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

CHAPTER IX U.K. CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS

Article 47 U.K. Obligation for notification of unexpected or adverse effects

1. On becoming aware of information concerning the authorised biocidal product, or the active substance(s) it contains, that may affect the authorisation, the holder of an authorisation shall without delay notify the competent authority F1 .... In particular, the following shall be notified:

(a) new data or information on the adverse effects of the active substance or biocidal product for humans, in particular vulnerable groups, animals or the environment;

(b) any data indicating the potential of the active substance for the development of resistance;

(c) new data or information indicating that the biocidal product is not sufficiently effective.

2. The competent authority F2 ..., shall examine whether the authorisation needs to be amended or cancelled in accordance with Article 48.

F3 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Words in Art. 47(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. 94(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 47(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. 94(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Art. 47(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. 94(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 48 U.K. Cancellation or amendment of an authorisation

1. Without prejudice to Article 23, the competent authority F4 ... shall at any time cancel or amend an authorisation it has granted where it considers that:

(a) the conditions referred to in Article 19 or, where relevant, in Article 25 are not satisfied;

(b) the authorisation was granted on the basis of false or misleading information; or

(c) the authorisation holder has failed to comply with its obligations under the authorisation or this Regulation.

2. Where the competent authority F5 ... intends to cancel or amend an authorisation, it shall inform the authorisation holder thereof and give it the opportunity to submit comments or additional information within a specified time limit. The [F6 competent authority] shall take due account of those comments when finalising its decision.

3. Where the competent authority F7 ... cancels or amends an authorisation in accordance with paragraph 1, it shall without delay notify the authorisation holder F8 ....

F9 ...

F10 ...

Textual Amendments

F4 Words in Art. 48(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. 95(2); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 48(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. 95(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 48(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. 95(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 48(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. 95(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 48(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. 95(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in Art. 48(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. 95(4)(c); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in Art. 48(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. 95(4)(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 49 U.K. Cancellation of an authorisation at the request of the authorisation holder

At the reasoned request of an authorisation holder, the competent authority F11 ... shall cancel the authorisation. F12 ...

Textual Amendments

F11 Words in Art. 49 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. 96(a); 2020 c. 1, Sch. 5 para. 1(1)

F12 Words in Art. 49 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. 96(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 50 U.K. Amendment of an authorisation at the request of the authorisation holder

F13 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. An authorisation holder seeking to change any of the information submitted in relation to the initial application for authorisation of the product shall apply to the competent [F14 authority]. [F15 The competent authority shall] decide whether the conditions of Article 19 or, where relevant, Article 25 are still met and whether the terms and conditions of the authorisation need to be amended.

The application shall be accompanied by the [F16 appropriate fees].

3. An amendment to an existing authorisation shall fall under one of the following categories of changes:

(a) administrative change;

(b) minor change; or

(c) major change.

Textual Amendments

F13 Art. 50(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. 97(2); 2020 c. 1, Sch. 5 para. 1(1)

F14 Word in Art. 50(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. 97(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F15 Words in Art. 50(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. 97(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in Art. 50(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. 97(3)(c); 2020 c. 1, Sch. 5 para. 1(1)

F17 Article 51 U.K. Detailed rules

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Textual Amendments

F17 Art. 51 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. 98; 2020 c. 1, Sch. 5 para. 1(1)

[F18 Article 52 U.K. Period of grace

Notwithstanding Article 89, where the competent authority F19 ... cancels or amends an authorisation or decides not to renew it, it shall grant a period of grace for the making available on the market and use of existing stocks, except in cases where continued making available on the market or use of the biocidal product would constitute an unacceptable risk to human health, animal health or the environment.

The period of grace shall not exceed 180 days for the making available on the market and an additional maximum period of 180 days for the use of existing stocks of the biocidal products concerned.]

Textual Amendments

F18 Substituted by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market (Text with EEA relevance).

F19 Words in Art. 52 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. 99; 2020 c. 1, Sch. 5 para. 1(1)