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... 64. In order to prevent unnecessary animal testing, interested parties should have a period of 45 days during which they may provide scientifically valid information and studies that address the relevant substance and hazard end-point, which is addressed by the testing proposal. The scientifically valid information and studies received by the Agency should be taken into account for decisions on testing proposals. ...

... 4. The Agency shall notify the competent authority of the relevant Member State within 30 days of the submission date, that the following information is available in the Agency database: ...

... 2. On request by a consumer any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance. The relevant information shall be provided, free of charge, within 45 days of receipt of the request. ...

... 2. Information relating to testing proposals involving tests on vertebrate animals shall be published on the Agency website. The Agency shall publish on its website the name of the substance, the hazard end-point for which vertebrate testing is proposed, and the date by which any third party information is required. It shall invite third parties to submit, using the format provided by the Agency, scientifically valid information and studies that address the relevant substance and hazard end-point, addressed by the testing proposal, within 45 days of the date of publication. All such scientifically valid information and studies received shall be taken into account by the Agency in preparing its decision in accordance with paragraph 3. ...

... (e) a decision in accordance with points (a), (b) or (c), if several registrants or downstream users of the same substance have submitted proposals for the same test, giving them the opportunity to reach an agreement on who will perform the test on behalf of all of them and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users, as appropriate, to perform the test on behalf of all of them. ...

... (e) a decision in accordance with points (a), (b) or (c), if several registrants or downstream users of the same substance have submitted proposals for the same test, giving them the opportunity to reach an agreement on who will perform the test on behalf of all of them and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users, as appropriate, to perform the test on behalf of all of them. ...

... 1. In the case of non phase-in substances, the Agency shall prepare a draft decision in accordance with Article 40(3) within 180 days of receiving a registration or downstream user report containing a testing proposal. ...

... 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. The Agency shall refer the matter to the Member State Committee, in order to agree which authority shall be the competent authority, taking into account the Member State in which the manufacturer(s) or importer(s) is located, the respective proportions of total Community gross domestic product, the number of substances already being evaluated by a Member State and the expertise available. 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. ...

... 1. The Agency shall notify any draft decision under Articles 40, 41 or 46 to the registrant(s) or downstream user(s) concerned, informing them of their right to comment within 30 days of receipt. If the concerned registrant(s) or downstream user(s) wish to comment, they shall provide their comments to the Agency. The Agency in turn shall inform the competent authority of the submission of the comments without delay. The competent authority (for decisions taken under Article 46) and the Agency (for decisions taken under Articles 40 and 41) shall take any comments received into account and may amend the draft decision accordingly. ...

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

... 4. If the Agency receives a proposal for amendment, it may modify the draft decision. The Agency shall refer a draft decision, together with any amendments proposed, to the Member State Committee within 15 days of the end of the 30-day period referred to in paragraph 2. ...

... 4. If the Agency receives a proposal for amendment, it may modify the draft decision. The Agency shall refer a draft decision, together with any amendments proposed, to the Member State Committee within 15 days of the end of the 30-day period referred to in paragraph 2. ...

... 5. The Agency shall forthwith communicate any proposal for amendment to any registrants or downstream users concerned and allow them to comment within 30 days. The Member State Committee shall take any comments received into account. ...

... 6. If, within 60 days of the referral, the Member State Committee reaches a unanimous agreement on the draft decision, the Agency shall take the decision accordingly. ...

... 1. Where registrants or downstream users are required to perform a test as a result of a decision taken under this Title, those registrants or downstream users shall make every effort to reach an agreement as to who is to carry it out on behalf of the other registrants or downstream users and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users to perform the test on behalf of all of them. ...

... 1. Where registrants or downstream users are required to perform a test as a result of a decision taken under this Title, those registrants or downstream users shall make every effort to reach an agreement as to who is to carry it out on behalf of the other registrants or downstream users and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users to perform the test on behalf of all of them. ...

... 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. ...

... 7. When comments are made or received, the Agency shall refer the dossier to the Member State Committee within 15 days of the end of the 60-day period referred to in paragraph 5. ...

... 7. When comments are made or received, the Agency shall refer the dossier to the Member State Committee within 15 days of the end of the 60-day period referred to in paragraph 5. ...

... 8. If, within 30 days of the referral, the Member State Committee reaches a unanimous agreement on the identification, the Agency shall include the substance in the list referred to in paragraph 1. The Agency may include that substance in its recommendations under Article 58(3). ...

... 5. The Agency shall send these draft opinions to the applicant by the end of the deadline set out in paragraph 1. Within one month of receipt of the draft opinion, the applicant may provide written notice that he wishes to comment. The draft opinion shall be deemed to have been received seven days after the Agency has sent it. 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. ...

... 5. The Agency shall send these draft opinions to the applicant by the end of the deadline set out in paragraph 1. Within one month of receipt of the draft opinion, the applicant may provide written notice that he wishes to comment. The draft opinion shall be deemed to have been received seven days after the Agency has sent it. 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. ...

... 5. The Agency shall send these draft opinions to the applicant by the end of the deadline set out in paragraph 1. Within one month of receipt of the draft opinion, the applicant may provide written notice that he wishes to comment. The draft opinion shall be deemed to have been received seven days after the Agency has sent it. 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. ...

... 5. The Agency shall send these draft opinions to the applicant by the end of the deadline set out in paragraph 1. Within one month of receipt of the draft opinion, the applicant may provide written notice that he wishes to comment. The draft opinion shall be deemed to have been received seven days after the Agency has sent it. 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. ...

... 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. ...

... 1. Within 12 months of the date of publication referred to in Article 69(6), the Committee for Socio-economic Analysis shall formulate an opinion on the suggested restrictions, based on its consideration of the relevant parts of the dossier and the socio-economic impact. It shall prepare a draft opinion on the suggested restrictions and on the related socio-economic impact, taking account of the analyses or information according to point (b) of Article 69(6), if there are any. The Agency shall publish the draft opinion on its website without delay. The Agency shall invite interested parties to give their comments on the draft opinion no later than 60 days from the publication of that draft opinion. ...

... 3. Where the opinion of the Committee for Risk Assessment diverges significantly from the restrictions suggested, the Agency may postpone the deadline for the opinion of the Committee for Socio-economic Analysis by a maximum of 90 days. ...

... 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. ...

... (f) making publicly available information as to which substances are being, and have been evaluated within 90 days of receipt of the information at the Agency, in accordance with Article 119(1); ...

... (a) the day-to-day administration of the Agency; ...

... (a) the day-to-day administration of the Agency; ...

... 2. The appeal, together with the statements of the grounds thereof, shall be filed in writing to the Agency within three months of the notification of the decision to the person concerned, or in the absence thereof, of the day on which it became known to the latter, unless otherwise provided in this Regulation. ...

... 1. If, after consultation with the Chairman of the Board of Appeal, the Executive Director considers the appeal to be admissible and well founded he may rectify the decision within 30 days of the appeal being filed in accordance with Article 92(2). ...

... 2. In cases other than those referred to in paragraph 1 of this Article, the Chairman of the Board of Appeal shall examine whether the appeal is admissible within 30 days of the appeal being filed in accordance with Article 92(2). In the affirmative, the appeal shall be remitted to the Board of Appeal for examination of the grounds. Parties to the appeal proceedings shall be entitled to make an oral presentation during the procedure. ...

... 2. The Commission shall take a decision in accordance with the procedure referred to in Article 133(3) within 60 days of receipt of the information from the Member State. This decision shall either: ...