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31978L0025

Council Directive 78/25/EEC of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products

Official Journal L 011 , 14/01/1978 P. 0018 - 0020 Finnish special edition: Chapter 13 Volume 8 P. 0039  Greek special edition: Chapter 13 Volume 7 P. 0034  Swedish special edition: Chapter 13 Volume 8 P. 0039  Spanish special edition: Chapter 13 Volume 8 P. 0086  Portuguese special edition Chapter 13 Volume 8 P. 0086

COUNCIL DIRECTIVE  of 12 December 1977  on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products  (78/25/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 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 the primary purpose of any laws concerning medicinal products must be to safeguard public health ; whereas, however, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community;  Whereas, although the Council Directive of 23 October 1962 (3), as last amended by Directive 76/399/EEC (4), established a single list of colouring matters authorized for use in foodstuffs intended for human consumption, the disparities between the laws of Member States concerning the colouring of medicinal products still exist ; whereas certain Member States apply the rules laid down for foodstuffs to medicinal products ; whereas others have separate lists of authorized colouring matters for medicinal products and for foodstuffs;  Whereas these disparities tend to hinder trade in medicinal products within the Community and trade in colouring matters which may be added to these products ; whereas such disparities therefore directly affect the establishment and functioning of the common market;  Whereas experience has shown that on health grounds there is no reason why the colouring matters authorized for use in foodstuffs intended for human consumption should not also be authorized for use in medicinal products ; whereas, consequently, Annexes I and III to the Directive of 23 October 1962, as they stand or as they subsequently may be amended, should also apply for medicinal products;  Whereas when the use of a colouring matter in foodstuffs and medicinal products is prohibited in order to safeguard public health, technological and economic disturbances should be avoided as far as is possible ; whereas to this end a procedure should be provided which establishes close cooperation between the Member States and the Commission within a Committee for the adjustment to technical progress of the Directives on the elimination of technical barriers to trade in the sector of colouring matters which may be added to medicinal products;  Whereas special consideration must be given to certain colouring matters hitherto permitted by certain Member States, in particular for colouring medicinal products for external use,  (1)OJ No C 62, 30.5.1974, p. 23. (2)OJ No C 116, 30.9.1974, p. 24. (3)OJ No 115, 11.11.1962, p. 2645/62. (4)OJ No L 108, 26.4.1976, p. 19.    HAS ADOPTED THIS DIRECTIVE:    Article 1 Member States shall not authorize, for the colouring of medicinal products for human and veterinary use as defined in Article 1 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 proprietary medicinal products (1), any colouring matters other than those covered by Annex I, Sections I and II, to the Directive of 23 October 1962 as subsequently amended. Any transitional provisions laid down for certain of these colouring matters shall also apply.   Article 2 Member States shall take all measures necessary to ensure that the colouring matters covered by Annex I, Sections I and II, to the Directive of 23 October 1962 satisfy the general and specific criteria of purity laid down in Annex III to that Directive.   Article 3 The methods of analysis needed to verify that the general and specific criteria of purity adopted pursuant to the Directive of 23 October 1962 are satisfied shall also apply for the purpose of this Directive.   Article 4 Where a colouring matter is deleted from Annex I to the Directive of 23 October 1962 but the marketing of foodstuffs containing this colouring matter is permitted to continue for a limited period, this provision shall also apply to medicinal products. This limited period of use may however be amended for medicinal products according to the procedure laid down in Article 6.   Article 5 1. A committee for the adaptation to technical progress of the Directives on the elimination of technical barriers to trade in the sector of colouring matters which may be added to medicinal products, hereinafter called the "Committee", is hereby set up and shall consist of representatives of the Member States with a representative of the Commission as chairman.  2. The Committee shall draw up its own rules of procedure.   Article 6 1. Where the procedure laid down in this Article is to be followed, matters shall be referred to the Committee by the chairman, either on his own initiative or at the request of the representative of a Member State.  2. The Commission representative shall submit a draft of the measures to be adopted. The Committee shall deliver its opinion on such measures within a time limit set by the chairman according to the urgency of the matter. Opinions shall be delivered by a majority of 41 votes, the votes of the Member States being weighted as provided in Article 148 (2) of the Treaty. The chairman shall not vote.  3. The Commission shall adopt the proposed measures where they are in accordance with the opinion of the Committee.  If these measures are not in accordance with the opinion of the Committee, or if the Committee does not deliver an opinion, the Commission shall forthwith submit to the Council a proposal regarding the measures to be adopted.  The Council shall act by a qualified majority.  If the Council has not taken a decision within three months of the matter being referred to it, the Commission shall adopt the proposed measures.   Article 7 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within 18 months of its notification and shall forthwith inform the Commission thereof.  2. However, any Member State may permit, on its own territory, until the end of a period of four years from the notification of this Directive, the marketing of medicinal products containing colouring matters which do not comply with the requirements of this Directive so long as these colouring matters were authorized in that Member State before the adoption of the Directive.  3. Depending on the opinion of the Scientific Committee for Food and of the Committee referred to in Article 5 the Commission shall if appropriate submit to the Council within two years of the adoption of this Directive a proposal for amendment of the Directive to allow the use of:  - the colouring matters:  = Brilliant Blue FCF CI 42090,   = Red 2G CI 18050,   - other colouring matters for medicinal products for external use only.  The Council shall take a decision on the Commission proposal no later than two years after its submission.  (1)OJ No 22, 9.2.1965, p. 369/65.    4. 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 8 This Directive is addressed to the Member States.     Done at Brussels, 12 December 1977.  For the Council  The President  A. HUMBLET


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32000L0053

Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles - Commission Statements

Official Journal L 269 , 21/10/2000 P. 0034 - 0043

Directive 2000/53/EC of the European Parliament and of the Councilof 18 September 2000on end-of life vehiclesTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Having consulted the Committee of the Regions,Acting in accordance with the procedure referred to in Article 251 of the Treaty in the light of the joint text approved by the Conciliation Committee on 23 May 2000(3),Whereas(1) The different national measures concerning end-of life vehicles should be harmonised in order, first, to minimise the impact of end-of life vehicles on the environment, thus contributing to the protection, preservation and improvement of the quality of the environment and energy conservation, and, second, to ensure the smooth operation of the internal market and avoid distortions of competition in the Community.(2) A Community-wide framework is necessary in order to ensure coherence between national approaches in attaining the objectives stated above, particularly with a view to the design of vehicles for recycling and recovery, to the requirements for collection and treatment facilities, and to the attainment of the targets for reuse, recycling and recovery, taking into account the principle of subsidiarity and the polluter-pays principle.(3) Every year end-of life vehicles in the Community generate between 8 and 9 million tonnes of waste, which must be managed correctly.(4) In order to implement the precautionary and preventive principles and in line with the Community strategy for waste management, the generation of waste must be avoided as much as possible.(5) It is a further fundamental principle that waste should be reused and recovered, and that preference be given to reuse and recycling.(6) Member States should take measures to ensure that economic operators set up systems for the collection, treatment and recovery of end-of life vehicles.(7) Member States should ensure that the last holder and/or owner can deliver the end-of life vehicle to an authorised treatment facility without any cost as a result of the vehicle having no or a negative, market value. Member States should ensure that producers meet all, or a significant part of, the costs of the implementation of these measures; the normal functioning of market forces should not be hindered.(8) This Directive should cover vehicles and end-of life vehicles, including their components and materials, as well as spare and replacement parts, without prejudice to safety standards, air emissions and noise control.(9) This Directive should be understood as having borrowed, where appropriate, the terminology used by several existing directives, namely 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(4), Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(5), and Council Directive 75/442/EEC of 15 July 1975 on waste(6).(10) Vintage vehicles, meaning historic vehicles or vehicles of value to collectors or intended for museums, kept in a proper and environmentally sound manner, either ready for use or stripped into parts, are not covered by the definition of waste laid down by Directive 75/442/EEC and do not fall within the scope of this Directive.(11) It is important that preventive measures be applied from the conception phase of the vehicle onwards and take the form, in particular, of reduction and control of hazardous substances in vehicles, in order to prevent their release into the environment, to facilitate recycling and to avoid the disposal of hazardous waste. In particular the use of lead, mercury, cadmium and hexavalent chromium should be prohibited. These heavy metals should only be used in certain applications according to a list which will be regularly reviewed. This will help to ensure that certain materials and components do not become shredder residues, and are not incinerated or disposed of in landfills.(12) The recycling of all plastics from end-of life vehicles should be continuously improved. The Commission is currently examining the environmental impacts of PVC. The Commission will, on the basis of this work, make proposals as appropriate as to the use of PVC including considerations for vehicles.(13) The requirements for dismantling, reuse and recycling of end-of life vehicles and their components should be integrated in the design and production of new vehicles.(14) The development of markets for recycled materials should be encouraged.(15) In order to ensure that end-of life vehicles are discarded without endangering the environment, appropriate collection systems should be set up.(16) A certificate of destruction, to be used as a condition for the de-registration of end-of life vehicles, should be introduced. Member States without a de-registration system should set up a system according to which a certificate of destruction is notified to the relevant competent authority when the end-of life vehicle is transferred to a treatment facility.(17) This Directive does not prevent Member States from granting, where appropriate, temporary deregistrations of vehicles.(18) Collection and treatment operators should be allowed to operate only when they have received a permit or, in case a registration is used instead of a permit, specific conditions have been complied with.(19) The recyclability and recoverability of vehicles should be promoted.(20) It is important to lay down requirements for storage and treatment operations in order to prevent negative impacts on the environment and to avoid the emergence of distortions in trade and competition.(21) In order to achieve results in the short term and to give operators, consumers and public authorities the necessary perspective for the longer term, quantified targets for reuse, recycling and recovery to be achieved by economic operators should be set.(22) Producers should ensure that vehicles are designed and manufactured in such a way as to allow the quantified targets for reuse, recycling and recovery to be achieved. To this end the Commission will promote the preparation of European standards and will take the other necessary measures in order to amend the pertinent European vehicle type-approval legislation.(23) Member States should ensure that in implementing the provisions of this Directive competition is preserved, in particular as regards the access of small and medium-sized enterprises to the collection, dismantling, treatment and recycling market.(24) In order to facilitate the dismantling and recovery, in particular recycling of end-of life vehicles, vehicle manufacturers should provide authorised treatment facilities with all requisite dismantling information, in particular for hazardous materials.(25) The preparation of European standards, where appropriate, should be promoted. Vehicle manufacturers and material producers should use component and material coding standards, to be established by the Commission assisted by the relevant committee. In the preparation of these standards the Commission will take account, as appropriate, of the work going on in this area in the relevant international forums.(26) Community-wide data on end-of life vehicles are needed in order to monitor the implementation of the objectives of this Directive.(27) Consumers have to be adequately informed in order to adjust their behaviour and attitudes; to this end information should be made available by the relevant economic operators.(28) Member States may choose to implement certain provisions by means of agreements with the economic sector concerned, provided that certain conditions are met.(29) The adaptation to scientific and technical progress of the requirements for treatment facilities and for the use of hazardous substances and, as well as the adoption of minimum standards for the certificate of destruction, the formats for the database and the implementation measures necessary to control compliance with the quantified targets should be effected by the Commission under a Committee procedure.(30) The measures to be taken for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7).(31) Member States may apply the provisions of this Directive in advance of the date set out therein, provided such measures are compatible with the Treaty,HAVE ADOPTED THIS DIRECTIVE:Article 1ObjectivesThis Directive lays down measures which aim, as a first priority, at the prevention of waste from vehicles and, in addition, at the reuse, recycling and other forms of recovery of end-of life vehicles and their components so as to reduce the disposal of waste, as well as at the improvement in the environmental performance of all of the economic operators involved in the life cycle of vehicles and especially the operators directly involved in the treatment of end-of life vehicles.Article 2DefinitionsFor the purposes of this Directive:1. "vehicle" means any vehicle designated as category M1 or N1 defined in Annex IIA to Directive 70/156/EEC, and three wheel motor vehicles as defined in Directive 92/61/EEC, but excluding motor tricycles;2. "end-of life vehicle" means a vehicle which is waste within the meaning of Article 1(a) of Directive 75/442/EEC;3. "producer" means the vehicle manufacturer or the professional importer of a vehicle into a Member State;4. "prevention" means measures aiming at the reduction of the quantity and the harmfulness for the environment of end-of life vehicles, their materials and substances;5. "treatment" means any activity after the end-of life vehicle has been handed over to a facility for depollution, dismantling, shearing, shredding, recovery or preparation for disposal of the shredder wastes, and any other operation carried out for the recovery and/or disposal of the end-of life vehicle and its components;6. "reuse" means any operation by which components of end-of life vehicles are used for the same purpose for which they were conceived;7. "recycling" means the reprocessing in a production process of the waste materials for the original purpose or for other purposes but excluding energy recovery. Energy recovery means the use of combustible waste as a means to generate energy through direct incineration with or without other waste but with recovery of the heat;8. "recovery" means any of the applicable operations provided for in Annex IIB to Directive 75/442/EEC;9. "disposal" means any of the applicable operations provided for in Annex IIA to Directive 75/442/EEC;10. "economic operators" means producers, distributors, collectors, motor vehicle insurance companies, dismantlers, shredders, recoverers, recyclers and other treatment operators of end-of life vehicles, including their components and materials;11. "hazardous substance" means any substance which is considered to be dangerous under Directive 67/548/EEC;12. "shredder" means any device used for tearing into pieces or fragmenting end-of life vehicles, including for the purpose of obtaining directly reusable metal scrap;13. "dismantling information" means all information required for the correct and environmentally sound treatment of end-of life vehicles. It shall be made available to authorised treatment facilities by vehicle manufacturers and component producers in the form of manuals or by means of electronic media (e.g. CD-ROM, on-line services).Article 3Scope1. This Directive shall cover vehicles and end-of life vehicles, including their components and materials. Without prejudice to Article 5(4), third subparagraph, this shall apply irrespective of how the vehicle has been serviced or repaired during use and irrespective of whether it is equipped with components supplied by the producer or with other components whose fitting as spare or replacement parts accords with the appropriate Community provisions or domestic provisions.2. This Directive shall apply without prejudice to existing Community legislation and relevant national legislation, in particular as regards safety standards, air emissions and noise controls and the protection of soil and water.3. Where a producer only makes or imports vehicles that are exempt from Directive 70/156/EEC by virtue of Article 8(2)(a) thereof, Member States may exempt that producer and his vehicles from Articles 7(4), 8 and 9 of this Directive.4. Special-purpose vehicles as defined in the second indent of Article 4(1)(a) of Directive 70/156/EEC shall be excluded from the provisions of Article 7 of this Directive.5. For three-wheel motor vehicles only Articles 5(1), 5(2) and 6 of this Directive shall apply.Article 4Prevention1. In order to promote the prevention of waste Member States shall encourage, in particular:(a) vehicle manufacturers, in liaison with material and equipment manufacturers, to limit the use of hazardous substances in vehicles and to reduce them as far as possible from the conception of the vehicle onwards, so as in particular to prevent their release into the environment, make recycling easier, and avoid the need to dispose of hazardous waste;(b) the design and production of new vehicles which take into full account and facilitate the dismantling, reuse and recovery, in particular the recycling, of end-of life vehicles, their components and materials;(c) vehicle manufacturers, in liaison with material and equipment manufacturers, to integrate an increasing quantity of recycled material in vehicles and other products, in order to develop the markets for recycled materials.2. (a) Member States shall ensure that materials and components of vehicles put on the market after 1 July 2003 do not contain lead, mercury, cadmium or hexavalent chromium other than in cases listed in Annex II under the conditions specified therein;(b) in accordance with the procedure laid down in Article 11 the Commission shall on a regular basis, according to technical and scientific progress, amend Annex II, in order to:(i) as necessary, establish maximum concentration values up to which the existence of the substances referred to in subparagraph (a) in specific materials and components of vehicles shall be tolerated;(ii) exempt certain materials and components of vehicles from the provisions of subparagraph (a) if the use of these substances is unavoidable;(iii) delete materials and components of vehicles from Annex II if the use of these substances is avoidable;(iv) under points (i) and (ii) designate those materials and components of vehicles that can be stripped before further treatment; they shall be labelled or made identifiable by other appropriate means;(c) the Commission shall amend Annex II for the first time not later than 21 October 2001. In any case none of the exemptions listed therein shall be deleted from the Annex before 1 January 2003.Article 5Collection1. Member States shall take the necessary measures to ensure:- that economic operators set up systems for the collection of all end-of life vehicles and, as far as technically feasible, of waste used parts removed when passenger cars are repaired,- the adequate availability of collection facilities within their territory.2. Member States shall also take the necessary measures to ensure that all end-of life vehicles are transferred to authorised treatment facilities.3. Member States shall set up a system according to which the presentation of a certificate of destruction is a condition for deregistration of the end-of life vehicle. This certificate shall be issued to the holder and/or owner when the end-of life vehicle is transferred to a treatment facility. Treatment facilities, which have obtained a permit in accordance with Article 6, shall be permitted to issue a certificate of destruction. Member States may permit producers, dealers and collectors on behalf of an authorised treatment facility to issue certificates of destruction provided that they guarantee that the end-of life vehicle is transferred to an authorised treatment facility and provided that they are registered with public authorities.Issuing the certificate of destruction by treatment facilities or dealers or collectors on behalf of an authorised treatment facility does not entitle them to claim any financial reimbursement, except in cases where this has been explicitly arranged by Member States.Member States which do not have a deregistration system at the date of entry into force of this Directive shall set up a system according to which a certificate of destruction is notified to the relevant competent authority when the end-of life vehicle is transferred to a treatment facility and shall otherwise comply with the terms of this paragraph. Member States making use of this subparagraph shall inform the Commission of the reasons thereof.4. Member States shall take the necessary measures to ensure that the delivery of the vehicle to an authorised treatment facility in accordance with paragraph 3 occurs without any cost for the last holder and/or owner as a result of the vehicle's having no or a negative market value.Member States shall take the necessary measures to ensure that producers meet all, or a significant part of, the costs of the implementation of this measure and/or take back end-of life vehicles under the same conditions as referred to in the first subparagraph.Member States may provide that the delivery of end-of life vehicles is not fully free of charge if the end-of life vehicle does not contain the essential components of a vehicle, in particular the engine and the coachwork, or contains waste which has been added to the end-of life vehicle.The Commission shall regularly monitor the implementation of the first subparagraph to ensure that it does not result in market distortions, and if necessary shall propose to the European Parliament and the Council an amendment thereto.5. Member States shall take the necessary measures to ensure that competent authorities mutually recognise and accept the certificates of destruction issued in other Member States in accordance with paragraph 3. To this end, the Commission shall draw up, not later than 21 October 2001 the minimum requirements for the certificate of destruction.Article 6Treatment1. Member States shall take the necessary measures to ensure that all end-of life vehicles are stored (even temporarily) and treated in accordance with the general requirements laid down in Article 4 of Directive 75/442/EEC, and in compliance with the minimum technical requirements set out in Annex I to this Directive, without prejudice to national regulations on health and environment.2. Member States shall take the necessary measures to ensure that any establishment or undertaking carrying out treatment operations obtains a permit from or be registered with the competent authorities, in compliance with Articles 9, 10 and 11 of Directive 75/442/EEC.The derogation from the permit requirement referred to in Article 11(1)(b) of Directive 75/442/EEC may apply to recovery operations concerning waste of end-of life vehicles after they have been treated according to Annex 1(3) to this Directive if there is an inspection by the competent authorities before the registration. This inspection shall verify:(a) type and quantities of waste to be treated;(b) general technical requirements to be complied with;(c) safety precautions to be taken,in order to achieve the objectives referred to in Article 4 of Directive 75/442/EEC. This inspection shall take place once a year. Member States using the derogation shall send the results to the Commission.3. Member States shall take the necessary measures to ensure that any establishment or undertaking carrying out treatment operations fulfils at least the following obligations in accordance with Annex I:(a) end-of life vehicles shall be stripped before further treatment or other equivalent arrangements are made in order to reduce any adverse impact on the environment. Components or materials labelled or otherwise made identifiable in accordance with Article 4(2) shall be stripped before further treatment;(b) hazardous materials and components shall be removed and segregated in a selective way so as not to contaminate subsequent shredder waste from end-of life vehicles;(c) stripping operations and storage shall be carried out in such a way as to ensure the suitability of vehicle components for reuse and recovery, and in particular for recycling.Treatment operations for depollution of end-of life vehicles as referred to in Annex I(3) shall be carried out as soon as possible.4. Member States shall take the necessary measures to ensure that the permit or registration referred to in paragraph 2 includes all conditions necessary for compliance with the requirements of paragraphs 1, 2 and 3.5. Member States shall encourage establishments or undertakings, which carry out treatment operations to introduce, certified environmental management systems.Article 7Reuse and recovery1. Member States shall take the necessary measures to encourage the reuse of components which are suitable for reuse, the recovery of components which cannot be reused and the giving of preference to recycling when environmentally viable, without prejudice to requirements regarding the safety of vehicles and environmental requirements such as air emissions and noise control.2. Member States shall take the necessary measures to ensure that the following targets are attained by economic operators:(a) no later than 1 January 2006, for all end-of life vehicles, the reuse and recovery shall be increased to a minimum of 85 % by an average weight per vehicle and year. Within the same time limit the reuse and recycling shall be increased to a minimum of 80 % by an average weight per vehicle and year;for vehicles produced before 1 January 1980, Member States may lay down lower targets, but not lower than 75 % for reuse and recovery and not lower than 70 % for reuse and recycling. Member States making use of this subparagraph shall inform the Commission and the other Member States of the reasons therefor;(b) no later than 1 January 2015, for all end-of life vehicles, the reuse and recovery shall be increased to a minimum of 95 % by an average weight per vehicle and year. Within the same time limit, the re-use and recycling shall be increased to a minimum of 85 % by an average weight per vehicle and year.By 31 December 2005 at the latest the European Parliament and the Council shall re-examine the targets referred to in paragraph (b) on the basis of a report of the Commission, accompanied by a proposal. In its report the Commission shall take into account the development of the material composition of vehicles and any other relevant environmental aspects related to vehicles.The Commission shall, in accordance with the procedure laid down in Article 11, establish the detailed rules necessary to control compliance of Member States with the targets set out in this paragraph. In doing so the Commission shall take into account all relevant factors, inter alia the availability of data and the issue of exports and imports of end-of life vehicles. The Commission shall take this measure not later than 21 October 2002.3. On the basis of a proposal from the Commission, the European Parliament and the Council shall establish targets for reuse and recovery and for reuse and recycling for the years beyond 2015.4. In order to prepare an amendment to Directive 70/156/EEC, the Commission shall promote the preparation of European standards relating to the dismantlability, recoverability and recyclability of vehicles. Once the standards are agreed, but in any case no later than by the end of 2001, the European Parliament and the Council, on the basis of a proposal from the Commission, shall amend Directive 70/156/EEC so that vehicles type-approved in accordance with that Directive and put on the market after three years after the amendment of the Directive 70/156/EEC are re-usable and/or recyclable to a minimum of 85 % by weight per vehicle and are re-usable and/or recoverable to a minimum of 95 % by weight per vehicle.5. In proposing the amendment to Directive 70/156/EEC relating to the ability to be dismantled, recoverability and recyclability of vehicles, the Commission shall take into account as appropriate the need to ensure that the reuse of components does not give rise to safety or environmental hazards.Article 8Coding standards/dismantling information1. Member States shall take the necessary measures to ensure that producers, in concert with material and equipment manufacturers, use component and material coding standards, in particular to facilitate the identification of those components and materials which are suitable for reuse and recovery.2. Not later than 21 October 2001 the Commission shall, in accordance with the procedure laid down in Article 11 establish the standards referred to in paragraph 1 of this Article. In so doing, the Commission shall take account of the work going on in this area in the relevant international forums and contribute to this work as appropriate.3. Member States shall take the necessary measures to ensure that producers provide dismantling information for each type of new vehicle put on the market within six months after the vehicle is put on the market. This information shall identify, as far as it is needed by treatment facilities in order to comply with the provisions of this Directive, the different vehicle components and materials, and the location of all hazardous substances in the vehicles, in particular with a view to the achievement of the objectives laid down in Article 7.4. Without prejudice to commercial and industrial confidentiality, Member States shall take the necessary measures to ensure that manufacturers of components used in vehicles make available to authorised treatment facilities, as far as it is requested by these facilities, appropriate information concerning dismantling, storage and testing of components which can be reused.Article 9Reporting and information1. At three-year intervals Member States shall send a report to the Commission on the implementation of this Directive. The report shall be drawn up on the basis of a questionnaire or outline drafted by the Commission in accordance with the procedure laid down in Article 6 of Directive 91/692/EEC(8) with a view to establishing databases on end-of life vehicles and their treatment. The report shall contain relevant information on possible changes in the structure of motor vehicle dealing and of the collection, dismantling, shredding, recovery and recycling industries, leading to any distortion of competition between or within Member States. The questionnaire or outline shall be sent to the Member States six months before the start of the period covered by the report. The report shall be made to the Commission within nine months of the end of the three-year period covered by it.The first report shall cover the period of three years from 21 April 2002.Based on the above information, the Commission shall publish a report on the implementation of this Directive within nine months of receiving the reports from the Member States.2. Member States shall require in each case the relevant economic operators to publish information on:- the design of vehicles and their components with a view to their recoverability and recyclability,- the environmentally sound treatment of end-of life vehicles, in particular the removal of all fluids and dismantling,- the development and optimisation of ways to reuse, recycle and recover end-of life vehicles and their components,- the progress achieved with regard to recovery and recycling to reduce the waste to be disposed of and to increase the recovery and recycling rates.The producer must make this information accessible to the prospective buyers of vehicles. It shall be included in promotional literature used in the marketing of the new vehicle.Article 10Implementation1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 21 April 2002. They shall immediately inform the Commission thereof.When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a 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 governed by this Directive.3. Provided that the objectives set out in this Directive are achieved, Member States may transpose the provisions set out in Articles 4(1), 5(1), 7(1), 8(1), 8(3) and 9(2) and specify the detailed rules of implementation of Article 5(4) by means of agreements between the competent authorities and the economic sectors concerned. Such agreements shall meet the following requirements(a) agreements shall be enforceable;(b) agreements need to specify objectives with the corresponding deadlines;(c) agreements shall be published in the national official journal or an official document equally accessible to the public and transmitted to the Commission;(d) the results achieved under an agreement shall be monitored regularly, reported to the competent authorities and to the Commission and made available to the public under the conditions set out in the agreement;(e) the competent authorities shall make provisions to examine the progress reached under an agreement;(f) in case of non-compliance with an agreement Member States must implement the relevant provisions of this Directive by legislative, regulatory or administrative measures.Article 11Committee procedure1. The Commission shall be assisted by the committee established by Article 18 of Directive 75/442/EEC, hereinafter referred to as "the Committee".2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its rules of procedure.4. The Commission, according to the procedure laid down in this Article, shall adopt:(a) the minimum requirements, as referred to in Article 5(5), for the certificate of destruction;(b) the detailed rules referred to in Article 7(2), third subparagraph;(c) the formats relating to the database system referred to in Article 9;(d) the amendments necessary for adapting the Annexes to this Directive to scientific and technical progress.Article 12Entry into force1. This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.2. Article 5(4) shall apply:- as from 1 July 2002 for vehicles put on the market as from this date,- as from 1 January 2007 for vehicles put on the market before the date referred to in the first indent.3. Member States may apply Article 5(4) in advance of the dates set out in paragraph 2.Article 13AddresseesThis Directive is addressed to the Member States.Done at Brussels, 18 September 2000.For the European ParliamentThe PresidentN. FontaineFor the CouncilThe PresidentH. Védrine(1) OJ C 337, 7.11.1997, p. 3, andOJ C 156, 3.6.1999, p. 5.(2) OJ C 129, 27.4.1998, p. 44.(3) Opinion of the European Parliament of 11 February 1999 (OJ C 150, 28.5.1999, p. 420), Council Common Position of 29 July 1999 (OJ C 317, 4.11.1999, p. 19) and Decision of the European Parliament of 3 February 2000 (not yet published in the Official Journal). Council Decision of 20 July 2000 and Decision of the European Parliament of 7 September 2000.(4) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 98/98/EC (OJ L 355, 30.12.1998, p. 1 ).(5) OJ L 42, 23.2.1970, p. 1. Directive as last amended by Directive 98/91/EC of the European Parliament and of the Council (OJ L 11, 16.1.1999, p. 25).(6) OJ L 194, 25.7.1975, p. 39. Directive as last amended by Commission Decision 96/350/EC (OJ L 135, 6.6.1996, p. 32).(7) OJ L 184, 17.7.1999, p. 23.(8) OJ L 377, 31.12.1991, p. 48.ANNEX IMinimum technical requirements for treatment in accordance with Article 6(1) and (3)1. Sites for storage (including temporary storage) of end-of-life vehicles prior to their treatament:- impermeable surfaces for appropriate areas with the provision of spillage collection facilities, decanters and cleanser-degeasers,- equipment for the treatment of water, including rainwater, in compliance with health and environmental regulations.2. Sites for treatment:- impermeable surfaces for appropriate areas with the provision of spillage collection facilities, decanters and cleanser-degreasers,- appropriate storage for dismantled spare parts, including impermeable storage for oil-contaminated spare parts,- appropriate containers for storage of batteries (with electrolyte neutralisation on site or elsewhere), filters and PCB/PCT-containing condensers,- appropriate storage tanks for the segregated storage of end-of-life vehicle fluids: fuel, motor oil, gearbox oil, transmission oil, hydraulic oil, cooling liquids, antifreeze, brake fluids, battery acids, air-conditioning system fluids and any other fluid contained in the end-of-life vehicle,- equipment for the treatment of water, including rainwater, in compliance with health and environmental regulations,- appropriate storage for used tyres, including the prevention of fire hazards and excessive stockpiling.3. Treatment operations for depollution of end-of-life vehicles:- removal of batteries and liquified gas tanks,- removal or neutralisation of potential explosive components, (e.g. air bags),- removal and separate collection and storage of fuel, motor oil, transmission oil, gearbox oil, hydraulic oil, cooling liquids, antifreeze, brake fluids, air-conditioning system fluids and any other fluid contained in the end-of-life vehicle, unless they are necessary for the re-use of the parts concerned,- removal, as far as feasible, of all components identified as containing mercury.4. Treatment operations in order to promote recycling:- removal or catalysts,- removal of metal components containing copper, aluminium and magnesium if these metals are not segregated in the shredding process,- removal of tyres and large plastic components (bumpers, dashboard, fluid containers, etc), if these materials are not segregated in the shredding process in such a way that they can be effectively recycled as materials,- removal of glass.5. Storage operations are to be carried out avoiding damage to components containing fluids or to recoverable components and spare parts.ANNEX IIMaterials and components exempt from Article 4(2)(a)>TABLE>Within the procedure referred to in Article 4(2)(b), the Commission shall evaluate the following applications:- lead as an alloy in aluminium in wheel rims, engine parts and window levers- lead in batteries- lead in balance weights- electrical components which contain lead in a glass or ceramics matrix compound- cadmium in batteries for electrical vehiclesas a matter of priority, in order to establish as soon as possible whether Annex II is to be amended accordingly.As regards cadmium in batteries for electrical vehicles, the Commission shall take into account, within the procedure referred to in Article 4(2)b and in the framework of an overall environmental assessment, the availability of substitutes as well as the need to maintain the availability of electrical vehicles.Commission statementsRe Article 5(1), first indentThe Commission confirms that Article 5(1), first indent, authorises Member States to use existing collection systems for the collection of waste used components and does not oblige them to set up separate collection systems (for waste used components) with specific financial requirements.Re Article 5(3), first subparagraphThe Commission considers that the reference to registration contained in Article 5(3) first subparagraph, authorises Member States to decide whether producers, dealers and collectors should be registered pursuant to the Framework Directive on Waste, or whether they should be entered in a new register established specifically for that purpose.Re Article 7(1)The Commission states that Article 7(1) does not introduce any additional requirements, measures or criteria with regard to technical controls.