The Cosmetic Products (Safety) Regulations 2004

Made: 17th August 2004

Laid before Parliament: 19th August 2004

Coming into force

Now, therefore, the Secretary of State in exercise of the powers conferred on her by sections 11, 28 and 30 of the 1987 Act and by section 2(2) of the 1972 Act, hereby makes the following Regulations—

Citation and commencement and transitory provisions

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• (1) These Regulations may be cited as the Cosmetic Products (Safety) Regulations 2004 and shall come into force on 11th September 2004 other than the provisions set out in paragraph (2) below.

• (2) The following provisions of these Regulations shall come into force on 11th March 2005—

• (a) regulation 7(2)(c); and

• (b) regulation 7(9)(b).

• (3) Schedules 3,4 and 6 to these Regulations shall have effect until 24th March 2005 with the insertion of the entries referred to in Part 1 of Schedule 1 to these Regulations as they appear in the Cosmetic Products (Safety) Regulations 2003[^f00004] in place of the corresponding entries in the Schedules to these Regulations and thereafter these entries shall have effect as they appear in the Schedules to these Regulations.

• (4) The entries referred to in Part 2 of Schedule 1 to these Regulations shall not form part of Schedules 3, 4 and 6 to these Regulations until 24th March 2005.

Revocation

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The Cosmetic Products (Safety) Regulations 2003 are hereby revoked.

Interpretation

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• (1) In these Regulations—

• “agent” means an agent established within the Community appointed by a manufacturer of a cosmetic product to act on his behalf in relation to these Regulations;

• “alternative method” means a testing method which is listed in Schedule 12 to these regulations;

• “approved supply list” shall have the same meaning as in regulation 2(1) of the CHIP Regulations;

• “the CHIP Regulations” means in Great Britain the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 and in Northern Ireland the Chemicals (Hazard Information and Packaging for Supply) Regulations (Northern Ireland) 2002 ;

• “common ingredients nomenclature” means the labelling nomenclature designated in the inventory of ingredients employed in cosmetic products, drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC[^f00005], as amended or substituted from time to time;

• “the Community” means the European Community and other States in the European Economic Area;

• “the Confidentiality Directive” means Commission Directive 95/17/EC[^f00006];

• “the 1987 Act” means the Consumer Protection Act 1987;

• “cosmetic ingredient” means any chemical substance or preparation of synthetic or natural origin, except for perfume and aromatic compositions, used in the composition of a cosmetic product;

• “cosmetic product” means any substance or preparation intended to be placed in contact with any part of the external surfaces of the human body (that is to say, the epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours except where such cleaning, perfuming, protecting, changing, keeping or correcting is wholly for the purpose of treating or preventing disease;

• “cosmetic product intended to come into contact with the mucous membranes” means a cosmetic product intended to be applied in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs, and does not include any cosmetic product which is intended to come into only brief contact with the skin;

• “the Directive” means Council Directive 76/768/EEC[^f00007] as amended by the Community instruments set out in Schedule 2;

• “EEA Agreement” means the Agreement on the European Economic area signed at Oporto on 2nd May 1992 as amended from time to time;

• “finished cosmetic product” means the cosmetic product in its final formulation as placed on the market and made available to the final consumer, or its prototype;

• “market research experiment” means any activity conducted for the purpose of ascertaining the opinion of persons of— any cosmetic product; anything in, on or with which the cosmetic product is supplied; the appearance or any other characteristic of the cosmetic product or any such thing; or the name or description under which the cosmetic product is supplied; but a cosmetic product is not the subject of a market research experiment unless— any person to whom a cosmetic product is supplied in the course of the experiment is informed, at or before the time at which it is supplied to him, that it is supplied for the purpose of a market research experiment; and no consideration in money or money’s worth is given by such a person for the cosmetic product or any other cosmetic product supplied to him for comparison;

• “Member State” means a State which is a Contracting Party to the EEA Agreement;

• “preservative” means a substance which is added to a cosmetic product for the primary purpose of inhibiting the development of micro-organisms in that product;

• “prototype” means a first model or design that has not been produced in batches and from which the finished cosmetic product is copied or finally developed;

• “supply” includes offering to supply, agreeing to supply, exposing for supply and possessing for supply, and cognate expressions shall be construed accordingly; and

• “UV filter” means a substance which is added to a sunscreen cosmetic product for the primary purpose of filtering ultra violet rays for the purpose of protecting the epidermis of the user from harmful effects of such ultra violet rays.

• (2) Unless the contrary intention appears, references in these Regulations to a numbered regulation or Schedule are references to the regulation or Schedule so numbered in these Regulations.

General requirements

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• (1) Subject to paragraph (2) below, no person shall supply any cosmetic product which is liable to cause damage to human health when it is applied under—

• (a) normal conditions of use; or

• (b) conditions of use which are reasonably foreseeable taking into account all the circumstances, including the cosmetic product’s presentation, labelling, any instructions for its use and disposal and any other information or indication provided by the manufacturer, his agent or the person who supplies the cosmetic product on the first occasion that it is supplied in the Community.

• (2) Paragraph (1) above shall apply only to the supply by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person.

• (3) The provision of any instructions, information or indication referred to in sub-paragraph (b) of paragraph (1) above shall not exempt any person from the obligation to comply with any other provisions of these Regulations which are applicable to him.

Particular requirements

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• (1) The following provisions of this regulation are without prejudice to regulation 4 and are subject to regulation 6.

• (2) No person shall supply a cosmetic product which contains—

• (a) any substance listed in column 2 of Part I of Schedule 3, provided that no account shall be taken of any such substance which is present only as a trace which could not reasonably have been removed during or after manufacture;

• (b) any substance listed in column 2 of Part II of Schedule 3 which is used as a fragrance ingredient in relation to a cosmetic product, provided that no account shall be taken of any such substance which is present only as a trace which could not reasonably have been removed during or after manufacture;

• (c) any substance listed in column 2 of Schedule 4, unless the requirements in column 3, 4, 5 and (in the case of Part II) 7 of that Schedule in relation to that substance are satisfied;

• (d) any colouring agent listed in columns 1 and 2 of Schedule 5 with the exception of a cosmetic product containing a colouring agent intended solely to colour hair unless—

• (i) the requirements in columns 3 and 4 of Part I of that Schedule in relation to that colouring agent are satisfied; or

• (ii) the requirements in columns 3 and 4 of Part II of that Schedule in relation to that colouring agent are satisfied and the cosmetic product in question was supplied on or before the date specified in column 5 of that Part;

• (e) any colouring agent which is not listed in Schedule 5 with the exception of a cosmetic product containing a colouring agent intended solely to colour hair;

• (f) any preservative listed in column 2 of Schedule 6 unless—

• (i) the requirements in columns 3, 4 and 5 of Part I of that Schedule in relation to that preservative are satisfied; or

• (ii) the requirements in columns 3, 4 and 5 of Part II of that Schedule in relation to that preservative are satisfied and the cosmetic product in question is supplied on or before the date specified in column 7 of that Part;

• (g) any preservative which is not listed in Schedule 6;

• (h) any preservative listed in column 2 of Part II of Schedule 6 after the date specified in column 7 of that Part;

• (i) any UV filter listed in column 2 of Schedule 7 unless—

• (i) the requirements in columns 3 and 4 of Part I of that Schedule in relation to that UV filter are satisfied; or

• (ii) the requirements in columns 3 and 4 of Part II of that Schedule in relation to that UV filter are satisfied and the cosmetic product in question is supplied on or before the date specified in column 6 of that Part; or

• (j) any UV filter which is not listed in Schedule 7.

• (3) Subject to paragraphs (4) to (6) below, no person shall supply a cosmetic product which contains any of the substances designated as a specified risk material in Annex V to Regulation (EC) No. 999/2001 of the European Parliament and of the Council[^f00008], or any ingredient derived from any of those substances.

• (4) For the purposes of paragraph (3) above, no account shall be taken of any substance referred to in that paragraph which is present in the cosmetic product only as a trace which could not reasonably have been removed during or after manufacture.

• (5) Paragraph (3) above shall not prohibit the supply of a cosmetic product which contains any tallow derivative so long as the relevant method set out in Schedule 8 was used in the manufacture of that derivative and the manufacturer of the derivative has certified that that method was used in its manufacture.

• (6) Paragraph (3) above shall not prohibit the supply of any cosmetic product which contains any substance or ingredient referred to in that paragraph but which was manufactured before 1st April 1998.

• (7) Subject to paragraph (8) below, no person shall supply a cosmetic product where the final formulation has been tested on animals in order that the cosmetic product might satisfy any requirements of these Regulations or the Directive using a method other than an alternative method where—

• (a) an alternative method is listed in column 4 of Part 1 or 2 of Schedule 12 to these Regulations; and

• (b) the final formulation is tested after the date given in column 5 of Part 1 or 2 of Schedule 12.

• (8) No person shall supply a cosmetic product where the final formulation has been tested on animals in order that the cosmetic product might satisfy any requirements of these Regulations or the Directive using a method other than an alternative method after—

• (a) 11th March 2013 in relation to tests concerning repeated dose toxicity, reproductive toxicity and toxicokinetics; or

• (b) 11th March 2009 in relation to all other tests.

• (9) Subject to paragraph (10) below, no person shall supply a cosmetic product which contains any ingredients or combination of ingredients which have been tested on animals in order that the cosmetic product, ingredient or combination of ingredients might satisfy any requirements of these Regulations or the Directive using a method other than an alternative method where—

• (a) an alternative method is listed in column 4 of Part 1 or 2 of Schedule 12 to these Regulations; and

• (b) the ingredient or combination of ingredients is tested after the date given in column 5 of Part 1 or 2 of Schedule 12.

• (10) No person shall supply a cosmetic product which contains any ingredients or combination of ingredients which have been tested on animals in order that the cosmetic product might satisfy any requirements of these Regulations or the Directive using a method other than an alternative method after—

• (a) 11th March 2013 in relation to tests concerning repeated dose toxicity, reproductive toxicity and toxicokinetics; or

• (b) 11th March 2009 in relation to all other tests.

• (11) No person shall test a finished cosmetic product on animals where such testing is undertaken in order that the said product might satisfy any requirements of these Regulations or the Directive.

• (12) Subject to paragraph (13) below, no person shall test any ingredient or combination of ingredients on animals in order to satisfy any requirement of these Regulations or the Directive using a method other than an alternative method where—

• (a) an alternative method is listed in column 4 of Part 1 or 2 of Schedule 12 to these Regulations; and

• (b) The ingredient or combination of ingredients is tested after the date given in column 5 of Part 1 or 2 of Schedule 12.

• (13) No person shall test any ingredient or combination of ingredients on animals in order to satisfy any requirement of these Regulations or the Directive using a method other than an alternative method after 11th March 2009.

• (14) The supply of any cosmetic product in respect of which a claim that the product or its ingredients have not been tested on animals appears on the packaging or in any document, notice, label, ring or collar accompanying or referring to the product is only permitted if—

• (a) the manufacturer and his supplier have not carried out any such tests on the finished product, its prototype or on any of the ingredients contained in the finished product or its prototype;

• (b) the manufacturer and his supplier have not commissioned any such tests on the finished product, its prototype or on any of the ingredients contained in the finished product or its prototype;

• (c) the cosmetic product contains no ingredients which have been tested on animals by others for the purpose of developing new cosmetic products.

• (15) No person shall supply a cosmetic product containing any substances classified as carcinogenic, mutagenic or toxic for reproduction of category 1, 2 or 3 in the approved supply list unless the substance is listed in Schedule 13 to these Regulations.

• (16) Paragraphs (14) and (15) above shall not apply to any cosmetic product placed on the market in a Member State before 11th September 2004.

Authorisation by the Secretary of State

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• (1) The Secretary of State may authorise the use in a cosmetic product for a maximum period of three years of a particular substance, not being a substance or ingredient referred to in regulation 5(3) or a substance listed in Schedule 3 or 4.

• (2) In giving an authorisation the Secretary of State may impose conditions relating to the use of a particular substance in a cosmetic product, and such conditions may relate to any matter which the Secretary of State considers appropriate including—

• (a) the purpose of the substance;

• (b) the type of cosmetic product;

• (c) the maximum concentration of the substance in any cosmetic product; and

• (d) information and marking requirements.

• (3) The Secretary of State may on reasonable notice vary or revoke any authorisation given under paragraph (1) above.

• (4) On giving, varying or revoking an authorisation, the Secretary of State shall arrange for the authorisation, variation or revocation, as the case may be, to be published in such manner as she considers appropriate for bringing it to the attention of persons who, in her opinion, would be likely to have an interest in it.

• (5) No person shall be convicted of an offence under section 12 of the 1987 Act by reason of a cosmetic product containing a particular substance provided that at the time when but for this regulation an offence would have been committed—

• (a) the use of that particular substance in that cosmetic product was duly authorised; and

• (b) all of the conditions imposed by the authorisation were complied with.

Marking

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• (1) Subject to paragraphs (5)(b) and (9) to (12) below, no person shall supply a cosmetic product unless the packaging in which it is supplied bears, in lettering which is visible, indelible and easily legible, a list of its cosmetics ingredients (preceded by the word “ingredients”) in descending order of weight, the weight to be determined at the time the ingredients are added to the product.

• (2) Subject to paragraphs (3), (4), (5)(a), (6) to (8), (13) and (14) below, no person shall supply a cosmetic product unless the container and packaging in which it is supplied bear the following particulars in lettering and other symbols (where appropriate) which is visible, indelible and easily legible—

• (a) the name or trade name and the address or registered office of the manufacturer of the product or of the supplier thereof, being a manufacturer or supplier established within a Member State of the Community;