Article 4U.K.Administrative data requirements

In addition to the information set out in Article 10(2) of Regulation (EU) 2015/2283, the application shall include the following administrative data:

(a)

the name(s) of the manufacturer(s) of the novel food, if different than the applicant's, address and contact details;

(b)

the name, address and contact details of the person responsible for the dossier authorised to communicate on behalf of the applicant with the [F1appropriate authority];

(c)

the date of submission of the dossier;

(d)

a table of contents of the dossier;

(e)

a detailed list of documents annexed to the dossier, including references to titles, volumes and pages;

(f)

a list of the parts of the dossier to be treated as confidential and verifiable justification in accordance with Article 23 of Regulation (EU) 2015/2283 and the rules set out in Annex II to this Regulation. Where the production process contains confidential data, a non-confidential summary of the production process shall be provided;

(g)

information and explanations substantiating the existence of the applicant's right of reference to the proprietary scientific evidence or scientific data in accordance with Article 26 of Regulation (EU) 2015/2283. That information shall be included in a separate folder.

Textual Amendments