Datasets:

eu_regulatory_ir

like 2

31996L0069

1996

Directive 96/69/EC of the European Parliament and of the Council of 8 October 1996 amending Directive 70/220/EEC on the approximation of the laws of the Member States relating to 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 100a 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 189b of the Treaty (3), (1) Whereas measures should be adopted within the framework of the attainment of the objectives of the internal market; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; (2) Whereas the first programme of action of the European Community on protection of the environment (4), approved by the Council on 22 November 1973, called for account to be taken of the latest scientific advances in combating atmospheric pollution caused by gases emitted from motor vehicles and for Directives adopted previously to be amended accordingly; whereas the fifth programme of action, the general approach of which was approved by the Council in its resolution of 1 February 1993 (5), provides for additional efforts to be made to effect a considerable reduction in the present level of pollutants emitted from motor vehicles; (3) Whereas the objective of reducing the level of pollutant emissions from motor vehicles and the operation of the internal market for vehicles cannot be sufficiently achieved by individual Member States; whereas they can, however, be better achieved at Community level by the approximation of the laws of the Member States relating to measures to be taken against air pollution by motor vehicles; (4) Whereas it is recognized that the development of transport in the Community has entailed significant constraints for the environment and that there is a risk of increased deterioration thereof; whereas official estimates of the increase in traffic density made hitherto have been exceeded by the actual trend throughout the Community and whereas for that reason very stringent emission standards should be laid down for all motor vehicles; (5) Whereas in 1993 the Commission adopted a European programme on emissions, fuels and engine technologies (Epefe); whereas that programme was established to ensure that proposals for future Directives on pollutant emissions seek the best solutions for the environment, for the consumer and for the economy; whereas, it deals with the pollution emitted by motor vehicles and the fuels which propel them; (6) Whereas Directive 70/220/EEC (6), which deals with the measures to be taken against air pollution by emissions from motor vehicles, is one of the separate Directives under the type-approval procedure laid down by Directive 70/156/EEC (7); (7) Whereas Directive 70/220/EEC lays down the limit values for carbon monoxide and unburnt hydrocarbon emissions from the engines of such vehicles; whereas these limit values were first reduced by Council Directive 74/290/EEC (8) and supplemented, in accordance with Commission Directive 77/102/EEC (9), by limit values for permissible emissions of nitrogen oxides; whereas the limit values for those three pollutants were successively reduced by Commission Directive 78/665/EEC (10) and Council Directives 83/351/EEC (11) and 88/76/EEC (12); whereas limit values for particulate pollutant emissions from diesel engines were introduced by Directive 88/436/EEC (13); whereas more stringent European standards for emissions of gaseous pollutants from motor vehicles below 1 400 cm³ were introduced by Directive 89/458/EEC (14); whereas those standards have been extended to all passenger cars independently of their engine capacity on the basis of an improved European test procedure including an extra-urban driving cycle; whereas requirements relating to the evaporative emissions and to the durability of emission-reducing vehicle components as well as more stringent particulate pollutant standards for motor vehicles equipped with diesel engines were introduced by Directive 91/441/EEC (15); whereas passenger cars designed to carry more than six passengers, including the driver, or having a maximum mass of more than 2 500 kg, light commercial vehicles and off-road vehicles covered by Directive 70/220/EEC have, pursuant to Directive 93/59/EEC (16), been subject to standards as stringent as those for passenger cars, taking into account the specific features of such vehicles; whereas the standards for passenger cars have been rendered more stringent by Directive 94/12/EC, which also introduced a new method for checking on the conformity of production; whereas it is necessary to harmonize the standards for light commercial vehicles with those for passenger cars so as to make them at least as stringent as those for passenger cars; (8) Whereas the work undertaken by the Commission in this field has shown that the best technology currently available to the Community industry can be further improved in order to allow light commercial vehicles to comply with considerably reduced emission limits; whereas the same is true of other new technologies which are emerging; whereas the proposed standards will apply both to the approval of new vehicle types and to checks on conformity of production, since the amended method of sampling and statistical evaluation enables the tolerances allowed for the limit values set under previous stages of value reduction pursuant to Directive 70/220/EEC to be removed; (9) Whereas the Commission has examined the feasibility of amalgamating vehicle classes II and III, the actual conditions under which light commercial vehicles are driven in urban and extra-urban traffic and the special characteristics of those vehicles; (10) Whereas Member States should be allowed to expedite, by means of tax incentives, the placing on the market of vehicles which satisfy the requirements adopted at Community level, such incentives having to comply with the provisions of the Treaty and satisfy certain conditions intended to avoid distortions of the internal market; whereas this Directive does not affect the Member States' right to include emissions of pollutants and other substances in the basis on which road traffic taxes on motor vehicles are calculated; (11) Whereas the prior notification requirement of this Directive stands without prejudice to notification requirements under other provisions of Community law, notably Article 93 (3) of the Treaty; (12) Whereas it is appropriate that the European Parliament and the Council should adopt, by 31 December 1997, the requirements valid for the stage beginning in 2000, on the basis of a proposal which the Commission must submit by 30 June 1996 and which is to be aimed at substantially reducing emissions from light commercial vehicles; (13) Whereas the measures to reduce air pollution emissions from the year 2000 must form part of an integrated and multidirectional approach embracing all measures for reducing air pollution due to road traffic; whereas all the parameters set out in Article 4 of Directive 94/12/EC are relevant; whereas, for the requirements valid as from the year 2000, the aim should be, for light commercial vehicles, to lay down standards of equivalent stringency to those laid down for passenger cars employing an emission reduction technology of a uniform technical level, account being taken of the special characteristics of light commercial vehicles and, for vehicles of category N1, classes II and III, of the need to take into consideration any appropriate stipulations as to durability; whereas the Commission must undertake an analysis of the environmental, technological and cost-efficiency aspects and provide, by the end of June 1996, quantified objectives for the adoption of Community measures applicable from the year 2000, Article 1 Annex I to Directive 70/220/EEC shall be amended in accordance with the Annex to this Directive. Article 2 1. With effect from 1 October 1996, Member States must accept compliance with the requirements of Directive 70/220/EEC, as amended by this Directive, for the purposes of Articles 4 (1) and 7 (1) of Directive 70/156/EEC. 2. With effect from 1 January 1997 for vehicles of class I and with effect from 1 January 1998 for vehicles of classes II and III, Member States may no longer grant: - EC type-approval in accordance with Article 4 (1) of Directive 70/156/EEC, or - national type-approval, except where the provisions of Article 8 (2) of Directive 70/156/EEC are invoked, for a vehicle type on grounds related to air pollution by engine emissions, if it fails to comply with Directive 70/220/EEC, as amended by this Directive. 3. With effect from 1 October 1997 for vehicles of class I and with effect from 1 October 1998 for vehicles of classes II and III, Member States must: - consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 70/156/EEC as no longer valid for the purposes of Article 7 (1) of that Directive; and - refuse the registration, sale or entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 70/156/EEC, except where the provisions of Article 8 (2) of Directive 70/156/EEC are invoked, on grounds relating to air pollution by engine emissions, if the requirements of Directive 70/220/EEC, as amended by this Directive, are not fulfilled. Article 3 Member States may make provision for tax incentives only in respect of motor vehicles which comply with Directive 70/220/EEC, as amended by this Directive. Such incentives must comply with the provisions of the Treaty and satisfy the following conditions: - they shall be valid for all new vehicles offered for sale on the market of a Member State which comply in advance with the requirements of Directive 70/220/EEC, as amended by this Directive, - they shall cease on the dates set in Article 2 (3) for the mandatory application of emission values for new motor vehicles, - for each type of motor vehicle they shall be for an amount lower than the additional cost of the technical devices introduced to ensure compliance with the values set and their installation on the vehicle. The Commission shall be informed of any plans to institute or change the tax incentives referred to in the first paragraph in sufficient time to submit its observations. Article 4 The European Parliament and the Council, acting under the conditions laid down in the Treaty, shall decide by 31 December 1997 on proposals, to be submitted by the Commission by 30 June 1996, for a further stage in the reduction, by the adoption of Community measures, of air pollution caused by emissions from motor vehicles covered by this Directive. The measures will apply from the year 2000. In these proposals, the Commission will follow the approach outlined in Article 4 of Directive 94/12/EC. Article 5 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 October 1996. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. 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.

31996L0065

1996

Commission Directive 96/65/EC of 11 October 1996 adapting to technical progress for the fourth time Council Directive 88/379/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations and modifying Directive 91/442/EEC on dangerous preparations the packaging of which must be fitted with child-resistant fastenings (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (1), as last amended by Commission Directive 93/18/EEC (2), and in particular Articles 6 and 15 thereof, Whereas Annex VI to Council Directive 67/548/EEC (3), as last amended by Commission Directive 96/54/EC (4), provides for new criteria and a new R phrase for 'Aspiration hazard` under the category of danger 'harmful`, and in particular R phrase 65; Whereas the provisions set out in Annex I to Directive 88/379/EEC, should therefore be supplemented; Whereas the Annex to Commission Directive 91/442/EEC (5) defines, in accordance with Article 6 of Directive 88/379/EEC, the characteristics of certain preparations which shall be fitted with child resistant fastenings; whereas these characteristics should be revised to correspond to the criteria for 'Aspiration hazard` of Annex VI to Directive 67/548/EEC. Whereas the provisions of 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 88/379/EEC is completed by a new paragraph 1.3. as in Annex I of this Directive. Article 2 Directive 91/442/EEC is modified as follows: - Article 2 of Directive 91/442/EEC is replaced by the following Article: 'Article 2 The provisions of Articles 1 and 2 of Directive 90/35/EEC and those of Article 1 of this Directive, with the exception of the preparations characterized in point (a) of the Annex, shall also apply to preparations offered or sold to the general public in the form of aerosols or in containers fitted with a sealed spray attachment.`, - the Annex is replaced by Annex II to this Directive. Article 3 1. The Member States shall bring into force the provisions necessary to comply with this Directive no later than 31 May 1998 and shall forthwith inform the Commission thereof. 2. This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. 3. 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 4 This Directive is addressed to the Member States.

31996L0067

1996

Council Directive 96/67/EC of 15 October 1996 on access to the groundhandling market at Community airports Having regard to the Treaty establishing the European Community, and in particular Article 84 (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 189c of the Treaty (3), (1) Whereas the Community has gradually introduced a common air transport policy with the aim of completing the internal market in accordance with Article 7a of the Treaty as a lasting contribution to promoting economic and social progress; (2) Whereas the objective of Article 59 of the Treaty is to eliminate the restrictions on freedom to provide services in the Community; whereas, in accordance with Article 61 of the Treaty, that objective must be achieved within the framework of the common transport policy; (3) Whereas through Council Regulations (EEC) No 2407/92 (4), (EEC) No 2408/92 (5) and (EEC) No 2409/92 (6) that objective has been attained with regard to air transport services as such; (4) Whereas groundhandling services are essential to the proper functioning of air transport; whereas they make an essential contribution to the efficient use of air transport infrastructure; (5) Whereas the opening-up of access to the groundhandling market should help reduce the operating costs of airline companies and improve the quality of service provided to airport users; (6) Whereas in the light of the principle of subsidiarity it is essential that access to the groundhandling market should take place within a Community framework, while allowing Member States the possibility of taking into consideration the specific nature of the sector; (7) Whereas in its communication of June 1994 entitled 'The way forward for civil aviation in Europe` the Commission indicated its intention of taking an initiative before the end of 1994 in order to achieve access to the groundhandling market at Community airports; whereas the Council, in its resolution of 24 October 1994 on the situation in European civil aviation (7), confirmed the need to take account of the imperatives linked to the situation of airports when opening up the market; (8) Whereas, in its resolution of 14 February 1995 on European civil aviation (8), the European Parliament repeated its concern that account should be taken of the impact of access to the groundhandling market on employment and safety conditions at Community airports; (9) Whereas free access to the groundhandling market is consistent with the efficient operation of Community airports; (10) Whereas free access to the groundhandling market must be introduced gradually and be adapted to the requirements of the sector; (11) Whereas for certain categories of groundhandling services access to the market and self-handling may come up against safety, security, capacity and available-space constraints; whereas it is therefore necessary to be able to limit the number of authorized suppliers of such categories of groundhandling services; whereas it should also be possible to limit self-handling; whereas, in that case, the criteria for limitation must be relevant, objective, transparent and non-discriminatory; (12) Whereas if the number of suppliers of groundhandling services is limited effective competition will require that at least one of the suppliers should ultimately be independent of both the managing body of the airport and the dominant carrier; (13) Whereas if airports are to function properly they must be able to reserve for themselves the management of certain infrastructures which for technical reasons as well as for reasons of profitability or environmental impact are difficult to divide or duplicate; whereas the centralized management of such infrastructures may not, however, constitute an obstacle to their use by suppliers of groundhandling services or by self-handling airport users; (14) Whereas in certain cases these constraints can be such that they may justify restrictions on market access or on self-handling to the extent that these restrictions are relevant, objective, transparent and non-discriminatory; (15) Whereas the purpose of such exemptions must be to enable airport authorities to overcome or at least reduce these constraints; whereas these exemptions must be approved by the Commission, assisted by an advisory committee, and must be granted for a specific period; (16) Whereas, if effective and fair competition is to be maintained where the number of suppliers of ground-handling services is limited, the latter need to be chosen according to a transparent and impartial procedure; whereas airport users should be consulted when it comes to selecting suppliers of ground-handling services, since they have a major interest in the quality and price of the ground-handling services which they require; (17) Whereas it is therefore necessary to arrange for the representation of airport users and their consultation when authorized suppliers of ground-handling services are selected, by setting up a committee composed of their representatives; (18) Whereas it is possible in certain circumstances and under specific conditions, in the context of selecting suppliers of ground-handling services at an airport, to extend the public service obligation to other airports in the same geographical region of the Member State concerned; (19) Whereas the managing body of the airport may also supply ground-handling services and, through its decisions, may exercise considerable influence on competition between suppliers of ground-handling services; whereas it is therefore essential, in order to maintain fair competition, that airports be required to keep separate accounts for their infrastructure management and regulatory activities on the one hand and for the supply of ground-handling services on the other; (20) Whereas an airport may not subsidize its ground-handling activities from the revenue it derives from its role as an airport authority; (21) Whereas the same transparency requirements must apply to all suppliers wishing to offer ground-handling services to third parties; (22) Whereas, in order to enable airports to fulfil their infrastructure management functions and to guarantee safety and security on the airport premises as well as to protect the environment and the social regulations in force, Member States must be able to make the supply of ground-handling services subject to approval; whereas the criteria for granting such approval must be objective, transparent and non-discriminatory; (23) Whereas, for the same reasons, Member States must retain the power to lay down and enforce the necessary rules for the proper functioning of the airport infrastructure; whereas those rules must relate to the intended objective and must not in practice reduce market access or the freedom to self-handle to a level below that provided for in this Directive; whereas the rules must comply with the principles of objectivity, transparency and non-discrimination; (24) Whereas Member States must retain the power to ensure an adequate level of social protection for the staff of undertakings providing ground-handling services; (25) Whereas access to airport installations must be guaranteed to suppliers authorized to provide ground-handling services and to airport users authorized to self-handle, to the extent necessary for them to exercise their rights and to permit fair and genuine competition; whereas it must be possible however, for such access to give rise to the collection of a fee; (26) Whereas it is justified that the rights recognized by this Directive should only apply to third-country suppliers of ground-handling services and third-country airport users subject to strict reciprocity; whereas where there is no such reciprocity the Member State should be able to suspend these rights with regard to those suppliers and users; (27) Whereas arrangements for greater cooperation over the use of Gibraltar airport were agreed in London on 2 December 1987 by the Kingdom of Spain and the United Kingdom in a joint declaration by the Ministers of Foreign Affairs of the two countries, and such arrangements have yet to come into operation; (28) Whereas this Directive does not affect the application of the rules of the Treaty; whereas in particular the Commission will continue to ensure compliance with these rules by exercising, when necessary, all the powers granted to it by Article 90 of the Treaty, Article 1 Scope 1. This Directive applies to any airport located in the territory of a Member State, subject to the provisions of the Treaty, and open to commercial traffic in the following circumstances: (a) The provisions of Article 7 (1) relating to categories of ground-handling services other than those referred to in Article 7 (2) shall apply to any airport regardless of its volume of traffic as from 1 January 1998. (b) The provisions relating to the categories of groundhandling services referred to in Article 7 (2) shall apply as from 1 January 1998 to airports whose annual traffic is not less than 1 million passenger movements or 25 000 tonnes of freight. (c) The provisions relating to the categories of groundhandling services referred to in Article 6 shall apply as from 1 January 1999 to airports: - whose annual traffic is not less than 3 million passenger movements or 75 000 tonnes of freight; or - whose traffic has been not less than 2 million passenger movements or 50 000 tonnes of freight during the six-month period prior to 1 April or 1 October of the preceding year. 2. Without prejudice to paragraph 1, the provisions of this Directive shall apply as from 1 January 2001 to any airport located in the territory of a Member State, subject to the provisions of the Treaty, and open to commercial traffic, whose annual traffic is not less than 2 million passenger movements or 50 000 tonnes of freight. 3. Where an airport reaches one of the freight traffic thresholds referred to in this Article without reaching the corresponding passenger movement threshold, the provisions of this Directive shall not apply to categories of groundhandling services reserved exclusively for passengers. 4. The Commission shall publish, for information, in the Official Journal of the European Communities a list of the airports referred to in this Article. The list shall first be published within three months following the entry into force of this Directive, and thereafter annually. Member States shall, before 1 July of each year, forward to the Commission the data required to compile the list. 5. Application of this Directive to the airport of Gibraltar is understood to be without prejudice to the respective legal positions of the Kingdom of Spain and the United Kingdom with regard to the dispute over sovereignty over the territory in which the airport is situated. 6. Application of this Directive to Gibraltar airport shall be suspended until the arrangements in the joint declaration made by the Foreign Ministers of the Kingdom of Spain and the United Kingdom on 2 December 1987 have come into operation. The Governments of Spain and the United Kingdom will so inform the Council on that date. Article 2 Definitions For the purposes of this Directive: (a) 'airport` means any area of land especially adapted for the landing, taking-off and manoeuvres of aircraft, including the ancillary installations which these operations may involve for the requirements of aircraft traffic and services including the installations needed to assist commercial air services; (b) 'airport system` means two or more airports grouped together to serve the same city or conurbation, as referred to in Annex II to Council Regulation (EEC) No 2408/92 of 23 July 1992 on access for Community air carriers to intra-Community air routes; (c) 'managing body of the airport` means a body which, in conjuntion with other activities or not as the case may be, has as its objective under national law or regulation the administration and management of the airport infrastructures, and the coordination and control of the activities of the different operators present in the airport or airport system concerned; (d) 'airport user` means any natural or legal person responsible for the carriage of passengers, mail and/or freight by air from, or to the airport in question; (e) 'groundhandling` means the services provided to airport users at airports as described in the Annex; (f) 'self-handling` means a situation in which an airport user directly provides for himself one or more categories of groundhandling services and concludes no contract of any description with a third party for the provision of such services; for the purposes of this definition, among themselves airport users shall not be deemed to be third parties where: - one holds a majority holding in the other; or - a single body has a majority holding in each; (g) 'supplier of groundhandling services` means any natural or legal person supplying third parties with one or more categories of groundhandling services. Article 3 Managing body of the airport 1. Where an airport or airport system is managed and operated not by a single body but by several separate bodies, each of these bodies shall be considered part of the managing body of the airport for the purposes of this Directive. 2. Similarly, where only a single managing body is set up for several airports or airport systems, each of those airports or airport systems shall be considered separately for the purposes of this Directive. 3. If the managing bodies of airports are subject to the supervision or control of a national public authority, that authority shall be obliged, in the context of the legal obligations devolving upon it, to ensure that this Directive is applied. Article 4 Separation of accounts 1. Where the managing body of an airport, the airport user or the supplier of groundhandling services provide groundhandling services, they must rigorously separate the accounts of their groundhandling activities from the accounts of their other activities, in accordance with current commercial practice. 2. An independent examiner appointed by the Member State must check that this separation of accounts is carried out. The examiner shall also check the absence of financial flows between the activity of the managing body as airport authority and its groundhandling activity. Article 5 Airport Users' Committee 1. Twelve months at the latest following the entry into force of this Directive, Member States shall ensure that, for each of the airports concerned, a committee of representatives of airport users or organizations representing airport users is set up. 2. All airport users shall have the right to be on this committee, or, if they so wish, to be represented on it by an organization appointed to that effect. Article 6 Groundhandling for third parties 1. Member States shall take the necessary measures in accordance with the arrangements laid down in Article 1 to ensure free access by suppliers of groundhandling services to the market for the provision of groundhandling services to third parties. Member States shall have the right to require that suppliers of groundhandling services be established within the Community. 2. Member States may limit the number of suppliers authorized to provide the following categories of groundhandling services: - baggage handling, - ramp handling, - fuel and oil handling, - freight and mail handling as regards the physical handling of freight and mail, whether incoming, outgoing or being transferred, between the air terminal and the aircraft. They may not, however, limit this number to fewer than two for each category of groundhandling service. 3. Moreover, as from 1 January 2001 at least one of the authorized suppliers may not be directly or indirectly controlled by: - the managing body of the airport, - any airport user who has carried more than 25 % of the passengers or freight recorded at the airport during the year preceding that in which those suppliers were selected, - a body controlling or controlled directly or indirectly by that managing body or any such user. However at 1 July 2000, a Member State may request that the obligation in this paragraph be deferred until 31 December 2002. The Commission, assisted by the Committee referred to in Article 10, shall examine such request and may, having regard to the evolution of the sector and, in particular, the situation at airports comparable in terms of traffic volume and pattern, decide to grant the said request. 4. Where pursuant to paragraph 2 they restrict the number of authorized suppliers, Member States may not prevent an airport user, whatever part of the airport is allocated to him, from having, in respect of each category of groundhandling service subject to restriction, an effective choice between at least two suppliers of groundhandling services, under the conditions laid down in paragraphs 2 and 3. Article 7 Self-handling 1. Member States shall take the necessary measures in accordance with the arrangements laid down in Article 1 to ensure the freedom to self-handle. 2. However, for the following categories of groundhandling services: - baggage handling, - ramp handling, - fuel and oil handling, - freight and mail handling as regards the physical handling of freight and mail, whether incoming, outgoing or being transferred, between the air terminal and the aircraft, Member States may reserve the right to self-handle to no fewer than two airport users, provided they are chosen on the basis of relevant, objective, transparent and non-discriminatory criteria. Article 8 Centralized infrastructures 1. Notwithstanding the application of Articles 6 and 7, Member States may reserve for the managing body of the airport or for another body the management of the centralized infrastructures used for the supply of groundhandling services whose complexity, cost or environmental impact does not allow of division or duplication, such as baggage sorting, de-icing, water purification and fuel-distribution systems. They may make it compulsory for suppliers of groundhandling services and self-handling airport users to use these infrastructures. 2. Member States shall ensure that the management of these infrastructures is transparent, objective and non-discriminatory and, in particular, that it does not hinder the access of suppliers of groundhandling services or self-handling airport users within the limits provided for in this Directive. Article 9 Exemptions 1. Where at an airport, specific constraints of available space or capacity, arising in particular from congestion and area utilization rate, make it impossible to open up the market and/or implement self-handling to the degree provided for in this Directive, the Member State in question may decide: (a) to limit the number of suppliers for one or more categories of groundhandling services other than those referred to in Article 6 (2) in all or part of the airport; in this case the provisions of Article 6 (2) and (3) shall apply; (b) to reserve to a single supplier one or more of the categories of groundhandling services referred to in Article 6 (2); (c) to reserve self-handling to a limited number of airport users for categories of groundhandling services other than those referred to in Article 7 (2), provided that those users are chosen on the basis of relevant, objective, transparent and non-discriminatory criteria; (d) to ban self-handling or to restrict it to a single airport user for the categories of groundhandling services referred to in Article 7 (2). 2. All exemptions decided pursuant to paragraph 1 must: (a) specify the category or categories of groundhandling services for which the exemption is granted and the specific constraints of available space or capacity which justify it; (b) be accompanied by a plan of appropriate measures to overcome the constraints. Moreover, exemptions must not: (i) unduly prejudice the aims of this Directive; (ii) give rise to distortions of competition between suppliers of groundhandling services and/or self-handling airport users; (iii) extend further than necessary. 3. Member States shall notify the Commission, at least three months before they enter into force, of any exemptions they grant on the basis of paragraph 1 and of the grounds which justify them. The Commission shall publish a summary of the decisions of which it is notified in the Official Journal of the European Communities and shall invite interested parties to submit comments. 4. The Commission shall examine closely exemption decisions submitted by Member States. To that end the Commission shall make a detailed analysis of the situation and a study of the appropriate measures submitted by the Member State to check that the alleged constraints exist and that it is impossible to open up the market and/or implement self-handling to the degree provided for in this Directive. 5. Further to that examination and after consulting the Member State concerned, the Commission may approve the Member State's decision or oppose it if it deems that the alleged constraints have not been proved to exist or that they are not so severe as to justify the exemption. After consulting the Member State concerned the Commission may also require the Member State to amend the extent of the exemption or restrict it to those parts of an airport or airport system where the alleged constraints have been proved to exist. The Commission's decision shall be taken no later than three months after notification by the Member State and shall be published in the Official Journal of the European Communities. 6. Exemptions granted by Member States pursuant to paragraph 1 may not exceed a duration of three years except for exemptions granted under paragraph 1 (b). Not later than three months before the end of that period the Member State must take a new decision on any request for exemption, which will also be subject to the procedure laid down in this Article. Exemptions under paragraph 1 (b) may not exceed a duration of two years. However, a Member State may on the basis of the provisions of paragraph 1 request that this period be extended by a single period of two years. The Commission, assisted by the Committee referred to in Article 10, shall decide on such request. Article 10 Advisory Committee 1. The Commission shall be assisted by an advisory committee made up of representatives of the Member States and chaired by the representative of the Commission. 2. The Committee shall advise the Commission on the application of Article 9. 3. The Committee may furthermore be consulted by the Commission on any other matter concerning the application of this Directive. 4. The Committee shall establish its own rules of procedure. Article 11 Selection of suppliers 1. Member States shall take the necessary measures for the organization of a selection procedure for suppliers authorized to provide groundhandling services at an airport where their number is limited in the cases provided for in Article 6 (2) or Article 9. This procedure must comply with the following principles: (a) In cases where Member States require the establishment of standard conditions or technical specifications to be met by the suppliers of groundhandling services, those conditions or specifications shall be established following consultation with the Airport Users' Committee. The selection criteria laid down in the standard conditions or technical specifications must be relevant, objective, transparent and non-discriminatory. After having notified the Commission, the Member State concerned may include among the standard conditions or technical specifications with which suppliers of groundhandling services must comply a public service obligation in respect of airports serving peripheral or developing regions which are part of its territory, which have no commercial interest but which are of vital importance for the Member State concerned. (b) An invitation to tender must be launched and published in the Official Journal of the European Communities, to which any interested supplier of groundhandling services may reply. (c) Suppliers of groundhandling services shall be chosen: (i) following consultation with the Airport Users' Committee by the managing body of the airport, provided the latter: - does not provide similar groundhandling services; and - has no direct or indirect control over any undertaking which provides such services; and - has no involvement in any such undertaking; (ii) in all other cases, by competent authorities of the Member States which are independent of the managing body of the airport concerned, and which shall first consult the Airport Users' Committee and that managing body. (d) Suppliers of groundhandling services shall be selected for a maximum period of seven years. (e) Where a supplier of groundhandling services ceases his activity before the end of the period for which he was selected, he shall be replaced on the basis of the same procedure. 2. Where the number of suppliers of groundhandling services is limited in accordance with Article 6 (2) or Article 9, the managing body of the airport may itself provide groundhandling services without being subject to the selection procedure laid down in paragraph 1. Similarly, it may, without submitting it to the said procedure, authorize an undertaking to provide groundhandling services at the airport in question: - if it controls that undertaking directly or indirectly; or - if the undertaking controls it directly or indirectly. 3. The managing body of the airport shall inform the Airport Users' Committee of decisions taken under this Article. Article 12 Island airports In the context of the selection of suppliers of groundhandling services at an airport as provided for in Article 11, a Member State may extend the obligation of public service to other airports in that Member State provided: - those airports are located on islands in the same geographical region; and - such airports each have a traffic volume of no less than 100 000 passenger movements per year; and - such an extension is approved by the Commission with the assistance of the Committee referred to in Article 10. Article 13 Consultations Member States shall see to it that a compulsory consultation procedure relating to the application of this Directive is organized between the managing body of the airport, the Airport Users' Committee and the undertakings providing groundhandling services. This consultation shall cover, inter alia, the price of those groundhandling services for which an exemption has been granted pursuant to Article 9 (1) (b) and the organization of the provision of those services. Such consultation shall be organized at least once a year. Article 14 Approval 1. Member States may make the groundhandling activity of a supplier of groundhandling services or a self-handling user at an airport conditional upon obtaining the approval of a public authority independent of the managing body of the airport. The criteria for such approval must relate to a sound financial situation and sufficient insurance cover, to the security and safety of installations, of aircraft, of equipment and of persons, as well as to environmental protection and compliance with the relevant social legislation. The criteria must comply with the following principles: (a) they must be applied in a non-discriminatory manner to the various suppliers of groundhandling services and airport users; (b) they must relate to the intended objective; (c) they may not, in practice, reduce market access or the freedom to self-handle to a level below that provided for in this Directive. These criteria shall be made public and the supplier of groundhandling services or self-handling airport user shall be informed in advance of the procedure for obtaining approval. 2. The approval may be withheld or withdrawn only if the supplier of groundhandling services or self-handling airport user does not meet, for reasons of his own doing, the criteria referred to in paragraph 1. The grounds for witholding or withdrawal must be communicated to the supplier or user concerned and to the managing body of the airport. Article 15 Rules of conduct A Member State may, where appropriate on a proposal from the managing body of the airport: - prohibit a supplier of groundhandling services or an airport user from supplying groundhandling services or self-handling if that supplier or user fails to comply with the rules imposed upon him to ensure the proper functioning of the airport; Those rules must comply with the following principles: (a) they must be applied in a non-discriminatory manner to the various suppliers of groundhandling services and airport users; (b) they must relate to the intended objective; (c) they may not, in practice, reduce market access or the freedom to self-handle to a level below that provided for in this Directive; - in particular require suppliers of groundhandling services at an airport to participate in a fair and non-discriminatory manner in carrying out the public service obligations laid down in national laws or rules, including the obligation to ensure continuous service. Article 16 Access to installations 1. Member States shall take the necessary measures to ensure that suppliers of groundhandling services and airport users wishing to self-handle have access to airport installations to the extent necessary for them to carry out their activities. If the managing body of the airport or, where appropriate, the public authority or any other body which controls it places conditions upon such access, those conditions must be relevant, objective, transparent and non-discriminatory. 2. The space available for groundhandling at an airport must be divided among the various suppliers of groundhandling services and self-handling airport users, including new entrants in the field, to the extent necessary for the exercise of their rights and to allow effective and fair competition, on the basis of the relevant, objective, transparent and non-discriminatory rules and criteria. 3. Where access to airport installations gives rise to the collection of a fee, the latter shall be determined according to relevant, objective, transparent and non-discriminatory criteria. Article 17 Safety and security The provisions of this Directive in no way affect the rights and obligations of Member States in respect of law and order, safety and security at airports. Article 18 Social and environmental protection Without prejudice to the application of this Directive, and subject to the other provisions of Community law, Member States may take the necessary measures to ensure protection of the rights of workers and respect for the environment. Article 19 Compliance with national provisions A supplier of groundhandling services at an airport in a Member State shall be required to comply with the provisions of national law which are compatible with Community law. Article 20 Reciprocity 1. Without prejudice to the international commitments of the Community, whenever it appears that a third country, with respect to access to the groundhandling or self-handling market: (a) does not, de jure or de facto, grant suppliers of groundhandling services and self-handling airport users from a Member State treatment comparable to that granted by Member States to suppliers of groundhandling services and self-handling airport users from that country; or (b) does not, de jure or de facto, grant suppliers of groundhandling services and self-handling airport users from a Member State national treatment; or (c) grants suppliers of groundhandling services and self-handling airport users from other third countries more favourable treatment than suppliers of groundhandling services and self-handling airport users from a Member State; a Member State may wholly or partially suspend the obligations arising from this Directive in respect of suppliers of groundhandling services and airport users from that third country, in accordance with Community law. 2. The Member State concerned shall inform the Commission of any withdrawal or suspension of rights or obligations. Article 21 Right of appeal Member States or, where appropriate, managing bodies of airports shall ensure that any party with a legitimate interest has the right to appeal against the decisions or individual measures taken pursuant to Articles 7 (2) and 11 to 16. It must be possible to bring the appeal before a national court or a public authority other than the managing body of the airport concerned and, where appropriate, independent of the public authority controlling it. Article 22 Information report and revision Member States shall communicate to the Commission the information required by it to draw up a report on the application of this Directive. The report, accompanied by any proposals for revision of the Directive, shall be drawn up not later than 31 December 2001. Article 23 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than one year from the date of its publication in the Official Journal of the European Communities. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 24 Entry into force This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 25 Addressees This Directive is addressed to the Member States.

31996L0072

1996

Council Directive 96/72/EC of 18 November 1996 amending Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 69/208/EEC and 70/458/EEC on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, seed of oil and fibre plants and vegetable seed Having regard to the Treaty establishing the European Community, and in particular Article 43 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 Article G of the Treaty on European Union replaced the term 'European Economic Community` by the term 'European Community`; whereas the abbreviation 'EEC` should therefore be replaced by the abbreviation 'EC`; Whereas the abbreviation 'EEC` appears in certain provisions of Directives 66/400/EEC (4), 66/401/EEC (5), 66/402/EEC (6), 66/403/EEC (7), 69/208/EEC (8), and 70/458/EEC (9) on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, seed of oil and fibre plants and vegetable seed and in particular in relation to packages and the labelling of seeds; whereas it is therefore appropriate to replace the abbreviation 'EEC` by the abbreviation 'EC` in the said provisions; Whereas, however, large stocks of labels are usually ordered in advance and those still bearing the abbreviation 'EEC` should, for a phasing-in period, continue to be allowed to be used, Article 1 Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 69/208/EEC and 70/458/EEC shall be amended as follows: 1. In Directive 66/400/EEC, the abbreviation 'EEC` in: - Article 2. 1. G., - Article 10 (1), (2) and (3), - Article 11 (1), - Article 11a (1) and (2), - Article 11b, - Article 14 (1) second indent, and - Annex III A I and B, title and point 1, shall be replaced by the abbreviation 'EC`. 2. In Directive 66/401/EEC, the abbreviation 'EEC` in: - Article 2. 1. F and G, - Article 9 (1), (2) and (3), - Article 10 (1), - Article 10a (1) and (2), - Article 10b, - Article 13 (3), - Article 14 (1) third indent, - Annex IV A I (a) 1 and (b) 1, and - Annex IV B, title, point (a) 1, point (b) 1 and point (c) 1, 3, 4, 5, 6 and 7, shall be replaced by the abbreviation 'EC`. 3. In Directive 66/402/EEC, the abbreviation 'EEC` in Annex IV A, (a) 1 shall be replaced by the abbreviation 'EC`. 4. In Directive 66/403/EEC, the abbreviation 'EEC` in Annex III, A, 1 shall be replaced by the abbreviation 'EC`. 5. In Directive 69/208/EEC, the abbreviation 'EEC` in Annex IV, A, (a) 1 and Annex IV, A, (b) 1 shall be replaced by the abbreviation 'EC`. 6. In Directive 70/458/EEC the abbreviation 'EEC` in: - Article 25 (1), and - Annex IV, A, (a) 1 and B, (a) 1, shall be replaced by the abbreviation 'EC`. Article 2 Remaining stocks of labels bearing the abbreviation 'EEC` may continue to be used until 31 December 2001. Article 3 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive on 1 July 1997. 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 immediately communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. 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.

31996L0077

1996

Commission Directive 96/77/EC of 2 December 1996 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 authorized for use in foodstuffs intended for human consumption (1), as amended by European Parliament and Council Directive 94/34/EC (2), and in particular Article 3 (3) (a) thereof, After consulting the Scientific Committee for Food, Whereas it is necessary to establish purity criteria for all additives other than colours and sweeteners mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (3); Whereas it is necessary to replace the purity criteria set out in Council Directive 65/66/EEC of 26 January 1965 laying down specific criteria of purity for preservatives authorized for use in foodstuffs intended for human consumption (4), as last amended by Directive 86/604/EEC (5); Whereas it is necessary to replace the purity criteria set out in Council Directive 78/664/EEC of 25 July 1978 laying down specific criteria of purity for antioxidants which may be used in foodstuffs intended for human consumption (6), as amended by Directive 82/712/EEC (7); Whereas Directives 65/66/EEC and 78/664/EEC should be repealed accordingly; Whereas 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); Whereas food additives, if prepared by production methods or starting materials significantly different from those included in the evaluation of the Scientific Committee for Food, or if different from those mentioned in this Directive, should be submitted for evaluation by the Scientific Committee for Food for the purposes of a full evaluation with emphasis on the purity criteria; Whereas, the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Foodstuffs, Article 1 The purity criteria referred to in Article 3 (3) (a) of Directive 89/107/EEC for food additives other than colours and sweeteners, as mentioned in Directive 95/2/EC, are set out in the Annex hereto. Article 2 Directives 65/66/EEC and 78/664/EEC are hereby repealed. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1997. 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. 2. Products put on the market or labelled before 1 July 1997 which do not comply with this Directive may be marketed until stocks are exhausted. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31996L0078

1996

Commission Directive 96/78/EC of 6 December 1996 amending certain Annexes to Council Directive 77/93/EEC 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 77/93/EEC of 21 December 1976 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 96/14/EC (2), and in particular Article 13, second subparagraph, fourth indent thereof, Whereas measures should be taken to protect the Community against Tilletia indica Mitra, which hitherto has not been known to occur in the Community; Whereas these measures should include provisions in respect of seeds and grain of the genera Triticum, Secale and X Triticosecale originating in third countries where Tilletia indica Mitra is known to occur; Whereas therefore the relevant Annexes to Directive 77/93/EEC should be amended accordingly; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 77/93/EEC is hereby amended as indicated 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 with effect from 1 January 1997. 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 the Member States. 2. The 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 following that of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0082

1996

Council Directive 96/82/EC of 9 December 1996 on the control of major-accident hazards involving dangerous substances Having regard to the Treaty establishing the European Community, and in particular Article 130s (1) 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 189c of the Treaty (3), (1) Whereas Council Directive 82/501/EEC of 24 June 1982 on the major-accident hazards of certain industrial activities (4) is concerned with the prevention of major accidents which might result from certain industrial activities and with the limitation of their consequences for man and the environment; (2) Whereas the objectives and principles of the Community's environment policy, as set out in Article 130r (1) and (2) of the Treaty and detailed in the European Community's action programmes on the environment (5), aim, in particular, at preserving and protecting the quality of the environment, and protecting human health, through preventive action; (3) Whereas the Council and the representatives of the Governments of the Member States, meeting within the Council, in their accompanying resolution concerning the fourth Action Programme on the Environment (6), highlighted the need for more effective implementation of Directive 82/501/EEC and called for a review of the Directive to include, if necessary, a possible widening of its scope and a greater exchange of information on the matter between Member States; whereas the fifth Action Programme, the general approach of which was approved by the Council and the representatives of the Governments of the Member States, meeting within the Council, in their resolution of 1 February 1993 (7), also presses for better risk-and-accident management; (4) Whereas, in the light of the accidents at Bhopal and Mexico City, which demonstrated the hazard which arises when dangerous sites and dwellings are close together, the Council Resolution of 16 October 1989 called on the Commission to include in Directive 82/501/EEC provisions concerning controls on land-use planning when new installations are authorized and when urban development takes place around existing installations; (5) Whereas the said Council resolution invited the Commission to work with Member States towards greater mutual understanding and harmonization of national principles and practices regarding safety reports; (6) Whereas it is desirable to pool the experience gained through different approaches to the control of major-accident hazards; whereas the Commission and the Member States should develop their relations with the relevant international bodies and seek to establish measures equivalent to those set out in this Directive for use in third countries; (7) Whereas the Convention on the Transboundary Effects of Industrial Accidents of the United Nations Economic Commission for Europe provides for measures regarding the prevention of, preparedness for and response to industrial accidents capable of causing transboundary effects as well as for international cooperation in this field; (8) Whereas Directive 82/501/EEC constituted a first stage in the harmonization process; whereas the said Directive should be revised and supplemented in order to ensure high levels of protection throughout the Community in a consistent and efficient manner; whereas the present harmonization is limited to the measures which are necessary to put in place a more effective system for preventing major accidents with widespread effects and for limiting their consequences; (9) Whereas major accidents can have consequences beyond frontiers; whereas the ecological and economic cost of an accident is borne not only by the establishment affected but also by the Member States concerned; whereas it is therefore necessary to take measures ensuring a high level of protection throughout the Community; (10) Whereas the provisions of this Directive must apply without prejudice to Community provisions as regards health and safety at work; (11) Whereas use of a list specifying certain installations while excluding others with identical hazards is not an appropriate practice, and may allow potential sources of major accidents to escape regulation; whereas the scope of Directive 82/501/EEC must be altered to make the provisions applicable to all establishments where dangerous substances are present in sufficiently large quantities to create a major-accident hazard; (12) Whereas, with due regard for the Treaty and in compliance with the relevant Community legislation, Member States may retain or adopt appropriate measures for transport-related activities at docks, wharves and marshalling yards, which are excluded from this Directive, in order to ensure a level of safety equivalent to that established by this Directive; (13) Whereas the transmission of dangerous substances through pipelines also has a potential to produce major accidents; whereas the Commission should, after collecting and evaluating information about existing mechanisms within the Community for regulating such activities and the occurrence of relevant incidents, prepare a communication setting out the case, and most appropriate instrument, for action in this area if necessary; (14) Whereas, with due regard for the Treaty and in compliance with the relevant Community legislation, Member States may retain or adopt measures on waste land-fill, which do not come within the scope of this Directive; (15) Whereas analysis of the major accidents reported in the Community indicates that the majority of them are the result of managerial and/or organizational shortcomings; whereas it is therefore necessary to lay down at Community level basic principles for management systems, which must be suitable for preventing and controlling major-accident hazards and limiting the consequences thereof; (16) Whereas differences in the arrangements for the inspection of establishments by the competent authorities may give rise to differing levels of protection; whereas it is necessary to lay down at Community level the essential requirements with which the systems for inspection established by the Member States must comply; (17) Whereas, in order to demonstrate that all that is necessary has been done to prevent major accidents, to prepare contingency plans and response measures, the operator should, in the case of establishments where dangerous substances are present in significant quantities, provide the competent authority with information in the form of a safety report containing details of the establishment, the dangerous substances present, the installation or storage facilities, possible major accidents and the management systems available, in order to prevent and reduce the risk of major accidents and to enable the necessary steps to be taken to limit the consequences thereof; (18) Whereas, in order to reduce the risk of domino effects, where establishments are sited in such a way or so close together as to increase the probability and possibility of major accidents, or aggravate their consequences, there should be provision for the exchange of appropriate information and cooperation on public information; (19) Whereas, in order to promote access to information on the environment, the public should have access to safety reports produced by operators, and persons likely to be affected by a major accident should be given information sufficient to inform them of the correct action to be taken in that event; (20) Whereas, in order to provide against emergencies, in the case of establishments where dangerous substances are present in significant quantities it is necessary to establish external and internal emergency plans and to create systems to ensure those plans are tested and revised as necessary and implemented in the event of a major accident or the likelihood thereof; (21) Whereas the staff of an establishment must be consulted on the internal emergency plan and the public must be consulted on the external emergency plan; (22) Whereas, in order to provide greater protection for residential areas, areas of substantial public use and areas of particular natural interest or sensitivity, it is necessary for land-use and/or other relevant policies applied in the Member States to take account of the need, in the long term, to keep a suitable distance between such areas and establishments presenting such hazards and, where existing establishments are concerned, to take account of additional technical measures so that the risk to persons is not increased; (23) Whereas, in order to ensure that adequate response measures are taken if a major accident occurs, the operator must immediately inform the competent authorities and communicate the information necessary for them to assess the impact of that accident; (24) Whereas, in order to provide for an information exchange and to prevent future accidents of a similar nature, Member States should forward information to the Commission regarding major accidents occurring in their territory, so that the Commission can analyze the hazards involved, and operate a system for the distribution of information concerning, in particular, major accidents and the lessons learned from them; whereas this information exchange should also cover 'near misses` which Member States regard as being of particular technical interest for preventing major accidents and limiting their consequences, Article 1 Aim This Directive is aimed at the prevention of major accidents which involve dangerous substances, and the limitation of their consequences for man and the environment, with a view to ensuring high levels of protection throughout the Community in a consistent and effective manner. Article 2 Scope 1. The Directive shall apply to establishments where dangerous substances are present in quantities equal to or in excess of the quantities listed in Annex I, Parts 1 and 2, column 2, with the exception of Articles 9, 11 and 13 which shall apply to any establishment where dangerous substances are present in quantities equal to or in excess of the quantities listed in Annex I, Parts 1 and 2, column 3. For the purposes of this Directive, the 'presence of dangerous substances` shall mean the actual or anticipated presence of such substances in the establishment, or the presence of those which it is believed may be generated during loss of control of an industrial chemical process, in quantities equal to or in excess of the thresholds in Parts 1 and 2 of Annex I. 2. The provisions of this Directive shall apply without prejudice to Community provisions concerning the working environment, and, in particular, 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 (8). Article 3 Definitions For the purposes of this Directive: 1. 'establishment` shall mean the whole area under the control of an operator where dangerous substances are present in one or more installations, including common or related infrastructures or activities; 2. 'installation` shall mean a technical unit within an establishment in which dangerous substances are produced, used, handled or stored. It shall include all the equipment, structures, pipework, machinery, tools, private railway sidings, docks, unloading quays serving the installation, jetties, warehouses or similar structures, floating or otherwise, necessary for the operation of the installation; 3. 'operator` shall mean any individual or corporate body who operates or holds an establishment or installation or, if provided for by national legislation, has been given decisive economic power in the technical operation thereof; 4. 'dangerous substance` shall mean a substance, mixture or preparation listed in Annex 1, Part 1, or fulfilling the criteria laid down in Annex 1, Part 2, and present as a raw material, product, by-product, residue or intermediate, including those substances which it is reasonable to suppose may be generated in the event of accident; 5. 'major accident` shall mean an occurrence such as a major emission, fire, or explosion resulting from uncontrolled developments in the course of the operation of any establishment covered by this Directive, and leading to serious danger to human health and/or the environment, immediate or delayed, inside or outside the establishment, and involving one or more dangerous substances; 6. 'hazard` shall mean the intrinsic property of a dangerous substance or physical situation, with a potential for creating damage to human health and/or the environment; 7. 'risk` shall mean the likelihood of a specific effect occurring within a specified period or in specified circumstances; 8. 'storage` shall mean the presence of a quantity of dangerous substances for the purposes of warehousing, depositing in safe custody or keeping in stock. Article 4 Exclusions This Directive shall not apply to the following: (a) military establishments, installations or storage facilities; (b) hazards created by ionizing radiation; (c) the transport of dangerous substances and intermediate temporary storage by road, rail, internal waterways, sea or air, outside the establishments covered by this Directive, including loading and unloading and transport to and from another means of transport at docks, wharves or marshalling yards; (d) the transport of dangerous substances in pipelines, including pumping stations, outside establishments covered by this Directive; (e) the activities of the extractive industries concerned with exploration for, and the exploitation of, minerals in mines and quarries or by means of boreholes; (f) waste land-fill sites. Article 5 General obligations of the operator 1. Member States shall ensure that the operator is obliged to take all measures necessary to prevent major accidents and to limit their consequences for man and the environment. 2. Member States shall ensure that the operator is required to prove to the competent authority referred to in Article 16, hereinafter referred to as the 'competent authority`, at any time, in particular for the purposes of the inspections and controls referred to in Article 18, that he has taken all the measures necessary as specified in this Directive. Article 6 Notification 1. Member States shall require the operator to send the competent authority a notification within the following time-limits: - for new establishments, a reasonable period of time prior to the start of construction or operation, - for existing establishments, one year from the date laid down in Article 24 (1). 2. The notification required by paragraph 1 shall contain the following details: (a) the name or trade name of the operator and the full address of the establishment concerned; (b) the registered place of business of the operator, with the full address; (c) the name or position of the person in charge of the establishment, if different from (a); (d) information sufficient to identify the dangerous substances or category of substances involved; (e) the quantity and physical form of the dangerous substance or substances involved; (f) the activity or proposed activity of the installation or storage facility; (g) the immediate environment of the establishment (elements liable to cause a major accident or to aggravate the consequences thereof). 3. In the case of existing establishments for which the operator has already provided all the information under paragraph 2 to the competent authority under the requirements of national law at the date of entry into force of this Directive, notification under paragraph 1 is not required. 4. In the event of: - any significant increase in the quantity or significant change in the nature or physical form of the dangerous substance present, as indicated in the notification provided by the operator pursuant to paragraph 2, or any change in the processes employing it, or - permanent closure of the installation, the operator shall immediately inform the competent authority of the change in the situation. Article 7 Major-accident prevention policy 1. Member States shall require the operator to draw up a document setting out his major-accident prevention policy and to ensure that it is properly implemented. The major-accident prevention policy established by the operator shall be designed to guarantee a high level of protection for man and the environment by appropriate means, structures and management systems. 2. The document must take account of the principles contained in Annex III and be made available to the competent authorities for the purposes of, amongst other things, implementation of Articles 5 (2) and 18. 3. This Article shall not apply to the establishments referred to in Article 9. Article 8 Domino effect 1. Member States shall ensure that the competent authority, using the information received from the operators in compliance with Articles 6 and 9, identifies establishments or groups of establishments where the likelihood and the possibility or consequences of a major accident may be increased because of the location and the proximity of such establishments, and their inventories of dangerous substances. 2. Member States must ensure that in the case of the establishments thus identified: (a) suitable information is exchanged in an appropriate manner to enable these establishments to take account of the nature and extent of the overall hazard of a major accident in their major accident prevention policies, safety management systems, safety reports and internal emergency plans; (b) provision is made for cooperation in informing the public and in supplying information to the competent authority for the preparation of external emergency plans. Article 9 Safety report 1. Member States shall require the operator to produce a safety report for the purposes of: (a) demonstrating that a major-accident prevention policy and a safety management system for implementing it have been put into effect in accordance with the information set out in Annex III; (b) demonstrating that major-accident hazards have been identified and that the necessary measures have been taken to prevent such accidents and to limit their consequences for man and the environment; (c) demonstrating that adequate safety and reliability have been incorporated into the design, construction, operation and maintenance of any installation, storage facility, equipment and infrastructure connected with its operation which are linked to major-accident hazards inside the establishment; (b) demonstrating that internal emergency plans have been drawn up and supplying information to enable the external plan to be drawn up in order to take the necessary measures in the event of a major accident; (e) providing sufficient information to the competent authorities to enable decisions to be made in terms of the siting of new activities or developments around existing establishments. 2. The safety report shall contain at least the data and information listed in Annex II. It shall also contain an updated inventory of the dangerous substances present in the establishment. Safety reports, or parts of reports, or any other equivalent reports produced in response to other legislation, may be combined to form a single safety report for the purposes of this Article, where such a format obviates the unnecessary duplication of information and the repetition of work by the operator or competent authority, on condition that all the requirements of this Article are complied with. 3. The safety report provided for in paragraph 1 shall be sent to the competent authority within the following time limits: - for new establishments, a reasonable period of time prior to the start of construction or of operation, - for existing establishments not previously covered by Directive 82/501/EEC, three years from the date laid down in Article 24 (1), - for other establishments, two years from the date laid down in Article 24 (1), - in the case of the periodic reviews provided for in paragraph 5, without delay. 4. Before the operator commences construction or operation, or in the cases referred to in the second, third and fourth indents of paragraph 3, the competent authority shall within a reasonable period of receipt of the report: - communicate the conclusions of its examination of the safety report to the operator, if necessary after requesting further information, or - prohibit the bringing into use, or the continued use, of the establishment concerned, in accordance with the powers and procedures laid down in Article 17. 5. The safety report shall be periodically reviewed and where necessary updated: - at least every five years, - at any other time at the initiative of the operator or the request of the competent authority, where justified by new facts or to take account of new technical knowledge about safety matters, for example arising from analysis of accidents or, as far as possible, 'near misses`, and of developments in knowledge concerning the assessment of hazards. 6. (a) Where it is demonstrated to the satisfaction of the competent authority that particular substances present at the establishment, or any part thereof, are in a state incapable of creating a major-accident hazard, then the Member State may, in accordance with the criteria referred to in subparagraph (b), limit the information required in safety reports to those matters which are relevant to the prevention of residual major-accident hazards and the limitation of their consequences for man and the environment. (b) Before this Directive is brought into application, the Commission, acting in accordance with the procedure laid down in Article 16 of Directive 82/501/EEC, shall establish harmonized criteria for the decision by the competent authority that an establishment is in a state incapable of creating a major accident hazard within the meaning of subparagraph (a). Subparagraph (a) shall not be applicable until those criteria have been established. (c) Member States shall ensure that the competent authority communicates a list of the establishments concerned to the Commission, giving reasons. The Commission shall forward the lists annually to the Committee referred to in Article 22. Article 10 Modification of an installation, an establishment or a storage facility In the event of the modification of an installation, establishment, storage facility, or process or of the nature or quantity of dangerous substances which could have significant repercussions on major-accident hazards, the Member States shall ensure that the operator: - reviews and where necessary revises the major-accident prevention policy, and the management systems and procedures referred to in Articles 7 and 9, - reviews, and where necessary revises, the safety report and informs the competent authority referred to in Article 16 of the details of such revision in advance of such modification. Article 11 Emergency plans 1. Member States shall ensure that, for all establishments to which Article 9 applies: (a) the operator draws up an internal emergency plan for the measures to be taken inside the establishment, - for new establishments, prior to commencing operation, - for existing establishments not previously covered by Directive 82/501/EEC, three years from the date laid down in Article 24 (1), - for other establishments, two years from the date laid down in Article 24 (1); (b) the operator supplies to the competent authorities, to enable the latter to draw up external emergency plans, the necessary information within the following periods of time: - for new establishments, prior to the start of operation, - for existing establishments not previously covered by Directive 82/501/EEC, three years from the date laid down in Article 24 (1), - for other establishments, two years from the date laid down in Article 24 (1); (c) the authorities designated for that purpose by the Member State draw up an external emergency plan for the measures to be taken outside the establishment. 2. The emergency plans must be established with the objectives of: - containing and controlling incidents so as to minimize the effects, and to limit damage to man, the environment and property, - implementing the measures necessary to protect man and the environment from the effects of major accidents, - communicating the necessary information to the public and to the services or authorities concerned in the area, - providing for the restoration and clean-up of the environment following a major accident. Emergency plans shall contain the information set out in Annex IV. 3. Without prejudice to the obligations of the competent authorities, Member States shall ensure that the internal emergency plans provided for in this Directive are drawn up in consultation with personnel employed inside the establishment and that the public is consulted on external emergency plans. 4. Member States shall ensure that internal and external emergency plans are reviewed, tested, and where necessary revised and updated by the operators and designated authorities at suitable intervals of no longer than three years. The review shall take into account changes occurring in the establishments concerned or within the emergency services concerned, new technical knowledge, and knowledge concerning the response to major accidents. 5. Member States shall ensure that emergency plans are put into effect without delay by the operator and, if necessary by the competent authority designated for this purpose: - when a major accident occurs, or - when an uncontrolled event occurs which by its nature could reasonably be expected to lead to a major accident. 6. The competent authority may decide, giving reasons for its decision, in view of the information contained in the safety report, that the requirement to produce an external emergency plan under paragraph 1 shall not apply. Article 12 Land-use planning 1. Member States shall ensure that the objectives of preventing major accidents and limiting the consequences of such accidents are taken into account in their land-use policies and/or other relevant policies. They shall pursue those objectives through controls on: (a) the siting of new establishments, (b) modifications to existing establishments covered by Article 10, (c) new developments such as transport links, locations frequented by the public and residential areas in the vicinity of existing establishments, where the siting or developments are such as to increase the risk or consequences of a major accident. Member States shall ensure that their land-use and/or other relevant policies and the procedures for implementing those policies take account of the need, in the long term, to maintain appropriate distances between establishments covered by this Directive and residential areas, areas of public use and areas of particular natural sensitivity or interest, and, in the case of existing establishments, of the need for additional technical measures in accordance with Article 5 so as not to increase the risks to people. 2. Member States shall ensure that all competent authorities and planning authorities responsible for decisions in this area set up appropriate consultation procedures to facilitate implementation of the policies established under paragraph 1. The procedures shall be designed to ensure that technical advice on the risks arising from the establishment is available, either on a case-by-case or on a generic basis, when decisions are taken. Article 13 Information on safety measures 1. Member States shall ensure that information on safety measures and on the requisite behaviour in the event of an accident is supplied, without their having to request it, to persons liable to be affected by a major accident originating in an establishment covered by Article 9. The information shall be reviewed every three years and, where necessary, repeated and updated, at least if there is any modification within the meaning of Article 10. It shall also be made permanently available to the public. The maximum period between the repetition of the information to the public shall, in any case, be no longer than five years. Such information shall contain, at least, the information listed in Annex V. 2. Member States shall, with respect to the possibility of a major accident with transboundary effects originating in an establishment under Article 9, provide sufficient information to the potentially affected Member States so that all relevant provisions contained in Articles 11, 12 and this Article can be applied, where applicable, by the affected Member State. 3. Where the Member State concerned has decided that an establishment close to the territory of another Member State is incapable of creating a major-accident hazard beyond its boundary for the purposes of Article 11 (6) and is not therefore required to produce an external emergency plan under Article 11 (1), it shall so inform the other Member State. 4. Member States shall ensure that the safety report is made available to the public. The operator may ask the competent authority not to disclose to the public certain parts of the report, for reasons of industrial, commercial or personal confidentiality, public security or national defence. In such cases, on the approval of the competent authority, the operator shall supply to the authority, and make available to the public, an amended report excluding those matters. 5. Member States shall ensure that the public is able to give its opinion in the following cases: - planning for new establishments covered by Article 9, - modifications to existing establishments under Article 10, where such modifications are subject to obligations provided for in this Directive as to planning, - developments around such existing establishments. 6. In the case of establishments subject to the provisions of Article 9, Member States shall ensure that the inventory of dangerous substances provided for in Article 9 (2) is made available to the public. Article 14 Information to be supplied by the operator following a major accident 1. Member States shall ensure that, as soon as practicable following a major accident, the operator shall be required, using the most appropriate means: (a) to inform the competent authorities; (b) to provide them with the following information as soon as it becomes available: - the circumstances of the accident, - the dangerous substances involved, - the data available for assessing the effects of the accident on man and the environment, and - the emergency measures taken; (c) to inform them of the steps envisaged: - to alleviate the medium- and long-term effects of the accident, - to prevent any recurrence of such an accident; (d) to update the information provided if further investigation reveals additional facts which alter that information or the conclusions drawn. 2. Member States shall require the competent authority: (a) to ensure that any urgent, medium- and long-term measures which may prove necessary are taken; (b) to collect, by inspection, investigation or other appropriate means, the information necessary for a full analysis of the technical, organizational and managerial aspects of the major accident; (c) to take appropriate action to ensure that the operator takes any necessary remedial measures; and (d) to make recommendations on future preventive measures. Article 15 Information to be supplied by the Member States to the Commission 1. For the purpose of prevention and mitigation of major accidents, Member States shall inform the Commission as soon as practicable of major accidents meeting the criteria of Annex VI which have occurred within their territory. They shall provide it with the following details: (a) the Member State, the name and address of the authority responsible for the report; (b) the date, time and place of the major accident, including the full name of the operator and the address of the establishment involved; (c) a brief description of the circumstances of the accident, including the dangerous substances involved, and the immediate effects on man and the environment; (d) a brief description of the emergency measures taken and of the immediate precautions necessary to prevent recurrence. 2. Member States shall, as soon as the information provided for in Article 14 is collected, inform the Commission of the result of their analysis and recommendations using a report form established and kept under review through the procedure referred to in Article 22. Reporting of this information by Member States may be delayed only to allow for the completion of legal proceedings where such reporting is liable to affect those proceedings. 3. Member States shall inform the Commission of the name and address of any body which might have relevant information on major accidents and which is able to advise the competent authorities of other Member States which have to intervene in the event of such an accident. Article 16 Competent authority Without prejudice to the operator's responsibilities, Member States shall set up or appoint the competent authority or authorities responsible for carrying out the duties laid down in this Directive and, if necessary, bodies to assist the competent authority or authorities at technical level. Article 17 Prohibition of use 1. Member States shall prohibit the use or bringing into use of any establishment, installation or storage facility, or any part thereof where the measures taken by the operator for the prevention and mitigation of major accidents are seriously deficient. Member States may prohibit the use or bringing into use of any establishment, installation or storage facility, or any part thereof if the operator has not submitted the notification, reports or other information required by this Directive within the specified period. 2. Member States shall ensure that operators may appeal against a prohibition order by a competent authority under paragraph 1 to an appropriate body determined by national law and procedures. Article 18 Inspections 1. Member States shall ensure that the competent authorities organize a system of inspections, or other measures of control appropriate to the type of establishment concerned. Those inspections or control measures shall not be dependent upon receipt of the safety report or any other report submitted. Such inspections or other control measures shall be sufficient for a planned and systematic examination of the systems being employed at the establishment, whether of a technical, organizational or managerial nature, so as to ensure in particular: - that the operator can demonstrate that he has taken appropriate measures, in connection with the various activities involved in the establishment, to prevent major accidents, - that the operator can demonstrate that he has provided appropriate means for limiting the consequences of major accidents, on site and off site, - that the data and information contained in the safety report, or any other report submitted, adequately reflects the conditions in the establishment, - that information has been supplied to the public pursuant to Article 13 (1). 2. The system of inspection specified in paragraph 1 shall comply with the following conditions: (a) there shall be a programme of inspections for all establishments. Unless the competent authority has established a programme of inspections based upon a systematic appraisal of major-accident hazards of the particular establishment concerned, the programme shall entail at least one on-site inspection made by the competent authority every twelve months of each establishment covered by Article 9; (b) following each inspection, a report shall be prepared by the competent authority; (c) where necessary, every inspection carried out by the competent authority shall be followed up with the management of the establishment, within a reasonable period following the inspection. 3. The competent authority may require the operator to provide any additional information necessary to allow the authority fully to assess the possibility of a major accident and to determine the scope of possible increased probability and/or aggravation of major accidents, to permit the preparation of an external emergency plan, and to take substances into account which, due to their physical form, particular conditions or location, may require additional consideration. Article 19 Information system and exchanges 1. Member States and the Commission shall exchange information on the experience acquired with regard to the prevention of major accidents and the limitation of their consequences. This information shall concern, in particular, the functioning of the measures provided for in this Directive. 2. The Commission shall set up and keep at the disposal of Member States a register and information system containing, in particular, details of the major accidents which have occurred within the territory of Member States, for the purpose of: (a) the rapid dissemination of the information supplied by Member States pursuant to Article 15 (1) among all competent authorities; (b) distribution to competent authorities of an analysis of the causes of major accidents and the lessons learned from them; (c) supply of information to competent authorities on preventive measures; (d) provision of information on organizations able to provide advice or relevant information on the occurrence, prevention and mitigation of major accidents. The register and information system shall contain, at least: (a) the information supplied by Member States in compliance with Article 15 (1); (b) an analysis of the causes of the accidents; (c) the lessons learned from the accidents; (d) the preventive measures necessary to prevent a recurrence. 3. Without prejudice to Article 20, access to the register and information system shall be open to government departments of the Member States, industry or trade associations, trade unions, non-governmental organizations in the field of the protection of the environment and other international or research organizations working in the field. 4. Member States shall provide the Commission with a three-yearly report in accordance with the procedure laid down in Council Directive 91/692/EEC of 23 December 1991 standardizing and rationalizing reports on the implementation of certain Directives relating to the environment (9) for establishments covered by Articles 6 and 9. The Commission shall publish a summary of this information every three years. Article 20 Confidentiality 1. Member States shall ensure, in the interests of transparency, that the competent authorities are required to make information received pursuant to this Directive available to any natural or legal person who so requests. Information obtained by the competent authorities or the Commission may, where national provisions so require, be kept confidential if it calls into question: - the confidentiality of the deliberations of the competent authorities and the Commission, - the confidentiality of international relations and national defence, - public security, - the confidentiality of preliminary investigation proceedings or of current legal proceedings, - commercial and industrial secrets, including intellectual property, - personal data and/or files, - data supplied by a third party if that party asks for them to be kept confidential. 2. This Directive shall not preclude the conclusion by a Member State of agreements with third countries on the exchange of information to which it is privy at internal level. Article 21 Terms of reference of the Committee The measures required to adapt the criteria referred to in Article 9 (6) (b) and Annexes II to VI to technical progress and to draw up the report form referred to in Article 15 (2) shall be adopted in accordance with the procedure laid down in Article 22. Article 22 Committee The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 23 Repeal of Directive 82/501/EEC 1. Directive 82/501/EEC shall be repealed 24 months after the entry into force of this Directive. 2. Notifications, emergency plans and information for the public presented or drawn up pursuant to Directive 82/501/EEC shall remain in force until such time as they are replaced under the corresponding provisions of this Directive. Article 24 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 24 months after its entry into force. 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 main provisions of domestic law which they adopt in the field governed by this Directive. Article 25 Entry into force This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 26 This Directive is addressed to the Member States.

31996L0086

1996

Commission Directive 96/86/EC of 13 December 1996 adapting 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), and in particular Article 8 thereof, Whereas the Annexes A and B to the Europe Agreement concerning the international carriage of dangerous goods by road, usually known as the ADR, as amended, should be attached to Directive 94/55/EC as the Annexes A and B and be applicable not only to cross-frontier transport, but also to transport within the individual Member States; Whereas the Annexes to Directive 94/55/EC contain the ADR as applicable from 1 January 1995, which has since been published in all languages (2); Whereas the ADR is updated every two years and therefore an amended version will be in force with effect from 1 January 1997; Whereas in accordance with Article 8, all the necessary modifications for adapting to technical and scientific progress in the field covered by the Directive and aiming at aligning it to the new rules have to be adopted in accordance with the procedure set out in Article 9; Whereas it is necessary to adapt the sector to the new ADR rules and therefore to amend the Annexes to Directive 94/55/EC; Whereas the measures provided for in the Directive are in accordance with the opinion of the Committee provided by Article 9 of Directive 94/55/EC, Article 1 Directive 94/55/EC is modified as follows: 1. Annex A: 'Annex A comprises the provisions of Marginals 2 000 to 3 999 of Annex A to the Europe Agreement on the international carriage of dangerous goods by road (ADR), as effective on 1 January 1997, "Member State" being substituted for "Contracting Party". NB: Versions in all the official languages of the Community of the amending text of 1997 to the consolidated text of 1995 of Annex A to the ADR will be published as soon as a text is available in all languages.` 2. Annex B: 'Annex B comprises the provisions of Marginals 10 000 to 270 000 of Annex B to the Europe agreement on the international carriage of dangerous goods by road (ADR), as effective on 1 January 1997, "Member State" being substituted for "Contracting Party". NB: Versions in all the official languages of the Community of the amending text of 1997 to the consolidated text of 1995 of Annex B to the ADR will be published as soon as a text is available in all languages.` Article 2 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1997. They shall forthwith inform the Commission thereof. When the Member States adopt these measures they shall contain a reference to this Directive or shall be accompanied by such 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 provisions of national law which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the day following of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0079

1996

Directive 96/79/EC of the European Parliament and of the Council of 16 December 1996 on the protection of occupants of motor vehicles in the event of a frontal impact and amending Directive 70/156/EEC Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), and in particular Article 13 (4) 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 laid down in Article 189b of the Treaty (4), Whereas the total harmonization of technical requirements for motor vehicles is necessary in order fully to achieve the internal market; Whereas, in order to reduce the number of road accident casualties in Europe, it is necessary to introduce legislative measures for improving the protection of occupants of motor vehicles in the event of a frontal impact as much as possible; whereas this Directive introduces frontal impact test requirements, including biomechanical criteria, to ensure that a high level of protection in the event of a frontal impact is provided; Whereas the aim of this Directive is to introduce requirements based on the results of research conducted by the European Experimental Vehicles Committee allowing the establishment of test criteria which are more representative of actual road accidents; Whereas lead times are required by vehicle manufacturers for the implementation of acceptable test criteria; Whereas, to avoid duplication of standards, it is necessary to exempt vehicles which comply with the requirements of this Directive from the need to comply with now superseded requirements in another Directive in respect of the behaviour of the steering wheel and column in an impact; Whereas this Directive will be one of the separate directives which must be complied with in order to ensure the conformity of vehicles with the requirements of the EC type-approval procedure established by Directive 70/156/EEC; whereas, therefore, the provisions of Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas the procedure for determining the seating reference point in motor vehicles is given in Annex III to Council Directive 77/649/EEC of 27 September 1977 on the approximation of the laws of the Member States relating to the field of vision of motor vehicle drivers (5); whereas it is therefore unnecessary to repeat it in this Directive; whereas reference should be made in this Directive to Council Directive 74/297/EEC of 4 June 1974 on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles (the behaviour of the steering mechanism in the event of an impact) (6); whereas reference is made to the United States of America Code of Federal Regulations (7), Article 1 For the purposes of this Directive, 'vehicle` shall have the meaning given to it in Article 2 of Directive 70/156/EEC. Article 2 1. No Member State may, on grounds concerning the protection of occupants of vehicles in the event of a frontal impact: - refuse, in respect of a vehicle type, to grant EC type-approval or national type-approval, or - prohibit the registration, sale or entry into service of a vehicle, if it complies with the requirements of this Directive. 2. With effect from 1 October 1998, Member States: - may no longer grant EC type-approval for a vehicle type in accordance with Article 4 of Directive 70/156/EEC, - may refuse national type-approval for a vehicle type, unless the vehicle satisfies the requirements of this Directive. 3. Paragraph 2 shall not apply to vehicle types approved before 1 October 1998 pursuant to Directive 74/297/EEC, or to subsequent extensions to that type-approval. 4. Vehicles type-approved in accordance with this Directive shall be regarded as satisfying the requirements of paragraph 5.1 of Annex I to Directive 74/297/EEC. 5. With effect from 1 October 2003, Member States: - shall consider certificates of conformity which accompany new vehicles in accordance with Directive 70/156/EEC to be no longer valid for the purposes of Article 7 (1) of that Directive, and - may refuse the registration, sale or entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 70/156/EEC, if the requirements of this Directive, including paragraphs 3.2.1.2 and 3.2.1.3 of Annex II, are not fulfilled. Article 3 In Part I of Annex IV to Directive 70/156/EEC, the table shall be supplemented as follows: >TABLE> Article 4 In the framework of the adaptation of this Directive to technical progress, the Commission shall: (a) review the Directive, within two years from the date mentioned in Article 5 (1), with a view to increasing the test speed and including vehicles of category N1. The review will cover inter alia accident research data, full-scale car-to-car test results, cost-benefit considerations and, in particular, the existing performance requirements (both biomechanical and geometric) and the addition of new requirements relating to footwell intrusion. The review will examine the potential gains in occupant protection and the industrial feasibility of increasing the test speed and extending the scope of the Directive to include vehicles of category N1. The results of this review will be submitted to the European Parliament and the Council in a report drawn up by the Commission; (b) before the end of 1996 review, and, if appropriate, amend Appendix 7 to Annex II so as to take into account assessment tests on the Hybrid III dummy's ankle including vehicle tests; (c) before the end of 1997, review and, if appropriate, amend the limit values for neck injury (as specified in paragraphs 3.2.1.2 and 3.2.1.3 of Annex II) on the basis of the values recorded during type-approval tests and on accident study and biomechanical research data; (d) also make, before the end of 1997, the necessary amendments to the separate Directives so as to ensure the compatibility of the type-approval and extension procedures provided by the directives with those in this Directive. Article 5 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 October 1996. 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. 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. 3. Member States shall take the measures necessary to ensure that the results of the type-approval tests carried out by their approval authorities are made available to the public. Article 6 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities. Article 7 This Directive is addressed to the Member States.

31996L0089

1996

Commission Directive 96/89/EC of 17 December 1996 amending Directive 95/12/EC implementing Council Directive 92/75/EEC with regard to energy labelling of household washing machines (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, Having regard to Commission Directive 95/12/EC of 23 May 1995 implementing Council Directive 92/75/EEC with regard to energy labelling of household washing machines (2), Whereas current measurement methods and information do not allow for the appropriate labelling of washing machines without an integral method of heating hot water; whereas such appliances must therefore be excluded from the scope of Directive 95/12/EC; Whereas 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 In Article 1 (1) of Directive 95/12/EC, in the list of types of household washing machine excluded from the scope of that Directive, the following item is added: '- Until 30 June 1998 machines with no internal means to heat water.` Article 2 1. Member States shall adopt and publish the laws, regulations and administrative provisions to comply with this Directive by 15 April 1997. They shall immediately notify the Commission of these measures. They shall apply those provisions from 15 May 1997. When Member States adopt these provisions either they shall contain a reference to this Directive, or shall be accompanied by such a reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall communicate to the Commission any measures which they take 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.

31996L0094

1996

Commission Directive 96/94/EC of 18 December 1996 establishing a second list of indicative limit values in implementation of Council Directive 80/1107/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (1), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular the first subparagraph of Article 8 (4) thereof, Having regard to the opinion of the Advisory Committee of Safety, Hygiene and Health Protection at Work, Whereas indicative limit values should be regarded as an important part of the overall approach to the setting of limit values and ensuring the protection of the health of workers at the workplace; Whereas a first list of indicative limit values was established by Commission Directive 91/322/EEC (2); Whereas a second list of indicative limit values can be drawn up at Community level following evaluation of the latest available scientific data on occupational health effects and on the availability of the measuring techniques; Whereas, is preparing its Directive, the Commission was assisted by a scientific committee set up pursuant to Commission Directive 95/320/EC (3); whereas this Committee was responsible for the evaluation of the available scientific data; Whereas, in addition, it is necessary to establish short-term limit values for certain substances to take account of effects arising from short-term exposure; Whereas, for some agents, it is necessary to have regard also to the possibility of penetration through the skin, in order to ensure the best possible level of protection; Whereas indicative limit values need to be kept under review and will need to be revised if new scientific data indicate that they are no longer valid; Whereas this Directive constitutes a practical step towards the achievement of the social dimension of the internal market; Whereas Member States must apply this Directive when they adopt provisions for the protection of workers in accordance with Article 3 (1) of Directive 80/1107/EEC; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee set up pursuant to Article 9 of Directive 80/1107/EEC, Article 1 A second list of indicative limit values, of which Member States shall take account, inter alia, when establishing the limit values referred to in Article 4 (4) (b) of Directive 80/1107/EEC, is set out in the Annex to this Directive. Article 2 1. Member States shall bring into force the provisions necessary to comply with this Directive: - by 1 June 1998 where they have adopted provisions for the protection of workers in accordance with Article 3 (1) of Directive 80/1107/EEC, or - at the time they adopt such provisions. 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. 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.

31996L0083

1996

Directive 96/83/EC of the European Parliament and of the Council of 19 December 1996 amending Directive 94/35/EC on sweeteners for use in foodstuffs Having regard to the Treaty establishing the European Community, and in particular Article 100a 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 authorized for use in foodstuffs intended for human consumption (1), and in particular Article 3 (2) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), Whereas since the adoption of Directive 94/35/EC (4) there have been many technical developments in the field of sweeteners; Whereas the Directive should be adapted to take account of these developments; Whereas the Scientific Committee for Food set up by Commission Decision 95/273/EC (5) was consulted before the adoption of provisions liable to have an effect on public health, Article 1 Directive 94/35/EC is hereby amended as follows: 1. the following paragraph shall be added to Article 1: '5. This Directive shall also apply to the corresponding foodstuffs intended for particular nutritional uses within the meaning of Directive 89/398/EEC.`; 2. Article 2 shall be amended as follows: (a) paragraph 3 shall be replaced by the following: '3. Sweeteners may not be used in food for infants and young children as referred to in Directive 89/398/EEC, including food for infants and young children who are not in good health, unless otherwise laid down in specific provisions.`; (b) the following paragraph shall be added: '5. In the Annex "quantum satis" means that no maximum level is specified. However, sweeteners shall be used in accordance with good manufacturing practice, at a dose level not higher than is necessary to achieve the intended purpose and provided the consumer is not misled.`; 3. the following Article shall be added: 'Article 2a Without prejudice to other Community provisions, the presence of a sweetener in a foodstuff is permissible: - in compound foodstuffs with no added sugar or energy-reduced, in compound dietary foodstuffs intended for a low-calorie diet and in compound foodstuffs with a long shelf-life, other than those mentioned in Article 2 (3), insofar as the sweetener is permitted in one of the ingredients of the compound foodstuff, or - if the foodstuff is intended to be used solely in the preparation of a compound foodstuff which conforms to this Directive.`; 4. the category 'Vitamins and dietary preparations` in the Annex shall be renamed 'Food supplements/diet integrators based on vitamins and/or mineral elements, syrup-type or chewable`; 5. the table in the Annex shall be supplemented by the table in the Annex to this Directive. Article 2 Member States shall, where necessary, amend their laws, regulations or administrative provisions in order to: - authorize trade in products conforming to this Directive, by 19 December 1997 at the latest; - prohibit trade in products not conforming to this Directive from 19 June 1998. However, products placed on the market or labelled before that date which do not comply with this Directive may be marketed until stocks are exhausted. 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 for making such reference shall be laid down by the Member States. Article 3 This Decision shall enter into force on the seventh day following that of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0085

1996

Directive 96/85/EC of the European Parliament and of the Council of 19 December 1996 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 100a 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 authorized for use in foodstuffs intended for human consumption (1), and in particular Article 3 (2) 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 laid down in Article 189b of the Treaty (4), Whereas processed Eucheuma seaweed constitutes a new food additive the use of which is justified on technological grounds; Whereas it is necessary to adapt the list of permitted food additives contained in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (5) in order to permit the use of this additive; Whereas the Scientific Committee for Food has been consulted; Whereas purity criteria will be adopted in accordance with the procedure laid down in Article 11 of Directive 89/107/EEC, Article 1 The following food additive is hereby inserted after E-No 407 in the table in Annex I to Directive 95/2/EC: >TABLE> Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than three months after its publication in order to allow trade in, and use of, products conforming to this Directive. They shall forthwith inform the Commission thereof. When these measures are adopted by Member States, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 3 This Directive shall enter into force on the seventh day following that of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31996L0098

1996

Council Directive 96/98/EC of 20 December 1996 on marine equipment Having regard to the Treaty establishing the European Community, and in particular Article 84 (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 189c of the Treaty (3), (1) Whereas within the framework of the common transport policy further measures must be adopted to ensure safety in maritime transport; (2) Whereas shipping accidents are a matter of serious concern to the Community, in particular those that cause loss of human life and pollution of the Member States' seas and coastlines; (3) Whereas the risk of shipping accidents can be effectively reduced by means of common standards that ensure high safety levels in the performance of the equipment carried on board ships; whereas testing standards and testing methods can have great influence on the future performance of equipment; (4) Whereas international conventions require flag States to ensure that the equipment carried on board ships complies with certain safety requirements and to issue the relevant certificates; whereas to that end testing standards for certain types of marine equipment have been developed by the international standardization bodies and by the International Maritime Organization (IMO); whereas the national testing standards implementing the international standards leave a margin of discretion certification authorities, which themselves have different levels of qualifications and experience; whereas that leads to varying levels of safety for products which the competent national authorities have certified as complying with the relevant international safety standards and to great reluctance on the part of Member States to accept that without further verification ships flying their flags carry equipment approved by other Member States; (5) Whereas common rules must be laid down to eliminate differences in the implementation of international standards; whereas such common rules will result in the elimination of unnecessary costs and administrative procedures relating to the approval of equipment, the improvement of operating conditions and of the competitive position of Community shipping and the elimination of technical barriers to trade by means of the mark of conformity affixed to equipment; (6) Whereas in its resolution of 8 June 1993 on a common policy on safe seas (4) the Council urged the Commission to submit proposals for harmonizing the implementation of IMO standards and the procedures for the approval of marine equipment; (7) Whereas action at Community level is the only possible way of achieving such harmonization, since Member States acting independently or through international organizations cannot establish the same level of safety performance in equipment; (8) Whereas a Council Directive is the appropriate legal instrument as it provides a framework for uniform and compulsory application of the international testing standards by Member States; (9) Whereas it is appropriate in the first place to address equipment the carriage of which on board ship and the approval of which by national administrations in accordance with safety standards laid down in international conventions or resolutions is mandatory under the main international conventions; (10) Whereas there are various Directives that ensure the free movement of certain products which could be used inter alia, as equipment on board ships but which do not concern the Member States' certification of equipment in accordance with the relevant international conventions; whereas equipment to be placed on board ships must therefore be regulated exclusively by new common rules; (11) Whereas new testing standards must be laid down, preferably at international level, for equipment for which such standards do not already exist or are not sufficiently detailed; (12) Whereas Member States should ensure that the notified bodies that assess the compliance of equipment with testing standards are independent, efficient and professionally competent to carry out their tasks; (13) Whereas compliance with international testing standards can best be demonstrated by means of conformity-assessment procedures such as those laid down in Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity-assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization Directives (5); (14) Whereas nothing in this Directive restricts the right granted to a flag State administration by international conventions to carry out operational-performance tests on board a ship for which it has issued a safety certificate, provided such tests do not duplicate the conformity-assessment procedures; (15) Whereas equipment covered by this Directive should, as a general rule, bear a mark to indicate its compliance with the requirement of this Directive; (16) Whereas Member States may in certain cases take provisional measures to limit or prohibit the use of equipment bearing the mark of conformity; (17) Whereas the use of equipment not bearing the mark of conformity may be allowed in exceptional circumstances; (18) Whereas a simplified procedure involving a regulatory committee must be followed for the amendment of this Directive, Article 1 The purpose of this Directive shall be to enhance safety at sea and the prevention of marine pollution through the uniform application of the relevant international instruments relating to equipment listed in Annex A to be placed on board ships for which safety certificates are issued by or on behalf of Member States pursuant to international conventions and to ensure the free movement of such equipment within the Community. Article 2 For the purposes of this Directive: (a) 'conformity-assessment procedures` shall mean the procedures set out in Article 10 and Annex B; (b) 'equipment` shall mean items listed in Annexes A.1 and A.2 which must be placed on board a ship for use in order to comply with international instruments or are voluntarily placed on board for use, and for which the approval of the flag State administration is required according to international instruments; (c) 'radiocommunications equipment` shall mean equipment required by Chapter IV of the 1984 Solas Convention, as amended with regard to the Global Maritime Distress and Safety System (GMDSS) in 1988, and two-way VHF radiotelephone apparatus required by Regulation III/6.2.1 of the same Convention; (d) 'international conventions` shall mean: - the 1996 International Convention on Load Lines (LL66), - the 1972 Convention on the International Regulations for Preventing Collisions at Sea (Colreg), - the 1973 International Convention for the Prevention of Pollution from Ships (Marpol) and - the 1974 International Convention for the Safety of Life at Sea (Solas), together with their Protocols and the amendments thereto in force on the date of the adoption of this Directive; (e) 'international instruments` shall mean the relevant international conventions, the relevant resolutions and circulars of the International Maritime Organization (IMO), and the relevant international testing standards; (f) 'mark` shall mean the symbol referred to in Article 11 and set out in Annex D; (g) 'notified body` shall mean an organization designated by the competent national administration of a Member State in accordance with Article 9; (h) 'placed on board` shall mean installed or placed on board a ship; (i) 'safety certificates` shall mean the certificates issued by or on behalf of Member States in accordance with international conventions; (j) 'ship` shall mean a ship falling within the scope of international conventions; warships shall not be covered; (k) 'Community ship` shall mean a ship for which safety certificates are issued by or on behalf of Member States under international conventions. This definition shall not include a Member State administration's issuing a certificate for a ship at the request of a third country's administration; (l) 'new ship` shall mean a ship the keel of which is laid or which is at a similar stage of construction on or after the date of the entry into force of this Directive. For the purposes of this definition, 'a similar stage of construction` shall mean the stage at which: (i) construction identifiable with a specific ship begins and (ii) assembly of that ship has commenced, comprising at least 50 tonnes or 1 % of the estimated mass of all structural material, whichever is less; (m) 'existing ship` shall mean a ship which is not a new ship; (n) 'testing standards` shall mean the standards set by - the International Maritime Organization (IMO), - the International Organization for Standardization (ISO), - the International Electrotechnical Commission (IEC), - the European Committee for Standardization (CEN), - the European Committee for Electrotechnical Standardization (Cenelec) and - the European Telecommunication Standards Institute (ETSI) in force on the date of the adoption of this Directive, and established in accordance with the relevant international conventions and with the relevant IMO resolutions and circulars to define testing methods and test results, but only in the form referred to in Annex A; (o) 'type-approval` shall mean the procedures for evaluating equipment produced in accordance with the appropriate testing standards and the issue of the appropriate certificate. Article 3 1. This Directive shall apply to equipment for use on board: (a) a new Community ship whether or not the ship is situated within the Community at the time of construction; (b) an existing Community ship - where such equipment was not previously carried on board or - where equipment which was previously carried on board the ship is replaced, except where international conventions permit otherwise, whether or not the ship is situated within the Community when the equipment is placed on board. 2. This Directive shall not apply to equipment which on the date of the entry into force of this Directive has already been placed on board a ship. 3. Notwithstanding the fact that the equipment referred to in paragraph 1 may fall within the scope of Directives other than this Directive for the purpose of free movement, and in particular Council Directives 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility (6) and 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (7), that equipment shall be subject only to this Directive, to the exclusion of all others for those purposes. Article 4 Each Member State or the organizations acting on its behalf shall ensure, when issuing or renewing the relevant safety certificates, that the equipment on board Community ships for which it issues safety certificates complies with the requirements of this Directive. Article 5 1. Equipment listed in Annex A.1 that is placed on board a Community ship on or after the date referred to in the second subparagraph of Article 20 (1) shall meet the applicable requirements of the international instruments referred to in that Annex. 2. The compliance of equipment with the applicable requirements of the international conventions and of the relevant resolutions and circulars of the International Maritime Organization shall be demonstrated solely in accordance with the relevant testing standards and the conformity-assessment procedures referred to in Annex A.1. For items listed in Annex A.1, where both IEC and ETSI testing standards are given, those standards shall be alternatives and a manufacturer or his authorized representative established within the Community may determine which of them is to be used. 3. Equipment listed in Annex A.1 and manufactured before the date referred to in paragraph 1 may also be placed on the market and on board a Community ship the certificates of which were issued by or on behalf of a Member State in accordance with international conventions during the two years following that date if it was manufactured in accordance with procedures for type-approval already in force within the territory of that Member State before the date of the adoption of this Directive. Article 6 1. No Member State shall prohibit the placing on the market or the placing on board a Community ship of equipment referred to in Annex A.1 which bears the mark or for other reasons complies with this Directive or refuse to issue or renew the safety certificates relating thereto. 2. A radio licence shall be issued in accordance with the international radio regulations by the competent authority before the relevant safety certificate is issued. Article 7 1. After the date of the entry into force of this Directive, the Community shall submit a request to the IMO or to the European standardization organizations, as appropriate, for the establishment of standards, including detailed testing standards, for the equipment listed in Annex A.2. 2. The request referred to in paragraph 1 shall be made: - by the Presidency of the Council and by the Commission, when it is submitted to the IMO, - by the Commission, in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (8), when it is submitted to the European standardization organizations. The mandates issued by the Commission shall aim for the development of international standards through procedures for cooperation between the European bodies and their counterparts at international level. 3. Member States shall do their utmost to ensure that the international organizations, including the IMO, develop those standards expeditiously. 4. The Commission shall monitor the development of the testing standards on a regular basis. 5. Should the international organizations, including the IMO, fail or refuse to adopt appropriate testing standards for a specific item of equipment within a reasonable time, standards based on the work of the European standardization organizations may be adopted in accordance with the procedure laid down in Article 18. 6. When the testing standards referred to in paragraphs 1 or 5 are adopted or enter into force, as appropriate, for a specific item of equipment, that equipment may be transferred from Annex A.2 to Annex A.1 in accordance with the procedure laid down in Article 18 and, Article 5 shall apply from the date of that transfer. Article 8 1. In the case of a new ship which, irrespective of its flag, is not registered in a Member State but is to be transferred to the register of a Member State, such a ship shall, on transfer, be subject to inspection by the receiving Member State to verify that the actual condition of its equipment corresponds to its safety certificates and either complies with this Directive and bears the mark or is equivalent, to the satisfaction of that Member State's administration, to equipment type-approval in accordance with this Directive. 2. Unless the equipment either bears the mark or that administration considers it to be equivalent, it shall be replaced. 3. Equipment which is considered equivalent pursuant to this Article shall be given a certificate by the Member State which shall at all times be carried with the equipment and which gives the flag Member State's permission for the equipment to be placed on board the ship and imposes any restrictions or lays down any provisions relating to the use of the equipment. 4. In the case of radiocommunications equipment, the flag State administration shall require that such equipment does not unduly affect the requirements of the radio-frequency spectrum. Article 9 1. Member States shall notify the Commission and the other Member States of the bodies which they have designated to carry out the procedures for in Article 10 together with the specific tasks which those notified bodies have been designated to carry out and the identification numbers assigned to them beforehand by the Commission. Each organization shall submit to the Member State which intends to designate it complete information concerning, and evidence of compliance with the criteria laid down in Annex C. 2. At least once every two years each Member State shall cause an audit of the duties its notified bodies are undertaking on its behalf to be carried out by the administration or by an impartial external organization appointed by the administration. That audit shall ensure that each notified body continues to comply with the criteria laid down in Annex C. 3. A Member State which has designated a body shall withdraw its designation if it finds that that body no longer complies with the criteria laid down in Annex C. It shall immediately inform the Commission and the other Member States accordingly. Article 10 1. The conformity-assessment procedure, details of which are listed in Annex B, shall be: (i) EC type-examination (module B) and, before equipment is placed on the market and according to the choice made by the manufacturer or his authorized representative established within the Community from the possibilities indicated in Annex A.1, all equipment shall be subject to: (a) the EC declaration of conformity to type (module C); (b) the EC declaration of conformity to type (production-quality assurance) (module D); (c) the EC declaration of conformity to type (product-quality assurance) (module E); (d) the EC declaration of conformity to type (product verification) (module F); or (ii) EC full-quality assurance (module H). 2. The declaration of conformity to type shall be in written form and shall give the information specified in Annex B. 3. Where sets of equipment are produced individually or in small quantities and not in series or in mass, the conformity-assessment procedure may be the EC unit verification (module G). 4. The Commission shall keep an up-to-date list of approved equipment and applications withdrawn or refused and shall make it available to interested parties. Article 11 1. Equipment referred to in Annex A.1 which complies with the relevant international instruments and is manufactured in accordance with the conformity-assessment procedures shall have the mark affixed to it by the manufacturer or his authorized representative established within the Community. 2. The mark shall be followed by the identification number of the notified body which has performed the conformity-assessment procedure, if that body is involved in the production-control phase, and by the last two digits of the number of the year in which the mark is affixed. The identification number of the notified body shall be affixed under its responsibility either by the body itself or by the manufacturer or his authorized representative established within the Community. 3. The form of the mark to be used shall be as set out in Annex D. 4. The mark shall be affixed to the equipment or to its data plate so as to be visible, legible and indelible throughout the anticipated useful life of the equipment. However, where that is not possible or not warranted on account of the nature of the piece of equipment, it shall be affixed to the packaging of the product, to a label or to a leaflet. 5. No marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the mark referred to in this Directive shall be affixed. 6. The mark shall be affixed at the end of the production phase. Article 12 1. Notwithstanding Article 6, each Member State may take the measures necessary to ensure that sample checks are carried out on equipment bearing the mark which is on its market and which has not yet been placed on board, in order to ensure that it complies with this Directive. Sample checks which are not provided for in the modules for conformity assessment in Annex B shall be carried out at the expense of the Member State. 2. Notwithstanding Article 6, after the installation of equipment which complies with this Directive on board a Community ship, evaluation by that ship's flag State administration of that equipment shall be permitted when operational on-board performance tests are required by international instruments for safety and/or pollution-prevention purposes, provided that they do not duplicate the conformity-assessment procedures already carried out. The flag State administration may require the manufacturer of the equipment, his authorized representative established within the Community or the person responsible for marketing the equipment within the Community to provide the inspection/testing reports. Article 13 1. Where a Member State ascertains by inspection or otherwise that, notwithstanding the fact that it bears the mark, a piece of equipment referred to in Annex A.1, when correctly installed, maintained and used for its intended purpose, may compromise the health and/or safety of the crew, the passengers or, where applicable, other persons, or adversely affect the marine environment from the market or prohibit or restrict its being placed on the market or being used on board a ship for which it issues the safety certificates. The Member State shall immediately inform the other Member States and the Commission of that measure and indicate the reasons for its decision and, in particular, whether non-compliance with this Directive is due to: (a) failure to comply with Article 5 (1) and (2); (b) incorrect application of the testing standards referred to in Article 5 (1) and (2); or (c) shortcomings in the testing standards themselves. 2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that: - the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the testing standards, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 18 within two months if the Member State which has taken the decision intends to maintain it and shall initiate the procedure referred to in Article 18, - the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorized representative established within the Community. 3. Where a non-complying piece of equipment bears the mark, the appropriate measures shall be taken by the Member State which has authority over whomsoever affixed the mark; that Member State shall inform the Commission and the other Member States of the measures it has taken. 4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure. Article 14 1. Notwithstanding the provisions of Article 5, in exceptional circumstances of technical innovation, the flag State administration may permit equipment which does not comply with the conformity-assessment procedures to be placed on board a Community ship if it is established by trial or otherwise to the satisfaction of the flag State administration that such equipment is at least as effective as equipment which does comply with the conformity-assessment procedures. In the case of radiocommunications equipment, the flag State administration shall require that such equipment does not unduly affect the requirements of the radio-frequency spectrum. 2. Such trial procedures shall in no way discriminate between equipment produced in the flag Member State and equipment produced in other States. 3. Equipment covered by this Article shall be given a certificate by the flag Member State which shall at all times be carried with the equipment and which gives the flag Member State's permission for the equipment to be placed on board the ship and imposes any restrictions or lays down any provisions relating to the use of the equipment. 4. Where a Member State allows equipment covered by this Article to be placed on board a Community ship, that Member State shall forthwith communicate the particulars thereof together with the reports of all relevant trials, assessments and conformity-assessment procedures to the Commission and the other Member States. 5. Equipment such as is referred to in paragraph 1 shall be added to Annex A.2 in accordance with the procedure laid down in Article 18. 6. Where a ship with equipment on board which is covered by paragraph 1 is transferred to another Member State, the receiving flag Member State may undertake the measures necessary, which may include tests and practical demonstrations, to ensure that the equipment is at least as effective as equipment which does comply with the conformity-assessment procedures. Article 15 1. Notwithstanding Article 5, a flag State administration may permit equipment which does not comply with the conformity-assessment procedures or is not covered by Article 14 to be placed on board a Community ship for reasons of testing or evaluation, but only when the following conditions are complied with: (a) the equipment must be given a certificate by the flag Member State which must at all times be carried with the equipment and which gives the flag Member State permission for the equipment to be placed on board the Community ship and imposes any restrictions or lays down any provisions relating to the use of the equipment; (b) the permission must be limited to a short period of time; (c) the equipment must not be relied on in place of equipment which meets the requirements of this Directive and must not replace such equipment, which must remain on board the Community ship in working and ready for immediate use. 2. In the case of radiocommunications equipment, the flag State administration shall require that such equipment does not unduly affect the requirements of the radio-frequency spectrum. Article 16 1. Where equipment needs to be replaced in a port outwith the Community and in exceptional circumstances which shall be duly justified to the flag State administration where it is not practicable in terms of reasonable time, delay and cost to place on board equipment which is EC type-approved, other equipment may be placed on board in accordance with the following procedure: (a) the equipment shall be accompanied by documentation issued by a recognized organization equivalent to a notified body, where an agreement has been concluded between the Community and the third country concerned on the mutual recognition of such organizations; (b) should it prove impossible to comply with (a), equipment accompanied by documentation issued by a Member State of the IMO which is a party to the relevant conventions, certifying compliance with the relevant IMO requirements, may be placed on board, subject to paragraphs 2 and 3. 2. The flag State administration shall be informed at once of the nature and characteristics of such other equipment. 3. The flag State administration shall, at the earliest opportunity, ensure that the equipment referred to in paragraph 1, along with its testing documentation, complies with the relevant requirements of the international instruments and of this Directive. 4. In the case of radiocommunications equipment, the flag State administration shall require that such equipment does not unduly affect the requirements of the radio-frequency spectrum. Article 17 This Directive may be amended in accordance with the procedure laid down in Article 18, in order: - to apply subsequent amendments of international instruments for the purposes of this Directive, - to update Annex A, both by introducing new equipment and by transferring equipment from Annex A.2 to Annex A.1 and vice versa, - to add the possibility of using modules B + C and module H for equipment listed in Annex A.1, - to include other standardization organizations in the definition of 'testing standards` in Article 2. Article 18 1. The Commission shall be assisted by the committee set up by Article 12 of 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 (9) in accordance with the procedure laid down in this Article. 2. The Commission representative shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. (b) If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If the Council has not acted within two months of the date of the referral to it, the Commission shall adopt the measures proposed. Article 19 The Member States shall offer each other mutual assistance with a view to the effective implementation and enforcement of this Directive. Article 20 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 June 1998. They shall apply those measures from 1 January 1999. When Member States adopt the measures referred to in the first subparagraph, these shall contain references to this Directive or shall be accompanied by such references on their official publication. The methods of making such references shall be laid down by the Member States. 2. The Member States shall immediately communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 21 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 22 This Directive is addressed to the Member States.

31996L0097

1996

Council Directive 96/97/EC of 20 December 1996 amending Directive 86/378/EEC on the implementation of the principle of equal treatment for men and women in occupational social security schemes Having regard to the Treaty establishing the European Community, and in particular Article 100 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 Article 119 of the Treaty provides that each Member State shall ensure the application of the principle that men and women should receive equal pay for equal work; whereas 'pay` should be taken to mean the ordinary basic or minimum wage or salary and any other consideration, whether in cash or in kind, which the worker receives, directly or indirectly, from his employer in respect of his employment; Whereas, in its judgement of 17 May 1990, in Case 262/88: Barber v. Guardian Royal Exchange Assurance Group (4), the Court of Justice of the European Communities acknowledges that all forms of occupational pension constitute an element of pay within the meaning of Article 119 of the Treaty; Whereas, in the abovementioned judgment, as clarified by the judgment of 14 December 1993 (Case C-110/91: Moroni v. Collo GmbH) (5), the Court interprets Article 119 of the Treaty in such a way that discrimination between men and women in occupational social security schemes is prohibited in general and not only in respect of establishing the age of entitlement to a pension or when an occupational pension is offered by way of compensation for compulsory retirement on economic grounds; Whereas, in accordance with Protocol 2 concerning Article 119 of the Treaty annexed to the Treaty establishing the European Community, benefits under occupational social security schemes shall not be considered as remuneration if and in so far as they are attributable to periods of employment prior to 17 May 1990, except in the case of workers or those claiming under them who have, before that date, initiated legal proceedings or raised an equivalent claim under the applicable national law; Whereas, in its judgments of 28 September 1994 (6) (Case C-57/93: Vroege v. NCIV Instituut voor Volkshuisvesting BV and Case C-128/93: Fisscher v. Voorhuis Hengelo BV), the Court ruled that the abovementioned Protocol did not affect the right to join an occupational pension scheme, which continues to be governed by the judgment of 13 May 1986 in Case 170/84: Bilka-Kaufhaus GmbH v. Hartz (7), and that the limitation of the effects in time of the judgment of 17 May 1990 in Case C-262/88: Barber v. Guardian Royal Exchange Assurance Group does not apply to the right to join an occupational pension scheme; whereas the Court also ruled that the national rules relating to time limits for bringing actions under national law may be relied on against workers who assert their right to join an occupational pension scheme, provided that they are not less favourable for that type of action than for similar actions of a domestic nature and that they do not render the exercise of rights conferred by Community law impossible in practice; whereas the Court has also pointed out that the fact that a worker can claim retroactively to join an occupational pension scheme does not allow the worker to avoid paying the contributions relating to the period of membership concerned; Whereas the exclusion of workers on the grounds of the nature of their work contracts from access to a company or sectorial social security scheme may constitute indirect discrimination against women; Whereas, in its judgment of 9 November 1993 (Case C-132/92: Birds Eye Walls Ltd v. Friedel M. Roberts) (8), the Court has also specified that it is not contrary to Article 119 of the Treaty, when calculating the amount of a bridging pension which is paid by an employer to male and female employees who have taken early retirement on grounds of ill health and which is intended to compensate, in particular, for loss of income resulting from the fact that they have not yet reached the age required for payment of the State pension which they will subsequently receive and to reduce the amount of the bridging pension accordingly, even though, in the case of men and women aged between 60 and 65, the result is that a female ex-employee receives a smaller bridging pension than that paid to her male counterpart, the difference being equal to the amount of the State pension to which she is entitled as from the age of 60 in respect of the periods of service completed with that employer; Whereas, in its judgment of 6 October 1993 (Case C-109/91: Ten Oever v. Stichting Bedrijfpensioenfonds voor het Glazenwassers- en Schoonmaakbedrijf) (9) and in its judgments of 14 December 1993 (Case C-110/91: Moroni v. Collo GmbH), 22 December 1993 (Case C-152/91: Neath v. Hugh Steeper Ltd) (10) and 28 September 1994 (Case C-200/91: Coloroll Pension Trustees Limited v. Russell and Others) (11), the Court confirms that, by virtue of the judgment of 17 May 1990 (Case C-262/88: Barber v. Guardian Royal Exchange Assurance Group), the direct effect of Article 119 of the Treaty may be relied on, for the purpose of claiming equal treatment in the matter of occupational pensions, only in relation to benefits payable in respect of periods of service subsequent to 17 May 1990, except in the case of workers or those claiming under them who have, before that date, initiated legal proceedings or raised an equivalent claim under the applicable national law; Whereas, in its abovementioned judgments (Case C-109/91: Ten Oever v. Stichting Bedrijfpensioenfonds voor het Glazenwassers- en Schoonmaakbedrijf and Case C-200/91: Coloroll Pension Trustees Limited v. Russell and Others), the Court confirms that the limitation of the effects in time of the Barber judgment applies to survivors' pensions and, consequently, equal treatment in this matter may be claimed only in relation to periods of service subsequent to 17 May 1990, except in the case of those who have, before that date, initiated legal proceedings or raised an equivalent claim under the applicable national law; Whereas, moreover, in its judgments in Case C-152/91 and Case C-200/91, the Court specifies that the contributions of male and female workers to a defined-benefit pension scheme must be the same, since they are covered by Article 119 of the Treaty, whereas inequality of employers' contributions paid under funded defined-benefit schemes, which is due to the use of actuarial factors differing according to sex, is not to be assessed in the light of that same provision; Whereas, in its judgments of 28 September 1994 (12) (Case C-408/92: Smith v. Advel Systems and Case C-28/93: Van den Akker v. Stichting Shell Pensioenfonds), the Court points out that Article 119 of the Treaty precludes an employer who adopts measures necessary to comply with the Barber judgment of 17 May 1990 (C-262/88) from raising the retirement age for women to that which exists for men in relation to periods of service completed between 17 May 1990 and the date on which those measures come into force; on the other hand, as regards periods of service completed after the latter date, Article 119 does not prevent an employer from taking that step; as regards periods of service prior to 17 May 1990, Community law imposed no obligation which would justify retroactive reduction of the advantages which women enjoyed; Whereas, in its abovementioned judgment in Case C-200/91: Coloroll Pension Trustees Limited v. Russell and Others), the Court ruled that additional benefits stemming from contributions paid by employees on a purely voluntary basis are not covered by Article 119 of the Treaty; Whereas, among the measures included in its third medium-term action programme on equal opportunities for women and men (1991 to 1995) (13), the Commission emphasizes once more the adoption of suitable measures to take account of the consequences of the judgment of 17 May 1990 in Case 262/88 (Barber v. Guardian Royal Exchange Assurance Group); Whereas that judgment automatically invalidates certain provisions of Council Directive 86/378/EEC of 24 July 1986 on the implementation of the principle of equal treatment for men and women in occupational social security schemes (14) in respect of paid workers; Whereas Article 119 of the Treaty is directly applicable and can be invoked before the national courts against any employer, whether a private person or a legal person, and whereas it is for these courts to safeguard the rights which that provision confers on individuals; Whereas, on grounds of legal certainty, it is necessary to amend Directive 86/378/EEC in order to adapt the provisions which are affected by the Barber case-law, Article 1 Directive 86/378/EEG shall be amended as follows: 1. Article 2 shall be replaced by the following: 'Article 2 1. "Occupational social security schemes" means schemes not governed by Directive 79/7/EEC whose purpose is to provide workers, whether employees or self-employed, in an undertaking or group of undertakings, area of economic activity, occupational sector or group of sectors with benefits intended to supplement the benefits provided by statutory social security schemes or to replace them, whether membership of such schemes is compulsory or optional. 2. This Directive does not apply to: (a) individual contracts for self-employed workers; (b) schemes for self-employed workers having only one member; (c) insurance contracts to which the employer is not a party, in the case of salaried workers; (d) optional provisions of occupational schemes offered to participants individually to guarantee them: - either additional benefits, or - a choice of date on which the normal benefits for self-employed workers will start, or a choice between several benefits; (e) occupational schemes in so far as benefits are financed by contributions paid by workers on a voluntary basis. 3. This Directive does not preclude an employer granting to persons who have already reached the retirement age for the purposes of granting a pension by virtue of an occupational scheme, but who have not yet reached the retirement age for the purposes of granting a statutory retirement pension, a pension supplement, the aim of which is to make equal or more nearly equal the overall amount of benefit paid to these persons in relation to the amount paid to persons of the other sex in the same situation who have already reached the statutory retirement age, until the persons benefiting from the supplement reach the statutory retirement age.` 2. Article 3 shall be replaced by the following: 'Article 3 This Directive shall apply to members of the working population, including self-employed persons, persons whose activity is interrupted by illness, maternity, accident or involuntary unemployment and persons seeking employment, to retired and disabled workers and to those claiming under them, in accordance with national law and/or practice.` 3. Article 6 shall be replaced by the following: 'Article 6 1. Provisions contrary to the principle of equal treatment shall include those based on sex, either directly or indirectly, in particular by reference to marital or family status, for: (a) determining the persons who may participate in an occupational scheme; (b) fixing the compulsory or optional nature of participation in an occupational scheme; (c) laying down different rules as regards the age of entry into the scheme or the minimum period of employment or membership of the scheme required to obtain the benefits thereof; (d) laying down different rules, except as provided for in points (h) and (i), for the reimbursement of contributions when a worker leaves a scheme without having fulfilled the conditions guaranteeing a deferred right to long-term benefits; (e) setting different conditions for the granting of benefits or restricting such benefits to workers of one or other of the sexes; (f) fixing different retirement ages; (g) suspending the retention or acquisition of rights during periods of maternity leave or leave for family reasons which are granted by law or agreement and are paid by the employer; (h) setting different levels of benefit, except in so far as may be necessary to take account of actuarial calculation factors which differ according to sex in the case of defined-contribution schemes. In the case of funded defined-benefit schemes, certain elements (examples of which are annexed) may be unequal where the inequality of the amounts results from the effects of the use of actuarial factors differing according to sex at the time when the scheme's funding is implemented; (i) setting different levels for workers' contributions; setting different levels for employers' contributions, except: - in the case of defined-contribution schemes if the aim is to equalize the amount of the final benefits or to make them more nearly equal for both sexes, - in the case of funded defined-benefit schemes where the employer's contributions are intended to ensure the adequacy of the funds necessary to cover the cost of the benefits defined, (j) laying down different standards or standards applicable only to workers of a specified sex, except as provided for in points (h) and (i), as regards the guarantee or retention of entitlement to deferred benefits when a worker leaves a scheme. 2. Where the granting of benefits within the scope of this Directive is left to the discretion of the scheme's management bodies, the latter must comply with the principle of equal treatment.` 4. Article 8 shall be replaced by the following: 'Article 8 1. Member States shall take the necessary steps to ensure that the provisions of occupational schemes for self-employed workers contrary to the principle of equal treatment are revised with effect from 1 January 1993 at the latest. 2. This Directive shall not preclude rights and obligations relating to a period of membership of an occupational scheme for self-employed workers prior to revision of that scheme from remaining subject to the provisions of the scheme in force during that period.` 5. Article 9 shall be replaced by the following: 'Article 9 As regards schemes for self-employed workers, Member States may defer compulsory application of the principle of equal treatment with regard to: (a) determination of pensionable age for the granting of old-age or retirement pensions, and the possible implications for other benefits: - either until the date on which such equality is achieved in statutory schemes, - or, at the latest, until such equality is prescribed by a directive; (b) survivors' pensions until Community law establishes the principle of equal treatment in statutory social security schemes in that regard; (c) the application of the first subparagraph of point (i) of Article 6 (1) to take account of the different actuarial calculation factors, at the latest until 1 January 1999.` 6. The following Article shall be inserted: 'Article 9a Where men and women may claim a flexible pensionable age under the same conditions, this shall not be deemed to be incompatible with this Directive.` 7. The following Annex shall be added: 'ANNEX Examples of elements which may be unequal, in respect of funded defined-benefit schemes, as referred to in Article 6 (h): - conversion into a capital sum of part of a periodic pension, - transfer of pension rights, - a reversionary pension payable to a dependant in return for the surrender of part of a pension, - a reduced pension where the worker opts to take early retirement.` Article 2 1. Any measure implementing this Directive, as regards paid workers, must cover all benefits derived from periods of employment subsequent to 17 May 1990 and shall apply retroactively to that date, without prejudice to workers or those claiming under them who have, before that date, initiated legal proceedings or raised an equivalent claim under national law. In that event, the implementation measures must apply retroactively to 8 April 1976 and must cover all the benefits derived from periods of employment after that date. For Member States which acceded to the Community after 8 April 1976, that date shall be replaced by the date on which Article 119 of the Treaty became applicable on their territory. 2. The second sentence of paragraph 1 shall not prevent national rules relating to time limits for bringing actions under national law from being relied on against workers or those claiming under them who initiated legal proceedings or raise an equivalent claim under national law before 17 May 1990, provided that they are not less favourable for that type of action than for similar actions of a domestic nature and that they do not render the exercise of Community law impossible in practice. 3. For Member States whose accession took place after 17 May 1990 and who were on 1 January 1994 Contracting Parties to the Agreement on the European Economic Area, the date of 17 May 1990 in paragraph 1 and 2 of this Directive is replaced by 1 January 1994. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 1997. 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 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, at the latest two years after the entry into force of this Directive, all information necessary to enable the Commission to draw up a report on the application of this Directive. Article 4 This Directive shall enter into force on the 20 day following that of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31997L0002

1997

Council Directive 97/2/EC of 20 January 1997 amending Directive 91/629/EEC laying down minimum standards for the protection of calves Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Whereas, pursuant to Article 6 of Directive 91/629/EEC (3), the Scientific Veterinary Committee gave an opinion on 9 November 1995, on the basis of which the Commission drew up a report which was submitted to the European Parliament and the Council; Whereas, on the basis of the conclusions of that report, it is appropriate to amend certain provisions of Directive 91/629/EEC in order to ensure that the rules are based on scientific evidence and do not go beyond what is necessary to enable the common organization of markets to function effectively; Whereas Declaration No 24 annexed to the Final Act of the Treaty on European Union calls upon the European institutions and the Member States, when drafting and implementing Community legislation, to pay full regard to the welfare requirements of animals; Whereas the harmonization of rules concerning the conditions of calf-rearing in the framework of the common organization of the markets is necessary to ensure the rational development of production under satisfactory conditions of competition; whereas in this regard it is recognized scientifically that calves should benefit from an environment corresponding to their needs as a herd-living species; whereas, for that reason, they should be reared in groups; whereas calves, both group-housed and individually penned, must have sufficient space for exercise, contact with other cattle, and for normal movements when standing up or lying down; Whereas it is necessary to allow time for holdings to make the necessary arrangements to comply with the new rules, Article 1 Directive 91/629/EEC is hereby amended as follows: 1. Article 3 (3) shall be replaced by the following: '3. From 1 January 1998, the following provisions shall apply on all newly built or rebuilt holdings and on all those brought into use after that date: (a) no calf shall be confined in an individual pen after the age of eight weeks, unless a veterinarian certifies that its health or behaviour requires it to be isolated in order to receive treatment. The width of any individual pen for a calf shall be at least equal to the height of the calf at the withers, measured in the standing position, and the length shall be at least equal to the body length of the calf, measured from the tip of the nose to the caudal edge of the tuber ischii (pin bone), multiplied by 1,1. Individual pens for calves (except those for isolating sick animals) must not have solid walls, but perforated walls which allow the calves to have direct visual and tactile contact; (b) For calves kept in groups, the unobstructed space allowance available to each calf shall be at least equal to 1,5 m² for each calf with a live weight of less than 150 kilograms, at least equal to 1,7 m² for each calf with a live weight of 150 kilograms or more but less than 220 kilograms, and at least equal to 1,8 m² for each calf with a live weight of 220 kilograms or more. However, the provisions of this paragraph shall not apply to: - holdings with fewer than six calves; - calves kept with their mothers for suckling. From 31 December 2006, the provisions provided for above shall apply on all holdings.` 2. The second indent of Article 3 (4) shall be deleted. 3. Article 4 (2) shall be deleted. 4. In Article 6, the date '1 October 1997` shall be replaced by '1 January 2006`. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1997. 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. However, as from the date set in paragraph 1, Member States may, in compliance with the general rules of the Treaty, maintain or apply within their territories stricter provisions for the protection of calves than those laid down in this Directive. They shall inform the Commission of any such measures. 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.

31997L0005

1997

Directive 97/5/EC of the European Parliament and of the Council of 27 January 1997 on cross-border credit transfers Having regard to the Treaty establishing the European Community, and in particular Article 100a 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, Acting in accordance with the procedure laid down in Article 189b of the Treaty (3) in the light of the joint text approved on 22 November 1996 by the Conciliation Committee, (1) Whereas the volume of cross-border payments is growing steadily as completion of the internal market and progress towards full economic and monetary union lead to greater trade and movement of people within the Community; whereas cross-border credit transfers account for a substantial part of the volume and value of cross-border payments; (2) Whereas it is essential for individuals and businesses, especially small and medium-sized enterprises, to be able to make credit transfers rapidly, reliably and cheaply from one part of the Community to another; whereas, in conformity with the Commission Notice on the application of the EC competition rules to cross-border credit transfers (4), greater competition in the market for cross-border credit transfers should lead to improved services and reduced prices; (3) Whereas this Directive seeks to follow up the progress made towards completion of the internal market, in particular towards liberalization of capital movements, with a view to the implementation of economic and monetary union; whereas its provisions must apply to credit transfers in the currencies of the Member States and in ecus; (4) Whereas the European Parliament, in its resolution of 12 February 1993 (5), called for a Council Directive to lay down rules in the area of transparency and performance of cross-border payments; (5) Whereas the issues covered by this Directive must be dealt with separately from the systemic issues which remain under consideration within the Commission; whereas it may become necessary to make a further proposal to cover these systemic issues, particularly the problem of settlement finality; (6) Whereas the purpose of this Directive is to improve cross-border credit transfer services and thus assist the European Monetary Institute (EMI) in its task of promoting the efficiency of cross-border payments with a view to the preparation of the third stage of economic and monetary union; (7) Whereas, in line with the objectives set out in the second recital, this Directive should apply to any credit transfer of an amount of less than ECU 50 000; (8) Whereas, having regard to the third paragraph of Article 3b of the Treaty, and with a view to ensuring transparency, this Directive lays down the minimum requirements needed to ensure an adequate level of customer information both before and after the execution of a cross-border credit transfer; whereas these requirements include indication of the complaints and redress procedures offered to customers, together with the arrangements for access thereto; whereas this Directive lays down minimum execution requirements, in particular in terms of performance, which institutions offering cross-border credit transfer services should adhere to, including the obligation to execute a cross-border credit transfer in accordance with the customer's instructions; whereas this Directive fulfils the conditions deriving from the principles set out in Commission Recommendation 90/109/EEC of 14 February 1990 on the transparency of banking conditions relating to cross-border financial transactions (6); whereas this Directive is without prejudice to Council Directive 91/308/EEC of 10 June 1991 on prevention of the use of the financial system for the purpose of money laundering (7); (9) Whereas this Directive should contribute to reducing the maximum time taken to execute a cross-border credit transfer and encourage those institutions which already take a very short time to do so to maintain that practice; (10) Whereas the Commission, in the report it will submit to the European Parliament and the Council within two years of implementation of this Directive, should particularly examine the time-limit to be applied in the absence of a time-limit agreed between the originator and his institution, taking into account both technical developments and the situation existing in each Member State; (11) Whereas there should be an obligation upon institutions to refund in the event of a failure to successfully complete a credit transfer; whereas the obligation to refund imposes a contingent liability on institutions which might, in the absence of any limit, have a prejudicial effect on solvency requirements; whereas that obligation to refund should therefore be applicable up to ECU 12 500; (12) Whereas Article 8 does not affect the general provisions of national law whereby an institution has responsibility towards the originator when a cross-border credit transfer has not been completed because of an error committed by that institution; (13) Whereas it is necessary to distinguish, among the circumstances with which institutions involved in the execution of a cross-border credit transfer may be confronted, including circumstances relating to insolvency, those caused by force majeure; whereas for that purpose the definition of force majeure given in Article 4 (6) of Directive 90/314/EEC of 13 June 1990 on package travel, package holidays and package tours (8) should be taken as a basis; (14) Whereas there need to be adequate and effective complaints and redress procedures in the Member States for the settlement of possible disputes between customers and institutions, using existing procedures where appropriate, SECTION I SCOPE AND DEFINITIONS Article 1 Scope The provisions of this Directive shall apply to cross-border credit transfers in the currencies of the Member States and the ECU up to the equivalent of ECU 50 000 ordered by persons other than those referred to in Article 2 (a), (b) and (c) and executed by credit institutions or other institutions. Article 2 Definitions For the purposes of this Directive: (a) 'credit institution` means an institution as defined in Article 1 of Council Directive 77/780/EEC (9), and includes branches, within the meaning of the third indent of that Article and located in the Community, of credit institutions which have their head offices outside the Community and which by way of business execute cross-border credit transfers; (b) 'other institution` means any natural or legal person, other than a credit institution, that by way of business executes cross-border credit transfers; (c) 'financial institution` means an institution as defined in Article 4 (1) of Council Regulation (EC) No 3604/93 of 13 December 1993 specifying definitions for the application of the prohibition of privileged access referred to in Article 104a of the Treaty (10); (d) 'institution` means a credit institution or other institution; for the purposes of Articles 6, 7 and 8, branches of one credit institution situated in different Member States which participate in the execution of a cross-border credit transfer shall be regarded as separate institutions; (e) 'intermediary institution` means an institution which is neither that of the originator nor that of the beneficiary and which participates in the execution of a cross-border credit transfer; (f) 'cross-border credit transfer` means a transaction carried out on the initiative of an originator via an institution or its branch in one Member State, with a view to making available an amount of money to a beneficiary at an institution or its branch in another Member State; the originator and the beneficiary may be one and the same person; (g) 'cross-border credit transfer order` means an unconditional instruction in any form, given directly by an originator to an institution to execute a cross-border credit transfer; (h) 'originator` means a natural or legal person that orders the making of a cross-border credit transfer to a beneficiary; (i) 'beneficiary` means the final recipient of a cross-border credit transfer for whom the corresponding funds are made available in an account to which he has access; (j) 'customer` means the originator or the beneficiary, as the context may require; (k) 'reference interest rate` means an interest rate representing compensation and established in accordance with the rules laid down by the Member State in which the establishment which must pay the compensation to the customer is situated; (l) 'date of acceptance` means the date of fulfilment of all the conditions required by the institution as to the execution of the cross-border credit transfer order and relating to the availability of adequate financial cover and the information required to execute that order. SECTION II TRANSPARENCY OF CONDITIONS FOR CROSS-BORDER CREDIT TRANSFERS Article 3 Prior information on conditions for cross-border credit transfers The institutions shall make available to their actual and prospective customers in writing, including where appropriate by electronic means, and in a readily comprehensible form, information on conditions for cross-border credit transfers. This information shall include at least: - indication of the time needed, when a cross-border credit transfer order given to the institution is executed, for the funds to be credited to the account of the beneficiary's institution; the start of that period must be clearly indicated, - indication of the time needed, upon receipt of a cross-border credit transfer, for the funds credited to the account of the institution to be credited to the beneficiary's account, - the manner of calculation of any commission fees and charges payable by the customer to the institution, including where appropriate the rates, - the value date, if any, applied by the institution, - details of the complaint and redress procedures available to the customer and arrangements for access to them, - indication of the reference exchange rates used. Article 4 Information subsequent to a cross-border credit transfer The institutions shall supply their customers, unless the latter expressly forgo this, subsequent to the execution or receipt of a cross-border credit transfer, with clear information in writing, including where appropriate by electronic means, and in a readily comprehensible form. This information shall include at least: - a reference enabling the customer to identify the cross-border credit transfer, - the original amount of the cross-border credit transfer, - the amount of all charges and commission fees payable by the customer, - the value date, if any, applied by the institution. Where the originator has specified that the charges for the cross-border credit transfer are to be wholly or partly borne by the beneficiary, the latter shall be informed thereof by his own institution. Where any amount has been converted, the institution which converted it shall inform its customer of the exchange rate used. SECTION III MINIMUM OBLIGATIONS OF INSTITUTIONS IN RESPECT OF CROSS-BORDER CREDIT TRANSFERS Article 5 Specific undertakings by the institution Unless it does not wish to do business with that customer, an institution must at a customer's request, for a cross-border credit transfer with stated specifications, give an undertaking concerning the time needed for execution of the transfer and the commission fees and charges payable, apart from those relating to the exchange rate used. Article 6 Obligations regarding time taken 1. The originator's institution shall execute the cross-border credit transfer in question within the time limit agreed with the originator. Where the agreed time limit in not complied with or, in the absence of any such time limit, where, at the end of the fifth banking business day following the date of acceptance of the cross-border credit transfer order, the funds have not been credited to the the account of the beneficiary's institution, the originator's institution shall compensate the originator. Compensation shall comprise the payment of interest calculated by applying the reference rate of interest to the amount of the cross-border credit transfer for the period from: - the end of the agreed time limit or, in the absence of any such time limit, the end of the fifth banking business day following the date of acceptance of the cross-border credit transfer order, to - the date on which the funds are credited to the account of the beneficiary's institution. Similarly, where non-execution of the cross-border credit transfer within the time limit agreed or, in the absence of any such time limit, before the end of the fifth banking business day following the date of acceptance of the cross-border credit transfer is attributable to an intermediary institution, that institution shall be required to compensate the originator's institution. 2. The beneficiary's institution shall make the funds resulting from the cross-border credit transfer available to the beneficiary within the time limit agreed with the beneficiary. Where the agreed time limit is not complied with or, in the absence of any such time limit, where, at the end of the banking business day following the day on which the funds were credited to the account of the beneficiary's institution, the funds have not been credited to the beneficiary's account, the beneficiary's institution shall compensate the beneficiary. Compensation shall comprise the payment of interest calculated by applying the reference rate of interest to the amount of the cross-border credit transfer for the period from: - the end of the agreed time limit or, in the absence of any such time limit, the end of the banking business day following the day on which the funds were credited to the account of the beneficiary's institution, to - the date on which the funds are credited to the beneficiary's account. 3. No compensation shall be payable pursuant to paragraphs 1 and 2 where the originator's institution or, as the case may be, the beneficiary's institution can establish that the delay is attributable to the originator or, as the case may be, the beneficiary. 4. Paragraphs 1, 2 and 3 shall be entirely without prejudice to the other rights of customers and institutions that have participated in the execution of a cross-border credit transfer order. Article 7 Obligation to execute the cross-border transfer in accordance with instructions 1. The originator's institution, any intermediary institution and the beneficiary's institution, after the date of acceptance of the cross-border credit transfer order, shall each be obliged to execute that credit transfer for the full amount thereof unless the originator has specified that the costs of the cross-border credit transfer are to be borne wholly or partly by the beneficiary. The first subparagraph shall be without prejudice to the possibility of the beneficiary's institution levying a charge on the beneficiary relating to the administration of his account, in accordance with the relevant rules and customs. However, such a charge may not be used by the institution to avoid the obligations imposed by the said subparagraph. 2. Without prejudice to any other claim which may be made, where the originator's institution or an intermediary institution has made a deduction from the amount of the cross-border credit transfer in breach of paragraph 1, the originator's institution shall, at the originator's request, credit, free of all deductions and at its own cost, the amount deducted to the beneficiary unless the originator requests that the amount be credited to him. Any intermediary institution which has made a deduction in breach of paragraph 1 shall credit the amount deducted, free of all deductions and at its own cost, to the originator's institution or, if the originator's institution so requests, to the beneficiary of the cross-border credit transfer. 3. Where a breach of the duty to execute the cross-border credit transfer order in accordance with the originator's instructions has been caused by the beneficiary's institution, and without prejudice to any other claim which may be made, the beneficiary's institution shall be liable to credit to the beneficiary, at its own cost, any sum wrongly deducted. Article 8 Obligation upon institutions to refund in the event of non-execution of transfers 1. If, after a cross-border credit transfer order has been accepted by the originator's institution, the relevant amounts are not credited to the account of the beneficiary's institution, and without prejudice to any other claim which may be made, the originator's institution shall credit the originator, up to ECU 12 500, with the amount of the cross-border credit transfer plus: - interest calculated by applying the reference interest rate to the amount of the cross-border credit transfer for the period between the date of the cross-border credit transfer order and the date of the credit, and - the charges relating to the cross-border credit transfer paid by the originator. These amounts shall be made available to the originator within fourteen banking business days following the date of his request, unless the funds corresponding to the cross-border credit transfer have in the meantime been credited to the account of the beneficiary's institution. Such a request may not be made before expiry of the time limit agreed between the originator's institution and the originator for the execution of the cross-border credit transfer order or, in the absence of any such time limit, before expiry of the time limit laid down in the second subparagraph of Article 6 (1). Similarly, each intermediary institution which has accepted the cross-border credit transfer order owes an obligation to refund at its own cost the amount of the credit transfer, including the related costs and interest, to the institution which instructed it to carry out the order. If the cross-border credit transfer was not completed because of errors or omissions in the instructions given by that institution, the intermediary institution shall endeavour as far as possible to refund the amount of the transfer. 2. By way of derogation from paragraph 1, if the cross-border credit transfer was not completed because of its non-execution by an intermediary institution chosen by the beneficiary's institution, the latter institution shall be obliged to make the funds available to the beneficiary up to ECU 12 500. 3. By way of derogation from paragraph 1, if the cross-border credit transfer was not completed because of an error or omission in the instructions given by the originator to his institution or because of non-execution of the cross-border credit transfer by an intermediary institution expressly chosen by the originator, the originator's institution and the other institutions involved shall endeavour as fas as possible to refund the amount of the transfer. Where the amount has been recovered by the originator's institution, it shall be obliged to credit it to the originator. The institutions, including the originator's institution, are not obliged in this case to refund the charges and interest accruing, and can deduct the costs arising from the recovery if specified. Article 9 Situation of force majeure Without prejudice to the provisions of Directive 91/308/EEC, institutions participating in the execution of a cross-border credit transfer order shall be released from the obligations laid down in this Directive where they can adduce reasons of force majeure, namely abnormal and unforeseeable circumstances beyond the control of the person pleading force majeure, the consequences of which would have been unavoidable despite all efforts to the contrary, which are relevant to its provisions. Article 10 Settlement of disputes Member States shall ensure that there are adequate and effective complaints and redress procedures for the settlement of disputes between an originator and his institution or between a beneficiary and his institution, using existing procedures where appropriate. SECTION IV FINAL PROVISIONS Article 11 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 14 August 1999 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. Member States shall communicate to the Commission the text of the main laws, regulations or administrative provisions which they adopt in the field governed by this Directive. Article 12 Report to the European Parliament and the Council No later than two years after the date of implementation of this Directive, the Commission shall submit a report to the European Parliament and the Council on the application of this Directive, accompanied where appropriate by proposals for its revision. This report shall, in the light of the situation existing in each Member State and of the technical developments that have taken place, deal particularly with the question of the time limit set in Article 6 (1). Article 13 Entry into force This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities. Article 14 Addressees This Directive is addressed to the Member States.

31997L0004

1997

Directive 97/4/EC of the European Parliament and of the Council of 27 January 1997 amending Directive 79/112/EEC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (1), and in particular Article 6 (2) (c) and (3) and Article 7, 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 laid down in Article 189b of the Treaty (4) in the light of the join text approved on 16 October 1996 by the Conciliation Committee, Whereas, in the context of achieving the objectives of the internal market, the use of the name customary in the Member State in which a product is manufactured should also be allowed in the case of products to be sold in another Member State; Whereas, with the twofold aim of providing the consumer with better information and ensuring fair trade, the labelling rules as regards the exact nature and characteristics of products need to be further improved; Whereas, in accordance with the rules of the Treaty, the provisions applicable to sales names remain subject to the general rules on labelling in Article 2 and more particularly the principle that they must not be such as to mislead the consumer about the characteristics of the foodstuff; Whereas the Court of Justice of the European Communities has delivered several judgments in which it recommends detailed labelling, in particular the compulsory affixing of suitable labels giving the nature of the product sold; whereas this course of action, which enables the consumer to make his choice in full knowledge of the facts, is the most appropriate since it creates fewest obstacles to free trade; Whereas it is for the Community legislature to adopt measures deriving from that case law, Article 1 Directive 79/112/EEC is hereby amended as follows: 1. the following recital shall be inserted after the sixth recital: 'Whereas that need means that Member States may, in compliance with the rules of the Treaty, impose language requirements;` 2. the following shall be added to Article 3 (1): '2a. the quantity of certain ingredients or categories of ingredients as provided for in Article 7;` 3. Article 5 (1) shall be replaced by the following: '1. The name under which a foodstuff is sold shall be the name provided for in the European Community provisions applicable to it. (a) In the absence of European Community provisions, the name under which a product is sold shall be the name provided for in the laws, regulations and administrative provisions applicable in the Member State in which the product is sold to the final consumer or to mass caterers. Failing this, the name under which a product is sold shall be the name customary in the Member State in which it is sold to the final consumer or to mass caterers, or a description of the foodstuff, and if necessary of its use, which is clear enough to let the purchaser know its true nature and distinguish it from other products with which it might be confused. (b) The use in the Member State of marketing of the sales name under which the product is legally manufactured and marketed in the Member State of production shall also be allowed. However, where the application of the other provisions of this Directive, in particular those set out in Article 3, would not enable consumers in the Member State of marketing to know the true nature of the foodstuff and to distinguish it from foodstuffs with which they could confuse it, the sales name shall be accompanied by other descriptive information which shall appear in proximity to the sales name. (c) In exceptional cases, the sales name of the Member State of production shall not be used in the Member State of marketing when the foodstuff which it designates is so different, as regards its composition or manufacture, from the foodstuff known under that name that the provisions of point (b) are not sufficient to ensure, in the Member State of marketing, correct information for consumers.`; 4. Article 6 (2) (c) shall be replaced by the following: '(c) products comprising a single ingredient, where: - the trade name is identical with the ingredient name, or - the trade name enables the nature of the ingredient to be clearly identified.`; 5. the first indent of Article 6 (5) (b) (Directive 79/112/EEC) shall be replaced by the following: '- ingredients which belong to one of the categories listed in Annex I and are constituents of another foodstuff need only be designated by the name of that category. Alterations to the list of categories in Annex I may be effected in accordance with the procedure laid down in Article 17. However, the designation "starch" listed in Annex I must always be complemented by the indication of its specific vegetable origin, when that ingredient may contain gluten,`; 6. the second indent of Article 6 (5) (b) (Directive 79/112/EEC) shall be replaced by the following: '- ingredients belonging to one of the categories listed in Annex II must be designated by the name of that category, followed by their specific name or EEC number; if an ingredient belongs to more than one of the categories, the category appropriate to the principal function in the case of the foodstuff in question shall be indicated. Amendments to this Annex based on advances in scientific and technical knowledge shall be adopted in accordance with the procedure laid down in Article 17. However, the designation "modified starch" listed in Annex II must always be complemented by the indication of its specific vegetable origin, when that ingredient may contain gluten.`; 7. Article 7 shall be replaced by the following: 'Article 7 1. The quantity of an ingredient or category of ingredients used in the manufacture or preparation of a foodstuff shall be stated in accordance with this Article. 2. The indication referred to in paragraph 1 shall be compulsory: (a) where the ingredient or category of ingredients concerned appears in the name under which the foodstuff is sold or is usually associated with that name by the consumer; or (b) where the ingredient or category of ingredients concerned is emphasized on the labelling in words, pictures or graphics; or (c) where the ingredient or category of ingredients concerned is essential to characterize a foodstuff and to distinguish it from products with which it might be confused because of its name or appearance; or (d) in the cases determined in accordance with the procedure laid down in Article 17. 3. Paragraph 2 shall not apply: (a) to an ingredient or category of ingredients: - the drained net weight of which is indicated in accordance with Article 8 (4), or - the quantities of which are already required to be given on the labelling under Community provisions, - which is used in small quantities for the purposes of flavouring, - which, while appearing in the name under which the food is sold, is not such as to govern the choice of the consumer in the country of marketing because the variation in quantity is not essential to characterize the foodstuff or does not distinguish it from similar foods. In cases of doubt it shall be decided by the procedure laid down in Article 17 whether the conditions laid down in this indent are fulfilled. (b) where specific Community provisions stipulate precisely the quantity of an ingredient or of a category of ingredients without providing for the indication thereof on the labelling; (c) in the cases referred to in the fourth and fifth indents of Article 6 (5) (a); (d) in the cases determined in accordance with the procedure laid down in Article 17. 4. The quantity indicated, expressed as a percentage, shall correspond to the quantity of the ingredient or ingredients at the time of its/their use. However, Community provisions may allow for derogations from this principle for certain foodstuffs. Such provisions shall be adopted in accordance with the procedure laid down in Article 17. 5. The indication referred to in paragraph 1 shall appear either in or immediately next to the name under which the foodstuff is sold or in the list of ingredients in connection with the ingredient or category of ingredients in question. 6. This Article shall apply without prejudice to Community rules on nutrition labelling for foodstuffs.`; 8. The following Article shall be inserted: 'Article 13a 1. Member States shall ensure that the sale is prohibited within their own territories of foodstuffs for which the particulars provided for in Article 3 and Article 4 (2) do not appear in a language easily understood by the consumer, unless the consumer is in fact informed by means of other measures determined in accordance with the procedure laid down in Article 17 as regards one or more labelling particulars. 2. Within its own territory, the Member State in which the product is marketed may, in accordance with the rules of the Treaty, stipulate that those labelling particulars shall be given in one or more languages which it shall determine from among the official languages of the Community. 3. Paragraphs 1 and 2 shall not preclude the labelling particulars from being indicated in several languages.`; 9. in Article 14, the second paragraph shall be deleted. Article 2 Member States shall, where appropriate, amend their laws, regulations and administrative provisions in order to: - allow trade in products conforming to this Directive no later than 14 August 1998, - prohibit trade in products not conforming to this Directive no later than 14 February 2000. However, trade in products not conforming to this Directive and labelled before that date shall be permitted until stocks are fully depleted. The Member States shall forthwith inform the Commission of those provisions. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 3 This Directive shall apply as from the date of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31997L0010

1997

Commission Directive 97/10/EC of 26 February 1997 adapting to technical progress for the 3rd 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 (CMRs) (Text with EEA relevance) Having regard to Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (1), as last amended by Commission Directive 96/55/EC (2), and in particular Article 2a thereof, introduced by Council Directive 89/678/EEC (3), Whereas the Council and the Representatives of the Governments of the Member States, meeting within the Council, adopted Decision 90/238/Euratom, ECSC, EEC (4) concerning a 1990 to 1994 action plan in the context of the 'Europe against Cancer` programme; Whereas Directive 94/60/EC (5) of the European Parliament and Council, amending for the 14th time Directive 76/769/EEC prohibited with certain exemptions the placing on the market for use by the general public of substances classified as carcinogenic, mutagenic and toxic to reproduction in categories 1 or 2 (CMRs) by adding such substances to Annex I of Directive 76/769/EEC; Whereas Annex I to Directive 76/769/EEC already contained substances classified CMR to which Directive 94/60/EC did not apply; Whereas placing on the market for use by the general public of these CMRs and preparations containing these CMRs should also be prohibited with certain exceptions; Whereas the restrictions laid down by this Directive take into account the current state of knowledge and techniques regarding safer alternatives; Whereas this Directive does not affect Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC (6) and in individual Directives based thereon, in particular Council Directive 90/394/EEC (7); Whereas 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 hereto. Article 2 Member States shall adopt and publish the provisions necessary to comply with this Directive by 31 December 1997 and shall forthwith inform the Commission thereof. They shall apply these provisions as from 30 June 1998. 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 is addressed to the Member States.

31997L0009

1997

Directive 97/9/EC of the European Parliament and of the Council of 3 March 1997 on investor-compensation schemes Having regard to the Treaty establishing the European Community, and in particular Article 57 (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 189b of the Treaty (4) in the light of the joint text approved by the Conciliation Committee on 18 December 1996, (1) Whereas on 10 May 1993 the Council adopted Directive 93/22/EEC on investment services in the securities field (5); whereas that Directive is an essential instrument for the achievement of the internal market for investment firms; (2) Whereas Directive 93/22/EEC lays down prudential rules which investment firms must observe at all times, including rules the purpose of which is to protect as far as possible investor's rights in respect of money or instruments belonging to them; (3) Whereas, however, no system of supervision can provide complete protection, particularly where acts of fraud are committed; (4) Whereas the protection of investors and the maintenance of confidence in the financial system are an important aspect of the completion and proper functioning of the internal market in this area; whereas to that end it is therefore essential that each Member State should have an investor-compensation scheme that guarantees a harmonized minimum level of protection at least for the small investor in the event of an investment firm being unable to meet its obligations to its investor clients; (5) Whereas small investors will therefore be able to purchase investment services from branches of Community investment firms or on the basis of the cross-border provision of services as confidently as from domestic investment firms, in the knowledge that a harmonized minimum level of protection would be available to them in the event of an investment firm being unable to meet its obligations to its investor clients; (6) Whereas, in the absence of such minimum harmonization, a host Member State might consider itself justified, by considerations of investor protection, in requiring membership of its compensation scheme when a Community investment firm operating through a branch or under the freedom to provide services either belonged to no investor-compensation scheme in its home Member State or belonged to a scheme which was not regarded as offering equivalent protection; whereas such a requirement might prejudice the operation of the internal market; (7) Whereas although most Member States currently have some investor-compensation arrangements those arrangements do not in general cover all investment firms that hold the single authorization provided for in Directive 93/22/EEC; (8) Whereas, therefore, every Member State should be required to have an investor-compensation scheme or schemes to which every such investment firm would belong; whereas each scheme must cover money and instruments held by an investment firm in connection with an investor's investment operations which, where an investment firm is unable to meet its obligations to its investor clients, cannot be returned to the investor; whereas this is entirely without prejudice to the rules and procedures applicable in each Member State as regards the decisions to be taken in the event of the insolvency or winding-up of an investment firm; (9) Whereas the definition of investment firm includes credit institutions which are authorized to provide investment services; whereas every such credit institution must also be required to belong to an investor-compensation scheme to cover its investment business; whereas, however, it is not necessary to require such a credit institution to belong to two separate schemes where a single scheme meets the requirements both of this Directive and of Directive 94/19/EC of the European Parliament and of the Council of 30 May 1994 on deposit-guarantee schemes (6); whereas, however, in the case of investment firms which are credit institutions it may in certain cases be difficult to distinguish between deposits covered by Directive 94/19/EC and money held in connection with investment business; whereas Member States should be allowed to determine which Directive shall apply to such claims; (10) Whereas Directive 94/19/EC allows a Member State to exempt a credit institution from the obligation to belong to a deposit-guarantee scheme where that credit institution belongs to a system which protects the credit institution itself and, in particular, ensures its solvency; whereas, where a credit institution belonging to such a system is also an investment firm, a Member State should also be allowed, subject to certain conditions, to exempt it from the obligation to belong to an investor-compensation scheme; (11) Whereas a harmonized minimum level of compensation of ECU 20 000 for each investor should be sufficient to protect the interests of the small investor where an investment firm is unable to meet its obligations to its investor clients; whereas it would therefore appear reasonable to set the harmonized minimum level of compensation at ECU 20 000; whereas, as in Directive 94/19/EC, limited transitional provisions might be required to enable compensation schemes to comply with that figure since this applies equally to Member States which, when this Directive is adopted, do not have any such scheme; (12) Whereas the same figure was adopted in Directive 94/19/EC; (13) Whereas in order to encourage investors to take due care in their choice of investment firms it is reasonable to allow Member States to require investors to bear a proportion of any loss; whereas, however, an investor must be covered for at least 90 % of any loss as long as the compensation paid is less than the Community minimum; (14) Whereas certain Member States' schemes offer levels of cover higher than the harmonized minimum level of protection under this Directive; whereas, however, it does not seem desirable to require any change in those schemes in that respect; (15) Whereas the retention in the Community of schemes providing levels of cover higher than the harmonized minimum may, within the same territory, lead to disparities in compensation and unequal conditions of competition between national investment firms and branches of firms from other Member States; whereas, in order to counteract those disadvantages, branches should be authorized to join their host countries' schemes so that they may offer their investors the same cover as is provided by the schemes of the countries in which they are located; whereas it is appropriate that, in its report on the application of this Directive, the Commission should indicate the extent to which branches have exercised that option and any difficulties which they or the investor-compensation schemes may have encountered in implementing those provisions; whereas the possibility that home Member States' schemes should themselves offer such supplementary cover, subject to the conditions such schemes may lay down, is not ruled out; (16) Whereas market disturbances could be caused by branches of investment firms established in Member States other than their Member States of origin which offer levels of cover higher than those offered by investment firms authorized in their host Member States; whereas it is not appropriate that the level or scope of cover offered by compensation schemes should become an instrument of competition; whereas it is therefore necessary, at least during an initial period, to stipulate that neither the level nor the scope of cover offered by a home Member State's scheme to investors at branches located in another Member State should exceed the maximum level or scope offered by the corresponding scheme in the host Member State; whereas any market disturbances should be reviewed at an early date, on the basis of the experience acquired and in the light of developments in the financial sector; (17) Whereas a Member State must be able to exclude certain categories of specifically listed investments or investors, if it does not consider that they need special protection, from the cover afforded by investor-compensation schemes; (18) Whereas some Member States have investor-compensation schemes under the responsibility of professional organizations; whereas in other Member States there are schemes that have been set up and are regulated on a statutory basis; whereas that diversity of status poses a problem only with regard to compulsory membership of and exclusion from schemes; whereas it is therefore necessary to take steps to limit the powers of schemes in that area; (19) Whereas the investor must be compensated without excessive delay once the validity of his claim has been established; whereas the compensation scheme itself must be able to fix a reasonable period for the presentation of claims; whereas, however, the fact that such a period has expired may not be invoked against an investor who for good reason has not been able to present his claim within the time allowed; (20) Whereas informing investors of compensation arrangements is an essential element of investor protection; whereas Article 12 of Directive 93/22/EEC required investment firms to inform investors, before doing business with them, of the possible application of a compensation scheme; whereas, therefore, this Directive should lay down rules on informing such intending investors regarding the compensation schemes covering their investment business; (21) Whereas, however, the unregulated use in advertising of references to the amount and scope of a compensation scheme could affect the stability of the financial system or investor confidence; whereas Member States should therefore lay down rules to limit such references; (22) Whereas in principle this Directive requires every investment firm to join an investor-compensation scheme; whereas the Directives governing the admission of any investment firm the head office of which is in a non-member country, and in particular Directive 93/22/EEC, allow Member States to decide whether and subject to what conditions to permit branches of such investment firms to operate within their territories; whereas such branches will not enjoy the freedom to provide services under the second paragraph of Article 59 of the Treaty, or the right of establishment in Member States other than those in which they are established; whereas, accordingly, a Member State admitting such branches must decide how to apply the principles of this Directive to such branches in accordance with Article 5 of Directive 93/22/EEC and with the need to protect investors and maintain the integrity of the financial system; whereas it is essential that investors at such branches should be fully aware of the compensation arrangements applicable to them; (23) Whereas it is not indispensable in this Directive to harmonize the ways in which investor-compensation schemes are to be financed given, on the one hand, that the cost of financing such schemes must, in principle, be borne by investment firms themselves and, on the other hand, that the financing capacities of such schemes must be in proportion to their liabilities; whereas that must not, however, jeopardize the stability of the financial system of the Member State concerned; (24) Whereas this Directive may not result in the Member States or their competent authorities being made liable in respect of investors if they have ensured that one or more schemes for the compensation or protection of investors under the conditions prescribed in this Directive have been introduced and officially recognized; (25) Whereas, in conclusion, a minimum degree of harmonization of investor-compensation arrangements is necessary for the completion of the internal market for investment firms since it will make it possible for investors to do business with such firms with greater confidence, especially firms from other Member States, and make it possible to avoid any difficulties caused by host Member States applying national investor-protection rules that are not coordinated at Community level; whereas a binding Community Directive is the only appropriate instrument for the achievement of the desired objective in the general absence of investor-compensation arrangements corresponding to the coverage of Directive 93/22/EEC; whereas this Directive effects only the minimum harmonization required, allows Member States to prescribe wider or higher coverage if they desire and gives Member States the necessary latitude as regards the organization and financing of investor-compensation schemes, Article 1 For the purposes of this Directive: 1. 'investment firm` shall mean an investment firm as defined in Article 1 (2) of Directive 93/22/EEC - authorized in accordance with Article 3 of Directive 93/22/EEC, or - authorized as a credit institution in accordance with Council Directive 77/780/EEC (7) and Council Directive 89/646/EEC (8), the authorization of which covers one or more of the investment services listed in Section A of the Annex to Directive 93/22/EEC; 2. 'investment business` shall mean any investment service as defined in Article 1 (1) of Directive 93/22/EEC and the service referred to in point 1 of Section C of the Annex to that Directive, 3. 'instruments` shall mean the instruments listed in Section B of the Annex to Directive 93/22/EEC; 4. 'investor` shall mean any person who has entrusted money or instruments to an investment firm in connection with investment business; 5. 'branch` shall mean a place of business which is a part of an investment firm, which has no legal personality and which provides investment services for which the investment firm has been authorized; all the places of business set up in the same Member State by an investment firm with headquarters in another Member State shall be regarded as a single branch; 6. 'joint investment business` shall mean investment business carried out for the account of two or more persons or over which two or more persons have rights that may be exercised by means of the signature of one or more of those persons; 7. 'competent authorities` shall mean the authorities defined in Article 22 of Directive 93/22/EEC; those authorities may, if appropriate, be those defined in Article 1 of Council Directive 92/30/EEC of 6 April 1992 on the supervision of credit institutions on a consolidated basis (9). Article 2 1. Each Member State shall ensure that within its territory one or more investor-compensation schemes are introduced and officially recognized. Except in the circumstances envisaged in the second subparagraph and in Article 5 (3), no investment firm authorized in that Member State may carry on investment business unless it belongs to such a scheme. A Member State may, however, exempt a credit institution to which this Directive applies from the obligation to belong to an investor-compensation scheme where that credit institution is already exempt under Article 3 (1) of Directive 94/19/EC from the obligation to belong to a desposit-guarantee scheme, provided that the protection and information given to depositors are also given to investors on the same terms and investors thus enjoy protection at least equivalent to that afforded by an investor-compensation scheme. Any Member State that avails itself of that option shall inform the Commission accordingly; it shall, in particular, disclose the characteristics of the protective systems in question and the credit institutions covered by them for the purposes of this Directive, as well as any subsequent changes to the information supplied. The Commission shall inform the Council thereof. 2. A scheme shall provide cover for investors in accordance with Article 4 where either: - the competent authorities have determined that in their view an instrument firm appears, for the time being, for reasons directly related to its financial circumstances, to be unable to meet its obligations arising out of investors' claims and has no early prospect of being able to do so, or - a judicial authority has made a ruling, for reasons directly related to an investment firm's financial circumstances, which has the effect of suspending investors' ability to make claims against it, whichever is the earlier. Cover shall be provided for claims arising out of an investment firm's inability to: - repay money owed to or belonging to investors and held on their behalf in connection with investment business, or - return to investors any instruments belonging to them and held, administered or managed on their behalf in connection with investment business, in accordance with the legal and contractual conditions applicable. 3. Any claim under paragraph 2 on a credit institution which, in a given Member State, would be subject both to this Directive and to Directive 94/19/EC shall be directed by that Member State to a scheme under one or other of those Directives as that Member State shall consider appropriate. No claim shall be eligible for compensation more than once under those Directives. 4. The amount of an investor's claim shall be calculated in accordance with the legal and contractual conditions, in particular those concerning set off and counterclaims, that are applicable to the assessment, on the date of the determination or ruling referred to in paragraph 2, of the amount of the money or the value, determined where possible by reference to the market value, of the instruments belonging to the investor which the investment firm is unable to repay or return. Article 3 Claims arising out of transactions in connection with which a criminal conviction has been obtained for money laundering, as defined in Article 1 of Council Directive 91/308/EEC of 10 June 1991 on prevention of the use of the financial system for the purpose of money laundering (10), shall be excluded from any compensation under investor-compensation schemes. Article 4 1. Member States shall ensure that schemes provide for cover of not less than ECU 20 000 for each investor in respect of the claims referred to in Article 2 (2). Until 31 December 1999 Member States in which, when this Directive is adopted, cover is less than ECU 20 000 may retain that lower level of cover, provided it is not less than ECU 15 000. That option shall also be available to Member States to which the transitional provisions of the second subparagraph of Article 7 (1) of Directive 94/19/EC apply. 2. A Member State may provide that certain investors shall be excluded from cover by schemes or shall be granted a lower level of cover. Those exclusions shall be as listed in Annex I. 3. This Article shall not preclude the retention or adoption of provisions which afford greater or more comprehensive cover to investors. 4. A Member State may limit the cover provided for in paragraph 1 or that referred to in paragraph 3 to a specified percentage of an investor's claim. The percentage covered must, however, be equal to or exceed 90 % of the claim as long as the amount to be paid under the scheme is less than ECU 20 000. Article 5 1. If an investment firm required by Article 2 (1) to belong to a scheme does not meet the obligations incumbent on it as a member of that scheme, the competent authorities which issued its authorization shall be notified and, in cooperation with the compensation scheme, shall take all measures appropriate, including the imposition of penalties, to ensure that the investment firm meets its obligations. 2. If those measures fail to secure compliance on the part of the investment firm, the scheme may, where national law permits the exclusion of a member, with the express consent of the competent authorities, give not less than 12 months' notice of its intention of excluding the investment firm from membership of the scheme. The scheme shall continue to provide cover under the second subparagraph of Article 2 (2) in respect of investment business transacted during that period. If, on expiry of the period of notice, the investment firm has not met its obligations, the compensation scheme may, again having obtained the express consent of the competent authorities, exclude it. 3. Where national law permits, and with the express consent of the competent authorities which issued its authorization, an investment firm excluded from an investor-compensation scheme may continue to provide investment services if, before its exclusion, it made alternative compensation arrangements which ensure that investors will enjoy cover that is at least equivalent to that offered by the officially recognized scheme and has characteristics equivalent to those of that scheme. 4. If an investment firm the exclusion of which is proposed under paragraph 2 is unable to make alternative arrangements which comply with the conditions imposed in paragraph 3, the competent authorities which issued its authorization shall withdraw it forthwith. Article 6 After the withdrawal of an investment firm's authorization, cover under the second subparagraph of Article 2 (2) shall continue to be provided in respect of investment business transacted up to the time of that withdrawal. Article 7 1. Investor-compensation schemes introduced and officially recognized in a Member State in accordance with Article 2 (1) shall also cover investors at branches set up by investment firms in other Member States. Until 31 December 1999, neither the level nor the scope, including the percentage, of the cover provided for may exceed the maximum level or scope of the cover offered by the corresponding compensation scheme within the territory of the host Member State. Before that date the Commission shall draw up a report on the basis of the experience acquired in applying this subparagraph and Article 4 (1) of Directive 94/19/EC referred to above and shall consider the need to continue those provisions. If appropriate, the Commission shall submit a proposal for a Directive to the European Parliament and the Council, with a view to the extension of their validity. Where the level or scope, including the percentage, of the cover offered by the host Member State's investor-compensation scheme exceeds the level or scope of the cover provided in the Member State in which an investment firm is authorized, the host Member State shall ensure that there is an officially recognized scheme within its territory which a branch may join voluntarily in order to supplement the cover which its investors already enjoy by virtue of its membership of its home Member State's scheme. If a branch joins such a scheme, that scheme shall be one that covers the category of institution to which the branch belongs or most closely corresponds in its host Member State. Member States shall ensure that objective and generally applied conditions are established concerning branches' membership of all investor-compensation schemes. Admission shall be conditional on a branch meeting the relevant membership obligations, including in particular the payment of all contributions and other charges. Member States shall follow the guiding principles set out in Annex II in implementing this paragraph. 2. If a branch which has exercised the option of voluntary membership under paragraph 1 does not meet the obligations incumbent on it as a member of an investor-compensation scheme, the competent authorities which issued its authorization shall be notified and, in cooperation with the compensation scheme, shall take all measures necessary to ensure that the branch meets the aforementioned obligations. If those measures fail to ensure that the branch meets the obligations referred to in this Article, after an appropriate period of notice of not less than 12 months the compensation scheme may, with the consent of the competent authorities which issued the authorization, exclude the branch. Investment business transacted before the date of exclusion shall continue to be covered after that date by the compensation scheme of which the branch was a voluntary member. Investors shall be informed of the withdrawal of the supplementary cover and of the date on which it takes effect. Article 8 1. The cover provided for in Article 4 (1), (3) and (4) shall apply to the investor's aggregate claim on the same investment firm under this Directive irrespective of the number of accounts, the currency and location within the Community. Member States may, however, provide that funds in currencies other than those of the Member States and the ecu shall be excluded from cover or be subject to lower cover. This option shall not apply to instruments. 2. Each investor's share in joint investment business shall be taken into account in calculating the cover provided for in Article 4 (1), (3) and (4). In the absence of special provisions, claims shall be divided equally amongst investors. Member States may provide that claims relating to joint investment business to which two or more persons are entitled as members of a business partnership, association or grouping of a similar nature which has no legal personality may, for the purpose of calculating the limits provided for in Article 4 (1), (3) and (4), be aggregated and treated as if arising from an investment made by a single investor. 3. Where an investor is not absolutely entitled to the sums or securities held, the person who is absolutely entitled shall receive the compensation, provided that that person has been or can be identified before the date of the determination or ruling referred to in Article 2 (2). If two or more persons are absolutely entitled, the share of each under the arrangements subject to which the sums or the securities are managed shall be taken into account when the limits laid down in Article 4 (1), (3) and (4) are calculated. This provision shall not apply to collective-investment undertakings. Article 9 1. The compensation scheme shall take appropriate measures to inform investors of the determination or ruling referred to in Article 2 (2) and, if they are to be compensated, to compensate them as soon as possible. It may fix a period during which investors shall be required to submit their claims. That period may not be less than five months from the date of the aforementioned determination or ruling or from the date on which that determination or ruling is made public. The fact that that period has expired may not, however, be invoked by the scheme to deny cover to an investor who has been unable to assert his right to compensation in time. 2. The scheme shall be in a position to pay an investor's claim as soon as possible and at the latest within three months of the establishment of the eligibility and the amount of the claim. In wholly exceptional circumstances and in special cases a compensation scheme may apply to the competent authorities for an extension of the time limit. No such extension may exceed three months. 3. Notwithstanding the time limit laid down in paragraph 2, where an investor or any other person entitled to or having an interest in investment business has been charged with an offence arising out of or in relation to money laundering as defined in Article 1 of Directive 91/308/EEC, the compensation scheme may suspend any payment pending the judgment of the court. Article 10 1. Member States shall ensure that each investment firm takes appropriate measures to make available to actual and intending investors the information necessary for the identification of the investor-compensation scheme of which the investment firm and its branches within the Community are members or any alternative arrangement provided for under the second subparagraph of Article 2 (1) or Article 5 (3). Investors shall be informed of the provisions of the investor-compensation scheme or any alternative arrangement applicable, including the amount and scope of the cover offered by the compensation scheme and any rules laid down by the Member States pursuant to Article 2 (3). That information shall be made available in a readily comprehensible manner. Information shall also be given on request concerning the conditions governing compensation and the formalities which must be completed to obtain compensation. 2. The information provided for in paragraph 1 shall be made available in the manner prescribed by national law in the official language or languages of the Member State in which a branch is established. 3. Member States shall establish rules limiting the use in advertising of the information referred to in paragraph 1 in order to prevent such use from affecting the stability of the financial system or investor confidence. In particular, a Member State may restrict such advertising to a factual reference to the scheme to which an investment firm belongs. Article 11 1. Each Member State shall check whether branches established by an investment firm the head office of which is outwith the Community have cover equivalent to that prescribed in this Directive. Failing such cover, a Member State may, subject to Article 5 of Directive 93/22/EEC, stipulate that branches established by an investment firm the head office of which is outwith the Community shall join investor-compensation schemes in operation within its territory. 2. Actual and intending investors at branches established by an investment firm the head office of which is outwith the Community shall be provided by that investment firm with all relevant information concerning the compensation arrangements which cover their investments. 3. The information provided for in paragraph 2 shall be made available in the manner prescribed by national law in the official language or languages of the Member State in which a branch is established and shall be drafted in a clear and comprehensible form. Article 12 Without prejudice to any other rights which they may have under national law, schemes which make payments in order to compensate investors shall have the right of subrogation to the rights of those investors in liquidation proceedings for amounts equal to their payments. Article 13 Member States shall ensure that an investor's right to compensation may be the subject of an action by the investor against the compensation scheme. Article 14 No later than 31 December 1999 the Commission shall submit a report to the European Parliament and to the Council on the application of this Directive together, where appropriate, with proposals for its revision. Article 15 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive no later than 26 September 1998. They shall forthwith inform the Commission thereof. When the Member States adopt those measures, they shall contain references to this Directive or shall be accompanied by such references on the occasion of their official publication. The methods of making such references shall be laid down by the Member States. 2. The Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 16 Article 12 of Directive 93/22/EEC shall be repealed with effect from the date referred to in Article 15 (1). 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.

31997L0011

1997

Council Directive 97/11/EC of 3 March 1997 amending Directive 85/337/EEC on the assessment of the effects of certain public and private projects on the environment Having regard to the Treaty establishing the European Community, and in particular Article 130s (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 189c of the Treaty (4), (1) Whereas Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment (5) aims at providing the competent authorities with relevant information to enable them to take a decision on a specific project in full knowledge of the project's likely significant impact on the environment; whereas the assessment procedure is a fundamental instrument of environmental policy as defined in Article 130r of the Treaty and of the Fifth Community Programme of policy and action in relation to the environment and sustainable development; (2) Whereas, pursuant to Article 130r (2) of the Treaty, Community policy on the environment is based on the precautionary principle and on the principle that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay; (3) Whereas the main principles of the assessment of environmental effects should be harmonized and whereas the Member States may lay down stricter rules to protect the environment; (4) Whereas experience acquired in environmental impact assessment, as recorded in the report on the implementation of Directive 85/337/EEC, adopted by the Commission on 2 April 1993, shows that it is necessary to introduce provisions designed to clarify, supplement and improve the rules on the assessment procedure, in order to ensure that the Directive is applied in an increasingly harmonized and efficient manner; (5) Whereas projects for which an assessment is required should be subject to a requirement for development consent; whereas the assessment should be carried out before such consent is granted; (6) Whereas it is appropriate to make additions to the list of projects which have significant effects on the environment and which must on that account as a rule be made subject to systematic assessment; (7) Whereas projects of other types may not have significant effects on the environment in every case; whereas these projects should be assessed where Member States consider they are likely to have significant effects on the environment; (8) Whereas Member States may set thresholds or criteria for the purpose of determining which such projects should be subject to assessment on the basis of the significance of their environmental effects; whereas Member States should not be required to examine projects below those thresholds or outside those criteria on a case-by-case basis; (9) Whereas when setting such thresholds or criteria or examining projects on a case-by-case basis for the purpose of determining which projects should be subject to assessment on the basis of their significant environmental effects, Member States should take account of the relevant selection criteria set out in this Directive; whereas, in accordance with the subsidiarity principle, the Member States are in the best position to apply these criteria in specific instances; (10) Whereas the existence of a location criterion referring to special protection areas designated by Member States pursuant to Council Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds (6) and 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (7) does not imply necessarily that projects in those areas are to be automatically subject to an assessment under this Directive; (11) Whereas it is appropriate to introduce a procedure in order to enable the developer to obtain an opinion from the competent authorities on the content and extent of the information to be elaborated and supplied for the assessment; whereas Member States, in the framework of this procedure, may require the developer to provide, inter alia, alternatives for the projects for which it intends to submit an application; (12) Whereas it is desirable to strengthen the provisions concerning environmental impact assessment in a transboundary context to take account of developments at international level; (13) Whereas the Community signed the Convention on Environmental Impact Assessment in a Transboundary Context on 25 February 1991, Article 1 Directive 85/337/EEC is hereby amended as follows: 1. Article 2 (1) shall be replaced by the following: '1. Member States shall adopt all measures necessary to ensure that, before consent is given, projects likely to have significant effects on the environment by virtue, inter alia, of their nature, size or location are made subject to a requirement for development consent and an assessment with regard to their effects. These projects are defined in Article 4.`; 2. The following paragraph shall be inserted in Article 2: '2a. Member States may provide for a single procedure in order to fulfil the requirements of this Directive and the requirements of Council Directive 96/61/EC of 24 September 1996 on integrated pollution prevention and control (1). (1) OJ No L 257, 10. 10. 1996, p. 26.`; 3. The first subparagraph of Article 2 (3) shall read as follows: '3. Without prejudice to Article 7, Member States may, in exceptional cases, exempt a specific project in whole or in part from the provisions laid down in this Directive.`; 4. In Article 2 (3) (c) the words 'where appropriate` shall be replaced by the words 'where applicable`; 5. Article 3 shall be replaced by the following: 'Article 3 The environmental impact assessment shall identify, describe and assess in an appropriate manner, in the light of each individual case and in accordance with Articles 4 to 11, the direct and indirect effects of a project on the following factors: - human beings, fauna and flora; - soil, water, air, climate and the landscape; - material assets and the cultural heritage; - the interaction between the factors mentioned in the first, second and third indents.`; 6. Article 4 shall be replaced by the following: 'Article 4 1. Subject to Article 2 (3), projects listed in Annex I shall be made subject to an assessment in accordance with Articles 5 to 10. 2. Subject to Article 2 (3), for projects listed in Annex II, the Member States shall determine through: (a) a case-by-case examination, or (b) thresholds or criteria set by the Member State whether the project shall be made subject to an assessment in accordance with Articles 5 to 10. Member States may decide to apply both procedures referred to in (a) and (b). 3. When a case-by-case examination is carried out or thresholds or criteria are set for the purpose of paragraph 2, the relevant selection criteria set out in Annex III shall be taken into account. 4. Member States shall ensure that the determination made by the competent authorities under paragraph 2 is made available to the public.`; 7. Article 5 shall be replaced by the following: 'Article 5 1. In the case of projects which, pursuant to Article 4, must be subjected to an environmental impact assessment in accordance with Articles 5 to 10, Member States shall adopt the necessary measures to ensure that the developer supplies in an appropriate form the information specified in Annex IV inasmuch as: (a) the Member States consider that the information is relevant to a given stage of the consent procedure and to the specific characteristics of a particular project or type of project and of the environmental features likely to be affected; (b) the Member States consider that a developer may reasonably be required to compile this information having regard inter alia to current knowledge and methods of assessment. 2. Member States shall take the necessary measures to ensure that, if the developer so requests before submitting an application for development consent, the competent authority shall give an opinion on the information to be supplied by the developer in accordance with paragraph 1. The competent authority shall consult the developer and authorities referred to in Article 6 (1) before it gives its opinion. The fact that the authority has given an opinion under this paragraph shall not preclude it from subsequently requiring the developer to submit further information. Member States may require the competent authorities to give such an opinion, irrespective of whether the developer so requests. 3. The information to be provided by the developer in accordance with paragraph 1 shall include at least: - a description of the project comprising information on the site, design and size of the project, - a description of the measures envisaged in order to avoid, reduce and, if possible, remedy significant adverse effects, - the data required to identify and assess the main effects which the project is likely to have on the environment, - an outline of the main alternatives studied by the developer and an indication of the main reasons for his choice, taking into account the environmental effects, - a non-technical summary of the information mentioned in the previous indents. 4. Member States shall, if necessary, ensure that any authorities holding relevant information, with particular reference to Article 3, shall make this information available to the developer.`; 8. Article 6 (1) shall be replaced by the following: '1. Member States shall take the measures necessary to ensure that the authorities likely to be concerned by the project by reason of their specific environmental responsibilities are given an opportunity to express their opinion on the information supplied by the developer and on the request for development consent. To this end, Member States shall designate the authorities to be consulted, either in general terms or on a case-by-case basis. The information gathered pursuant to Article 5 shall be forwarded to those authorities. Detailed arrangements for consultation shall be laid down by the Member States.`; Article 6 (2) shall be replaced by the following: '2. Member States shall ensure that any request for development consent and any information gathered pursuant to Article 5 are made available to the public within a reasonable time in order to give the public concerned the opportunity to express an opinion before the development consent is granted.`; 9. Article 7 shall be replaced by the following: 'Article 7 1. Where a Member State is aware that a project is likely to have significant effects on the environment in another Member State or where a Member State likely to be significantly affected so requests, the Member State in whose territory the project is intended to be carried out shall send to the affected Member State as soon as possible and no later than when informing its own public, inter alia: (a) a description of the project, together with any available information on its possible transboundary impact; (b) information on the nature of the decision which may be taken, and shall give the other Member State a reasonable time in which to indicate whether it wishes to participate in the Environmental Impact Assessment procedure, and may include the information referred to in paragraph 2. 2. If a Member State which receives information pursuant to paragraph 1 indicates that it intends to participate in the Environmental Impact Assessment procedure, the Member State in whose territory the project is intended to be carried out shall, if it has not already done so, send to the affected Member State the information gathered pursuant to Article 5 and relevant information regarding the said procedure, including the request for development consent. 3. The Member States concerned, each insofar as it is concerned, shall also: (a) arrange for the information referred to in paragraphs 1 and 2 to be made available, within a reasonable time, to the authorities referred to in Article 6 (1) and the public concerned in the territory of the Member State likely to be significantly affected; and (b) ensure that those authorities and the public concerned are given an opportunity, before development consent for the project is granted, to forward their opinion within a reasonable time on the information supplied to the competent authority in the Member State in whose territory the project is intended to be carried out. 4. The Member States concerned shall enter into consultations regarding, inter alia, the potential transboundary effects of the project and the measures envisaged to reduce or eliminate such effects and shall agree on a reasonable time frame for the duration of the consultation period. 5. The detailed arrangements for implementing the provisions of this Article may be determined by the Member States concerned.`; 10. Article 8 shall be replaced by the following: 'Article 8 The results of consultations and the information gathered pursuant to Articles 5, 6 and 7 must be taken into consideration in the development consent procedure.`; 11. Article 9 shall be replaced by the following: 'Article 9 1. When a decision to grant or refuse development consent has been taken, the competent authority or authorities shall inform the public thereof in accordance with the appropriate procedures and shall make available to the public the following information: - the content of the decision and any conditions attached thereto, - the main reasons and considerations on which the decision is based, - a description, where necessary, of the main measures to avoid, reduce and, if possible, offset the major adverse effects. 2. The competent authority or authorities shall inform any Member State which has been consulted pursuant to Article 7, forwarding to it the information referred to in paragraph 1.`; 12. Article 10 shall be replaced by the following: 'Article 10 The provisions of this Directive shall not affect the obligation on the competent authorities to respect the limitations imposed by national regulations and administrative provisions and accepted legal practices with regard to commercial and industrial confidentiality, including intellectual property, and the safeguarding of the public interest. Where Article 7 applies, the transmission of information to another Member State and the receipt of information by another Member State shall be subject to the limitations in force in the Member State in which the project is proposed.`; 13. Article 11 (2) shall be replaced by the following: '2. In particular, Member States shall inform the Commission of any criteria and/or thresholds adopted for the selection of the projects in question, in accordance with Article 4 (2).`; 14. Article 13 shall be deleted; 15. Annexes I, II and III shall be replaced by Annexes I, II, III and IV as they appear in the Annex. Article 2 Five years after the entry into force of this Directive, the Commission shall send the European Parliament and the Council a report on the application and effectiveness of Directive 85/337/EEC as amended by this Directive. The report shall be based on the exchange of information provided for by Article 11 (1) and (2). On the basis of this report, the Commission shall, where appropriate, submit to the Council additional proposals with a view to ensuring further coordination in the application of this Directive. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 14 March 1999 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 at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. If a request for development consent is submitted to a competent authority before the end of the time limit laid down in paragraph 1, the provisions of Directive 85/337/EEC prior to these amendments shall continue to apply. 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.

31997L0012

1997

Council Directive 97/12/EC of 17 March 1997 amending and updating Directive 64/432/EEC on health problems affecting intra-Community trade in bovine animals and swine Having regard to the Treaty establishing the European Community, and in particular Article 43 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 important progress has been made in the harmonization of the veterinary field, in particular through the adoption by the Council of Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (4), Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (5), Directive 85/511/EEC of 18 November 1985 introducing Community measures for the control of foot-and-mouth disease (6), and Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease (7); Whereas the Council in its resolution 94/C 16/01 of 22 December 1993 on the strengthening of veterinary epidemiological surveillance measures (8) agreed to do everything in its power to ensure rapid implementation of the principles of that resolution in the context of the amendment of Directive 64/432/EEC of 26 June 1964 on health problems affecting intra-Community trade in bovine animals and swine (9); Whereas it is necessary, in the light of this situation, to amend Directive 64/432/EEC in particular as regards the period of residence in a Member State prior to movement, rules for trade in animals under 15 days old, rules for control of certain diseases and rules applicable to assembly centres, transporters and dealers; Whereas for the purpose of rapid and accurate tracing of animals for animal health reasons each Member State should create a computerized database which shall record the identity of the animals, all holdings on their territory and the movements of the animals; Whereas Directive 64/432/EEC has been substantially amended on a number of occasions; whereas for the sake of clarity that Directive should be updated, Article 1 As from 1 July 1998 the Articles and the Annexes to Directive 64/432/EEC are hereby replaced by the text annexed 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 1 July 1998. 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 governed by this Directive. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31997L0014

1997

Commission Directive 97/14/EC of 21 March 1997 amending Annex III to Council Directive 77/93/EEC 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 Directive 77/93/EEC of 21 December 1976 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 Directive 97/3/EC (2), and in particular Article 13, second subparagraph, fourth indent thereof, Whereas some provisions for protective measures against tubers of Solanum tuberosum L., should be modified because it is no longer appropriate to maintain the current prohibitions set out in Directive 77/93/EEC in respect of tubers of Solanum tuberosum L., other than those intended for planting, from Algeria; Whereas therefore the relevant Annex to Directive 77/93/EEC should be amended accordingly; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 77/93/EEC is hereby amended as indicated 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 with effect from 1 May 1997. 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 the Member States. 2. The 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 following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31997L0013

1997

Directive 97/13/EC of the European Parliament and of the Council of 10 April 1997 on a common framework for general authorizations and individual licences in the field of telecommunications services Having regard to the Treaty establishing the European Community, and in particular Articles 57 (2), 66 and 100a 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 189b of the Treaty (3), (1) Whereas the Council resolution of 22 July 1993 on the review of the situation in the telecommunications sector and the need for further development in that market (4), together with the resolution of 22 December 1994 on the principles and timetable for the liberalization of telecommunications infrastructures (5), as well as the European Parliament resolutions of 20 April 1993 (6), 7 April 1995 (7) and 19 May 1995 (8), have supported the process of complete liberalization of telecommunications services and infrastructures by 1 January 1998, with transition periods for certain Member States; (2) Whereas the Commission communication of 25 January 1995 on the consultation on the Green Paper on the liberalization of telecommunications infrastructure and cable television networks has confirmed the need for rules at Community level, in order to ensure that general authorization and individual licensing regimes are based on the principle of proportionality and are open, non-discriminatory and transparent; whereas the Council resolution of 18 September 1995 on the implementation of the future regulatory framework for telecommunications (9) recognizes as a key factor for this regulatory framework in the Union the establishment, in accordance with the principle of subsidiarity, of common principles for general authorizations and individual licensing regimes in the Member States, based on categories of balanced rights and obligations; whereas those principles should cover all authorizations which are required for the provision of any telecommunications services and for the establishment and/or operation of any infrastructure for the provision of telecommunications services; (3) Whereas a common framework should be established for general authorizations and individual licences granted by Member States in the field of telecommunications services; whereas under Community law and in particular under Commission Directive 90/388/EEC of 28 June 1990 on competition in the markets for telecommunications services (10), market entry should be restricted on the basis only of objective, non-discriminatory, proportionate and transparent selection criteria relating to the availability of scarce resources or on the basis of the implementation by national regulatory authorities of objective, non-discriminatory and transparent award procedures; whereas Directive 90/388/EEC also sets out principles regarding, inter alia, fees, numbers and rights of way; whereas these rules should be supplemented and enlarged by this Directive to determine this common framework; (4) Whereas conditions attached to authorizations are necessary in order to attain public interest objectives to the benefit of telecommunications users; whereas under Articles 52 and 59 of the Treaty, the regulatory regime in the field of telecommunications should be compatible and consistent with the principles of freedom of establishment and freedom to provide services and should take into account the need to facilitate the introduction of new services as well as the widespread application of technological improvements; whereas, therefore, general authorization and individual licensing systems should provide for the lightest possible regulation compatible with the fulfilment of applicable requirements; whereas Member States should not be required to introduce or maintain authorization schemes, in particular where the provision of telecommunications services or the establishment and/or operation of telecommunications networks is not subject to an authorization scheme at the date of entry into force of this Directive; (5) Whereas this Directive therefore will make a significant contribution to the entry of new operators into the market, as part of the development of the Information Society; (6) Whereas Member States may define and grant different categories of authorization; whereas this should not prevent undertakings from determining the type of telecommunications services or networks which they wish to provide, subject to compliance with relevant regulatory obligations; (7) Whereas in order to facilitate the Community-wide provision of telecommunications services, priority should be given to market access schemes not requiring authorizations or relying on general authorizations, to be supplemented where necessary by rights and obligations requiring individual licences for those elements which cannot be suitably dealt with by general authorizations; (8) Whereas general authorizations permit the provision of a service and the establishment and/or operation of a network without requiring an explicit decision by the national regulatory authority; whereas such general authorizations may take the form of either a set of specific conditions defined in advance in a general manner, such as a class licence, or a general legislation which may allow the provision of the service and the establishment and/or operation of the network concerned; (9) Whereas Member States may attach conditions to authorizations in order to ensure compliance with essential requirements; whereas Member States may, in addition, attach other conditions in accordance with the Annex to this Directive; (10) Whereas any conditions attached to authorizations should be objectively justified in relation to the service concerned and should be non-discriminatory, proportionate and transparent; whereas authorizations may be the means for applying conditions required by Community law, in particular in the area of open network provision; (11) Whereas the harmonization of the procedures associated with the granting of authorizations and the conditions attached to such authorizations should significantly facilitate the free provision of telecommunications services in the Community; (12) Whereas any fees or charges imposed on undertakings as part of authorization procedures must be based on objective, non-discriminatory and transparent criteria; (13) Whereas the introduction of individual licensing systems should be restricted to limited, pre-defined situations; whereas Member States may limit the number of individual licences for any category of telecommunications services only to the extent required to ensure the efficient use of radio frequencies or for the time necessary to make available sufficient numbers in accordance with Community law; (14) Whereas Member States should be allowed to impose specific conditions on undertakings providing public telecommunications networks and telecommunications services by virtue of their market power; whereas the market power of an undertaking is defined by the provisions of the Directive of the European Parliament and of the Council on interconnection in telecommunications with regard to ensuring universal service and interoperability through application of the principles of open network provision (ONP) (hereinafter referred to as the 'Interconnection Directive`); (15) Whereas telecommunications services have a role to play in strengthening social and economic cohesion, inter alia by furthering the achievement of universal service, in particular in remote, peripheral, landlocked and rural areas and islands; whereas Member States should therefore be allowed to impose universal service obligations by means of individual licences which require the licensee to provide universal service; whereas obligations to contribute to the financing of universal service are not by themselves a justification for imposing individual licences; (16) Whereas in order to facilitate the granting of individual licences to undertakings applying for such licences in more than one Member State and in order to facilitate notification procedures in the case of general authorizations, a 'one-stop-shopping procedure` should be established; (17) Whereas national regulatory authorities should, where possible, endeavour under the one-stop-shopping procedure to shorten the time limits for taking a decision on the grand of individual licences for certain categories of services in response to commercial needs; (18) Whereas the 'one-stop-shopping procedure` should be implemented without prejudice to national provisions relating to the language used in the relevant procedures; (19) Whereas a degree of harmonization of the procedures is already provided for in this Directive; whereas further harmonization may be desirable in order to achieve a more integrated telecommunications market; whereas this possibility should be assessed in the report to be drawn up by the Commission; (20) Whereas any authorization systems should take account of the establishment of trans-European telecommunications networks as envisaged in Title XII of the Treaty; whereas to this end Member States should ensure that their national regulatory authorities shall coordinate where possible their authorization procedures at the request of an undertaking intending to provide a telecommunications service or to establish and/or operate a telecommunications network in more than one Member State; (21) Whereas Community undertakings should have effective and comparable access to third countries' markets and enjoy treatment in third countries similar to that offered in the Community to undertakings owned wholly, controlled through majority ownership or effectively controlled by nationals of the third countries concerned; (22) Whereas a committee should be established to assist the Commission; (23) Whereas, on the one hand, it is necessary, due to the particular commercial sensitivity of information which may be obtained by national regulatory authorities in the course of issuing, managing, controlling and enforcing licences, to establish common principles applicable to these national regulatory authorities in the field of confidentiality; whereas, on the other hand, in this field the members of the institutions of the Community, the members of committees, and the officials and other servants of the Community are required by Community law and in particular by Article 214 of the Treaty not to disclose information of the kind covered by the obligation of professional secrecy, in particular information about undertakings, their business relations or their cost components; (24) Whereas the functioning of this Directive should be reviewed in due course, in the light of the development of the telecommunications sector and of trans-European networks, as well as in the light of experience gained from the harmonization and one-stop-shopping procedures set out in this Directive; (25) Whereas on the basis of the full implementation of a competitive framework, in order to achieve the essential goal of ensuring the development of the internal market in the field of telecommunications and specifically the free provision of telecommunications services and networks throughout the Community, the adoption of this Directive will substantially contribute to the attainment of this goal; whereas Member States should implement this common framework, in particular through their national regulatory authorities; (26) Whereas this Directive applies to both existing and future authorizations; whereas certain licences have been granted for periods which go beyond 1 January 1999; whereas clauses in such authorizations contrary to Community law, in particular those conferring on the licensees special or exclusive rights, are, according to the case-law of the Court of Justice, inoperative from the date indicated in the relevant Community measures; whereas regarding other rights which do not affect the interests of other undertakings under Community law, Member States could extend their validity in order to avoid claims for compensation; (27) Whereas in principle obligations in authorizations existing at the date of entry into force of this Directive which have not been brought into line with the provisions of this Directive by 1 January 1999 should be inoperative; whereas on request Member States may be granted a deferment of that date by the Commission, SECTION I SCOPE, DEFINITIONS AND PRINCIPLES Article 1 Scope 1. This Directive concerns the procedures associated with the granting of authorizations and the conditions attached to such authorizations, for the purpose of providing telecommunications services, including authorizations for the establishment and/or operation of telecommunications networks required for the provision of such services. 2. This Directive is without prejudice to the specific rules adopted by the Member States in accordance with Community law, governing the distribution of audiovisual programmes intended for the general public, and the content of such programmes. It is also without prejudice to measures taken by Member States concerning defence and to measures taken by Member States in accordance with public interest requirements recognized by the Treaty, in particular Articles 36 and 56, especially in relation to public morality, public security, including the investigation of criminal activity, and public policy. Article 2 Definitions 1. For the purposes of this Directive, (a) 'authorizations` means any permission setting out rights and obligations specific to the telecommunications sector and allowing undertakings to provide telecommunications services and, where applicable, to establish and/or operate telecommunications networks for the provision of such services, in the form of a 'general authorization` or 'individual licence`, as defined below: - 'general authorization` means an authorization, regardless of whether it is regulated by a 'class licence` or under general law and whether such regulation requires registration, which does not require the undertaking concerned to obtain an explicit decision by the national regulatory authority before exercising the rights stemming from the authorization, - 'individual licence` means an authorization which is granted by a national regulatory authority and which gives an undertaking specific rights or which subjects that undertaking's operations to specific obligations supplementing the general authorization where applicable, where the undertaking is not entitled to exercise the rights concerned until it has received the decision by the national regulatory authority; (b) 'national regulatory authority` means the body or bodies, legally distinct and functionally independent of the telecommunications organizations, charged by a Member State with the elaboration of, and supervision of compliance with, authorizations; (c) 'one-stop-shopping procedure` means a procedural arrangement facilitating the obtaining of individual licences from, or, in the case of general authorizations and if required, the notification to more than one national regulatory authority, in a coordinated procedure and at a single location; (d) 'essential requirements` means the non-economic reasons in the public interest which may cause a Member State to impose conditions on the establishment and/or operation of telecommunications networks or the provision of telecommunications services. Those reasons shall be the security on network operations, the maintenance of network integrity and, where justified, the interoperability of services, data protection, the protection of the environment and town and country planning objectives, as well as the effective use of the frequency spectrum and the avoidance of harmful interference between radio-based telecommunications systems and other space-based or terrestrial technical systems. Data protection may include the protection of personal data, the confidentiality of information transmitted or stored, and the protection of privacy. 2. Other definitions given in 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 (11) and the Interconnection Directive shall apply, where relevant, to this Directive. Article 3 Principles governing authorizations 1. Where Member States make the provision of a telecommunications service subject to an authorization, the grant of such authorization and the conditions to be attached thereto shall comply with the principles set out in paragraphs 2, 3 and 4. 2. Authorizations may contain only the conditions listed in the Annex. Moreover, such conditions shall be objectively justified in relation to the service concerned, non-discriminatory, proportionate and transparent. 3. Member States shall ensure that telecommunications services and/or telecommunications networks can be provided either without authorization or on the basis of general authorizations, to be supplemented where necessary by rights and obligations requiring an individual assessment of applications and giving rise to one or more individual licences. Member States may issue an individual licence only where the beneficiary is given access to scarce physical and other resources or is subject to particular obligations or enjoys particular rights, in accordance with the provisions of Section III. 4. Member States shall, in the formulation and application of their authorization systems, facilitate the provision of telecommunications services between Member States. SECTION II GENERAL AUTHORIZATIONS Article 4 Conditions attached to general authorizations 1. Where Member States subject the provision of telecommunications services to general authorizations, the conditions which, where justified, may be attached to such authorizations are set out in points 2 and 3 of the Annex. Such authorizations shall entail the least onerous system possible consistent with enforcing the relevant essential requirements and relevant other public interest requirements set out in points 2 and 3 of the Annex. 2. Member States shall ensure that the conditions attached to general authorizations are published in an appropriate manner so as to provide easy access to that information for interested parties. Reference to the publication of this information shall be made in the national official gazette of the Member State concerned and in the Official Journal of the European Communities. 3. Member States may amend the conditions attached to a general authorization in objectively justified cases and in a proportionate manner. When doing so, Member States shall give appropriate notice of their intention to do so and enable interested parties to express their views on the proposed amendments. Article 5 Procedures for general authorizations 1. Without prejudice to the provisions of Section III, Member States shall not prevent an undertaking which complies with the applicable conditions attached to a general authorization in accordance with Article 4 from providing the intended telecommunications service and/or telecommunications networks. 2. Member States may require that, before providing the telecommunications service and/or telecommunications networks, the undertaking enjoying the general authorization shall notify the national regulatory authority of its intention to do so, and shall communicate the information relating to the service concerned which is necessary for the purpose of ensuring compliance with the applicable conditions attached in accordance with Article 4. The undertaking may be required to wait for up to four weeks after formal receipt of all the information required as published in accordance with paragraph 4, before starting to provide the services covered by the general authorization. 3. Where the undertaking enjoying a general authorization does not comply with a condition attached to a general authorization in accordance with Article 4, the national regulatory authority may inform the undertaking concerned that it is not entitled to avail itself of the general authorization and/or impose on that undertaking, in a proportionate manner, specific measures aimed at ensuring compliance. The national regulatory authority shall, at the same time, give the undertaking concerned a reasonable opportunity to state its views on the application of the conditions and to remedy any breaches within one month starting from the intervention of the national regulatory authority. If the undertaking concerned remedies the breaches, the national regulatory authority shall, within two months of its initial intervention, annul or modify its decision as appropriate and state the reasons for its decision. If the undertaking concerned does not remedy the breaches, the national regulatory authority shall, within two months of its initial intervention, confirm its decision and state the reasons for its decision. The decision shall be communicated within one week of its adoption to the undertaking concerned. Member States shall lay down a procedure for appealing against such a decision to an institution independent of the national regulatory authority. 4. Member States shall ensure that information concerning the procedures relating to general authorizations is published in an appropriate manner, so as to provide easy access to that information. Reference to the publication of this information shall be made in the national official gazette of the Member State concerned and in the Official Journal of the European Communities. Article 6 Fees and charges for general authorizations procedures Without prejudice to financial contributions to the provision of universal service in accordance with the Annex, Member States shall ensure that any fees imposed on undertakings as part of the authorization procedures seek only to cover the administrative costs incurred in the issue, management, control and enforcement of the applicable general authorization scheme. Such fees shall be published in an appropriate and sufficiently detailed manner, so as to be readily accessible. SECTION III INDIVIDUAL LICENCES Article 7 Scope 1. Member States may issue individual licences for the following purposes only: (a) to allow the licensee access to radio frequencies or numbers; (b) to give the licensee particular rights with regard to access to public or private land; (c) to impose obligations and requirements on the licensee relating to the mandatory provision of publicly available telecommunications services and/or public telecommunications networks, including obligations which require the licensee to provide universal service and other obligations under ONP legislation; (d) to impose specific obligations, in accordance with Community competition rules, where the licensee has significant market power, as defined in Article 4 (3) of the Interconnection Directive in relation to the provision of public telecommunications networks and publicly available telecommunications services. 2. Notwithstanding paragraph 1, the provision of publicly available voice telephony services, the establishment and provision of public telecommunications networks as well as other networks involving the use of radio frequencies may be subject to individual licences. Article 8 Conditions attached to individual licences 1. The conditions which, in addition to those set out for general authorizations, may, where justified, be attached to individual licences are set out in points 2 and 4 of the Annex. Such conditions shall relate only to the situations justifying the grant of such a licence, as defined in Article 7. 2. Member States may incorporate the terms of the applicable general authorizations in the individual licence by attaching to the individual licence conditions set out in the Annex. The rights given under and the conditions attached to any general authorizations must not be restricted or complemented by the granting of an individual licence, except in objectively justified cases and in a proportionate manner, in particular to reflect obligations relating to the provision of universal service and/or the control of significant market power, or obligations corresponding to offers in the course of a comparative bidding process. 3. Without prejudice to Article 20, Member States shall ensure that information concerning the conditions which will be attached to any individual licence is published in an appropriate manner, so as to provide easy access to that information. Reference to the publication of this information shall be made in the national official gazette of the Member State concerned and in the Official Journal of the European Communities. 4. Member States may amend the conditions attached to an individual licence in objectively justified cases and in a proportionate manner. When doing so, Member States shall give appropriate notice of their intention to do so and enable interested parties to express their views on the proposed amendments. Article 9 Procedures for the granting of individual licences 1. Where a Member State grants individual licences, it shall ensure that information concerning the procedures for individual licences is published in an appropriate manner, so as to be readily accessible. Reference to the publication of this information shall be made in the national official gazette of the Member State concerned and in the Official Journal of the European Communities. 2. Where a Member State intends to grant individual licences: - it shall grant individual licences through open, non-discriminatory and transparent procedures and, to this end, shall subject all applicants to the same procedures, unless there is an objective reason for differentiation, and - it shall set reasonable time limits; inter alia, it shall inform the applicant of its decision as soon as possible but not more than six weeks after receiving the application. In the provisions adopted to implement this Directive, Member States may extend this time limit to up to four months in objectively justified cases which have been defined specifically in those provisions. In the case of comparative bidding procedures in particular, Member States may further extend this time limit by up to four months. These time limits shall be without prejudice to any applicable international agreements relating to international frequency and satellite coordination. 3. Without prejudice to Article 10 (1), any undertaking which fulfils the conditions decided and published by Member States in accordance with the relevant provisions of this Directive shall be entitled to receive an individual licence. However, where an undertaking applying for an individual licence does not provide the information which is reasonably required in order to demonstrate that it fulfils the conditions imposed in accordance with the relevant provisions of this Directive, the national regulatory authority may refuse to grant the individual licence. 4. Where the beneficiary of an individual licence does not comply with a condition attached to the licence in accordance with the relevant provisions of this Directive, the national regulatory authority may withdraw, amend or suspend the individual licence or impose, in a proportionate manner, specific measures aimed at ensuring compliance. The national regulatory authority shall, at the same time, give the undertaking concerned a reasonable opportunity to state its view on the application of the conditions and, except in the case of repeated breaches by the said undertaking, where the national regulatory authority can immediately take the appropriate measures, to remedy any breaches, within one month starting from the intervention of the national regulatory authority. If the undertaking concerned remedies the breaches, the national regulatory authority shall, within two months of its initial intervention, annul or modify its decision as appropriate and state the reasons for its decision. If the undertaking concerned does not remedy the breaches, the national regulatory authority shall, within two months of its initial intervention, confirm its decision and state the reasons for its decision. The decision shall be communicated within one week of its adoption to the undertaking concerned. Member States shall lay down a procedure for appealing against such a decision to an institution independent of the national regulatory authority. 5. In the event of harmful interference between a telecommunications network using radio frequencies and other technical systems the national regulatory authority may take immediate action to remedy that problem. In such a case the undertaking concerned shall thereafter be given a reasonable opportunity to state its view and to propose any remedies to the harmful interference. 6. Member States refusing to grant or withdrawing, amending or suspending an individual licence shall inform the undertaking concerned of the reasons therefor. Member States shall lay down an appropriate procedure for appealing against such refusals, withdrawals, amendments or suspensions to an institution independent of the national regulatory authority. Article 10 Limitation on the number of individual licences 1. Member States may limit the number of individual licences for any category of telecommunications services and for the establishment and/or operation of telecommunications infrastructure, only to the extent required to ensure the efficient use of radio frequencies or for the time necessary to make available sufficient numbers in accordance with Community law. 2. Where a Member State intends to limit the number of individual licences granted in accordance with paragraph 1, it shall: - give due weight to the need to maximize benefits for users and to facilitate the development of competition, - enable all interested parties to express their views on any limitation, - publish its decision to limit the number of individual licences, stating the reasons therefor, - review the limitation at reasonable intervals, - invite applications for licences. 3. Member States shall grant such individual licences on the basis of selection criteria which must be objective, non-discriminatoriy, detailed, transparent and proportionate. Any such selection must give due weight to the need to facilitate the development of competition and to maximize benefits for users. Member States shall ensure that information on such criteria is published in advance in an appropriate manner, so as to be readily accessible. Reference to the publication of this information shall be made in the national official gazette of the Member State concerned. 4. Where, on its own initiative or following a request by an undertaking, a Member State finds, either at the time of entry into force of this Directive or thereafter, that the number of individual licences can be increased, it shall publish this fact and invite applications for additional licences. Article 11 Fees and charges for individual licences 1. Member States shall ensure that any fees imposed on undertakings as part of authorization procedures seek only to cover the administrative costs incurred in the issue, management, control and enforcement of the applicable individual licences. The fees for an individual licence shall be proportionate to the work involved and be published in an appropriate and sufficiently detailed manner, so as to be readily accessible. 2. Notwithstanding paragraph 1, Member States may, where scarce resources are to be used, allow their national regulatory authorities to impose charges which reflect the need to ensure the optimal use of these resources. Those charges shall be non-discriminatory and take into particular account the need to foster the development of innovative services and competition. SECTION IV PROVISION OF TELECOMMUNICATIONS SERVICES THROUGHOUT THE COMMUNITY Article 12 Harmonization 1. Wherever necessary, the conditions attached to general authorizations and the procedures for general authorization shall be harmonized. The harmonization of these conditions and procedures shall aim to develop the least onerous system possible consistent with ensuring compliance with the provisions of this Directive, in particular Articles 3, 4 and 5 thereof and with the relevant essential requirements and other public interest requirements set out in points 1, 2 and 3 of the Annex. Harmonization shall furthermore aim to establish balanced sets of rights and obligations for the undertakings enjoying authorizations. 2. The Commission shall, in accordance with the procedure laid down in Article 16, give mandates to the European Conference of Postal and Telecommunications Administrations (CEPT)/the European Committee for Telecommunications Regulatory Affairs (Ectra), CEPT/European Radiocommunications Committee (ERC) or other relevant harmonization bodies. These mandates shall define the tasks to be performed and the categories of general authorizations to be harmonized and shall lay down a timetable for the preparation of harmonized conditions and procedures. 3. In the light of the work performed on the basis of paragraph 2 and without prejudice to Article 7, a decision stating that a harmonized general authorization is applicable shall be adopted in accordance with the procedure laid down in Article 17. Article 13 One-stop-shopping procedure 1. Where appropriate and in conjunction with CEPT/Ectra and CEPT/ERC, the Commission shall take the steps necessary for the operation of a one-stop-shopping procedure for the grant of individual licences and, in the case of general authorizations, for notification procedures, including suitable arrangements for its administration, in accordance with the procedure laid down in Article 17. Information on that one-stop-shopping procedure shall be published in the Official Journal of the European Communities. 2. The one-stop-shopping procedure shall comply with the following conditions: (a) it shall be open to all undertakings wishing to provide telecommunications services in the Community; (b) the submission of applications and notifications shall be possible and one or more bodies to which the applications and the notifications may be submitted shall be designated; (c) in the case of individual licences, applications shall be passed to the national regulatory authorities concerned, within seven working days of formal receipt, by the bodies to which they were submitted. In the case of general authorizations, notifications shall be passed to the national regulatory authorities concerned, within two working days of formal receipt, by the bodies to which they were submitted; (d) in the case of individual licences, the national regulatory authorities concerned shall decide on the grant of such a licence within the time limits referred to in Article 9 (2); they shall inform both the applicant and the bodies to which the relevant application was submitted of that decision within one week of taking their decision. In the case of general authorizations, the national regulatory authorities concerned shall comply with the time limit referred to in Article 5 (2); (e) Article 9 and Article 5 shall apply respectively to applications for individual licences and to notifications made by means of the one-stop-shopping procedure; (f) the bodies to which the applications and notifications may be submitted shall report annually to the Commission on the operation of the one-stop-shopping procedure, including information on refusals of applications and objections raised to notifications; (g) the bodies involved in the one-stop-shopping procedure shall undertake to observe the level of confidentiality prescribed in Article 20. SECTION V LICENSING COMMITTEE Article 14 Establishment of the Licensing Committee The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission. The Committee shall be called the Licensing Committee (hereinafter referred to as 'the Committee`). Article 15 Exchange of information The Commission shall, where necessary, inform the Committee on the outcome of regular consultations with the representatives of telecommunications organizations, users, consumers, manufacturers, service providers and trade unions. In addition, the Committee shall, taking account of the Community's telecommunications 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 the authorization of telecommunications services. Article 16 Committee procedure No I (12*) The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft, within a time limit which the Chairman may lay down according to the urgency of the matter, if necessary by taking a vote. The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes. The Commission shall take the utmost account of the opinion delivered by the Committee. It shall inform the Committee of the manner in which its opinion has been taken into account. Article 17 Committee Procedure No II (b) (13*) The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States Within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. The Commission shall adopt the measures which shall apply immediately. However, if these measures are not in accordance with the opinion of the committee, they shall be communicated by the Commission to the Council forthwith. In that event: - the Commission shall defer application of the measures on which it has decided for a period of three months from the date of communication, - the Council, acting by qualified majority, may take a different decision within the time limit referred to in the first indent. SECTION VI GENERAL AND FINAL PROVISIONS Article 18 Third countries 1. Member States may inform the Commission of any general difficulties encountered, de jure or de facto, by Community organizations in obtaining authorizations and in operating under authorizations in third countries, which have been brought to their attention. 2. Whenever the Commission is informed of such difficulties, it may, if necessary, submit proposals to the Council for an appropriate mandate for negotiation of comparable rights for Community organizations in these third countries. The Council shall decide by qualified majority. 3. Measures taken pursuant to paragraph 2 shall be without prejudice to the obligations of the Community and of the Member States under relevant international agreements. Article 19 New services Without prejudice to Sections II and III, where the provision of a telecommunications service is not yet covered by a general authorization and where such a service and/or network cannot be provided without authorization, Member States shall, not later than six weeks after they have received an application, adopt provisional conditions allowing the undertaking to start providing the service or reject the application and inform the undertaking concerned of the reasons therefor. As soon as possible thereafter, Member States shall adopt definitive conditions or consent to the provision of the service concerned without authorization or provide reasons for any refusal to do so. Member States shall lay down an appropriate procedure for appealing to an institution independent of the national regulatory authority against refusals to adopt provisional or definitive conditions, rejections of applications or refusals to consent to the provision of the service concerned without authorization. Article 20 Confidentiality 1. National regulatory authorities shall not disclose information covered by the obligation of professional secrecy, in particular information about undertakings, their business relations or their cost components. 2. Paragraph 1 shall be without prejudice to the right of national regulatory authorities to undertake disclosure where it is essential for the purposes of fulfilling their duties, in which case such disclosure shall be proportionate and shall have regard to the legitimate interests of undertakings in the protection of their business secrets. 3. Paragraph 1 shall not preclude publication of information on licensing conditions which does not include information of a confidential nature. Article 21 Notification 1. In addition to the information already required under Directive 90/388/EEC, Member States shall supply the Commission with the following information: - the names and addresses of the national authorities and bodies competent to issue national authorizations, - information on national authorization regimes. 2. Member States shall notify any changes in respect of the information supplied under paragraph 1, within one month of their entry into force. Article 22 Authorizations existing at the date of entry into force of this Directive 1. Member States shall make all necessary efforts to bring authorizations in force at the date of entry of this Directive into line with its provisions before 1 January 1999. 2. Where application of the provisions of this Directive results in amendments to the terms of authorizations already in existence, Member States may extend the validity of terms, other than those giving special or exclusive rights which have been or are to be terminated under Community law, provided that this can be done without affecting the rights of other undertakings under Community law, including this Directive. In such cases, Member States shall notify the Commission of the action taken to that end and shall state the reasons therefor. 3. Without prejudice to the provisions of paragraph 2, obligations in authorizations existing at the date of entry into force of this Directive which have not been brought into line by 1 January 1999 with the provisions of this Directive shall be inoperative. Where justified, Member States may, upon request, be granted a deferment of that date by the Commission. Article 23 Review procedures Before 1 January 2000, the Commission shall prepare a report to be submitted to the European Parliament and Council and to be accompanied, where appropriate, by new legislative proposals. The report shall include an assessment, on the basis of the experience gained, of the need for further development of the regulatory structures as regards authorizations, in particular in relation to the harmonization of the procedures and the scope of individual licences, to other aspects of harmonization and to trans-European services and networks. The report shall also include proposals with a view to consolidating the various committees existing in Community telecommunications legislation. Any amendments necessary to adapt the content of the Annex to new technological developments and appropriate practical procedures, together with Article 7 (2), shall also be considered in this report. Article 24 Deferment Deferment of the obligations under Articles 3 (3), 7, 9, 10 (1), 12, 13, 22 shall be granted to those Member States identified in the Council's resolutions of 22 July 1993 and 22 December 1994 which benefit from an additional transition period for the liberalization of telecommunications services for as long as and to the extent that they avail themselves of such transition periods. Member States shall inform the Commission of their intention to use them. Article 25 Implementation Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive and publish the conditions and procedures attached to authorizations as soon as possible and, in any event, not later than 31 December 1997. 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 methods of making such a reference shall be laid down by the Member States. Article 26 Entry into force This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 27 Addressees This Directive is addressed to the Member States.

31997L0018

1997

Commission Directive 97/18/EC of 17 April 1997 postponing the date after which animal tests are prohibited for ingredients or combinations of ingredients of cosmetic products (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/768/EEC of 27 July 1996 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Commission Directive 97/1/EC (2), and in particular Article 4 (1) (i) thereof; After consulting the Scientific Committee on Cosmetology, Whereas the main objective of Directive 76/768/EEC is to protect public health; whereas, to this end, it is indispensable to carry out the certain toxicological tests to evaluate the safety for human health of ingredients and combinations of ingredients used in cosmetic product formulations, Whereas pursuant to Article 4 (1) (i) of Directive 76/768/EEC Member States must ban the placing on the market of cosmetic products containing ingredients or combinations of ingredients tested on animals after 1 January 1998 in order to meet the requirements of the Directive; Whereas the second sentence of this provision provides that the Commission shall submit draft measures to postpone the date of implementation if there has been insufficient progress in developing satisfactory methods to replace animal testing, and in particular in those cases where alternative methods of testing, despite all reasonable endeavours, have not been scientifically validated as offering an equivalent level of protection for the consumer, taking into account OECD toxicity test guidelines; Whereas progress has been made in research into alternative methods of testing, in particular in the fields of percutaneous absorption and local risks to the eyes and skin; whereas it has not yet been possible to validate scientifically any alternative testing method; whereas the OECD has not yet adopted pertinent guidelines for toxicity tests in the field of alternative testing methods; Whereas it is unlikely that the state of the art will change before 1 January 1998; whereas, therefore, the date provided for in Article 4 (1) (i) of Directive 76/768/EEC should be postponed, in compliance with the second sentence of this provision; Whereas Directive 76/768/EEC provides that the date be postponed for a sufficient period, and in any case for no less than two years; whereas, therefore, it is necessary to stipulate a date later than 1 January 2000; whereas at this stage it is extremely difficult to foresee the date by which certain alternative methods for testing certain ingredients or combinations of ingredients for the presence of certain risks for human health will have been scientifically validated; Whereas, however, it can be foreseen that alternative methods will progressively become available in regard to percutaneous absorption, photoirritation, eye irritation and skin irritation; Whereas, likewise, taking into account the provision's objective, scientific reassessment should not be excessively delayed; whereas, therefore, it is necessary to lay down at this stage a date before which it can be foreseen that no alternative method of testing will have been adequately scientifically validated; Whereas it is therefore appropriate to postpone the date to 30 June 2000; Whereas, in these circumstances, it is not possible to lay down a time limit offering the certainty that it will be possible to implement the ban on animal experiments on a specified date; whereas, therefore, the Commission is not in a position to exercise its powers under Article 4 (1) (i) of the Directive except in part; Whereas it is therefore necessary to provide that the Commission shall submit new draft measures under the conditions provided for in this Article; Whereas postponement of the date shall not be prejudicial to the objective of reducing the number of test animals and their suffering wherever possible, notably through the use of screening tests; Whereas everything must be done to ensure that alternative methods to animal experiments are developed, validated and accepted; whereas, pursuant to the provisions of Article 130f (3) of the Treaty and the Fourth Framework Programme for Research, the Commission must take the necessary measures to promote research into and the validation of alternative methods to animal experiments in the field of ingredients and combinations of ingredients used in cosmetic product formulations; Whereas 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 on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector, Article 1 The date of '1 January 1998` shall be replaced by '30 June 2000` in the first sentence of Article 4 (1) (i) of Directive 76/768/EEC. Article 2 If there has been insufficient progress in developing satisfactory methods to replace animal testing, and in particular in those cases where alternative methods of testing, despite all reasonable endeavours, have not been scientifically validated as offering an equivalent level of protection for the consumer, taking into account OECD toxicity test guidelines, the Commission shall, by 1 January 2000, submit draft measures to postpone the date referred to in Article 1 for those testing methods in respect of which there has been insufficient progress in developing alternative methods, in accordance with the procedure laid down in Article 10 of Directive 76/768/EEC. Before submitting such measures, the Commission will consult the Scientific Committee on Cosmetology. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 31 December 1997. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted 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 4 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31997L0019

1997

Commission Directive 97/19/EC of 18 April 1997 adapting to technical progress Council Directive 70/221/EEC on the approximation of the laws of the Member States relating to liquid fuel tanks and rear underrun protection of motor vehicles and their trailers (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/221/EEC of 20 March 1970 on the approximation of the laws of the Member States relating to liquid fuel tanks and rear underrun protection of motor vehicles and their trailers (1), as last amended by Commission Directive 81/333/EEC (2), and in particular Article 3 thereof, Whereas Directive 70/221/EEC is one of the separate directives in the EC type-approval procedure established by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (3), as last amended by Directive 96/79/EC of the European Parliament and of the Council (4); whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to Directive 70/221/EEC; Whereas, in particular, pursuant to Articles 3 (4) and 4 (3) of Directive 70/156/EEC it is necessary that each separate directive has attached to it an information document incorporating the relevant items of Annex I to Directive 70/156/EEC and also a type-approval certificate based on Annex VI to Directive 70/156/EEC in order that type-approval may be computerized; Whereas these amendments relate only to the administrative provisions contained in Directive 70/221/EEC; whereas it is not necessary therefore to invalidate existing approvals pursuant to Directive 70/221/EEC nor to prevent the registration, sale and entry into service of new vehicles covered by such approvals; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Directive 70/221/EEC is hereby amended as follows: 1. Article 1 is replaced by the following: 'Article 1 For the purposes of this Directive, 'vehicle` means any motor vehicle intended for use on the road, with or without bodywork, having at least four wheels and a maximum design speed exceeding 25 kilometres per hour, and its trailers, with the exception of vehicles which run on rails and of agricultural and forestry tractors and all mobile machinery.`; 2. Article 2 is amended as follows: (a) in paragraph 2: 'within the meaning of Article 9a of Directive 70/156/EEC and installed in accordance with the requirements of item II.5 of the Annex.` is replaced by: 'within the meaning of Article 2 of Directive 70/156/EEC and installed in accordance with the requirements set out in item 5 of Annex II.`; (b) in paragraph 3: 'within the meaning of Article 9a of Directive 70/156/EEC, satisfies the relevant requirements set out in the Annex.` is replaced by: 'within the meaning of Article 2 of Directive 70/156/EEC, satisfies the relevant requirements set out in Annex II`; 3. Article 2a is amended as follows: (a) in paragraph 2: 'within the meaning of Article 9a of Directive 70/156/EEC and installed in accordance with the requirements set out in item II.5 of the Annex.` is replaced by: 'within the meaning of Article 2 of Directive 70/156/EEC and installed in accordance with the requirements set out in item 5 of Annex II`; (b) in paragraph 3, 'Article 9a` is replaced by 'Article 2`; 4. in Article 2b, 'items II.2.1 and II.2.2 of the Annex` is replaced by 'items 2.1 and 2.2 of Annex II`; 5. in Article 3, 'item I` is replaced by 'Annex I`; 6. the Annex is replaced by the Annex to this Directive. Article 2 With effect from 1 October 1997, Member States - shall no longer grant EC type-approval pursuant to Article 4 (1) and, if applicable, Article 4 (4) of Directive 70/156/EEC, and - may refuse national type-approval, for a new type of vehicle on grounds relating to liquid fuel tanks and rear underrun protection or, for a new type of a rear underrun protective device as a separate technical unit, if it fails to comply with the provisions of Directive 70/221/EEC, as amended by this Directive. This Directive shall not invalidate any approval previously granted pursuant to Directive 70/221/EEC nor prevent extensions of such approvals under the terms of the Directive under which they were originally granted. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 1997. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted 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 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 State.

31997L0020

1997

Commission Directive 97/20/EC of 18 April 1997 adapting to technical progress Council Directive 72/306/EEC on the approximation of the laws of the Member States relating to the measures to be taken against the emission of pollutants from diesel engines for use in vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 72/306/EEC of 2 August 1972 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of pollutants from diesel engines for use in vehicles (1), as last amended by Commission Directive 89/491/EEC (2), and in particular Article 4 thereof, Whereas Directive 72/306/EEC is one of the separate directives in the EC type-approval procedure established by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of Member States relating to the type-approval of motor vehicles and their trailers (3), as last amended by Directive 96/79/EC of the European Parliament and of the Council (4); whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to Directive 72/306/EEC; Whereas, in particular, pursuant to Articles 3 (4) and 4 (3) of Directive 70/156/EEC, it is necessary that each separate directive has attached to it an information document incorporating the relevant items of Annex I to Directive 70/156/EEC and also a type-approval certificate based on Annex VI to Directive 70/156/EEC in order that type-approval may be computerized; Whereas these amendments relate only to the administrative provisions contained in Directive 72/306/EEC, whereas it is not necessary therefore to invalidate existing approvals pursuant to Directive 72/306/EEC nor to prevent the registration, sale and entry into service of new vehicles covered by such approvals; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Directive 72/306/EEC is hereby amended as follows: 1. Article 1 is replaced by the following: 'Article 1 For the purposes of this Directive "vehicle" means any vehicle with a diesel engine, intended for use on the road, with or without bodywork, having at least four wheels and a maximum design speed exceeding 25 km/h, with the exception of vehicles which run on rails and of agricultural and forestry tractors and of all mobile machinery.`; 2. in Article 2, 'Annexes I, II, III, IV and VI` are replaced by 'the requirements of the relevant Annexes to this Directive`; 3. in Article 3, 'item 2.2` is replaced by 'item 1.1`; 4. the Annexes are amended in accordance with the Annex to this Directive. Article 2 With effect from 1 October 1997, Member States: - shall no longer grant EC type-approval pursuant to Article 4 (1) of Directive 70/156/EEC, and - may refuse national type-approval, for a new type of vehicle on grounds relating to the emission of pollutants from diesel engines if it fails to comply with the provisions of Directive 72/306/EEC, as amended by this Directive. This Directive shall not invalidate any approval previously granted pursuant to Directive 72/306/EEC nor prevent extensions of such approvals under the terms of the Directive under which they were originally granted. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 1997. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted 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 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.

31997L0021

1997

Commission Directive 97/21/EC of 18 April 1997 adapting to technical progress Council Directive 80/1269/EEC on the approximation of the laws of the Member States relating to the engine power of motor vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 80/1269/EEC of 16 December 1980 on the approximation of the laws of the Member States relating to the engine power of motor vehicles (1), as last amended by Commission Directive 89/491/EEC (2), and in particular Article 3 thereof, Whereas Directive 80/1269/EEC is one of the separate directives in the EC type-approval procedure established by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (3), as last amended by Directive 96/79/EC of the European Parliament and of the Council (4); whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to Directive 80/1269/EEC; Whereas, in particular, pursuant to Article 3 (4) and Article 4 (3) of Directive 70/156/EEC it is necessary that each separate Directive has attached to it an information document incorporating the relevant items of Annex I to Directive 70/156/EEC and also a type-approval certificate based on Annex VI to Directive 70/156/EEC in order that type-approval may be computerized; Whereas these amendments relate only to the administrative provisions contained in Directive 80/1269/EEC; whereas it is not necessary therefore to invalidate existing approvals pursuant to Directive 80/1269/EEC nor to prevent the registration, sale and entry into service of new vehicles covered by such approvals; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Directive 80/1269/EEC is hereby amended as follows: 1. Article 1 is replaced by the following: 'Article 1 For the purposes of this Directive, "vehicle" means any motor vehicle intended for use on the road, with or without bodywork, having at least four wheels and a maximum design speed exceeding 25 km/h, with the exception of vehicles which run on rails and of agricultural and forestry tractors and all mobile machinery.`; 2. in Article 2, 'Annexes I and II` is replaced by 'the relevant Annexes`; 3. the Annexes are amended in accordance with the Annex to this Directive. Article 2 With effect from 1 October 1997, Member States: - shall no longer grant EC type-approval pursuant to Article 4 (1) of Directive 70/156/EEC, and - may refuse national type-approval, for a new type of vehicle on grounds relating to the engine power if the engine power has not been determined in accordance with Directive 80/1269/EEC, as amended by this Directive. This Directive shall not invalidate any approval previously granted pursuant to Directive 80/1269/EEC nor prevent extensions of such approvals under the terms of the directive under which they were originally granted. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 1997. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted 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 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.

31997L0031

1997

Commission Directive 97/31/EC of 11 June 1997 adapting to technical progress Council Directive 76/760/EEC relating to the rear registration plate lamps for 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 relating to the type-approval of motor vehicles and their trailers (1), as last amended by European Parliament and Council Directive 96/79/EC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 76/760/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to the rear registration plate lamps for motor vehicles and their trailers (3), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 10 thereof, Whereas Directive 76/760/EEC is one of the separate Directives of the EEC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC require each separate Directive to have attached to it an information document and also a type-approval certificate based on Annex VI to that Directive in order that type-approval may be computerized; whereas the type-approval certificate(s) provided for in Directive 76/760/EEC must be amended accordingly; Whereas the procedures need to be simplified in order to maintain the equivalence established by Article 9 (2) of Directive 70/156/EEC between certain separate Directives and the corresponding regulations of the United Nations' Economic Commission for Europe when the said regulations are amended; whereas, as a first step, the technical requirements of Directive 76/760/EEC need to be replaced by those of Regulation No 4 by way of cross-reference; Whereas reference is made to Council Directive 76/756/EEC (4), as last amended by Commission Directive 97/28/EC (5), and to Directive 76/761/EEC (6), as last amended by the Act of Accession of Austria, Finland and Sweden; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Directive 76/760/EEC is hereby amended as follows: 1. Article 1 (1) is replaced by the following: '1. Member States shall grant EEC component type-approval for any type of rear registration plate lamp which satisfies the construction and testing requirements laid down in the relevant Annexes.` 2. The first paragraph of Article 2 is replaced by the following: 'Member States shall for each type of rear registration plate lamp which they approve pursuant to Article 1, issue to the manufacturer an EEC component type-approval mark conforming to the model shown in Annex 1, Appendix 3.` 3. Article 4 is replaced by the following: 'Article 4 The competent authorities of the Member States shall inform each other, by means of the procedure specified in Article 4 (6) of Directive 70/156/EEC, of each approval which they have granted, refused or withdrawn pursuant to this Directive.` 4. Article 9 is replaced by the following: 'Article 9 For the purposes of this Directive, "vehicle" means any motor vehicle intended for use on the road, with or without bodywork, having at least four wheels and a maximum design speed exceeding 25 km/h, and its trailers, with the exception of vehicles which run on rails and of agricultural and forestry tractors and all mobile machinery.` 5. The Annexes are replaced by the Annex to this Directive. Article 2 1. From 1 January 1998, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 July 1997, six months after the actual date of publication of these texts, Member States may not, on grounds relating to rear registration plate lamps: - refuse, in respect of a type of vehicle or a type of lamp mentioned above, to grant EC type-approval or national type-approval, or - prohibit the registration, sale or entry into service of vehicles, or the sale or entry into service of rear registration plate lamps, provided that the lamps comply with the requirements of Directive 76/760/EEC, as amended by this Directive, and that, as far as vehicles are concerned, they are installed in accordance with the requirements laid down in Directive 76/756/EEC. 2. From 1 October 1998 Member States: - shall no longer grant EC type-approval, and - may refuse to grant national type-approval for any type of vehicle on grounds relating to rear registration plate lamps, and for any type of rear registration plate lamp, if the requirements of Directive 76/760/EEC, as amended by this Directive, are not fulfilled. 3. From 1 October 1999 the requirements of Directive 76/760/EEC relating to rear registration plate lamps as components, as amended by this Directive, shall be applicable for the purposes of Article 7 (2) of Directive 70/156/EEC. 4. Notwithstanding paragraphs 2 and 3 above, for the purposes of replacement parts Member States shall continue to grant EC type-approval of rear registration plate lamps, and to permit their sale and entry into service, in accordance with previous versions of Directive 76/760/EEC provided that such lamps - are intended to be fitted to vehicles already in use, and - comply with the requirements of that Directive which were applicable when the vehicles were first registered. Article 3 The paragraphs and annexes of UN/ECE Regulation No 4 referred to in Annex II, item 2.1, shall be published in the Official Journal of the European Communities before 1 July 1997. Article 4 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1998; however, if the publication of the texts referred to in Article 3 is delayed beyond 1 July 1997, Member States shall comply with this obligation six months after the actual date of publication of these texts. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 January 1998, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 July 1997, Member States shall implement these provisions six months after the actual date of publication of these texts. 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. 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 5 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.

31997L0030

1997

Commission Directive 97/30/EC of 11 June 1997 adapting to technical progress Council Directive 76/758/EEC relating to the end-outline marker lamps, front position (side) lamps, rear position (side) lamps and stop lamps for 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 relating to the type-approval of motor vehicles and their trailers (1), as last amended by European Parliament and Council Directive 96/79/EC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 76/758/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to the end-outline marker lamps, front position (side) lamps, rear position (side) lamps and stop lamps for motor vehicles and their trailers (3), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 10 thereof, Whereas Directive 76/758/EEC is one of the separate Directives of the EC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC require each separate Directive to have attached to it an information document and also a type-approval certificate based on Annex VI to that Directive in order that type-approval may be computerized; whereas the type-approval certificate(s) provided for in Directive 76/758/EEC must be amended accordingly; Whereas the procedures need to be simplified in order to maintain the equivalence, established by Article 9 (2) of Directive 70/156/EEC, between certain separate Directives and the corresponding regulations of the United Nations' Economic Commission for Europe when the said regulations are amended; whereas, as a first step, the technical requirements of Directive 76/758/EEC need to be replaced by those of Regulations No 7, 87 and 91 by way of cross-reference; Whereas it is necessary to include daytime running lamps, third stop lamps and side marker lamps within the scope of Directive 76/758/EEC; Whereas reference is made to Council Directive 76/756/EEC (4), as last amended by Commission Directive 97/28/EC (5), and to Council Directive 76/761/EEC (6), as last amended by the Act of Accession of Austria, Finland and Sweden; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Directive 76/758/EEC is hereby amended as follows: 1. The title is replaced by the following: 'on the approximation of the laws of the Member States relating to the end-outline marker lamps, front position (side) lamps, rear position (side) lamps, stop lamps, daytime running lamps and side marker lamps for motor vehicles and their trailers.` 2. Article 1 (1) is replaced by the following: '1. Member States shall grant EC component type-approval in respect of any type of end-outline marker lamps, front position (side) lamps, rear position (side) lamps, stop lamps, daytime running lamps and side marker lamps which satisfies the construction and testing requirements laid down in the relevant Annexes.` 3. Articles 2, 3 and 4 are replaced by the following: 'Article 2 Member States shall for each type of end-outline marker lamp, front position (side) lamp, rear position (side) lamp, stop lamp, daytime running lamp and side marker lamp which they approve pursuant to Article 1, issue to the manufacturer an EC component type-approval mark conforming to the models shown in Annex I, Appendix 3. Member States shall take all appropriate measures to prevent the use of marks liable to create confusion between end-outline marker lamps, front position (side) lamps, rear position (side) lamps, stop lamps, daytime running lamps and side marker lamps which have been type-approved pursuant to Article 1, and other devices. Article 3 1. No Member State may prohibit the placing on the market of end-outline marker lamps, front position (side) lamps, rear position (side) lamps, stop lamps, daytime running lamps and side marker lamps on grounds relating to their construction or method of functioning if they bear the EC component type-approval mark. 2. Nevertheless, a Member State may prohibit the placing on the market of end-outline marker lamps, front position (side) lamps, rear position (side) lamps, stop lamps, daytime running lamps and side marker lamps bearing the EC component type-approval mark which consistently fail to conform to the approved type. That State shall forthwith inform the other Member States and the Commission of the measures taken, specifying the reasons for its decision. Article 4 The competent authorities of the Member States shall inform each other, by means of the procedure specified in Article 4 (6) of Directive 70/156/EEC, of each approval which they have granted, refused or withdrawn pursuant to this Directive.` 4. Article 5 (1) is replaced by the following: '1. If the Member State which has granted EC component type-approval finds that a number of end-outline marker lamps, front position (side) lamps, rear position (side) lamps, stop lamps, daytime running lamps and side marker lamps bearing the same EC component type-approval mark do not conform to the type which it has approved, it shall take the necessary measures to ensure that production models conform to the approved type. The competent authorities of that State shall advise those of the other Member States of the measures taken, which may, where there is consistent failure to conform, extend to withdrawal of EC component type-approval. The said authorities shall take the same measures if they are informed by the competent authorities of another Member State of such failure to conform.` 5. Articles 6 to 9 are replaced by the following: 'Article 6 Any decision taken pursuant to the provisions adopted in implementation of this Directive, to refuse or withdraw EC component type-approval for end-outline marker lamps, front position (side) lamps, rear position (side) lamps, stop lamps, daytime running lamps and side marker lamps, or prohibit their placing on the market or use shall set out in detail the reasons on which it is based. Such decisions shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member States and of the time limits allowed for the exercise of such remedies. Article 7 No Member State may refuse to grant EC type-approval or national type-approval of any vehicle on grounds relating to its end-outline marker lamps, front position (side) lamps, rear position (side) lamps, stop lamps, daytime running lamps and side marker lamps if these bear the EC component type-approval mark and are fitted in accordance with the requirements laid down in Directive 76/756/EEC. Article 8 No Member State may refuse or prohibit the sale, registration, entry into service or use of any vehicle on grounds relating to its end-outline marker lamps, front position (side) lamps, rear position (side) lamps, stop lamps, daytime running lamps and side marker lamps if these bear the EC component type-approval mark and are fitted in accordance with the requirements laid down in Directive 76/756/EEC. Article 9 For the purposes of this Directive, "vehicle" means any motor vehicle intended for use on the road, with or without bodywork, having at least four wheels and a maximum design speed exceeding 25 km/h, and its trailers, with the exception of vehicles which run on rails and of agricultural and forestry tractors and all mobile machinery.` 6. The Annexes are replaced by the Annex to this Directive. Article 2 1. From 1 January 1998, or, if publication of the texts referred to in Article 3 is delayed beyond 1 July 1997, six months after the actual date of publication of these texts, Member States may not, on grounds relating to end-outline marker lamps, front position (side) lamps, rear position (side) lamps, stop lamps, daytime running lamps and side marker lamps: - refuse, in respect of a type of vehicle or a type of lamp mentioned above, to grant EC type-approval or national type-approval, or - prohibit the registration, sale or entry into service of vehicles, or the sale or entry into service of end-outline marker lamps, front position (side) lamps, rear position (side) lamps, stop lamps, daytime running lamps and side marker lamps, provided that the lamps comply with the requirements of Directive 76/758/EEC, as amended by this Directive, and that, as far as vehicles are concerned, they are installed in accordance with the requirements laid down in Directive 76/756/EEC. 2. From 1 October 1998 Member States: - shall no longer grant EC type-approval, and - may refuse to grant national type-approval for any type of vehicle on grounds relating to end-outline marker lamps, front position (side) lamps, rear position (side) lamps, stop lamps, daytime running lamps and side marker lamps, and for any type of end-outline marker lamps, front position (side) lamps, rear position (side) lamps, stop lamp, daytime running lamp and side marker lamp, if the requirements of Directive 76/758/EEC, as amended by this Directive, are not fulfilled. 3. From 1 October 1999 the requirements of Directive 76/758/EEC relating to end-outline marker lamps, front position (side) lamps, rear position (side) lamps, stop lamps, daytime running lamps and side marker lamps as components, as amended by this Directive, are applicable for the purposes of Article 7 (2) of Directive 70/156/EEC. 4. Notwithstanding paragraphs 2 and 3 above, for the purposes of replacement parts, Member States shall continue to grant EC type-approval of end-outline marker lamps, front position (side) lamps, rear position (side) lamps and stop lamps, and to permit their sale and entry into service, in accordance with previous versions of Directive 76/758/EEC, provided that such lamps - are intended to be fitted to vehicles already in use; and - comply with the requirements of that Directive which were applicable when the vehicles were first registered. Article 3 The paragraphs and annexes of UN-ECE Regulations No 7, 87 and 91 referred to in Annexes II, III and IV, items 2.1, shall be published in the Official Journal of the European Communities before 1 July 1997. Article 4 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1998; however, if the publication of the texts referred to in Article 3 is delayed beyond 1 July 1997, the Member States shall comply with this obligation six months after the actual date of publication of these texts. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 January 1998, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 July 1997, six months after the actual date of publication of these texts. 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. 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 5 This Directive shall enter into force on the 20 day following its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.

31997L0028

1997

Commission Directive 97/28/EC of 11 June 1997 adapting to technical progress Council Directive 76/756/EEC relating to the installation of lighting and light- signalling devices on 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 relating to the type-approval of motor vehicles and their trailers (1), as last amended by European Parliament and Council Directive 96/79/EC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 76/756/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to the installation of lighting and light-signalling devices on motor vehicles and their trailers (3), as last amended by Commission Directive 91/663/EEC (4), and in particular Article 5 thereof, Whereas Directive 76/756/EEC is one of the separate Directives of the EC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC require each separate Directive to have attached to it an information document and also a type-approval certificate based on Annex VI to that Directive in order that type-approval may be computerized; whereas the type-approval certificate provided for in Directive 76/756/EEC must be amended accordingly; Whereas the procedures need to be simplified in order to maintain the equivalence, established by Article 9 (2) of Directive 70/156/EEC, between certain separate Directives and the corresponding regulations of the United Nations' Economic Commission for Europe when the said regulations are amended; whereas, as a first step, the technical requirements of Directive 76/756/EEC need to be replaced by those of Regulation No 48 by way of cross-reference; Whereas, in order to improve road traffic safety, it has inter alia been decided to require the mandatory installation of a third stop lamp on vehicles of category M1 and to permit the optional installation of daytime running lamps on motor vehicles; Whereas there is a need to examine further the optional provisions relating to the performance requirements of individual lighting and light signalling devices and their installation on motor vehicles and their trailers; whereas it is essential that the necessary technical work be completed so that further amendments can be introduced expeditiously into Directive 76/756/EEC; Whereas reference is made to Council Directive 76/757/EEC (5), as last amended by Commission Directive 97/29/EC (6); Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Directive 76/756/EEC is hereby amended as follows: 1. The first sentence of Article 4 is replaced by the following: 'A Member State which has granted EC type-approval shall take the necessary measures to ensure that it is informed of any modification to any of the parts or characteristics referred to in the definition of vehicle type with regard to the installation of lighting and light-signalling devices.` 2. The Annexes are replaced by the Annex to this Directive. Article 2 1. From 1 January 1998, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 July 1997, six months after the actual date of publication of these texts, Member States may not, on grounds relating to the installation of lighting and light-signalling devices, - refuse, in respect of a type of vehicle, to grant EC type-approval or national type-approval, or - prohibit the registration, sale or entry into service of vehicles, provided that the vehicles comply with the requirements of Directive 76/756/EEC, as amended by this Directive. 2. From 1 October 1998 Member States: - shall no longer grant EC type-approval, and - may refuse to grant national type-approval for any type of vehicle on grounds relating to the installation of lighting and light-signalling devices, if the requirements of Directive 76/756/EEC, as amended by this Directive, are not complied with. 3. From 1 October 2000 Member States: - shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 70/156/EEC to be no longer valid for the purposes of Article 7 (1) of that Directive, and - may refuse the registration, sale and entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 70/156/EEC on grounds relating to the installation of lighting and light-signalling devices, if the requirements of Directive 76/756/EEC, as amended by this Directive, are not complied with. Article 3 The paragraphs and annexes of UN-ECE Regulation No 48 referred to in Annex II, item 1, shall be published in the Official Journal of the European Communities before 1 July 1997. Article 4 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1998; however, if the publication of the texts referred to in Article 3 is delayed beyond 1 July 1997, the Member States shall comply with this obligation six months after the actual date of publication of these texts. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 January 1998, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 July 1997, six months after the actual date of publication of those texts. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted 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 5 This Directive shall enter into force on the 20 day following its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.

31997L0029

1997

Commission Directive 97/29/EC of 11 June 1997 adapting to technical progress Council Directive 76/757/EEC relating to retro-reflectors for 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 relating to the type-approval of motor vehicles and their trailers (1), as last amended by European Parliament and Council Directive 96/79/EC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 76/757/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to retro-reflectors for motor vehicles and their trailers (3), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 10 thereof, Whereas Directive 76/757/EEC is one of the separate Directives of the EC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC require each separate Directive to have attached to it an information document and also a type-approval certificate based on Annex VI to that Directive in order that type-approval may be computerized; whereas the type-approval certificate provided for in Directive 76/757/EEC must be amended accordingly; Whereas the procedures need to be simplified in order to maintain the equivalence envisaged by Article 9 (2) of Directive 70/156/EEC between certain separate Directives and the corresponding regulations of the United Nations' Economic Commission for Europe when the said regulations are amended; whereas, as a first step, the technical requirements of Directive 76/757/EEC need to be replaced by those of Regulation No 3 by way of cross-reference; Whereas reference is made to Council Directive 76/756/EEC (4), as last amended by Commission Directive 97/28/EC (5); Whereas a discrepancy in the technical terminology used has been noted between the English version of Directive 76/757/EEC and the other language versions; whereas it is desirable to correct that language version; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Directive 76/757/EEC is hereby amended as follows: 1. The title term 'reflex reflector(s)` is replaced by the term 'retro-reflectors`. 2. Article 1 (1) is replaced by the following: '1. Each Member State shall grant EC component type-approval for any type of retro-reflector which satisfies the construction and texting requirements laid down in the relevant Annexes.` 3. The first paragraph of Article 2 is replaced by the following: 'Member States shall, for each type of retro-reflector which they approve pursuant to Article 1, issue to the manufacturer an EC component type-approval mark conforming to the model shown in Annex I, Appendix 3.` 4. Article 4 is replaced by the following: 'Article 4 The competent authorities of the Member States shall inform each other, by means of the procedure specified in Article 4 (6) of Directive 70/156/EEC, of each approval which they have granted, refused or withdrawn pursuant to this Directive.` 5. Article 9 is replaced by the following: 'Article 9 For the purposes of this Directive, "vehicle" means any motor vehicle intended for use on the road, with or without bodywork, having at least four wheels and a maximum design speed exceeding 25 km/h, and its trailers, with the exception of vehicles which run on rails and of agricultural and forestry tractors and all mobile machinery.` 6. The Annexes are replaced by the Annex to this Directive. Article 2 1. From 1 January 1998, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 July 1997, six months after the actual date of publication of these texts, Member States may not, on grounds relating to retro-reflectors: - refuse, in respect of a type of vehicle or a type of retro-reflector, to grant EC type-approval or national type-approval, or - prohibit the registration, sale or entry into service of vehicles, or the sale or entry into service of retro-reflectors, provided that the retro-reflectors comply with the requirements of Directive 76/757/EEC, as amended by this Directive, and that, as far as vehicles are concerned, they are installed in accordance with the requirements laid down in Directive 76/756/EEC. 2. From 1 October 1998 Member States: - shall no longer grant EC type-approval, and - may refuse to grant national type-approval for any type of vehicle on grounds relating to retro-reflectors, and for any type of retro-reflector, if the requirements of Directive 76/757/EEC, as amended by this Directive, are not fulfilled. 3. From 1 October 1999 the requirements of Directive 76/757/EEC relating to retro-reflectors as components, as amended by this Directive, shall be applicable for the purposes of Article 7 (2) of Directive 70/156/EEC. 4. Notwithstanding paragraphs 2 and 3 above, for the purposes of replacement parts Member States shall continue to grant EC type-approval of retro-reflectors, and to permit their sale and entry into service, in accordance with previous versions of Directive 76/757/EEC, provided that such retro-reflectors - are intended to be fitted to vehicles already in use, and - comply with the requirements of that Directive which were applicable when the vehicles were first registered. Article 3 The paragraphs and annexes of UN-ECE Regulation No 3 referred to in Annex II, item 2.1, shall be published in the Official Journal of the European Communities before 1 July 1997. Article 4 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1998; however, if the publication of the texts referred to in Article 3 is delayed beyond 1 July 1997, the Member States shall comply with this obligation six months after the actual date of publication of these texts. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 January 1998, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 July 1997, six months after the actual date of publication of those texts. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted 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 5 This Directive shall enter into force on the 20 day following its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.

31997L0032

1997

Commission Directive 97/32/EC of 11 June 1997 adapting to technical progress Council Directive 77/539/EEC relating to reversing lamps for 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 the type-approval of motor vehicles and their trailers (1), as last amended by European Parliament and Council Directive 96/79/EC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 77/539/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to reversing lamps for motor vehicles and their trailers (3), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 10 thereof, Whereas Directive 77/539/EEC is one of the separate Directives of the EEC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC require each separate Directive to have attached to it an information document and also a type-approval certificate based on Annex VI to that Directive in order that type-approval may be computerized; whereas the type approval certificate(s) provided for in Directive 77/539/EEC must be amended accordingly; Whereas the procedures need to be simplified in order to maintain the equivalence, established by Article 9 (2) of Directive 70/156/EEC, between certain separate Directives and the corresponding regulations of the United Nations' Economic Commission for Europe when the said regulations are amended; whereas, as a first step, the technical requirements of Directive 77/539/EEC need to be replaced by those of Regulation No 23 by way of cross-reference; Whereas reference is made to Council Directive 76/756/EEC (4), as last amended by Commission Directive 97/28/EC (5), and to Council Directive 76/761/EEC (6), as last amended by the Act of Accession of Austria, Finland and Sweden; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Directive 77/539/EEC is hereby amended as follows: 1. Article 1 (1) is replaced by the following: '1. Each Member State shall grant EEC component type-approval for any type of reversing lamp which satisfies the construction and testing requirements laid down in the relevant Annexes.` 2. The first paragraph of Article 2 is replaced by the following: 'Member States shall for each type of reversing lamp which they approve pursuant to Article 1, issue to the manufacturer an EEC component type-approval mark conforming to the model shown in Annex I, Appendix 3.` 3. Article 4 is replaced by the following: 'Article 4 The competent authorities of the Member States shall inform each other, by means of the procedure specified in Article 4 (6) of Directive 70/156/EEC, of each approval which they have granted, refused or withdrawn pursuant to this Directive.` 4. Article 9 is replaced by the following: 'Article 9 For the purposes of this Directive, "vehicle" means any motor vehicle intended for use on the road, with or without bodywork, having at least four wheels and a maximum design speed exceeding 25 km/h, and its trailers, with the exception of vehicles which run on rails and of agricultural and forestry tractors and all mobile machinery.` 5. The Annexes are replaced by the Annex to this Directive. Article 2 1. From 1 January 1998, or, if publication of the texts referred to in Article 3 is delayed beyond 1 July 1997, six months after the actual date of publication of these texts, Member States may not, on grounds relating to reversing lamps: - refuse, in respect of a type of vehicle or a type of lamp mentioned above, to grant EC type-approval or national type-approval, or - prohibit the registration, sale or entry into service of vehicles, or the sale or entry into service of reversing lamps, provided that the lamps comply with the requirements of Directive 77/539/EEC, as amended by this Directive, and that, as far as vehicles are concerned, they are installed in accordance with the requirements laid down in Directive 76/756/EEC. 2. From 1 October 1998 Member States: - shall no longer grant EC type-approval, and - may refuse to grant national type-approval for any type of vehicle on grounds relating to reversing lamps, and for any type of reversing lamp, if the requirements of Directive 77/539/EEC, as amended by this Directive, are not fulfilled. 3. From 1 October 1999 the requirements of Directive 77/539/EEC relating to reversing lamps as components, as amended by this Directive, shall be applicable for the purposes of Article 7 (2) of Directive 70/156/EEC. 4. Notwithstanding paragraphs 2 and 3 above, for the purposes of replacement parts Member States shall continue to grant EC type-approval of reversing lamps, and to permit their sale and entry into service, in accordance with previous versions of Directive 77/539/EEC provided that such lamps - are intended to be fitted to vehicles already in use, and - comply with the requirements of that Directive which were applicable when the vehicles were first registered. Article 3 The paragraphs and annexes of UN/ECE Regulation No 23 referred to in Annex II, item 2.1, shall be published in the Official Journal of the European Communities before 1 July 1997. Article 4 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1998; however, if the publication of the texts referred to in Article 3 is delayed beyond 1 July 1997, the Member States shall comply with this obligation six months after the actual date of publication of these texts. They shall forthwith inform the Commission thereof. They shall apply those provisions from 1 January 1998, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 July 1997, six months after the actual date of publication of those texts. 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. 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 5 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.

31997L0035

1997

Commission Directive 97/35/EC of 18 June 1997 adapting to technical progress for the second time Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (1), as amended by Commission Directive 94/15/EC (2), and in particular Article 20 thereof, Whereas Annex III to Directive 90/220/EEC contains the additional information required in the case of notification for placing on the market of genetically modified organisms (GMOs); Whereas on the basis of the experience gained with the placing on the market of GMOs it is necessary to facilitate the gathering of data and information after the placing on the market of products in accordance with the Directive; Whereas this data and information will assist the evaluation of similar or more complex products to be placed on the market and the application of control measures in accordance with Directive 90/220/EEC; Whereas this can be achieved by extending the information to be provided in notifications submitted in accordance with part C of the Directive as well as on the label of such products; Whereas it is therefore appropriate that Annex III is amended to include such information requirements; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee established under Article 21 of Directive 90/220/EEC, Article 1 Annex III to Directive 90/220/EEC is replaced by the Annex hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 July 1997. 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 day following its publication in the Official Journal of the European Communities.

31997L0037

1997

Commission Directive 97/37/EC of 19 June 1997 adapting to technical progress Annexes I and II to Directive 96/74/EC of the European Parliament and of the Council on textile names (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 96/74/EC of the European Parliament and of the Council of 16 December 1966 on textile names (1), and in particular Article 16 (1) thereof, Whereas textile products may only be placed on the market within the Community if they satisfy the provisions of the said Directive; Whereas this Directive on textile names provides for labelling or marking or indicating the name of the textile fibres in products, in order to ensure that consumer interests are protected by correct information; Whereas only the textile fibres listed in Annex I to said Directive may be used in the composition of textile products intended for the Community's internal market; whereas it is necessary to adapt to technical progress the Annexes containing the list of fibres in order to insert the new fibres which have appeared since the last amendment to the Directive; Whereas the provisions of this Directive are in accordance with the opinion of the Committee for Directives relating to Textile Names and Labelling, Article 1 Annex I to Directive 96/74/EC is hereby amended as follows: 1. No 2 is amended as follows: - in the column 'Name`, the word 'Cashgora` is inserted after 'guanaco`, - in the column 'Fibre description`, the words 'cashgora goat` (a cross between the kashmir goat and the angora goat) are added after the word 'guanaco`. 2. No 30 is amended as follows: - the text in the column 'Name` reads 'Polyamide or nylon`, - the description of the fibres is replaced by the following text: 'Fibre formed from synthetic linear macromolecules having in the chain recurring amide linkages of which at least 85 % are joined to aliphatic or cycloaliphatic units`. 3. Nos 31 to 41 now read 34 to 44. 4. A new No 31 is added: - the text in the column 'Name` reads 'Aramid`, - the text in the column 'Fibre description` reads: 'Fibre formed from synthetic linear macromolecules made up of aromatic groups joined by amide or imide linkages, of which at least 85 % are joined directly to two aromatic rings and with the number of imide linkages, if the latter are present, not exceeding the number of amide linkages`. 5. A new No 32 is added: - the text in the column 'Name` reads 'Polyimide`, - the text in the column 'Fibre description` reads: 'Fibre formed from synthetic linear macromolecules having in the chain recurring imide units`. 6. A new No 33 is added: - the text in the column 'Name` reads 'Lyocell`, - the text in the column 'Fibre description` reads: 'A regenerated cellulose fibre obtained by dissolution, and an organic solvent spinning process, without formation of derivatives`, - a reference to the footnote is added after the text in the column 'Name`. The footnote reads: 'It is understood that an "organic solvent" means essentially a mixture of organic chemicals and water`. 7. Consequently, No 22 is amended as follows: the description is replaced by the following text: 'A regenerated cellulose fibre obtained by a modified viscose process having a high breaking force and high wet modulus. The breaking force (BC) in the conditioned state and the force (BM) required to produce an elongation of 5 % in the wet state are: BC (CN) ≥ 1,3 √T + 2 T BM (CN) ≥ 0,5 √T where T is the mean linear density in decitex`. Article 2 Annex II to Directive 96/74/EEC is amended as follows: 1. Nos 31 to 41 read 34 to 44 2. A new number 31 is added: the text in the Fibres and Percentages columns reads: >TABLE> 3. A new number 32 is added: the text in the Fibres and Percentages columns reads: >TABLE> 4. A new number 33 is added: the text in the Fibres and Percentages columns reads: >TABLE> Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions needed to comply with the Annex to Directive 96/74/EC by 1 June 1998 at the latest. They shall immediately inform the Commission thereof. The provisions adopted by the Member States 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 the Member States. 2. Member States shall forward to the Commission the text of the main provisions of domestic law which they adopt in the subject area governed by this Directive. Article 4 This Directive is addressed to the Member States.

31997L0038

1997

Commission Directive 97/38/EC of 20 June 1997 amending Annex C to Council Directive 92/51/EEC on a second general system for the recognition of professional education and training to supplement Council Directive 89/48/EEC (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to 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 (1), as last amended by Commission Directive 95/43/EC (2), and in particular Article 15 thereof, Whereas the government of the United Kingdom has made a reasoned request to remove three of its training courses from Annex C to the Directive; Whereas the United Kingdom has altered its education and training course for medical laboratory scientific officer, with the result that this course now requires three years of higher education and thus comes under Council Directive 89/48/EEC (3); whereas, accordingly, the course of education and training for the profession of medical laboratory scientific officer should no longer be included in Annex C since holders of qualifications obtained under the former regulation and which are covered by Directive 92/51/EEC could, by virtue of Article 1 (a) of Directive 89/48/EEC, apply to be treated in the same way; Whereas the profession of prosthetist is currently not regulated in the United Kingdom; Whereas the profession of probation officer is no longer regulated in the United Kingdom; Whereas the measures provided for by the present directive are in conformity with the opinion given by the Committee established by Article 15 of Council Directive 92/51/EEC, Article 1 Annex C to Directive 92/51/EEC is hereby amended as shown in the Annex to this Directive. Article 2 1. Member States shall adopt the laws, regulations and administrative provisions necessary for them to comply with this Directive by 30 September 1997. They shall forthwith inform the Commission thereof. When Member States adopt these measures, the latter shall include a reference to this Directive or be accompanied by such reference at the time of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the 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.

31997L0039

1997

Commission Directive 97/39/EC of 24 June 1997 adapting to technical progress Council Directive 75/443/EEC of 26 June 1975 relating to the reverse and speedometer equipment of motor vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC (1) of 6 February 1970 relating to the type-approval of motor vehicles and their trailers, as last amended by European Parliament and Council Directive 96/79/EC (2), and in particular Article 13 (2) thereof, Having regard to Council Directive 75/443/EEC of 26 June 1975 on the approximation of the laws of the Member States relating to the reverse and speedometer equipment of motor vehicles (3), and in particular Article 6 thereof, Whereas Directive 75/443/EEC is one of the separate Directives of the EC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; Whereas, in particular, Articles 3 (4) and 4 (3) of Directive 70/156/EEC necessitate that each separate Directive has attached to it an information document incorporating the relevant items of Annex I to that Directive and also a type-approval certificate based on Annex VI thereto in order that type-approval may be computerised; Whereas it is also desirable to align the technical specifications of this Directive with those of the corresponding UN-EEC Regulation No 39; Whereas the provisions of this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Directive 75/443/EEC shall be amended as follows: 1. Article 1 shall be amended to read at the end: '. . . rails and of agricultural and forestry tractors and all mobile machinery.`. 2. The Annexes shall be amended in accordance with the Annex to this Directive. Article 2 1. With effect from 1 October 1997 Member States may not: - refuse, in respect of a type of vehicle, to grant EC type-approval or national type-approval, or - prohibit the registration, sale or entry into service of vehicles, on grounds relating to the reverse and speedometer equipment if the vehicles comply with the requirements of Directive 75/443/EEC, as amended by this Directive. 2. With effect from 1 October 1998, the Member States: - shall no longer grant EC type-approval, and - may refuse to grant national type-approval for a type of vehicle on grounds relating to the reverse and speedometer equipment, if the requirements of Directive 75/443/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 before 1 October 1997. They shall forthwith inform the Commission thereof. 2. When the Member States adopt these provisions, 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. 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 4 This Directive shall enter into force the twentieth day after its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31997L0042

1997

Council Directive 97/42/EC of 27 June 1997 amending for the first time Directive 90/394/EEC 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) Having regard to the Treaty establishing the European Community, and in particular Article 118a thereof, Having regard to 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) (1), and in particular Article 16 thereof, Having regard to the proposal from the Commission (2), drawn up following consultation with the Advisory Committee on Safety, Hygiene and Health Protection at Work, Having regard to the opinion of the Economic and Social Committee (3), Acting in accordance with the procedure referred to in Article 189c of the Treaty (4), (1) Whereas Article 118a of the Treaty provides that the Council is to 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) Whereas, under the terms of that Article, 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-size undertakings; (3) Whereas Commission Directive 91/325/EEC of 1 March 1991 adapting to technical progress for the twelfth 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 (5) introduces in Annex III new risk phrases to indicate the health hazards resulting from prolonged exposure and the risk of cancer through inhalation; (4) Whereas in all work situations workers must be protected in respect of preparations containing one or more carcinogens and from carcinogenic compounds arising at work; (5) Whereas, for some agents it is necessary to consider all absorption pathways, including the possibility of penetration through the skin, in order to ensure the best possible level of protection; (6) Whereas the wording of point 2 of Annex I to Directive 90/394/EEC relating to polycyclic aromatic hydrocarbons has posed problems of interpretation in many Member States; whereas, therefore, a new, more precise wording is called for; (7) Whereas Article 16 of Directive 90/394/EEC makes provision for the establishment of exposure limit values on the basis of the available information, including scientific and technical data, in respect of all those carcinogens for which this is possible; (8) Whereas occupational exposure limit values must be regarded as an important component of the general arrangements for the protection of workers; whereas such limit values must be revised whenever this becomes necessary in the light of more recent scientific data; (9) Whereas benzene is a carcinogen which is present in many work situations; whereas, therefore, a large number of workers are exposed to a potential health risk; whereas, although current scientific knowledge is not such that a level can be established below which risks to health cease to exist, a reduction in exposure to benzene will nonetheless reduce these risks; (10) Whereas the respect of the minimum requirements on the protection of health and safety of workers from the specific risks related to carcinogens aims not only to ensure the protection of the health and safety of each individual worker but also to provide a level of minimum protection of all workers in the Community; (11) Whereas a consistent level of protection from the risks related to carcinogens has to be established for the Community as a whole and whereas that level of protection has to be set not by detailed prescriptive requirements but by a framework of general principles to enable Member States to apply the minimum requirements consistently; (12) Whereas this amendment constitutes a practical aspect of the realization of the social dimension of the internal market; (13) Whereas, pursuant to Decision 74/325/EEC (6), the Advisory Committee on Safety, Hygiene and Health Protection at Work is to be consulted by the Commission with a view to drawing up proposals in this field, Article 1 Directive 90/394/EEC is hereby amended as follows: 1. in Article 1, the following paragraph shall be added: '4. As regards asbestos and vinyl chloride monomer, which are dealt with by specific Directives, the provisions of this Directive shall apply when they are more favourable to safety and health at work.`; 2. Article 2 shall be replaced by the following: 'Article 2 For the purposes of this Directive, (a) "carcinogen" means: (i) a substance which meets the criteria for classification as a category 1 or 2 carcinogen set out in Annex VI of Directive 67/548/EEC; (ii) a preparation composed of one or more substances referred to in point (i) where the concentration of one or more of the individual substances meets the requirements for concentration limits for the classification of a preparation as a category 1 or 2 carcinogen set out either: - in Annex I to Directive 67/548/EEC, or - in Annex I to Directive 88/379/EEC where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits; (iii) a substance, preparation or process referred to in Annex I as well as a substance or preparation released by a process referred to in Annex I; (b) "limit value" means, unless otherwise specified, the limit of the time-weighted average of the concentration for a "carcinogen" in the air within the breathing zone of a worker in relation to a specified reference period as set out in Annex III.`; 3. Article 3 (3) shall be replaced by the following: '3. Furthermore, when assessing the risk, account shall be taken of all other routes of exposure, such as absorption into and/or through the skin`. 4. in Article 5, the following paragraph shall be inserted after paragraph 3: '4. Exposure shall not exceed the limit value of a carcinogen as set out in Annex III.` Former paragraph 4 shall become paragraph 5. 5. item 2 of Annex I shall be replaced by the following: '2. Work involving exposure to polycyclic aromatic hydrocarbons present in coal soot, coal tar or coal pitch`. 6. Part A of Annex III shall be replaced by the following: 'A. LIMIT VALUES FOR OCCUPATIONAL EXPOSURE >TABLE> Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 27 June 2000. 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 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 This Directive is addressed to the Member States.

31997L0033

1997

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) Having regard to the Treaty establishing the European Community, and in particular Article 100a 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 189b of the Treaty (3) in the light of the joint text approved by the Conciliation Committee on 19 March 1997, (1) Whereas from 1 January 1998, with transition periods for certain Member States, the provision of telecommunications services and infrastructure in the Community will be liberalized; whereas the Council Resolution of 7 February 1994 on universal service principles in the telecommunications sector (4) recognizes that in order to promote Community-wide telecommunications services there is a need to ensure interconnection of public networks and, in the future competitive environment, interconnection between different national and Community operators; whereas 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 (5) lays down harmonized principles for open and efficient access to, and use of, public telecommunications networks and, where applicable, publicly available services; whereas the Council Resolution of 22 July 1993 on the review of the situation in the telecommunications sector and the need for further development in that market (6) recognizes that open network provision measures provide an appropriate framework for harmonizing interconnection conditions; whereas this harmonization is essential for the establishment and proper functioning of the internal market for telecommunications services; whereas the Council Resolution of 18 September 1995 on the implementation of the future regulatory framework for telecommunications (7) recognizes as key factors of this future regulatory framework the maintenance and development of a universal service as well as a specific regulation on interconnection, and sets out some guidelines on these subjects; (2) Whereas a general framework for interconnection to public telecommunications networks and publicly available telecommunications services, irrespective of the supporting technologies employed, is needed in order to provide end-to-end interoperability of services for Community users; whereas fair, proportionate and non-discriminatory conditions for interconnection and interoperability are key factors in fostering the development of open and competitive markets; (3) Whereas the abolition of special and exclusive rights in telecommunications means that certain existing definitions need to be revised; whereas for the purposes of this Directive, telecommunications services do not include radio and television broadcasting services; whereas the technical conditions, tariffs, usage and supply conditions that apply to interconnection may be different from the conditions that apply at end-user/network interfaces; (4) Whereas the regulatory framework for interconnection covers those situations where the interconnected networks are used for the commercial provision of publicly available telecommunications services; whereas the regulatory framework for interconnection does not cover cases where a telecommunications network is used for the provision of telecommunications services available only to a specific end-user or to a closed user group, but covers only cases where a telecommunications network is used for the provision of publicly available services; whereas telecommunications networks which are interconnected may be owned by the parties involved or may be based on leased lines and/or transmission capacity not owned by the parties involved; (5) Whereas, following the removal of special and exclusive rights for telecommunications services and infrastructure in the Community, the provision of telecommunications networks or services may require some form of authorization by Member States; whereas organizations authorized to provide public telecommunications networks or publicly available telecommunications services in all or part of the Community should be free to negotiate interconnection agreements on a commercial basis in accordance with Community law, subject to supervision and, if necessary, intervention by national regulatory authorities; whereas it is necessary to ensure adequate interconnection within the Community of certain networks and interoperability of services essential for the social and economic well-being of Community users, notably fixed and mobile public telephone networks and services, and leased lines; whereas, for the purpose of this Directive 'public` does not refer to ownership, nor does it refer to a limited set of offerings designated as 'public networks` or 'public services`, but means any network or service that is made publicly available for use by third parties; (6) Whereas it is necessary to define those organizations which have rights and obligations for interconnection; whereas in order to stimulate development of new types of telecommunications services, it is important to encourage new forms of interconnection and special network access at points other than the network termination points offered to the majority of end-users; whereas the market power of an organization depends on a number of factors including its share of the relevant product or service market in the relevant geographical market, its turnover relative to the size of the market, its ability to influence market conditions, its control of the means of access to end-users, its international links, its access to financial resources and its experience in providing products and services in the market; whereas, the determination of which organizations have significant market power should be undertaken by national regulatory authorities taking into account the situation in the relevant market; (7) Whereas the concept of universal service must evolve to keep pace with advances in technology, market development and changes in user demand; whereas the new conditions for the provision of universal service should be assessed in the future review of this Directive; (8) Whereas obligations for the provision of universal service contribute to the Community objective of economic and social cohesion and territorial equity; whereas there may be more than one organization in a Member State with universal service obligations; whereas Member States should encourage the early introduction of new technologies like the integrated services digital network (ISDN) on as broad a basis as possible; whereas at its current stage of development in the Community, ISDN is not accessible for all users and is not subject to the universal service provisions of this Directive; whereas it may be appropriate in due course to consider whether ISDN should be part of the universal service; whereas the calculation of the net cost of universal service should take due account of costs and revenues, as well as economic externalities and the intangible benefits resulting from providing universal service but should not hinder the on-going process of tariff rebalancing; whereas costs of universal service obligations should be calculated on the basis of transparent procedures; whereas financial contributions related to the sharing of universal service obligations should be unbundled from charges for interconnection; whereas, when a universal service obligation represents an unfair burden on an organization, it is appropriate to allow Member States to establish mechanisms for sharing the net cost of universal provision of a fixed public telephone network or a fixed public telephone service with other organizations operating public telecommunications networks and/or publicly available voice telephony services; whereas this should respect the principles of Community law, in particular those of non-discrimination and proportionality and should be without prejudice to Article 100a (2) of the Treaty; (9) Whereas it is important to lay down principles to guarantee transparency, access to information, non-discrimination and equality of access, in particular for organizations with significant market power; (10) Whereas pricing for interconnection is a key factor in determining the structure and the intensity of competition in the transformation process towards a liberalized market; whereas organizations with significant market power must be able to demonstrate that their interconnection charges are set on the basis of objective criteria and follow the principles of transparency and cost orientation, and are sufficiently unbundled in terms of network and service elements offered; whereas publication of a list of interconnection services, charges, terms and conditions enhances the necessary transparency and non-discrimination; whereas flexibility in the methods of charging for interconnection traffic should be possible, including capacity-based charging; whereas the level of charges should promote productivity and encourage efficient and sustainable market entry, and should not be below a limit calculated by the use of long-run incremental cost and cost allocation and attribution methods based on actual cost causation, nor above a limit set by the stand-alone cost of providing the interconnection in question; whereas charges for interconnection based on a price level closely linked to the long-run incremental cost for providing access to interconnection are appropriate for encouraging the rapid development of an open and competitive market; (11) Whereas, where an organization with special or exclusive rights in a non-telecommunications field also provides telecommunications services, accounting separation or structural separation are appropriate means to discourage unfair cross-subsidies at least above a certain turnover in telecommunications activities; whereas, when an organization enjoys significant market power, appropriate accounting separation between interconnection activities and other telecom activities, so as to identify all elements of cost and revenue related to those activities, ensures transparency of internal cost transfers; (12) Whereas national regulatory authorities have an important role in encouraging the development of a competitive market in the interests of Community users, and of securing adequate interconnection of networks and interoperability of services; whereas adequate interconnection takes account of the requests of the operator wishing to interconnect, in particular concerning the most appropriate interconnection points, with each operator having responsibility for carrying calls and setting charges to each other up to the interconnection point; whereas negotiation of interconnection agreements can be facilitated by national regulatory authorities setting down certain conditions in advance, in accordance with Community law, taking into account the recommendations defined by the Commission so as to facilitate the development of a genuine European home market, and identifying other areas to be covered in interconnection agreements; whereas in the event of a dispute over interconnection between parties in the same Member State, an aggrieved party must be able to call on the national regulatory authority to resolve the dispute; whereas national regulatory authorities must be able to require organizations to interconnect their facilities, where it can be demonstrated that this is in the users' interests; (13) Whereas, in accordance with Directive 90/387/EEC, the essential requirements justifying restrictions on access to and use of public telecommunications networks or services are limited to security of network operations, maintenance of network integrity, interoperability of services in justified cases, and protection of data as appropriate; whereas the reasons for these restrictions must be made public; whereas the provisions of this Directive do not prevent a Member State from taking measures justified on grounds set out in Articles 36 and 56 of the Treaty, and in particular on grounds of public security, public policy and public morality; (14) Whereas facility sharing can be of benefit for town planning, environmental, economic or other reasons, and should be encouraged by national regulatory authorities on the basis of voluntary agreements; whereas compulsory facility sharing may be appropriate in some circumstances, but should be imposed on organizations only after full public consultation; (15) Whereas numbering is a key element for equal access; whereas national regulatory authorities should have the responsibility for administering and controlling national numbering plans, and those naming and addressing aspects of telecommunications services where coordination at a national level is required, so as to ensure effective competition; whereas in exercising this responsibility, national regulatory authorities must have regard to the principle of proportionality, particularly as to the effect of any measures on network operators, resellers and consumers; whereas number portability is an important facility for users, and should be implemented as soon as practicable; whereas numbering schemes should be developed in full consultation with all the parties involved and in harmony with a long-term Europe-wide numbering framework and international numbering schemes as being considered in the European Conference of Postal and Telecommunications Administrations (CEPT); whereas numbering requirements in Europe, the need for the provision of pan-European and new services and the globalization and synergy of the telecommunications market require coordination of national positions in accordance with the Treaty in international organizations and fora where numbering decisions are taken; (16) Whereas, in accordance with Directive 90/387/EEC, the harmonization of technical interfaces and access conditions must be based on common technical specifications which take account of international standardization; whereas the development of new European standards for interconnection may be needed; whereas, in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (8), new national standards must not be developed in areas where harmonized European standards are under development; (17) Whereas, in accordance with Directive 90/387/EEC, open network provision conditions must be transparent and published in an appropriate manner; whereas that Directive set up a Committee (the ONP Committee) to assist the Commission, and provides a procedure for consultation with telecommunications organizations, users, consumers, manufacturers and service providers; (18) Whereas, in addition to the rights of recourse granted under national or Community law, there is a need for a simple procedure to resolve cross-border disputes which lie outside the competence of a single national regulatory authority; whereas this procedure, to be initiated at the request of either party in dispute, should be responsive, inexpensive and transparent; (19) Whereas, to enable the Commission to monitor effectively the application of this Directive, it is necessary that Member States notify to the Commission the national regulatory authorities which will be responsible for the functions created by this Directive and the organizations covered by its provisions; (20) Whereas, given the dynamic development in this sector, a responsive procedure for adjustment of some Annexes to this Directive should be established which takes full account of the views of Member States and should involve the ONP Committee; (21) Whereas a modus vivendi (9) between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was concluded on 20 December 1994; (22) Whereas the implementation of certain obligations must be linked to the date of liberalization of telecommunications services and infrastructure and, in particular in regard to the relevant Member States, take full account of the relevant transition periods, including the retention of special or exclusive rights in relation to direct interconnection between the mobile networks of those Member States and the fixed or mobile networks of other Member States; whereas deferment of the obligation to provide number portability may be granted where the Commission agrees that the obligation would impose an excessive burden on certain organizations; (23) Whereas this Directive does not, in the case of undertakings which are not established in the Community, prevent the adoption of measures in accordance with both Community law and existing international obligations designed to ensure that nationals of the Member States enjoy similar treatment in third countries; whereas Community undertakings should benefit in third countries from treatment and effective access that is comparable to the treatment and access to the market which is conferred on nationals of the countries concerned within the Community context; whereas in negotiations on telecommunications the Community will have to seek a balanced multilateral agreement which provides Community operators with effective and comparable access in third countries; (24) Whereas the functioning of this Directive should be reviewed by 31 December 1999, in particular to examine the scope of universal service and the timetable for number portability; whereas the situation with regard to interconnection with third countries should also be periodically reviewed, to allow appropriate action to be taken; (25) Whereas the essential goal of interconnection of networks and interoperability of services throughout the Community cannot be sufficiently achieved at Member State level, and can therefore be better achieved at Community level by this Directive; whereas it is desirable, when this Directive is reviewed, to assess the case for the establishment of a European Regulatory Authority, taking into account inter alia preparatory work undertaken by the Commission; whereas when effective competition is achieved in the market the competition rules of the Treaty will in principle be sufficient to monitor fair competition ex-post so that the need for this Directive will be reconsidered, with the exception of the provisions on universal service and the settlement of disputes; (26) Whereas this Directive is without prejudice to the application of the competition rules of the Treaty, Article 1 Scope and aim This Directive establishes a regulatory framework for securing in the Community the interconnection of telecommunications networks and in particular the interoperability of services, and with regard to ensuring provision of universal service in an environment of open and competitive markets. It concerns the harmonization of conditions for open and efficient interconnection of and access to public telecommunications networks and publicly available telecommunications services. Article 2 Definitions 1. For the purposes of this Directive: (a) 'interconnection` means the physical and logical linking of telecommunications networks used by the same or a different organization in order to allow the users of one organization to communicate with users of the same or another organization, or to access services provided by another organization. Services may be provided by the parties involved or other parties who have access to the network; (b) 'public telecommunications network` means a telecommunications network used, in whole or in part, for the provision of publicly available telecommunications services; (c) 'telecommunications network` means transmission systems and, where applicable, switching equipment and other resources which permit the conveyance of signals between defined termination points by wire, by radio, by optical or by other electromagnetic means; (d) 'telecommunications services` means services whose provision consists wholly or partly in the transmission and routing of signals on telecommunications networks, with the exception of radio and television broadcasting; (e) 'users` means individuals, including consumers or organizations, using or requesting publicly available telecommunications services; (f) 'special rights` means rights that are granted by a Member State to a limited number of undertakings through any legislative, regulatory or administrative instrument which, within a given geographical area, limits to two or more the number of such undertakings authorized to provide a service or undertake an activity, otherwise than according to objective, proportionate and non-discriminatory criteria, or designates, otherwise than according to such criteria, several competing undertakings as being authorized to provide a service or undertake an activity, or confers, on any undertaking or undertakings, otherwise than according to such criteria, legal or regulatory advantages which substantially affect the ability of any other undertaking to provide the same service or to undertake the same activity in the same geographical area under substantially the same conditions; (g) 'universal service` means a defined minimum set of services of specified quality which is available to all users independent of their geographical location and, in the light of specific national conditions, at an affordable price. 2. Further definitions given in Directive 90/387/EEC shall apply, where relevant. Article 3 Interconnection at national and Community level 1. Member States shall take all necessary measures to remove any restrictions which prevent organizations authorized by Member States to provide public telecommunications networks and publicly available telecommunications services from negotiating interconnection agreements between themselves in accordance with Community law. The organizations concerned may be in the same Member State or in different Member States. Technical and commercial arrangements for interconnection shall be a matter for agreement between the parties involved, subject to the provisions of this Directive and the competition rules of the Treaty. 2. Member States shall ensure the adequate and efficient interconnection of the public telecommunications networks set out in Annex I, to the extent necessary to ensure interoperability of these services for all users within the Community. 3. Member States shall ensure that organizations which interconnect their facilities to public telecommunications networks and/or publicly available telecommunications services respect at all times the confidentiality of information transmitted or stored. Article 4 Rights and obligations for interconnection 1. Organizations authorized to provide public telecommunications networks and/or publicly available telecommunications services as set out in Annex II shall have a right and, when requested by organizations in that category, an obligation to negotiate interconnection with each other for the purpose of providing the services in question, in order to ensure provision of these networks and services throughout the Community. On a case-by-case basis, the national regulatory authority may agree to limit this obligation on a temporary basis and on the grounds that there are technically and commercially viable alternatives to the interconnection requested, and that the requested interconnection is inappropriate in relation to the resources available to meet the request. Any such limitation imposed by a national regulatory authority shall be fully reasoned and made public in accordance with Article 14 (2). 2. Organizations authorized to provide public telecommunications networks and publicly available telecommunications services as set out in Annex I which have significant market power shall meet all reasonable requests for access to the network including access at points other than the network termination points offered to the majority of end-users. 3. An organization shall be presumed to have significant market power when it has a share of more than 25 % of a particular telecommunications market in the geographical area in a Member State within which it is authorized to operate. National regulatory authorities may nevertheless determine that an organization with a market share of less than 25 % in the relevant market has significant market power. They may also determine that an organization with a market share of more than 25 % in the relevant market does not have significant market power. In either case, the determination shall take into account the organization's ability to influence market conditions, its turnover relative to the size of the market, its control of the means of access to end-users, its access to financial resources and its experience in providing products and services in the market. Article 5 Interconnection and universal service contributions 1. Where a Member State determines, in accordance with the provisions of this Article, that universal service obligations represent an unfair burden on an organization, it shall establish a mechanism for sharing the net cost of the universal service obligations with other organizations operating public telecommunications networks and/or publicly available voice telephony services. Member States shall take due account of the principles of transparency, non-discrimination and proportionality in setting the contributions to be made. Only public telecommunications networks and publicly available telecommunications services as set out in Part 1 of Annex I may be financed in this way. 2. Contributions to the cost of universal service obligations if any may be based on a mechanism specifically established for the purpose and administered by a body independent of the beneficiaries, and/or may take the form of a supplementary charge added to the interconnection charge. 3. In order to determine the burden if any which the provision of universal service represents, organizations with universal service obligations shall, at the request of their national regulatory authority, calculate the net cost of such obligations in accordance with Annex III. The calculation of the net cost of universal service obligations shall be audited by the national regulatory authority or another competent body, independent of the telecommunications organization, and approved by the national regulatory authority. The results of the cost calculation and the conclusions of the audit shall be open to the public in accordance with Article 14 (2). 4. Where justified on the basis of the net cost calculation referred to in paragraph 3, and taking into account the market benefit if any which accrues to an organization that offers universal service, national regulatory authorities shall determine whether a mechanism for sharing the net cost of universal service obligations is justified. 5. Where a mechanism for sharing the net cost of universal service obligations as referred to in paragraph 4 is established, national regulatory authorities shall ensure that the principles for cost sharing, and details of the mechanism used, are open to public inspection in accordance with Article 14 (2). National regulatory authorities shall ensure that an annual report is published giving the calculated cost of universal service obligations, and identifying the contributions made by all the parties involved. 6. Until such time as the procedure described in paragraphs 3, 4 and 5 is implemented, any charges payable by an interconnected party which include or serve as a contribution to the cost of universal service obligations shall be notified, prior to their introduction, to the national regulatory authority. Without prejudice to Article 17 of this Directive, where the national regulatory authority finds, on its own initiative, or after a substantiated request by an interested party, that such charges are excessive, the organization concerned shall be required to reduce the relevant charges. Such reductions shall be applied retrospectively, from the date of introduction of the charges, but not before 1 January 1998. Article 6 Non-discrimination and transparency For interconnection to public telecommunications networks and publicly available telecommunications services as set out in Annex I provided by organizations which have been notified by national regulatory authorities as having significant market power, Member States shall ensure that: (a) the organizations concerned adhere to the principle of non-discrimination with regard to interconnection offered to others. They shall apply similar conditions in similar circumstances to interconnected organizations providing similar services, and shall provide interconnection facilities and information to others under the same conditions and of the same quality as they provide for their own services, or those of their subsidiaries or partners; (b) all necessary information and specifications are made available on request to organizations considering interconnection, in order to facilitate conclusion of an agreement; the information provided should include changes planned for implementation within the next six months, unless agreed otherwise by the national regulatory authority; (c) interconnection agreements are communicated to the relevant national regulatory authorities, and made available on request to interested parties, in accordance with Article 14 (2), with the exception of those parts which deal with the commercial strategy of the parties. The national regulatory authority shall determine which parts deal with the commercial strategy of the parties. In every case, details of interconnection charges, terms and conditions and any contributions to universal service obligations shall be made available on request to interested parties; (d) information received from an organization seeking interconnection is used only for the purpose for which it was supplied. It shall not be passed on to other departments, subsidiaries or partners for whom such information could provide a competitive advantage. Article 7 Principles for interconnection charges and cost accounting systems 1. Member States shall ensure that the provisions of paragraphs 2 to 6 apply to organizations operating the public telecommunications networks and/or publicly available telecommunications services as set out in Parts 1 and 2 of Annex I, which have been notified by national regulatory authorities as having significant market power. 2. Charges for interconnection shall follow the principles of transparency and cost orientation. The burden of proof that charges are derived from actual costs including a reasonable rate of return on investment shall lie with the organization providing interconnection to its facilities. National regulatory authorities may request an organization to provide full justification for its interconnection charges, and where appropriate shall require charges to be adjusted. This paragraph shall also apply to organizations set out in Part 3 of Annex I which have been notified by national regulatory authorities as having significant market power on the national market for interconnection. 3. National regulatory authorities shall ensure the publication, in accordance with Article 14 (1), of a reference interconnection offer. The reference interconnection offer shall include a description of the interconnection offerings broken down into components according to market needs, and the associated terms and conditions including tariffs. Different tariffs, terms and conditions for interconnection may be set for different categories of organizations which are authorized to provide networks and services, where such differences can be objectively justified on the basis of the type of interconnection provided and/or the relevant national licensing conditions. National regulatory authorities shall ensure that such differences do not result in distortion of competition, and in particular that the organization applies the appropriate interconnection tariffs, terms and conditions when providing interconnection for its own services or those of its subsidiaries or partners, in accordance with Article 6 (a). The national regulatory authority shall have the ability to impose changes in the reference interconnection offer, where justified. Annex IV provides a list of examples of elements for further elaboration of interconnection charges, tariff structures and tariff elements. Where an organization makes changes to the published reference interconnection offer, adjustments required by the national regulatory authority may be retrospective in effect, from the date of introduction of the change. 4. Charges for interconnection shall, in accordance with Community law, be sufficiently unbundled, so that the applicant is not required to pay for anything not strictly related to the service requested. 5. The Commission shall, acting in accordance with the procedure laid down in Article 15, draw up recommendations on cost accounting systems and accounting separation in relation to interconnection. National regulatory authorities shall ensure that the cost accounting systems used by the organizations concerned are suitable for implementation of the requirements of this Article, and are documented to a sufficient level of detail, as indicated in Annex V. National regulatory authorities shall ensure that a description of the cost accounting system, showing the main categories under which costs are grouped and the rules used for the allocation of costs to interconnection, is made available on request. Compliance with the cost accounting system shall be verified by the national regulatory authority or another competent body, independent of the telecommunications organization and approved by the national regulatory authority. A statement concerning compliance shall be published annually. 6. Where they exist, charges related to the sharing of the cost of universal service obligations, as described in Article 5, shall be unbundled and identified separately. Article 8 Accounting separation and financial reports 1. Member States shall require organizations providing public telecommunications networks and/or publicly available telecommunications services which have special or exclusive rights for the provision of services in other sectors in the same or another Member State to keep separate accounts for the telecommunications activities, to the extent that would be required if the telecommunications activities in question 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 telecommunications activities including an itemized breakdown of fixed asset and structural costs, or to have structural separation for the telecommunications activities. Member States may choose not to apply the requirements referred to in the first subparagraph to these organizations where their annual turnover in telecommunications activities in the Community is less than the limit set in Part 1 of Annex VI. 2. Member States shall require organizations operating public telecommunications networks and/or publicly available telecommunications services as set out in Parts 1 and 2 of Annex I and notified by national regulatory authorities as organizations having significant market power which provide public telecommunications networks and/or telecommunications services available for users and which offer interconnection services to other organizations, to keep separate accounts for, on the one hand, their activities related to interconnection - covering both interconnection services provided internally and interconnection services provided to others - and, on the other hand, other activities, 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 interconnection activity, including an itemized breakdown of fixed asset and structural costs. Member States may choose not to apply the requirements referred to in the first subparagraph to organizations where their annual turnover in telecommunications activities in the Member States is less than the limit set in Part 2 of Annex VI. 3. Organizations providing public telecommunications networks and/or publicly available telecommunications services shall provide financial information to their national regulatory authority promptly on request and to the level of detail required. National regulatory authorities may publish such information as would contribute to an open and competitive market, while taking account of considerations of commercial confidentiality. 4. The financial reports of organizations providing public telecommunications networks or publicly available telecommunications services shall be drawn up and submitted to independent audit and published. The audit shall be carried out in accordance with the relevant rules of national legislation. The first subparagraph shall also apply to the separate accounts required in paragraphs 1 and 2. Article 9 General responsibilities of the national regulatory authorities 1. National regulatory authorities shall encourage and secure adequate interconnection in the interests of all users, exercising their responsibility in a way that provides maximum economic efficiency and gives the maximum benefit to end-users. In particular, national regulatory authorities shall take into account: - the need to ensure satisfactory end-to-end communications for users, - the need to stimulate a competitive market, - the need to ensure the fair and proper development of a harmonized European telecommunication market, - the need to cooperate with their counterparts in other Member States, - the need to promote the establishment and development of trans-European networks and services, and the interconnection of national networks and interoperability of services, as well as access to such networks and services, - the principles of non-discrimination (including equal access) and proportionality, - the need to maintain and develop universal service. 2. General conditions set down in advance by the national regulatory authority shall be published in accordance with Article 14 (1). In particular, in relation to interconnection between organizations set out in Annex II, national regulatory authorities: - may set ex ante conditions in the areas listed in Part 1 of Annex VII; - shall encourage coverage in interconnection agreements of the issues listed in Part 2 of Annex VII. 3. In pursuit of the aims stated in paragraph 1, national regulatory authorities may intervene on their own initiative at any time, and shall do so if requested by either party, in order to specify issues which must be covered in an interconnection agreement, or to lay down specific conditions to be observed by one or more parties to such an agreement. National regulatory authorities may, in exceptional cases, require changes to be made to interconnection agreements already concluded, where justified to ensure effective competition and/or interoperability of services for users. Conditions set by the national regulatory authority may include inter alia conditions designed to ensure effective competition, technical conditions, tariffs, supply and usage conditions, conditions as to compliance with relevant standards, compliance with essential requirements, protection of the environment, and/or the maintenance of end-to-end quality of service. The national regulatory authority may, on its own initiative at any time or if requested by either party, also set time limits within which negotiations on interconnection are to be completed. If agreement is not reached within the time allowed, the national regulatory authority shall take steps to bring about an agreement under procedures laid down by that authority. The procedures shall be open to the public in accordance with Article 14 (2). 4. Where an organization authorized to provide public telecommunications networks or publicly available telecommunications services enters into interconnection agreements with others, the national regulatory authority shall have the right to inspect all such interconnection agreements in their entirety. 5. In the event of an interconnection dispute between organizations in a Member State, the national regulatory authority of that Member State shall, at the request of either party, take steps to resolve the dispute within six months of this request. The resolution of the dispute shall represent a fair balance between the legitimate interests of both parties. In so doing, the national regulatory authority shall take into account, inter alia: - the user interest, - regulatory obligations or constraints imposed on any of the parties, - the desirability of stimulating innovative market offerings, and of providing users with a wide range of telecommunications services at a national and at a Community level, - the availability of technically and commercially viable alternatives to the interconnection requested, - the desirability of ensuring equal access arrangements, - the need to maintain the integrity of the public telecommunications network and the interoperability of services, - the nature of the request in relation to the resources available to meet the request, - the relative market positions of the parties, - the public interest (e.g. the protection of the environment), - the promotion of competition, - the need to maintain a universal service. A decision on the matter by a national regulatory authority shall be made available to the public in accordance with national procedures. The parties concerned shall be given a full statement of the reasons on which it is based. 6. In cases where organizations which are authorized to provide public telecommunications networks and/or publicly available telecommunications services have not interconnected their facilities, national regulatory authorities, in compliance with the principle of proportionality and in the interest of users, shall be able, as a last resort, to require the organizations concerned to interconnect their facilities in order to protect essential public interests and, where appropriate, shall be able to set terms of interconnection. Article 10 Essential requirements Without prejudice to action which may be taken in accordance with Articles 3 (5) and 5 (3) of Directive 90/387/EEC, the essential requirements as specified in Article 3 (2) of Directive 90/387/EEC shall for the purpose of this Directive apply to interconnection to public telecommunications networks and/or publicly available telecommunications services as set out in points (a) to (d) of this Article. Where the national regulatory authority imposes conditions based on essential requirements in interconnection agreements, these conditions shall be published in the manner laid down in Article 14 (1). (a) Security of network operations: Member States shall take all necessary steps to ensure that the availability of public telecommunications networks and publicly available telecommunications services is maintained in the event of catastrophic network breakdown or in exceptional cases of force majeure, such as extreme weather, earthquakes, flood, lightning or fire. In the event of the circumstances referred to in the first subparagraph, the bodies concerned shall make every endeavour to maintain the highest level of service to meet any priorities laid down by the competent national authorities. The need to meet these requirements shall not constitute a valid reason for refusal to negotiate terms for interconnection. Furthermore, the national regulatory authority shall ensure that any conditions for interconnection related to the security of networks as regards risk of accidents are proportionate and non-discriminatory in nature, and are based on objective criteria identified in advance. (b) Maintenance of network integrity: Member States shall take all necessary steps to ensure that the integrity of public telecommunications networks is maintained. The need to maintain network integrity does not constitute a valid reason for refusal to negotiate terms for interconnection. The national regulatory authority shall ensure that any conditions for interconnection related to protection of network integrity are proportionate and non-discriminatory in nature, and are based on objective criteria identified in advance. (c) Interoperability of services: Member States may impose conditions in interconnection agreements in order to ensure interoperability of services, including conditions designed to ensure satisfactory end-to-end quality. Such conditions may include implementation of specific technical standards, or specifications, or codes of conduct agreed by the market players. (d) Protection of data: Member States may impose conditions in interconnection agreements in order to ensure the protection of data, to the extent necessary to ensure compliance with relevant regulatory provisions on the protection of data including protection of personal data, the confidentiality of information processed, transmitted or stored, and the protection of privacy, compatible with Community law. Article 11 Collocation and facility sharing Where an organization providing public telecommunications networks and/or publicly available telecommunications services has the right under national legislation to install facilities on, over or under public or private land, or may take advantage of a procedure for the expropriation or use of property, national regulatory authorities shall encourage the sharing of such facilities and/or property with other organizations providing telecommunications networks and publicly available services, in particular where essential requirements deprive other organizations of access to viable alternatives. Agreements for collocation or facility sharing shall normally be a matter for commercial and technical agreement between the parties concerned. The national regulatory authority may intervene to resolve disputes, as provided for in Article 9. Member States may impose facility and/or property sharing arrangements (including physical collocation) only after an appropriate period of public consultation during which all interested parties must be given an opportunity to express their views. Such arrangements may include rules for apportioning the costs of facility and/or property sharing. Article 12 Numbering 1. Member States shall ensure the provision of adequate numbers and numbering ranges for all publicly available telecommunications services. 2. In order to ensure full interoperability of Europe-wide networks and services, Member States in accordance with the Treaty shall take all necessary steps to ensure the coordination of their national positions in international organizations and fora where numbering decisions are taken, taking into account possible future developments in numbering in Europe. 3. Member States shall ensure that national telecommunications numbering plans are controlled by the national regulatory authority, in order to guarantee independence from organizations providing telecommunications networks or telecommunications services and facilitate number portability. In order to ensure effective competition, national regulatory authorities shall ensure that the procedures for allocating individual numbers and/or numbering ranges are transparent, equitable and timely and the allocation is carried out in an objective, transparent and non-discriminatory manner. National regulatory authorities may lay down conditions for the use of certain prefixes or certain short codes, in particular where these are used for services of general public interest (e.g. freephone services, kiosk billed services, directory services, emergency services), or to ensure equal access. 4. National regulatory authorities shall ensure that the main elements of the national numbering plans, and all subsequent additions or amendments to them, are published in accordance with Article 14 (1), subject only to limitations imposed on the grounds of national security. 5. National regulatory authorities shall encourage the earliest possible introduction of the number portability facility whereby end-users who so request can retain their number(s) on the fixed public telephone network at a specific location independent of the organization providing service, and shall ensure that this facility is available at least in all major centres of population before 1 January 2003. In order to ensure that charges to consumers are reasonable, national regulatory authorities shall ensure that pricing for interconnection related to the provision of this facility is reasonable. 6. National regulatory authorities shall ensure that numbering plans and procedures are applied in a manner that gives fair and equal treatment to all providers of publicly available telecommunications services. In particular, Member States shall ensure that an organization allocated a range of numbers shall avoid undue discrimination in the number sequences used to give access to the services of other telecommunications operators. Article 13 Technical standards 1. Without prejudice to Article 5 (3) of Directive 90/387/EEC whereby the implementation of specified European standards may be made compulsory, national regulatory authorities shall ensure that organizations providing public telecommunications networks or publicly available telecommunications services take full account of standards listed in the Official Journal of the European Communities as being suitable for the purpose of interconnection. In the absence of such standards, national regulatory authorities shall encourage the provision of technical interfaces for interconnection according to the standards or specifications listed below: - standards adopted by European standardization bodies such as the European Telecommunications Standards Institute (ETSI) or the European Committee for Standardization/European Committee for Electrotechnical Standardization (CEN/CENELEC), or, in the absence of such standards, - international standards or recommendations adopted by the International Telecommunications Union (ITU), the International Organization for Standardization (ISO) or the International Electrotechnical Committee (IEC), or, in the absence of such standards, - national standards. 2. The Commission may, acting in accordance with the procedure laid down in Article 15, request standards for interconnection and access to be drawn up, where appropriate, by European standardization bodies. Reference to standards for interconnection and access may be published in the Official Journal of the European Communities in accordance with Article 5 of Directive 90/387/EEC. Article 14 Publication of and access to information 1. With regard to the information identified in Article 7 (3), Article 9 (2), Article 10 and Article 12 (4), national regulatory authorities shall ensure that up-to-date information is published in an appropriate manner in order to provide easy access to that information for interested parties. Reference shall be made in the national Official Gazette of the Member State concerned to the manner in which this information is published. 2. With regard to the information identified in Article 4 (1), Article 5 (3), Article 5 (5), Article 6 (c) and Article 9 (3), national regulatory authorities shall ensure that up-to-date specific information referred to in those Articles is made available on request to interested parties, free of charge, during normal working hours. Reference shall be made in the national Official Gazette of the Member State concerned to the times and location(s) at which the information is available. 3. Member States shall notify to the Commission before 1 January 1998 - and immediately thereafter in case of any change - the manner in which the information referred to in paragraphs 1 and 2 is made available. The Commission shall regularly publish a corresponding reference to such notifications in the Official Journal of the European Communities. Article 15 Advisory Committee procedure 1. The Commission shall be assisted by the committee set up by Article 9 (1) of Directive 90/387/EEC, hereinafter referred to as the 'ONP Committee`. 2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote. 3. The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes. The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account. Article 16 Regulatory Committee procedure 1. Notwithstanding the provisions of Article 15, the following procedure shall apply in respect of the matters covered by Article 19. 2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. 4. If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 17 Procedure for resolving disputes between organizations operating under authorizations provided by different Member States 1. Without prejudice to: (a) any action that the Commission or any Member State may take pursuant to the Treaty; (b) the rights of the party invoking the procedure in paragraphs 2 and 3, of the organizations concerned or of any other party under applicable national law; the procedure set out in paragraphs 2 and 3 shall be available for the resolution of interconnection disputes between organizations operating under authorizations granted by different Member States, where such dispute does not fall within the responsibility of a single national regulatory authority exercising its power in accordance with Article 9. 2. Any party having a complaint against another organization over interconnection may refer the complaint to the national regulatory authority of the Member State that has granted the authorization of the organization against which the complaint is made. The national regulatory authority shall take steps to resolve the dispute in accordance with the procedures and timescale set out in Article 9 (5). 3. Where there are concurrent disputes between the same two organizations, the national regulatory authorities concerned shall, on request of either party in dispute, coordinate their efforts in order to bring about resolution of the disputes, in accordance with the principles set out in Article 9 (1), within 6 months of referral. The solutions shall represent a fair balance between the legitimate interests of both parties in dispute and be consistent with interconnection rules in the Member States concerned, in conformity with Community law. Article 18 Notification 1. Member States shall ensure that national regulatory authorities have the necessary means for carrying out the tasks identified in this Directive, and shall notify to the Commission by 31 January 1997 the national regulatory authorities responsible for those tasks. 2. National regulatory authorities shall notify to the Commission by 31 January 1997, and immediately thereafter in the event of any change, the names of those organizations which: - have universal service obligations for the provision of the public telecommunications networks and publicly available telecommunications services set out in Part 1 of Annex I and which are authorized to collect directly a contribution to the net cost of universal service under the procedure in Article 5 (2), - are subject to the provisions of this Directive concerning organizations with significant market power, - are covered by Annex II. The Commission may request national regulatory authorities to provide their reasons for classifying an organization as having or not having significant market power. 3. The Commission shall publish the names referred to in paragraph 2 in the Official Journal of the European Communities. Article 19 Technical adjustment Modifications necessary to adapt Annexes IV, V and VII to the Directive to new technological developments or to changes in market and consumer demand shall be determined by the Commission in accordance with the procedure laid down in Article 16. Article 20 Deferment 1. Deferment of the obligations under Articles 3 (1), 3 (2), 4 (1), 4 (2), 9 (1) and 9 (3) insofar as those obligations concern direct interconnection between the mobile networks of that Member State and the fixed or mobile networks of other Member States, and under Article 5, shall be granted to those Member States identified in the Council Resolutions of 22 July 1993 and 22 December 1994 which benefit from an additional transition period for the liberalization of telecommunications services for as long as and to the extent that they avail themselves of such transition periods. Member States shall inform the Commission of their intention to make use of them. 2. Deferment of the obligations under Article 12 (5) may be requested where the Member State concerned can prove that they would impose an excessive burden on certain organizations or classes of organization. The Member State shall inform the Commission of the reasons for requesting a deferment, the date by which the requirements can be met, and the measures envisaged in order to meet this deadline. The Commission shall consider the request taking into account the particular situation in that Member State and the need to ensure a coherent regulatory environment at a Community level, and shall inform the Member State whether it deems that the particular situation in that Member State justifies a deferment and, if so, until which date such deferment is justified. Article 21 Interconnection with third country organizations 1. Member States may inform the Commission of any general difficulties encountered, de jure or de facto, by Community organizations in interconnecting with organizations in third countries, which have been brought to their attention. 2. Whenever the Commission is informed of the existence of such difficulties, the Commission may, if necessary, submit proposals to the Council for an appropriate mandate for negotiation of comparable rights for Community organizations in these third countries. The Council shall decide by qualified majority. 3. Measures taken pursuant to paragraph 2 shall be without prejudice to the Community's and Member States' obligations under relevant international agreements. Article 22 Review 1. The Commission shall report to the European Parliament and to the Council by 31 December 1997, and periodically thereafter, on the availability of rights to interconnect in third countries for the benefit of Community organizations. 2. The Commission shall examine and report periodically to the European Parliament and to the Council on the functioning of this Directive, on the first occasion not later than 31 December 1999. For this purpose, the Commission may request information from the Member States. The report shall examine what provisions of this Directive should be adapted in the light of the developments in the market, the evolution of technology and the changes in user demand, in particular: (a) for the provisions under Article 5, (b) to confirm the timetable laid down in Article 12 (5). The Commission shall also investigate in the report the added value of the setting up of a European Regulatory Authority to carry out those tasks which would prove to be better undertaken at Community level. Article 23 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1997. 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. 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 24 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities. Article 25 Addressees This Directive is addressed to the Member States.

31997L0036

1997

Directive 97/36/EC of the European Parliament and of the Council of 30 June 1997 amending Council Directive 89/552/EEC on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the pursuit of television broadcasting activities Having regard to the Treaty establishing the European Community, and in particular Articles 57 (2) and 66 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 189b of the Treaty (3) in the light of the joint text approved by the Conciliation Committee on 16 April 1997, (1) Whereas Council Directive 89/552/EEC (4) constitutes the legal framework for television broadcasting in the internal market; (2) Whereas Article 26 of Directive 89/552/EEC states that the Commission shall, not later than the end of the fifth year after the date of adoption of the Directive, submit to the European Parliament, the Council and the Economic and Social Committee a report on the application of the Directive and, if necessary, make further proposals to adapt it to developments in the field of television broadcasting; (3) Whereas the application of Directive 89/552/EEC and the report on its application have revealed the need to clarify certain definitions or obligations on Member States under this Directive; (4) Whereas the Commission, in its communication of 19 July 1994 entitled 'Europe's way to the information society: an action plan`, underlined the importance of a regulatory framework applying to the content of audiovisual services which would help to safeguard the free movement of such services in the Community and be responsive to the opportunities for growth in this sector opened up by new technologies, while at the same time taking into account the specific nature, in particular the cultural and sociological impact, of audiovisual programmes, whatever their mode of transmission; (5) Whereas the Council welcomed this action plan at its meeting of 28 September 1994 and stressed the need to improve the competitiveness of the European audiovisual industry; (6) Whereas the Commission has submitted a Green Paper on the Protection of Minors and Human Dignity in audiovisual and information services and has undertaken to submit a Green Paper focusing on developing the cultural aspects of these new services; (7) Whereas any legislative framework concerning new audiovisual services must be compatible with the primary objective of this Directive which is to create the legal framework for the free movement of services; (8) Whereas it is essential that the Member States should take action with regard to services comparable to television broadcasting in order to prevent any breach of the fundamental principles which must govern information and the emergence of wide disparities as regards free movement and competition; (9) Whereas the Heads of State and Government meeting at the European Council in Essen on 9 and 10 December 1994 called on the Commission to present a proposal for a revision of Directive 89/552/EEC before their next meeting; (10) Whereas the application of Directive 89/552/EEC has revealed the need to clarify the concept of jurisdiction as applied specifically to the audiovisual sector; whereas, in view of the case law of the Court of Justice of the European Communities, the establishment criterion should be made the principal criterion determining the jurisdiction of a particular Member State; (11) Whereas the concept of establishment, according to the criteria laid down by the Court of Justice in its judgment of 25 July 1991 in the Factortame case (5), involves the actual pursuit of an economic activity through a fixed establishment for an indefinite period; (12) Whereas the establishment of a television broadcasting organization may be determined by a series of practical criteria such as the location of the head office of the provider of services, the place where decisions on programming policy are usually taken, the place where the programme to be broadcast to the public is finally mixed and processed, and the place where a significant proportion of the workforce required for the pursuit of the television broadcasting activity is located; (13) Whereas the fixing of a series of practical criteria is designed to determine by an exhaustive procedure that one Member State and one only has jurisdiction over a broadcaster in connection with the provision of the services which this Directive addresses; nevertheless, taking into account the case law of the Court of Justice and so as to avoid cases where there is a vacuum of jurisdiction it is appropriate to refer to the criterion of establishment within the meaning of Articles 52 and following of the Treaty establishing the European Community as the final criterion determining the jurisdiction of a Member State; (14) Whereas the Court of Justice has constantly held (6) that a Member State retains the right to take measures against a television broadcasting organization that is established in another Member State but directs all or most of its activity to the territory of the first Member State if the choice of establishment was made with a view to evading the legislation that would have applied to the organization had it been established on the territory of the first Member State; (15) Whereas Article F (2) of the Treaty on European Union stipulates that the Union shall respect fundamental rights as guaranteed by the European Convention for the Protection of Human Rights and Fundamental Freedoms as general principles of Community law; whereas any measure aimed at restricting the reception and/or suspending the retransmission of television broadcasts taken under Article 2a of Directive 89/552/EEC as amended by this Directive must be compatible with such principles; (16) Whereas it is necessary to ensure the effective application of the provisions of Directive 89/552/EEC as amended by this Directive throughout the Community in order to preserve free and fair competition between firms in the same industry; (17) Whereas directly affected third parties, including nationals of other Member States, must be able to assert their rights, according to national law, before competent judicial or other authorities of the Member State with jurisdiction over the television broadcasting organization that may be failing to comply with the national provisions arising out of the application of Directive 89/552/EEC as amended by this Directive; (18) Whereas it is essential that Member States should be able to take measures to protect the right to information and to ensure wide access by the public to television coverage of national or non-national events of major importance for society, such as the Olympic games, the football World Cup and European football championship; whereas to this end Member States retain the right to take measures compatible with Community law aimed at regulating the exercise by broadcasters under their jurisdiction of exclusive broadcasting rights to such events; (19) Whereas it is necessary to make arrangements within a Community framework, in order to avoid potential legal uncertainty and market distortions and to reconcile free circulation of television services with the need to prevent the possibility of circumvention of national measures protecting a legitimate general interest; (20) Whereas, in particular, it is appropriate to lay down in this Directive provisions concerning the exercise by broadcasters of exclusive broadcasting rights that they may have purchased to events considered to be of major importance for society in a Member State other than that having jurisdiction over the broadcasters, and whereas, in order to avoid speculative rights purchases with a view to circumvention of national measures, it is necessary to apply these provisions to contracts entered into after the publication of this Directive and concerning events which take place after the date of implementation, and whereas, when contracts that predate the publication of this Directive are renewed, they are considered to be new contracts; (21) Whereas events of major importance for society should, for the purposes of this Directive, meet certain criteria, that is to say be outstanding events which are of interest to the general public in the European Union or in a given Member State or in an important component part of a given Member State and are organized in advance by an event organizer who is legally entitled to sell the rights pertaining to that event; (22) Whereas, for the purposes of this Directive, 'free television` means broadcasting on a channel, either public or commercial, of programmes which are accessible to the public without payment in addition to the modes of funding of broadcasting that are widely prevailing in each Member State (such as licence fee and/or the basic tier subscription fee to a cable network); (23) Whereas Member States are free to take whatever measures they deem appropriate with regard to broadcasts which come from third countries and which do not satisfy the conditions laid down in Article 2 of Directive 89/552/EEC as amended by this Directive, provided they comply with Community law and the international obligations of the Community; (24) Whereas in order to eliminate the obstacles arising from differences in national legislation on the promotion of European works, Directive 89/552/EEC as amended by this Directive contains provisions aimed at harmonizing such legislation; whereas those provisions which, in general, seek to liberalize trade must contain clauses harmonizing the conditions of competition; (25) Whereas, moreover, Article 128 (4) of the Treaty establishing the European Community requires the Community to take cultural aspects into account in its action under other provisions of the Treaty; (26) Whereas the Green Paper on 'Strategy options to strengthen the European programme industry in the context of the audiovisual policy of the European Union`, adopted by the Commission on 7 April 1994, puts forward inter alia measures to promote European works in order to further the development of the sector; whereas the Media II programme, which seeks to promote training, development and distribution in the audiovisual sector, is also designed to enable the production of European works to be developed; whereas the Commission has proposed that production of European works should also be promoted by a Community mechanism such as a Guarantee Fund; (27) Whereas broadcasting organizations, programme makers, producers, authors and other experts should be encouraged to develop more detailed concepts and strategies aimed at developing European audiovisual fiction films that are addressed to an international audience; (28) Whereas, in addition to the considerations cited above, it is necessary to create conditions for improving the competitiveness of the programme industry; whereas the communications on the application of Articles 4 and 5 of Directive 89/552/EEC, adopted by the Commission on 3 March 1994 and 15 July 1996 pursuant to Article 4 (3) of that Directive, draw the conclusion that measures to promote European works can contribute to such an improvement but that they need to take account of developments in the field of television broadcasting; (29) Whereas channels broadcasting entirely in a language other than those of the Member States should not be covered by the provisions of Articles 4 and 5; whereas, nevertheless, where such a language or languages represent a substantial part but not all of the channel's transmission time, the provisions of Articles 4 and 5 should not apply to that part of transmission time; (30) Whereas the proportions of European works must be achieved taking economic realities into account; whereas, therefore, a progressive system for achieving this objective is required; (31) Whereas, with a view to promoting the production of European works, it is essential that the Community, taking into account the audiovisual capacity of each Member State and the need to protect lesser used languages of the European Union, should promote independent producers; whereas Member States, in defining the notion of 'independent producer`, should take appropriate account of criteria such as the ownership of the production company, the amount of programmes supplied to the same broadcaster and the ownership of secondary rights; (32) Whereas the question of specific time scales for each type of television showing of cinematographic works is primarily a matter to be settled by means of agreements between the interested parties or professionals concerned; (33) Whereas advertising for medicinal products for human use is subject to the provisions of Directive 92/28/EEC (7); (34) Whereas daily transmission time allotted to announcements made by the broadcaster in connection with its own programmes and ancillary products directly derived from these, or to public service announcements and charity appeals broadcast free of charge, is not to be included in the maximum amounts of daily or hourly transmission time that may be allotted to advertising and teleshopping; (35) Whereas, in order to avoid distortions of competition, this derogation is limited to announcements concerning products that fulfil the dual condition of being both ancillary to and directly derived from the programmes concerned; whereas the term ancillary refers to products intended specifically to allow the viewing public to benefit fully from or to interact with these programmes; (36) Whereas in view of the development of teleshopping, an economically important activity for operators as a whole and a genuine outlet for goods and services within the Community, it is essential to modify the rules on transmission time and to ensure a high level of consumer protection by putting in place appropriate standards regulating the form and content of such broadcasts; (37) Whereas it is important for the competent national authorities, in monitoring the implementation of the relevant provisions, to be able to distinguish, as regards channels not exclusively devoted to teleshopping, between transmission time devoted to teleshopping spots, advertising spots and other forms of advertising on the one hand and, on the other, transmission time devoted to teleshopping windows; whereas it is therefore necessary and sufficient that each window be clearly identified by optical and acoustic means at least at the beginning and the end of the window; (38) Whereas Directive 89/552/EEC as amended by this Directive applies to channels exclusively devoted to teleshopping or self-promotion, without conventional programme elements such as news, sports, films, documentaries and drama, solely for the purposes of these Directives and without prejudice to the inclusion of such channels in the scope of other Community instruments; (39) Whereas it is necessary to make clear that self-promotional activities are a particular form of advertising in which the broadcaster promotes its own products, services, programmes or channels; whereas, in particular, trailers consisting of extracts from programmes should be treated as programmes; whereas self-promotion is a new and relatively unknown phenomenon and provisions concerning it may therefore be particularly subject to review in future examinations of this Directive; (40) Whereas it is necessary to clarify the rules for the protection of the physical, mental and moral development of minors; whereas the establishment of a clear distinction between programmes that are subject to an absolute ban and those that may be authorized subject to the use of appropriate technical means should satisfy concern about the public interest expressed by Member States and the Community; (41) Whereas none of the provisions of this Directive that concern the protection of minors and public order requires that the measures in question must necessarily be implemented through the prior control of television broadcasts; (42) Whereas an investigation by the Commission, in liaison with the competent Member State authorities, of the possible advantages and drawbacks of further measures to facilitate the control exercised by parents or guardians over the programmes that minors may watch shall consider, inter alia, the desirability of: - the requirement for new television sets to be equipped with a technical device enabling parents or guardians to filter out certain programmes, - the setting up of appropriate rating systems, - encouraging family viewing policies and other educational and awareness measures, - taking into account experience gained in this field in Europe and elsewhere as well as the views of interested parties such as broadcasters, producers, educationalists, media specialists and relevant associations, with a view to presenting, if necessary before the deadline laid down in Article 26, appropriate proposals for legislative or other measures; (43) Whereas it is appropriate to amend Directive 89/552/EEC to allow natural or legal persons whose activities include the manufacture or the sale of medicinal products and medical treatment available only on prescription to sponsor television programmes, provided that such sponsorship does not circumvent the prohibition of television advertising for medicinal products and medical treatment available only on prescription; (44) Whereas the approach in Directive 89/552/EEC and this Directive has been adopted to achieve the essential harmonization necessary and sufficient to ensure the free movement of television broadcasts in the Community; whereas Member States remain free to apply to broadcasters under their jurisdiction more detailed or stricter rules in the fields coordinated by this Directive, including, inter alia, rules concerning the achievement of language policy goals, protection of the public interest in terms of television's role as a provider of information, education, culture and entertainment, the need to safeguard pluralism in the information industry and the media, and the protection of competition with a view to avoiding the abuse of dominant positions and/or the establishment or strengthening of dominant positions by mergers, agreements, acquisitions or similar initiatives; whereas such rules must be compatible with Community law; (45) Whereas the objective of supporting audiovisual production in Europe can be pursued within the Member States in the framework of the organization of their broadcasting services, inter alia, through the definition of a public interest mission for certain broadcasting organizations, including the obligation to contribute substantially to investment in European production; (46) Whereas Article B of the Treaty on European Union states that one of the objectives the Union shall set itself is to maintain in full the 'acquis communautaire`, Article 1 Directive 89/552/EEC is hereby amended as follows: 1. in Article 1: (a) the following new point (b) shall be inserted: '(b) "broadcaster" means the natural or legal person who has editorial responsibility for the composition of schedules of television programmes within the meaning of (a) and who transmits them or has them transmitted by third parties;` (b) the former point (b) shall become point (c) and shall read as follows: '(c) "television advertising" means any form of announcement broadcast whether in return for payment or for similar consideration or broadcast for self-promotional purposes by a public or private undertaking in connection with a trade, business, craft or profession in order to promote the supply of goods or services, including immovable property, rights and obligations, in return for payment;` (c) the former points (c) and (d) shall become points (d) and (e); (d) the following point shall be added: '(f) "teleshopping" means direct offers broadcast to the public with a view to the supply of goods or services, including immovable property, rights and obligations, in return for payment.`; 2. Article 2 shall be replaced by the following: 'Article 2 1. Each Member State shall ensure that all television broadcasts transmitted by broadcasters under its jurisdiction comply with the rules of the system of law applicable to broadcasts intended for the public in that Member State. 2. For the purposes of this Directive the broadcasters under the jurisdiction of a Member State are: - those established in that Member State in accordance with paragraph 3; - those to whom paragraph 4 applies. 3. For the purposes of this Directive, a broadcaster shall be deemed to be established in a Member State in the following cases: (a) the broadcaster has its head office in that Member State and the editorial decisions about programme schedules are taken in that Member State; (b) if a broadcaster has its head office in one Member State but editorial decisions on programme schedules are taken in another Member State, it shall be deemed to be established in the Member State where a significant part of the workforce involved in the pursuit of the television broadcasting activity operates; if a significant part of the workforce involved in the pursuit of the television broadcasting activity operates in each of those Member States, the broadcaster shall be deemed to be established in the Member State where it has its head office; if a significant part of the workforce involved in the pursuit of the television broadcasting activity operates in neither of those Member States, the broadcaster shall be deemed to be established in the Member State where it first began broadcasting in accordance with the system of law of that Member State, provided that it maintains a stable and effective link with the economy of that Member State; (c) if a broadcaster has its head office in a Member State but decisions on programme schedules are taken in a third country, or vice-versa, it shall be deemed to be established in the Member State concerned, provided that a significant part of the workforce involved in the pursuit of the television broadcasting activity operates in that Member State. 4. Broadcasters to whom the provisions of paragraph 3 are not applicable shall be deemed to be under the jurisdiction of a Member State in the following cases: (a) they use a frequency granted by that Member State; (b) although they do not use a frequency granted by a Member State they do use a satellite capacity appertaining to that Member State; (c) although they use neither a frequency granted by a Member State nor a satellite capacity appertaining to a Member State they do use a satellite up-link situated in that Member State. 5. If the question as to which Member State has jurisdiction cannot be determined in accordance with paragraphs 3 and 4, the competent Member State shall be that in which the broadcaster is established within the meaning of Articles 52 and following of the Treaty establishing the European Community. 6. This Directive shall not apply to broadcasts intended exclusively for reception in third countries, and which are not received directly or indirectly by the public in one or more Member States.`; 3. the following Article shall be inserted: 'Article 2a 1. Member States shall ensure freedom of reception and shall not restrict retransmissions on their territory of television broadcasts from other Member States for reasons which fall within the fields coordinated by this Directive. 2. Member States may, provisionally, derogate from paragraph 1 if the following conditions are fulfilled: (a) a television broadcast coming from another Member State manifestly, seriously and gravely infringes Article 22 (1) or (2) and/or Article 22a; (b) during the previous 12 months, the broadcaster has infringed the provision(s) referred to in (a) on at least two prior occasions; (c) the Member State concerned has notified the broadcaster and the Commission in writing of the alleged infringements and of the measures it intends to take should any such infringement occur again; (d) consultations with the transmitting Member State and the Commission have not produced an amicable settlement within 15 days of the notification provided for in (c), and the alleged infringement persists. The Commission shall, within two months following notification of the measures taken by the Member State, take a decision on whether the measures are compatible with Community law. If it decides that they are not, the Member State will be required to put an end to the measures in question as a matter of urgency. 3. Paragraph 2 shall be without prejudice to the application of any procedure, remedy or sanction to the infringements in question in the Member State which has jurisdiction over the broadcaster concerned.`; 4. Article 3 shall be replaced by the following: 'Article 3 1. Member States shall remain free to require television broadcasters under their jurisdiction to comply with more detailed or stricter rules in the areas covered by this Directive. 2. Member States shall, by appropriate means, ensure, within the framework of their legislation, that television broadcasters under their jurisdiction effectively comply with the provisions of this Directive. 3. The measures shall include the appropriate procedures for third parties directly affected, including nationals of other Member States, to apply to the competent judicial or other authorities to seek effective compliance according to national provisions. Article 3a 1. Each Member State may take measures in accordance with Community law to ensure that broadcasters under its jurisdiction do not broadcast on an exclusive basis events which are regarded by that Member State as being of major importance for society in such a way as to deprive a substantial proportion of the public in that Member State of the possibility of following such events via live coverage or deferred coverage on free television. If it does so, the Member State concerned shall draw up a list of designated events, national or non-national, which it considers to be of major importance for society. It shall do so in a clear and transparent manner in due and effective time. In so doing the Member State concerned shall also determine whether these events should be available via whole or partial live coverage, or where necessary or appropriate for objective reasons in the public interest, whole or partial deferred coverage. 2. Member States shall immediately notify to the Commission any measures taken or to be taken pursuant to paragraph 1. Within a period of three months from the notification, the Commission shall verify that such measures are compatible with Community law and communicate them to the other Member States. It shall seek the opinion of the Committee established pursuant to Article 23a. It shall forthwith publish the measures taken in the Official Journal of the European Communities and at least once a year the consolidated list of the measures taken by Member States. 3. Member States shall ensure, by appropriate means, within the framework of their legislation that broadcasters under their jurisdiction do not exercise the exclusive rights purchased by those broadcasters following the date of publication of this Directive in such a way that a substantial proportion of the public in another Member State is deprived of the possibility of following events which are designated by that other Member State in accordance with the preceding paragraphs via whole or partial live coverage or, where necessary or appropriate for objective reasons in the public interest, whole or partial deferred coverage on free television as determined by that other Member State in accordance with paragraph 1.`; 5. in Article 4 (1), the words 'and teletext services` shall be replaced by the words 'teletext services and teleshopping`; 6. in Article 5, the words 'and teletext services` shall be replaced by the words 'teletext services and teleshopping`; 7. Article 6 shall be amended as follows: (a) paragraph 1 (a) shall be replaced by the following: '(a) works originating from Member States;` (b) in paragraph 1, the following subparagraph shall be added: 'Application of the provisions of (b) and (c) shall be conditional on works originating from Member States not being the subject of discriminatory measures in the third countries concerned.`; (c) paragraph 3 shall be replaced by the following: '3. The works referred to in paragraph 1 (c) are works made exclusively or in co-production with producers established in one or more Member States by producers established in one or more European third countries with which the Community has concluded agreements relating to the audiovisual sector, if those works are mainly made with authors and workers residing in one or more European States.`; (d) paragraph 4 shall become paragraph 5 and the following paragraph shall be inserted: '4. Works that are not European works within the meaning of paragraph 1 but that are produced within the framework of bilateral co-production treaties concluded between Member States and third countries shall be deemed to be European works provided that the Community co-producers supply a majority share of the total cost of the production and that the production is not controlled by one or more producers established outside the territory of the Member States.`; (e) in the new paragraph 5, the words 'paragraph 1` shall be replaced by the words 'paragraphs 1 and 4`; 8. Article 7 shall be replaced by the following: 'Article 7 Member States shall ensure that broadcasters under their jurisdiction do not broadcast cinematographic works outside periods agreed with the rights holders.`; 9. Article 8 shall be deleted; 10. Article 9 shall be replaced by the following: 'Article 9 This Chapter shall not apply to television broadcasts that are intended for local audiences and do not form part of a national network.`; 11. the title of Chapter IV shall be replaced by the following: 'Television advertising, sponsorship and teleshopping`. 12. Article 10 shall be replaced by the following: 'Article 10 1. Television advertising and teleshopping shall be readily recognizable as such and kept quite separate from other parts of the programme service by optical and/or acoustic means. 2. Isolated advertising and teleshopping spots shall remain the exception. 3. Advertising and teleshopping shall not use subliminal techniques. 4. Surreptitious advertising and teleshopping shall be prohibited.`; 13. Article 11 shall be replaced by the following: 'Article 11 1. Advertising and teleshopping spots shall be inserted between programmes. Provided the conditions set out in paragraphs 2 to 5 are fulfilled, advertising and teleshopping spots may also be inserted during programmes in such a way that the integrity and value of the programme, taking into account natural breaks in and the duration and nature of the programme, and the rights of the rights holders are not prejudiced. 2. In programmes consisting of autonomous parts, or in sports programmes and similarly structured events and performances containing intervals, advertising and teleshopping spots shall only be inserted between the parts or in the intervals. 3. The transmission of audiovisual works such as feature films and films made for television (excluding series, serials, light entertainment programmes and documentaries), provided their scheduled duration is more than 45 minutes, may be interrupted once for each period of 45 minutes. A further interruption shall be allowed if their scheduled duration is at least 20 minutes longer than two or more complete periods of 45 minutes. 4. Where programmes, other than those covered by paragraph 2, are interrupted by advertising or teleshopping spots, a period of at least 20 minutes should elapse between each successive advertising break within the programme. 5. Advertising and teleshopping shall not be inserted in any broadcast of a religious service. News and current affairs programmes, documentaries, religious programmes and children's programmes, when their scheduled duration is less than 30 minutes, shall not be interrupted by advertising or by teleshopping. If their scheduled duration is 30 minutes or longer, the provisions of the previous paragraphs shall apply.`; 14. in Article 12, the introductory words shall be replaced by the following: 'Television advertising and teleshopping shall not:`; 15. Article 13 shall be replaced by the following: 'Article 13 All forms of television advertising and teleshopping for cigarettes and other tobacco products shall be prohibited.`; 16. in Article 14, the present text shall become paragraph 1 and the following paragraph shall be added: '2. Teleshopping for medicinal products which are subject to a marketing authorization within the meaning of 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 (*), as well as teleshopping for medical treatment, shall be prohibited. (*) OJ No 22, 9. 2. 1965, p. 369. Directive as last amended by Directive 93/39/EEC (OJ No L 214, 24. 8. 1993, p. 22).`; 17. in Article 15, the introductory words shall be replaced by the following: 'Television advertising and teleshopping for alcoholic beverages shall comply with the following criteria:`; 18. in Article 16, the present text shall become paragraph 1 and the following paragraph shall be added: '2. Teleshopping shall comply with the requirements referred to in paragraph 1 and, in addition, shall not exhort minors to contract for the sale or rental of goods and services.`; 19. Article 17 shall be amended as follows: (a) paragraph 2 shall be replaced by the following: '2. Television programmes may not be sponsored by undertakings whose principal activity is the manufacture or sale of cigarettes and other tobacco products.`; (b) paragraph 3 shall become paragraph 4 and the following paragraph shall be inserted: '3. Sponsorship of television programmes by undertakings whose activities include the manufacture or sale of medicinal products and medical treatment may promote the name or the image of the undertaking but may not promote specific medicinal products or medical treatments available only on prescription in the Member State within whose jurisdiction the broadcaster falls.`; 20. Article 18 shall be replaced by the following: 'Article 18 1. The proportion of transmission time devoted to teleshopping spots, advertising spots and other forms of advertising, with the exception of teleshopping windows within the meaning of Article 18a, shall not exceed 20 % of the daily transmission time. The transmission time for advertising spots shall not exceed 15 % of the daily transmission time. 2. The proportion of advertising spots and teleshopping spots within a given clock hour shall not exceed 20 %. 3. For the purposes of this Article, advertising does not include: - announcements made by the broadcaster in connection with its own programmes and ancillary products directly derived from those programmes; - public service announcements and charity appeals broadcast free of charge.`; 21. the following Article shall be inserted: 'Article 18a 1. Windows devoted to teleshopping broadcast by a channel not exclusively devoted to teleshopping shall be of a minimum uninterrupted duration of 15 minutes. 2. The maximum number of windows per day shall be eight. Their overall duration shall not exceed three hours per day. They must be clearly identified as teleshopping windows by optical and acoustic means.`; 22. Article 19 shall be replaced by the following: 'Article 19 Chapters I, II, IV, V, VI, VIa and VII shall apply mutatis mutandis to channels exclusively devoted to teleshopping. Advertising on such channels shall be allowed within the daily limits established by Article 18 (1). Article 18 (2) shall not apply.`; 23. the following Article shall be inserted: 'Article 19a Chapters I, II, IV, V, VI, VIa and VII shall apply mutatis mutandis to channels exclusively devoted to self-promotion. Other forms of advertising on such channels shall be allowed within the limits established by Article 18 (1) and (2). This provision in particular shall be subject to review in accordance with Article 26.`; 24. Article 20 shall be replaced by the following: 'Article 20 Without prejudice to Article 3, Member States may, with due regard for Community law, lay down conditions other than those laid down in Article 11 (2) to (5) and Articles 18 and 18a in respect of broadcasts intended solely for the national territory which cannot be received, directly or indirectly by the public, in one or more other Member States.`; 25. Article 21 shall be deleted. 26. the title of Chapter V shall be replaced by the following: 'Protection of minors and public order`; 27. Article 22 shall be replaced by the following: 'Article 22 1. Member States shall take appropriate measures to ensure that television broadcasts by broadcasters under their jurisdiction do not include any programmes which might seriously impair the physical, mental or moral development of minors, in particular programmes that involve pornography or gratuitous violence. 2. The measures provided for in paragraph 1 shall also extend to other programmes which are likely to impair the physical, mental or moral development of minors, except where it is ensured, by selecting the time of the broadcast or by any technical measure, that minors in the area of transmission will not normally hear or see such broadcasts. 3. Furthermore, when such programmes are broadcast in unencoded form Member States shall ensure that they are preceded by an acoustic warning or are identified by the presence of a visual symbol throughout their duration.`; 28. the following Article shall be inserted: 'Article 22a Member States shall ensure that broadcasts do not contain any incitement to hatred on grounds of race, sex, religion or nationality.`; 29. the following Article shall be inserted: 'Article 22b 1. The Commission shall attach particular importance to application of this Chapter in the report provided for in Article 26. 2. The Commission shall within one year from the date of publication of this Directive, in liaison with the competent Member State authorities, carry out an investigation of the possible advantages and drawbacks of further measures with a view to facilitating the control exercised by parents or guardians over the programmes that minors may watch. This study shall consider, inter alia, the desirability of: - the requirement for new television sets to be equipped with a technical device enabling parents or guardians to filter out certain programmes; - the setting up of appropriate rating systems, - encouraging family viewing policies and other educational and awareness measures, - taking into account experience gained in this field in Europe and elsewhere as well as the views of interested parties such as broadcasters, producers, educationalists, media specialists and relevant associations.`; 30. Article 23 (1) shall be replaced by the following: '1. Without prejudice to other provisions adopted by the Member States under civil, administrative or criminal law, any natural or legal person, regardless of nationality, whose legitimate interests, in particular reputation and good name, have been damaged by an assertion of incorrect facts in a television programme must have a right of reply or equivalent remedies. Member States shall ensure that the actual exercise of the right of reply or equivalent remedies is not hindered by the imposition of unreasonable terms or conditions. The reply shall be transmitted within a reasonable time subsequent to the request being substantiated and at a time and in a manner appropriate to the broadcast to which the request refers.`; 31. after Article 23, the following new Chapter VIa shall be inserted: 'CHAPTER VIa Contact committee Article 23a 1. A contact committee shall be set up under the aegis of the Commission. 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 meet either on his initiative or at the request of the delegation of a Member State. 2. The tasks of this committee shall be: (a) to facilitate effective implementation of this Directive through regular consultation on any practical problems arising from its application, and particularly from the application of Article 2, as well as on any other matters on which exchanges of views are deemed useful; (b) to deliver own-initiative opinions or opinions requested by the Commission on the application by the Member States of the provisions of this Directive; (c) to be the forum for an exchange of views on what matters should be dealt with in the reports which Member States must submit pursuant to Article 4 (3), on the methodology of these, on the terms of reference for the independent study referred to in Article 25a, on the evaluation of tenders for this and on the study itself; (d) to discuss the outcome of regular consultations which the Commission holds with representatives of broadcasting organizations, producers, consumers, manufacturers, service providers and trade unions and the creative community; (e) to facilitate the exchange of information between the Member States and the Commission on the situation and the development of regulatory activities regarding television broadcasting services, taking account of the Community's audiovisual policy, as well as relevant developments in the technical field; (f) to examine any development arising in the sector on which an exchange of views appears useful.`; 32. the following Article shall be inserted: 'Article 25a A further review as provided for in Article 4 (4) shall take place before 30 June 2002. It shall take account of an independent study on the impact of the measures in question at both Community and national level.`; 33. Article 26 shall be replaced by the following: 'Article 26 Not later than 31 December 2000, 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 as amended and, if necessary, make further proposals to adapt it to developments in the field of television broadcasting, in particular in the light of recent technological developments.` Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1998. They shall immediately inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 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.

31997L0043

1997

COUNCIL DIRECTIVE 97/43/EURATOM of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure, and repealing Directive 84/466/Euratom Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 31 thereof, Having regard to the proposal from the Commission, drawn up after obtaining the opinion of a group of persons appointed by the Scientific and Technical Committee, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the Economic and Social Committee (2), (1) Whereas the Council has adopted Directives laying down the basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation, as last amended by Directive 96/29/Euratom (3); (2) Whereas in accordance with Article 33 of the Treaty, each Member State is to lay down the appropriate provisions, whether by legislation, regulation or administrative action, to ensure compliance with the basic standards which have been established and take the necessary measures with regard to teaching, education and vocational training; (3) Whereas, on 3 September 1984 the Council adopted Directive 84/466/Euratom laying down the basic measures for the radiation protection of persons undergoing medical examination or treatment (4); (4) Whereas, as in 1984, medical exposure continues to constitute the major source of exposure to artificial sources of ionizing radiation of European Union citizens; whereas the use of ionizing radiation has enabled great progress to be made in many aspects of medicine; whereas practices causing medical exposure need to be carried out in optimized radiation protection conditions; (5) Whereas, recognizing the development of scientific knowledge in the field of radiation protection applied to medical exposure, the International Commission on Radiological Protection reviewed the subject in its 1990 and 1996 recommendations; (6) Whereas such developments make it necessary to repeal Directive 84/466/Euratom; (7) Whereas Directive 96/29/Euratom lays down basic safety standards for the protection of the workers administering the medical exposure and of the members of the public; whereas the same Directive ensures that the total of contributions to the exposure of the population as a whole, is kept under review; (8) Whereas health and safety requirements, including radiation protection aspects, regarding the design, manufacture and placing on the market of the medical devices are dealt with by Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (5); whereas pursuant to Article 1 (8) of that Directive, the relevant Directives adopted under the Euratom Treaty are not to be affected by its provisions; whereas it is necessary to set out radiation protection requirements for the medical use of radiological installations from the date of the commencement of their operation; (9) Whereas provisions need to be adapted for the protection as regards exposure incurred by volunteers and persons knowingly and willingly helping persons undergoing medical examination or treatment; (10) Whereas the Committee of Ministers of the Council of Europe adopted on 6 February 1990 Recommendation R(90)3 on medical research on human beings, concerning inter alia the setting up of an ethics committee; (11) Whereas detailed requirements are needed for the correct application of the justification and optimization principles in relation to exposure within the scope of this Directive; (12) Whereas responsibilities for administering medical exposure need to be set out; (13) Whereas appropriate training for the staff involved, the establishment of quality assurance and audit programmes, and inspections by the competent authorities are necessary to ensure that medical exposure is delivered under good radiation protection conditions; (14) Whereas specific provisions are necessary as regards special practice, pregnant and breastfeeding females, volunteers in research and helping persons; (15) Whereas potential exposure needs to be taken into account, Article 1 Purpose and scope 1. This Directive supplements Directive 96/29/Euratom and lays down the general principles of the radiation protection of individuals in relation to the exposure referred to in paragraphs 2 and 3. 2. This Directive shall apply to the following medical exposure: (a) the exposure of patients as part of their own medical diagnosis or treatment; (b) the exposure of individuals as part of occupational health surveillance; (c) the exposure of individuals as part of health screening programmes; (d) the exposure of healthy individuals or patients voluntarily participating in medical or biomedical, diagnostic or therapeutic, research programmes; (e) the exposure of individuals as part of medico-legal procedures. 3. This Directive shall also apply to exposure of individuals knowingly and willingly helping (other than as part of their occupation) in the support and comfort of individuals undergoing medical exposure. Article 2 Definitions For the purpose of this Directive, the following terms have the meaning hereby assigned them: — Clinical audit: a systematic examination or review of medical radiological procedures which seeks to improve the quality and the outcome of patient care through structured review whereby radiological practices, procedures and results are examined against agreed standards for good medical radiological procedures, with modification of practices where indicated and the application of new standards if necessary. — Clinical Responsibility: responsibility regarding individual medical exposures attributed to a practitioner, notably: justification; optimization; clinical evaluation of the outcome; cooperation with other specialists and the staff, as appropriate, regarding practical aspects; obtaining information, if appropriate, of previous examinations; providing existing radiological information and/or records to other practitioners and/or prescribers, as required; giving information on the risk of ionizing radiation to patients and other individuals involved, as appropriate. — Competent Authorities: any authority designated by a Member State. — Diagnostic Reference Levels: dose levels in medical radiodiagnostic practices or, in the case of radio-pharmaceuticals, levels of activity, for typical examinations for groups of standard-sized patients or standard phantoms for broadly defined types of equipment. These levels are expected not to be exceeded for standard procedures when good and normal practice regarding diagnostic and technical performance is applied. — Dose Constraint: a restriction on the prospective doses to individuals which may result from a defined source, for use at the planning stage in radiation protection whenever optimization is involved. — Exposure: the process of being exposed to ionizing radiation. — Health screening: a procedure using radiological installations for early diagnosis in population groups at risk. — Holder: any natural or legal person who has the legal responsibility under national law for a given radiological installation. — Individual Detriment: clinically observable deleterious effects that are expressed in individuals or their descendants, the appearance of which is either immediate or delayed and, in the latter case, implies a probability rather than a certainty of appearance. — Inspection: inspection is an investigation by any competent authority to verify compliance with national provisions on radiological protection for medical radiological procedures, equipment in use or radiological installations. — Medical Physics Expert: an expert in radiation physics or radiation technology applied to exposure, within the scope of this Directive, whose training and competence to act is recognized by the competent authorities; and who, as appropriate, acts or gives advice on patient dosimetry, on the development and use of complex techniques and equipment, on optimization, on quality assurance, including quality control, and on other matters relating to radiation protection, concerning exposure within the scope of this Directive. — Medical Radiological Procedure: any procedure concerning medical exposure. — Medico-legal procedures: procedures performed for insurance or legal purposes without a medical indication. — Occupational health surveillance: the medical surveillance for workers as specified by Member States or competent authorities. — Patient dose: the dose, concerning patients or other individuals undergoing medical exposure. — Patient dosimetry: the dosimetry concerning patients or other individuals undergoing medical exposure. — Practical Aspects: the physical conduct of any of the exposure referred to in Article 1 (2) and any supporting aspects including handling and use of radiological equipment, and the assessment of technical and physical parameters including radiation doses, calibration and maintenance of equipment, preparation and administration of radio-pharmaceuticals and the development of films. — Practitioner: a medical doctor, dentist or other health professional, who is entitled to take clinical responsibility for an individual medical exposure in accordance with national requirements. — Prescriber: a medical doctor, dentist or other health professional, who is entitled to refer individuals for medical exposure to a practitioner, in accordance with national requirements. — Quality Assurance: all those planned and systematic actions necessary to provide adequate confidence that a structure, system, component or procedure will perform satisfactorily complying with agreed standards. — Quality control: is a part of quality assurance. The set of operations (programming, coordinating, implementing) intended to maintain or to improve quality. It covers monitoring, evaluation and maintenance at required levels of all characteristics of performance of equipment that can be defined, measured, and controlled. — Radiological: pertaining to radiodiagnostic and radio-therapeutic procedures, and interventional radiology or other planning and guiding radiology. — Radiological installation: a facility containing radiological equipment. — Radiodiagnostic: pertaining to in vivo diagnostic nuclear medicine, medical diagnostic radiology, and dental radiology. — Radiotherapeutic: pertaining to radiotherapy including nuclear medicine for therapeutic purposes. Article 3 Justification 1. Medical exposure referred to in Article 1 (2) shall show a sufficient net benefit, weighing the total potential diagnostic or therapeutic benefits it produces, including the direct health benefits to an individual and the benefits to society, against the individual detriment that the exposure might cause, taking into account the efficacy, benefits and risks of available alternative techniques having the same objective but involving no or less exposure to ionizing radiation. In particular: (a) — all new types of practices involving medical exposure shall be justified in advance before being generally adopted, — existing types of practices involving medical exposure may be reviewed whenever new, important evidence about their efficacy or consequences is acquired. (b) all individual medical exposures shall be justified in advance taking into account the specific objectives of the exposure and the characteristics of the individual involved. If a type of practice involving a medical exposure is not justified in general, a specific individual exposure of this type could be justified in special circumstances, to be evaluated on a case-by-case basis. The prescriber and the practitioner as specified by Member States, shall seek, where practicable, to obtain previous diagnostic information or medical records relevant to the planned exposure and consider these data to avoid unnecessary exposure. (c) medical exposure for biomedical and medical research shall be examined by an ethics committee, set up in accordance with national procedures and/or by the competent authorities. (d) special attention shall be given to the justification of those medical exposures where there is no direct health benefit for the person undergoing the exposure and especially for those exposures on medico-legal grounds. 2. Exposure referred to in Article 1 (3) shall show a sufficient net benefit, taking into account also the direct health benefits to a patient, the benefits to individuals referred to in Article 1 (3) and the detriment that the exposure might cause. 3. If an exposure can not be justified, it should be prohibited. Article 4 Optimization 1. (a) All doses due to medical exposure for radiological purposes except radiotherapeutic procedures referred to in Article 1 (2) shall be kept as low as reasonably achievable consistent with obtaining the required diagnostic information, taking into account economic and social factors. (b) For all medical exposure of individuals for radio-therapeutic purposes, as mentioned in Article 1 (2) (a), exposures of target volumes shall be individually planned; taking into account that doses of non-target volumes and tissues shall be as low as reasonably achievable and consistent with the intended radiotherapeutic purpose of the exposure. 2. Member States shall: (a) promote the establishment and the use of diagnostic reference levels for radiodiagnostic examinations, as referred to in Article 1 (2) (a), (b), (c) and (e), and the availability of guidance for this purpose having regard to European diagnostic reference levels where available; (b) ensure that for each biomedical and medical research project as mentioned in Article 1 (2) (d): — the individuals concerned shall participate voluntarily, — these individuals shall be informed about the risks of this exposure, — a dose constraint is established for individuals for whom no direct medical benefit is expected from this exposure, — in the case of patients, who voluntarily accept to undergo an experimental diagnostic or therapeutic practice and who are expected to receive a diagnostic or therapeutical benefit from this practice, the target levels of doses shall be planned on an individual basis by the practitioner and/or prescriber, (c) ensure that special attention be given, to keep the dose arising from the medico-legal exposure referred to in Article 1 (2) (e) as low as reasonably achievable. 3. The optimization process shall include the selection of equipment, the consistent production of adequate diagnostic information or therapeutic outcome as well as the practical aspects, quality assurance including quality control and the assessment and evaluation of patient doses or administered activities, taking into account economic and social factors. 4. Member States shall ensure that: (a) dose constraints are established for exposure, as referred to in Article 1 (3), of those individuals knowingly and willingly helping (other than as part of their occupation) in the support and comfort of patients undergoing medical diagnosis or treatment where appropriate; (b) appropriate guidance is established for exposure as referred to in Article 1 (3); (c) in the case of a patient undergoing a treatment or diagnosis with radionuclides, where appropriate the practitioner or the holder of the radiological installation provides the patient or legal guardian with written instructions, with a view to the restriction of doses to persons in contact with the patient as far as reasonably achievable and to provide information on the risks of ionizing radiation. These instructions shall be handed out before leaving the hospital or clinic or a similar institution. Article 5 Responsibilities 1. The prescriber as well as the practitioner shall be involved as specified by Member States in the justification process at the appropriate level. 2. Member States shall ensure that any medical exposure referred to in Article 1 (2) is effected under the clinical responsibility of a practitioner. 3. The practical aspects for the procedure or part of it may be delegated by the holder of the radiological installation or the practitioner, as appropriate, to one or more individuals entitled to act in this respect in a recognized field of specialization. 4. Member States shall ensure the laying down of procedures to be observed in case of medico-legal examinations. Article 6 Procedures 1. Written protocols for every type of standard radiological practice shall be established for each equipment. 2. Member States shall ensure that recommendations concerning referral criteria for medical exposure, including radiation doses, are available to the prescribers of medical exposure. 3. In radiotherapeutic practices, a medical physics expert shall be closely involved. In standardized therapeutical nuclear medicine practices and in diagnostic nuclear medicine practices, a medical physics expert shall be available. For other radiological practices, a medical physics expert shall be involved, as appropriate, for consultation on optimization including patient dosimetry and quality assurance including quality control, and also to give advice on matters relating to radiation protection concerning medical exposure, as required. 4. Clinical audits shall be carried out in accordance with national procedures. 5. Member States shall ensure that appropriate local reviews are undertaken whenever diagnostic reference levels are consistently exceeded and that corrective actions are taken where appropriate. Article 7 Training 1. Member States shall ensure that practitioners and those individuals mentioned in Articles 5 (3) and 6 (3) have adequate theoretical and practical training for the purpose of radiological practices, as well as relevant competence in radiation protection. For this purpose Member States shall ensure that appropriate curricula are established and shall recognize the corresponding diplomas, certificates or formal qualifications. 2. Individuals undergoing relevant training programmes may participate in practical aspects for the procedures mentioned in Article 5 (3). 3. Member States shall ensure that continuing education and training after qualification is provided and, in the special case of the clinical use of new techniques, the organization of training related to these techniques and the relevant radiation protection requirements. 4. Member States shall encourage the introduction of a course on radiation protection in the basic curriculum of medical and dental schools. Article 8 Equipment 1. Member States shall take such steps as they may consider necessary with a view to avoiding unnecessary proliferation of radiological equipment. 2. Member States shall ensure that: — all radiological equipment in use is kept under strict surveillance regarding radiation protection, — an up-to-date inventory of radiological equipment for each radiological installation is available to the competent authorities, — appropriate quality assurance programmes including quality control measures and patient dose or administered activity assessments are implemented by the holder of the radiological installation, and — acceptance testing is carried out before the first use of the equipment for clinical purposes, and thereafter performance testing on a regular basis, and after any major maintenance procedure. 3. Competent authorities shall take steps to ensure that necessary measures are taken by the holder of the radiological installation to improve inadequate or defective features of the equipment. They shall also adopt specific criteria of acceptability for equipment in order to indicate when appropriate remedial action is necessary, including, if appropriate, taking the equipment out of service. 4. In the case of fluoroscopy, examinations without an image intensification or equivalent techniques are not justified and shall therefore be prohibited. 5. Fluoroscopic examinations without devices to control the dose rate shall be limited to justified circumstances. 6. If new radiodiagnostical equipment is used, it shall have, where practicable, a device informing the practitioner of the quantity of radiation produced by the equipment during the radiological procedure. Article 9 Special Practices 1. Member States shall ensure that appropriate radiological equipment, practical techniques and ancillary equipment are used for the medical exposure — of children, — as part of a health screening programme, — involving high doses to the patient, such as interventional radiology, computed tomography or radiotherapy. Special attention shall be given to the quality assurance programmes, including quality control measures and patient dose or administered activity assessment, as mentioned in Article 8, for these practices. 2. Member States shall ensure that practitioners and those individuals referred to in Article 5 (3) performing the exposure referred to in the first paragraph obtain appropriate training on these radiological practices as required by Article 7 (1) and (2). Article 10 Special protection during pregnancy and breastfeeding 1. (a) In the case of a female of childbearing age, the prescriber and the practitioner shall inquire as specified by Member States whether she is pregnant, or breastfeeding, if relevant; and (b) if pregnancy cannot be excluded, depending on the type of medical exposure, in particular if abdominal and pelvic regions are involved, special attention shall be given to the justification, particularly the urgency, and to the optimization of the medical exposure taking into account the exposure both of the expectant mother and the unborn child. 2. In the case of breastfeeding females, in nuclear medicine depending on the type of medical examination or treatment, special attention shall be given to the justification, particularly the urgency, and to the optimization of the medical exposure, taking into account the exposure both for the mother and the child. 3. Without prejudice to Article 10 (1) and (2), any measure contributing to increasing the awareness of women subject to this Article, such as public notices in appropriate places, could be helpful. Article 11 Potential exposure Member States shall ensure that all reasonable steps to reduce the probability and the magnitude of accidental or unintended doses of patients from radiological practices are taken, economic and social factors being taken into account. The main emphasis in accident prevention should be on the equipment and procedures in radiotherapy, but some attention should be paid to accidents with diagnostic equipment. Working instructions and written protocols as referred to in Article 6 (1) and quality assurance programmes as referred to in Article 8 (2) and the criteria referred to in Article 8 (3) are of particular relevance for this purpose. Article 12 Estimates of population doses Member States shall ensure that the distribution of individual dose estimates from medical exposure referred to in Article 1 (2) is determined for the population and for relevant reference groups of the population as may be deemed necessary by the Member State. Article 13 Inspection Member States shall ensure that a system of inspection as defined in Article 2 enforces the provisions introduced in compliance with this Directive. Article 14 Transposition into Member State law 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 13 May 2000. 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 adopted by Member States. 2. Member States shall communicate to the Commission the text of the main laws, regulations or administrative provisions which they adopt in the field covered by this Directive. Article 15 Repeal Directive 84/466/Euratom is hereby repealed with effect from 13 May 2000. Article 16 This Directive is addressed to the Member States.

31997L0045

1997

21st Commission Directive 97/45/EC of 14 July 1997 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Commission Directive 97/1/EC (2) and in particular Article 8 (2) thereof, After consultation of the Scientific Committee on Cosmetology, Whereas the available scientific data indicate that the polyaromatic hydrocarbons (PAHs) level in refined coal tar are in the same range as the PAHs level in crude coal tar; whereas several studies show that PAHs enter the skin exposed to coal tars, which may lead to dermal and systemic carcinogenesis; whereas numerous PAHs are genotoxic carcinogens, and consequently no safe level can be established, the use of crude and refine coal tars in cosmetic products should be prohibited; Whereas a further toxicological evaluation, based on new data submitted by industry, of benzethonium chloride, shows that an acceptable safety margin is obtained as long as its use is limited to preservatives, at a limited concentration and for a reduced time of contact with the skin; Whereas, on the basis of the latest scientific and technical research, octyl methoxycinnamate may be used as an UV filter in cosmetic products; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directive on the removal of technical barriers to trade in the cosmetics products sector, Article 1 Directive 76/768/EEC is hereby amended as shown in the Annex. Article 2 1. Member States shall take the necessary measures to ensure that as from 1 July 1998 for the substances set out in the Annex, neither manufacturers nor importers established in the Community shall place on the market products which do not comply with the requirements of this Directive. 2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 containing the substances set out in the Annex shall not be sold or otherwise supplied to the final consumer after 30 June 1999. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 June 1998. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publications. The procedure for such reference shall be adopted 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 4 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31997L0027

1997

Directive 97/27/EC of the European Parliament and of the Council of 22 July 1997 relating to the masses and dimensions of certain categories of motor vehicles and their trailers and amending Directive 70/156/EEC Having regard to the Treaty establishing the European Community, and in particular Article 100a 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 189b of the Treaty (3), (1) Whereas the total harmonization of technical requirements for motor vehicles is necessary in order to achieve the smooth functioning of the internal market, while ensuring a high level of safety for the public; (2) Whereas the technical requirements which certain vehicle categories must satisfy pursuant to national laws relate, inter alia, to their masses and dimensions; (3) Whereas these requirements differ from one Member State to another; whereas it is therefore necessary that all Member States adopt the same requirements either in addition to or in place of their existing rules in order to allow, in particular, the EC type-approval procedure which was the subject 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 (4), to be applied in respect of each type of vehicle; (4) Whereas it is desirable to harmonize the maximum masses and dimensions of motor vehicles and their trailers to be registered in the Member States in accordance with Directive 96/53/EC of 25 July 1996 laying down, for certain road vehicles circulating within the Community, the maximum authorized dimensions in national and international traffic and the maximum authorized weights in international traffic (5); whereas the aforementioned Directive applies only to the traffic on the territories of the Member States and not to technical requirements as laid down in Directive 70/156/EEC; (5) Whereas Directive 96/53/EC lays down certain maximum authorized dimensions for both national and international traffic in the Member States with a certain lead time for their entry into force; whereas some other maximum authorized dimensions, as well as maximum authorized masses, remain applicable only to international traffic; (6) Whereas, as a consequence, the harmonization of the maximum authorized masses of motor vehicles and their trailers to be registered in the Member States does not appear to be feasible in the short term; whereas on the other hand it does now appear feasible to achieve, as far as possible, the harmonization of their maximum dimensions, to deal with the question of masses by providing for the possibility of a uniform procedure to determine the registration/in-service maximum permissible masses of vehicles in each Member State, and to pursue the constant improvement of safety, in particular with regard to certain categories of trailers; (7) Whereas, according to Article 4 (3) and (4) of Directive 96/53/EC, Member States may allow the circulation on their territory of category N vehicles with dimensions exceeding the limits laid down in that Directive, either for the carriage of indivisible loads or for the purpose of certain national transport operations that do not significantly affect international competition in the transport sector; whereas, as far as category M2 and M3 vehicles are concerned, Directive 96/53/EC applies only to international traffic; whereas it is therefore necessary by way of derogation to allow approvals for vehicles of dimensions exceeding the maximum dimensions authorized by this Directive and for certain other characteristics, together with the possibility for Member States to refuse vehicles approved under those derogating provisions; (8) Whereas this Directive is one of the separate directives which must be complied with in order to ensure the conformity of vehicles with the requirements of the EC type-approval procedure established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to this Directive; (9) Whereas, in particular, pursuant to Articles 3 (4) and 4 (3) of Directive 70/156/EEC, each separate directive must have attached to it an information document incorporating the relevant items of Annex I to that Directive and also a type-approval certificate based on Annex VI thereto so that type-approval can be computerized; (10) Whereas special provisions have been incorporated as regards incomplete vehicles in order to facilitate second-stage approval of completed vehicles; (11) Whereas special provisions are introduced in this Directive to take account of retractable or loadable axles; whereas it is acknowledged that such axles should also be taken into account in Council Directive 71/320/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to the braking devices of certain categories of motor vehicles and of their trailers (6) and in Council Directive 70/311/EEC of 8 June 1970 on the approximation of the laws of the Member States relating to steering equipment for motor vehicles and their trailers (7); (12) Whereas special provisions should also be incorporated into Directive 71/320/EEC in order to take better account of the technical conditions under which vehicles of categories M2, M3 and N may tow trailers; (13) Whereas special provisions should also be incorporated into Council Directive 76/114/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to statutory plates and inscriptions for motor vehicles and their trailers, and their location and method of attachment (8) to take account of the fact that vehicles may be registered at different masses in the Member States, Article 1 For the purposes of this Directive, 'vehicle` means any motor vehicle or trailer as defined in Article 2 of and Annex II to Directive 70/156/EEC, with the exception of vehicles of category M1. Article 2 No Member State may refuse to grant EC type-approval or national type-approval of a vehicle type, or refuse or prohibit the sale, registration, entry into service or use of a vehicle on grounds relating to its masses and dimensions if these satisfy the requirements set out in Annex I hereto. Article 3 However, a Member State may refuse to grant national type-approval of a vehicle type, or refuse or prohibit the sale, registration, entry into service or use of a vehicle, or consider its certificate of conformity as not valid within the meaning of Article 7 (1) of Directive 70/156/EEC, or authorize it only for the carriage of indivisible loads if, having been granted approval under this Directive, it benefits from the derogation provided for in Article 7 thereof and that derogation conflicts with the national requirements in force in that Member State. Article 4 When Member States grant national type-approval of vehicles approved under this Directive or permit the registration, entry into service or use of such vehicles, they assign to them national registration/in-service maximum permissible masses according to their relevant national maximum authorized masses. For the determination of these registration/in-service maximum permissible masses, no Member State may refuse to apply the procedure provided for in Annex IV, should the manufacturer request its application. Article 5 By way of derogation from Article 2, Member States may submit loadable and retractable axles to national technical requirements. However, no Member State may refuse to apply the technical requirements laid down in section 3 of Annex IV should the manufacturer request their application. Article 6 By way of derogation from Article 2 and section 7.3.2.1 of Annex I, Member States may refuse to grant national type-approval of, or refuse or prohibit the sale, registration or entry into service or use of buses or coaches the width of which exceeds 2,50 m until 31 December 1999, as provided by Article 9 of Directive 96/53/EC. Article 7 By way of derogation from Article 2 and section 7.3 of Annex I, and without the requirements of section 7.6 of Annex I having to be fulfilled, Member States may approve vehicles with dimensions exceeding those laid down in those sections. Details of the derogation shall be included in the type-approval certificate in Annex III to this Directive and the provisions of Article 3 shall apply. Article 8 Directive 70/156/EEC is amended as follows: (a) Annex I is supplemented as follows: 1. Footnote (j) shall be supplemented as follows: 'for vehicles other than those of category M1, Directive 97/27/EC, Annex I, section 2.4.1`. 2. Footnote (k) shall be supplemented as follows: 'for vehicles other than those of category M1, Directive 97/27/EC, Annex I, section 2.4.2`. 3. Footnote (l) shall be supplemented as follows: 'for vehicles other than those of category M1, Directive 97/27/EC, Annex I, section 2.4.3`. (b) Item 48 of Annex IV is replaced by the following text: '>TABLE> ` Article 9 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 22 July 1999 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 communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. Article 10 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 11 This Directive is addressed to the Member States.

31997L0044

1997

Eighth Directive 97/44/EC of the European Parliament and of the Council of 22 July 1997 on summer-time arrangements Having regard to the Treaty establishing the European Community, and in particular Article 100a 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 189b of the Treaty (3), Whereas Seventh Directive 94/21/EC of the European Parliament and of the Council of 30 May 1994 on summer-time arrangements (4) introduced a common date and time throughout the Community for the beginning of summertime in 1995, 1996 and 1997; whereas the Seventh Directive retained two different dates for the end of summertime in 1995, one for Member States other than Ireland and the United Kingdom and one for Ireland and the United Kingdom, but nonetheless introduced a common date and time for the end of summertime in 1996 and 1997; Whereas, 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; Whereas, with regard to the principle of subsidiarity, Community action is necessary to ensure complete harmonization of the timetable with a view to facilitating transport and communications; Whereas the date considered most appropriate by Member States for the end of the summer-time period is the end of October; whereas this date should therefore be maintained; Whereas Article 4 of the Seventh Directive lays down that the European Parliament and the Council must adopt by 1 January 1997 the arrangements to apply from 1998 onwards; Whereas, for geographical reasons, common summer-time arrangements should not apply to the overseas territories of the Member States; Whereas, for reasons of timetabling, particularly in the transport and communications sectors, the timing of summer-time arrangements should be set for a sufficiently long period; whereas provisions should accordingly be adopted for 1998, 1999, 2000 and 2001, 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 In each Member State the summer-time period for 1998, 1999, 2000 and 2001 shall begin at 1 a.m. Greenwich Mean Time (GMT) on the last Sunday in March, i.e.: - in 1998: on 29 March, - in 1999: on 28 March, - in 2000: on 26 March, - in 2001: on 25 March. Article 3 In each Member State the summer-time period for 1998, 1999, 2000 and 2001 shall end at 1 a.m. Greenwich Mean Time on the last Sunday in October, i.e.: - in 1998: on 25 October, - in 1999: on 31 October, - in 2000: on 29 October, - in 2001: on 28 October. Article 4 The arrangements to apply from 2002 onwards shall be adopted by 1 January 2001 on a proposal from the Commission to be submitted before 1 January 2000. Article 5 This Directive shall not apply to the overseas territories of the Member States. Article 6 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1997 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 7 This Directive is addressed to the Member States.

31997L0047

1997

Commission Directive 97/47/EC of 28 July 1997 amending the Annexes to Council Directives 77/101/EEC, 79/373/EEC and 91/357/EEC (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 77/101/EEC of 23 November 1976 on the marketing of straight feedingstuffs (1), as last amended by Directive 90/654/EEC (2), and in particular Article 10 thereof, Having regard to Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs (3), as last amended by Directive 96/24/EC (4), and in particular Article 10 (e) thereof, Whereas cases of bovine spongiform encephalopathy (BSE) have been reported in some Member States; whereas scrapie is also known to exist in some Member States; whereas BSE and scrapie agents may be transmitted by the oral route; Whereas BSE in bovine animals is considered to originate from the use in feed of protein obtained from ruminants, constituting a vector for the transmission of agents of transmissible spongiform encephalopathies and not effectively treated to inactivate such agents; Whereas, to protect ruminants from the health risks arising from the fact that methods of treating protein could not always ensure that the agents were totally inactivated, the Commission adopted Decision 94/381/EC of 27 June 1994 concerning certain protection measures with regard to bovine spongiform encephalopathy and the feeding of mammalian derived protein (5), as last amended by Decision 95/60/EC (6); whereas that instrument bans the feeding to ruminants of protein obtained from mammalian tissue while laying down that some products are to be exempted given that they present no health risk; Whereas, given the health risks associated with the feeding to ruminants of feedingstuffs containing infected protein derived from mammalian tissue and the fact that the transmission of the disease to humans cannot be ruled out, the Council decided at its meeting of 1 to 3 April 1996 to adopt additional measures to protect human and animal health; Whereas, for practical reasons and for the sake of legal consistency, Commission Decision 95/274/EC of 10 July 1995 amending Decision 91/516/EEC establishing a list of ingredients whose use is prohibited in compound feedingstuffs (7) prohibits the use of protein derived from mammalian tissue in compound feedingstuffs for ruminants; Whereas Directives 77/101/EEC and 79/373/EEC lay down general and specific rules for the marketing and labelling of straight and compound feedingstuffs; whereas, to prevent the users of feedingstuffs containing protein derived from certain tissue of mammals from feeding them to ruminants through ignorance of current feedingstuffs and veterinary rules, appropriate labelling of such feedingstuffs must call attention to the prohibition on their use in ruminant feed; whereas Directive 77/101/EEC will be repealed by Council Directive 96/25/EC (8) on the circulation of feed materials, and similar measures will therefore also have to be laid down in Directive 96/25/EC; Whereas the provisions laid down shall apply without prejudice to more stringent provisions which some Member States may have adopted as permitted by Article 1 (2) of Council Directive 90/667/EEC of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedstuffs of animal or fish origin and amending Directive 90/425/EEC (9); Whereas Member States applying more stringent prohibitions must adapt the provisions on labelling in accordance with the prohibitions applying in those Member States; Whereas the categories of ingredients listed in Commission Directive 91/357/EEC of 13 June 1991 laying down the categories of ingredients which may be used for the purposes of labelling compound feedingstuffs for animals other than pet animals (10) allow several ingredients to be grouped under a common description; whereas, however, livestock farmers must have accurate and meaningful information on compound feedingstuffs containing ingredients comprising protein derived from mammalian tissue; whereas the category 'Land animal products` pertaining to that group of ingredients should therefore be deleted from the labelling of compound feedingstuffs; whereas, consequently, feedingstuff producers must give an accurate description of the ingredients covered by that category since they no longer fall within any of the categories set out in the Annex to Directive 91/357/EEC; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 The provisions of this Directive shall apply without prejudice to Decision 94/381/EC. Article 2 Amendment to Directive 77/101/EEC The following point is hereby added to Part A of the Annex to Directive 77/101/EEC: '3. Labelling of straight feedingstuffs comprising protein derived from mammalian tissue. 3.1. The labelling of straight feedingstuffs comprising protein derived from mammalian tissue must contain the following statement: "This straight feedingstuff comprises protein derived from mammalian tissue the feeding of which to ruminants is prohibited". This does not apply to: - milk and milk products, - gelatin, - amino acids obtained from hides and skins by a process which involves exposure of the material to a pH of 1 to 2 followed by a pH of > 11, followed by heat treatment at 140 °C for 30 minutes at 3 bar, - dicalcium phosphate derived from defatted bones, and - dried plasma and other blood products. 3.2. Where a Member State prohibits the use of protein derived from mammalian tissue as referred to in 3.1, first sentence, in feedingstuffs for certain animals other than ruminants as permitted by Article 1 (2) of Council Directive 90/667/EEC (*), the statement required in 3.1 must mention in addition the other species or categories of animals to which it has extended the prohibition on the use of the products in question. (*) OJ No L 363, 27. 12. 1990, p. 51.` Article 3 Amendment to Directive 79/373/EEC The following point is hereby added to Part A of the Annex to Directive 79/373/EEC: '7. Labelling of compound feedingstuffs containing protein derived from mammalian tissue. 7.1. The labelling of compound feedingstuffs containing protein derived from mammalian tissue and intended for animals other than pets must contain the following statement: "This compound feedingstuff contains protein derived from mammalian tissue the feeding of which to ruminants is prohibited". This does not apply to compound feedingstuffs which contain no protein derived from mammalian tissue other than the following: - milk and milk products, - gelatin, - amino acids obtained from hides and skins by a process which involves exposure of the material to a pH of 1 to 2 followed by a pH of > 11, followed by heat treatment at 140 °C for 30 minutes at 3 bar, - dicalcium phosphate derived from defatted bones, and - dried plasma and other blood products. 7.2. Where a Member State prohibits the use of protein derived from mammalian tissue as referred to in 7.1, first sentence, in feedingstuffs for certain animals other than ruminants as permitted by Article 1 (2) of Council Directive 90/667/EEC (*), the statement required in 7.1 must mention in addition the other species or categories of animals to which it has extended the prohibition on the use of the products in question. (*) OJ No L 363, 27. 12. 1990, p. 51.` Article 4 Amendment to Directive 91/357/EEC The Annex to Directive 91/357/EEC is hereby amended as follows: 1. Category 12 'Land animal products` is deleted; 2. in column 1, the numbers '13`, '14`, '15` and '16` are replaced by '12`, '13`, '14` and '15` respectively. Article 5 1. Member States shall bring into force not later than 1 December 1997 the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive. They shall immediately 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 the Member States. 2. 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 6 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. Article 7 This Directive is addressed to the Member States.

31997L0048

1997

Commission Directive 97/48/EC of 29 July 1997 amending for the second time Council Directive 82/711/EEC laying down the basic rules necessary for testing migration of the constituents of 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, Whereas Council Directive 82/711/EEC of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs (2), as amended by Directive 93/8/EEC (3), does not specify the migration tests to be carried out in cases where the fatty food simulants are inappropriate; Whereas the application of the test using the fatty food simulants is time consuming and difficult to conduct and therefore alternative tests in some specified conditions should be permitted; Whereas it is not clear whether Directive 82/711/EEC authorizes the use of plastic materials and articles which are not intended to come into contact with foodstuffs of all types but which are intended to come into contact with more than one single foodstuff or more than one specific group of foodstuffs; whereas this use may be authorized without posing any problem to health provided an appropriate indication informs the consumer or the retailer of the type(s) of foodstuff(s) with which it may or may not come into contact; Whereas the indication of an excessive number of foodstuffs types which could be in contact with some plastic materials and articles may not be easy to understand and therefore these materials and articles should be submitted to all the food simulants or test media provided by this Directive to protect the consumer; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, Article 1 The Annex to Directive 82/711/EEC is replaced by the Annex hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive as from 1 July 1998. 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 that of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31997L0053

1997

Commission Directive 97/53/EC of 11 September 1997 adapting to technical progress Council Directive 79/196/EEC on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres employing certain types of protection (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/117/EEC of 18 December 1975 on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres (1), as last amended by the Act of Accession of Spain and Portugal, Having regard to Council Directive 79/196/EEC of 6 February 1979 on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres employing certain types of protection (2), as last amended by Commission Directive 94/26/EC (3), and in particular Article 5 thereof, Whereas it is necessary to adapt the contents of Annex I to Directive 79/196/EEC to technical progress by incorporating seven new European standards recently drawn up by the European Committee for Electrotechnical Standardization (Cenelec); Whereas, in view of the present state of technical progress, it is now necessary to adapt the contents of the harmonized standards referred to in Annex I to Directive 79/196/EEC; Whereas, in view of the nature of the equipment concerned, a provision should be made for transitional arrangements in order to enable the industry to adapt appropriately to the changes to the standards; Whereas 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 in the Sector of Electrical Equipment for Use in Potentially Explosive Atmospheres, Article 1 Annex I to Directive 79/196/EEC 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 not later than 31 May 1998. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such reference shall be laid down by Member States. 2. Until 30 June 2003 the Member States shall continue to apply the measures provided for in Article 4 of Directive 76/117/EEC as regards the equipment for which conformity to the harmonized standards referred to in amended Directive 79/196/EEC, is attested by the issue of a certificate of conformity in accordance with Article 8 of Directive 76/117/EEC, provided that the certificate has been issued before 30 September 1998. 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.

31997L0057

1997

Council Directive 97/57/EC of 22 September 1997 establishing Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market 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), and in particular Article 18 (1) thereof, Having regard to the proposal from the Commission, Whereas, by the judgment of the Court of Justice of the European Communities of 18 June 1996 (2), Council Directive 94/43/EC (3) of 27 July 1994, establishing Annex VI to Directive 91/414/EEC, was annulled; Whereas Annex VI to Directive 91/414/EEC lays down uniform principles aiming to ensure that the Member States, in deciding on authorizations for plant protection products, apply the requirements of Article 4 (1) (b), (c), (d) and (e) of that Directive in an equivalent manner and at the high level of protection of human and animal health and the environment sought by the Directive; Whereas it is therefore necessary to lay down detailed principles concerning the evaluation of information on plant protection products supplied by applicants and the decision to be made on authorization on the basis of the results of that evaluation; Whereas such principles have to be laid down for each of the different requirements provided for in Article 4 (1) (b), (c), (d) and (e); Whereas, initially, it is possible to lay down at this stage uniform principles for chemical plant protection products only; whereas therefore it remains for the uniform principles for products containing micro-organisms to be laid down in accordance with the same procedure as provided for in Article 18 (1) of Directive 91/414/EEC; whereas such approach is in line with Directive 91/414/EEC, and in particular Article 23 (2) thereof; Whereas in particular for all plant protection products a high level of protection for all groundwater must be satisfied under the conditions of use which will be laid down in the authorization; whereas therefore it must be provided that plant protection products may only be authorized when it is adequately demonstrated that their use in accordance with the conditions to be laid down in the authorization will not lead to concentrations of the active substance or of relevant metabolites, degradation or reaction products in groundwater which exceed the lower of the limit values for groundwater referred to in this Directive; whereas this applies as well for plant protection products containing active substances, already on the market two years after notification of Directive 91/414/EEC, which means that for such products an authorization can be granted only where it is adequately demonstrated that, under the new conditions of use which will be laid down in the authorization, the expected concentrations resulting exclusively from the new use will not exceed the lower of the limit values referred to in this Directive; Whereas the provisions of this Directive concerning the protection of water, including the provisions related to monitoring, are without prejudice to Member States' obligations under the Directives concerned, and in particular Directives 75/440/EEC (4), 80/68/EEC (5) and 80/778/EEC (6); Whereas a review of the abovementioned directives is in progress, and where necessary will have to be followed by an adaptation of this Directive; Whereas a short implementation period is justified given that in the light of the decision of the Court of Justice of the European Communities of 18 June 1996 only those provisions concerning groundwater have been reviewed, Article 1 Annex VI to Directive 91/414/EEC is hereby established 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 not later than 1 October 1997. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. Article 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.

31997L0051

1997

Directive 97/51/EC of the European Parliament and of the Council of 6 October 1997 amending Council Directives 90/387/EEC and 92/44/EEC for the purpose of adaptation to a competitive environment in telecommunications Having regard to the Treaty establishing the European Community, and in particular Article 100a 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 189b of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 28 May 1997, (1) Whereas 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) (ONP) concerns the harmonization of conditions for open and efficient access to and use of public telecommunications networks and, where applicable, services; whereas, in accordance with that Directive, the Council adopted Directive 92/44/EEC of 5 June 1992 on the application of open network provision to leased lines (5); (2) Whereas the Council resolution of 22 July 1993 on the review of the situation in the telecommunications sector and the need for further development in that market (6), combined with the Council resolution of 22 December 1994 on the principles and timetable for the liberalization of telecommunications infrastructures (7), call for the liberalization of telecommunications services and infrastructures by 1 January 1998 (with transitional periods for certain Member States); whereas this is supported by the European Parliament resolution of 20 April 1993 on the Commission's 1992 review of the situation in the telecommunications sector (8), and the European Parliament resolution of 19 May 1995 on the Green Paper on the liberalization of telecommunications infrastructures and cable television networks (Part II) (9); (3) Whereas the Council resolution of 22 July 1993 considered as a major goal for the Community's telecommunications policy the application throughout the Community and, where necessary, the adaptation, in the light of further liberalization, of open network provision principles in respect of the entities covered and of such issues as universal service, interconnection and access charges as well as the consequent questions connected with licensing conditions; whereas the Council resolution of 18 September 1995 on the implementation of the future regulatory framework for telecommunications (10) called on the Commission, in accordance with the timetable set out in the Council resolutions of 22 July 1993 and 22 December 1994, to present to the European Parliament and the Council before 1 January 1996 all legislative provisions intended to establish the European regulatory framework for telecommunications accompanying the full liberalization of this sector, in particular concerning the adaptation of open network provision measures to the future competitive environment; (4) Whereas the European Parliament resolution of 6 May 1994 on the Commission communication accompanied by the proposal for a Council resolution on universal service principles in the telecommunications sector (11) emphasizes the central importance of universal service principles; whereas the Council resolution of 7 February 1994 on universal service principles in the telecommunications sector (12) provides a basic definition of universal service and calls upon the Member States to establish and maintain an appropriate regulatory framework in order to ensure universal service throughout their territories; whereas, as was recognized by the Council in that resolution, the concept of universal service must evolve to keep pace with advances in technology, market development and changes in user demand; whereas universal service in telecommunications will have a role to play in strengthening social and economic cohesion, in particular in remote, peripheral, landlocked and rural areas and islands of the Community; whereas, where justified, the net cost of universal service obligations may be shared by market players in accordance with Community law; (5) Whereas the basic principles concerning access to and the use of public telecommunications networks and services, set out within the open network provision framework, must be adapted to ensure Europe-wide services in a liberalized environment, in order to benefit users and organizations providing public telecommunications networks and/or services; whereas a voluntary approach based on common technical standards and specifications, with consultations undertaken where necessary to satisfy user needs, is appropriate in a liberalized environment; whereas, nevertheless, the provision of universal service and the availability of a minimum set of services must be guaranteed to all users in the Community in accordance with the Community measures applicable; whereas a general framework for interconnection to public telecommunications networks and public telecommunications services is needed in order to provide end-to-end interoperability of services for Community users; (6) Whereas open network provision conditions must not restrict the use of or access to public telecommunications networks or publicly available telecommunications services except on grounds of essential requirements or the exercise of special and exclusive rights retained by Member States in accordance with Community law; (7) Whereas the provisions of this Directive do not prevent a Member State from taking measures justified on grounds set out in Articles 36 and 56 of the Treaty, and in particular on grounds of public security, public policy and public morality; (8) Whereas a modus vivendi (13) between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was concluded on 20 December 1994; (9) Whereas 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, and ensure that the national regulatory authority or authorities of each Member State will play a keyrole in the implementation of the regulatory framework set out in relevant Community legislation; whereas 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 in accordance with Article 222 of the Treaty; whereas the national regulatory authorities should be in possession of all the resources necessary, in terms of staffing, expertise, and financial means, for the performance of their function; (10) Whereas numbering and the more general concepts of addressing and naming play an important role; whereas adherence to a harmonized approach for numbering/addressing and, where applicable, naming will contribute to Europe-wide end-to-end communications for users and the interoperability of services; whereas in addition to numbering it may be appropriate to apply the principles of objectivity, transparency, non-discrimination and proportionality in the allocation of names and addresses; whereas Commission Directive 96/19/EC of 13 March 1996 amending Directive 90/388/EEC with regard to the implementation of full competition in telecommunications markets (14) provides for adequate numbers to be available for all telecommunications services, and for numbers to be allocated in an objective, transparent, non-discriminatory and proportionate manner; (11) Whereas in order to guarantee the provision of leased lines throughout the Community, Member States should ensure that at every point in their territories users have access to a minimum set of leased lines from at least one organization; whereas organizations with obligations to provide leased lines should be designated by Member States; whereas Member States must notify the Commission of the organizations subject to this Directive, the leased line types within the minimum set which they are required to provide, and the geographical area in which this requirement applies; whereas, within a specific geographical area, all the leased line types provided by a notified organization are subject to the general provisions of this Directive; (12) Whereas the market power of an organization depends on a number of factors, including its share of the relevant product or service market in the relevant geographical market, its turnover relative to the size of the market, its ability to influence market conditions, its control of the means of access to end-users, its access to financial resources and its experience in providing products and services in the market; whereas determining which organizations have significant market power should be a function of national regulatory authorities, taking into account the situation on the relevant market; (13) Whereas the concept of leased-lines services will evolve with new technological advances and market demand, allowing users more flexible use of the leased-line bandwidth; (14) Whereas, in order to achieve more efficient communications within the Community, it is important that Member States encourage the provision of an additional harmonized set of higher-order leased lines, taking into account market demand and progress with standardization; (15) Whereas until an effective competitive environment is achieved, there is a need for the regulatory supervision of tariffs for leased lines with a view to ensuring cost orientation and transparency in accordance with the principle of proportionality; whereas it is appropriate to allow the requirements for cost orientation and transparency in specific markets to be set aside where no organization has significant market power or where effective competition ensures that tariffs for leased lines are reasonable; (16) Whereas common technical regulations (CTRs) adopted under Council Directive 91/263/EEC of 29 April 1991 on the approximation of the laws of the Member States concerning telecommunications terminal equipment, including the mutual recognition of their conformity (15), and Council Directive 93/97/EEC of 29 October 1993 supplementing Directive 91/263/EEC in respect of satellite earth station equipment (16) define the conditions for the connection of terminal equipment to leased lines; (17) Whereas certain amendments to existing open network provision measures are appropriate in order to ensure their consistency with new technical developments and with other regulatory measures that will form part of the overall regulatory framework for telecommunications; (18) Whereas all the areas identified in Annex I to Directive 90/387/EEC as possible areas for the application of open network provision conditions have been addressed in analysis reports subject to public consultation, in accordance with the procedure laid down in Article 4 of that Directive; whereas all the priority measures identified in Annex III thereto have been adopted; (19) Whereas in order to enable the Commission to carry out the monitoring task assigned to it by the Treaty, changes in national regulatory authority or authorities and the organizations affected must be swiftly communicated to the Commission; (20) Whereas, in accordance with the principles of subsidiarity and proportionality as stated in Article 3b of the Treaty, the objective of adapting Directives 90/387/EEC and 92/44/EEC to a competitive environment in telecommunications cannot be sufficiently achieved by the Member States and can therefore be better achieved by the Community; (21) Whereas the functioning of Directives 90/387/EEC and 92/44/EEC should be reviewed no later than 31 December 1999; whereas that review should take account of the increasing effectivness of competition in telecommunications markets; (22) Whereas, when bringing forward proposals for any further measures in pursuit of the aims of this Directive, consideration should be given to a single consolidated text incorporating all relevant European Parliament and Council Directives implementing the ONP provisions so as to improve the transparency of Community legislation; (23) Whereas pursuant to Articles 52 and 59 of the Treaty, the regulatory regime in the field of telecommunications should be compatible and consistent with the principles of freedom of establishment and freedom to provide services and should take into account the need to facilitate the introduction of new services as well as the widespread application of technological improvements, Article 1 Amendment of Directive 90/387/EEC Directive 90/387/EEC is hereby amended as follows: 1. Article 1 shall be amended as follows: (a) paragraph 2 shall be replaced by the following: '2. The purpose of the conditions prescribed in paragraph 1 shall be to facilitate the provision of public telecommunications networks and/or public telecommunications services, within and between Member States, and in particular the provision of services by companies, firms or natural persons established in a Member State other than that of the company, firm or natural person for whom the services are intended.`; (b) the following paragraph shall be added: '3. Open network provision conditions shall aim at: - ensuring the availability of a minimum set of services, - securing access and interconnection to public telecommunications networks and public telecommunications services, - encouraging the provision of harmonized telecommunications services to the benefit of users, in particular by identifying and promoting by voluntary means harmonized technical interfaces for open and efficient access and interconnection, and associated standards and/or specifications and - guaranteeing the provision of universal service in telecommunications, taking account of any future evolution, throughout the Community.` 2. Article 2 shall be replaced by the following: 'Article 2 For the purposes of this Directive: 1. 'users` shall mean individuals, including consumers, or organizations using or requesting publicly available telecommunications services; 2. 'telecommunications network` shall mean transmission systems and, where applicable, switching equipment and other resources which permit the conveyance of signals between defined termination points by wire, by radio, by optical or by other electromagnetic means; 'public telecommunications network` shall mean a telecommunications network used, wholly or in part, for the provision of publicly available telecommunications services; 3. 'telecommunications services` shall mean services the provision of which consists wholly or partly in the transmission and routing of signals on telecommunications networks, with the exception of radio and television broadcasting; 4. 'universal service` shall mean a defined minimum set of services 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; 5. 'network termination point` shall mean the physical point at which a user is provided with access to a public telecommunications network. The locations of network termination points shall be defined by the national regulatory authority and shall represent a boundary, for regulatory purposes, of the public telecommunications network; 6. 'essential requirements` shall mean the non-economic reasons in the public interest which may cause a Member State to impose conditions on the establishment and/or operation of telecommunications networks or the provision of telecommunications services. Those reasons shall be the security of network operations, the maintenance of network integrity and, where justified, the interoperability of services, data protection, the protection of the environment and town and country planning objectives as well as the effective use of the frequency spectrum and the avoidance of harmful interference between radio-based telecommunications systems and other space-based or terrestrial technical systems. Data protection may include protection of personal data, the confidentiality of information transmitted or stored and the protection of privacy; 7. 'interconnection` shall mean the physical and logical linking of telecommunications networks used by the same or a different organization in order to allow the users of one organization to communicate with users of the same or another organization or to access services provided by another organizations. Services may be provided by the parties involved or other parties who have access to the network; 8. 'open network provision conditions` shall mean the conditions, harmonized in accordance with this Directive, which govern open and efficient access to public telecommunications networks and, where applicable, public telecommunications services and the efficient use of those networks and services. Without prejudice to their application on a case-by-case basis, open network provision conditions may include harmonized conditions with regard to: - technical interfaces, including the definition and implementation of network termination points, where required, - usage conditions, - tariff principles and - access to frequencies and numbers/addresses/names, where required in accordance with the reference framework of the Annex; 9. "technical specifications", "standards" and "terminal equipment" shall have the same meanings as in Article 1 of Directive 91/263/EEC (*). (*) OJ L 128, 23. 5. 1991, p. 1.`; 3. Article 3 shall be amended as follows: (a) paragraphs 2 and 3 shall be replaced by the following: '2. Open network provision conditions shall not restrict access to public telecommunications networks or public telecommunications services, except on grounds of essential requirements within the framework of Community law. In addition, the conditions generally applicable to the connection of terminal equipment to the network shall apply. 3. Open network provision conditions may not allow for any additional restrictions on the use of the public telecommunications networks and/or public telecommunications services, except those which are compatible with Community law.`; (b) paragraph 4 shall be deleted; (c) paragraph 5 shall be replaced by the following: '5. Without prejudice to the specific Directives adopted in the field of open network provision and in so far as the application of the essential requirements referred to in paragraph 2 may cause Member States to limit access to public telecommunications networks or services, the rules for uniform application of the essential requirements, in particular concerning the interoperability of services and the protection of data, shall be determined, where appropriate, by the Commission, in accordance with the procedure laid down in Article 10.`; 4. Article 4 shall be deleted; 5. Article 5 shall be replaced by the following: 'Article 5 1. References to standards and/or specifications drawn up as a basis for harmonized technical interfaces and/or service features for open network provision shall be published in the Official Journal of the European Communities as suitable for the requirement of open and efficient access, interconnection and interoperability in order to encourage the provision of harmonized telecommunications services to the benefit of users throughout the Community. Where necessary, the Commission may, in consultation with the committee referred to in Article 9, request standards to be drawn up by European standardization bodies. 2. Member States shall encourage the use of the standards and/or specifications to which reference is made in the Official Journal of the European Communities, in accordance with paragraph 1, for the provision of technical interfaces and/or network functions. As long as such standards and/or specifications are not adopted, Member States shall encourage: - standards and/or specifications adopted by European standardization bodies such as the European Telecommunications Standards Institute (ETSI) or the joint European standards institution, the European Committee for Standardization (CEN)/European Committee for Electrotechnical Standardization (Cenelec), or, in the absence of such standards and/or specifications, - international standards or recommendations adopted by the International Telecommunications Union (ITU), the International Organization for Standardization (ISO) or the International Electrotechnical Committee (IEC), or, in the absence of such standards and/or specifications, - national standards and/or specifications. 3. If the implementation of the standards and/or specifications referred to in paragraph 1 appears to be inadequate to ensure the interoperability of transfrontier services in one or more Member States, the implementation of such standards and/or specifications may be made compulsory under the procedure laid down in Article 10, to the extent strictly necessary to ensure such interoperability and to improve freedom of choice for users, subject to Articles 85 and 86 of the Treaty. Before the implementation of the standards and/or specifications is made compulsory in accordance with the first subparagraph, the Commission shall, by publishing a notice to that effect in the Official Journal of the European Communities, invite public comment by all parties concerned. 4. Where a Member State or the Commission considers that the harmonized standards and/or specifications referred to in paragraph 1 do not correspond to the objective of open and efficient access, interconnection and interoperability, in particular the basic principles and the essential requirements referred to in Article 3, it shall be decided whether or not it is necessary to withdraw references to those standards and/or specifications from the Official Journal of the European Communities in accordance with the procedure laid down in Article 10. 5. The Commission shall inform the Member States of any such decision and publish information on the withdrawal of those standards and/or specifications in the Official Journal of the European Communities.`; 6. the following Article shall be inserted: 'Article 5a 1. Where the tasks assigned to the national regulatory authority in Community legislation are undertaken by more than one body, Member States shall ensure that the tasks to be undertaken by each body are made public. 2. In order to guarantee the independence of national regulatory authorities: - national regulatory authorities shall be legally distinct from and functionally independent of all organizations providing telecommunications networks, equipment or services, - Member States that retain ownership or a significant degree of control of organizations providing telecommunications 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 suitable mechanisms exist at national level under which a party affected by a decision of the national regulatory authority has a right of appeal to a body independent of the parties involved. 4. Member States may take steps to ensure that national regulatory authorities are able to obtain from organizations providing telecommunications networks and/or services all the information necessary for them to apply Community legislation.`; 7. Articles 6 and 7 shall be deleted; 8. Article 8 shall be replaced by the following: 'Article 8 The Commission shall examine and report to the European Parliament and to the Council on the functioning of this Directive, on the first occasion no later than 31 December 1999. The report shall be based inter alia on the information supplied by the Member States to the Commission and to the committee referred to in Articles 9 and 10. Where necessary, the report shall examine what provisions of this Directive should be adapted in the light of the developments in the market. Further measures may be proposed in the report in pursuit of the aims of this Directive. The Commission shall also investigate in the report the added value of the setting up of a European Regulatory Authority to carry out those tasks which would prove to be better undertaken at Community level.`; 9. in the second paragraph of Article 9 (1), 'telecommunications organizations` shall be replaced by 'organizations providing public telecommunications networks and/or publicly available telecommunications services.`; 10. Annexes I and III shall be deleted; 11. Annex II shall be replaced by Annex I to this Directive. Article 2 Amendment of Directive 92/44/EEC Directive 92/44/EEC is hereby amended as follows: 1. 'telecommunications organizations` shall be replaced by 'organizations notified in accordance with Article 11 (1) (a)` throughout; 2. the following paragraphs shall be added to Article 1: 'Member States shall ensure that at every point in their territory at least one organization is subject to the provisions of this Directive. Member States shall ensure that obligations arising out of this Directive are not imposed on organizations without significant market power in the relevant leased-lines market, unless there are no organizations with significant market power in the relevant leased-lines market in a given Member State.`; 3. Article 2 shall be replaced by the following: 'Article 2 Definitions 1. The definitions given in Directive 90/387/EEC, as amended by Directive 97/51/EC (*), shall apply, where relevant, to this Directive. 2. In addition, for the purposes of this Directive, - "leased lines" shall mean the telecommunications facilities which provide for transparent transmission capacity between network termination points and which do not include on-demand switching (switching functions which the user can control as part of the leased line provision), - "Open Network Provision Committee" shall mean the committee referred to in Articles 9 and 10 of Directive 90/387/EEC, - "national regulatory authority" shall mean the body referred to in Article 5a of Directive 90/387/EEC. 3. For the purposes of this Directive, an organization shall be presumed to have significant market power when its share of the relevant leased-lines market in a Member State is 25 % or more. The relevant leased-lines market shall be assessed on the basis of the type(s) of leased line offered in a particular geographical area. The geographical area may cover the whole or part of the territory of a Member State. National regulatory authorities may determine that an organization with a market share that is less than 25 % of the relevant leased-lines market has significant market power. They may also determine that an organization with a market share that is 25 % or more of the relevant leased-lines market does not have significant market power. In either case, the determination shall take into account the organization's ability to influence the leased-lines market conditions, its turnover relative to the size of the market, its access to financial resources and its experience in providing products and services in the market. (*) OJ L 295, 29. 10. 1991, p. 23.`; 4. Article 3 shall be amended as follows: (a) the second sentence of paragraph 1 shall be replaced by the following: 'Changes in existing offerings and information on new offerings shall be published as soon as possible. The national regulatory authority may lay down a suitable period of notice.`; (b) paragraph 3 shall be deleted; 5. The first subparagraph of the second indent in Article 4 shall be replaced by the following: '- the typical delivery period, which is the period, counted from the date when the user has made a firm request for a leased line, in which 95 % of all leased lines of the same type have been put through to the customers,`; 6. Article 6 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: '1. Member States shall ensure that when access to and use of leased lines is restricted in accordance with Community law those restrictions are imposed by the national regulatory authorities through regulatory means. No technical restrictions shall be introduced or maintained for the interconnection of leased lines among each other or for the interconnection of leased lines and public telecommunications networks.`; (b) the second subparagraph of paragraph 3 (a) shall be replaced by the following: 'An emergency situation in this context shall mean an exceptional case of force majeure, such as extreme weather, earthquakes, flood, lightning or fire.`; (c) the first subparagraph of paragraph 4 and footnote 1 shall be replaced by the following: 'Access conditions relating to terminal equipment shall be considered to be fulfilled when the terminal equipment complies with the approval conditions laid down for its connection to the network-termination point of the type of leased line concerned in accordance with Directive 91/263/EEC (*) or 93/97/EEC (**). (*) OJ L 128, 23. 5. 1991, p. 1. (**) OJ L 290, 24. 11. 1993, p. 1.`; 7. Article 7 shall be amended as follows: (a) the following paragraph shall be inserted: '2a. Member States shall encourage provision of the additional types of leased lines specified in Annex III, taking into account market demand and progress with standardization`; (b) paragraph 3 shall be replaced by the following: '3. The amendments necessary to adapt Annexes II and III to new technical developments and to changes in market demand, including the possible deletion of certain types of leased lines from the Annexes, shall be adopted by the Commission under the procedure provided for in Article 10 of Directive 90/387/EEC, taking into account the state of development of national networks.`; 8. Article 8 (2) shall be replaced by the following: '2. The national regulatory authority shall ensure that the organizations notified in accordance with Article 11 (1) (a) adhere to the principle of non-discrimination when providing leased lines. Those organizations shall apply similar conditions in similar circumstances to organizations providing similar services, and shall provide leased lines to others under the same conditions and of the same quality as they provide for their own services, or those of their subsidiaries or partners, where applicable.`; 9. Article 9 shall be deleted; 10. Article 10 shall be amended as follows: (a) paragraph 1 (a) shall be replaced by the following: '(a) tariffs for leased lines shall be independent of the type of application which the users of the leased lines implement, without prejudice to the principle of non-discrimination set out in Article 8 (2);` (b) paragraph 2 (b) (iii) shall be replaced by the following: '(iii) when neither direct nor indirect measures of cost allocation can be found, the cost category shall be allocated on the basis of a general allocator computed by using the ratio of all expenses directly assigned or allocated to leased lines, on the one hand, to those allocated to other services, on the other hand;` (c) the following paragraph shall be added: '4. The national regulatory authority shall not apply the requirements of paragraph 1 where an organization does not have significant market power in respect of a specific leased-lines offering in a specific geographical area. The national regulatory authority may decide not to apply the requirements of paragraph 1 in a specific geographical area where it is satisfied that there is effective competition in the relevant leased-lines market as evidenced by tariffs that already comply with those requirements.`; 11. Article 11 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: '1. Member States shall notify the Commission of their national regulatory authority or authorities responsible for carrying out the tasks specified in this Directive. They shall promptly notify the Commission of any changes in their national regulatory authorities.`; (b) the following paragraph shall be inserted: '1a. National regulatory authorities shall notify the Commission of the names of those organizations providing leased lines subject to requirements pursuant to this Directive. That notification shall, where appropriate, include the types of leased lines that each organization is required to provide in each geographical area in order to comply with Article 1 and shall include any cases where, pursuant to Article 10 (4), Article 10 (1) is not applied.`; (c) the second subparagraph of paragraph 2 shall be replaced by the following: 'The national regulatory authority shall keep available and submit to the Commission on request the data on all cases in which access to or use of leased lines has been restricted, as well as details of the measures taken, including the reasons why they were taken.`; 12. Article 14 shall be replaced by the following: 'Article 14 Report The Commission shall examine and report to the European Parliament and to the Council on the functioning of this Directive, on the first occasion no later than 31 December 1999. The report shall be based inter alia on the information supplied by the Member States to the Commission and to the Open Network Provision Committee. The report shall include an assessment of the need for continuation of this Directive, taking account of developments towards a fully competitive environment. Where necessary, the report shall examine what provisions of this Directive should be adapted in the light of the developments in the market, and further measures may be proposed in the report in pursuit of the aims of this Directive.`; 13. Annex I shall be amended as follows: (a) footnote 1 shall be replaced by the following: 'OJ L 109, 26. 4. 1983, p. 8. Directive as last amended by Directive 94/10/EC of the European Parliament and of the Council (OJ L 100, 19. 4. 1994, p. 30).`; (b) in Section D, points 1, 2, 3, 5 and 6 shall be deleted; (c) Section E shall be replaced by the following: 'E. Conditions for the attachment of terminal equipment The information on the attachment conditions must include a complete overview of the requirements with which terminal equipment to be attached to the relevant leased line must comply in accordance with Directive 91/263/EEC or 93/97/EEC.`; 14 Annex II to this Directive shall be added as Annex III. Article 3 Transposition 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 31 December 1997. They shall immediately inform the Commission thereof. When the 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 the Member States. 2. The Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 5 Addressees This Directive is addressed to the Member States.

31997L0061

1997

Council Directive 97/61/EC of 20 October 1997 amending the Annex to Directive 91/492/EEC laying down the health conditions for the production and placing on the market of live bivalve molluscs Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and placing on the market of live bivalve molluscs (1), and in particular Article 11 thereof, Having regard to the proposal from the Commission, Whereas Chapter V of the Annex to Directive 91/492/EEC sets the acceptable limit values for two types of marine toxin that constitute a danger to public health; Whereas there is scientific evidence that a new marine toxin 'Amnesic Shellfish Poisoning` (ASP) that could endanger consumer health has appeared in the areas where bivalve molluscs are produced; Whereas the public health requirements concerning live bivalve molluscs in Chapter V of the Annex to Directive 91/492/EEC must be adjusted to take account of this new marine toxin; Whereas an acceptable limit value must be set for this new marine toxin, in order to protect public health; Whereas experience has shown that the registration document for the identification of the batches of molluscs provided for in point 6 of Chapter II of the Annex to Directive 91/492/EEC should contain information concerning the health status of the area of origin and any purification or relaying operations that have been carried out on the molluscs; Whereas it must be possible to trace the origin of bivalve molluscs placed on the market; whereas to do this it should be possible to link the information shown on the registration document with each batch placed on the market in a register kept by the dispatch centre; Whereas a standard registration document would be more easily understood by operators and inspection services regardless of the language in which it is drawn up; whereas such standard document should be introduced by the Commission, Article 1 The Annex to Directive 91/492/EEC is hereby amended as follows: 1. point 6 of Chapter II shall be replaced by the following: '6. A registration document for the identification of batches of live bivalve molluscs during transport from the production area to a dispatch centre, purification centre, relaying area or processing plant must be issued by the competent authority upon request by the gatherer. For each batch, the gatherer must complete legibly and indelibly the relevant sections of the registration document which must contain the following information: - the gatherer's identity and address, - the date of harvesting, - the location of the production area described in as precise detail as is practicable or by a code number, - the health status of the production area as referred to in Chapter I, - the shellfish species and quantity indicated in as precise detail as is practicable, - the approval number and place of destination for wrapping, relaying, purification or processing. The registration document must be dated and signed by the gatherer. The registration documents must be numbered regularly and in sequence. The competent authority must keep a register indicating numbers of registration documents together with the names of the persons collecting live bivalve molluscs to whom the documents were issued. The registration document for each batch of live bivalve molluscs must be date-stamped upon delivery of a batch to a dispatch centre, purification centre, relaying area or processing plant and must be kept by operators of such centres, areas or plants for at least twelve months. In addition, the gatherer is also obliged to keep it for the same period. However, if gathering is carried out by the same staff operating the dispatch centre, purification centre, relaying area or processing plant of destination, the registration document may be replaced by a permanent transport authorization granted by the competent authority. A standard registration document, containing a reference to the various requirements which are to be included in it and which are mentioned in Chapters II, III and IV of this Annex, will be introduced by the Commission in accordance with the procedure laid down in Article 12 of the Directive.`; 2. point 9 of Chapter III shall be replaced by the following: '9. after harvesting from the relaying area, batches must, during transport from the relaying area to the approved dispatch centre, purification centre or processing plant, be accompanied by a registration document, a specimen of which will be drawn up by the Commission in accordance with the procedure laid down in Article 12 of the Directive, setting out, in addition to the information specified in point 6 of Chapter II of this Annex, inter alia the location and approval number of the relaying area and the duration of relaying, together with any other information needed to identify and trace the product. However, the above shall not be required where the same staff operate both in the relaying area and in the dispatch centre, purification centre or processing plant.`; 3. the second subparagraph of point 13 of section III of Chapter IV shall be replaced by the following: 'Purification centres dispatching batches of live bivalve molluscs to dispatch centres must provide a registration document, a specimen of which will be drawn up by the Commission in accordance with the procedure laid down in Article 12 of the Directive, setting out, in addition to the information specified in point 6 of Chapter II of this Annex, inter alia the approval number and address of the purification plant and the duration of purification, the dates of entering and leaving the purification centre, together with any other information needed to identify and trace the product.`; 4. point 4 of section IV of Chapter IV shall be replaced by the following: '4. Dispatch centres must keep the following at the disposal of the competent authority: - the results of microbiological tests on live bivalve molluscs from an approved production area or relaying area or from a purification plant, - the dates and quantities of live bivalve molluscs delivered to the dispatch centre, together with the corresponding registration documents, - dispatch details including the names and addresses of consignees, the dates and quantities of live bivalve molluscs dispatched, together with the corresponding entry registration document number(s). These data must be classified chronologically and preserved for a period to be laid down by the competent authority, but not less than twelve months.`; 5. The following point shall be inserted in Chapter V: '7a. The total Amnesic Shellfish Poison (ASP) content in the edible parts of molluscs (the entire body or any part edible separately) must not exceed 20 micrograms of domoic acid per gramme using the HPLC method.` Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1998. 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 at the time of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. 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.

31997L0060

1997

Directive 97/60/EC of the European Parliament and of the Council of 27 October 1997 amending for the third time Directive 88/344/EEC on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients Having regard to the Treaty establishing the European Community, and in particular Article 100a 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 189b of the Treaty (3), Whereas the Scientific Committee for Food has reexamined all the extraction solvents listed in Directive 88/344/EEC (4), with a view to replacing the provisional acceptable daily intakes (ADIs) set in 1981 by definitive figures; whereas this has not always been possible because the information needed, although requested from the industry, has not been communicated; whereas, on the basis of the information received, the Scientific Committee for Food has been able to confirm its agreement for the majority of the solvents; whereas the maximum residues of the solvents in certain foodstuffs can be reduced; Whereas some solvents are no longer used and should thus be taken off the list; Whereas as a result of scientific progress other substances have been developed which can be added to the Directive; whereas a new solvent which has received a favourable opinion from the Scientific Committee should be authorized; Whereas this new solvent, namely 1, 1, 1, 2-tetrafluoroethane, is used solely for the extraction of flavourings and whereas residues in foodstuffs do not exceed 0,02 mg/kg; whereas, apart from those residues, the solvent is fully recycled, so that its use under these conditions has no impact on global warming of the atmosphere; Whereas the amendments needed, in the light of technical and scientific progress, amount to measures of a technical nature; whereas to simplify and speed up the procedure, adoption of these measures should be entrusted to the Commission; Whereas a procedure of this kind makes for quicker placing on the market of innovations, which is to the benefit of both industry and the consumer, Article 1 Directive 88/344/EEC is hereby amended as follows: (1) The following paragraph shall be added to Article 4: '(a) The necessary amendments to the Annex in the light of scientific and technical progress in the field of the use of solvents, their conditions of use and maximum residue limits.` Former paragraphs (a), (b) and (c) become paragraphs (b), (c), and (d) respectively. (2) The Annex shall be amended as follows: (a) PART I The substance 'Butyl acetate` shall be deleted. (b) PART II The entry for hexane shall be amended as follows: >TABLE> (c) PART III - The substance 'methyl-propan-1-ol` shall be deleted. - The following substance shall be added: >TABLE> Article 2 1. Member States shall amend their laws, regulations and administrative provisions so as to: - authorize trade in products complying with Directive 88/344/EEC, as amended by this Directive by 27 October 1998 at the latest; - ban trade in products not complying with Directive 88/344/EEC, as amended by this Directive, as from 27 April 1999. However, products placed on the market or labelled before that date and not complying with Directive 88/344/EEC, as amended by this Directive, may be marketed until stocks are used up. They shall forthwith inform the Commission thereof. 2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31997L0064

1997

Commission Directive 97/64/EC of 10 November 1997 adapting to technical progress for the fourth 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 (lamp oils) (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (1), as last amended by Commission Directive 97/16/EC (2), and in particular Article 2a thereof, introduced by Council Directive 89/678/EEC (3), Whereas Council Directive 89/677/EEC (4) amending for the eighth time Directive 76/769/EEC prohibited the use of certain dangerous substances and preparations in ornamental objects, tricks and jokes, and games; Whereas it has since become known that certain of these dangerous substances and preparations in the form of oils classified as presenting an aspiration hazard, notably when coloured, pose a risk to human health and specifically to the health of young children, especially when used in decorative lamps; Whereas the marketing of such coloured oils for use in decorative lamps should be restricted; Whereas the restrictions on the marketing of such coloured oils laid down by this Directive take into account the current state of knowledge and techniques regarding safer alternatives; Whereas 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); Whereas 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 hereto. Article 2 Member States shall adopt and publish the provisions necessary to comply with this Directive by 30 June 1998 at the latest and shall forthwith inform the Commission thereof. They shall apply these provisions as from 31 December 1998. 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 is addressed to the Member States.

31997L0063

1997

Directive 97/63/EC of the European Parliament and of the Council of 24 November 1997 amending Directives 76/116/EEC, 80/876/EEC, 89/284/EEC and 89/530/EEC on the approximation of the laws of the Member States relating to fertilizers Having regard to the Treaty establishing the European Community, and in particular Article 100a 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 189b of the Treaty (3), Whereas Article G of the Treaty on European Union replaced the term 'European Economic Community` by the term 'European Community`; whereas the initials 'EEC` should therefore be replaced by the initials 'EC`; Whereas the term 'EEC fertilizer` is contained in certain provisions of Council Directive 76/116/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to fertilizers (4), Council Directive 80/876/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to straight ammonium nitrate fertilizers of high nitrogen content (5), Council Directive 89/284/EEC of 13 April 1989 supplementing and amending Directive 76/116/EEC in respect of the calcium, magnesium, sodium and sulphur content of fertilizers (6) and Council Directive 89/530/EEC of 18 September 1989 supplementing and amending Directive 76/116/EEC in respect of the trace elements boron, cobalt, copper, iron, manganese, molybdenum and zinc contained in fertilizers (7); whereas, in consequence, the term 'EEC fertilizer` should be replaced in these provisions by the term 'EC fertilizer`; Whereas, however, manufacturers normally keep in stock large quantities of packagings, labels and accompanying documents, thereby exposing themselves to the risk of incurring additional expenditure in the event of such a change being implemented with immediate effect; whereas, therefore, a period should be fixed during which packagings, labels and accompanying documents marked 'EEC fertilizer` can continue to be used, Article 1 1. Directive 76/116/EEC is hereby amended as follows: (a) in Article 1, the term 'EEC fertilizer` shall be replaced by the term 'EC fertilizer`; (b) in Article 2, the term 'EEC fertilizer` shall be replaced by the term 'EC fertilizer`; (c) in Article 7, the term 'EEC fertilizer` shall be replaced by the term 'EC fertilizer`; (d) in Article 8 (1), the term 'EEC fertilizer` shall be replaced by the term 'EC fertilizer`; (e) in Annex II, point 1 (a), the term 'EEC FERTILIZER` shall be replaced by the term 'EC FERTILIZER`. 2. Directive 80/876/EEC is hereby amended as follows: (a) in Article 2, the term 'EEC fertilizer` shall be replaced by the term 'EC fertilizer`; (b) in Article 4, the term 'EEC fertilizer` shall be replaced by the term 'EC fertilizer`; (c) in Article 6, the term 'EEC fertilizer` shall be replaced by the term 'EC fertilizer`; (d) in Article 7 (1), the term 'EEC fertilizer` shall be replaced by the term 'EC fertilizer`; (e) in Article 7 (3), the term 'EEC fertilizer` shall be replaced by the term 'EC fertilizer`. 3. Directive 89/284/EEC is hereby amended as follows: (a) in Article 1, the term 'EEC fertilizers` shall be replaced by the term 'EC fertilizers`; (b) in Article 2, the term 'EEC fertilizers` shall be replaced by the term 'EC fertilizers`; (c) in Article 4, the term 'EEC FERTILIZER` shall be replaced by the term 'EC FERTILIZER`; (d) in Article 6 (a), the term 'EEC FERTILIZER` shall be replaced by the term 'EC FERTILIZER`; (e) in Article 9 (1) and (2), the term 'EEC fertilizer` shall be replaced by the term 'EC fertilizer`. 4. Directive 89/530/EEC is hereby amended as follows: (a) in Article 1 (1), the term 'EEC FERTILIZER` shall be replaced by the term 'EC FERTILIZER`; (b) in Article 1 (2), the term 'EEC FERTILIZER` shall be replaced by the term 'EC FERTILIZER`; (c) in Article 2, the term 'EEC fertilizers` shall be replaced by the term 'EC fertilizers`; (d) in the introductory wording to Article 3 (1), the term 'EEC fertilizers` shall be replaced by the term 'EC fertilizers`; (e) in Article 3 (1) (b), the term 'EEC fertilizers` shall be replaced by the term 'EC fertilizers`; (f) in Article 4 (a), the term 'EEC FERTILIZER` shall be replaced by the term 'EC FERTILIZER`; (g) in the first subparagraph of Article 6, the term 'EEC fertilizers` shall be replaced by the term 'EC fertilizers`; (h) in Chapters C and D of the Annex, the term 'EEC FERTILIZERS` shall be replaced by the term 'EC FERTILIZERS`. Article 2 Packagings, labels and accompanying documents marked 'EEC FERTILIZER` can continue to be used until 31 December 1998. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 1998 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 for making such reference shall be laid down by Member States. 2. Member States shall forthwith communicate to the Commission the text of all provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States accordingly. 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.

31997L0069

1997

Commission Directive 97/69/EC of 5 December 1997 adapting to technical progress for the 23rd 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 Directive 95/56/EC of the European Parliament and the Council (2), and in particular Article 28 thereof, Whereas Annex I to Directive 67/548/EEC contains a list of dangerous substances, together with particulars of the classification and labelling in respect of each substance or group of substances; Whereas laboratory studies have shown that certain man-made vitreous (silicate) fibres have carcinogenic effects; whereas epidemiological surveys have raised concern over the health effects of man-made vitreous (silicate) fibres; Whereas the list of dangerous substances contained in Annex I to that Directive should therefore be adapted and enlarged, particularly to include certain man-made vitreous (silicate) fibres; whereas in consequence it is necessary to amend the Foreword to Annex I so as to include notes and particulars relating to the identification, classification and labelling of man-made vitreous (silicate) fibres; Whereas in the current state of knowledge, it seems justified under certain circumstances to exclude some man-made vitreous (silicate) fibres from classification as a carcinogen; whereas this possibility should be reviewed in the light of scientific and technical developments, in particular in the area of carcinogenicity testing; Whereas the abbreviation 'EEC` appears in certain provisions of Annexes I and VI to Directive 67/548/EEC; Whereas Article G of the Treaty on European Union has replaced the term 'European Economic Community` with the term 'European Community`; whereas the abbreviation 'EEC` should therefore be replaced by the abbreviation 'EC` in the abovementioned provisions; Whereas Directive 96/56/EC has amended Articles 21 and 23 of Directive 67/548/EEC accordingly and allows the placing on the market of dangerous substances whose labels bear an 'EEC number` and the words 'EEC label` until 31 December 2000; Whereas 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) The fifth paragraph of the chapter entitled 'Nomenclature` of the Foreword is replaced by the following text: 'Article 23 (2) (a) requires that for substances appearing in Annex I, the name of the substance to be used on the label should be one of the designations given in the Annex. For certain substances, additional information has been added in square brackets in order to help identify the substance. This additional information need not be included on the label.`; (b) Note A in the Foreword is replaced by the following text: 'Note A: The name of the substance must appear on the label in the form of one of the designations given in Annex I (see Article 23 (2) (a)). In Annex I, use is sometimes made of a general description such as ". . . compounds" or ". . . salts". In this case, the manufacturer or any other person who markets such a substance is required to state on the label the correct name, due account being taken of the chapter "Nomenclature" of the Foreword: Example: for BeCl2: beryllium chloride.`; (c) The following Notes Q and R are added to the Foreword: 'Note Q: The classification as a carcinogen need not apply if it can be shown that the substance fulfils one of the following conditions: - a short-term biopersistence test by inhalation has shown that the fibres longer than 20 ìm have a weighted half life less than 10 days, or - a short-term biopersistence test by intratracheal instillation has shown that the fibres longer than 20 ìm have a weighted half life less than 40 days, or - an appropriate intra-peritoneal test has shown no evidence of excess carcinogenicity, or - absence of relevant pathogenicity or neoplastic changes in a suitable long term inhalation test. 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 6 ìm.`; (d) The entries in the Annex to this Directive are added; (e) All references to 'EEC number` are replaced by 'EC number`. 2. Annex VI is amended as follows: (a) All reference to 'EEC number` are replaced by 'EC number`; (b) All references to 'EEC label` are replaced by 'EC label`. Article 2 During the period of five years after entry into force of this Directive, the Commission shall evaluate scientific developments and adopt measures to delete or amend Note Q. Article 3 1. Not later than 16 December 1998, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. Member States 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. 2. Notwithstanding Article 1, Member States shall permit the placing on the market of substances whose labels bear the words 'EEC number` or the words 'EEC label` until 31 December 2000. Article 4 This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31997L0070

1997

Council Directive 97/70/EC of 11 December 1997 setting up a harmonised safety regime for fishing vessels of 24 metres in length and over Having regard to the Treaty establishing the European Community, and in particular Article 84(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 referred to in Article 189c of the Treaty (3), (1) Whereas Community action in the sector of maritime transport should aim at the improvement of maritime safety; (2) Whereas 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; (3) Whereas the enforcement of this Protocol at Community level for fishing vessels flying the flag of a Member State or operating in the internal waters or territorial sea of a Member State or landing their catch in a port of a Member State will enhance the safety of such fishing vessels as various national legislations do not yet require the safety level established by the Protocol; whereas such a common safety level will, by harmonising the different and varying national safety requirements, ensure that competition will take place on an equal level for fishing vessels operating in the same area without compromising safety standards; (4) Whereas, in view, in particular, of the internal market dimension, action at Community level is the most effective way to establish a common safety level for fishing vessels throughout the Community; (5) Whereas a Council Directive is the appropriate legal instrument as it provides a framework for a uniform and compulsory application of the safety standards by Member States, while leaving to each Member State the choice of form and methods, that best fit its internal system; (6) Whereas several important chapters of the Torremolinos Protocol apply only to fishing vessels of 45 metres in length and over; whereas limiting the application of the Protocol at Community level only to such vessels would create a safety gap between the latter and smaller fishing vessels between 24 and 45 metres in length, and would therefore distort competition; (7) Whereas Article 3(4) of that Protocol states that each Party shall determine which of its regulations for which the length limit is greater than 24 metres should apply, wholly or in part, to a fishing vessel of 24 metres in length or over but less than the prescribed length limit and entitled to fly a flag of that Party; whereas Article 3(5) of that Protocol states that Parties shall endeavour to establish uniform standards for these fishing vessels operating in the same region; (8) Whereas, in order to enhance safety and to avoid distortions of competition, the aim must be pursued of applying the safety rules of this Directive to all fishing vessels of 24 metres in length and over, operating in the fishing zones of the Community, irrespective of the flag they fly; whereas this must be achieved, for fishing vessels flying the flag of third States operating in the internal waters or territorial sea of a Member State or landing their catch in a port of a Member State, in accordance with the general rules of international law; (9) Whereas the relevant provisions of Council Directives adopted under the social policy of the Community must continue to apply; (10) Whereas Member States should, for all those reasons, apply to new and, where required, to existing fishing vessels of 45 metres in length and over the provisions of the Annex to the Torremolinos Protocol, taking account of the relevant provisions listed in Annex I to this Directive; whereas Member States should also apply the provisions of Chapters IV, V, VII and IX of the Annex to the Torremolinos Protocol, as adapted by Annex II to this Directive, to all new vessels of 24 metres in length and over but less than 45 metres flying their flag; (11) Whereas specific requirements, as set out in Annex III, can be justified for reasons relating to specific regional circumstances, such as geographical and climatic conditions; whereas such provisions have been developed for operation in the northern and southern zones, respectively; (12) Whereas, in order to further increase the level of safety, vessels flying the flag of a Member State should comply with the specific requirements set out in Annex IV; (13) Whereas fishing vessels flying the flag of third States should not be allowed to operate in the internal waters or territorial sea of a Member State or to land their catch in a Member State's port, and therefore compete with vessels flying the flag of a Member State, unless their flag State has certified that they comply with the technical provisions laid down in this Directive; (14) Whereas equipment complying with the requirements of Council Directive 96/98/EC of 20 December 1996 on marine equipment (4), when installed on board fishing vessels should be automatically recognised to be in conformity with the specific provisions imposed on such equipment in this Directive, since the requirements of Directive 96/98/EC are at least equivalent to those of the Torremolinos Protocol and this Directive; (15) Whereas Member States could encounter local circumstances which justify the application of specific safety measures to all fishing vessels operating in certain areas; whereas they may also consider it appropriate to adopt exemptions from, or equivalent requirements to, the provisions of the Annex to the Torremolinos Protocol; whereas they should be entitled to adopt such measures subject to control under the Committee procedure; (16) Whereas at present there are no uniform international technical standards for fishing vessels as regards their hull strength, main and auxiliary machinery and electrical and automatic plants; whereas such standards may be fixed according to the rules of recognised organisations or national administrations; (17) Whereas, for the control of the effective implementation and enforcement of this Directive, Member States should carry out surveys and issue a certificate of compliance to fishing vessels which comply with the specific requirements of this Directive; (18) Whereas, in order to ensure full application of this Directive, and in accordance with the procedure established in Article 4 of the Torremolinos Protocol, fishing vessels should be subject to port State control; whereas a Member State may undertake controls also on board fishing vessels of third countries which are not operating in the internal waters or territorial sea of a Member State nor landing their catch in the ports of a Member State, when they are in a port of that Member State, in order to verify that they comply with that Protocol, once it has entered into force; (19) Whereas it is necessary for a committee composed of the representatives of the Member States to assist the Commission in the effective application of this Directive; whereas the committee set up in Article 12 of 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), can take on this task; (20) Whereas, in order to ensure a consistent implementation of this Directive, certain provisions may be adapted through this committee to take account of relevant developments at international level; (21) Whereas the International Maritime Organisation (IMO) should be informed of this Directive in accordance with the Torremolinos Protocol; (22) Whereas, in order to ensure full application of this Directive, Member States should lay down a system of penalties for breaching the national provisions adopted pursuant to this Directive, Article 1 Purpose 1. The purpose of this Directive is to lay down safety standards for seagoing fishing vessels of 24 metres in length and over, both new, and existing, in so far as the Annex to the Torremolinos Protocol applies to the latter, and - flying the flag of a Member State and registered in the Community, or - operating in the internal waters or territorial sea of a Member State, or - landing their catch in the port of a Member State. Recreational craft engaged in non-commercial fishing are excluded from the scope of this Directive. 2. This Directive is without prejudice to the provisions of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (6), its individual Directives and, in particular Council Directive 93/103/EC of 23 November 1993 concerning the minimum health and safety requirements for work on board fishing vessels (13th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (7). Article 2 Definitions For the purpose of this Directive: 1. 'fishing vessel` or 'vessel` means any vessel equipped or used commercially for catching fish or other living resources of the sea; 2. 'new fishing vessel` means a fishing vessel for which: (a) on or after 1 January 1999 the building or major conversion contract is placed; or (b) the building or major conversion contract has been placed before 1 January 1999, and which is delivered three years or more after that date; or (c) in the absence of a building contract, on or after 1 January 1999: - the keel is laid, or - construction identifiable with a specific ship begins, or - assembly has commenced comprising at least 50 tonnes or 1 % of the estimated mass of all structural material, whichever is less; 3. 'existing fishing vessel` means a fishing vessel which is not a new fishing vessel; 4. 'Torremolinos Protocol` means the Torremolinos Protocol relating to the Torremolinos International Convention for the Safety of Fishing Vessels, 1977, together with the amendments thereto; 5. 'Certificate` means the certificate of compliance referred to in Article 6; 6. 'length` means, unless provided otherwise, 96 % of the total length on a waterline at 85 % of the least moulded depth measured from the keel line, or the length from the foreside of the stem to the axis of the rudder stock on that waterline, if that be greater. In vessels designed with rake of keel the waterline on which this length is measured shall be parallel to the designed waterline; 7. 'operating` means catching or catching and processing fish or other living resources of the sea without prejudice to the right of innocent passage in the territorial sea and the freedom of navigation in the 200 mile exclusive economic zone; 8. 'recognised organisation` means an organisation recognised in conformity with Article 4 of Council Directive 94/57/EC of 22 November 1994 on common rules and standards for ship inspection and survey organisations and for the relevant activities of maritime administrations (8). Article 3 General requirements 1. Member States shall ensure that the provisions of the Annex to the Torremolinos Protocol are applied to the fishing vessels concerned flying their flag, unless Annex I to this Directive provides otherwise. Unless provided otherwise in this Directive, existing fishing vessels shall comply with the relevant requirements of the Annex to the Torremolinos Protocol not later than 1 July 1999. 2. Member States shall ensure that those requirements in Chapters IV, V, VII and IX of the Annex to the Torremolinos Protocol which apply to vessels of 45 metres in length and over are also applied to new fishing vessels of 24 metres in length and over, flying their flag, unless Annex II to this Directive provides otherwise. 3. However, Member States shall ensure that vessels flying their flag operating in specific areas shall comply with the provisions for the relevant areas, as defined in Annex III. 4. Member States shall ensure that vessels flying their flag shall comply with the specific safety requirements laid down in Annex IV. 5. Member States shall prohibit fishing vessels flying the flag of a third country from operating in their internal waters or territorial sea or landing their catch in their ports unless they are certified by their flag State administration to comply with the requirements referred to in paragraphs 1, 2, 3 and 4 and in Article 5. 6. Marine equipment listed in Annex A.1 to Directive 96/98/EC and complying with the requirements of the latter, when placed on board a fishing vessel to comply with the provisions of this Directive, shall be automatically considered to be in conformity with such provisions, whether or not these provisions require that the equipment must be approved and subjected to tests to the satisfaction of the administration of the flag State. Article 4 Specific requirements, exemptions and equivalents 1. If a Member State or a group of Member States considers that certain situations due to specific local circumstances or the vessel's particulars require specific safety measures for fishing vessels operating in a certain area, and if the need therefore is demonstrated, they may, subject to the procedure in paragraph 4, adopt such specific safety measures to take account of local circumstances such as the nature and climatic conditions of the waters these vessels operate in, the length of their journeys, or their particulars, such as their construction material. The measures adopted shall be added in Annex III. 2. Member States shall apply the provisions of Regulation 3, paragraph 3 of Chapter 1 of the Annex to the Torremolinos Protocol, for adopting measures containing exemptions, subject to the procedure laid down in paragraph 4 of this Article. 3. Member States may adopt measures allowing equivalents in accordance with Regulation 4, paragraph 1 of Chapter 1 of the Annex to the Torremolinos Protocol, subject to the procedure laid down in paragraph 4 of this Article. 4. A Member State which avails itself of the provisions of paragraphs 1, 2 or 3 shall follow the following procedure: (a) The Member State shall notify the Commission of the measures which it intends to adopt, including particulars to the extent necessary to confirm that the level of safety is adequately maintained. (b) If, within a period of six months from the notification, it is decided, in accordance with the procedure laid down in Article 9, that the proposed measures are not justified, the said Member State may be required to amend or not to adopt the proposed measures. (c) The adopted measures shall be specified in the relevant national legislation and communicated to the Commission, which shall inform the other Member States of all particulars thereof. (d) Any of such measures shall be applied to all fishing vessels when operating under the same specified conditions, without discrimination with regard to their flag or to the nationality of their operator. (e) The measures referred to in paragraph 2 shall only apply as long as the fishing vessel operates under the specified conditions. Article 5 Standards for design, construction and maintenance The standards for the design, construction and maintenance of hull, main and auxiliary machinery, electrical and automatic plants of a fishing vessel shall be the rules in force at the date of its construction, specified for classification by a recognised organisation or used by an administration. For new vessels, these rules shall be in accordance with the procedure and subject to the conditions laid down in Article 14(2) of Directive 94/57/EC. Article 6 Surveys and certificates 1. Member States shall issue to fishing vessels flying their flag and complying with Articles 3 and 5, a certificate of compliance with the terms of this Directive, supplemented by a record of equipment and, where appropriate, exemption certificates. The certificate of compliance, record of equipment and exemption certificate shall have a format as laid down in Annex V. The certificates shall be issued by the administration of the flag State or by a recognised organisation acting on its behalf after an initial survey, carried out by the exclusive surveyors either of the administration of the flag State itself or of a recognised organisation or of the Member State authorised by the flag State to carry out surveys, in accordance with Regulation 6, paragraph (1)(a) of Chapter 1 of the Annex to the Torremolinos Protocol. 2. The periods of validity of the certificates referred to in paragraph 1 shall not exceed those established in Regulation 11 of Chapter 1 of the Annex to the Torremolinos Protocol. Renewal of the certificate of compliance, shall be issued after periodical surveys, in accordance with Regulation 6 of Chapter 1 of the Annex to the Torremolinos Protocol, have been carried out. Article 7 Control provisions 1. Fishing vessels operating in the internal waters or territorial sea of a Member State or landing their catch in its ports and not being fishing vessels flying the flag of that Member State shall be subject to control by the Member State, in accordance with Article 4 of the Torremolinos Protocol and without discrimination with regard to flag or nationality of the operator, in order to verify that they comply with this Directive. 2. Fishing vessels, which are not operating in the internal waters or territorial sea of a Member State nor landing their catch in the ports of a Member State and flying the flag of another Member State, shall be subject to control by the Member State, when in its ports, in accordance with Article 4 of the Torremolinos Protocol and without discrimination with regard to flag or nationality of the operator, in order to verify that they comply with this Directive. 3. Fishing vessels flying the flag of a third State, which are not operating in the internal waters or territorial sea of a Member State nor landing their catch in the ports of a Member State, shall be subject to control by the Member State, when in its ports, in accordance with Article 4 of the Torremolinos Protocol, in order to verify their compliance with the Torremolinos Protocol, once it has entered into force. Article 8 Adaptations In accordance with the procedure laid down in Article 9: (a) provisions may be adopted and incorporated for: - a harmonised interpretation of provisions of the Annex to the Torremolinos Protocol which have been left to the discretion of the administrations of individual contracting parties, as far as necessary to ensure their consistent implementation in the Community, - the implementation of this Directive without broadening its scope. (b) Articles 2, 3, 4, 6 and 7 of this Directive may be adapted and its Annexes may be amended in order to apply, for the purpose of this Directive, subsequent amendments to the Torremolinos Protocol which have entered into force after the adoption of this Directive. Article 9 Committee 1. The Commission shall be assisted by the committee established by Article 12(1) of Directive 93/75/EEC. 2. Where reference is made to this Article, the following procedure shall apply: (a) The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. (b) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. (c) If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of eight weeks from the date of the referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 10 Notification to IMO The Presidency of the Council and the Commission shall inform the IMO of the adoption of this Directive, whereby reference shall be made to Article 3(5) of the Torremolinos Protocol. Article 11 Penalties Member States shall lay down the system of penalties for breaching the 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 for shall be effective, proportionate and dissuasive. 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 1999. 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 immediately communicate to the Commission all provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 13 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 14 Addressees This Directive is addressed to the Member States.

31997L0072

1997

Commission Directive 97/72/EC of 15 December 1997 amending Council Directive 70/524/EEC concerning additives in feedingstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Directive 97/6/EC (2), and in particular Article 7 thereof, Whereas Directive 70/524/EEC stipulates that the contents of its Annexes are to be kept up to date with advances in scientific and technical knowledge; whereas the Annexes were consolidated by Commission Directive 91/248/EEC (3); Whereas for an additive belonging to the group 'Antibiotics`, the details in the column 'Chemical formula, description` should be supplemented; Whereas a new use of an additive belonging to the group 'Coccidiostats and other medicinal substances` and a new use of one belonging to the group 'Binders, anti-caking agents and coagulants` have been widely tested in certain Member States; whereas in the light of the experience gained and research carried out these new uses may be authorized throughout the Community; Whereas the provisions of the Annexes on one additive of the group 'Emulsifiers, stabilizers, thickeners and gelling agents` require adjustment to the Community provisions adopted on this matter as regards foodstuffs; Whereas for two additives of the group 'Emulsifiers, stabilizers, thickeners and gelling agents` and for one of the group 'Preservatives` the entry in the 'Other provisions` column should be altered; Whereas a new use of an additive of the group 'Antibiotics` and of one of the group 'Coccidiostats and other medicinal substances` have been successfully tested in certain Member States; whereas provisional national authorization of these new uses should be permitted pending possible general Community authorization; Whereas the minimum authorized content of an additive of the 'Micro-organisms` group should be altered; Whereas research into various additives in Annex II, use of which can accordingly be authorized nationally, has not yet been completed; whereas for each of these this option should therefore be extended by a set period; Whereas Directive 97/6/EC prohibited use of the glycopeptide antibiotic avoparcin with effect from 1 April 1997 on the grounds that it could not be ruled out that its use in animal feed was liable to induce resistance to glycopeptides used in human medicine; Whereas another glycopeptide, ardacin, was given provisional authorization by Commission Directive 94/77/EC of 20 December 1994 amending Council Directive 70/524/EEC concerning additives in feedingstuffs (4); whereas although this additive is not at present marketed, as a precautionary measure and in line with the Scientific Committee's recommendations, in the absence of results from the research still to be carried out on avoparcin, its authorization should not be prolonged; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 The Annexes to Directive 70/524/EEC are hereby amended as set out in the Annex to this Directive. Article 2 1. Member States shall bring into force, immediately informing the Commission thereof, the laws, regulations and administrative provisions needed to comply with the Annex to this Directive by 31 March 1998. These provisions shall contain a reference to this Directive or be accompanied by such a reference on official publication. Details of the reference shall be set by the Member State. 2. Member States shall send the Commission the text of primary provisions of national law adopted on the matters regulated 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.

31997L0067

1997

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 Having regard to the Treaty establishing the European Community, and in particular Articles 57 (2), 66 and 100a 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), Having regard to the resolution of the European Parliament of 22 January 1993 concerning the green paper on the development of the single market for postal services (4), Having regard to the Council resolution of 7 February 1994 on the development of Community postal services (5), Acting in accordance with the procedure laid down in Article 189b of the Treaty, in the light of the joint text approved by the Conciliation Committee on 7 November 1997 (6), (1) Whereas measures should be adopted with the aim of establishing the internal market in accordance with Article 7a of the Treaty; whereas this market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; (2) Whereas the establishment of the internal market in the postal sector is of proven importance for the economic and social cohesion of the Community, in that postal services are an essential instrument of communication and trade; (3) Whereas on 11 June 1992 the Commission presented a Green Paper on the development of the single market for postal services and, on 2 June 1993, a Communication on the guidelines for the development of Community postal services; (4) Whereas the Commission has conducted wide-ranging public consultation on those aspects of postal services that are of interest to the Community and the interested parties in the postal sector have communicated their observations to the Commission; (5) Whereas the current extent of the universal postal service and the conditions governing its provision vary significantly from one Member State to another; whereas, in particular, performance in terms of quality of services is very unequal amongst Member States; (6) Whereas cross-border postal links do not always meet the expectations of users and European citizens, and performance, in terms of quality of service with regard to Community cross-border postal services, is at the moment unsatisfactory; (7) Whereas the disparities observed in the postal sector have considerable implications for those sectors of activity which rely especially on postal services and effectively impede the progress towards internal Community cohesion, in that the regions deprived of postal services of sufficiently high quality find themselves at a disadvantage as regards both their letter service and the distribution of goods; (8) Whereas measures seeking to ensure the gradual and controlled liberalisation of the market and to secure a proper balance in the application thereof are necessary in order to guarantee, throughout the Community, and subject to the obligations and rights of the universal service providers, the free provision of services in the postal sector itself; (9) Whereas action at Community level to ensure greater harmonisation of the conditions governing the postal sector is therefore necessary and steps must consequently be taken to establish common rules; (10) Whereas, in accordance with the principle of subsidiarity, a set of general principles should be adopted at Community level, whilst the choice of the exact procedures should be a matter for the Member States, which should be free to choose the system best adapted to their own circumstances; (11) Whereas it is essential to guarantee at Community level a universal postal service encompassing a minimum range of services of specified quality to be provided in all Member States at an affordable price for the benefit of all users, irrespective of their geographical location in the Community; (12) Whereas the aim of the universal services is to offer all users easy access to the postal network through the provision, in particular, of a sufficient number of access points and by ensuring satisfactory conditions with regard to the frequency of collections and deliveries; whereas the provision of the universal service must meet the fundamental need to ensure continuity of operation, whilst at the same time remaining adaptable to the needs of users as well as guaranteeing them fair and non-discriminatory treatment; (13) Whereas universal service must cover national services as well as cross-border services; (14) Whereas users of the universal service must be given adequate information on the range of services offered, the conditions governing their supply and use, the quality of the services provided, and the tariffs; (15) Whereas the provisions of this Directive relating to universal service provision are without prejudice to the right of universal service operators to negotiate contracts with customers individually; (16) Whereas the maintenance of a range of those services that may be reserved, in compliance with the rules of the Treaty and without prejudice to the application of the rules on competition, appears justified on the grounds of ensuring the operation of the universal service under financially balanced conditions; whereas the process of liberalisation should not curtail the continuing supply of certain free services for blind and partially sighted persons introduced by the Member States; (17) Whereas items of correspondence weighing 350 grammes and over represent less than 2 % of letter volume and less than 3 % of the receipts of the public operators; whereas the criteria of price (five times the basic tariff) will better permit the distinction between the reserved service and the express service, which is liberalised; (18) Whereas, in view of the fact that the essential difference between express mail and universal postal services lies in the value added (whatever form it takes) provided by express services and perceived by customers, the most effective way of determining the extra value perceived is to consider the extra price that customers are prepared to pay, without prejudice, however, to the price limit of the reserved area which must be respected; (19) Whereas it is reasonable to allow, on an interim basis, for direct mail and cross-border mail to continue to be capable of reservation within the price and weight limits provided; whereas, as a further step towards the completion of the internal market of postal services, a decision on the further gradual controlled liberalisation of the postal market, in particular with a view to the liberalisation of cross-border and direct mail as well as on a further review of the price and weight limits, should be taken by the European Parliament and the Council not later than 1 January 2000, on a proposal from the Commission following a review of the sector; (20) Whereas, for reasons of public order and public security, Member States may have a legitimate interest in conferring on one or more entities designated by them the right to site on the public highway letter-boxes intended for the reception of postal items; whereas, for the same reasons, they are entitled to appoint the entity or entities responsible for issuing postage stamps identifying the country of origin and those responsible for providing the registered mail service used in the course of judicial or administrative procedures in accordance with their national legislation; whereas they may also indicate membership of the European Union by integrating the 12-star symbol; (21) Whereas new services (services quite distinct from conventional services) and document exchange do not form part of the universal service and consequently there is no justification for their being reserved to the universal service providers; whereas this applies equally to self-provision (provision of postal services by the natural or legal person who is the originator of the mail, or collection and routing of these items by a third party acting solely on behalf of that person), which does not fall within the category of services; (22) Whereas Member States should be able to regulate, by appropriate authorization procedures, on their territory, the provision of postal services which are not reserved to the universal service providers; whereas those procedures must be transparent, non-discriminatory, proportionate and based on objective criteria; (23) Whereas the Member States should have the option of making the grant of licences subject to universal service obligations or contributions to a compensation fund intended to compensate the universal service provider for the provision of services representing an unfair financial burden; whereas Member States should be able to include in the authorisations an obligation that the authorised activities must not infringe the exclusive or special rights granted to the universal service providers for the reserved services; whereas an identification system for direct mail may be introduced for the purposes of supervision where direct mail is liberalised; (24) Whereas measures necessary for the harmonisation of authorisation procedures laid down by the Member States governing the commercial provision to the public of non-reserved services will have to be adopted; (25) Whereas, should this prove necessary, measures shall be adopted to ensure the transparency and non-discriminatory nature of conditions governing access to the public postal network in Member States; (26) Whereas, in order to ensure sound management of the universal service and to avoid distortions of competition, the tariffs applied to the universal service should be objective, transparent, non-discriminatory and geared to costs; (27) Whereas the remuneration for the provision of the intra-Community cross-border mail service, without prejudice to the minimum set of obligations derived from Universal Postal Union acts, should be geared to cover the costs of delivery incurred by the universal service provider in the country of destination; whereas this remuneration should also provide an incentive to improve or maintain the quality of the cross-border service through the use of quality-of-service targets; whereas this would justify suitable systems providing for an appropriate coverage of costs and related specifically to the quality of service achieved; (28) Whereas separate accounts for the different reserved services and non-reserved services are necessary in order to introduce transparency into the actual costs of the various services and in order to ensure that cross-subsidies from the reserved sector to the non-reserved sector do not adversely affect the competitive conditions in the latter; (29) Whereas, in order to ensure the application of the principles set out in the previous three recitals, universal service providers should implement, within a reasonable time limit, cost accounting systems, which can be independently verified, by which costs can be allocated to services as accurately as possible on the basis of transparent procedures; whereas such requirements can be fulfilled, for example, by implementation of the principle of fully distributed costing; whereas such cost accounting systems may not be required in circumstances where genuine conditions of open competition exist; (30) Whereas consideration should be given to the interests of users, who are entitled to services of a high quality; whereas, therefore, every effort must be made to improve and enhance the quality of services provided at Community level; whereas such improvements in quality require Member States to lay down standards, to be attained or surpassed by the universal service providers, in respect of the services forming part of the universal service; (31) Whereas the quality of service expected by users constitutes an essential aspect of the services provided; whereas the evaluation standards for this quality of service and the levels of quality achieved must be published in the interests of users; whereas it is necessary to have available harmonised quality-of-service standards and a common methodology for measurement in order to be able to evaluate the convergence of the quality of service throughout the Community; (32) Whereas national quality standards consistent with Community standards must be determined by Member States; whereas, in the case of intra-Community cross-border services requiring the combined efforts of at least two universal service providers from two different Member States, quality standards must be defined at Community level; (33) Whereas compliance with these standards must be independently verified at regular intervals and on a harmonised basis; whereas users must have the right to be informed of the results of this verification and Member States should ensure that corrective action is taken where those results demonstrate that the standards are not being met; (34) Whereas Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (7) applies to postal operators; (35) Whereas the need for improvement of quality of service means that disputes have to be settled quickly and efficiently; whereas, in addition to the forms of legal redress available under national and Community law, a procedure dealing with complaints should be provided, which should be transparent, simple and inexpensive and should enable all relevant parties to participate; (36) Whereas progress in the interconnection of postal networks and the interests of users require that technical standardisation be encouraged; whereas technical standardisation is indispensable for the promotion of interoperability between national networks and for an efficient Community universal service; (37) Whereas guidelines on European harmonisation provide for specialised technical standardisation activities to be entrusted to the European Committee for Standardisation; (38) Whereas a committee should be established to assist the Commission with the implementation of this Directive, particularly in relation to the future work on the development of measures relating to the quality of Community cross-border service and technical standardisation; (39) Whereas, in order to ensure the proper functioning of the universal service and to ensure undistorted competition in the non-reserved sector, it is important to separate the functions of the regulator, on the one hand, and the operator, on the other; whereas no postal operator may be both judge and interested party; whereas it is for the Member State to define the statute of one or more national regulatory authorities, which may be chosen from public authorities or independent entities appointed for that purpose; (40) Whereas the effects of the harmonised conditions on the functioning of the internal market in postal services will need to be the subject of an assessment; whereas, therefore, the Commission will present a report to the European Parliament and the Council on the application of this Directive, including the appropriate information on developments in the sector, particularly concerning economic, social, employment and technological aspects, as well as on quality of service, three years following the date of its entry into force, and in any event no later than 31 December 2000; (41) Whereas this Directive does not affect the application of the rules of the Treaty, and in particular its rules on competition and the freedom to provide services; (42) Whereas nothing shall prevent Member States from maintaining in force or introducing measures for the postal sector which are more liberal than those provided for by this Directive, nor, should this Directive lapse, from maintaining in force measures which they have introduced in order to implement it, provided in each case that such measures are compatible with the Treaty; (43) Whereas it is appropriate that this Directive should apply until 31 December 2004 unless otherwise decided by the European Parliament and the Council on the basis of a proposal from the Commission; (44) Whereas this Directive does not apply to any activity which falls outside the scope of Community law, such as those provided for 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; (45) Whereas this Directive does not, in the case of undertakings which are not established in the Community, prevent the adoption of measures in accordance with both Community law and existing international obligations designed to ensure that nationals of the Member States enjoy similar treatment in third countries; whereas Community undertakings should benefit in third countries from treatment and effective access that is comparable to the treatment and access to the market which is conferred on nationals of the countries concerned within the Community context, CHAPTER 1 Objective and scope Article 1 This Directive establishes common rules concerning: - the provision of a universal postal service within the Community, - the criteria defining the services which may be reserved for universal service providers and the conditions governing the provision of non-reserved services, - tariff principles and transparency of accounts for universal service provision, - the setting of quality standards for universal service provision and the setting-up of a system to ensure compliance with those standards, - the harmonisation of technical standards, - the creation of independent national regulatory authorities. Article 2 For the purposes of this Directive, the following definitions shall apply: 1. postal services: services involving the clearance, sorting, transport and delivery of postal items; 2. public postal network: the system of organisation and resources of all kinds used by the universal service provider(s) for the purposes in particular of: - the clearance of postal items covered by a universal service obligation from access points throughout the territory, - the routing and handling of those items from the postal network access point to the distribution centre, - distribution to the addresses shown on items; 3. access points: physical facilities, including letter boxes provided for the public either on the public highway or at the premises of the universal service provider, where postal items may be deposited with the public postal network by customers; 4. clearance: the operation of collecting postal items deposited at access points; 5. distribution: the process from sorting at the distribution centre to delivery of postal items to their addressees; 6. postal item: an item addressed in the final form in which it is to be carried by the universal service provider. In addition to items of correspondence, such items also include for instance books, catalogues, newspapers, periodicals and postal packages containing merchandise with or without commercial value; 7. item of correspondence: a communication in written form on any kind of physical medium to be conveyed and delivered at the address indicated by the sender on the item itself or on its wrapping. Books, catalogues, newspapers and periodicals shall not be regarded as items of correspondence; 8. direct mail: a communication consisting solely of advertising, marketing or publicity material and comprising an identical message, except for the addressee's name, address and identifying number as well as other modifications which do not alter the nature of the message, which is sent to a significant number of addressees, to be conveyed and delivered at the address indicated by the sender on the item itself or on its wrapping. The national regulatory authority shall interpret the term 'significant number of addressees` within each Member State and shall publish an appropriate definition. Bills, invoices, financial statements and other non-identical messages shall not be regarded as direct mail. A communication combining direct mail with other items within the same wrapping shall not be regarded as direct mail. Direct mail shall include cross-border as well as domestic direct mail; 9. registered item: a service providing a flat-rate guarantee against risks of loss, theft or damage and supplying the sender, where appropriate upon request, with proof of the handing in of the postal item and/or of its delivery to the addressee; 10. insured item: a service insuring the postal item up to the value declared by the sender in the event of loss, theft or damage; 11. cross-border mail: mail from or to another Member State or from or to a third country; 12. document exchange: provision of means, including the supply of ad hoc premises as well as transportation by a third party, allowing self-delivery by mutual exchange of postal items between users subscribing to this service; 13. universal service provider: the public or private entity providing a universal postal service or parts thereof within a Member State, the identity of which has been notified to the Commission in accordance with Article 4; 14. authorisations: means any permission setting out rights and obligations specific to the postal sector and allowing undertakings to provide postal services and, where applicable, to establish and/or operate postal networks for the provision of such services, in the form of a 'general authorisation` or 'individual licence` as defined below: - 'general authorisation` means an authorisation, regardless of whether it is regulated by a 'class licence` or under general law and regardless of whether such regulation requires registration or declaration procedures, which does not require the undertaking concerned to obtain an explicit decision by the national regulatory authority before exercising the rights stemming from the authorisation, - 'individual licence` means an authorisation which is granted by a national regulatory authority and which gives an undertaking specific rights, or which subjects that undertaking's operations to specific obligations supplementing the general authorisation where applicable, where the undertaking is not entitled to exercise the rights concerned until it has received the decision by the national regulatory authority; 15. terminal dues: the remuneration of universal service providers for the distribution of incoming cross-border mail comprising postal items from another Member State or from a third country; 16. sender: a natural or legal person responsible for originating postal items; 17. users: any natural or legal person benefiting from universal service provision as a sender or an addressee; 18. national regulatory authority: the body or bodies, in each Member State, to which the Member State entrusts, inter alia, the regulatory functions falling within the scope of this Directive; 19. essential requirements: general non-economic reasons which can induce a Member State to impose conditions on the supply of postal services. These reasons are the confidentiality of correspondence, security of the network as regards the transport of dangerous goods and, where justified, data protection, environmental protection and regional planning. Data protection may include personal data protection, the confidentiality of information transmitted or stored and protection of privacy. CHAPTER 2 Universal service Article 3 1. Member States shall ensure that users enjoy the right to a universal service involving the permanent provision of a postal service of specified quality at all points in their territory at affordable prices for all users. 2. To this end, Member States shall take steps to ensure that the density of the points of contact and of the access points takes account of the needs of users. 3. They shall take steps to ensure that the universal service provider(s) guarantee(s) every working day and not less than five days a week, save in circumstances or geographical conditions deemed exceptional by the national regulatory authorities, as a miminum: - one clearance, - one delivery to the home or premises of every natural or legal person or, by way of derogation, under conditions at the discretion of the national regulatory authority, one delivery to appropriate installations. Any exception or derogation granted by a national regulatory authority in accordance with this paragraph must be communicated to the Commission and to all national regulatory authorities. 4. Each Member State shall adopt the measures necessary to ensure that the universal service includes the following minimum facilities: - the clearance, sorting, transport and distribution of postal items up to two kilograms, - the clearance, sorting, transport and distribution of postal packages up to 10 kilograms, - services for registered items and insured items. 5. The national regulatory authorities may increase the weight limit of universal service coverage for postal packages to any weight not exceeding 20 kilograms and may lay down special arrangements for the door-to-door delivery of such packages. Notwithstanding the weight limit of universal service coverage for postal packages established by a given Member State, Member States shall ensure that postal packages received from other Member States and weighing up to 20 kilograms are delivered within their territories. 6. The minimum and maximum dimensions for the postal items in question shall be those laid down in the Convention and the Agreement concerning Postal Parcels adopted by the Universal Postal Union. 7. The universal service as defined in this Article shall cover both national and cross-border services. Article 4 Each Member State shall ensure that the provision of the universal service is guaranteed and shall notify the Commission of the steps it has taken to fulfil this obligation and, in particular, the identity of its universal service provider(s). Each Member State shall determine in accordance with Community law the obligations and rights assigned to the universal service provider(s) and shall publish them. Article 5 1. Each Member State shall take steps to ensure that universal service provision meets the following requirements: - it shall offer a service guaranteeing compliance with the essential requirements, - it shall offer an identical service to users under comparable conditions, - it shall be made available without any form of discrimination whatsoever, especially without discrimination arising from political, religious or ideological considerations, - it shall not be interrupted or stopped except in cases of force majeure, - it shall evolve in response to the technical, economic and social environment and to the needs of users. 2. The provisions of paragraph 1 shall not preclude measures which the Member States take in accordance with requirements relating to public interest recognized by the Treaty, in particular Articles 36 and 56 thereof, concerning, inter alia, public morality, public security, including criminal investigations, and public policy. Article 6 Member States shall take steps to ensure that users are regularly given sufficiently detailed and up-to-date information by the universal service provider(s) regarding the particular features of the universal services offered, with special reference to the general conditions of access to these services as well as to prices and quality standard levels. This information shall be published in an appropriate manner. Member States shall notify the Commission, within 12 months of the date of entry into force of this Directive, how the information to be published in accordance with the first subparagraph is being made available. Any subsequent modifications shall be notified to the Commission at the earliest opportunity. CHAPTER 3 Harmonization of the services which may be reserved Article 7 1. To the extent necessary to ensure the maintenance of universal service, the services which may be reserved by each Member State for the universal service provider(s) shall be the clearance, sorting, transport and delivery of items of domestic correspondence, whether by accelerated delivery or not, the price of which is less than five times the public tariff for an item of correspondence in the first weight step of the fastest standard category where such category exists, provided that they weigh less than 350 grams. In the case of the free postal service for blind and partially sighted persons, exceptions to the weight and price restrictions may be permitted. 2. To the extent necessary to ensure the maintenance of universal service, cross-border mail and direct mail may continue to be reserved within the price and weight limits laid down in paragraph 1. 3. As a further step towards the completion of the internal market of postal services, the European Parliament and the Council shall decide not later than 1 January 2000 and without prejudice to the competence of the Commission, on the further gradual and controlled liberalisation of the postal market, in particular with a view to the liberalisation of cross-border and direct mail, as well as on a further review of the price and weight limits, with effect from 1 January 2003, taking into account the developments, in particular economic, social and technological developments, that have occurred by that date, and also taking into account the financial equilibrium of the universal service provider(s), with a view to further pursuing the goals of this Directive. Such decisions shall be based upon a proposal from the Commission to be tabled before the end of 1998, following a review of the sector. Upon request by the Commission, Member States shall provide all the information necessary for completion of the review. 4. Document exchange may not be reserved. Article 8 The provisions of Article 7 shall be without prejudice to Member States' right to organise the siting of letter boxes on the public highway, the issue of postage stamps and the registered mail service used in the course of judicial or administrative procedures in accordance with their national legislation. CHAPTER 4 Conditions governing the provision of non-reserved services and access to the network Article 9 1. For non-reserved services which are outside the scope of the universal service as defined in Article 3, Member States may introduce general authorisations to the extent necessary in order to guarantee compliance with the essential requirements. 2. For non-reserved services which are within the scope of the universal service as defined in Article 3, Member States may introduce authorisation procedures, including individual licences, to the extent necessary in order to guarantee compliance with the essential requirements and to safeguard the universal service. The granting of authorisations may: - where appropriate, be made subject to universal service obligations, - if necessary, impose requirements concerning the quality, availability and performance of the relevant services, - be made subject to the obligation not to infringe the exclusive or special rights granted to the universal service provider(s) for the reserved postal services under Article 7(1) and (2). 3. The procedures described in paragraphs 1 and 2 shall be transparent, non-discriminatory, proportionate and based on objective criteria. Member States must ensure that the reasons for refusing an authorisation in whole or in part are communicated to the applicant and must establish an appeal procedure. 4. In order to ensure that the universal service is safeguarded, where a Member State determines that the universal service obligations, as provided for by this Directive, represent an unfair financial burden for the universal service provider, it may establish a compensation fund administered for this purpose by a body independent of the beneficiary or beneficiaries. In this case, it may make the granting of authorisation subject to an obligation to make a financial contribution to that fund. The Member State must ensure that the principles of transparency, non-discrimination and proportionality are respected in establishing the compensation fund and when fixing the level of the financial contributions. Only those services set out in Article 3 may be financed in this way. 5. Member States may provide for an identification system for direct mail, allowing the supervision of such services where they are liberalised. Article 10 1. The European Parliament and the Council, acting on a proposal from the Commission and on the basis of Articles 57(2), 66 and 100a of the Treaty, shall adopt the measures necessary for the harmonisation of the procedures referred to in Article 9 governing the commercial provision to the public of non-reserved postal services. 2. The harmonisation measures referred to in paragraph 1 shall concern, in particular, the criteria to be observed and the procedures to be followed by the postal operator, the manner of publication of those criteria and procedures, as well as the appeal procedures to be followed. Article 11 The European Parliament and the Council, acting on a proposal from the Commission and on the basis of Articles 57(2), 66 and 100a of the Treaty, shall adopt such harmonisation measures as are necessary to ensure that users and the universal service provider(s) have access to the public postal network under conditions which are transparent and non-discriminatory. CHAPTER 5 Tariff principles and transparency of accounts Article 12 Member States shall take steps to ensure that the tariffs for each of the services forming part of the provision of the universal service comply with the following principles: - prices must be affordable and must be such that all users have access to the services provided, - prices must be geared to costs; Member States may decide that a uniform tariff should be applied throughout their national territory, - the application of a uniform tariff does not exclude the right of the universal service provider(s) to conclude individual agreements on prices with customers, - tariffs must be transparent and non-discriminatory. Article 13 1. In order to ensure the cross-border provision of the universal service, Member States shall encourage their universal service providers to arrange that in their agreements on terminal dues for intra-Community cross-border mail, the following principles are respected: - terminal dues shall be fixed in relation to the costs of processing and delivering incoming cross-border mail, - levels of remuneration shall be related to the quality of service achieved, - terminal dues shall be transparent and non-discriminatory. 2. The implementation of these principles may include transitional arrangements designed to avoid undue disruption on postal markets or unfavourable implications for economic operators provided there is agreement between the operators of origin and receipt; such arrangements shall, however, be restricted to the minimum required to achieve these objectives. Article 14 1. Member States shall take the measures necessary to ensure, within two years of the date of entry into force of this Directive, that the accounting of the universal service providers is conducted in accordance with the provisions of this Article. 2. The universal service providers shall keep separate accounts within their internal accounting systems at least for each of the services within the reserved sector on the one hand and for the non-reserved services on the other. The accounts for the non-reserved services should clearly distinguish between services which are part of the universal service and services which are not. Such internal accounting systems shall operate on the basis of consistently applied and objectively justifiable cost accounting principles. 3. The accounting systems referred to in paragraph 2 shall, without prejudice to paragraph 4, allocate costs to each of the reserved and to the non-reserved services respectively in the following manner: (a) costs which can be directly assigned to a particular service shall be so assigned; (b) common costs, that is costs which cannot be directly assigned to a particular service, shall be allocated as follows: (i) whenever possible, common costs shall be allocated on the basis of direct analysis of the origin of the costs themselves; (ii) when direct analysis is not possible, common cost categories shall be allocated on the basis of an indirect linkage to another cost category or group of cost categories for which a direct assignment or allocation is possible; the indirect linkage shall be based on comparable cost structures; (iii) when neither direct nor indirect measures of cost allocation can be found, the cost category shall be allocated on the basis of a general allocator computed by using the ratio of all expenses directly or indirectly assigned or allocated, on the one hand, to each of the reserved services and, on the other hand, to the other services. 4. Other cost accounting systems may be applied only if they are compatible with paragraph 2 and have been approved by the national regulatory authority. The Commission shall be informed prior to their application. 5. National regulatory authorities shall ensure that compliance with one of the cost accounting systems described in paragraphs 3 or 4 is verified by a competent body which is independent of the universal service provider. Member States shall ensure that a statement concerning compliance is published periodically. 6. The national regulatory authority shall keep available, to an adequate level of detail, information on the cost accounting systems applied by a universal service provider, and shall submit such information to the Commission on request. 7. On request, detailed accounting information arising from these systems shall be made available in confidence to the national regulatory authority and to the Commission. 8. Where a given Member State has not reserved any of the services reservable under Article 7 and as not established a compensation fund for universal service provision, as permitted under Article 9(4), and where the national regulatory authority is satisfied that none of the designated universal service providers in that Member State is in receipt of State subvention, hidden or otherwise, the national regulatory authority may decide not to apply the requirements of paragraphs 2, 3, 4, 5, 6 and 7 of this Article. The national regulatory authority shall inform the Commission of all such decisions. Article 15 The financial accounts of all universal service providers shall be drawn up, submitted to audit by an independent auditor and published in accordance with the relevant Community and national legislation to commercial undertakings. CHAPTER 6 Quality of services Article 16 Member States shall ensure that quality-of-service standards are set and published in relation to universal service in order to guarantee a postal service of good quality. Quality standards shall focus, in particular, on routing times and on the regularity and reliability of services. These standards shall be set by: - the Member States in the case of national services, - the European Parliament and the Council in the case of intra-Community cross-border services (see Annex). Future adjustment of these standards to technical progress or market developments shall be made in accordance with the procedure laid down in Article 21. Independent performance monitoring shall be carried out at least once a year by external bodies having no links with the universal service providers under standardised conditions to be specified in accordance with the procedure laid down in Article 21 and shall be the subject of reports published at least once a year. Article 17 Member States shall day down quality standards for national mail and shall ensure that they are compatible with those laid down for intra-Community cross-border services. Member States shall notify their quality standards for national services to the Commission, who will publish them in the same manner as the standards for intra-Community cross-border services referred to in Article 18. National regulatory authorities shall ensure that independent performance monitoring is carried out in accordance with the fourth subparagraph of Article 16, that the results are justified, and that corrective action is taken where necessary. Article 18 1. In accordance with Article 16, quality standards for intra-Community cross-border services are laid down in the Annex. 2. Where exceptional situations relating to infrastructure or geography so require, the national regulatory authorities may determine exemptions from the quality standards provided for in the Annex. Where national regulatory authorities determine exemptions in this manner, they shall notify the Commission forthwith. The Commission shall submit an annual report of the notifications received during the previous 12 months to the Committee established under Article 21 for its information. 3. The Commission shall publish in the Official Journal of the European Communities any adjustments made to the quality standards for intra-Community cross-border services and shall take steps to ensure the regular independent monitoring and the publication of performance levels certifying compliance with these standards and the progress accomplished. National regulatory authorities shall ensure that corrective action is taken where necessary. Article 19 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. Member States shall adopt measures to ensure that those procedures enable disputes to be settled fairly and promptly with provision, where warranted, for a system of reimbursement and/or compensation. Without prejudice to other possibilities of appeal under national and Community legislation, Member States shall ensure that users, acting individually or, where permitted by national law, jointly with organisations representing the interests of users and/or consumers, may bring before the competent national authority cases where users' complaints to the universal service provider have not been satisfactory resolved. In accordance with Article 16, Member States shall ensure that the universal service providers publish, together with the annual report on the monitoring of their performance, information on the number of complaints and the manner in which they have been dealt with. CHAPTER 7 Harmonisation of technical standards Article 20 The harmonisation of technical standards shall be continued, taking into account in particular the interests of users. The European Committee for Standardisation shall be entrusted with drawing up technical standards applicable in the postal sector on the basis of remits to it pursuant to the principles set out in Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (8). This work shall take account of the harmonisation measures adopted at international level and in particular those decided upon within the Universal Postal Union. The standards applicable shall be published in the Official Journal of the European Communities once a year. Member States shall ensure that universal service providers refer to the standards published in the Official Journal where necessary in the interests of users and in particular when they supply the information referred to in Article 6. The Committee provided for in Article 21 shall be kept informed of the discussions within the European Committee for Standardisation and the progress achieved in this area by that body. CHAPTER 8 The committee Article 21 The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by a representative of the Commission. The committee shall establish its own rules of procedure. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, upon the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. CHAPTER 9 The national regulatory authority Article 22 Each Member State shall designate one or more national regulatory authorities for the postal sector that are legally separate from and operationally independent of the postal operators. Member States shall inform the Commission which national regulatory authorities they have designated to carry out the tasks arising from this Directive. The national regulatory authorities shall have as a particular task ensuring compliance with the obligations arising from this Directive. They may also be charged with ensuring compliance with competition rules in the postal sector. CHAPTER 10 Final provisions Article 23 Without prejudice to Article 7(3), three years after the date of entry into force of this Directive, and in any event no later than 31 December 2000, 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. Article 24 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 12 months after the date of its entry into force. 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. Article 25 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 26 1. This Directive shall not prevent any Member State from maintaining or introducing measures which are more liberal than those provided for by this Directive. Such measures must be compatible with the Treaty. 2. Should this Directive lapse, the measures taken by the Member States to implement it may be maintained, to the extent that they are compatible with the Treaty. Article 27 The provisions of this Directive, with the exception of Article 26, shall apply until 31 December 2004 unless otherwise decided in accordance with Article 7(3). Article 28 This Directive is addressed to the Member States.

31997L0073

1997

Commission Directive 97/73/EC of 15 December 1997 including an active substance (imazalil) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), as last amended by Directive 97/57/EC (2), and in particular Article 6 (1) and the fourth subparagraph of Article 8 (2) thereof, Whereas Commission Regulation (EEC) No 3600/92 (3), as last amended by Regulation (EC) No 1199/97 (4), has laid down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8 (2) of Directive 91/414/EEC (hereinafter referred to as 'the Directive`); whereas, pursuant to that Regulation, Commission Regulation (EC) No 933/94 (5), as last amended by Regulation (EC) No 2230/95 (6), laid down the list of active substances of plant protection products to be assessed, with a view to their possible inclusion in Annex I to the Directive; Whereas those active substances should be included in that Annex when it may be expected that there will not be any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment; Whereas such inclusion should be made for a period not exceeding 10 years; Whereas the Directive, at Article 8 (2), provides that after inclusion of an active substance in Annex I to the Directive, Member States shall, within a prescribed period, grant, vary or withdraw, as appropriate, the authorizations of the plant protection products containing the active substance; whereas, in particular, Articles 4 (1) and 13 (1) of the Directive require that plant protection products are not authorized unless account is taken of the conditions associated with the inclusion of the active substance in Annex I and the uniform principles laid down in Annex VI on the basis of a dossier satisfying the data requirements laid down in Article 13; Whereas for imazalil the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92, for a number of uses proposed by the notifiers; whereas Belgium, acting on behalf of Luxembourg as designated rapporteur Member State pursuant to Regulation (EC) No 933/94, has submitted to the Commission on 15 July 1996 the relevant assessment report; Whereas the submitted report has been reviewed by the Member States and the Commission within the Standing Committee on Plant Health; whereas this review has been finalized on 11 July 1997 in the format of the Commission review report for imazalil, in accordance with the provisions of Article 7 (6) of Regulation (EEC) No 3600/92; whereas it may be necessary to update this report from time to time to take into account technical and scientific developments; whereas in such case the conditions for the inclusion of imazalil in Annex I to Directive 91/414/EEC will also need to be amended pursuant to Article 6 (1) of that Directive; Whereas it has appeared from the assessments made that plant protection products containing the active substance concerned may be expected to satisfy in general the requirements laid down in Article 5 (1) (a) and (b) of the Directive, in particular with regard to the uses which were examined; whereas therefore it is necessary to include the active substance concerned in Annex I, in order to ensure that, in all Member States, the granting, varying or withdrawing, as appropriate, of the authorizations of plant protection products containing the active substance concerned can be organized in accordance with the provisions of the Directive, and to ensure that this activity is not further delayed; Whereas before inclusion a reasonable deadline is necessary to permit Member States and the interested parties to prepare themselves to the new requirements which will result from the inclusion; whereas moreover after inclusion a reasonable period is necessary for the Member States to implement the Directive and in particular to vary or withdraw, as appropriate, existing authorizations or grant new authorizations in accordance with the provisions of Directive 91/414/EEC; whereas a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product in accordance with the uniform principles laid down in Annex VI to the Directive; whereas, however, for plant protection products containing several active substances, the complete evaluation on the basis of the uniform principles can only be carried out when all the active substances concerned have been included in Annex I to the Directive; Whereas the periods laid down for implementation of this Directive do not prejudice the periods which will be established for the inclusion of other active substances in Annex I to the Directive; Whereas 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 these principles refer to the evaluation of the Annex II data which were submitted for the purpose of the inclusion of the active substance in Annex I to the Directive; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Imazalil is hereby designated as an active substance in Annex I to Directive 91/414/EEC, 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, not later than 30 June 1999 (7); in particular they shall, in accordance with the provisions of Directive 91/414/EEC, where necessary, vary or withdraw existing authorizations for plant protection products containing imazalil as active substance within such period. 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 subparagraph is extended: - for plant protection products containing only imazalil, and not intended for outdoor foliar uses, to four years from the entry into force of this Directive, - for plant protection products containing imazalil and other active substances not yet included in Annex I, and not intended for outdoor foliar uses, to four years from the entry into force of such Directive as shall include the last of those substances in Annex I. 2. When Member States adopt the provisions referred to in paragraph 1, 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 1 January 1999 (8). Article 4 This Directive is addressed to the Member States.

31997L0076

1997

Council Directive 97/76/EC of 16 December 1997 amending Directive 77/99/EEC and Directive 72/462/EEC with regard to the rules applicable to minced meat, meat preparations and certain other products of animal origin Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the Economic and Social Committee (2), Whereas Council Directive 77/99/EEC of 21 December 1976 on health problems affecting the production and marketing of meat products and certain other products of animal origin (3), updated by Directive 92/5/EEC (4) provides for the possibility of using meat as referred to in Article 2 of Directive 88/657/EEC in the preparation of meat products; Whereas Directive 88/657/EEC has been repealed with effect from 1 January 1996 and replaced by Council Directive 94/65/EC of 14 December 1994 laying down the requirements for the production and placing on the market of minced meat and meat preparations (5); whereas, in order to ensure legal certainty, references to Directive 88/657/EEC should be amended accordingly; Whereas those provisions which, because of their temporary nature, are now out of date should be deleted from Directive 77/99/EEC; Whereas, furthermore, given the special production conditions for stomachs, bladders and intestines, arrangements other than those previously laid down by Directive 77/99/EEC should be applied to them; whereas a reasonable time limit should be laid down for the Member States to comply with these new arrangements both with regard to their national production and their imports from third countries, Article 1 Directive 77/99/EEC is hereby amended as follows: 1. In the fifth indent of Article 2(a)(ii) and 2(d), the reference to Directive 88/657/EEC shall be replaced by a reference to Directive 94/65/EC. 2. In Article 3: (a) the second indent of point A.1 shall read '- in accordance with Article 9(1) . . .`; (b) the following subparagraph shall be added to point A.1: 'or, which have been registered and inspected in accordance with Article 9(2)`; (c) point A.9 shall be amended as follows: - paragraph (a) shall be deleted, - the words '(b) from 1 July 1993` shall be deleted, - point (i) shall become point (a) and point (ii) shall become point (b). 3. Article 9(2) shall be amended as follows: '2. Member States may extend the derogation provided for in paragraph 1 to the establishments referred to in Article 4, section A, point (a)(i), and sections C, D and E of Directive 64/433/EEC, on the understanding that the processing of products in those establishments must meet the other requirements of this Directive`. 4. In Article 13(1)(c), the words 'until 1 July 1993, the health certificate provided for in Annex D` shall be deleted. 5. In the final subparagraph of Article 13(1), the reference to Directive 88/657/EEC shall be replaced by a reference to Directive 94/65/EC. 6. Article 21 shall be deleted. 7. In the first and second indents of point 2 of Chapter III of Annex B, the reference to Directive 88/657/EEC shall be replaced by a reference to Directive 94/65/EC. 8. The fifth indent of point 4 of Chapter V of Annex B shall be worded as follows: '- Where the legislation of a Member State authorises the use of starch or of proteins of animal or vegetable origin for other than technological purposes, a reference to such use in connection with the sales description`. 9. Chapter III of Annex C shall be replaced by the text appearing in the Annex to this Directive. Article 2 In Article 21b of Directive 72/462/EEC (6), the date '31 December 1997` in the second subparagraph shall be replaced by '31 December 1998`. Article 3 On the basis of a Commission report, accompanied by any relevant proposals on which the Council will decide by a qualified majority, the Council shall, before 31 December 2001, re-examine the provisions laid down in the Annex, with a view to re-examining the conditions governing the establishments from which the intestines originally came. Article 4 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1999. They shall immediately inform the Commission thereof. When the measures referred to in the first paragraph are adopted by the Member States, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall forward to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 5 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 6 This Directive is addressed to the Member States.

31997L0068

1997

Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery Having regard to the Treaty establishing the European Community, and in particular Article 100a 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 189b of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 11 November 1997, (1) Whereas the Community programme of policy and action in relation to the environment and sustainable development (4) recognizes as a fundamental principle that all persons should be effectively protected against recognized health risks from air pollution and that this necessitates in particular the control of emissions of nitrogen dioxide (NO2), particulates (PT) - black smoke, and other pollutants such as carbon monoxide (CO); whereas with regard to the prevention of tropospheric ozone (O3) formation and its associated health and environmental impact, the emissions of the precursors nitrogenoxides (NOx) and hydrocarbons (HC) must be reduced; whereas the environmental damage caused by acidification will also require reductions inter alia on the emission of NOx and HC; (2) Whereas the Community signed the UN/ECE protocol on volatile organic compound (VOC) reduction in April 1992 and adhered to the protocol on NOx reduction in December 1993, both of which are related to the 1979 Convention on Long-range Transboundary Air Pollution which was approved in July 1982; (3) Whereas the objective of reducing the level of pollutant emissions from non-road mobile machinery engines and the establishment and operation of the internal market for engines and machinery cannot be sufficiently achieved by individual Member States, and can therefore be better achieved by the approximation of the laws of the Member States relating to measures against air pollution by engines to be installed in non-road mobile machinery; (4) Whereas recent investigations undertaken by the Commission show that the emissions from non-road mobile machinery engines constitute a significant proportion of the total man-made emissions of certain noxious atmospheric pollutants; whereas the category of compression ignition engines which will be regulated by this Directive is responsible for a considerable share of air pollution by NOx and PT, in particular when it is compared with that coming from the road transport sector; (5) Whereas emissions from non-road mobile machinery operating on the ground equipped with compression ignition engines, and in particular the emissions of NOx and PT, constitute a primary cause of concern in this area; whereas these sources should be regulated in the first instance; whereas, however, it will also be appropriate subsequently to extend the scope of this Directive to include the control of emissions from other non-road mobile machinery engines, including transportable generating sets, based on appropriate test cycles, and in particular from gasoline engines; whereas a considerable reduction of the CO and HC emissions may be achievable with the envisaged enlargement of the scope of this Directive to include gasoline engines; (6) Whereas emissions control legislation on agricultural and forestry tractor engines, ensuring a level of environmental protection equivalent to the level established pursuant to this Directive, with standards and requirements fully consistent with it, should be introduced as soon as possible; (7) Whereas, in respect of certification procedures, that type-approval approach has been taken which, as a European method, has stood the test of time for approvals of road vehicles and their components; whereas, as a new element, the approval of a parent engine on behalf of a group of engines (engine family) built using similar components according to similar construction principles, has been introduced; (8) Whereas the engines produced in compliance with the requirements of this Directive will have to be accordingly marked and notified to the approval authorities; whereas, in order to keep administrative burdens low, no direct control by the authority of the engine production dates relevant for strengthened requirements has been foreseen; whereas this freedom for the manufacturers requires them to facilitate the preparation of spot checks by the authority and to make available relevant production planning information at regular intervals; whereas absolute compliance with notification made in accordance with this procedure is not obligatory but a high degree of compliance would facilitate the approval authorities' planning of assessments and contribute to a relationship of increased trust between manufacturers and type-approval authorities; (9) Whereas approvals granted in accordance with Directive 88/77/EEC (5) and with UN/ECE Regulation 49 Series 02, as listed in Annex IV, Appendix II to Directive 92/53/EEC (6) are recognized as equivalent to those required by this Directive in its first stage; (10) Whereas engines which are in compliance with the requirements of this Directive and covered by its scope must be permitted to be placed on the market in the Member States; whereas these engines must not be subject to any other national emission requirement; whereas the Member State granting approvals will take the necessary control measures; (11) Whereas, in laying down the new test procedures and limit values, it is necessary to take into account the specific usage patterns of these types of engines; (12) Whereas it is appropriate to introduce these new standards according to the proven principle of a two-stage approach; (13) Whereas, for engines with higher power output, the achievement of substantial emission reduction seems to be easier, as existing technology that has been developed for engines of road vehicles can be used; whereas, taking this into account a staggered implementation of the requirements has been foreseen, beginning with the highest of three powerbands for stage I; whereas this principle has been retained for stage II with the exception of a new fourth powerband not covered by stage I; (14) Whereas for this sector of non-road mobile machinery applications, which is now regulated and is the most important one besides agricultural tractors if compared with emissions coming from road transport, a considerable reduction of emissions can be expected by the implementation of this Directive; whereas due to, in general, very good performance of diesel engines with respect to CO and HC emissions, the margin for improvement in respect of the total amount emitted is very small; (15) Whereas, in order to make provision for the case of exceptional technical or economic circumstances, procedures have been integrated which could exempt manufacturers from the obligations arising from this Directive; (16) Whereas, in order to ensure 'conformity of production`(COP) once an approval is granted for an engine, manufacturers will be required to provide corresponding arrangements; whereas provisions have been made for the case of discovered non-conformity which lay down information procedures, corrective actions and a cooperation procedure which will allow the settling of possible differences of opinion between Member States in respect of conformity of certified engines; (17) Whereas the entitlement of Member States to lay down requirements ensuring that workers are protected when using non-road mobile machinery shall not be affected by this Directive; (18) Whereas the technical provisions in certain Annexes to this Directive should be supplemented and, as necessary, adapted to technical progress according to a committee procedure; (19) Whereas provisions should be laid down to ensure testing of the engines in compliance with the rules of good laboratory practice; (20) Whereas there is a need to promote global trade in this sector by harmonizing, as far as possible, emission standards in the Community with those applied or planned in third countries; (21) Whereas it is therefore necessary to envisage the possibility of reconsidering the situation on the basis of the availability and the economic feasibility of new technologies and taking account of progress achieved in the implementation of the second stage; (22) Whereas an agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was reached on 20 December 1994 (7), Article 1 Objectives This Directive aims at approximating the laws of the Member States relating to emission standards and type-approval procedures for engines to be installed in non-road mobile machinery. It will contribute to the smooth functioning of the internal market, while protecting human health and the environment. Article 2 Definitions For the purposes of this Directive: - non-road mobile machinery shall mean any mobile machine, transportable industrial equipment or vehicle with or without body work, not intended for the use of passenger- or goods-transport on the road, in which an internal combustion engine as specified in Annex I section 1 is installed, - type-approval shall mean the procedure whereby a Member State certifies that an internal combustion engine type or engine family with regard to the level of emission of gaseous and particulate pollutants by the engine(s), satisfies the relevant technical requirements of this Directive, - engine type shall mean a category of engines which do not differ in such essential engine characteristics as specified in Annex II, Appendix 1, - engine family shall mean a manufacturer's grouping of engines which, through their design, are expected to have similar exhaust emission characteristics and which comply with the requirements of this Directive, - parent engine shall mean an engine selected from an engine family in such a way that it complies with the requirements set out in sections 6 and 7 of Annex I, - engine power output shall mean net power as specified in section 2.4 of Annex I, - engine production date shall mean the date when the engine passes the final check after it has left the production line. At this stage the engine is ready to be delivered or to be put on stock, - placing on the market small mean the action of making available on the Community market, for payment or free of charge, a product covered by this Directive, with a view to distribution and/or use in the Community, - manufacturer shall mean the person or body who is 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 engine, - approval authority shall mean a Member State's competent authority or authorities responsible for all aspects of type-approval of an engine or of an engine family, for issuing and withdrawing approval certificates, for serving as the contact point with the approval authorities of the other Member States, and for verifying the manufacturer's conformity of production arrangements, - technical service shall mean the organization(s) or body(ies) that has(have) 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, - information document shall mean the document set out in Annex II that prescribes the information to be supplied by an applicant, - information folder shall mean the total folder or file of data, drawings, photographs, etc. supplied by the applicant to the technical service or the approval authority as prescribed in the information document, - information package shall mean the information folder plus any test reports or other documents that the technical service or the approval authority have added to the information folder in the course of carrying out their functions, - index to the information package shall mean the document in which the contents of the information package, suitably numbered or otherwise marked to clearly identify all pages, are listed. Article 3 Application for type-approval 1. Application for engine or engine family type-approval shall be submitted by the manufacturer to the approval authority of a Member State. An application shall be accompanied by an information folder, the contents of which are given in the information document in Annex II. An engine conforming to the engine type characteristics described in Annex II, Appendix 1, shall be submitted to the technical service responsible for conducting the approval tests. 2. In the case of an application for type-approval of an engine family, if the approval authority determines that, with regard to the selected parent engine, the submitted application does not fully represent the engine family described in Annex II, Appendix 2, an alternative and, if necessary, an additional parent engine which is determined by the approval authority shall be provided for approval according to paragraph 1. 3. No application in respect of one engine type or engine family may be submitted to more than one Member State. A separate application shall be submitted for each engine type or engine family to be approved. Article 4 Type-approval procedure 1. The Member State receiving the application shall grant type-approval to all engine types or engine families which conform to the particulars in the information folder and which meet the requirements of this Directive. 2. The Member State shall complete all applicable sections of the type-approval certificate, the model being given in Annex VI, for each engine type or engine family which it approves and shall compile or verify the contents of the index to the information package. Type-approval certificates shall be numbered in accordance with the method described in Annex VII. The completed type-approval certificate and its attachments shall be delivered to the applicant. 3. Where the engine to be approved fulfils its function or offers a specific feature only in conjunction with other parts of the non-road mobile machinery, and for this reason compliance with one or more requirements can be verified only when the engine to be approved operates in conjunction with other machinery parts, whether real or simulated, the scope of the type-approval of the engine(s) must be restricted accordingly. The type-approval certificate for an engine type or engine family shall then include any restrictions on its use and shall indicate any conditions for fitting it. 4. The approval authority of each Member State shall: (a) send monthly to the approval authorities of the other Member States a list (containing the particulars shown in Annex VIII) of the engine and engine family type-approvals it has granted, refused to grant or withdrawn during that month; (b) on receiving a request from the approval authority of another Member State, send forthwith: - a copy of the engine or engine family type-approval certificate with/without information package for each engine type or engine family which it has approved or refused to approve or withdrawn, and/or - the list of engines produced according to type-approvals granted, as described in Article 6(3), containing the particulars shown in Annex IX, and/or - a copy of the declaration described in Article 6(4). 5. The approval authority of each Member State shall yearly, or in addition on receiving a corresponding application, send the Commission a copy of the data sheet as shown in Annex X related to the engines approved since the last notification was made. Article 5 Amendments to approvals 1. The Member State which has granted type-approval must take the necessary measures to ensure that it is informed of any change in the particulars appearing in the information package. 2. The application for the amendment or extension of a type-approval shall be submitted exclusively to the approval authority of the Member State which granted the original type-approval. 3. If particulars appearing in the information package have changed, the approval authority of the Member State in question shall: - issue revised page(s) of the information package as necessary, marking each revised page to show clearly the nature of the change and the date of re-issue. Wherever revised pages are issued the index to the information package (which is attached to the type-approval certificate) shall also be amended to show the latest dates of revised pages, and - issue a revised type-approval certificate (denoted by an extension number) if any information on it (excluding its attachments) has changed or if the standards of this Directive have changed since the date currently on the approval. The revised certificate shall show clearly the reason for revision and the date of re-issue. If the approval authority of the Member State in question finds that an amendment to an information package warrants fresh tests or checks, it shall inform the manufacturer thereof and issue the documents mentioned above only after the conduct of successful fresh tests or checks. Article 6 Conformity 1. The manufacturer shall affix to each unit manufactured in conformity with the approved type the markings as defined in section 3 of Annex I, including the type-approval number. 2. Where the type-approval certificate, in accordance with Article 4(3), includes restrictions on use, the manufacturer shall deliver with each unit manufactured, detailed information on these restrictions and shall indicate any conditions for fitting it. Where a series of engine types is delivered to one single manufacturer of machinery, it is sufficient that he will be provided with only one such information document, at the latest on the delivery date of the first engine, which additionally lists the relevant engine identification numbers. 3. The manufacturer shall send on demand to the approval authority which granted the type-approval, within 45 days after the end of each calendar year, and without delay after each application date when the requirements of this Directive change, and immediately following each additional date the authority may stipulate, a list which contains the range of identification numbers for each engine type produced in accordance with the requirements of this Directive since the last reporting was made, or since the requirements of this Directive were first applicable. Where not clarified by the engine coding system, this list must specify correlations of the identification numbers to the corresponding engine types or engine families and to the type-approval numbers. Additionally, this list must contain particular information if the manufacturer ceases to produce an approved engine type or engine family. Where this list is not required to be regularly sent to the approval authority, the manufacturer must maintain these records for a minimum period of 20 years. 4. The manufacturer shall send to the approval authority which granted the type-approval, within 45 days after the end of each calendar year and at each application date referred to in Article 9, a declaration specifying the engine types and engine families together with the relevant engine identification codes for those engines he intends to produce from this date on. Article 7 Acceptance of equivalent approvals 1. The European Parliament and the Council, acting on a proposal from the Commission, may acknowledge the equivalence between the conditions and provisions for type-approval of engines established by this Directive and the procedures established by international regulations or regulations of third countries, in the framework of multilateral or bilateral agreements between the Community and third countries. 2. Type-approvals according to Directive 88/77/EEC which are in compliance with stages A or B, provided for in Article 2 and section 6.2.1 of Annex I to Directive 91/542/EEC (8), and, where applicable, the pertaining approval marks shall be accepted for stage I provided for in Article 9(2) of this Directive. This validity shall be terminated with effect from the mandatory implementation of stage II provided for in Article 9(3) of this Directive. Article 8 Registration and placing on the market 1. Member States may not refuse registration, where applicable, or placing on the market of new engines, whether or not already installed in machinery, which meet the requirements of this Directive. 2. Member States shall only permit registration, where applicable, or placing on the market of new engines, whether or not already installed in machinery, which meet the requirements of this Directive. 3. The approval authority of a Member State granting a type-approval shall take the necessary measures in relation to that approval to register and control, if need be in cooperation with the approval authorities of the other Member States, the identification numbers of those engines produced in conformity with the requirements of this Directive. 4. An additional control of the identification numbers may take place in conjunction with the control of conformity of production as described in Article 11. 5. With regard to the control of the identification numbers, the manufacturer or his agents established in the Community shall without delay give, on request, to the responsible approval authority all the information needed related to his/their purchasers together with the identification numbers of the engines reported as produced in accordance with Article 6(3). Where engines are sold to a manufacturer of machinery, further information is not required. 6. If, at the request of the approval authority, the manufacturer is not able to verify the requirements as specified in Article 6 particularly in conjunction with paragraph 5 of this Article, the approval granted in respect of the corresponding engine type or family pursuant to this Directive may be withdrawn. The information procedure shall then be carried out as described in Article 12(4). Article 9 Timetable 1. GRANT OF TYPE-APPROVALS After 30 June 1998, Member States may not refuse to grant type-approval for an engine type or engine family or to issue the document as described in Annex VI, and may not impose any other type-approval requirements with regard to air-polluting emissions for non-road mobile machinery in which an engine is installed, if the engine meets the requirements specified in this Directive as regards the emissions of gaseous and particulate pollutants. 2. TYPE-APPROVALS STAGE I (ENGINE CATEGORIES A/B/C) Member States shall refuse to grant type-approval for an engine type or engine family and to issue the document as described in Annex VI, and shall refuse to grant any other type-approval for non-road mobile machinery in which an engine is installed: after 30 June 1998 for engines of a power output: >TABLE> if the engine fails to meet the requirements specified in this Directive and where the emissions of gaseous and particulate pollutants from the engine do not comply with the limit values as set out in the table in section 4.2.1 of Annex I. 3. TYPE-APPROVALS STAGE II (ENGINE CATEGORIES: D, E, F, G) Member States shall refuse to grant type-approval for an engine type or engine family and to issue the document as described in Annex VI, and shall refuse to grant any other type-approval for non-road mobile machinery in which an engine is installed: >TABLE> if the engine fails to meet the requirements specified in this Directive and where the emissions of gaseous and particulate pollutants from the engine do not comply with the limit values as set out in the table in section 4.2.3. of Annex I. 4. REGISTRATION AND PLACING ON THE MARKET: ENGINE PRODUCTION DATES After the dates referred to hereafter, with the exception of machinery and engines intended for export to third countries, Member States shall permit the registration, where applicable, and placing on the market of new engines, whether or not already installed in machinery, only if they meet the requirements of this Directive, and only if the engine is approved in compliance with one of the categories as defined in paragraphs 2 and 3. >TABLE> Nevertheless, for each category, Member States may postpone each date mentioned in the above requirement for two years in respect of engines with a production date prior to the said date. The permission granted for stage I-engines shall be terminated with effect from the mandatory implementation of stage II. Article 10 Exemptions and alternative procedures 1. The requirements of Article 8(1) and (2) and of Article 9(4) do not apply to: - engines for use by the armed services, - engines exempted in accordance with paragraph 2. 2. Each Member State may, at the request of the manufacturer, exempt end-of-series engines which are still in stock, or stocks of non-road mobile machinery in respect of their engines, from the time limit(s) for placing on the market set out in Article 9(4) in accordance with the following conditions: - the manufacturer must submit an application to the approval authorities of that Member State which approved the corresponding engine type(s) or engine family(ies) before the entry into force of the time limit(s), - the application of the manufacturer must include a list as defined in Article 6(3) of those new engines which are not placed on the market within the time limit(s); in the case of engines covered by this Directive for the first time, he must submit his application to the type-approval authority of that Member State where the engines are stored, - the request must specify the technical and/or economic reasons on which it is based, - the engines must conform to a type or family for which the type-approval is no longer valid, or which did not need a type-approval before, but which have been produced according to the time limit(s), - the engines must have been physically stored within the Community within the time limit(s), - the maximum number of new engines of one or more types placed on the market in each Member State by the application of this exemption must not exceed 10 % of the new engines of all types concerned placed on the market in that Member State during the previous year, - if the request is accepted by the Member State, the latter must, within one month, send the approval authorities of the other Member States particulars of, and reasons for, the exemptions granted to the manufacturer, - the Member State granting exemptions according to this Article shall be responsible for ensuring that the manufacturer complies with all corresponding obligations, - the approval authority shall release for each engine in question a certificate of conformity on which a special entry has been made. If applicable a consolidated document that contains all engine identification numbers in question may be used, - Member States shall each year send the Commission a list of exemptions granted specifying the reasons. This option shall be limited to a period of 12 months as from the date on which the engines for the first time were subject to the time limit(s) for placing on the market. Article 11 Conformity of production arrangements 1. The Member State granting a type-approval shall take the necessary measures to verify, with regard to the specifications laid down in section 5 of Annex I, if need be in cooperation with the approval authorities of the other Member States, that adequate arrangements have been made to ensure effective control of the conformity of production before it grants type-approval. 2. The Member State which has granted a type-approval shall take the necessary measures to verify, with regard to the specifications laid down in section 5 of Annex I, if need be in cooperation with the approval authorities of the other Member States, that the arrangements referred to in paragraph 1 continue to be adequate and that each production engine bearing a type-approval number pursuant to this Directive continues to conform to the description as given in the approval certificate and its Annexes for the approved engine type or family. Article 12 Non-conformity with the approved type or family 1. There shall be failure to conform to the approved type or family where deviations from the particulars in the type-approval certificate and/or the information package are found to exist and where these deviations have not been authorized, pursuant to Article 5(3), by the Member State which granted the type-approval. 2. If a Member State which has granted type-approval finds that engines accompanied by a certificate of conformity or bearing an approval mark do not conform to the type or family it has approved, it shall take the necessary measures to ensure that the engines in production again conform to the approved type or family. The approval authorities of that Member State shall advise those of the other Member States of the measures taken which may, where necessary, extend to withdrawal of type-approval. 3. If a Member State demonstrates that engines bearing a type-approval number do not conform to the approved type or family it may request the Member State which granted the type-approval to verify that engines in production conform to the approved type or family. Such action shall be taken within six months of the date of the request. 4. The approval authorities of the Member States shall inform each other within one month of any withdrawal of type-approval and of the reasons for such measure. 5. If the Member State which granted type-approval disputes the failure to conform notified to it, the Member States concerned shall endeavour to settle the dispute. The Commission shall be kept informed and shall, where necessary, hold appropriate consultations for the purpose of reaching a settlement. Article 13 Worker protection requirements The provisions of this Directive shall not affect Member States' entitlement to lay down, in due observance of the Treaty, such requirements as they may deem necessary to ensure that workers are protected when using the machinery referred to in this Directive, provided that this does not affect the placing on the market of the engines in question. Article 14 Adaptation to technical progress Any amendments which are necessary in order to adapt the Annexes to this Directive, with exemption of the requirements specified in section 1, sections 2.1 to 2.8 and section 4 of Annex I, to take account of technical progress shall be adopted by the Commission assisted by the Committee established in accordance with Article 13 of Directive 92/53/EEC and in accordance with the procedure laid down in Article 15 of this Directive. Article 15 Committee procedure 1. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 2. (a) The Commission shall adopt measures which shall apply immediately. (b) However, if the measures envisaged are not in accordance with the opinion of the committee, they shall be communicated by the Commission to the Council forthwith. In that event: - the Commission shall defer application of the measures which it has decided for a period not exceeding three months from the date of the communication, - the Council, acting by a qualified majority, may take a different decision within the time limit referred to in the first indent. Article 16 Approval authorities and technical services The Member States shall notify to the Commission and to the other Member States the names and addresses of the approval authorities and technical services that are responsible for the purposes of this Directive. The notified services must satisfy the requirements as laid down in Article 14 of Directive 92/53/EEC. Article 17 Transposal into national law 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 June 1998. 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 communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive. Article 18 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 19 Further reduction in emission limit values The European Parliament and the Council shall decide, by the end of the year 2000 on a proposal which the Commission will submit before the end of 1999, on a further reduction in emission limit values, taking into account the global availability of techniques for controlling air-polluting emissions from compression ignition engines and the air quality situation. Article 20 Addressees This Directive is addressed to the Member States.

31997L0079

1997

Council Directive 97/79/EC of 18 December 1997 amending Directives 71/118/EEC, 72/462/EEC, 85/73/EEC, 91/67/EEC, 91/492/EEC, 91/493/EEC, 92/45/EEC and 92/118/EEC as regards the organisation of veterinary checks on products entering the Community from third countries Having regard to the Treaty establishing the European Community, and in particular Article 43 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 for the sake of clarity and rationality, Council Directive 90/675/EEC, laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (4), has been repealed and replaced by Directive 97/78/EC (5); Whereas the replacement of Directive 90/675/EEC by Directive 97/78/EC has consequences for the existing texts of the following Council Directives: - Directive 71/118/EEC of 15 February 1971 on health problems affecting the production and placing on the market of fresh poultrymeat (6), - Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine, ovine, caprine animals and swine, fresh meat or meat products from third countries (7), - Directive 85/73/EEC of 29 January 1985 on the financing of veterinary inspections and controls covered by Directives 89/662/EEC, 90/425/EEC, 90/675/EEC and 91/496/EEC (amended and consolidated) (8), - Directive 91/67/EEC of 28 January 1991 concerning the animal health conditions governing the placing on the market of aquaculture animals and products (9), - Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs (10), - Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products (11), - Directive 92/45/EEC of 16 June 1992 on public health and animal health problems relating to the killing of wild game and the placing on the market of wild-game meat (12), - Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC (13); Whereas for that reason, those Directives should be brought into line with the text of Directive 97/78/EC, Article 1 1. Directive 71/118/EEC is hereby amended as follows: (a) in Article 14b(2)(a), the second sentence shall be deleted; (b) in Article 17, the second subparagraph shall be deleted. 2. Directive 72/462/EEC is hereby amended as follows: (a) in Article 31a, 'Article 17 of Directive 90/675/EEC` shall be replaced by 'Article 18 of Directive 97/78/EC`; (b) Article 31 shall be deleted. 3. In Article 3(1) of Directive 85/73/EC, 'Article 20 of Directive 90/675/EEC` shall be replaced by 'Article 23 of Directive 98/78/EC`. 4. Directive 91/67/EEC is hereby amended as follows: (a) Article 23 shall be replaced by the following: 'Article 23 The principles and rules laid down in Directives 91/496/EEC and 97/78/EC shall apply, with particular reference to the organisation of and follow-up to the checks to be carried out by the Member States and the safeguard measures to be implemented.`; (b) Article 24 shall be deleted. 5. The second subparagraph of Article 10(2) of Directive 91/492/EEC shall be deleted. 6. Directive 91/493/EEC is hereby amended as follows: (a) in the second subparagraph of Article 10, 'Article 18(3) of Directive 90/675/EEC` shall be replaced by 'Article 19(2) of Directive 97/78/EC`; (b) Article 12(2) shall be deleted. 7. Directive 92/45/EEC is hereby amended as follows: (a) Article 17(2) shall be deleted; (b) the second paragraph of Article 19 shall be deleted. 8. Directive 92/118/EEC is hereby amended as follows: (a) in the second subparagraph of Article 12(1), 'Article 8(2) of Directive 90/675/EEC` shall be replaced by 'Article 4(4)(b) of Directive 97/78/EC`; (b) Article 12(2) shall be deleted. Article 2 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1999. They shall forthwith inform the Commission thereof. They shall apply those provisions as from 1 July 1999. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for making such reference shall be adopted by Member States. 2. 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 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.

31998L0001

1998

Commission Directive 98/1/EC of 8 January 1998 amending certain Annexes to Council Directive 77/93/EEC 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 77/93/EEC of 21 December 1976 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 97/14/EC (2), and in particular Article 13, second paragraph, third and fourth indents, thereof, Whereas measures should be taken to protect the Community against Diabrotica barberi Smith & Lawrence, Diabrotica undecimpunctata howardi Barber, Diabrotica undecimpunctata undecimpuctata Mannerheim and Diabrotica virgifera Le Conte, harmful organisms which have not hitherto been known to occur in the Community; Whereas measures should be taken against the introduction into and spread within the Community of Meloidogyne chitwoodi Golden et al. (all populations) and M. fallax Karssen and Tomato yellow leaf curl virus; Whereas the provisions on protective measures against Enarmonia prunivora Walsh and Ditylenchus dipsaci (Kühn) Filipjev, organisms listed in the Annexes to the said Directive, should be improved, and in particular the list of host plants should be extended; Whereas it is no longer appropriate to maintain the current provisions on protective measures against Tomato spotted wilt virus; Whereas certain measures against Gymnosporangium asiaticum Miyabe ex Yamada, in particular in respect of plants of Photinia Ldl., should be modified because it has been determined that the said organism is only present in some third countries; Whereas improved measures should be taken to protect the Community against the introduction of harmful organisms affecting hybrids of Solanum L., other than those intended for planting, and aquarium plants; Whereas certain provisions concerning organisms affecting naturally or artificially dwarfed plants for planting, other than seeds, originating in non-European countries should be improved; Whereas certain provisions concerning organisms affecting isolated bark of Castanea Mill. should be amended and, in particular, adapted to the present distribution of organisms such as non-European Pissodes spp. and Scolytidae spp.; Whereas certain provisions concerning Monilinia fructicola (Winter) Honey, should be amended because it has been determined that only Prunus fruits from non-European countries should be subjected to phystosanitary control in the high-risk period from 15 February to 30 September; Whereas since it has been determined that the risk of spreading Xanthomonas campestris pv. pruni by intra-Community trade in P. laurocerasus L. and P. lusitanica L., is minimal, the relevant measures should be modified; Whereas since it has become apparent that there is no risk of transmitting Bemisia tabaci Genn with seeds, tubers and corms of Begonia L., the relevant measures should be modified; Whereas certain measures against Clavibacter michiganensis spp. insidiosus Davis et al. should be modified in order to take account of the area of origin of the seeds and the presence of the disease in that area; Whereas in order to take into account the phytosanitary risk involved with the import of parts of certain plants, other than fruits and seeds, certain measures should be modified; Whereas these amendments are in accordance with the requests of the Member States concerned; Whereas, therefore, the relevant Annexes to Directive 77/93/EEC should be amended accordingly; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Comittee on Plant Health, Article 1 Annexes I to V to Directive 77/93/EEC are hereby amended as indicated 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 with effect from 1 May 1998. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Member States shall immediately communicate to the Commission the main provisions of domestic law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof. Article 3 This Regulation 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.

31998L0002

1998

Commission Directive 98/2/EC of 8 January 1998 amending Annex IV to Council Directive 77/93/EEC 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 77/93/EEC of 21 December 1976 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 97/14/EC (2), and in particular Article 13, second subparagraph, fourth indent thereof, Whereas some provisions for protective measures aimed at protection against the introduction, on citrus fruit, of Xanthomonas campestris (all strains pathogenic to Citrus), Cercospora angolensis Carv. et Mendes and Guignardia citricarpa Kiely (all strains pathogenic to Citrus), which are not present in the Community or in certain Citrus growing zones thereof, should be modified, to have a better protection for the Community against these harmful organisms which are already listed in Council Directive 77/93/EEC; Whereas therefore the relevant Annex to Directive 77/93/EEC should be amended accordingly; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 77/93/EEC is hereby amended as indicated 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 with effect from 1 May 1998. 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 the Member States. 2. The 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 following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31998L0003

1998

Commission Directive 98/3/EC of 15 January 1998 adapting to technical progress Council Directive 76/116/EEC on the approximation of the laws of the Member States relating to fertilisers (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to Council Directive 76/116/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to fertilisers (1), as last amended by Council and European Parliament Directive 97/63/EC (2), and in particular Article 9(1) thereof, Whereas Article 7a of the Treaty envisages an area without internal frontiers in which the free circulation of goods, persons, services and capital is assured; Whereas Directive 76/116/EEC laid down rules for the marketing of fertilisers within the internal market; Whereas new fertilisers need to be added to Annex I to Directive 76/116/EEC to enable them to benefit from the Community marking provided for in Annex II to that Directive; Whereas notice 94/C 138/04 (3) establishes a procedure that should be observed by any person (manufacturer or his representative) wanting to apply to a fertiliser the Community marking provided for in Annex II to Directive 76/116/EEC, by way submitting a technical file to the Member State authorities which will act as rapporteur for the file to the Working Party on Fertilizers of the European Commission; Whereas 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 Removing Technical Barriers to Trade in Fertilisers, Article 1 Annex I to Directive 76/116/EEC shall be amended as follows: The fertilisers included in the Annex to this Directive shall be added to Part C, point 1 entitled 'Straight fluid fertilisers`. Article 2 The following products and tolerances are added under part A.1 in Annex III to Directive 76/116/EEC: '>TABLE> `. Article 3 Member States shall adopt and publish the provisions necessary to comply with this Directive by 31 December 1998 at the latest and shall forthwith inform the Commission thereof. They shall apply these provisions as from 1 January 1999. 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 4 This Directive is addressed to the Member States.

31998L0008

1998

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 Having regard to the Treaty establishing the European Community, and in particular Article 100a 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 189b of the Treaty (3) in the light of the joint text approved on 16 December 1997 by the Conciliation Committee, (1) Whereas, in their resolution of 1 February 1993 on a Community programme of policy and action in relation to the environment and sustainable development (4), the Council and the representatives of the Governments of the Member States, meeting within the Council, approved the general approach and strategy of the programme presented by the Commission, in which the need for risk management of non-agricultural pesticides is emphasised; (2) Whereas, both when the eighth Amendment (5) 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 (6) was adopted in 1989 and during the discussion in the Council on Directive 91/414/EEC concerning the placing of plant protection products on the market (7), the Council expressed concern at the lack of harmonised Community provisions for biocides, formerly known as non-agricultural pesticides, and invited the Commission to examine the situation in Member States and the possibility for action at Community level; (3) Whereas biocidal products are necessary for the control of organisms that are harmful to human or animal health and for the control of organisms that cause damage to natural or manufactured products; whereas biocidal products can pose risks to humans, animals and the environment in a variety of ways due to their intrinsic properties and associated use patterns; (4) Whereas the Commission review showed differences in the regulatory situation in the Member States; whereas such differences may constitute barriers not only to trade in biocidal products but also to trade in products treated with them, thereby affecting the functioning of the internal market; whereas, therefore, the Commission proposed the development of a framework of rules relating to the placing on the market for use of biocidal products, taking as a condition a high level of protection for humans, animals and the environment; whereas, having regard to the principle of subsidiarity, decisions taken at Community level should be restricted to those necessary for the proper functioning of the common market and to avoid duplication of work by Member States; whereas a directive on biocidal products is the most appropriate way of establishing such a framework; (5) Whereas the framework of rules should provide that biocidal products should not be placed on the market for use unless they have complied with the relevant procedures of this Directive; (6) Whereas, to take account of the specific nature of some biocidal products and the risks associated with their proposed use, it is appropriate to provide for simplified authorisation procedures, including registration; (7) Whereas it is appropriate that the applicant submit dossiers which contain information which is necessary to evaluate the risks that will arise from proposed uses of the product; whereas a common core data set for active substances and for biocidal products in which they are contained is necessary so as to assist both the applicants seeking authorisation and those carrying out the evaluation to decide on the authorisation; whereas, furthermore, specific data requirements need to be elaborated for each of the product types covered by this Directive; (8) Whereas it is necessary, when biocidal products are being authorised, to make sure that, when properly used for the purpose intended, they are sufficiently effective and have no unacceptable effect on the target organisms such as resistance or unacceptable tolerance, and, in the case of vertebrate animals, unnecessary suffering and pain, and have, in the light of current scientific and technical knowledge, no unacceptable effect on the environment and, in particular, on human or animal health; (9) Whereas it is necessary to provide common principles for the evaluation and authorisation of biocidal products to ensure a harmonised approach by Member States; (10) Whereas Member States should not be prevented from imposing additional requirements on the use of biocidal products in so far as these additional requirements are in conformity with Community law and in particular do not run counter to the provisions of this Directive; whereas such provisions are intended to protect the environment and human and animal health by means such as epidemic control and food and feedingstuff protection; (11) Whereas, in the light of the diversity of both the active substances and the biocidal products concerned, the data and test requirements should suit the individual circumstances and result in an overall risk assessment; (12) Whereas it is necessary to establish a Community list of active substances permitted for inclusion in biocidal products; whereas a Community procedure must be laid down for assessing whether or not an active substance can be entered in the Community list; whereas the information that interested parties must submit with a view to admission of an active substance to the list has to be specified; whereas active substances on the list should be reviewed periodically, and, if appropriate, compared with each other under specific conditions, to take account of developments in science and technology; (13) Whereas, when due account is taken of products which pose only a low risk, their active substances should be incorporated in a specific annex; whereas substances the main use of which is non-pesticidal but which have some minor use as a biocide either directly, or in a product consisting of an active substance and a simple diluent should be incorporated in a separate specific annex; (14) Whereas when an active substance is evaluated for its entry or otherwise in the relevant annexes of the Directive, it is necessary for such an evaluation to cover, where appropriate, the same aspects as those covered by the evaluation made under Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (8) and Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (9) as far as the risk assessment is concerned; whereas, therefore, the risks associated with the production, use and disposal of the active substance and materials treated with it are to be considered in a similar way as they are in the aforementioned legislation; (15) Whereas it is in the interest of the free circulation of biocidal products, as well as of materials treated with them, that authorisation granted by one Member State should be recognised by other Member States subject to the specific conditions contained in this Directive; (16) Whereas, while envisaging harmonised provisions for all biocidal product types, including those intended to control vertebrates, the actual use of such types might give rise to concern; whereas therefore Member States should be allowed, subject to the Treaty, to derogate from the principle of mutual recognition for biocidal products falling under three particular types of biocides whenever intended to control particular kinds of vertebrates, in so far as such derogations are justified and do not jeopardise the purpose of this Directive; (17) Whereas it is therefore desirable that a system for the mutual exchange of information should be established and that Member States and the Commission should make available to each other on request the particulars and scientific documentation submitted in connection with applications for authorisation of biocidal products; (18) Whereas it should be possible for Member States to authorise, for a limited period of time, biocidal products which do not comply with the abovementioned conditions, especially in the event of an unforeseen danger threatening humans, animals or the environment which cannot be contained by other means; whereas the Community procedure should not prevent Member States from authorising, for a limited period of time for use in their territory, biocidal products containing an active substance not yet entered in the Community list, provided that a dossier meeting Community requirements has been submitted and the Member State concerned believes that the active substance and the biocidal product satisfy the Community conditions set for them; (19) Whereas it is essential that this Directive help to minimise the number of tests on animals and that testing should be made dependent on the purpose and use of a product; (20) Whereas close coordination should be ensured with other Community legislation and in particular with Directive 91/414/EEC, the Directives concerned with the protection of water and those concerned with the contained use and deliberate release of genetically modified organisms; (21) Whereas the Commission is to draw up technical notes for guidance in particular on the implementation of the authorisation procedures, the entry of active substances in the appropriate Annexes, the Annexes relating to data requirements and the Annex dealing with the common principles; (22) Whereas, in order to ensure that the requirements laid down in respect of authorised biocidal products are satisfied when they are placed on the market, Member States should make provision for appropriate control and inspection arrangements; (23) Whereas the implementation of this Directive, the adaptation of its Annexes to the development of technical and scientific knowledge and the inclusion of active substances in the appropriate Annexes necessitate close cooperation between the Commission, the Member States and the applicants; whereas, in cases where the procedure of the Standing Committee on Biocidal Products is to be applied, this constitutes a suitable basis for such cooperation; (24) Whereas an agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the EC Treaty was reached on 20 December 1994 (10); (25) Whereas the Commission will apply the modus vivendi to the implementing measures flowing from this Directive that it envisages adopting, including those concerning Annexes IA and IB; (26) Whereas, since the full implementation of this Directive, and especially the review programme, will not be achieved for several years, Directive 76/769/EEC provides a framework to complement the development of the positive list by limitations of the marketing and use of certain active substances and products or groups thereof; (27) Whereas the review programme on active substances will need to take account of other work programmes within the framework of other Community legislation concerned with the review or authorisation of substances and products or relevant international Conventions; (28) Whereas the costs of the procedures associated with the operation of the Directive need to be recovered from those seeking to place, or placing, biocidal products on the market and from those supporting the entries of active substances in the relevant Annexes; (29) Whereas minimum rules concerning the use of biocidal products at work are laid down under Directives on health and safety at work; whereas it is desirable to develop further rules in this area, Article 1 Scope 1. This Directive concerns: (a) the authorisation and the placing on the market for use of biocidal products within the Member States; (b) the mutual recognition of authorisations within the Community; (c) the establishment at Community level of a positive list of active substances which may be used in biocidal products. 2. This Directive shall apply to biocidal products as defined in Article 2(l)(a) but shall exclude products that are defined or within the scope of the following instruments for the purposes of these Directives: (a) Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (11), (b) Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States on veterinary medicinal products (12), (c) Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological medicinal products (13), (d) 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 (14), (e) Council Directive 92/74/EEC of 22 September 1992 widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products (15), (f) 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 (16), (g) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (17), (h) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (18), (i) 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 (19), Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production (20) and European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (21), (j) 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 (22), (k) Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk based products (23), (l) Council Directive 89/437/EEC of 20 June 1989 on hygiene and health problems affecting the production and the placing on the market of egg products (24), (m) Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products (25), (n) Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community (26), (o) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (27), Council Directive 82/471/EEC of 30 June 1982 on certain products used in animal nutrition (28) and Council Directive 77/101/EEC of 23 November 1976 on the marketing of straight feedingstuffs (29), (p) Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (30), (q) Council Directive 95/5/EC of 27 February 1995 amending Directive 92/120/EEC on the conditions for granting temporary and limited derogations from specific Community health rules on the production and marketing of certain products of animal origin (31), (r) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (32). 3. This Directive shall apply, without prejudice to relevant Community provisions or measures taken in accordance with them, in particular, to: (a) 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 (33), (b) Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (34), (c) Council Regulation (EEC) No 2455/92 of 23 July 1992 concerning the export and import of certain dangerous chemicals ( (35)), (d) Council Directive 80/1107/EEC of 27 November 1980, on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (36), 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 (37) and individual Directives based on these Directives, (e) Council Directive 84/450/EEC of 10 September 1984 relating to the approximation of the laws, regulations or administrative provisions of the Member States concerning misleading advertising (38). 4. Article 20 shall not apply to the carriage of biocidal products by rail, road, inland waterway, sea or air. Article 2 Definitions 1. For the purposes of this Directive the following definitions shall apply: (a) Biocidal products Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means. An exhaustive list of 23 product types with an indicative set of descriptions within each type is given in Annex V. (b) Low-risk biocidal product A biocidal product which contains as active substance(s) only one or more of those listed in Annex IA and which does not contain any substance(s) of concern. Under the conditions of use, the biocidal product shall pose only a low risk to humans, animals and the environment. (c) Basic substance A substance which is listed in Annex I B, whose major use is non-pesticidal but which has some minor use as a biocide either directly or in a product consisting of the substance and a simple diluent which itself is not a substance of concern and which is not directly marketed for this biocidal use. The substances, which could potentially enter Annex IB in accordance with the procedure laid down in Articles 10 and 11, are inter alia the following: — carbon dioxide, — nitrogen, — ethanol, — 2-propanol, — acetic acid, — kieselguhr. (d) Active substance A substance or micro-organism including a virus or a fungus having general or specific action oh or against harmful organisms. (e) Substance of concern Any substance, other than the active substance, which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to create such an effect. Such a substance, unless there are other grounds for concern, would be normally a substance classified as dangerous according 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 (39), and present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of Article 3 of Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (40). (f) Harmful organism Any organism which has an unwanted presence or a detrimental effect for humans, their activities or the products they use or produce, or for animals or for the environment. (g) Residues One or more of the substances present in a biocidal product which remains as a result of its use including the metabolites of such substances and products resulting from their degradation or reaction. (h) Placing on the market Any supply, whether in return for payment or free of charge, or subsequent storage other than storage followed by consignment from the customs territory of the Community or disposal. Importation of a biocidal product into the customs territory of the Community shall be deemed to constitute placing on the market for the purposes of this Directive. (i) Authorisation An administrative act by which the competent authority of a Member State authorises, following an application submitted by an applicant, the placing on the market of a biocidal product in its territory or in a part thereof. (j) Frame-formulation Specifications for a group of biocidal products having the same use and user type. This group of products must contain the same active substances of the same specifications, and their compositions must present only variations from a previously authorised biocidal product which do not affect the level of risk associated with them and their efficacy. In this context, a variation is the allowance of a reduction in the percentage of the active substance and/or an alteration in percentage composition of one or more non-active substances and/or the replacement of one or more pigments, dyes, perfumes by others presenting the same or a lower risk, and which do not decrease its efficacy. (k) Registration An administrative act by which the competent authority of a Member State, following an application submitted by an applicant, after verification that the dossier meets the relevant requirements of this Directive, allows the placing on the market of a low-risk biocidal product in its territory or in a part thereof. (l) Letter of access A document, signed by the owner or owners of relevant data protected under the provisions of this Directive, which states that these data may be used by the competent authority for the purpose of granting an authorisation or a registration of a biocidal product under this Directive. 2. For the purposes of this Directive the definitions for: (a) substance, (b) preparation, (c) scientific research and development, (d) process-orientated research and development laid down in Article 2 of Council Directive 67/548/EEC shall apply. Article 3 Authorisation for placing on the market of biocidal products 1. Member States shall prescribe that a biocidal product shall not be placed on the market and used in their territory unless it has been authorised in accordance with this Directive. 2. By way of derogation from paragraph 1: (i) Member States shall, subject to registration, allow the placing on the market and use of a low-risk biocidal product, provided that a dossier in accordance with Article 8(3) has been submitted and verified by the competent authorities. Unless otherwise specified, all provisions relating to authorisation under this Directive shall also apply to registration. (ii) Member States shall allow the placing on the market and use of commodity substances for biocidal purposes once they have been entered in Annex IB. 3. (i) Every application for authorisation shall be decided on without undue delay. (ii) For applications for biocidal products that require registration, the competent authority shall take a decision within a period of 60 days. 4. Member States shall, on request, or may, on their own initiative, and where relevant, establish a frame-formulation and communicate it to the applicant when issuing an authorisation for a particular biocidal product. Without prejudice to Articles 8 and 12 and providing that the applicant has a right of access to the frame-formulation in the form of a letter of access, when a subsequent application for authorisation for a new biocidal product is based on this frame-formulation, the competent authority shall take a decision with regard to this application within a period of 60 days. 5. Member States shall prescribe that biocidal products are to be classified, packaged and labelled in accordance with the provisions of this Directive. 6. Without prejudice to Article 7(1), authorisations shall be granted for a maximum period of 10 years from the date of first or renewed inclusion of the active substance in Annex I or I A for the product type, without exceeding the deadline specified for the active substance in Annex I or I A; they may be renewed after verification that the conditions imposed in Article 5(1) and (2) are still satisfied. Renewal may, where necessary, be granted only for the period necessary to allow the competent authorities of the Member States to make such verification, where an application for renewal has been made. 7. Member States shall prescribe that biocidal products are to be properly used. Proper use shall include compliance with conditions established pursuant to Article 5 and specified under the labelling provisions of this Directive. Proper use shall also involve the rational application of a combination of physical, biological, chemical or other measures as appropriate, whereby the use of biocidal products is limited to the minimum necessary. Where biocidal products are used at work, use shall also be in accordance with the requirements of Directives for the protection of workers. Article 4 Mutual recognition of authorisations 1. Without prejudice to Article 12, a biocidal product that has already been authorised or registered in one Member State shall be authorised or registered in another Member State within 120 days, or 60 days respectively, of an application being received by the other Member State, provided that the active substance of the biocidal product is included in Annex I or I A and conforms to the requirements thereof. For the mutual recognition of authorisations, the application shall include a summary of the dossier as required in Article 8(2)(a) and Annex II B, Section X and a certified copy of the first authorisation granted. For mutual recognition of registration of low-risk biocidal products, the application shall include the data requirements of Article 8(3), except for the efficacy data for which a summary shall suffice. The authorisation may be subject to provisions resulting from the implementation of other measures in accordance with Community law, relating to the conditions for distribution and use of biocidal products intended to protect the health of the distributors, users and workers concerned. This mutual recognition procedure shall be without prejudice to measures taken by Member States pursuant to Community law intended to protect the health of workers. 2. If, in accordance with Article 5, a Member State establishes that: (a) the target species is not present in harmful quantities, (b) unacceptable tolerance or resistance of the target organism to the biocidal product is demonstrated, or (c) the relevant circumstances of use, such as climate or breeding period of the target species, differ significantly from those in the Member State where the biocidal product was first authorised, and an unchanged authorisation may therefore present unacceptable risks to humans or the environment, the Member State may request that certain conditions referred to in Article 20(3)(e), (f), (h), (j) and (1) be adjusted to the different circumstances, so that conditions for issue of an authorisation laid down in Article 5 are satisfied. 3. Where a Member State believes that a low-risk biocidal product which has been registered by another Member State does not comply with the definition provided for in Article 2(1)(b), it may provisionally refuse registration thereof and shall immediately communicate its concerns to the competent authority responsible for the verification of the dossier. If, within a maximum period of 90 days, an agreement is not reached between the authorities concerned, the matter will be forwarded to the Commission for a decision in accordance with the procedure laid down in paragraph 4. 4. Notwithstanding paragraphs 2 and 3, where a Member State believes a biocidal product authorised by another Member State cannot meet the conditions set out pursuant to Article 5(1) and consequently proposes to refuse the authorisation or the registration or to restrict the authorisation under certain conditions, it shall notify the Commission, other Member States and the applicant and shall provide them with an explanatory document containing the name of the product and its specification and setting out the grounds on which it proposes to refuse or to restrict the authorisation. The Commission shall prepare a proposal on these matters in accordance with Article 27 for a decision in accordance with the procedure laid down in Article 28(2). 5. If the procedure laid down in paragraph 4 leads to the confirmation of a refusal of a second or subsequent registration by a Member State, the Member State that had previously registered the low-risk biocidal product shall, where deemed appropriate by the Standing Committee, take this refusal into consideration and review its registration according to Article 6. If this procedure confirms the initial registration, the Member State having introduced the procedure shall register the low-risk biocidal product concerned. 6. By way of derogation from paragraph 1, Member States may refuse, subject to the Treaty, mutual recognition of authorisations granted for product types 15, 17 and 23 of Annex V provided that such a limitation can be justified and does not jeopardise the purpose of the Directive. Member States shall inform each other and the Commission of any decision taken in this respect and indicate the reasons therefor. Article 5 Conditions for issue of an authorisation 1. Member States shall authorise a biocidal product only if (a) the active substance(s) included therein are listed in Annex I or IA and any requirements laid down in these Annexes are fulfilled; (b) it is established, in the light of current scientific and technical knowledge, and is shown from appraisal of the dossier provided for in Article 8, according to the common principles for the evaluation of dossiers as laid down in Annex VI, that, when used as authorised and having regard to: — all normal conditions under which the biocidal product may be used, — how the material treated with it may be used, — the consequences from use and disposal, the biocidal product: (i) is sufficiently effective, (ii) has no unacceptable effects on the target organisms, such as unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates, (iii) has no unacceptable effects itself or as a result of its residues, on human or animal health, directly or indirectly (e.g. through drinking water, food or feed, indoor air or consequences in the place of work) or on surface water and groundwater, (iv) has no unacceptable effect itself, or as a result of its residues, on the environment having particular regard to the following considerations: — its fate and distribution in the environment; particularly contamination of surface waters (including estuarian and seawater), groundwater and drinking water, — its impact on non-target organisms; (c) the nature and quantity of its active substances and, where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants, and its residues of toxicological or environmental significance, which result from authorised uses, can be determined according to the relevant requirements in Annex IIA, IIB, IIIA, IIIB, IVA or IVB; (d) its physical and chemical properties have been determined and deemed acceptable for purposes of the appropriate use, storage and transport of the product. 2. A biocidal product classified according to Article 20(1) as toxic, very toxic or as a category 1 or 2 carcinogen, or as a category 1 or 2 mutagen or classified as toxic for reproduction category 1 or 2, shall not be authorised for marketing to, or use by the general public. 3. Authorisation may be conditional on, and must stipulate the conditions relating to marketing and use necessary to ensure compliance with the provisions of paragraph 1. 4. Where other Community provisions impose requirements relevant to the conditions for the issue of an authorisation and for use of the biocidal product, and particularly where these are intended to protect the health of distributors, users, workers and consumers or animal health or the environment, the competent authority shall take these into account when issuing an authorisation and where necessary shall issue the authorisation subject to those requirements. Article 6 Review of an authorisation During the period for which an authorisation has been granted, it may be reviewed at any time, e.g. following information received according to Article 14, if there are indications that any of the conditions referred to in Article 5 are no longer satisfied. In such instances the Member States may require the authorisation holder, or the applicant to whom a modification of the authorisation has been granted in accordance with Article 7, to submit further information necessary for the review. If need be, the authorisation may be prolonged only for the period necessary to complete the review, but shall be prolonged for the period necessary to provide for further information. Article 7 Cancellation or modification of an authorisation 1. An authorisation shall be cancelled if: (a) the active substance is no longer included in Annex I or IA as required by Article 5(l)(a); (b) the conditions within the meaning of Article 5(1) for obtaining the authorisation are no longer satisfied; (c) it is discovered that false or misleading particulars were supplied concerning the facts on the basis of which the authorisation was granted. 2. An authorisation may also be cancelled if the authorisation holder so requests and states the reasons for the cancellation. 3. When a Member State intends to cancel an authorisation, it shall inform and hear the authorisation holder. When cancelling the authorisation, the Member State may grant a period of grace for the disposal or for the storage, marketing and use of existing stocks, of a length in accordance with the reason for the cancellation without prejudice to any period provided for by decision taken pursuant to Directive 76/769/EEC or in connection with paragraph l(a). 4. Where a Member State considers it necessary, on the basis of developments in scientific and technical knowledge and to protect health and the environment, it shall modify the conditions of use of an authorisation and, in particular, the manner of use or the amounts used. 5. An authorisation may also be modified if the authorisation holder requests it and states the reasons for the modification. 6. Where a proposed modification concerns an extension of uses, a Member State shall extend the authorisation subject to the particular conditions placed on the active substance listed in Annex I or IA. 7. Where a proposed modification of an authorisation involves changes to the particular conditions placed on the active substance listed in Annex I or IA, such changes can be made only after evaluation of the active substance, with regard to the proposed changes, in accordance with the procedures laid down in Article 11. 8. Modifications shall be granted only if it is established that the conditions within the meaning of Article 5 remain satisfied. Article 8 Requirements for authorisation 1. Application for authorisation shall be made by, or on behalf of, the person who will be responsible for the first placing on the market of a biocidal product in a particular Member State and shall be to the competent authority of that Member State. Every applicant shall be required to have a permanent office within the Community. 2. Member States shall require that an applicant for authorisation of a biocidal product shall submit to the competent authority: (a) a dossier or a letter of access for the biocidal product satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex IIB and, where specified, the relevant parts of Annex IIIB, and (b) for each active substance in the biocidal product, a dossier or a letter of access satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex IIA and, where specified, the relevant parts of Annex IIIA. 3. By way of derogating from paragraph 2(a), Member States shall require a dossier comprising the following data for a low-risk biocidal product: (i) applicant: 1.1. name and address, 1.2. manufacturers of the biocidal product and the active substances, (names and addresses including location of manufacturer of the active substance) 1.3. where appropriate, a letter of access to any relevant data needed, (ii) identity of the biocidal product: 2.1. trade name, 2.2. full composition of the biocidal product, 2.3. physical and chemical properties as referred to in Article 5(1)(d), (iii) intended uses: 3.1. product type (Annex V) and field of use, 3.2. category of users, 3.3. method of use, (iv) efficacy data, (v) analytical methods, (vi) classification, packaging and labelling, including a draft label, according to Article 20, (vii) safety data sheet prepared in accordance with Article 10 of Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous substances (41), or Article 27 of Directive 67/548/EEC. 4. The dossiers shall include a detailed and full description of the studies conducted and of the methods used or a bibliographical reference to those methods. The information in the dossiers supplied in accordance with Article 8(2) shall be sufficient for an evaluation to be made of the effects and properties referred to in Article 5(1)(b), (c) and (d). It shall be submitted to the competent authority in the form of technical dossiers, containing the information and results of the studies referred to in Annexes IIA and IIB and, where specified, the relevant parts of Annexes IIIA and IIIB. 5. Information which is not necessary owing to the nature of the biocidal product or of its proposed uses need not be supplied. The same applies where it is not scientifically necessary or technically possible to supply the information. In such cases, a justification, acceptable to the competent authority must be submitted. Such a justification may be the existence of a frame-formulation which the applicant has the right to access. 6. If the evaluation of the dossier shows that further information, including data and results from further testing, is necessary to evaluate the risks of the biocidal product, the competent authority shall ask the applicant to submit such information. The time period for the evaluation of the dossier shall start only after the dossier is complete. 7. The name of an active substance must be given as registered in the list contained in Annex I to Directive 67/548/EEC or, if the name is not included therein, as given in the European Inventory of Existing Chemical Substances (Einecs), or, if the name is not included therein, the active substance must be given its International Standards Organisation (ISO) common name. If the latter is not available, the substance must be designated by its chemical designation according to International Union of Pure and Applied Chemistry (IUPAC) rules. 8. As a general principle, tests must be conducted according to the methods described in Annex V to Directive 67/548/EEC. In the event of a method being inappropriate or not described, other methods used should, whenever possible, be internationally recognised and must be justified. Where appropriate, tests must be conducted in accordance with the provisions laid down in Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (42) and Council Directive 87/18/EEC of 18 December 1986 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (43). 9. Where test data exist that have been generated before the adoption of this Directive by methods other than those laid down in Annex V to Directive 67/548/EEC, the adequacy of such data for the purposes of this Directive and the need to conduct new tests according to Annex V must be decided on a case-by-case basis, taking into account, among other factors, the need to minimise testing on vertebrate animals. 10. Competent authorities as referred to within the meaning of Article 26 shall ensure that a file is compiled on each application. Each file shall contain at least a copy of the application, a record of the administrative decisions taken by the Member State concerning the application and concerning the dossiers submitted in accordance with paragraph 2, together with a summary of the latter. On request, Member States shall make available to the other competent authorities and to the Commission the files provided for in this paragraph; they shall supply to them, on request, all information necessary for full comprehension of applications and shall, where requested, ensure that applicants provide a copy of the technical documentation laid down in paragraph 2. 11. Member States my require that samples of the preparation and of its ingredients be provided. 12. Member States may require that applications for authorisation be submitted in their national or official languages or one of these languages. Article 9 Placing on the market of active substances Member States shall prescribe that where a substance is an active substance for use in biocidal products it may not be placed on the market for such use unless: (a) where the active substance was not on the market before the date referred to in Article 34(1), a dossier has been forwarded to a Member State, which satisfies the requirements of Article 11(1) and is accompanied by the declaration that the active substance is intended for inclusion in a biocidal product. This shall not apply to substances for use pursuant to Article 17; (b) it is classified, packaged and labelled in accordance with the provisions of Directive 67/548/EEC. Article 10 Inclusion of an active substance in Annexes I, IA or IB 1. In the light of current scientific and technical knowledge, an active substance shall be included in Annex I, Annex IA or IB for an initial period not exceeding 10 years if it may be expected that — biocidal products containing the active substance, — low-risk biocidal products complying with the definition in Article 2(1)(b), — commodity substances complying with the definition in Article 2(1)(c), will fulfil the conditions laid down in Article 5(1)(b), (c) and (d), taking into account, where relevant, cumulation effects from the use of biocidal products containing the same active substances. An active substance cannot be included in Annex IA if it is classified according to Directive 67/548/EEC as: — carcinogenic, — mutagenic, — toxic for reproduction, — sensitising, or — is bioaccumulative and does not readily degrade. Where appropriate, the entry of an active substance in Annex IA shall refer to the concentration ranges between which the substance can be used. 2. Inclusion of an active substance in Annexes I, IA or IB shall, where appropriate, be subject to the following: (i) requirements on: (a) the minimum degree of purity of the active substance, (b) the nature and maximum content of certain impurities, (c) product type in which it may be used, (d) manner and area of use, (e) designation of categories of users (e.g. industrial, professional or non-professional), (f) other particular conditions from the evaluation of the information which has been made available in the context of this Directive; (ii) the establishment of the following: (a) acceptable operator exposure level (AOEL), if necessary, (b) where relevant, an acceptable daily intake for man (ADI) and a maximum residue limit (MRL), (c) fate and behaviour in the environment and impact on non-target organisms. 3. The inclusion in Annex I, IA or IB of an active substance shall be restricted to those product types in Annex V for which relevant data have been submitted in accordance with Article 8. 4. The inclusion of an active substance in Annex I, IA or IB may be renewed on one or more occasions for periods not exceeding 10 years. The initial inclusion, as well as any renewed inclusion, may be reviewed at any time if there are indications that any of the requirements referred to in paragraph 1 are not longer satisfied. Renewal may, where necessary, be granted only for the minimum period necessary to complete a review, where an application has been made for such renewal, and shall be granted for the period necessary to provide further information requested in accordance with Article 11(2). 5. (i) An entry of an active substance in Annex I and, — where relevant, IA or IB may be refused or removed, if the evaluation of the active substance in accordance with Article 11(2) shows that, under normal conditions under which it may be used in authorised biocidal products, risks to health or the environment still give rise to concern, and — if there is another active substance on Annex I for the same product type which, in the light of scientific or technical knowledge, presents significantly less risk to health or to the environment. When such a refusal or removal is considered, an assessment of an alternative active substance or substances shall take place to demonstrate that it can be used with similar effect on the target organism without significant economic and practical disadvantages for the user and without an increased risk for health or for the environment. The assessment shall be circulated in accordance with the procedures in Article 11(2) for decision in accordance with the procedures laid down in Articles 27 and 28(3). (ii) The refusal or removal of an Annex I and, where relevant, IA or IB entry shall be carried out under the following conditions: 1. the chemical diversity of the active substances should be adequate to minimise occurrence of resistance in the target organism; 2. it should be applied only to active substances which, when used under normal conditions in authorised biocidal products, present a significantly different level of risk; 3. it should be applied only to active substances used in products of the same product type; 4. it should be applied only after allowing the possibility, where necessary, of acquiring experience from use in practice, if it is not already available; 5. the complete data dossiers of the evaluation serving or having served for entry in Annex I, IA or IB shall be put at the disposal of the Committee referred to in Article 28(3). (iii) A decision to remove an Annex I entry shall not have immediate effect but shall be delayed for a period of up to a maximum of four years from the date of that decision. Article 11 Procedure for inclusion of an active substance in Annex I, IA or IB 1. Inclusion, or subsequent changes to the inclusion, of an active substance in Annex I, IA or IB shall be considered when: (a) an applicant has forwarded to the competent authority of one of the Member States: (i) a dossier for the active substance satisfying the requirements of Annex IVA or the requirements of Annex IIA and, where specified, the relevant parts of Annex IIIA; (ii) a dossier for at least one biocidal product containing the active substance satisfying the requirements of Article 8, with the exception of paragraph 3 thereof; (b) the receiving competent authority has verified the dossiers and believes them to satisfy the requirements of Annex IVA and Annex IVB or the requirements of Annex IIA and Annex IIB and, where relevant, Annexes IIIA and IIIB, accepts them and agrees to the applicant forwarding a summary of the dossiers to the Commission and the other Member States. 2. The receiving competent authority shall, within 12 months of accepting the dossiers, carry out an evaluation thereof. A copy of the evaluation shall be sent by the competent authority to the Commission, the other Member States and to the applicant, together with a recommendation for the inclusion, or otherwise, of the active substance in Annex I, IA or IB. If, when the dossiers are evaluated, it appears that further information is necessary for full evaluation to be made, the receiving competent authority shall ask that the applicant submit such information. The 12-month period shall be suspended from the date of issue of the competent authority's request until the date the information is received. The competent authority shall inform the other Member States and the Commission of its action when it informs the applicant. 3. To avoid dossiers being evaluated by only a few Member States, the evaluation can be carried out by Member States other than the receiving one. A request for this shall be given when the dossiers are accepted, and the decision shall be taken in accordance with the procedure laid down in Article 28(2). The decision shall be taken at the latest one month after receipt by the Commission of the request. 4. On receipt of the evaluation, the Commission shall, in accordance with the procedure in Article 27, prepare a proposal without undue delay for decision in accordance with the procedure laid down in Article 28(3). The decision shall be taken at the latest 12 months after the receipt by the Commission of the evaluation referred to in paragraph 2. Article 12 Use of data held by competent authorities for other applicants 1. Member States shall not make use of the information referred to in Article 8 for the benefit of a second or subsequent applicant: (a) unless the second or subsequent applicant has the written agreement in the form of a letter of access of the first applicant that use may be made of such information, or (b) in the case of an active substance not on the market on the date referred to in Article 34(1), for a period of 15 years from the date of first inclusion in Annex I or IA, or (c) in the case of an active substance already on the market on the date referred to in Article 34(1): (i) for a period of 10 years from the date referred to in Article 34(1) for any information submitted for the purposes of this Directive, except where such information is already protected under existing national rules relating to biocidal products. In such cases, the information shall continue to be protected in that Member State until the expiry of any remaining period of data protection provided for under national rules, up to a maximum of 10 years from the date referred to in Article 34(1); (ii) for a period of 10 years from the date of entry of an active substance onto Annex I or IA for information submitted for the first time in support of the first inclusion in Annex I or IA of either the active substance or an additional product type for that active substance, (d) in the case of any further information submitted for the first time for any of the following: (i) variation of the requirements of the entry on Annex I or IA; (ii) maintenance of the entry of Annex I or. IA for a period of five years from the date of decision following receipt of further information unless the five-year period expires before the period provided for in paragraphs 1(b) and (c), in which case the period of five years shall be extended so as to expire on the same date as those periods. 2. Member States shall not make use of the information referred to in Article 8, for the benefit of a second or subsequent applicant: (a) unless the second or subsequent applicant has the written agreement in the form of a letter of access of the first applicant that use may be made of such information; or (b) in the case of a biocidal product containing an active substance not on the market on the date referred to in Article 34(1) for a period of 10 years from the date of first authorisation in any Member State, or; (c) in the case of a biocidal product containing an active substance already on the market on the date referred to in Article 34(1); (i) for a period of 10 years from the date referred to in Article 34(1) for any information submitted for the purposes of this Directive, except in the case where data are already protected according to existing national rules relating to biocidal products, in which case such data shall be protected in that Member State until the expiry of any remaining period of data protection provided for under those national rules, up to a maximum of 10 years from the date referred to in Article 34(1); (ii) for a period of 10 years from the date of entry of an active substance onto Annex I or IA, for information which is submitted for the first time in support of the inclusion in Annex I or IA either of the active substance or of an additional product type for that active substance; (d) in the case of any data submitted for the first time for either of the following: (i) variation of the conditions of authorisation of a biocidal product; (ii) submission of data necessary to maintain entry of an active substance onto Annex I or IA for a period of five years from the date of first receipt of further information, unless the five-year period expires before the period in paragraphs (b) and (c), in which case the period of five years shall be extended so as to expire on the same date as those periods. 3. For decisions to be taken in accordance with Article 10(5), the information referred to in paragraphs 1 and 2 can be used by the Commission, the Scientific Committees as referred to in Article 27 and the Member States. Article 13 Cooperation in the use of data for second and subsequent applications for authorisation 1. In the case of a biocidal product which has already been authorised in accordance with Articles 3 and 5, and without prejudice to the obligations imposed pursuant to Article 12, the competent authority may agree that a second or subsequent applicant for authorisation may refer to data provided by the first applicant in so far as the second or subsequent applicant can provide evidence that the biocidal product is similar and its active substances are the same as the one formerly authorised, including degree of purity and nature of impurities. 2. Notwithstanding Article 8(2): (a) an applicant for authorisation of biocidal products shall, before carrying out experiments involving vertebrate animals, enquire of the competent authority of the Member State to which he intends making application: — whether the biocidal product for which an application is to be made is similar to a biocidal product for which authorisation has been granted, and — as to the name and address of the holder or holders of the authorisation or authorisations. The enquiry shall be supported by evidence that the prospective applicant intends to apply for authorisation on his own behalf and that the other information specified in Article 8(2) is available; (b) the competent authority of the Member State, if satisfied that the applicant intends to apply, shall provide the name and address of the holder or holders of former relevant authorisations and shall at the time inform the holders of the authorisations of the name and address of the applicant. The holder or holders of former authorisations and the applicant shall take all reasonable steps to reach agreement on the sharing of information, so as to avoid, if possible, the duplication of testing on vertebrate animals. The competent authorities of the Member States shall encourage data-holders to cooperate in the provision of the requested data, with a view to limiting the duplication of testing on vertebrate animals. If it is still not possible for the applicant and holders of former authorisations of the same product to reach an agreement on the sharing of data, Member States may introduce national measures obliging the applicant and holders of former authorisations located within their territory to share the data with a view to avoiding duplicative testing on vertebrate animals and determine both the procedure for utilising information, and the reasonable balance of the interests of the parties concerned. Article 14 New information 1. Member States shall prescribe that the holder of an authorisation for a biocidal product shall immediately notify the competent authority of information of which he or she is aware or of which he or she may reasonably be expected to be aware concerning an active substance or a biocidal product containing it and which may affect continuing authorisation. In particular, the following shall be notified: — new knowledge or information on the effects of the active substance or biocidal product for humans or the environment, — changes in the source or composition of the active substance, — changes in composition of a biocidal product, — development of resistance, — changes of an administrative nature or other aspects, such as the nature of the packaging. 2. Member States shall immediately notify other Member States and the Commission of any such information they receive concerning potentially harmful effects for humans or the environment or the new composition of a biocidal product, its active substances, impurities, co-formulants or residues. Article 15 Derogation from the requirements 1. By way of derogating from Articles 3 and 5, a Member State may authorise temporarily for a period not exceeding 120 days, the placing on the market of biocidal products not complying with the provisions of this Directive for a limited and controlled use if such a measure appears necessary because of an unforseen danger which cannot be contained by other means. In this case, the Member State concerned shall immediately inform the other Member States and the Commission of its action and the justification for it. The Commission shall make a proposal and it shall be decided without delay, in accordance with the procedure laid down in Article 28(2), whether, and, if so, under what conditions, the action taken by the Member State may be extended for a period to be determined, be repeated, or be revoked. 2. By way of derogation from Article 5(1)(a) and until an active substance is listed in Annex I or IA, a Member State may authorise provisionally, for a period not exceeding three years, the placing on the market of a biocidal product containing an active substance not listed in Annex I or IA and not yet available on the market on the date referred to in Article 34(1) for purposes other than those defined in Article 2(2)(c) and (d). Such an authorisation may be issued only if, after dossiers have been evaluated in accordance with Article 11, the Member State believes that: — the active substance satisfies the requirements of Article 10 and, — the biocidal product may be expected to satisfy the conditions of Articles 5(l)(b), (c) and (d), and no other Member State, on the basis of the summary it receives, makes legitimate objection, in accordance with Article 18(2), to the completeness of the dossiers. Where an objection is made, a decision on the completeness of dossiers shall be taken in accordance with the procedure laid down in Article 28(2) without undue delay. If, following the procedures laid down in Articles 27 and 28(2), it is decided that the active substance does not satisfy the requirements specified in Article 10, the Member State shall ensure that the provisional authorisation is cancelled. In cases where evaluation of dossiers for the purposes of inclusion of an active substance in Annex I or IA is not completed when the period of three years expires, the competent authority may further provisionally authorise the product for a period not exceeding one year, providing there are good reasons to believe the active substance will satisfy the requirements of Article 10. Member States shall inform other Member States and the Commission of such action. Article 16 Transitional measures 1. By way of further derogating from Articles 3(1), 5(1), 8(2) and 8(4), and without prejudice to paragraphs 2 and 3, a Member State may, for a period of 10 years from the date referred to in Article 34(1), continue to apply its current system or practice of placing biocidal products on the market. It may, in particular, according to its national rules, authorise the placing on the market in its territory of a biocidal product containing active substances not listed in Annex I or IA for that product type. Such active substances must be on the market on the date referred to in Article 34(1) as active substances of a biocidal product for purposes other than those defined in Article 2(2)(c) and (d). 2. Following the adoption of this Directive, the Commission shall commence at 10-year programme of work for the systematic examination of all active substances already on the market on the date referred to in Article 34(1) as active substances of a biocidal product for purposes other than those defined in Article 2(2)(c) and (d). A Regulation, adopted according to the procedure laid down in Article 28(3), will provide for all provisions necessary for the establishment and implementation of the programme including the setting of priorities for the evaluation of the different active substances and a timetable. No later than two years before completion of the work programme, the Commission shall forward to the European Parliament and the Council a report on the progress achieved with the programme. During that 10-year period and from the date referred to in Article 34(1), it may be decided pursuant to the procedure laid down in Article 28(3) that an active substance shall be included in Annexes I, IA or IB and under which conditions, or, in cases where the requirements of Article 10 are not satisfied or the requisite information and data have not been submitted within the prescribed period, that such active substance shall not be included in Annex I, IA or IB. 3. Following such a decision to include or not to include an active substance in Annex I, IA or IB, Member States shall ensure that authorisations or, where relevant, registrations for biocidal products containing the active substances and complying with the provisions of this Directive are granted, modified or cancelled as appropriate. 4. Where, following a review of an active substance, it is concluded that the substance does not meet the requirements of Article 10 and consequently cannot be included in Annex I, IA or IB, the Commission shall bring forward proposals for restricting the marketing and use of that substance in accordance with Directive 76/769/EEC. 5. The provisions of Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and Regulations (44) shall continue to apply during the transitional period referred to in paragraph 2. Article 17 Research and development 1. By way of derogation from Article 3, Member States shall prescribe that any experiment or test for the purposes of research or development involving the placing on the market of an unauthorized biocidal product or an active substance intended exclusively for use in a biocidal product shall not take place unless: (a) in the case of scientific research and development, the persons concerned draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data, quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance and compile a dossier containing all available data on possible effects on human or animal health or impact on the environment. This information shall, if requested, be made available to the competent authority, (b) in the case of process-oriented research and development, the information required in (a) is notified to the competent authority where and before placing on the market occurs and to the competent authority of the Member State where the experiment or test is to be conducted. 2. Member States shall prescribe that an unauthorised biocidal product or an active substance for exclusive use in a biocidal product may not be placed on the market for the purpose of any experiment or test which may involve, or result in, release into the environment unless the competent authority has assessed the available data and issued an authorisation for this purpose which limits the quantities to be used and the areas to be treated and may impose further conditions. 3. Where any experiment or test takes place in a Member State other than the Member State where placing on the market occurs, the applicant shall obtain experiments or tests authorisation from the competent authority of the Member State in the territory of which the experiments or tests are to be conducted. If the proposed experiments or tests referred to in paragraphs 1 and 2 are liable to have harmful effects on human or animal health or to have an unacceptable adverse influence on the environment, the Member State concerned may either prohibit them or only allow them subject to such conditions as it considers necessary to prevent those consequences. 4. Paragraph 2 shall not apply if the Member State has granted the person concerned the right to undertake certain experiments and tests and has determined the conditions under which the experiments and tests have to be undertaken. 5. Common conditions for the application of this Article, in particular the maximum quantities of active substances or biocidal products that may be released during experiments, and the minimum data to be submitted in accordance with paragraph 2, shall be adopted in accordance with the procedure laid down in Article 28(2). Article 18 Information exchange 1. Within a period of one month from the end of each quarter, Member States shall inform each other and the Commission of any biocidal products which have been authorised or registered within their territory or for which an authorisation or registration has been refused, modified, renewed or cancelled, indicating at least: (a) the name or business name of the applicant for, or the holder of, the authorisation or registration; (b) the trade name of the biocidal product; (c) the name and amount of each active substance which it contains, as well as the name and amount of each dangerous substance in the meaning of Article 2(2) of Directive 67/548/EEC and their classification; (d) the product-type and the use or uses for which it is authorised; (e) the type of formulation; (f) any proposed limits on residues which have been established; (g) conditions of the authorisation and where relevant, the reasons for the modification or cancellation of an authorisation; (h) an indication of whether the product is of a special type (e.g. within a frame-formulation, low-risk biocidal product). 2. Where a Member State receives a summary of the dossiers in accordance with Articles 11 (1)(b) and 15(2) and has legitimate reason to believe the dossiers are incomplete, it shall immediately communicate its concerns to the competent authority responsible for the evaluation of the dossiers and shall without undue delay inform the Commission and other Member States of its concerns. 3. Each Member State shall draw up an annual list of the biocidal products authorised or registered in its territory and shall communicate that list to the other Member States and the Commission. 4. In accordance with the procedure laid down in Article 28(2), a standardised information system shall be set up to facilitate the application of paragraphs 1 and 2. 5. The Commission shall draw up a report on the implementation of this Directive and, in particular, on the functioning of the simplified procedures (frame-formulations, low-risk biocidal products and commodity substances) seven years after the date mentioned in Article 34(1). The Commission shall submit the report to the Council, accompanied by proposals if necessary. Article 19 Confidentiality 1. Without prejudice to Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment (45), an applicant may indicate to the competent authority the information which he considers to be commercially sensitive and disclosure of which might harm him industrially or commercially and which he therefore wishes to be kept confidential from all persons other than the competent authorities and the Commission. Full justification will be required in each case. Without prejudice to the information referred to in paragraph 3 and the provisions of Directives 67/548/EEC and 88/379/EEC, Member States shall take the necessary steps to ensure the confidentiality of the full composition of product formulations if requested by the applicant. 2. The competent authority receiving the application shall decide, on the basis of documentary evidence produced by the applicant, which information shall be confidential within the terms of paragraph 1. Information accepted as being confidential by the receiving competent authority shall be treated as being confidential by the other competent authorities, Member States and the Commission. 3. After the authorisation has been granted, confidentiality shall not in any case apply to: (a) the name and address of the applicant; (b) the name and address of the biocidal product manufacturer; (c) the name and address of the active substance manufacturer; (d) the names and content of the active substance or substances in the biocidal product and the name of the biocidal product; (e) the names of other substances which are regarded as dangerous within the meaning of Directive 67/548/EEC and contribute to the classification of the product; (f) physical and chemical data concerning the active substance and biocidal product; (g) any ways of rendering the active substance or biocidal product harmless; (h) a summary of the results of the tests required pursuant to Article 8 to establish the substance's or product's efficacy and effects on humans, animals and the environment and, where applicable, its ability to promote resistance; (i) recommended methods and precautions to reduce dangers from handling, storage, transport and use as well as from fire or other hazards; (j) safety data sheets; (k) methods of analysis referred to in Article 5(1)(c); (l) methods of disposal of the product and of its packaging; (m) procedures to be followed and measures to be taken in the case of spillage or leakage; (n) first aid and medical advice to be given in the case of injury to persons. If the applicant or manufacturer or importer of the biocidal product or active substance should later disclose previously confidential information, the competent authority shall be informed accordingly. 4. The detailed provisions and format for making information publicly available and for implementing this Article shall be decided in accordance with the procedures set out in Article 28(2). Article 20 Classification, packaging and labelling of biocidal products 1. Biocidal products shall be classified in accordance with the provisions relating to classification in Directive 88/379/EEC. 2. Biocidal products shall be packaged in accordance with Article 6 of Directive 88/379/EEC. In addition: (a) products which may be mistaken for food, drink or feedingstuff shall be packaged to minimize the likelihood of such a mistake being made; (b) products available to the general public which may be mistaken for food, drink or feedingstuff shall contain components to discourage their consumption. 3. Biocidal products shall be labelled in accordance with the provisions relating to labelling in Directive 88/379/EEC. Labels shall not be misleading or give an exaggerated impression of the product and, in any case, not mention the indications ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’ or similar indications. In addition, the label must show clearly and indelibly the following: (a) the identity of every active substance and its concentration in metric units; (b) the authorisation number allocated to the biocidal product by the competent authority; (c) the type of preparation (e.g. liquid concentrates, granules, powders, solids, etc.); (d) the uses for which the biocidal product is authorised (e.g. wood preservation, disinfection, surface biocide, anti-fouling, etc.); (e) directions for use and the dose rate, expressed in metric units, for each use provided for under the terms of the authorisation; (f) particulars of likely direct or indirect adverse side effects and any directions for first aid; (g) if accompanied by a leaflet, the - sentence ‘Read attached instructions before use’; (h) directions for safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on reuse of packaging; (i) the formulation batch number or designation and the expiry date relevant to normal conditions of storage; (j) the period of time needed for the biocidal effect, the interval to be observed between applications of the biocidal product or between application and the next use of the product treated, or the next access by man or animals to the area where the biocidal product has been used, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas; particulars for adequate cleaning of equipment; particulars concerning precautionary measures during use, storage and transport (e.g. personal protective clothing and equipment, measures for protection against fire, covering of furniture, removal of food and feedingstuff and directions to prevent animals from being exposed); and where applicable: (k) the categories of users to which the biocidal product is restricted; (l) information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water; (m) for microbiological biocidal products, labelling requirements according to Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (46). Member States shall require that items 3(a), (b), (d) and where applicable (g) and (k) always be carried on the label of the product. Member States shall permit items 3(c), (e), (f), (h), (i), (j) and (1) to be carried elsewhere on the packaging or on an accompanying leaflet integral to the packaging. These items of information shall be regarded as label information for the purposes of this Directive. 4. Where a biocidal product identified as insecticide, acaricide, rodenticide, avicide or molluscicide is authorised pursuant to this Directive and is also subject to classification, packaging and labelling according to Council Directive 78/63 I/EEC of 26 June 1978 on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides) (47) by virtue of other Community provisions, Member States shall permit changes to the packaging and labelling of that product which may be required as a consequence of those provisions in so far as they do not conflict with the conditions of an authorisation issued under this Directive. 5. Member States may require the provision of samples, models or drafts of the packaging, labelling and leaflets. 6. Member States shall make the placing of biocidal products on the market in their territories subject to them being labelled in their national language or languages. Article 21 Safety-data sheets Member States shall take the necessary measures to ensure that a system of specific information is established to enable professional and industrial users and, as appropriate, other users of biocidal products to take the necessary measures for the. protection of the environment and health as well as health and safety at the workplace. This shall be done in the form of a safety-data sheet provided by those responsible for the placing on the market of the product. The safety-data sheets shall be prepared: — for biocidal products classified as dangerous and in accordance with Article 10 of Directive 88/379/EEC, — for active substancess used exclusively in biocidal products in accordance with the requirements of Article 27 of Directive 67/548/EEC. Article 22 Advertising 1. Member States shall require that every advertisement for a biocidal product is accompanied by the sentences ‘Use biocides safely. Always read the label and product information before use’. The sentences shall be clearly distinguishable in relation to the whole advertisement. Member States shall prescribe that advertisers may replace the word ‘Biocides’ in the prescribed sentences with an accurate description of the product-type being advertised, for example wood preservatives, disinfectants, surface biocides, anti-fouling products, etc. 2. Member States shall require that advertisements for biocidal products do not refer to the product in a manner which is misleading in respect of the risks from the product to man or the environment. Under no circumstances may the advertising of a biocidal product mention ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’ or any similar indications. Article 23 Poison control Member States shall appoint a body or bodies responsible for receiving information on biocidal products which have been placed on the market, including information on the chemical composition of such products, and for making such information available in cases where suspected poisoning arises from biocidal products. Such information may only be used to meet any medical demand by formulating preventive and curative measures, in particular in emergencies. Member States shall ensure that the information is not used for other purposes. Member States shall take the necessary steps to ensure that the appointed bodies provide all the requisite guarantees for maintaining the confidentiality of the information received. Member States shall ensure that the appointed bodies have at their disposal all the information required to carry out the tasks for which they are responsible from the manufacturers or persons responsible for marketing. For biocidal products already on the market on the date referred to in Article 34(1), Member States shall take measures to comply with this Article within three years of the date referred to Article 34(1). Article 24 Compliance with requirements Member States shall take the necessary arrangements for biocidal products which have been placed on the market to be monitored to establish whether they comply with the requirements of this Directive. Every three years after the date referred to in Article 34(1), Member States shall forward to the Commission by 30 November of the third year a report on their action in these matters together with information on any poisonings involving biocidal products. The Commission shall within one year of receipt of this information prepare and publish a composite report. Article 25 Charges Member States shall establish systems obliging those having placed or seeking to place biocidal products on the market and those supporting entries for active substances on Annexes I, IA or IB to pay charges, corresponding as far as possible to their costs in carrying out all the different procedures associated with the provisions of this Directive. Article 26 Competent authorities 1. Member States shall designate a competent authority or competent authorities responsible for carrying out the duties imposed on Member States pursuant to this Directive. 2. Member States shall inform the Commission of the identity of their competent authority or competent authorities, not later than the date referred to in Article 34(1). Article 27 Commission procedures 1. When the Commission receives from a Member State either: (a) an evaluation and recommendations concerning an active substance in accordance with Article 11(2) and/or an assessment according to Article 10(5), or (b) a proposal to refuse an authorisation or a registration and an explanatory document in accordance with Article 4(4), it shall allow a period of 90 days during which other Member States and the applicant may submit comments to it in writing. 2. At the end of the period for comment, the Commission shall, on the basis of: — the documents received from the Member State evaluating the dossiers and, — any advice obtained from advisory scientific committees, — comments received from other Member States and the applicants and, — any other relevant information, prepare a draft for decision in accordance with the relevant procedures laid down in Article 28(2) or 28(3). 3. The Commission shall ask the applicant and/or his authorised representative to submit remarks to it, unless a favourable decision is envisaged. Article 28 Committees and procedures 1. The Commission shall be assisted by a Standing Committee on Biocidal Products (the Standing Committee). The Standing Committee shall be composed of representatives of the Member States and chaired by a representative of the Commission. The Standing Committee shall adopt its own rules of procedure. 2. For matters referred to the Standing Committee by virtue of Articles 4, 11(3), 15, 17, 18, 19, 27(l)(b), 29 and 33 and the elaboration of specific data by product type referred to in Annex V, to be drawn from Annexes IIIA and IIIB and, as appropriate, from Annexes IVA and IVB, the representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. The Commission shall adopt the measures envisaged which shall apply immediately. However, if these measures are not in accordance with the opinion of the Committee, they shall be communicated by the Commission to the Council forthwith. In that event: The Commission shall defer application of the measures which it has decided for a period of three months from the date of communication. The Council, acting by a qualified majority, may take a different decision within the time limit referred to in the previous subparagraph. 3. For matters referred to the Standing Committee by virtue of Articles 10, 11(4), 16, 27(l)(a) and (2), and 32, the representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority. Article 29 Adaptation to technical progress The amendments necessary for adapting Annexes IIA, IIB, IIIA, IIIB, IVA and IVB, the descriptions of the product-types in Annex V to technical progress and for specifying data requirements for each of these product types, shall be adopted in accordance with the procedure laid down in Article 28(2). Article 30 Modification or adaptation of Annexes V and VI Acting on a proposal from the Commission, the Council and the European Parliament shall, in accordance with the procedures laid down in the Treaty, modify or adapt to technical progress the titles of the product-types of Annex V and the provisions of Annex VI. Article 31 Civil and criminal liability The granting of authorisation and all other measures in conformity with this Directive shall be without prejudice to general civil and criminal liability in the Member States of the manufacturer and, where applicable, of the person responsible for placing the biocidal product on the market or using it. Article 32 Safeguard clause Where a Member State has valid reasons to consider that a biocidal product which it has authorised, registered or is bound to authorise or register pursuant to Articles 3 or 4, constitutes an unacceptable risk to human or animal health or the environment, it may provisionally restrict or prohibit the use or sale of that product on its territory. It shall immediately inform the Commission and the other Member States of such action and give reasons for its decision. A decision shall be taken on the matter within 90 days in accordance with the procedure laid down in Article 28(3). Article 33 Technical notes for guidance The Commission, in accordance with the procedure laid down in Article 28(2), shall draw up technical notes for guidance to facilitate the day-to-day implementation of this Directive. These technical notes shall be published in the ‘C’ series of the Official Journal of the European Communities. Article 34 Implementation of the Directive 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 24 months after its entry into force. They shall forthwith inform the Commission thereof. 2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 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 35 This Directive shall enter into force on the 20th day following its publication. Article 36 This Directive is addressed to the Member States.

31998L0010

1998

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 Having regard to the Treaty establishing the European Community, and in particular Article 100a 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 189b of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 14 January 1998, (1) Whereas from 1 January 1998, with transition periods for certain Member States, the provision of telecommunications services and infrastructure in the Community will be liberalised; whereas the Council (4), the European Parliament (5), the Economic and Social Committee (6) and the Committee of the Regions have all recognised that liberalisation goes hand in hand with parallel action to create a harmonised regulatory framework which secures the delivery of universal service; whereas the concept of universal service must evolve to keep pace with advances in technology, market developments and changes in user demand; whereas progress has been made in the Community towards defining the scope of universal service and laying down rules for its costing and financing (7); whereas the Commission has undertaken to publish a report on the monitoring of the scope, level, quality and affordability of the universal telephone service in the Community before 1 January 1998, and at regular intervals thereafter; (2) Whereas 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 (8), provides a general framework for the application of ONP principles in specific areas; (3) Whereas Article 32(1) of European Parliament and Council Directive 95/62/EC of 13 December 1995 on the application of open network provision (ONP) to voice telephony (9) calls for the European Parliament and the Council to decide by 1 January 1998, on the basis of a proposal submitted by the Commission, on the revision of the Directive to adapt it to the requirements of market liberalisation; whereas Directive 95/62/EC does not apply to mobile telephony services; whereas in view of the growing demand for mobile telephony services it is appropriate that certain provisions of this Directive should apply to mobile telephony services; whereas this Directive does not prevent Member States, in conformity with Community law, from extending the application of provisions of the Directive to mobile networks and/or services even if they are not explicitly mentioned in its scope; whereas, in moving to a competitive market, there are certain obligations which should apply to all organisations providing telephone services over fixed networks and whereas there are others which should apply only to organisations enjoying significant market power or which have been designated as a universal service operator in accordance with Article 5; whereas full account has been taken of the user and consumer requirements for affordability, cost control and user facilities as expressed in the public consultation on universal service for telecommunications; whereas, since the modifications required to Directive 95/62/EC are substantial, it is convenient for the sake of clarity to reformulate the said Directive; whereas this Directive does not affect the timescale for Member States' implementation of Directive 95/62/EC, as set out in Annex IV; (4) Whereas a fundamental requirement of universal service is to provide users on request with a connection to the fixed public telephone network at a fixed location, at an affordable price; whereas there should be no constraints on the technical means by which the connection is provided, allowing for wire or wireless technologies; whereas fixed public telephone network infrastructure newly installed after 1 January 1998 should be of a quality which supports, in addition to speech, data communications at rates suitable for access to online information services; whereas affordable price means a price which the Member States define at national level in the light of specific national conditions, including town and country planning aspects, after carrying out the consultation referred to in Article 24; whereas the Commission is to prepare reports on the evolution of tariffs throughout the Community on the basis of the rules and criteria for ensuring affordability published at national level and in doing so may carry out additional consultation at the European level; whereas 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; whereas, in relation to the provisions for affordable services for users in rural or high cost areas, Member States may make exceptions for holiday homes; (5) Whereas tariff rebalancing is leading to a move away from non-cost oriented tariffs; whereas, until competition is effectively established, safeguards may be necessary to ensure that price increases in remote or rural areas are not used to compensate for losses in revenue resulting from price decreases elsewhere; whereas tariff rebalancing is an essential feature of a competitive market; whereas price caps or geographical averaging or similar schemes may be used to ensure that the necessary rebalancing does not unduly affect users and does not endanger the affordability of telephone services; (6) Whereas the importance of the fixed public telephone network and service is such that the latter should be available to anyone reasonably requesting it; whereas, in accordance with the principle of subsidiarity, it is for Member States to decide on the basis of objective criteria which organisations have the responsibility for providing the universal service for telecommunications as defined in this Directive, taking into account the ability and, where appropriate, the willingness of organisations to provide all or part of it; whereas corresponding obligations could be included as conditions in authorisations to provide publicly available telephone services; whereas, in accordance with Article 5(1) 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) (10), Member States may establish mechanisms for sharing the net cost of the universal service obligations with other organisations operating public telecommunications networks and/or publicly available voice telephony services; whereas public telecommunications networks include both public fixed networks and public mobile networks; whereas national regulatory authorities should satisfy themselves that those organisations benefiting from universal service funding provide sufficient level of detail of the specific elements requiring such funding in order to justify their request; whereas, in accordance with Community law, Member States' schemes for the costing and financing of universal service will be communicated to the Commission for verification of compatibility with the Treaty; (7) Whereas provision of directory services is a competitive activity; whereas 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 regulates the processing of personal data (11); whereas 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 (12), in particular in the Integrated Services Digital Network (ISDN) and in digital mobile networks, will give the subscriber the right to be omitted, or to have certain data omitted, from a printed or electronic directory at his or her request; whereas users and consumers desire comprehensive directories and directory enquiry service covering all listed telephone subscribers and their numbers (including fixed, mobile and personal telephone numbers); whereas the situation whereby certain telephone directories and directory services are provided in a manner which is perceived to be free of charge to the user is not affected by this Directive; (8) Whereas Member States shall, where appropriate, take suitable measures in order to guarantee access to and affordability of all fixed public telephone services for disabled users and users with special social needs; whereas specific measures for disabled users could include, as appropriate, making available public text telephones or equivalent measures for deaf or speech impaired people, providing services such as directory enquiry services free of charge or equivalent measures for blind or partially sighted people, and providing itemised bills in alternative format on request for blind or partially sighted people; (9) Whereas Council Decision 91/396/EEC of 29 July 1991 on the introduction of a single European emergency call number (13) called for Member States to ensure that no later than 31 December 1996 the number '112` is introduced in public telephone networks as the single European emergency call number; whereas it is important that users are 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 coins or cards; (10) Whereas transparency of network interface specifications is a prerequisite for a competitive market in terminal equipment; whereas the national regulatory authority may consult the interested parties and especially terminal equipment suppliers and the representatives of the users and consumers on the changes in existing network interface specifications; (11) Whereas Directive 97/13/EC (14) provides for a common framework for general authorisations and individual licences in the field of telecommunications services; whereas quality and price are key factors in a competitive market and whereas national regulatory authorities should be able to monitor achieved quality of service for organisations with significant market power or which have been designated in accordance with Article 5; whereas national regulatory authorities should also be able to monitor the achieved quality of services by other organisations providing fixed public telephone networks and/or fixed public telephone services where the latter have been operating for more than 18 months and where the national regulatory authority deems it necessary; whereas, in relation to the quality of service attained by both types of organisations, national regulatory authorities shall be able to take appropriate corrective measures where they deem it necessary; whereas the Commission will report by 1 January 1998, and at regular intervals thereafter, on the quality, level and scope of universal service in the European Community, as indicated in its Communication of 13 March 1996 on Universal Service for Telecommunications in the perspective of a fully liberalised environment; whereas these powers are without prejudice to the application of competition law by national and Community authorities; (12) Whereas conditions on access to and use of fixed public telephone networks or publicly available telephone services may be imposed exceptionally by a Member State on the grounds of essential requirements; whereas national regulatory authorities should have procedures to address at least those situations where an organisation providing voice telephony services which has significant market power or has been designated in accordance with Article 5 and has significant market power interrupts, reduces or varies the availability of services to organisations providing telecommunications networks and/or services; whereas, 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; whereas in some Member States such access may continue to be provided only if the subscriber continues to pay line rental charges; whereas the provisions of this Directive do not prevent a Member State from taking measures justified on grounds set out in Articles 36 and 56 of the Treaty, in particular on grounds of public security, public policy and public morality; (13) Whereas tone dialling and itemised billing facilities are normally available on modern telephone exchanges and can therefore be provided inexpensively once old exchanges are modernised or new exchanges installed; whereas tone dialling is increasingly being used for interaction with special services and facilities, including value added services, and whereas lack of this facility can prevent users from accessing certain services; whereas itemised billing and selective call barring are valuable means for users to control and monitor their usage of telephone networks; whereas Directive 97/66/EC on the processing of personal data and the protection of privacy in the telecommunications sector safeguards the privacy of users with regard to itemised billing, gives them the means to protect their right to privacy when calling line identification is implemented and safeguards them against nuisance which may be caused by call forwarding; whereas 'number portability` is a facility whereby end users who so request can retain their number(s) on the fixed public telephone network at a specific location independently of the organisation providing service; whereas harmonised technical interface standards have been drawn up by the European standardisation organisations for access to the Integrated Services Digital Network (ISDN) at what is known as the S/T reference point; (14) Whereas price transparency should ensure that residential subscribers do not subsidise discounts to business customers; whereas certain obligations concerning tariffs and cost accounting systems will no longer be appropriate once competition is introduced and whereas others can be relaxed by the competent national regulatory authority as soon as competition achieves the desired objectives; whereas in all cases the non-discrimination requirements of the competition rules of Community law apply; whereas the requirement for unbundling does not prevent facilities from being combined in a tariff package, provided this practice is not used to unduly restrict the users' freedom of choosing their suppliers for the different services they may wish to use; (15) Whereas issues related to the level of affordability, quality of service and future scope of the universal service should be the subject of consultation at national level with all interested parties; whereas this requires that adequate information on the level, quality and affordability of universal service is available; whereas disabled users should, wherever possible, receive a broadly similar level of services compared to other users in terms of their access to or use of telephone services; (16) Whereas the Commission has to be able to monitor effectively the application of this Directive and whereas European users need to know where to find published information on telephone services in other Member States; whereas, in accordance with Directive 97/13/EC on licensing, national regulatory authorities shall not disclose information covered by the obligation of professional secrecy, except where such disclosure is essential for the purpose of fulfilling their duties; (17) Whereas, in view of the forecast convergence of fixed and mobile telephone services, the extent to which this Directive applies to mobile services should be re-examined when the Directive is reviewed; whereas the review date of 31 December 1999 will allow for a coordinated review of all the ONP Directives in the light of experience with the liberalisation of public telecommunications networks and voice telephony services; whereas the review should also examine the removal of obligations no longer needed in a market where there is effective competition; (18) Whereas the essential goals of ensuring universal service for telecommunications for all European users and of harmonising conditions for access to and use of fixed public telephone networks and publicly available telephone services cannot be realised satisfactorily at Member State level; (19) Whereas a modus vivendi was concluded on 20 December 1994 between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty, CHAPTER I SCOPE, AIM AND DEFINITIONS Article 1 Scope and Aim 1. This Directive concerns the harmonisation of conditions for open and efficient access to and use of fixed public telephone networks and fixed public telephone services in an environment of open and competitive markets, in accordance with the principles of open network provision (ONP). The aims are to ensure the availability throughout the Community of good quality fixed public telephone services and to define the set of services to which all users, including consumers, should have access in the context of universal service in the light of specific national conditions, at an affordable price. 2. This Directive does not apply to public mobile telephone networks and public mobile telephone services, with the exception of Articles 6, 9(b) and (c), 10 and 11(1). 3. This Directive replaces Directive 95/62/EC. Article 2 Definitions 1. The definitions given in Directive 90/387/EEC shall apply, where relevant to this Directive. 2. For the purposes of this Directive: (a) 'users` means individuals, including consumers, or organisations using or requesting publicly available telecommunications services; (b) 'consumer` means any natural person who uses a publicly available telecommunications service for purposes which are outside his or her trade, business or profession; (c) 'subscriber` shall mean any natural or legal person who or which is party to a contract with the provider of publicly available telecommunications services for the supply of such services; (d) 'public pay-telephone` means a telephone available to the general public, for the use of which the means of payment are coins and/or credit/debit cards and/or pre-payment cards; (e) 'voice telephony service` means a service available to the public for the commercial provision of direct transport of real-time speech via the public switched network or networks such that any user can use equipment connected to a network termination point at a fixed location to communicate with another user of equipment connected to another termination point; (f) 'universal service` means a defined minimum set of services of specified quality which is available to all users independent of their geographical location and, in the light of specific national conditions, at an affordable price; (g) 'national regulatory authority` means the body or bodies in each Member State entrusted by that Member State with, inter alia, the regulatory functions addressed in this Directive; (h) 'ONP Committee` means the Committee created by Article 9(1) of Directive 90/387/EEC; (i) 'organisation with significant market power` means an organisation authorised to provide fixed public telephone networks and/or voice telephony services in a Member State which, for the purpose of this Directive, has been designated by the national regulatory authority in that Member State as having significant market power and notified to the Commission. An organisation shall be presumed to have significant market power when it has a share of 25 % or more of the relevant market in the geographical area in a Member State within which it is authorised to operate. National regulatory authorities may determine that an organisation with a market share of less than 25 % in the relevant market has significant market power. They may also determine that an organisation with a market share of more than 25 % in the relevant market does not have significant market power. In either case, the determination shall take into account the organisation's ability to influence market conditions, its turnover relative to the size of the market, its control of the means of access to end-users, its access to financial resources and its experience in providing products and services in the market. 3. For the purposes of this Directive: (a) The terms 'fixed public telephone network` and 'public mobile telephone network` are described in Annex I of Directive 97/33/EC on Interconnection. (b) The term 'publicly available telephone services` includes both fixed public telephone services and public mobile telephone services. Fixed public telephone services, as indicated in Annex I part I of Directive 97/33/EC on Interconnection, may include - in addition to voice telephony service - access to emergency '112` services, the provision of operator assistance, directory services, provision of public pay phones, provision of service under special terms and/or provision of special facilities for customers with disabilities or with special social needs, as set out in this Directive, but does not include value added services provided over the public telephone network. CHAPTER II PROVISION OF A DEFINED SET OF SERVICES WHICH MAY BE FUNDED IN THE CONTEXT OF UNIVERSAL SERVICE Article 3 Availability of services 1. Member States shall ensure that the services set out in this Chapter are made available to all users in their territory, independent of geographical location, and, in light of specific national conditions, at an affordable price. Taking into account the progressive adjustment of tariffs towards costs, Member States shall in particular maintain the affordability of the services set out in this Chapter for users in rural or high cost areas and for vulnerable groups of users such as the elderly, those with disabilities or those with special social needs. To this end, Member States shall remove obligations which prevent or restrict the use of special or targeted tariff schemes for the provision of the services specified in this Directive and may, in accordance with Community law, implement price caps or geographical averaging or other similar schemes for some or all of the specified services until such time as competition provides effective price control. Schemes designed to ensure affordability shall follow the principles of transparency and non-discrimination. Member States shall publish the rules and criteria for ensuring affordability at the national level, taking into account Article 24. 2. Member States shall publish regular reports on the evolution of tariffs which should be made available to the public. The Commission shall publish regular reports on the evolution of tariffs throughout the Community. Article 4 Financing schemes Where the services set out in this Chapter cannot be commercially provided on the basis of conditions laid down by the Member State, Member States may set up universal service funding schemes for the shared financing of those services, in conformity with Community law and, in particular, with Directive 97/33/EC on Interconnection. National regulatory authorities shall ensure that organisations benefiting from such a shared financing scheme make a declaration to their national regulatory authority indicating the specific elements for which funding is requested, the information referred to in Article 5 of Directive 97/33/EC on Interconnection being made available to interested parties on request, in accordance with Article 11(4). Member States may impose additional requirements concerning the provision of telecommunication services in accordance with existing Community law. Such additional requirements may not have an impact on the costing of universal service provision as laid down at Community level and may not be financed from a mandatory contribution by market players. Article 5 Provision of network connections and access to telephone services 1. Member States shall ensure that all reasonable requests for connection to the fixed public telephone network at a fixed location and access to fixed public telephone services are met by at least one operator and may, if necessary to this end, designate one or more operators so that the whole of their territory is covered. 2. The connection provided shall be capable of allowing users to make and receive national and international calls, supporting speech, facsimile and/or data communications. Article 6 Directory services 1. The provisions of this Article are subject to the requirements of relevant legislation on the protection of personal data and privacy, such as Directive 95/46/EC and Directive 97/66/EC. 2. Member States shall ensure that: (a) subscribers have the right to have an entry in publicly available directories and to verify and, if necessary, correct or request removal of that entry; (b) directories of all subscribers who have not expressed opposition to being listed, including fixed, mobile and personal numbers, are available to users in a form approved by the national regulatory authority, whether printed or electronic, or both, and are updated on a regular basis; (c) at least one telephone directory enquiry service covering all listed subscribers numbers is available to all users, including users of public pay telephones; 3. In order to ensure provision of the services referred to in paragraph 2(b) and 2(c), Member States shall ensure that all organisations which assign telephone numbers to subscribers meet all reasonable requests to make available the relevant information in an agreed format on terms which are fair, cost oriented and non-discriminatory. 4. Member States shall ensure that organisations providing the service referred to in paragraph 2(b) and 2(c) follow the principle of non-discrimination in their treatment and presentation of information provided to them. Article 7 Public pay telephones 1. Member States shall ensure that public pay telephones are provided to meet the reasonable needs of users in terms of both numbers and geographical coverage. A Member State may authorise its national regulatory authority not to apply the requirements of this paragraph in all or part of its territory if it is satisfied that these facilities are widely available. 2. Member States shall ensure that it is possible to make emergency calls from public pay telephones using the single European emergency call number '112` referred to in Decision 91/396/EEC and other national emergency numbers, all free of charge and without having to use coins or cards. Article 8 Specific measures for disabled users and users with special social needs Member States shall, where appropriate, take specific measures to ensure equal access to and affordability of fixed public telephone services, including directory services for disabled users and users with special social needs. CHAPTER III SPECIFIC PROVISIONS CONCERNING ORGANISATIONS PROVIDING FIXED AND/OR MOBILE PUBLIC TELEPHONE NETWORKS AND/OR PUBLICLY AVAILABLE TELEPHONE SERVICES Article 9 Connection of terminal equipment and use of the network Member States shall ensure that all users provided with a connection to the fixed public telephone network can: (a) connect and use terminal equipment suitable for the connection provided, in accordance with national and Community law; (b) access operator assistance services and directory enquiry services in accordance with Article 6.2(c), unless the subscriber decides otherwise; (c) access Emergency Services at no charge, using the dialling code '112` and any other dialling codes specified by national regulatory authorities for use at a national level. Member States shall ensure that mobile users can also access the services mentioned in (b) and (c). Article 10 Contracts 1. National regulatory authorities shall ensure that organisations providing access to fixed public telephone networks and mobile public telephone networks provide a contract. The contract shall specify the service to be provided or shall make reference to publicly available terms and conditions. The contract or the publicly available terms and conditions shall at least specify the supply time for initial connection and the types of maintenance service offered, the compensation and/or refund arrangements for subscribers which apply if the contracted service is not met and a summary of the method of initiating procedures for the settlement of disputes in accordance with Article 26 and shall provide information on service quality levels offered. 2. National regulatory authorities or other competent bodies according to national legislation shall be able on their own initiative or upon request by an organisation representing user or consumer interests to require the alteration of the conditions of contracts referred to in paragraph 1 and the conditions of any compensation and/or refund schemes used insofar as they concern the provisions of this Directive in order to protect the rights of users and/or subscribers. Article 11 Publication of and access to information 1. Member States shall ensure that all organisations providing fixed public telephone networks and mobile public telephone networks or publicly available telephone services publish adequate and up-to-date information for consumers on their standard terms and conditions with regard to access to and use of the public telephone networks and/or publicly available telephone services. In particular, national regulatory authorities shall ensure that tariffs for end-users, any minimum contractual period, if relevant, and conditions of renewal of the contracts are presented clearly and accurately. 2. National regulatory authorities shall ensure that organisations providing fixed public telephone networks provide them with details of technical interface specifications for network access, as identified in Annex II, part 1, to be made available in accordance with paragraph 4. Changes in existing network interface specifications and information on new network interface specifications shall be communicated to the national regulatory authority in advance of implementation. The national regulatory authority may lay down a suitable period of notice. 3. Where and for as long as the provision of fixed public telecommunications networks and voice telephony services are subject to special or exclusive rights in a Member State, national regulatory authorities shall ensure that adequate and up-to-date information on access to and use of the fixed public telecommunications networks and fixed public telephone services is published according to the list of headings given in Annex II, part 2 in the manner laid down in paragraph 4. 4. National regulatory authorities shall ensure that the information is made available in an appropriate manner in order to provide easy access to that information for interested parties. Reference to the manner in which this information is published shall be made in the national Official Gazette of the Member State concerned. 5. National regulatory authorities shall notify to the Commission by no later than 30 June 1998 the manner in which the information referred to in paragraphs 2 and 3 is made available. The Commission shall regularly publish a reference to such notifications in the Official Journal of the European Communities. Any changes shall be notified immediately. Article 12 Quality of service 1. Member States shall be able to set the quality of services identified in this Directive for organisations providing fixed public telephone networks and/or fixed public telephone services in accordance with the procedures set out in this Article. In accordance with Directive 97/13/EC on Licensing, they may to this end set performance targets in the individual licences, in particular for organisations which have significant market power in the provision of fixed public telephone networks and/or voice telephony services or which have been designated in accordance with Article 5. In the case of organisations which retain special or exclusive rights for the provision of fixed public telecommunications networks and/or voice telephony services, Member States shall ensure that targets are set and published for the relevant parameters laid down in Annex III, in accordance with Article 11(4). 2. National regulatory authorities shall ensure that organisations with significant market power or which have been designated in accordance with Article 5 start to keep up-to-date information concerning their performance based on the parameters, definitions and measurement methods laid down in Annex III. National regulatory authorities shall also be able to request that other organisations which have been providing fixed public telephone networks and/or fixed public telephony services for more than 18 months do the same. This information shall be provided to the national regulatory authority on request. 3. Where appropriate, and taking account of, in particular, the views of interested parties in accordance with the provisions of Article 24, national regulatory authorities shall ensure publication, in accordance with Article 11(4), of the performance data referred to in paragraph 1 and may set performance targets for organisations providing fixed public telephone networks and/or fixed public telephone services which either have significant market power or have been designated in accordance with Article 5 where such targets do not exist already. Persistent failure by an organisation to meet performance targets may result in specific measures being taken in accordance with conditions set out in the relevant authorisation for that organisation. 4. National regulatory authorities shall have the right to call for independent audits of the performance data in order to ensure the accuracy and comparability of the data made available by the organisations referred to in paragraph 2. Article 13 Conditions of access and use and essential requirements 1. Without prejudice to the procedure for the resolution of national disputes laid down in Article 26(1), national regulatory authorities shall have procedures in order to address situations where organisations providing fixed public telephone networks and/or fixed public telephone services, or at least those organisations providing voice telephony services which either have significant market power or have been designated in accordance with Article 5 and have significant market power, take measures such as the interruption, termination, significant variation or reduction in availability of services at least to organisations providing telecommunications networks and/or services. The national regulatory authority shall ensure that these procedures provide for a transparent decision-making process in which due respect is given to the rights of the parties. The decision shall be taken after both parties have been given the opportunity to state their case. The decision shall be duly substantiated and notified to the parties within one week of its adoption. A summary of these procedures shall be published in the manner laid down in Article 11(4). This provision shall not prejudice the rights of the parties concerned to apply to the courts. 2. Member States shall ensure that, when access to or use of fixed public telephone networks and/or the fixed public telephone services is restricted on the basis of essential requirements, the relevant national provisions identify which of the essential requirements set out in (a) to (e) below are the basis of such restrictions. These restrictions shall be imposed through regulatory means and shall be published in the manner laid down in Article 11(4). Without prejudice to action which may be taken in accordance with Articles 3(5) and 5(3) of Directive 90/387/EEC, the following essential requirements shall apply to the fixed public telephone network and fixed public telephone services in the following manner: (a) security of network operations Member States shall take all necessary steps to ensure that the availability of fixed public telephone networks and of fixed public telephone services is maintained in the event of catastrophic network breakdown or in cases of force majeure, such as extreme weather, earthquake, flood, lightning or fire. In the event of the circumstances referred to in the first subparagraph, the bodies concerned shall make every endeavour to maintain the highest level of service to meet any priorities laid down by the competent authorities. National regulatory authorities shall ensure that any restrictions on access to and use of the fixed public telephone network on the grounds of the security of networks are proportionate and non-discriminatory and are based on objective criteria identified in advance. (b) maintenance of network integrity Member States shall take all necessary steps to ensure that the integrity of the fixed public telephone network is maintained. National regulatory authorities shall ensure that restrictions on access to and use of the fixed public telephone network on the grounds of maintenance of network integrity, in order to protect, inter alia, network equipment, software or stored data, are kept to the minimum necessary to provide for normal operation of the network. Such restrictions shall be non-discriminatory and based on objective criteria identified in advance. (c) interoperability of services When terminal equipment is operating in compliance with Directive 91/263/EEC (15), no further restrictions on use shall be imposed on the grounds of interoperability of services. (d) protection of data Conditions on access to and use of fixed public telephone networks and/or fixed public telephone services based on the grounds of protection of data may be imposed only in accordance with relevant legislation on the protection of personal data and privacy, such as Directive 95/46/EC and Directive 97/66/EC. (e) effective use of the frequency spectrum Member States shall take all necessary steps to ensure the effective use of the frequency spectrum and the avoidance of harmful interference between radio-based systems which could restrict or limit access to or use of fixed public telephone networks and fixed public telephone services. 3. Where and for as long as Member States maintain special or exclusive rights for the provision of public telecommunications networks and voice telephony services, conditions imposed on users on the basis of such special or exclusive rights shall be imposed through regulatory means under the authority of the national regulatory authority. Article 14 Itemised billing, tone dialling and selective call barring 1. In order to ensure that users have access over fixed public telephone networks as early as possible to the facilities of: - tone dialling, - itemised billing and selective call barring as facilities available on request, Member States may designate one or more operators to provide these facilities to most telephone users before 31 December 1998 and to ensure that they are generally available by 31 December 2001. A Member State may authorise its national regulatory authority not to apply the requirements of this paragraph in all or part of its territory if it is satisfied that these facilities are widely available. Tone dialling and selective call barring are specified in Annex I, part 1. 2. Subject to the requirements of relevant legislation on the protection of personal data and privacy, such as Directive 95/46/EC and Directive 97/66/EC, itemised bills shall show a sufficient level of detail to allow verification and control of the charges incurred in using the fixed public telephone network and/or fixed public telephone services. A basic level of itemised billing shall be available at no extra charge to the user. Where appropriate, additional levels of detail may be offered to subscribers at reasonable tariffs or at no charge. National regulatory authorities may lay down the basic level of itemised bills. Calls which are free of charge to the calling subscriber, including calls to helplines, shall not be identified in the calling subscriber's itemised bill. Article 15 Provision of additional facilities 1. National regulatory authorities shall ensure that organisations providing voice telephony services, which either have significant market power or have been designated in accordance with Article 5 and have significant market power, provide, subject to technical feasibility and economic viability, the facilities listed in Annex I, part 2. 2. Subject to the requirements of relevant legislation on the protection of personal data and privacy, such as Directive 95/46/EC and Directive 97/66/EC, Member States shall take all necessary measures to remove any regulatory restrictions which prevent provision of the services and facilities listed in Annex I, part 3, in compliance with the competition rules of Community law. 3. National regulatory authorities shall ensure that dates for the introduction of the facilities listed in Annex I, part 2 are set, taking into account the state of network development, market demand and progress with standardisation, and are published in the manner laid down in Article 11(4). 4. Where the facility of number portability, as referred to in Article 12(5) of Directive 97/33/EC on Interconnection, is not yet in use, national regulatory authorities shall ensure that, for a reasonable period after a subscriber has changed supplier, either a telephone call to his old number can be re-routed to his new number for a reasonable fee or callers are given an indication of the new number, without charging the called party for this service. National regulatory authorities shall ensure that any fees for the above facilities are reasonable. Article 16 Special network access 1. National regulatory authorities shall ensure that organisations with significant market power in the provision of fixed public telephone networks deal with reasonable requests from organisations providing telecommunications services for access to the fixed public telephone network at network termination points other than the commonly provided network termination points referred to in Annex II, part 1. This obligation may only be limited on a case-by-case basis and on the grounds that there are technically and commercially viable alternatives to the special access requested, and if the requested access is inappropriate in relation to the resources available to meet the request. 2. The organisation making such a request shall be granted an opportunity to put its case to the national regulatory authority before a final decision is taken to restrict or deny access in response to a particular request. Where a request for special network access is denied, the organisation making the request should be given a prompt and justified explanation of why the request has been refused. 3. Technical and commercial arrangements for special network access shall be a matter for agreement between the parties involved, subject to intervention by the national regulatory authority as laid down in paragraphs 2, 4 and 5. The agreement may include reimbursement to the organisation of its costs incurred in providing the network access requested; these charges shall fully respect the principles of cost orientation set out in Annex II to Directive 90/387/EEC. 4. National regulatory authorities may intervene on their own initiative at any time, where justified, in order to ensure effective competition and/or interoperability of services and shall do so, if requested by either party, in order to set conditions which are non-discriminatory, fair and reasonable for both parties and offer the greatest benefit to all users. 5. National regulatory authorities shall also have the right, in the interest of all users, to ensure that the agreements include conditions which meet the criteria set out in paragraph 4, are entered into and implemented in an efficient and timely manner and include conditions on conformity with relevant standards, compliance with essential requirements and/or the maintenance of end-to-end quality. 6. Conditions set by national regulatory authorities in accordance with paragraph 5 shall be published in the manner laid down in Article 11(4). 7. National regulatory authorities shall ensure that organisations with significant market power referred to in paragraph 1 adhere to the principle of non-discrimination when they make use of the fixed public telephone network and, in particular, use any form of special network access, for providing publicly available telecommunications services. Such organisations shall apply similar conditions in similar circumstances to organisations providing similar services and shall provide special network access facilities and information to others under the same conditions and of the same quality as they provide for their own services or those of their subsidiaries or partners. 8. Where appropriate, the Commission shall, in consultation with the ONP Committee, acting in accordance with the procedure laid down in Article 29, request the European Telecommunications Standards Institute (ETSI) to draw up standards for new types of network access. Reference to such standards shall be published in the Official Journal of the European Communities in accordance with Article 5 of Directive 90/387/EEC. 9. Details of agreements for special network access shall be made available to the national regulatory authority on request. Without prejudice to the rights and obligations referred to in Article 20(2) of Directive 97/13/EC on Licensing, national regulatory authorities shall keep confidential those parts of the agreements referred to in paragraph 3 which deal with the commercial strategy of the parties. Article 17 Tariff principles 1. Without prejudice to the specific provisions of Article 3 in relation to affordability or to paragraph 6, national regulatory authorities shall ensure that organisations providing voice telephony services which either have significant market power or have been designated in accordance with Article 5 and have significant market power comply with the provisions of this Article. 2. Tariffs for use of the fixed public telephone network and fixed public telephone services shall follow the basic principles of cost orientation set out in Annex II to Directive 90/387/EEC. 3. Without prejudice to Article 7(3) of Directive 97/33/EC on Interconnection, tariffs for access to and use of the fixed public telephone network shall be independent of the type of application which the users implement, except to the extent that they require different services or facilities. 4. Tariffs for facilities additional to the provision of connection to the fixed public telephone network and fixed public telephone services shall, in accordance with Community law, be sufficiently unbundled so that the user is not required to pay for facilities which are not necessary for the service requested. 5. Tariff changes shall be implemented only after an appropriate public notice period, set by the national regulatory authority, has been observed. 6. Without prejudice to Article 3 in relation to affordability, a Member State may authorize its national regulatory authority not to apply paragraphs 1, 2, 3, 4 or 5 of this Article in a specific geographical area where it is satisfied that there is effective competition in the fixed public telephone services market. Article 18 Cost accounting principles 1. Member States shall ensure that, where an organisation has an obligation for its tariffs to follow the principle of cost orientation in accordance with Article 17, the cost accounting systems operated by such organisations are suitable for the implementation of Article 17 and that compliance with such systems are verified by a competent body which is independent of those organisations. National regulatory authorities shall ensure that a statement concerning compliance is published annually. 2. National regulatory authorities shall ensure that a description of the cost accounting systems referred to in paragraph 1, showing the main categories under which costs are compiled and the rules used for the allocation of costs to voice telephony services, is made available to them on request. National regulatory authorities shall submit to the Commission, on request, information on the cost accounting systems applied by the organisations concerned. 3. Where and as long as the provision of public telecommunications networks and voice telephony services are subject to special or exclusive rights in a Member State, the systems referred to in paragraph 1 shall, without prejudice to the last subparagraph of this paragraph, include the following elements: (a) the costs of the voice telephony service shall include, in particular, the direct costs incurred by the telecommunications organisations in setting up, operating and maintaining the voice telephony service and in marketing and billing the service; (b) common costs, i.e. costs which cannot be directly assigned to either the voice telephony service or other activities, shall be allocated as follows: (i) whenever possible, common cost categories shall be allocated on the basis of direct analysis of the origin of the costs themselves; (ii) when direct analysis is not possible, common cost categories shall be allocated on the basis of an indirect linkage to another cost category or group of cost categories for which direct assignment or allocation is possible; the indirect linkage shall be based on comparable cost structures; (iii) when neither direct nor indirect measures of cost allocation can be found, the cost category shall be allocated on the basis of a general allocator computed by using the ratio of all expenses directly or indirectly assigned or allocated to, on the one hand, the voice telephony service and, on the other hand, other services. Other cost accounting systems may be applied if they are suitable for the implementation of Article 17 and have been approved as such by the national regulatory authority for application by the telecommunications organisations, subject to the Commission's being informed prior to their application. 4. Member States shall ensure that the financial accounts of all organisations providing fixed public telephone networks and/or voice telephony services are drawn up, submitted to audit and published in accordance with the provisions of national and Community legislation applying to commercial undertakings. Detailed accounting information shall be made available to the national regulatory authority in order to ensure compliance with the provisions of this Directive, on its request and in confidence, without prejudice to the rights and obligations of national regulatory authorities referred to in Article 20(2) of Directive 97/13/EC on Licensing. Article 19 Discounts and other special tariff provisions Member States shall ensure that, where an organisation has an obligation for its tariffs to follow the principle of cost orientation in accordance with Article 17, discount schemes for users, including consumers, are fully transparent and are published and applied in accordance with the principle of non-discrimination. National regulatory authorities may require such discount schemes to be modified or withdrawn. Article 20 Specifications for network access, including the socket 1. Standards suitable for access to fixed public telephone networks shall be published in the ONP List of Standards referred to in Article 5 of Directive 90/387/EEC. 2. Where the services referred to in this Directive are supplied to users over the ISDN network at the S/T reference point, national regulatory authorities shall ensure that the ISDN network termination points comply with the relevant physical interface specifications, in particular those for the socket, referenced in the ONP List of Standards. Article 21 Non-payment of bills Member States shall authorise specified measures, which shall be proportionate, non-discriminatory and published in the manner laid down in Article 11(4), to cover non-payment of telephone bills for use of the fixed public telephone network. These measures shall ensure that due warning of any consequent service interruption or disconnection is given to the subscriber beforehand. Except in cases of fraud, persistent late payment or non-payment, these measures shall ensure, as far as is technically feasible, that any service interruption is confined to the service concerned. Member States may decide that, where appropriate, complete disconnection takes place only after a stated period during which calls which do not incur a charge to that subscriber are permitted. Article 22 Conditions for the termination of offerings 1. This Article shall apply where and for as long as the provision of public telecommunications networks and voice telephony services are subject to special or exclusive rights in a Member State. 2. National regulatory authorities shall ensure that service offerings of organisations with such special or exclusive rights continue for a reasonable period of time and that termination of an offering, or a change that materially alters the use that can be made of it, can be done only after consultation with users affected and an appropriate public notice period set by the national regulatory authority. 3. Without prejudice to other rights of appeal provided for by national law, Member States shall ensure that users and, where national law so provides, organisations representing user and/or consumer interests can bring before the national regulatory authority cases where the users affected do not agree with the termination date as envisaged by the organisation concerned. Article 23 Variation of published conditions 1. This Article shall apply where and for as long as the provision of public telecommunications networks and voice telephony services are subject to special or exclusive rights in a Member State. 2. Where, in response to a particular request, an organisation with such special or exclusive rights considers it unreasonable to provide a connection to the fixed public telephone network under its published tariffs and supply conditions, it must seek the agreement of the national regulatory authority to vary those conditions in that case. CHAPTER IV PROCEDURAL PROVISIONS Article 24 Consultation with interested parties Member States shall take into account, in accordance with national procedures, the views of the representatives of organisations providing public telecommunications networks, of users, consumers, manufacturers and service providers on issues related to the scope, affordability and quality of publicly available telephone services. Article 25 Notification and reporting 1. Member States shall notify to the Commission any changes in the information which had to be published under Directive 95/62/EC. The Commission shall publish this information in the Official Journal of the European Communities. 2. Member States shall also notify to the Commission: - organisations with significant market power for the purposes of this Directive, - details of situations where organisations providing fixed public telephone networks and/or voice telephony services no longer have to follow the principle of cost orientation of tariffs, in accordance with Article 17(6), - organisations designated in accordance with Article 5, if any. The Commission may request national regulatory authorities to provide their reasons for classifying or not classifying organisations in either or both of the categories referred to in the first two indents. 3. Where a Member State maintains special or exclusive rights for the provision of public telecommunications networks and voice telephony services, national regulatory authorities shall keep available and submit to the Commission, on request, details of individual cases brought before them other than those covered by Article 21, where access to or use of the fixed public telephone network or voice telephony service has been restricted or denied, including the measures taken and their justification. Article 26 Conciliation and resolution of national disputes Without prejudice to: (a) any action which the Commission or any Member State may take pursuant to the Treaty; (b) the rights of the person invoking the procedure in points 3 and 4, of the organisations concerned or of any other person under applicable national law, except insofar as they enter into an agreement for the resolution of disputes between them; (c) Article 10(2), which allows the national regulatory authorities to alter the conditions of subscriber contracts, the following procedures shall be available: (1) Member States shall ensure that any party, including, for example, users, service providers, consumers or other organisations having an unresolved dispute with an organisation providing fixed public telephone networks and/or fixed public telephone services concerning an alleged infringement of the provisions of this Directive, shall have a right to bring cases before the national regulatory authority or another independent body. Easily accessible and in principle inexpensive procedures shall be available at a national level to resolve such disputes in a fair, transparent and timely manner. These procedures shall, in particular, apply in cases where users are in dispute with an organisation over their telephone bills or over the terms and conditions under which telephone service is provided. Organisations representing user and/or consumer interests may bring to the attention of the national regulatory authority or another independent body cases where terms and conditions under which telephone service is provided are deemed to be unsatisfactory for users. (2) A user or an organisation may, where the dispute involves organisations in more than one Member State, invoke the conciliation procedure provided for in points 3 and 4 by means of a written notification to the national regulatory authority and to the Commission. Member States may also allow their national regulatory authority to invoke the conciliation procedure. (3) Where the national regulatory authority or the Commission finds that there is a case for further examination, following a notification based on point 2, it may refer the matter to the Chairman of the ONP Committee. (4) In the circumstances referred to in point 3, the Chairman of the ONP Committee shall initiate the procedure described below if he is satisfied that all reasonable steps have been taken at national level: - the Chairman of the ONP Committee shall convene as soon as possible a working group including at least two members of the ONP Committee and one representative of the national regulatory authorities concerned, and the Chairman of the ONP Committee or another official of the Commission appointed by him. The working group shall be chaired by the representative of the Commission and shall normally meet within ten days of having been convened. The Chairman of the working group may decide, on a proposal by any of the members of the working group, to invite a maximum of two other persons as experts to advise it, - the working group shall give the party invoking this procedure, the national regulatory authorities of the Member States involved and the organisations involved the opportunity to present their opinions in oral or written form, - the working group shall endeavour to reach agreement between the parties involved within three months of the date of receipt of the notification referred to in paragraph 2. The Chairman of the ONP Committee shall inform that Committee of the results of the procedure so that it may express its views. (5) The party invoking the procedure shall bear its own costs of participating in this procedure. Article 27 Deferment of certain obligations 1. Deferments granted in relation to Articles 12 and 13 of Directive 95/62/EC shall remain unchanged with regard to Articles 17 and 18 of this Directive. 2. Deferment of the obligations under Article 15(4) may be requested where the Member State concerned can prove that they would impose an excessive burden on certain organisations or classes of organisation. The Member State shall inform the Commission of the reasons for requesting a deferment, the date by which the requirements can be met, and the measures envisaged in order to meet this deadline. The Commission shall consider the request taking into account the particular situation in that Member State and the need to ensure a coherent regulatory environment at a Community level, and shall inform the Member State whether it deems that the particular situation in that Member State justifies a deferment and, if so, until which date such deferment is justified. Article 28 Technical adjustment Modifications necessary to adapt Annexes I, II and III to this Directive to technological developments or to changes in market demand shall be determined in accordance with the procedure laid down in Article 30. Article 29 Advisory Committee procedure 1. The Commission shall be assisted by the ONP Committee. The Committee shall, in particular, consult the representatives of the organisations providing fixed public telephone networks, publicly available telephone services, users, consumers and manufacturers. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter, if necessary by taking a vote. The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes. The Commission shall take the utmost account of the opinion delivered by the Committee. It shall inform the Committee of the manner in which its opinion has been taken into account. Article 30 Regulatory Committee procedure 1. Notwithstanding the provisions of Article 29, the following procedure shall apply in respect of the matters covered by Article 28. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote. 3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 31 Review The Commission shall examine and report to the European Parliament and to the Council on the functioning of this Directive, on the first occasion not later than 31 December 1999, taking into account the Report on Universal Service to be published by the Commission before 1 January 1998. The review shall be based on, inter alia, the information provided by the Member States to the Commission and shall examine in particular: - the scope of the Directive, in particular the extent to which it is desirable to apply the provisions of this Directive to mobile telephony, - the provisions in Chapter II in the light of changes in market conditions, user demand and technological progress, - the maintenance of the obligations imposed under Articles 17, 18 and 19 in the light of the emergence of competition. Where necessary, further periodic reviews may be proposed in the report. Article 32 Transposition 1. Member States shall take the measures necessary to comply with this Directive by 30 June 1998. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. Member States shall inform the Commission of the main provisions of national law which they adopt in the field governed by this Directive. Article 33 Repeal of Directive 95/62/EC Directive 95/62/EC is hereby repealed with effect from 30 June 1998, without prejudice to Member States' obligations for implementation of that Directive according to the timescales laid down in Annex IV. References made to the repealed Directive shall be construed as being made to this Directive. Annex V provides a comparative table showing the relationship between the Articles of Directive 95/62/EC and the Articles of this Directive. Article 34 Entry into force This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 35 Addressees This Directive is addressed to the Member States.

31998L0016

1998

Twenty-second Commission Directive 98/16/EC of 5 March 1998 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 (1) on the approximation of the laws of the Member States relating to cosmetic products, as last amended by Commission Directive 97/45/EC (2), and in particular Article 8(2) thereof, Whereas Commission Directive 97/1/EC (3) temporarily prohibited, as a precautionary measure, the use of bovine, ovine and caprine tissues and fluids from the encephalon, the spinal cord and the eyes, and ingredients derived therefrom; this Directive was to be reviewed following the examination of the elements on which it was based, and generally adapted in the light of the development of scientific knowledge; Whereas Commission Decision 97/534/EC of 30 July 1997 on the prohibition of the use of material presenting risks as regards transmissible spongiform encephalopathies (4), defines specified risk materials, provides for their elimination at source and prohibits their import into the Community; Whereas Directive 76/768/EEC requires Member States to ensure that only cosmetic products which conform to the provisions of this Directive may be put on the market in the EU and whereas, more particularly, Member States shall prohibit the marketing of cosmetic products containing substances listed in Annex II; Whereas these provisions apply to all cosmetic products to be placed on the market in the Community, nothwithstanding the origin of the product or the raw materials contained therein; whereas, thereby, the compliance with Community law of cosmetic products, starting materials and intermediate products which are imported into the Community to be used in the manufacture of cosmetic products is controlled and checked; Whereas Directive 76/768/EEC should be amended to align the list of prohibited animal materials to that contained in the Decision 97/534/EC; Whereas the opinion of the Scientific Committee on Cosmetology of 24 June 1997 stated that tallow derivatives such as fatty acids, glycerine, fatty acid esters and soaps, used in the production of cosmetic products, are considered safe provided that, as a minimum, they have been obtained by certain specified methods which have been strictly certified, and that other tallow derivatives such as fatty alcohols and fatty amides produced from the abovementioned derivatives and subsequently processed are regarded as safe; Whereas, according to this scientific opinion, it is possible to grant a derogation for tallow derivatives; this derogation also applies to other derivatives of tallow such as fatty alcohols, fatty amines and fatty amides, and materials made from the abovementioned that are manufactured according to the methods indicated in the Annex and subjected to additional subsequent treatments; Whereas 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 on the removal of technical barriers to trade in the cosmetic products sector; Whereas Member States have the right to maintain in force until 1 April 1998 those measures adopted in concordance with Directive 97/1/EC, Article 1 Directive 76/768/EEC is hereby amended as shown in the Annex. Article 2 Member States shall take the necessary measures to ensure that the cosmetic products containing the substances set out in the Annex cannot be placed on the market from 1 April 1998. This does not apply to products produced before 1 April 1998. Member States may retain in force those measures implementing Directive 97/1/EC until 1 April 1998. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 April 1998. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted 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 4 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31998L0017

1998

Commission Directive 98/17/EC of 11 March 1998 amending Directive 92/76/EEC recognising protected zones exposed to particular plant health risks in the Community (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 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 98/2/EC (2), and in particular the first subparagraph of Article 2(1)(h) thereof, Having regard to Commission Directive 92/76/EEC of 6 October 1992 recognising protected zones exposed to particular plant health risks in the Community (3), as last amended by Directive 96/76/EC (4), Whereas within the meaning of Commission Directive 92/76/EEC certain zones in France, Ireland and Italy were provisionally recognised as 'protected zones` in respect of certain harmful organisms for a period expiring on 31 December 1997; Whereas, from information supplied by Ireland and Italy and from the survey monitoring information gathered by Commission experts it appears that the provisional recognition of the protected zones for Ireland and Italy in respect of Erwinia amylovora (Burr.) Winsl. et al. should be extended for a further limited period to enable the responsible official bodies of Ireland and Italy to complete the information on the distribution of Erwinia amylovora and to complete their efforts for the eradication of this harmful organism in their respective countries; Whereas, from information supplied by France and from the survey monitoring information gathered by Commission experts it became apparent that the provisional recognition of the protected zone for France in respect of beet nectrotic yellow vein virus should be changed to a 'permanent` status and extended beyond 31 December 1997; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 In the first subparagraph of Article 1 of Directive 92/76/EEC: (a) the text 'in the case of (b) 2 for Ireland and the region of Apulia in Italy the said zones are recognised until 31 December 1997` is replaced by 'in the case of (b) 2 for Ireland and the region of Apulia in Italy the said zones are recognised until 31 December 1998`, and (b) the text 'and for France, the zone is recognised until 31 December 1997` is deleted. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 15 March 1998. 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. 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 3 This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31998L0019

1998

Commission Directive 98/19/EC of 18 March 1998 amending Council Directive 70/524/EEC concerning additives in feedingstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Commission Directive 97/72/EC (2), and in particular Article 11 thereof, Whereas, pursuant to Article 11 of Directive 70/524/EEC, a Member State which, as a result of new information or of a reassessment of existing information made since the provisions in question were adopted, has detailed grounds for establishing that the use of one of the additives listed in Annex I constitutes a danger to animal or human health or the environment may temporarily suspend the authorization to use that additive; Whereas Germany prohibited the use on its territory of ronidazole in turkey feed on 19 January 1996; whereas in accordance with Directive 70/524/EEC, on 15 April 1996 Germany notified the other Member States and the Commission of the reasons for its decision, duly substantiated by detailed arguments; Whereas Germany argued in its notification that it suspected ronidazole of mutagenic, carcinogenic and genotoxic properties and, in view of this worrying situation for the health of consumers, this Member State took the view that its use in animal feed should be banned at Community level; Whereas in its reasoned argument Germany concluded that the use of ronidazole in animal feed resulted in some residues remaining in animal tissue, even with a six-day withdrawal period in accordance with the rules; whereas in view of the carcinogenic and mutagenic properties that ronidazole as the parent substance might have and the possibility that its nitroimidazole structure might be released from bound residues, a risk to consumer health cannot be ruled out, even where the withdrawal period is complied with; Whereas the Commission has consulted the Scientific Committee on Animal Nutrition; whereas, after thoroughly examining the situation, that Committee has concluded, in the opinion expressed on 26 September 1997 and reinforced on 5 November 1997, that, while ronidazole clearly shows a mutagenic effect on prokaryotic cells, there are no data on its possible genotoxic effect on eukaryotic cells; whereas it was not possible to evaluate conclusively the carcinogenic mechanism because raw data on the experiments into carciongenisis were not available; whereas it is therefore impossible to evaluate the risk to consumers; whereas the data on metronidazole cannot be used to make inferences about ronidazole since chemical substances belonging to the same family may have totally different toxicological properties; whereas information is lacking on the metabolic fate of ronidazole in turkeys, such as the nature of the faecal metabolites, or its presence in various tissues after the withdrawal period; whereas it should be noted, however, that the substantial information available on pigs could be reasonably applied to turkeys, where justified; whereas, on the other hand, the limited amount of data that does exist on the presence of trace quantities of a nitroimidazole compound released chemically from these bound residues is strongly suggestive of analytical artefact; Whereas the Scientific Committee on Animal Nutrition has finally concluded that, while not all the scientific arguments submitted by Germany to prohibit ronidazole can be accepted, some important issues have not been resolved and, in the absence of the additional data, an acceptable daily dose of ronidazole residues cannot be established to ensure consumer safety; Whereas, in view of the uncertainty still surrounding the safety of ronidazole, its use as an additive in turkey feed should be prohibited to protect consumer health; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 Annex I to Directive 70/524/EEC is hereby amended as set out in the Annex hereto. Article 2 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 31 May 1998. They shall immediately inform the Commission thereof. They shall apply the measures from 1 June 1998. 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 procedure for such reference shall be adopted by Member States. 2. 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 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,

31998L0024

1998

Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) Having regard to the Treaty establishing the European Community, and in particular Article 118a thereof, Having regard to the proposal from the Commission (1), drawn up 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), Acting in accordance with the procedure laid down in Article 189c of the Treaty (3), (1) Whereas Article 118a of the Treaty provides that the Council shall adopt by means of Directives minimum requirements for encouraging improvements, especially in the working environment, to guarantee a better level of protection of the safety and health of workers; (2) Whereas, pursuant to that Article, such Directives shall avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings; (3) Whereas the improvement of workers' safety, hygiene and health at work is an objective which should not be subordinated to purely economic considerations; (4) Whereas the respect of minimum requirements on the protection of the health and safety of workers from the risks related to chemical agents aims to ensure not only the protection of the health and safety of each individual worker but also to provide a level of minimum protection of all workers in the Community which avoids any possible distortion in the area of competition; (5) Whereas a consistent level of protection from the risks related to chemical agents has to be established for the Community as a whole; whereas that level of protection has to be set not by detailed prescriptive requirements but by a framework of general principles to enable Member States to apply the minimum requirements consistently; (6) Whereas a work activity involving chemical agents is likely to expose workers to risk; (7) Whereas Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (4), Council Directive 82/605/EEC of 28 July 1982 on the protection of workers from the risks related to exposure to metallic lead and its ionic compounds at work (first individual Directive within the meaning of Article 8 of Directive 80/1107/EEC) (5) and Council Directive 88/364/EEC of 9 June 9 1988 on the protection of workers by the banning of certain specific agents and/or certain work activities (fourth individual Directive within the meaning of Article 8 of Directive 80/1107/EEC) (6), for the sake of consistency and clarity as well as for technical reasons, should be revised and included in a single Directive laying down minimum requirements for the protection of the health and safety of workers in work activities involving chemical agents; whereas these Directives can be repealed; (8) Whereas 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 (7); (9) Whereas therefore the provisions of the said Directive apply in full to the exposure of workers to chemical agents, without prejudice to more stringent and/or specific provisions contained in this Directive; (10) Whereas more stringent and/or specific provisions relating to the transport of hazardous chemical agents are contained in binding international agreements and conventions incorporated into Community provisions on transport of dangerous goods by road, rail, water and air; (11) Whereas in Directive 67/548/EEC (8) and Directive 88/379/EEC (9) on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of, respectively, dangerous substances and preparations, the Council laid down a system of criteria for the classification of dangerous substances and preparations; (12) Whereas the definition of hazardous chemical agent should include any chemical substance which meets these criteria and also any chemical substance which whilst not meeting these criteria may because of its physico-chemical, chemical or toxicological properties, and the way it is used or is present in the workplace, present a risk to the safety and health of workers; (13) Whereas in Directive 90/492/EEC (10) the Commission defined and laid down a system of specific information on dangerous substances and preparations, in the form of safety data sheets principally intended for industrial users to enable them to take the measures necessary to ensure the protection of the safety and health of workers; whereas Council Directive 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety and/or health signs at work (ninth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (11) establishes a system for marking containers and pipes used for dangerous substances or preparations at work; (14) Whereas the employer should assess any risk to the safety and health of workers arising from the presence of hazardous chemical agents at the workplace, in order to take the necessary preventive and protective measures set out in this Directive; (15) Whereas the preventive measures identified by the assessment of risk and taken by the employer should be consistent with the need to protect public health and the environment; (16) Whereas, to supplement the information available to workers so as to ensure an improved level of protection, it is necessary for workers and their representatives to be informed about the risks which chemical agents can pose for their safety and health and about the measures necessary to reduce or eliminate those risks, and for them to be in a position to check that the necessary protective measures are taken; (17) Whereas the health surveillance of workers for whom the results of the aforementioned assessment reveal a risk to health, can contribute to the prevention and protection measures to be undertaken by the employer; (18) Whereas the employer must on a regular basis carry out evaluation and measurements and be aware of new developments in technology with a view to improving the protection of workers's safety and health; (19) Whereas the latest scientific data should be evaluated by independent scientists to assist the Commission in setting occupational exposure limit values; (20) Whereas, although in some cases scientific knowledge may not be such that a level of exposure to a chemical agent can be established below which risks to health cease to exist, a reduction in exposure to these chemical agents will nonetheless reduce these risks; (21) Whereas in Directive 91/322/EEC (12) and Directive 96/94/EC (13) the Commission laid down indicative limit values as provided for by Directive 80/1107/EEC; whereas the former Directives should be maintained as part of the current framework; (22) Whereas necessary technical adjustments to this Directive should be drawn up by the Commission in cooperation with the Committee set up by Directive 89/391/EEC to assist the Commission in making technical adaptations to individual Directives adopted under the framework of that Directive; whereas the Commission, after first seeking the advice of the Advisory Committee on Safety, Hygiene and Health Protection at Work in accordance with Decision 74/325/EEC (14), should also draw up practical guidelines for the application of this Directive; (23) Whereas the repeal of Directive 80/1107/EEC must not give rise to the lowering of the present standards of worker protection from chemical, physical and biological agents; whereas standards resulting from the existing Directives on biological agents, the proposed Directive on physical agents, this Directive and any amendments to these texts should reflect and at least maintain the standards laid down in the said Directive; (24) Whereas this Directive is a practical contribution towards creating the social dimension of the internal market, SECTION I GENERAL PROVISIONS Article 1 Objective and scope 1. This Directive, which is the fourteenth 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 safety and health arising, or likely to arise, from the effects of chemical agents that are present at the workplace or as a result of any work activity involving chemical agents. 2. The requirements of this Directive apply where hazardous chemical agents are present or may be present at the workplace, without prejudice to the provisions for chemical agents to which measures for radiation protection apply pursuant to Directives adopted under the Treaty establishing the European Atomic Energy Community. 3. For carcinogens at work the provisions of this Directive shall apply without prejudice to more stringent and/or specific provisions contained in Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens (sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (15). 4. The provisions of Directive 89/391/EEC shall apply fully to the whole field referred to in this Article, without prejudice to more stringent and/or specific provisions contained in this Directive. 5. As far as the transport of hazardous chemical agents is concerned, the provisions of this Directive shall apply without prejudice to more stringent and/or specific provisions contained in Directive 94/55/EC (16), in Directive 96/49/EC (17), in the provisions of the IMDG Code, IBC Code and IGC Code as defined in Article 2 of Directive 93/75/EEC (18), in the provisions of the European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterway and of the Regulation for the Carriage of Dangerous Substances on the Rhine as incorporated in Community law and in the technical instructions for the safe transport of dangerous goods issued, at the date of entry into force of this Directive, by the International Civil Aviation Organisation. Article 2 Definitions For the purpose of this Directive, the terms used shall have the following meanings: (a) 'Chemical agent` means any chemical element or compound, on its own or admixed, as it occurs in the natural state or as produced, used or released, including release as waste, by any work activity, whether or not produced intentionally and whether or not placed on the market; (b) 'Hazardous chemical agent` means: (i) any chemical agent which meets the criteria for classification as a dangerous substance according to the criteria in Annex VI to Directive 67/548/EEC, whether or not that substance is classified under that Directive, other than those substances which only meet the criteria for classification as dangerous for the environment; (ii) any chemical agent which meets the criteria for classification as a dangerous preparation within the meaning of Directive 88/379/EEC, whether or not that preparation is classified under that Directive, other than those preparations which only meet the criteria for classification as dangerous for the environment; (iii) any chemical agent which, whilst not meeting the criteria for classification as dangerous in accordance with (i) and (ii), may, because of its physico-chemical, chemical or toxicological properties and the way it is used or is present in the workplace, present a risk to the safety and health of workers, including any chemical agent assigned an occupational exposure limit value under Article 3. (c) 'Activity involving chemical agents` means any work in which chemical agents are used, or are intended to be used, in any process, including production, handling, storage, transport or disposal and treatment, or which result from such work; (d) 'Occupational exposure limit value` means, unless otherwise specified, the limit of the time-weighted average of the concentration of a chemical agent in the air within the breathing zone of a worker in relation to a specified reference period; (e) 'Biological limit value` means the limit of the concentration in the appropriate biological medium of the relevant agent, its metabolite, or an indicator of effect; (f) 'Health surveillance` means the assessment of an individual worker to determine the state of health of that individual, as related to exposure to specific chemical agents at work; (g) 'Hazard` means the intrinsic property of a chemical agent with the potential to cause harm; (h) 'Risk` means the likelihood that the potential for harm will be attained under the conditions of use and/or exposure. Article 3 Occupational exposure limit values and biological limit values 1. The Commission shall evaluate the relationship between the health effects of hazardous chemical agents and the level of occupational exposure by means of an independent scientific assessment of the latest available scientific data. 2. On the basis of the evaluation described in paragraph 1, the Commission, after first consulting the Advisory Committee on Safety, Hygiene and Health protection at Work, shall propose European objectives in the form of indicative occupational exposure limit values for the protection of workers from chemical risks, to be set at Community level. These limit values shall be established or revised, taking into account the availability of measurement techniques, in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC. Member States shall keep workers' and employers' organisations informed of indicative occupational exposure limit values set at Community level. 3. For any chemical agent for which an indicative occupational exposure limit value is established at Community level, Member States shall establish a national occupational exposure limit value, taking into account the Community limit value, determining its nature in accordance with national legislation and practice. 4. Binding occupational exposure limit values may be drawn up at Community level and, in addition to the factors considered when establishing indicative occupational exposure limit values, shall reflect feasibility factors while maintaining the aim of ensuring the health of workers at work. Such limit values shall be established in accordance with Article 118a of the Treaty and laid down in Annex I to this Directive. 5. For any chemical agent for which a binding occupational exposure limit value is established. Member States shall establish a corresponding national binding occupational exposure limit value based on, but not exceeding, the Community limit value. 6. Binding biological limit values may be drawn up at Community level on the basis of the evaluation described in paragraph 1 and of the availability of measurement techniques, and shall reflect feasibility factors while maintaining the aim of ensuring the health of workers at work. Such limit values shall be established in accordance with the procedure laid down in Article 118a of the Treaty and laid down in Annex II to this Directive, together with other relevant health surveillance information. 7. For any chemical agent for which a binding biological limit value is established, Member States shall establish a corresponding national binding biological limit value based on, but not exceeding, the Community limit value. 8. Where a Member State introduces or revises a national occupational exposure limit value or a national biological limit value for a chemical agent, it shall inform the Commission and other Member States thereof together with the relevant scientific and technical data. The Commission shall undertake the appropriate action. 9. On the basis of the reports provided by the Member States under Article 15, the Commission shall carry out an assessment of the way in which Member States have taken account of Community indicative limit values when establishing the corresponding national occupational exposure limit values. 10. Standardised methods for the measurement and evaluation of workplace air concentrations in relation to occupational exposure limit values shall be developed in accordance with Article 12(2). SECTION II EMPLOYERS' OBLIGATIONS Article 4 Determination and assessment of risk of hazardous chemical agents 1. In carrying out the obligations laid down in Articles 6(3) and 9(1) of Directive 89/391/EEC, the employer shall first determine whether any hazardous chemical agents are present at the workplace. If so, he shall then assess any risk to the safety and health of workers arising from the presence of those chemical agents, taking into consideration the following: - their hazardous properties, - information on safety and health that shall be provided by the supplier, (e.g. the relevant safety data sheet in accordance with the provisions of Directive 67/548/EEC or Directive 88/379/EEC), - the level, type and duration of exposure, - the circumstances of work involving such agents, including their amount, - any occupational exposure limit values or biological limit values established on the territory of the Member State in question, - the effect of preventive measures taken or to be taken, - where available, the conclusions to be drawn from any health surveillance already undertaken. The employer shall obtain additional information which is needed for the risk assessment from the supplier or from other readily available sources. Where appropriate, this information shall comprise the specific assessment concerning the risk to users established on the basis of Community legislation on chemical agents. 2. The employer must be in possession of an assessment of the risk in accordance with Article 9 of Directive 89/391/EEC, and shall identify which measures have been taken in accordance with Articles 5 and 6 of this Directive. The risk assessment shall be documented in a suitable form according to national law and practice, and may include a justification by the employer that the nature and extent of the risks related to chemical agents make a further detailed risk assessment unnecessary. The risk assessment shall be kept up-to-date, 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. 3. Certain activities within the undertaking or establishment, such as maintenance, in respect of which it is foreseeable that there is a potential for significant exposure, or which may result in deleterious effects to safety and health for other reasons, even after all technical measures have been taken, shall be included in the risk assessment. 4. In the case of activities involving exposure to several hazardous chemical agents, the risk shall be assessed on the basis of the risk presented by all such chemical agents in combination. 5. In the case of a new activity involving hazardous chemical agents, work shall only commence after an assessment of the risk of that activity has been made and any preventive measures identified have been implemented. 6. Practical guidelines for the determination and assessment of risk, and for their review and, if necessary, adjustment, shall be developed in accordance with Article 12(2). Article 5 General principles for prevention of risks associated with hazardous chemical agents and application of this Directive in relation to assessment of risks 1. In carrying out his obligation to ensure the health and safety of workers in any activity involving hazardous chemical agents the employer shall take the necessary preventive measures set out in Article 6(1) and (2) of Directive 89/391/EEC and include the measures set out in this Directive. 2. Risks to the health and safety of workers at work involving hazardous chemical agents shall be eliminated or reduced to a minimum by: - the design and organisation of systems of work at the workplace, - the provision of suitable equipment for work with chemical agents and maintenance procedures which ensure the health and safety of workers at work, - reducing to a minimum the number of workers exposed or likely to be exposed, - reducing to a minimum the duration and intensity of exposure, - appropriate hygiene measures, - reducing the quantity of chemical agents present at the workplace to the minimum required for the type of work concerned, - suitable working procedures including arrangements for the safe handling, storage and transport within the workplace of hazardous chemical agents and waste containing such chemical agents. Practical guidelines for preventive measures to control risk shall be developed in accordance with Article 12(2). 3. Where the results of the assessment referred to in Article 4(1) reveal a risk to the safety and health of workers, the specific protection, prevention and monitoring measures laid down in Articles 6, 7 and 10 shall be applied. 4. Where the results of the risk assessment referred to in Article 4(1) show that, because of the quantities of a hazardous chemical agent present in the workplace, there is only a slight risk to the safety and health of workers, and the measures taken in accordance with paragraphs 1 and 2 of this Article are sufficient to reduce that risk, the provisions of Articles 6, 7 and 10 shall not apply. Article 6 Specific protection and prevention measures 1. The employer shall ensure that the risk from a hazardous chemical agent to the safety and health of workers at work is eliminated or reduced to a minimum. 2. In applying paragraph 1, substitution shall by preference be undertaken, whereby the employer shall avoid the use of a hazardous chemical agent by replacing it with a chemical agent or process which, under its condition of use, is not hazardous or less hazardous to workers' safety and health, as the case may be. Where the nature of the activity does not permit risk to be eliminated by substitution, having regard to the activity and risk assessment referred to in Article 4, the employer shall ensure that the risk is reduced to a minimum by application of protection and prevention measures, consistent with the assessment of the risk made pursuant to Article 4. These will include, in order of priority: (a) design of appropriate work processes and engineering controls and use of adequate equipment and materials, so as to avoid or minimise the release of hazardous chemical agents which may present a risk to workers' safety and health at the place of work; (b) application of collective protection measures at the source of the risk, such as adequate ventilation and appropriate organizational measures; (c) where exposure cannot be prevented by other means, application of individual protection measures including personal protective equipment. Practical guidelines for protection and prevention measures to control risk shall be developed in accordance with Article 12(2). 3. The measures referred to in paragraph 2 of this Article shall be accompanied by health surveillance in accordance with Article 10 if it is appropriate to the nature of the risk. 4. Unless the employer clearly demonstrates by other means of evaluation that, in accordance with paragraph 2, adequate prevention and protection have been achieved, the employer shall carry out on a regular basis, and when any change occurs in the conditions which may affect workers' exposure to chemical agents, such measurements of chemical agents which may present a risk to worker's health at the workplace as are necessary, in particular in relation to the occupational exposure limit values. 5. The employer shall take into account the results of the procedures referred to in paragraph 4 of this Article in carrying out the obligations laid down in or resulting as a consequence of Article 4. In any event, where an occupational exposure limit value effectively established on the territory of a Member State has been exceeded, the employer shall immediately take steps, taking into account the nature of that limit, to remedy the situation by carrying out preventive and protective measures. 6. On the basis of the overall assessment of and general principles for the prevention of risks in Articles 4 and 5, the employer shall take technical and/or organisational measures appropriate to the nature of the operation, including storage, handling and segregation of incompatible chemical agents, providing protection of workers against hazards arising from the physico-chemical properties of chemical agents. In particular he shall take measures, in order of priority, to: (a) prevent the presence at the workplace of hazardous concentrations of inflammable substances or hazardous quantities of chemically unstable substances or, where the nature of the work does not allow that, (b) avoid the presence of ignition sources which could give rise to fires and explosions, or adverse conditions which could cause chemically unstable substances or mixtures of substances to give rise to harmful physical effects, and (c) mitigate the detrimental effects to the health and safety of workers in the event of fire or explosion due to the ignition of inflammable substances, or harmful physical effects arising from chemically unstable substances or mixtures of substances. Work equipment and protective systems provided by the employer for the protection of workers shall comply with the relevant Community provisions on design, manufacture and supply with respect to health and safety. Technical and/or organisational measures taken by the employer shall take account of and be consistent with the equipment group categorisation in Annex I to Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres (19). The employer shall take measures to provide sufficient control of plant, equipment and machinery or provision of explosion suppression equipment or explosion pressure relief arrangements. Article 7 Arrangements to deal with accidents, incidents and emergencies 1. Without prejudice to the obligations laid down in Article 8 of Directive 89/391/EEC, the employer shall, in order to protect the safety and health of workers from an accident, incident or emergency related to the presence of hazardous chemical agents at the workplace, establish procedures (action plans) which can be put into effect when any such event occurs, so that appropriate action is taken. These arrangements shall include any relevant safety drills which are to be performed at regular intervals, and the provision of appropriate first aid facilities. 2. In the case of the occurrence of an event such as is mentioned in paragraph 1, the employer shall immediately take steps to mitigate the effects of the event and to inform the workers concerned thereof. In order to restore the situation to normal: - the employer shall implement appropriate measures to remedy the situation as soon as possible, - only those workers who are essential to the carrying out of repairs and other necessary work shall be permitted to work in the affected area. 3. The workers who are permitted to work in the affected area shall be provided with appropriate protective clothing, personal protective equipment, specialised safety equipment and plant which they must use as long as the situation persists; that situation shall not be permanent. Unprotected persons shall not be permitted to remain in the affected area. 4. Without prejudice to Article 8 of Directive 89/391/EEC the employer shall take the measures necessary to provide the warning and other communication systems required to signal an increased risk to safety and health, to enable an appropriate response and to launch remedial actions, assistance, escape and rescue operations immediately if the need arises. 5. The employer shall ensure that information on emergency arrangements involving hazardous chemical agents is available. The relevant internal and external accident and emergency services shall have access to this information. It shall include the following: - advance notice of relevant work hazards, hazard identification arrangements, precautions and procedures, so that the emergency services can prepare their own response procedures and precautionary measures; and - any available information concerning specific hazards arising, or likely to rise, at the time of an accident or emergency, including information on procedures prepared pursuant to this Article. Article 8 Information and training for workers 1. Without prejudice to Articles 10 and 12 of Directive 89/391/EEC the employer shall ensure that workers and/or their representatives are provided with: - the data obtained pursuant to Article 4 of this Directive, and further informed whenever a major alteration at the workplace leads to a change in these data, - information on the hazardous chemical agents occurring in the workplace, such as the identity of those agents, the risks to safety and health, relevant occupational exposure limit values and other legislative provisions, - training and information on appropriate precautions and actions to be taken in order to safeguard themselves and other workers at the workplace, - access to any safety data sheet provided by the supplier in accordance with Article 10 of Directive 88/379/EEC and Article 27 of Directive 92/32/EEC (20); and that the information is: - provided in a manner appropriate to the outcome of the risk assessment pursuant to Article 4 of this Directive. This may vary from oral communication to individual instruction and training supported by information in writing, depending on the nature and degree of the risk revealed by the assessment required by the said Article, - updated to take account of changing circumstances. 2. Where containers and pipes for hazardous chemical agents used at work are not marked in accordance with the relevant Community legislation on the labelling of chemical agents and on safety signs at the workplace, the employer shall, without prejudice to the derogations provided for in the abovementioned legislation, ensure that the contents of the containers and pipes, together with the nature of those contents and any associated hazards, are clearly identifiable. 3. Member States may take measures necessary to ensure that employers may, preferably from the producer or supplier, obtain on request all information on hazardous chemical agents needed to apply Article 4(1) of this Directive, insofar as Directives 67/548/EEC and 88/379/EEC do not include any obligation to provide information. SECTION III MISCELLANEOUS PROVISIONS Article 9 Prohibitions 1. To prevent the exposure of workers to health risks from certain chemical agents and/or certain activities involving chemical agents, the production, manufacture or use at work of the chemical agents and the activities set out in Annex III shall be prohibited to the extent specified therein. 2. Member States may permit derogations from requirements of paragraph 1 in the following circumstances: - for the sole purpose of scientific research and testing, including analysis, - for activities intended to eliminate chemical agents that are present in the form of by-products or waste products, - for the production of the chemical agents referred to in paragraph 1 for use as intermediates, and for such use. The exposure of workers to chemical agents referred to in paragraph 1 must be prevented, in particular by providing that the production and earliest possible use of such chemical agents as intermediates must take place in a single closed system, from which the aforesaid chemical agents may be removed only to the extent necessary to monitor the process or service the system. Member States may provide for systems of individual authorisations. 3. When derogations are permitted pursuant to paragraph 2, the competent authority shall request the employer to submit the following information: - the reason for requesting the derogation, - the quantity of the chemical agent to be used annually, - the activities and/or reactions or processes involved, - the number of workers liable to be involved, - the precautions envisaged to protect the safety and health of workers concerned, - the technical and organisational measures taken to prevent the exposure of workers. 4. The Council, in accordance with the procedure laid down in Article 118a of the Treaty, may amend the list of prohibitions under paragraph 1 of this Article, to include further chemical agents or activities. Article 10 Health surveillance 1. Without prejudice to Article 14 of Directive 89/391/EEC, Member States shall introduce arrangements for carrying out appropriate health surveillance of workers for whom the results of the assessment referred to in Article 4 of this Directive reveal a risk to health. These arrangements, including the requirements specified for health and exposure records and their availability, shall be introduced in accordance with national laws and/or practice. Health surveillance, the results of which shall be taken into account in applying preventive measures in the specific workplace, shall be appropriate where: - the exposure of the worker to a hazardous chemical agent is such that an identifiable disease or adverse health effect may be related to the exposure, and - there is a likelihood that the disease or effect may occur under the particular conditions of the worker's work, and - the technique of investigation is of low risk to workers. Furthermore, there shall be valid techniques for detecting indications of the disease or effect. Where a binding biological limit value has been set as indicated in Annex II, health surveillance shall be a compulsory requirement for work with the hazardous chemical agent in question, in accordance with the procedures in that Annex. Workers shall be informed of this requirement before being assigned to the task involving risk of exposure to the hazardous chemical agent indicated. 2. Member States shall establish arrangements to ensure that for each worker who undergoes health surveillance in accordance with the requirements of paragraph 1, individual health and exposure records are made and kept up-to-date. 3. Health and exposure records shall contain a summary of the results of health surveillance carried out and of any monitoring data representative of the exposure of the individual. Biological monitoring and related requirements may form part of health surveillance. Health and exposure records shall be kept in a suitable form so as to permit 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 and exposure records relating to him personally. Where an undertaking ceases to trade, the health and exposure records shall be made available to the competent authority. 4. 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 at work to a hazardous chemical agent, or - a binding biological limit value is found to have been exceeded, the worker shall be informed by the doctor or other suitably qualified person of the result which relates to him personally, including information and advice regarding any health surveillance which he should undergo following the end of the exposure, and the employer shall: - review the risk assessment made pursuant to Article 4(1), - review the measures provided to eliminate or reduce risks pursuant to Articles 5 and 6, - 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 6, 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 11 Consultation and participation of workers Consultation and participation of workers and/or their representatives shall take place in accordance with Article 11 of Directive 89/391/EEC on the matters covered by this Directive, including the Annexes hereto. Article 12 Adaptation of the Annexes, preparation and adoption of technical guidance 1. Adjustments of a strictly technical nature to the Annexes in line with: - the adoption of Directives in the field of technical harmonisation and standardisation concerning chemical agents, and/or - technical progress, changes in international standards or specifications and new findings concerning chemical agents, shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC. 2. The Commission shall draw up practical guidelines of a non-binding nature. These guidelines shall address the topics referred to in Articles 3, 4, 5 and 6, and Annex II, section 1. The Commission shall first consult the Advisory Committee on Safety, Hygiene and Health Protection at Work in accordance with Decision 74/325/EEC. In the context of the application of this Directive, Member States shall take account as far as possible of these guidelines in drawing up their national policies for the protection of the health and safety of workers. Article 13 Repeal and amendment of earlier Directives 1. Directives 80/1107/EEC, 82/605/EEC and 88/364/EEC shall be repealed on the date referred to in Article 14(1). 2. Council Directive 83/477/EEC of 19 September 1983 on the protection of workers from the risks related to exposure to asbestos at work (second individual Directive within the meaning of Article 8 of Directive 80/1107/EEC) (21), is amended as follows: (a) in the first sentence of Article 1(1), the following words shall be deleted: 'which is the second individual Directive within the meaning of Article 8 of Directive 80/1107/EEC`; (b) Article 9(2) shall be replaced by the following: '2. The amendments necessary to adapt the Annexes to this Directive to technical progress shall be adopted in accordance with the procedure laid down in Article 17 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 the workplace (*). (*) OJ L 183, 29. 6. 1989, p. 1.`; (c) in the second subparagraph of Article 15(1) the words 'in accordance with the procedure set out in Article 10 of Directive 80/1107/EEC` shall be replaced by 'in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC`. 3. Council Directive 86/188/EEC of 12 May 1986 on the protection of workers from the risks related to exposure to noise at work (22) is amended as follows: (a) in Article 1(1), the following words shall be deleted: 'which is the third individual Directive within the meaning of Directive 80/1107/EEC`; (b) in Article 12(2), the second subparagraph shall be replaced by the following: 'Annexes I and II shall be adapted to technical progress in accordance with the procedure laid down in Article 17 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 the workplace (*). (*) OJ L 183, 29. 6. 1989, p. 1.` 4. Any other reference in Directive 83/477/EEC and Directive 86/188/EEC to Directive 80/1107/EEC shall be obsolete from the date of repeal of the said Directive. 5. Directives 91/322/EEC and 96/94/EC remain in force. SECTION IV Final provisions Article 14 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 5 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 methods for making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they have already adopted or which they adopt in the field governed by this Directive. Article 15 Member States shall report to the Commission every five years on the practical implementation of this Directive, indicating the views of employers and workers. The Commission shall inform the European Parliament, the Council and the Economic and Social Committee thereof. Article 16 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities. Article 17 This Directive is addressed to the Member States.

31998L0022

1998

Commission Directive 98/22/EC of 15 April 1998 laying down the minimum conditions for carrying out plant health checks in the Community, at inspection posts other than those at the place of destination, of plants, plant products or other objects coming from third countries Having regard to the Treaty establishing the European Community, Having regard to Council Directive 77/93/EEC of 21 December 1976 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 98/2/EC (2), and in particular the penultimate subparagraph of Article 12(6) thereof, Whereas, if arrangements for the plant health checks of plants, plant products or other objects listed in part B of Annex V to Directive 77/93/EEC coming from third countries are to be operated efficiently, harmonised minimum conditions should be laid down for carrying out these checks at inspection posts other than those at the place of destination; Whereas the minimum conditions laid down for carrying out such plant health checks must take account of technical requirements applicable to the responsible official bodies as referred to in Article 2(1)(g) of Directive 77/93/EEC in charge of the said inspection posts as well as of provisions applicable to facilities, tools and equipment enabling the said responsible official bodies to carry out the required plant health checks; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Member States shall ensure that the plant health checks referred to in Article 12(6), fourth subparagraph of Directive 77/93/EEC, of plants, plant products or other objects listed in Annex V, part B of the said Directive and coming from third countries, and carried out at inspection posts other than those at the place of destination, satisfy at least the minimum conditions laid down in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive on 1 October 1998. 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 a reference at the time 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 all 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 day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31998L0035

1998

Council Directive 98/35/EC of 25 May 1998 amending Directive 94/58/EC on the minimum level of training of seafarers Having regard to the Treaty establishing the European Community, and in particular Article 84(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 189c of the Treaty (3), (1) Whereas Article 12(2) of Council Directive 94/58/EC of 22 November 1994 on the minimum level of training of seafarers (4) provides that following the adoption of new instruments or protocols to the International Convention on Standards of Training, Certification and Watchkeeping for Seafarers (STCW Convention) the Council, acting on a proposal from the Commission, shall decide on the detailed arrangements for ratifying those new instruments or protocols, while ensuring that they are applied uniformly and simultaneously in the Member States; (2) Whereas Article 9(3)(a) of that Directive provides that a set of criteria for the recognition of types of certificates issued by institutes or administrations of third countries will be defined by the Council, acting in accordance with the conditions of the Treaty; (3) Whereas actions to be taken at Community level in the field of maritime safety and pollution prevention at sea should be in line with internationally agreed rules and standards; (4) Whereas in its resolution of 24 March 1997 on a new strategy to increase the competitiveness of Community shipping (5) the Council sought to promote the employment of Community seafarers and shore-based personnel; whereas to that end the Council agreed that action should be undertaken to help Community shipping to continue striving for high quality and improve its competitiveness by ensuring the continued high-quality training of Community seafarers of all ranks and of shore-based personnel; (5) Whereas the 1995 Conference of Parties to the STCW Convention adopted the revised Annex to the STCW Convention and the Seafarers' Training, Certification and Watchkeeping Code (STCW Code); (6) Whereas Member States may establish standards higher than the minimum standards laid down in the STCW Convention and the Directive; (7) Whereas the Regulations of the STCW Convention set out in Annex I to this Directive should be supplemented by the mandatory provisions contained in Part A of the STCW Code; whereas Part B of the STCW Code contains recommended guidance intended to assist Parties to the STCW Convention and those involved in implementing, applying or enforcing its measures to give the Convention full and complete effect in a uniform manner; (8) Whereas the establishment of common criteria for the Member States' recognition of certificates issued by third countries should be based on the training and certification requirements as agreed in the framework of the STCW Convention; (9) Whereas, in the interests of safety at sea, Member States should recognise qualifications proving the required level of training only where these are issued by or on behalf of Parties to the STCW Convention which have been identified by the Maritime Safety Committee of the International Maritime Organisation (IMO) as having been shown to have given, and still to be giving, full effect to the standards set out in that Convention; whereas, to bridge the time gap until that IMO Committee has been able to carry out such identification, a procedure for the preliminary recognition of certificates is needed; (10) Whereas, where appropriate, maritime institutes, training programmes and courses should be inspected; whereas criteria for such inspection should therefore be established; (11) Whereas the Council should review Annex II in the light of the experience gained in applying the Directive, acting on a proposal to be submitted by the Commission within five years of the adoption of this Directive; (12) Whereas until 1 February 2002 Member States should be allowed to accept on their ships seafarers holding certificates issued in accordance with the provisions which applied before 1 February 1997, the date of entry into force of the revised STCW Convention, provided that those seafarers began their service or training before 1 August 1998; (13) Whereas for the enhancement of maritime safety and pollution prevention at sea provisions on minimum rest periods for watchkeeping personnel should be established in this Directive in accordance with the STCW Convention; whereas those provisions should be reviewed within the framework of the establishment of a possible separate instrument on working time; (14) Whereas it is appropriate to include in this Directive provisions on port State control, pending the amendment of Council Directive 95/21/EC of 19 June 1995 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) (6) in order to transfer to that Directive the provisions on port State control which are included in Articles 8(6), 10, 10a and 11 of this Directive, Article 1 Directive 94/58/EC is hereby amended as follows: (1) Article 2 shall be replaced by the following: 'Article 2 1. Member States shall take the measures necessary to ensure that seafarers serving on ships as defined in Article 1 are trained as a minimum in accordance with the requirements of the STCW Convention, as laid down in Annex I to this Directive, and hold certificates as defined in Article 3 or appropriate certificates as defined in Article 4(aa). 2. Member States shall take the measures necessary to ensure that those crew members that must be certified in accordance with Regulation III/10.4 of the International Convention on the Safety of Life at Sea (SOLAS Convention) are trained and certificated in accordance with this Directive.`; (2) the following Article shall be inserted: 'Article 3a Certificates and endorsements 1. Certificates shall be issued in accordance with Article 5d. 2. Certificates for masters, officers and radio operators shall be endorsed by the Member State as prescribed in this Article. 3. Certificates shall be in the official language or languages of the issuing Member State. 4. In respect of radio operators, Member States may: (1) include the additional knowledge required by the relevant regulations in the examination for the issue of a certificate complying with the Radio Regulations; or (2) issue a separate certificate indicating that the holder has the additional knowledge required by the relevant regulations. 5. At the discretion of a Member State endorsements may be incorporated in the format of the certificates being issued as provided for in section A-I/2 of the STCW Code. If so incorporated the form used shall be that set out in section A-I/2, paragraph 1. If issued otherwise, the form of endorsements used shall be that set out in paragraph 2 of that section. 6. A Member State which recognises a certificate under the procedure laid down in Article 9(3)(a) shall endorse that certificate to attest its recognition. The form of the endorsement used shall be that set out in paragraph 3 of section A-I/2 of the STCW Code. 7. The endorsements referred to in paragraphs 5 and 6: (1) may be issued as separate documents; (2) shall each be assigned a unique number, except that endorsements attesting the issue of a certificate may be assigned the same number as the certificate concerned, provided that that number is unique; and (3) shall each expire as soon as the certificate endorsed expires or is withdrawn, suspended or cancelled by the Member State or third country which issued it and, in any case, within five years of its date of issue. 8. The capacity in which the holder of a certificate is authorised to serve shall be identified in the form of endorsement in terms identical to those used in the applicable safe-manning requirements of the Member State concerned. 9. A Member State may use a format different from the format laid down in section A-I/2 of the STCW Code, provided that, as a minimum, the required information is provided in roman characters and Arabic figures, taking account of the variations permitted under section A-I/2. 10. Subject to Article 9(4) any certificate required by the Directive must be kept available in its original form on board the ship on which the holder is serving.`; (3) Article 4 shall be replaced by the following: 'Article 4 For the purposes of this Directive: (a) "master" shall mean the person having command of a ship; (b) "officer" shall mean a member of the crew, other than the master, designated as such by national law or regulations or, in the absence of such designation, by collective agreement or custom; (c) "deck officer" shall mean an officer qualified in accordance with the provisions of Chapter II of Annex I; (d) "chief mate" shall mean the officer next in rank to the master upon whom the command of the ship will fall in the event of the incapacity of the master; (e) "engineer officer" shall mean an officer qualified in accordance with the provisions of Chapter III of Annex I; (f) "chief engineer officer" shall mean the senior engineer officer responsible for the mechanical propulsion and the operation and maintenance of the mechanical and electrical installations of the ship; (g) "second engineer officer" shall mean the engineer officer next in rank to the chief engineer officer upon whom the responsibility for the mechanical propulsion and the operation and maintenance of the mechanical and electrical installations of the ship will fall in the event of the incapacity of the chief engineer officer; (h) "assistant engineer officer" shall mean a person under training to become an engineer officer and designated as such by national law or regulations; (i) "radio operator" shall mean a person holding an appropriate certificate issued or recognised by the competent authorities under the provisions of the Radio Regulations; (j) "rating" shall mean a member of the ship's crew other than the master or an officer; (k) "seagoing ship" shall mean a ship other than those which navigate exclusively in inland waters or in waters within, or closely adjacent to, sheltered waters or areas where port regulations apply; (l) "ship flying the flag of a Member State" shall mean a ship registered in and flying the flag of a Member State in accordance with its legislation. A ship not corresponding to this definition shall be regarded as a ship flying the flag of a third country; (m) "near-coastal voyages" shall mean voyages in the vicinity of a Member State as defined by that Member State; (n) "propulsion power" shall mean the total maximum continuous rated output power in kilowatts of all of a ship's main propulsion machinery which appears on the ship's certificate of registry or other official document; (o) "oil tanker" shall mean a ship constructed and used for the carriage of petroleum and petroleum products in bulk; (p) "chemical tanker" shall mean a ship constructed or adapted and used for the carriage in bulk of any liquid product listed in Chapter 17 of the International Bulk Chemical Code as in force at the time of the adoption of this Directive; (q) "liquefied-gas tanker" shall mean a ship constructed or adapted and used for the carriage in bulk of any liquefied gas or other product listed in Chapter 19 of the International Gas Carrier Code as in force at the time of the adoption of this Directive; (r) "Radio Regulations" shall mean the revised radio regulations, adopted by the World Administrative Radio Conference for the Mobile Service as in force at the time of the adoption of this Directive; (s) "passenger ship" shall mean a seagoing ship which carries more than 12 passengers; (t) "fishing vessel" shall mean a vessel used for catching fish or other living resources of the sea; (u) "STCW Convention" shall mean the International Convention on Standards of Training, Certification and Watchkeeping for Seafarers as it applies to the matters concerned taking into account the transitional provisions of Article VII and Regulation I/15 of the Convention and including, where appropriate, the applicable provisions of the STCW Code, all being applied as in force at the time of the adoption of this Directive; (v) "radio duties" shall include, as appropriate, watchkeeping and technical maintenance and repairs conducted in accordance with the Radio Regulations, the International Convention for the Safety of Life at Sea (1974) (SOLAS) as in force at the time of the adoption of this Directive and, at the discretion of each Member State, the relevant recommendations of the International Maritime Organisation (IMO); (w) "ro-ro passenger ship" shall mean a passenger ship with ro-ro cargo spaces or special-category spaces as defined in the SOLAS Convention; (x) "STCW Code" shall mean the Seafarers' Training, Certification and Watchkeeping (STCW) Code as adopted by Resolution 2 of the 1995 STCW Conference of Parties, as in force at the time of the adoption of this Directive; (y) "function" shall mean a group of tasks, duties and responsibilities, as specified in the STCW Code, necessary for ship operation, safety of life at sea or protection of the marine environment; (z) "company" shall mean the owner of the ship or any other organisation or person such as the manager or the bareboat charterer who has assumed the responsibility for operation of the ship from the shipowner and who, on assuming such responsibility, has agreed to take over all the duties and responsibilities imposed on the company by these regulations; (aa) "appropriate certificate" shall mean a certificate issued and endorsed in accordance with this Directive and entitling the lawful holder thereof to serve in the capacity and perform the functions involved at the level of responsibility specified therein on a ship of the type, tonnage, power and means of propulsion concerned while engaged on the particular voyage concerned; (ab) "seagoing service" shall mean service on board a ship relevant to the issue of a certificate or other qualification; (ac) "approved" shall mean approved by a Member State in accordance with this Directive; (ad) "third country" shall mean any country which is not a Member State; (ae) "month" shall mean a calendar month or 30 days made up of periods of less than one month.`; (4) the following Articles shall be inserted: 'Article 5a Principles governing near-coastal voyages 1. When defining near-coastal voyages Member States shall not impose training, experience or certification requirements on seafarers serving on board ships entitled to fly the flag of another Member State or of another Party to the STCW Convention and engaged on such voyages in a manner resulting in more stringent requirements for such seafarers than for seafarers serving on board ships entitled to fly its own flag. In no case shall a Member State impose requirements in respect of seafarers serving on board ships flying the flag of another Member State or of another Party to the STCW Convention in excess of those of the Directive in respect of ships not engaged on near-coastal voyages. 2. With respect to ships entitled to fly the flag of a Member State regularly engaged on near-coastal voyages off the coast of another Member State or of another Party to the STCW Convention, the Member State the flag of which a ship is entitled to fly shall prescribe training, experience and certification requirements for seafarers serving on such ships at least equal to those of the Member State or the Party to the STCW Convention off the coast of which the ship is engaged, provided that they do not exceed the requirements of the Directive in respect of ships not engaged on near-coastal voyages. Seafarers serving on a ship which extends its voyage beyond what is defined as a near-coastal voyage by a Member State and enters waters not covered by that definition shall fulfil the appropriate requirements of the Directive. 3. A Member State may afford a ship which is entitled to fly its flag the benefits of the near-coastal voyage provisions of this Directive when it is regularly engaged off the coast of a non-Party to the STCW Convention on near-coastal voyages as defined by that Member State. 4. Upon deciding on the definition of near-coastal voyages and the conditions of education and training required thereof in accordance with the requirements of this Article, Member States shall communicate to the Commission the details of the provisions they have adopted. Article 5b Penalties or disciplinary measures 1. Member States shall establish processes and procedures for the impartial investigation of any reported incompetence, act or omission, that may pose a direct threat to safety of life or property at sea or to the marine environment, on the part of the holders of certificates or endorsements issued by that Member State in connection with their performance of duties relating to their certificates and for the withdrawal, suspension and cancellation of such certificates for such cause and for the prevention of fraud. 2. Each Member State shall prescribe penalties or disciplinary measures for cases in which the provisions of its national legislation giving effect to the Directive are not complied with in respect of ships entitled to fly its flag or of seafarers duly certificated by it. 3. In particular, such penalties or disciplinary measures shall be prescribed and enforced in cases in which: (1) a company or a master has engaged a person not holding a certificate as required by the Directive; (2) a master has allowed any function or service in any capacity which under the Directive must be performed by a person holding an appropriate certificate to be performed by a person not holding the required certificate, a valid dispensation or having the documentary proof required by Article 9(4); or (3) a person has obtained by fraud or forged documents an engagement to perform any function or serve in any capacity which under the Directive must be performed or filled by a person holding a certificate or dispensation. 4. Member States within the jurisdiction of which any company which or any person who is believed on clear grounds to have been responsible for or to have knowledge of any apparent non-compliance with the Directive specified in paragraph 3 is located shall extend cooperation to any Member State or other party to the STCW Convention which advises them of its intention to initiate proceedings under its jurisdiction. Article 5c Quality standards 1. Each Member State shall ensure that: (1) all training, assessment of competence, certification, endorsement and revalidation activities carried out by non-governmental agencies or entities under its authority are continuously monitored through a quality-standards system to ensure the achievement of defined objectives, including those concerning the qualifications and experience of instructors and assessors; (2) where governmental agencies or entities perform such activities, there shall be a quality-standards system; (3) the education and training objectives and related standards of competence to be achieved are clearly defined and identify the levels of knowledge, understanding and skills appropriate to the examinations and assessments required under the STCW Convention. The objectives and related quality standards may be specified separately for different courses and training programmes and shall cover the administration of the certification system; (4) the field of application of the quality standards cover the administration of the certification systems, all training courses and programmes, examinations and assessments carried out by or under the authority of each Member State and the qualifications and experience required of instructors and assessors, having regard to the policies, systems, controls and internal quality-assurance reviews established to ensure achievement of the defined objectives. 2. Member States shall also ensure that independent evaluations of the knowledge, understanding, skills and competence acquisition and assessment activities, and of the administration of the certification system, are conducted at intervals of not more than five years by qualified persons who are not themselves involved in the activities concerned in order to verify that: (1) all internal management control and monitoring measures and follow-up actions comply with planned arrangements and documented procedures and are effective in ensuring achievement of the defined objectives; (2) the results of each independent evaluation are documented and brought to the attention of those responsible for the area evaluated; (3) timely action is taken to correct deficiencies. 3. A report relating to each evaluation carried out pursuant to paragraph 2 shall be communicated by the Member State concerned to the Commission within six months of the date of the evaluation. Article 5d Medical standards - Issue and registration of certificates 1. Member States shall establish standards of medical fitness for seafarers, particularly regarding eyesight and hearing. 2. Member States shall ensure that certificates are issued only to candidates who comply with the requirements of this Article. 3. Each candidate for certification shall provide satisfactory proof: (1) of his identity; (2) that his age is not less than that prescribed in the regulations in Annex I relevant to the certificate applied for; (3) that he meets the standards of medical fitness, particularly regarding eyesight and hearing, established by the Member State and holds a valid document attesting to his medical fitness, issued by a duly qualified medical practitioner recognised by the competent authority of the Member State; (4) of having completed the seagoing service and any related compulsory training prescribed in the regulations in Annex I for the certificate applied for; (5) that he meets the standards of competence prescribed in the regulations in Annex I for the capacities, functions and levels that are to be identified in the endorsement to the certificate. 4. Each Member State shall undertake: (1) to maintain a register or registers of all certificates and endorsements for masters and officers and, as appropriate, ratings, which are issued, have expired or have been revalidated, suspended, cancelled or reported lost or destroyed and of dispensations issued; (2) to make available information on the status of such certificates, endorsements and dispensations to other Member States or other parties to the Convention and companies which request verification of the authenticity and validity of certificates produced to them by seafarers seeking recognition of their certificates or employment on board ship. Article 5e Revalidation of certificates 1. Every master, officer and radio operator holding a certificate issued or recognised under any chapter of Annex I other than Chapter VI who is serving at sea or intends to return to sea after a period ashore shall, in order to continue to qualify for seagoing service, be required at intervals not exceeding five years: (1) to meet the standards of medical fitness prescribed by Article 5d; and (2) to establish continued professional competence in accordance with section A-I/11 of the STCW Code. 2. Every master, officer and radio operator shall, for continuing seagoing service on board ships for which special training requirements have been internationally agreed upon, successfully complete approved relevant training. 3. Each Member State shall compare the standards of competence which it required of candidates for certificates issued before 1 February 2002 with those specified for the appropriate certificate in Part A of the STCW Code, and shall determine the need to require the holders of such certificates to undergo appropriate refresher and updating training or assessment. Refresher and updating courses shall be approved and include changes in relevant national and international regulations concerning the safety of life at sea and the protection of the marine environment and take account of any updating of the standard of competence concerned. 4. Each Member State shall, in consultation with those concerned, formulate or promote the formulation of a structure of refresher and updating courses as provided for in section A-I/11 of the STCW Code. 5. For the purpose of updating the knowledge of masters, officers and radio operators, each Member State shall ensure that the texts of recent changes in national and international regulations concerning the safety of life at sea and the protection of the marine environment are made available to ships entitled to fly its flag. Article 5f Use of simulators 1. The performance standards and other provisions set out in section A-I/12 of the STCW Code and such other requirements as are prescribed in Part A of the STCW Code for any certificate concerned shall be complied with in respect of: (1) all mandatory simulator-based training; (2) any assessment of competence required by Part A of the STCW Code which is carried out by means of a simulator; (3) any demonstration, by means of a simulator, of continued proficiency required by Part A of the STCW Code. 2. Simulators installed or brought into use before 1 February 2002 may be exempted from full compliance with the performance standards referred to in paragraph 1 at the discretion of each Member State. Article 5g Responsibilities of companies 1. In accordance with paragraphs 2 and 3 Member States shall hold companies responsible for the assignment of seafarers for service in their ships in accordance with this Directive, and shall require every company to ensure that: (1) each seafarer assigned to any of its ships holds an appropriate certificate in accordance with the provisions of this Directive and as established by the Member State; (2) its ships are manned in accordance with the applicable safe-manning requirements of the Member State; (3) documentation and data relevant to all seafarers employed on its ships are maintained and readily accessible, and include, without being limited to, documentation and data on their experience, training, medical fitness and competence in assigned duties; (4) on being assigned to any of its ships seafarers are familiarised with their specific duties and with all ship arrangements, installations, equipment, procedures and ship characteristics that are relevant to their routine or emergency duties; (5) the ship's complement can effectively coordinate their activities in an emergency situation and in performing functions vital to safety or to the prevention or mitigation of pollution. 2. Companies, masters and crew members shall each have responsibility for ensuring that the obligations set out in this Article are given full and complete effect and that such other measures as may be necessary are taken to ensure that each crew member can make a knowledgeable and informed contribution to the safe operation of the ship. 3. The company shall provide written instructions to the master of each ship to which the Directive applies, setting out the policies and the procedures to be followed to ensure that all seafarers who are newly employed on board the ship are given a reasonable opportunity to become familiar with the shipboard equipment, operating procedures and other arrangements needed for the proper performance of their duties, before being assigned to those duties. Such policies and procedures shall include: (1) the allocation of a reasonable period of time during which each newly employed seafarer will have an opportunity to become acquainted with: 1.1. the specific equipment the seafarer will be using or operating; and 1.2. ship-specific watchkeeping, safety, environmental protection and emergency procedures and arrangements the seafarer needs to know to perform the assigned duties properly; (2) the designation of a knowledgeable crew member who will be responsible for ensuring that each newly employed seafarer is given an opportunity to receive essential information in a language the seafarer understands. Article 5h Fitness for duty 1. For the purpose of preventing fatigue Member States shall establish and enforce rest periods for watchkeeping personnel and require that watch systems are so arranged that the efficiency of watchkeeping personnel is not impaired by fatigue and that duties are so organised that the first watch at the start of a voyage and subsequent relieving watches are sufficiently rested and otherwise fit for duty. 2. All persons who are assigned duty as officer in charge of a watch or as a rating forming part of a watch shall be allowed at least 10 hours of rest in any 24 hour period. 3. The hours of rest may be divided into no more than two periods, one of which shall be at least six hours long. 4. The requirements for rest periods laid down in paragraphs 1 and 2 need not be maintained in the event of an emergency or drill or in other overriding operational conditions. 5. Notwithstanding paragraphs 2 and 3, the minimum period of 10 hours may be reduced to not less than six consecutive hours provided that no such reduction shall extend beyond two days and at least 70 hours of rest are provided each seven-day period. 6. Member States shall require that watch schedules be posted where they are easily accessible.`; (5) Article 7 shall be replaced by the following: 'Article 7 1. Member States shall designate the authorities or bodies which shall: - give the training referred to in Article 5, - organise and/or supervise the examinations where required, - issue the certificates of competence referred to in Article 5d, and - grant the dispensations provided for in Article 6. 2. Member States shall ensure that: Training and assessment (a) all training and assessment of seafarers is: (1) structured in accordance with the written programmes, including such methods and media of delivery, procedures and course material as are necessary to achieve the prescribed standard of competence; and (2) conducted, monitored, evaluated and supported by persons qualified in accordance with paragraphs (d), (e) and (f); (b) persons conducting in-service training or assessment on board ship do so only when such training or assessment will not adversely affect the normal operation of the ship and they can dedicate their time and attention to training or assessment; Qualifications of instructors, supervisors and assessors (c) instructors, supervisors and assessors are appropriately qualified for the particular types and levels of training or assessment of competence of seafarers either on board or ashore; In-service training (d) any person conducting in-service training of a seafarer, either on board or ashore, which is intended to be used in qualifying for certification under the Directive: (1) has an appreciation of the training programme and an understanding of the specific training objectives for the particular type of training being conducted, (2) is qualified in the task for which training is being conducted, and (3) if conducting training using a simulator: 3.1. has received appropriate guidance in instructional techniques involving the use of simulators, and 3.2. has gained practical operational experience on the particular type of simulator being used; (e) any person responsible for the supervision of the in-service training of a seafarer intended to be used in qualifying for certification has a full understanding of the training programme and the specific objectives for each type of training being conducted; Assessment of competence (f) any person conducting in-service assessment of the competence of a seafarer, either on board or ashore, which is intended to be used in qualifying for certification: (1) has an appropriate level of knowledge and understanding of the competence to be assessed; (2) is qualified in the task for which the assessment is being made; (3) has received appropriate guidance in assessment methods and practice; (4) has gained practical assessment experience; and (5) if conducting assessment involving the use of simulators, has gained practical assessment experience on the particular type of simulator under the supervision and to the satisfaction of an experienced assessor; Training and assessment within an institution (g) when a Member State recognises a course of training, a training institution, or a qualification granted by a training institution, as part of its requirements for the issue of a certificate, the qualifications and experience of instructors and assessors are covered in the application of the quality standard provisions of Article 5e. Such qualification, experience and application of quality standards shall incorporate appropriate training in instructional techniques and training and assessment methods and practice and comply with all applicable requirements of paragraphs (d) to (f).`; (6) Article 8 shall be replaced by the following: 'Article 8 Member States shall ensure that: (1) without prejudice to paragraphs 2 and 4, there are at all times, on board all ships flying the flag of a Member State, means in place for effective oral communication relating to safety between all members of the ship's crew, particularly with regard to the correct and timely reception and understanding of messages and instructions; (2) on board all passenger ships flying the flag of a Member State and on board all passenger ships starting and/or finishing a voyage in a Member State port, to ensure effective crew performance in safety matters, a working language is established and recorded in the ship's log-book. The company or the master, as appropriate, shall determine the appropriate working language. Each seafarer shall be required to understand and, where appropriate, give orders and instructions and report back in that language. If the working language is not an official language of the Member State, all plans and lists that must be posted shall include translations into the working language; (3) on board passenger ships, personnel nominated on muster lists to assist passengers in emergency situations are readily identifiable and have communication skills that are sufficient for that purpose, taking into account an appropriate and adequate combination of any of the following factors: (a) the language or languages appropriate to the principal nationalities of passengers carried on a particular route; (b) the likelihood that an ability to use elementary English vocabulary for basic instructions can provide a means of communicating with a passenger in need of assistance whether or not the passenger and crew member share a common language; (c) the possible need to communicate during an emergency by some other means (e.g. by demonstration, hand signals, or calling attention to the location of instructions, muster stations, life-saving devices or evacuation routes when verbal communication is impractical); (d) the extent to which complete safety instructions have been provided to passengers in their native language or languages; (e) the languages in which emergency announcements may be broadcast during an emergency or drill to convey critical guidance to passengers and to facilitate crew members in assisting passengers; (4) on board oil tankers, chemical tankers and liquefied gas tankers flying the flag of a Member State, the master, officers and ratings are able to communicate with each other in (a) common working language(s); (5) there are adequate means for communication between the ship and the shore-based authorities, either in a common language or in the language of those authorities; (6) when carrying out port State control under Directive 95/21/EC, Member States also check that ships flying the flag of a State other than a Member State comply with this Article.`; (7) Articles 9(3) and (4) shall be replaced by the following: '3. Seafarers who do not possess the certificates referred to in Article 3 may be allowed to serve on ships flying the flag of a Member State, provided a decision on the recognition of their appropriate certificates has been adopted through the procedure set out below: (a) when recognising, by endorsement, an appropriate certificate issued by a third country, the Member State shall proceed in accordance with the procedures and criteria set out in Annex II; (b) Member States shall notify the Commission, which shall inform the other Member States, of the appropriate certificates they have recognised or intend to recognise in accordance with the criteria referred to in (a); (c) if within three months of Member States having been informed by the Commission in accordance with paragraph (b) an objection is raised by a Member State or the Commission on the basis of the criteria referred to in (a), the Commission shall subject the matter to the procedure laid down in Article 13. The Member State concerned shall take appropriate measures to implement the decisions taken in accordance with the procedure laid down in Article 13; (d) when an appropriate certificate issued by a third country has been recognised under the above procedure, and if, after the completion of its evaluation the Maritime Safety Committee of the IMO has not been able to identify the third country as having demonstrated that full and complete effect is given to the provisions of the STCW Convention, the Commission shall subject the matter to the procedure laid down in Article 13 in order to reassess the recognition of the certificates issued by that country. The Member State concerned shall take appropriate measures to implement the decisions taken in accordance with the procedure laid down in Article 13; (e) the Commission shall draw up and update a list of the appropriate certificates that have been recognised under the above procedure. The list shall be published in the Official Journal of the European Communities. 4. Notwithstanding Article 3a(6), a Member State may, if circumstances require, allow a seafarer to serve in a capacity other than radio officer or radio operator, except as provided by the Radio Regulations, for a period not exceeding three months on board a ship flying its flag, while holding an appropriate and valid certificate issued and endorsed as required by a third country, but not yet endorsed for recognition by the Member State concerned so as to render it appropriate for service on board a ship flying its flag. Documentary proof shall be kept readily available that application for an endorsement has been submitted to the competent authorities.`; (8) Articles 10 and 11 shall be replaced by the following: 'Article 10 Port State control 1. Irrespective of the flag it flies each ship, with the exception of those types of ships excluded by Article 1, shall, while in the ports of a Member State, be subject to port State control by officers duly authorised by that Member State to verify that all seafarers serving on board who are required to be certificated by the STCW Convention are so certificated or hold appropriate dispensations. 2. When exercising port State control under this Directive, Member States shall ensure that all relevant provisions and procedures laid down in Directive 95/21/EC are applied. Article 10a Port State control procedures 1. Without prejudice to Directive 95/21/EC, port State control pursuant to Article 10 shall be limited to the following: - verification that every seafarer serving on board who must be certificated in accordance with the STCW Convention holds an appropriate certificate or a valid dispensation or provides documentary proof that an application for an endorsement attesting recognition has been submitted to the authorities of the Flag State, - verification that the numbers and certificates of the seafarers serving on board are in accordance with the safe-manning requirements of the authorities of the Flag State. 2. The ability of the ship's seafarers to maintain watchkeeping standards as required by the STCW Convention shall be assessed in accordance with Part A of the STCW Code if there are clear grounds for believing that such standards are not being maintained because any of the following has occurred: - the ship has been involved in a collision, grounding or stranding, - there has been a discharge of substances from the ship when under way, at anchor or at berth which is illegal under any international convention, - the ship has been manoeuvred in an erratic or unsafe manner whereby routing measures adopted by the IMO, or safe navigation practices and procedures have not been followed, - the ship is otherwise being operated in such a manner as to pose a danger to persons, property or the environment, - a certificate has been fraudulently obtained or the holder of a certificate is not the person to whom that certificate was originally issued, - the ship is flying the flag of a country which has not ratified the STCW Convention, or has a master, officer or rating holding a certificate issued by a third country which has not ratified the STCW Convention. 3. Notwithstanding verification of the certificate, assessment under paragraph 2 may require the seafarer to demonstrate the relevant competence at the place of duty. Such a demonstration may include verification that operational requirements in respect of watchkeeping standards have been met and that there is a proper response to emergency situations within the seafarer's level of competence. Article 11 Detention Without prejudice to Directive 95/21/EC, the following deficiencies, in so far as it has been determined by the officer carrying out the port State control that they pose a danger to persons, property or the environment, shall be the only grounds under this Directive on which a Member State may detain a ship: - failure of seafarers to hold certificates, to have appropriate certificates, to have valid dispensations or provide documentary proof that an application for an endorsement attesting recognition has been submitted to the authorities of the Flag State, - failure to comply with the applicable safe-manning requirements of the Flag State, - failure of navigational or engineering-watch arrangements to conform to the requirements specified for the ship by the Flag State, - absence in a watch of a person qualified to operate equipment essential to safe navigation, safety radiocommunications or the prevention of marine pollution, - failure to provide proof of professional proficiency for the duties assigned to seafarers for the safety of the ship and the prevention of pollution, - inability to provide for the first watch at the commencement of a voyage and for subsequent relieving watches persons who are sufficiently rested and otherwise fit for duty.`; (9) Article 12 shall be amended as follows: - in paragraph 1, '(q), (r) and (s)` shall be replaced by '(p), (q), (r), (w) and (x)`; - the following paragraph 1a shall be inserted: 'The Council shall decide, in accordance with the conditions of the Treaty, on any amendment of Annex II, acting on a proposal to be submitted by the Commission within five years of the adoption of the amending Directive 98/35/EC (*) in the light of the experience gained in applying this Directive; (*) OJ L 172, 17.6.1998, p. 1.`, - in paragraph 2, '(v)` shall be replaced by '(u)`; (10) the following Article shall be inserted: 'Article 13a Transitional provisions 1. Until 1 February 2002 Member States may continue to issue, recognise and endorse certificates in accordance with the provisions which applied before 1 February 1997 in respect of those seafarers who began approved seagoing service, approved education and training programmes or approved training courses before 1 August 1998. 2. Until 1 February 2002 Member States may continue to renew and revalidate certificates and endorsements in accordance with the provisions which applied before 1 February 1997. 3. Where pursuant to Article 5e a Member State reissues or extends the validity of certificates which it originally issued under the provisions which applied before 1 February 1997, the Member State may, at its discretion, replace tonnage limitations appearing on the original certificates as follows: (1) "200 gross registered tonnes" may be replaced by "500 gross tonnage"; (2) "1 600 gross registered tonnes" may be replaced by "3 000 gross tonnage"`; (11) the Annex shall be replaced by Annex I to this Directive; (12) Annex II to this Directive shall be added. Article 2 1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 1999 or within one year of the adoption of this Directive, whichever is earlier. 2. When the Member States adopt those measures they shall contain references to this Directive or shall be accompanied by such references on the occasion of their official publication. The methods of making such references shall be laid down by the Member States. 3. Member States shall lay down systems of penalties for breaching the 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 for shall be effective, proportionate and dissuasive. 4. The Member States shall immediately communicate to the Commission the texts of all the provisions of national 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. Article 4 This Directive is addressed to the Member States.

31998L0041

1998

Council Directive 98/41/EC of 18 June 1998 on the registration of persons sailing on board passenger ships operating to or from ports of the Member States of the Community Having regard to the Treaty establishing the European Community, and in particular Article 84(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 189c of the Treaty (3), (1) Whereas within the framework of the common transport policy further measures must be taken to enhance safety in maritime transport; (2) Whereas the Community is seriously concerned by shipping accidents involving passenger ships which have resulted in massive loss of life, particularly those involving the Herald of Free Enterprise and the Estonia; whereas persons using passenger ships and high-speed passenger craft throughout the Community have the right to expect and to be able to rely on an appropriate level of safety and upon an adequate information system which will facilitate search and rescue and the efficient handling of the aftermath of any accident that might occur; (3) Whereas it is necessary to ensure that the number of passengers on board a passenger ship does not exceed the number for which the ship and its safety equipment have been certified; whereas companies should be able to inform the search and rescue services of the number of persons involved in an accident; (4) Whereas information must be compiled on passengers and crew in order to facilitate search and rescue and the efficient handling of the aftermath of an accident, i.e. identifying the persons involved, providing clearer information on related legal issues and contributing to more appropriate medical care for rescued persons; whereas such information would prevent unnecessary anxiety on the part of relatives and other persons concerned regarding persons on board passenger ships involved in marine accidents in waters for which Member States bear responsibility under the 1979 International Convention on Maritime Search and Rescue (SAR); (5) Whereas passengers should therefore be counted and registered before any ship departs; (6) Whereas Chapter III of the International Convention on the Safety of Life at Sea (the SOLAS Convention) provides for the counting and registration of all persons on board all passenger ships sailing on international voyages, from 1 July 1997 and 1 January 1999 respectively, while permitting Administrations to exempt passenger ships sailing in sheltered waters from those requirements and from the requirement to register if the scheduled voyages of such ships render it impracticable for them to prepare such records; whereas that Chapter of the SOLAS Convention does not apply to domestic voyages and leaves important points of interpretation to the discretion of individual Member States; (7) Whereas this Directive is in accordance with the right of Member States to impose on passenger ships sailing to or from their ports certain requirements more stringent than those laid down in the SOLAS Convention; (8) Whereas in view, in particular, of the internal-market dimension of maritime passenger transport, action at Community level is the most effective way of establishing a common minimum level of safety for ships throughout the Community; (9) Whereas, in view of the principle of proportionality a Council Directive is the appropriate legal instrument as it provides a framework for the Member States' uniform and compulsory application of safety standards while leaving each Member State the right to decide which implementation tools best fit its internal system; (10) Whereas a Member State can ensure compliance with the safety rules applicable on the part of passenger ships flying its flag and the companies that operate them; whereas those rules should not be imposed upon ships operating between ports in third countries; whereas the provisions of the SOLAS Convention apply to those voyages; (11) Whereas the only way of ensuring the safe and efficient handling of the aftermath of accidents for all passenger ships, irrespective of their flags, operating or wishing to operate from their ports, is for the Member States to require effective compliance with the relevant rules as a condition of operating from their ports; whereas the granting of exemptions from those rules cannot be left solely to the flag State since only the port State is in a position to determine the requirements for the best possible search and rescue operations for passenger ships sailing to and from a port; (12) Whereas in order to harmonise safety protection and avoid distortions of competition, Member States should not, for reasons other than those mentioned in this Directive, grant exemptions or derogations from the relevant SOLAS provisions on 'information on passengers` for voyages starting from or arriving at Community ports; (13) Whereas for reasons of practicability and to avoid distortion of competition, a uniform approach must be established to determine the voyages for which the registration of all persons on board should be mandatory; whereas the twenty-mile threshold is the result of taking into consideration general principles and specific points of concern endorsed by all Member States; (14) Whereas, for specific operational reasons, the counting of persons on board passenger ships crossing the Strait of Messina might, for a limited period of time, be done in a simpler way than individual counting; whereas Member States should enjoy the possibility of granting some relaxation from the obligation to communicate to the shore the number of persons in the case of passenger ships operating on regular services of short duration carried out exclusively in protected sea areas, as defined in this Directive; whereas passenger ships operating exclusively in protected sea areas constitute a more limited risk and should, therefore, enjoy the possibility of exemption; whereas in certain specific circumstances it may be impracticable for shipping companies to register persons on board and therefore a derogation from the obligation to register could be permitted under specific circumstances and well defined conditions; (15) Whereas the collection and processing of data concerning named individuals must be carried out in accordance with the principles of data protection laid down in Directive 95/46/EC (4); whereas, in particular, individuals should be fully informed at the time of collection of the purposes for which the data are required, and the data should be retained only for a very short period which should not in any case be any longer than necessary for the purposes of this Directive; (16) Whereas it is necessary that a committee consisting of representatives of the Member States assist the Commission in the effective application of this Directive; whereas the committee set up by Article 12 of Directive 93/75/EEC (5) can assume that function; (17) Whereas certain provisions of this Directive may be adapted by that Committee to take into account future amendments to the SOLAS Convention that have entered into force, Article 1 The purpose of this Directive shall be to enhance the safety and possibilities of rescue of passengers and crew on board passenger ships operating to or from ports in Member States of the Community and to ensure that search and rescue and the aftermath of any accident which may occur can be dealt with more effectively. Article 2 For the purposes of this Directive: - 'persons` shall mean all people on board irrespective of age, - 'passenger ship` shall mean a sea-going ship or a sea-going high-speed craft which carries more than twelve passengers, - 'high-speed craft` shall mean a high-speed craft as defined in Regulation 1 of Chapter X of the 1974 SOLAS Convention, as in force at the time of the adoption of this Directive, - 'company` shall mean the owner of a passenger ship or any other organisation or person such as the manager or the bareboat charterer, who has assumed responsibility for operating the passenger ship from the owner, - 'ISM Code` shall mean the International Management Code for the Safe Operation of Ships and for Pollution Prevention adopted by the International Maritime Organization (IMO) through Assembly Resolution A.741(18) of 4 November 1993, - 'passenger registrar` shall mean the responsible shore-based person designated by a company to fulfil the ISM Code obligations or a shore-based person designated by a company as responsible for the keeping of information on persons who have embarked on a company passenger ship, - 'designated authority` shall mean the competent authority of the Member State responsible for search and rescue or concerned with the aftermath of an accident, - 'a mile` is 1 852 metres, - 'protected sea area` shall mean a sea area sheltered from open sea effects where a ship is at no time more than six miles from a place of refuge where shipwrecked persons can land and in which the proximity of search and rescue facilities is ensured, - 'regular service` shall mean a series of ship crossings operated so as to serve traffic between the same two or more ports, either: (a) according to a published timetable, or (b) with crossings so regular or frequent that they constitute a recognizable systematic series, - 'third country` shall mean any country which is not a Member State. Article 3 This Directive shall apply to passenger ships with the exception of: - ships of war and troop ships, and - pleasure yachts unless they are or will be crewed and carry more than twelve passengers for commercial purposes. Article 4 1. All persons on board any passenger ship which departs from a port located in a Member State shall be counted before that passenger ship departs. 2. Before the passenger ship departs the number of persons on board shall be communicated to the master of the passenger ship and to the company's passenger registrar or to a shore-based company system that performs the same function. Article 5 1. The following information shall be recorded regarding every passenger ship that departs from a port located in a Member State to undertake a voyage of more than twenty miles from the point of departure: - the family names of the persons on board, - their forenames or initials, - their sex, - an indication of the category of age (adult, child or infant) to which each person belongs, or the age, or the year of birth, - when volunteered by a passenger, information concerning the need for special care or assistance in emergency situations. 2. That information shall be collected before departure and communicated not later than thirty minutes after the passenger ship's departure to the company's passenger registrar or to a shore-based company system that performs the same function. Article 6 1. Each Member State shall, as regards every passenger ship that flies its flag and departs from a port located outwith the Community and is bound for a port located within the Community, require the company to ensure that the information specified in Articles 4(1) and 5(1) is provided as laid down in Articles 4(2) and 5(2). 2. Each Member State shall, as regards every passenger ship that flies the flag of a third country and departs from a port located outwith the Community and is bound for a port located within the Community, require the company to ensure that the information specified in Articles 4(1) and 5(1) is collected and maintained so that it is available to the designated authority when needed for purposes of search and rescue and in the aftermath of an accident. 3. Where under the relevant SOLAS provisions a Member State grants an exemption or derogation relating to the information concerning passengers to a ship flying its flag arriving at a port located within the Community from a port located outwith the Community, it may do so only under the conditions laid down for exemptions or derogations in this Directive. Article 7 Before a passenger ship departs from a port located in a Member State its master shall ensure that the number of persons on board does not exceed the number the passenger ship is permitted to carry. Article 8 Each company assuming responsibility for operating a passenger ship shall, where required under Articles 4 and 5: - set up a system for the registration of passenger information. The system shall meet the criteria laid down in Article 11, - appoint a passenger registrar responsible for the keeping and the transmission of that information should an emergency occur or in the aftermath of an accident. The company shall ensure that the information required by this Directive is at all times readily available for transmission to the designated authority for search and rescue purposes in the event of an emergency or in the aftermath of an accident. Personal data collected in accordance with Article 5 shall not be kept longer than necessary for the purposes of this Directive. The company shall ensure that information concerning persons who have declared a need for special care or assistance in emergency situations is properly recorded and communicated to the master before the passenger ship departs. Article 9 1. A Member State from a port in which a passenger ship departs may lower the twenty-mile threshold laid down in Article 5. Any decision lowering that threshold for journeys between two ports in different Member States shall be taken jointly by those two Member States. 2. (a) When implementing Article 4(1) the Italian Republic may, for regular services crossing the Strait of Messina, adopt provisions for counting the maximum number of persons permitted to be carried on board a passenger ship carrying passenger-train carriages and road vehicles on the basis of the maximum number of passengers authorised to be carried by train carriages and all other vehicles on board, if the persons cannot be counted individually for operational reasons. The application of this provision shall be limited to a period of four years. Any extension shall be decided, in accordance with paragraph 3, in the light of the experience gained. (b) A Member State from a port in which a ship departs may exempt passenger ships operating, exclusively in protected sea areas, regular services of less than one hour between port calls from the obligation laid down in Article 4(2) to communicate the number of persons on board to the passenger registrar or to a shore-based company system that performs the same function. (c) A Member State may exempt passenger ships sailing, exclusively in protected sea areas, between two ports or from and to the same port without intermediate calls from the obligations laid down in Article 5. 3. In the circumstances set out in paragraph 2, the following procedure shall apply: (a) the Member State shall without delay inform the Commission of its decision to grant an exemption or a derogation from the relevant provisions of Articles 4 and 5 giving substantive reasons therefor; (b) if within six months of such notification the Commission considers that that decision is not justified or could have adverse effects on competition, it may, acting in accordance with the procedure laid down in Article 13, require the Member State to amend or withdraw its decision. 4. For regular services in an area where the annual probability of the significant wave height's exceeding two metres is less than 10%, and - if the voyage does not exceed about thirty miles from the point of departure or - where the primary purpose of the service is to provide regular links to outlying communities for customary purposes, a Member State from a port in which passenger ships sail on domestic voyages or two Member States between ports in which passenger ships sail may request the Commission, if they consider it impracticable for companies to record the information specified in Article 5(1) to derogate, wholly or partly, from this requirement. To this end, evidence of such impracticability shall be provided. In addition, it shall be demonstrated that in the area where such ships operate, shore-based navigational guidance and reliable weather forecasts are provided and that adequate and sufficient search and rescue facilities are available. Derogations granted under this paragraph may not have any adverse effect on competition. A decision shall be taken in accordance with the procedure laid down in Article 13. 5. A Member State shall not, under the provisions of this Directive, exempt or grant derogations to any passenger ship sailing from its ports and flying the flag of a third country that is a contracting party to the SOLAS Convention which under the relevant SOLAS provisions does not agree to the application of such exemptions. Article 10 The registration systems set up in accordance with Article 8 shall be approved by the Member States. Member States shall at least carry out random checks on the proper functioning of the registration systems set up pursuant to this Directive within their territories. Each Member State shall designate the authority to which the companies covered by Article 8 shall communicate the information required by this Directive. Article 11 1. For the purposes of this Directive registration systems shall meet the following functional criteria: (i) readability: the required data must be in a format that is easy to read, (ii) availability: the required data must be easily available to the designated authorities for which the information contained in the system is relevant, (iii) facilitation: the system must be designed in such a way that no undue delay is caused for passengers embarking and/or disembarking the vessel; (iv) security: the data must be appropriately protected against accidental or unlawful destruction or loss and unauthorised alteration, disclosure or access. 2. A multiplicity of systems on the same or similar routes is to be avoided. Article 12 Without prejudice to the procedures for amending the SOLAS Convention, this Directive may be amended in accordance with the procedure laid down in Article 13, in order to ensure the application, for the purposes of this Directive and without broadening its scope, of subsequent amendments to the SOLAS Convention relating to the registration systems which have entered into force after the adoption of this Directive. Article 13 The Commission shall be assisted by the committee set up pursuant to Article 12(1) of Directive 93/75/EEC. The committee shall operate in accordance with the procedure laid down in paragraphs 2 and 3 of that Article. Article 14 Member States shall lay down systems of penalties for breaching the 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 for shall be effective, proportionate and dissuasive. Article 15 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1999. They shall forthwith inform the Commission thereof. Article 5 shall be applied no later than 1 January 2000. 2. When the Member States adopt those measures, they shall contain references to this Directive or shall be accompanied by such references on the occasion of their official publication. The methods of making such references shall be laid down by the Member States. 3. The Member States shall immediately communicate to the Commission the texts of all provisions of national law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof. Article 16 This Directive shall enter into force on the twentieth day after its publication. Article 17 This Directive is addressed to the Member States.

31998L0034

1998

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 Having regard to the Treaty establishing the European Community, and in particular Articles 100a, 213 and 43 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 189b of the Treaty (3), (1) Whereas Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (4) has been variously and substantially amended; whereas for reasons of clarity and rationality the said Directive should be consolidated; (2) Whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; whereas, therefore, the prohibition of quantitative restrictions on the movement of goods and of measures having an equivalent effect is one of the basic principles of the Community; (3) Whereas in order to promote the smooth functioning of the internal market, as much transparency as possible should be ensured as regards national initiatives for the establishment of technical standards or regulations; (4) Whereas barriers to trade resulting from technical regulations relating to products may be allowed only where they are necessary in order to meet essential requirements and have an objective in the public interest of which they constitute the main guarantee; (5) Whereas it is essential for the Commission to have the necessary information at its disposal before the adoption of technical provisions; whereas, consequently, the Member States which are required to facilitate the achievement of its task pursuant to Article 5 of the Treaty must notify it of their projects in the field of technical regulations; (6) Whereas all the Member States must also be informed of the technical regulations contemplated by any one Member State; (7) Whereas the aim of the internal market is to create an environment that is conducive to the competitiveness of undertakings; whereas increased provision of information is one way of helping undertakings to make more of the advantages inherent in this market; whereas it is therefore necessary to enable economic operators to give their assessment of the impact of the national technical regulations proposed by other Member States, by providing for the regular publication of the titles of notified drafts and by means of the provisions relating to the confidentiality of such drafts; (8) Whereas it is appropriate, in the interests of legal certainty, that Member States publicly announce that a national technical regulation has been adopted in accordance with the formalities laid down in this Directive; (9) Whereas, as far as technical regulations for products are concerned, the measures designed to ensure the proper functioning or the continued development of the market include greater transparency of national intentions and a broadening of the criteria and conditions for assessing the potential effect of the proposed regulations on the market; (10) Whereas it is therefore necessary to assess all the requirements laid down in respect of a product and to take account of developments in national practices for the regulation of products; (11) Whereas requirements, other than technical specifications, referring to the life cycle of a product after it has been placed on the market are liable to affect the free movement of that product or to create obstacles to the proper functioning of the internal market; (12) Whereas it is necessary to clarify the concept of a de facto technical regulation; whereas, in particular, the provisions by which the public authority refers to technical specifications or other requirements, or encourages the observance thereof, and the provisions referring to products with which the public authority is associated, in the public interest, have the effect of conferring on such requirements or specifications a more binding value than they would otherwise have by virtue of their private origin; (13) Whereas the Commission and the Member States must also be allowed sufficient time in which to propose amendments to a contemplated measure, in order to remove or reduce any barriers which it might create to the free movement of goods; (14) Whereas the Member State concerned must take account of these amendments when formulating the definitive text of the measure envisaged; (15) Whereas it is inherent in the internal market that, in particular where the principle of mutual recognition cannot be implemented by the Member States, the Commission adopts or proposes the adoption of binding Community acts; whereas a specific temporary standstill period has been established in order to prevent the introduction of national measures from compromising the adoption of binding Community acts by the Council or the Commission in the same field; (16) Whereas the Member State in question must, pursuant to the general obligations laid down in Article 5 of the Treaty, defer implementation of the contemplated measure for a period sufficient to allow either a joint examination of the proposed amendments or the preparation of a proposal for a binding act of the Council or the adoption of a binding act of the Commission; whereas the time limits laid down in the Agreement of the representatives of the Governments of the Member States meeting within the Council of 28 May 1969 providing for standstill and notification to the Commission (5), as amended by the Agreement of 5 March 1973 (6), have proved inadequate in the cases concerned and should accordingly be extended; (17) Whereas the procedure concerning the standstill arrangement and notification of the Commission contained in the abovementioned agreement of 28 May 1969 remains applicable to products subject to that procedure which are not covered by this Directive; (18) Whereas, with a view to facilitating the adoption of Community measures by the Council, Member States should refrain from adopting technical regulations once the Council has adopted a common position on a Commission proposal concerning that sector; (19) Whereas, in practice, national technical standards may have the same effects on the free movement of goods as technical regulations; (20) Whereas it would therefore appear necessary to inform the Commission of draft standards under similar conditions to those which apply to technical regulations; whereas, pursuant to Article 213 of the Treaty, the Commission may, within the limits and under the conditions laid down by the Council in accordance with the provisions of the Treaty, collect any information and carry out any checks required for the performance of the tasks entrusted to it; (21) Whereas it is also necessary for the Member States and the standards institutions to be informed of standards contemplated by standards institutions in the other Member States; (22) Whereas systematic notification is actually necessary only in the case of new subjects for standardisation and in so far as the treatment of these subjects at national level may give rise to differences in national standards which are liable to disturb the functioning of the market as a result; whereas any subsequent notification or communication relating to the progress of national activities must depend on the interest in such activities expressed by those to whom this new subject has already been communicated; (23) Whereas the Commission must nevertheless be able to request the communication of all or part of the national standardisation programmes so that it can review the development of standardisation activity in particular economic sectors; (24) Whereas the European standardisation system must be organised by and for the parties concerned, on a basis of coherence, transparency, openness, consensus, independence of special interests, efficiency and decision-making based on national representation; (25) Whereas the functioning of standardisation in the Community must be based on fundamental rights for the national standardisation bodies, such as the possibility of obtaining draft standards, being informed of the action taken in response to comments submitted, being associated with national standardisation activities or requesting the preparation of European standards in place of national standards; whereas it is for the Member States to take the appropriate measures in their power to ensure that their standardisation bodies observe these rights; (26) Whereas the provisions concerning the standstill arrangements applicable to national standardisation bodies when a European standard is in preparation must be brought into line with the relevant provisions adopted by the standardisation bodies within the framework of the European standardisation bodies; (27) Whereas it is necessary to set up a Standing Committee, the members of which will be appointed by the Member States with the task of helping the Commission to examine draft national standards and cooperating in its efforts to lessen any adverse effects thereof on the free movement of goods; (28) Whereas the Standing Committee should be consulted on the draft standardisation requests referred to in this Directive; (29) Whereas this Directive must not affect the obligations of the Member States concerning the deadlines for transposition of the Directives set out in Annex III, Part B, Article 1 For the purposes of this Directive, the following meanings shall apply: 1. 'product`, any industrially manufactured product and any agricultural product, including fish products; 2. 'technical specification`, a specification contained in a document which lays down the characteristics required of a product such as levels of quality, performance, safety or dimensions, including the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures. The term 'technical specification` also covers production methods and processes used in respect of agricultural products as referred to Article 38(1) of the Treaty, products intended for human and animal consumption, and medicinal products as defined in Article 1 of Directive 65/65/EEC (7), as well as production methods and processes relating to other products, where these have an effect on their characteristics; 3. 'other requirements`, a requirement, other than a technical specification, imposed on a product for the purpose of protecting, in particular, consumers or the environment, and which affects its life cycle after it has been placed on the market, such as conditions of use, recycling, reuse or disposal, where such conditions can significantly influence the composition or nature of the product or its marketing; 4. 'standard`, a technical specification approved by a recognised standardisation body for repeated or continuous application, with which compliance is not compulsory and which is one of the following: - international standard: a standard adopted by an international standardisation organisation and made available to the public, - European standard: a standard adopted by a European standardisation body and made available to the public, - national standard: a standard adopted by a national standardisation body and made available to the public; 5. 'standards programme`, a work programme of a recognised standardisation body listing the subjects on which standardisation work is being carried out; 6. 'draft standard`, document containing the text of the technical specifications concerning a given subject, which is being considered for adoption in accordance with the national standards procedure, as that document stands after the preparatory work and as circulated for public comment or scrutiny; 7. 'European standardisation body`, a body referred to in Annex I; 8. 'national standardisation body`, a body referred to in Annex II; 9. 'technical regulation`, technical specifications and other requirements, including the relevant administrative provisions, the observance of which is compulsory, de jure or de facto, in the case of marketing or use in a Member State or a major part thereof, as well as laws, regulations or administrative provisions of Member States, except those provided for in Article 10, prohibiting the manufacture, importation, marketing or use of a product. De facto technical regulations include: - laws, regulations or administrative provisions of a Member State which refer either to technical specifications or other requirements or to professional codes or codes of practice which in turn refer to technical specifications or other requirements and compliance with which confers a presumption of conformity with the obligations imposed by the aforementioned laws, regulations or administrative provisions, - voluntary agreements to which a public authority is a contracting party and which provide, in the public interest, for compliance with technical specifications or other requirements, excluding public procurement tender specifications, - technical specifications or other requirements which are linked to fiscal or financial measures affecting the consumption of products by encouraging compliance with such technical specifications or other requirements; technical specifications or other requirements linked to national social-security systems are not included. This comprises technical regulations imposed by the authorities designated by the Member States and appearing on a list to be drawn up by the Commission before 1 July 1995, in the framework of the Committee referred to in Article 5. The same procedure shall be used for amending this list; 10. 'draft technical regulation`, the text of a technical specification or other requirement, including administrative provisions formulated with the aim of enacting it or of ultimately having it enacted as a technical regulation, the text being at a stage of preparation at which substantial amendments can still be made. This Directive shall not apply to those measures Member States consider necessary under the Treaty for the protection of persons, in particular workers, when products are used, provided that such measures do not affect the products. Article 2 1. The Commission and the standardisation bodies referred to in Annexes I and II shall be informed of the new subjects for which the national bodies referred to in Annex II have decided, by including them in their standards programme, to prepare or amend a standard, unless it is an identical or equivalent transposition of an international or European standard. 2. The information referred to in paragraph 1 shall indicate, in particular, whether the standard concerned: - will transpose an international standard without being the equivalent, - will be a new national standard, or - will amend a national standard. After consulting the Committee referred to in Article 5, the Commission may draw up rules for the consolidated presentation of this information and a plan and criteria governing the presentation of this information in order to facilitate its evaluation. 3. The Commission may ask for all or part of the standards programmes to be communicated to it. It shall make this information available to the Member States in a form which allows the different programmes to be assessed and compared. 4. Where appropriate, the Commission shall amend Annex II on the basis of communications from the Member States. 5. The Council shall decide, on the basis of a proposal from the Commission, on any amendment to Annex I. Article 3 The standardisation bodies referred to in Annexes I and II, and the Commission, shall be sent all draft standards on request; they shall be kept informed by the body concerned of the action taken on any comments they have made relating to drafts. Article 4 1. Member States shall take all necessary steps to ensure that their standardisation bodies: - communicate information in accordance with Articles 2 and 3, - publish the draft standards in such a way that comments may also be obtained from parties established in other Member States, - grant the other bodies referred to in Annex II the right to be involved passively or actively (by sending an observer) in the planned activities, - do not object to a subject for standardisation in their work programme being discussed at European level in accordance with the rules laid down by the European standardisation bodies and undertake no action which may prejudice a decision in this regard. 2. Member States shall refrain in particular from any act of recognition, approval or use by reference to a national standard adopted in breach of Articles 2 and 3 and of paragraph 1 of this Article. Article 5 A Standing Committee shall be set up consisting of representatives appointed by the Member States who may call on the assistance of experts or advisers; its chairman shall be a representative of the Commission. The Committee shall draw up its own rules of procedure. Article 6 1. The Committee shall meet at least twice a year with the representatives of the standards institutions referred to in Annexes I and II. 2. The Commission shall submit to the Committee a report on the implementation and application of the procedures set out in this Directive, and shall present proposals aimed at eliminating existing or foreseeable barriers to trade. 3. The Committee shall express its opinion on the communications and proposals referred to in paragraph 2 and may in this connection propose, in particular, that the Commission: - request the European standards institutions to draw up a European standard within a given time limit, - ensure where necessary, in order to avoid the risk of barriers to trade, that initially the Member States concerned decide amongst themselves on appropriate measures, - take all appropriate measures, - identify the areas where harmonisation appears necessary, and, should the case arise, undertake appropriate harmonisation in a given sector. 4. The Committee must be consulted by the Commission: (a) before any amendment is made to the lists in Annexes I and II (Article 2(1)); (b) when drawing up the rules for the consolidated presentation of information and the plan and criteria for the presentation of standards programmes (Article 2(2)); (c) when deciding on the actual system whereby the exchange of information provided for in this Directive is to be effected and on any change to it; (d) when reviewing the operation of the system set up by this Directive; (e) on the requests to the standards institutions referred to in the first indent of paragraph 3. 5. The Committee may be consulted by the Commission on any preliminary draft technical regulation received by the latter. 6. Any question regarding the implementation of this Directive may be submitted to the Committee at the request of its chairman or of a Member State. 7. The proceedings of the Committee and the information to be submitted to it shall be confidential. However, the Committee and the national authorities may, provided that the necessary precautions are taken, consult, for an expert opinion, natural or legal persons, including persons in the private sector. Article 7 1. Member States shall take all appropriate measures to ensure that, during the preparation of a European standard referred to in the first indent of Article 6(3) or after its approval, their standardisation bodies do not take any action which could prejudice the harmonisation intended and, in particular, that they do not publish in the field in question a new or revised national standard which is not completely in line with an existing European standard. 2. Paragraph 1 shall not apply to the work of standards institutions undertaken at the request of the public authorities to draw up technical specifications or a standard for specific products for the purpose of enacting a technical regulation for such products. Member States shall communicate all requests of the kind referred to in the preceding subparagraph to the Commission as draft technical regulations, in accordance with Article 8(1), and shall state the grounds for their enactment. Article 8 1. Subject to Article 10, Member States shall immediately communicate to the Commission any draft technical regulation, except where it merely transposes the full text of an international or European standard, in which case information regarding the relevant standard shall suffice; they shall also let the Commission have a statement of the grounds which make the enactment of such a technical regulation necessary, where these have not already been made clear in the draft. Where appropriate, and unless it has already been sent with a prior communication, Member States shall simultaneously communicate the text of the basic legislative or regulatory provisions principally and directly concerned, should knowledge of such text be necessary to assess the implications of the draft technical regulation. Member States shall communicate the draft again under the above conditions if they make changes to the draft that have the effect of significantly altering its scope, shortening the timetable originally envisaged for implementation, adding specifications or requirements, or making the latter more restrictive. Where, in particular, the draft seeks to limit the marketing or use of a chemical substance, preparation or product on grounds of public health or of the protection of consumers or the environment, Member States shall also forward either a summary or the references of all relevant data relating to the substance, preparation or product concerned and to known and available substitutes, where such information may be available, and communicate the anticipated effects of the measure on public health and the protection of the consumer and the environment, together with an analysis of the risk carried out as appropriate in accordance with the general principles for the risk evaluation of chemical substances as referred to in Article 10(4) of Regulation (EEC) No 793/93 (8) in the case of an existing substance or in Article 3(2) of Directive 67/548/EEC (9), in the case of a new substance. The Commission shall immediately notify the other Member States of the draft and all documents which have been forwarded to it; it may also refer this draft, for an opinion, to the Committee referred to in Article 5 and, where appropriate, to the committee responsible for the field in question. With respect to the technical specifications or other requirements referred to in the second subparagraph of Article 1(9), third indent, the detailed comments or opinions of the Commission or the Member States may concern only the aspect which may hinder trade and not the fiscal or financial aspect of the measure. 2. The Commission and the Member States may make comments to the Member State which has forwarded a draft technical regulation; that Member State shall take such comments into account as far as possible in the subsequent preparation of the technical regulation. 3. Member States shall communicate the definitive text of a technical regulation to the Commission without delay. 4. Information supplied under this Article shall not be confidential except at the express request of the notifying Member State. Any such request shall be supported by reasons. In cases of this kind, if necessary precautions are taken, the Committee referred to in Article 5 and the national authorities may seek expert advice from physical or legal persons in the private sector. 5. When draft technical regulations form part of measures which are required to be communicated to the Commission at the draft stage under another Community act, Member States may make a communication within the meaning of paragraph 1 under that other act, provided that they formally indicate that the said communication also constitutes a communication for the purposes of this Directive. The absence of a reaction from the Commission under this Directive to a draft technical regulation shall not prejudice any decision which might be taken under other Community acts. Article 9 1. Member States shall postpone the adoption of a draft technical regulation for three months from the date of receipt by the Commission of the communication referred to in Article 8(1). 2. Member States shall postpone: - for four months the adoption of a draft technical regulation in the form of a voluntary agreement within the meaning of Article 1(9), second indent, - without prejudice to paragraphs 3, 4 and 5, for six months the adoption of any other draft technical regulation, from the date of receipt by the Commission of the communication referred to in Article 8(1) if the Commission or another Member State delivers a detailed opinion, within three months of that date, to the effect that the measure envisaged may create obstacles to the free movement of goods within the internal market. The Member State concerned shall report to the Commission on the action it proposes to take on such detailed opinions. The Commission shall comment on this reaction. 3. Member States shall postpone the adoption of a draft technical regulation for 12 months from the date of receipt by the Commission of the communication referred to in Article 8(1) if, within the three months following that date, the Commission announces its intention to propose or adopt a directive, regulation or decision on the matter in accordance with Article 189 of the Treaty. 4. Member States shall postpone the adoption of a draft technical regulation for 12 months from the date of receipt by the Commission of the communication referred to in Article 8(1) if, within the three months following that date, the Commission announces its finding that the draft technical regulation concerns a matter which is covered by a proposal for a directive, regulation or decision presented to the Council in accordance with Article 189 of the Treaty. 5. If the Council adopts a common position during the standstill period referred to in paragraphs 3 and 4, that period shall, subject to paragraph 6, be extended to 18 months. 6. The obligations referred to in paragraphs 3, 4 and 5 shall lapse: - when the Commission informs the Member States that it no longer intends to propose or adopt a binding Community act, - when the Commission informs the Member States of the withdrawal of its draft or proposal, - when the Commission or the Council has adopted a binding Community act. 7. Paragraphs 1 to 5 shall not apply in those cases where, for urgent reasons, occasioned by serious and unforeseeable circumstances relating to the protection of public health or safety, the protection of animals or the preservation of plants, a Member State is obliged to prepare technical regulations in a very short space of time in order to enact and introduce them immediately without any consultations being possible. The Member State shall give, in the communication referred to in Article 8, the reasons which warrant the urgency of the measures taken. The Commission shall give its views on the communication as soon as possible. It shall take appropriate action in cases where improper use is made of this procedure. The European Parliament shall be kept informed by the Commission. Article 10 1. Articles 8 and 9 shall not apply to those laws, regulations and administrative provisions of the Member States or voluntary agreements by means of which Member States: - comply with binding Community acts which result in the adoption of technical specifications, - fulfil the obligations arising out of international agreements which result in the adoption of common technical specifications in the Community, - make use of safeguard clauses provided for in binding Community acts, - apply Article 8(1) of Directive 92/59/EEC (10), - restrict themselves to implementing a judgment of the Court of Justice of the European Communities, - restrict themselves to amending a technical regulation within the meaning of Article 1(9) of this Directive, in accordance with a Commission request, with a view to removing an obstacle to trade. 2. Article 9 shall not apply to the laws, regulations and administrative provisions of the Member States prohibiting manufacture insofar as they do not impede the free movement of products. 3. Article 9(3) to (6) shall not apply to the voluntary agreements referred to in Article 1(9), second indent. 4. Article 9 shall not apply to the technical specifications or other requirements referred to in Article 1(9), third indent. Article 11 The Commission shall report every two years to the European Parliament, the Council and the Economic and Social Committee on the results of the application of this Directive. Lists of standardisation work entrusted to the European standardisation organisations pursuant to this Directive, as well as statistics on the notifications received, shall be published on an annual basis in the Official Journal of the European Communities. Article 12 When Member States adopt a technical regulation, it shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of its official publication. The methods of making such reference shall be laid down by Member States. Article 13 1. The Directives and Decisions listed in Annex III, Part A are hereby repealed without prejudice to the obligations of the Member States concerning the deadlines for transposition of the said Directives, set out in Annex III, Part B. 2. References to the repealed directives and decisions shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex IV. Article 14 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 15 This Directive is addressed to the Member States.

31998L0037

1998

Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery Having regard to the Treaty establishing the European Community, and in particular Article 100a 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 189b of the Treaty (2), (1) Whereas Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery (3) has been frequently and substantially amended; whereas for reasons of clarity and rationality the said Directive should be consolidated; (2) Whereas the internal market consists of an area without internal frontiers within which the free movement of goods, persons, services and capital is guaranteed; (3) Whereas the machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the Community economy; (4) Whereas the social cost of the large number of accidents caused directly by the use of machinery can be reduced by inherently safe design and construction of machinery and by proper installations and maintenance; (5) Whereas Member States are responsible for ensuring the health and safety on their territory of persons and, where appropriate, of domestic animals and goods and, in particular, of workers, notably in relation to the risks arising out of the use of machinery; (6) Whereas, in the Member States, the legislative systems regarding accident prevention are very different; whereas the relevant compulsory provisions, frequently supplemented by de facto mandatory technical specifications and/or voluntary standards, do not necessarily lead to different levels of health and safety, but nevertheless, owing to their disparities, constitute barriers to trade within the Community; whereas, furthermore, conformity certification and national certification systems for machinery differ considerably; (7) Whereas existing national health and safety provisions providing protection against the risks caused by machinery must be approximated to ensure free movement on the market of machinery without lowering existing justified levels of protection in the Member States; whereas the provisions of this Directive concerning the design and construction of machinery, essential for a safer working environment, shall be accompanied by specific provisions concerning the prevention of certain risks to which workers can be exposed at work, as well as by provisions based on the organisation of safety of workers in the working environment; (8) Whereas Community law, in its present form, provides - by way of derogation from one of the fundamental rules of the Community, namely the free movement of goods - that obstacles to movement within the Community resulting from disparities in national legislation relating to the marketing of products must be accepted in so far as the provisions concerned can be recognised as being necessary to satisfy imperative requirements; (9) Whereas paragraphs 65 and 68 of the White Paper on the completion of the internal market, approved by the European Council in June 1985, provide for a new approach to legislative harmonisation; whereas, therefore, the harmonisation of laws in this case must be limited to those requirements necessary to satisfy the imperative and essential health and safety requirements relating to machinery; whereas these requirements must replace the relevant national provisions because they are essential; (10) Whereas the maintenance or improvement of the level of safety attained by the Member States constitutes one of the essential aims of this Directive and of the principle of safety as defined by the essential requirements; (11) Whereas the field of application of this Directive must be based on a general definition of the term 'machinery` so as to allow the technical development of products; whereas the development of complex installations and the risks they involve are of an equivalent nature and their express inclusion in the Directive is therefore justified; (12) Whereas it is also necessary to deal with safety components which are placed on the market separately and the safety function of which is declared by the manufacturer or his authorised representative established in the Community; (13) Whereas, for trade fairs, exhibitions, etc., it must be possible to exhibit machinery which does not conform to this Directive; whereas, however, interested parties should be properly informed that the machinery does not conform and cannot be purchased in that condition; (14) Whereas the essential health and safety requirements must be observed in order to ensure that machinery is safe; whereas these requirements must be applied with discernment to take account of the state of the art at the time of construction and of technical and economic requirements; (15) Whereas the putting into service of machinery within the meaning of this Directive can relate only to the use of the machinery itself as intended by the manufacturer; whereas this does not preclude the laying-down of conditions of use external to the machinery, provided that it is not thereby modified in a way not specified in this Directive; (16) Whereas it is necessary not only to ensure the free movement and putting into service of machinery bearing the 'CE` marking and having an EC conformity certificate but also to ensure free movement of machinery not bearing the 'CE` marking where it is to be incorporated into other machinery or assembled with other machinery to form a complex installation; (17) Whereas, therefore, this Directive defines only the essential health and safety requirements of general application, supplemented by a number of more specific requirements for certain categories of machinery; whereas, in order to help manufacturers to prove conformity to these essential requirements and in order to allow inspection for conformity to the essential requirements, it is desirable to have standards harmonised at European level for the prevention of risks arising out of the design and construction of machinery; whereas these standards harmonised at European level are drawn up by private-law bodies and must retain their non-binding status; whereas for this purpose the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) are the bodies recognised as competent to adopt harmonised standards in accordance with the general guidelines for cooperation between the Commission and these two bodies signed on 13 November 1984; whereas, within the meaning of this Directive, a harmonised standard is a technical specification (European standard or harmonisation document) adopted by either or both of these bodies, on the basis of a remit from the Commission in accordance with the provisions of Directive 83/189/EEC (4) and on the basis of general guidelines referred to above; (18) Whereas it was found necessary to improve the legislative framework in order to ensure an effective and appropriate contribution by employers and employees to the standardisation process; (19) Whereas the Member States' responsibility for safety, health and the other aspects covered by the essential requirements on their territory must be recognised in a safeguard clause providing for adequate Community protection procedures; (20) Whereas, as is currently the practice in Member States, manufacturers should retain the responsibility for certifying the conformity of their machinery to the relevant essential requirements; whereas conformity to harmonised standards creates a presumption of conformity to the relevant essential requirements; whereas it is left to the sole discretion of the manufacturer, where he feels the need, to have his products examined and certified by a third party; (21) Whereas, for certain types of machinery having a higher risk factor, a stricter certification procedure is desirable; whereas the EC type-examination procedure adopted may result in an EC declaration being given by the manufacturer without any stricter requirement such as a guarantee of quality, EC verification or EC supervision; (22) Whereas it is essential that, before issuing an EC declaration of conformity, the manufacturer or his authorised representative established in the Community should provide a technical construction file; whereas it is not, however, essential that all documentation be permanently available in a material manner, but it must be made available on demand; whereas it need not include detailed plans of the sub-assemblies used in manufacturing the machines, unless knowledge of these is indispensable in order to ascertain conformity with essential safety requirements; (23) Whereas, in its communication of 15 June 1989 on a global approach to certification and testing (5), the Commission proposed that common rules be drawn up concerning a 'CE` conformity marking with a single design; whereas, in its resolution of 21 December 1989 on a global approach to conformity assessment (6), the Council approved as a guiding principle the adoption of a consistent approach such as this with regard to the use of the 'CE` marking; whereas the two basic elements of the new approach which must be applied are therefore the essential requirements and the conformity assessment procedures; (24) Whereas the addressees of any decision taken under this Directive must be informed of the reasons for such a decision and the legal remedies open to them; (25) Whereas this Directive must not affect the obligations of the Member States concerning the deadlines for transposition and application of the Directives set out in Annex VIII, part B, CHAPTER I SCOPE, PLACING ON THE MARKET AND FREEDOM OF MOVEMENT Article 1 1. This Directive applies to machinery and lays down the essential health and safety requirements therefor, as defined in Annex I. It shall also apply to safety components placed on the market separately. 2. For the purposes of this Directive: (a) 'machinery` means: - an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material, - an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole, - interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool; (b) 'safety components` means a component, provided that it is not interchangeable equipment, which the manufacturer or his authorised representative established in the Community places on the market to fulfil a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons. 3. The following are excluded from the scope of this Directive: - machinery whose only power source is directly applied manual effort, unless it is a machine used for lifting or lowering loads, - machinery for medical use used in direct contact with patients, - special equipment for use in fairgrounds and/or amusement parks, - steam boilers, tanks and pressure vessels, - machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity, - radioactive sources forming part of a machine, - firearms, - storage tanks and pipelines for petrol, diesel fuel, inflammable liquids and dangerous substances, - means of transport, i.e. vehicles and their trailers intended solely for transporting passengers by air or on road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, on public road or rail networks or on water. Vehicles used in the mineral extraction industry shall not be excluded, - seagoing vessels and mobile offshore units together with equipment on board such vessels or units, - cableways, including funicular railways, for the public or private transportation of persons, - agricultural and forestry tractors, as defined in Article 1(1) of Directive 74/150/EEC (7), - machines specially designed and constructed for military or police purposes, - lifts which permanently serve specific levels of buildings and constructions, having a car moving between guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and designed for the transport of: (i) persons; (ii) persons and goods; (iii) goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within reach of a person inside, - means of transport of persons using rack and pinion rail mounted vehicles, - mine winding gear, - theatre elevators, - construction site hoists intended for lifting persons or persons and goods. 4. Where, for machinery or safety components, the risks referred to in this Directive are wholly or partly covered by specific Community Directives, this Directive shall not apply, or shall cease to apply, in the case of such machinery or safety components and of such risks on the implementation of these specific Directives. 5. Where, for machinery, the risks are mainly of electrical origin, such machinery shall be covered exclusively by Directive 73/23/EEC (8). Article 2 1. Member States shall take all appropriate measures to ensure that machinery or safety components covered by this Directive may be placed on the market and put into service only if they do not endanger the health or safety of persons and, where appropriate, domestic animals or property, when properly installed and maintained and used for their intended purpose. 2. This Directive shall not affect Member States' entitlement to lay down, in due observance of the Treaty, such requirements as they may deem necessary to ensure that persons and in particular workers are protected when using the machinery or safety components in question, provided that this does not mean that the machinery or safety components are modified in a way not specified in the Directive. 3. At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing of machinery or safety components which do not conform to the provisions of this Directive, provided that a visible sign clearly indicates that such machinery or safety components do not conform and that they are not for sale until they have been brought into conformity by the manufacturer or his authorised representative established in the Community. During demonstrations, adequate safety measures shall be taken to ensure the protection of persons. Article 3 Machinery and safety components covered by this Directive shall satisfy the essential health and safety requirements set out in Annex I. Article 4 1. Member States shall not prohibit, restrict or impede the placing on the market and putting into service in their territory of machinery and safety components which comply with this Directive. 2. Member States shall not prohibit, restrict or impede the placing on the market of machinery where the manufacturer or his authorised representative established in the Community declares in accordance with point B of Annex II that it is intended to be incorporated into machinery or assembled with other machinery to constitute machinery covered by this Directive, except where it can function independently. 'Interchangeable equipment`, as referred to in the third indent of Article 1(2)(a), must in all cases bear the CE marking and be accompanied by the EC declaration of conformity referred to in Annex II, point A. 3. Member States may not prohibit, restrict or impede the placing on the market of safety components as defined in Article 1(2) where they are accompanied by an EC declaration of conformity by the manufacturer or his authorised representative established in the Community as referred to in Annex II, point C. Article 5 1. Member States shall regard the following as conforming to all the provisions of this Directive, including the procedures for checking the conformity provided for in Chapter II: - machinery bearing the CE marking and accompanied by the EC declaration of conformity referred to in Annex II, point A, - safety components accompanied by the EC declaration of conformity referred to in Annex II, point C. In the absence of harmonised standards, Member States shall take any steps they deem necessary to bring to the attention of the parties concerned the existing national technical standards and specifications which are regarded as important or relevant to the proper implementation of the essential safety and health requirements in Annex I. 2. Where a national standard transposing a harmonised standard, the reference for which has been published in the Official Journal of the European Communities, covers one or more of the essential safety requirements, machinery or safety components constructed in accordance with this standard shall be presumed to comply with the relevant essential requirements. Member States shall publish the references of national standards transposing harmonised standards. 3. Member States shall ensure that appropriate measures are taken to enable the social partners to have an influence at national level on the process of preparing and monitoring the harmonised standards. Article 6 1. Where a Member State or the Commission considers that the harmonised standards referred to in Article 5(2) do not entirely satisfy the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the committee set up under Directive 83/189/EEC, giving the reasons therefor. The committee shall deliver an opinion without delay. Upon receipt of the committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the published information referred to in Article 5(2). 2. A standing committee shall be set up, consisting of representatives appointed by the Member States and chaired by a representative of the Commission. The standing committee shall draw up its own rules of procedure. Any matter relating to the implementation and practical application of this Directive may be brought before the standing committee, in accordance with the following procedure: The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote. The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes. The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account. Article 7 1. Where a Member State ascertains that: - machinery bearing the CE marking, or - safety components accompanied by the EC declaration of conformity, used in accordance with their intended purpose are liable to endanger the safety of persons, and, where appropriate, domestic animals or property, it shall take all appropriate measures to withdraw such machinery or safety components from the market, to prohibit the placing on the market, putting into service or use thereof, or to restrict free movement thereof. Member States shall immediately inform the Commission of any such measure, indicating the reason for its decision and, in particular, whether non-conformity is due to: (a) failure to satisfy the essential requirements referred to in Article 3; (b) incorrect application of the standards referred to in Article 5(2); (c) shortcomings in the standards themselves referred to in Article 5(2). 2. The Commission shall enter into consultation with the parties concerned without delay. Where the Commission considers, after this consultation, that the measure is justified, it shall immediately so inform the Member State which took the initiative and the other Member States. Where the Commission considers, after this consultation, that the action is unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorised representative established within the Community. Where the decision referred to in paragraph 1 is based on a shortcoming in the standards, and where the Member State at the origin of the decision maintains its position, the Commission shall immediately inform the committee in order to initiate the procedures referred to in Article 6(1). 3. Where: - machinery which does not comply bears the CE marking, - a safety component which does not comply is accompanied by an EC declaration of conformity, the competent Member State shall take appropriate action against whom so ever has affixed the marking or drawn up the declaration and shall so inform the Commission and other Member States. 4. The Commission shall ensure that Member States are kept informed of the progress and outcome of this procedure. CHAPTER II CONFORMITY ASSESSMENT PROCEDURES Article 8 1. The manufacturer or his authorised representative established in the Community must, in order to certify that machinery and safety components are in conformity with this Directive, draw up for all machinery or safety components manufactured an EC declaration of conformity based on the model given in Annex II, point A or C as appropriate. In addition, for machinery alone, the manufacturer or his authorised representatives established in the Community must affix to the machine the CE marking. 2. Before placing on the market, the manufacturer, or his authorised representative established in the Community, shall: (a) if the machinery is not referred to in Annex IV, draw up the file provided for in Annex V; (b) if the machinery is referred to in Annex IV and its manufacturer does not comply, or only partly complies, with the standards referred to in Article 5(2) or if there are no such standards, submit an example of the machinery for the EC type-examination referred to in Annex VI; (c) if the machinery is referred to in Annex IV and is manufactured in accordance with the standards referred to in Article 5(2): - either draw up the file referred to in Annex VI and forward it to a notified body, which will acknowledge receipt of the file as soon as possible and keep it, - submit the file referred to in Annex VI to the notified body, which will simply verify that the standards referred to in Article 5(2) have been correctly applied and will draw up a certificate of adequacy for the file, - or submit the example of the machinery for the EC type-examination referred to in Annex VI. 3. Where the first indent of paragraph 2(c) of this Article applies, the provisions of the first sentence of paragraphs 5 and 7 of Annex VI shall also apply. Where the second indent of paragraph 2(c) of this Article applies, the provisions of paragraphs 5, 6 and 7 of Annex VI shall also apply. 4. Where paragraph 2(a) and the first and second indents of paragraph 2(c) apply, the EC declaration of conformity shall solely state conformity with the essential requirements of the Directive. Where paragraph 2(b) and the third indent of paragraph 2(c) apply, the EC declaration of conformity shall state conformity with the example that underwent EC type-examination. 5. Safety components shall be subject to the certification procedures applicable to machinery pursuant to paragraphs 2, 3 and 4. Furthermore, during EC type-examination, the notified body shall verify the suitability of the safety component for fulfilling the safety functions declared by the manufacturer. 6. (a) Where the machinery is subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that the machinery is also presumed to conform to the provisions of those other Directives. (b) However, where one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity only to the Directives applied by the manufacturer. In this case, particulars of the Directives applied, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the directives and accompanying such machinery. 7. Where neither the manufacturer nor his authorised representative established in the Community fulfils the obligations of paragraphs 1 to 6, these obligations shall fall to any person placing the machinery or safety component on the market in the Community. The same obligations shall apply to any person assembling machinery or parts thereof or safety components of various origins or constructing machinery or safety components for his own use. 8. The obligations referred to in paragraph 7 shall not apply to persons who assemble with a machine or tractor interchangeable equipment as provided for in Article 1, provided that the parts are compatible and each of the constituent parts of the assembled machine bears the CE marking and is accompanied by the EC declaration of conformity. Article 9 1. Member States shall notify the Commission and the other Member States of the approved bodies which they have appointed to carry out the procedures referred to in Article 8 together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission. The Commission shall publish in the Official Journal of the European Communities a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date. 2. Member States shall apply the criteria laid down in Annex VII in assessing the bodies to be indicated in such notification. Bodies meeting the assessment criteria laid down in the relevant harmonised standards shall be presumed to fulfil those criteria. 3. A Member State which has approved a body must withdraw its notification if it finds that the body no longer meets the criteria referred to in Annex VII. It shall immediately inform the Commission and the other Member States accordingly. CHAPTER III CE MARKING Article 10 1. The CE conformity marking shall consist of the initials 'CE`. The form of the marking to be used is shown in Annex III. 2. The CE marking shall be affixed to machinery distinctly and visibly in accordance with point 1.7.3 of Annex I. 3. The affixing of markings on the machinery which are likely to deceive third parties as to the meaning and form of the CE marking shall be prohibited. Any other marking may be affixed to the machinery provided that the visibility and legibility of the CE marking is not thereby reduced. 4. Without prejudice to Article 7: (a) where a Member State establishes that the CE marking has been affixed unduly, the manufacturer or his authorised representative established within the Community shall be obliged to make the product conform as regards the provisions concerning the CE marking and to end the infringement under the conditions imposed by the Member State; (b) where non-conformity continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market in accordance with the procedure laid down in Article 7. CHAPTER IV FINAL PROVISIONS Article 11 Any decision taken pursuant to this Directive which restricts the placing on the market and putting into service of machinery or a safety component shall state the exact grounds on which it is based. Such a decision shall be notified as soon as possible to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State concerned and of the time limits to which such remedies are subject. Article 12 The Commission will take the necessary steps to have information on all the relevant decisions relating to the management of this Directive made available. Article 13 1. 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. 2. The Commission shall, before 1 January 1994, examine the progress made in the standardisation work relating to this Directive and propose any appropriate measures. Article 14 1. The Directives listed in Annex VIII, Part A, are hereby repealed, without prejudice to the obligations of the Member States concerning the deadlines for transposition and application of the said Directives, as set out in Annex VIII, Part B. 2. References to the repealed Directives shall be construed as references to this Directive and be read in accordance with the correlation table set out in Annex IX. Article 15 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 16 This Directive is addressed to the Member States.

31998L0046

1998

Council Directive 98/46/EC of 24 June 1998 amending Annexes A, D (Chapter I) and F to Directive 64/432/EEC on health problems affecting intra-Community trade in bovine animals and swine Having regard to Council Directive 64/432/EEC of 26 June 1964 on health problems affecting intra-Community trade in bovine animals and swine (1), and in particular Article 16(1)(a) thereof, Having regard to the proposal from the Commission (2), Having regard to the opinion of the European Parliament (3), Whereas in Article 16 of Directive 64/432/EEC the Commission has been requested to make proposals to amend Annexes A, D (Chapter I) and F to the said Directive, in particular with regard to their adaptation to technological developments; Whereas in the same Article it is stipulated that the Council is to decide on these proposals by a qualified majority before 1 January 1998; Whereas in recent times the development of veterinary administrative procedures regarding herd management, animal movement control, animal identification and information handling in relation to disease control requires amendments to be made to certain Annexes to Directive 64/432/EEC, Article 1 Annexes A, D (Chapter I) and F to Directive 64/432/EEC are hereby replaced by the Annexes 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 1 July 1999. 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 domestic law which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31998L0045

1998

Council Directive 98/45/EC of 24 June 1998 amending Directive 91/67/EEC concerning the animal health conditions governing the placing on the market of aquaculture animals and products Having regard to the Treaty establishing the European Community, and in particular Article 43 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 Directive 91/67/EEC (4) laid down the Community rules governing the placing on the market of aquaculture animals for the purpose, in particular, of avoiding the spread of certain serious diseases; Whereas the diseases set out in list III of Annex A of the said Directive, including gyrodactylosis, can have serious economic repercussions if they break out in a region which was previously disease free; Whereas consequently it is necessary to prevent the spread of the said diseases by strengthening the provisions currently applied; Whereas it is necessary to ensure that the placing on the market of fish from a non-approved zone does not prejudice the health status of non-infected farms situated in a non-approved zone; whereas this can be achieved through certification of consignments intended for intra-Community trade; Whereas it is necessary to adapt certain provisions as regards the frequency of inspections and sampling and testing requirements for fish diseases to international standards, Article 1 Directive 91/67/EEC is amended as follows: 1. in Article 13, paragraphs 1 and 2 shall be replaced by the following: '1. Where a Member State considers that its territory or part of its territory is free from one of the diseases listed in Annex A, column 1, of List III, it shall submit to the Commission appropriate justifications setting out in particular: - the name of the disease and the previous history of its occurrence in that Member State, - the results of surveillance testing based on serological, virological, microbiological or pathological findings, or identification of the parasite, as appropriate, and on the fact that the disease is compulsorily notifiable to the competent authorities, - the period over which the surveillance was carried out, - the control arrangements for verifying that the area concerned remains free from the disease. The Commission shall define, in accordance with the procedure laid down in Article 26, general criteria to ensure uniform implementation of this paragraph. 2. The Commission shall examine the justifications communicated by the Member State and, in accordance with the procedure laid down in Article 26, define the zones that are to be regarded as free from, and the species that are susceptible to, the disease in question, and the additional guarantees, general or specific, which may be required for the introduction of aquaculture animals and products into those areas. Live fish, shellfish or crustaceans and if appropriate, their eggs and gametes, introduced into such zones must be accompanied by a movement document, corresponding to a model to be drawn up in accordance with the procedure laid down in Article 26, certifying that they comply with such additional guarantees.`; 2. in Article 16(1), the following sentence shall be added: 'In addition, the Commission, in accordance with the procedure laid down in Article 26, shall draw up specimens of the certificates which must accompany aquaculture animals, their eggs and gametes in intra-Community trade between non-approved zones as regards the diseases referred to in list II of Annex A, and shall decide on arrangements for extending the "ANIMO" computerized system linking competent authorities to cover trade in the above animals and products.`; 3. in Annex B: (a) point I. B., the first sentence of point 2 shall be replaced by the following: '2. all farms in the continental zone are placed under the supervision of the official services. Two health inspections per year for two years must have been carried out.`; (b) point I. C., point 2 shall be replaced by the following: '2. each farm must undergo two health inspections annually in accordance with point B.2, except farms without broodstock which must be inspected once per year. However, samples will be taken by rotation in 50 % of the fish farms in the continental zone each year;`. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1999. 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 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.

31998L0047

1998

Commission Directive 98/47/EC of 25 June 1998 including an active substance (azoxystrobin) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), as last amended by Commission Directive 97/73/EC (2), hereafter referred to as 'the Directive`, and in particular Article 6(3) thereof, Whereas in accordance with Article 6(2) of Directive 91/414/EEC, Germany received on 15 September 1995 an application from Zeneca Agrochemicals, hereafter referred to as 'the applicant`, for the inclusion of the active substance azoxystrobin in Annex I to the Directive; Whereas in accordance with the provisions of Article 6(3) of the Directive the Commission confirmed in its Decision 96/523/EC (3) that the dossier submitted for azoxystrobin could be considered as satisfying, in principle, the data and information requirements of Annex II and for a plant protection product containing this active substance, of Annex III to the Directive; Whereas, in accordance with Article 5(1) of the Directive, an active substance should be included for a period not exceeding 10 years in Annex I when it may be expected that there will not be any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment; Whereas for azoxystrobin, 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 applicant; whereas Germany acting as nominated rapporteur Member State, has submitted to the Commission on 5 February 1997 the assessment report concerned; Whereas the submitted report has been reviewed by the Member States and the Commission within the Standing Committee on Plant Health; whereas this review has been finalised on 22 April 1998 in the format of the Commission review report for azoxystrobin; whereas it may be necessary to update this report to take account of technical and scientific developments; whereas in such case the conditions for the inclusion of azoxystrobin in Annex I to Directive 91/414/EEC will also need to be amended pursuant to Article 6(1) of that Directive; Whereas the dossier and the information from the review have also been submitted to the Scientific Committee for Plants for consultation; Whereas it has appeared from the assessments made that plant protection products containing the active substance 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; whereas therefore it is necessary to include the active substance concerned in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing the active substance concerned can be granted in accordance with the provisions of the Directive; Whereas after inclusion a reasonable period is necessary to permit Member States to implement the provisions of Directive 91/414/EEC on plant protection products containing azoxystrobin 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; whereas a longer period may also be required for plant protection products containing azoxystrobin and other active substances included in Annex I; Whereas it is appropriate to provide that the finalised review report (except for confidential information in the meaning of Article 14 of the Directive) is kept available or made available by the Member States for consultation by any interested parties; Whereas 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 these principles refer to the evaluation of the Annex II data which were submitted for the purpose of the inclusion of the active substance in Annex I to the Directive; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Azoxystrobin is hereby designated as an active substance in Annex I to Directive 91/414/EEC, 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 1 January 1999. 2. However for plant protection products containing azoxystrobin together with another active substance included 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 concerning the inclusion of this other active substance in Annex I to Directive 91/414/EEC. 3. Member States shall keep available the review report (except for confidential information in the meaning of Article 14 of the Directive) for consultation by any interested parties or shall make it available to them on specific request. 4. When Member States adopt the 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 laid down by the Member States. Article 3 This Directive shall enter into force on 1 July 1998. Article 4 This Directive is addressed to the Member States.

31998L0049

1998

COUNCIL DIRECTIVE 98/49/EC of 29 June 1998 on safeguarding the supplementary pension rights of employed and self-employed persons moving within the Community Having regard to the Treaty establishing the European Community, and in particular Articles 51 and 235 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), (1) Whereas one of the fundamental freedoms of the Community is the free movement of persons; whereas the Treaty provides that the Council shall, acting unanimously, adopt such measures in the field of social security as are necessary to provide freedom of movement of workers; (2) Whereas the social protection of workers is ensured by statutory social security schemes complemented by supplementary social security schemes; (3) Whereas the legislation already adopted by the Council with a view to protecting the social security rights of workers moving within the Community and of members of their family, namely Council Regulations (EEC) No 1408/71 of 14 June 1971 on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the Community (4) and (EEC) No 574/72 of 21 March 1972 laying down the procedure for implementing Regulation (EEC) No 1408/71 on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the Community (5), concern only statutory pension schemes; whereas the system of coordination provided for in those Regulations does not extend to supplementary pension schemes, except for schemes which are covered by the term ‘legislation’ as defined by the first subparagraph of Article l(j) of Regulation (EEC) No 1408/71 or in respect of which a Member State makes a declaration under that Article; (4) Whereas the Council has a wide discretion regarding the choice of the most appropriate measures for attaining the objective of Article 51 of the Treaty; and whereas the system of coordination provided for in Regulations (EEC) No 1408/71 and (EEC) No 574/72, and in particular the rules of aggregation, are not appropriate to supplementary pension schemes, except for schemes which are covered by the term ‘legislation’ as defined by the first subparagraph of Article l(j) of Regulation (EEC) No 1408/71 or in respect of which a Member State makes a declaration under that Article, and should therefore be subject to specific measures, of which this Directive is the first, in order to take account of their special nature and characteristics and the diversity of such schemes within and between Member States; (5) Whereas no pension or benefit should be subject to both the provisions of this Directive and those of Regulations (EEC) No 1408/71 and (EEC) No 574/72, and therefore any supplementary pension scheme which comes within the scope of those Regulations, because a Member State has made a declaration to that effect under Article l(j) of Regulation (EEC) No 1408/71, cannot be subject to the provisions of this Directive; (6) Whereas in its Recommendation 92/442/EEC of 27 July 1992 on the convergence of social protection objectives and policies (6) the Council recommended that Member States should ‘promote, where necessary, changes to the conditions governing the acquisition of pension and, especially, supplementary pension rights with a view to eliminating obstacles to the mobility of employed workers’; (7) Whereas a contribution to this objective can be made if workers who move or whose place of employment moves from one Member State to another are guaranteed equal treatment as regards the protection of their supplementary pension rights with workers who remain or whose place of employment changes but remains within the same Member State; (8) Whereas freedom of movement for persons, which is one of the basic rights enshrined in the Treaty, is not confined to employed persons but also extends to self-employed persons; (9) Whereas the Treaty does not provide powers other than those of Article 235 to take appropriate measures within the field of social security for self-employed persons; (10) Whereas, in order to enable the right of free movement to be exercised effectively, workers and others holding entitlement should have certain guarantees for equal treatment regarding the preservation of their vested pension rights deriving from supplementary pension schemes; (11) Whereas the Member States should take the necessary measures to ensure that benefits under supplementary pension schemes are paid to members and former members thereof as well as others holding entitlement under such schemes in all Member States, given that all restrictions on the free movement of payments and capital are prohibited under Article 73b of the Treaty; (12) Whereas in order to facilitate the exercise of the right to free movement, national regulations should, where necessary, be adjusted in order to enable contributions to continue to be made to a supplementary pension scheme established in one Member State by or on behalf of workers who are posted to another Member State in accordance with Title II of Regulation (EEC) No 1408/71; (13) Whereas in this regard the Treaty requires not only the abolition of any discrimination based on nationality between workers of the Member States but also the elimination of any national measure likely to impede or render less attractive for those workers the exercise of the fundamental freedoms guaranteed by the Treaty as interpreted by the Court of Justice of the European Communities in successive judgments; (14) Whereas workers exercising their right to free movement should be adequately informed by employers, trustees or others responsible for the management of supplementary pension schemes, particularly with regard to the choices and alternatives available to them; (15) Whereas this Directive is without prejudice to the laws of the Member States concerning collective action to defend the interests of trades and professions; (16) Whereas, by reason of the diversity of supplementary social security schemes, the Community should lay down only a general framework of objectives and therefore a Directive is the appropriate legal instrument; (17) Whereas, in accordance with the principles of subsidiarity and proportionality as set out in Article 3b of the Treaty, the objectives of this Directive cannot be sufficiently achieved by the Member States and can therefore be better achieved by the Community; whereas this Directive does not go beyond what is necessary to achieve those objectives, CHAPTER I OBJECTIVE AND SCOPE Article 1 The aim of this Directive is to protect the rights of members of supplementary pension schemes who move from one Member State to another, thereby contributing to the removal of obstacles to the free movement of employed and self-employed persons within the Community. Such protection refers to pension rights under both voluntary and compulsory supplementary pension schemes, with the exception of schemes covered by Regulation (EEC) No 1408/71. Article 2 This Directive shall apply to members of supplementary pension schemes and others holding entitlement under such schemes who have acquired or are in the process of acquiring rights in one or more Member States. CHAPTER II DEFINITIONS Article 3 For the purpose of this Directive: (a) ‘supplementary pension’ means retirement pensions and, where provided for by the rules of a supplementary pension scheme established in conformity with national legislation and practice, invalidity and survivors' benefits, intended to supplement or replace those provided in respect of the same contingencies by statutory social security schemes; (b) ‘supplementary pension scheme’ means any occupational pension scheme established in conformity with national legislation and practice such as a group insurance contract or pay-as-you-go scheme agreed by one or more branches or sectors, funded scheme or pension promise backed by book reserves, or any collective or other comparable arrangement intended to provide a supplementary pension for employed or self-employed persons; (c) ‘pension rights’ means any benefits to which scheme members and others holding entitlement are entitled under the rules of a supplementary pension scheme and, where applicable, under national legislation; (d) ‘vested pension rights’ means any entitlement to benefits obtained after fulfilment of the conditions required by the rules of a supplementary pension scheme and, where applicable, under national legislation; (e) ‘posted worker’ means a person who is posted to work in another Member State and who under the terms of Title II of Regulation (EEC) No 1408/71 continues to be subject to the legislation of the Member State of origin, and ‘posting’ shall be construed accordingly; (f) ‘contribution’ means any payment made or deemed to have been made to a supplementary pension scheme. CHAPTER III MEASURES FOR SAFEGUARDING THE SUPPLEMENTARY PENSION RIGHTS OF WORKERS MOVING WIRHIN THE COMMUNITY Article 4 Equality of treatment as regards preservation of pension rights Member States shall take the necessary measures to ensure the preservation of vested pension rights for membrs of a supplementary pension scheme in respect of whom contributions are no longer being made to that scheme as a consequence of their moving from one Member State to another, to the same extent as for members in respect of whom contributions are no longer being made but who remain within the same Member State. This Article shall also apply to other persons holding entitlement under the rules of the supplementary pension scheme in question. Article 5 Cross border payments Member States shall ensure that, in respect of members of supplementary pension schemes, as well as others holding entitlement under such schemes, supplementary pension schemes make payment in other Member States, net of any taxes and transaction charges which may be applicable, of all benefits due under such schemes. Article 6 Contributions to supplementary pension schemes by and on behalf of posted workers 1. Member States shall adopt such measures as are necessary to enable contributions to continue to be made to a supplementary pension scheme established in a Member State by or on behalf of a posted worker who is a member of such a scheme during the period of his or her posting in another Member State. 2. Where, pursuant to paragraph 1, contributions continue to be made to a supplementary pension scheme in one Member State, the posted worker and, where applicable, his employer shall be exempted from any obligation to make contributions to a supplementary pension scheme in another Member State. Article 7 Information to scheme members Member States shall take measures to ensure that employers, trustees or others responsible for the management of supplementary pension schemes provide adequate information to scheme members, when they move to another Member State, as to their pension rights and the choices which are available to them under the scheme. Such information shall at least correspond to information given to scheme members in respect of whom contributions cease to be made but who remain within the same Member State. CHAPTER IV FINAL PROVISIONS Article 8 Member States may provide that the provisions of Article 6 shall apply only to postings that commence on or after 25 July 2001. Article 9 Member States shall introduce into their national legal systems such measures as are necessary to enable all persons who consider themselves wronged by failure to apply the provisions of this Directive to pursue their claims by judicial process after possible recourse to other competent authorities. Article 10 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 36 months following the date of its entry into force, or shall ensure by that date at the latest that management and labour introduce the requisite provisions by way of agreement. Member States shall take all necessary steps to enable themselves at all times to guarantee the results imposed by this Directive. 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. They shall inform the Commission of the national authorities to be contacted regarding the application of this Directive. 2. Not later than 25 January 2002 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. 3. On the basis of the information supplied by Member States, the Commission shall submit a report to the European Parliament, the Council and the Economic and Social Committee, within six years of the entry into force of this Directive. The report shall deal with the application of this Directive and shall, where appropriate, propose any amendments that may prove necessary. 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.

31998L0044

1998

DIRECTIVE 98/44/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 July 1998 on the legal protection of biotechnological inventions Having regard to the Treaty establishing the European Community, and in particular Article 100a 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 189b of the Treaty (3), (1) Whereas biotechnology and genetic engineering are playing an increasingly important role in a broad range of industries and the protection of biotechnological inventions will certainly be of fundamental importance for the Community's industrial development; (2) Whereas, in particular in the field of genetic engineering, research and development require a considerable amount of high-risk investment and therefore only adequate legal protection can make them profitable; (3) Whereas effective and harmonised protection throughout the Member States is essential in order to maintain and encourage investment in the field of biotechnology; (4) Whereas following the European Parliament's rejection of the joint text, approved by the Conciliation Committee, for a European Parliament and Council Directive on the legal protection of biotechnological inventions (4), the European Parliament and the Council have determined that the legal protection of biotechnological inventions requires clarification; (5) Whereas differences exist in the legal protection of biotechnological inventions offered by the laws and practices of the different Member States; whereas such differences could create barriers to trade and hence impede the proper functioning of the internal market; (6) Whereas such differences could well become greater as Member States adopt new and different legislation and administrative practices, or whereas national case-law interpreting such legislation develops differently; (7) Whereas uncoordinated development of national laws on the legal protection of biotechnological inventions in the Community could lead to further disincentives to trade, to the detriment of the industrial development of such inventions and of the smooth operation of the internal market; (8) Whereas legal protection of biotechnological inventions does not necessitate the creation of a separate body of law in place of the rules of national patent law; whereas the rules of national patent law remain the essential basis for the legal protection of biotechnological inventions given that they must be adapted or added to in certain specific respects in order to take adequate account of technological developments involving biological material which also fulfil the requirements for patentability; (9) Whereas in certain cases, such as the exclusion from patentability of plant and animal varieties and of essentially biological processes for the production of plants and animals, certain concepts in national laws based upon international patent and plant variety conventions have created uncertainty regarding the protection of biotechnological and certain microbiological inventions; whereas harmonisation is necessary to clarify the said uncertainty; (10) Whereas regard should be had to the potential of the development of biotechnology for the environment and in particular the utility of this technology for the development of methods of cultivation which are less polluting and more economical in their use of ground; whereas the patent system should be used to encourage research into, and the application of, such processes; (11) Whereas the development of biotechnology is important to developing countries, both in the field of health and combating major epidemics and endemic diseases and in that of combating hunger in the world; whereas the patent system should likewise be used to encourage research in these fields; whereas international procedures for the dissemination of such technology in the Third World and to the benefit of the population groups concerned should be promoted; (12) Whereas the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) (5) signed by the European Community and the Member States, has entered into force and provides that patent protection must be guaranteed for products and processes in all areas of technology; (13) Whereas the Community's legal framework for the protection of biotechnological inventions can be limited to laying down certain principles as they apply to the patentability of biological material as such, such principles being intended in particular to determine the difference between inventions and discoveries with regard to the patentability of certain elements of human origin, to the scope of protection conferred by a patent on a biotechnological invention, to the right to use a deposit mechanism in addition to written descriptions and lastly to the option of obtaining non-exclusive compulsory licences in respect of interdependence between plant varieties and inventions, and conversely; (14) Whereas a patent for invention does not authorise the holder to implement that invention, but merely entitles him to prohibit third parties from exploiting it for industrial and commercial purposes; whereas, consequently, substantive patent law cannot serve to replace or render superfluous national, European or international law which may impose restrictions or prohibitions or which concerns the monitoring of research and of the use or commercialisation of its results, notably from the point of view of the requirements of public health, safety, environmental protection, animal welfare, the preservation of genetic diversity and compliance with certain ethical standards; (15) Whereas no prohibition or exclusion exists in national or European patent law (Munich Convention) which precludes a priori the patentability of biological matter; (16) Whereas patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person; whereas it is important to assert the principle that the human body, at any stage in its formation or development, including germ cells, and the simple discovery of one of its elements or one of its products, including the sequence or partial sequence of a human gene, cannot be patented; whereas these principles are in line with the criteria of patentability proper to patent law, whereby a mere discovery cannot be patented; (17) Whereas significant progress in the treatment of diseases has already been made thanks to the existence of medicinal products derived from elements isolated from the human body and/or otherwise produced, such medicinal products resulting from technical processes aimed at obtaining elements similar in structure to those existing naturally in the human body and whereas, consequently, research aimed at obtaining and isolating such elements valuable to medicinal production should be encouraged by means of the patent system; (18) Whereas, since the patent system provides insufficient incentive for encouraging research into and production of biotechnological medicines which are needed to combat rare or ‘orphan’ diseases, the Community and the Member States have a duty to respond adequately to this problem; (19) Whereas account has been taken of Opinion No 8 of the Group of Advisers on the Ethical Implications of Biotechnology to the European Commission; (20) Whereas, therefore, it should be made clear that an invention based on an element isolated from the human body or otherwise produced by means of a technical process, which is susceptible of industrial application, is not excluded from patentability, even where the structure of that element is identical to that of a natural element, given that the rights conferred by the patent do not extend to the human body and its elements in their natural environment; (21) Whereas such an element isolated from the human body or otherwise produced is not excluded from patentability since it is, for example, the result of technical processes used to identify, purify and classify it and to reproduce it outside the human body, techniques which human beings alone are capable of putting into practice and which nature is incapable of accomplishing by itself; (22) Whereas the discussion on the patentability of sequences or partial sequences of genes is controversial; whereas, according to this Directive, the granting of a patent for inventions which concern such sequences or partial sequences should be subject to the same criteria of patentability as in all other areas of technology: novelty, inventive step and industrial application; whereas the industrial application of a sequence or partial sequence must be disclosed in the patent application as filed; (23) Whereas a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention; (24) Whereas, in order to comply with the industrial application criterion it is necessary in cases where a sequence or partial sequence of a gene is used to produce a protein or part of a protein, to specify which protein or part of a protein is produced or what function it performs; (25) Whereas, for the purposes of interpreting rights conferred by a patent, when sequences overlap only in parts which are not essential to the invention, each sequence will be considered as an independent sequence in patent law terms; (26) Whereas if an invention is based on biological material of human origin or if it uses such material, where a patent application is filed, the person from whose body the material is taken must have had an opportunity of expressing free and informed consent thereto, in accordance with national law; (27) Whereas if an invention is based on biological material of plant or animal origin or if it uses such material, the patent application should, where appropriate, include information on the geographical origin of such material, if known; whereas this is without prejudice to the processing of patent applications or the validity of rights arising from granted patents; (28) Whereas this Directive does not in any way affect the basis of current patent law, according to which a patent may be granted for any new application of a patented product; (29) Whereas this Directive is without prejudice to the exclusion of plant and animal varieties from patentability; whereas on the other hand inventions which concern plants or animals are patentable provided that the application of the invention is not technically confined to a single plant or animal variety; (30) Whereas the concept ‘plant variety’ is defined by the legislation protecting new varieties, pursuant to which a variety is defined by its whole genome and therefore possesses individuality and is clearly distinguishable from other varieties; (31) Whereas a plant grouping which is characterised by a particular gene (and not its whole genome) is not covered by the protection of new varieties and is therefore not excluded from patentability even if it comprises new varieties of plants; (32) Whereas, however, if an invention consists only in genetically modifying a particular plant variety, and if a new plant variety is bred, it will still be excluded from patentability even if the genetic modification is the result not of an essentially biological process but of a biotechnological process; (33) Whereas it is necessary to define for the purposes of this Directive when a process for the breeding of plants and animals is essentially biological; (34) Whereas this Directive shall be without prejudice to concepts of invention and discovery, as developed by national, European or international patent law; (35) Whereas this Directive shall be without prejudice to the provisions of national patent law whereby processes for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body are excluded from patentability; (36) Whereas the TRIPs Agreement provides for the possibility that members of the World Trade Organisation may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law; (37) Whereas the principle whereby inventions must be excluded from patentability where their commercial exploitation offends against ordre public or morality must also be stressed in this Directive; (38) Whereas the operative part of this Directive should also include an illustrative list of inventions excluded from patentability so as to provide national courts and patent offices with a general guide to interpreting the reference to ordre public and morality; whereas this list obviously cannot presume to be exhaustive; whereas processes, the use of which offend against human dignity, such as processes to produce chimeras from germ cells or totipotent cells of humans and animals, are obviously also excluded from patentability; (39) Whereas ordre public and morality correspond in particular to ethical or moral principles recognised in a Member State, respect for which is particularly important in the field of biotechnology in view of the potential scope of inventions in this field and their inherent relationship to living matter; whereas such ethical or moral principles supplement the standard legal examinations under patent law regardless of the technical field of the invention; (40) Whereas there is a consensus within the Community that interventions in the human germ line and the cloning of human beings offends against ordre public and morality; whereas it is therefore important to exclude unequivocally from patentability processes for modifying the germ line genetic identity of human beings and processes for cloning human beings; (41) Whereas a process for cloning human beings may be defined as any process, including techniques of embryo splitting, designed to create a human being with the same nuclear genetic information as another living or deceased human being; (42) Whereas, moreover, uses of human embryos for industrial or commercial purposes must also be excluded from patentability; whereas in any case such exclusion does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it; (43) Whereas pursuant to Article F(2) of the Treaty on European Union, the Union is to respect fundamental rights, as guaranteed by the European Convention for the Protection of Human Rights and Fundamental Freedoms signed in Rome on 4 November 1950 and as they result from the constitutional traditions common to the Member States, as general principles of Community law; (44) Whereas the Commission's European Group on Ethics in Science and New Technologies evaluates all ethical aspects of biotechnology; whereas it should be pointed out in this connection that that Group may be consulted only where biotechnology is to be evaluated at the level of basic ethical principles, including where it is consulted on patent law; (45) Whereas processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit in terms of research, prevention, diagnosis or therapy to man or animal, and also animals resulting from such processes, must be excluded from patentability; (46) Whereas, in view of the fact that the function of a patent is to reward the inventor for his creative efforts by granting an exclusive but time-bound right, and thereby encourage inventive activities, the holder of the patent should be entitled to prohibit the use of patented self-reproducing material in situations analogous to those where it would be permitted to prohibit the use of patented, non-self-reproducing products, that is to say the production of the patented product itself; (47) Whereas it is necessary to provide for a first derogation from the rights of the holder of the patent when the propagating material incorporating the protected invention is sold to a farmer for farming purposes by the holder of the patent or with his consent; whereas that initial derogation must authorise the farmer to use the product of his harvest for further multiplication or propagation on his own farm; whereas the extent and the conditions of that derogation must be limited in accordance with the extent and conditions set out in Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights (6); (48) Whereas only the fee envisaged under Community law relating to plant variety rights as a condition for applying the derogation from Community plant variety rights can be required of the farmer; (49) Whereas, however, the holder of the patent may defend his rights against a farmer abusing the derogation or against a breeder who has developed a plant variety incorporating the protected invention if the latter fails to adhere to his commitments; (50) Whereas a second derogation from the rights of the holder of the patent must authorise the farmer to use protected livestock for agricultural purposes; (51) Whereas the extent and the conditions of that second derogation must be determined by national laws, regulations and practices, since there is no Community legislation on animal variety rights; (52) Whereas, in the field of exploitation of new plant characteristics resulting from genetic engineering, guaranteed access must, on payment of a fee, be granted in the form of a compulsory licence where, in relation to the genus or species concerned, the plant variety represents significant technical progress of considerable economic interest compared to the invention claimed in the patent; (53) Whereas, in the field of the use of new plant characteristics resulting from new plant varieties in genetic engineering, guaranteed access must, on payment of a fee, be granted in the form of a compulsory licence where the invention represents significant technical progress of considerable economic interest; (54) Whereas Article 34 of the TRIPs Agreement contains detailed provisions on the burden of proof which is binding on all Member States; whereas, therefore, a provision in this Directive is not necessary; (55) Whereas following Decision 93/626/EEC (7) the Community is party to the Convention on Biological Diversity of 5 June 1992; whereas, in this regard, Member States must give particular weight to Article 3 and Article 8(j), the second sentence of Article 16(2) and Article 16(5) of the Convention when bringing into force the laws, regulations and administrative provisions necessary to comply with this Directive; (56) Whereas the Third Conference of the Parties to the Biodiversity Convention, which took place in November 1996, noted in Decision III/17 that ‘further work is required to help develop a common appreciation of the relationship between intellectual property rights and the relevant provisions of the TRIPs Agreement and the Convention on Biological Diversity, in particular on issues relating to technology transfer and conservation and sustainable use of biological diversity and the fair and equitable sharing of benefits arising out of the use of genetic resources, including the protection of knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity’, CHAPTER I Patentability Article 1 1. Member States shall protect biotechnological inventions under national patent law. They shall, if necessary, adjust their national patent law to take account of the provisions of this Directive. 2. This Directive shall be without prejudice to the obligations of the Member States pursuant to international agreements, and in particular the TRIPs Agreement and the Convention on Biological Diversity. Article 2 1. For the purposes of this Directive, (a) ‘biological material’ means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system; (b) ‘microbiological process’ means any process involving or performed upon or resulting in microbiological material. 2. A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection. 3. The concept of ‘plant variety’ is defined by Article 5 of Regulation (EC) No 2100/94. Article 3 1. For the purposes of this Directive, inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used. 2. Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature. Article 4 1. The following shall not be patentable: (a) plant and animal varieties; (b) essentially biological processes for the production of plants or animals. 2. Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety. 3. Paragraph 1(b) shall be without prejudice to the patentability of inventions which concern a microbiological or other technical process or a product obtained by means of such a process. Article 5 1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. 2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. 3. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application. Article 6 1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation. 2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable: (a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes; (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes. Article 7 The Commission's European Group on Ethics in Science and New Technologies evaluates all ethical aspects of biotechnology. CHAPTER II Scope of protection Article 8 1. The protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall extend to any biological material derived from that biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics. 2. The protection conferred by a patent on a process that enables a biological material to be produced possessing specific characteristics as a result of the invention shall extend to biological material directly obtained through that process and to any other biological material derived from the directly obtained biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics. Article 9 The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in Article 5(1), in which the product in incorporated and in which the genetic information is contained and performs its function. Article 10 The protection referred to in Articles 8 and 9 shall not extend to biological material obtained from the propagation or multiplication of biological material placed on the market in the territory of a Member State by the holder of the patent or with his consent, where the multiplication or propagation necessarily results from the application for which the biological material was marketed, provided that the material obtained is not subsequently used for other propagation or multiplication. Article 11 1. By way of derogation from Articles 8 and 9, the sale or other form of commercialisation of plant propagating material to a farmer by the holder of the patent or with his consent for agricultural use implies authorisation for the farmer to use the product of his harvest for propagation or multiplication by him on his own farm, the extent and conditions of this derogation corresponding to those under Article 14 of Regulation (EC) No 2100/94. 2. By way of derogation from Articles 8 and 9, the sale or any other form of commercialisation of breeding stock or other animal reproductive material to a farmer by the holder of the patent or with his consent implies authorisation for the farmer to use the protected livestock for an agricultural purpose. This includes making the animal or other animal reproductive material available for the purposes of pursuing his agricultural activity but not sale within the framework or for the purpose of a commercial reproduction activity. 3. The extent and the conditions of the derogation provided for in paragraph 2 shall be determined by national laws, regulations and practices. CHAPTER III Compulsory cross-licensing Article 12 1. Where a breeder cannot acquire or exploit a plant variety right without infringing a prior patent, he may apply for a compulsory licence for non-exclusive use of the invention protected by the patent inasmuch as the licence is necessary for the exploitation of the plant variety to be protected, subject to payment of an appropriate royalty. Member States shall provide that, where such a licence is granted, the holder of the patent will be entitled to a cross-licence on reasonable terms to use the protected variety. 2. Where the holder of a patent concerning a biotechnological invention cannot exploit it without infringing a prior plant variety right, he may apply for a compulsory licence for non-exclusive use of the plant variety protected by that right, subject to payment of an appropriate royalty. Member States shall provide that, where such a licence is granted, the holder of the variety right will be entitled to a cross-licence on reasonable terms to use the protected invention. 3. Applicants for the licences referred to in paragraphs 1 and 2 must demonstrate that: (a) they have applied unsuccessfully to the holder of the patent or of the plant variety right to obtain a contractual licence; (b) the plant variety or the invention constitutes significant technical progress of considerable economic interest compared with the invention claimed in the patent or the protected plant variety. 4. Each Member State shall designate the authority or authorities responsible for granting the licence. Where a licence for a plant variety can be granted only by the Community Plant Variety Office, Article 29 of Regulation (EC) No 2100/94 shall apply. CHAPTER IV Deposit, access and re-deposit of a biological material Article 13 1. Where an invention involves the use of or concerns biological material which is not available to the public and which cannot be described in a patent application in such a manner as to enable the invention to be reproduced by a person skilled in the art, the description shall be considered inadequate for the purposes of patent law unless: (a) the biological material has been deposited no later than the date on which the patent application was filed with a recognised depositary institution. At least the international depositary authorities which acquired this status by virtue of Article 7 of the Budapest Treaty of 28 April 1977 on the international recognition of the deposit of micro-organisms for the purposes of patent procedure, hereinafter referred to as the ‘Budapest Treaty’, shall be recognised; (b) the application as filed contains such relevant information as is available to the applicant on the characteristics of the biological material deposited; (c) the patent application states the name of the depository institution and the accession number. 2. Access to the deposited biological material shall be provided through the supply of a sample: (a) up to the first publication of the patent application, only to those persons who are authorised under national patent law; (b) between the first publication of the application and the granting of the patent, to anyone requesting it or, if the applicant so requests, only to an independent expert; (c) after the patent has been granted, and notwithstanding revocation or cancellation of the patent, to anyone requesting it. 3. The sample shall be supplied only if the person requesting it undertakes, for the term during which the patent is in force: (a) not to make it or any material derived from it available to third parties; and (b) not to use it or any material derived from it except for experimental purposes, unless the applicant for or proprietor of the patent, as applicable, expressly waives such an undertaking. 4. At the applicant's request, where an application is refused or withdrawn, access to the deposited material shall be limited to an independent expert for 20 years from the date on which the patent application was filed. In that case, paragraph 3 shall apply. 5. The applicant's requests referred to in point (b) of paragraph 2 and in paragraph 4 may only be made up to the date on which the technical preparations for publishing the patent application are deemed to have been completed. Article 14 1. If the biological material deposited in accordance with Article 13 ceases to be available from the recognised depositary institution, a new deposit of the material shall be permitted on the same terms as those laid down in the Budapest Treaty. 2. Any new deposit shall be accompanied by a statement signed by the depositor certifying that the newly deposited biological material is the same as that originally deposited. CHAPTER V Final provisions Article 15 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 July 2000. 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 16 The Commission shall send the European Parliament and the Council: (a) every five years as from the date specified in Article 15(1) a report on any problems encountered with regard to the relationship between this Directive and international agreements on the protection of human rights to which the Member States have acceded; (b) within two years of entry into force of this Directive, a report assessing the implications for basic genetic engineering research of failure to publish, or late publication of, papers on subjects which could be patentable; (c) annually as from the date specified in Article 15(1), a report on the development and implications of patent law in the field of biotechnology and genetic engineering. 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.

31998L0052

1998

Council Directive 98/52/EC of 13 July 1998 on the extension of Directive 97/80/EC on the burden of proof in cases of discrimination based on sex to the United Kingdom of Great Britain and Northern Ireland Having regard to the Treaty establishing the European Community, and in particular Article 100 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 the Council, acting in accordance with the Agreement on social policy annexed to Protocol 14 on social policy annexed to the EC Treaty, and in particular Article 2(2) thereof, adopted Directive 97/80/EC (4); whereas, as a result, the said Directive does not apply to the United Kingdom; Whereas the Amsterdam European Council, held on 16 and 17 June 1997, noted with approval the agreement of the Intergovernmental Conference to incorporate the Agreement on social policy in the Treaty and also noted that a means had to be found to give legal effect to the wish of the United Kingdom to accept the Directives already adopted on the basis of that Agreement and those which may be adopted before the entry into force of the Treaty of Amsterdam; Whereas, at the Council of 24 July 1997, the Council and the Commission agreed to put into effect the conclusions adopted at the Amsterdam European Council; whereas they also agreed to apply the same procedure, mutatis mutandis, to future Directives adopted on the basis of the Agreement on social policy; whereas this Directive seeks to achieve this aim by extending Directive 97/80/EC to the United Kingdom; Whereas the fact that Directive 97/80/EC is not applicable in the United Kingdom directly affects the functioning of the common market; whereas an effective implementation of the principle of equal treatment for men and women, in particular as regards the rules organizing the burden of proof in cases of discrimination based on sex, in all the Member States will improve the functioning of the common market; Whereas the adoption of this Directive will make Directive 97/80/EC applicable in the United Kingdom; whereas, from the date on which this Directive enters into force, the term 'Member States` in Directive 97/80/EC should be construed as including the United Kingdom; Whereas the United Kingdom should benefit from the same period of three years that was granted to other Member States to bring into force the necessary provisions to comply with Directive 97/80/EC, Article 1 Without prejudice to Article 2, Directive 97/80/EC shall apply to the United Kingdom of Great Britain and Northern Ireland. Article 2 The following paragraph shall be inserted after the first paragraph of Article 7 of Directive 97/80/EC: 'As regards the United Kingdom of Great Britain and Northern Ireland, the date of 1 January 2001 in paragraph 1 shall be replaced by 22 July 2001.` Article 3 This Directive shall enter into force on the day of its publication. Article 4 This Directive is addressed to the Member States.

31998L0054

1998

Commission Directive 98/54/EC of 16 July 1998 amending Directives 71/250/EEC, 72/199/EEC, 73/46/EEC and repealing Directive 75/84/EEC (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs (1), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 2 thereof, Whereas Directive 70/373/EEC stipulates that official controls of feedingstuffs for the purpose of checking compliance with the requirements arising under the laws, regulations and administrative provisions governing their quality and composition must be carried out using Community sampling and analysis methods; Whereas the First Commission Directive 71/250/EEC of 15 June 1971 establishing Community methods of analysis for the official control of feedingstuffs (2) as last amended by Directive 81/680/EEC (3) sets out methods of analysis for, inter alia, the determination of lupin alkaloids; whereas Council Directive 74/63/EEC of 17 December 1973 on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs (4), as last amended by Commission Directive 97/8/EC (5), does not require that feedingstuffs are officially controlled for the presence of lupin alkaloids; whereas, therefore, a Community method of analysis for the official control of lupin alkaloids is not necessary and it is appropriate to delete this method; Whereas the Third Commission Directive 72/199/EEC of 27 April 1972 establishing Community methods of analysis for the official control of feedingstuffs (6), as last amended by Directive 93/28/EC (7) sets out methods of analysis for, inter alia, the detection and identification of antibiotics of the tetracycline group, the determination of chlortetracycline, oxytetracycline and tetracycline and the determination of oleandomycin; whereas these methods are no longer required for the purposes of Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (8), as last amended by Commission Directive 98/19/EC (9); whereas the methods described are no longer valid in the light of advances in scientific and technical knowledge for use for other purposes; whereas it is therefore appropriate to delete these methods; Whereas the Fourth Commission Directive 73/46/EEC of 5 December 1972 establishing Community methods of analysis for the official control of feedingstuffs (10), as last amended by Directive 92/89/EC (11), sets out methods of analysis for, inter alia, the determination of thiamine (vitamin B1, aneurine) and the determination of ascorbic acid and dehydroascorbic acid (vitamin c); whereas these methods are no longer valid for their intended purpose and have been superseded by advances in scientific and technical knowledge; whereas it is therefore appropriate to delete these methods; Whereas the Sixth Commission Directive 75/84/EEC of 20 December 1974 establishing Community methods of analysis for the official control of feedingstuffs (12), as last amended by Directive 81/680/EEC, sets out methods of analysis for the determination of buquinolate, sulphaquinoxaline and furazolidone; whereas these methods are no longer required for the purposes of Directive 70/524/EEC; whereas there are grounds to assume in the light of advances in scientific and technical knowledge that these methods yield incorrect results; whereas it is preferable to have no method of analysis rather than a method which yields false results; whereas it is therefore appropriate to delete these methods; Whereas 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 (13), and in particular Article 18 thereof, Member States, in the absence of Community methods of sampling and analysis, ensure that methods of analysis are used, complying with standards recognised by international bodies or, in the absence of such standards, complying with scientifically recognised rules; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Feedingstuffs, Article 1 Directive 71/250/EEC is amended as follows: 1. in Article 1, 'and the determination of alkaloids in lupins` is deleted; 2. point 15, 'Determination of lupin alkaloids`, in the Annex to the Directive is deleted. Article 2 Directive 72/199/EEC is amended as follows: 1. in Article 2, 'of detecting and identifying antibiotics of the tetracycline group and also` and 'chlortetracycline, oxytetracycline, tetracyclin, oleandomycin,` are deleted; 2. points 1, 'Detection and identification of antibiotics of the tetracycline group`, 2, 'Determination of chlortetracycline, oxytetracycline and tetracycline` and 3, 'Determination of oleandomycin` in Annex II to the Directive are deleted. Article 3 Directive 73/46/EEC is amended as follows: 1. in Article 2, 'thiamine (aneurine, vitamin B1), ascorbic and dehydroascorbic acids (vitamin C)` is deleted; 2. points 2, 'Determination of thiamine (vitamin B1, aneurine)` and 3, 'Determination of ascorbic acid and dehydroascorbic acid (vitamin C)` in Annex II to the Directive are deleted. Article 4 Directive 75/84/EEC is repealed. Article 5 The Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with the provisions of this Directive, not later than nine months after its entry into force. 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 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.

31998L0058

1998

Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes Having regard to the Treaty establishing the European Community, and in particular Article 43 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 all Member States have ratified the European Convention for the Protection of Animals Kept for Farming Purposes (hereinafter called 'the Convention`); whereas the Community has also approved this Convention by Decision 78/923/EEC (4) and has deposited its instrument of approval; Whereas the Community, as a contracting party, must give effect to the principles laid down in the Convention; Whereas those principles include the provision of housing, food, water and care appropriate to the physiological and ethological needs of the animals, in accordance with established experience and scientific knowledge; Whereas it is also necessary for the Community to make further provision for the uniform application of the Convention and its recommendations and for specific rules concerning the application of this Directive; Whereas the European Parliament, in its resolution of 20 February 1987 on animal welfare policy (5) called on the Commission to make proposals for Community rules covering general aspects of the rearing of livestock; Whereas Declaration No 24 annexed to the Final Act of the Treaty on European Union calls on the European institutions and the Member States, when drafting and implementing Community legislation, in particular on the common agricultural policy, to pay full regard to the welfare requirements of animals; Whereas differences which may distort conditions of competition interfere with the smooth running of the organisation of the market in animals; Whereas there is therefore a need to establish common minimum standards for the protection of animals kept for farming purposes in order to ensure rational development of production and to facilitate the organisation of the market in animals; whereas to that end it is appropriate to take account of animal welfare provisions already laid down in Community rules; Whereas a comparative examination of animal welfare provisions applicable in the Community and in certain non-member countries together with an appraisal thereof should be undertaken with a view to determining the nature of future Community initiatives aimed at eliminating distortions of competition, Article 1 1. This Directive lays down minimum standards for the protection of animals bred or kept for farming purposes. 2. It shall not apply to: (a) animals living in the wild; (b) animals intended for use in competitions, shows, cultural or sporting events or activities; (c) experimental or laboratory animals; (d) any invertebrate animal. 3. This Directive shall apply without prejudice to specific Community rules laid down elsewhere, and in particular to Directives 88/166/EEC (6), 91/629/EEC (7) and 91/630/EEC (8), which shall continue to apply. Article 2 For the purposes of this Directive the following definitions shall apply: 1. 'animal`: any animal (including fish, reptiles or amphibians) bred or kept for the production of food, wool, skin or fur or for other farming purposes; 2. 'owner` or 'keeper`: any natural or legal person or persons responsible for or in charge of animals whether on a permanent or temporary basis; 3. 'competent authority`: the competent authority within the meaning of Article 2(6) of Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (9). Article 3 Member States shall make provision to ensure that the owners or keepers take all reasonable steps to ensure the welfare of animals under their care and to ensure that those animals are not caused any unnecessary pain, suffering or injury. Article 4 Members States shall ensure that the conditions under which animals (other than fish, reptiles or amphibians) are bred or kept, having regard to their species and to their degree of development, adaptation and domestication, and to their physiological and ethological needs in accordance with established experience and scientific knowledge, comply with the provisions set out in the Annex. Article 5 1. The Commission shall submit to the Council any proposals which may be necessary for the uniform application of the European Convention for the Protection of Animals Kept for Farming Purposes and, on the basis of a scientific evaluation, any recommendations made under this Convention and any other appropriate specific rules. 2. In addition, every five years and for the first time five years after the date of entry into force of this Directive, the Commission, on the basis of experience acquired since the implementation of this Directive, in particular concerning the measures referred to in paragraph 1 and technical and scientific developments, shall submit to the Council a report, accompanied by any appropriate proposals taking into account the report's conclusions. 3. The Council shall act by qualified majority on these proposals. Article 6 1. Member States shall ensure that inspections are carried out by the competent authority to check compliance with the provisions of this Directive. Such inspections may be carried out at the same time as checks for other purposes. 2. From a date to be determined in accordance with the procedure laid down in paragraph 3, Member States shall submit to the Commission reports on the inspections required under paragraph 1. The Commission shall submit summaries of those reports to the Standing Veterinary Committee. 3. The Commission shall before 1 July 1999, in accordance with the procedure laid down in Article 9 submit proposals with a view to harmonising: (a) the inspections required under paragraph 1; (b) the format, content and frequency of submission of the reports referred to in paragraph 2. Article 7 1. Whenever uniform application of the requirements of this Directive renders it necessary, veterinary experts from the Commission may, in conjunction with the competent authorities; (a) verify that the Member States are complying with the said requirements; (b) make on-the-spot checks to ensure that the checks are carried out in accordance with this Directive. 2. A Member State in whose territory an inspection is made shall provide the veterinary experts from the Commission with any assistance they may require in the performance of their tasks. The outcome of the checks made must be discussed with the competent authority of the Member State concerned before a final report is drawn up and circulated. 3. The competent authority of the Member State concerned shall take any measures which may be necessary to take account of the results of the check. 4. Detailed rules for the application of this Article shall be adopted, where necessary, in accordance with the procedure laid down in Article 9. Article 8 1. Before 30 June 1999 the Commission shall submit to the Council a report on: - the comparison between animal welfare provisions in the Community and in non-member countries which supply the Community, - the scope for obtaining wider international acceptance of the welfare principles laid down in this Directive, and - the extent to which Community objectives in relation to animal welfare may be liable to be undermined as a result of competition from non-member countries which do not apply equivalent standards. 2. The report referred to in paragraph 1 shall be accompanied by any necessary proposals with the aim of eliminating distortions of competition. Article 9 1. Where the procedure laid down in this Article is to be followed, the matter shall be referred without delay to the Standing Veterinary Committee set up by Directive 68/361/EEC (10), hereinafter referred to as 'the Committee`, by its chairman acting either on his own initiative or at the request of a Member State. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. (b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the Commission shall adopt the proposed measures and implement them immediately, save where the Council has decided against the said measures by a simple majority. Article 10 1. Member States shall bring into force the laws, regulations and administrative provisions, including any sanctions, necessary to comply with this Directive not later than 31 December 1999, subject to any different decision taken by the Council in the light of the report referred to in Article 8. 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. However, after 31 December 1999, Member States may, in compliance with the general rules of the Treaty, maintain or apply within their territories stricter provisions for the protection of animals kept for farming purposes than those laid down in this Directive. They shall inform the Commission of any such measures. 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 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.

31998L0056

1998

Council Directive 98/56/EC of 20 July 1998 on the marketing of propagating material of ornamental plants Having regard to the Treaty establishing the European Community, and in particular Article 43 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), (1) Whereas the production of ornamental plants occupies an important place in the agriculture of the Community; (2) Whereas satisfactory results in the cultivation of ornamental plants depend to a large extent on the quality and health of the material used for their propagation; (3) Whereas the establishment of harmonised conditions at Community level will ensure that purchasers throughout the Community receive propagating material which is healthy and of good quality; (4) Whereas, so far as they relate to plant health, such harmonised conditions must be consistent with Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plants or plant products and against their spread in the Community (4); (5) Whereas it is appropriate to establish Community rules for all genera and species of ornamental plants in the Community, with the exception of those covered by Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein (5); (6) Whereas, without prejudice to the plant health provisions of Directive 77/93/EEC, it is not appropriate to apply the Community rules on the marketing of propagating material when it is shown that such material and plants are intended for export to third countries, as the rules applicable there may be different from those contained in this Directive; (7) Whereas the determination of plant health and quality standards for particular genus and species of ornamental plant requires lengthy and detailed technical and scientific consideration; whereas a procedure should accordingly be established for the determination of these standards; (8) Whereas in the first instance it is the responsibility of the suppliers of propagating material to ensure that their products fulfil the conditions laid down in this Directive; (9) Whereas the competent authorities of the Member States, when carrying out controls and inspections, should ensure that suppliers fulfil those conditions; (10) Whereas Community control measures should be introduced to ensure uniform application in all the Member States of the standards laid down in this Directive; (11) Whereas it is in the interests of the purchasers of propagating material that the names of varieties or of groups of plants be known and that their identity be safeguarded; (12) Whereas the characteristics specific to the industry operating in the ornamental plant sector are a complicating factor; whereas, accordingly, the objective stated above can best be achieved either through common knowledge of the variety or, in the case of varieties or groups of plants, through the availability of a description drawn up and kept by the suppliers; (13) Whereas, in order to ensure the identity and orderly marketing of propagating material, Community rules must be laid down concerning the separation of lots and marking; whereas the labels should give the particulars needed both for official control and for the information of the grower; (14) Whereas rules should be established permitting, in the case of temporary supply difficulties, the marketing of propagating material subject to requirements less stringent than those contained in this Directive; (15) Whereas provisions should be made for authorising the marketing, within the Community, of propagating material produced in third countries, provided always it affords equivalent guarantees in all respects to propagating material produced in the Community and complying with Community rules; (16) Whereas, in order to harmonise technical methods of examination used in the Member States and to compare propagating material produced in the Community with those produced in third countries, comparative trials should be carried out to check compliance of propagating material with the requirements of this Directive; (17) Whereas, in order to facilitate the effective operation of this Directive, the Commission should be entrusted with the task of adopting measures for its implementation; whereas such measures should be adopted by a procedure involving close cooperation between the Commission and the Member States within a Standing Committee for Propagating Material of Ornamental Plants; (18) Whereas Council Directive 91/682/EEC of 19 December 1991 on the marketing of ornamental plant propagating material and ornamental plants (6) established harmonised conditions at Community level to ensure that purchasers throughout the Community receive propagating material and ornamental plants which are healthy and of good quality; (19) Whereas Member States have experienced difficulties in the interpretation and transposition of the said Directive; (20) Whereas the said Directive was considered to be suitable for inclusion in the SLIM Initiative (Simpler Legislation for the Internal Market) which was launched by the Commission in May 1996; (21) Whereas the Ornamental Plants SLIM team made various recommendations aimed at simplifying the said Directive; whereas those recommendations are contained in the Communication from the Commission to the Council and the European Parliament on the SLIM Initiative; (22) Whereas those recommendations related to the persons to be controlled by the said Directive, the species to be covered by that Directive, varietal authenticity, the interrelationship with Directive 77/93/EEC and third country equivalence; (23) Whereas, after consideration of those recommendations it is desirable to amend certain provisions of Directive 91/682/EEC; whereas given the number of such amendments, the said Directive should be recast in the interests of clarity, TITLE I SCOPE Article 1 1. This Directive shall apply to the marketing of propagating material of ornamental plants within the Community. This shall be without prejudice to the rules on protection of wild flora laid down by Regulation (EC) No 338/97, the rules on packaging and packaging waste laid down by Directive 94/62/EC of the European Parliament and of the Council (7), or, save where otherwise provided for in this Directive or on the basis thereof, the plant health rules laid down by Directive 77/93/EEC. 2. This Directive shall not apply to: - material shown to be intended for export to third countries, which is identified as such and is kept sufficiently isolated, - material the products of which are not intended for ornamental purposes, if it is covered by other Community legislation on the marketing of such material. 3. In accordance with the procedure laid down in Article 17, it may be decided that some or all of the requirements of this Directive shall not apply in respect of seed of particular species or groups of plants, where intended for the production of further propagating material and where there is no significant connection between the quality of such seed and the quality of the material grown from it. TITLE II DEFINITIONS Article 2 For the purpose of this Directive, the following definitions shall apply: 1. 'Propagating material`: plant material intended for: - the propagation of ornamental plants, or - the production of ornamental plants; however, in the case of production from complete plants, this definition applies only to the extent that the resulting ornamental plant is intended for further marketing. 'Propagation`: reproduction by vegetative or other means. 2. 'Supplier`: any natural or legal person engaged professionally in marketing or importing of propagating material. 3. 'Marketing`: sale or delivery by a supplier to another person. 'Sale` includes holding available or in stock, display with a view to sale, offering for sale. 4. 'Responsible official body`: (a) an authority, established or designated by the Member State under the supervision of the national government and responsible for questions concerning quality; (b) any State authority established: - either at national level, or - at regional level, under the supervision of national authorities, within the limits set by the constitution of the Member State concerned. The bodies referred to above may, in accordance with their national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to any legal person, whether governed by public or by private law, which, under its officially approved constitution, is charged exclusively with specific public functions, provided that such person, and its members, has no personal interest in the outcome of the measures it takes. Moreover, in accordance with the procedure laid down in Article 17, other legal persons established on behalf of the body referred to in point (a) and acting under the authority and supervision of such body may be approved, provided that such person has no personal interest in the outcome of the measures it takes. Member States shall notify the Commission of their responsible official bodies. The Commission shall forward that information to the other Member States. 5. 'Lot`: a number of units of a single commodity, identifiable by its homogeneity of composition and origin. TITLE III REQUIREMENTS TO BE MET BY PROPAGATING MATERIAL Article 3 1. Suppliers may market propagating material only if it meets the requirements laid down in this Directive. 2. Paragraph 1 shall not apply to propagating material intended for: (a) trials or scientific purposes, (b) selection work, or (c) the conservation of genetic diversity. 3. Detailed rules for the application of paragraph 2 may be adopted in accordance with the procedure laid down in Article 17. Article 4 Propagating material shall, where applicable, comply with the relevant plant health conditions laid down in Directive 77/93/EEC. Article 5 1. Without prejudice to the provisions of Article 1 and Article 4, propagating material when marketed: - shall at least on visual inspection, be substantially free from any harmful organisms impairing quality, or any signs or symptoms thereof, which reduce its usefulness, - shall be substantially free of any defects likely to impair its quality as propagating material, - shall have satisfactory vigour and dimensions in respect of its usefulness as propagating material, - in the case of seeds, shall have satisfactory germination capacity, - if marketed with reference to a variety pursuant to Article 9, shall have satisfactory varietal identity and purity. 2. Any propagating material which, on the basis of visible signs or symptoms, is not substantially free of harmful organisms, shall be properly treated or, where appropriate, shall be removed. 3. In the case of citrus material the following requirements shall also be met: (a) it shall be derived from initial material which has been checked and found to show no symptoms of any viruses, virus-like organisms or diseases; (b) it shall have been checked and found to be substantially free of such viruses, virus-like organisms or disease since the beginning of the last cycle of vegetation; and (c) in the case of grafting, it shall have been grafted onto rootstocks other than those susceptible to viroids. 4. In the case of flower bulbs the following requirement shall also be met: - the propagating material shall be derived directly from material which, at the stage of the growing crop, has been checked and found to be substantially free from any harmful organisms and diseases, signs or symptoms thereof. 5. In accordance with the procedure laid down in Article 18, a schedule may be established for a particular genus or species, laying down additional conditions concerning the quality with which propagating material when marketed must comply. A genus or species shall only be included in the schedule if there is a demonstrated need for such additional rules. In determining such need the following criteria shall apply: - the existence of problems with the quality of propagating material of the species or genus concerned, which can only be resolved satisfactorily through legislative means, - the economic importance of propagating material of the species or genus concerned, - consistency with any international standards on regulated non-quarantine pests. TITLE IV REQUIREMENTS TO BE MET BY SUPPLIERS OF PROPAGATING MATERIAL Article 6 1. Without prejudice to paragraph 2, suppliers shall be officially registered in relation to the activities which they carry out under this Directive. The responsible official body may deem suppliers, who are already registered under Directive 77/93/EEC, to be registered for the purposes of the current Directive. Such suppliers shall nonetheless comply with the requirements of the current Directive. 2. Paragraph 1 shall not apply to suppliers marketing only to persons not professionally engaged in the production or sale of ornamental plants or propagating material. Such suppliers shall nonetheless comply with the requirements of the current Directive. Article 7 1. Suppliers engaged in production of propagating material shall: - identify and monitor critical points in their production process which influence the quality of the material, - keep information, for examination when requested by the responsible official body on the monitoring laid down in the first indent, - take samples where necessary for analysis in a laboratory with suitable facilities and expertise, - ensure that, during production, lots of propagating material remain separately identifiable. 2. In the case of the appearance, on the premises of a supplier engaged in the production of propagating material, of a harmful organism listed in Directive 77/93/EEC or in any measures established pursuant to Article 5(5), the supplier shall report it to the responsible official body and shall carry out any measures laid down by that body. 3. When propagating material is marketed, registered suppliers shall keep records of their sales or purchases for at least 12 months. 4. Rules for the application of paragraph 1 above may be established in accordance with the procedure laid down in Article 17. TITLE V MARKETING AND LABELLING OF PROPAGATING MATERIAL Article 8 1. Propagating material shall be marketed in lots. However, propagating material of different lots may be marketed in a single consignment, provided that the supplier keeps records of the composition and origin of the different lots. 2. Propagating material when marketed shall be accompanied by a label or other document made out by the supplier. 3. In accordance with the procedure laid down in Article 17, requirements as to the label or document referred to in paragraph 2 shall be established. In the case of marketing of propagating material for persons not professionally engaged in the production or sale of ornamental plants or propagating material, requirements on labelling may be confined to appropriate product information. Requirements as to packaging of propagating material may be adopted in accordance with the same procedure. 4. Paragraph 1 shall not apply to propagating material which is marketed for persons not professionally engaged in the production or sale of ornamental plants or propagating material. Article 9 1. Propagating material may be marketed with a reference to a variety, only if the variety concerned is: - legally protected by a plant variety right in accordance with provisions on the protection of new varieties, or - officially registered, or - commonly known, or - entered on a list kept by a supplier with its detailed description and denomination. Such lists shall be drawn up in accordance with accepted international guidelines, where these are applicable. The lists shall be available, on request, to the responsible official body of the Member State concerned. 2. As far as possible, each variety shall bear the same denomination in all the Member States, in accordance with implementing measures which may be adopted in accordance with the provisions of Article 17 or, in their absence, in accordance with accepted international guidelines. 3. Where propagating material is marketed with a reference to a group of plants rather than a variety referred to in paragraph 1, the supplier shall indicate the group of plants in such a way as to avoid confusion with any varietal denomination. 4. Additional implementing provisions for the fourth indent of paragraph 1 may be adopted in accordance with the procedure laid down in Article 17. TITLE VI PROPAGATING MATERIAL MEETING LESS STRINGENT REQUIREMENTS Article 10 In the event of temporary difficulties in the supply of propagating material satisfying the requirements of this Directive which cannot be overcome within the Community, rules may be adopted, in accordance with the procedure laid down in Article 17, concerning the marketing of propagating material meeting less stringent requirements. TITLE VII PROPAGATING MATERIAL PRODUCED IN THIRD COUNTRIES Article 11 1. In accordance with the procedure laid down in Article 17, it shall be decided whether propagating material produced in a third country affords equivalent guarantees in all respects to material produced in the Community in accordance with this Directive. 2. Pending the decision referred to in paragraph 1, propagating material may not be imported from third countries unless the importing supplier ensures prior to import that the material to be imported affords equivalent guarantees in all respects to propagating material produced in the Community in accordance with this Directive, in particular in relation to quality, identification and plant health. 3. The importer shall notify the responsible official bodies of material imported under paragraph 2 and shall keep documentary evidence of his contract with the supplier in the third country. 4. Implementing measures relating to the procedure to be followed and further requirements to be met by importers may be established in accordance with the procedure laid down in Article 17. TITLE VIII CONTROL MEASURES AND GENERAL PROVISIONS Article 12 1. Member States shall require that suppliers take all necessary measures to guarantee compliance with the requirements of this Directive. To this end Member States shall ensure that propagating material is officially inspected: - at least by random checks, and - at least in respect of marketing to persons professionally engaged in production or sale of ornamental plants or propagating material, to verify compliance with the requirements. Member States may also take samples in order to verify compliance. In carrying out supervision and monitoring, the responsible official bodies shall have free access to all parts of suppliers' establishments at all reasonable times. The Commission shall, by 31 December 2002, submit a report to the Council, on the operation of the control arrangements foreseen in this Article, together with any appropriate proposals which may, if appropriate, include proposals for removing requirements of this Directive from retail sales. 2. Detailed implementing procedures for official inspections under this Directive may be established in accordance with the procedure laid down in Article 17. Article 13 1. If, during official inspections referred to in Article 12, or the trials referred to in Article 14, it is found that propagating material does not meet the requirements of this Directive, the responsible official body shall ensure that the supplier takes appropriate corrective action or, if that is not possible, shall prohibit the marketing of that propagating material in the Community. 2. If it is found that propagating material marketed by a particular supplier does not comply with the requirements of this Directive, the Member State concerned shall ensure that appropriate measures are taken in relation to that supplier. 3. Any measures taken under paragraph 2 shall be withdrawn as soon as it has been established with sufficient certainty that the propagating material intended for marketing by the supplier will, in future, comply with the requirements and conditions of this Directive. Article 14 1. Where appropriate, trials or tests shall be carried out in the Member States on samples to check that propagating material complies with the requirements and conditions of this Directive. The Commission may organise inspections of trials by representatives of the Member States and of the Commission. 2. It may be decided in accordance with the procedure laid down in Article 17 that it is necessary to carry out Community trials or tests for the same purpose as mentioned in paragraph 1. The Commission may organise inspections of Community trials by representatives of the Member States and of the Commission. 3. The trials or tests referred to in paragraphs 1 and 2 shall be used to harmonise technical methods of examination of propagating material. Progress reports on the trials or tests shall be sent to the Commission and submitted to the Committee referred to in Article 17. 4. The Commission shall ensure that, in appropriate cases, arrangements for coordinating, carrying out and inspecting the trials referred to in paragraphs 1 and 2, and assessing their results, are made within the Committee referred to in Article 17. When problems occur in relation to organisms covered by Directive 77/93/EEC, the Commission shall notify the Standing Committee on Plant Health, which shall also be consulted on protocols for Community trials where these concern organisms covered by Directive 77/93/EEC. Propagating material produced in third countries may be included in the trials. Article 15 The marketing of propagating material which complies with the requirements of this Directive shall be subject to no restrictions as regards supplier, quality, plant health, labelling and packaging, other than those laid down in this Directive. Article 16 In accordance with the procedure laid down in Article 17, a Member State may at its request and under certain conditions be wholly or partially released from certain obligations under this Directive in respect of types of propagating material of certain genera or species the production of which is of minimal economic importance in its territory, save where this would run counter to Article 15. TITLE IX COMMITTEE PROCEDURES Article 17 1. Where reference is made to the procedure laid down in this Article, the Commission shall be assisted by a Committee, referred to as the Standing Committee for Propagating Material of Ornamental Plants, chaired by a representative of the Commission. 2. The representative of the Commission shall submit to the Standing Committee a draft of the measures to be taken. The Standing Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. (a) The Commission shall adopt measures which shall apply immediately. (b) However, if these measures are not in accordance with the opinion of the Committee, they shall be communicated by the Commission to the Council forthwith.In that event:- the Commission may defer application of the measures which it has decided for a period of not more than one month from the date of such communication; - the Council, acting by a qualified majority, may take a different decision within the time referred to in the first indent. 4. The Committee, at the request of the chairman or one of the Member States, may examine any questions relevant to the subject matter of this Directive. Article 18 1. Where reference is made to the procedure laid down in this Article, the Commission shall be assisted by the Standing Committee for Propagating Materials and Ornamental Plants, chaired by the representative of the Commission. 2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion will be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. (b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. TITLE X FINAL PROVISIONS Article 19 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive on 1 July 1999. They shall forthwith inform the Commission thereof. 2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods for making such reference shall be adopted by the Member States. 3. 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 20 1. Directive 91/682/EEC shall be repealed with effect from 1 July 1999 without prejudice to Member States' obligations in relation to the period of transposition and implementation referred to in Part A of the Annex hereto. 2. References to the repealed Directive 91/682/EEC shall be understood as references to this Directive and shall be read in accordance with the correlation table in Part B of the Annex hereto. 3. Implementing provisions adopted under Directive 91/682/EEC shall continue to have effect unless amended or repealed by new implementing provisions. Article 21 This Directive is addressed to the Member States.

31998L0060

1998

Commission Directive 98/60/EC of 24 July 1998 amending Council Directive 74/63/EEC on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 74/63/EEC of 17 December 1973 on undesirable substances and products in animal nutrition (1), as last amended by Commission Directive 97/8/EC (2), and in particular Article 6 thereof, Whereas citrus pulp pellets originating in or consigned from Brazil were found to be contaminated by dioxins at such high levels which pose a risk to human health; whereas citrus pulp pellets are used as feed material; whereas feedingstuffs contaminated by dioxins results in dioxin contamination of food products of animal origin; whereas dioxins are classified by the relevant international organisations as carcinogenic to humans; whereas it is recommended by these relevant international organisations to take measures to reduce the intake of dioxin through diet as much as is reasonably achievable; it is, therefore, appropriate to prohibit the use of citrus pulp pellets contaminated by dioxins at unacceptable levels as feedingstuff and for the production of compound feedingstuff; Whereas all sources of contamination by dioxins at such unacceptable levels has not been possible to be determined with sufficient certainty within the short time limits available; whereas, therefore, no sufficient guarantees exist for the moment that the possible sources of contamination have been removed from the production process of citrus pulp pellets; whereas a more complete scientific assessment of the tolerable maximum level for dioxins cannot be performed within short notice; it is therefore urgent to fix provisionally the maximum limit at the detection level (500 pg I - TEQ/kg) whilst awaiting the scientific assessment of the risk involved; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs, Article 1 Annex I and Annex II, Part A to Directive 74/63/EEC are hereby amended as set out in the Annex to this Directive. This provision shall be reviewed before 1 January 1999 according to the availability of evidence concerning the sources of contamination or of a scientific risk assessment. Article 2 1. Member States shall adopt and publish not later than 31 July 1998 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall inform the Commission thereof forthwith. The provisions adopted shall apply from 1 August 1998. When the Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted 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 This Directive shall enter into force of the third day following its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States.

31998L0065

1998

Commission Directive 98/65/EC of 3 September 1998 adapting to technical progress Council Directive 82/130/EEC on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres in mines susceptible to firedamp (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 82/130/EEC of 15 February 1982 on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres in mines susceptible to firedamp (1), as last amended by Commission Directive 94/44/EC (2), and in particular Article 7 thereof, Whereas, in view of the present state of technical progress, it is now necessary to adapt the contents of the harmonised standards referred to in Annex A to Directive 82/130/EEC; Whereas, in view of the present state of the standardisation of the types of protection involved, it is necessary to provide for the first and second editions of the standards for electrical equipment for use in potentially explosive atmospheres to be used in parallel; Whereas certificates issued on the basis of the first edition standards listed in Annex A to Directive 82/130/EEC, as amended, are referred to as 'generation D certificates`, and certificates issued on the basis of the second edition standards listed in Annex I to this Directive are referred to as 'generation E certificates`; whereas 'generation D certificates` and 'generation E certificates` are to be used in parallel; Whereas Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres (3) stipulates that Directive 82/130/EEC be repealed as from 1 July 2003; Whereas the measures provided for in this Directive are in accordance with the opinion of the Restricted Committee of the Safety and Health Commission for the Mining and other Extractive Industries, Article 1 Directive 82/130/EEC is hereby amended as follows: 1. in the first sentence of Annex A, the reference to the 'table below` shall be replaced by the 'tables below`; 2. Annex I to the present Directive shall be added to Annex A; 3. Annex II to the present Directive shall be added to Annex B. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1999 and shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States. Member States shall communicate to the Commission the texts of the provisions of national law which they have already adopted or adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States. It shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.

31998L0062

1998

23rd Commission Directive 98/62/EC of 3 September 1998 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Commission Directive 98/16/EC (2) and in particular Article 8(2) thereof, After consulting the Scientific Committee on Cosmetology, Whereas, in the absence of fresh scientific data, in particular as regards long-term toxicity, the Scientific Committee on Cosmetology recommends that the use of moskene and musk tibetene should be prohibited in cosmetic products as they may present a risk to the health of consumers; Whereas a further toxicological evaluation of strontium chloride, based on new data submitted by industry, shows that the use of this substance may be extended, without any safety risk, to shampoos and face care products provided a maximum concentration is not exceeded; Whereas, on the basis of the latest scientific data, the use may be permitted of benzalkonium chloride, bromide and saccharinate as preservatives in cosmetic products subject to the requirements of the Directive; Whereas, on the basis of the latest scientific research and data, 3-iodo-2-propynyl butylcarbamate (iodopropynyl butylcarbamate) may be provisionally used as a preservative in cosmetic products subject to certain conditions on concentrations and use; Whereas, on the basis of the latest scientific data, phenol 2-(2H-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3-tetramethyl-1-(trimethylsilyl)oxy)-disiloxanyl)propyl) may be used as a UV filter in cosmetic products subject to the requirements of the Directive; Whereas, on the basis of the latest scientific data, benzoic acid,4,4-((6-(((1,1-dimethylethyl)amino)carbonyl)phenyl)amino) 1,3,5-triazine-2,4-diyl)diamino)bis-,bis(2-ethylhexyl)ester may be used as a UV filter in cosmetic products; Whereas, on the basis of the latest scientific research and data, ethoxylated ethyl-4-aminobenzoate, isopentyl-4-methoxycinnamate, 2,4,6-trianilino-(p-carbo-2'-ethylhexyl-1'oxy)-1,3,5-triazine and 2-Ethylhexyl salicylate may be used as UV filters in cosmetic products subject to the requirements of the Directive; Whereas, on the basis of the latest scientific research and data, 3-(4'-methylbenzylidene)-d-1camphor and 3-benzylidene camphor may be used as UV filters in cosmetic products; Whereas the measures laid down in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector, Article 1 Directive 76/768/EEC is hereby amended as shown in the Annex. Article 2 1. Member States shall take the necessary measures to ensure that, as from 1 July 1999, for the substances set out in the Annex, neither manufacturers nor importers established in the Community place on the market products which do not comply with the requirements of this Directive. 2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 containing the substances set out in the Annex are not sold or otherwise supplied to the final consumer after 30 June 2000. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 June 1999. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted 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 4 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31998L0068

1998

COMMISSION DIRECTIVE 98/68/EC of 10 September 1998 laying down the standard document referred to in Article 9(1) of Council Directive 95/53/EC and certain rules for checks at the introduction into the Community of feedingstuffs from third countries (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 95/53/EC of 25 October 1995 fixing the principles governing the organisation of official inspections in the field of animal nutrition (1), and in particular Article 9(2) thereof, Whereas when products are introduced into the customs territory of the Community and are not released for free circulation in the territory of the Member State which carries out the checks the competent authority shall provide the person concerned with a document indicating the type of check carried out and its outcome; Whereas rules should be adopted for the compilation and the delivery of the document; Whereas in defining the layout of the document it should be taken into account the future possibility of an eventual electronic transmission of the information contained in it; Whereas this uniform approach allows the document to be drawn up only in one of the official langauges of the Community; Whereas a close cooperation between the customs authority and the competent authority in the field of animal nutrition must be established in order to ensure that inspection procedures are not eluded; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs, Article 1 1. The document referred to in Article 9(1) of Directive 95/53/EC must be drawn up in accordance with the model laid down in Annex A. The document must take up a single sheet only. 2. For the compilation of the document based on the model laid down in Annex A the rules laid down in Annex B are applicable. 3. The document based on the model laid down in Annex A must be made out in one of the languages of the Community which is acceptable to the competent authority of the Member State where the products coming from third countries are introduced into the customs territory of the Community. If necessary, the competent authority of the Member State of destination may require from the person concerned referred to in Article 2(1) a translation of the document based on the model laid down in Annex A completed according to Annex B into one of the official languages of that Member State. The translation shall replace the corresponding particulars in the document in question. 4. Any alteration or erasure on the document based on the model laid down in Annex A by an unauthorised person makes it invalid. Article 2 1. A document based on the model laid down in Annex A shall be delivered by the competent authority of the entry point to the person concerned in the cases referred to in Article 9(1) of Directive 95/53/EC and precisely: (a) when the products are coming directly from a third country and are intended for the release for free circulation in a Member State other than that which carried out the checks referred to in Article 5 and, where appropriate, in Article 7 of Directive 95/53/EC; (b) when non-Community products are leaving a free zone, a free warehouse or a customs warehouse and are intended for the release for free circulation in a Member State other than that where the free zone, the free warehouse or the customs warehouse are located. 2. If the batch is split in different parts, a document based on the model laid down in Annex A must be delivered for each part of it. 3. The document based on the model laid down in Annex A completed according to Annex B must accompany the batch to which it referes up to the moment of its release for free circulation in the Community and must be presented to the competent authority of the Member State where the products are released for free circulation together with a copy of the results of the laboratory analyses, where available. 4. The Member States shall ensure that the customs authorities do not authorise the release of the products for free circulation into the customs territory of the Community unless information has been supplied that, both on the basis of the document based on the model laid down in Annex A completed according to Annex B and of possible further controls carried out by the competent authorities, the checks on the products in question have been carried out in accordance with Article 5 and 7 of Directive 95/53/EC to the satisfaction of the competent authority of the Member State where the products are released for free circulation. 5. The competent authority of the Member State where the products are released for free circulation into the customs territory of the Community shall keep the document based on the model laid down in Annex A as well as a copy of the results of the laboratory analysis, where available, for at least 18 months. Article 3 1. Member States shall adopt and publish no later than 31 March 1999, immediately informing the Commission thereof, the laws, regulations and administrative provisions needed to comply with this Directive. They shall apply these provisions from 1 April 1999. The provisions shall contain a reference to this Directive or be accompanied by such a reference on official publication. Details of the reference shall be set by the Member State. 2. Member States shall send the Commission the text of primary provisions of national law adopted on the matters regulated 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.

31998L0077

1998

Commission Directive 98/77/EC of 2 October 1998 adapting to technical progress Council Directive 70/220/EEC on the approximation of the laws of the Member States relating to measures to be taken against air pollution by emissions from motor vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/220/EEC of 20 March 1970 on the approximation of the laws of the Member States relating to measures to be taken against air pollution by emissions from motor vehicles (1), as last amended by Directive 96/69/EC of the European Parliament and of the Council (2), Whereas Directive 70/220/EEC 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 (3), as amended by Commission Directive 98/14/EC (4); Whereas Article 13(2) of Directive 70/156/EEC lays down that the procedure of Article 13 shall also apply to the introduction of provisions on the type-approval of separate technical units into the separate directives; Whereas to provide a harmonised basis to guarantee that replacement catalytic converters, intended to be fitted on vehicles of category M1 and N1 not equipped with on-board diagnostic systems, are of sufficient quality, it is appropriate to introduce into Directive 70/220/EEC new technical requirements for the EC type-approval of replacement catalytic converters as a separate technical unit; whereas these technical requirements are in accordance with the technical requirements adopted by the United Nations Economic Commission for Europe in its Regulation No 103 relating to the approval of replacement catalytic converters for power-driven vehicles (5); Whereas in the light of technical progress it is appropriate to introduce into Directive 70/220/EEC new technical requirements for the EC type-approval of vehicles which can be fuelled with liquefied petroleum gas (LPG) or natural gas (NG); whereas the use of LPG and NG for the propulsion of vehicles permit to achieve very low levels of noxious emissions and should then benefit by the EC type-approval system; whereas these technical requirements are in accordance with the technical requirements adopted by the United Nations Economic Commission for Europe in its Regulation No 83 relating to the approval of vehicles with regard to their emission of pollutants (6); Whereas it is appropriate to clarify the methods regarding the measurement of vehicle rolling resistance; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC, Article 1 Article 1 of Directive 70/220/EEC is replaced by the following Article: 'Article 1 For the purposes of this Directive: - "vehicle" means any vehicle as defined in Annex II Section A to Directive 70/156/EEC, - "automotive LPG or NG equipment" means any assembly of automotive LPG or NG components designed to be fitted on one or more given types of motor vehicle, which can be approved as a separate technical unit as defined in Article 4(1)(d) of Directive 70/156/EEC, - "replacement catalytic converter" means a catalytic converter or an assembly of catalytic converters intended to replace an original equipment catalytic converter on a vehicle approved according to Directive 70/220/EEC, which can be approved as a separate technical unit as defined in Article 4(1)(d) of Directive 70/156/EEC.` Article 2 The Annexes to Directive 70/220/EEC are amended in accordance with the Annex to this Directive. Article 3 1. With regards to new replacement catalytic converters intended to be fitted on EC-approved vehicles which are not equipped with on-board diagnostic systems (OBD), Member States: (1) with effect from 1 January 1999, may not: - refuse to grant EC type-approval pursuant to Article 4(1) of Directive 70/156/EEC, or - prohibit their sale or installation on a vehicle, if they comply with the requirements of Directive 70/220/EEC as amended by this Directive; (2) with effect from 1 October 1999 subject to the provision of Article 7(2) of Directive 70/156/EEC shall refuse the sale or installation on a vehicle of a replacement catalytic converter(s), if it is not of a type in respect of which a type-approval has been granted in compliance with Directive 70/220/EEC, as amended by this Directive. 2. With regard to new vehicles fuelled with LPG or NG or which can be fuelled with either petrol or LPG, or NG on grounds relating to air pollution by emissions, Member States: (1) with effect from 1 January 1999 may not: - refuse to grant EC type-approval pursuant to Article 4(1) of Directive 70/156/EEC, or - refuse to grant national type-approval, or - prohibit the registration, sale or entry into service if they comply with the requirements of Directive 70/220/EEC as amended by this Directive; (2) with effect from 1 October 1999, shall refuse the registration, sale or entry into service of new vehicles which do not comply with the provision of Directive 70/220/EEC as amended by this Directive. Article 4 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 31 December 1998 they shall forthwith inform the Commission thereof. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the occasion of their official publication. The procedure for such reference shall be adopted by the Member States. 2. Member States shall communicate to the Commission the texts of the main procedure of the national law that they adopt in the field governed by this Directive. 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.

31998L0080

1998

Council Directive 98/80/EC of 12 October 1998 supplementing the common system of value added tax and amending Directive 77/388/EEC - Special scheme for investment gold Having regard to the Treaty establishing the European Community and in particular Article 99 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, under 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) transactions concerning gold are in principle taxable although, on the basis of the transitional derogation provided for in Article 28(3) in conjunction with point 26 of Annex F to the said Directive, Member States may continue to exempt transactions concerning gold other than gold for industrial use; whereas the application by some Member States of that transitional derogation is the cause of a certain distortion of competition; Whereas gold does not only serve as an input for production but is also acquired for investment purposes; whereas the application of the normal tax rules constitutes a major obstacle to its use for financial investment purposes and therefore justifies the application of a specific tax scheme for investment gold; whereas such a scheme should also enhance the international competitiveness of the Community gold market; Whereas supplies of gold for investments purposes are similar in nature to other financial investments often exempted from tax under the current rules of the sixth Directive, and therefore exemption from tax appears to be the most appropriate tax treatment for supplies of investment gold; Whereas the definition of investment gold should only comprise forms and weights of gold of very high purity as traded in the bullion markets and gold coins the value of which primarily reflects its gold price; whereas, in the case of gold coins, for reasons of transparency, a yearly list of qualifying coins should be drawn up providing security for the operators trading in such coins; whereas the legal security of traders demands that coins included in this list be deemed to fulfil the criteria for exemption of this Directive for the whole year for which the list is valid; whereas such list will be without prejudice to the exemption, on a case-by-case basis, of coins, including newly minted coins which are not included in the list but which meet the criteria laid down in this Directive; Whereas since a tax exemption does, in principle, not allow for the deduction of input tax while tax on the value of the gold may be charged on previous operations, the deduction of such input tax should be allowed in order to guarantee the advantages of the special scheme and to avoid distortions of competition with regard to imported investment gold; Whereas the possibility of using gold for both industrial and investment purposes requires the possibility for operators to opt for normal taxation where their activity consists either in the producing of investment gold or transformation of any gold into investment gold, or in the wholesale of such gold when they supply in their normal trade gold for industrial purposes; Whereas the dual use of gold may offer new opportunities for tax fraud and tax evasion that will require effective control measures to be taken by Member States; whereas a common standard of minimum obligations in accounting and documentation to be held by the operators is therefore desirable although, where this information does already exist pursuant to other Community legislation, a Member State may consider these requirements to be met; Whereas experience has shown that, with regard to most supplies of gold of more than a certain purity the application of a reverse charge mechanism can help to prevent tax fraud while at the same time alleviating the financing charge for the operation; whereas it is justified to allow Member States to use such mechanism; whereas for importation of gold Article 23 of the Sixth Directive allows, in a similar way, that tax is not paid at the moment of importation provided it is mentioned in the declaration pursuant to Article 22(4) of that Directive; Whereas transactions carried out on a bullion market regulated by a Member State require further simplifications in their tax treatment because of the huge number and the speed of such operations; whereas Member States are allowed to disapply the special scheme, to suspend tax collection and to dispense with recording requirements; Whereas since the new tax scheme will replace existing provisions under Article 12(3)(e) and point 26 of Annex F of the Sixth Directive, these provisions should be deleted, Article 1 The following Article 26b shall be added to Directive 77/388/EEC: 'Article 26b Special scheme for investment gold A. Definition For the purposes of this Directive, and without prejudice to other Community provisions: "investment gold" shall mean: (i) gold, in the form of a bar or a wafer of weights accepted by the bullion markets, of a purity equal to or greater than 995 thousandths, whether or not represented by securities. Member States may exclude from the scheme small bars or wafers of a weight of 1 g or less; (ii) gold coins which: - are of a purity equal to or greater than 900 thousandths, - are minted after 1800, - are or have been legal tender in the country of origin, and - are normally sold at a price which does not exceed the open market value of the gold contained in the coins by more than 80 %. Such coins are not, for the purpose of this Directive, considered to be sold for numismatic interest. Each Member State shall inform the Commission before 1 July each year, starting in 1999, of the coins meeting these criteria which are traded in that Member State. The Commission shall publish a comprehensive list of these coins in the "C" series of the Official Journal of the European Communities before 1 December each year. Coins included in the published list shall be deemed to fulfil these criteria for the whole year for which the list is published. B. Special arrangements applicable to investment gold transactions Member States shall exempt from value added tax the supply, intra-Community acquisition and importation of investment gold, including investment gold represented by certificates for allocated or unallocated gold or traded on gold accounts and including, in particular, gold loans and swaps, involving a right of ownership or claim in respect of investment gold, as well as transactions concerning investment gold involving futures and forward contracts leading to a transfer of right of ownership or claim in respect of investment gold. Member States shall also exempt services of agents who act in the name and for the account of another when they intervene in the supply of investment gold for their principal. C. Option to tax Member States shall allow taxable persons who produce investment gold or transform any gold into investment gold as defined in A a right of option for taxation of supplies of investment gold to another taxable person which would otherwise be exempt under B. Member States may allow taxable persons, who in their trade normally supply gold for industrial purposes, a right of option for taxation of supplies of investment gold as defined in A(i) to another taxable person, which would otherwise be exempt under B. Member States may restrict the scope of this option. Where the supplier has exercised a right of option for taxation pursuant to the first or second paragraph, Member States shall allow a right of option for taxation for the agent in respect of the services mentioned in the second paragraph of B. Member States shall specify the details of the use of these options, and shall inform the Commission of the rules of application for the exercise of these options in that Member State. D. Right of deduction 1. Taxable persons shall be entitled to deduct (a) tax due or paid in respect of investment gold supplied to them by a person who has exercised the right of option under C or supplied to them pursuant to the procedure laid down in G; (b) tax due or paid in respect of supply to them, or intra-Community acquisition or importation by them, of gold other than investment gold which is subsequently transformed by them or on their behalf into investment gold; (c) tax due or paid in respect of services supplied to them consisting of change of form, weight or purity of gold including investment gold, if their subsequent supply of this gold is exempt under this Article. 2. Taxable persons who produce investment gold or transform any gold into investment gold, shall be entitled to deduct tax due or paid by them in respect of supplies, or intra-Community acquisition or importation of goods or services linked to the production or transformation of that gold as if their subsequent supply of the gold exempted under this Article were taxable. E. Special obligations for traders in investment gold Member States shall, as a minimum, ensure that traders in investment gold keep account of all substantial transactions in investment gold and keep the documentation to allow identification of the customer in such transactions. Traders shall keep this information for a period of at least five years. Member States may accept equivalent obligations under measures adopted pursuant to other Community legislation, such as Council Directive 91/308/EEC of 10 June 1991 on prevention of the use of the financial system for the purpose of money laundering (*), to meet the requirements of the first paragraph. Member States may lay down stricter obligations, in particular on special record keeping or special accounting requirements. F. Reverse charge procedure By way of derogation from Article 21(1)(a), as amended by Article 28g, in the case of supplies of gold material or semi-manufactured products of a purity of 325 thousandths or greater, or supplies of investment gold where an option referred to in C of this Article has been exercised, Member States may designate the purchaser as the person liable to pay the tax, according to the procedures and conditions which they shall lay down. When they exercise this option, Member States shall take the measures necessary to ensure that the person designated as liable for the tax due fulfils the obligations to submit a statement and to pay the tax in accordance with Article 22. G. Procedure for transactions on a regulated gold bullion market 1. A Member State may, subject to consultation provided for under Article 29, disapply the exemption for investment gold provided for by this special scheme in respect of specific transactions, other than intra-Community supplies or exports, concerning investment gold taking place in that Member State: (a) between taxable persons who are members of a bullion market regulated by the Member State concerned, and (b) where the transaction is between a member of a bullion market regulated by the Member State concerned and another taxable person who is not a member of that market. Under these circumstances, these transactions shall be taxable and the following shall apply. 2.(a) For transactions under 1(a), for the purpose of simplification, the Member State shall authorise suspension of the tax to be collected as well as dispense with the recording requirements of value added tax. (b) For transactions under 1(b), the reverse charge procedure under F shall be applicable. Where a non-member of the bullion market would not, other than for these transactions, be liable for registration for VAT in the relevant Member State, the member shall fulfil the fiscal obligations on behalf of the non-member, according to the provisions of that Member State. (*) OJ L 166, 28.6.1991, p. 77.` Article 2 Article 12(3)(e) and point 26 of Annex F to Directive 77/388/EEC shall be deleted. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 January 2000. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the provisions of domestic law which they adopt in the field governed 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.

31998L0071

1998

DIRECTIVE 98/71/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 October 1998 on the legal protection of designs Having regard to the Treaty establishing the European Community and in particular Article 100a thereof, Having regard to the proposal by 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 189b of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 29 July 1998, (1) Whereas the objectives of the Community, as laid down in the Treaty, include laying the foundations of an ever closer union among the peoples of Europe, fostering closer relations between Member States of the Community, and ensuring the economic and social progress of the Community countries by common action to eliminate the barriers which divide Europe; whereas to that end the Treaty provides for the establishment of an internal market characterised by the abolition of obstacles to the free movement of goods and also for the institution of a system ensuring that competition in the internal market is not distorted; whereas an approximation of the laws of the Member States on the legal protection of designs would further those objectives; (2) Whereas the differences in the legal protection of designs offered by the legislation of the Member States directly affect the establishment and functioning of the internal market as regards goods embodying designs; whereas such differences can distort competition within the internal market; (3) Whereas it is therefore necessary for the smooth functioning of the internal market to approximate the design protection laws of the Member States; (4) Whereas, in doing so, it is important to take into consideration the solutions and the advantages with which the Community design system will provide undertakings wishing to acquire design rights; (5) Whereas it is unnecessary to undertake a full-scale approximation of the design laws of the Member States, and it will be sufficient if approximation is limited to those national provisions of law which most directly affect the functioning of the internal market; whereas provisions on sanctions, remedies and enforcement should be left to national law; whereas the objectives of this limited approximation cannot be sufficiently achieved by the Member States acting alone; (6) Whereas Member States should accordingly remain free to fix the procedural provisions concerning registration, renewal and invalidation of design rights and provisions concerning the effects of such invalidity; (7) Whereas this Directive does not exclude the application to designs of national or Community legislation providing for protection other than that conferred by registration or publication as design, such as legislation relating to unregistered design rights, trade marks, patents and utility models, unfair competition or civil liability; (8) Whereas, in the absence of harmonisation of copyright law, it is important to establish the principle of cumulation of protection under specific registered design protection law and under copyright law, whilst leaving Member States free to establish the extent of copyright protection and the conditions under which such protection is conferred; (9) Whereas the attainment of the objectives of the internal market requires that the conditions for obtaining a registered design right be identical in all the Member States; whereas to that end it is necessary to give a unitary definition of the notion of design and of the requirements as to novelty and individual character with which registered design rights must comply; (10) Whereas it is essential, in order to facilitate the free movement of goods, to ensure in principle that registered design rights confer upon the right holder equivalent protection in all Member States; (11) Whereas protection is conferred by way of registration upon the right holder for those design features of a product, in whole or in part, which are shown visibly in an application and made available to the public by way of publication or consultation of the relevant file; (12) Whereas protection should not be extended to those component parts which are not visible during normal use of a product, or to those features of such part which are not visible when the part is mounted, or which would not, in themselves, fulfil the requirements as to novelty and individual character; whereas features of design which are excluded from protection for these reasons should not be taken into consideration for the purpose of assessing whether other features of the design fulfil the requirements for protection; (13) Whereas the assessment as to whether a design has individual character should be based on whether the overall impression produced on an informed user viewing the design clearly differs from that produced on him by the existing design corpus, taking into consideration the nature of the product to which the design is applied or in which it is incorporated, and in particular the industrial sector to which it belongs and the degree of freedom of the designer in developing the design; (14) Whereas technological innovation should not be hampered by granting design protection to features dictated solely by a technical function; whereas it is understood that this does not entail that a design must have an aesthetic quality; whereas, likewise, the interoperability of products of different makes should not be hindered by extending protection to the design of mechanical fittings; whereas features of a design which are excluded from protection for these reasons should not be taken into consideration for the purpose of assessing whether other features of the design fulfil the requirements for protection; (15) Whereas the mechanical fittings of modular products may nevertheless constitute an important element of the innovative characteristics of modular products and present a major marketing asset and therefore should be eligible for protection; (16) Whereas a design right shall not subsist in a design which is contrary to public policy or to accepted principles of morality; whereas this Directive does not constitute a harmonisation of national concepts of public policy or accepted principles of morality; (17) Whereas it is fundamental for the smooth functioning of the internal market to unify the term of protection afforded by registered design rights; (18) Whereas the provisions of this Directive are without prejudice to the application of the competition rules under Articles 85 and 86 of the Treaty; (19) Whereas the rapid adoption of this Directive has become a matter of urgency for a number of industrial sectors; whereas full-scale approximation of the laws of the Member States on the use of protected designs for the purpose of permitting the repair of a complex product so as to restore its original appearance, where the product incorporating the design or to which the design is applied constitutes a component part of a complex product upon whose appearance the protected design is dependent, cannot be introduced at the present stage; whereas the lack of full-scale approximation of the laws of the Member States on the use of protected designs for such repair of a complex product should not constitute an obstacle to the approximation of those other national provisions of design law which most directly affect the functioning of the internal market; whereas for this reason Member States should in the meantime maintain in force any provisions in conformity with the Treaty relating to the use of the design of a component part used for the purpose of the repair of a complex product so as to restore its original appearance, or, if they introduce any new provisions relating to such use, the purpose of these provisions should be only to liberalise the market in such parts; whereas those Member States which, on the date of entry into force of this Directive, do not provide for protection for designs of component parts are not required to introduce registration of designs for such parts; whereas three years after the implementation date the Commission should submit an analysis of the consequences of the provisions of this Directive for Community industry, for consumers, for competition and for the functioning of the internal market; whereas, in respect of component parts of complex products, the analysis should, in particular, consider harmonisation on the basis of possible options, including a remuneration system and a limited term of exclusivity; whereas, at the latest one year after the submission of its analysis, the Commission should, after consultation with the parties most affected, propose to the European Parliament and the Council any changes to this Directive needed to complete the internal market in respect of component parts of complex products, and any other changes which it considers necessary; (20) Whereas the transitional provision in Article 14 concerning the design of a component part used for the purpose of the repair of a complex product so as to restore its original appearance is in no case to be construed as constituting an obstacle to the free movement of a product which constitutes such a component part; (21) Whereas the substantive grounds for refusal of registration in those Member States which provide for substantive examination of applications prior to registration, and the substantive grounds for the invalidation of registered design rights in all the Member States, must be exhaustively enumerated, Article 1 Definitions For the purpose of this Directive: (a) ‘design’ means the appearance of the whole or a part of a product resulting from the features of, in particular, the lines, contours, colours, shape, texture and/or materials of the product itself and/or its ornamentation; (b) ‘product’ means any industrial or handicraft item, including inter alia parts intended to be assembled into a complex product, packaging, get-up, graphic symbols and typographic typefaces, but excluding computer programs; (c) ‘complex product’ means a product which is composed of multiple components which can be replaced permitting disassembly and reassembly of the product. Article 2 Scope of application 1. This Directive shall apply to: (a) design rights registered with the central industrial property offices of the Member States; (b) design rights registered at the Benelux Design Office; (c) design rights registered under international arrangements which have effect in a Member State; (d) applications for design rights referred to under (a), (b) and (c). 2. For the purpose of this Directive, design registration shall also comprise the publication following filing of the design with the industrial property office of a Member State in which such publication has the effect of bringing a design right into existence. Article 3 Protection requirements 1. Member States shall protect designs by registration, and shall confer exclusive rights upon their holders in accordance with the provisions of this Directive. 2. A design shall be protected by a design right to the extent that it is new and has individual character. 3. A design applied to or incorporated in a product which constitutes a component part of a complex product shall only be considered to be new and to have individual character: (a) if the component part, once it has been incorporated into the complex product, remains visible during normal use of the latter, and (b) to the extent that those visible features of the component part fulfil in themselves the requirements as to novelty and individual character. 4. ‘Normal use’ within the meaning of paragraph (3)(a) shall mean use by the end user, excluding maintenance, servicing or repair work. Article 4 Novelty A design shall be considered new if no identical design has been made available to the public before the date of filing of the application for registration or, if priority is claimed, the date of priority. Designs shall be deemed to be identical if their features differ only in immaterial details. Article 5 Individual character 1. A design shall be considered to have individual character if the overall impression it produces on the informed user differs from the overall impression produced on such a user by any design which has been made available to the public before the date of filing of the application for registration or, if priority is claimed, the date of priority. 2. In assessing individual character, the degree of freedom of the designer in developing the design shall be taken into consideration. Article 6 Disclosure 1. For the purpose of applying Articles 4 and 5, a design shall be deemed to have been made available to the public if it has been published following registration or otherwise, or exhibited, used in trade or otherwise disclosed, except where these events could not reasonably have become known in the normal course of business to the circles specialised in the sector concerned, operating within the Community, before the date of filing of the application for registration or, if priority is claimed, the date of priority. The design shall not, however, be deemed to have been made available to the public for the sole reason that it has been disclosed to a third person under explicit or implicit conditions of confidentiality. 2. A disclosure shall not be taken into consideration for the purpose of applying Articles 4 and 5 if a design for which protection is claimed under a registered design right of a Member State has been made available to the public: (a) by the designer, his successor in title, or a third person as a result of information provided or action taken by the designer, or his successor in title; and (b) during the 12-month period preceding the date of filing of the application or, if priority is claimed, the date of priority. 3. Paragraph 2 shall also apply if the design has been made available to the public as a consequence of an abuse in relation to the designer or his successor in title. Article 7 Designs dictated by their technical function and designs of interconnections 1. A design right shall not subsist in features of appearance of a product which are solely dictated by its technical function. 2. A design right shall not subsist in features of appearance of a product which must necessarily be reproduced in their exact form and dimensions in order to permit the product in which the design is incorporated or to which it is applied to be mechanically connected to or placed in, around or against another product so that either product may perform its function. 3. Notwithstanding paragraph 2, a design right shall, under the conditions set out in Articles 4 and 5, subsist in a design serving the purpose of allowing multiple assembly or connection of mutually interchangeable products within a modular system. Article 8 Designs contrary to public policy or morality A design right shall not subsist in a design which is contrary to public policy or to accepted principles of morality. Article 9 Scope of protection 1. The scope of the protection conferred by a design right shall include any design which does not produce on the informed user a different overall impression. 2. In assessing the scope of protection, the degree of freedom of the designer in developing his design shall be taken into consideration. Article 10 Term of protection Upon registration, a design which meets the requirements of Article 3(2) shall be protected by a design right for one or more periods of five years from the date of filing of the application. The right holder may have the term of protection renewed for one or more periods of five years each, up to a total term of 25 years from the date of filing. Article 11 Invalidity or refusal of registration 1. A design shall be refused registration, or, if the design has been registered, the design right shall be declared invalid: (a) if the design is not a design within the meaning of Article l(a); or (b) if it does not fulfil the requirements of Articles 3 to 8; or (c) if the applicant for or the holder of the design right is not entitled to it under the law of the Member State concerned; or (d) if the design is in conflict with a prior design which has been made available to the public after the date of filing of the application or, if priority is claimed, the date of priority, and which is protected from a date prior to the said date by a registered Community design or an application for a registered Community design or by a design right of the Member State concerned, or by an application for such a right. 2. Any Member State may provide that a design shall be refused registration, or, if the design has been registered, that the design right shall be declared invalid: (a) if a distinctive sign is used in a subsequent design, and Community law or the law of the Member State concerned governing that sign confers on the right holder of the sign the right to prohibit such use; or (b) if the design constitutes an unauthorised use of a work protected under the copyright law of the Member State concerned; or (c) if the design constitutes an improper use of any of the items listed in Article 6b of the Paris Convention for the Protection of Industrial Property, or of badges, emblems and escutcheons other than those covered by Article 6b of the said Convention which are of particular public interest in the Member State concerned. 3. The ground provided for in paragraph 1(c) may be invoked solely by the person who is entitled to the design right under the law of the Member State concerned. 4. The grounds provided for in paragraph 1(d) and in paragraph 2(a) and (b) may be invoked solely by the applicant for or the holder of the conflicting right. 5. The ground provided for in paragraph 2(c) may be invoked solely by the person or entity concerned by the use. 6. Paragraphs 4 and 5 shall be without prejudice to the freedom of Member States to provide that the grounds provided for in paragraphs 1(d) and 2(c) may also be invoked by the appropriate authority of the Member State in question on its own initiative. 7. When a design has been refused registration or a design right has been declared invalid pursuant to paragraph 1(b) or to paragraph 2, the design may be registered or the design right maintained in an amended form, if in that form it complies with the requirements for protection and the identity of the design is retained. Registration or maintenance in an amended form may include registration accompanied by a partial disclaimer by the holder of the design right or entry in the design Register of a court decision declaring the partial invalidity of the design right. 8. Any Member State may provide that, by way of derogation from paragraphs 1 to 7, the grounds for refusal of registration or for invalidation in force in that State prior to the date on which the provisions necessary to comply with this Directive enter into force shall apply to design applications which have been made prior to that date and to resulting registrations. 9. A design right may be declared invalid even after it has lapsed or has been surrendered. Article 12 Rights conferred by the design right 1. The registration of a design shall confer on its holder the exclusive right to use it and to prevent any third party not having his consent from using it. The aforementioned use shall cover, in particular, the making, offering, putting on the market, importing, exporting or using of a product in which the design is incorporated or to which it is applied, or stocking such a product for those purposes. 2. Where, under the law of a Member State, acts referred to in paragraph 1 could not be prevented before the date on which the provisions necessary to comply with this Directive entered into force, the rights conferred by the design right may not be invoked to prevent continuation of such acts by any person who had begun such acts prior to that date. Article 13 Limitation of the rights conferred by the design right 1. The rights conferred by a design right upon registration shall not be exercised in respect of: (a) acts done privately and for non-commercial purposes; (b) acts done for experimental purposes; (c) acts of reproduction for the purposes of making citations or of teaching, provided that such acts are compatible with fair trade practice and do not unduly prejudice the normal exploitation of the design, and that mention is made of the source. 2. In addition, the rights conferred by a design right upon registration shall not be exercised in respect of: (a) the equipment on ships and aircraft registered in another country when these temporarily enter the territory of the Member State concerned; (b) the importation in the Member State concerned of spare parts and accessories for the purpose of repairing such craft; (c) the execution of repairs on such craft. Article 14 Transitional provision Until such time as amendments to this Directive are adopted on a proposal from the Commission in accordance with the provisions of Article 18, Member States shall maintain in force their existing legal provisions relating to the use of the design of a component part used for the purpose of the repair of a complex product so as to restore its original appearance and shall introduce changes to those provisions only if the purpose is to liberalise the market for such parts. Article 15 Exhaustion of rights The rights conferred by a design right upon registration shall not extend to acts relating to a product in which a design included within the scope of protection of the design right is incorporated or to which it is applied, when the product has been put on the market in the Community by the holder of the design right or with his consent. Article 16 Relationship to other forms of protection The provisions of this Directive shall be without prejudice to any provisions of Community law or of the law of the Member State concerned relating to unregistered design rights, trade marks or other distinctive signs, patents and utility models, typefaces, civil liability or unfair competition. Article 17 Relationship to copyright A design protected by a design right registered in or in respect of a Member State in accordance with this Directive shall also be eligible for protection under the law of copyright of that State as from the date on which the design was created or fixed in any form. The extent to which, and the conditions under which, such a protection is conferred, including the level of originality required, shall be determined by each Member State. Article 18 Revision Three years after the implementation date specified in Article 19, the Commission shall submit an analysis of the consequences of the provisions of this Directive for Community industry, in particular the industrial sectors which are most affected, particularly manufacturers of complex products and component parts, for consumers, for competition and for the functioning of the internal market. At the latest one year later the Commission shall propose to the European Parliament and the Council any changes to this Directive needed to complete the internal market in respect of component parts of complex products and any other changes which it considers necessary in light of its consultations with the parties most affected. Article 19 Implementation 1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 28 October 2001. 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 provisions of national law which they adopt in the field governed by this Directive. Article 20 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 21 Addressees This Directive is addressed to the Member States.

31998L0070

1998

Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC Having regard to the Treaty establishing the European Community, and in particular Article 100a 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 189b of the Treaty (3) in the light of the joint text approved on 29 June 1998 by the Conciliation Committee, (1) Whereas disparity between the laws or administrative measures adopted by the Member States on specifications of conventional and alternative fuels used by vehicles equipped with positive-ignition and compression-ignition engines creates barriers to trade in the Community and may thereby directly affect the establishment and functioning of the internal market and the international competitiveness of the European vehicle and refining industries; whereas in accordance with the provisions of Article 3b of the Treaty, it therefore appears necessary to approximate the laws in this field; (2) Whereas Article 100a(3) of the Treaty envisages that Commission proposals aimed at the establishment and functioning of the internal market and concerning, inter alia, health and environmental protection will take as a base a high level of protection; (3) Whereas primary air pollutants such as nitrogen oxides, unburnt hydrocarbons, particulate matter, carbon monoxide, benzenes and other toxic exhaust emissions which contribute to the formation of secondary pollutants such as ozone are emitted in significant amounts through the exhaust and evaporative fumes of motor vehicles thereby posing directly and indirectly a considerable risk to human health and the environment; (4) Whereas despite the increasing stringency of vehicle emission limit values laid down by Council Directive 70/220/EEC (4), and by Council Directive 88/77/EEC (5), further measures to reduce atmospheric pollution caused by vehicles and other sources are necessary in order to achieve satisfactory air quality; (5) Whereas Article 4 of Directive 94/12/EC of the European Parliament and of the Council (6) introduced a new approach with regard to emission reduction policies for and beyond the year 2000 and required the Commission to examine, inter alia, the contribution that improvements in the quality of petrol and diesel and other fuels could make to reducing air pollution; (6) Whereas, in addition to an initial stage of fuel specifications beginning in the year 2000, provision must be made for a second stage, to come into effect in 2005, to enable the industry to make the necessary investments to adapt its production plans; (7) Whereas petrol and diesel fuel complying with the specifications set out in Annexes I, II, III and IV are already available on the market in the European Community; (8) Whereas the European auto/oil programme, the details of which are outlined in the Commission's communication on a future strategy for the control of atmospheric emissions from road transport, contributes towards a scientific, technical and economic basis for recommending the introduction at Community level of new environmental fuel specifications for petrol and diesel fuels; (9) Whereas the introduction of environmental fuels specifications for petrol and diesel fuels is an important element of the cost-effective package of Europe-wide and national/regional/local measures that should be put into effect, taking into account the costs and benefits of any action; (10) Whereas the implementation of a combination of Europe-wide and national/regional/local measures to reduce vehicle emissions is part of the Commission's overall strategy to reduce air emissions from mobile and stationary sources in a way that is balanced and meets cost-benefit criteria; (11) Whereas it is necessary to obtain in the short term a reduction, in particular in urban areas, of polluting vehicle emissions, including primary pollutants such as unburnt hydrocarbons and carbon monoxide, secondary pollutants such as ozone, toxic emissions such as benzene and particle emissions; whereas the reduction of polluting vehicle emissions in urban areas can be immediately achieved on motor vehicles through changes in fuel composition; (12) Whereas the incorporation of oxygen and the significant reduction in aromatics, olefins, benzene and sulphur can permit better fuel quality to be obtained from an air quality standpoint; (13) Whereas the provisions of Council Directive 92/81/EEC of 19 October 1992 on the harmonisation of the structures of excise duties on mineral oils (7), and in particular Article 8(4) thereof, discourage and may prevent Member States from operating excise tax differentiation designed to accelerate fuel quality above Community-wide fuel specifications; (14) Whereas the use by Member States of differentiated excise taxation can encourage the introduction of more advanced fuels in line with national priorities, capacity and requirements; (15) Whereas the Commission has brought forward a proposal for an Energy Products Directive; whereas this proposal has the objective of, inter alia, permitting Member States to make more active use of fiscal incentives through differentiated excise taxation, so as to facilitate the introduction of more advanced fuels; (16) Whereas fuel specifications aiming at the reduction of both exhaust and evaporative emissions are generally lacking; (17) Whereas atmospheric pollution by lead arising from the combustion of leaded petrol constitutes a risk for human health and the environment; whereas it is a great step forward that by 2000 virtually all petrol-driven road vehicles will be able to run on unleaded petrol and whereas therefore it is appropriate to restrict severely the marketing of leaded petrol; (18) Whereas the need for vehicle emission reduction and the availability of the necessary refinery technology justify the setting of environmental fuel specifications for the marketing of unleaded petrol and diesel fuels; (19) Whereas it seems appropriate to provide for the availability of two types of diesel and petrol fuel, one of which would be a higher-quality diesel and one of which would be a higher quality petrol; whereas it is appropriate for this higher quality diesel or petrol to replace diesel or petrol of lower quality on the market by 2005; whereas, however, appropriate provision should be made for such replacement to be delayed when application of the date of 2005 in a Member State would cause severe difficulties for its industries in making the necessary changes in its manufacturing facilities; (20) Whereas, in order to protect human health and/or the environment in specific agglomerations or in specific ecologically sensitive areas with special problems of air quality, Member States should be permitted, subject to a procedure established in this Directive, to require that fuels may be marketed only if they comply with more stringent environmental specifications than established under this Directive; whereas this procedure is a derogation from the information procedure laid down in Directive 98/34/EC of 22 June 1998 of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services (8); (21) Whereas, in order to ensure compliance with the fuel quality standards required under this Directive, Member States should introduce monitoring systems; whereas such monitoring systems should be based on common procedures for sampling and testing and whereas information on fuel quality collected by Member States should be communicated to the Commission according to a common format; (22) Whereas, on the basis of a comprehensive assessment, the Commission is to submit a proposal complementing the mandatory specifications for petrol and diesel fuels referred to in Annexes III and IV to be applied as from 1 January 2005; whereas the Commission's proposal may, as appropriate, also set down environmental specifications for other types of fuel such as liquid petroleum gas, natural gas and biofuels; whereas captive vehicle fleets exist (buses, taxis, commercial vehicles, etc.) which are responsible for a large proportion of urban pollution and would benefit from separate specifications; (23) Whereas further developments with regard to reference methods for measuring the specifications set out in this Directive may be desirable in the light of scientific and technical progress; whereas to this end, provisions should be made in order to adapt the Annexes to this Directive to technical progress; (24) Whereas Council Directive 85/210/EEC of 20 March 1985 on the approximation of the laws of the Member States concerning the lead content of petrol (9), Council Directive 85/536/EEC of 5 December 1985 relating to crude-oil savings through the use of substitute fuel components in petrol (10), and Article 1(1)(b) and Article 2(1) of Council Directive 93/12/EEC of 23 March 1993 relating to the sulphur content of certain liquid fuels (11), should be repealed accordingly; (25) Whereas the transitional measures for Austria referred to in Article 69 of the 1994 Act of Accession include Article 7 of Directive 85/210/EEC; whereas the application of this transitional measure should, for specific reasons of the protection of the environment, be prolonged until 1 January 2000; (26) Whereas a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty (12) was concluded on 20 December 1994, Article 1 Scope This Directive sets technical specifications on health and environmental grounds for fuels to be used for vehicles equipped with positive-ignition and compression-ignition engines. Article 2 Definitions For the purpose of this Directive: 1. 'petrol` means any volatile mineral oil intended for the operation of internal combustion positive-ignition engines for the propulsion of vehicles and falling within CN codes 2710 00 27, 2710 00 29, 2710 00 32, 2710 00 34 and 2710 00 36; 2. 'diesel fuels` means gas oils falling within CN codes 2710 00 66 and used for self-propelling vehicles as referred to in Directive 70/220/EEC and Directive 88/77/EEC. For gas oils used for engines in non-road mobile machinery and agricultural tractors Member States may require the same sulphur content as defined for diesel fuels in this Directive or the sulphur content as defined for diesel fuels in Directive 93/12/EEC. Article 3 Petrol 1. No later than 1 January 2000, Member States shall prohibit the marketing of leaded petrol within their territory. 2. (a) Member States shall ensure that, no later than 1 January 2000, unleaded petrol can be marketed within their territory only if it complies with the environmental specifications set out in Annex I. (b) Without prejudice to the provisions of subparagraph (a), Member States shall, from 1 January 2000, permit the marketing within their territory of unleaded petrol complying with the specifications of Annex III. (c) Member States shall also ensure that, no later than 1 January 2005, unleaded petrol can be marketed within their territory only if it complies with the environmental specifications set out in Annex III. 3. By way of derogation from paragraph 1, a Member State may be allowed, on a request to be submitted to the Commission no later than 31 August 1999, to continue to permit the marketing of leaded petrol, until at the latest 1 January 2005, if it can demonstrate that the introduction of a ban would result in severe socioeconomic problems or would not lead to overall environmental or health benefits because of, inter alia, the climatic situation in that Member State. The lead content of leaded petrol shall not exceed 0,15 g/l and the benzene content shall comply with the specifications in Annex I. The other values of the specifications may remain unchanged compared to the present situation. 4. Notwithstanding the provisions of paragraph 2, a Member State may be authorised, on a request to be submitted to the Commission no later than 31 August 1999, to continue to permit the marketing within its territory, until at the latest 1 January 2003, of unleaded petrol with a sulphur content which does not comply with the specification for sulphur content in Annex I but which does not exceed the current content, if it can demonstrate that severe difficulties would ensue for its industries in making the necessary changes in their manufacturing facilities during the period of time between the date of adoption of this Directive and 1 January 2000. 5. Notwithstanding the provisions of paragraph 2, a Member State may be authorised, on a request to be submitted to the Commission no later than 31 August 2003, to continue to permit the marketing within its territory, until at the latest 1 January 2007, of unleaded petrol with a sulphur content which does not comply with Annex III but which does comply with Annex I, if it can demonstrate that severe difficulties would ensue for its industries in making the necessary changes in their manufacturing facilities during the period of time between the date of adoption of this Directive and 1 January 2005. 6. The Commission may authorise the derogations referred to in paragraphs 3, 4 and 5 in accordance with the Treaty. The Commission shall notify the Member States and inform the European Parliament and the Council of its decision. 7. Notwithstanding paragraph 1, Member States may continue to permit the marketing of small quantities of leaded petrol with the specifications mentioned in the second subparagraph of paragraph 3 to a maximum of 0,5 % of total sales to be used by old vehicles of a characteristic nature and to be distributed through special interest groups. Article 4 Diesel fuel 1. (a) Member States shall ensure that, no later than 1 January 2000, diesel fuel can be marketed within their territory only if it complies with the environmental specifications set out in Annex II. (b) Without prejudice to the provisions of subparagraph (a), Member States shall, from 1 January 2000, permit the marketing within their territory of diesel fuel complying with the specifications of Annex IV. (c) Member States shall also ensure that, no later than 1 January 2005, diesel fuel can be marketed within their territory only if it complies with the environmental specifications set out in Annex IV. 2. Notwithstanding the provisions of paragraph 1, a Member State may be authorised, on a request to be submitted to the Commission no later than 31 August 1999, to continue to permit the marketing within its territory, until at the latest 1 January 2003, of diesel fuel with a sulphur content which does not comply with the specification for sulphur content in Annex II but which does not exceed the current content, if it can demonstrate that severe difficulties would ensue for its industries in making the necessary changes in their manufacturing facilities during the period of time between the date of adoption of this Directive and 1 January 2000. 3. Notwithstanding the provisions of paragraph 1, a Member State may be authorised, on a request to be submitted to the Commission no later than 31 August 2003, to continue to permit the marketing within its territory, until at the latest 1 January 2007, of diesel fuel with a sulphur content which does not comply with Annex IV but which does comply with Annex II, if it can demonstrate that severe difficulties would ensue for its industries in making the necessary changes in their manufacturing facilities during the period of time between the date of adoption of this Directive and 1 January 2005. 4. The Commission may authorise the derogations referred to in paragraphs 2 and 3 in accordance with the Treaty. The Commission shall notify the Member States and inform the Council and the European Parliament of its decision. Article 5 Free circulation No Member State may prohibit, restrict or prevent the placing on the market of fuels which comply with the requirements of this Directive. Article 6 Marketing of fuels with more stringent environmental specifications 1. By way of derogation from Articles 3, 4 and 5, Member States may require that in specific areas fuels may only be marketed if they comply with more stringent environmental specifications than those provided for in this Directive for all or part of the vehicle fleet with a view to protecting the health of the population in a specific agglomeration or the environment in a specific ecologically sensitive area in a Member State, if atmospheric pollution constitutes or may reasonably be expected to constitute a serious and recurrent problem for human health or the environment. 2. A Member State wishing to make use of a derogation provided for in paragraph 1 shall submit its request in advance, including the justification for it, to the Commission. The justification shall include evidence that the derogation respects the principle of proportionality and that it will not disrupt the free movements of persons and goods. 3. The Member States involved shall provide the Commission with data on ambient air quality for the area in question a well as the predicted effects on air quality of the measures proposed. 4. The Commission shall provide this information to the other Member States without delay. 5. Member States may give their comments on the request and its justification within two months of the date of the Commission's provision of information. 6. The Commission shall take a decision on the request of Member States within three months after the date on which Member States have submitted their comments. The Commission will take Member States' comments into account and will notify them of its decision and inform the European Parliament and the Council at the same time. 7. Any Member State may refer the Commission's decision to the Council within one month of its notification or, in the case of a non-decision, refer the matter to the Council within one month of the expiry of the period referred to in paragraph 6. 8. The Council, acting by a qualified majority, may take a different decision within two months of the matter being referred to it. Article 7 Change in supply of crude oils If, as a result of exceptional events, a sudden change in the supply of crude oils or petroleum products renders it difficult for the refineries in a Member State to respect the fuel specification requirements of Articles 3 and 4, that Member State shall inform the Commission thereof. The Commission, after informing the other Member States, may authorise higher limit values in that Member State for one or more fuel components for a period not exceeding six months. The Commission shall notify the Member States and inform the European Parliament and the Council of its decision. Any Member State may refer the Commission's decision to the Council within one month of its notification. The Council, acting by a qualified majority, may take a different decision within one month of the matter being referred to it. Article 8 Monitoring compliance and reporting 1. Member States shall monitor compliance with the requirements of Articles 3 and 4 on the basis of the analytical methods set out in Annex I and II. 2. The Commission will promote the development of a uniform system for fuel quality monitoring. The Commission may for the purpose of developing such a system request the assistance of the European Committee for Standardisation. 3. The Commission shall establish a common format for the submission of a summary of national fuel quality data no later than 30 June 2000. 4. Each year by 30 June Member States shall submit their summary for the preceding calendar year to the Commission for the first time by 30 June 2002. Article 9 Review process 1. The Commission shall, periodically and for the first time not later than 12 months from the date of adoption of this Directive but in any event not later than 31 December 1999, and in the light of the assessment carried out in accordance with the requirements of Article 3 of 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 (13), submit to the European Parliament and the Council a proposal for a revision of this Directive as an integral part of the strategy designed to produce effects to meet the requirements of the Community air quality standards and related objectives. 2. The proposal shall contain environmental specifications complementing the mandatory specifications stipulated in Annex III for petrol and Annex IV for diesel fuels on the basis, inter alia, of accumulated knowledge concerning requirements on emission reductions related to air quality, the effective functioning of new pollution abatement technologies and developments affecting international fuel markets. 3. In addition to the provisions of paragraphs 1 and 2, the Commission may, inter alia, bring forward - proposals taking into consideration the particular situation of captive fleets and the need to propose levels of specifications for the special fuels they use, - proposals setting levels of specifications applicable to liquid petroleum gas, natural gas and biofuels. Article 10 Procedure for adaptation to technical progress Any amendments which are necessary in order to adapt the measuring methods as laid down in the right hand section ('tests`) of Annexes I, II, III and IV to this Directive, to take account of technical progress, shall be adopted by the Commission assisted by the Committee established in accordance with Article 12 of Directive 96/62/EC (14) and in accordance with the procedure laid down in Article 11 of this Directive. Such adaptation must not result in any direct or indirect modification of the limit values laid down in this Directive or to any change in the dates from which they apply. Article 11 Committee procedure 1. The representative of the Commission shall submit to the committee referred to in Article 10 a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 2. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 12 Repeal and amendment of the Directives related to the fuel quality of petrol and diesel fuels 1. Directives 85/210/EEC, 85/536/EEC and 87/441/EEC are repealed as from 1 January 2000. 2. Directive 93/12/EEC is amended by deleting Article 1(1)(b) and Article 2(1) as from 1 January 2000. Article 13 Transposition into national legislation 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1999. They shall immediately inform the Commission thereof. Member States shall apply these measures from 1 January 2000. 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 domestic law which they adopt in the field covered by this Directive. Article 14 Austria Article 7 of Directive 85/210/EEC, as far as the benzene content of petrol referred to in Article 4 of that Directive is concerned, shall, until 1 January 2000, not apply to Austria. Article 15 Entry into force of the Directive 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.

31998L0069

1998

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 Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposals from the Commission (1), Having regard to the Opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189 b of the Treaty (3), in the light of the joint text approved on 29 June 1998 by the Conciliation Committee, (1) Whereas measures should be adopted within the framework of the internal market; (2) Whereas the first programme of action of the European Community on protection of the environment (4), approved by the Council on 22 November 1973, called for account to be taken of the latest scientific advances in combating atmospheric pollution caused by gases emitted from motor vehicles and for Directives adopted previously to be amended accordingly; whereas the fifth programme of action, which in its general approach was approved by the Council in its Resolution of 1 February 1993 (5), provided for additional efforts to be made for a considerable reduction in the present level of emissions of pollutants from motor vehicles; whereas this fifth programme also set targets in terms of emission reductions for various pollutants on the understanding that emissions from both mobile and stationary sources would have to be reduced; (3) Whereas Council Directive 70/220/EEC (6) lays down the limit values for carbon monoxide and unburnt hydrocarbon emissions from the engines of such vehicles; whereas these limit values were first reduced by Council Directive 74/290/EEC (7) and supplemented, in accordance with Commission Directive 77/102/EEC (8), by limit values for permissible emissions of nitrogen oxides; whereas the limit values for these three types of pollution were successively reduced by Commission Directive 78/665/EEC (9) and Council Directives 83/351/EEC (10) and 88/76/EEC (11); whereas limit values for particulate pollutant emissions from diesel engines were introduced by Council Directive 88/436/EEC (12); whereas more stringent European standards for the emissions of gaseous pollutants from motor vehicles below 1 400 cm (13) were introduced by Council Directive 89/458/EEC (14); whereas these standards have been extended to all passenger cars independently of their engine capacity on the basis of an improved European test procedure comprising an extra-urban driving cycle; whereas requirements relating to evaporative emissions and to the durability of emission-related vehicle components as well as more stringent particulate pollutant standards for motor vehicles equipped with diesel engines were introduced by Council Directive 91/441/EEC (15); whereas Directive 94/12/EC of the European Parliament and of the Council (13) introduced more stringent limit values for all pollutants and a new method for checking on the conformity of production; whereas passenger cars designed to carry more than six occupants and having a maximum mass of more than 2 500 kg, light commercial vehicles, and off-road vehicles, covered by Directive 70/220/EEC, which previously benefited from less stringent standards, have since been subject, pursuant to Council Directive 93/59/EEC (16) and Directive 96/69/EC of the European Parliament and of the Council (17), to standards as stringent as the respective standards for passenger cars, taking into account the specific conditions of these vehicles; (4) Whereas an additional effort should be undertaken in order to commercialise more environmentally friendly vehicles; whereas, in the sectors of public and collective passenger transport and urban freight distribution, an increased share of more environmentally friendly vehicles should be aimed at; (5) Whereas Article 4 of Directive 94/12/EC requires that the Commission propose standards which will be enforced after the year 2000, according to a new multi-faceted approach, based on a comprehensive assessment of costs and efficiency of all measures aimed at reducing road transport pollution; whereas the proposal should, besides the tightening of car emission standards, include complementary measures such as an improvement in fuel quality and a strengthening of the motor-vehicle inspection and maintenance programme; whereas the proposal should be based on the establishment of air quality criteria and associated emission reduction objectives and an evaluation of the cost-effectiveness of each package of measures, taking into account the potential contribution of other measures such as traffic management, enhancement of urban public transport, new propulsion technologies or the use of alternative fuels; whereas, given the urgency of community action on the limitation of pollutant emissions by motor vehicles, the present proposals are also based on present or anticipated best available anti-pollution technologies which are liable to speed up the replacement of polluting motor vehicles; (6) Whereas an adequate framework should be created as soon as possible to accelerate the introduction on to the market of vehicles with innovative propulsion technologies and vehicles which use alternative fuels with a low environmental impact; whereas the introduction of vehicles with alternative fuels can produce a significant improvement in the quality of city air; (7) Whereas, in order to help resolve the problem of atmospheric pollution, it is necessary to step in with a global strategy, encompassing the technological, management and tax aspects, for the development of sustainable mobility, taking into account the specific characteristics of the various European urban areas; (8) Whereas the Commission has implemented a European programme on air quality, road traffic emissions, fuels and engines technologies (the Auto/Oil Programme) with a view to fulfilling the requirements of Article 4 of Directive 94/12/EC; whereas the Commission has implemented the APHEA Project which estimates the external costs of air pollution by motor vehicles at 0,4 % of EU GNP, and further assessments conclude that the external costs amount to 3 % of EU GNP, whereas the Commission has implemented the ‘Car of Tomorrow’ Action Plan which strives to contribute to the promotion of the ‘Car of Tomorrow’ which will be clean, safe, energy efficient and ‘intelligent’; whereas this action plan enforces Community action promoting R & D leading to clean cars and whereas neither the R & D efforts undertaken in the framework of the ‘Car of Tomorrow’ Action Plan nor EU competitiveness in automobile R & D should be jeopardised; whereas the European motor vehicle and oil industries have carried out the European Programme on Emissions, fuels and Engine Technologies (EPEFE) to determine the contribution which can be made both by future vehicles and the fuels which propel them; whereas the Auto/Oil and EPEFE programmes strive to ensure that proposals for Directives on polluting emissions seek the best solutions for both the citizen and for the economy; whereas the need for Community action for the forthcoming Steps 2000 and 2005 has become urgent; whereas it has become apparent that a further improvement of car emission technology is necessary with a view to achieving air quality in the year 2010 as described in the Commission communication on the Auto/Oil Programme; (9) Whereas it is important to give weight to factors such as fluctuations as a result of competitive developments, the real distribution of costs between the industries taking part with a view to the annual reduction of emissions, costs avoided elsewhere by investment in a given area and reductions in the burden on the economy; (10) Whereas the improvement of requirements for new passenger cars and light commercial vehicles in Directive 70/220/EEC constitutes part of a consistent global Community strategy which will also include a revision of standards for light commercial vehicles and heavy duty vehicles from the year 2000, an improvement of motor fuels and more accurate assessment of in-service vehicle emission performance; whereas alongside these measures, additional cost-effective local measures will nevertheless be needed to achieve the air-quality criteria in the most polluting areas; (11) Whereas Directive 70/220/EEC 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 (18); whereas the objective of reducing the level of pollutant emissions from motor vehicles cannot be sufficiently achieved by individual Member States and can therefore be better achieved by the approximation of the laws of the Member States relating to measures to be taken against air pollution by motor vehicles; (12) Whereas reductions of the Type I test limits applicable from the year 2000 (corresponding to a drop of 40 % in nitrogen oxides, 40 % in total hydrocarbons, 30 % in carbon monoxide for petrol-driven passenger cars, 20 % in nitrogen oxides, 20 % in the combined value for hydrocarbons plus nitrogen oxides, 40 % in carbon monoxide, 35 % in particulates for indirect injection diesel passenger cars and 40 % in nitrogen oxides, 40 % in the combined value for hydrocarbons plus nitrogen oxides, 40 % in carbon monoxide and 50 % in particulates for direct-injection diesel passenger cars and a reduction of 20 % in nitrogen oxides, 65 % in hydrocarbons, 40 % in carbon monoxide and 35 % in particulates for diesel light commercial vehicles) have been identified as key measures to achieve sufficient medium-term air quality; whereas these reductions have been applied to hydrocarbons and nitrogen oxides on the assumption that nitrogen oxides represent respectively 45 % and 80 % of the weight of the combined value measured for petrol/diesel passenger cars complying with Directive 94/12/EC and Directive 96/69/EC respectively; whereas separate limit values are now normally fixed for petrol-driven vehicles in order to monitor the emissions of both pollutants; whereas a combined limit value is maintained for diesel vehicles for which the Stage 2000 standards are the most demanding, with a view to facilitating engineering of future engines; whereas these reductions will take into account the effect on real emissions of a modification also adopted for the test cycle with a view to better representing emissions after a cold start (‘deletion of 40 s’); (13) Whereas Commission Directive 96/44/EC (19) brought the test conditions of Directive 70/220/EEC into line with those of Council Directive 80/1268/EEC of 16 December 1980 relating to the carbon dioxide emissions and the fuel consumption of motor vehicles (20), in particular as far as the relationship between the reference mass of the vehicle and the equivalent inertia which is to be used is concerned; whereas it is now appropriate to align the reference mass definitions of vehicles of Category N1 Classes I, II and III with those of Directive 96/44/EC; (14) Whereas new provisions for on-board diagnostics (OBD) should be introduced with a view to permitting an immediate detection of failure of anti-pollution vehicle equipment and thus allowing a significant upgrading of the maintenance of initial emissions performance on in-service vehicles through periodic or kerbside control; whereas, however, OBD are at a less developed stage for diesel vehicles and cannot be fitted on all such vehicles before 2005; whereas installing an on-board measurement system (OBM) or other systems to detect any faults by measuring individual pollutants emitted shall be permissible provided that the OBD system integrity is maintained; whereas in order for the Member States to ensure that vehicle owners meet their obligation to repair faults once they have been indicated, the distance travelled since the fault is indicated shall be recorded; whereas on-board diagnostics systems must offer unrestricted and standardised access; whereas motor vehicle manufacturers must provide the information required for the diagnosis, servicing or repair of the vehicle; whereas such access and such information are required to ensure that vehicles may be inspected, serviced and repaired without hindrance throughout the European Union, and that competition in the market for vehicle parts and repairs is not distorted to the disadvantage of part manufacturers, independent vehicle-part wholesalers, independent repair garages and consumers; whereas manufacturers of spare or retrofit parts will be obliged to make the parts they manufacture compatible with the on-board diagnostic system concerned with a view to fault-free operation assuring the user against malfunctions; (15) Whereas the Type IV test which makes it possible to determine the evaporative emissions from vehicles with positive-ignition engines can be improved better to represent real evaporative emissions as well as the status of measuring techniques; (16) Whereas to adapt the behaviour of the exhaust-emission control systems of vehicles with positive-ignition engines to the actual requirements of practice, a new test should be introduced to measure emissions at low temperatures; (17) Whereas the characteristics of the reference fuels used for emission testing should reflect the evolution of the market fuel specifications to be available following legislation on the quality of petrol and diesel fuels; (18) Whereas a new method for checking conformity of production on in-service vehicles has been identified as a cost-effective accompanying measure, and is included in the emissions Directive with the objective of implementation in the year 2001; (19) Whereas the circulation of obsolete vehicles, which causes many times more pollution than vehicles now being marketed, is an important source of road transport pollution; whereas measures to promote the faster replacement of existing vehicles with vehicles having a lower environmental impact should be investigated; (20) Whereas Member States should be allowed, by means of tax incentives, to expedite the placing on the market of vehicles which satisfy the requirements adopted at Community level, such incentives having to comply with the provisions of the Treaty and satisfy certain conditions intended to avoid distortions of the internal market; whereas this Directive does not affect the Member States' right to include emissions of pollutants and other substances in the basis for calculating road traffic taxes on motor vehicles; (21) Whereas with a view to the harmonious development of the internal market and the protection of consumer interests, a binding long-term approach is required; whereas it is therefore necessary to establish a two-stage approach with mandatory limit values to be applied from the years 2000 and 2005 which can be used for the purpose of granting tax incentives to encourage the early introduction of vehicles containing the most advanced anti-pollution equipment; (22) Whereas the Commission will closely monitor technological developments in emission control and, where appropriate, will propose the adaptation of this Directive; whereas the Commission is carrying out research projects to deal with outstanding questions, the findings of which will be incorporated in a proposal for future legislation after the year 2005; (23) Whereas Member States may take measures to encourage the retrofitting of older vehicles with emission control devices and components; (24) Whereas Member States may take measures to encourage faster progress towards replacing existing vehicles with low-emission vehicles; (25) Whereas Article 5 of Directive 70/220/EEC lays down that the amendments which are necessary to adapt the requirements of the Annexes to technical progress shall be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC; whereas in the meantime several other Annexes have been added to the Directive and it is essential that all Annexes to Directive 70/220/EEC can be adapted to technical progress in accordance with the said procedure; (26) Whereas is modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was concluded on 20 December 1994 (21); whereas this modus vivendi applies inter alia to measures taken in accordance with Article 13 of Directive 70/156/EEC; (27) Whereas Directive 70/220/EEC should be amended accordingly, Article 1 Directive 70/220/EEC is hereby amended as follows: 1. In Article 5, ‘Annexes I to VII’ shall be replaced by ‘Annexes I to XI’; 2. The Annexes are hereby amended in accordance with the Annex to this Directive. Article 2 1. Subject to the provisions of Article 7, with effect as from nine months after this Directive enters into force no Member State may, on grounds relating to air pollution by emissions from motor vehicles: — refuse to grant EC type-approval pursuant to Article 4(1) of Directive 70/156/EEC, or — refuse to grant national type-approval, or — prohibit the registration, sale or entry into service of vehicles, pursuant to Article 7 of Directive 70/156/EEC, if the vehicles comply with the requirements of Directive 70/220/EEC, as amended by this Directive. 2. Subject to the provisions of Article 7, with effect from 1 January 2000 for vehicles in category M as defined in Annex II, Section A, to Directive 70/156/EEC — except vehicles the maximum mass of which exceeds 2 500 kg — , for vehicles in Category N1 Class I and, with effect from 1 January 2001, for vehicles in Category N1 Classes II and III as defined in the table in Section 5.3.1.4 of Annex I to Directive 70/220/EEC, and for vehicles in category M the maximum mass of which exceeds 2 500 kg, Member States may no longer grant: — EC type-approval pursuant to Article 4(1) of Directive 70/156/EEC, or — national type-approval, except where the provisions of Article 8(2) of Directive 70/156/EEC are invoked, for a new vehicle type on grounds relating to air pollution by emissions if it fails to comply with the provisions of Directive 70/220/EEC, as amended by this Directive. For the Type I test the limit values set out in row A of the table in section 5.3.1.4 of Annex I to Directive 70/220/EEC are to be used. 3. With effect from 1 January 2001 for vehicles in category M — except vehicles the maximum mass of which exceeds 2 500 kg — , for vehicles in Category N1 Class I and, with effect from 1 January 2002, for vehicles in Category N1 Classes II and III as defined in the table in Section 5.3.1.4 of Annex I to Directive 70/220/EEC, and for vehicles in category M the maximum mass of which exceeds 2 500 kg, Member States shall: — consider certificates of conformity which accompany new vehicles pursuant to Directive 70/156/EEC as no longer valid for the purpose of Article 7(1) of that Directive, and — refuse the registration, sale or entry into service of new vehicles which are not accompanied by a valid certificate of conformity pursuant to Directive 70/156/EEC, except where the provisions of Article 8(2) of Directive 70/156/EEC are invoked, on grounds relating to air pollution by emissions, if the vehicles fail to comply with the provisions of Directive 70/220/EEC, as amended by this Directive. For the Type I test the limit values set out in row A of the table in section 5.3.1.4 of Annex I to Directive 70/220/EEC are to be used. 4. Subject to the provisions of Article 7, with effect from 1 January 2005 for vehicles in Category M as defined in Annex II, Section A, to Directive 70/156/EEC — except vehicles the maximum mass of which exceeds 2 500 kg — , for vehicles in Category N1 Class I and, with effect from 1 January 2006, for vehicles in Category N1, Classes II and III as defined in the table in Section 5.3.1.4 of Annex I to Directive 70/220/EEC, and for vehicles in category M whose maximum mass exceeds 2 500 kg, Member States may no longer grant: — EC type-approval pursuant to Article 4(1) of Directive 70/156/EEC, or — national type-approval except where the provisions of Article 8(2) of Directive 70/156/EEC are invoked, for a new type of vehicle on grounds relating to air pollution by emissions if it fails to comply with the provisions of Directive 70/220/EEC, as amended by this Directive. For the Type I test the limit values set out in row B of the table in Section 5.3.1.4 of Annex I to Directive 70/220/EEC are to be used. 5. With effect from 1 January 2006 for vehicles in category M — except vehicles the maximum mass of which exceeds 2 500 kg — , for vehicles in Category N1 Class I, and, with effect from 1 January 2007, for vehicles in Category N1 Classes II and III, as defined in the table in Section 5.3.1.4 of Annex I to Directive 70/220/EEC, and for vehicles in category M whose maximum mass exceeds 2 500 kg, Member States shall: — consider certificates of conformity which accompany new vehicles pursuant to Directive 70/156/EEC as no longer valid for the purpose of Article 7(1) of that Directive, and — refuse the registration, sale or entry into service of new vehicles which are not accompanied by a valid certificate of conformity pursuant to Directive 70/156/EEC, except where the provisions of Article 8(2) of Directive are invoked, on grounds relating to air pollution by emissions, if the vehicles fail to comply with the provisions of Directive 70/220/EEC, as amended by this Directive. For the Type I test the limit values set out in row B of the table in Section 5.3.1.4 of Annex I to Directive 70/220/EEC are to be used. 6. Until 1 January 2003, vehicles in Category M1, fitted with compression ignition engines the maximum mass of which exceeds 2 000 kg and which are — designed to carry more than six occupants including the driver, or — off-road vehicles as defined in Annex II to Directive 70/156/EEC shall be considered, for the purposes of paragraphs 2 and 3, as vehicles in Category N1. 7. Member States shall: — consider as no longer valid the certificates of conformity for vehicles approved in accordance with footnote 1, as amended by footnotes 2 and 3, to the table in Section 5.3.1.4 of Annex I to Directive 70/220/EEC as inserted by Directive 96/69/EC, and — refuse the registration, sale or entry into service of new vehicles: (a) with effect from 1 January 2001, for vehicles in Category M1 and in Category N1, Class I, except vehicles designed to carry more than six occupants including the driver and vehicles the maximum mass of which exceeds 2 500 kg, and b) with effect from 1 January 2002, for vehicles in Category N1, Classes II and III, vehicles designed to carry more than six occupants including the driver and vehicles the maximum mass of which exceeds 2 500 kg. 8. Until the dates referred to in paragraphs 2 and 3 type-approval may be granted and conformity-of-production verifications carried out in accordance with Directive 70/220/EEC as amended by Directive 96/69/EC. Article 3 1. Not later than 31 December 1999, the Commission shall submit a proposal to the European Parliament and to the Council confirming or complementing this Directive. The measures contained in the proposal shall take effect from 1 January 2005. The proposal shall contain: — Category N1, Classes II and III limit values for cold start in low temperature ambient air (266 K) (- 7o C), — Community provisions for improved roadworthiness testing, — the threshold limit values for OBD for 2005/6 for M1 and N1 vehicles, — examination of Type V testing, including the possibility of abolishing it. 2. After 31 December 1999 the Commission shall submit further proposals for legislation to come into force after 2005 which consider: — modification to the durability requirements, including extending the durability test, — fuel quality standards including in particular in the light of vehicle technology, — the contribution of possible measures, including those relating to fuels and vehicles, to the attainment of longer term Community objectives on air quality, taking into account technological developments and the results of new air pollution related research including effects of particulate matter on human health, — the potential and feasibility of local measures to reduce vehicle emissions; in this context the contribution of transport and other policy measures such as traffic management, urban public transport, enhanced inspection and maintenance and vehicle scrappage schemes should be evaluated, — the particular situation of captive fleets and the potential for emission reductions related to the use by such fleets of fuels with very stringent environmental specifications, — the potential emission reductions to be gained from fixing the environmental specifications of fuels to be used in agricultural tractors as covered by Directive 74/150/EEC and in internal combustion engines to be installed in non-road mobile machinery as covered by Directive 97/68/EC, — requirements for the operation of an on-board measurement system (OBM). 3. All proposals shall take into account the following background considerations: — evaluation of the impact of the provisions of this Directive in terms of their contribution to air quality, examination of technical feasibility and cost-effectiveness including an evaluation of the benefits and availability of enhanced technology, — compatibility with the attainment of other Community objectives, such as regarding the attainment of air quality objectives and other related objectives such as acidification and eutrophication and the reduction of greenhouse gas emissions, — noxious pollutant emissions in the Community from transport and non-transport sources and an estimate of the contribution that existing and pending and potential emission reduction measures from all sources could make towards improving air quality, — emissions from direct-injection petrol engines including particulate emissions, — developments in exhaust purification at full load, — development of alternative fuels and new propulsion technologies, — progress towards the industrial availability of key after-treatment systems such as DeNOx catalysts and traps and the technical feasibility of achieving the implementation date for diesel engines, — improvements in the test procedures for small particulates, — refinery technologies and the supply situation and qualities of crude oil available to the Community, — the contribution that selective and differentiated fiscal measures could make to reducing vehicle emissions without any negative impact on the functioning of the internal market, taking into account the effects of revenue losses on neighbouring countries. Article 4 1. By 1 January 2000, the Commission shall submit a report to the European Parliament and the Council on the drawing up of a standard electronic format for repair information taking account of relevant international standards. By 30 June 2002 the Commission shall submit a report to the European Parliament and the Council on the development of on-board diagnostics (OBD) giving its opinion on the need for an extension of the OBD procedure and on requirements for the operation of an on-board measurement system (OBM). On the basis of the report, the Commission will submit a proposal for measures to enter into force no later than 1 January 2005 to include the technical specifications and corresponding annexes in order to provide for the type approval of OBM systems ensuring at least equivalent levels of monitoring to the OBD system and which shall be compatible with these systems. The Commission shall submit a report to the European Parliament and the Council on the extension of OBD to cover other electronic vehicle control systems relating to active and passive safety, inter alia in a manner which is compatible with emission control systems. 2. By 1 January 2001 the Commission shall take appropriate measures to ensure that replacement or retro-fitted components can be brought to the market. Such measures shall include suitable approval procedures for replacement parts to be defined as soon as possible for those emission control components that are critical to the correct functioning of OBD systems. 3. By 30 June 2000 the Commission shall take appropriate measures to ensue that the development of replacement or retro-fit components which are critical to the correct functioning of the OBD system is not restricted by the unavailability of pertinent information, unless that information is covered by intellectual property rights or constitutes specific know-how of the manufacturers or the OEM (Original Equipment Manufacturers) suppliers: in this case the necessary technical information shall not be improperly withheld. 4. In addition the Commission shall submit, by 30 June 2000, appropriate proposals to ensure that spare and retrofit parts are compatible inter alia with the specifications of the appropriate on-board diagnostic system, so that repair, replacement and fault-free operation are possible. The type-approval procedure laid down in the Annex to this Directive shall serve as a basis for this. Article 5 Member States may make provision for tax incentives only in respect of motor vehicles in series production which comply with Directive 70/220/EEC, as amended by this Directive. Such incentives shall comply with the provisions of the Treaty and satisfy the following conditions: — they shall apply to all new series-production vehicles offered for sale on the market of a Member State which comply in advance with the mandatory limit values set out in row A of the table in section 5.3.1.4 of Annex I to Directive 70/220/EEC, as amended by this Directive, and thereafter as from 1 January 2000 for vehicles in Category M1 and Category N1, Class I, and, with effect from 1 January 2001, for vehicles in Category N1, Classes II and III, which comply with the limit values set out in row B of the same table, — they shall be terminated with effect from the application of the emission limit values laid down in Article 2(3) for new motor vehicles, or with effect from the dates laid down in Article 2(4), — for each type of motor vehicle, they shall not exceed the additional cost of the technical solutions introduced to ensure compliance with the values set in Article 2(3) or Article 2(5) and of their installation on the vehicle. The Commission shall be informed in sufficient time of plans to institute or change the incentives referred to in the first subparagraph, so that it can submit its observations. Member States may inter alia introduce tax or financial incentives for the re-equipment of in-use vehicles to meet the values laid down in this Directive or previous amendments to Directive 70/220/EEC, and for laying up vehicles which do not comply. Article 6 Rules for a type-approval for vehicles with alternative propulsion systems and vehicles using alternative fuels shall be further defined as appropriate. Article 7 This Directive shall be brought into effect at the same time as, and in accordance with the same timetable for, the introduction of measures specified in Directive 98/70/EC (22). Article 8 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive with effect as from nine months after this Directive enters into force. 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 communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. 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.

31998L0081

1998

Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms Having regard to the Treaty establishing the European Community, and in particular Article 103s(1) 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 189c of the Treaty (3), (1) Whereas, within the meaning of the Treaty, action by the Community relating to the environment should be based on the principle that preventive action is to be taken and shall have as its objective to preserve, protect and improve the environment and to protect human health; (2) Whereas contained uses of genetically modified micro-organisms (GMMs) should be classified in relation to the risks they present for human health and the environment; whereas such classification should be in line with international practice and based on an assessment of the risk; (3) Whereas in order to ensure a high level of protection the containment and other protective measures applied to a contained use must correspond to the classification of the contained use; whereas in case of uncertainty the appropriate containment and other protective measures for the higher classification should be applied until less stringent measures are justified by appropriate data; (4) Whereas appropriate measures should be adopted and used for the control of the disposal of material from contained uses of GMMs; (5) Whereas GMMs which are disposed of without appropriate provisions for specific containment measures to limit their contact with the general population and the environment do not fall within the scope of the present Directive; other Community legislation such as Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (4) may apply; (6) Whereas exemptions pursuant to this Directive do not entail exemptions pursuant to any other Community legislation that may apply, such as Directive 90/220/EEC; (7) Whereas for all activities involving GMMs the principles of good microbiological practice and good occupational safety and hygiene should apply in accordance with relevant Community legislation; (8) Whereas the containment and other protective measures applied to contained uses should be reviewed periodically; (9) Whereas people employed in contained uses should be consulted in accordance with the requirements of relevant Community legislation, in particular Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (5); (10) Whereas weaknesses have been identified in Directive 90/219/EEC (6); whereas the administrative procedures and notification requirements should be linked to the risk of the contained uses; (11) Whereas Directive 90/219/EEC did not permit sufficient adaptation to technical progress; whereas the technical parts of that Directive need to be adapted to technical progress; (12) Whereas the implementation of Directive 90/219/EEC could benefit from the addition of a list of GMMs that are safe for human health and the environment; whereas these GMMs should meet certain criteria in order to establish their safety; (13) Whereas, to take account of the pace at which biotechnology is advancing, the nature of the criteria to be developed and the limited scope of this list, it is appropriate for the Council to define and revise these criteria; (14) Whereas there is now considerable experience and knowledge of the risks associated with the contained use of GMMs; (15) Whereas Directive 90/219/EEC should therefore be amended accordingly, Article 1 Directive 90/219/EEC is hereby amended as follows: 1. Articles 2 to 16 shall be replaced by the following: 'Article 2 For the purposes of this Directive: (a) "micro-organism" shall mean any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, animal and plant cells in culture; (b) "genetically modified micro-organism" (GMM) shall mean a micro-organism 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: (i) genetic modification occurs at least through the use of the techniques listed in Annex I, Part A; (ii) the techniques listed in Annex I, Part B, are not considered to result in genetic modification; (c) "contained use" shall mean any activity in which micro-organisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with the general population and the environment; (d) "accident" shall mean any incident involving a significant and unintended release of GMMs in the course of their contained use which could present an immediate or delayed hazard to human health or the environment; (e) "user" shall mean any natural or legal person responsible for the contained use of GMMs; (f) "notification" shall mean the presentation of the requisite information to the competent authorities of a Member State. Article 3 Without prejudice to Article 5(1) this Directive shall not apply: - where genetic modification is obtained through the use of the techniques/methods listed in Annex II, Part A, or - for contained uses involving only types of GMMs meeting the criteria listed in Annex II, Part B which establish their safety to human health and the environment. These types of GMMs shall be listed in Annex II, Part C. Article 4 Article 5(3) and 5(6) and Articles 6 to 12 shall not apply to the transport of GMMs by road, rail, inland waterway, sea or air. This Directive shall not apply to the storage, culture, transport, destruction, disposal or use of GMMs which have been placed on the market in accordance with Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (*) or pursuant to other Community legislation, which provides for a specific environmental risk assessment similar to that laid down in the said Directive, provided that the contained use is in accordance with the conditions, if any, of the consent for placing on the market. (*) OJ L 117, 8.5.1990, p. 15. Directive as last amended by Commission Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72). Article 5 1. Member States shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the contained use of GMMs. 2. To this end the user shall carry out an assessment of the contained uses as regards the risks to human health and the environment that these contained uses may incur, using as a minimum the elements of assessment and the procedure set out in Annex III, sections A and B. 3. The assessment referred to in paragraph 2 shall result in the final classification of the contained uses in four classes applying the procedure set out in Annex III, which will result in the assignment of containment levels in accordance with Article 6: >TABLE> 4. Where there is doubt as to which class is appropriate for the proposed contained use, the more stringent protective measures shall be applied unless sufficient evidence, in agreement with the competent authority, justifies the application of less stringent measures. 5. The assessment referred to in paragraph (2) shall especially take into account the question of disposal of waste and effluents. Where appropriate, the necessary safety measures shall be implemented in order to protect human health and the environment. 6. A record of the assessment referred to in paragraph (2) shall be kept by the user and made available in an appropriate form to the competent authority as part of the notification pursuant to Articles 7, 9 and 10 or on request. Article 6 1. The user shall apply, except to the extent that paragraph 2 of Annex IV allows other measures to be applied, the general principles and the appropriate containment and other protective measures set out in Annex IV corresponding to the class of the contained use, so as to keep workplace and environmental exposure to any GMMs to the lowest reasonably practicable level, and so that a high level of safety is ensured. 2. The assessment referred to in Article 5(2) and the containment and other protective measures applied shall be reviewed periodically, and forthwith if: (a) the containment measures applied are no longer adequate or the class assigned to the contained uses is no longer correct, or (b) there is reason to suspect that the assessment is no longer appropriate judged in the light of new scientific or technical knowledge. Article 7 When premises are to be used for the first time for contained uses, the user shall be required to submit to the competent authorities, before commencing such use, a notification containing at least the information listed in Annex V, Part A. Article 8 Following the notification referred to in Article 7, subsequent class 1 contained use may proceed without further notification. Users of GMMs in class 1 contained uses shall be required to keep the record of each assessment referred to in Article 5(6), which shall be made available to the competent authority on request. Article 9 1. For first and subsequent class 2 contained uses to be carried out in premises notified in accordance with Article 7, a notification containing the information listed in Annex V, Part B shall be submitted. 2. If the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses and any associated consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification. The applicant can, however, himself request a decision on a formal authorisation from the competent authority. The decision must be made within a maximum of 45 days from the notification. 3. If the premises have not been the subject of a previous notification to carry out class 2 or a higher class of contained uses, the class 2 contained use may, in the absence of any indication to the contrary from the competent authority, proceed 45 days after submission of the notification referred to in paragraph 1, or earlier with the agreement of the competent authority. Article 10 1. For first and subsequent class 3 or class 4 contained uses to be carried out in premises notified in accordance with Article 7, a notification containing the information listed in Annex V, Part C shall be submitted. 2. A class 3 or higher class of contained use may not proceed without the prior consent of the competent authority which shall communicate its decision in writing: (a) at the latest 45 days after submission of the new notification, in the case of premises which have been the subject of a previous notification to carry out class 3 or a higher class of contained uses and where any associated consent requirements have been satisfied for the same or a higher class than the contained use with which it is intended to proceed; (b) at the latest 90 days after submission of the notification, in other cases. Article 11 1. Member States shall designate the authority or authorities competent to implement the measures which they adopt in application of this Directive and to receive and acknowledge the notifications referred to in Articles 7, 9 and 10. 2. The competent authorities shall examine the conformity of the notifications with the requirements of this Directive, the accuracy and completeness of the information given, the correctness of the assessment referred to in Article 5(2) and the class of contained uses and, where appropriate, the suitability of the containment and other protective measures, the waste management, and emergency response measures. 3. If necessary, the competent authority may: (a) ask the user to provide further information or to modify the conditions of the proposed contained use or to amend the class assigned to the contained use(s). In this case the competent authority may require that the contained use, if proposed, does not begin, or, if in progress, is suspended or terminated, until the competent authority has given its approval on the basis of the further information obtained or of the modified conditions of the contained use; (b) limit the time for which the contained use should be permitted or subject it to certain specific conditions. 4. For the purpose of calculating the periods referred to in Articles 9 and 10, any period of time during which the competent authority: - is awaiting any further information which it may have requested from the notifier in accordance with paragraph 3(a), or - is carrying out a public inquiry or consultation in accordance with Article 13 shall not be taken into account. Article 12 If the user becomes aware of relevant new information or modifies the contained use in a way which could have significant consequences for the risks posed by it, the competent authority shall be informed as soon as possible and the notification pursuant to Articles 7, 9 and 10 shall be modified. If information subsequently becomes available to the competent authority which could have significant consequences for the risks posed by the contained use, the competent authority may require the user to modify the conditions of, or suspend or terminate, the contained use. Article 13 Where a Member State considers it appropriate, it may provide that the public shall be consulted on aspects of the proposed contained use, without prejudice to Article 19. Article 14 The competent authorities shall ensure that before a contained use commences: (a) an emergency plan is drawn up for contained uses where failure of the containment measures could lead to serious danger, whether immediate or delayed, to humans outside the premises and/or to the environment, except where such an emergency plan has been drawn up under other Community legislation; (b) information on such emergency plans, including the relevant safety measures to be applied, is supplied in an appropriate manner, and without their having to request it, to bodies and authorities liable to be affected by the accident. The information shall be updated at appropriate intervals. It shall also be made publicly available. The Member States concerned shall at the same time make available to other Member States concerned, as a basis for all necessary consultation within the framework of their bilateral relations, the same information as that which is disseminated to their nationals. Article 15 1. Member States shall take the necessary measures to ensure that, in the event of an accident, the user shall be required to inform immediately the competent authority specified in Article 11 and provide the following information: - the circumstances of the accident, - the identity and quantities of the GMMs concerned, - any information necessary to assess the effects of the accident on the health of the general population and the environment, - the measures taken. 2. Where information is given pursuant to paragraph 1, the Member States shall be required to: - ensure that any measures necessary are taken, and immediately alert any Member States which could be affected by the accident, - collect, where possible, the information necessary for a full analysis of the accident and, where appropriate, make recommendations to avoid similar accidents in the future and to limit the effects thereof. Article 16 1. Member States shall be required to: (a) consult with other Member States, likely to be affected in the event of an accident, on the proposed implementation of emergency plans; (b) inform the Commission as soon as possible of any accident within the scope of this Directive, giving details of the circumstances of the accident, the identity and quantities of the GMMs concerned, the response measures taken and their effectiveness and an analysis of the accident, including recommendations to limit its effects and avoid similar accidents in the future. 2. The Commission, in consultation with the Member States, shall establish a procedure for the exchange of information pursuant to paragraph 1. It shall also set up and keep at the disposal of the Member States a register of accidents within the scope of this Directive, including an analysis of the causes of the accidents, experience gained and measures taken to avoid similar accidents in the future.` 2. Articles 18, 19 and 20 shall be replaced by the following: 'Article 18 1. Member States shall send to the Commission, at the end of each year, a summary report on class 3 and class 4 contained uses notified during that year pursuant to Article 10 including the description, purpose and risks of the contained use(s). 2. Every three years, Member States shall send the Commission a summary report on their experience with this Directive, the first time being on 5 June 2003. 3. Every three years, the Commission shall publish a summary based on the reports referred to in paragraph 2, the first time being on 5 June 2004. 4. The Commission may publish general statistical information on the implementation of this Directive and related matters, as long as it contains no information likely to cause harm to the competitive position of a user. Article 19 1. Where its disclosure affects one or more of the items mentioned in Article 3(2) of Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment (*), the notifier may indicate the information in the notifications submitted pursuant to this Directive that should be treated as confidential. Verifiable justification must be given in such cases. 2. The competent authority shall decide, after consultation with the notifier, which information will be kept confidential and shall inform the notifier of its decision. 3. In no case may the following information, when submitted according to Articles 7, 9 or 10, be kept confidential: - the general characteristics of the GMMs, name and address of the notifier, and location of use, - class of contained use and measures of containment, - the evaluation of foreseeable effects, in particular any harmful effects on human health and the environment. 4. The Commission and the competent authorities shall not divulge to third parties any information decided to be confidential according to paragraph 2 and notified or otherwise provided pursuant to this Directive, and shall protect intellectual property rights relating to the data received. 5. If, for whatever reasons, the notifier withdraws the notification, the competent authority must respect the confidentiality of the information supplied. (*) OJ L 158, 23.6.1990, p. 56. Article 20 Amendments necessary to adapt Annex II, Part A, and Annexes III to V to technical progress and to adapt Annex II, Part C, shall be decided in accordance with the procedure laid down in Article 21.` 3. The following Article shall be inserted: 'Article 20a Before 5 December 2000 Annex II, Part B, listing the criteria for inclusion of types of GMMs into Annex II, Part C, shall be adopted by the Council acting by qualified majority on a proposal from the Commission. Amendments to Annex II, Part B, shall be adopted by the Council acting by qualified majority on a proposal from the Commission.` 4. The Annexes are replaced by the Annexes shown 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 not later than 18 months after the date of its entry into force. 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. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive enters 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.

31998L0082

1998

Commission Directive 98/82/EC of 27 October 1998 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 97/71/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 97/71/EC, and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels of pesticide residues in and on products of plant origin, including fruit and vegetables (4), as last amended by Directive 97/71/EC, and in particular Article 7 thereof, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (5), as last amended by Commission Directive 98/47/EC (6), Whereas Council Directives 93/57/EEC (7) and 93/58/EEC (8) amended the Annexes II to Directives 86/362/EEC and 86/363/EEC and 90/642/EEC to establish maximum residue levels for a first list of pesticides for cereals and products of animal origin and for products of plant origin, including fruit and vegetables, respectively; whereas, however, certain positions were left open where available data were insufficient to establish maximum levels and interested parties were given the opportunity to generate the missing data within a specified timetable; whereas, if maximum levels are not adopted by 31 October 1998 the appropriate lower limit of analytical determination will apply; Whereas, in accordance with the provisions of Directive 91/414/EEC, authorisations of plant protection products for use on specific crops are the responsibility of the Member States; whereas such authorisations are required to be based on the evaluation of effects on human and animal health and influence on the environment; whereas elements to be taken into account in such evaluations include operator and bystander exposure and impact on the terrestrial, aquatic and aerial environments, as well as impact on humans and animals through consumption of residues on treated crops; Whereas, for cereals and products of plant origin, including fruit and vegetables, maximum residue levels reflect the use of minimum quantities of pesticides to achieve effective protection of plants, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable, in particular in view of the protection of the environment and in terms of estimated dietary intake; whereas, for foodstuffs of animal origin, maximum residue levels reflect the consumption of cereals and products of plant origin treated with pesticides resulting in residues in animals and animal products, as well as taking into account the direct consequences of the use of veterinary medicines where appropriate; Whereas maximum residue levels are fixed at the lower limit of analytical determination where authorised uses of plant protection 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 with such necessary data; Whereas the lifetime exposure of consumers of food products treated with the pesticides covered by this Directive have 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); Whereas the scientific approach and procedures for calculating acute reference doses (ARfDs) and estimating short-term acute dietary exposure have not yet been agreed at European Community level; whereas the Scientific Committee on Plants, considering that the scientific approach and procedures developed in the 1997 FAO/WHO consultation (10) is appropriate pending agreement at Community level, has calculated the maximum toxicologically acceptable residue levels for pome fruit, peaches, apricots and peppers (11) with regard to methamidophos; whereas on the basis of information on GAP and supervised field trials MRLs for methamidophos can be fixed at the levels indicated to be toxicologically acceptable for peaches and apricots; whereas in the absence of such information for pome fruit, in order to accommodate the residues of methamidophos arising from the use of acephate, the MRL for methamidophos should also be fixed at the toxicologically acceptable level; whereas Member States have to review, in particular for the abovementioned agricultural products, existing good agricultural practices to ensure that the established MRLs for acephate and methamidophos are satisfied; Whereas maximum residue levels for pesticides should be kept under review; whereas the levels may be changed to take account of new information and data and, in particular, should be urgently reconsidered with a view to reduction if concerns about dietary exposure of consumers, based on new or reviewed information, are brought to the attention of the Commission, in particular in implementation of Article 9 of Directive 86/362/EEC, Article 9 of Directive 86/363/EEC or Article 8 of Directive 90/642/EEC; whereas, in particular, the MRLs fixed for acephate, metamidophos and vinclozolin in this Directive should be urgently reviewed together with the MRLs for these pesticides fixed by Directives 93/57/EEC and 93/58/EEC based on the evaluation work on these active substances under the provisions of Article 8(2) of Directive 91/414/EEC; Whereas Community maximum residue levels and levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures; whereas however the information in the relevant evaluations of the FAO/WHO Joint Meeting on Pesticide Residues (JMPR) concerning the pesticides covered by this Directive have been presented in a way which over-summarises authorised uses/good agricultural practices and supervised residue trials and does not indicate a clear basis for the recommended maximum level; whereas authorisations of plant protection products in third countries may require the use of greater quantities of pesticides or shorter pre-harvest intervals than are authorised in the Community and consequently may require higher residue levels; whereas 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 and discussed by the Standing Committee on Plant Health; whereas the possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the European Community on the basis of the submission of acceptable data; Whereas the maximum residue levels established in this Directive will have to be reviewed in the framework of the re-evaluation of active substances provided for in the programme of work established in Article 8(2) of Directive 91/414/EEC; Whereas the opinion of the Scientific Committee on Plants, in particular concerning the protection of consumers of food products treated with pesticides, has been taken into account; Whereas this Directive is in accordance with the opinion of the Standing Committee on Plant Health, Article 1 In Annex II of Directive 86/362/EEC in the lists of maximum residue levels for chlorothalonil, chlorpyriphos, chlorpyriphos-methyl, cypermethrin, deltamethrin, fenvalerate, glyphosate, imazalil, iprodione, permethrin, 'the benomyl group` (benomyl, carbendazim, thiophanate-methyl), 'the maneb group` (maneb, mancozeb, metiram, propineb, zineb) and procymidon are replaced by the lists set out in Annex A to this Directive. Article 2 In Annex II of Directive 86/363/EEC the lists of maximum residue levels for chlorothalonil, chlorpyriphos, chlorpyriphos-methyl, cypermethrin, deltamethrin, fenvalerate, glyphosate, imazalil, iprodione, permethrin, 'the benomyl group` (benomyl, carbendazim, thiophanate-methyl), 'the maneb group` (maneb, mancozeb, metiram, propineb, zineb) and procymidon are replaced by the lists set out in Annex B to this Directive. Article 3 In Annex II of Directive 90/642/EEC the lists of maximum residue levels for chlorothalonil, chlorpyriphos, chlorpyriphos-methyl, cypermethrin, deltamethrin, fenvalerate, glyphosate, imazalil, iprodione, permethrin, 'the benomyl group` (benomyl, carbendazim, thiophanate-methyl), 'the maneb group` (maneb, mancozeb, metiram, propineb, zineb) and procymidon and the maximum levels specifically fixed for tea are replaced by the lists set out in Annex C to this Directive. Article 4 The maximum residue levels set out in Annex D to this Directive are fixed on a temporary basis for acephate, methamidophos and vinclozolin, in advance of the adoption for all agricultural products of reviewed maximum residue levels for these three pesticides on the basis of the evaluation works on these active substances under the provisions of Article 8(2) of Directive 91/414/EEC, and before 30 April 2001 at the latest, for acephate and methamidophos and before 31 December 1999 at the latest for vinclozolin. Article 5 1. This Directive will enter into force on 1 November 1998. 2. Member States shall adopt and publish the legislative, regulatory or administrative measures to comply with this Directive by 30 April 1999. They shall immediately inform the Commission thereof. They shall apply these measures as from 1 August 1999. 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 procedure for such reference shall be adopted by Member States. Article 6 This Directive is addressed to the Member States.

31998L0079

1998

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices Having regard to the Treaty establishing the European Community, and in particular Article 100a 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 189b of the Treaty (3), (1) Whereas measures should be adopted for the smooth operation of the internal market; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; (2) Whereas the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety, health protection and performance, characteristics and authorisation procedures for in vitro diagnostic medical devices are different; whereas the existence of such disparities creates barriers to trade, and whereas the need to establish harmonised rules has been confirmed by a comparative survey of national legislations carried out on behalf of the Commission; (3) Whereas the harmonisation of national legislation is the only means of removing such barriers to free trade and of preventing new barriers from arising; whereas this objective cannot be achieved in a satisfactory manner by other means by the individual Member States; whereas this Directive lays down only such requirements as are necessary and sufficient to ensure, under the best safety conditions, free movement of the in vitro diagnostic medical devices to which it applies; (4) Whereas the harmonised provisions must be distinguished from measures adopted by the Member States to manage the funding of public health and sickness insurance schemes relating directly or indirectly to such devices; whereas, therefore, the harmonised provisions do not affect the ability of the Member States to implement such measures provided that they comply with Community law; (5) Whereas in vitro diagnostic medical devices should provide patients, users and third parties with a high level of health protection and attain the performance levels originally attributed to them by the manufacturer; whereas, therefore, maintenance or improvement of the level of health protection attained in the Member States is one of the main objectives of this Directive; (6) Whereas, in accordance with the principles set out in the Council resolution of 7 May 1985 on a new approach to technical harmonisation and standards (4), rules regarding the design, manufacture and packaging of relevant products must be confined to the provisions required to meet the essential requirements; whereas, because they are essential, such requirements should replace the corresponding national provisions; whereas the essential requirements, including requirements to minimise and reduce risks, should be applied with discretion, taking into account the technology and practice at the time of design and technical and economic considerations compatible with a high level of protection of health and safety; (7) Whereas the major part of medical devices are covered by Council Directive 90/385/EEC of 20 June 1990 on the approximation of laws relating to active implantable medical devices (5) and Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (6) with the exclusion of in vitro diagnostic medical devices; whereas this Directive seeks to extend the harmonisation to in vitro diagnostic medical devices and whereas, in the interest of uniform Community rules, this Directive is based largely on the provisions of the said two Directives; (8) Whereas instruments, apparatus, appliances, materials or other articles, including software, which are intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation; (9) Whereas, although internationally certified reference materials and materials used for external quality assessment schemes are not covered by this Directive, calibrators and control materials needed by the user to establish or verify performances of devices are in vitro diagnostic medical devices; (10) Whereas, having regard to the principle of subsidiarity, reagents which are produced within health-institution laboratories for use in that environment and are not subject to commercialtransactions are not covered by this Directive; (11) Whereas, however, devices that are manufactured and intended to be used in a professional and commercial context for purposes of medical analysis without being marketed are subject to this Directive; (12) Whereas mechanical laboratory equipment especially designed for in vitro diagnostic examinations falls within the scope of this Directive and whereas, therefore, in order to harmonise the relevant directives, Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery (7), should be appropriately amended to bring it into line with this Directive; (13) Whereas this Directive should include requirements regarding the design and manufacture of devices emitting ionizing radiation; whereas this Directive does not affect the application of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation (8); (14) Whereas, since electromagnetic compatibility aspects form an integral part of the essential requirements of this Directive, Council Directive 89/336/EEC of 2 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility (9) does not apply; (15) Whereas, in order to ease the task of proving conformity with the essential requirements and to enable conformity to be verified, it is desirable to have harmonised standards in respect of the prevention of risks associated with the design, manufacture and packaging of medical devices; whereas such harmonised standards are drawn up by private-law bodies and should retain their status as non-mandatory texts; whereas, to this end, the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) are recognised as the competent bodies for the adoption of harmonised standards in accordance with the general guidelines on cooperation between the Commission and those two bodies signed on 13 November 1984; (16) Whereas, for the purpose of this Directive, a harmonised standard is a technical specification (European standard of harmonisation document) adopted, on a mandate from the Commission, by CEN or Cenelec or by both of those bodies 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 (10), and pursuant to the abovementioned general guidelines; (17) Whereas, by way of exception to the general principles, the drawing up of common technical specifications takes account of a current practice in some Member States whereby for selected devices mainly used for the evaluation of the safety of blood supply and of organ donation, such specifications are adopted by the public authorities; whereas it is appropriate that these particular specifications should be replaced by common technical specifications; whereas these common technical specifications can be used for performance evaluation and reevaluation; (18) Whereas scientific experts from various interested parties could be involved in the drafting of common technical specifications and in the examination of other specific or general questions; (19) Whereas manufacturing, as covered by this Directive, also includes the packaging of the medical device, insofar as such packaging is related to the safety and performance aspects of this device; (20) Whereas certain devices have a limited life owing to the decline in their performance over time, which is related, for example, to the deterioriation in their physical or chemical properties, including the sterility or integrity of the packaging; whereas the manufacturer should determine and indicate the period during which the device will perform as intended; whereas the labelling should indicate the date until which the device or one of its components can be used with complete safety; (21) Whereas, in Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives (11), the Council laid down harmonised conformity assessment procedures; whereas the details added to these modules are justified by the nature of the verification required for in vitro diagnostic medical devices and by the need for consistency with Directives 90/385/EEC and 93/42/EEC; (22) Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group in vitro diagnostic medical devices into two main product classes; whereas, since the large majority of such devices do not constitute a direct risk to patients and are used by competently trained professionals, and the results obtained can often be confirmed by other means, the conformity assessment procedures can be carried out, as a general rule, under the sole responsibility of the manufacturer; whereas, taking account of existing national regulations and of notifications received following the procedure laid down in Directive 98/34/EC, the intervention of notified bodies is needed only for defined devices, the correct performance of which is essential to medical practice and the failure of which can cause a serious risk to health; (23) Whereas, among the in vitro diagnostic medical devices for which intervention of a notified body is required, the groups of products used in blood transfusion and the prevention of AIDS and certain types of hepatitis require a conformity assessment guaranteeing, with a view to their design and manufacture, an optimum level of safety and reliability; (24) Whereas the list of in vitro diagnostic medical devices to be subjected to third-party conformity assessment needs updating, taking account of technological progress and of developments in the field of health protection; whereas such updating measures must be taken in line with procedure III(a) as laid down in Council Decision 87/373/EEC of 13 July 1987 laying down the procedures for the exercise of implementing powers conferred on the Commission (12); (25) Whereas an agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was reached on 20 December 1994 (13); (26) Whereas medical devices should, as a general rule, bear the CE marking indicating their conformity with the provisions of this Directive to enable them to move freely within the Community and to be put into service in accordance with their intended purpose; (27) Whereas manufacturers will be able, when the intervention of a notified body is required, to choose from a list of bodies published by the Commission; whereas, although Member States do not have an obligation to designate such notified bodies, they must ensure that bodies designated as notified bodies comply with the assessment criteria laid down in this Directive; (28) Whereas the director and staff of the notified bodies should not, themselves or through an intermediary, have any interest in the establishments subject to assessment and verification which is likely to compromise their independence; (29) Whereas the competent authorities in charge of market surveillance should be able, particularly in emergencies, to contact the manufacturer or his authorised representative established in the Community, in order to take any protection measures that should prove necessary; whereas cooperation and exchange of information between Member States are necessary with a view to uniform application of this Directive, in particular for the purpose of market surveillance; whereas to that end it is necessary to establish and manage a database containing data on manufacturers and their authorised representatives, on devices placed on the market, on certificates issued, suspended or withdrawn, and on the vigilance procedure; whereas a system of adverse incident reporting (vigilance procedure) constitutes a useful tool for surveillance of the market, including the performance of new devices; whereas information obtained from the vigilance procedure as well as from external quality assessment schemes is useful for decision-making on classification of devices; (30) Whereas it is essential that manufacturers notify the competent authorities of the placing on the market of 'new products` with regard both to the technology used and the substances to be analysed or other parameters; whereas this is true in particular of high-density DNA probe devices (known as micro-chips) used in genetic screening; (31) Whereas, when a Member State considers that, as regards a given product or group of products, it is necessary, in order to protect health and safety and/or ensure compliance with the imperatives of public health, in accordance with Article 36 of the Treaty, to prohibit or restrict their availability or to subject it to special conditions, it may take any transitional measures that are necessary and justified; whereas, in such cases, the Commission consults the interested parties and the Member States and, if the national measures are justified, adopts the necessary Community measures, in accordance with procedure III(a) as laid down in Decision 87/373/EEC; (32) Whereas this Directive covers in vitro diagnostic medical devices manufactured from tissues, cells or substances of human origin; whereas it does not refer to the other medical devices manufactured using substances of human origin; whereas, therefore, work will have to continue in this connection in order to produce Community legislation as soon as possible; (33) Whereas, in view of the need to protect the integrity of the human person during the sampling, collection and use of substances derived from the human body, it is appropriate to apply the principles laid down in the Convention of the Council of Europe for the protection of human rights and dignity of the human being with regard to the application of biology and medicine; whereas, furthermore, national regulations relating to ethics continue to apply; (34) Whereas, in the interests of overall consistency between directives on medical devices, some of the provisions of this Directive should be incorporated into Directive 93/42/EEC, which needs to be amended accordingly; (35) Whereas it is necessary to draw up as quickly as possible the legislation which is lacking on medical devices manufactured using substances of human origin, Article 1 Scope, definitions 1. This Directive shall apply to in vitro diagnostic medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. Both in vitro diagnostic medical devices and accessories shall hereinafter be termed devices. 2. For the purposes of this Directive, the following definitions shall apply: (a) 'medical device` means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: - diagnosis, prevention, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap, - investigation, replacement or modification of the anatomy or of a physiological process, - control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; (b) 'in vitro diagnostic medical device` means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: - concerning a physiological or pathological state, or - concerning a congenital abnormality, or - to determine the safety and compatibility with potential recipients, or - to monitor therapeutic measures. Specimen receptacles are considered to be in vitro diagnostic medical devices. 'Specimen receptacles` are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination; (c) 'accessory` means an article which, whilst not being an in vitro diagnostic medical device, is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose. For the purposes of this definition, invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not be considered to be accessories to in vitro diagnostic medical devices; (d) 'device for self-testing` means any device intended by the manufacturer to be able to be used by lay persons in a home environment; (e) 'device for performance evaluation` means any device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside his own premises; (f) 'manufacturer` means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as devices with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient; (g) 'authorised representative` means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive; (h) 'intended purpose` means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use and/or in promotional materials; (i) 'placing on the market` means the first making available in return for payment or free of charge of a device other than a device intended for performance evaluation with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished; (j) 'putting into service` means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose. 3. For the purposes of this Directive, calibration and control materials refer to any substance, material or article intended by their manufacturer either to establish measurement relationships or to verify the performance characteristics of a device in conjunction with the intended use of that device. 4. For the purposes of this Directive, the removal, collection and use of tissues, cells and substances of human origin shall be governed, in relation to ethics, by the principles laid down in the Convention of the Council of Europe for the protection of human rights and dignity of the human being with regard to the application of biology and medicine and by any Member States regulations on this matter. 5. This Directive shall not apply to devices manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity. This does not affect the right of Member State to subject such activities to appropriate protection requirements. 6. This Directive shall not affect national laws which provide for the supply of devices by a medical prescription. 7. This Directive is a specific directive within the meaning of Article 2(2) of Directive 89/336/EEC, which shall cease to apply to devices which have complied with this Directive. Article 2 Placing on the market and putting into service Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose. This involves the obligation of Member States to monitor the security and quality of these devices. This Article applies also to devices made available for performance evaluation. Article 3 Essential requirements Devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned. Article 4 Free movement 1. Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article 16 if these devices have undergone conformity assessment in accordance with Article 9. 2. Member States shall not create any obstacle to devices intended for performance evaluation being made available for that purpose to the laboratories or other institutions listed in the statement referred to in Annex VIII if they meet the conditions laid down in Article 9(4) and Annex VIII. 3. At trade fairs, exhibitions, demonstrations, scientific or technical gatherings, etc. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that such devices are not used on specimens taken from the participants and that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply. 4. Member States may require the information to be supplied pursuant to Annex I, part B, section 8 to be in their official language(s) when a device reaches the final user. Provided that safe and correct use of the device is ensured, Member States may authorise the information referred to in the first subparagraph to be in one or more other official Community language(s). In the application of this provision, Member States shall take into account the principle of proportionality and, in particular: (a) whether the information can be supplied by harmonised symbols or recognised codes or other measures; (b) the type of user anticipated for the device. 5. Where the devices are subject to other directives concerning other aspects which also provide for the affixing of the CE marking, the latter shall indicate that the devices also fulfil the provisions of the other directives. However, should one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the devices fulfil the provisions only of those directives applied by the manufacturer. In this case, the particulars of these directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the directives and accompanying such devices. Article 5 Reference to standards 1. Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards transposing the harmonised standards the reference numbers of which have been published in the Official Journal of the European Communities; Member States shall publish the reference numbers of such national standards. 2. If a Member State or the Commission considers that the harmonised standards do not entirely meet the essential requirements referred to in Article 3, the measures to be taken by the Member States with regard to these standards and the publication referred to in paragraph 1 of this Article shall be adopted by the procedure defined in Article 6(2). 3. Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices designed and manufactured in conformity with common technical specifications drawn up for the devices in List A of Annex II and, where necessary, the devices in List B of Annex II. These specifications shall establish appropriate performance evaluation and re-evaluation criteria, batch release criteria, reference methods and reference materials. The common technical specifications shall be adopted in accordance with the procedure mentioned in Article 7(2) and be published in the Official Journal of the European Communities. Manufacturers shall as a general rule be required to comply with the common technical specifications; if for duly justified reasons manufacturers do not comply with those specifications they must adopt solutions of a level at least equivalent thereto. Where, in this Directive, reference is made to harmonised standards, this is also meant to refer to the common technical specifications. Article 6 Committee on Standards and Technical Regulations 1. The Commission shall be assisted by the committee set up by Article 5 of Directive 98/34/EC. 2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote. The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes. The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account. Article 7 Committee on Medical Devices 1. The Commission shall be assisted by the committee set up by Article 6(2) of Directive 90/385/EEC. 2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. 3. The committee referred to in paragraph 1 may examine any question connected with the implementation of this Directive. Article 8 Safeguard clause 1. Where a Member State ascertains that the devices referred to in Article 4(1), when correctly installed, maintained and used for their intended purpose may compromise the health and/or safety of patients, users or, where applicable, other persons, or the safety of property, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to: (a) failure to meet the essential requirements referred to in Article 3; (b) incorrect application of the standards referred to in Article 5, insofar as it is claimed that the standards have been applied; (c) shortcomings in the standards themselves. 2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that: - the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the procedures referred to in Article 6; where the measure referred to in paragraph 1 is attributed to problems related to the contents or to the application of the common technical specifications, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 7(1) within two months, - the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorised representative. 3. Where a non-complying device bears the CE marking, the competent Member State shall take appropriate action against whomsoever affixed the marking and shall inform the Commission and the other Member States thereof. 4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure. Article 9 Conformity assessment procedures 1. For all devices other than those covered by Annex II and devices for performance evaluation, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex III and draw up the EC declaration of conformity required before placing the devices on the market. For all devices for self-testing other than those covered by Annex II and devices for performance evaluation, the manufacturer shall, prior to the drawing up of the aforementioned declaration of conformity, fulfil the supplementary requirements set out in Annex III, point 6. Instead of applying this procedure, the manufacturer may follow the procedure referred to in paragraphs 2 or 3. 2. For all devices referred to in List A in Annex II other than those intended for performance evaluation, the manufacturer shall, in order to affix the CE marking either: (a) follow the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance), or (b) follow the procedure relating to EC type-examination set out in Annex V coupled with the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance). 3. For all devices referred to in List B in Annex II other than those intended for performance evaluation, the manufacturer shall for the purposes of affixing the CE marking, follow either: (a) the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance) or (b) the procedure relating to EC type-examination set out in Annex V couplet with: (i) the procedure relating to EC verification set out in Annex VI, or (ii) the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance). 4. In the case of devices for performance evaluation, the manufacturer shall follow the procedure referred to in Annex VIII and draw up the statement set out in that Annex before such devices are made available. This provision does not affect national regulations relating to the ethical aspects of carrying out performance evaluation studies using tissues or substances of human origin. 5. During the conformity assessment procedure for a device, the manufacturer and, if involved, the notified body shall take account of the results of any assessment and verification operations which, where appropriate, have been carried out in accordance with this Directive at an intermediate state of manufacture. 6. The manufacturer may instruct his authorised representative to initiate the procedures provided for in Annexes III, V, VI and VIII. 7. The manufacturer must keep the declaration of conformity, the technical documentation referred to in Annexes III to VIII, as well as the decisions, reports and certificates, established by notified bodies, and make it available to the national authorities for inspection purposes for a period ending five years after the last product has been manufactured. Where the manufacturer is not established in the Community, the obligation to make the aforementioned documentation available on request applies to his authorised representative. 8. Where the conformity assessment procedure involves intervention of a notified body, the manufacturer, or authorised representative, may apply to a body of his choice within the framework of tasks for which the body has been notified. 9. The notified body may require, where duly justified, any information or data, which is necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure. 10. Decisions taken by the notified bodies in accordance with Annexes III, IV, and V shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both parties, for further periods of up to five years. 11. The records and correspondence relating to the procedures referred to in paragraphs 1 to 4 shall be in an official language of the Member State in which the procedures are carried out and/or in another Community language acceptable to the notified body. 12. By way of derogation from paragraphs 1 to 4, the competent authorities may authorise, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 to 4 have not been carried out and the use of which is in the interest of protection of health. 13. The provisions of this Article shall apply accordingly to any natural or legal person who manufacturers devices covered by this Directive and, without placing them on the market, puts them into service and uses them in the context of his professional activity. Article 10 Registration of manufacturers and devices 1. Any manufacturer who places devices on the market under his own name shall notify the competent authorities of the Member State in which he has his registered place of business: - of the address of the registered place of business, - of information relating to the reagents, reagent products and calibration and control materials in terms of common technological characteristics and/or analytes and of any significant change thereto including discontinuation of placing on the market; for other devices, the appropriate indications, - in the case of devices covered by Annex II and of devices for self-testing, of all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Annex I, part A, section 3, the outcome of performance evaluation pursuant to Annex VIII, certificates and any significant change thereto, including discontinuation of placing on the market. 2. For devices covered by Annex II and for devices for self-testing, Member States may request to be informed of the data allowing identification together with the label and the instructions for use when such devices are placed on the market and/or put into service within their territory. These measures cannot constitute a precondition for the placing on the market and/or putting into service of devices which are in conformity with this Directive. 3. Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a Member State, he shall designate an authorised representative. The authorised representative shall notify the competent authorities of the Member State in which he has his registered place of business of all particulars as referred to in paragraph 1. 4. The notification referred to in paragraph 1 shall also include any new device. In addition, where, in the context of such notification, a device notified, bearing the CE marking, is a 'new product`, the manufacturer shall indicate this fact on his notification. For the purposes of this Article, a device is 'new` if: (a) there has been no such device continuously available on the Community market during the previous three years for the relevant analyte or other parameter; (b) the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Community market during the previous three years. 5. Member States shall take all necessary measures to ensure that the notifications referred to in paragraphs 1 and 3 are registered immediately in the databank described in Article 12. The procedures for implementing this Article and in particular those referring to the notification and the concept of significant change shall be adopted in accordance with the procedure referred to in Article 7. 6. Transitionally, pending the establishment of a European databank accessible to the competent authorities of the Member States and containing the data relating to all devices available on the territory of the Community, the manufacturer shall give such notification to the competent authorities of each Member State concerned by the placing on the market. Article 11 Vigilance procedure 1. Member States shall take the necessary steps to ensure that any information brought to their knowledge, in accordance with the provisions of this Directive, regarding the incidents mentioned below involving devices bearing the CE marking is recorded and evaluated centrally: (a) any malfunction, failure or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health; (b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (a), leading to systematic recall of devices of the same type by the manufacturer. 2. Where a Member State requires medical practitioners, the medical institutions or the organisers of external quality assessment schemes to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the incident. 3. After carrying out an assessment, if possible together with the manufacturer, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of the incidents referred to in paragraph 1 for which appropriate measures, including possible withdrawal, have been taken or are contemplated. 4. Where, in the context of notification referred to in Article 10, a device notified, bearing the CE marking, is a 'new` product, the manufacturer shall indicate this fact on his notification. The competent authority so notified may at any time within the following two years and on justified grounds, require the manufacturer to submit a report relating to the experience gained with the device subsequent to its being placed on the market. 5. The Member States shall on request inform the other Member States of the details referred to in paragraphs 1 to 4. The procedures implementing this Article shall be adopted in accordance with the procedure referred to in Article 7(2). Article 12 European databank 1. Regulatory data in accordance with this Directive shall be stored in a European databank accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis. The databank shall contain the following: (a) data relating to registration of manufacturers and devices in accordance with Article 10; (b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedure as laid down in Annexes III to VII; (c) data obtained in accordance with the vigilance procedure as defined in Article 11. 2. Data shall be forwarded in a standardised format. 3. The procedures implementing this Article shall be adopted in accordance with the procedure laid down in Article 7(2). Article 13 Particular health monitoring measures Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed pursuant to Article 36 of the Treaty, the availability of such products should be prohibited, restricted or made subject to particular requirements, it may take any necessary and justified transitional measures. It shall then inform the Commission and all the other Member States, giving the reasons for its decision. The Commission shall consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community measures in accordance with the procedure referred to in Article 7(2). Article 14 Amendments to Annex II, and derogation clause 1. Where a Member State considers that: (a) the list of devices in Annex II should be amended or extended, or (b) the conformity of a device or category of devices should be established, by way of derogation from the provisions of Article 9, by applying one or more given procedures taken from amongst those referred to in Article 9, it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. The measures shall be adopted in accordance with the procedure laid down in Article 7(2). 2. When a measure is to be taken in accordance with paragraph 1, due consideration shall be given to: (a) any relevant information available from the vigilance procedures and from external quality assessment schemes as referred to in Article 11; (b) the following criteria: (i) whether total reliance has to be placed on the result obtained with a given device, this result having a direct impact on subsequent medical action, and (ii) whether action taken on the basis of an incorrect result obtained using a given device could prove to be hazardous to the patient, to a third party or to the public, in particular as a consequence of false positive or false negative results, and (iii) whether the involvement of a notified body would be conducive to establishing the conformity of the device. 3. The Commission shall inform the Member States of the measures taken and, where appropriate, publish these measures in the Official Journal of the European Communities. Article 15 Notified bodies 1. Member States shall notify the Commission and other Member States of the bodies which they have designated for carrying out the tasks pertaining to the procedures referred to in Article 9 and the specific tasks for which the bodies have been designated. The Commission shall assign identification numbers to these bodies, hereinafter referred to as 'notified bodies`. The Commission shall publish a list of the notified bodies, together with the identification numbers it has allocated to them and the tasks for which they have been notified, in the Official Journal of the European Communities. It shall ensure that the list is kept up to date. Member States shall not be obliged to designate a notified body. 2. Member States shall apply the criteria set out in Annex IX for the designation of bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonised standards shall be presumed to meet the relevant criteria. 3. Member States shall apply continual surveillance of notified bodies to ensure ongoing compliance with the criteria set out in Annex IX. A Member State that has notified a body shall withdraw or restrict that notification if it finds that the body no longer meets the criteria referred to in Annex IX. It shall immediately inform the other Member States and the Commission of any withdrawal of notification or any restriction placed on it. 4. The notified body and the manufacturer, or his authorised representative established in the Community, shall lay down, by common accord, the time limits for completion of the assessment and verification operations referred to in Annexes III to VII. 5. The notified body shall inform the other notified bodies and the competent authority about all certificates suspended or withdrawn and, on request, about certificates issued or refused. It shall also make available, on request, all additional relevant information. 6. Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or where a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer. In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof. The Member State shall inform the other Member States and the Commission. 7. The notified body shall, on request, supply all relevant information and documents, including budgetary documents, required to enable the Member State to verify compliance with Annex IX requirements. Article 16 CE marking 1. Devices, other than devices for performance evaluation, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market. 2. The CE marking of conformity, as shown in Annex X, must appear in a visible, legible and indelible form on the device, where practicable and appropriate, and on the instructions for use. The CE marking of conformity must also appear on the sales packaging. The CE marking shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes III, IV, VI and VII. 3. It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not thereby reduced. Article 17 Wrongly affixed CE marking 1. Without prejudice to Article 8: (a) where a Member State establishes that the CE marking has been wrongly affixed, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State; (b) where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8. 2. The provisions stated in paragraph 1 shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive. Article 18 Decisions in respect of refusal or restriction 1. Any decision taken pursuant to this Directive: (a) to refuse or restrict the placing on the market or any making available or putting into service of a device, or (b) to withdraw devices from the market, shall state the exact grounds on which it is based. Such decisions shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the national law in force in the Member State in question and of the time limits to which such remedies are subject. 2. In the event of a decision as referred to in paragraph 1, the manufacturer or his authorised representative shall have an opportunity to put forward his point of view in advance, unless such consultation is not possible because of the urgency of the measure to be taken as justified in particular by public health requirements. Article 19 Confidentiality Without prejudice to national law and practice on medical secrecy, Member States shall ensure that all the parties involved in the application of this Directive are bound to observe confidentiality with regard to information obtained in carrying out their tasks. This does not affect the obligations of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law. Article 20 Cooperation between Member States Member States shall take appropriate measures to ensure that competent authorities charged with the implementation of this Directive cooperate with each other and convey to each other the information necessary to ensure application in compliance with this Directive. Article 21 Amendment of directives 1. In Directive 89/392/EEC, the second indent of Article 1(3), 'machinery for medical use, used in direct contact with patients` shall be replaced by the following: '- medical devices,`. 2. Directive 93/42/EEC is hereby amended as follows: (a) in Article 1(2): - point (c) shall be replaced by the following: '(c) "in vitro diagnostic medical device" means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: - concerning a physiological or pathological state, or - concerning a congenital abnormality, or - to determine the safety and compatibility with potential recipients, or - to monitor therapeutic measures. Specimen receptacles are considered to be in vitro diagnostic medical devices. "Specimen receptacles" are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;` - point (i) shall be replaced by the following: '(i) "putting into service" means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose;` - the following point shall be added: '(j) "authorised representative" means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;` (b) Article 2 shall be replaced by the following: 'Article 2 Placing on the market and putting into service Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose.` (c) the following paragraph shall be added to Article 14(1): 'For all medical devices of classes IIb and III, Member States may request to be informed of all data allowing for identification of such devices together with the label and the instructions for use when such devices are put into service within their territory.` (d) the following Articles shall be inserted: 'Article 14a European databank 1. Regulatory data in accordance with this Directive shall be stored in a European database accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis. The databank shall contain the following: (a) data relating to registration of manufacturers and devices in accordance with Article 14; (b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures, as laid down in Annexes II to VII; (c) data obtained in accordance with the vigilance procedure as defined in Article 10; 2. Data shall be forwarded in a standardised format. 3. The procedures implementing this Article shall be adopted in accordance with the procedure laid down in Article 7(2). Article 14b Particular health monitoring measures Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed pursuant to Article 36 of the Treaty, the availability of such products should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures. It shall then inform the Commission and all the other Member States giving the reasons for its decision. The Commission shall, whenever possible, consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community measures in accordance with the procedure referred to in Article 7(2).` (e) the following paragraphs shall be added to Article 16: '5. The notified body shall inform the other notified bodies and the competent authority about all certificates suspended or withdrawn and, on request, about certificates issued or refused. It shall also make available, on request, all additional relevant information. 6. Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or where a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer. In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof. The Member State shall inform the other Member States and the Commission. 7. The notified body shall, on request, supply all relevant information and documents including budgetary documents, required to enable the Member State to verify compliance with Annex XI requirements.` (f) the following paragraph shall be added to Article 18: 'Those provisions shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.` (g) in Article 22(4), the first subparagraph shall be replaced by the following: '4. Member States shall accept: - devices which conform to the rules in force in their territory on 31 December 1994 being placed on the market during a period of five years following the adoption of this Directive, and - the aforementioned devices being put into service until 30 June 2001 at the latest.` (h) Annex II, section 6.2, Annex III, section 7.1, Annex V, section 5.2 and Annex VI, section 5.2 shall be deleted; (i) in Annex XI, section 3 the following sentence shall be inserted after the second sentence: 'This presupposes the availability of sufficient scientific staff within the organisation who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of this Directive and, in particular, those set out in Annex I.` Article 22 Implementation, transitional provisions 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 7 December 1999. They shall immediately inform the Commission thereof. Member States shall apply these provisions with effect from 7 June 2000. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive. 3. The Committee referred to in Article 7 may undertake its tasks from the date of entry into force of this Directive. The Member States may take the measures referred to in Article 15 as from the entry force of this Directive. 4. Member States shall take the necessary action to ensure that the notified bodies which are responsible pursuant to Article 9 for conformity assessment take account of any relevant information regarding the characteristics and performance of such devices, including in particular the results of any relevant test and verification already carried out under pre-existing national law, regulations or administrative provisions in respect of such devices. 5. During a period of five years following the entry into force of this Directive, Member States shall accept the placing on the market of devices which conform to the rules in force in their territory on the date on which this Directive enters into force. For an additional period of two years, the said devices may be put into service. 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.

31998L0083

1998

Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption Having regard to the Treaty establishing the European Community and, in particular, Article 130s(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 189c (4), (1) Whereas it is necessary to adapt Council Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for human consumption (5) to scientific and technological progress; whereas experience gained from implementing that Directive shows that it is necessary to create an appropriately flexible and transparent legal framework for Member States to address failures to meet the standards; whereas, furthermore, that Directive should be re-examined in the light of the Treaty on European Union and in particular the principle of subsidiarity; (2) Whereas in keeping with Article 3b of the Treaty, which provides that no Community action should go beyond what is necessary to achieve the objectives of the Treaty, it is necessary to revise Directive 80/778/EEC so as to focus on compliance with essential quality and health parameters, leaving Member States free to add other parameters if they see fit; (3) Whereas, in accordance with the principle of subsidiarity, Community action must support and supplement action by the competent authorities in the Member States; (4) Whereas, in accordance with the principle of subsidiarity, the natural and socio-economic differences between the regions of the Union require that most decisions on monitoring, analysis, and the measures to be taken to redress failures be taken at a local, regional or national level insofar as those differences do not detract from the establishment of the framework of laws, regulations and administrative provisions laid down in this Directive; (5) Whereas Community standards for essential and preventive health-related quality parameters in water intended for human consumption are necessary if minimum environmental-quality goals to be achieved in connection with other Community measures are to be defined so that the sustainable use of water intended for human consumption may be safeguarded and promoted; (6) Whereas, in view of the importance of the quality of water intended for human consumption for human health, it is necessary to lay down at Community level the essential quality standards with which water intended for that purpose must comply; (7) Whereas it is necessary to include water used in the food industry unless it can be established that the use of such water does not affect the wholesomeness of the finished product; (8) Whereas to enable water-supply undertakings to meet the quality standards for drinking water, appropriate water-protection measures should be applied to ensure that surface and groundwater is kept clean; whereas the same goal can be achieved by appropriate water-treatment measures to be applied before supply; (9) Whereas the coherence of European water policy presupposes that a suitable water framework Directive will be adopted in due course; (10) Whereas it is necessary to exclude from the scope of this Directive natural mineral waters and waters which are medicinal products, since special rules for those types of water have been established; (11) Whereas measures are required for all parameters directly relevant to health and for other parameters if a deterioration in quality has occurred; whereas, furthermore, such measures should be carefully coordinated with the implementation of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (6) and 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 (7); (12) Whereas it is necessary to set individual parametric values for substances which are important throughout the Community at a level strict enough to ensure that this Directive's purpose can be achieved; (13) Whereas the parametric values are based on the scientific knowledge available and the precautionary principle has also been taken into account; whereas those values have been selected to ensure that water intended for human consumption can be consumed safely on a life-long basis, and thus represent a high level of health protection; (14) Whereas a balance should be struck to prevent both microbiological and chemical risks; whereas, to that end, and in the light of a future review of the parametric values, the establishment of parametric values applicable to water intended for human consumption should be based on public-health considerations and on a method of assessing risk; (15) Whereas there is at present insufficient evidence on which to base parametric values for endocrine-disrupting chemicals at Community level, yet there is increasing concern regarding the potential impact on humans and wildlife of the effects of substances harmful to health; (16) Whereas in particular the standards in Annex I are generally based on the World Health Organisation's 'Guidelines for drinking water quality`, and the opinion of the Commission's Scientific Advisory Committee to examine the toxicity and ecotoxicity of chemical compounds; (17) Whereas Member States must set values for other additional parameters not included in Annex I where that is necessary to protect human health within their territories; (18) Whereas Member States may set values for other additional parameters not included in Annex I where that is deemed necessary for the purpose of ensuring the quality of the production, distribution and inspection of water intended for human consumption; (19) Whereas, when Member States deem it necessary to adopt standards more stringent than those set out in Annex I, Parts A and B, or standards for additional parameters not included in Annex I but necessary to protect human health, they must notify the Commission of those standards; (20) Whereas Member States are bound, when introducing or maintaining more stringent protection measures, to respect the principles and rules of the Treaty, as they are interpreted by the Court of Justice; (21) Whereas the parametric values are to be complied with at the point where water intended for human consumption is made available to the appropriate user; (22) Whereas the quality of water intended for human consumption can be influenced by the domestic distribution system; whereas, furthermore, it is recognised that neither the domestic distribution system nor its maintenance may be the responsibility of the Member States; (23) Whereas each Member State should establish monitoring programmes to check that water intended for human consumption meets the requirements of this Directive; whereas such monitoring programmes should be appropriate to local needs and should meet the minimum monitoring requirements laid down in this Directive; (24) Whereas the methods used to analyse the quality of water intended for human consumption should be such as to ensure that the results obtained are reliable and comparable; (25) Whereas, in the event of non-compliance with the standards imposed by this Directive the Member State concerned should investigate the cause and ensure that the necessary remedial action is taken as soon as possible to restore the quality of the water; (26) Whereas it is important to prevent contaminated water causing a potential danger to human health; whereas the supply of such water should be prohibited or its use restricted; (27) Whereas, in the event of non-compliance with a parameter that has an indicator function, the Member State concerned must consider whether that non-compliance poses any risk to human health; whereas it should take remedial action to restore the quality of the water where that is necessary to protect human health; (28) Whereas, should such remedial action be necessary to restore the quality of water intended for human consumption, in accordance with Article 130r(2) of the Treaty, priority should be given to action which rectifies the problem at source; (29) Whereas Member States should be authorised, under certain conditions, to grant derogations from this Directive; whereas, furthermore, it is necessary to establish a proper framework for such derogations, provided that they must not constitute a potential danger to human health and provided that the supply of water intended for human consumption in the area concerned cannot otherwise be maintained by any other reasonable means; (30) Whereas, since the preparation or distribution of water intended for human consumption may involve the use of certain substances or materials, rules are required to govern the use thereof in order to avoid possible harmful effects on human health; (31) Whereas scientific and technical progress may necessitate rapid adaptation of the technical requirements laid down in Annexes II and III; whereas, furthermore, in order to facilitate application of the measures required for that purpose, provision should be made for a procedure under which the Commission can adopt such adaptations with the assistance of a committee composed of representatives of the Member States; (32) Whereas consumers should be adequately and appropriately informed of the quality of water intended for human consumption, of any derogations granted by the Member States and of any remedial action taken by the competent authorities; whereas, furthermore, consideration should be given both to the technical and statistical needs of the Commission, and to the rights of the individual to obtain adequate information concerning the quality of water intended for human consumption; (33) Whereas, in exceptional circumstances and for geographically defined areas, it may be necessary to allow Member States a more extensive timescale for compliance with certain provisions of this Directive; (34) Whereas this Directive should not affect the obligations of the Member States as to the time limit for transposition into national law, or as to application, as shown in Annex IV, Article 1 Objective 1. This Directive concerns the quality of water intended for human consumption. 2. The objective of this Directive shall be to protect human health from the adverse effects of any contamination of water intended for human consumption by ensuring that it is wholesome and clean. Article 2 Definitions For the purposes of this Directive: 1. 'water intended for human consumption` shall mean: (a) all water either in its original state or after treatment, intended for drinking, cooking, food preparation or other domestic purposes, regardless of its origin and whether it is supplied from a distribution network, from a tanker, or in bottles or containers; (b) all water used in any food-production undertaking for the manufacture, processing, preservation or marketing of products or substances intended for human consumption unless the competent national authorities are satisfied that the quality of the water cannot affect the wholesomeness of the foodstuff in its finished form; 2. 'domestic distribution system` shall mean the pipework, fittings and appliances which are installed between the taps that are normally used for human consumption and the distribution network but only if they are not the responsibility of the water supplier, in its capacity as a water supplier, according to the relevant national law. Article 3 Exemptions 1. This Directive shall not apply to: (a) natural mineral waters recognised as such by the competent national authorities, in accordance with Council Directive 80/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters (8); (b) waters which are medicinal products within the meaning of 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 (9). 2. Member States may exempt from the provisions of this Directive: (a) water intended exclusively for those purposes for which the competent authorities are satisfied that the quality of the water has no influence, either directly or indirectly, on the health of the consumers concerned; (b) water intended for human consumption from an individual supply providing less than 10 m³ a day as an average or serving fewer than 50 persons, unless the water is supplied as part of a commercial or public activity. 3. Member States that have recourse to the exemptions provided for in paragraph 2(b) shall ensure that the population concerned is informed thereof and of any action that can be taken to protect human health from the adverse effects resulting from any contamination of water intended for human consumption. In addition, when a potential danger to human health arising out of the quality of such water is apparent, the population concerned shall promptly be given appropriate advice. Article 4 General obligations 1. Without prejudice to their obligations under other Community provisions, Member States shall take the measures necessary to ensure that water intended for human consumption is wholesome and clean. For the purposes of the minimum requirements of this Directive, water intended for human consumption shall be wholesome and clean if it: (a) is free from any micro-organisms and parasites and from any substances which, in numbers or concentrations, constitute a potential danger to human health, and (b) meets the minimum requirements set out in Annex I, Parts A and B; and if, in accordance with the relevant provisions of Articles 5 to 8 and 10 and in accordance with the Treaty, Member States take all other measures necessary to ensure that water intended for human consumption complies with the requirements of this Directive. 2. Member States shall ensure that the measures taken to implement this Directive in no circumstances have the effect of allowing, directly or indirectly, either any deterioration of the present quality of water intended for human consumption so far as that is relevant for the protection of human health or any increase in the pollution of waters used for the production of drinking water. Article 5 Quality standards 1. Member States shall set values applicable to water intended for human consumption for the parameters set out in Annex I. 2. The values set in accordance with paragraph 1 shall not be less stringent than those set out in Annex I. As regards the parameters set out in Annex I, Part C, the values need be fixed only for monitoring purposes and for the fulfilment of the obligations imposed in Article 8. 3. A Member State shall set values for additional parameters not included in Annex I where the protection of human health within its national territory or part of it so requires. The values set should, as a minimum, satisfy the requirements of Article 4(1)(a). Article 6 Point of compliance 1. The parametric values set in accordance with Article 5 shall be complied with: (a) in the case of water supplied from a distribution network, at the point, within premises or an establishment, at which it emerges from the taps that are normally used for human consumption; (b) in the case of water supplied from a tanker, at the point at which it emerges from the tanker; (c) in the case of water put into bottles or containers intended for sale, at the point at which the water is put into the bottles or containers; (d) in the case of water used in a food-production undertaking, at the point where the water is used in the undertaking. 2. In the case of water covered by paragraph 1(a), Member States shall be deemed to have fulfilled their obligations under this Article and under Articles 4 and 8(2) where it can be established that non-compliance with the parametric values set in accordance with Article 5 is due to the domestic distribution system or the maintenance thereof except in premises and establishments where water is supplied to the public, such as schools, hospitals and restaurants. 3. Where paragraph 2 applies and there is a risk that water covered by paragraph 1(a) would not comply with the parametric values established in accordance with Article 5, Member States shall nevertheless ensure that: (a) appropriate measures are taken to reduce or eliminate the risk of non-compliance with the parametric values, such as advising property owners of any possible remedial action they could take, and/or other measures, such as appropriate treatment techniques, are taken to change the nature or properties of the water before it is supplied so as to reduce or eliminate the risk of the water not complying with the parametric values after supply; and (b) the consumers concerned are duly informed and advised of any possible additional remedial action that they should take. Article 7 Monitoring 1. Member States shall take all measures necessary to ensure that regular monitoring of the quality of water intended for human consumption is carried out, in order to check that the water available to consumers meets the requirements of this Directive and in particular the parametric values set in accordance with Article 5. Samples should be taken so that they are representative of the quality of the water consumed throughout the year. In addition, Member States shall take all measures necessary to ensure that, where disinfection forms part of the preparation or distribution of water intended for human consumption, the efficiency of the disinfection treatment applied is verified, and that any contamination from disinfection by-products is kept as low as possible without compromising the disinfection. 2. To meet the obligations imposed in paragraph 1, appropriate monitoring programmes shall be established by the competent authorities for all water intended for human consumption. Those monitoring programmes shall meet the minimum requirements set out in Annex II. 3. The sampling points shall be determined by the competent authorities and shall meet the relevant requirements set out in Annex II. 4. Community guidelines for the monitoring prescribed in this Article may be drawn up in accordance with the procedure laid down in Article 12. 5 (a) Member States shall comply with the specifications for the analyses of parameters set out in Annex III. (b) Methods other than those specified in Annex III, Part 1, may be used, providing it can be demonstrated that the results obtained are at least as reliable as those produced by the methods specified. Member States which have recourse to alternative methods shall provide the Commission with all relevant information concerning such methods and their equivalence. (c) For those parameters listed in Annex III, Parts 2 and 3, any method of analysis may be used provided that it meets the requirements set out therein. 6. Member States shall ensure that additional monitoring is carried out on a case-by-case basis of substances and micro-organisms for which no parametric value has been set in accordance with Article 5, if there is reason to suspect that they may be present in amounts or numbers which constitute a potential danger to human health. Article 8 Remedial action and restrictions in use 1. Member States shall ensure that any failure to meet the parametric values set in accordance with Article 5 is immediately investigated in order to identify the cause. 2. If, despite the measures taken to meet the obligations imposed in Article 4(1), water intended for human consumption does not meet the parametric values set in accordance with Article 5, and subject to Article 6(2), the Member State concerned shall ensure that the necessary remedial action is taken as soon as possible to restore its quality and shall give priority to their enforcement action, having regard inter alia to the extent to which the relevant parametric value has been exceeded and to the potential danger to human health. 3. Whether or not any failure to meet the parametric values has occurred, Member States shall ensure that any supply of water intended for human consumption which constitutes a potential danger to human health is prohibited or its use restricted or such other action is taken as is necessary to protect human health. In such cases consumers shall be informed promptly thereof and given the necessary advice. 4. The competent authorities or other relevant bodies shall decide what action under paragraph 3 should be taken, bearing in mind the risks to human health which would be caused by an interruption of the supply or a restriction in the use of water intended for human consumption. 5. Member States may establish guidelines to assist the competent authorities to fulfil their obligations under paragraph 4. 6. In the event of non-compliance with the parametric values or with the specifications set out in Annex I, Part C, Member States shall consider whether that non-compliance poses any risk to human health. They shall take remedial action to restore the quality of the water where that is necessary to protect human health. 7. Member States shall ensure that, where remedial action is taken, consumers are notified except where the competent authorities consider the non-compliance with the parametric value to be trivial. Article 9 Derogations 1. Member States may provide for derogations from the parametric values set out in Annex I, Part B, or set in accordance with Article 5(3), up to a maximum value to be determined by them, provided no derogation constitutes a potential danger to human health and provided that the supply of water intended for human consumption in the area concerned cannot otherwise be maintained by any other reasonable means. Derogations shall be limited to as short a time as possible and shall not exceed three years, towards the end of which a review shall be conducted to determine whether sufficient progress has been made. Where a Member State intends to grant a second derogation, it shall communicate the review, along with the grounds for its decision on the second derogation, to the Commission. No such second derogation shall exceed three years. 2. In exceptional circumstances, a Member State may ask the Commission for a third derogation for a period not exceeding three years. The Commission shall take a decision on any such request within three months. 3. Any derogation granted in accordance with paragraphs 1 or 2 shall specify the following: (a) the grounds for the derogation; (b) the parameter concerned, previous relevant monitoring results, and the maximum permissible value under the derogation; (c) the geographical area, the quantity of water supplied each day, the population concerned and whether or not any relevant food-production undertaking would be affected; (d) an appropriate monitoring scheme, with an increased monitoring frequency where necessary; (e) a summary of the plan for the necessary remedial action, including a timetable for the work and an estimate of the cost and provisions for reviewing; (f) the required duration of the derogation. 4. If the competent authorities consider the non-compliance with the parametric value to be trivial, and if action taken in accordance with Article 8(2) is sufficient to remedy the problem within 30 days, the requirements of paragraph 3 need not be applied. In that event, only the maximum permissible value for the parameter concerned and the time allowed to remedy the problem shall be set by the competent authorities or other relevant bodies. 5. Recourse may no longer be had to paragraph 4 if failure to comply with any one parametric value for a given water supply has occurred on more than 30 days on aggregate during the previous 12 months. 6. Any Member State which has recourse to the derogations provided for in this Article shall ensure that the population affected by any such derogation is promptly informed in an appropriate manner of the derogation and of the conditions governing it. In addition the Member State shall, where necessary, ensure that advice is given to particular population groups for which the derogation could present a special risk. These obligations shall not apply in the circumstances described in paragraph 4 unless the competent authorities decide otherwise. 7. With the exception of derogations granted in accordance with paragraph 4 a Member State shall inform the Commission within two months of any derogation concerning an individual supply of water exceeding 1 000 m³ a day as an average or serving more than 5 000 persons, including the information specified in paragraph 3. 8. This Article shall not apply to water intended for human consumption offered for sale in bottles or containers. Article 10 Quality assurance of treatment, equipment and materials Member States shall take all measures necessary to ensure that no substances or materials for new installations used in the preparation or distribution of water intended for human consumption or impurities associated with such substances or materials for new installations remain in water intended for human consumption in concentrations higher than is necessary for the purpose of their use and do not, either directly or indirectly, reduce the protection of human health provided for in this Directive; the interpretative document and technical specifications pursuant to Article 3 and Article 4 (1) of Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products (10) shall respect the requirements of this Directive. Article 11 Review of Annexes 1. At least every five years, the Commission shall review Annex I in the light of scientific and technical progress and shall make proposals for amendments, where necessary, under the procedure laid down in Article 189c of the Treaty. 2. At least every five years, the Commission shall adapt Annexes II and III to scientific and technical progress. Such changes as are necessary shall be adopted in accordance with the procedure laid down in Article 12. Article 12 Committee procedure 1. The Commission shall be assisted by a committee composed of representatives of the Member States and chaired by a Commission representative. 2. The Commission representative shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. The Commission shall adopt measures which shall apply immediately. However, if those measures are not in accordance with the committee's opinion, the Commission shall communicate them to the Council forthwith. In that event: (a) the Commission shall defer application of the measures which it has adopted for a period of three months from the date of communication; (b) the Council, acting by a qualified majority, may take a different decision within the time limit referred to in point (a). Article 13 Information and reporting 1. Member States shall take the measures necessary to ensure that adequate and up-to-date information on the quality of water intended for human consumption is available to consumers. 2. Without prejudice to Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment (11), each Member State shall publish a report every three years on the quality of water intended for human consumption with the objective of informing consumers. The first report shall cover the years 2002, 2003 and 2004. Each report shall include, as a minimum, all individual supplies of water exceeding 1 000 m³ a day as an average or serving more than 5 000 persons and it shall cover three calendar years and be published within one calendar year of the end of the reporting period. 3. Member States shall send their reports to the Commission within two months of their publication. 4. The formats and the minimum information for the reports provided for in paragraph 2 shall be determined having special regard to the measures referred to in Article 3(2), Article 5(2) and (3), Article 7(2), Article 8, Article 9(6) and (7) and 15(1), and shall if necessary be amended in accordance with the procedure laid down in Article 12. 5. The Commission shall examine the Member States' reports and, every three years, publish a synthesis report on the quality of water intended for human consumption in the Community. That report shall be published within nine months of the receipt of the Member States' reports. 6. Together with the first report on this Directive as mentioned in paragraph 2, Member States shall also produce a report to be forwarded to the Commission on the measures they have taken or plan to take to fulfill their obligations pursuant to Article 6(3) and Annex I, Part B, note 10. The Commission shall submit, as appropriate, a proposal on the format of this report in accordance with the procedure laid down in Article 12. Article 14 Timescale for compliance Member States shall take the measures necessary to ensure that the quality of water intended for human consumption complies with this Directive within five years of its entry into force, without prejudice to Notes 2, 4 and 10 in Annex I, Part B. Article 15 Exceptional circumstances 1. A Member State may, in exceptional circumstances and for geographically defined areas, submit a special request to the Commission for a period longer than that laid down in Article 14. The additional period shall not exceed three years, towards the end of which a review shall be carried out and forwarded to the Commission which may, on the basis of that review, permit a second additional period of up to three years. This provision shall not apply to water intended for human consumption offered for sale in bottles or containers. 2. Any such request, grounds for which shall be given, shall set out the difficulties experienced and include, as a minimum, all the information specified in Article 9(3). 3. The Commission shall examine that request in accordance with the procedure laid down in Article 12. 4. Any Member State which has recourse to this Article shall ensure that the population affected by its request is promptly informed in an appropriate manner of the outcome of that request. In addition, the Member State shall, where necessary, ensure that advice is given to particular population groups for which the request could present a special risk. Article 16 Repeal 1. Directive 80/778/EEC is hereby repealed with effect from five years after the entry into force of this Directive. Subject to paragraph 2, this repeal shall be without prejudice to Member States' obligations regarding deadlines for transposition into national law and for application as shown in Annex IV. Any reference to the Directive repealed shall be construed as a reference to this Directive and shall be read in accordance with the correlation table set out in Annex V. 2. As soon as a Member State has brought into force the laws, regulations and administrative provisions necessary to comply with this Directive and has taken the measures provided for in Article 14, this Directive, not Directive 80/778/EEC, shall apply to the quality of water intended for human consumption in that Member State. Article 17 Transposition into national law 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within two years of its entry into force. They shall forthwith inform the Commission thereof. When the Member States adopt those measures, these shall contain references to this Directive or shall be accompanied by such references on the occasion of their official publication. The methods of making such references 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 which they adopt in the field covered by this Directive. Article 18 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Article 19 Addressees This Directive is addressed to the Member States.

31998L0085

1998

Commission Directive 98/85/EC of 11 November 1998 amending Council Directive 96/98/EC on marine equipment (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 96/98/EC of 20 December 1996 on marine equipment (1), and in particular the first and second indents thereof, (1) Whereas, for the purposes of Council Directive 96/98/EC, the international conventions, including the 1974 SOLAS Convention, and testing standards are those, together with their amendments, in force on the date of the adoption of that Directive; (2) Whereas amendments to the SOLAS Convention and to other international conventions and new testing standards have entered into force since the adoption of that Directive or will enter into force shortly; (3) Whereas new rules regarding the equipment to be placed on board ships have been laid down by those instruments; (4) Whereas Directive 96/98/EC should be amended accordingly; (5) Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 12 of Council Directive 93/75/EEC (2), as last amended by Commission Directive 98/74/EC (3), Article 1 Directive 96/98/EC is hereby amended as follows: 1. Article 2 is amended as follows: (a) Point (c) is replaced by the following: '(c) "radiocommunications equipment" shall mean equipment required by Chapter IV of the 1974 SOLAS Convention, in the version in force on 1 January 1999, and survival craft two-way VHF radiotelephone apparatus required by Regulation III/6.2.1 of the same Convention;` (b) In points (d) and (n), the words 'the date of the adoption of this Directive` are replaced by '1 January 1999`. 2. Annex A 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 30 April 1999 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 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.

31998L0090

1998

Commission Directive 98/90/EC of 30 November 1998 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 Commission Directive 98/14/EC (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 vehicles and their trailers (3), as amended by the Act of Accession of Denmark, Ireland and the United Kingdom, and in particular Article 3 thereof, Whereas Directive 70/387/EEC is one of the separate Directives of the EC type-approval procedure established by Directive 70/156/EEC; whereas consequently the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to the present Directive; Whereas it is possible further to adapt Directive 70/387/EEC to technical progress by improving safety of persons entering and leaving the driver's compartment of some heavy goods vehicles; Whereas, in particular, Article 3(4) and Article 4(3) of Directive 70/156/EEC necessitate that each separate Directive has attached to it an information document incorporating the relevant items referred to in Annex I to that Directive and also a type-approval certificate based on Annex VI thereto in order that type-approval may be computerised; Whereas with a view to the practical application of Directive 70/387/EEC, it is necessary to ensure that uniform provisions exist in all Member States; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the adaption to technical progress established by Directive 70/156/EEC, Article 1 Directive 70/387/EEC is amended as follows: 1. In Article 1, the words 'agricultural tractors` are replaced by 'agricultural and forestry tractors` and the words 'machinery and public works vehicles` are replaced by 'all mobile machinery`. 2. The Annexes are amended in accordance with the Annex to this Directive. Article 2 1. With effect from l January 1999 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, 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 l October 2000 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 31 December 1998 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 seventh day following that of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States.

31998L0099

1998

Council Directive 98/99/EC of 14 December 1998 amending Directive 97/12/EC amending and updating Directive 64/432/EEC on health problems affecting intra-Community trade in bovine animals and swine Having regard to the Treaty establishing the European Community, and in particular Article 43 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 the adoption of Directive 97/12/EC (4) provided an improved legal basis for implementation of measures to prevent spread of animal diseases via trade in live bovine animals and swine; Whereas Directive 97/12/EC contained special requirements for further updating of the criteria for defining the health status of animal populations at herd, region and Member State level as regards bovine tuberculosis, bovine brucellosis and enzootic bovine leucosis; whereas the updating of these criteria should, based on a proposal submitted to the Council before July 1997, have been decided before 1 January 1998; Whereas the review carried out by the Council of diagnostic procedures of most importance for implementation of effective surveillance and monitoring programmes for bovine tuberculosis, bovine brucellosis and enzootic bovine leucosis included in-depth examination of laboratory testing methods and resulted in time-consuming deliberations; Whereas the changes required for updated monitoring programmes and surveillance programmes cannot be implemented in this field at short notice; Whereas in accordance with Directive 97/12/EC swine intended for intra-Community trade are no longer subjected to brucellosis testing prior to departure; whereas, this provision should be anticipated in order to facilitate trade between the Member States; Whereas to avoid obstacles in intra-Community trade and to ensure uniform application of the provisions, harmonised rules concerning the use and the issue of health certificates should be laid down for the period until the date by which the Member States have to comply with the amended provisions of Council Directive 64/432/EEC of 26 June 1964 on health problems affecting intra-Community trade in bovine animals and swine (5); Whereas on 24 June 1998 the Council adopted Directive 98/46/EC to amend the Annexes A, D (Chapter I) and F of Directive 64/432/EEC; whereas owing to this amendment certain references in Directive 97/12/EC have changed; Whereas this fact has been taken into account by attaching a table of correspondence in Annex II to Directive 98/46/EC; whereas for the sake of improved clarity and of the coherence of the legal texts it is necessary to correct the references in the corresponding articles; Whereas it is therefore necessary to amend Directive 97/12/EC in particular as regards the period made available for Member States to transpose and introduce new rules for disease monitoring and surveillance, Article 1 Directive 97/12/EC is hereby amended as follows: 1. Article 1 shall be replaced by the following: 'Article 1 The Articles of and the Annexes B, C, D (Chapter II) and E to Directive 64/432/EEC shall be replaced by the text annexed to this Directive, the Annexes A, D (Chapter I) and F shall be replaced by the text annexed to Directive 98/46/EC`. 2. In the first sentence of Article 2(1) the terms 'not later than 1 July 1998` shall be replaced by 'not later than 1 July 1999`. 3. The Annex shall be amended as follows: (a) Amendments to Article 2(2): - in paragraph (d), the terms 'Annex A.I paragraphs 1, 2 and 3` shall be replaced by the terms 'Annex A.I, paragraphs 1 and 2`; - in paragraph (e), the terms 'Annex A.I, paragraphs 4, 5 and 6` shall be replaced by the terms 'Annex A.I, paragraphs 4 and 5`; - in paragraph (f), the terms 'Annex A.II, paragraphs 1, 2 and 3` shall be replaced by the terms 'Annex A.II, paragraphs 1 and 2`; - in paragraph (h), the terms 'Annex A.II, paragraphs 10, 11 and 12` shall be replaced by the terms 'Annex A.II, paragraphs 7, 8 and 9`; - in paragraph (i), the terms 'Annex A.II, paragraphs 4, 5 and 6` shall be replaced by the terms 'Annex A.II, paragraphs 4 and 5`; - in paragraph (k), the terms 'Annex D, Chapter I, Sections E, F and G` shall be replaced by the terms 'Annex D, Chapter I, Sections E and F`. (b) Amendments to Article 5: - in paragraph 1, the terms 'certificate conforming to the model set out in Annex F` shall be replaced by the term 'certificate conforming to either model 1 or 2 set out in Annex F as appropriate`. - in paragraphs 2(a) and 2(b), the terms 'certificate contained in Annex F` and in paragraph 5, the terms 'certificate in Annex F` shall be replaced by the terms 'certificate according to either model 1 or 2 in Annex F as appropriate`. - in paragraph 4, the terms 'Part D of the certificate the model of which appears in Annex F` shall be replaced by the terms 'Section C of the certificate according to either model 1 or 2 in Annex F as appropriate`. - in paragraph 5, the terms in brackets '(including Section DI)` shall be replaced by the terms '(including Section C)`. Article 2 With regard to the examination and certification of live bovine and swine intended for intra-Community trade the following rules shall be applicable: 1. as from 1 January 1999 the obligation for brucellosis testing prior to departure of swine intended for intra-Community trade according to Article 3(4) second sentence of Directive 64/432/EEC is no longer applicable. 2. until 30 June 1999, the certificates must be in conformity with Annex F of Directive 64/432/EEC (as in force on 30 June 1998) with the following exception: as from 1 January 1999, point v(b) first indent (as well as the corresponding footnote 5) of the health certificate for swine for breeding and production laid down in model III has to be deleted on its issue by the issuing authority. 3. as from 1 July 1999 the certificates have to be in conformity with the models laid down in Annex F of Directive 64/432/EEC as amended by Directive 98/46/EC. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 1 of this Directive not later than 1 July 1999 and to comply with Article 2 of this Directive not later than 1 January 1999. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 4 The 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.