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Regulation (EC) No 1907/2006 of the European Parliament and of the CouncilShow full title

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)

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[X1 TITLE X U.K. AGENCY

F1 Article 75 U.K. Establishment and review

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F2 Article 76 U.K. Composition

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Article 77 U.K. Tasks

[F3A1. 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

(c) send a copy of the explanation to the appropriate authorities.

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 [F4appropriate 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. [F5The Agency] shall undertake the following tasks:

F6 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F6 (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F6 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F6 (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F7(e) establishing and maintaining database(s) with information on all registered substances F8 ....] 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. F9 ...;

(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;

F10 (h) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(i) providing guidance to stakeholders F11 ... on communication to the public of information on the risks and safe use of substances, on their own, in [F7mixtures] 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 F12 ... request [F13of any appropriate authority] , providing technical and scientific support for steps to improve cooperation [F14with] 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;

(m) keeping a Manual of Decisions and Opinions F15 ... regarding interpretation and implementation of this Regulation;

(n) notification of decisions taken by the Agency;

(o) provision of formats for submission of information to the Agency.

F16 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F16 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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F17 Article 78 U.K. Powers of the Management Board

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F17 Article 79 U.K. Composition of the Management Board

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F17 Article 80 U.K. Chairmanship of the Management Board

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F17 Article 81 U.K. Meetings of the Management Board

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F17 Article 82 U.K. Voting of the Management Board

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Article 83 U.K. [F18Annual report by the Agency to the appropriate authorities ]

F19 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F19 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. Each year, the [F20Agency] shall submit the following to the [F21Secretary of State] for approval:

(a) a draft report covering the activities of the Agency in the previous year, including information about the number of registration dossiers received, the number of substances evaluated, the number of applications for authorisation received, the number of proposals for restriction [F22prepared by the Agency] , the time taken for completion of the associated procedures, and the substances authorised, dossiers rejected, substances restricted; [F23the Agency's compliance with Article 77(A1) by taking into account scientific knowledge and advice (including knowledge and advice relating to socio-economic matters);] complaints received and the action taken F24 ...;

(b) a draft work-programme for the coming year;

(c) the draft annual accounts;

(d) the draft forecast budget for the coming year;

(e) a draft multiannual work programme.

[F25The Agency must provide any draft submitted to the Secretary of State under points (a) to (e) to the other appropriate authorities at the same time it is submitted to the Secretary of State.

The Secretary of State must consult the other appropriate authorities before giving approval to any draft submitted under points (a) to (e).]

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F26 Article 84 U.K. Appointment of the Executive Director

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F26 Article 85 U.K. Establishment of the Committees

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F26 Article 86 U.K. Establishment of the Forum

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F26 Article 87 U.K. Rapporteurs of Committees and use of experts

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Article 88 U.K. Qualification and interests

[F271. The details of the suitably qualified or experienced persons that provide advice to the Agency under Article 77(A2)(a) must be made public. Individuals may request that their names not be made public if they believe that such publication could place them at risk. The Agency must decide whether to agree to such requests. When details are published, the professional qualifications of each suitably qualified or experienced person must be specified.]

2. [F28Suitably qualified or experienced persons that provide advice to the Agency pursuant to Article 77(A2)(a)] shall make a declaration of commitment to fulfil their duties and a declaration of interests which could be considered to be prejudicial to their independence. These declarations shall be made annually in writing and, without prejudice to paragraph 1, be entered in a register held by the Agency which is accessible to the public, on request, at the Agency's offices.

F29 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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F30 Article 89 U.K. Establishment of the Board of Appeal

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F31 Article 90 U.K. Members of the Board of Appeal

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Article 91 U.K. Decisions subject to appeal

1. An appeal may be brought against decisions of the Agency taken pursuant to Article 9, Article 20, Article 27(6), [F32Article 51 and Article 52] .

[F331A. An appeal pursuant to paragraph 1 lies to the First-tier Tribunal.]

2. An appeal lodged pursuant to paragraph 1 shall have suspensive effect.

[F343. On an appeal pursuant to paragraph 1, the First-tier Tribunal—

(a) may dismiss the appeal, or

(b) if it allows the appeal may—

(i) quash the decision and (if appropriate) remit the matter to the Agency, or

(ii) substitute for the decision any other decision which could have been made by the Agency.]

Textual Amendments

Article 92 U.K. Persons entitled to appeal F35 ...

1. Any natural or legal person may appeal against a decision addressed to that person, or against a decision which, although addressed to another person, is of direct and individual concern to the former.

F36 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F36 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Article 93 U.K. [F37Change of decision where appeal made]

[F38 1. If—

(a) an appeal against a decision is brought pursuant to Article 91, and

(b) the Agency considers the appeal to be admissible and well founded,

the Agency may rectify the decision within the period of 30 days beginning with the day when the appeal is brought.]

F39 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F39 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F39 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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F40 Article 94 U.K. Actions before the Court of First Instance and the Court of Justice

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Article 95 U.K. Conflicts of opinion with other bodies

1. The Agency shall take care to ensure early identification of potential sources of conflict between its opinions and those of other [F41public bodies] carrying out a similar task in relation to issues of common concern.

2. Where the Agency identifies a potential source of conflict, it shall contact the body concerned in order to ensure that any relevant scientific or technical information is shared and to identify the scientific or technical points which are potentially contentious.

3. Where there is a fundamental conflict over scientific or technical points F42 ..., the Agency and the body concerned shall work together either to solve the conflict or to submit a joint document to the [F43appropriate authorities] clarifying the scientific and/or technical points of conflict.

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F44 Article 96 U.K. The budget of the Agency

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F44 Article 97 U.K. Implementation of the budget of the Agency

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F44 Article 98 U.K. Combating fraud

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F44 Article 99 U.K. Financial rules

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F44 Article 100 U.K. Legal personality of the Agency

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F44 Article 101 U.K. Liability of the Agency

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F44 Article 102 U.K. Privileges and immunities of the Agency

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F44 Article 103 U.K. Staff rules and regulations

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F44 Article 104 U.K. Languages

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F44 Article 105 U.K. Duty of confidentiality

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F44 Article 106 U.K. Participation of third countries

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F44 Article 107 U.K. Participation of international organisations

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Article 108 U.K. Contacts with stakeholder organisations

The [F45Agency must develop appropriate contacts with] relevant stakeholder organisations.

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Article 109 U.K. Rules on transparency

To ensure transparency, the [F46Agency must] adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the safety of substances on their own, in [F7mixtures] or in articles which is not of a confidential nature.

Textual Amendments

Article 110 U.K. Relations with relevant [F47public] bodies

1. The Agency shall cooperate with other [F48public] bodies to ensure mutual support in the accomplishment of their respective tasks in particular to avoid duplication of work.

2. The [F49Agency, having consulted the Food Standards Agency and Food Standards Scotland] shall establish rules of procedure concerning substances for which an opinion has been sought in a food safety context. F50 ...

This Title shall not otherwise affect the competences vested in the [F51Food Standards Agency and Food Standards Scotland] .

3. This Title shall not affect the competences vested in the [F52Medicines and Healthcare products Regulatory Agency] .

F53 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 111 U.K. Formats and software for submission of information to the Agency

The Agency shall specify formats and make them available free of charge, and software packages and make them available on its website for any submissions to the Agency. [F54Manufacturers] , importers, distributors or downstream users shall use these formats and packages in their submissions to the Agency pursuant to this Regulation. In particular, the Agency shall make available software tools to facilitate the submission of all information relating to substances registered in accordance with Article 12(1).

For the purposes of registration, the format of the technical dossier referred to in Article 10(a) shall be IUCLID. The Agency shall coordinate the further development of this format with the Organisation for Economic Cooperation and Development to ensure maximum harmonisation.]

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