Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance) (c. 2468)

Article 4 U.K. Structure, content and presentation of an application

1. An application shall be submitted electronically to the [F1 appropriate authority] and shall consist of the following:

(a) a cover letter;

(b) a technical dossier;

(c) a summary of the dossier;

(d) duly reasoned safety objections referred to in Article 15(2) of Regulation (EU) 2015/2283;

(e) the applicant's response to duly reasoned safety objections.

2. The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex II.

3. The technical dossier referred to in paragraph 1(b) shall contain:

(a) the administrative data as provided for in Article 5;

(b) the scientific data as provided for in Article 6.

4. Where the applicant submits an application to modify the conditions of use, the specifications, specific labelling requirements or post-market monitoring requirements of an authorised traditional food from a third country, it may not be necessary for the applicant to provide all the data required under Article 6 where the applicant provides verifiable justification explaining that the proposed changes not affect the results of the existing safety assessment.

5. The summary of the dossier referred to in paragraph 1(c) shall provide evidence that the use of a traditional food from a third country complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283.

Textual Amendments

F1 Words in Art. 4(1) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 42; 2020 c. 1, Sch. 5 para. 1(1)