Regulation (EC) No 1331/2008 of the European Parliament and of the CouncilShow full title

CHAPTER II U.K. COMMON PROCEDURE

Article 3 U.K. Main stages of the common procedure

1. The common procedure for [F1 determining the authorisation status of a substance] may be started either on the initiative of the [F2 Authority] 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 [F4 Regulation 234/2011]. Applications shall be sent to the [F5 appropriate authority].

2. The [F6 appropriate authority] shall seek the opinion of the [F7 Authority], to be given in accordance with Article 5.

However, for [F8 a determination of the authorisation status of a substance described in Article 2B(1)(b) or (c)], the [F6 appropriate authority] shall not be required to seek the opinion of the Authority if [F9 any changes as a result of the determination] in question are not liable to have an effect on human health.

[F10 3. The common procedure is to end with the appropriate authority [F11 determining the authorisation status of the substance concerned], in accordance with Article 7.]

4. By way of derogation from paragraph 3, the [F12 appropriate authority] may end the common procedure and decide not to proceed with [F13 determining the authorisation status of a substance], at any stage of the procedure, if it judges that such [F14 a determination] is not justified. Where applicable, it shall take account of the opinion of the Authority, F15 ..., any relevant provisions of [F16 assimilated] law and any other legitimate factors relevant to the matter under consideration.

In such cases, where applicable, the [F17 appropriate authority] shall inform the applicant F18 ... directly, indicating in its letter the reasons for not [F19 determining the authorisation status of the substance concerned].

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)

Article 4 U.K. Initiating the procedure

1. On receipt of an application to [F20 determine the authorisation status of a substance], the [F21 appropriate authority]:

(a) shall acknowledge receipt of the application in writing to the applicant within 14 working days of receiving it;

(b) where applicable, shall as soon as possible notify the Authority of the application and request its opinion in accordance with Article 3(2).

F22 ...

F23 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Words in Art. 4(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(6) (with reg. 23)

F21 Words in Art. 4(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, 41(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F22 Words in Art. 4(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, 41(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F23 Art. 4(2) 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, 41(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 5 U.K. Opinion of the Authority

1. The Authority shall give its opinion within nine months of receipt of a valid application.

2. The Authority shall forward its opinion to the [F24 appropriate authority] and, where applicable, the applicant.

Textual Amendments

F24 Words in Art. 5(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, 42; 2020 c. 1, Sch. 5 para. 1(1)

Article 6 U.K. Additional information concerning risk assessment

1. In duly justified cases where the Authority requests additional information from applicants, the period referred to in Article 5(1) may be extended. After consulting the applicant, the Authority shall lay down a period within which this information can be provided F25 ....

2. If the additional information is not sent to the Authority within the additional period referred to in paragraph 1, the Authority shall finalise its opinion on the basis of the information already provided.

3. Where applicants submit additional information on their own initiative, they shall send it to the Authority F26 .... In such cases, the Authority shall give its opinion within the original period without prejudice to Article 10.

F27 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F25 Words in Art. 6(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, 43(a); 2020 c. 1, Sch. 5 para. 1(1)

F26 Words in Art. 6(3) 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, 43(b); 2020 c. 1, Sch. 5 para. 1(1)

F27 Art. 6(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, 43(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 7 U.K. [F28 Determination of authorisation status and amendment of sectoral food laws]

[F29 1. Within nine months of receiving the opinion of the Authority, the appropriate authority must [F30 determine the authorisation status of the substance concerned,] taking into account the opinion of the Authority, any relevant provisions of [F31 assimilated] law and any other legitimate factors relevant to the matter under consideration.

In those cases where the Authority has not given an opinion, the nine month period starts from the date the appropriate authority receives a valid application.]

[F32 1A. Where the appropriate authority makes a determination as to the authorisation status of a substance:

(a) the appropriate authority must:

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

(ii) communicate the determination to the Authority;

(b) the Authority must update the domestic list referred to in Article 2C accordingly.]

F33 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F34 3. Where the [F35 determination] is not in accordance with the opinion of the Authority, the appropriate authority must explain the reasons for its [F35 determination].]

4. The measures, designed to amend non-essential elements of each sectoral food law, relating to the [F36 revocation of the authorisation of substances generally], [F37 may be prescribed by the appropriate authority after seeking advice from the Authority].

5. On grounds of efficiency, the measures designed to amend non-essential elements of each sectoral food law, inter alia, by supplementing it, relating to the [F38 authorisation of substances generally] and for [F39 modifying] conditions, specifications or restrictions associated with the [F40 authorisation of substances generally], [F41 may be prescribed by the appropriate authority after seeking advice from the Authority].

F42 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F28 Art. 7 heading 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(7)(a) (with reg. 23)

F29 Art. 7(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, 45(a); 2020 c. 1, Sch. 5 para. 1(1)

F30 Words in Art. 7(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(7)(b) (with reg. 23)

F31 Word in Art. 7(1) 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(b)

F32 Art. 7(1A) 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), 6(7)(c) (with reg. 23)

F33 Art. 7(2) 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, 45(b); 2020 c. 1, Sch. 5 para. 1(1)

F34 Art. 7(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, 45(c); 2020 c. 1, Sch. 5 para. 1(1)

F35 Word in Art. 7(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(7)(d) (with reg. 23)

F36 Words in Art. 7(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(7)(e) (with reg. 23)

F37 Words in Art. 7(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, 45(d); 2020 c. 1, Sch. 5 para. 1(1)

F38 Words in Art. 7(5) 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(7)(f)(i) (with reg. 23)

F39 Word in Art. 7(5) 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(7)(f)(ii) (with reg. 23)

F40 Words in Art. 7(5) 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(7)(f)(iii) (with reg. 23)

F41 Words in Art. 7(5) 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, 45(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F42 Art. 7(6) 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, 45(f); 2020 c. 1, Sch. 5 para. 1(1)

Article 8 U.K. Additional information concerning risk management

1. Where the [F43 Authority] requests additional information from applicants on matters concerning risk management, it shall determine, together with the applicant, a period within which that information can be provided. In such cases, the period referred to in Article 7 may be extended accordingly. F44 ...

2. If the additional information is not sent within the additional period referred to in paragraph 1, the [F45 Authority] shall act on the basis of the information already provided.

Textual Amendments

F43 Word in Art. 8(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, 46(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F44 Words in Art. 8(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, 46(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F45 Word in Art. 8(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, 46(b); 2020 c. 1, Sch. 5 para. 1(1)