Law-ref.org REACH - Registration, Evaluation and Authorisation of Chemicals
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... 85. In relation to Annex XVII Member States should be allowed to maintain for a transitional period more stringent restrictions, provided that these restrictions have been notified according to the Treaty. This should concern substances on their own, substances in preparations and substances in articles, the manufacturing, the placing on the market and the use of which is restricted. The Commission should compile and publish an inventory of these restrictions. This would provide an opportunity for the Commission to review the measures concerned with a view to possible harmonisation. ...
... 92. For reasons of transparency, the Agency should publish the relevant dossier including the suggested restrictions while requesting comments. ...


ARTICLE-3: Definitions     [go to this ARTICLE]
... 27) Full study report: means a complete and comprehensive description of the activity performed to generate the information. This covers the complete scientific paper as published in the literature describing the study performed or the full report prepared by the test house describing the study performed; ...


ARTICLE-28: Duty to pre-register for phase-in substances     [go to this ARTICLE]
... 4. The Agency shall by 1 January 2009 publish on its website a list of the substances referred to in paragraph 1(a) and (d). That list shall comprise only the names of the substances, including their EINECS and CAS number if available and other identity codes, and the first envisaged registration deadline. ...
... 5. After the publication of the list a downstream user of a substance not appearing on the list may notify the Agency of his interest in the substance, his contact details and the details of his current supplier. The Agency shall publish on its website the name of the substance and on request provide contact details of the downstream user to a potential registrant. ...
... 7. Manufacturers or importers of phase-in substances in quantities of less than 1 tonne per year that appear on the list published by the Agency in accordance with paragraph 4 of this Article, as well as downstream users of those substances and third parties holding information on those substances, may submit the information referred to in paragraph 1 of this Article or any other relevant information to the Agency for those substances, with the intention of being part of the substance information exchange forum as referred to in Article 29. ...


ARTICLE-40: Examination of testing proposals     [go to this ARTICLE]
... 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. ...
... 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. ...


ARTICLE-44: Criteria for substance evaluation     [go to this ARTICLE]
... 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. ...


ARTICLE-54: Publication of information on evaluation     [go to this ARTICLE]
... By 28 February of each year, the Agency shall publish on its website a report on the progress made over the previous calendar year towards discharging the obligations incumbent upon it in relation to evaluation. This report shall include, in particular, recommendations to potential registrants in order to improve the quality of future registrations. ...


ARTICLE-59: Identification of substances referred to in Article 57     [go to this ARTICLE]
... 4. The Agency shall publish on its website a notice that an Annex XV dossier has been prepared for a substance. The Agency shall invite all interested parties to submit comments within a specified deadline to the Agency. ...
... 10. The Agency shall publish and update the list referred to in paragraph 1 on its website without delay after a decision on inclusion of a substance has been taken. ...


ARTICLE-64: Procedure for authorisation decisions     [go to this ARTICLE]
... 9. Summaries of the Commission decisions, including the authorisation number and the reasons for the decision, in particular where suitable alternatives exist, shall be published in the Official Journal of the European Union and shall be made publicly available in a database established and kept up to date by the Agency. ...


ARTICLE-67: General provisions     [go to this ARTICLE]
... 3. Until 1 June 2013, a Member State may maintain any existing and more stringent restrictions in relation to Annex XVII on the manufacture, placing on the market or use of a substance, provided that those restrictions have been notified according to the Treaty. The Commission shall compile and publish an inventory of these restrictions by 1 June ...


ARTICLE-69: Preparation of a proposal     [go to this ARTICLE]
... 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. ...


ARTICLE-71: Agency opinion: Committee for Socio-economic Analysis     [go to this ARTICLE]
... 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. ...


ARTICLE-72: Submission of an opinion to the Commission     [go to this ARTICLE]
... 2. Without prejudice to Articles 118 and 119 the Agency shall publish the opinions of the two Committees on its website without delay. ...


ARTICLE-83: Duties and powers of the Executive Director     [go to this ARTICLE]
... The Executive Director shall, following approval by the Management Board, forward the work programme for the coming year and the multi-annual work programme to the Member States, the European Parliament, the Council and the Commission, and shall have them published. The Executive Director shall, following approval by the Management Board, forward the Agency's general report to the Member States, the European Parliament, the Council, the Commission, the European Economic and Social Committee and the Court of Auditors, and shall have it published. ...
... The Executive Director shall, following approval by the Management Board, forward the work programme for the coming year and the multi-annual work programme to the Member States, the European Parliament, the Council and the Commission, and shall have them published. The Executive Director shall, following approval by the Management Board, forward the Agency's general report to the Member States, the European Parliament, the Council, the Commission, the European Economic and Social Committee and the Court of Auditors, and shall have it published. ...


ARTICLE-84: Appointment of the Executive Director     [go to this ARTICLE]
... 1. The Executive Director of the Agency shall be appointed by the Management Board on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and in other periodicals or on Internet sites. The Executive Director shall be appointed on the grounds of merit and documented administrative and management skills, as well as his relevant experience in the fields of chemical safety or regulation. The Management Board shall take its decision by a two-thirds majority of all members with a right to vote. Power to dismiss the Executive Director shall lie with the Management Board, in accordance with the same procedure. Before being appointed, the candidate selected by the Management Board shall be invited as soon as possible to make a statement before the European Parliament and to answer questions from Members of Parliament. ...


ARTICLE-85: Establishment of the Committees     [go to this ARTICLE]
... 1. Each Member State may nominate candidates to membership of the Committee for Risk Assessment. The Executive Director shall establish a list of the nominees, which shall be published on the Agency's website, without prejudice to Article 88(1). The Management Board shall appoint the members of the Committee from this list, including at least one member but not more than two from the nominees of each Member State that has nominated candidates. Members shall be appointed for their role and experience in performing the tasks specified in Article 77(3). ...
... 2. Each Member State may nominate candidates to membership of the Committee for Socio-economic Analysis. The Executive Director shall establish a list of the nominees, which shall be published on the Agency's website, without prejudice to Article 88(1). The Management Board shall appoint the members of the Committee from this list, including at least one member but not more than two from the nominees of each Member State that has nominated candidates. Members shall be appointed for their role and experience in performing the tasks specified in Article 77(3). ...
... 8. When preparing an opinion, each Committee shall use its best endeavours to reach a consensus. If such a consensus cannot be reached, the opinion shall consist of the position of the majority of members, including their grounds. The minority position(s), including their grounds, shall also be published. ...


ARTICLE-88: Qualification and interests     [go to this ARTICLE]
... 1. The membership of the Committees and of the Forum shall be made public. Individual members may request that their names not be made public if they believe that such publication could place them at risk. The Executive Director shall decide whether to agree to such requests. When each appointment is published, the professional qualifications of each member shall be specified. ...


ARTICLE-89: Establishment of the Board of Appeal     [go to this ARTICLE]
... 3. The Chairman, the other members and the alternates shall be appointed by the Management Board on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and in other periodicals or on Internet sites. They shall be appointed on the basis of their relevant experience and expertise in the field of chemical safety, natural sciences or regulatory and judicial procedures from a list of qualified candidates adopted by the Commission. The Management Board may appoint additional members and their alternates, on recommendation by the Executive Director, following the same procedure, if this is necessary to ensure that the appeals can be processed at a satisfactory rate. ...


ARTICLE-97: Implementation of the budget of the Agency     [go to this ARTICLE]
... 8. The final accounts shall be published. ...


ARTICLE-117: Reporting     [go to this ARTICLE]
... 4. Every five years, the Commission shall publish a general report on ...
... (b) the amount and distribution of funding made available by the Commission for the development and evaluation of alternative test methods. The first report shall be published by 1 June 2012. ...


... 2. The Commission may present legislative proposals as soon as a practicable and cost-efficient way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be established, and after publishing a report on the following: ...