Article 3Structure, content and presentation of an application
1.
An application shall be submitted electronically to the F1appropriate 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.