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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 VI U.K. EVALUATION

CHAPTER 1 U.K. Dossier evaluation

Article 40 U.K. Examination of testing proposals

[F11 . The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance. Priority shall be given to registrations of substances which have or may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances above 100 tonnes per year with uses resulting in widespread and diffuse exposure, provided they fulfil the criteria for any of the following hazard classes or categories set out in Annex I of Regulation (EC) No 1272/2008:

( a ) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

( b ) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

( c ) hazard class 4.1;

( d ) hazard class 5.1.]

2 . Information relating to testing proposals involving tests on vertebrate animals shall be published on the Agency website. The Agency shall publish on its website the name of the substance, the hazard end-point for which vertebrate testing is proposed, and the date by which any third party information is required. It shall invite third parties to submit, using the format provided by the Agency, scientifically valid information and studies that address the relevant substance and hazard end-point, addressed by the testing proposal, within 45 days of the date of publication. All such scientifically valid information and studies received shall be taken into account by the Agency in preparing its decision in accordance with paragraph 3.

3 . On the basis of the examination under paragraph 1, the Agency shall draft one of the following decisions and that decision shall be taken in accordance with the procedure laid down in Articles 50 and 51:

( a ) a decision requiring the registrant(s) or downstream user(s) concerned to carry out the proposed test and setting a deadline for submission of the study summary, or the robust study summary if required by Annex I;

( b ) a decision in accordance with point (a), but modifying the conditions under which the test is to be carried out;

( c ) a decision in accordance with points (a), (b) or (d) but requiring registrant(s) or downstream user(s) to carry out one or more additional tests in cases of non-compliance of the testing proposal with Annexes IX, X and XI;

( d ) a decision rejecting the testing proposal;

( e ) a decision in accordance with points (a), (b) or (c), if several registrants or downstream users of the same substance have submitted proposals for the same test, giving them the opportunity to reach an agreement on who will perform the test on behalf of all of them and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users, as appropriate, to perform the test on behalf of all of them.

4 . The registrant or downstream user shall submit the information required to the Agency by the deadline set.

Textual Amendments

Article 41 U.K. Compliance check of registrations

1. The Agency may examine any registration in order to verify any of the following:

(a) that the information in the technical dossier(s) submitted pursuant to Article 10 complies with the requirements of Articles 10, 12 and 13 and with Annexes III and VI to X;

(b) that the adaptations of the standard information requirements and the related justifications submitted in the technical dossier(s) comply with the rules governing such adaptations set out in Annexes VII to X and with the general rules set out in Annex XI;

(c) that any required chemical safety assessment and chemical safety report comply with the requirements of Annex I and that the proposed risk management measures are adequate;

(d) that any explanation(s) submitted in accordance with Article 11(3) or Article 19(2) have an objective basis.

2. The list of dossiers being checked for compliance by the Agency shall be made available to [F2the appropriate authorities that request it].

3. On the basis of an examination made pursuant to paragraph 1, the Agency may, within 12 months of the start of the compliance check, prepare a draft decision requiring the registrant(s) to submit any information needed to bring the registration(s) into compliance with the relevant information requirements and specifying adequate time limits for the submission of further information. Such a decision shall be taken in accordance with the procedure laid down in Articles 50 and 51.

4. The registrant shall submit the information required to the Agency by the deadline set.

5.[F3The registration dossiers selected by the Agency for compliance checking must include—

(a)until 27 October 2027, not less than 20% of the registration dossiers received by the Agency for substances referred to in Article 127P(4B)(a);

(b)until 27 October 2030, not less than 20% of the registration dossiers received by the Agency for substances referred to in Article 127P(4B)(b);

(c)until 27 October 2035, not less than 20% of the registration dossiers received by the Agency for substances referred to in Article 127P(4B)(c).]

[F4In this paragraph, references to registration dossiers do not include the dossiers referred to in Article 127B(9).]

F56.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F67. The Secretary of State may, by regulations, make provision to modify the effect of paragraph 5 by—

(a)modifying the percentage of dossiers to be selected;

(b)modifying the criteria which determine the dossiers to which priority is to be given.

Regulations under this paragraph may amend paragraph 5.

The Secretary of State must consult the Agency before making regulations under this paragraph.

Regulations under this paragraph are to be made by statutory instrument; and a statutory instrument containing regulations under this paragraph is subject to annulment in pursuance of a resolution of either House of Parliament.

The function of making regulations under this paragraph is subject to the consent requirement in Article 4A.]

Textual Amendments

Article 42 U.K. Check of information submitted and follow-up to dossier evaluation

1. The Agency shall examine any information submitted in consequence of a decision taken under Articles 40 or 41, and draft any appropriate decisions in accordance with these Articles, if necessary.

2. Once the dossier evaluation is completed, the Agency shall notify the [F7appropriate authorities that request the notification] of the information obtained and any conclusions made. F8... The Agency shall use the information obtained from this evaluation for the purposes of Article 44.

Textual Amendments

Article 43 U.K. Procedure and time periods for examination of testing proposals

1. In the case of non phase-in substances, the Agency shall prepare a draft decision in accordance with Article 40(3) within 180 days of receiving a registration or downstream user report containing a testing proposal.

2. In the case of phase-in substances, the Agency shall prepare the draft decisions in accordance with Article 40(3):

F9 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F9 (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c) by 1 June [F102023] for any registrations containing testing proposals received [F11by ECHA] by 1 June 2018.

3. The list of registration dossiers being evaluated under Article 40 shall be made available to [F12appropriate authorities that request it] .

Textual Amendments

CHAPTER 2 U.K. Substance evaluation

Article 44 U.K. Criteria for substance evaluation

1. [F13The] Agency shall in cooperation with the [F14appropriate authorities] develop criteria for prioritising substances with a view to further evaluation. Prioritisation shall be on a risk-based approach. The criteria shall consider:

(a) hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;

(b) exposure information;

(c) tonnage, including aggregated tonnage from the registrations submitted by several registrants.

2. The Agency shall use the criteria in paragraph 1 for the purpose of compiling a draft F15 ... rolling action plan which shall cover a period of three years and shall specify substances to be evaluated each year. Substances shall be included if there are grounds for considering (either on the basis of a dossier evaluation carried out by the Agency or on the basis of any other appropriate source, including information in the registration dossier) that a given substance constitutes a risk to human health or the environment. [F16The Agency must submit its draft rolling action plan to the appropriate authorities within 12 months of IP completion day and give the appropriate authorities the opportunity to comment on it. The Agency must submit a draft annual update to its rolling action plan by 31 May in each subsequent year and give the appropriate authorities the opportunity to comment on it. The Agency must adopt a final rolling annual action plan for each year (after taking account of any comments made on the draft by the appropriate authorities) and must publish it on its website.]

F17 ...

Textual Amendments

Article 45 U.K. [F18Evaluation of substances on the rolling action plan]

1. The Agency shall be responsible for F19 ... ensuring that substances on the F20 ... rolling action plan are evaluated. F21 ...

F22 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F22 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F22 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F22 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 46 U.K. Requests for further information and check of information submitted

1. If the [F23Agency] considers that further information is required, including, if appropriate, information not required in Annexes VII to X, it shall prepare a draft decision, stating reasons, requiring the registrant(s) to submit the further information and setting a deadline for its submission. A draft decision shall be prepared within 12 months of the publication of the F24 ... rolling action plan on the Agency's website for substances to be evaluated that year. The decision shall be taken in accordance with the procedure laid down in Articles 50 and 52.

2. The registrant shall submit the information required to the Agency by the deadline set.

3. The [F25Agency] shall examine any information submitted, and shall draft any appropriate decisions in accordance with this Article, if necessary, within 12 months of the information being submitted.

4. The [F26Agency] shall finish its evaluation activities within 12 months of the start of the evaluation of the substance or within 12 months of the information being submitted under paragraph 2 F27 .... If this deadline is exceeded, the evaluation shall be deemed to be finished.

Textual Amendments

Article 47 U.K. Coherence with other activities

1. An evaluation of a substance shall be based on all relevant information submitted on that particular substance and on any previous evaluation under this Title. Where information on intrinsic properties of a substance has been generated by reference to structurally related substance(s), the evaluation may also cover these related substances. In cases where a decision on an evaluation has been previously taken in accordance with Article 51 or Article 52, any draft decision requiring further information under Article 46 may be justified only by a change of circumstances or acquired knowledge.

F28 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F29 Article 48 U.K. Follow-up to substance evaluation

Once the substance evaluation has been completed, the Agency must consider how to use the information obtained from this evaluation for the purposes of Article 59(3) and Article 69(4). The Agency must inform the appropriate authorities and the registrant of its conclusions as to whether or how to use the information obtained.]

Textual Amendments

CHAPTER 3 U.K. Evaluation of intermediates

Article 49 U.K. Further information on on-site isolated intermediates

For on-site isolated intermediates that are used in strictly controlled conditions, neither dossier nor substance evaluation shall apply. However, where the [F30Agency] considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, it may:

(a)

require the registrant to submit further information directly related to the risk identified. This request shall be accompanied by a written justification;

(b)

examine any information submitted and, if necessary, recommend any appropriate risk reduction measures to address the risks identified in relation to the site in question.

[F31Where the appropriate authority in relation to the part of Great Britain where the site is located considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, that appropriate authority may request the Agency to take the steps set out in points (a) and (b) of the first paragraph.

The Agency must inform the appropriate authorities that request them of the results of an assessment under this Article.]

Textual Amendments

CHAPTER 4 U.K. Common provisions

Article 50 U.K. Registrants' and downstream users' rights

1. The Agency shall notify any draft decision under Articles 40, 41 or 46 to the registrant(s) or downstream user(s) concerned, informing them of their right to comment within 30 days of receipt. If the concerned registrant(s) or downstream user(s) wish to comment, they shall provide their comments to the Agency. F32 ...

2. If a registrant has ceased the manufacture or import of the substance, or the production or import of an article, or the downstream user the use, he shall inform the Agency of this fact with the consequence that the registered volume in his registration, if appropriate, shall be put to zero and no further information may be requested with respect to that substance, unless the registrant notifies the restart of the manufacture or import of the substance or the production or import of the article, or the downstream user notifies the restart of the use. The Agency shall inform the [F33appropriate authorities that request it, when a registrant has informed the Agency in accordance with this paragraph] .

3. The registrant may cease the manufacture or import of the substance or the production or import of the article, or the downstream user the use, upon receipt of the draft decision. In such cases, the registrant, or downstream user, shall inform the Agency of this fact with the consequence that his registration, or report, shall no longer be valid, and no further information may be requested with respect to that substance, unless he submits a new registration or report. The Agency shall inform the [F34appropriate authorities that request it, when a registrant has informed the Agency in accordance with this paragraph] .

4. Notwithstanding paragraphs 2 and 3, further information may be required in accordance with Article 46 in either or both of the following cases:

(a) where the [F35Agency] prepares a dossier in accordance with Annex XV concluding that there is a potential long-term risk to human health or the environment justifying the need for further information;

(b) where the exposure to the substance manufactured or imported by the registrant(s), or to the substance in the article produced or imported by the registrant(s), or to the substance used by the downstream user(s) contributes significantly to that risk.

The procedure in Articles 69 to 73 shall apply mutatis mutandis .

Textual Amendments

[F36 Article 51 U.K. Adoption of decisions under dossier evaluation

1. This Article applies where the Agency has notified its draft decision in accordance with Article 40 or 41.

2. If the Agency receives no comments from the registrant or downstream user, the Agency must make its decision in the version notified under paragraph 1.

3. If the Agency receives any comments from the registrant or downstream user, the Agency must—

(a) take the comments into account, and

(b) make its decision (whether that is to make the decision in the version notified or vary the decision notified).

4. The Agency must notify the registrant or downstream user and the appropriate authorities of the decision made under paragraph 2 or 3.

5. An appeal may be brought, in accordance with Articles 91, 92 and 93 against a decision made under paragraph 2 or 3.]

Textual Amendments

[F37 Article 52 U.K. Adoption of decisions under substance evaluation

1. This Article applies where the Agency has circulated its draft decision in accordance with Article 46.

2. If the Agency receives no comments from the registrant or the downstream user, the Agency must make its decision in the version circulated under paragraph 1.

3. If the Agency receives any comments from the registrant or the downstream user, the Agency must—

(a) take the comments into account, and

(b) make its decision (whether that is to make the decision in the version circulated or vary the decision circulated).

4. The Agency must notify the registrant or the downstream user, and the appropriate authorities, of the decision made under paragraph 2 or 3.

5. An appeal may be brought, in accordance with Articles 91, 92 and 93 against a decision made under paragraph 2 or 3.]

Textual Amendments

Article 53 U.K. Cost sharing for tests without an agreement between registrants and/or downstream users

1 . Where registrants or downstream users are required to perform a test as a result of a decision taken under this Title, those registrants or downstream users shall make every effort to reach an agreement as to who is to carry it out on behalf of the other registrants or downstream users and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users to perform the test on behalf of all of them.

2 . If a registrant or downstream user performs a test on behalf of others, they shall all share the cost of that study equally.

3 . In the case referred to in paragraph 1, the registrant or downstream user who performs the test shall provide each of the others concerned with a copy of the full study report.

4 . The person performing and submitting the study shall have a claim against the others accordingly. Any person concerned shall be able to make a claim in order to prohibit another person from manufacturing, importing or placing the substance on the market if that other person either fails to pay his share of the cost or to provide security for that amount or fails to hand over a copy of the full study report of the study performed. All claims shall be enforceable in the national courts. Any person may choose to submit their claims for remuneration to an arbitration board and accept the arbitration order.

Article 54 U.K. Publication of information on evaluation

By 28 February of each year, the Agency shall publish on its website a report on the progress made over the previous calendar year towards discharging the obligations incumbent upon it in relation to evaluation. This report shall include, in particular, recommendations to potential registrants in order to improve the quality of future registrations. ]

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