The Cosmetic Products (Safety) Regulations 2008

Information to be made accessible to competent authority U.K.

16.—(1) Where a cosmetic product is manufactured or supplied in the United Kingdom a responsible person shall keep the following information easily accessible to a United Kingdom competent authority for control purposes—

(a) the qualitative and quantitative composition of the product, except to the extent that the product is composed of any perfume or perfume composition, in which case the responsible person shall only be required to keep the name and code number of the perfume or perfume composition and the identity of the supplier;

(b) the physico-chemical and microbiological specifications of the raw materials and the finished product and the purity and microbiological control criteria of the cosmetic product;

(c) the method of manufacture which shall be in accordance with good manufacturing practice, that is to say that the cosmetic product shall be manufactured in such a way that under normal and reasonably foreseeable conditions of use it shall not endanger human health or safety;

(d) a health assessment;

(e) a specific health assessment in respect of cosmetic products intended for use on children under the age of 3 and for cosmetic products intended exclusively for use in external intimate hygiene;

(f) the name and address of the qualified person or persons responsible for the health assessment;

(g) existing data on undesirable effects on human health resulting from use of the cosmetic product;

(h) proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product; and

(i) data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety evaluation of the product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of countries which are not Member States;

the information should be kept available at the address or registered office specified on the container or packaging of the cosmetic product.

(2) In this regulation, “health assessment” means an assessment of the safety for human health of the finished product. The health assessment shall be carried out in accordance with the principles of good laboratory practice referred to in Article 1 of European Parliament and Council Directive 2004/10/EC M1 on the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances and shall take particular account of the following—

(a) the general toxicological profile of each ingredient used;

(b) the chemical structure of each ingredient;

(c) the level of exposure of each ingredient;

(d) the specific exposure characteristics of the areas on which the cosmetic product will be applied; and

(e) the specific exposure characteristics of the class of individuals for whom the cosmetic product is intended.

(3) Without prejudice to the protection in particular of commercial secrecy and of intellectual property rights where a cosmetic product is manufactured or supplied in the United Kingdom a responsible person shall ensure that the information specified in paragraphs (1)(a) and (1)(g) shall be made easily accessible to the public by any appropriate means.

(4) For the purposes of paragraph (3), the quantitative information required under paragraph (1)(a) shall be limited to information relating to dangerous substances covered by Directive 67/548/EEC.

(5) Where the manufacturer manufactures a cosmetic product at two or more places within the EEA, and one of those places is within the United Kingdom, the responsible person may choose a single place of manufacture within the EEA where the information referred to in paragraph (1) will be kept available provided that, if requested by a United Kingdom competent authority, the responsible person informs the said authority of the location at which the said information is to be kept.

(6) Where the information referred to in paragraph (1) is to be kept accessible to a United Kingdom competent authority it must be in English or a language readily understood by the said authority.

Marginal Citations

M1 OJ No L50, 20.2.2004, p44, implemented by the Good Laboratory Practice (Codification Amendment Etc.) Regulations 2004 (S.I. 2004/994).