Regulation (EU) No 528/2012 of the European Parliament and of the CouncilDangos y teitl llawn

CHAPTER III U.K. RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE

Article 12 U.K. Conditions for renewal

1. The [F1 Secretary of State] shall renew the approval of an active substance if the active substance still meets the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2).

2. In the light of scientific and technical progress, the [F2 Secretary of State] shall review and, where appropriate, amend the conditions specified for the active substance referred to in Article 4(3).

3. The renewal of an approval of an active substance shall be for 15 years for all product-types to which the approval applies, unless a shorter period is specified in the [F3 decision issued] in accordance with point (a) of Article 14(4) renewing such an approval.

[F4 4. The renewal of an approval under paragraph 1 or amendment of the conditions in paragraph 2 is subject to the consent requirement.]

Textual Amendments

F1 Words in Art. 12(1) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 73(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 12(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 73(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 12(3) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 73(c); 2020 c. 1, Sch. 5 para. 1(1)

F4 Art. 12(4) inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 73(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 13 U.K. Submission and acceptance of applications

1. Applicants wishing to seek renewal of the approval of an active substance for one or more product-types shall submit an application to the [F5 competent authority] at least 550 days before the expiry of the approval. Where there are different expiry dates for different product-types, the application shall be submitted at least 550 days before the earliest expiry date.

2. When applying for the renewal of the approval of the active substance, the applicant shall submit:

(a) without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial approval or, as appropriate, previous renewal; and

(b) its assessment of whether the conclusions of the initial or previous assessment of the active substance remain valid and any supporting information.

F6 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F7 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F5 Words in Art. 13(1) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 74(a); 2020 c. 1, Sch. 5 para. 1(1)

F6 Art. 13(3) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 74(b); 2020 c. 1, Sch. 5 para. 1(1)

F7 Art. 13(4) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 74(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 14 U.K. Evaluation of applications for renewal

1. On the basis of an assessment of the available information and the need to review the conclusions of the initial evaluation of the application for approval or, as appropriate, the previous renewal, the F8 ... competent authority shall, within 90 days of [F9 receiving] an application in accordance with Article [F10 13], decide whether, in the light of current scientific knowledge, a full evaluation of the application for renewal is necessary taking account of all product-types for which renewal is requested.

2. Where the F11 ... competent authority decides that a full evaluation of the application is necessary, the evaluation shall be carried out in accordance with paragraphs 1, 2 and 3 of Article 8.

Where the F11 ... competent authority decides that a full evaluation of the application is not necessary, it shall, within 180 days of [F12 receiving] the application in accordance with Article [F13 13], prepare and submit to the [F14 Secretary of State and the Devolved Authorities] a recommendation on the renewal of the approval of the active substance. It shall provide the applicant with a copy of its recommendation.

The F11 ... competent authority shall, as soon as possible after [F15 it has received] an application, notify the applicant of the [F16 appropriate fees]. The F11 ... competent authority shall reject the application if the applicant fails to pay the fees within 30 days of the notification and shall inform the applicant accordingly.

3. Within 270 days of [F17 the completion of the evaluation conclusions], if it has carried out a full evaluation of the application, or 90 days otherwise, the [F18 competent authority] shall prepare and submit to the [F19 Secretary of State and the Devolved Authorities] an opinion on renewal of the approval of the active substance.

4. The [F20 Secretary of State] shall, on receipt of the opinion of the [F21 competent authority], [F22 issue]:

(a) [F23 a decision] providing that the approval of an active substance is renewed for one or more product-types, and under which conditions; or

(b) [F24 a] decision that the approval of an active substance is not renewed.

F25 ...

Article 9(2) shall apply.

[F26 4A. The competent authority shall update the GB List with details of the renewal of the approval of the active substance]

[F27 5. Where, for reasons beyond the control of the applicant, the approval of the active substance is likely to expire before a decision has been taken on its renewal, the Secretary of State shall issue a decision postponing the expiry date of approval for a period sufficient to enable the competent authority to examine the application.]

[F28 5A. A decision issued under paragraph 4 or 5 above is subject to the consent requirement.]

6. Where the [F29 Secretary of State] decides not to renew or decides to amend the approval of an active substance for one or more product-types, the [F30 competent authority] shall cancel or, where appropriate, amend the authorisations of biocidal products of the product-type(s) concerned containing that active substance. Articles 48 and 52 shall apply accordingly.

Textual Amendments

F8 Word in Art. 14(1) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F9 Word in Art. 14(1) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

F10 Word in Art. 14(1) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(2)(c); 2020 c. 1, Sch. 5 para. 1(1)

F11 Word in Art. 14(2) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F12 Word in Art. 14(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(3)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F13 Word in Art. 14(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(3)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F14 Words in Art. 14(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(3)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F15 Words in Art. 14(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(3)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in Art. 14(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(3)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F17 Words in Art. 14(3) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F18 Words in Art. 14(3) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

F19 Words in Art. 14(3) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(4)(c); 2020 c. 1, Sch. 5 para. 1(1)

F20 Words in Art. 14(4) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(5)(a); 2020 c. 1, Sch. 5 para. 1(1)

F21 Words in Art. 14(4) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(5)(b); 2020 c. 1, Sch. 5 para. 1(1)

F22 Word in Art. 14(4) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(5)(c); 2020 c. 1, Sch. 5 para. 1(1)

F23 Words in Art. 14(4)(a) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(5)(d); 2020 c. 1, Sch. 5 para. 1(1)

F24 Word in Art. 14(4)(b) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(5)(e); 2020 c. 1, Sch. 5 para. 1(1)

F25 Words in Art. 14(4) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(5)(f); 2020 c. 1, Sch. 5 para. 1(1)

F26 Art. 14(4A) inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(6) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 26); 2020 c. 1, Sch. 5 para. 1(1)

F27 Art. 14(5) substituted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(7); 2020 c. 1, Sch. 5 para. 1(1)

F28 Art. 14(5A) inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(8); 2020 c. 1, Sch. 5 para. 1(1)

F29 Words in Art. 14(6) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(9)(a); 2020 c. 1, Sch. 5 para. 1(1)

F30 Words in Art. 14(6) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 75(9)(b); 2020 c. 1, Sch. 5 para. 1(1)

[F31 Article 15 U.K. Review of approval of an active substance

1. The Secretary of State may review the approval of an active substance for one or more product-types at any time where there are significant indications that the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2) are no longer met. The Secretary of State may also review the approval of an active substance for one or more product-types at the request of the competent authority if there are indications that the use of the active substance in biocidal products or treated articles raises significant concerns about the safety of such biocidal products or treated articles. The Secretary of State shall make publically available the information that it is carrying out a review and shall provide an opportunity for the applicant to submit comments. The Secretary of State shall take due account of those comments in the review.

2. Where any of the Devolved Authorities proposes that an active substance should be reviewed the Secretary of State shall have regard to such proposals in deciding whether to review the approval of an active substance.

3. Where those indications are confirmed, the Secretary of State shall issue a decision amending the conditions of approval of an active substance or cancelling its approval. Article 9(2) shall apply. The competent authority shall inform the initial applicants for the approval accordingly.

4. On duly justified imperative grounds of urgency the Secretary of State may issue immediately applicable decisions.

5. Paragraphs 1, 3 and 4 are subject to the consent requirement.

6. Where the Secretary of State decides to cancel or amend the approval of an active substance for one or more product-types the competent authority shall cancel or, where appropriate, amend the authorisations of biocidal products of the product-type(s) concerned containing that active substance. Articles 48 and 52 shall apply accordingly.]

Textual Amendments

F31 Art. 15 substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 76; 2020 c. 1, Sch. 5 para. 1(1)

F32 Article 16 U.K. Implementing measures

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F32 Art. 16 omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 77; 2020 c. 1, Sch. 5 para. 1(1)