THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, as last amended by Commission Directive 94/32/EC, and in particular Article 6 (1) (g) thereof,

Whereas there is a need to specify the criteria and conditions under which a manufacturer may, for reasons of trade secrecy, apply not to include one or more ingredients on the minimum list of ingredients which must be included on the packaging of cosmetic products, or, where this is impossible for practical reasons, on an enclosed leaflet, label, tape or card;

Whereas approval of confidentiality should not, however, impinge on the other obligations pursuant to Directive 76/768/EEC and the responsibilities arising from the Articles concerning the cosmetic product's safety, from the Annexes, and from the provisions as to the information necessary for appropriate medical treatment and the case-file to which the national monitoring authorities must have access;

Whereas approval of confidentiality should not be prejudicial to consumer safety;

Whereas the request for confidentiality must be submitted in the Member State of manufacture or initial importation into the Community market, which must also have access to the information referred to in Article 7a of Directive 76/768/EEC, as amended by Directive 93/35/EEC, for control purposes;

Whereas to be adequately assessed and monitored the request must include all the particulars necessary for identifying the applicants, for the identification and human health assessment of the ingredient as used in the cosmetic product(s) and for determining the intended use of the ingredient concerned, as well as the grounds for confidentiality and the name(s) of the product containing the ingredient;

Whereas for economic reasons and in deference to his rights the competent authority should inform the applicant, within a brief period of not more than four months, other than in exceptional cases, of the ruling in this case; whereas any refusal to grant confidentiality should be duly reasoned and the means of appeal and time limits clearly indicated;

Whereas in the interests of transparency and monitoring, the competent authority should allocate a registration number to each request it approves; whereas this number should replace the ingredient in the list of ingredients referred to in Article 6 (1) (g) of Directive 76/768/EEC;

Whereas all amendments to the particulars contained in the initial request must be communicated by the applicant to the competent authority, which may then withdraw its approval of confidentiality in view of those modifications, or if new information makes such a measure necessary for compelling public health reasons;

Whereas the duration of the right to confidentiality should not exceed five years, subject to the option, in exceptional circumstances, of an extension for a further three years at the most;

Whereas, in the interests of monitoring product safety and proper enforcement of the Directive, the Commission and the other Member States should be adequately informed of the decisions taken by the competent authority; whereas, on the other hand, such decisions should be recognized throughout the Community territory, except for exceptional reasons;

Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetics Products Sector,

HAS ADOPTED THIS DIRECTIVE: