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... 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. ...

... 40. The Commission, Member States, industry and other stakeholders should continue to contribute to the promotion of alternative test methods on an international and national level including computer supported methodologies, in vitro methodologies, such as appropriate, those based on toxicogenomics, and other relevant methodologies. The Community's strategy to promote alternative test methods is a priority and the Commission should ensure that within its future Research Framework Programmes and initiatives such as the Community Action Plan on the Protection and Welfare of Animals 2006-2010 this remains a priority topic. Participation of stakeholders and initiatives involving all interested parties should be sought. ...

... 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. ...

... 68. Evaluation may lead to the conclusion that action should be taken under the restriction or authorisation procedures or that risk management action should be considered in the framework of other appropriate legislation. Information on the progress of evaluation proceedings should therefore be made public. ...

... 68. Evaluation may lead to the conclusion that action should be taken under the restriction or authorisation procedures or that risk management action should be considered in the framework of other appropriate legislation. Information on the progress of evaluation proceedings should therefore be made public. ...

... 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. ...

... 93. In order to finalise the procedure in due time, the Agency should submit its opinions on the suggested action and its impact on the basis of a draft opinion prepared by a rapporteur. ...

... (a) Community workplace and environmental legislation, including Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work⁽³⁾, Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control⁽⁴⁾; Directive 98/24/EC, Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy⁽⁵⁾and Directive 2004/37/EC; ...

... (c) the dossier is for a substance listed in the Community rolling action plan referred to in Article 44(2). ...

... 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. The Agency shall adopt the final Community rolling action plan on the basis of an opinion from the Member State Committee set up under Article 76(1)(e) (hereinafter referred to as "the Member State Committee") and shall publish the plan on its website, identifying the Member State who will carry out the evaluation of the substances listed therein as determined according to Article 45. ...

... 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. The Agency shall adopt the final Community rolling action plan on the basis of an opinion from the Member State Committee set up under Article 76(1)(e) (hereinafter referred to as "the Member State Committee") and shall publish the plan on its website, identifying the Member State who will carry out the evaluation of the substances listed therein as determined according to Article 45. ...

... 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. The Agency shall adopt the final Community rolling action plan on the basis of an opinion from the Member State Committee set up under Article 76(1)(e) (hereinafter referred to as "the Member State Committee") and shall publish the plan on its website, identifying the Member State who will carry out the evaluation of the substances listed therein as determined according to Article 45. ...

... 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. The Agency shall adopt the final Community rolling action plan on the basis of an opinion from the Member State Committee set up under Article 76(1)(e) (hereinafter referred to as "the Member State Committee") and shall publish the plan on its website, identifying the Member State who will carry out the evaluation of the substances listed therein as determined according to Article 45. ...

... 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. ...

... 2. A Member State may choose (a) substance(s) from the draft Community rolling action plan, with the aim of becoming a competent authority for the purposes of Articles 46, 47 and 48. In the event of a substance from the draft Community rolling action plan not being chosen by any Member State, the Agency shall ensure that the substance is evaluated. ...

... 2. A Member State may choose (a) substance(s) from the draft Community rolling action plan, with the aim of becoming a competent authority for the purposes of Articles 46, 47 and 48. In the event of a substance from the draft Community rolling action plan not being chosen by any Member State, the Agency shall ensure that the substance is evaluated. ...

... 5. A Member State may notify the Agency at any time of a substance not on the Community rolling action plan, whenever it is in possession of information which suggests that the substance is a priority for evaluation. The Agency shall decide whether to add this substance to the Community rolling action plan on the basis of an opinion from the Member State Committee. If the substance is added to the Community rolling action plan, the proposing Member State, or another Member State who agrees, shall evaluate that substance. ...

... 5. A Member State may notify the Agency at any time of a substance not on the Community rolling action plan, whenever it is in possession of information which suggests that the substance is a priority for evaluation. The Agency shall decide whether to add this substance to the Community rolling action plan on the basis of an opinion from the Member State Committee. If the substance is added to the Community rolling action plan, the proposing Member State, or another Member State who agrees, shall evaluate that substance. ...

... 5. A Member State may notify the Agency at any time of a substance not on the Community rolling action plan, whenever it is in possession of information which suggests that the substance is a priority for evaluation. The Agency shall decide whether to add this substance to the Community rolling action plan on the basis of an opinion from the Member State Committee. If the substance is added to the Community rolling action plan, the proposing Member State, or another Member State who agrees, shall evaluate that substance. ...

... 1. If the competent authority considers that further information is required, including, if appropriate, information not required in Annexes VII to X, it shall prepare a draft decision, stating reasons, requiring the registrant(s) to submit the further information and setting a deadline for its submission. A draft decision shall be prepared within 12 months of the publication of the Community rolling action plan on the Agency's website for substances to be evaluated that year. The decision shall be taken in accordance with the procedure laid down in Articles 50 and 52. ...

... 1. Authorisations granted in accordance with Article 60 shall be regarded as valid until the Commission decides to amend or withdraw the authorisation in the context of a review, provided that the holder of the authorisation submits a review report at least 18 months before the expiry of the time-limited review period. Rather than re-submitting all elements of the original application for the current authorisation, the holder of an authorisation may submit only the number of the current authorisation, subject to the second, third and fourth subparagraphs. A holder of an authorisation granted in accordance with Article 60 shall submit an update of the analysis of alternatives referred to in Article 62(4)(e), including information about any relevant research and development activities by the applicant, if appropriate, and any substitution plan submitted under Article 62(4)(f). If the update of the analysis of alternatives shows that there is a suitable alternative available taking into account the elements in Article 60(5), he shall submit a substitution plan, including a timetable for proposed actions by the applicant. If the holder cannot demonstrate that the risk is adequately controlled, he shall also submit an update of the socio-economic analysis contained in the original application. If he can now demonstrate that the risk is adequately controlled, he shall submit an update of the chemical safety report. If any other elements of the original application have changed, he shall also submit updates of these element(s). When any updated information is submitted in accordance with this paragraph, any decision to amend or withdraw the authorisation in the context of the review shall be taken in accordance with the procedure referred to in Article 64 applied mutatis mutandis. ...

... (f) where the analysis referred to in point (e) shows that suitable alternatives are available, taking into account the elements in Article 60(5), a substitution plan including a timetable for proposed actions by the applicant. ...

... 3. Within 12 months of the receipt of the request from the Commission in paragraph 1 and if this dossier demonstrates that action on a Community-wide basis is necessary, beyond any measures already in place, the Agency shall suggest restrictions, in order to initiate the restrictions process. ...

... 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. ...

... (d) a Committee for Socio-economic Analysis, which shall be responsible for preparing the opinion of the Agency on applications for authorisation, proposals for restrictions, and any other questions that arise from the operation of this Regulation relating to the socio-economic impact of possible legislative action on substances; ...

... (a) a draft report covering the activities of the Agency in the previous year, including information about the number of registration dossiers received, the number of substances evaluated, the number of applications for authorisation received, the number of proposals for restriction received by the Agency and opined upon, the time taken for completion of the associated procedures, and the substances authorised, dossiers rejected, substances restricted; complaints received and the action taken; an overview of the activities of the Forum; ...

... 7. The Board of Appeal shall decide as to the action to be taken in the cases specified in paragraphs 5 and 6 without the participation of the member concerned. For the purposes of taking this decision, the member concerned shall be replaced on the Board of Appeal by an alternate. ...

... 3. The Board of Appeal may exercise any power which lies within the competence of the Agency or remit the case to the competent body of the Agency for further action. ...

... Actions before the Court of First Instance and the Court of Justice ...

... 1. An action may be brought before the Court of First Instance or the Court of Justice, in accordance with Article 230 of the Treaty, contesting a decision taken by the Board of Appeal or, in cases where no right of appeal lies before the Board, by the Agency. ...

... 1. Harmonised classification and labelling at Community level shall, from 1 June 2007, normally be added to Annex I of Directive 67/548/EEC for classification of a substance as carcinogenic, mutagenic or toxic for reproduction category 1, 2 or 3, or as a respiratory sensitiser. Harmonised classification and labelling for other effects may also be added to Annex I of Directive 67/548/EEC on a case-by-case basis if justification is provided demonstrating the need for action at Community level. To this end, Member State competent authorities may submit proposals to the Agency for harmonised classification and labelling in accordance with Annex XV. ...

... Where urgent action is essential to protect human health, safety or the environment, such as emergency situations, the Agency may disclose the information referred to in this paragraph. ...

... 4. Decisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 1049/2001 may form the subject of a complaint to the Ombudsman or of an action before the Court of Justice, under the conditions laid down in Articles 195 and 230 of the Treaty respectively. ...

... 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. ...

... 2. The requests to a notifier to provide further information for a substance in accordance with Article 16(1) of Directive 67/548/EEC, shall be considered as decisions adopted in accordance with Article 52 of this Regulation. Such substance shall be regarded as being included in the Community rolling action plan in accordance with Article 44(2) of this Regulation and shall be regarded as being chosen in accordance with Article 45(2) of this Regulation by the Member State whose competent authority has requested further information in accordance with Article 7(2) and Article 16(1) of Directive 67/548/EEC. ...

... (c) prepare a documentation of how it considers that any other risks identified would need to be addressed by action other than an amendment of Annex XVII of this Regulation. ...