Article 3 Structure, content and presentation of a notification
1 A notification shall be submitted electronically to the appropriate authority and shall consist of the following:
(a) a cover letter;
(b) a technical dossier;
(c) a summary of the dossier.
Words in Art. 3(1) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 41; 2020 c. 1, Sch. 5 para. 1(1)
2 The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex I.
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 a notification 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 do 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.