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... Having regard to the opinion of the European Economic and Social Committee⁽¹⁾, ...

... Having regard to the opinion of the European Economic and Social Committee⁽²⁾, ...

... 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. ...

... 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. ...

... 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. ...

... 102. Through a Committee for Risk Assessment and a Committee for Socio-economic Analysis, the Agency should take over the role of the Scientific Committees attached to the Commission in issuing scientific opinions in its field of competence. ...

... 102. Through a Committee for Risk Assessment and a Committee for Socio-economic Analysis, the Agency should take over the role of the Scientific Committees attached to the Commission in issuing scientific opinions in its field of competence. ...

... 102. Through a Committee for Risk Assessment and a Committee for Socio-economic Analysis, the Agency should take over the role of the Scientific Committees attached to the Commission in issuing scientific opinions in its field of competence. ...

... 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. ...

... 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. ...

... 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. ...

... 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. ...

... 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. ...

... 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. ...

... 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. ...

... 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. ...

... 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. ...

... 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. ...

... 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. ...

... 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. ...

... 7. If the Member State Committee fails to reach unanimous agreement, the Commission shall prepare a draft decision to be taken in accordance with the procedure referred to in Article 133(3). ...

... 3. Prior to a decision to include substances in Annex XIV, the Agency shall, taking into account the opinion of the Member State Committee, recommend priority substances to be included specifying for each substance the items set out in paragraph 1. Priority shall normally be given to substances with: ...

... 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). ...

... 9. If the Member State Committee fails to reach a unanimous agreement, the Commission shall prepare a draft proposal on the identification of the substance within three months of receipt of the opinion of the Member State Committee. A final decision on the identification of the substance shall be taken in accordance with the procedure referred to in Article 133(3). ...

... 9. If the Member State Committee fails to reach a unanimous agreement, the Commission shall prepare a draft proposal on the identification of the substance within three months of receipt of the opinion of the Member State Committee. A final decision on the identification of the substance shall be taken in accordance with the procedure referred to in Article 133(3). ...

... 2. Without prejudice to paragraph 3, an authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIV is adequately controlled in accordance with section 6.4 of Annex I and as documented in the applicant's chemical safety report, taking into account the opinion of the Committee for Risk Assessment referred to in Article 64(4)(a). When granting the authorisation, and in any conditions imposed therein, the Commission shall take into account all discharges, emissions and losses, including risks arising from diffuse or dispersive uses, known at the time of the decision. 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⁽¹⁾, Council Directive 93/42/EEC of 14 June 1993 concerning medical devices⁽²⁾or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices⁽³⁾. ...

... 4. If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken after consideration of all of the following elements and taking into account the opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis referred to in Article 64(4)(a) and (b): ...

... 4. If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken after consideration of all of the following elements and taking into account the opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis referred to in Article 64(4)(a) and (b): ...

... 1. The Agency shall acknowledge the date of receipt of the application. The Agency's Committees for Risk Assessment and Socio-economic Analysis shall give their draft opinions within ten months of the date of receipt of the application. ...

... 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. ...

... 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. ...

... 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. ...

... 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. ...

... (a) Committee for Risk Assessment: an assessment of the risk to human health and/or the environment arising from the use(s) of the substance, including the appropriateness and effectiveness of the risk management measures as described in the application and, if relevant, an assessment of the risks arising from possible alternatives; ...

... (b) Committee for Socio-economic Analysis: an assessment of the socio-economic factors and the availability, suitability and technical feasibility of alternatives associated with the use(s) of the substance as described in the application, when an application is made in accordance with Article 62 and of any third party contributions submitted under paragraph 2 of this Article. ...

... 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. ...

... 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. ...

... Agency opinion: Committee for Risk Assessment ...

... Within nine months of the date of publication referred to in Article 69(6), the Committee for Risk Assessment shall formulate an opinion as to whether the suggested restrictions are appropriate in reducing the risk to human health and/or the environment, based on its consideration of the relevant parts of the dossier. This opinion shall take account of the Member State dossier or of the dossier prepared by the Agency at the request of the Commission, and the views of interested parties referred to in point (a) of Article 69(6). ...

... Agency opinion: Committee for Socio-economic Analysis ...

... 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. ...

... 2. The Committee for Socio-economic Analysis shall without delay adopt its opinion, taking into account where appropriate further comments received by the deadline set. This opinion shall take account of the comments and socio-economic analyses of interested parties submitted under point (b) of Article 69(6) and under paragraph 1 of this Article. ...

... 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. ...

... 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. ...

... 1. The Agency shall submit to the Commission without delay the opinions of the Committees for Risk Assessment and Socio-economic Analysis on restrictions suggested for substances on their own, in preparations or in articles. If one or both of the Committees do not formulate an opinion by the deadline set in Article 70 and Article 71(1) the Agency shall inform the Commission accordingly, stating the reasons. ...

... 1. The Agency shall submit to the Commission without delay the opinions of the Committees for Risk Assessment and Socio-economic Analysis on restrictions suggested for substances on their own, in preparations or in articles. If one or both of the Committees do not formulate an opinion by the deadline set in Article 70 and Article 71(1) the Agency shall inform the Commission accordingly, stating the reasons. ...

... 2. Without prejudice to Articles 118 and 119 the Agency shall publish the opinions of the two Committees on its website without delay. ...

... 1. If the conditions laid down in Article