http://www.legislation.gov.uk/eur/2015/2283/article/10Regulation (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.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. 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)