The Cosmetic Products (Safety) Regulations 2003

Product Information

9.  —

(1) Subject to paragraph (6) below, where a cosmetic product is manufactured or supplied in the United Kingdom a responsible person shall for control purposes keep readily accessible to a United Kingdom competent authority at the address or registered office specified on the container or packaging of the cosmetic product in accordance with regulation 7(2)(a) above the following information—

(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) assessment of the safety for human health of the finished product taking into consideration the general toxicological profile of each ingredient used, its chemical structure and its level of exposure;

(e) the name and address of the person or persons, qualified in accordance with paragraph (3) below, responsible for the assessment referred to in sub-paragraph (d) above;

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

(g) proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product.

(2) The assessment referred to in paragraph (1)(d) above shall be carried out in accordance with the principles of good laboratory practice referred to in Article 1 of Council Directive 87/18/EEC(1) on the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances.

(3) The person referred to in paragraph (1)(e) above must be—

(a) subject to paragraph (4) below, the holder of an appropriate European diploma within the meaning of section 4A of the Pharmacy Act 1954(2) or any other person who has the right, granted by a competent authority in a Member State, to take up and pursue the activities of a pharmaceutical chemist;

(b) subject to paragraph (4) below, a person who is entitled to be registered under section 3(1) of the Medical Act 1983(3) as a fully registered medical practitioner and who has the right, granted by a competent authority in a Member State, to take up and pursue the activities of a doctor; or

(c) the holder of a diploma within the meaning of regulation 2(1) of the European Communities (Recognition of Professional Qualifications) Regulations 1991(4) showing that the holder has the qualifications required to practise as a chartered biologist or that he has the qualifications required to practise as a chartered chemist or that he has the qualifications required to practise a profession equivalent to the profession of chartered biologist or chartered chemist in a Member State other than the United Kingdom.

(4) Any diploma or other evidence of qualification required for the purposes of paragraph (3)(a) or (b) above shall satisfy that requirement only if—

(a) the education and training attested were received mainly within the European Community; or

(b) the holder has spent at least three years in lawful pursuit in a Member State of the relevant profession, and such professional experience has been certified by a competent authority in a Member State (being a State which recognised a diploma or other evidence of qualification obtained in a non-Member State).

(5) Where the responsible person is the manufacturer or the person who first imports the cosmetic product into the Community he must possess appropriate experience or an appropriate level of professional qualification in accordance with the legislation and practice of the United Kingdom if it is the place of manufacture or first importation.

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

(7) Where the information referred to in paragraph (1) above 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.

(1)

O.J. No. L15, 17.1.87, p. 29, implemented by the Notification of New Substances (Amendment) Regulations 1991 (S.I. 1991/1914). Article 1 was amended by Commission Directive 1999/11/EC (O.J. No. L77, 23.3.99, p. 8.), implemented by the Good Laboratory Practice Regulations 1999 (S.I. 1999/3106).

(2)

1954 c. 61.

(3)

1983 c. 54.

(4)

S.I. 1991/824, to which there is an amendment not relevant to these Regulations.