# Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance), Article 3: Structure, content and presentation of an application

Extent: E+W+S+N.I.

1. An application 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.
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 4;
(b) the scientific data as provided for in Article 5.
4. Where the applicant submits an application to modify the conditions of use, the specifications, additional specific labelling requirements or post-market monitoring requirements of an authorised novel food, it may not be necessary for the applicant to provide all the data required under Article 5 of this Regulation where the applicant provides verifiable justification explaining that the proposed changes do not affect the results of the existing risk assessment.
5. In addition to the information referred to in points (a), (b) and (e) of Article 10(2) of Regulation (EU) 2015/2283, the summary of the dossier referred to in paragraph 1(c) of this Article shall set out the reasons why the use of the novel food complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283.

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Source: https://www.legislation.gov.uk/eur/2017/2469/article/3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2017-2469/article-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.