Commission Directive 95/17/ECDangos y teitl llawn

Article 3 U.K.

The request referred to in Article 2 must include the following particulars:

(a)

name or style and address or head office of the applicant;

(b)

precise identification of the ingredient for which confidentiality is requested, namely:

• the CAS, Einecs and colour index numbers, the chemical name, the Iupac name, the INCI(1) name, the European Pharmacopoeia name, the international non-proprietary name recommended by the World Health Organization, and the common nomenclature name referred to in Article 7 (2) of Directive 76/768/EEC, where they exist,

• the Elincs name and the official number allocated to it if it has been notified pursuant to Council Directive 67/548/EEC(2) and indication of approval or refusal to approve a request for confidentiality pursuant to Article 19 of that Directive,

• where the names or numbers referred to in the first and second indents do not exist, as in the case of certain ingredients of natural origin, the name of the base material, the name of the part of the plant or animal used, and the names of the ingredient's components, such as solvents;

(c)

the evaluation of the safety for human health of the ingredient as used in the finished product(s), taking into account the ingredient's toxicological profile, chemical structure and the level of exposure, as specified in Article 7a (1) (d) and (e) and Article 7a (2) of Directive 76/768/EEC;

(d)

the envisaged use of the ingredient and in particular the different categories of products in which it will be used;

(e)

a detailed justification of why, by way of exception, confidentiality is sought; for example:

• the fact that the identity of the ingredient or its function in the cosmetic product to be marketed has not been described in the literature and is unknown to others in the trade,

• the fact that the information is not yet in the public domain, even though a patent application has been lodged for the ingredient or its use,

• the fact that if the information were known it would be easily reproducible, to the detriment of the applicant;

(f)

if known, the name of each product which is to contain the ingredient(s), and if different names are to be used in the Community market, precise details on each one of them.

If the name of a product is not yet known, it may be communicated at a later date, but at least 15 days before placing the product on the market.

If the ingredient is used in several products, one request shall suffice, provided that the products are clearly indicated to the competent authority;

(g)

a statement setting out whether a request has been submitted to the competent authority of any other Member State in respect of the ingredient for which confidentiality is sought, and particulars on the outcome of any such request.

(1)

Formerly: CTFA name.

(2)

OJ No L 196, 16.8.1967, p. 1.