003. However, at the request of the manufacturer the previous model of the certificate of conformity may still be used for 12 months thereafter. 3. From 9 May 2003 Member States shall not prohibit the first entry into service of vehicles complying with this Directive. 4. 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 21 This Directive shall not invalidate any approvals granted before 9 November 2003, nor prevent extension of such approvals under the terms of the Directive under which they were originally granted. However, as from 9 November 2004 certificates of conformity issued by the manufacturer shall comply with the model specified in Annex IV. Article 22 Pending the harmonisation of registration and taxation systems in the Member States in relation to vehicles covered by this Directive, Member States may use national code systems in order to facilitate registration and taxation in their territory. Member States may also request that the certificate of conformity be supplemented by the national code number. Article 23 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 24 This Directive is addressed to the Member States.

32002L0029

2002

Commission Directive 2002/29/EC of 19 March 2002 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 2001/33/EC(2), and in particular the first subparagraph of Article 2(1)(h) thereof, Having regard to Commission Directive 2001/32/EC of 8 May 2001 recognising protected zones exposed to particular plant health risks in the Community and repealing Directive 92/76/EEC(3) and in particular Article 2 thereof, Whereas: (1) Under Directive 2001/32/EC, Ireland, Italy (Emilia-Romagna: provinces of Forlí-Cesena, Parma, Piacenza and Rimini; Lombardia; Trentino-Alto Adige: autonomous province of Bolzano; Veneto), and Austria (Burgenland, Kärnten, Niederösterreich, Osttirol, Steiermark, Wien), were provisionally recognised as "protected zones" in respect of Erwinia amylovora (Burr.) Winsl. et al. for a period expiring on 31 March 2002. (2) Under Directive 2001/32/EC, the United Kingdom was provisionally recognised as a protected zone for beet necrotic yellow vein virus for a period expiring on 31 March 2002. (3) From information supplied by Austria, Ireland and Italy it appears that the provisional recognition of the protected zones for those countries in respect of Erwinia amylovora (Burr.) Winsl. et al. should exceptionally be extended for a further period to enable the responsible official bodies of those countries to complete the information on the distribution of Erwinia amylovora (Burr.) Winsl. et al. and to complete efforts for the eradication of this harmful organism in the areas concerned. (4) From information supplied by Italy it appears that the protected zone of Apulia should no longer be recognised as a permanent protected zone in respect of Erwinia amylovora (Burr.) Winsl. et al. but should now be provisionally recognised as a protected zone as regards Erwinia amylovora (Burr.) Winsl. et al. for a limited period expiring on 31 March 2003 to enable the responsible official bodies to complete the information on the distribution of Erwinia amylovora (Burr.) Winsl. et al. and to complete efforts for the eradication of this harmful organism within this protected zone. (5) From information supplied by Italy it appears that some parts of the province of Veneto should no longer be recognised as protected zones in respect of Erwinia amylovora (Burr.) Winsl. et al. because it appears to be widespread within those zones whilst the provisional recognition as protected zones for other zones in respect of Erwinia amylovora (Burr.) Winsl. et al. should be extended exceptionally for a further limited period. (6) From information supplied by the United Kingdom on the presence of beet necrotic yellow vein virus it appears that it is no longer appropriate to maintain the protected zone for the whole of the United Kingdom in respect of beet necrotic yellow vein virus but should be restricted to Northern Ireland only. (7) Under Directive 2001/32/EC Sweden was recognised as a protected zone on a permanent basis in respect of beet necrotic yellow vein virus. From information supplied by Sweden on the presence of beet necrotic yellow vein virus it appears that Sweden should now be provisionally recognised as a protected zone as regards beet necrotic yellow vein virus for a limited period expiring on 31 March 2003 to enable the responsible official bodies to complete the information on the distribution of beet necrotic yellow vein virus and to complete efforts for the eradication of this harmful organism. (8) The definition of the plants for which protected zones were recognised as regards Citrus tristeza virus should be modified. (9) From information supplied by the United Kingdom based on updated surveys it appears that the protected zone recognised for Dendroctonus micans Kugelan in the United Kingdom should be modified. (10) From information supplied by France based on updated surveys it appears that the protected zone recognised for Matsucoccus feytaudi Duc. in France should no longer be maintained. (11) Directive 2001/32/EC should, therefore, be amended accordingly. (12) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 2001/32/EC is hereby amended as follows: 1. Article 1 is amended as follows: (a) the second paragraph is replaced by: "In the case of point (b)(2), for Ireland, for Italy (Puglia, Emilia-Romagna: provinces of Forlí-Cesena, Parma, Piacenza and Rimini; Lombardia; Trentino-Alto Adige: autonomous province of Bolzano; Veneto: except in the province of Rovigo the communes Rovigo, Polesella, Villamarzana, Fratta Polesine, San Bellino, Badia Polesine, Trecenta, Ceneselli, Pontecchio Polesine, Arquà Polesine, Costa di Rovigo, Occhiobello, Lendinara, Canda, Ficarolo, Guarda Veneta, Frassinelle Polesine, Villanova del Ghebbo, Fiesso Umbertiano, Castelguglielmo, Bagnolo di Po, Giacciano con Baruchella, Bosaro, Canaro, Lusia, Pincara, Stienta, Gaiba, Salara, and in the province of Padova the communes Castelbaldo, Barbona, Piacenza d'Adige, Vescovana, S. Urbano, Boara Pisani, Masi, and in the province of Verona the communes of Palù, Roverchiara, Legnago (the portion of the communal territory situated to the north east of the Transpolesana national road), Castagnaro, Ronco all'Adige, Villa Bartolomea, Oppeano, Terrazzo, Isola Rizza, Angiari), and for Austria (Burgenland, Kärnten, Niederösterreich, Tirol (administrative district Lienz), Steiermark, Wien), the said zones are recognised until 31 March 2003';" (b) the third paragraph is replaced by: "In the case of point (d)(1), the said zone in Sweden is recognised until 31 March 2003"; 2. the Annex is amended in accordance with the Annex to this Directive. Article 2 Member States shall adopt and publish by 31 March 2002 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 2002. 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 its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32002L0028

2002

Commission Directive 2002/28/EC of 19 March 2002 amending certain annexes 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 2001/33/EC(2) and in particular Article 14(c) thereof, Having regard to the agreement of the Member States concerned, Whereas: (1) From information supplied by the United Kingdom based on updated surveys it appears that the protected zone recognised for Dendroctonus micans Kugelan in the United Kingdom should be modified. (2) From information supplied by the United Kingdom on the presence of beet necrotic yellow vein virus it appears that it is no longer appropriate to maintain the protected zone for the whole of the United Kingdom in respect of beet necrotic yellow vein virus but should be restricted to Northern Ireland only. (3) From information supplied by Italy the description of the protected zones in respect of Erwinia amylovora (Burr.) Winsl. et al. should be modified to take into account the present distribution of the organism. (4) The description of the protected zones relating to host plants of Erwinia amylovora (Burr.) Winsl. et al. as regards the special requirements to be met should be modified to take into account the present distribution of the organism. (5) From information supplied by France on the presence of Matsucoccus feytaudi Duc. it appears that it is no longer appropriate to maintain the protected zone for this organism. (6) Therefore, Directive 2000/29/EC should be amended accordingly. (7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Annexes I, II, III and IV 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 31 March 2002 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 2002. 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. 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 Communities. Article 4 This Directive is addressed to the Member States.

32002L0031

2002

Commission Directive 2002/31/EC of 22 March 2002 implementing Council Directive 92/75/EEC with regard to energy labelling of household air-conditioners (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) Directive 92/75/EEC requires the Commission to adopt implementing Directives in respect of various household appliances, including air-conditioners. (2) Electricity use by air-conditioners accounts for a significant part of total Community household energy demand. The scope for reduced energy use by these appliances is substantial. (3) Harmonised standards are technical specifications adopted by the European standardisation bodies, as referred to in Annex I to 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(2), as amended by Directive 98/48/EC(3), and in accordance with the general guidelines for cooperation between the Commission and those bodies signed on 13 November 1984 as amended. (4) Information concerning noise emissions should be given where required by Member States pursuant to Council Directive 86/594/EEC of 1 December 1986 on airborne noise emitted by household appliances(4). (5) 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 This Directive shall apply to electric mains operated household air-conditioners as defined in the European standards EN 255-1, EN 814-1 or the harmonised standards referred to in Article 2. It shall not apply to the following appliances: - appliances that can also use other energy sources, - air-to-water and water-to-water appliances, - units with an output (cooling power) greater than 12 kW. Article 2 1. The information required by this Directive will be obtained by measurements made in accordance with harmonised standards adopted by the European Committee for Standardisation (CEN) under mandate from the Commission in accordance with Directive 98/34/EC, the reference numbers of which have been published in the Official Journal of the European Communities and for which Member States have published the reference numbers of the national standards transposing those harmonised standards. The provisions in Annexes I, II and III to this Directive 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. 2. In this Directive expressions used have the same meaning as in Directive 92/75/EEC. Article 3 1. The technical documentation referred to in Article 2(3) of Directive 92/75/EEC shall include: (a) the name and address of the supplier; (b) a general description of the model, sufficient for it to be uniquely and easily identified; (c) information, including drawings as relevant, on the main design features of the model and in particular items which appreciably affect its energy consumption; (d) reports of relevant measurement tests carried out under the test procedures of the harmonised standards referred to in Article 2(1) of this Directive; (e) operating instructions, if any. 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 the mathematical model for calculating performance of split systems, and of measurements taken to verify this model). 2. The label referred to in Article 2(1) of Directive 92/75/EEC shall be as specified in Annex I to this Directive. The label shall be placed on the outside of the front or top of the appliance in such a way as to be clearly visible and not obscured. 3. The content and format of the fiche referred to in Article 2(1) of Directive 92/75/EEC shall be as specified in Annex II to this Directive. 4. 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 to this Directive. 5. The energy efficiency class of an appliance shall be determined in accordance with Annex IV. Article 4 As a transitional measure, Member States shall permit, until 30 June 2003, the placing on the market, the commercialisation and/or the display of products and the distribution of communications referred to in Article 3(4) which do not conform with this Directive. Article 5 1. Member States shall adopt and publish, before 1 January 2003, the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions with effect from 1 January 2003. 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 provisions of national law which they adopt in the field covered by this Directive. Article 6 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 7 This Directive is addressed to the Member States.

32002L0035

2002

Commission Directive 2002/35/EC of 25 April 2002 amending Council Directive 97/70/EC setting up a harmonised safety regime for fishing vessels of 24 metres in length and over (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 97/70/EC of 11 December 1997 setting up a harmonised safety regime for vessels of 24 metres in length and over(1), as amended by Commission Directive 1999/19/EC(2), and in particular Article 8 thereof, Whereas: (1) The Torremolinos Protocol relating to the Torremolinos International Convention for the Safety of Fishing Vessels, 1977, hereinafter referred to as the "Torremolinos Protocol" was adopted on 2 April 1993. (2) Directive 97/70/EC establishes a harmonised safety regime for certain fishing vessels, applying the Torremolinos Protocol to them. (3) In order to ensure consistency in the application of the provisions of the Annex to the Torremolinos Protocol for the application of Article 3(1) of Directive 97/70/EC, it appears necessary to harmonise the interpretations left to the discretion of the administrations of the Member States of certain of those provisions. These harmonised interpretations should apply only to fishing vessels constructed on or after 1 January 2003 as they imply important changes in the construction of fishing vessels. (4) Directive 97/70/EC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 12 of Council Directive 93/75/EEC(3), as last amended by Commission Directive 98/74/EC(4), Article 1 Annex I to Directive 97/70/EC is hereby replaced by the text in the Annex to this Directive. Article 2 1. Member States shall adopt and publish, before 1 January 2003 the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions 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. 2. Member States shall communicate to the Commission 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 its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32002L0038

2002

Council Directive 2002/38/EC of 7 May 2002 amending and amending temporarily Directive 77/388/EEC as regards the value added tax arrangements applicable to radio and television broadcasting services and certain electronically supplied services 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 Economic and Social Committee(3), Whereas: (1) The rules currently applicable to VAT on radio and television broadcasting services and on electronically supplied services, under Article 9 of 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), are inadequate for taxing such services consumed within the Community and for preventing distortions of competition in this area. (2) In the interests of the proper functioning of the internal market, such distortions should be eliminated and new harmonised rules introduced for this type of activity. Action should be taken to ensure, in particular, that such services where effected for consideration and consumed by customers established in the Community are taxed in the Community and are not taxed if consumed outside the Community. (3) To this end, radio and television broadcasting services and electronically supplied services provided from third countries to persons established in the Community or from the Community to recipients established in third countries should be taxed at the place of the recipient of the services. (4) To define electronically supplied services, examples of such services should be included in an annex to the Directive. (5) To facilitate compliance with fiscal obligations by operators providing electronically supplied services, who are neither established nor required to be identified for tax purposes within the Community, a special scheme should be established. In applying this scheme any operator supplying such services by electronic means to non-taxable persons within the Community, may, if he is not otherwise identified for tax purposes within the Community, opt for identification in a single Member State. (6) The non-established operator wishing to benefit from the special scheme should comply with the requirements laid down therein, and with any relevant existing provision in the Member State where the services are consumed. (7) The Member State of identification must under certain conditions be able to exclude a non-established operator from the special scheme. (8) Where the non-established operator opts for the special scheme, any input value added tax that he has paid with respect to goods and services used by him for the purpose of his taxed activities falling under the special scheme, should be refunded by the Member State where the input value added tax was paid, in accordance with the arrangements of the thirteenth Council Directive 86/560/EEC of 17 November 1986 on the harmonisation of the laws of the Member States relating to turnover taxes - arrangements for the refund of value added tax to taxable persons not established in Community territory(5). The optional restrictions for refund in Article 2(2) and (3) and Article 4(2) of the same Directive should not be applied. (9) Subject to conditions which they lay down, Member States should allow certain statements and returns to be made by electronic means, and may also require that electronic means are used. (10) Those provisions pertaining to the introduction of electronic tax returns and statements should be adopted on a permanent basis. It is desirable to adopt all other provisions for a temporary period of three years which may be extended for practical reasons but should, in any event, based on experience, be reviewed within three years from 1 July 2003. (11) Directive 77/388/EEC should therefore be amended accordingly, Article 1 Directive 77/388/EEC is hereby temporarily amended as follows: 1. in Article 9: (a) in paragraph (2)(e), a comma shall replace the final full stop and the following indents shall be added: "- radio and television broadcasting services, - electronically supplied services, inter alia, those described in Annex L." (b) in paragraph 2, the following point shall be added: "(f) the place where services referred to in the last indent of subparagraph (e) are supplied when performed for non-taxable persons who are established, have their permanent address or usually reside in a Member State, by a taxable person who has established his business or has a fixed establishment from which the service is supplied outside the Community or, in the absence of such a place of business or fixed establishment, has his permanent address or usually resides outside the Community, shall be the place where the non-taxable person is established, has his permanent address or usually resides." (c) in paragraph 3, the introductory phrase shall be replaced by the following: "3. In order to avoid double taxation, non-taxation or the distortion of competition, the Member States may, with regard to the supply of services referred to in paragraph 2(e), except for the services referred to in the last indent when supplied to non-taxable persons, and also with regard to the hiring out of forms of transport consider:" (d) paragraph 4 shall be amended as follows: "4. In the case of telecommunications services and radio and television broadcasting services referred to in paragraph 2(e) when performed for non-taxable persons who are established, have their permanent address or usually reside in a Member State, by a taxable person who has established his business or has a fixed establishment from which the service is supplied outside the Community, or in the absence of such a place of business or fixed establishment, has his permanent address or usually resides outside the Community, Member States shall make use of paragraph 3(b)." 2. in Article 12(3)(a), the following fourth subparagraph shall be added: "The third subparagraph shall not apply to the services referred to in the last indent of Article 9(2)(e)." 3. the following Article shall be added: "Article 26c Special scheme for non-established taxable persons supplying electronic services to non-taxable persons A. Definitions For the purposes of this Article, the following definitions shall apply without prejudice to other Community provisions: (a) 'non-established taxable person' means a taxable person who has neither established his business nor has a fixed establishment within the territory of the Community and who is not otherwise required to be identified for tax purposes under Article 22; (b) 'electronic services' and 'electronically supplied services' means those services referred to in the last indent of Article 9(2)(e); (c) 'Member State of identification' means the Member State which the non-established taxable person chooses to contact to state when his activity as a taxable person within the territory of the Community commences in accordance with the provisions of this Article; (d) 'Member State of consumption' means the Member State in which the supply of the electronic services is deemed to take place according to Article 9(2)(f); (e) 'value added tax return' means the statement containing the information necessary to establish the amount of tax that has become chargeable in each Member State. B. Special scheme for electronically supplied services 1. Member States shall permit a non-established taxable person supplying electronic services to a non-taxable person who is established or has his permanent address or usually resides in a Member State to use a special scheme in accordance with the following provisions. The special scheme shall apply to all those supplies within the Community. 2. The non-established taxable person shall state to the Member State of identification when his activity as a taxable person commences, ceases or changes to the extent that he no longer qualifies for the special scheme. Such a statement shall be made electronically. The information from the non-established taxable person to the Member State of identification when his taxable activities commence shall contain the following details for the identification: name, postal address, electronic addresses, including websites, national tax number, if any, and a statement that the person is not identified for value added tax purposes within the Community. The non-established taxable person shall notify the Member State of identification of any changes in the submitted information. 3. The Member State of identification shall identify the non-established taxable person by means of an individual number. Based on the information used for this identification, Member States of consumption may keep their own identification systems. The Member State of identification shall notify the non-established taxable person by electronic means of the identification number allocated to him. 4. The Member State of identification shall exclude the non-established taxable person from the identification register if: (a) he notifies that he no longer supplies electronic services, or (b) it otherwise can be assumed that his taxable activities have ended, or (c) he no longer fulfils the requirements necessary to be allowed to use the special scheme, or (d) he persistently fails to comply with the rules concerning the special scheme. 5. The non-established taxable person shall submit by electronic means to the Member State of identification a value added tax return for each calendar quarter whether or not electronic services have been supplied. The return shall be submitted within 20 days following the end of the reporting period to which the return refers. The value added tax return shall set out the identification number and, for each Member State of consumption where tax has become due, the total value, less value added tax, of supplies of electronic services for the reporting period and total amount of the corresponding tax. The applicable tax rates and the total tax due shall also be indicated. 6. The value added tax return shall be made in euro. Member States which have not adopted the euro may require the tax return to be made in their national currencies. If the supplies have been made in other currencies, the exchange rate valid for the last date of the reporting period shall be used when completing the value added tax return. The exchange shall be done following the exchange rates published by the European Central Bank for that day, or, if there is no publication on that day, on the next day of publication. 7. The non-established taxable person shall pay the value added tax when submitting the return. Payment shall be made to a bank account denominated in euro, designated by the Member State of identification. Member States which have not adopted the euro may require the payment to be made to a bank account denominated in their own currency. 8. Notwithstanding Article 1(1) of Directive 86/560/EEC, the non-established taxable person making use of this special scheme shall, instead of making deductions under Article 17(2) of this Directive, be granted a refund according to Directive 86/560/EEC. Articles 2(2), 2(3) and 4(2) of Directive 86/560/EEC shall not apply to the refund related to electronic supplies covered by this special scheme. 9. The non-established taxable person shall keep records of the transactions covered by this special scheme in sufficient detail to enable the tax administration of the Member State of consumption to determine that the value added tax return referred to in paragraph 5 is correct. These records should be made available electronically on request to the Member State of identification and to the Member State of consumption. These records shall be maintained for a period of 10 years from the end of the year when the transaction was carried out. 10. Article 21(2)(b) shall not apply to a non-established taxable person who has opted for this special scheme." Article 2 Article 22, contained in Article 28h of Directive 77/388/EEC, is hereby amended as follows: 1. in paragraph 1, point (a) shall be replaced by the following: "(a) Every taxable person shall state when his activity as a taxable person commences, changes or ceases. Member States shall, subject to conditions which they lay down, allow the taxable person to make such statements by electronic means, and may also require that electronic means are used." 2. in paragraph 4, point (a) shall be replaced by the following: "(a) Every taxable person shall submit a return by a deadline to be determined by Member States. That deadline may not be more than two months later than the end of each tax period. The tax period shall be fixed by each Member State at one month, two months or a quarter. Member States may, however, set different periods provided that they do not exceed one year. Member States shall, subject to conditions which they lay down, allow the taxable person to make such returns by electronic means, and may also require that electronic means are used." 3. in paragraph 6, point (a) shall be replaced by the following: "(a) Member States may require a taxable person to submit a statement, including all the particulars specified in paragraph 4, concerning all transactions carried out in the preceding year. That statement shall provide all the information necessary for any adjustments. Member States shall, subject to conditions which they lay down, allow the taxable person to make such statements by electronic means, and may also require that electronic means are used." 4. in paragraph 6, the second paragraph in point (b) shall be replaced by: "The recapitulative statement shall be drawn up for each calendar quarter within a period and in accordance with procedures to be determined by the Member States, which shall take the measures necessary to ensure that the provisions concerning administrative cooperation in the field of indirect taxation are in any event complied with. Member States shall, subject to conditions which they lay down, allow the taxable person to make such statements by electronic means, and may also require that electronic means are used." Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 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. 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 domestic law which they adopt in the field covered by this Directive. Article 4 Article 1 shall apply for a period of three years starting from 1 July 2003. Article 5 The Council, on the basis of a report from the Commission, shall review the provisions of Article 1 of this Directive before 30 June 2006 and shall either, acting in accordance with Article 93 of the Treaty, adopt measures on an appropriate electronic mechanism on a non-discriminatory basis for charging, declaring, collecting and allocating tax revenue on electronically supplied services with taxation in the place of consumption or, if considered necessary for practical reasons, acting unanimously on the basis of a proposal from the Commission, extend the period mentioned in Article 4. Article 6 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 7 This Directive is addressed to the Member States.

32002L0040

2002

Commission Directive 2002/40/EC of 8 May 2002 implementing Council Directive 92/75/EEC with regard to energy labelling of household electric ovens (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 Article 9 thereof, Whereas: (1) Directive 92/75/EEC requires the Commission to adopt implementing Directives in respect of various household appliances including electric ovens. (2) Electricity use by electric ovens accounts for a significant part of total Community household energy demand. The scope for a reduction of energy use by these appliances is substantial. (3) Harmonised standards are technical specifications adopted by the European standardisation bodies, as listed in Annex I to 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(2), as amended by Directive 98/48/EC(3). (4) Information concerning noise emissions should be given where required by Member States pursuant to Council Directive 86/594/EEC of 1 December 1986 on airborne noise emitted by household appliances(4). (5) Council Directive 79/531/EEC of 14 May 1979 applying to electric ovens Directive 79/530/EEC on the indication by labelling of the energy consumption of household appliances(5), as last amended by the Act of Accession of Austria, Finland and Sweden, should be repealed as from the date on which this Directive becomes applicable. (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 1. This Directive shall apply to electric mains operated household electric ovens including ovens being part of larger appliances. 2. This Directive shall not apply to the following ovens: (a) ovens that can also use other energy sources; (b) ovens which do not fall within the scope of the harmonised standards referred to in Article 2; (c) portable ovens, being appliances other than fixed appliances, having a mass of less than 18 kg, provided they are not designed for built-in installations. 3. The energy consumption of the steam functions, other than the hot steam function, are not covered by this Directive. Article 2 1. The information required by this Directive shall be obtained by means of measurements made in accordance with harmonised standards adopted by the European Committee for Electrotechnical Standardisation (Cenelec) under mandate from the Commission in accordance with Directive 98/34/EC, the reference numbers of which have been published in the Official Journal of the European Communities and for which Member States have published the reference numbers of the national standards transposing those harmonised standards. The provisions of Annexes I, II and III to this Directive 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. 2. In this Directive expressions used have the same meaning as in Directive 92/75/EEC. Article 3 1. The technical documentation referred to in Article 2(3) of Directive 92/75/EEC shall include: (a) the name and address of the supplier; (b) a general description of the model, sufficient for it to be unequivocally and easily identified; (c) information, including drawings as relevant, on the main design features of the model and in particular items which appreciably affect its energy consumption; (d) reports of relevant measurement tests carried out under the test procedures of the harmonised standards referred to in Article 2(1); (e) operating instructions, if any. 2. The label referred to in Article 2(1) of Directive 92/75/EEC shall be as specified in Annex I to this Directive. The label shall be placed on the door of the appliance, in such a way as to be clearly visible and not obscured. For multi-cavity ovens, each cavity shall have its own label, except a cavity which does not fall within the scope of the harmonised standards referred to in Article 2. 3. The content and format of the fiche referred to in Article 2(1) of Directive 92/75/EEC shall be as specified in Annex II to this Directive. 4. Where the appliances are offered for sale, hire, or hire purchase by way of a printed or written communication or by other means whereby 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 other electronic media, that communication shall include all the information specified in Annex III. This requirement shall also apply in respect of offers for built-in ovens for integrated kitchens. 5. The energy efficiency class of each cavity of an oven shall be determined in accordance with Annex IV. 6. The appropriate terms to be used on the label and the fiche as referred to in Article 2(1) of Directive 92/75/EEC shall be selected from the table set out in Annex V to this Directive. Article 4 Member States shall permit, until 30 June 2003, the placing on the market, the marketing and/or the display of products and the distribution of communications referred to in Article 3(4) which do not conform to this Directive. Article 5 1. Member States shall adopt and publish, by 31 December 2002, the provisions necessary to comply with this Directive. 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. 2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive. Article 6 Directive 79/531/EEC is repealed with effect from 1 January 2003. Article 7 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 8 This Directive is addressed to the Member States.

32002L0042

2002

Commission Directive 2002/42/EC of 17 May 2002 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for pesticide residues (bentazone and pyridate) 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 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 2002/23/EC(2), 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(3), as last amended by Directive 2002/23/EC, 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(4), as last amended by Directive 2002/23/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(5), as last amended by Commission Directive 2002/37/EC(6), and in particular Article 4(1)(f) thereof, Whereas: (1) The existing active substances bentazone and pyridate were included in Annex I to Directive 91/414/EEC by Commission Directives 2000/68/EC(7) and 2001/21/EC(8), for use as a herbicide on cereals, vegetables and forage. (2) The inclusion in Annex I to Directive 91/414/EEC of the active substances concerned was based on the assessment of the information submitted concerning the proposed uses. Information relating to these uses 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 these active substances may be authorised. (4) With respect to the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned, the related technical and scientific evaluations were finalised in the form of Commission review reports. The reports were finalised on 13 July 2000, in the case of bentazone and on 12 December 2000 in the case of pyridate. They fixed the acceptable daily intake (ADI) for bentazone at 0,1 mg/kg bw/day and for pyridate at 0,036 mg/kg bw/day. The lifetime exposure of consumers of food products treated with the active substances concerned has been assessed and evaluated in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation(9) and the opinion of the Scientific Committee for Plants(10) on the methodology employed. It is concluded that the MRLs proposed will not lead to those ADIs being exceeded. (5) No acute toxic effects requiring the setting of an acute reference dose were noted during the evaluations and discussions preceding the inclusion of pyridate in Annex I to Directive 91/414/EEC. The acute reference dose for bentazone was established at 0,25 mg/kg bw/day. According to the exposure assessment the MRLs proposed will not lead to an unacceptable acute exposure of consumers. (6) In order to ensure that the consumer is adequately protected from exposure to residues in or on products, for which no authorisation has 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, 86/363/EEC and 90/642/EEC. (7) The setting at Community level of such provisional MRLs does not prevent the Member States from establishing provisional MRLs for bentazone and pyridate 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 most further uses of the active substances concerned. The provisional MRL should then become definitive. (8) The Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly. (9) The Commission notified this Directive in draft form to the World Trade Organisation and no comments have been received. 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. (10) 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 levels are added to Part A of Annex II to Directive 86/362/EEC: "" Article 2 The following maximum pesticide residue levels are added to Part B of Annex II to Directive 86/363/EEC: "" Article 3 The maximum pesticide residue levels for bentazone and pyridate as shown in the Annex to this Directive are added to Annex II to Directive 90/642/EEC. 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. 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 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.

32002L0041

2002

Commission Directive 2002/41/EC of 17 May 2002 adapting to technical progress Directive 95/1/EC of the European Parliament and of the Council on the maximum design speed, maximum torque and maximum net engine power of two- or three-wheel motor vehicles Having regard to the Treaty establishing the European Community, Having regard to Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two- or three-wheel motor vehicles(1), as last amended by European Parliament and Council Directive 2000/7/EC(2) and in particular Article 16 thereof, Having regard to Directive 95/1/EC of the European Parliament and of the Council of 2 February 1995 on the maximum design speed, maximum torque and maximum net engine power of two- or three-wheel motor vehicles(3), and in particular Article 4 thereof, Whereas: (1) Directive 95/1/EC is one of the separate directives under the Community type-approval procedure introduced by Directive 92/61/EEC. The provisions of Directive 92/61/EEC relating to systems, components and separate technical units for vehicles therefore apply to Directive 95/1/EC. (2) In order to enable the full type-approval system to function properly, it is necessary to clarify or supplement certain requirements of Directive 95/1/EC. (3) To that end, it is necessary to specify the values to be entered in the test report to ensure the consistent application of Directive 95/1/EC in the case of mopeds, motorcycles and tricycles with spark-ignition engines and two- or three-wheel motor vehicles with compression-ignition engines. (4) Directive 95/1/EC should therefore 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 set up under Article 13 of Council Directive 70/156/EEC(4), as last amended by Commission Directive 2001/116/EC(5), Article 1 The Annexes to Directive 95/1/EC are amended in accordance with the Annex to this Directive. Article 2 1. With effect from 1 July 2003, Member States may not, on grounds relating to the maximum design speed, maximum torque and maximum net engine power: - refuse to grant EC type-approval for a type of two- or three-wheel motor vehicle, or - prohibit the registration, sale or entry into service of two- or three-wheel motor vehicles; if the maximum design speed, maximum torque and maximum net engine power of the vehicles comply with the requirements of Directive 95/1/EC, as amended by this Directive. 2. With effect from 1 January 2004, Member States shall refuse to grant EC type-approval for any new type of two- or three-wheel motor vehicle on grounds relating to the maximum design speed, maximum torque and maximum net engine power if the requirements of Directive 95/1/EC, as amended by this Directive, are not fulfilled. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 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. 2. Member States shall communicate to the Commission the main provisions of national law that they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

32002L0046

2002

Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (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 Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) There is an increasing number of products marketed in the Community as foods containing concentrated sources of nutrients and presented for supplementing the intake of those nutrients from the normal diet. (2) Those products are regulated in Member States by differing national rules that may impede their free movement, create unequal conditions of competition, and thus have a direct impact on the functioning of the internal market. It is therefore necessary to adopt Community rules on those products marketed as foodstuffs. (3) An adequate and varied diet could, under normal circumstances, provide all necessary nutrients for normal development and maintenance of a healthy life in quantities which meet those established and recommended by generally acceptable scientific data. However, surveys show that this ideal situation is not being achieved for all nutrients and by all groups of the population across the Community. (4) Consumers, because of their particular lifestyles or for other reasons, may choose to supplement their intake of some nutrients through food supplements. (5) In order to ensure a high level of protection for consumers and facilitate their choice, the products that will be put on to the market must be safe and bear adequate and appropriate labelling. (6) There is a wide range of nutrients and other ingredients that might be present in food supplements including, but not limited to, vitamins, minerals, amino acids, essential fatty acids, fibre and various plants and herbal extracts. (7) As a first stage, this Directive should lay down specific rules for vitamins and minerals used as ingredients of food supplements. Food supplements containing vitamins or minerals as well as other ingredients should also be in conformity with the specific rules on vitamins and minerals laid down in this Directive. (8) Specific rules concerning nutrients, other than vitamins and minerals, or other substances with a nutritional or physiological effect used as ingredients of food supplements should be laid down at a later stage, provided that adequate and appropriate scientific data about them become available. Until such specific Community rules are adopted and without prejudice to the provisions of the Treaty, national rules concerning nutrients or other substances with nutritional or physiological effect used as ingredients of food supplements, for which no Community specific rules have been adopted, may be applicable. (9) Only vitamins and minerals normally found in, and consumed as part of, the diet should be allowed to be present in food supplements although this does not mean that their presence therein is necessary. Controversy as to the identity of those nutrients that could potentially arise should be avoided. Therefore, it is appropriate to establish a positive list of those vitamins and minerals. (10) There is a wide range of vitamin preparations and mineral substances used in the manufacture of food supplements currently marketed in some Member States that have not been evaluated by the Scientific Committee on Food and consequently are not included in the positive lists. These should be submitted to the European Food Safety Authority for urgent evaluation, as soon as appropriate files are presented by the interested parties. (11) The chemical substances used as sources of vitamins and minerals in the manufacture of food supplements should be safe and also be available to be used by the body. For this reason, a positive list of those substances should also be established. Such substances as have been approved by the Scientific Committee on Food, on the basis of the said criteria, for use in the manufacture of foods intended for infants and young children and other foods for particular nutritional uses can also be used in the manufacture of food supplements. (12) In order to keep up with scientific and technological developments it is important to revise the lists promptly, when necessary. Such revisions would be implementing measures of a technical nature and their adoption should be entrusted to the Commission in order to simplify and expedite the procedure. (13) Excessive intake of vitamins and minerals may result in adverse effects and therefore necessitate the setting of maximum safe levels for them in food supplements, as appropriate. Those levels must ensure that the normal use of the products under the instructions of use provided by the manufacturer will be safe for the consumer. (14) When maximum levels are set, therefore, account should be taken of the upper safe levels of the vitamins and minerals, as established by scientific risk assessment based on generally acceptable scientific data, and of intakes of those nutrients from the normal diet. Due account should also be taken of reference intake amounts when setting maximum levels. (15) Food supplements are purchased by consumers for supplementing intakes from the diet. In order to ensure that this aim is achieved, if vitamins and minerals are declared on the label of food supplements, they should be present in the product in a significant amount. (16) The adoption of the specific values for maximum and minimum levels for vitamins and minerals present in food supplements, based on the criteria set out in this Directive and appropriate scientific advice, would be an implementing measure and should be entrusted to the Commission. (17) General labelling provisions and definitions are contained in 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), and do not need to be repeated. This Directive should therefore be confined to the necessary additional provisions. (18) Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs(5) does not apply to food supplements. Information relating to nutrient content in food supplements is essential for allowing the consumer who purchases them to make an informed choice and use them properly and safely. That information should, in view of the nature of those products, be confined to the nutrients actually present and be compulsory. (19) Given the particular nature of food supplements, additional means to those usually available to monitoring bodies should be available in order to facilitate efficient monitoring of those products. (20) 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(6), Article 1 1. This Directive concerns food supplements marketed as foodstuffs and presented as such. These products shall be delivered to the ultimate consumer only in a pre-packaged form. 2. This Directive shall not apply to medicinal products as defined 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(7). Article 2 For the purposes of this Directive: (a) "food supplements" means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities; (b) "nutrients" means the following substances: (i) vitamins, (ii) minerals. Article 3 Member States shall ensure that food supplements may be marketed within the Community only if they comply with the rules laid down in this Directive. Article 4 1. Only vitamins and minerals listed in Annex I, in the forms listed in Annex II, may be used for the manufacture of food supplements, subject to paragraph 6. 2. The purity criteria for substances listed in Annex II shall be adopted in accordance with the procedure referred to in Article 13(2), except where they apply pursuant to paragraph 3. 3. Purity criteria for substances listed in Annex II, specified by Community legislation for their use in the manufacture of foodstuffs for purposes other than those covered by this Directive, shall apply. 4. For those substances listed in Annex II for which purity criteria are not specified by Community legislation, and until such specifications are adopted, generally acceptable purity criteria recommended by international bodies shall be applicable and national rules setting stricter purity criteria may be maintained. 5. Modifications to the lists referred to in paragraph 1 shall be adopted in accordance with the procedure referred to in Article 13(2). 6. By way of derogation from paragraph 1 and until 31 December 2009, Member States may allow in their territory the use of vitamins and minerals not listed in Annex I, or in forms not listed in Annex II, provided that: (a) the substance in question is used in one or more food supplements marketed in the Community on the date of entry into force of this Directive, (b) the European Food Safety Authority has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than 12 July 2005. 7. Notwithstanding paragraph 6, Member States may, in compliance with the rules of the Treaty, continue to apply existing national restrictions or bans on trade in food supplements containing vitamins and minerals not included in the list in Annex I or in the forms not listed in Annex II. 8. Not later than 12 July 2007, the Commission shall submit to the European Parliament and the Council a report on the advisability of establishing specific rules, including, where appropriate, positive lists, on categories of nutrients or of substances with a nutritional or physiological effect other than those referred to in paragraph 1, accompanied by any proposals for amendment to this Directive which the Commission deems necessary. Article 5 1. Maximum amounts of vitamins and minerals present in food supplements per daily portion of consumption as recommended by the manufacturer shall be set, taking the following into account: (a) upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different consumer groups; (b) intake of vitamins and minerals from other dietary sources. 2. When the maximum levels referred to in paragraph 1 are set, due account should also be taken of reference intakes of vitamins and minerals for the population. 3. To ensure that significant amounts of vitamins and minerals are present in food supplements, minimum amounts per daily portion of consumption as recommended by the manufacturer shall be set, as appropriate. 4. The maximum and minimum amounts of vitamins and minerals referred to in paragraphs 1, 2 and 3 shall be adopted in accordance with the procedure referred to in Article 13(2). Article 6 1. For the purposes of Article 5(1) of Directive 2000/13/EC, the name under which products covered by this Directive are sold shall be "food supplement". 2. The labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties. 3. Without prejudice to Directive 2000/13/EC, the labelling shall bear the following particulars: (a) the names of the categories of nutrients or substances that characterise the product or an indication of the nature of those nutrients or substances; (b) the portion of the product recommended for daily consumption; (c) a warning not to exceed the stated recommended daily dose; (d) a statement to the effect that food supplements should not be used as a substitute for a varied diet; (e) a statement to the effect that the products should be stored out of the reach of young children. Article 7 The labelling, presentation and advertising of food supplements shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general. Rules for implementing this Article may be specified in accordance with the procedure referred to in Article 13(2). Article 8 1. The amount of the nutrients or substances with a nutritional or physiological effect present in the product shall be declared on the labelling in numerical form. The units to be used for vitamins and minerals shall be those specified in Annex I. Rules for implementing this paragraph may be specified in accordance with the procedure referred to in Article 13(2). 2. The amounts of the nutrients or other substances declared shall be those per portion of the product as recommended for daily consumption on the labelling. 3. Information on vitamins and minerals shall also be expressed as a percentage of the reference values mentioned, as the case may be, in the Annex to Directive 90/496/EEC. Article 9 1. The declared values mentioned in Article 8(1) and (2) shall be average values based on the manufacturer's analysis of the product. Further rules for implementing this paragraph with regard in particular to the differences between the declared values and those established in the course of official checks shall be decided upon in accordance with the procedure referred to in Article 13(2). 2. The percentage of the reference values for vitamins and minerals mentioned in Article 8(3) may also be given in graphical form. Rules for implementing this paragraph may be adopted in accordance with the procedure referred to in Article 13(2). Article 10 To facilitate efficient monitoring of food supplements, Member States may require the manufacturer or the person placing the product on the market in their territory to notify the competent authority of that placing on the market by forwarding it a model of the label used for the product. Article 11 1. Without prejudice to Article 4(7), Member States shall not, for reasons related to their composition, manufacturing specifications, presentation or labelling, prohibit or restrict trade in products referred to in Article 1 which comply with this Directive and, where appropriate, with Community acts adopted in implementation of this Directive. 2. Without prejudice to the Treaty, in particular Articles 28 and 30 thereof, paragraph 1 shall not affect national provisions which are applicable in the absence of Community acts adopted under this Directive. Article 12 1. Where a Member State, as a result of new information or of a reassessment of existing information made since this Directive or one of the implementing Community acts was adopted, has detailed grounds for establishing that a product referred to in Article 1 endangers human health though it complies with the said Directive or said acts, that Member State may temporarily suspend or restrict application of the provisions in question within its territory. It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision. 2. The Commission shall examine as soon as possible the grounds adduced by the Member State concerned and shall consult the Member States within the Standing Committee on the Food Chain and Animal Health, and shall then deliver its opinion without delay and take appropriate measures. 3. If the Commission considers that amendments to this Directive or to the implementing Community acts are necessary in order to remedy the difficulties mentioned in paragraph 1 and to ensure the protection of human health, it shall initiate the procedure referred to in Article 13(2) with a view to adopting those amendments. The Member State that has adopted safeguard measures may in that event retain them until the amendments have been adopted. Article 13 1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Regulation (EC) No 178/2002(8) (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. Article 14 Provisions that may have an effect upon public health shall be adopted after consultation with the European Food Safety Authority. Article 15 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 July 2003. They shall forthwith inform the Commission thereof. Those laws, regulations and administrative provisions shall be applied in such a way as to: (a) permit trade in products complying with this Directive, from 1 August 2003 at the latest; (b) prohibit trade in products which do not comply with the Directive, from 1 August 2005 at the latest. 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 adopted by the Member States. Article 16 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 17 This Directive is addressed to the Member States.

32002L0039

2002

Directive 2002/39/EC of the European Parliament and of the Council of 10 June 2002 amending Directive 97/67/EC with regard to the further opening to competition of Community postal services 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), 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) In its Resolution of 7 February 1994 on the development of Community postal services(5), the Council identified as one of the main objectives of Community postal policy the reconciliation of the furtherance of the gradual, controlled liberalisation of the postal market and that of a durable guarantee of the provision of universal service. (2) Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service(6) established a regulatory framework for the postal sector at Community level, including measures to guarantee a universal service and the setting of maximum limits for the postal services which Member States may reserve to their universal service provider(s) with a view to the maintenance of the universal service, and a timetable for decision-making on the further opening of the market to competition, for the purposes of creating a single market in postal services. (3) Article 16 of the Treaty highlights the place occupied by services of general economic interest in the shared values of the Union as well as their role in promoting social and territorial cohesion. It goes on to state that care should be taken that such services operate on the basis of principles and conditions which enable them to fulfil their missions. (4) The European Parliament's Resolutions of 14 January 1999(7) and 18 February 2000(8) on European postal services highlight the social and economic importance of postal services and the need to maintain a high quality of universal service. (5) The measures in this area should be designed in such a way that the social tasks of the Community pursuant to Article 2 of the Treaty, namely, a high level of employment and of social protection, are also achieved as objectives. (6) The rural postal network inter alia in mountain and island regions plays an essential role in integrating businesses into the national/global economy and in maintaining cohesion in social and employment terms in rural mountain and island regions. Furthermore, rural post offices in mountain and island regions can provide an essential infrastructure network affording universal access to new telecommunications technologies. (7) The European Council, meeting in Lisbon, on 23 and 24 March 2000, set out in its Presidency conclusions two decisions applying to postal services, whereby action was requested of the Commission, the Council and the Member States in accordance with their respective powers. The requested actions are: first, to set out by the end of 2000 a strategy for the removal of barriers to postal services, and secondly, to speed up liberalisation in areas such as postal services, the stated aim being to achieve a fully operational market in such services. (8) The Lisbon European Council also considered it essential that, in the framework of the internal market and of a knowledge-based economy, full account is taken of the Treaty provisions relating to services of general economic interest and to the undertakings entrusted with operating such services. (9) The Commission has undertaken a thorough review of the Community postal sector, including the commissioning of studies on the economic, social and technological developments in the sector, and has consulted extensively with interested parties. (10) The Community postal sector requires a modern regulatory framework which aims in particular at enhancing the internal market for postal services. Increased competitiveness should enable the postal sector to be integrated with alternative methods of communication and allow the quality of the service provided to ever-more demanding users to be improved. (11) The basic aim of safeguarding the durable provision of a universal service matching the standard of quality defined by the Member States in accordance with Article 3 of Directive 97/67/EC on a consistent basis throughout the Community can be secured if, in this area, the possibility of reserving services is maintained and, at the same time, conditions of high efficiency ensured by a sufficient degree of freedom to provide services. (12) The increase in demand within the postal sector as a whole, predicted for the medium term, could help to offset the loss of market share that the universal service providers may incur as a result of further market-opening and would thereby further safeguard the universal service. (13) Amongst the factors which bring about change affecting employment in the postal sector, technological development and market pressure for efficiency gains are the most important; of the remaining factors for change, market-opening will play a less prominent part. Market-opening will help to expand the overall size of the postal markets, and any reductions in staff levels among the universal service providers due to such measures (or their anticipation) are likely to be offset by the resulting growth in employment among private operators and new market entrants. (14) It is appropriate to provide at Community level a timetable for a gradual and controlled opening of the letters market to competition which allows all universal service providers sufficient time to put in place the further measures of modernisation and restructuring required to ensure their long-term viability under the new market conditions. An appropriate period of time is also needed to enable Member States to adapt their regulatory systems to a more open environment. It is therefore appropriate to provide for a step-by-step approach to further market-opening, consisting of intermediate steps representing significant but controlled opening of the market, followed by a review and proposal confirming, if appropriate, the date of 2009 for the full accomplishment of the internal market for postal services or determining a relevant alternative step towards it in the light of the review results. (15) It is appropriate to ensure that the next phases of market-opening are both substantial in nature and achievable in practice for the Member States whilst also ensuring the continuing of universal service. (16) General reductions to 100 grams in 2003 and 50 grams in 2006 in the weight limit of the services which may be reserved to the universal service providers, combined with opening outgoing cross-border mail fully to competition with possible exceptions to the extent necessary to ensure the provision of universal service, represent relatively simple and controlled further phases which are nevertheless significant. (17) In the Community, items of ordinary correspondence weighing between 50 grams and 350 grams represent on average approximately 16 % of the total postal revenues of the universal service providers, out of which 9 % correspond to items of ordinary correspondence weighing between 100 grams and 350 grams, whilst items of outward cross-border correspondence below the 50-gram weight limit represent a further 3 % or so, on average, of the total postal revenues of the universal service providers. (18) Price limits for the services capable of being reserved, of respectively three in 2003 and two-and-a-half times in 2006 the public tariff for an item of correspondence in the first weight step of the fastest standard category, are appropriate in combination with 100-gram and 50-gram weight limits where applicable. (19) Direct mail already represents in most Member States a dynamic and growing market with substantial growth prospects while in the remaining Member States there is considerable potential for growth. Direct mail is already largely open to competition in six Member States. The improvements in service flexibility and pricing resultant from competition would improve the position of direct mail versus alternative communications media, which, in turn, would be likely to lead to new postal items as an additional spin-off and strengthen the position of the postal industry as a whole. Nevertheless, to the extent necessary to ensure the provision of universal service, it should be provided that direct mail may continue to be reserved within the above weight and price limits. (20) Outgoing cross-border mail represents on average 3 % of total postal revenues. Opening this part of the market in all Member States, with exceptions that would be necessary to ensure the provision of universal service, would allow different postal operators to collect, sort and transport all outgoing cross-border mail. (21) Opening incoming cross-border mail to competition would allow circumvention of the 100-gram in 2003 and 50-gram in 2006 limits through relocation of the posting of a proportion of bulk domestic mail, thereby making its effects unpredictable. Identifying the origins of items of correspondence could present additional enforcement difficulties. 100-gram and 50-gram weight limits for items of ordinary incoming cross-border correspondence and direct mail, as for ordinary domestic correspondence, are practical as they do not present a risk of circumvention either in this way or through an artificial increase in the weight of individual items of correspondence. (22) Setting a timetable now, aimed at further steps towards the full accomplishment of the internal market for postal services, is important for both the long-term viability of the universal service and the continued development of modern and efficient posts. (23) It is appropriate to continue to provide for the possibility for Member States to reserve certain postal services to their universal service provider(s). These arrangements will enable the universal service providers to complete the process of adapting their operations and human resources to conditions of greater competition without upsetting their financial equilibrium and thus without jeopardising the safeguarding of universal service. (24) It is appropriate both to define the new weight and price limits and the services to which they may apply and to provide for a further review and decision confirming, if appropriate, the date of 2009 for the full accomplishment of the internal market for postal services, or determining a relevant alternative step towards it in the light of the review results. (25) Measures adopted by a Member State, including the establishment of a compensation fund or any change in its operation or any implementation of, or payment from, it, may involve aid granted by a Member State or through State resources in any form whatsoever within the meaning of Article 87(1) of the Treaty necessitating prior notification to the Commission pursuant to Article 88(3) thereof. (26) The concept of licensing competitors in the universal service area can be combined with requirements obliging such licensees to contribute to the provision of universal service. (27) Directive 97/67/EC established that Member States are to designate one or more national regulatory authorities for the postal sector that are legally separate from, and operationally independent of, the postal operators. In view of the dynamics of the European Postal markets, the important role national regulatory authorities play should be acknowledged and furthered, in particular concerning the task of ensuring that the reserved services are respected, except in Member States where there are no reserved services. Article 9 of Directive 97/67/EC allows Member States to go beyond the objectives of that Directive. (28) It might be appropriate for national regulatory authorities to link the introduction of licences to requirements that consumers of the licensees' services are to have transparent, simple and inexpensive procedures available to them for dealing with their complaints, regardless of whether they relate to the services of the universal service provider(s) or to those of operators holding authorisations, including individual licence-holders. It might be further appropriate for these procedures to be available to users of all postal services, whether or not they are universal services. Such procedures should include procedures for determining responsibility in case of loss of, or damage to, mail items. (29) The universal service providers normally provide services, for example to business customers, consolidators of mail for different customers and bulk mailers, enabling them to enter the mail stream at different points and under different conditions by comparison with the standard letters service. In doing this, the universal service providers should comply with the principles of transparency and non-discrimination, both as between different third parties and as between third parties and universal service providers supplying equivalent services. It is also necessary for such services to be available to private customers who post in similar conditions, given the need for non-discrimination in the provision of services. (30) In order to keep the European Parliament and the Council informed on the development of the internal market for postal services, the Commission should regularly submit reports to those institutions on the application of this Directive. (31) It is appropriate to postpone until 31 December 2008 the date for the expiry of Directive 97/67/EC. Authorisation procedures established in Member States in compliance with the Directive 97/67/EC should not be affected by this date. (32) Directive 97/67/EC should therefore be amended accordingly. (33) This Directive is without prejudice to the application of the Treaty rules on competition and on the freedom to provide services, as explained in particular in the Notice from the Commission on the application of the competition rules to the postal sector and on the assessment of certain State measures relating to postal services(9), Article 1 Directive 97/67/EC is hereby amended as follows: 1. Article 7 shall be replaced by the following: "Article 7 1. To the extent necessary to ensure the maintenance of universal service, Member States may continue to reserve services to universal service provider(s). Those services shall be limited to the clearance, sorting, transport and delivery of items of domestic correspondence and incoming cross-border correspondence, whether by accelerated delivery or not, within both of the following weight and price limits. The weight limit shall be 100 grams from 1 January 2003 and 50 grams from 1 January 2006. These weight limits shall not apply as from 1 January 2003 if the price is equal to, or more than, three times the public tariff for an item of correspondence in the first weight step of the fastest category, and, as from 1 January 2006, if the price is equal to, or more than, two and a half times this tariff. In the case of the free postal service for blind and partially sighted persons, exceptions to the weight and price restrictions may be permitted. To the extent necessary to ensure the provision of universal service, direct mail may continue to be reserved within the same weight and price limits. To the extent necessary to ensure the provision of universal service, for example when certain sectors of postal activity have already been liberalised or because of the specific characteristics particular to the postal services in a Member State, outgoing cross-border mail may continue to be reserved within the same weight and price limits. 2. Document exchange may not be reserved. 3. The Commission shall finalise a prospective study which will assess, for each Member State, the impact on universal service of the full accomplishment of the postal internal market in 2009. Based on the study's conclusions, the Commission shall submit by 31 December 2006 a report to the European Parliament and the Council accompanied by a proposal confirming, if appropriate, the date of 2009 for the full accomplishment of the postal internal market or determining any other step in the light of the study's conclusions."; 2. the following indents shall be added to Article 12: "- whenever universal service providers apply special tariffs, for example for services for businesses, bulk mailers or consolidators of mail from different customers, they shall apply the principles of transparency and non-discrimination with regard both to the tariffs and to the associated conditions. The tariffs shall take account of the avoided costs, as compared to the standard service covering the complete range of features offered for the clearance, transport, sorting and delivery of individual postal items and, together with the associated conditions, shall apply equally both as between different third parties and as between third parties and universal service providers supplying equivalent services. Any such tariffs shall also be available to private customers who post under similar conditions, - cross-subsidisation of universal services outside the reserved sector out of revenues from services in the reserved sector shall be prohibited except to the extent to which it is shown to be strictly necessary to fulfil specific universal service obligations imposed in the competitive area; except in Member States where there are no reserved services, rules shall be adopted to this effect by the national regulatory authorities who shall inform the Commission of such measures."; 3. the first and second subparagraphs of Article 19 shall be replaced by the following: "Member States shall ensure that transparent, simple and inexpensive procedures are drawn up for dealing with users' complaints, particularly in cases involving loss, theft, damage or non-compliance with service quality standards (including procedures for determining where responsibility lies in cases where more than one operator is involved). Member States may provide that this principle is also applied to beneficiaries of services which are: - outside the scope of the universal service as defined in Article 3, and - within the scope of the universal service as defined in Article 3, but which are not provided by the universal service provider. Member States shall adopt measures to ensure that the procedures referred to in the first subparagraph enable disputes to be settled fairly and promptly with provision, where warranted, for a system of reimbursement and/or compensation."; 4. the third subparagraph of Article 22 shall be replaced by the following: "The national regulatory authorities shall have as a particular task ensuring compliance with the obligations arising from this Directive and shall, where appropriate, establish controls and specific procedures to ensure that the reserved services are respected. They may also be charged with ensuring compliance with competition rules in the postal sector." 5. Article 23 shall be replaced by the following: "Article 23 Without prejudice to Article 7, every two years, on the first occasion no later than 31 December 2004, the Commission shall submit a report to the European Parliament and the Council on the application of this Directive, including the appropriate information about developments in the sector, particularly concerning economic, social, employment and technological aspects, as well as about quality of service. The report shall be accompanied where appropriate by proposals to the European Parliament and the Council."; 6. Article 27 shall be replaced by the following: "Article 27 The provisions of this Directive, with the exception of Article 26, shall expire on 31 December 2008 unless otherwise decided in accordance with Article 7(3). The authorisation procedures described in Article 9 shall not be affected by this date." Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 31 December 2002. 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. 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 day of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

32002L0056

2002

Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof, Having regard to the proposal from the Commission, Having regard to the Opinion of the European Parliament(1), Having consulted the Economic and Social Committee, Whereas: (1) Council Directive 66/403/EEC of 14 June 1966 on the marketing of seed potatoes(2) has been frequently and substantially amended(3). For reasons of clarity and rationality the said Directive should be codified. (2) Potato production occupies an important place in the agriculture of the Community. (3) Satisfactory results in potato cultivation depend to a large extent on the use of appropriate seed potatoes. (4) Greater productivity will be achieved in Community potato cultivation if for the choice of the varieties permitted to be marketed the Member States apply uniform rules which are as strict as possible, in particular as regards health status. A common catalogue of varieties of agricultural plant species is therefore provided for in Council Directive 2002/53/EC(4). (5) It is desirable to establish a uniform certification scheme for the Community based on the experience gained in the application of schemes in the Member States and that of the Economic Commission for Europe. In the context of the consolidation of the Internal Market, the Community scheme should cover the production of seed with a view to marketing and to marketing within the Community, and should offer no possibilities for the Member States to derogate unilaterally in a way that would hinder the free movement of plants within the Community. (6) As a general rule, seed potatoes should be allowed to be marketed only if they have been officially examined and certified, in accordance with the rules for certification, as basic seed potatoes or certified seed potatoes. The choice of the technical terms "basic seed potatoes" and "certified seed potatoes" is based on already existing international terminology. It should be possible, under specified conditions, to place on the market bred seed potato of generations prior to basic seed potato and seed potato as grown. (7) Member States may subdivide the categories of seed potatoes into grades satisfying different requirements. It seems appropriate to provide that Community grades and their requirements may be established in an accelerated procedure. In this respect it should be left to Member States to decide the extent to which they apply these grades to their own production. (8) In the light of modern advances in propagation techniques, it is appropriate to lay down a Community procedure for the establishment of specific rules applicable to the marketing of seed potatoes produced by techniques involving micropropagation. (9) Community rules should not apply to seed potatoes shown to be intended for export to third countries. (10) In order to improve not only the genetic value and health status of Community seed potatoes but also their external characteristics, provision should be made for tolerances in respect of impurities, blemishes and diseases in seed potatoes. (11) Member States may be authorised, in respect of the marketing of seed potatoes in all or part of their territories, to take more stringent measures than provided for in Annex I against particular virus diseases which do not exist in those regions or which appear particularly harmful to crops in those regions. It has appeared that the scope of this provision should be extended to harmful organisms other than virus diseases. (12) In order to ensure the identity of the seed potatoes, Community rules on packaging, sealing and marking must be established. To this end the labels should give the particulars needed both for official verification and for the information of the user and should clearly show the Community nature of the certification. (13) Rules should be introduced on the marketing of chemically treated seed potatoes, seed potatoes suitable for organic growing and on the conservation of genetic resources of plants in the interest of conservation by use in situ of varieties threatened with genetic erosion. (14) Derogations should be permitted under certain conditions, without prejudice to the provisions of Article 14 of the Treaty. Member States making use of the derogations should assist each other administratively as regards inspection. (15) In order to ensure that both the requirements as to the quality of the seed potatoes and the provisions for ensuring their identity are complied with during marketing, Member States must make provision for appropriate control arrangements. (16) Seed potatoes satisfying these requirements should, without prejudice to Article 30 of the Treaty, be subject to no marketing restrictions other than those provided for in Community rules, except in those cases where Community rules provide for tolerances in respect of diseases, harmful organisms or their vectors. (17) Provision should be made for authorising the marketing within the Community of seed potatoes harvested in third countries only if they afford the same assurances as seed potatoes officially certified within the Community and complying with Community rules. (18) During periods in which there are difficulties in obtaining supplies of certified seed potatoes of the various categories, seed potatoes satisfying less stringent requirements should temporarily be permitted to be marketed, as well as seed potatoes belonging to varieties not included in the Common Catalogue of varieties nor in the National Catalogue of Varieties. (19) In order to ensure that seed potatoes certified in the Member States satisfy the requirements laid down and to enable comparisons to be made in the future between such seed potatoes and those coming from third countries, Community comparative tests should be established in Member States to permit annual post-control of the various categories of certified seed potatoes. The Member States should be authorised to prohibit the marketing of all or certain varieties of seed potatoes coming from other Member States if the comparative tests have given unsatisfactory results over a period of several years. (20) It is desirable to organise temporary experiments for the purpose of seeking improved alternatives to certain provisions set out in this Directive. (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(5). (22) This Directive should not affect the obligations of the Member States concerning the deadlines for transposition of the Directives set out in Annex IV, part B, Article 1 This Directive shall apply to the production with a view to marketing, and to the marketing, of seed potatoes within the Community. It shall not apply to seed potatoes shown to be intended for export to third countries. Article 2 For the purposes of this Directive: (a) "marketing": means the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer aimed at commercial exploitation of seed potatoes to third parties, whether or not for consideration. Trade in seed potatoes not aimed at commercial exploitation of the variety, such as the following operations, shall not be regarded as marketing: - the supply of seed potatoes to official testing and inspection bodies, - the supply of seed potatoes to providers of services for processing or packaging, provided the provider of services does not acquire title to seed potatoes thus supplied. The supply of seed potatoes under certain conditions to providers of services for the production of certain agricultural raw materials intended for industrial purposes, or seed propagation for that purpose, shall not be regarded as marketing, provided the provider of services does not acquire title to either the seed thus supplied or the product of the harvest. The supplier of seed potatoes shall provide the certification authority with a copy of the relevant parts of the contract made with the provider of services and this shall include the standards and conditions currently met by the seed potatoes provided. The conditions for the application of this provision shall be determined in accordance with the procedure laid down in article 25(2); (b) "basic seed potatoes": means potato tubers (i) which have been produced according to accepted practices for the maintenance of the variety and of health; (ii) which are intended mainly for the production of certified seed potatoes; (iii) which satisfy the minimum conditions laid down in Annexes I and II for basic seed potatoes; and (iv) which have been found by official examination to satisfy the minimum conditions laid down above; (c) "certified seed potatoes": means potato tubers (i) which have been produced directly from basic seed or certified seed, or from seed of a generation prior to basic seed which have been found on official examination to satisfy the conditions laid down for basic seed; (ii) which are intended mainly for the production of potatoes other than seed potatoes; (iii) which satisfy the minimum conditions laid down in Annexes I and II for certified seed potatoes; and (iv) which have been found by official examination to satisfy the abovementioned minimum conditions; (d) "official measures": means measures taken (i) by State authorities; or (ii) by any legal person whether governed by public or by private law, acting under the responsibility of the State; or (iii) in the case of ancillary activities which are also subject to State control, by any natural person duly sworn for that purpose, provided that the persons mentioned under (ii) and (iii) derive no private gain from such measures. Article 3 1. Member States shall provide that seed potatoes may not be placed on the market unless they have been officially certified as "basic seed potatoes" or "certified seed potatoes" and unless they satisfy the minimum conditions laid down in Annexes I and II. The Member States shall provide that seed potatoes which do not, during marketing, satisfy the minimum conditions laid down in Annex II may be sorted. The tubers which are not rejected shall then undergo a further official examination. 2. Member States may subdivide the categories of seed potatoes provided for in Article 2 into grades satisfying different requirements. 3. For seed potatoes which have been officially certified, the following may be determined in accordance with the procedure referred to in Article 25(2): - Community grades, - the conditions applicable to such grades, - designations applicable to such grades. Member States may prescribe the extent to which they apply these Community grades in certifying their own production. 4. For seed potatoes produced by micropropagation techniques and not meeting the size requirements of this Directive, the following may be determined in accordance with the procedure referred to in Article 25(2): - derogation from specific provisions of this Directive, - the conditions applicable to such seed potatoes, - the designations applicable to such seed potatoes. Article 4 Notwithstanding Article 3(1), Member States shall provide that bred seed potatoes of generations prior to basic seed potatoes may be placed on the market. Article 5 Member States may, as regards the minimum conditions laid down in Annexes I and II, impose additional or more stringent requirements for the certification of seed potatoes produced in their own territory. Article 6 1. Notwithstanding Article 3(1), Member States may authorise producers in their own territory to place on the market: (a) small quantities of seed potatoes for scientific purposes or selection work; (b) appropriate quantities of seed potatoes for other test or trial purposes, provided they belong to varieties for which an application for entry in the catalogue has been submitted in the Member State in question. In the case of genetically modified material, such authorisation may be granted only if all appropriate measures have been taken to avoid adverse effects on human health and the environment. For the environmental risk assessment to be carried out in this respect, the provisions of Article 7(4) of Directive 2002/53/EC shall apply accordingly. 2. The purposes for which the authorisations referred to in paragraph 1(b) may be given, the provisions relating to the marking of packages, and the quantities and the conditions under which Member States may grant such authorisation shall be determined in accordance with the procedure referred to in Article 25(2). 3. Authorisation granted, before 14 December 1998, by Member States to producers in their own territory for the purposes set out in paragraph 1 shall remain in force pending determination of the provisions referred to in paragraph 2. Thereafter, all such authorisations shall respect the provisions established in accordance with paragraph 2. Article 7 Member States shall require that, for the examination of seed potato tubers for certification, samples are taken officially in accordance with appropriate methods. Article 8 1. Member States may require that seed potatoes produced in their own territory may be separated during production from other potatoes for plant health reasons. 2. The requirements provided for in paragraph 1 may include measures to: - separate the production of seed and other potatoes, - separate the grading, storage, transportation and handling of seed and other potatoes. Article 9 Member States shall provide that seed potatoes may not be placed on the market if they have been treated with sprout inhibitors. Article 10 1. Member States shall provide that seed potatoes may not be placed on the market unless they have a minimum size such that they do not pass through a square mesh of 25 × 25 mm. In the case of tubers which are too large to pass through a square mesh of 35 × 35 mm, the upper and lower size limits shall be expressed in multiples of five. The maximum variation in size between tubers in a lot shall be such that the difference between the dimensions of the two square meshes used does not exceed 25 mm. These sizing standards may be modified in accordance with the procedure referred to in Article 25(2). 2. A lot shall not contain more than 3 % by weight of tubers smaller than the minimum size indicated or more than 3 % by weight of tubers larger than the maximum size indicated. 3. Member States may, in respect of seed potatoes produced in their national territory, further reduce the permitted variation in size between tubers in a lot. Article 11 1. Member States shall require that basic seed potatoes and certified seed potatoes be marketed only in sufficiently homogeneous lots and in closed packages or containers which must be sealed and bear, as prescribed in Articles 12 and 13, a sealing device and markings. The packages must be new; the containers must be clean. 2. Member States may, for the marketing of small quantities to the final consumer, provide for derogations from the provisions of paragraph 1 in respect of packaging, sealing and marking. Article 12 1. Member States shall require that packages and containers of basic seed potatoes and certified potatoes be sealed officially or under official supervision in such a manner that they cannot be opened without damaging the system of sealing or leaving evidence of tampering on either the official label provided for in Article 13(1) or the package. In order to ensure closure, the sealing system shall comprise at least either the official label or the affixing of an official seal. The measures provided for in the second subparagraph above shall not be necessary where a non-reusable sealing system is used. In accordance with the procedure referred to in Article 25(2) it may be established whether a particular sealing system complies with the provisions of this paragraph. 2. Packages and containers which have been officially sealed shall not be resealed, whether one or more times, except officially or under official supervision. If packages are resealed, the fact of resealing, the most recent date of resealing and the authority responsible therefor shall be stated on the label required under Article 13(1). 3. Member States may provide for exceptions to paragraph 1 in the case of small packages sealed in their own territory. Conditions relating to these exceptions may be determined in accordance with the procedure referred to in Article 25(2). Article 13 1. Member States shall require that packages and containers of basic seed potatoes and certified seed potatoes: (a) be labelled on the outside with an official label which has not previously been used, which fulfils the conditions laid down in Annex III and the particulars of which are provided in one of the official languages of the Community. The colour of the label shall be white for basic seed potatoes and blue for certified seed potatoes. When a label with a string-hole is used, its attachment shall be ensured in all cases with an official seal. The use of official adhesive labels shall be authorised. In accordance with with procedure referred to in Article 25(2), the indelible printing of the prescribed particulars on the package in accordance with the label model may be authorised under official supervision; (b) contain an official document, in the same colour as the label, providing at least the label particulars required under Annex III(A)(3), (4) and (6). This document shall be drawn up in such a manner that it cannot be confused with the official label referred to under (a). This document shall not be necessary if the particulars are printed indelibly on the package or if, in accordance with the provisions under (a), an adhesive label or a label of tear resistant material is used. 2. Member States may provide for exceptions to paragraph 1 in the case of small packages sealed in their own territory. Conditions relating to these exceptions may be determined in accordance with the procedure referred to in Article 25(2). Article 14 In accordance with the procedure referred to in Article 25(2), it may be provided that, in cases other than those provided for in this Directive, packages or containers of basic seed potatoes or certified seed potatoes shall bear a supplier's label (which may either be a label separate from the official label or take the form of the suppliers' information printed on the package or container itself). The particulars to be provided on any such label shall also be established in accordance with the procedure referred to in Article 25(2). Article 15 In the case of seed potatoes of a variety which has been genetically modified, any label or document, official or otherwise, which is affixed to or accompanies the seed lot, under the provisions of this Directive, shall clearly indicate that the variety has been genetically modified. Article 16 Member States shall require that any chemical treatment of basic seed potatoes or certified seed potatoes be noted either on the official label or on the supplier's label and on the package or inside it or on the container. Article 17 1. Member States shall ensure that seed potatoes which are placed on the market under the provisions of this Directive, whether mandatory or discretionary, are not subject to any marketing restrictions as regards their characteristics, examination requirements, marking and sealing other than those laid down in this or any other Directive. 2. The Commission, acting in accordance with the procedure referred to in Article 25(2), shall, in respect of the marketing of seed potatoes in all or part of the territory of one or more Member States, authorise more stringent measures than those provided for in Annexes I and II to be taken against harmful organisms which do not exist in those regions or which appear particularly harmful to crops in those regions. Where there is imminent danger of the introduction or spread of such harmful organisms, and until such time as the Commission has given a final ruling on the matter, such measures may be taken by the Member State concerned as soon as its request has been submitted. Article 18 The conditions under which bred seed potatoes of generations prior to basic seed potatoes may be placed on the market under Article 4, shall be as follows: (a) they must have been produced in accordance with accepted practices for the maintenance of the variety and of health; (b) they must be intended mainly for the production of basic seed potatoes; (c) they must satisfy the minimum conditions to be established by the procedure referred to in Article 25(2) for pre-basic seed potatoes; (d) they must have been found by official examination to satisfy the minimum conditions referred to in (c); (e) they must be placed in packages or containers in accordance with this Directive; and (f) the packages or containers must bear an official label giving at least the following particulars: - certification authority and Member State or their distinguishing abbreviation, - producer's identification number or lot reference number, - month and year of sealing, - species, indicated at least in roman characters, under its botanical name, which may be given in abridged form and without the authors' names, or under its common name, or both, - variety, indicated at least in roman characters, - the description "pre-basic seed potatoes". The label shall be white with a diagonal violet line. Article 19 For the purpose of seeking improved alternatives to certain provisions set out in this Directive, other than those relating to plant health, it may be decided to organise temporary experiments under specified conditions at Community level in accordance with the provisions referred to in Article 25(2). In the framework of such experiments, Member States may be released from certain obligations laid down in this Directive. The extent of that release shall be defined with reference to the provisions to which it applies. The duration of an experiment shall not exceed seven years. Article 20 1. In accordance with the procedure referred to in Article 25(2), the Commission may prohibit, in whole or in part, the marketing of seed potatoes harvested in a particular area of the Community if the progeny of officially drawn samples of basic seed potatoes or certified seed potatoes harvested in that particular area and grown in one or more Community test fields has for three successive years fallen appreciably below the minimum conditions laid down in Annex I(1)(c), (2)(c), (3) and (4). Satisfaction of the other minimum conditions laid down in Annex I may also be checked during the comparative tests. 2. Any measures taken under paragraph 1 shall be withdrawn by the Commission as soon as it has been established with adequate certainty that the basic seed potatoes and certified seed potatoes harvested in the particular area of the Community concerned will in future satisfy the minimum conditions referred to in paragraph 1. 3. The necessary arrangements shall be made, in accordance with the procedure referred to in Article 25(2), for the comparative tests to be carried out. Seed potatoes harvested in third countries may be included in the comparative tests. Article 21 1. The Council, acting by a qualified majority on a proposal from the Commission, shall determine whether seed potatoes harvested in a third country and affording the same assurances as regards their characteristics and the arrangements for their inspection, for ensuring identity, for marking and for control are equivalent in these respects to basic seed potatoes or certified seed potatoes harvested within the Community and complying with the provisions of this Directive. 2. Until such time as the Council has taken a decision under paragraph 1, the Member States shall be free to take such decisions themselves. This right shall expire on 1 July 1975. 3. Member States are hereby authorised to extend until 31 March 2002 the validity of decisions taken in accordance with paragraph 2, it being understood that these decisions may be used only in accordance with Member States' obligations under the common rules on plant health laid down by 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 in the Community(6). The period in the first subparagraph may be extended for third countries, in accordance with the procedure laid down in Article 25(2), if the available information does not permit a determination according to paragraph 1 and for as long as such information does not permit such a determination. 4. Paragraphs 1 and 2 shall also apply in respect of any new Member State from the date of its accession to the date on which it is to bring into force the laws, regulations or administrative provisions necessary to comply with this Directive. Article 22 1. In order to remove any temporary difficulties in the general supply of basic seed potatoes or certified seed potatoes that occur in the Community and cannot be otherwise overcome, it may be decided in accordance with the procedure referred to in Article 25(2) that Member States shall permit, for a specified period, the marketing throughout the Community in quantities necessary to resolve the supply difficulties of seed potatoes of a category subject to less stringent requirements, or of seed potatoes of varieties not included in the Common Catalogue of Varieties of Agricultural Plant Species or in the national catalogues of varieties of the Member States. 2. For a category of seed potatoes of any given variety, the official label shall be that provided for the corresponding category; for seed potatoes of varieties not included in the abovementioned catalogues the colour of the official label shall be brown. The label shall always state that the seed potatoes in question are of a category satisfying less stringent requirements. 3. Rules for the application of paragraph 1 may be adopted in accordance with the procedure referred to in Article 25(2). Article 23 1. Member States shall ensure that official inspections are carried out in relation to the marketing of seed potatoes, at least by random checks, to verify compliance with the requirements and conditions of this Directive. 2. Without prejudice to the free movement of seed potatoes within the Community, Member States shall take all necessary measures to ensure that they are supplied with the following particulars during the marketing of quantities exceeding two kilograms of seed potatoes imported from third countries: (a) species, (b) variety; (c) category; (d) country of production and control authority; (e) country of dispatch; (f) importer; (g) quantity of seed potatoes. The manner in which these particulars must be presented may be determined in accordance with the procedure laid down in Article 25(2). Article 24 Amendments to be made to the content of the Annexes in the light of the development of scientific or technical knowledge shall be adopted according to the procedure referred to in Article 25(2). Article 25 1. The Commission shall be assisted by the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry, set up by Article 1 of Council Decision 66/399/EEC(7). 2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply. The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month. 3. The Committee shall adopt its rules of procedure. Article 26 Save as otherwise provided in Annexes I and II in respect of tolerances for diseases, harmful organisms or their vectors, this Directive shall be without prejudice to the provisions of national laws justified on grounds of the protection of health and life of humans, animals or plants or the protection of industrial and commercial property. Article 27 1. Specific conditions may be established in accordance with the procedure referred to in Article 25(2) to take account of developments in the areas of: (a) conditions under which chemically treated seed may be marketed; (b) conditions under which seed may be marketed in relation to the conservation in situ and the sustainable use of plant genetic resources, which are associated with specific natural and semi-natural habitats and are threatened by genetic erosion; (c) conditions under which seed suitable for organic production may be marketed. 2. The specific conditions referred to in paragraph 1(b) shall include in particular the following points: (a) the seed of these species shall be of a known provenance approved by the appropriate authority in each Member State for marketing the seed in defined areas; (b) appropriate quantitative restrictions. Article 28 Member States shall communicate to the Commission the text of the main provisions of domestic law they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof. Article 29 Directive 66/403/EEC, as amended by the acts set out in Annex IV, part A, is repealed, without prejudice to the obligations of the Member States concerning the deadline for transposition of the said Acts set out in Annex IV, part B. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex V. Article 30 This Directive shall enter into force the twentieth day following that of its publication in the Official Journal of the European Communities. Article 31 This Directive is addressed to the Member States.

32002L0044

2002

Directive 2002/44/EC of the European Parliament and of the Council of 25 June 2002 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) - Joint Statement by the European Parliament and the Council 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 April 2002, Whereas: (1) Under the Treaty the Council may, by means of directives, adopt 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) 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 [4], 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. (3) As a first step, it is considered necessary to introduce measures protecting workers from the risks arising from vibrations owing to their effects on the health and safety of workers, in particular muscular/bone structure, neurological and vascular disorders. 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. (4) This Directive lays down minimum requirements, thus giving Member States the option of maintaining or adopting more favourable provisions for the protection of workers, in particular the fixing of lower values for the daily action value or the daily exposure limit value for vibrations. The implementation of this Directive should not serve to justify any regression in relation to the situation which already prevails in each Member State. (5) A system of protection against vibration 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. (6) The level of exposure to vibration 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. (7) Employers should make adjustments in the light of technical progress and scientific knowledge regarding risks related to exposure to vibration, with a view to improving the safety and health protection of workers. (8) In the case of sea and air transport, given the current state of the art it is not possible to comply in all circumstances with the exposure limit values for whole-body vibration; provision should therefore be made for duly justified exemptions in some cases. (9) Since this Directive is an individual Directive within the meaning of Article 16(1) 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 [5], that Directive therefore applies to the exposure of workers to vibration, without prejudice to more stringent and/or specific provisions contained in this Directive. (10) This Directive constitutes a practical step towards creating the social dimension of the internal market. (11) 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 [6], SECTION I GENERAL PROVISIONS Article 1 Aim and scope 1. This Directive, which is the 16th 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 mechanical vibration. 2. The requirements of this Directive shall apply to activities in which workers are or are likely to be exposed to risks from mechanical vibration during 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 more specific provisions contained in this Directive. Article 2 Definitions For the purposes of this Directive, the following terms shall mean: (a) "hand-arm vibration": the mechanical vibration that, when transmitted to the human hand-arm system, entails risks to the health and safety of workers, in particular vascular, bone or joint, neurological or muscular disorders; (b) "whole-body vibration": the mechanical vibration that, when transmitted to the whole body, entails risks to the health and safety of workers, in particular lower-back morbidity and trauma of the spine. Article 3 Exposure limit values and action values 1. For hand-arm vibration: (a) the daily exposure limit value standardised to an eight-hour reference period shall be 5 m/s2; (b) the daily exposure action value standardised to an eight-hour reference period shall be 2,5 m/s2. Workers' exposure to hand-arm vibration shall be assessed or measured on the basis of the provisions of Point 1 of Part A of the Annex. 2. For whole-body vibration: (a) the daily exposure limit value standardised to an eight-hour reference period shall be 1,15 m/s2 or, at the choice of the Member State concerned, a vibration dose value of 21 m/s1,75; (b) the daily exposure action value standardised to an eight-hour reference period shall be 0,5 m/s2 or, at the choice of the Member State concerned, a vibration dose value of 9,1 m/s1,75. Workers' exposure to whole-body vibration shall be assessed or measured on the basis of the provisions of Point 1 of Part B of the Annex. SECTION II OBLIGATION OF EMPLOYERS Article 4 Determination and assessment of risks 1. In carrying out the obligations laid down in Article 6(3) and Article 9(1) of Directive 89/391/EEC, the employer shall assess and, if necessary, measure the levels of mechanical vibration to which workers are exposed. Measurement shall be carried out in accordance with Point 2 of Part A or Point 2 of Part B of the Annex to this Directive, as appropriate. 2. The level of exposure to mechanical vibration may be assessed by means of observation of specific working practices and reference to relevant information on the probable magnitude of the vibration corresponding to the equipment or the types of equipment used in the particular conditions of use, including such information provided by the manufacturer of the equipment. That operation shall be distinguished from measurement, which requires the use of specific apparatus and appropriate methodology. 3. 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 mechanical vibration shall be preserved in a suitable form so as to permit consultation at a later stage. 4. 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 intermittent vibration or repeated shocks; (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 at particularly sensitive risk; (d) any indirect effects on worker safety resulting from interactions between mechanical vibration and the workplace or other work equipment; (e) information provided by the manufacturers of work equipment in accordance with the relevant Community Directives; (f) the existence of replacement equipment designed to reduce the levels of exposure to mechanical vibration; (g) the extension of exposure to whole-body vibration beyond normal working hours under the employer's responsibility; (h) specific working conditions such as low temperatures; (i) appropriate information obtained from health surveillance, including published information, as far as possible. 5. 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 and 6 of this Directive. The risk assessment shall be recorded on a suitable medium, according to national law and practice; it may include a justification by the employer that the nature and extent of the risks related to mechanical vibration make a further detailed risk assessment unnecessary. 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 mechanical vibration 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. 2. On the basis of the risk assessment referred to in Article 4, once the exposure action values laid down in Article 3(1)(b) and (2)(b) are exceeded, the employer shall establish and implement a programme of technical and/or organisational measures intended to reduce to a minimum exposure to mechanical vibration and the attendant risks, taking into account in particular: (a) other working methods that require less exposure to mechanical vibration; (b) the choice of appropriate work equipment of appropriate ergonomic design and, taking account of the work to be done, producing the least possible vibration; (c) the provision of auxiliary equipment that reduces the risk of injuries caused by vibration, such as seats that effectively reduce whole-body vibration and handles which reduce the vibration transmitted to the hand-arm system; (d) appropriate maintenance programmes for work equipment, the workplace and workplace systems; (e) the design and layout of workplaces and work stations; (f) adequate information and training to instruct workers to use work equipment correctly and safely in order to reduce their exposure to mechanical vibration to a minimum; (g) limitation of the duration and intensity of the exposure; (h) appropriate work schedules with adequate rest periods; (i) the provision of clothing to protect exposed workers from cold and damp. 3. In any event, workers shall not be exposed above the exposure limit value. If, despite the measures taken by the employer to comply with this Directive, the exposure limit value is exceeded, the employer shall take immediate action to reduce exposure below the exposure limit value. He shall identify the reasons why the exposure limit value has been exceeded, and shall amend the protection and prevention measures accordingly in order to prevent it being exceeded again. 4. 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 at particular risk. Article 6 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 the risks from mechanical vibration at work and/or their representatives receive information and training relating to the outcome of the risk assessment provided for in Article 4(1) of this Directive, concerning in particular: (a) the measures taken to implement this Directive in order to eliminate or reduce to a minimum the risks from mechanical vibration; (b) the exposure limit values and the exposure action values; (c) the results of the assessment and measurement of the mechanical vibration carried out in accordance with Article 4 of this Directive and the potential injury arising from the work equipment in use; (d) why and how to detect and report signs of injury; (e) the circumstances in which workers are entitled to health surveillance; (f) safe working practices to minimise exposure to mechanical vibration. Article 7 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. SECTION III MISCELLANEOUS PROVISIONS Article 8 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 with reference to the outcome of the risk assessment provided for in Article 4(1) of this Directive where it indicates a risk to their health. Those provisions, including the requirements specified for health records and their availability, shall be introduced in accordance with national laws and/or practice. Health surveillance, the results of which are taken into account in the application of preventive measures at a specific workplace, shall be intended to prevent and diagnose rapidly any disorder linked with exposure to mechanical vibration. Such surveillance shall be appropriate where: - the exposure of workers to vibration is such that a link can be established between that exposure and an identifiable illness or harmful effects on health, - it is probable that the illness or the effects occur in a worker's particular working conditions, and - there are tested techniques for the detection of the illness or the harmful effects on health. In any event, workers exposed to mechanical vibration in excess of the values stated in Article 3(1)(b) and (2)(b) shall be entitled to appropriate health surveillance. 2. Member States shall establish arrangements to ensure that, for each worker who undergoes health surveillance in accordance with paragraph 1, 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 request, have access to the health records relating to him personally. 3. Where, as a result of health surveillance, a worker is found to have an identifiable disease or adverse health effect which is considered by a doctor or occupational health-care professional to be the result of exposure to mechanical vibration at work: (a) the worker shall be informed by the doctor or other suitably qualified person of the result which relates to him personally. He shall, in particular, receive information and advice regarding any health surveillance which he should undergo following the end of exposure; (b) the employer shall be informed of any significant findings from the health surveillance, taking into account any medical confidentiality. (c) the employer shall: - review the risk assessment carried out pursuant to Article 4, - review the measures provided for to eliminate or reduce risks pursuant to Article 5, - take into account the advice of the occupational health-care professional or other suitably qualified person or the competent authority in implementing any measures required to eliminate or reduce risk in accordance with Article 5, including the possibility of assigning the worker to alternative work where there is no risk of further exposure, and - arrange continued health surveillance and provide for a review of the health status of any other worker who has been similarly exposed. In such cases, the competent doctor or occupational health care professional or the competent authority may propose that exposed persons undergo a medical examination. Article 9 Transitional periods With regard to implementation of the obligations laid down in Article 5(3), Member States, after consultation of the two sides of industry in accordance with national legislation or practice, shall be entitled to make use of a maximum transitional period of five years from 6 July 2005 where work equipment is used which was given to workers before 6 July 2007 and which does not permit the exposure limit values to be respected, taking into account the latest technical advances and/or the organisational measures taken. With regard to equipment used in the agriculture and forestry sectors, Member States shall be entitled to extend the maximum transitional period by up to four years. Article 10 Derogations 1. In compliance with the general principles of health and safety protection for workers, Member States may, in the case of sea and air transport, derogate from Article 5(3) in duly justified circumstances with respect to whole-body vibration where, given the state of the art and the specific characteristics of workplaces, it is not possible to comply with the exposure limit value despite the technical and/or organisation measures taken. 2. In a case where the exposure of a worker to mechanical vibration is usually below the exposure action values given in Article 3(1)(b) and (2)(b) but varies markedly from time to time and may occasionally exceed the exposure limit value, Member States may also grant derogations from Article 5(3). However, the exposure value averaged over 40 hours must be less than the exposure limit value and there must be evidence to show that the risks from the pattern of exposure to the work are lower than those from exposure at the exposure limit value. 3. The derogations referred to in paragraphs 1 and 2 shall be granted by Member States after consultation of the two sides of industry in accordance with national laws and 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. 4. Every four years Member States shall forward to the Commission a list of derogations as referred to in paragraphs 1 and 2, indicating the exact reasons and circumstances which made them decide to grant the derogations. Article 11 Technical amendments Amendments to the Annex of a strictly technical nature 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; (b) technical progress, changes in the most appropriate harmonised European standards or specifications and new findings concerning mechanical vibration; shall be adopted in accordance with the regulatory procedure laid down in Article 12(2). Article 12 Committee 1. The Commission shall be assisted by the Committee referred to in Article 17(2) of Directive 89/391/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 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. SECTION IV FINAL PROVISIONS Article 13 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 the two sides of industry. It shall contain a description of best practice for preventing vibrations 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 the Directive, including implementation in the light of research and scientific information, and shall inform the European Parliament, the Council, the Economic and Social Committee and the Advisory Committee on Safety, Hygiene and Health Protection at Work thereof and, if necessary, propose amendments. Article 14 Transposition 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 6 July 2005. They shall forthwith inform the Commission thereof. They shall also include a list, giving detailed reasons, of the transitional arrangements which the Member States have adopted in accordance with Article 9. 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 the provisions of national law which they adopt or have already adopted in the field covered by this Directive to the Commission. Article 15 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 16 Addressees This Directive is addressed to the Member States.

32002L0049

2002

Directive 2002/49/EC of the European Parliament and of the Council of 25 June 2002 relating to the assessment and management of environmental noise - Declaration by the Commission in the Conciliation Committee on the Directive relating to the assessment and management of environmental noise 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), and in the light of the joint text approved by the Conciliation Committee on 8 April 2002, Whereas: (1) It is part of Community policy to achieve a high level of health and environmental protection, and one of the objectives to be pursued is protection against noise. In the Green Paper on Future Noise Policy, the Commission addressed noise in the environment as one of the main environmental problems in Europe. (2) In its Resolution of 10 June 1997(5) on the Commission Green Paper, the European Parliament expressed its support for that Green Paper, urged that specific measures and initiatives should be laid down in a Directive on the reduction of environmental noise, and noted the lack of reliable, comparable data regarding the situation of the various noise sources. (3) A common noise indicator and a common methodology for noise calculation and measurement around airports were identified in the Commission Communication of 1 December 1999 on Air Transport and the Environment. This communication has been taken into account in the provisions of this Directive. (4) Certain categories of noise emissions from products are already covered by Community legislation, such as Council Directive 70/157/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles(6), Council Directive 77/311/EEC of 29 March 1977 on the approximation of the laws of the Member States relating to the driver-perceived noise level of wheeled agricultural or forestry tractors(7), Council Directive 80/51/EEC of 20 December 1979 on the limitation of noise emissions from subsonic aircraft(8) and its complementary directives, Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles(9) and Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors(10). (5) This Directive should inter alia provide a basis for developing and completing the existing set of Community measures concerning noise emitted by the major sources, in particular road and rail vehicles and infrastructure, aircraft, outdoor and industrial equipment and mobile machinery, and for developing additional measures, in the short, medium and long term. (6) Certain categories of noise such as noise created inside means of transport and noise from domestic activities should not be subject to this Directive. (7) In accordance with the principle of subsidiarity as set out in Article 5 of the Treaty, the Treaty objectives of achieving a high level of protection of the environment and of health will be better reached by complementing the action of the Member States by a Community action achieving a common understanding of the noise problem. Data about environmental noise levels should therefore be collected, collated or reported in accordance with comparable criteria. This implies the use of harmonised indicators and evaluation methods, as well as criteria for the alignment of noise-mapping. Such criteria and methods can best be established by the Community. (8) It is also necessary to establish common assessment methods for "environmental noise" and a definition for "limit values", in terms of harmonised indicators for the determination of noise levels. The concrete figures of any limit values are to be determined by the Member States, taking into account, inter alia, the need to apply the principle of prevention in order to preserve quiet areas in agglomerations. (9) The selected common noise indicators are Lden, to assess annoyance, and Lnight, to assess sleep disturbance. It is also useful to allow Member States to use supplementary indicators in order to monitor or control special noise situations. (10) Strategic noise mapping should be imposed in certain areas of interest as it can capture the data needed to provide a representation of the noise levels perceived within that area. (11) Action plans should address priorities in those areas of interest and should be drawn up by the competent authorities in consultation with the public. (12) In order to have a wide spread of information to the public, the most appropriate information channels should be selected. (13) Data collection and the consolidation of suitable Community-wide reports are required as a basis for future Community policy and for further information of the public. (14) An evaluation of the implementation of this Directive should be carried out regularly by the Commission. (15) The technical provisions governing the assessment methods should be supplemented and adapted as necessary to technical and scientific progress and to progress in European standardisation. (16) 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 1. The aim of this Directive shall be to define a common approach intended to avoid, prevent or reduce on a prioritised basis the harmful effects, including annoyance, due to exposure to environmental noise. To that end the following actions shall be implemented progressively: (a) the determination of exposure to environmental noise, through noise mapping, by methods of assessment common to the Member States; (b) ensuring that information on environmental noise and its effects is made available to the public; (c) adoption of action plans by the Member States, based upon noise-mapping results, with a view to preventing and reducing environmental noise where necessary and particularly where exposure levels can induce harmful effects on human health and to preserving environmental noise quality where it is good. 2. This Directive shall also aim at providing a basis for developing Community measures to reduce noise emitted by the major sources, in particular road and rail vehicles and infrastructure, aircraft, outdoor and industrial equipment and mobile machinery. To this end, the Commission shall submit to the European Parliament and the Council, no later than 18 July 2006, appropriate legislative proposals. Those proposals should take into account the results of the report referred to in Article 10(1). Article 2 Scope 1. This Directive shall apply to environmental noise to which humans are exposed in particular in built-up areas, in public parks or other quiet areas in an agglomeration, in quiet areas in open country, near schools, hospitals and other noise-sensitive buildings and areas. 2. This Directive shall not apply to noise that is caused by the exposed person himself, noise from domestic activities, noise created by neighbours, noise at work places or noise inside means of transport or due to military activities in military areas. Article 3 Definitions For the purposes of this Directive: (a) "environmental noise" shall mean unwanted or harmful outdoor sound created by human activities, including noise emitted by means of transport, road traffic, rail traffic, air traffic, and from sites of industrial activity such as those defined in Annex I to Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control(12); (b) "harmful effects" shall mean negative effects on human health; (c) "annoyance" shall mean the degree of community noise annoyance as determined by means of field surveys; (d) "noise indicator" shall mean a physical scale for the description of environmental noise, which has a relationship with a harmful effect; (e) "assessment" shall mean any method used to calculate, predict, estimate or measure the value of a noise indicator or the related harmful effects; (f) "Lden" (day-evening-night noise indicator) shall mean the noise indicator for overall annoyance, as further defined in Annex I; (g) "Lday" (day-noise indicator) shall mean the noise indicator for annoyance during the day period, as further defined in Annex I; (h) "Levening" (evening-noise indicator) shall mean the noise indicator for annoyance during the evening period, as further defined in Annex I; (i) "Lnight" (night-time noise indicator) shall mean the noise indicator for sleep disturbance, as further defined in Annex I; (j) "dose-effect relation" shall mean the relationship between the value of a noise indicator and a harmful effect; (k) "agglomeration" shall mean part of a territory, delimited by the Member State, having a population in excess of 100000 persons and a population density such that the Member State considers it to be an urbanised area; (l) "quiet area in an agglomeration" shall mean an area, delimited by the competent authority, for instance which is not exposed to a value of Lden or of another appropriate noise indicator greater than a certain value set by the Member State, from any noise source; (m) "quiet area in open country" shall mean an area, delimited by the competent authority, that is undisturbed by noise from traffic, industry or recreational activities; (n) "major road" shall mean a regional, national or international road, designated by the Member State, which has more than three million vehicle passages a year; (o) "major railway" shall mean a railway, designated by the Member State, which has more than 30000 train passages per year; (p) "major airport" shall mean a civil airport, designated by the Member State, which has more than 50000 movements per year (a movement being a take-off or a landing), excluding those purely for training purposes on light aircraft; (q) "noise mapping" shall mean the presentation of data on an existing or predicted noise situation in terms of a noise indicator, indicating breaches of any relevant limit value in force, the number of people affected in a certain area, or the number of dwellings exposed to certain values of a noise indicator in a certain area; (r) "strategic noise map" shall mean a map designed for the global assessment of noise exposure in a given area due to different noise sources or for overall predictions for such an area; (s) "limit value" shall mean a value of Lden or Lnight, and where appropriate Lday and Levening, as determined by the Member State, the exceeding of which causes competent authorities to consider or enforce mitigation measures; limit values may be different for different types of noise (road-, rail-, air-traffic noise, industrial noise, etc.), different surroundings and different noise sensitiveness of the populations; they may also be different for existing situations and for new situations (where there is a change in the situation regarding the noise source or the use of the surrounding); (t) "action plans" shall mean plans designed to manage noise issues and effects, including noise reduction if necessary; (u) "acoustical planning" shall mean controlling future noise by planned measures, such as land-use planning, systems engineering for traffic, traffic planning, abatement by sound-insulation measures and noise control of sources; (v) "the public" shall mean one or more natural or legal persons and, in accordance with national legislation or practice, their associations, organisations or groups. Article 4 Implementation and responsibilities 1. Member States shall designate at the appropriate levels the competent authorities and bodies responsible for implementing this Directive, including the authorities responsible for: (a) making and, where relevant, approving noise maps and action plans for agglomerations, major roads, major railways and major airports; (b) collecting noise maps and action plans. 2. The Member States shall make the information referred to in paragraph 1 available to the Commission and to the public no later than 18 July 2005. Article 5 Noise indicators and their application 1. Member States shall apply the noise indicators Lden and Lnight as referred to in Annex I for the preparation and revision of strategic noise mapping in accordance with Article 7. Until the use of common assessment methods for the determination of Lden and Lnight is made obligatory, existing national noise indicators and related data may be used by Member States for this purpose and should be converted into the indicators mentioned above. These data must not be more than three years old. 2. Member States may use supplementary noise indicators for special cases such as those listed in Annex I(3). 3. For acoustical planning and noise zoning, Member States may use other noise indicators than Lden and Lnight. 4. No later than 18 July 2005, Member States shall communicate information to the Commission on any relevant limit values in force within their territories or under preparation, expressed in terms of Lden and Lnight and where appropriate, Lday and Levening, for road-traffic noise, rail-traffic noise, aircraft noise around airports and noise on industrial activity sites, together with explanations about the implementation of the limit values. Article 6 Assessment methods 1. The values of Lden and Lnight shall be determined by means of the assessment methods defined in Annex II. 2. Common assessment methods for the determination of Lden and Lnight shall be established by the Commission in accordance with the procedure laid down in Article 13(2) through a revision of Annex II. Until these methods are adopted, Member States may use assessment methods adapted in accordance with Annex II and based upon the methods laid down in their own legislation. In such case, they must demonstrate that those methods give equivalent results to the results obtained with the methods set out in paragraph 2.2 of Annex II. 3. Harmful effects may be assessed by means of the dose-effect relations referred to in Annex III. Article 7 Strategic noise mapping 1. Member States shall ensure that no later than 30 June 2007 strategic noise maps showing the situation in the preceding calendar year have been made and, where relevant, approved by the competent authorities, for all agglomerations with more than 250000 inhabitants and for all major roads which have more than six million vehicle passages a year, major railways which have more than 60000 train passages per year and major airports within their territories. No later than 30 June 2005, and thereafter every five years, Member States shall inform the Commission of the major roads which have more than six million vehicle passages a year, major railways which have more than 60000 train passages per year, major airports and the agglomerations with more than 250000 inhabitants within their territories. 2. Member States shall adopt the measures necessary to ensure that no later than 30 June 2012, and thereafter every five years, strategic noise maps showing the situation in the preceding calendar year have been made and, where relevant, approved by the competent authorities for all agglomerations and for all major roads and major railways within their territories. No later than 31 December 2008, Member States shall inform the Commission of all the agglomerations and of all the major roads and major railways within their territories. 3. The strategic noise maps shall satisfy the minimum requirements laid down in Annex IV. 4. Neighbouring Member States shall cooperate on strategic noise mapping near borders. 5. The strategic noise maps shall be reviewed, and revised if necessary, at least every five years after the date of their preparation. Article 8 Action plans 1. Member States shall ensure that no later than 18 July 2008 the competent authorities have drawn up action plans designed to manage, within their territories, noise issues and effects, including noise reduction if necessary for: (a) places near the major roads which have more than six million vehicle passages a year, major railways which have more than 60000 train passages per year and major airports; (b) agglomerations with more than 250000 inhabitants. Such plans shall also aim to protect quiet areas against an increase in noise. The measures within the plans are at the discretion of the competent authorities, but should notably address priorities which may be identified by the exceeding of any relevant limit value or by other criteria chosen by the Member States and apply in particular to the most important areas as established by strategic noise mapping. 2. Member States shall ensure that, no later than 18 July 2013, the competent authorities have drawn up action plans notably to address priorities which may be identified by the exceeding of any relevant limit value or by other criteria chosen by the Member States for the agglomerations and for the major roads as well as the major railways within their territories. 3. Member States shall inform the Commission of the other relevant criteria referred to in paragraphs 1 and 2. 4. The action plans shall meet the minimum requirements of Annex V. 5. The action plans shall be reviewed, and revised if necessary, when a major development occurs affecting the existing noise situation, and at least every five years after the date of their approval. 6. Neighbouring Member States shall cooperate on the action plans for border regions. 7. Member States shall ensure that the public is consulted about proposals for action plans, given early and effective opportunities to participate in the preparation and review of the action plans, that the results of that participation are taken into account and that the public is informed on the decisions taken. Reasonable time-frames shall be provided allowing sufficient time for each stage of public participation. If the obligation to carry out a public participation procedure arises simultaneously from this Directive and any other Community legislation, Member States may provide for joint procedures in order to avoid duplication. Article 9 Information to the public 1. Member States shall ensure that the strategic noise maps they have made, and where appropriate adopted, and the action plans they have drawn up are made available and disseminated to the public in accordance with relevant Community legislation, in particular Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment(13), and in conformity with Annexes IV and V to this Directive, including by means of available information technologies. 2. This information shall be clear, comprehensible and accessible. A summary setting out the most important points shall be provided. Article 10 Collection and publication of data by Member States and the Commission 1. No later than 18 January 2004, the Commission will submit a report to the European Parliament and the Council containing a review of existing Community measures relating to sources of environmental noise. 2. The Member States shall ensure that the information from strategic noise maps and summaries of the action plans as referred to in Annex VI are sent to the Commission within six months of the dates laid down in Articles 7 and 8 respectively. 3. The Commission shall set up a database of information on strategic noise maps in order to facilitate the compilation of the report referred to in Article 11 and other technical and informative work. 4. Every five years the Commission shall publish a summary report of data from strategic noise maps and action plans. The first report shall be submitted by 18 July 2009. Article 11 Review and reporting 1. No later than 18 July 2009, the Commission shall submit to the European Parliament and the Council a report on the implementation of this Directive. 2. That report shall in particular assess the need for further Community actions on environmental noise and, if appropriate, propose implementing strategies on aspects such as: (a) long-term and medium-term goals for the reduction of the number of persons harmfully affected by environmental noise, taking particularly into account the different climates and different cultures; (b) additional measures for a reduction of the environmental noise emitted by specific sources, in particular outdoor equipment, means and infrastructures of transport and certain categories of industrial activity, building on those measures already implemented or under discussion for adoption; (c) the protection of quiet areas in open country. 3. The report shall include a review of the acoustic environment quality in the Community based on the data referred to in Article 10 and shall take account of scientific and technical progress and any other relevant information. The reduction of harmful effects and the cost-effectiveness ratio shall be the main criteria for the selection of the strategies and measures proposed. 4. When the Commission has received the first set of strategic noise maps, it shall reconsider: - the possibility for a 1,5 metre measurement height in Annex I, paragraph 1, in respect of areas having houses of one storey, - the lower limit for the estimated number of people exposed to different bands of Lden and Lnight in Annex VI. 5. The report shall be reviewed every five years or more often if appropriate. It shall contain an assessment of the implementation of this Directive. 6. The report shall, if appropriate, be accompanied by proposals for the amendment of this Directive. Article 12 Adaptation The Commission shall adapt Annex I, point 3, Annex II and Annex III hereto to technical and scientific progress in accordance with the procedure provided for in Article 13(2). Article 13 Committee 1. The Commission shall be assisted by the committee set up by Article 18 of Directive 2000/14/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 14 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 18 July 2004. They shall 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. The methods of making such a reference shall be laid down by the Member States. 2. The 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 15 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 16 Addressees This Directive is addressed to the Member States.

32002L0045

2002

Directive 2002/45/EC of the European Parliament and of the Council of 25 June 2002 amending for the twentieth time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (short-chain chlorinated paraffins) 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 22 April 2002, Whereas: (1) Limitations already adopted or planned by certain Member States on the use of short-chain chlorinated paraffins (SCCPs) following PARCOM (Convention for the Prevention of Marine Pollution from Land-Based Sources) Decision 95/1 directly affect 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] taking into account Community risk-assessments and the relevant scientific evidence in support of PARCOM Decision 95/1. (2) SCCPs are classified as dangerous to the environment, since they are very toxic to aquatic organisms and may cause long-term adverse effects in the aquatic environment. (3) The Commission has adopted a Recommendation, in the framework of Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances [5], calling for specific measures to restrict the use of SCCPs, in particular in metalworking fluids and leather finishing products, in order to protect the aquatic environment. (4) The remaining uses of all chlorinated paraffins are to be reviewed in the light of relevant scientific knowledge, in particular with regard to emissions containing chlorinated paraffins. The Commission should make appropriate proposals to reduce such uses. (5) On 27 November 1998 the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) delivered its opinion on the risks of SCCPs, as identified by the Recommendation. (6) This Directive applies without prejudice to Community legislation on protection of the safety and health of workers at work, 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 [6] and Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risk related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) [7], Article 1 In Annex I to Directive 76/769/EEC the following point shall be added: "42.Alkanes, C10-C13, chloro (short-chain chlorinated paraffins) | 1.May not be placed on the market for use as substances or as constituents of other substances or preparations in concentrations higher than 1 %:in metalworking;for fat liquoring of leather.2.Before 1 January 2003 all remaining uses of SCCPs will be reviewed by the European Commission, in cooperation with the Member States and the OSPAR Commission, in the light of any relevant new scientific data on risks posed by SCCPs to health and the environment.The European Parliament will be informed of the outcome of this review." | Article 2 1. Member States shall adopt and publish, not later than 6 of July 2003, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those measures from 6 January 2004 at the latest. 2. 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 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.

32002L0059

2002

Directive 2002/59/EC of the European Parliament and of the Council of 27 June 2002 establishing a Community vessel traffic monitoring and information system and repealing Council Directive 93/75/EEC 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 indicated in Article 251 of the Treaty(4), Whereas: (1) In its communication of 24 February 1993 on a common policy on safe seas, the Commission indicated that one objective at Community level was the introduction of a mandatory information system to give Member States rapid access to all important information relating to the movements of ships carrying dangerous or polluting materials and to the precise nature of their cargo. (2) 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) introduced a system whereby the competent authorities receive information regarding ships bound for or leaving a Community port and carrying dangerous or polluting goods, and regarding incidents at sea. That Directive requires the Commission to produce new proposals for the introduction of a fuller reporting system for the Community, possibly covering ships transiting along the coasts of Member States. (3) The Council Resolution of 8 June 1993 on a common policy on safe seas(6) agreed that the main objectives of Community action included the adoption of a fuller information system. (4) Setting up a Community vessel traffic monitoring and information system should help to prevent accidents and pollution at sea and to minimise their impact on the marine and coastal environment, the economy and the health of local communities. The efficiency of maritime traffic, and in particular of the management of ships' calls into ports, also depends on ships giving sufficient advance notice of their arrival. (5) Several mandatory ship reporting systems have been set up along Europe's coasts, in accordance with the relevant rules adopted by the International Maritime Organisation (IMO). It ought to be ensured that ships comply with the reporting requirements in force under these systems. (6) Vessel traffic services and ships' routing systems have also been introduced and are playing an important part in the prevention of accidents and pollution in certain shipping areas which are congested or hazardous for shipping. It is necessary that ships use vessel traffic services and that they follow the rules applicable to ships' routing systems approved by the IMO. (7) Key technological progress has been made in the area of on-board equipment allowing automatic identification of ships (AIS systems) for enhanced ship monitoring, as well as voyage data recording (VDR systems or "black boxes") to facilitate investigations following accidents. Given its importance in the formulation of a policy to prevent shipping accidents, such equipment should be made compulsory on board ships making national or international voyages which call at Community ports. The data provided by a VDR system can be used both after an accident to investigate its causes and preventively to learn the necessary lessons from such situations. Member States should encourage the use of such data for both purposes. (8) Member States should ensure that the coastal stations of the competent authorities have available, in addition to appropriate technical equipment, sufficient and properly qualified staff. (9) Accurate knowledge of dangerous or polluting goods being carried on board ships and of other relevant safety information, such as information relating to navigational incidents, is essential to the preparation and effectiveness of operations to tackle pollution or the risk of pollution at sea. Ships leaving or bound for Member States' ports must notify this information to the competent authorities or port authorities of those Member States. (10) To streamline and accelerate the transmission and utilisation of what may be huge amounts of information on cargo, such information ought to be sent, whenever practicable, electronically to the competent authority or port authority concerned. For the same reasons, exchanges of information between the competent authorities of the Member States should take place electronically. (11) Where the companies concerned have, to the satisfaction of the Member States, introduced internal procedures to ensure that information required by the Directive is sent to the competent authority without delay, it must be possible to exempt scheduled services between two or more States, of which at least one is a Member State, from the reporting requirement for each voyage. (12) Because of their behaviour or condition, some ships pose potential risks to the safety of shipping and the environment. Member States should pay particular attention to the monitoring of such ships, take the appropriate measures to prevent any worsening of the risk they pose, and send any relevant information they possess on these ships to the other Member States concerned. Such appropriate measures could be measures provided for by port State control activities. (13) Member States need to guard against the threats to maritime safety, to the safety of individuals and to the marine and coastal environment created by incidents, accidents or certain other situations at sea and by the presence of polluting slicks or packages drifting at sea. To this end, masters of ships sailing within Member States' search and rescue region/exclusive economic zone or equivalent, should report such occurrences to the coastal authorities, supplying all appropriate information. In the light of their specific situation, Member States should be given flexibility in choosing which of the abovementioned geographical areas should be covered by the reporting obligation. (14) In the event of an incident or accident at sea, full and complete cooperation by the parties involved in the carriage contributes significantly to the effectiveness of operations by the competent authorities. (15) Where a competent authority designated by a Member State considers, upon a sea state and weather forecast provided by a qualified meteorological information service, that exceptionally bad weather or sea conditions are creating a serious threat for the safety of human life or of pollution, it should inform the master of a ship, which intends to enter or leave the port, of the situation and may take any other appropriate measures. Without prejudice to the duty of assistance to ships in distress, these might include a prohibition to enter or to leave port, until the situation returns to normal. In the event of a possible risk to safety or of pollution and taking into account the specific situation in the port concerned, the competent authority may recommend ships not to leave the port. If the master chooses to leave the port, he/she does so in any case under his/her own responsibility and should state the reasons for his/her decision. (16) Non-availability of a place of refuge may have serious consequences in the event of an accident at sea. Member States should therefore draw up plans whereby ships in distress may, if the situation so requires, be given refuge in their ports or any other sheltered area in the best conditions possible. Where necessary and feasible, these plans should include the provision of adequate means and facilities for assistance, salvage and pollution response. Ports accommodating a ship in distress should be able to rely on prompt compensation for any costs and damage involved in this operation. The Commission should therefore examine the possibilities for introducing an adequate system of compensation for ports in the Community accommodating a ship in distress and the feasibility of requiring a ship coming to a Community port to be adequately insured. (17) A framework for cooperation between the Member States and the Commission needs to be established to enhance the implementation of the monitoring and information system for maritime traffic, with proper communication links being established between the competent authorities and ports of the Member States. Moreover, the coverage of the ship identification and monitoring system needs to be supplemented in those shipping areas of the Community where it is insufficient. In addition, information management centres ought to be set up in the Community's maritime regions so as to facilitate the exchange or sharing of useful data in relation to traffic monitoring and the implementation of this Directive. The Member States and the Commission should also endeavour to cooperate with third countries to achieve these objectives. (18) The effectiveness of this Directive depends greatly on the Member States enforcing its implementation strictly. To this end, Member States must regularly carry out appropriate inspections or any other action required to ensure that the communication links established to meet the requirements of this Directive are operating satisfactorily. A system of sanctions should also be introduced to ensure that the parties concerned comply with the reporting and equipment carrying requirements laid down by this Directive. (19) 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). (20) Certain provisions of this Directive may be amended by that procedure so as to take account of the development of Community and international instruments and of experience gained in implementing this Directive, in so far as such amendments do not broaden the scope of the Directive. A useful tool for the Commission to evaluate the experience gained in implementing the Directive is an adequate reporting by Member States on such implementation. (21) The provisions of Directive 93/75/EEC are significantly reinforced, extended and amended by this Directive. Accordingly, Directive 93/75/EEC should be repealed. (22) Since the objectives of the proposed action, namely the enhancing of the safety and efficiency of maritime traffic, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale or 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 those objectives, Article 1 Purpose The purpose of this Directive is to establish in the Community a vessel traffic monitoring and information system with a view to enhancing the safety and efficiency of maritime traffic, improving the response of authorities to incidents, accidents or potentially dangerous situations at sea, including search and rescue operations, and contributing to a better prevention and detection of pollution by ships. Member States shall monitor and take all necessary and appropriate measures to ensure that the masters, operators or agents of ships, as well as shippers or owners of dangerous or polluting goods carried on board such ships, comply with the requirements under this Directive. Article 2 Scope 1. This Directive applies to ships of 300 gross tonnage and upwards, unless stated otherwise. 2. This Directive shall not apply to: (a) warships, naval auxiliaries and other ships owned or operated by a Member State and used for non-commercial public service; (b) fishing vessels, traditional ships and recreational craft with a length of less than 45 metres; (c) bunkers below 5000 tons, ships' stores and equipment for use on board ships. Article 3 Definitions For the purpose of this Directive (a) "Relevant international instruments" means the following instruments: - MARPOL means the International Convention for the Prevention of Pollution from Ships, 1973 and the 1978 Protocol thereto; - SOLAS means the International Convention for the Safety of Life at Sea, together with the protocols and amendments thereto; - the International Convention on Tonnage Measurement of Ships, 1969; - the International Convention relating to Intervention on the High Seas in Cases of Oil Pollution Casualties, 1969 and its 1973 Protocol relating to Intervention on the High Seas in Cases of Pollution by Substances other than Oil; - SAR Convention means the International Convention on Maritime Search and Rescue, 1979; - ISM Code means the International Safety Management Code; - IMDG Code means the International Maritime Dangerous Goods Code; - IBC Code means the IMO International Code for the construction and equipment of ships carrying dangerous chemicals in bulk; - IGC Code means the IMO International Code for the construction and equipment of ships carrying liquefied gases in bulk; - BC Code means the IMO Code of Safe Practice for Solid Bulk Cargoes; - 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; - IMO Resolution A.851(20) means International Maritime Organisation Resolution 851(20) entitled "General principles for ship reporting systems and ship reporting requirements, including guidelines for reporting incidents involving dangerous goods, harmful substances and/or marine pollutants"; (b) "operator" means the owner or manager of a ship; (c) "agent" means any person mandated or authorised to supply information on behalf of the operator of the ship; (d) "shipper" means any person by whom or in whose name or on whose behalf a contract of carriage of goods has been concluded with a carrier; (e) "company" means a company within the meaning of Regulation 1(2) of Chapter IX of the SOLAS Convention; (f) "ship" means any sea-going vessel or craft; (g) "dangerous goods" means: - goods classified in the IMDG Code, - dangerous liquid substances listed in Chapter 17 of the IBC Code, - liquefied gases listed in Chapter 19 of the IGC Code, - solids referred to in Appendix B of the BC Code. Also included are goods for the carriage of which appropriate preconditions have been laid down in accordance with paragraph 1.1.3 of the IBC Code or paragraph 1.1.6 of the IGC Code; (h) "polluting goods" means: - oils as defined in Annex I to the MARPOL Convention, - noxious liquid substances as defined in Annex II to the MARPOL Convention, - harmful substances as defined in Annex III to the MARPOL Convention; (i) "cargo transport unit" means a road freight vehicle, a railway freight wagon, a freight container, a road tank vehicle, a railway wagon, or portable tank; (j) "address" means the name and the communication links whereby contact may, where necessary, be made with the operator, agent, port authority, competent authority or any other authorised person or body in possession of detailed information regarding the ship's cargo; (k) "competent authorities" means the authorities and organisations designated by Member States to receive and pass on information reported pursuant to this Directive; (l) "port authority" means the competent authority or body designated by Member States for each port to receive and pass on information reported pursuant to this Directive; (m) "place of refuge" means a port, the part of a port or another protective berth or anchorage or any other sheltered area identified by a Member State for accommodating ships in distress; (n) "coastal station" means any of the following, designated by Member States pursuant to this Directive: a vessel traffic service; a shore-based installation responsible for a mandatory reporting system approved by the IMO; or a body responsible for coordinating search and rescue operations or operations to tackle pollution at sea; (o) "vessel traffic service (VTS)" means a service designed to improve the safety and efficiency of vessel traffic and to protect the environment, which has the capability to interact with the traffic and to respond to traffic situations developing in the VTS area; (p) "ship's routing system" means any system of one or more routes or routing measures aimed at reducing the risk of casualties; it includes traffic separation schemes, two-way routes, recommended tracks, areas to be avoided, inshore traffic zones, roundabouts, precautionary areas and deep-water routes; (q) "traditional ships" means all kinds of historical ships and their replicas including those designed to encourage and promote traditional skills and seamanship, that together serve as living cultural monuments, operated according to traditional principles of seamanship and technique; (r) "casualty" means a casualty within the meaning of the IMO Code for the investigation of marine casualties and incidents. TITLE I SHIP REPORTING AND MONITORING Article 4 Notification prior to entry into ports of the Member States 1. The operator, agent or master of a ship bound for a port of a Member State shall notify the information in Annex I(1) to the port authority: (a) at least twenty-four hours in advance; or (b) at the latest, at the time the ship leaves the previous port, if the voyage time is less than twenty-four hours; or (c) if the port of call is not known or it is changed during the voyage, as soon as this information is available. 2. Ships coming from a port outside the Community and bound for a port of a Member State carrying dangerous or polluting goods, shall comply with the notification obligations of Article 13. Article 5 Monitoring of ships entering the area of mandatory ship reporting systems 1. The Member State concerned shall monitor and take all necessary and appropriate measures to ensure that all ships entering the area of a mandatory ship reporting system, adopted by the IMO according to Regulation 11 Chapter V of the SOLAS Convention and operated by one or more States, of which at least one is a Member State, in accordance with the relevant guidelines and criteria developed by the IMO, comply with that system in reporting the information required without prejudice to additional information required by a Member State in accordance with IMO Resolution A.851(20). 2. When submitting a new mandatory ship reporting system to the IMO for adoption or a proposal to amend an existing reporting system, a Member State shall include in its proposal at least the information referred to in Annex I(4). Article 6 Use of automatic identification systems 1. Any ship calling at a port of a Member State must, in accordance with the timetable set out in Annex II(I), be fitted with an AIS which meets the performance standards drawn up by the IMO. 2. Ships fitted with an AIS, shall maintain it in operation at all times except where international agreements, rules or standards provide for the protection of navigational information. Article 7 Use of ship's routing systems 1. Member States shall monitor and take all necessary and appropriate measures to ensure that all ships entering the area of a mandatory ships' routing system adopted by the IMO according to Regulation 10 Chapter V of the SOLAS Convention and operated by one or more States, of which at least one is a Member State, use the system in accordance with the relevant guidelines and criteria developed by the IMO. 2. When implementing a ship's routing system, which has not been adopted by the IMO, under their responsibility, Member States shall take into account, wherever possible, the guidelines and criteria developed by the IMO and promulgate all information necessary for the safe and effective use of the ship's routing system. Article 8 Monitoring of the compliance of ships with vessel traffic services Member States shall monitor and take all necessary and appropriate measures to ensure that: (a) ships entering the area of applicability of a VTS operated by one or more States, of which at least one is a Member State, within their territorial sea and based on the guidelines developed by the IMO, participate in, and comply with, the rules of that VTS; (b) ships flying the flag of a Member State or ships bound for a port of a Member State and entering the area of applicability of such a VTS outside the territorial sea of a Member State and based on the guidelines developed by the IMO, comply with the rules of that VTS; (c) ships flying the flag of a third State and not bound for a port in a Member State entering a VTS area outside the territorial sea of a Member State, follow the rules of that VTS wherever possible. Member States should report to the flag State concerned any apparent serious breach of those rules in such a VTS area. Article 9 Infrastructure for ship reporting systems, ships' routing systems and vessel traffic services 1. Member States shall take all necessary and appropriate measures to provide themselves gradually, on a time-schedule compatible with the timetable set out in Annex II(I), with appropriate equipment and shore-based installations for receiving and utilising the AIS information taking into account a necessary range for transmission of the reports. 2. The process of building up all necessary equipment and shore-based installations for implementing this Directive shall be completed by the end of 2007. Member States shall ensure that the appropriate equipment for relaying the information to, and exchanging it between, the national systems of Member States shall be operational at the latest one year thereafter. 3. Member States shall ensure that the coastal stations in charge of monitoring the compliance with vessel traffic services and ships' routing systems have sufficient and properly qualified staff available, as well as appropriate means of communication and ship monitoring and that they operate in accordance with the relevant IMO guidelines. Article 10 Voyage data recorder systems 1. Member States shall monitor and take all necessary and appropriate measures to ensure that ships calling at a port of a Member State are fitted with a voyage data recorder (VDR) system in accordance with the rules laid down in Annex II(II). Any exemptions granted to ro-ro ferries or high-speed passenger craft under Article 4(1)(d) 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(8) shall terminate on 5 August 2002. 2. Data which have been collected from a VDR system shall be made available to the Member State concerned in the event of an investigation following a casualty occurring within the waters under the jurisdiction of a Member State. Member States shall ensure that such data are used in the investigation and are properly analysed. Member States shall ensure that the findings of the investigation are published as soon as possible after its conclusion. Article 11 Casualty investigation Without prejudice to Article 12 of Directive 1999/35/EC, Member States shall comply with the provisions of the IMO Code for the investigation of marine casualties and incidents when conducting any marine casualty or incident investigation involving a ship referred to in this Directive. Member States shall cooperate in the investigation of marine casualties and incidents involving ships flying their flag. TITLE II NOTIFICATION OF DANGEROUS OR POLLUTING GOODS ON BOARD SHIPS (HAZMAT) Article 12 Obligations on the shipper No dangerous or polluting goods may be offered for carriage or taken on board any ship, irrespective of its size, in a port of a Member State unless a declaration has been delivered to the master or operator containing the information listed in Annex I(2). It shall be the duty of the shipper to deliver to the master or operator such declaration and to ensure that the shipment offered for carriage is indeed the one declared in compliance with the first subparagraph. Article 13 Notification of dangerous or polluting goods carried on board 1. The operator, agent or master of a ship, irrespective of its size, carrying dangerous or polluting goods and leaving a port of a Member State shall, at the latest at the moment of departure, notify the information indicated in Annex I(3) to the competent authority designated by that Member State. 2. The operator, agent or master of a ship, irrespective of its size, carrying dangerous or polluting goods coming from a port located outside the Community and bound for a port of a Member State or an anchorage located in a Member State's territorial waters shall, at the latest upon departure from the loading port or as soon as the port of destination or the location of the anchorage is known, if this information is unavailable at the moment of departure, notify the information indicated in Annex I(3) to the competent authority of the Member State in which the first port of destination or anchorage is located. 3. Member States may put in place a procedure authorising the operator, agent or master of a ship referred to in paragraphs 1 and 2 to notify the information listed in Annex I(3) to the port authority of the port of departure or destination in the Community, as appropriate. The procedure put in place must ensure that the competent authority has access to the information indicated in Annex I(3) at all times should it be needed. To this end, the port authority concerned shall retain the information listed in Annex I(3) long enough for it to be usable in the event of an incident or accident at sea. The port authority shall take the necessary measures to provide this information electronically and without delay to the competent authority, 24 hours a day upon request. 4. The operator, agent or master of the ship must communicate the cargo information indicated in Annex I(3) to the port authority or the competent authority. The information must be transferred electronically whenever practicable. The electronic message exchange must use the syntax and procedures set out in Annex III. Article 14 Computerised exchange of data between Member States Member States shall cooperate to ensure the interconnection and interoperability of the national systems used to manage the information indicated in Annex I. Communication systems set up pursuant to the first subparagraph must display the following features: (a) data exchange must be electronic and enable messages notified in accordance with Article 13 to be received and processed; (b) the system must allow information to be transmitted 24 hours a day; (c) each Member State must be able, upon request, to send information on the ship and the dangerous or polluting goods on board without delay to the competent authority of another Member State. Article 15 Exemptions 1. Member States may exempt scheduled services performed between ports located on their territory from the requirement laid down in Article 13 where the following conditions are met: (a) the company operating the scheduled services referred to above keeps and updates a list of the ships concerned and sends it to the competent authority concerned, (b) for each voyage performed, the information listed in Annex I(3) is kept available for the competent authority upon request. The company must establish an internal system to ensure that, upon request 24 hours a day and without delay, the said information can be sent to the competent authority electronically, in accordance with Article 13(4). 2. When an international scheduled service is operated between two or more States, of which at least one is a Member State, any of the Member States involved may request of the other Member States that an exemption be granted to that service. All Member States involved, including the coastal States concerned, shall collaborate in granting an exemption to the service concerned in accordance with the conditions laid down in paragraph 1. 3. Member States shall periodically check that the conditions laid down in paragraphs 1 and 2 are being met. Where at least one of these conditions is no longer being met, Member States shall immediately withdraw the privilege of the exemption from the company concerned. 4. Member States shall communicate to the Commission a list of companies and ships granted exemption under this Article, as well as any updating of that list. TITLE III MONITORING OF HAZARDOUS SHIPS AND INTERVENTION IN THE EVENT OF INCIDENTS AND ACCIDENTS AT SEA Article 16 Transmission of information concerning certain ships 1. Ships meeting the criteria set out below shall be considered to be ships posing a potential hazard to shipping or a threat to maritime safety, the safety of individuals or the environment: (a) ships which, in the course of their voyage: - have been involved in incidents or accidents at sea as referred to in Article 17; or - have failed to comply with the notification and reporting requirements imposed by this Directive; or - have failed to comply with the applicable rules in ships' routing systems and VTS placed under the responsibility of a Member State; (b) ships in respect of which there is proof or presumptive evidence of deliberate discharges of oil or other infringements of the MARPOL Convention in waters under the jurisdiction of a Member State; (c) ships which have been refused access to ports of the Member States or which have been the subject of a report or notification by a Member State in accordance with Annex I-1 to Council Directive 95/21/EC of 19 June 1995 on port State control of shipping(9). 2. Coastal stations holding relevant information on the ships referred to in paragraph 1 shall communicate it to the coastal stations concerned in the other Member States located along the planned route of the ship. 3. Member States shall ensure that the information communicated to them under paragraph 2 is transmitted to the relevant port authorities and/or any other authority designated by the Member State. Within the limits of their available staff capacity, Member States shall carry out any appropriate inspection or verification in their ports either on their own initiative or at the request of another Member State, without prejudice to any port State control obligation. They shall inform all Member States concerned of the results of the action they take. Article 17 Reporting of incidents and accidents at sea 1. Without prejudice to international law and with a view to preventing or mitigating any significant threat to maritime safety, the safety of individuals or the environment, Member States shall monitor and take all appropriate measures to ensure that the master of a ship sailing within their search and rescue region/exclusive economic zone or equivalent, immediately reports to the coastal station responsible for that geographical area: (a) any incident or accident affecting the safety of the ship, such as collision, running aground, damage, malfunction or breakdown, flooding or shifting of cargo, any defects in the hull or structural failure; (b) any incident or accident which compromises shipping safety, such as failures likely to affect the ship's manoeuvrability or seaworthiness, or any defects affecting the propulsion system or steering gear, the electrical generating system, navigation equipment or communications equipment; (c) any situation liable to lead to pollution of the waters or shore of a Member State, such as the discharge or threat of discharge of polluting products into the sea; (d) any slick of polluting materials and containers or packages seen drifting at sea. 2. The report message sent in application of paragraph 1 shall include at least the ship's identity, its position, the port of departure, the port of destination, the address from which information may be obtained on the dangerous and polluting goods carried on board, the number of persons aboard, details of the incident and any relevant information referred to in IMO Resolution A.851(20). Article 18 Measures in the event of exceptionally bad weather 1. Where the competent authorities designated by Member States consider, in the event of exceptionally bad weather or sea conditions, that there is a serious threat of pollution of their shipping areas or coastal zones, or of the shipping areas or coastal zones of other States, or that the safety of human life is in danger: (a) they should, where possible, fully inform the master of a ship which is in the port area concerned, and intends to enter or leave that port, of the sea state and weather conditions and, when relevant and possible, of the danger they may present to his/her ship, the cargo, the crew and the passengers; (b) they may take, without prejudice to the duty of assistance to ships in distress and in accordance with Article 20, any other appropriate measures, which may include a recommendation or a prohibition either for a particular ship or for ships in general to enter or leave the port in the areas affected, until it has been established that there is no longer a risk to human life and/or to the environment; (c) they shall take appropriate measures to limit as much as possible or, if necessary, prohibit the bunkering of ships in their territorial waters. 2. The master shall inform the company of the appropriate measures or recommendations referred to under paragraph 1. These do not however prejudice the decision of the master on the basis of his/her professional judgement corresponding to the SOLAS Convention. Where the decision taken by the master of the ship is not in accordance with the measures referred to under paragraph 1, he/she shall inform the competent authorities of the reasons for his/her decision. 3. The appropriate measures or recommendations, referred to under paragraph 1, shall be based upon a sea state and weather forecast provided by a qualified meteorological information service recognised by the Member State. Article 19 Measures relating to incidents or accidents at sea 1. In the event of incidents or accidents at sea as referred to in Article 17, Member States shall take all appropriate measures consistent with international law, where necessary to ensure the safety of shipping and of persons and to protect the marine and coastal environment. Annex IV sets out a non-exhaustive list of measures available to Member States pursuant to this Article. 2. The operator, the master of the ship and the owner of the dangerous or polluting goods carried on board must, in accordance with national and international law, cooperate fully with the competent national authorities, at the latter's request, with a view to minimising the consequences of an incident or accident at sea. 3. The master of a ship to which the provisions of the ISM Code are applicable shall, in accordance with that Code, inform the company of any incident or accident, as referred to in Article 17(1), which occurs at sea. As soon as it has been informed of such a situation, the company must contact the competent coastal station and place itself at its disposal as necessary. Article 20 Places of refuge Member States, having consulted the parties concerned, shall draw up, taking into account relevant guidelines by IMO, plans to accommodate, in the waters under their jurisdiction, ships in distress. Such plans shall contain the necessary arrangements and procedures taking into account operational and environmental constraints, to ensure that ships in distress may immediately go to a place of refuge subject to authorisation by the competent authority. Where the Member State considers it necessary and feasible, the plans must contain arrangements for the provision of adequate means and facilities for assistance, salvage and pollution response. Plans for accommodating ships in distress shall be made available upon demand. Member States shall inform the Commission by 5 February 2004 of the measures taken in application of the first paragraph. Article 21 Information of the parties concerned 1. The competent coastal station of the Member State concerned shall, as necessary, broadcast within the relevant areas any incident or accident notified under Article 17(1) and information with regard to any ship that poses a threat to maritime safety, the safety of individuals or the environment. 2. Competent authorities holding information notified in accordance with Articles 13 and 17 shall make adequate arrangements to provide such information at any time upon request for safety reasons by the competent authority of another Member State. 3. Any Member State the competent authorities of which have been informed, pursuant to this Directive or in some other way, of facts which involve or increase the risk for another Member State of a hazard being posed to certain shipping areas and coastal zones, shall take the appropriate measures to inform any interested Member State thereof as soon as possible and consult it regarding the action being envisaged. Where appropriate, Member States shall cooperate with a view to pooling the arrangements for joint action. Each Member State shall make the necessary arrangements to use fully the reports which ships are required to transmit to them pursuant to Article 17. TITLE IV ACCOMPANYING MEASURES Article 22 Designation and publication of a list of competent bodies 1. Each Member State shall designate the competent authorities, port authorities and coastal stations to which the notifications required by this Directive must be made. 2. Each Member State shall ensure that the shipping industry is properly informed and regularly updated, notably via nautical publications, regarding the authorities and stations designated pursuant to paragraph 1, including where appropriate the geographical area for which they are competent, and the procedures laid down for notifying the information required by this Directive. 3. Member States shall send the Commission a list of the authorities and stations they designate pursuant to paragraph 1, as well as any updating thereof. Article 23 Cooperation between Member States and the Commission Member States and the Commission shall cooperate in attaining the following objectives: (a) making optimum use of the information notified pursuant to this Directive, notably by developing appropriate telematic links between coastal stations and port authorities with a view to exchanging data relating to ships' movements, their estimated times of arrival in ports and their cargo; (b) developing and enhancing the effectiveness of telematic links between the coastal stations of the Member States with a view to obtaining a clearer picture of traffic, improving the monitoring of ships in transit, and harmonising and, as far as possible, streamlining the reports required from ships en route; (c) extending the cover of and/or updating the Community vessel traffic monitoring and information system with a view to enhanced identification and monitoring of ships. To this end, the Member States and the Commission shall work together to put in place, where necessary, mandatory reporting systems, mandatory vessel traffic services and appropriate ships' routing systems, with a view to submitting them to the IMO for approval; (d) drawing up, if appropriate, concerted plans to accommodate ships in distress. Article 24 Confidentiality of information Member States shall, in accordance with their national legislation, take the necessary measures to ensure the confidentiality of information sent to them pursuant to this Directive. Article 25 Monitoring the implementation of this Directive and sanctions 1. Member States shall carry out regular inspections and any other action required to check the functioning of the shore-based telematic systems set up to meet the requirements of this Directive, and in particular their capacity to meet the requirements of receiving or sending without delay, 24 hours a day, information notified pursuant to Articles 13 and 15. 2. Member States shall lay down a system of sanctions for the breach of national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that those sanctions are applied. The sanctions thus provided shall be effective, proportionate and dissuasive. 3. Member States shall, without delay, inform the flag State and any other State concerned of measures taken in respect of ships not flying their flag pursuant to Articles 16 and 19 and to paragraph 2 of this Article. 4. Where a Member State finds, on the occasion of an incident or accident at sea referred to in Article 19, that the company has not been able to establish and maintain a link with the ship or with the coastal stations concerned, it shall so inform the State which issued the ISM document of compliance and associated safety management certificate, or on whose behalf it was issued. Where the seriousness of the failure shows the existence of a major incidence of non-compliance in the functioning of the safety management system of a company established in a Member State, the Member State which issued the document of compliance or safety management certificate to the ship shall immediately take the necessary measures against the company concerned with the view to having the document of compliance and the associated safety management certificate withdrawn. Article 26 Evaluation 1. Member States must report to the Commission by 5 February 2007 on the progress in implementing this Directive and, in particular, the provisions of Articles 9, 10, 18, 20, 22, 23 and 25. Member States must report to the Commission by 31 December 2009 on the full implementation of the Directive. 2. On the basis of the reports referred to in paragraph 1, the Commission shall report to the European Parliament and to the Council six months thereafter on the implementation of this Directive. In its reports, the Commission shall ascertain whether and to what extent the provisions of this Directive as implemented by the Member States are helping to increase the safety and efficiency of maritime transport and prevent pollution by ships. 3. The Commission shall examine the need for, and feasibility of, measures at Community level aimed at facilitating the recovery of, or compensation for, costs and damage incurred for the accommodation of ships in distress, including appropriate requirements for insurance or other financial security The Commission shall report to the European Parliament and to the Council by 5 February 2007 the results of such examination. FINAL PROVISIONS Article 27 Amendment procedure 1. The definitions in Article 3, the references to Community and IMO instruments and the Annexes may be amended in accordance with the procedure laid down in Article 28(2) in order to bring them into line with Community or international law which have been adopted, amended or brought into force, insofar as such amendments do not broaden the scope of this Directive. 2. Furthermore, Annexes I, III and IV may be amended in accordance with the procedure laid down in Article 28(2), in the light of experience gained with this Directive, in so far as such amendments do not broaden the scope of this Directive. Article 28 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 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 29 1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive by 5 February 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 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 Member States. 2. Member States shall notify to the Commission the provisions of their national legislation which they adopted in the field governed by this Directive. Article 30 Council Directive 93/75/EEC is hereby repealed as from 5 February 2004. Article 31 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 32 This Directive is addressed to the Member States.

32002L0058

2002

Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) 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 consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) 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(4) requires Member States to ensure the rights and freedoms of natural persons with regard to the processing of personal data, and in particular their right to privacy, in order to ensure the free flow of personal data in the Community. (2) This Directive seeks to respect 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 the rights set out in Articles 7 and 8 of that Charter. (3) Confidentiality of communications is guaranteed in accordance with the international instruments relating to human rights, in particular the European Convention for the Protection of Human Rights and Fundamental Freedoms, and the constitutions of the Member States. (4) 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(5) translated the principles set out in Directive 95/46/EC into specific rules for the telecommunications sector. Directive 97/66/EC has to be adapted to developments in the markets and technologies for electronic communications services in order to provide an equal level of protection of personal data and privacy for users of publicly available electronic communications services, regardless of the technologies used. That Directive should therefore be repealed and replaced by this Directive. (5) New advanced digital technologies are currently being introduced in public communications networks in the Community, which give rise to specific requirements concerning the protection of personal data and privacy of the user. The development of the information society is characterised by the introduction of new electronic communications services. Access to digital mobile networks has become available and affordable for a large public. These digital networks have large capacities and possibilities for processing personal data. The successful cross-border development of these services is partly dependent on the confidence of users that their privacy will not be at risk. (6) The Internet is overturning traditional market structures by providing a common, global infrastructure for the delivery of a wide range of electronic communications services. Publicly available electronic communications services over the Internet open new possibilities for users but also new risks for their personal data and privacy. (7) In the case of public communications networks, specific legal, regulatory and technical provisions should be made in order to protect fundamental rights and freedoms of natural persons and legitimate interests of legal persons, in particular with regard to the increasing capacity for automated storage and processing of data relating to subscribers and users. (8) Legal, regulatory and technical provisions adopted by the Member States concerning the protection of personal data, privacy and the legitimate interest of legal persons, in the electronic communication sector, should be harmonised in order to avoid obstacles to the internal market for electronic communication in accordance with Article 14 of the Treaty. Harmonisation should be limited to requirements necessary to guarantee that the promotion and development of new electronic communications services and networks between Member States are not hindered. (9) The Member States, providers and users concerned, together with the competent Community bodies, should cooperate in introducing and developing the relevant technologies where this is necessary to apply the guarantees provided for by this Directive and taking particular account of the objectives of minimising the processing of personal data and of using anonymous or pseudonymous data where possible. (10) In the electronic communications sector, Directive 95/46/EC applies in particular to all matters concerning protection of fundamental rights and freedoms, which are not specifically covered by the provisions of this Directive, including the obligations on the controller and the rights of individuals. Directive 95/46/EC applies to non-public communications services. (11) Like Directive 95/46/EC, this Directive does not address issues of protection of fundamental rights and freedoms related to activities which are not governed by Community law. Therefore it does not alter the existing balance between the individual's right to privacy and the possibility for Member States to take the measures referred to in Article 15(1) of this Directive, necessary for the protection of public security, defence, State security (including the economic well-being of the State when the activities relate to State security matters) and the enforcement of criminal law. Consequently, this Directive does not affect the ability of Member States to carry out lawful interception of electronic communications, or take other measures, if necessary for any of these purposes and in accordance with the European Convention for the Protection of Human Rights and Fundamental Freedoms, as interpreted by the rulings of the European Court of Human Rights. Such measures must be appropriate, strictly proportionate to the intended purpose and necessary within a democratic society and should be subject to adequate safeguards in accordance with the European Convention for the Protection of Human Rights and Fundamental Freedoms. (12) Subscribers to a publicly available electronic communications service may be natural or legal persons. By supplementing Directive 95/46/EC, this Directive is aimed at protecting the fundamental rights of natural persons and particularly their right to privacy, as well as the legitimate interests of legal persons. This Directive does not entail an obligation for Member States to extend the application of Directive 95/46/EC to the protection of the legitimate interests of legal persons, which is ensured within the framework of the applicable Community and national legislation. (13) The contractual relation between a subscriber and a service provider may entail a periodic or a one-off payment for the service provided or to be provided. Prepaid cards are also considered as a contract. (14) Location data may refer to the latitude, longitude and altitude of the user's terminal equipment, to the direction of travel, to the level of accuracy of the location information, to the identification of the network cell in which the terminal equipment is located at a certain point in time and to the time the location information was recorded. (15) A communication may include any naming, numbering or addressing information provided by the sender of a communication or the user of a connection to carry out the communication. Traffic data may include any translation of this information by the network over which the communication is transmitted for the purpose of carrying out the transmission. Traffic data may, inter alia, consist of data referring to the routing, duration, time or volume of a communication, to the protocol used, to the location of the terminal equipment of the sender or recipient, to the network on which the communication originates or terminates, to the beginning, end or duration of a connection. They may also consist of the format in which the communication is conveyed by the network. (16) Information that is part of a broadcasting service provided over a public communications network is intended for a potentially unlimited audience and does not constitute a communication in the sense of this Directive. However, in cases where the individual subscriber or user receiving such information can be identified, for example with video-on-demand services, the information conveyed is covered within the meaning of a communication for the purposes of this Directive. (17) For the purposes of this Directive, consent of a user or subscriber, regardless of whether the latter is a natural or a legal person, should have the same meaning as the data subject's consent as defined and further specified in Directive 95/46/EC. Consent may be given by any appropriate method enabling a freely given specific and informed indication of the user's wishes, including by ticking a box when visiting an Internet website. (18) Value added services may, for example, consist of advice on least expensive tariff packages, route guidance, traffic information, weather forecasts and tourist information. (19) The application of certain requirements relating to presentation and restriction of calling and connected line identification and to automatic call forwarding to subscriber lines connected to analogue exchanges should not be made mandatory in specific cases where such application would prove to be technically impossible or would require a disproportionate economic effort. It is important for interested parties to be informed of such cases and the Member States should therefore notify them to the Commission. (20) Service providers should take appropriate measures to safeguard the security of their services, if necessary in conjunction with the provider of the network, and inform subscribers of any special risks of a breach of the security of the network. Such risks may especially occur for electronic communications services over an open network such as the Internet or analogue mobile telephony. It is particularly important for subscribers and users of such services to be fully informed by their service provider of the existing security risks which lie outside the scope of possible remedies by the service provider. Service providers who offer publicly available electronic communications services over the Internet should inform users and subscribers of measures they can take to protect the security of their communications for instance by using specific types of software or encryption technologies. The requirement to inform subscribers of particular security risks does not discharge a service provider from the obligation to take, at its own costs, appropriate and immediate measures to remedy any new, unforeseen security risks and restore the normal security level of the service. The provision of information about security risks to the subscriber should be free of charge except for any nominal costs which the subscriber may incur while receiving or collecting the information, for instance by downloading an electronic mail message. Security is appraised in the light of Article 17 of Directive 95/46/EC. (21) Measures should be taken to prevent unauthorised access to communications in order to protect the confidentiality of communications, including both the contents and any data related to such communications, by means of public communications networks and publicly available electronic communications services. National legislation in some Member States only prohibits intentional unauthorised access to communications. (22) The prohibition of storage of communications and the related traffic data by persons other than the users or without their consent is not intended to prohibit any automatic, intermediate and transient storage of this information in so far as this takes place for the sole purpose of carrying out the transmission in the electronic communications network and provided that the information is not stored for any period longer than is necessary for the transmission and for traffic management purposes, and that during the period of storage the confidentiality remains guaranteed. Where this is necessary for making more efficient the onward transmission of any publicly accessible information to other recipients of the service upon their request, this Directive should not prevent such information from being further stored, provided that this information would in any case be accessible to the public without restriction and that any data referring to the individual subscribers or users requesting such information are erased. (23) Confidentiality of communications should also be ensured in the course of lawful business practice. Where necessary and legally authorised, communications can be recorded for the purpose of providing evidence of a commercial transaction. Directive 95/46/EC applies to such processing. Parties to the communications should be informed prior to the recording about the recording, its purpose and the duration of its storage. The recorded communication should be erased as soon as possible and in any case at the latest by the end of the period during which the transaction can be lawfully challenged. (24) Terminal equipment of users of electronic communications networks and any information stored on such equipment are part of the private sphere of the users requiring protection under the European Convention for the Protection of Human Rights and Fundamental Freedoms. So-called spyware, web bugs, hidden identifiers and other similar devices can enter the user's terminal without their knowledge in order to gain access to information, to store hidden information or to trace the activities of the user and may seriously intrude upon the privacy of these users. The use of such devices should be allowed only for legitimate purposes, with the knowledge of the users concerned. (25) However, such devices, for instance so-called "cookies", can be a legitimate and useful tool, for example, in analysing the effectiveness of website design and advertising, and in verifying the identity of users engaged in on-line transactions. Where such devices, for instance cookies, are intended for a legitimate purpose, such as to facilitate the provision of information society services, their use should be allowed on condition that users are provided with clear and precise information in accordance with Directive 95/46/EC about the purposes of cookies or similar devices so as to ensure that users are made aware of information being placed on the terminal equipment they are using. Users should have the opportunity to refuse to have a cookie or similar device stored on their terminal equipment. This is particularly important where users other than the original user have access to the terminal equipment and thereby to any data containing privacy-sensitive information stored on such equipment. Information and the right to refuse may be offered once for the use of various devices to be installed on the user's terminal equipment during the same connection and also covering any further use that may be made of those devices during subsequent connections. The methods for giving information, offering a right to refuse or requesting consent should be made as user-friendly as possible. Access to specific website content may still be made conditional on the well-informed acceptance of a cookie or similar device, if it is used for a legitimate purpose. (26) The data relating to subscribers processed within electronic communications networks to establish connections and to transmit information contain information on the private life of natural persons and concern the right to respect for their correspondence or concern the legitimate interests of legal persons. Such data may only be stored to the extent that is necessary for the provision of the service for the purpose of billing and for interconnection payments, and for a limited time. Any further processing of such data which the provider of the publicly available electronic communications services may want to perform, for the marketing of electronic communications services or for the provision of value added services, may only be allowed if the subscriber has agreed to this on the basis of accurate and full information given by the provider of the publicly available electronic communications services about the types of further processing it intends to perform and about the subscriber's right not to give or to withdraw his/her consent to such processing. Traffic data used for marketing communications services or for the provision of value added services should also be erased or made anonymous after the provision of the service. Service providers should always keep subscribers informed of the types of data they are processing and the purposes and duration for which this is done. (27) The exact moment of the completion of the transmission of a communication, after which traffic data should be erased except for billing purposes, may depend on the type of electronic communications service that is provided. For instance for a voice telephony call the transmission will be completed as soon as either of the users terminates the connection. For electronic mail the transmission is completed as soon as the addressee collects the message, typically from the server of his service provider. (28) The obligation to erase traffic data or to make such data anonymous when it is no longer needed for the purpose of the transmission of a communication does not conflict with such procedures on the Internet as the caching in the domain name system of IP addresses or the caching of IP addresses to physical address bindings or the use of log-in information to control the right of access to networks or services. (29) The service provider may process traffic data relating to subscribers and users where necessary in individual cases in order to detect technical failure or errors in the transmission of communications. Traffic data necessary for billing purposes may also be processed by the provider in order to detect and stop fraud consisting of unpaid use of the electronic communications service. (30) Systems for the provision of electronic communications networks and services should be designed to limit the amount of personal data necessary to a strict minimum. Any activities related to the provision of the electronic communications service that go beyond the transmission of a communication and the billing thereof should be based on aggregated, traffic data that cannot be related to subscribers or users. Where such activities cannot be based on aggregated data, they should be considered as value added services for which the consent of the subscriber is required. (31) Whether the consent to be obtained for the processing of personal data with a view to providing a particular value added service should be that of the user or of the subscriber, will depend on the data to be processed and on the type of service to be provided and on whether it is technically, procedurally and contractually possible to distinguish the individual using an electronic communications service from the legal or natural person having subscribed to it. (32) Where the provider of an electronic communications service or of a value added service subcontracts the processing of personal data necessary for the provision of these services to another entity, such subcontracting and subsequent data processing should be in full compliance with the requirements regarding controllers and processors of personal data as set out in Directive 95/46/EC. Where the provision of a value added service requires that traffic or location data are forwarded from an electronic communications service provider to a provider of value added services, the subscribers or users to whom the data are related should also be fully informed of this forwarding before giving their consent for the processing of the data. (33) The introduction of itemised bills has improved the possibilities for the subscriber to check the accuracy of the fees charged by the service provider but, at the same time, it may jeopardise the privacy of the users of publicly available electronic communications services. Therefore, in order to preserve the privacy of the user, Member States should encourage the development of electronic communication service options such as alternative payment facilities which allow anonymous or strictly private access to publicly available electronic communications services, for example calling cards and facilities for payment by credit card. To the same end, Member States may ask the operators to offer their subscribers a different type of detailed bill in which a certain number of digits of the called number have been deleted. (34) It is necessary, as regards calling line identification, to protect the right of the calling party to withhold the presentation of the identification of the line from which the call is being made and the right of the called party to reject calls from unidentified lines. There is justification for overriding the elimination of calling line identification presentation in specific cases. Certain subscribers, in particular help lines and similar organisations, have an interest in guaranteeing the anonymity of their callers. It is necessary, as regards connected line identification, to protect the right and the legitimate interest of the called party to withhold the presentation of the identification of the line to which the calling party is actually connected, in particular in the case of forwarded calls. The providers of publicly available electronic communications services should inform their subscribers of the existence of calling and connected line identification in the network and of all services which are offered on the basis of calling and connected line identification as well as the privacy options which are available. This will allow the subscribers to make an informed choice about the privacy facilities they may want to use. The privacy options which are offered on a per-line basis do not necessarily have to be available as an automatic network service but may be obtainable through a simple request to the provider of the publicly available electronic communications service. (35) In digital mobile networks, location data giving the geographic position of the terminal equipment of the mobile user are processed to enable the transmission of communications. Such data are traffic data covered by Article 6 of this Directive. However, in addition, digital mobile networks may have the capacity to process location data which are more precise than is necessary for the transmission of communications and which are used for the provision of value added services such as services providing individualised traffic information and guidance to drivers. The processing of such data for value added services should only be allowed where subscribers have given their consent. Even in cases where subscribers have given their consent, they should have a simple means to temporarily deny the processing of location data, free of charge. (36) Member States may restrict the users' and subscribers' rights to privacy with regard to calling line identification where this is necessary to trace nuisance calls and with regard to calling line identification and location data where this is necessary to allow emergency services to carry out their tasks as effectively as possible. For these purposes, Member States may adopt specific provisions to entitle providers of electronic communications services to provide access to calling line identification and location data without the prior consent of the users or subscribers concerned. (37) Safeguards should be provided for subscribers against the nuisance which may be caused by automatic call forwarding by others. Moreover, in such cases, it must be possible for subscribers to stop the forwarded calls being passed on to their terminals by simple request to the provider of the publicly available electronic communications service. (38) Directories of subscribers to electronic communications services are widely distributed and public. The right to privacy of natural persons and the legitimate interest of legal persons require that subscribers are able to determine whether their personal data are published in a directory and if so, which. Providers of public directories should inform the subscribers to be included in such directories of the purposes of the directory and of any particular usage which may be made of electronic versions of public directories especially through search functions embedded in the software, such as reverse search functions enabling users of the directory to discover the name and address of the subscriber on the basis of a telephone number only. (39) The obligation to inform subscribers of the purpose(s) of public directories in which their personal data are to be included should be imposed on the party collecting the data for such inclusion. Where the data may be transmitted to one or more third parties, the subscriber should be informed of this possibility and of the recipient or the categories of possible recipients. Any transmission should be subject to the condition that the data may not be used for other purposes than those for which they were collected. If the party collecting the data from the subscriber or any third party to whom the data have been transmitted wishes to use the data for an additional purpose, the renewed consent of the subscriber is to be obtained either by the initial party collecting the data or by the third party to whom the data have been transmitted. (40) Safeguards should be provided for subscribers against intrusion of their privacy by unsolicited communications for direct marketing purposes in particular by means of automated calling machines, telefaxes, and e-mails, including SMS messages. These forms of unsolicited commercial communications may on the one hand be relatively easy and cheap to send and on the other may impose a burden and/or cost on the recipient. Moreover, in some cases their volume may also cause difficulties for electronic communications networks and terminal equipment. For such forms of unsolicited communications for direct marketing, it is justified to require that prior explicit consent of the recipients is obtained before such communications are addressed to them. The single market requires a harmonised approach to ensure simple, Community-wide rules for businesses and users. (41) Within the context of an existing customer relationship, it is reasonable to allow the use of electronic contact details for the offering of similar products or services, but only by the same company that has obtained the electronic contact details in accordance with Directive 95/46/EC. When electronic contact details are obtained, the customer should be informed about their further use for direct marketing in a clear and distinct manner, and be given the opportunity to refuse such usage. This opportunity should continue to be offered with each subsequent direct marketing message, free of charge, except for any costs for the transmission of this refusal. (42) Other forms of direct marketing that are more costly for the sender and impose no financial costs on subscribers and users, such as person-to-person voice telephony calls, may justify the maintenance of a system giving subscribers or users the possibility to indicate that they do not want to receive such calls. Nevertheless, in order not to decrease existing levels of privacy protection, Member States should be entitled to uphold national systems, only allowing such calls to subscribers and users who have given their prior consent. (43) To facilitate effective enforcement of Community rules on unsolicited messages for direct marketing, it is necessary to prohibit the use of false identities or false return addresses or numbers while sending unsolicited messages for direct marketing purposes. (44) Certain electronic mail systems allow subscribers to view the sender and subject line of an electronic mail, and also to delete the message, without having to download the rest of the electronic mail's content or any attachments, thereby reducing costs which could arise from downloading unsolicited electronic mails or attachments. These arrangements may continue to be useful in certain cases as an additional tool to the general obligations established in this Directive. (45) This Directive is without prejudice to the arrangements which Member States make to protect the legitimate interests of legal persons with regard to unsolicited communications for direct marketing purposes. Where Member States establish an opt-out register for such communications to legal persons, mostly business users, the provisions of Article 7 of 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) are fully applicable. (46) The functionalities for the provision of electronic communications services may be integrated in the network or in any part of the terminal equipment of the user, including the software. The protection of the personal data and the privacy of the user of publicly available electronic communications services should be independent of the configuration of the various components necessary to provide the service and of the distribution of the necessary functionalities between these components. Directive 95/46/EC covers any form of processing of personal data regardless of the technology used. The existence of specific rules for electronic communications services alongside general rules for other components necessary for the provision of such services may not facilitate the protection of personal data and privacy in a technologically neutral way. It may therefore be necessary to adopt measures requiring manufacturers of certain types of equipment used for electronic communications services to construct their product in such a way as to incorporate safeguards to ensure that the personal data and privacy of the user and subscriber are protected. The adoption of such measures in accordance with Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity(7) will ensure that the introduction of technical features of electronic communication equipment including software for data protection purposes is harmonised in order to be compatible with the implementation of the internal market. (47) Where the rights of the users and subscribers are not respected, national legislation should provide for judicial remedies. Penalties should be imposed on any person, whether governed by private or public law, who fails to comply with the national measures taken under this Directive. (48) It is useful, in the field of application of this Directive, to draw on the experience of the Working Party on the Protection of Individuals with regard to the Processing of Personal Data composed of representatives of the supervisory authorities of the Member States, set up by Article 29 of Directive 95/46/EC. (49) To facilitate compliance with the provisions of this Directive, certain specific arrangements are needed for processing of data already under way on the date that national implementing legislation pursuant to this Directive enters into force, Article 1 Scope and aim 1. This Directive harmonises the provisions of the Member States required to ensure an equivalent level of protection of fundamental rights and freedoms, and in particular the right to privacy, with respect to the processing of personal data in the electronic communication sector and to ensure the free movement of such data and of electronic communication equipment and services in the Community. 2. The provisions of this Directive particularise and complement Directive 95/46/EC for the purposes mentioned in paragraph 1. Moreover, they provide for protection of the legitimate interests of subscribers who are legal persons. 3. This Directive shall not apply to activities which fall outside the scope of the Treaty establishing the European Community, such as those covered by Titles V and VI of the Treaty on European Union, and in any case to activities concerning public security, defence, State security (including the economic well-being of the State when the activities relate to State security matters) and the activities of the State in areas of criminal law. Article 2 Definitions Save as otherwise provided, the definitions in Directive 95/46/EC and in Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive)(8) shall apply. The following definitions shall also apply: (a) "user" means any natural person using a publicly available electronic communications service, for private or business purposes, without necessarily having subscribed to this service; (b) "traffic data" means any data processed for the purpose of the conveyance of a communication on an electronic communications network or for the billing thereof; (c) "location data" means any data processed in an electronic communications network, indicating the geographic position of the terminal equipment of a user of a publicly available electronic communications service; (d) "communication" means any information exchanged or conveyed between a finite number of parties by means of a publicly available electronic communications service. This does not include any information conveyed as part of a broadcasting service to the public over an electronic communications network except to the extent that the information can be related to the identifiable subscriber or user receiving the information; (e) "call" means a connection established by means of a publicly available telephone service allowing two-way communication in real time; (f) "consent" by a user or subscriber corresponds to the data subject's consent in Directive 95/46/EC; (g) "value added service" means any service which requires the processing of traffic data or location data other than traffic data beyond what is necessary for the transmission of a communication or the billing thereof; (h) "electronic mail" means any text, voice, sound or image message sent over a public communications network which can be stored in the network or in the recipient's terminal equipment until it is collected by the recipient. Article 3 Services concerned 1. This Directive shall apply to the processing of personal data in connection with the provision of publicly available electronic communications services in public communications networks in the Community. 2. Articles 8, 10 and 11 shall apply to subscriber lines connected to digital exchanges and, where technically possible and if it does not require a disproportionate economic effort, to subscriber lines connected to analogue exchanges. 3. Cases where it would be technically impossible or require a disproportionate economic effort to fulfil the requirements of Articles 8, 10 and 11 shall be notified to the Commission by the Member States. Article 4 Security 1. The provider of a publicly available electronic communications service must take appropriate technical and organisational measures to safeguard security of its services, if necessary in conjunction with the provider of the public communications network with respect to network security. Having regard to the state of the art and the cost of their implementation, these measures shall ensure a level of security appropriate to the risk presented. 2. In case of a particular risk of a breach of the security of the network, the provider of a publicly available electronic communications service must inform the subscribers concerning such risk and, where the risk lies outside the scope of the measures to be taken by the service provider, of any possible remedies, including an indication of the likely costs involved. Article 5 Confidentiality of the communications 1. Member States shall ensure the confidentiality of communications and the related traffic data by means of a public communications network and publicly available electronic communications services, through national legislation. In particular, they shall prohibit listening, tapping, storage or other kinds of interception or surveillance of communications and the related traffic data by persons other than users, without the consent of the users concerned, except when legally authorised to do so in accordance with Article 15(1). This paragraph shall not prevent technical storage which is necessary for the conveyance of a communication without prejudice to the principle of confidentiality. 2. Paragraph 1 shall not affect any legally authorised recording of communications and the related traffic data when carried out in the course of lawful business practice for the purpose of providing evidence of a commercial transaction or of any other business communication. 3. Member States shall ensure that the use of electronic communications networks to store information or to gain access to information stored in the terminal equipment of a subscriber or user is only allowed on condition that the subscriber or user concerned is provided with clear and comprehensive information in accordance with Directive 95/46/EC, inter alia about the purposes of the processing, and is offered the right to refuse such processing by the data controller. This shall not prevent any technical storage or access for the sole purpose of carrying out or facilitating the transmission of a communication over an electronic communications network, or as strictly necessary in order to provide an information society service explicitly requested by the subscriber or user. Article 6 Traffic data 1. Traffic data relating to subscribers and users processed and stored by the provider of a public communications network or publicly available electronic communications service must be erased or made anonymous when it is no longer needed for the purpose of the transmission of a communication without prejudice to paragraphs 2, 3 and 5 of this Article and Article 15(1). 2. Traffic data necessary for the purposes of subscriber billing and interconnection payments may be processed. Such processing is permissible only up to the end of the period during which the bill may lawfully be challenged or payment pursued. 3. For the purpose of marketing electronic communications services or for the provision of value added services, the provider of a publicly available electronic communications service may process the data referred to in paragraph 1 to the extent and for the duration necessary for such services or marketing, if the subscriber or user to whom the data relate has given his/her consent. Users or subscribers shall be given the possibility to withdraw their consent for the processing of traffic data at any time. 4. The service provider must inform the subscriber or user of the types of traffic data which are processed and of the duration of such processing for the purposes mentioned in paragraph 2 and, prior to obtaining consent, for the purposes mentioned in paragraph 3. 5. Processing of traffic data, in accordance with paragraphs 1, 2, 3 and 4, must be restricted to persons acting under the authority of providers of the public communications networks and publicly available electronic communications services handling billing or traffic management, customer enquiries, fraud detection, marketing electronic communications services or providing a value added service, and must be restricted to what is necessary for the purposes of such activities. 6. Paragraphs 1, 2, 3 and 5 shall apply without prejudice to the possibility for competent bodies to be informed of traffic data in conformity with applicable legislation with a view to settling disputes, in particular interconnection or billing disputes. Article 7 Itemised billing 1. Subscribers shall have the right to receive non-itemised bills. 2. Member States shall apply national provisions in order to reconcile the rights of subscribers receiving itemised bills with the right to privacy of calling users and called subscribers, for example by ensuring that sufficient alternative privacy enhancing methods of communications or payments are available to such users and subscribers. Article 8 Presentation and restriction of calling and connected line identification 1. Where presentation of calling line identification is offered, the service provider must offer the calling user the possibility, using a simple means and free of charge, of preventing the presentation of the calling line identification on a per-call basis. The calling subscriber must have this possibility on a per-line basis. 2. Where presentation of calling line identification is offered, the service provider must offer the called subscriber the possibility, using a simple means and free of charge for reasonable use of this function, of preventing the presentation of the calling line identification of incoming calls. 3. Where presentation of calling line identification is offered and where the calling line identification is presented prior to the call being established, the service provider must offer the called subscriber the possibility, using a simple means, of rejecting incoming calls where the presentation of the calling line identification has been prevented by the calling user or subscriber. 4. Where presentation of connected line identification is offered, the service provider must offer the called subscriber the possibility, using a simple means and free of charge, of preventing the presentation of the connected line identification to the calling user. 5. Paragraph 1 shall also apply with regard to calls to third countries originating in the Community. Paragraphs 2, 3 and 4 shall also apply to incoming calls originating in third countries. 6. Member States shall ensure that where presentation of calling and/or connected line identification is offered, the providers of publicly available electronic communications services inform the public thereof and of the possibilities set out in paragraphs 1, 2, 3 and 4. Article 9 Location data other than traffic data 1. Where location data other than traffic data, relating to users or subscribers of public communications networks or publicly available electronic communications services, can be processed, such data may only be processed when they are made anonymous, or with the consent of the users or subscribers to the extent and for the duration necessary for the provision of a value added service. The service provider must inform the users or subscribers, prior to obtaining their consent, of the type of location data other than traffic data which will be processed, of the purposes and duration of the processing and whether the data will be transmitted to a third party for the purpose of providing the value added service. Users or subscribers shall be given the possibility to withdraw their consent for the processing of location data other than traffic data at any time. 2. Where consent of the users or subscribers has been obtained for the processing of location data other than traffic data, the user or subscriber must continue to have the possibility, using a simple means and free of charge, of temporarily refusing the processing of such data for each connection to the network or for each transmission of a communication. 3. Processing of location data other than traffic data in accordance with paragraphs 1 and 2 must be restricted to persons acting under the authority of the provider of the public communications network or publicly available communications service or of the third party providing the value added service, and must be restricted to what is necessary for the purposes of providing the value added service. Article 10 Exceptions Member States shall ensure that there are transparent procedures governing the way in which a provider of a public communications network and/or a publicly available electronic communications service may override: (a) the elimination of the presentation of calling line identification, on a temporary basis, upon application of a subscriber requesting the tracing of malicious or nuisance calls. In this case, in accordance with national law, the data containing the identification of the calling subscriber will be stored and be made available by the provider of a public communications network and/or publicly available electronic communications service; (b) the elimination of the presentation of calling line identification and the temporary denial or absence of consent of a subscriber or user for the processing of location data, on a per-line basis for organisations dealing with emergency calls and recognised as such by a Member State, including law enforcement agencies, ambulance services and fire brigades, for the purpose of responding to such calls. Article 11 Automatic call forwarding Member States shall ensure that any subscriber has the possibility, using a simple means and free of charge, of stopping automatic call forwarding by a third party to the subscriber's terminal. Article 12 Directories of subscribers 1. Member States shall ensure that subscribers are informed, free of charge and before they are included in the directory, about the purpose(s) of a printed or electronic directory of subscribers available to the public or obtainable through directory enquiry services, in which their personal data can be included and of any further usage possibilities based on search functions embedded in electronic versions of the directory. 2. Member States shall ensure that subscribers are given the opportunity to determine whether their personal data are included in a public directory, and if so, which, to the extent that such data are relevant for the purpose of the directory as determined by the provider of the directory, and to verify, correct or withdraw such data. Not being included in a public subscriber directory, verifying, correcting or withdrawing personal data from it shall be free of charge. 3. Member States may require that for any purpose of a public directory other than the search of contact details of persons on the basis of their name and, where necessary, a minimum of other identifiers, additional consent be asked of the subscribers. 4. Paragraphs 1 and 2 shall apply to subscribers who are natural persons. Member States shall also ensure, in the framework of Community law and applicable national legislation, that the legitimate interests of subscribers other than natural persons with regard to their entry in public directories are sufficiently protected. Article 13 Unsolicited communications 1. The use of automated calling systems without human intervention (automatic calling machines), facsimile machines (fax) or electronic mail for the purposes of direct marketing may only be allowed in respect of subscribers who have given their prior consent. 2. Notwithstanding paragraph 1, where a natural or legal person obtains from its customers their electronic contact details for electronic mail, in the context of the sale of a product or a service, in accordance with Directive 95/46/EC, the same natural or legal person may use these electronic contact details for direct marketing of its own similar products or services provided that customers clearly and distinctly are given the opportunity to object, free of charge and in an easy manner, to such use of electronic contact details when they are collected and on the occasion of each message in case the customer has not initially refused such use. 3. Member States shall take appropriate measures to ensure that, free of charge, unsolicited communications for purposes of direct marketing, in cases other than those referred to in paragraphs 1 and 2, are not allowed either without the consent of the subscribers concerned or in respect of subscribers who do not wish to receive these communications, the choice between these options to be determined by national legislation. 4. In any event, the practice of sending electronic mail for purposes of direct marketing disguising or concealing the identity of the sender on whose behalf the communication is made, or without a valid address to which the recipient may send a request that such communications cease, shall be prohibited. 5. Paragraphs 1 and 3 shall apply to subscribers who are natural persons. Member States shall also ensure, in the framework of Community law and applicable national legislation, that the legitimate interests of subscribers other than natural persons with regard to unsolicited communications are sufficiently protected. Article 14 Technical features and standardisation 1. In implementing the provisions of this Directive, Member States shall ensure, subject to paragraphs 2 and 3, that no mandatory requirements for specific technical features are imposed on terminal or other electronic communication equipment which could impede the placing of equipment on the market and the free circulation of such equipment in and between Member States. 2. Where provisions of this Directive can be implemented only by requiring specific technical features in electronic communications networks, Member States shall inform the Commission in accordance with the procedure provided for by 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(9). 3. Where required, measures may be adopted to ensure that terminal equipment is constructed in a way that is compatible with the right of users to protect and control the use of their personal data, in accordance with Directive 1999/5/EC and Council Decision 87/95/EEC of 22 December 1986 on standardisation in the field of information technology and communications(10). Article 15 Application of certain provisions of Directive 95/46/EC 1. Member States may adopt legislative measures to restrict the scope of the rights and obligations provided for in Article 5, Article 6, Article 8(1), (2), (3) and (4), and Article 9 of this Directive when such restriction constitutes a necessary, appropriate and proportionate measure within a democratic society to safeguard national security (i.e. State security), defence, public security, and the prevention, investigation, detection and prosecution of criminal offences or of unauthorised use of the electronic communication system, as referred to in Article 13(1) of Directive 95/46/EC. To this end, Member States may, inter alia, adopt legislative measures providing for the retention of data for a limited period justified on the grounds laid down in this paragraph. All the measures referred to in this paragraph shall be in accordance with the general principles of Community law, including those referred to in Article 6(1) and (2) of the Treaty on European Union. 2. The provisions of Chapter III on judicial remedies, liability and sanctions of Directive 95/46/EC shall apply with regard to national provisions adopted pursuant to this Directive and with regard to the individual rights derived from this Directive. 3. The Working Party on the Protection of Individuals with regard to the Processing of Personal Data instituted by Article 29 of Directive 95/46/EC shall also carry out the tasks laid down in Article 30 of that Directive with regard to matters covered by this Directive, namely the protection of fundamental rights and freedoms and of legitimate interests in the electronic communications sector. Article 16 Transitional arrangements 1. Article 12 shall not apply to editions of directories already produced or placed on the market in printed or off-line electronic form before the national provisions adopted pursuant to this Directive enter into force. 2. Where the personal data of subscribers to fixed or mobile public voice telephony services have been included in a public subscriber directory in conformity with the provisions of Directive 95/46/EC and of Article 11 of Directive 97/66/EC before the national provisions adopted in pursuance of this Directive enter into force, the personal data of such subscribers may remain included in this public directory in its printed or electronic versions, including versions with reverse search functions, unless subscribers indicate otherwise, after having received complete information about purposes and options in accordance with Article 12 of this Directive. Article 17 Transposition 1. Before 31 October 2003 Member States shall bring into force the provisions necessary to comply with this Directive. 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 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 governed by this Directive and of any subsequent amendments to those provisions. Article 18 Review The Commission shall submit to the European Parliament and the Council, not later than three years after the date referred to in Article 17(1), a report on the application of this Directive and its impact on economic operators and consumers, in particular as regards the provisions on unsolicited communications, taking into account the international environment. For this purpose, the Commission may request information from the Member States, which shall be supplied without undue delay. Where appropriate, the Commission shall submit proposals to amend this Directive, taking account of the results of that report, any changes in the sector and any other proposal it may deem necessary in order to improve the effectiveness of this Directive. Article 19 Repeal Directive 97/66/EC is hereby repealed with effect from the date referred to in Article 17(1). References made to the repealed Directive shall be construed as being made to this Directive. Article 20 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 21 Addressees This Directive is addressed to the Member States.

32002L0066

2002

Commission Directive 2002/66/EC of 16 July 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 in and on fruit and vegetables, cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively (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 2000/82/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 2002/42/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 2002/42/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 2002/42/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 should 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 practicable and toxicologically acceptable, having regard, in particular to the protection of the environment and the protection of the health of consumers in terms of estimated dietary intake of consumers. In the case of foodstuffs of animal origin, residue levels should 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 to the amounts of such residues that might be found in commodities when good agricultural practices have been respected by producers. (2) MRLs for pesticides should be kept under review and the levels may be changed to take account of new information and data. MRLs should be fixed at the lower limit of analytical determination where there are no authorised uses. (3) Commission Decisions have been taken not to include active substances in Annex I to Council Directive 91/414/EEC of 15 June 1991 on the placing of plant protection products on the market(7), as last amended by Commission Directive 2002/48/EC(8) for: lindane (Commission Decision 2000/801/EC)(9), quintozene (Commission Decision 2000/816/EC)(10), permethrin (Commission Decision 2000/817/EC)(11), zineb (Commission Decision 2001/245/EC)(12) and parathion (Commission Decision 2001/520/EC)(13). These Decisions provided that plant protection products containing these active substances shall no longer be authorised for use in the Community. It is therefore necessary to add all of the pesticide residues arising from use of these plant protection products to the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC to allow for proper surveillance and control of the prohibition of their uses and to protect the consumer. Since it is not possible to discriminate in routine monitoring between zineb and other dithiocarbamates, it is not possible to set MRLs for zineb. In order to allow legitimate expectations to be fulfilled for existing stocks of pesticides to be used, the Commission non-inclusion Decisions allowed a phasing out period, and it is appropriate that MRLs premised on the notion that use of the substance concerned is not authorised in the Community, should not apply until the end of the phasing out period applying to that substance. (4) Maximum residue levels have previously been fixed in relation to lindane and parathion for some commodities, in Annex II to Directive 76/895/EEC (as amended by Commission Directive 82/528/EEC)(14), but this Directive allows Member States to establish higher MRLs. To establish harmonised maximum levels of pesticide residues for lindane and parathion in and on fruit and vegetables at Community level it is necessary to include these MRLs instead in Directive 90/642/EEC. Further, the MRLs should be amended to reflect the withdrawal of authorisations at Community level. (5) Community maximum residue levels and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are a limited number of Codex maximum residue limits for lindane, quintozene, permethrin and parathion. These have been considered in the setting of the maximum residue levels fixed in this Directive. Codex MRLs that will be recommended for withdrawal in the near future were not taken into account. The Codex MRLs for lindane 0,1 mg/kg (eggs) and 0,7 mg/kg (poultry meat) are EMRLs (extraneous residue limits). These MRLs are not set at the level which would result from current use of plant protection products, but take account of the fact that uses of the substances in the past have left residues which can be considered as contaminants. The MRLs based on Codex MRLs having been evaluated in the light of the risks for the consumers, no risk was established when using the toxicological end points based on the studies available to the Commission. The ADI for lindane is 0,001 mg/kg bw/day (JMPR 1997), no acute reference dose being considered necessary, the ADI for parathion is 0,004 mg/kg bw/day (JMPR 1995), the ARfD being 0,01 mg/kg bw/day (JMPR 1995), the ADI for permethrin is 0,05 mg/kg bw/day (JMPR 1999), no ARfD being considered necessary, the ADI for quintozene is 0,01 mg/kg bw/day (JMPR 1995), no ARfD being considered necessary. (6) The Community notified the draft Commission Directive to the World Trade Organisation and the comments received have been considered in finalising the Directive. MRLs for specific pesticide/crop combinations used in third countries could be examined by the Commission on the basis of the acceptable data submitted(15). (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 In Annex II to Directive 76/895/EEC the entries relating to lindane and parathion shall be deleted. Article 2 In the table in Part A of Annex II to Directive 86/362/EEC entries in respect of the following pesticide residues shall be added: "" Article 3 Entries in respect of the following pesticide residues shall be added to the table in part A of Annex II to Directive 86/363/EEC: "" Article 4 In the table in Annex II to Directive 90/642/EEC, the entries for pesticide residues as set out in the Annex to this Directive shall be added or modified. 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. 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 November 2002 at the latest. They shall forthwith inform the Commission thereof. 2. They shall apply these provisions as of 1 December 2002 for lindane, quintozene and permethrin and as of 1 May 2003 for parathion. 3. 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 is addressed to the Member States.

32002L0067

2002

Commission Directive 2002/67/EC of 18 July 2002 on the labelling of foodstuffs containing quinine, and of foodstuffs containing caffeine (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to 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(1), as amended by Commission Directive 2001/101/EC(2), and in particular Article 4(2) and (3) thereof, Whereas: (1) Quinine and caffeine are used in the production or preparation of certain foodstuffs, either as a flavouring or, in the case of caffeine, as an ingredient. For most consumers, the consumption of these substances in moderation is unlikely to present any health risks. (2) According to the conclusions of the Scientific Committee for Food, there is no objection from the point of view of toxicology to the continued use of quinine at a certain maximum level in bitter drinks. However, consumption of quinine may be counter-indicated for certain people for medical reasons, or because they are hypersensitive to the substance. (3) As far as caffeine is concerned, the Scientific Committee for Food, in its opinion of 21 January 1999 on caffeine and other substances used as ingredients in "energy drinks", concluded that, for adults, apart from pregnant women, the contribution of "energy drinks" to the total consumption of caffeine did not appear to be a cause for concern, assuming that "energy drinks" replace other sources of caffeine. However, for children, an increase in the daily intake of caffeine to a certain level of consumption per day may bring about temporary changes in behaviour, such as increased excitability, irritability, nervousness or anxiety. In addition, for pregnant women, the Committee's view is that moderation of caffeine intake is advisable. (4) These findings make it necessary to provide labelling which gives the consumer clear information on the presence or otherwise of quinine or caffeine in a foodstuff and, in the case of caffeine, to provide a warning message and an indication of the amount of caffeine, where this is in excess of a specific level, in beverages which do not naturally contain caffeine. (5) Directive 2000/13/EC does not provide for compulsory and specific mention of flavourings in the list of ingredients. Quinine or caffeine, used as a flavouring, might as a result not be listed by name in the ingredients. Moreover, even where caffeine is mentioned as such in the list of ingredients, there is no requirement to indicate whether the level is high. (6) Some Member States have enacted national legislation making it compulsory to mention the presence of quinine and/or caffeine on the labels of foodstuffs which contain these substances, in certain cases also stating the amount of caffeine, with a warning. The existence and application of different national legislation causes technical problems for intra-Community trade in the foodstuffs concerned. (7) It is therefore necessary, with a view to providing information for all consumers throughout the Community and to facilitating the free movement of the products in question, to introduce harmonised provisions to apply to foodstuffs containing quinine and those containing caffeine. These provisions must make it necessary to include compulsory particulars on the label in addition to those set out in Directive 2000/13/EC. (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 By derogation from Article 6(6), second subparagraph, third indent, of Directive 2000/13/EC, quinine and/or caffeine used as a flavouring in the production or preparation of a foodstuff must be mentioned by name in the list of ingredients indicated in Article 3(1)(2), of Directive 2000/13/EC, immediately after the term "flavouring". Article 2 1. Where a beverage which is intended for consumption without modification, or after reconstitution of the concentrated or dried product, contains caffeine, from whatever source, in a proportion in excess of 150 mg/l, the following message must appear on the label in the same field of vision as the name under which the product is sold: "High caffeine content". This message shall be followed, in brackets and in accordance with Article 13(2) of Directive 2000/13/EC, by the caffeine content expressed in mg/100 ml. 2. Paragraph 1 shall not apply to beverages based on coffee, tea or coffee or tea extract where the name under which the product is sold includes the term "coffee" or "tea". Article 3 1. The Member States shall permit trade in products which comply with this Directive as of 1 July 2003. 2. The Member States shall prohibit trade in products which do not comply with this Directive as of 1 July 2004. However, products which do not comply with this Directive and which were labelled before 1 July 2004 shall be authorised while stocks last. Article 4 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 June 2003. They shall forthwith inform the Commission thereof. When the Member States adopt these provisions, these 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 references shall be adopted by Member States. Article 5 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.