http://www.legislation.gov.uk/eur/2015/2283/chapter/III/section/IRegulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (Text with EEA relevance)Regulation (EU) 2015/2283 of the European Parliament and of the CouncilRegulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (Text with EEA relevance)King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015R2283texttext/xmlen2025-12-08Expert Participation2025-11-13 CHAPTER III<Strong>AUTHORISATION PROCEDURES FOR A NOVEL FOOD</Strong>SECTION I<Strong><Emphasis>General rules</Emphasis></Strong><Substitution ChangeId="key-7e03b752821c6c0643f9ec8bed54cf61-1669219701821" CommentaryRef="key-7e03b752821c6c0643f9ec8bed54cf61"><Substitution ChangeId="key-7bf7c22776d0a3f052a2fd1836961023-1747385806418" CommentaryRef="key-7bf7c22776d0a3f052a2fd1836961023">Procedure for determining authorisation status</Substitution></Substitution>Article 101The procedure for determining the authorisation status of a novel food ... 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.2The application for an authorisation must include—athe name and address of the applicant;bthe name and description of the novel food;cthe description of the production process;dthe detailed composition of the novel food;escientific evidence demonstrating that the novel food does not pose a safety risk to human health;fwhere appropriate, the analysis method;ga 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.3Upon request by the appropriate authority, the Food Safety Authority must give its opinion as to whether the proposed determination of authorisation status is liable to have an effect on human health.4When 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.5The procedure for authorising the placing on the market within Great Britain of a novel food ... as provided for in Article 9 ends when the appropriate authority determines the authorisation status of that novel food in accordance with Article 12.6By way of derogation from paragraph 5, the appropriate authority may terminate the procedure at any stage, and decide not to proceed with a determination of the authorisation status of the novel food concerned where the appropriate authority considers that a determination is not justified.7The applicant may withdraw its application at any time, thereby terminating the procedure.<Substitution ChangeId="key-2145bf4919e93c62f5dcf049f2451f39-1669220028779" CommentaryRef="key-2145bf4919e93c62f5dcf049f2451f39">Opinion of the Food Safety Authority</Substitution>Article 111Where the appropriate authority requests an opinion from the Food Safety Authority, it must forward the valid application to the Food Safety Authority without delay, and not later than one month after having verified its validity. The Food Safety Authority must adopt its opinion within nine months from the date of receipt of a valid application.2In assessing the safety of novel foods, the Food Safety Authority must, where appropriate, consider whether—athe novel food concerned is as safe as food from a comparable food category already placed on the market within Great Britain;bthe composition of the novel food and the conditions of its use do not pose a safety risk to human health in Great Britain;ca novel food, which is intended to replace another food, does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.3The Food Safety Authority must forward its opinion to the appropriate authority and, where applicable, to the applicant.4In duly justified cases, where the Food Safety Authority requests additional information from the applicant, the nine month period provided for in paragraph 1 may be extended. After consulting the applicant, the Food Safety Authority must specify a period within which that additional information is to be provided.5Where the additional information referred to in paragraph 4 is not provided to the Food Safety Authority within the additional period referred to in that paragraph, the Food Safety Authority must draw up its opinion on the basis of the available information.6Where an applicant submits additional information on its own initiative, it must send that information to the Food Safety Authority. In such cases, the Food Safety Authority must give its opinion within the nine month period provided for in paragraph 1.7The Food Safety Authority must make the additional information provided in accordance with paragraphs 4 and 6 available to the appropriate authority.<Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">Authorisation of a novel food </Substitution><CommentaryRef Ref="key-1f47d78136900b28dd96e799811ef685"/><Substitution ChangeId="key-639166f5e69ef0d706991afa4ff94bf9-1669284936646" CommentaryRef="key-639166f5e69ef0d706991afa4ff94bf9">...</Substitution>Article 121Within seven months from the date of publication of the Food Safety Authority's opinion, the appropriate authority must determine the authorisation status of a novel food, taking into account the following—athe conditions provided for in points (a) and (b) of Article 7 and, where applicable, in point (c) of that Article;bany relevant provision of assimilated direct legislation, including the precautionary principle as referred to in Article 7 of Regulation (EC) No. 178/2002;cthe Food Safety Authority's opinion;dany other legitimate factors relevant to the application under consideration.2Where the appropriate authority has not requested an opinion from the Food Safety Authority in accordance with Article 10(3), the seven month period provided for in paragraph 1 of this Article starts from the date on which the valid application is received by the appropriate authority in accordance with Article 10(1).2A.Where the appropriate authority determines the authorisation status of a novel food, the appropriate authority must specify the date on which the authorisation, modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the domestic list referred to in Article 3B accordingly.Implementing acts laying down administrative and scientific requirements for applicationsArticle 13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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)Art. 11 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 17 (as amended by S.I. 2020/1504, regs. 1(2), 15(5)); 2020 c. 1, Sch. 5 para. 1(1)Art. 12 substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 18 (as amended by S.I. 2020/1504, regs. 1(2), 15(5)); 2020 c. 1, Sch. 5 para. 1(1)Art. 13 omitted (31.12.2020) by virtue of The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 19; 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 12(1)(b) 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. 22Art. 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)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)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)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)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)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)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)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)Words in Art. 12 heading 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(8)(a) (with reg. 23)Art. 12(2A) 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), 17(8)(c) (with reg. 23)Words in Art. 12(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(8)(b) (with reg. 23)