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Article 12 Modification, suspension and revocation of authorisation

United Kingdom

Original text. Later amendments are not shown.

1.

The applicant or any business operator using the authorised substance or materials or articles containing the authorised substance may, in accordance with the procedure laid down in Article 9(1), apply for modification of the existing authorisation.

2.

The application shall be accompanied by the following:

(a)

a reference to the original application;

(b)

a technical dossier containing the new information in accordance with the guidelines referred to in Article 9(2);

(c)

a new complete summary of the technical dossier in a standardised form.

3.

On its own initiative or following a request from F1the appropriate authority, the F2Food Safety Authority shall evaluate whether the opinion or the authorisation is still in accordance with this Regulation, in accordance with the procedure laid down in Article 10, where applicable. The Food Safety Authority may, where necessary, consult the applicant.

F34.

The appropriate authority must examine the opinion of the Food Safety Authority without delay and F4determine whether the authorisation is to be modified, suspended or revoked, including without limitation changes in the conditions of use and, if any, in the restrictions specified in the authorisation.

F54A.

Where the appropriate authority determines that an authorisation is, or is not, to be modified, suspended or revoked:

(a)

the appropriate authority must:

(i)

specify the date on which the modification, suspension or revocation is to have effect; and

(ii)

communicate the determination to the Food Safety Authority;

(b)

the Food Safety Authority must ensure that the domestic list referred to in Article 12A is updated accordingly.

4B.

For the purposes of this Article, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which:

(a)

existing stocks of the substance, material or article concerned, and any products derived from it or containing it, may be placed on the market or used;

(b)

the substance, material or article concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used;

(c)

the labelling of the substance, material or article concerned, and any products derived from it or containing it, may continue to be applied.

4C.

The appropriate authority may prescribe other transitional measures not falling within paragraph 4B in relation to the modification, suspension or revocation of an authorisation.

F65.

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F76.

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Annotations

Textual amendments

F1

Words in Art. 12(3) substituted (31.12.2020) by The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 21(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F2

Words in Art. 12(3) substituted (31.12.2020) by The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 21(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F3

Art. 12(4) substituted (31.12.2020) by The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 21(b); 2020 c. 1, Sch. 5 para. 1(1)

F4

Words in Art. 12(4) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 11(6)(a) (with reg. 23)

F5

Art. 12(4A)-(4C) inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 11(6)(b) (with reg. 23)

F6

Art. 12(5) omitted (31.12.2020) by virtue of The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 21(c); 2020 c. 1, Sch. 5 para. 1(1)

F7

Art. 12(6) omitted (31.12.2020) by virtue of The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 21(c); 2020 c. 1, Sch. 5 para. 1(1)