Regulation (EU) 2015/2283 of the European Parliament and of the CouncilDangos y teitl llawn

[F1 Article 10 U.K. [F2 Procedure for determining authorisation status]

1. The procedure for [F3 determining the authorisation status] of a novel food F4 ... provided for in Article 9 must start either on the initiative of the appropriate authority or following an application to the appropriate authority by an applicant. The appropriate authority must make the summary of the application, based on the information referred to in points (a), (b) and (e) of paragraph 2 of this Article, publicly available.

2. The application for an authorisation must include—

(a) the name and address of the applicant;

(b) the name and description of the novel food;

(c) the description of the production process;

(d) the detailed composition of the novel food;

(e) scientific evidence demonstrating that the novel food does not pose a safety risk to human health;

(f) where appropriate, the analysis method;

(g) a proposal for the conditions of intended use and for specific labelling requirements which do not mislead the consumer or a verifiable justification why those elements are not necessary.

3. Upon request by the appropriate authority, the Food Safety Authority must give its opinion as to whether the [F5 proposed determination of authorisation status] is liable to have an effect on human health.

4. When test methods are applied to engineered nanomaterials as referred to in points (a) (viii) and (ix) of Article 3(2), an explanation must be provided by the applicants of their scientific appropriateness for nanomaterials and, where applicable, of the technical adaptations or adjustments that have been made in order to respond to the specific characteristics of those materials.

5. The procedure for authorising the placing on the market within Great Britain of a novel food F6 ... as provided for in Article 9 ends when the appropriate authority [F7 determines the authorisation status] of that novel food in accordance with Article 12.

6. By way of derogation from paragraph 5, the appropriate authority may terminate the procedure at any stage, and decide not to proceed with [F8 a determination of the authorisation status of the novel food concerned] where the appropriate authority considers that [F9 a determination] is not justified.

7. The applicant may withdraw its application at any time, thereby terminating the procedure.]

Textual Amendments

F1 Art. 10 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 16 (as amended by S.I. 2020/1504, regs. 1(2), 15(5)); 2020 c. 1, Sch. 5 para. 1(1)

F2 Art. 10 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), 17(7)(a) (with reg. 23)

F3 Words in Art. 10(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), 17(7)(b)(i) (with reg. 23)

F4 Words in Art. 10(1) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(7)(b)(ii) (with reg. 23)

F5 Words in Art. 10(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), 17(7)(c) (with reg. 23)

F6 Words in Art. 10(5) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 17(7)(d)(i) (with reg. 23)

F7 Words in Art. 10(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), 17(7)(d)(ii) (with reg. 23)

F8 Words in Art. 10(6) 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), 17(7)(e)(i) (with reg. 23)

F9 Words in Art. 10(6) 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), 17(7)(e)(ii) (with reg. 23)