CHAPTER IIU.K. CONTENT, DRAFTING AND PRESENTATION OF AN APPLICATION

Article 4U.K.Administrative data

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

(a)

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

(b)

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

(c)

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

(d)

date of submission of the dossier;

(e)

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

(f)

where applicable, chemical name according to IUPAC nomenclature;

(g)

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

(h)

where applicable, a reference to similar authorised food enzymes;

(i)

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

(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 feed(1);

(k)

table of content of the dossier;

(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;

(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.

Textual Amendments