Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance) (c. 1907)

[X1 TITLE X U.K. AGENCY

Article 77 U.K. Tasks

[F1A1. When forming opinions the Agency must take relevant scientific knowledge and advice into account (including any relevant knowledge and advice relating to socio-economic matters).

A2. The Agency may take any such knowledge or advice into account when forming an opinion only if—

(a) the knowledge or advice has been commissioned by the Agency, from one or more suitably qualified or experienced persons who are independent of the Agency, for the purposes of forming the opinion concerned, or

(b) the knowledge or advice—

(i) is already in existence (whether within the Agency or externally),

(ii) is produced within the Agency for the purposes of forming the opinion concerned, or

(iii) is, in accordance with Article 2B, produced by the Environment Agency or one of the other environmental regulators in connection with the Agency forming the opinion concerned and then passed on to the Agency, and the Agency considers that it is appropriate to take it into account, rather than to commission knowledge or advice in compliance with point (a).

The knowledge or advice that the Agency may take into account in compliance with point (b)(i) includes knowledge or advice which has previously been commissioned by the Agency from one or more suitably qualified or experienced persons who are independent of the Agency for the purposes of forming a previous opinion on any matter.

A3. The Agency must comply with this paragraph if —

(a) it is forming—

(i) an opinion in connection with deciding whether to grant an authorisation under Article 60,

(ii) an opinion under Article 70 as to whether suggested restrictions are appropriate in reducing the risk to human health or the environment, or

(iii) an opinion under Article 71 on suggested restrictions and on the related socio-economic impact, and

(b) it only takes into account knowledge or advice that is not commissioned in compliance with paragraph A2(a) for the purposes of forming that opinion.

The Agency must—

(a) produce an explanation of why it considered that it was appropriate to take only that knowledge or advice into account,

(b) publish the explanation, and

A4. When exercising its functions, the Agency must act in a way that ensures a high degree of transparency.

A5. The Agency must produce and publish a statement of how it will comply with paragraphs A1, A2 and A4.

The Agency must produce and publish the first statement within the period of 3 months beginning with the day after IP completion day.

The Agency must consult such persons as it considers appropriate before producing the first, or any subsequent, statement.

A6. The statement must include—

(a) information about the qualifications or relevant experience that are suitable in order for persons to be commissioned to provide knowledge or advice to the Agency,

(b) examples of situations in which the Agency envisages that it might be appropriate to take existing knowledge or advice (rather than knowledge or advice commissioned as mentioned in paragraph A2(a)) into account.

A7. Paragraphs A1 to A6 do not limit the Agency's duties under Article 2B.]

1. The Agency shall provide the [F2appropriate authorities] with the best possible scientific and technical advice on questions relating to chemicals which fall within its remit and which are referred to it in accordance with the provisions of this Regulation.

2. [F3The Agency] shall undertake the following tasks:

F4 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F4 (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F4 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F4 (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F5(e) establishing and maintaining database(s) with information on all registered substances F6 ....] It shall make the information identified in Article 119(1) and (2) in the database(s) publicly available, free of charge, over the Internet, except where a request made under Article 10(a)(xi) is considered justified. F7 ...;

(f) making publicly available information as to which substances are being, and have been evaluated within 90 days of receipt of the information at the Agency, in accordance with Article 119(1);

(g) providing technical and scientific guidance and tools where appropriate for the operation of this Regulation in particular to assist the development of chemical safety reports (in accordance with Article 14, Article 31(1) and Article 37(4)) and application of Article 10(a)(viii), Article 11(3) and Article 19(2) by industry and especially by SMEs; and technical and scientific guidance for the application of Article 7 by producers and importers of articles;

F8 (h) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(i) providing guidance to stakeholders F9 ... on communication to the public of information on the risks and safe use of substances, on their own, in [F5mixtures] or in articles;

(j) providing advice and assistance to manufacturers and importers registering a substance in accordance with Article 12(1);

(k) preparing explanatory information on this Regulation for other stakeholders;

(l) at the F10 ... request [F11of any appropriate authority] , providing technical and scientific support for steps to improve cooperation [F12with] 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;