Law-ref.org REACH - Registration, Evaluation and Authorisation of Chemicals
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... 24. In preparation for this Regulation, the Commission has launched REACH Implementation Projects (RIPs), involving relevant experts from stakeholder groups. Some of those projects aim at developing draft guidelines and tools which should help the Commission, the Agency, Member States, manufacturers, importers and downstream users of substances to fulfil, in concrete terms, their obligations under this Regulation. This work should enable the Commission and the Agency to make available appropriate technical guidance, in due time, with regard to the deadlines introduced by this Regulation. ...
... 33. Joint submission and the sharing of information on substances should be provided for in order to increase the efficiency of the registration system, to reduce costs and to reduce testing on vertebrate animals. One of a group of multiple registrants should submit information on behalf of the others according to rules which ensure that all the required information is submitted, while allowing sharing of the costs burden. A registrant should be able to submit information directly to the Agency in certain specified cases. ...
... 69. To ensure a sufficiently high level of protection for human health, including having regard to relevant human population groups and possibly to certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention. Authorisation should be granted where natural or legal persons applying for an authorisation demonstrate to the granting authority that the risks to human health and the environment arising from the use of the substance are adequately controlled. Otherwise, uses may still be authorised if it can be shown that the socio-economic benefits from the use of the substance outweigh the risks connected with its use and there are no suitable alternative substances or technologies that are economically and technically viable. Taking into account the good functioning of the internal market it is appropriate that the Commission should be the granting authority. ...
... 114. To ensure a harmonised protection for the general public, and, in particular, for persons who come into contact with certain substances, and the proper functioning of other Community legislation relying on the classification and labelling, an inventory should record the classification in accordance with Directive 67/548/EEC and Directive 1999/45/EC agreed by manufacturers and importers of the same substance, if possible, as well as decisions taken at Community level to harmonise the classification and labelling of some substances. This should take full account of the work and experience accumulated in connection with the activities under Directive 67/548/EEC, including the classification and labelling of specific substances or groups of substances listed in Annex I of Directive 67/548/EEC. ...


ARTICLE-14: Chemical safety report and duty to apply and recommend risk reduction measures     [go to this ARTICLE]
... 1. Without prejudice to Article 4 of Directive 98/24/EC, a chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in accordance with this Chapter in quantities of 10 tonnes or more per year per registrant. The chemical safety report shall document the chemical safety assessment which shall be conducted in accordance with paragraphs 2 to 7 and with Annex I for either each substance on its own or in a preparation or in an article or a group of substances. ...


ARTICLE-62: Applications for authorisations     [go to this ARTICLE]
... 3. Applications may be made for one or several substances, that meet the definition of a group of substances in section 1.5 of Annex XI, and for one or several uses. Applications may be made for the applicant's own use(s) and/or for uses for which he intends to place the substance on the market. ...


ARTICLE-76: Composition     [go to this ARTICLE]
... 2. The Committees referred to in points (c), (d) and (e) of paragraph 1 (hereinafter referred to as "the Committees") and the Forum may each establish working groups. For this purpose they shall adopt, in accordance with their rules of procedure, precise arrangements for delegating certain tasks to these working groups. ...
... 2. The Committees referred to in points (c), (d) and (e) of paragraph 1 (hereinafter referred to as "the Committees") and the Forum may each establish working groups. For this purpose they shall adopt, in accordance with their rules of procedure, precise arrangements for delegating certain tasks to these working groups. ...


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. ...
... 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. ...
... 9. Each Committee shall draft a proposal for its own rules of procedure, to be approved by the Management Board, within six months of the Committees first being appointed. These rules shall in particular lay down the procedures for replacing members, the procedures for delegating certain tasks to working groups, the creation of working groups and the establishment of a procedure for the urgent adoption of opinions. The Chairman of each Committee shall be an employee of the Agency. ...
... 9. Each Committee shall draft a proposal for its own rules of procedure, to be approved by the Management Board, within six months of the Committees first being appointed. These rules shall in particular lay down the procedures for replacing members, the procedures for delegating certain tasks to working groups, the creation of working groups and the establishment of a procedure for the urgent adoption of opinions. The Chairman of each Committee shall be an employee of the Agency. ...


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. ...
... 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. ...
... 4. The Forum shall draft a proposal for its own rules of procedure, to be adopted by the Management Board, within six months of the Forum first being appointed. These rules shall in particular lay down the procedures for appointing and replacing the Chairman, replacing members and the procedures for delegating certain tasks to working groups. ...


ARTICLE-87: Rapporteurs of Committees and use of experts     [go to this ARTICLE]
... 2. Member States shall transmit to the Agency the names of experts with proven experience in the tasks required by Article 77, who would be available to serve on working groups of the Committees, together with an indication of their qualifications and specific areas of expertise. The Agency shall keep an up-to-date list of experts. The list shall include the experts referred to in the first subparagraph and other experts identified directly by the Secretariat. ...
... 3. The provision of services by Committee members or any expert serving on a working group of the Committees or Forum, or performing any other task for the Agency shall be governed by a written contract between the Agency and the person concerned, or where appropriate between the Agency and the employer of the person concerned. The person concerned, or his employer, shall be remunerated by the Agency in accordance with a scale of fees to be included in the financial arrangements established by the Management Board. Where the person concerned fails to fulfil his duties, the Executive Director has the right to terminate or suspend the contract or withhold remuneration. ...


ARTICLE-113: Obligation to notify the Agency     [go to this ARTICLE]
... 1. Any manufacturer, producer of articles or importer, or group of manufacturers or producers of articles or importers, who place on the market a substance within the scope of Article 112, shall notify to the Agency the following information in order for it to be included in the inventory in accordance with Article 114, unless submitted as part of the registration: ...