CHAPTER IICONTENT, DRAFTING AND PRESENTATION OF AN APPLICATION

Article 4Administrative data

The administrative data as referred to in Article 2(3)(a) shall include:

  1. (a)

    name of the applicant (company, organisation, etc.), address and contact details;

  2. (b)

    name of the manufacturer(s) of the substance, if different than the applicant’s, address and contact details;

  3. (c)

    name of the person responsible for the dossier, address and contact details;

  4. (d)

    date of submission of the dossier;

  5. (e)

    type of the application, i.e. concerning a food additive, a food enzyme, or a flavouring;

  6. (f)

    where applicable, chemical name according to IUPAC nomenclature;

  7. (g)

    where applicable, E-number of the additive F1...;

  8. (h)

    where applicable, a reference to similar authorised food enzymes;

  9. (i)

    where applicable, the FL-number of a flavouring substance F2...;

  10. (j)
    where applicable, the information on authorisations falling within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed13;
  11. (k)

    table of content of the dossier;

  12. (l)

    list of documents and other particulars; the applicant shall identify the number and titles of volumes of documentation submitted in support of the application; a detailed index with a reference to volumes and pages shall be included;

  13. (m)

    list of the parts of the dossier to be treated as confidential; applicants shall indicate what they wish to be treated as confidential and give verifiable justification in accordance with Article 12 of Regulation (EC) No 1331/2008.