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... 2. The efficient functioning of the internal market for substances can be achieved only if requirements for substances do not differ significantly from Member State to Member State. ...

... 15. There is a need to ensure effective management of the technical, scientific and administrative aspects of this Regulation at Community level. A central entity should therefore be created to fulfil this role. A feasibility study on the resource requirements for this central entity concluded that an independent central entity offered a number of long-term advantages over other options. A European Chemicals Agency (hereinafter referred to as "the Agency") should therefore be established. ...

... 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. ...

... 28. Scientific research and development normally takes place in quantities below 1 tonne per year. There is no need to exempt such research and development because substances in those quantities do not have to be registered in any case. However, in order to encourage innovation, product and process oriented research and development should be exempted from the obligation to register for a certain time period where a substance is not yet intended to be placed on the market to an indefinite number of customers because its application in preparations or articles still requires further research and development performed by the potential registrant himself or in cooperation with a limited number of known customers. In addition, it is appropriate to provide for a similar exemption to downstream users using the substance for the purposes of product and process oriented research and development, provided that the risks to human health and the environment are adequately controlled in accordance with the requirements of legislation for the protection of workers and the environment. ...

... 29. Since producers and importers of articles should be responsible for their articles, it is appropriate to impose a registration requirement on substances which are intended to be released from articles and have not been registered for that use. In the case of substances of very high concern which are present in articles above tonnage and concentration thresholds, where exposure to the substance cannot be excluded and where the substance has not been registered by any person for this use, the Agency should be notified. The Agency should also be empowered to request that a registration be submitted if it has grounds for suspecting that the release of a substance from the article may present a risk to human health or the environment and the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year. The Agency should consider the need for a proposal for a restriction where it considers that the use of such substances in articles poses a risk to human health or the environment that is not adequately controlled. ...

... 30. The requirements for undertaking chemical safety assessments by manufacturers and importers should be defined in detail in a technical annex to allow them to meet their obligations. To achieve fair burden sharing with their customers, manufacturers and importers should in their chemical safety assessment address not only their own uses and the uses for which they place their substances on the market, but also all uses which their customers ask them to address. ...

... 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. ...

... 34. Requirements for generation of information on substances should be tiered according to the volumes of manufacture or importation of a substance, because these provide an indication of the potential for exposure of man and the environment to the substances, and should be described in detail. To reduce the possible impact on low volume substances, new toxicological and ecotoxicological information should only be required for priority substances between 1 and 10 tonnes. For other substances in that quantity range there should be incentives to encourage manufacturers and importers to provide this information. ...

... 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⁽¹⁰⁾, 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⁽¹¹⁾. ...

... 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. ...

... 41. For reasons of workability and because of their special nature, specific registration requirements should be laid down for intermediates. Polymers should be exempted from registration and evaluation until those that need to be registered due to the risks posed to human health or the environment can be selected in a practicable and cost-efficient way on the basis of sound technical and valid scientific criteria. ...

... 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. ...

... 59. The requirements for undertaking chemical safety assessments by downstream users should also be prescribed in detail to allow them to meet their obligations. These requirements should only apply above a total quantity of 1 tonne of substance or preparation. In any case, however, the downstream users should consider the use and identify and apply appropriate risk management measures. Downstream users should report certain basic information on use to the Agency. ...

... 59. The requirements for undertaking chemical safety assessments by downstream users should also be prescribed in detail to allow them to meet their obligations. These requirements should only apply above a total quantity of 1 tonne of substance or preparation. In any case, however, the downstream users should consider the use and identify and apply appropriate risk management measures. Downstream users should report certain basic information on use to the Agency. ...

... 82. To allow effective monitoring and enforcement of the authorisation requirement, downstream users benefiting from an authorisation granted to their supplier should inform the Agency of their use of the substance. ...

... 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. ...

... 90. In order to provide a harmonised approach to restrictions, the Agency should fulfil a role as coordinator of this procedure, for example by appointing the relevant rapporteurs and verifying conformity with the requirements of the relevant Annexes. The Agency should maintain a list of substances for which a restriction dossier is being prepared. ...

... 111. It is important to avoid confusion between the mission of the Agency and the respective missions of the European Medicines Agency (EMEA) established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency⁽¹³⁾, the European Food Safety Authority (EFSA) established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety⁽¹⁴⁾ and the Advisory Committee on Safety, Hygiene and Health Protection at Work set up by the Council Decision of 22 July 2003⁽¹⁵⁾. Consequently, the Agency should establish rules of procedure where cooperation with the EFSA or the Advisory Committee on Safety, Hygiene and Health Protection at Work is necessary. This Regulation should otherwise be without prejudice to the competence conferred on the EMEA, the EFSA and the Advisory Committee on Safety, Hygiene and Health Protection at Work by Community legislation. ...

... 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. ...

... 118. Disclosure of information under this Regulation is subject to the specific requirements of Regulation (EC) No 1049/2001. That Regulation sets binding deadlines for the release of information as well as procedural guarantees, including the right of appeal. The Management Board should adopt the practical arrangements for application of those requirements to the Agency. ...

... 118. Disclosure of information under this Regulation is subject to the specific requirements of Regulation (EC) No 1049/2001. That Regulation sets binding deadlines for the release of information as well as procedural guarantees, including the right of appeal. The Management Board should adopt the practical arrangements for application of those requirements to the Agency. ...

... 4. The Agency may decide to impose conditions with the aim of ensuring that the substance or the preparation or article in which the substance is incorporated will be handled only by staff of listed customers as referred to in paragraph 2(e) in reasonably controlled conditions, in accordance with the requirements of legislation for the protection of workers and the environment, and will not be made available to the general public at any time either on its own or in a preparation or article and that remaining quantities will be re-collected for disposal after the exemption period. In such cases, the Agency may ask the notifier to provide additional necessary information. ...

... General requirements for generation of information on intrinsic properties of substances ...

... 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. ...

... (c) which information requirements would require new studies involving vertebrate animals to be carried out by him; ...

... (d) which information requirements would require other new studies to be carried out by him. ...

... 3. The previous registrant and potential registrant(s) shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way. This may be facilitated by following cost sharing guidance based on those principles which is adopted by the Agency in accordance with Article 77(2)(g). Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements. ...

... 1. Before testing is carried out in order to meet the information requirements for the purposes of registration, a SIEF participant shall inquire whether a relevant study is available by communicating within his SIEF. If a relevant study involving tests on vertebrate animals is available within the SIEF, a participant of that SIEF shall request that study. If a relevant study not involving tests on vertebrate animals is available within the SIEF, a SIEF participant may request that study. Within one month of the request, the owner of the study shall provide proof of its cost to the participant(s) requesting it. The participant(s) and the owner shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non discriminatory way. This may be facilitated by following any cost sharing guidance which is based on those principles and is adopted by the Agency in accordance with Article 77(2)(g). If they cannot reach such an agreement, the cost shall be shared equally. The owner shall give permission to refer to the full study report for the purpose of registration within two weeks of receipt of payment. Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements. ...

... 1. Before testing is carried out in order to meet the information requirements for the purposes of registration, a SIEF participant shall inquire whether a relevant study is available by communicating within his SIEF. If a relevant study involving tests on vertebrate animals is available within the SIEF, a participant of that SIEF shall request that study. If a relevant study not involving tests on vertebrate animals is available within the SIEF, a SIEF participant may request that study. Within one month of the request, the owner of the study shall provide proof of its cost to the participant(s) requesting it. The participant(s) and the owner shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non discriminatory way. This may be facilitated by following any cost sharing guidance which is based on those principles and is adopted by the Agency in accordance with Article 77(2)(g). If they cannot reach such an agreement, the cost shall be shared equally. The owner shall give permission to refer to the full study report for the purpose of registration within two weeks of receipt of payment. Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements. ...

... 2. If a relevant study involving tests is not available within the SIEF, only one study shall be conducted per information requirement within each SIEF by one of its participants acting on behalf of the others. They shall take all reasonable steps to reach an agreement within a deadline set by the Agency as to who is to carry out the test on behalf of the other participants and to submit a summary or robust study summary to the Agency. If no agreement is reached, the Agency shall specify which registrant or downstream user shall perform the test. All participants of the SIEF who require a study shall contribute to the costs for the elaboration of the study with a share corresponding to the number of participating potential registrants. Those participants that do not carry out the study themselves shall have the right to receive the full study report within two weeks following payment to the participant that carried out the study. ...

... 3. If the owner of a study as referred to in paragraph 1 which involves testing on vertebrate animals refuses to provide either proof of the cost of that study or the study itself to (an)other participant(s), he shall not be able to proceed with registration until he provides the information to the other participants(s). The other participant(s) shall proceed with registration without fulfilling the relevant information requirement, explaining the reason for this in the registration dossier. The study shall not be repeated unless within 12 months of the date of registration of the other participant(s), the owner of this information has not provided it to them and the Agency decides that the test should be repeated by them. However, if a registration containing this information has already been submitted by another registrant, the Agency shall give the other participant(s) permission to refer to the information in his registration dossier(s). The other registrant shall have a claim on the other participant(s) for an equal share of the cost, provided he makes the full study report available to the other participant(s), which shall be enforceable in the national courts. ...

... Requirements for Safety Data Sheets ...

... (e) the substance is present in a preparation in a concentration lower than any of the concentrations set out in Article 14(2); (f) the downstream user is using the substance for the purposes of product and process oriented research and development, provided that the risks to human health and the environment are adequately controlled in accordance with the requirements of legislation for the protection of workers and the environment. ...

... 1. Downstream users shall be required to comply with the requirements of Article 37 at the latest 12 months after receiving a registration number communicated to them by their suppliers in a safety data sheet. ...

... 2. Downstream users shall be required to comply with the requirements of Article 38 at the latest six months after receiving a registration number communicated to them by their suppliers in a safety data sheet. ...

... (a) that the information in the technical dossier(s) submitted pursuant to Article 10 complies with the requirements of Articles 10, 12 and 13 and with Annexes III and VI to X; ...

... (b) that the adaptations of the standard information requirements and the related justifications submitted in the technical dossier(s) comply with the rules governing such adaptations set out in Annexes VII to X and with the general rules set out in Annex XI; ...

... (c) that any required chemical safety assessment and chemical safety report comply with the requirements of Annex I and that the proposed risk management measures are adequate; ...

... 3. On the basis of an examination made pursuant to paragraph 1, the Agency may, within 12 months of the start of the compliance check, prepare a draft decision requiring the registrant(s) to submit any information needed to bring the registration(s) into compliance with the relevant information requirements and specifying adequate time limits for the submission of further information. Such a decision shall be taken in accordance with the procedure laid down in Articles 50 and 51. ...

... (b) the dossier is for a substance manufactured or imported in quantities of 1 tonne or more per year and does not meet the requirements of Annex VII applying under either Article 12(1)(a) or (b), as the case may be; or ...

... (a) by 1 December 2012 for all registrations received by 1 December 2010 containing proposals for testing in order to fulfil the information requirements in Annexes IX and X; ...

... (b) by 1 June 2016 for all registrations received by 1 June 2013 containing proposals for testing in order to fulfil the information requirements in Annex IX only; ...

... (b) the use(s) of that substance on its own or in a preparation or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been exempted from the authorisation requirement in Annex XIV itself in accordance with Article 58(2); or ...

... (e) uses or categories of uses exempted from the authorisation requirement, if any, and conditions for such exemptions, if any. ...

... 2. Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled. In the establishment of such exemptions, account shall be taken, in particular, of the proportionality of risk to human health and the environment related to the nature of the substance, such as where the risk is modified by the physical form. ...

... 2. Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled. In the establishment of such exemptions, account shall be taken, in particular, of the proportionality of risk to human health and the environment related to the nature of the substance, such as where the risk is modified by the physical form. ...

... 4. Before the Agency sends its recommendation to the Commission it shall make it publicly available on its website, clearly indicating the date of publication, taking into account Articles 118 and 119 on access to information. The Agency shall invite all interested parties to submit comments within three months of the date of publication, in particular on uses which should be exempt from the authorisation requirement. The Agency shall update its recommendation, taking into account the comments received. ...

... 7. An authorisation shall be granted only if the application is made in conformity with the requirements of Article 62. ...

... (ii) discharges of a substance from a point source governed by the requirement for prior regulation referred to in Article 11(3)(g) of Directive 2000/60/EC and legislation adopted under Article 16 of that Directive. ...

... 3. In preparing its opinion, each Committee referred to in paragraph 1 shall first check that the application includes all the information specified in Article 62 that is relevant to its remit. If necessary, the Committees shall, in consultation with each other, make a joint request to the applicant for additional information to bring the application into conformity with the requirements of Article 62. The Committee for Socio-economic Analysis may, if it deems it necessary, require the applicant or request third parties to submit, within a specified time period, additional information on possible alternative substances or technologies. Each Committee shall also take into account any information submitted by third parties. ...

... 1. If the Commission considers that the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed, it shall ask the Agency to prepare a dossier which conforms to the requirements of Annex XV. ...

... 2. After the date referred to in Article 58(1)(c)(i) for a substance listed in Annex XIV, the Agency shall consider whether the use of that substance in articles poses a risk to human health or the environment that is not adequately controlled. If the Agency considers that the risk is not adequately controlled, it shall prepare a dossier which conforms to the requirements of Annex XV. ...

... 4. If a Member State considers that the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed it shall notify the Agency that it proposes to prepare a dossier which conforms to the requirements of the relevant sections of Annex XV. If the substance is not on the list maintained by the Agency referred to in paragraph 5 of this Article, the Member State shall prepare a dossier which conforms to the requirements of Annex XV within 12 months of the notification to the Agency. If this dossier demonstrates that action on a Community-wide basis is necessary, beyond any measures already in place, the Member State shall submit it to the Agency in the format outlined in Annex XV, in order to initiate the restrictions process. 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 Committee for Risk Assessment and the Committee for Socio-economic Analysis shall check whether the dossier submitted conforms to the requirements of Annex XV. Within 30 days of receipt, the respective Committee shall inform the Agency or the Member State suggesting restrictions, as to whether the dossier conforms. If the dossier does not conform, the reasons shall be given to the Agency or the Member State in writing within 45 days of receipt. The Agency or the Member State shall bring the dossier into conformity within 60 days of the date of receipt of the reasons from the Committees, otherwise the procedure under this Chapter shall be terminated. The Agency shall publish without delay the intention of the Commission or of a Member State to instigate a restriction procedure for a substance and shall inform those who submitted a registration for that substance. ...

... 4. If a Member State considers that the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed it shall notify the Agency that it proposes to prepare a dossier which conforms to the requirements of the relevant sections of Annex XV. If the substance is not on the list maintained by the Agency referred to in paragraph 5 of this Article, the Member State shall prepare a dossier which conforms to the requirements of Annex XV within 12 months of the notification to the Agency. If this dossier demonstrates that action on a Community-wide basis is necessary, beyond any measures already in place, the Member State shall submit it to the Agency in the format outlined in Annex XV, in order to initiate the restrictions process. 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 Committee for Risk Assessment and the Committee for Socio-economic Analysis shall check whether the dossier submitted conforms to the requirements of Annex XV. Within 30 days of receipt, the respective Committee shall inform the Agency or the Member State suggesting restrictions, as to whether the dossier conforms. If the dossier does not conform, the reasons shall be given to the Agency or the Member State in writing within 45 days of receipt. The Agency or the Member State shall bring the dossier into conformity within 60 days of the date of receipt of the reasons from the Committees, otherwise the procedure under this Chapter shall be terminated. The Agency shall publish without delay the intention of the Commission or of a Member State to instigate a restriction procedure for a substance and shall inform those who submitted a registration for that substance. ...

... 4. If a Member State considers that the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed it shall notify the Agency that it proposes to prepare a dossier which conforms to the requirements of the relevant sections of Annex XV. If the substance is not on the list maintained by the Agency referred to in paragraph 5 of this Article, the Member State shall prepare a dossier which conforms to the requirements of Annex XV within 12 months of the notification to the Agency. If this dossier demonstrates that action on a Community-wide basis is necessary, beyond any measures already in place, the Member State shall submit it to the Agency in the format outlined in Annex XV, in order to initiate the restrictions process. 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 Committee for Risk Assessment and the Committee for Socio-economic Analysis shall check whether the dossier submitted conforms to the requirements of Annex XV. Within 30 days of receipt, the respective Committee shall inform the Agency or the Member State suggesting restrictions, as to whether the dossier conforms. If the dossier does not conform, the reasons shall be given to the Agency or the Member State in writing within 45 days of receipt. The Agency or the Member State shall bring the dossier into conformity within 60 days of the date of receipt of the reasons from the Committees, otherwise the procedure under this Chapter shall be terminated. The Agency shall publish without delay the intention of the Commission or of a Member State to instigate a restriction procedure for a substance and shall inform those who submitted a registration for that substance. ...

... 5. The Agency shall maintain a list of substances for which a dossier conforming to the requirements of Annex XV is planned or underway by either the Agency or a Member State for the purposes of a proposed restriction. If a substance is on the list, no other such dossier shall be prepared. If it is proposed by either a Member State or the Agency that an existing restriction listed in Annex XVII should be re-examined a decision on whether to do so shall be taken in accordance with the procedure referred to in Article 133(2) based on evidence presented by the Member State or the Agency. ...

... (b) a socio-economic analysis, or information which can contribute to one, of the suggested restrictions, examining the advantages and drawbacks of the proposed restrictions. It shall conform to the requirements in Annex XVI. ...

... 1. Where, in accordance with Article 77, a Committee is required to provide an opinion or consider whether a Member State dossier conforms with the requirements of Annex XV, it shall appoint one of its members as a rapporteur. The Committee concerned may appoint a second member to act as co-rapporteur. For each case, rapporteurs and co-rapporteurs shall undertake to act in the interests of the Community and shall make a declaration of commitment to fulfil their duties and a declaration of interests in writing. A member of a Committee shall not be appointed rapporteur for a particular case if he indicates any interest that might be prejudicial to the independent consideration of that case. The Committee concerned may replace the rapporteur or co-rapporteur by another one of its members at any time, if, for example, they are unable to fulfil their duties within the prescribed time limits, or if a potentially prejudicial interest comes to light. ...

... 3. Every three years the Agency, in accordance with the objective of promoting non-animal testing methods, shall submit to the Commission a report on the status of implementation and use of non-animal test methods and testing strategies used to generate information on intrinsic properties and for risk assessment to meet the requirements of this Regulation. The first report shall be submitted by 1 June 2011. ...

... 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. ...