The Cosmetic Products (Safety) Regulations 2008
2008 No. 1284
Consumer Protection
The Cosmetic Products (Safety) Regulations 2008
Made 13th May 2008
Laid before Parliament 13th May 2008
Coming into force 18th June 2008
The Secretary of State is a Minister designated for the purposes of section 2 of, and paragraph 1A of Schedule 2 to, the European Communities Act 19721in relation to measures for safety and consumer protection as respects cosmetic products and any provisions concerning the composition, labelling, marketing, classification or description of cosmetic products and in relation to indication of origin on imported goods2.
These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Secretary of State that it is expedient for certain references to provisions of Community instruments to be construed as references to those provisions as amended from time to time.
In accordance with section 11(5) of the Consumer Protection Act 1987 the Secretary of State has consulted such organisations as appear to him to be representative of interests substantially affected by the following Regulations, such other persons as he considered appropriate and the Health and Safety Commission.
The Secretary of State makes regulations 10, 11, 14, 16(1)(i) and regulation 26 in exercise of the powers conferred by section 2(2) of the European Communities Act 1972 (as read with paragraph 1A of Schedule 2 to that Act) and all other provisions in these Regulations in exercise of the powers conferred by section 11 of the Consumer Protection Act 19873.
Citation, Commencement and revocation
1.—(1) These Regulations may be cited as the Cosmetic Products (Safety) Regulations 2008 and shall come into force on 18th June 2008.
(2) The Regulations listed in Schedule 1 are revoked.
Transitional provisions
2.—(1) In Schedule 4 (substances subject to restrictions and conditions) the labelling requirement for any toothpaste containing 0.1 to 0.15% fluoride in respect of entries numbered 26 to 43, 47 and 56 of Part 1 does not apply until 19th March 2009.
(2) In Schedule 5 (colouring agents) the substance numbered 45425 is omitted after 17th October 2008.
(3) In Schedule 6 (Preservatives) reference number 10 is deleted and the text of entry 56 is replaced after 17th October 2008.
(4) Cosmetic products which fail to comply with the amendments to these Regulations referred to in paragraphs (2) and (3) may not be placed on the market by EEA manufacturers or by importers established within the EEA after 17th October 2008 and cosmetic products which fail to comply with those changes may not be disposed of to the final consumer after 18th April 2009.
Interpretation
3. In these Regulations—
“the 1987 Act” means the Consumer Protection Act 1987;
“agent” means an agent established within the EEA appointed by a manufacturer of a cosmetic product to act on his behalf in relation to these Regulations;
“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 the various external parts of the human body (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, correcting body odours, protecting them, or keeping them in good condition 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/EEC4as amended by the Community instruments set out in Schedule 2;
“the EEA” means the area comprised of the EEA States;
“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;
“Member State” means an EEA State;
“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.
General safety requirement
4.—(1) No person shall supply a cosmetic product which may cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking into account, in particular—
(a)
(a) the product’s presentation,
(b)
(b) its labelling,
(c)
(c) any instructions for its use and disposal, and
(d)
(d) any other indications or information provided by the manufacturer or his authorised agent or by any other person responsible for placing the product on the market in the EEA.
(2) Paragraph (1) only applies 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, to the supply by that other person.
(3) The provision of warnings shall not, in any event, exempt any person from compliance with the other requirements of these Regulations.
Substances prohibited in cosmetic products
5.—(1) No person shall supply a cosmetic product containing a substance listed in Schedule 3 (substances which must not form part of the composition of cosmetic products).
(2) The presence of traces of a substance listed in Schedule 3 is allowed provided that such presence is technically unavoidable in good manufacturing practice.
Substances subject to restrictions and conditions
6. No person shall supply a cosmetic product containing a substance listed in Part 1 (substances subject to restrictions and conditions) or Part 2 (substances subject to restrictions and conditions provisionally allowed) of Schedule 4 unless the restrictions and conditions there set out in respect of that substance are satisfied.
Colouring agents
7.—(1) No person shall supply a cosmetic product containing a colouring agent—
(a)
(a) that is not listed in Schedule 5,
(b)
(b) that is listed in Schedule 5 unless the restrictions and conditions there set out in respect of that substance are satisfied.
(2) Paragraph (1) does not apply to a cosmetic product containing a colouring agent intended solely to colour hair.
Preservatives
8. No person shall supply a cosmetic product containing a preservative—
(a) that is not listed in Schedule 6,
(b) that is listed in Schedule 6 unless the requirements set out in columns (c) (d) and (e) of Schedule 6 are satisfied,
(c) beyond the limits and outside the conditions laid down in Schedule 6 except where other concentrations are used for specific purposes apparent from the presentation of the product;
UV Filters
9. No person shall supply a cosmetic product containing a UV filter—
(a) that is not listed in Schedule 7,
(b) that is listed in Schedule 7, unless the requirements in columns (c), (d) and (e) of that Schedule are satisfied.
Restrictions on animal testing
10.—(1) No person shall supply a cosmetic product where, in order that the cosmetic product, or an ingredient or combination of ingredients might meet a requirement of these Regulations or the Directive—
(a)
(a) the final formulation, or
(b)
(b) an ingredient or combination of ingredients contained in the cosmetic product
has been tested on an animal using a method other than an alternative method.
(2) No person shall test any ingredient or combination of ingredients on an animal in order to meet a requirement of these Regulations or the Directive using a method other than an alternative method.
(3) Paragraph (1) applies only—
(a)
(a) where an alternative method is listed—
(i) in the Commission Regulation on test methods as specified in Article 13(2) of Regulation (EC) No. 1907/2006of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals5;
(ii) in Annex IX to the Directive;
(b)
(b) after 11th March 2013 in respect of tests concerning repeated dose toxicity, reproductive toxicity and toxicokinetics;
(c)
(c) after 11th March 2009 in respect of all other tests.
(4) Paragraph (2) applies only—
(a)
(a) where an alternative method is listed—
(i) in the Commission Regulations on test methods as specified in Article 13(2) of Regulation (EC) No. 1907/2006;
(ii) in Annex IX to the Directive;
(b)
(b) after 11th March 2009 in respect of all other tests.
(5) References in paragraphs (3) and (4) to the Commission Regulation on...
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