... (9) The assessment of the operation of the four main legal instruments governing chemicals in the Community, i.e. 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 ⁽⁴⁾, 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 ⁽⁵⁾, Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations ⁽⁶⁾ and Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances ⁽⁷⁾, identified a number of problems in the functioning of Community legislation on chemicals, resulting in disparities between the laws, regulations and administrative provisions in Member States directly affecting the functioning of the internal market in this field, and the need to do more to protect public health and the environment in accordance with the precautionary principle. ...

... (9) The assessment of the operation of the four main legal instruments governing chemicals in the Community, i.e. 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 ⁽⁴⁾, 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 ⁽⁵⁾, Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations ⁽⁶⁾ and Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances ⁽⁷⁾, identified a number of problems in the functioning of Community legislation on chemicals, resulting in disparities between the laws, regulations and administrative provisions in Member States directly affecting the functioning of the internal market in this field, and the need to do more to protect public health and the environment in accordance with the precautionary principle. ...

... (9) The assessment of the operation of the four main legal instruments governing chemicals in the Community, i.e. 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 ⁽⁴⁾, 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 ⁽⁵⁾, Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations ⁽⁶⁾ and Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances ⁽⁷⁾, identified a number of problems in the functioning of Community legislation on chemicals, resulting in disparities between the laws, regulations and administrative provisions in Member States directly affecting the functioning of the internal market in this field, and the need to do more to protect public health and the environment in accordance with the precautionary principle. ...

... (13) This Regulation should apply without prejudice to the prohibitions and restrictions laid down in Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products ⁽¹⁰⁾ in so far as substances are used and marketed as cosmetic ingredients and are within the scope of this Regulation. A phase-out of testing on vertebrate animals for the purpose of protecting human health as specified in Directive 76/768/EEC should take place with regard to the uses of those substances in cosmetics. ...

... (20) The evaluation provisions should provide for follow-up to registration, by allowing for checks on whether registrations are in compliance with the requirements of this Regulation and if necessary by allowing for generation of more information on the properties of substances. If the Agency in cooperation with the Member States considers that there are grounds for considering that a substance constitutes a risk to human health or the environment, the Agency should, after having included the substance in the Community rolling action plan for substance evaluation, relying on the competent authorities of Member States, ensure that this substance is evaluated. ...

... (20) The evaluation provisions should provide for follow-up to registration, by allowing for checks on whether registrations are in compliance with the requirements of this Regulation and if necessary by allowing for generation of more information on the properties of substances. If the Agency in cooperation with the Member States considers that there are grounds for considering that a substance constitutes a risk to human health or the environment, the Agency should, after having included the substance in the Community rolling action plan for substance evaluation, relying on the competent authorities of Member States, ensure that this substance is evaluated. ...

... (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. ...

... (35) The Member States, the Agency and all interested parties should take full account of the results of the RIPs, in particular with regard to the registration of substances which occur in nature. ...

... (37) If tests are performed, they should comply with the relevant requirements of protection of laboratory animals, set out 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 ⁽¹¹⁾, and, in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 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 application for tests on chemical substances ⁽¹²⁾. ...

... (38) The generation of information by alternative means offering equivalence to prescribed tests and test methods should also be allowed, for example when this information comes from valid qualitative or quantitative structure activity models or from structurally related substances. To this end the Agency, in cooperation with Member States and interested parties, should develop appropriate guidance. It should also be possible not to submit certain information if appropriate justification can be provided. Based on experience gained through RIPs, criteria should be developed defining what constitutes such justification. ...

... (39) In order to help companies, and in particular SMEs, to comply with the requirements of this Regulation, Member States, in addition to the operational guidance documents provided by the Agency, should establish national helpdesks. ...

... (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, 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 to 2010 this remains a priority topic. Participation of stakeholders and initiatives involving all interested parties should be sought. ...

... (63) It is also necessary to ensure that generation of information is tailored to real information needs. To this end evaluation should require the Agency to decide on the programmes of testing proposed by manufacturers and importers. In cooperation with Member States, the Agency should give priority to certain substances, for instance those which may be of very high concern. ...

... (66) The Agency should also be empowered to require further information from manufacturers, importers or downstream users on substances suspected of posing a risk to human health or the environment, including by reason of their presence on the internal market in high volumes, on the basis of evaluations performed. Based on the criteria for prioritising substances developed by the Agency in cooperation with the Member States a Community rolling action plan for substance evaluation should be established, relying on Member State competent authorities to evaluate substances included therein. If a risk equivalent to the level of concern arising from the use of substances subject to authorisation arises from the use of isolated intermediates on site, the competent authorities of the Member States should also be allowed to require further information, when justified. ...

... (66) The Agency should also be empowered to require further information from manufacturers, importers or downstream users on substances suspected of posing a risk to human health or the environment, including by reason of their presence on the internal market in high volumes, on the basis of evaluations performed. Based on the criteria for prioritising substances developed by the Agency in cooperation with the Member States a Community rolling action plan for substance evaluation should be established, relying on Member State competent authorities to evaluate substances included therein. If a risk equivalent to the level of concern arising from the use of substances subject to authorisation arises from the use of isolated intermediates on site, the competent authorities of the Member States should also be allowed to require further information, when justified. ...

... (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. ...

... (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. ...

... (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. ...

... (89) In order to give Member States the opportunity to submit proposals to address a specific risk for human health and the environment, they should prepare a dossier in conformity with detailed requirements. The dossier should set out the justification for Community-wide action. ...

... (95) The Agency should be central to ensuring that chemicals legislation and the decision-making processes and scientific basis underlying it have credibility with all stakeholders and the public. The Agency should also play a pivotal role in coordinating communication around this Regulation and in its implementation. The confidence in the Agency of the Community institutions, the Member States, the general public and interested parties is therefore essential. For this reason, it is vital to ensure its independence, high scientific, technical and regulatory capacities, as well as transparency and efficiency. ...

... (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. ...

... (103) Through a Member State Committee, the Agency should aim to reach agreement amongst Member States' authorities on specific issues which require a harmonised approach. ...

... (104) It is necessary to ensure close cooperation between the Agency and the competent authorities working within the Member States so that the scientific opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis are based on the broadest possible scientific and technical expertise appropriate which is available within the Community. To the same end, these Committees should be able to rely on additional particular expertise. ...

... (105) In the light of the increased responsibility of natural or legal persons for ensuring safe use of chemicals, enforcement needs to be strengthened. The Agency should therefore provide a Forum for Member States to exchange information on and to coordinate their activities related to the enforcement of chemicals legislation. The currently informal cooperation between Member States in this respect would benefit from a more formal framework. ...

... (105) In the light of the increased responsibility of natural or legal persons for ensuring safe use of chemicals, enforcement needs to be strengthened. The Agency should therefore provide a Forum for Member States to exchange information on and to coordinate their activities related to the enforcement of chemicals legislation. The currently informal cooperation between Member States in this respect would benefit from a more formal framework. ...

... (109) The Agency should contribute, through cooperation with organisations having interests in the harmonisation of international regulations, to the role of the Community and the Member States in such harmonisation activities. To promote broad international consensus the Agency should take account of existing and emerging international standards in the regulation of chemicals such as the Globally Harmonised System (GHS) of classification and labelling of chemicals. ...

... (116) Regular reports by the Member States and the Agency on the operation of this Regulation will be an indispensable means of monitoring the implementation of this Regulation as well as trends in this field. Conclusions drawn from findings in the reports will be useful and practical tools for reviewing this Regulation and, where necessary, for formulating proposals for amendments. ...

... (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 ⁽¹⁷⁾, 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 ⁽¹⁸⁾ 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. ...

... (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. ...

... (121) In order to ensure compliance with this Regulation, Member States should put in place effective monitoring and control measures. The necessary inspections should be planned, carried out and their results should be reported. ...

... (122) In order to ensure transparency, impartiality and consistency in the level of enforcement activities by Member States, it is necessary for Member States to set up an appropriate framework for penalties with a view to imposing effective, proportionate and dissuasive penalties for non-compliance, as non-compliance can result in damage to human health and the environment. ...

... (122) In order to ensure transparency, impartiality and consistency in the level of enforcement activities by Member States, it is necessary for Member States to set up an appropriate framework for penalties with a view to imposing effective, proportionate and dissuasive penalties for non-compliance, as non-compliance can result in damage to human health and the environment. ...

... (130) Since the objectives of this Regulation, namely laying down rules for substances and establishing a European Chemicals Agency, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. ...

... 3. Member States may allow for exemptions from this Regulation in specific cases for certain substances, on their own, in a preparation or in an article, where necessary in the interests of defence. ...

... (i) as a food additive in foodstuffs within the scope of 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 ⁽³³⁾; ...

... (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 ⁽³⁴⁾ 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 ⁽³⁵⁾; ...

... 19. competent authority: means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation; ...

... 9. The Agency and the competent authorities of the Member States concerned shall always keep confidential the information submitted in accordance with paragraphs 1 to 8. ...

... If the manufacturer has production sites in more than one Member State, the relevant Member State shall be the one in which the head office of the manufacturer is established. The other Member States where the production sites are established shall also be notified. ...

... 2. The list of dossiers being checked for compliance by the Agency shall be made available to Member States competent authorities. ...

... 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. ...

... 3. The list of registration dossiers being evaluated under Article 40 shall be made available to Member States. ...

... 1. In order to ensure a harmonised approach, the Agency shall in cooperation with the Member States develop criteria for prioritising substances with a view to further evaluation. Prioritisation shall be on a risk-based approach. The criteria shall consider: ...

... 2. The Agency shall use the criteria in paragraph 1 for the purpose of compiling a draft Community rolling action plan which shall cover a period of three years and shall specify substances to be evaluated each year. Substances shall be included if there are grounds for considering (either on the basis of a dossier evaluation carried out by the Agency or on the basis of any other appropriate source, including information in the registration dossier) that a given substance constitutes a risk to human health or the environment. The Agency shall submit the first draft rolling action plan to the Member States by 1 December 2011. The Agency shall submit draft annual updates to the rolling action plan to the Member States by 28 February each year. ...

... 2. The Agency shall use the criteria in paragraph 1 for the purpose of compiling a draft Community rolling action plan which shall cover a period of three years and shall specify substances to be evaluated each year. Substances shall be included if there are grounds for considering (either on the basis of a dossier evaluation carried out by the Agency or on the basis of any other appropriate source, including information in the registration dossier) that a given substance constitutes a risk to human health or the environment. The Agency shall submit the first draft rolling action plan to the Member States by 1 December 2011. The Agency shall submit draft annual updates to the rolling action plan to the Member States by 28 February each year. ...

... 1. The Agency shall be responsible for coordinating the substance evaluation process and ensuring that substances on the Community rolling action plan are evaluated. In doing so, the Agency shall rely on the competent authorities of Member States. In carrying out an evaluation of a substance, the competent authorities may appoint another body to act on their behalf. ...

... 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 competent authority, the competent authority for the purposes of Articles 46, 47 and 48 shall be determined in accordance with the following procedure. ...

... If, within 60 days of the referral, the Member State Committee reaches unanimous agreement, the Member States concerned shall adopt substances for evaluation accordingly. ...

... If the Member State Committee fails to reach a unanimous agreement, the Agency shall submit the conflicting opinions to the Commission, which shall decide which authority shall be the competent authority, in accordance with the procedure referred to in Article 133(3), and the Member States concerned shall adopt substances for evaluation accordingly. ...

... Once the substance evaluation has been completed, the competent authority shall consider how to use the information obtained from this evaluation for the purposes of Article 59(3), Article 69(4) and Article 115(1). The competent authority shall inform the Agency of its conclusions as to whether or how to use the information obtained. The Agency shall in turn inform the Commission, the registrant and the competent authorities of the other Member States. ...

... The procedure provided for in the first paragraph may be undertaken only by the competent authority referred to therein. The competent authority shall inform the Agency of the results of such an evaluation, which shall then inform the competent authorities of the other Member States and make the results available to them. ...

... 1. The Agency shall notify its draft decision in accordance with Articles 40 or 41, together with the comments of the registrant, to the competent authorities of the Member States. ...

... 2. Within 30 days of circulation, the Member States may propose amendments to the draft decision to the Agency. ...

... 1. The competent authority shall circulate its draft decision in accordance with Article 46, together with any comments by the registrant or downstream user, to the Agency and to the competent authorities of the other Member States. ...

... 2. The Commission may ask the Agency to prepare a dossier in accordance with relevant Sections of Annex XV for substances which in its opinion meet the criteria set out in Article 57. The dossier may be limited, if appropriate, to a reference to an entry in Annex I of Directive 67/548/EEC. The Agency shall make this dossier available to the Member States. ...

... 3. Any Member State may prepare a dossier in accordance with Annex XV for substances which in its opinion meet the criteria set out in Article 57 and forward it to the Agency. The dossier may be limited, if appropriate, to a reference to an entry in Annex I of Directive 67/548/EEC. The Agency shall make this dossier available within 30 days of receipt to the other Member States. ...

... 5. Within 60 days of circulation, the other Member States or the Agency may comment on the identification of the substance in relation to the criteria in Article 57 in the dossier to the Agency. ...

... The Commission shall not consider the risks to human health arising from the use of a substance in a medical device regulated by 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 ⁽⁴⁸⁾, Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ⁽⁴⁹⁾ or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ⁽⁵⁰⁾. ...

... If the applicant does not wish to comment, the Agency shall send these opinions to the Commission, the Member States and the applicant, within 15 days of the end of the period within which the applicant may comment or within 15 days of receipt of notice from the applicant that he does not intend to comment. ...

... If the applicant wishes to comment, he shall send his written argumentation to the Agency within two months of the receipt of the draft opinion. The Committees shall consider the comments and adopt their final opinions within two months of receipt of the written argumentation, taking this argumentation into account where appropriate. Within a further 15 days the Agency shall send the opinions, with the written argumentation attached, to the Commission, the Member States and the applicant. ...

... 2. The Agency shall establish and keep up to date a register of downstream users who have made a notification in accordance with paragraph 1. The Agency shall grant access to this register to the competent authorities of the Member States. ...

... The Agency or Member States shall refer to any dossier, chemical safety report or risk assessment submitted to the Agency or Member State under this Regulation. The Agency or Member States shall also refer to any relevant risk assessment submitted for the purposes of other Community Regulations or Directives. To this end other bodies, such as agencies, established under Community law and carrying out a similar task shall provide information to the Agency or Member State concerned on request. ...

... The Agency or Member States shall refer to any dossier, chemical safety report or risk assessment submitted to the Agency or Member State under this Regulation. The Agency or Member States shall also refer to any relevant risk assessment submitted for the purposes of other Community Regulations or Directives. To this end other bodies, such as agencies, established under Community law and carrying out a similar task shall provide information to the Agency or Member State concerned on request. ...

... 2. A final decision shall be taken in accordance with the procedure referred to in Article 133(4). The Commission shall send the draft amendment to the Member States at least 45 days before voting. ...

... (e) a Member State Committee, which shall be responsible for resolving potential divergences of opinions on draft decisions proposed by the Agency or the Member States under Title VI and proposals for identification of substances of very high concern to be subjected to the authorisation procedure under Title VII; ...

... (f) a Forum for Exchange of Information on Enforcement (hereinafter referred to as the Forum) which shall coordinate a network of Member States authorities responsible for enforcement of this Regulation; ...

... 1. The Agency shall provide the Member States and the institutions of the Community with the best possible scientific and technical advice on questions relating to chemicals which fall within its remit and which are referred to it in accordance with the provisions of this Regulation. ...

... (h) providing technical and scientific guidance on the operation of this Regulation for Member State competent authorities and providing support to the helpdesks established by Member States under Title XIII; ...

... (l) at the Commission's request, providing technical and scientific support for steps to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries; ...

... (b) at the Executive Director's request, providing technical and scientific support for steps to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries; ...

... The Executive Director shall, following approval by the Management Board, forward the work programme for the coming year and the multiannual work programme to the Member States, the European Parliament, the Council and the Commission, and shall have them published. ...

... The Executive Director shall, following approval by the Management Board, forward the Agency's general report to the Member States, the European Parliament, the Council, the Commission, the European Economic and Social Committee and the Court of Auditors, and shall have it published. ...

... 6. The members of the Committees shall be supported by the scientific and technical resources available to the Member States. To this end, Member States shall provide adequate scientific and technical resources to the members of the Committees that they have nominated. Each Member State competent authority shall facilitate the activities of the Committees and their working groups. ...

... 6. The members of the Committees shall be supported by the scientific and technical resources available to the Member States. To this end, Member States shall provide adequate scientific and technical resources to the members of the Committees that they have nominated. Each Member State competent authority shall facilitate the activities of the Committees and their working groups. ...

... 7. The Member States shall refrain from giving the members of the Committee for Risk Assessment or of the Committee for Socio-Economic Analysis, or their scientific and technical advisers and experts, any instruction which is incompatible with the individual tasks of those persons or with the tasks, responsibilities and independence of the Agency. ...

... 3. The members of the Forum shall be supported by the scientific and technical resources available to the competent authorities of the Member States. Each Member State competent authority shall facilitate the activities of the Forum and its working groups. The Member States shall refrain from giving the Forum members, or their scientific and technical advisers and experts any instruction which is incompatible with the individual tasks of those persons or with the tasks and responsibilities of the Forum. ...

... 3. The members of the Forum shall be supported by the scientific and technical resources available to the competent authorities of the Member States. Each Member State competent authority shall facilitate the activities of the Forum and its working groups. The Member States shall refrain from giving the Forum members, or their scientific and technical advisers and experts any instruction which is incompatible with the individual tasks of those persons or with the tasks and responsibilities of the Forum. ...

... 2. Member States shall transmit to the Agency the names of experts with proven experience in the tasks required by Article 77, who would be available to serve on working groups of the Committees, together with an indication of their qualifications and specific areas of expertise. ...

... (c) any voluntary contribution from the Member States. ...

... 2. In the case of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by it or by its servants in the performance of their duties. ...

... 3. The Agency's staff shall consist of officials assigned or seconded by the Commission or Member States on a temporary basis and of other servants recruited by the Agency as necessary to carry out its tasks. The Agency shall recruit its personnel on the basis of a staffing plan to be included in the multiannual work programme referred to in Article 78(d). ...

... The Agency shall specify formats and make them available free of charge, and software packages and make them available on its website for any submissions to the Agency. Member States, manufactures, importers, distributors or downstream users shall use these formats and packages in their submissions to the Agency pursuant to this Regulation. In particular, the Agency shall make available software tools to facilitate the submission of all information relating to substances registered in accordance with Article 12(1). ...

... 1. Every five years, Member States shall submit to the Commission a report on the operation of this Regulation in their respective territories, including sections on evaluation and enforcement as described in Article 127. ...

... Member States shall appoint the competent authority or competent authorities responsible for performing the tasks allotted to competent authorities under this Regulation and for cooperating with the Commission and the Agency in the implementation of this Regulation. Member States shall place adequate resources at the disposal of the competent authorities to enable them, in conjunction with any other available resources, to fulfil their tasks under this Regulation in a timely and effective manner. ...

... Member States shall appoint the competent authority or competent authorities responsible for performing the tasks allotted to competent authorities under this Regulation and for cooperating with the Commission and the Agency in the implementation of this Regulation. Member States shall place adequate resources at the disposal of the competent authorities to enable them, in conjunction with any other available resources, to fulfil their tasks under this Regulation in a timely and effective manner. ...

... The competent authorities shall cooperate with each other in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States all the necessary and useful support to this end. ...

... The competent authorities of the Member States shall inform the general public about the risks arising from substances where this is considered necessary for the protection of human health or the environment. The Agency, in consultation with competent authorities and stakeholders and drawing as appropriate on relevant best practice, shall provide guidance for the communication of information on the risks and safe use of chemical substances, on their own, in preparations or in articles, with a view to coordinating Member States in these activities. ...

... The competent authorities of the Member States shall inform the general public about the risks arising from substances where this is considered necessary for the protection of human health or the environment. The Agency, in consultation with competent authorities and stakeholders and drawing as appropriate on relevant best practice, shall provide guidance for the communication of information on the risks and safe use of chemical substances, on their own, in preparations or in articles, with a view to coordinating Member States in these activities. ...

... Member States shall establish national helpdesks to provide advice to manufacturers, importers, downstream users and any other interested parties on their respective responsibilities and obligations under this Regulation, in particular in relation to the registration of substances in accordance with Article 12(1), in addition to the operational guidance documents provided by the Agency under Article 77(2)(g). ...

... Tasks of the Member States ...

... Member States shall maintain a system of official controls and other activities as appropriate to the circumstances. ...

... Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission no later than 1 December 2008 and shall notify it without delay of any subsequent amendment affecting them. ...

... Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission no later than 1 December 2008 and shall notify it without delay of any subsequent amendment affecting them. ...

... 1. Subject to paragraph 2, Member States shall not prohibit, restrict or impede the manufacturing, import, placing on the market or use of a substance, on its own, in a preparation or in an article, falling within the scope of this Regulation, which complies with this Regulation and, where appropriate, with Community acts adopted in implementation of this Regulation. ...

... 2. Nothing in this Regulation shall prevent Member States from maintaining or laying down national rules to protect workers, human health and the environment applying in cases where this Regulation does not harmonise the requirements on manufacture, placing on the market or use. ...

... 1. Where a Member State has justifiable grounds for believing that urgent action is essential to protect human health or the environment in respect of a substance, on its own, in a preparation or in an article, even if satisfying the requirements of this Regulation, it may take appropriate provisional measures. The Member State shall immediately inform the Commission, the Agency and the other Member States thereof, giving reasons for its decision and submitting the scientific or technical information on which the provisional measure is based. ...

... This Regulation shall be binding in its entirety and directly applicable in all Member States. ...

... Where individual protection measures are needed, specify in detail which equipment will provide adequate and suitable protection. Take into account Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment [59] and make reference to the appropriate CEN standards: ...

... Indicate other important safety parameters, such as miscibility, fat solubility (solvent — oil to be specified), conductivity, melting point/melting range, gas group (useful for 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 [60]), auto-ignition temperature, etc. ...

... Indicate any special precautions which a user needs to be aware of or needs to comply with in connection with transport or conveyance either within or outside his premises. Where relevant, provide information on the transport classification for each of the modal regulations: IMDG (sea), ADR (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 [62]), RID (Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail [63]), ICAO/IATA (air). This might include inter alia: ...

... Indicate any special precautions which a user needs to be aware of or needs to comply with in connection with transport or conveyance either within or outside his premises. Where relevant, provide information on the transport classification for each of the modal regulations: IMDG (sea), ADR (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 [62]), RID (Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail [63]), ICAO/IATA (air). This might include inter alia: ...

... The Agency in collaboration with the Commission, Member States and interested parties shall develop and provide guidance in assessing which (Q)SARs will meet these conditions and provide examples. ...

... 6.Asbestos fibres(a)CrocidoliteCAS No 12001-28-4(b)AmositeCAS No 12172-73-5(c)AnthophylliteCAS No 77536-67-5(d)ActinoliteCAS No 77536-66-4(e)TremoliteCAS No 77536-68-6(f)Chrysotile [73]CAS No 12001-29-5CAS No 132207-32-0 | 1.The placing on the market and use of these fibres and of articles containing these fibres added intentionally shall be prohibited.However, Member States may except the placing on the market and use of diaphragms containing chrysotile (point (f)) for existing electrolysis installations until they reach the end of their service life, or until suitable asbestos-free substitutes become available, whichever is the sooner. The Commission will review this derogation before 1 January 2008.2.The use of articles containing asbestos fibres referred to in paragraph 1 which were already installed and/or in service before 1 January 2005 shall continue to be permitted until they are disposed of or reach the end of their service life. However, Member States may, for reasons of protection of human health, prohibit the use of such articles before they are disposed of or reach the end of their service life.Member States shall not permit the introduction of new applications for chrysotile asbestos on their territories.3.Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the placing on the market and use of these fibres and of articles containing these fibres, as permitted according to the preceding derogations, shall be permitted only if the articles bear a label in accordance with the provisions of Appendix 7 to this Annex. | ...

... 6.Asbestos fibres(a)CrocidoliteCAS No 12001-28-4(b)AmositeCAS No 12172-73-5(c)AnthophylliteCAS No 77536-67-5(d)ActinoliteCAS No 77536-66-4(e)TremoliteCAS No 77536-68-6(f)Chrysotile [73]CAS No 12001-29-5CAS No 132207-32-0 | 1.The placing on the market and use of these fibres and of articles containing these fibres added intentionally shall be prohibited.However, Member States may except the placing on the market and use of diaphragms containing chrysotile (point (f)) for existing electrolysis installations until they reach the end of their service life, or until suitable asbestos-free substitutes become available, whichever is the sooner. The Commission will review this derogation before 1 January 2008.2.The use of articles containing asbestos fibres referred to in paragraph 1 which were already installed and/or in service before 1 January 2005 shall continue to be permitted until they are disposed of or reach the end of their service life. However, Member States may, for reasons of protection of human health, prohibit the use of such articles before they are disposed of or reach the end of their service life.Member States shall not permit the introduction of new applications for chrysotile asbestos on their territories.3.Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the placing on the market and use of these fibres and of articles containing these fibres, as permitted according to the preceding derogations, shall be permitted only if the articles bear a label in accordance with the provisions of Appendix 7 to this Annex. | ...

... 6.Asbestos fibres(a)CrocidoliteCAS No 12001-28-4(b)AmositeCAS No 12172-73-5(c)AnthophylliteCAS No 77536-67-5(d)ActinoliteCAS No 77536-66-4(e)TremoliteCAS No 77536-68-6(f)Chrysotile [73]CAS No 12001-29-5CAS No 132207-32-0 | 1.The placing on the market and use of these fibres and of articles containing these fibres added intentionally shall be prohibited.However, Member States may except the placing on the market and use of diaphragms containing chrysotile (point (f)) for existing electrolysis installations until they reach the end of their service life, or until suitable asbestos-free substitutes become available, whichever is the sooner. The Commission will review this derogation before 1 January 2008.2.The use of articles containing asbestos fibres referred to in paragraph 1 which were already installed and/or in service before 1 January 2005 shall continue to be permitted until they are disposed of or reach the end of their service life. However, Member States may, for reasons of protection of human health, prohibit the use of such articles before they are disposed of or reach the end of their service life.Member States shall not permit the introduction of new applications for chrysotile asbestos on their territories.3.Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the placing on the market and use of these fibres and of articles containing these fibres, as permitted according to the preceding derogations, shall be permitted only if the articles bear a label in accordance with the provisions of Appendix 7 to this Annex. | ...

... 16.Lead carbons:(a)Neutral anhydrous carbonate (PbCO3)CAS No 598-63-0EINECS No 209-943-4(b)Trilead-bis(carbonate)-dihydroxide 2 Pb CO3-Pb(OH)2CAS No 1319-46-6EINECS No 215-290-6 | Shall not be used as substances and a constituent of preparations intended for use as paints, except for the restoration and maintenance of works of art and historic buildings and their interiors, where Member States wish to permit this on their territory, in accordance with the provisions of ILO Convention 13 on the use of white lead and sulphates of lead in paint. | ...

... 22.PentachlorophenolCAS No 87-86-5EINECS No 201-778-6and its salts and esters | 1.Shall not be used in a concentration equal to or greater than 0,1 % by mass in substances or preparations placed on the market.2.Transitional provisions:By way of derogation until 31 December 2008 France, Ireland, Portugal, Spain and the United Kingdom may chose not to apply this provision to substances and preparations intended for use in industrial installations not permitting the emission and/or discharge of pentachlorophenol (PCP) in quantities greater than those prescribed by existing legislation:(a)in the treatment of wood.However, treated wood shall not be used:inside buildings whether for decorative purposes or not, whatever their purpose (residence, employment, leisure),for the manufacture and re-treatment of:(i)containers intended for growing purposes;(ii)packaging that may come into contact with raw materials, intermediate or finished products destined for human and/or animal consumption;(iii)other materials that may contaminate the products mentioned in (i) and (ii);(b)in the impregnation of fibres and heavy-duty textiles not intended in any case for clothing or for decorative furnishings;(c)by way of special exception, Member States may on a case-by-case basis, permit on their territory specialised professionals to carry out in situ and for buildings of cultural, artistic and historical interest, or in emergencies, a remedial treatment of timber and masonry infected by dry rot fungus (Serpula lacrymans) and cubic rot fungi.In any case:(a)Pentachlorophenol used alone or as a component of preparations employed within the framework of the above exceptions must have a total hexachlorodibenzoparadioxin (HCDD) content of not more than two parts per million (ppm);(b)these substances and preparations shall not:be placed on the market except in packages of 20 litres or more;be sold to the general public.3.Without prejudice to the implementation of other Community provisions concerning the classification, packaging and labelling of dangerous substances and preparations, the packaging of substances and preparations covered by paragraphs 1 and 2 shall be marked clearly and indelibly:"Reserved for industrial and professional use".This provision shall not apply to waste covered by Directives 91/689/EEC and 2006/12/EC. | ...

... 23.CadmiumCAS No 7440-43-9EINECS No 231-152-8and its compounds | 1.Shall not be used to give colour to finished articles manufactured from the substances and preparations listed below:(a)polyvinyl chloride (PVC) [3904 10] [3904 21] [3904 22] [74],polyurethane (PUR) [3909 50] [74],low-density polyethylene (ld PE), with the exception of low-density polyethylene used for the production of coloured masterbatch [3901 10] [74],cellulose acetate (CA) [3912 11] [3912 12] [74],cellulose acetate butyrate (CAB) [3912 11] [3912 12] [74],epoxy resins [3907 30] [74],melamine — formaldehyde (MF) resins [3909 20] [74],urea — formaldehyde (UF) resins [3909 10] [74],unsaturated polyesters (UP) [3907 91] [74],polyethylene terephthalate (PET) [3907 60] [74],polybutylene terephthalate (PBT) [74],transparent/general-purpose polystyrene [3903 11] [3903 19] [74],acrylonitrile methylmethacrylate (AMMA) [74],cross-linked polyethylene (VPE) [74],high-impact polystyrene [74],polypropylene (PP) [3902 10] [74];(b)paints [3208] [3209] [74].However, if the paints have a high zinc content, their residual concentration of cadmium shall be as low as possible and shall at all events not exceed 0,1 % by mass.In any case, whatever their use or intended final purpose, finished articles or components of articles manufactured from the substances and preparations listed above coloured with cadmium shall not be placed on the market if their cadmium content (expressed as Cd metal) exceeds 0,01 % by mass of the plastic material.2.However, paragraph 1 does not apply to articles to be coloured for safety reasons.3.Shall not be used to stabilise the finished articles listed below manufactured from polymers or copolymers of vinyl chloride:packaging materials (bags, containers, bottles, lids) [3923 29 10] [3920 41] [3920 42] [74],office or school supplies [3926 10] [74],fittings for furniture, coachwork or the like [3926 30] [74],articles of apparel and clothing accessories (including gloves) [3926 20] [74],floor and wall coverings [3918 10] [74],impregnated, coated, covered or laminated textile fabrics [5903 10] [74],imitation leather [4202] [74],gramophone records [8524 10] [74],tubes and pipes and their fittings [3917 23] [74],swing doors [74],vehicles for road transport (interior, exterior, underbody) [74],coating of steel sheet used in construction or in industry [74],insulation for electrical wiring [74].In any case, whatever their use or intended final purpose, the placing on the market of the above finished articles or components of articles manufactured from polymers or copolymers of vinyl chloride, stabilised by substances containing cadmium shall be prohibited, if their cadmium content (expressed as Cd metal) exceeds 0,01 % by mass of the polymer.4.However, paragraph 3 does not apply to finished articles using cadmium-based stabilisers for safety reasons.5.Within the meaning of this Regulation, "cadmium plating "means any deposit or coating of metallic cadmium on a metallic surface.Shall not be used for cadmium plating metallic articles or components of the articles used in the sectors/applications listed below:(a)equipment and machinery for:food production [8210] [8417 20] [8419 81] [8421 11] [8421 22] [8422] [8435] [8437] [8438] [8476 11] [74],agriculture [8419 31] [8424 81] [8432] [8433] [8434] [8436] [74],cooling and freezing [8418] [74],printing and book-binding [8440] [8442] [8443] [74];(b)equipment and machinery for the production of:household goods [7321] [8421 12] [8450] [8509] [8516] [74],furniture [8465] [8466] [9401] [9402] [9403] [9404] [74],sanitary ware [7324] [74],central heating and air conditioning plant [7322] [8403] [8404] [8415] [74].In any case, whatever their use or intended final purpose, the placing on the market of cadmium-plated articles or components of such articles used in the sectors/applications listed in points (a) and (b) above and of articles manufactured in the sectors listed in point (b) above shall be prohibited.6.The provisions referred to in paragraph 5 are also applicable to cadmium-plated articles or components of such articles when used in the sectors/applications listed in points (a) and (b) below and to articles manufactured in the sectors listed in (b) below:(a)equipment and machinery for the production of:paper and board [8419 32] [8439] [8441] [74],textiles and clothing [8444] [8445] [8447] [8448] [8449] [8451] [8452] [74];(b)equipment and machinery for the production of:industrial handling equipment and machinery [8425] [8426] [8427] [8428] [8429] [8430] [8431] [74],road and agricultural vehicles [chapter 87] [74],rolling stock [chapter 86] [74],vessels [chapter 89] [74].7.However, the restrictions in paragraphs 5 and 6 do not apply to:articles and components of the articles used in the aeronautical, aerospace, mining, offshore and nuclear sectors whose applications require high safety standards and in safety devices in road and agricultural vehicles, rolling stock and vessels,electrical contacts in any sector of use, on account of the reliability required of the apparatus on which they are installed.Owing to the development of knowledge and techniques in respect of substitutes less dangerous than cadmium and its compounds, the Commission shall, in consultation with the Member States, assess the situation at regular intervals in accordance with the procedure laid down in Article 133(3) of this Regulation. | ...

... 24.Monomethyl — tetrachlorodiphenyl methaneTrade name: Ugilec 141CAS No 76253-60-6 | 1.The placing on the market and use of this substance and of preparations and articles containing it shall be prohibited.2.By way of exception paragraph 1 shall not apply:(a)in the case of plant and machinery already in service on 18 June 1994 until such plant and machinery is disposed of.However, Member States may, on grounds of human health protection and environmental protection, prohibit within their territory the use of such plant or machinery before it is disposed of;(b)in the case of the maintenance of plant and machinery already in service within a Member State on 18 June 1994.3.The placing on the second-hand market of this substance, preparations containing this substance and plant/machinery containing this substance, shall be prohibited. | ...

... 40.Substances meeting the criteria of flammability in Directive 67/548/EEC and classified as flammable, highly flammable or extremely flammable regardless of whether they appear in Annex I to that Directive or not. | 1Shall not be used on their own or in the form of preparations in aerosol generators that are placed on the market for the general public for entertainment and decorative purposes such as the following:metallic glitter intended mainly for decoration,artificial snow and frost,"whoopee "cushions,silly string aerosols,imitation excrement,horn for parties,decorative flakes and foams,artificial cobwebs,stink bombs,etc.2.Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances, the following words must appear legibly and indelibly on the packaging of aerosol generators referred to above:"For professional users only".3.By way of derogation, paragraphs 1 and 2 shall not apply to the aerosol generators referred to in Article 9a of Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers [75].4.The articles referred to in paragraphs 1 and 2 shall not be placed on the market unless they conform to the requirements indicated. | ...

... 48.TolueneCAS No 108-88-3 | Shall not be placed on the market or used as a substance or constituent of preparations in a concentration equal to or higher than 0,1 % by mass in adhesives and spray paints intended for sale to the general public. Member States shall apply these measures from 15 June 2007. | ...

... 49.TrichlorobenzeneCAS No 120-82-1 | Shall not be placed on the market or used as a substance or constituent of preparations in a concentration equal to or higher than 0,1 % by mass for all uses except: as an intermediate of synthesis, oras a process solvent in closed chemical applications for chlorination reactions, orin the manufacture of 1,3,5 — trinitro — 2,4,6 — triaminobenzene (TATB).Member States shall apply these measures from 15 June 2007. | ...

... 50.Polycyclic-aromatic hydrocarbons (PAH)1.Benzo(a)pyrene (BaP)CAS No 50-32-82.Benzo(e)pyrene (BeP)CAS No 192-97-23.Benzo(a)anthracene (BaA)CAS No 56-55-34.Chrysen (CHR)CAS No 218-01-95.Benzo(b)fluoranthene (BbFA)CAS No 205-99-26.Benzo(j)fluoranthene (BjFA)CAS No 205-82-37.Benzo(k)fluoranthene (BkFA)CAS No 207-08-98.Dibenzo(a, h)anthracene (DBAhA)CAS No 53-70-3 | 1.Extender oils shall not be placed on the market and used for the production of tyres or parts of tyres, if they contain:more than 1 mg/kg BaP, ormore than 10 mg/kg of the sum of all listed PAHs.These limits are regarded as kept, if the polycyclic aromatics (PCA) extract is less than 3 % by mass, as measured by the Institute of Petroleum standard IP346: 1998 (Determination of PCA in unused lubricating base oils and asphaltene free petroleum fractions — Dimethyl sulphoxide extraction refractive index method), provided that compliance with the limit values of BaP and of the listed PAHs, as well as the correlation of the measured values with the PCA extract, is controlled by the manufacturer or importer every six months or after each major operational change, whichever is earlier.2.Furthermore, the tyres and treads for retreading manufactured after 1 January 2010 may not be placed on the market if they contain extender oils exceeding the limits indicated in paragraph 1.These limits are regarded as kept, if the vulcanised rubber compounds do not exceed the limit of 0,35 % Bay protons as measured and calculated by ISO 21461 (Rubber vulcanised — Determination of aromaticity of oil in vulcanised rubber compounds).3.By way of derogation, paragraph 2 shall not apply to retreaded tyres if their tread does not contain extender oils exceeding the limits referred to in paragraph 1.4.Member States shall apply these measures from 1 January 2010. | ...

... Member States may exclude from the provision of the first subparagraph articles intended to be placed on the market in their territory. The labelling of these articles must however bear the wording "contains asbestos"; ...

... [42] 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). ...