The European Agency
The European Agency
A European Chemicals Agency is established by REACH. It shall comprise:
(a) a Management Board;
(b) an Executive Director;
(c) a Committee for Risk Assessment, which shall be responsible for preparing the opinion of the Agency on applications for authorisation, proposals fo restrictions, and any other questions that arise from the operation of REACH relating to risks to human health or the environment;
(d) a Committee for Socio-economic Analysis, which shall be responsible for preparing the opinion of the Agency on applications for authorisation, proposals for restrictions, and any other questions that arise from the operation of REACH including the socio-economic analysis of the effect of possible legislative action on substances;
(e) a Member State Committee, which shall be responsible for resolving divergences of opinions on draft decisions proposed by Member States and preparing the opinion of the Agency on proposals for classification and labelling and proposals for identification of substances of very high concern to be subjected to the authorisation procedure;
(f) a Forum for Exchange of Information on Enforcement, which shall co-ordinate a network of Member States authorities responsible for enforcement of this Regulation;
(g) a Secretariat, which shall provide technical, scientific and administrative support for the Committees and the Forum and ensure appropriate coordination between them. It shall also undertake the work required of the Agency under the procedures for pre-registration, registration and mutual recognition of evaluation as well as preparation of guidance, database maintenance and information provision;
(h) a Board of Appeal, which shall decide on appeals against decisions taken by the Agency.
Tasks
The Agency shall advise the Member States and the Community within the context of the REACH System.
The tasks to be performed by the Secretariat are essentially administrative, requiring a good understanding of the REACH system but limited technical expertise judgement, so it would be inappropriate to involve the Committees:
- dissemination of information to Member States and other interested parties;
- establishment and maintenance of the database that is the primary store of information that will be available to the Competent Authorities as well as the source of non-confidential information to be made available on request;
- making publicly available information on which substances have been, and are, subject to evaluation;
- preparation of documents for companies concerning their obligations under the REACH system;
- establishing a help desk to support Member State competent authorities’own help desks. The Member States competent authorities’ help desks provide advice to companies and the Agency’s help desk promotes a harmonised approach by the Member States competent authorities. The Agency’s help desk does not provide advice direct to industry;
- preparation of descriptive documents to help non-industry stakeholders understand the REACH system;
- at the Commission's request, providing technical and scientific support for steps to improve co-operation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries.
The tasks to be performed by the Committees provide for:
- the work under the procedures leading to the adoption of opinions or recommendations for substances to be included in Step 1 of authorisation or to be classified at Community level;
- technical support to Community participation in international harmonisation activities;
- at the Commission's request, drawing up an opinion on any other aspects concerning the safety of substances on their own, in preparations or articles.
The Forum shall undertake the following tasks:
- spreading good practice and highlighting problems at Community level;
- proposing, co-ordinating and evaluating harmonised enforcement projects and joint inspections;
- co-ordinating exchange of inspectors;
- identifying enforcement strategies, as well as minimum enforcement criteria;
- developing working methods and tools of use to local inspectors;
- developing an electronic information exchange procedure;
- liaising with industry and other stakeholders, including relevant international organisations, as necessary.
Establishment of the Committees and Forum
Each Member State may nominate candidates to the Risk Assessment and Socio-economic Analysis Committees. The Management Board will appoint at least one member from each Member State having made a nomination to that committee.
The Member States shall appoint one member each to the Member State Committee and one to the Forum.
Members of the Committees and the Forum shall be appointed for a term of three years which shall be renewable.
The members shall have the expertise relevant to one of the Committees or to the Forum. It is intended that the members of the Risk Assessment and Socio-economic Analysis Committees shall give their views as experts and not as representatives of their Member State. It is nevertheless appropriate to draw these members from the Member States because this will give the Committees, access to the collective expertise of the Member States, will promote mutual acceptance of decisions and so support the harmonisation of regulatory practices across the Community. In order to provide a good range of expertise on each Committee and on the Forum, they may co-opt up to five further members and be accompanied by scientific and technical advisers having the expertise relevant to a particular item. The Committees and the Forum may each establish working groups and delegate them certain tasks.
Meetings of the Committees and the Forum shall be open to the Commission and to the Executive Director of the Agency.
Committee and forum members shall ensure appropriate co-ordination between the work of Member States competent authority and that of their Committee, in order to promote a common European approach. The Member States are required to provide scientific and technical support to the work of the Committees, Forum and working groups. Member States are not permitted to give instructions to members of the Committes and Forum that might conflict with an objective analysis of the issues under discussion. To facilitate the work of the committees, opinions may be adopted by a majority of Committee members, with due recording of minority views.
Contacts with stakeholder organisations
The Management Board shall, in agreement with the Commission, develop appropriate contacts between the Agency and the representatives of industry, consumer protection, worker protection and environmental protection organisations. These contacts may include the participation of observers in certain aspects of the Agency's work, under conditions determined beforehand by the Management Board, in agreement with the Commission.
The aim is to promote transparency and so secure widespread acceptance of the work of the Agency among key stakeholders.
Transitional measures
The Commission shall fulfil the functions of the Agency during the period following the entry into force of REACH until these functions are transferred to the Agency.