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... 83. It is suitable in these circumstances that final decisions granting or refusing authorisations be adopted by the Commission pursuant to a regulatory procedure in order to allow for an examination of their wider implications within the Member States and to associate the latter more closely with the decisions. ...

... 95. The Agency should be central to ensuring that chemicals legislation and the decision-making processes and scientific basis underlying it have credibility with all stakeholders and the public. The Agency should also play a pivotal role in coordinating communication around this Regulation and in its implementation. The confidence in the Agency of the Community institutions, the Member States, the general public and interested parties is therefore essential. For this reason, it is vital to ensure its independence, high scientific, technical and regulatory capacities, as well as transparency and efficiency. ...

... 124. In particular, power should be conferred on the Commission to amend the Annexes in certain cases, to set rules on test methods, to vary the percentage of dossiers selected for compliance checking and to modify the criteria for their selection, and to set the criteria defining what constitutes adequate justification that testing is technically not possible. Since these measures are of general scope and are designed to amend non-essential elements of this Regulation or supplement this Regulation by adding new non-essential elements thereto, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. ...

... 125. It is essential that chemicals be regulated in an effective and timely manner during the transition to full applicability of the provisions of this Regulation and, in particular, during the start-up period of the Agency. Provision should therefore be made for the Commission to provide the necessary support towards the setting up of the Agency, including the conclusion of contracts and the appointment of an Executive Director ad interim until the Agency's Management Board can appoint an Executive Director itself. ...

... 15. regulatory information; ...

... 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⁾. ...

... 6. The application shall not include the risks to human health arising from the use of a substance in a medical device regulated by Directives 90/385/EEC, 93/42/EEC or 98/79/EC. ...

... 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. ...

... 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. ...

... To ensure transparency, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the safety of substances on their own, in preparations or in articles which is not of a confidential nature. ...