Law-ref.org REACH - Registration, Evaluation and Authorisation of Chemicals
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PREAMBLE     [go to this PREAMBLE]
... Having regard to the proposal from the Commission, ...
... 14. This Regulation will generate information on substances and their uses. Available information, including that generated by this Regulation, should be used by the relevant actors in the application and implementation of appropriate Community legislation, for example that covering products, and Community voluntary instruments, such as the eco-labelling scheme. The Commission should consider in the review and development of relevant Community legislation and voluntary instruments how information generated by this Regulation should be used, and examine possibilities for establishing a European quality mark. ...
... 22. The authorisation provisions should ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled. Authorisations for the placing on the market and use should be granted by the Commission only if the risks arising from their use are adequately controlled, where this is possible, or the use can be justified for socio-economic reasons and no suitable alternatives are available, which are economically and technically viable. ...
... 24. In preparation for this Regulation, the Commission has launched REACH Implementation Projects (RIPs), involving relevant experts from stakeholder groups. Some of those projects aim at developing draft guidelines and tools which should help the Commission, the Agency, Member States, manufacturers, importers and downstream users of substances to fulfil, in concrete terms, their obligations under this Regulation. This work should enable the Commission and the Agency to make available appropriate technical guidance, in due time, with regard to the deadlines introduced by this Regulation. ...
... 24. In preparation for this Regulation, the Commission has launched REACH Implementation Projects (RIPs), involving relevant experts from stakeholder groups. Some of those projects aim at developing draft guidelines and tools which should help the Commission, the Agency, Member States, manufacturers, importers and downstream users of substances to fulfil, in concrete terms, their obligations under this Regulation. This work should enable the Commission and the Agency to make available appropriate technical guidance, in due time, with regard to the deadlines introduced by this Regulation. ...
... 24. In preparation for this Regulation, the Commission has launched REACH Implementation Projects (RIPs), involving relevant experts from stakeholder groups. Some of those projects aim at developing draft guidelines and tools which should help the Commission, the Agency, Member States, manufacturers, importers and downstream users of substances to fulfil, in concrete terms, their obligations under this Regulation. This work should enable the Commission and the Agency to make available appropriate technical guidance, in due time, with regard to the deadlines introduced by this Regulation. ...
... 31. The Commission, in close cooperation with industry, Member States and other relevant stakeholders, should develop guidance to fulfil the requirements under this Regulation related to preparations (in particular with regard to safety data sheets incorporating exposure scenarios) including assessment of substances incorporated into special preparations – such as metals incorporated in alloys. In doing so, the Commission should take full account of the work that will have been carried out within the framework of the RIPs and should include the necessary guidance on this matter in the overall REACH guidance package. This guidance should be available before the application of this Regulation. ...
... 31. The Commission, in close cooperation with industry, Member States and other relevant stakeholders, should develop guidance to fulfil the requirements under this Regulation related to preparations (in particular with regard to safety data sheets incorporating exposure scenarios) including assessment of substances incorporated into special preparations – such as metals incorporated in alloys. In doing so, the Commission should take full account of the work that will have been carried out within the framework of the RIPs and should include the necessary guidance on this matter in the overall REACH guidance package. This guidance should be available before the application of this Regulation. ...
... 40. The Commission, Member States, industry and other stakeholders should continue to contribute to the promotion of alternative test methods on an international and national level including computer supported methodologies, in vitro methodologies, such as appropriate, those based on toxicogenomics, and other relevant methodologies. The Community's strategy to promote alternative test methods is a priority and the Commission should ensure that within its future Research Framework Programmes and initiatives such as the Community Action Plan on the Protection and Welfare of Animals 2006-2010 this remains a priority topic. Participation of stakeholders and initiatives involving all interested parties should be sought. ...
... 40. The Commission, Member States, industry and other stakeholders should continue to contribute to the promotion of alternative test methods on an international and national level including computer supported methodologies, in vitro methodologies, such as appropriate, those based on toxicogenomics, and other relevant methodologies. The Community's strategy to promote alternative test methods is a priority and the Commission should ensure that within its future Research Framework Programmes and initiatives such as the Community Action Plan on the Protection and Welfare of Animals 2006-2010 this remains a priority topic. Participation of stakeholders and initiatives involving all interested parties should be sought. ...
... 47. In accordance with Directive 86/609/EEC, it is necessary to replace, reduce or refine testing on vertebrate animals. Implementation of this Regulation should be based on the use of alternative test methods, suitable for the assessment of health and environmental hazards of chemicals, wherever possible. The use of animals should be avoided by recourse to alternative methods validated by the Commission or international bodies, or recognised by the Commission or the Agency as appropriate to meet the information requirements under this Regulation. To this end, the Commission, following consultation with relevant stakeholders, should propose to amend the future Commission Regulation on test methods or this Regulation, where appropriate, to replace, reduce or refine animal testing. The Commission and the Agency should ensure that reduction of animal testing is a key consideration in the development and maintenance of guidance for stakeholders and in the Agency's own procedures. ...
... 47. In accordance with Directive 86/609/EEC, it is necessary to replace, reduce or refine testing on vertebrate animals. Implementation of this Regulation should be based on the use of alternative test methods, suitable for the assessment of health and environmental hazards of chemicals, wherever possible. The use of animals should be avoided by recourse to alternative methods validated by the Commission or international bodies, or recognised by the Commission or the Agency as appropriate to meet the information requirements under this Regulation. To this end, the Commission, following consultation with relevant stakeholders, should propose to amend the future Commission Regulation on test methods or this Regulation, where appropriate, to replace, reduce or refine animal testing. The Commission and the Agency should ensure that reduction of animal testing is a key consideration in the development and maintenance of guidance for stakeholders and in the Agency's own procedures. ...
... 47. In accordance with Directive 86/609/EEC, it is necessary to replace, reduce or refine testing on vertebrate animals. Implementation of this Regulation should be based on the use of alternative test methods, suitable for the assessment of health and environmental hazards of chemicals, wherever possible. The use of animals should be avoided by recourse to alternative methods validated by the Commission or international bodies, or recognised by the Commission or the Agency as appropriate to meet the information requirements under this Regulation. To this end, the Commission, following consultation with relevant stakeholders, should propose to amend the future Commission Regulation on test methods or this Regulation, where appropriate, to replace, reduce or refine animal testing. The Commission and the Agency should ensure that reduction of animal testing is a key consideration in the development and maintenance of guidance for stakeholders and in the Agency's own procedures. ...
... 47. In accordance with Directive 86/609/EEC, it is necessary to replace, reduce or refine testing on vertebrate animals. Implementation of this Regulation should be based on the use of alternative test methods, suitable for the assessment of health and environmental hazards of chemicals, wherever possible. The use of animals should be avoided by recourse to alternative methods validated by the Commission or international bodies, or recognised by the Commission or the Agency as appropriate to meet the information requirements under this Regulation. To this end, the Commission, following consultation with relevant stakeholders, should propose to amend the future Commission Regulation on test methods or this Regulation, where appropriate, to replace, reduce or refine animal testing. The Commission and the Agency should ensure that reduction of animal testing is a key consideration in the development and maintenance of guidance for stakeholders and in the Agency's own procedures. ...
... 47. In accordance with Directive 86/609/EEC, it is necessary to replace, reduce or refine testing on vertebrate animals. Implementation of this Regulation should be based on the use of alternative test methods, suitable for the assessment of health and environmental hazards of chemicals, wherever possible. The use of animals should be avoided by recourse to alternative methods validated by the Commission or international bodies, or recognised by the Commission or the Agency as appropriate to meet the information requirements under this Regulation. To this end, the Commission, following consultation with relevant stakeholders, should propose to amend the future Commission Regulation on test methods or this Regulation, where appropriate, to replace, reduce or refine animal testing. The Commission and the Agency should ensure that reduction of animal testing is a key consideration in the development and maintenance of guidance for stakeholders and in the Agency's own procedures. ...
... 62. Communication up and down the supply chain should be facilitated. The Commission should develop a system categorising brief general descriptions of uses taking into account the outcomes of the RIPs. ...
... 67. Collective agreement within the Agency's Member State Committee on its draft decisions should provide the basis for an efficient system that respects the principle of subsidiarity, while maintaining the internal market. If one or more Member States or the Agency do not agree to a draft decision, it should be adopted subject to a centralised procedure. If the Member State Committee fails to reach unanimous agreement, the Commission should adopt a decision in accordance with a Committee procedure. ...
... 69. To ensure a sufficiently high level of protection for human health, including having regard to relevant human population groups and possibly to certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention. Authorisation should be granted where natural or legal persons applying for an authorisation demonstrate to the granting authority that the risks to human health and the environment arising from the use of the substance are adequately controlled. Otherwise, uses may still be authorised if it can be shown that the socio-economic benefits from the use of the substance outweigh the risks connected with its use and there are no suitable alternative substances or technologies that are economically and technically viable. Taking into account the good functioning of the internal market it is appropriate that the Commission should be the granting authority. ...
... 81. In order to provide a harmonised approach to the authorisation of the uses of particular substances, the Agency should issue opinions on the risks arising from those uses, including whether or not the substance is adequately controlled and on any socio-economic analysis submitted to it by third parties. These opinions should be taken into account by the Commission when considering whether or not to grant an authorisation. ...
... 83. It is suitable in these circumstances that final decisions granting or refusing authorisations be adopted by the Commission pursuant to a regulatory procedure in order to allow for an examination of their wider implications within the Member States and to associate the latter more closely with the decisions. ...
... 84. In order to accelerate the current system the restriction procedure should be restructured and Directive 76/769/EEC, which has been substantially amended and adapted several times, should be replaced. In the interests of clarity and as a starting point for this new accelerated restriction procedure, all the restrictions developed under that Directive should be incorporated into this Regulation. Where appropriate, the application of Annex XVII of this Regulation should be facilitated by guidance developed by the Commission. ...
... 85. In relation to Annex XVII Member States should be allowed to maintain for a transitional period more stringent restrictions, provided that these restrictions have been notified according to the Treaty. This should concern substances on their own, substances in preparations and substances in articles, the manufacturing, the placing on the market and the use of which is restricted. The Commission should compile and publish an inventory of these restrictions. This would provide an opportunity for the Commission to review the measures concerned with a view to possible harmonisation. ...
... 85. In relation to Annex XVII Member States should be allowed to maintain for a transitional period more stringent restrictions, provided that these restrictions have been notified according to the Treaty. This should concern substances on their own, substances in preparations and substances in articles, the manufacturing, the placing on the market and the use of which is restricted. The Commission should compile and publish an inventory of these restrictions. This would provide an opportunity for the Commission to review the measures concerned with a view to possible harmonisation. ...
... 88. In order to prepare a restrictions proposal and in order for such legislation to operate effectively, there should be good cooperation, coordination and information between the Member States, the Agency, other bodies of the Community, the Commission and the interested parties. ...
... 91. In order to give the Commission the opportunity to address a specific risk for human health and the environment that needs to be addressed Community wide, it should be able to entrust the Agency with the preparation of a restriction dossier. ...
... 94. In order to speed up the procedure for restrictions, the Commission should prepare its draft amendment within a specific time limit of receiving the Agency's opinions. ...
... 98. In the interests of efficiency, the staff of the Agency Secretariat should perform essentially technical-administrative and scientific tasks without calling on the scientific and technical resources of the Member States. The Executive Director should ensure the efficient execution of the Agency's tasks in an independent manner. To ensure that the Agency fulfils its role, the composition of the Management Board should be designed to represent each Member State, the Commission and other interested parties appointed by the Commission in order to ensure the involvement of stakeholders, and the European Parliament and to secure the highest standard of competence and a broad range of relevant expertise in chemicals safety or the regulation of chemicals, whilst ensuring that there is relevant expertise in the field of general financial and legal matters. ...
... 98. In the interests of efficiency, the staff of the Agency Secretariat should perform essentially technical-administrative and scientific tasks without calling on the scientific and technical resources of the Member States. The Executive Director should ensure the efficient execution of the Agency's tasks in an independent manner. To ensure that the Agency fulfils its role, the composition of the Management Board should be designed to represent each Member State, the Commission and other interested parties appointed by the Commission in order to ensure the involvement of stakeholders, and the European Parliament and to secure the highest standard of competence and a broad range of relevant expertise in chemicals safety or the regulation of chemicals, whilst ensuring that there is relevant expertise in the field of general financial and legal matters. ...
... 100. A Commission Regulation should specify the structure and amounts of fees, including specifying the circumstances under which a proportion of the fees will be transferred to the relevant Member State competent authority. ...
... 102. Through a Committee for Risk Assessment and a Committee for Socio-economic Analysis, the Agency should take over the role of the Scientific Committees attached to the Commission in issuing scientific opinions in its field of competence. ...
... 107. The Agency should be financed partly by fees paid by natural or legal persons and partly by the general budget of the European Communities. The Community budgetary procedure should remain applicable as far as any subsidies chargeable to the general budget of the European Communities are concerned. Moreover, the auditing of accounts should be undertaken by the Court of Auditors in accordance with Article 91 of Commission Regulation (EC, Euratom) No 2343/2002 of 23 December 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities(12)107. . ...
... 108. Where the Commission and Agency consider it appropriate, it should be possible for representatives of third countries to participate in the work of the Agency. ...
... 115. Resources should be focused on substances of the highest concern. A substance should therefore be added to Annex I of Directive 67/548/EEC if it meets the criteria for classification as carcinogenic, mutagenic or toxic for reproduction categories 1, 2 or 3, as a respiratory sensitiser, or in respect of other effects on a case-by-case basis. Provision should be made to enable competent authorities to submit proposals to the Agency. The Agency should give its opinion on the proposal while interested parties should have an opportunity to comment. The Commission should take a decision subsequently. ...
... 117. EU-citizens should have access to information about chemicals to which they may be exposed, in order to allow them to make informed decisions about their use of chemicals. A transparent means of achieving this is to grant them free and easy access to basic data held in the Agency's database, including brief profiles of hazardous properties, labelling requirements and relevant Community legislation including authorised uses and risk management measures. The Agency and Member States should allow access to information in accordance with Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information(16), Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(17) and with the UNECE Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters, to which the European Community is a party. ...
... 119. Apart from their participation in the implementation of Community legislation, Member State competent authorities should, because of their closeness to stakeholders in the Member States, play a role in the exchange of information on risks of substances and on the obligations of natural or legal persons under chemicals legislation. At the same time, close cooperation between the Agency, the Commission and the competent authorities of the Member States is necessary to ensure the coherence and efficiency of the global communication process. ...
... 120. In order for the system established by this Regulation to operate effectively, there should be good cooperation, coordination and exchange of information between the Member States, the Agency and the Commission regarding enforcement. ...
... 123. The measures necessary for the implementation of this Regulation and certain amendments to it 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(18). ...
... 124. In particular, power should be conferred on the Commission to amend the Annexes in certain cases, to set rules on test methods, to vary the percentage of dossiers selected for compliance checking and to modify the criteria for their selection, and to set the criteria defining what constitutes adequate justification that testing is technically not possible. Since these measures are of general scope and are designed to amend non-essential elements of this Regulation or supplement this Regulation by adding new non-essential elements thereto, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. ...
... 125. It is essential that chemicals be regulated in an effective and timely manner during the transition to full applicability of the provisions of this Regulation and, in particular, during the start-up period of the Agency. Provision should therefore be made for the Commission to provide the necessary support towards the setting up of the Agency, including the conclusion of contracts and the appointment of an Executive Director ad interim until the Agency's Management Board can appoint an Executive Director itself. ...
... 126. To take full advantage of the work performed under Regulation (EEC) No 793/93 as well as under Directive 76/769/EEC and to avoid such work being lost, the Commission should be empowered during the start-up period to initiate restrictions based on that work without following the full restrictions procedure laid down in this Regulation. All those elements should be used, as soon as this Regulation enters into force, to support risk reduction measures. ...
... 128. This Regulation replaces Directive 76/769/EEC, Commission Directive 91/155/EEC(19), Commission Directive 93/67/EEC(20), Commission Directive 93/105/EC(21), Commission Directive 2000/21/EC(22), Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94(23). These Directives and Regulations should therefore be repealed. ...
... 128. This Regulation replaces Directive 76/769/EEC, Commission Directive 91/155/EEC(19), Commission Directive 93/67/EEC(20), Commission Directive 93/105/EC(21), Commission Directive 2000/21/EC(22), Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94(23). These Directives and Regulations should therefore be repealed. ...
... 128. This Regulation replaces Directive 76/769/EEC, Commission Directive 91/155/EEC(19), Commission Directive 93/67/EEC(20), Commission Directive 93/105/EC(21), Commission Directive 2000/21/EC(22), Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94(23). These Directives and Regulations should therefore be repealed. ...
... 128. This Regulation replaces Directive 76/769/EEC, Commission Directive 91/155/EEC(19), Commission Directive 93/67/EEC(20), Commission Directive 93/105/EC(21), Commission Directive 2000/21/EC(22), Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94(23). These Directives and Regulations should therefore be repealed. ...
... 128. This Regulation replaces Directive 76/769/EEC, Commission Directive 91/155/EEC(19), Commission Directive 93/67/EEC(20), Commission Directive 93/105/EC(21), Commission Directive 2000/21/EC(22), Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94(23). These Directives and Regulations should therefore be repealed. ...
... OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1). Corrected in OJ L 216, 16.6.2004, p. 3. ...
... OJ L 200, 30.7.1999, p. 1. Directive as last amended by Commission Directive 2006/8/EC (OJ L 19, 24.1.2006, p. 12). ...
... OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2005/80/EC (OJ L 303, 22.11.2005, p. 32). ...
... Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC (OJ L 76, 22.3.1991, p. 35). Directive as last amended by Directive 2001/58/EC (OJ L212, 7.8.2001, p. 24). ...
... Commission Directive 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and the environment of substances notified in accordance with Council Directive 67/548/EEC (OJ L 227, 8.9.1993, p. 9). ...
... Commission Directive 93/105/EC of 25 November 1993 laying down Annex VII D, containing information required for the technical dossier referred to in Article 12 of the seventh amendment of Council Directive 67/548/EEC (OJ L 294, 30.11.1993, p. 21). ...
... Commission Directive 2000/21/EC of 25 April 2000 concerning the list of Community legislation referred to in the fifth indent of Article 13(1) of Council Directive 67/548/EEC (OJ L 103, 28.4.2000, p. 70). ...
... Commission Regulation (EC) No 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man and the environment of existing substances in accordance with Council Regulation (EEC) No 793/93 (OJ L 161, 29.6.1994, p. 3). ...


ARTICLE-2: Application     [go to this ARTICLE]
... (ii) as a flavouring in foodstuffs within the scope of 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(9)and Commission Decision 1999/217/EC of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council(10); ...
... OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8). ...
... OJ L 213, 21.7.1982, p. 8. Directive as last amended by Commission Directive 2004/116/EC (OJ L 379, 24.12.2004, p. 81). ...


ARTICLE-3: Definitions     [go to this ARTICLE]
... 36) SME: means small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises(1); ...


ARTICLE-13: General requirements for generation of information on intrinsic properties of substances     [go to this ARTICLE]
... 2. These methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved. The Commission, following consultation with relevant stakeholders, shall, as soon as possible, make a proposal, if appropriate, to amend the Commission Regulation on test methods adopted in accordance with the procedure referred to in Article 133(4), and the Annexes of this Regulation, if relevant, so as to replace, reduce or refine animal testing. Amendments to that Commission Regulation shall be adopted in accordance with the procedure specified in paragraph 3 and amendments to the Annexes of this Regulation shall be adopted in accordance with the procedure referred to in Article 131. ...
... 2. These methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved. The Commission, following consultation with relevant stakeholders, shall, as soon as possible, make a proposal, if appropriate, to amend the Commission Regulation on test methods adopted in accordance with the procedure referred to in Article 133(4), and the Annexes of this Regulation, if relevant, so as to replace, reduce or refine animal testing. Amendments to that Commission Regulation shall be adopted in accordance with the procedure specified in paragraph 3 and amendments to the Annexes of this Regulation shall be adopted in accordance with the procedure referred to in Article 131. ...
... 2. These methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved. The Commission, following consultation with relevant stakeholders, shall, as soon as possible, make a proposal, if appropriate, to amend the Commission Regulation on test methods adopted in accordance with the procedure referred to in Article 133(4), and the Annexes of this Regulation, if relevant, so as to replace, reduce or refine animal testing. Amendments to that Commission Regulation shall be adopted in accordance with the procedure specified in paragraph 3 and amendments to the Annexes of this Regulation shall be adopted in accordance with the procedure referred to in Article 131. ...
... 3. Where tests on substances are required to generate information on intrinsic properties of substances, they shall be conducted in accordance with the test methods laid down in a Commission Regulation or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate. The Commission shall adopt that Regulation, designed to amend the non-essential elements of this Regulation by supplementing it, in accordance with the procedure referred to in Article 133(4). Information on intrinsic properties of substances may be generated in accordance with other test methods provided that the conditions set out in Annex XI are met. ...
... 3. Where tests on substances are required to generate information on intrinsic properties of substances, they shall be conducted in accordance with the test methods laid down in a Commission Regulation or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate. The Commission shall adopt that Regulation, designed to amend the non-essential elements of this Regulation by supplementing it, in accordance with the procedure referred to in Article 133(4). Information on intrinsic properties of substances may be generated in accordance with other test methods provided that the conditions set out in Annex XI are met. ...
... 3. Where tests on substances are required to generate information on intrinsic properties of substances, they shall be conducted in accordance with the test methods laid down in a Commission Regulation or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate. The Commission shall adopt that Regulation, designed to amend the non-essential elements of this Regulation by supplementing it, in accordance with the procedure referred to in Article 133(4). Information on intrinsic properties of substances may be generated in accordance with other test methods provided that the conditions set out in Annex XI are met. ...
... 4. Ecotoxicological and toxicological tests and analyses shall be carried out in compliance with the principles of good laboratory practice provided for in Directive 2004/10/EC or other international standards recognised as being equivalent by the Commission or the Agency and with the provisions of Directive 86/609/EEC, if applicable. ...


ARTICLE-15: Substances in plant protection and biocidal products     [go to this ARTICLE]
... 1. Active substances and co-formulants manufactured or imported for use in plant protection products only and included either in Annex I to Directive 91/414/EEC(1)or in Regulation (EEC) No 3600/92(2), Regulation (EC) No 703/2001(3), Regulation (EC) No 1490/2002(4), Decision 2003/565/EC(5)and for any substance for which a Commission Decision on the completeness of the dossier has been taken pursuant to Article 6 Directive 91/414/EEC shall be regarded as being registered and the registration as completed for manufacture or import for the use as a plant protection product and therefore as fulfilling the requirements of Chapters 1 and 5 of this Title. ...
... 2. Active substances manufactured or imported for use in biocidal products only and included either in Annexes I, IA or IB to 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(6)or in Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC(7), until the date of the decision referred to in the second subparagraph of Article 16(2) of Directive 98/8/EC, shall be regarded as being registered and the registration as completed for manufacture or import for the use in a biocidal product and therefore as fulfilling the requirements of Chapters 1 and 5 of this Title. ...
... Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1). Directive as last amended by Commission Directive 2006/19/EC (OJ L 44, 15.2.2006, p. 15). ...
... Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 366, 15.12.1992, p. 10). Regulation as last amended by Commission Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27). ...
... Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 366, 15.12.1992, p. 10). Regulation as last amended by Commission Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27). ...
... Commission Regulation (EC) No 703/2001 of 6 April 2001 laying down the active substances of plant protection products to be assessed in the second stage of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC and revising the list of Member States designated as rapporteurs for those substances (OJ L 98, 7.4.2001, p. 6). ...
... Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (OJ L 224, 21.8.2002, p. 23). Regulation as last amended by Commission Regulation (EC) No 1744/2004 (OJ L 311, 8.10.2004, p. 23). ...
... Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (OJ L 224, 21.8.2002, p. 23). Regulation as last amended by Commission Regulation (EC) No 1744/2004 (OJ L 311, 8.10.2004, p. 23). ...
... Commission Decision 2003/565/EC of 25 July 2003 extending the time period provided for in Article 8(2) of Council Directive 91/414/EEC (OJ L 192, 31.7.2003, p. 40). ...


ARTICLE-16: Duties of the Commission, the Agency and registrants of substances regarded as being registered     [go to this ARTICLE]
... Duties of the Commission, the Agency and registrants of substances regarded as being registered ...
... 1. The Commission or the relevant Community body shall make information equivalent to that required by Article 10 available to the Agency for substances regarded as registered according to Article 15. The Agency shall include this information or a reference thereto in its databases and notify the competent authorities thereof by 1 December 2008. ...


ARTICLE-41: Compliance check of registrations     [go to this ARTICLE]
... 7. The Commission may, after consulting with the Agency, take a decision to vary the percentage of dossiers selected and amend or include further criteria in paragraph 5 in accordance with the procedure referred to in Article 133(4) ...


ARTICLE-42: Check of information submitted and follow-up to dossier evaluation     [go to this ARTICLE]
... 2. Once the dossier evaluation is completed, the Agency shall notify the Commission and the competent authorities of the Member States of the information obtained and any conclusions made. The competent authorities shall use the information obtained from this evaluation for the purposes of Article 45(5), Article 59(3) and Article 69(4). The Agency shall use the information obtained from this evaluation for the purposes of Article 44. ...


ARTICLE-45: Competent authority     [go to this ARTICLE]
... 3. In cases where two or more Member States have expressed an interest in evaluating the same substance and they cannot agree who should be the