Article 4Administrative 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:

  1. (a)

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

  2. (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;

  3. (c)

    the date of submission of the dossier;

  4. (d)

    a table of contents of the dossier;

  5. (e)

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

  6. (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;

  7. (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.