Law-ref.org REACH - Registration, Evaluation and Authorisation of Chemicals
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competence [Global Index]


... 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. ...
... 21. Although the information yielded on substances through evaluation should be used in the first place by manufacturers and importers to manage the risks related to their substances, it may also be used to initiate the authorisation or restrictions procedures under this Regulation or risk management procedures under other Community legislation. Therefore it should be ensured that this information is available to the competent authorities and may be used by them for the purpose of such procedures. ...
... 66. The Agency should also be empowered to require further information from manufacturers, importers or downstream users on substances suspected of posing a risk to human health or the environment, including by reason of their presence on the internal market in high volumes, on the basis of evaluations performed. Based on the criteria for prioritising substances developed by the Agency in cooperation with the Member States a Community rolling action plan for substance evaluation should be established, relying on Member State competent authorities to evaluate substances included therein. If a risk equivalent to the level of concern arising from the use of substances subject to authorisation arises from the use of isolated intermediates on site, the competent authorities of the Member States should also be allowed to require further information, when justified. ...
... 66. The Agency should also be empowered to require further information from manufacturers, importers or downstream users on substances suspected of posing a risk to human health or the environment, including by reason of their presence on the internal market in high volumes, on the basis of evaluations performed. Based on the criteria for prioritising substances developed by the Agency in cooperation with the Member States a Community rolling action plan for substance evaluation should be established, relying on Member State competent authorities to evaluate substances included therein. If a risk equivalent to the level of concern arising from the use of substances subject to authorisation arises from the use of isolated intermediates on site, the competent authorities of the Member States should also be allowed to require further information, when justified. ...
... 98. In the interests of efficiency, the staff of the Agency Secretariat should perform essentially technical-administrative and scientific tasks without calling on the scientific and technical resources of the Member States. The Executive Director should ensure the efficient execution of the Agency's tasks in an independent manner. To ensure that the Agency fulfils its role, the composition of the Management Board should be designed to represent each Member State, the Commission and other interested parties appointed by the Commission in order to ensure the involvement of stakeholders, and the European Parliament and to secure the highest standard of competence and a broad range of relevant expertise in chemicals safety or the regulation of chemicals, whilst ensuring that there is relevant expertise in the field of general financial and legal matters. ...
... 100. A Commission Regulation should specify the structure and amounts of fees, including specifying the circumstances under which a proportion of the fees will be transferred to the relevant Member State competent authority. ...
... 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. ...
... 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. ...
... 115. Resources should be focused on substances of the highest concern. A substance should therefore be added to Annex I of Directive 67/548/EEC if it meets the criteria for classification as carcinogenic, mutagenic or toxic for reproduction categories 1, 2 or 3, as a respiratory sensitiser, or in respect of other effects on a case-by-case basis. Provision should be made to enable competent authorities to submit proposals to the Agency. The Agency should give its opinion on the proposal while interested parties should have an opportunity to comment. The Commission should take a decision subsequently. ...
... 119. Apart from their participation in the implementation of Community legislation, Member State competent authorities should, because of their closeness to stakeholders in the Member States, play a role in the exchange of information on risks of substances and on the obligations of natural or legal persons under chemicals legislation. At the same time, close cooperation between the Agency, the Commission and the competent authorities of the Member States is necessary to ensure the coherence and efficiency of the global communication process. ...
... 119. Apart from their participation in the implementation of Community legislation, Member State competent authorities should, because of their closeness to stakeholders in the Member States, play a role in the exchange of information on risks of substances and on the obligations of natural or legal persons under chemicals legislation. At the same time, close cooperation between the Agency, the Commission and the competent authorities of the Member States is necessary to ensure the coherence and efficiency of the global communication process. ...


ARTICLE-3: Definitions     [go to this ARTICLE]
... 19) Competent authority: means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation; ...


ARTICLE-9: Exemption from the general obligation to register for product and process orientated research and development (PPORD)     [go to this ARTICLE]
... 3. The Agency shall check the completeness of the information supplied by the notifier and Article 20(2) shall apply adapted as necessary. The Agency shall assign a number to the notification and a notification date, which shall be the date of receipt of the notification at the Agency, and shall forthwith communicate that number and date to the manufacturer, or importer, or producer of articles concerned. The Agency shall also communicate this information to the competent authority of the Member State(s) concerned. ...
... 8. The Agency shall forthwith communicate any draft decisions to the competent authorities of each Member State in which the manufacture, import, production or product and process orientated research takes place. When taking decisions as provided for in paragraphs 4 and 7, the Agency shall take into account any comments made by such competent authorities. ...
... 8. The Agency shall forthwith communicate any draft decisions to the competent authorities of each Member State in which the manufacture, import, production or product and process orientated research takes place. When taking decisions as provided for in paragraphs 4 and 7, the Agency shall take into account any comments made by such competent authorities. ...
... 9. The Agency and the competent authorities of the Member States concerned shall always keep confidential the information submitted in accordance with paragraphs 1 to 8. ...


ARTICLE-16: Duties of the Commission, the Agency and registrants of substances regarded as being registered     [go to this ARTICLE]
... 1. The Commission or the relevant Community body shall make information equivalent to that required by Article 10 available to the Agency for substances regarded as registered according to Article 15. The Agency shall include this information or a reference thereto in its databases and notify the competent authorities thereof by 1 December 2008. ...


ARTICLE-20: Duties of the Agency     [go to this ARTICLE]
... 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: ...
... The relevant Member State shall be the Member State within which the manufacture takes place or the importer is established. If the manufacturer has production sites in more than one Member State, the relevant Member State shall be the one in which the head office of the manufacturer is established. The other Member States where the production sites are established shall also be notified. The Agency shall forthwith notify the competent authority of the relevant Member State(s) when any further information submitted by the registrant is available on the Agency database. ...


ARTICLE-22: Further duties of registrants     [go to this ARTICLE]
... The Agency shall communicate this information to the competent authority of the relevant Member State. ...
... 2. A registrant shall submit to the Agency an update of the registration containing the information required by the decision made in accordance with Articles 40, 41 or 46 or take into account a decision made in accordance with Articles 60 and 73, within the deadline specified in that decision. The Agency shall notify the competent authority of the relevant Member State that the information is available on its database. ...


ARTICLE-36: Obligation to keep information     [go to this ARTICLE]
... 1. Each manufacturer, importer, downstream user and distributor shall assemble and keep available all the information he requires to carry out his duties under this Regulation for a period of at least 10 years after he last manufactured, imported, supplied or used the substance or preparation. That manufacturer, importer, downstream user or distributor shall submit this information or make it available without delay upon request to any competent authority of the Member State in which he is established or to the Agency, without prejudice to Titles II and VI. ...


ARTICLE-41: Compliance check of registrations     [go to this ARTICLE]
... 2. The list of dossiers being checked for compliance by the Agency shall be made available to Member States competent authorities. ...


ARTICLE-42: Check of information submitted and follow-up to dossier evaluation     [go to this ARTICLE]
... 2. Once the dossier evaluation is completed, the Agency shall notify the Commission and the competent authorities of the Member States of the information obtained and any conclusions made. The competent authorities shall use the information obtained from this evaluation for the purposes of Article 45(5), Article 59(3) and Article 69(4). The Agency shall use the information obtained from this evaluation for the purposes of Article 44. ...
... 2. Once the dossier evaluation is completed, the Agency shall notify the Commission and the competent authorities of the Member States of the information obtained and any conclusions made. The competent authorities shall use the information obtained from this evaluation for the purposes of Article 45(5), Article 59(3) and Article 69(4). The Agency shall use the information obtained from this evaluation for the purposes of Article 44. ...


ARTICLE-45: Competent authority     [go to this ARTICLE]
... Competent authority ...
... 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. ...
... 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. ...
... 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. ...
... 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. ...
... 4. The competent authority identified in accordance with paragraphs 2 and 3 shall evaluate the allocated substances in accordance with this Chapter. ...


ARTICLE-46: Requests for further information and check of information submitted     [go to this ARTICLE]
... 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. ...
... 3. The competent authority shall examine any information submitted, and shall draft any appropriate decisions in accordance with this Article, if necessary, within 12 months of the information being submitted. ...
... 4. The competent authority shall finish its evaluation activities within 12 months of the start of the evaluation of the substance or within 12 months of the information being submitted under paragraph 2, and notify the Agency accordingly. If this deadline is exceeded, the evaluation shall be deemed to be finished. ...


ARTICLE-48: Follow-up to substance evaluation     [go to this ARTICLE]
... Once the substance evaluation has been completed, the competent authority shall consider how to use the information obtained from this evaluation for the purposes of Article 59(3), Article 69(4) and Article 115(1). The competent authority shall inform the Agency of its conclusions as to whether or how to use the information obtained. The Agency shall in turn inform the Commission, the registrant and the competent authorities of the other Member States. ...
... Once the substance evaluation has been completed, the competent authority shall consider how to use the information obtained from this evaluation for the purposes of Article 59(3), Article 69(4) and Article 115(1). The competent authority shall inform the Agency of its conclusions as to whether or how to use the information obtained. The Agency shall in turn inform the Commission, the registrant and the competent authorities of the other Member States. ...
... Once the substance evaluation has been completed, the competent authority shall consider how to use the information obtained from this evaluation for the purposes of Article 59(3), Article 69(4) and Article 115(1). The competent authority shall inform the Agency of its conclusions as to whether or how to use the information obtained. The Agency shall in turn inform the Commission, the registrant and the competent authorities of the other Member States. ...


ARTICLE-49: Further information on on-site isolated intermediates     [go to this ARTICLE]
... For on-site isolated intermediates that are used in strictly controlled conditions, neither dossier nor substance evaluation shall apply. However, where the competent authority of the Member State in whose territory the site is located considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, it may: ...
... The procedure provided for in the first paragraph may be undertaken only by the competent authority referred to therein. The competent authority shall inform the Agency of the results of such an evaluation, which shall then inform the competent authorities of the other Member States and make the results available to them. ...
... The procedure provided for in the first paragraph may be undertaken only by the competent authority referred to therein. The competent authority shall inform the Agency of the results of such an evaluation, which shall then inform the competent authorities of the other Member States and make the results available to them. ...
... The procedure provided for in the first paragraph may be undertaken only by the competent authority referred to therein. The competent authority shall inform the Agency of the results of such an evaluation, which shall then inform the competent authorities of the other Member States and make the results available to them. ...


ARTICLE-50: Registrants' and downstream users' rights     [go to this ARTICLE]
... 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. ...
... 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. If a registrant has ceased the manufacture or import of the substance, or the production or import of an article, or the downstream user the use, he shall inform the Agency of this fact with the consequence that the registered volume in his registration, if appropriate, shall be put to zero and no further information may be requested with respect to that substance, unless the registrant notifies the restart of the manufacture or import of the substance or the production or import of the article, or the downstream user notifies the restart of the use. The Agency shall inform the competent authority of the Member State in which the registrant or downstream user is located. ...
... 3. The registrant may cease the manufacture or import of the substance or the production or import of the article, or the downstream user the use, upon receipt of the draft decision. In such cases, the registrant, or downstream user, shall inform the Agency of this fact with the consequence that his registration, or report, shall no longer be valid, and no further information may be requested with respect to that substance, unless he submits a new registration or report. The Agency shall inform the competent authority of the Member State in which the registrant or downstream user is located. ...
... (a) where the competent authority prepares a dossier in accordance with Annex XV concluding that there is a potential long-term risk to human health or the environment justifying the need for further information; ...


ARTICLE-51: Adoption of decisions under dossier evaluation     [go to this ARTICLE]
... 1. The Agency shall notify its draft decision in accordance with Articles 40 or 41, together with the comments of the registrant, to the competent authorities of the Member States. ...


ARTICLE-52: Adoption of decisions under substance evaluation     [go to this ARTICLE]
... 1. The competent authority shall circulate its draft decision in accordance with Article 46, together with any comments by the registrant or downstream user, to the Agency and to the competent authorities of the other Member States. ...
... 1. The competent authority shall circulate its draft decision in accordance with Article 46, together with any comments by the registrant or downstream user, to the Agency and to the competent authorities of the other Member States. ...


ARTICLE-66: Downstream users     [go to this ARTICLE]
... 2. The Agency shall establish and keep up to date a register of downstream users who have made a notification in accordance with paragraph 1. The Agency shall grant access to this register to the competent authorities of the Member States. ...


ARTICLE-74: Fees and charges     [go to this ARTICLE]
... 3. The structure and amount of the fees referred to in paragraph 1 shall take account of the work required by this Regulation to be carried out by the Agency and the competent authority and shall be fixed at such a level as to ensure that the revenue derived from them when combined with other sources of the Agency's revenue pursuant to Article 96(1) is sufficient to cover the cost of the services delivered. The fees set for registration shall take into account the work that may be done pursuant to Title VI. In the case of Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2) and Article 18(2), the structure and amount of fees shall take account of the tonnage range of the substance being registered. In all cases, a reduced fee shall be set for SMEs. In the case of Article 11(4), the structure and amount of fees shall take into account whether information has been submitted jointly or separately. In the case of a request made under Article 10(a)(xi), the structure and amount of fees shall take into account the work required by the Agency in assessing the justification. ...
... 4. The Regulation referred to in paragraph 1 shall specify the circumstances under which a proportion of the fees will be transferred to the relevant Member State competent authority. ...


... (h) providing technical and scientific guidance on the operation of this Regulation for Member State competent authorities and providing support to the helpdesks established by Member States under Title XIII; ...
... (i) providing guidance to stakeholders including Member State competent authorities on communication to the public of information on the risks and safe use of substances, on their own, in preparations or in articles; ...


ARTICLE-85: Establishment of the Committees     [go to this ARTICLE]
... 4. The Committees shall aim to have a broad range of relevant expertise among their members. To this end each Committee may co-opt a maximum of five additional members chosen on the basis of their specific competence. Members of the Committees shall be appointed for a term of three years which shall be renewable. The members of the Management Board may not be members of the Committees. The members of each Committee may be accompanied by advisers on scientific, technical or regulatory matters. The Executive Director or his representative and representatives of the Commission shall be entitled to attend all the meetings of the Committees and working groups convened by the Agency or its committees as observers. Stakeholders may also be invited to attend meetings as observers, as appropriate, at the request of the Committee members, or the Management Board. ...
... 5. The members of each Committee appointed following nomination by a Member State shall ensure that there is appropriate coordination between the tasks of the Agency and the work of their Member State competent authority. ...
... 6. The members of the Committees shall be supported by the scientific and technical resources available to the Member States. To this end, Member States shall provide adequate scientific and technical resources to the members of the Committees that they have nominated. Each Member State competent authority shall facilitate the activities of the Committees and their working groups. ...


ARTICLE-86: Establishment of the Forum     [go to this ARTICLE]
... 1. Each Member State shall appoint, for a three-year term, which shall be renewable, one member to the Forum. Members shall be chosen for their role and experience in enforcement of chemicals legislation and shall maintain relevant contacts with the Member State competent authorities. The Forum shall aim to have a broad range of relevant expertise among its members. To this end the Forum may coopt a maximum of five additional members chosen on the basis of their specific competence. These members shall be appointed for a term of three years, which shall be renewable. Members of the Management Board may not be members of the Forum. The members of the Forum may be accompanied by scientific and technical advisers. The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all the meetings of the Forum and its working groups. Stakeholders may also be invited to attend meetings as observers, as appropriate, at the request of Forum members, or the Management Board. ...
... 1. Each Member State shall appoint, for a three-year term, which shall be renewable, one member to the Forum. Members shall be chosen for their role and experience in enforcement of chemicals legislation and shall maintain relevant contacts with the Member State competent authorities. The Forum shall aim to have a broad range of relevant expertise among its members. To this end the Forum may coopt a maximum of five additional members chosen on the basis of their specific competence. These members shall be appointed for a term of three years, which shall be renewable. Members of the Management Board may not be members of the Forum. The members of the Forum may be accompanied by scientific and technical advisers. The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all the meetings of the Forum and its working groups. Stakeholders may also be invited to attend meetings as observers, as appropriate, at the request of Forum members, or the Management Board. ...
... 2. The members of the Forum appointed by a Member State shall ensure that there is appropriate coordination between the tasks of the Forum and the work of their Member State competent authority. ...
... 3. The members of the Forum shall be supported by the scientific and technical resources available to the competent authorities of the Member States. Each Member State competent authority shall facilitate the activities of the Forum and its working groups. The Member States shall refrain from giving the Forum members, or their scientific and technical advisers and experts any instruction which is incompatible with the individual tasks of those persons or with the tasks and responsibilities of the Forum. ...
... 3. The members of the Forum shall be supported by the scientific and technical resources available to the competent authorities of the Member States. Each Member State competent authority shall facilitate the activities of the Forum and its working groups. The Member States shall refrain from giving the Forum members, or their scientific and technical advisers and experts any instruction which is incompatible with the individual tasks of those persons or with the tasks and responsibilities of the Forum. ...


ARTICLE-93: Examination and decisions on appeal     [go to this ARTICLE]
... 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. ...
... 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. ...


ARTICLE-110: Relations with relevant Community bodies     [go to this ARTICLE]
... 2. The Executive Director, having consulted the Committee on Risk Assessment and the European Food Safety Authority, shall establish rules of procedure concerning substances for which an opinion has been sought in a food safety context. These rules of procedure shall be adopted by the Management Board, in agreement with the Commission. This Title shall not otherwise affect the competences vested in the European Food Safety Authority. ...
... 3. This Title shall not affect the competences vested in the European Medicines Agency. ...
... 4. The Executive Director, having consulted the Committee on Risk Assessment, the Committee on Socio-economic Analysis and the Advisory Committee on Safety, Hygiene and Health Protection at Work, shall establish rules of procedure concerning worker protection issues. These rules of procedure shall be adopted by the Management Board, in agreement with the Commission. This Title shall not affect the competences vested in the Advisory Committee on Safety, Hygiene and Health Protection at Work and the European Agency for Health and Safety at Work. ...


ARTICLE-115: Harmonisation of classification and labelling Committee for Risk Assessment shall adopt an opinion on the proposal, giving parties     [go to this ARTICLE]
... 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. ...


ARTICLE-121: Appointment     [go to this ARTICLE]
... Member States shall appoint the competent authority or competent authorities responsible for performing the tasks allotted to competent authorities under this Regulation and for cooperating with the Commission and the Agency in the implementation of this Regulation. Member States shall place adequate resources at