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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

Editorial Information