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Article 3 Main stages of the common procedure

United Kingdom

Original text. Later amendments are not shown.

1.

The common procedure for F1determining the authorisation status of a substance may be started either on the initiative of the F2Authority or following an application. Applications may be made F3... by an interested party, who may represent several interested parties, in accordance with the conditions provided for by F4Regulation 234/2011. Applications shall be sent to the F5appropriate authority.

2.

The F6appropriate authority shall seek the opinion of the F7Authority, to be given in accordance with Article 5.

However, for F8a determination of the authorisation status of a substance described in Article 2B(1)(b) or (c), the appropriate authority shall not be required to seek the opinion of the Authority if F9any changes as a result of the determination in question are not liable to have an effect on human health.

F103.

The common procedure is to end with the appropriate authority F11determining the authorisation status of the substance concerned, in accordance with Article 7.

4.

By way of derogation from paragraph 3, the F12appropriate authority may end the common procedure and decide not to proceed with F13determining the authorisation status of a substance, at any stage of the procedure, if it judges that such F14a determination is not justified. Where applicable, it shall take account of the opinion of the Authority, F15..., any relevant provisions of F16assimilated law and any other legitimate factors relevant to the matter under consideration.

In such cases, where applicable, the F17appropriate authority shall inform the applicant F18... directly, indicating in its letter the reasons for not F19determining the authorisation status of the substance concerned.

Annotations

Textual amendments

F1

Words in Art. 3(1) 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), 6(5)(a) (with reg. 23)

F2

Word in Art. 3(1) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F3

Words in Art. 3(1) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F4

Words in Art. 3(1) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(a)(iv); 2020 c. 1, Sch. 5 para. 1(1)

F5

Words in Art. 3(1) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(a)(v); 2020 c. 1, Sch. 5 para. 1(1)

F6

Words in Art. 3(2) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F7

Word in Art. 3(2) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F8

Words in Art. 3(2) 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), 6(5)(b)(i) (with reg. 23)

F9

Words in Art. 3(2) 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), 6(5)(b)(ii) (with reg. 23)

F10

Art. 3(3) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(c); 2020 c. 1, Sch. 5 para. 1(1)

F11

Words in Art. 3(3) 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), 6(5)(c) (with reg. 23)

F12

Words in Art. 3(4) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(d)(i); 2020 c. 1, Sch. 5 para. 1(1)

F13

Words in Art. 3(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), 6(5)(d)(i)(aa) (with reg. 23)

F14

Words in Art. 3(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), 6(5)(d)(i)(bb) (with reg. 23)

F15

Words in Art. 3(4) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F16

Word in Art. 3(4) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 12(a)

F17

Words in Art. 3(4) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(e)(i); 2020 c. 1, Sch. 5 para. 1(1)

F18

Words in Art. 3(4) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 40(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F19

Words in Art. 3(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), 6(5)(d)(ii) (with reg. 23)