CHAPTER II COMMON PROCEDURE

Article 3 Main stages of the common procedure
1. The common procedure for determining the authorisation status of a substance may be started either on the initiative of the Authority or following an application. Applications may be made ... by an interested party, who may represent several interested parties, in accordance with the conditions provided for by Regulation 234/2011. Applications shall be sent to the appropriate authority.
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)
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)
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)
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)
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)
2. The appropriate authority shall seek the opinion of the Authority, to be given in accordance with Article 5.
However, for a 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 any changes as a result of the determination in question are not liable to have an effect on human health.
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)
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)
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)
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)
3. The common procedure is to end with the appropriate authority determining the authorisation status of the substance concerned, in accordance with Article 7.
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)
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)
4. By way of derogation from paragraph 3, the appropriate authority may end the common procedure and decide not to proceed with determining the authorisation status of a substance, at any stage of the procedure, if it judges that such a determination is not justified. Where applicable, it shall take account of the opinion of the Authority, ..., any relevant provisions of assimilated law and any other legitimate factors relevant to the matter under consideration.
In such cases, where applicable, the appropriate authority shall inform the applicant ... directly, indicating in its letter the reasons for not determining the authorisation status of the substance concerned.
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)
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)
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)
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)
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)
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)
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)
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 Initiating the procedure
1. On receipt of an application to determine the authorisation status of a substance, the 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).
...
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)
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)
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)
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 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 appropriate authority and, where applicable, the applicant.
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 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 ....
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)
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 .... In such cases, the Authority shall give its opinion within the original period without prejudice to Article 10.
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)
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 Determination of authorisation status and amendment of sectoral food laws
1. Within nine months of receiving the opinion of the Authority, the appropriate authority must determine the authorisation status of the substance concerned, taking into account the opinion of the Authority, any relevant provisions of 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.
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)
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)
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)
(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.
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)
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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)
3. Where the determination is not in accordance with the opinion of the Authority, the appropriate authority must explain the reasons for its determination.
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)
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)
4. The measures, designed to amend non-essential elements of each sectoral food law, relating to the revocation of the authorisation of substances generally, may be prescribed by the appropriate authority after seeking advice from the Authority.
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)
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)
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 authorisation of substances generally and for modifying conditions, specifications or restrictions associated with the authorisation of substances generally, may be prescribed by the appropriate authority after seeking advice from the Authority.
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)
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)
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)
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)
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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)
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)

Article 8 Additional information concerning risk management
1. Where the 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. ...
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)
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)
2. If the additional information is not sent within the additional period referred to in paragraph 1, the Authority shall act on the basis of the information already provided.
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)