The Cosmetic Products (Safety) Regulations 2008

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/EEC(1) as 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) the product’s presentation,

(b) its labelling,

(c) any instructions for its use and disposal, and

(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) that is not listed in Schedule 5,

(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) the final formulation, or

(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) where an alternative method is listed—

(i) in the Commission Regulation on test methods as specified in Article 13(2) of Regulation (EC) No. 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals(2);

(ii) in Annex IX to the Directive;

(b) after 11th March 2013 in respect of tests concerning repeated dose toxicity, reproductive toxicity and toxicokinetics;

(c) after 11th March 2009 in respect of all other tests.

(4) Paragraph (2) applies only—

(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) after 11th March 2009 in respect of all other tests.

(5) References in paragraphs (3) and (4) to the Commission Regulation on test methods and to Annex IX to the Directive are to that Regulation and Annex as amended from time to time.

11.  No person shall test a finished cosmetic product on an animal where such testing is undertaken in order that the product might satisfy a requirement of these Regulations or the Directive.

Labelling requirements

12.—(1) No person shall supply a cosmetic product unless the container and packaging displays the following information in indelible, easily legible and visible lettering—

(a) the name or style and the address or registered office of the manufacturer or the person responsible for marketing the cosmetic product who is established within the EEA. Such information may be abbreviated in so far as the abbreviation makes it generally possible to identify the undertaking. Where the cosmetic product is manufactured outside the EEA, the country of origin must also be specified.

(b) the date of minimum durability—

(i) indicated by the words: ‘best used before the end of’ followed by either the date itself, or details of where it appears on the packaging;

(ii) clearly expressed and consisting of either the month and year or the day, month and year in that order;

(iii) supplemented, if necessary, by an indication of the conditions which must be satisfied to guarantee the stated durability;

except where the cosmetic product has a minimum durability of more than 30 months, in which case it is not mandatory to indicate the date of durability, but such a product shall have an indication of the period of time after opening for which the product can be used without any harm to the consumer. This information shall be indicated by the symbol given in Part 2 of Schedule 8 followed by the period in months or years or both months and years.

(c) particular precautions to be observed in use. The ‘Conditions of use and warnings which must be printed on the label’ set out in Schedules 4, 5, 6 and 7 and any special precautionary information on cosmetic products for professional use, in particular in hairdressing, must appear on the container and packaging;

(d) the batch number of manufacture or the reference for identifying the goods;

(e) the function of the product, unless it is clear from the presentation of the product.

(2) No person shall supply a cosmetic product unless the packaging in which it is supplied bears, in indelible, easily legible and visible lettering a list, preceded by the word ‘ingredients’ of the ingredients in descending order of weight as they are added—

(a) an ingredient must be identified by the name provided for in the International Nomenclature of Cosmetic Ingredients (INCI) or in the absence of such identification, by its chemical name, its European Pharmacopoeia name, its International Non-proprietary name (INN) as recommended by the World Health Organisation, its EINECS, ELINCS or CAS identification reference or its colour index number(3).

(b) the following shall not however be regarded as ingredients:

(i) impurities in the raw materials used;

(ii) subsidiary technical materials used in the preparation but not present in the final product;

(iii) materials used in strictly necessary quantities as solvents or as carriers for perfumes and aromatic compositions;

(c) perfume and aromatic compositions and their raw materials shall be referred to by the word ‘perfume’ or ‘aroma’.

(d) the presence of substances, the mention of which is required under the column ‘other limitations and requirements’ in Schedule 4 shall be indicated in the list irrespective of their function in the product;

(e) ingredients in concentrations of less than 1% may be listed in any order after those in concentrations of more than 1%;

(f) colouring agents may be listed in any order after the other ingredients, in accordance with the colour index number or denomination adopted in Schedule 5;

(g) for decorative cosmetic products marked in several colour shades, all colouring agents used in the range may be listed, provided that the words ‘may contain’ or ‘+/-‘ are added.

(3) The particulars referred to—

(a) in paragraph 1(b), (c) and (e) above shall be in English, but this shall not prohibit the additional use of other languages;

(b) in paragraph (2) shall be in a language easily understood by the consumer.

(4) Where two or more cosmetic products are supplied together as a single item, each product being in a separate container and the containers being enclosed together in packaging which bears clear and conspicuous instructions to the effect that the products must be mixed together in specified proportions before use, the particulars referred to in paragraph (1)(c) shall appear on an enclosed leaflet and an indication shall appear on both the containers and the packaging referring the consumer to the information in the leaflet.

13.—(1) Where a cosmetic product other than soap is supplied in neither a container nor packaging, the particulars referred to in paragraph (1) shall appear on the container in which the product is exposed for supply or a notice in immediate proximity to that container.

(2) Where a cosmetic product has no packaging or it is impossible for practical reasons for the list of ingredients referred to in regulation 12(2) to appear on the packaging, the list shall appear on the container; and where a cosmetic product is supplied in neither a container nor packaging, the list shall appear on the container in which the product is exposed for supply or a notice in immediate proximity.

(3) Where it is impossible for practical reasons for the required particulars as to the conditions of use or list of ingredients to appear on the container and packaging an enclosed leaflet, label, tape or card must contain that information to which the consumer is referred either by abbreviated information or the symbol in Part 1 of Schedule 8 which—

(a) in the case of conditions of use must appear on the container and the packaging, and

(b) in the case of the list of ingredients, must appear on the packaging.

(4) Where it is impracticable, for reasons of size or shape, for the required particulars as to the conditions of use or list of ingredients to appear in an enclosed leaflet those particulars shall appear on a label, tag, tape or card which is enclosed or attached to the cosmetic product.

(5) In the case of soap, bath balls and other small products where it is impracticable, for reasons of size or shape, for the required information as to the ingredients to appear on a label, tag, tape or card or in an enclosed leaflet, those particulars shall appear on a notice in immediate proximity to the container in which the cosmetic product is exposed for sale.

(6) Where it is impossible for practical reasons for the batch number of manufacturer or the reference for identifying the goods to appear on the container and packaging because the cosmetic product is too small such information need only appear on the packaging.

14.  The supply of a cosmetic product in respect of which a claim that the product or its ingredients have not been tested on animals appears on the product packaging or in any documents, 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; and

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

Responsible persons and competent authorities

15.—(1) A responsible person means in relation to a relevant cosmetic product—

(a) the manufacturer of the product,

(b) the manufacturer’s agent,

(c) the person to whose order that cosmetic product is manufactured, or

(d) where the manufacturer or the person to whose order the cosmetic product is manufactured is not established in the EEA and either—

(i) the manufacturer has not appointed an agent, or

(ii) the manufacturer’s agent is not the supplier of that cosmetic product,

the person who first supplies the cosmetic product in the EEA.

(2) A “competent authority” means a body responsible for requiring and receiving the information provided for in regulations 16, 17 and 19 and granting and refusing requests for confidentiality in accordance with regulation 21, and which is—

(a) a United Kingdom competent authority; or

(b) a competent authority of a Member State other than the United Kingdom, having been notified as a competent authority by the Member State concerned to the Commission in accordance with Articles 7.3 and 7a.5 of the Directive and Article 10 of Directive 95/17/EC(4);

(3) The United Kingdom competent authority shall be the Secretary of State provided that he may from time to time appoint such person as he thinks fit to be a United Kingdom competent authority in addition to or in substitution for himself.

Information to be made accessible to competent authority

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(5) 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.

17.  Where the place of manufacture or initial importation into the EEA of a type of cosmetic product is within the United Kingdom, the responsible person shall notify a United Kingdom competent authority of the address of the place of manufacture or, as the case may be, initial importation into the EEA of that type of cosmetic product before its first supply in the EEA.

Qualified persons

18.—(1) The qualified person referred to in regulation 16(1)(f) must be—

(a) a person who is “appropriately qualified” within the meaning of article 11(1)(a)(i) of the Pharmacists and Pharmacy Technicians Order 2007(6) or any other person who has the right, granted by a competent authority of a Member State, to take up and pursue the activities of a pharmacist;

(b) a person who is entitled to be registered under section 3(1) of the Medical Act 1983(7) 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 professional qualification within the meaning of regulation 7 of the European Communities (Recognition of Professional Qualifications) Regulations 2007(8) showing that the holder has the qualifications required to practise as a chartered biologist or as a chartered chemist or a profession equivalent to the profession of chartered biologist or chartered chemist in a Member State other than the United Kingdom.

(2) Any diploma or other evidence of qualification required for the purposes of paragraph (1)(a) or (b) shall satisfy that requirement only if—

(a) the education and training attested were received mainly within the EEA; 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).

Medical treatment

19.—(1) A United Kingdom competent authority may, where difficulties are encountered in providing prompt and appropriate medical treatment, require any holder of appropriate and adequate information on substances used in cosmetic products to make such information available to it, where the difficulties referred to may be overcome or eased by the provision of the said information.

(2) Where the information referred to in paragraph (1) is made available, the United Kingdom competent authority shall ensure that it is used solely for the purposes of the treatment referred to in paragraph (1).

Authorisation by the Secretary of State

20.—(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 listed in Schedule 3 (substances which must not form part of the composition of cosmetic products) or Schedule 4 (substances subject to restrictions and conditions).

(2) An authorisation as to the use of a particular substance in a cosmetic product may contain conditions relating 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 labelling requirements.

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

(4) The Secretary of State shall arrange for the authorisation, variation or revocation, as the case may be, to be published in such manner as he considers appropriate for bringing it to the attention of persons who, in his opinion, would be likely to have an interest in it.

(5) The fact that a cosmetic product contains a particular substance does not constitute a contravention of these Regulations provided that at the relevant time—

(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.

Requests for confidentiality

21.—(1) A responsible person who for reasons of trade secrecy wishes not to include one or more cosmetic ingredients in the list of cosmetic ingredients referred to in regulation 12(2) shall submit a request to that effect to the competent authority.

(2) In this regulation “applicant” means a responsible person who submits a request for confidentiality.

(3) The applicant shall ensure that—

(a) the request for confidentiality includes the particulars laid down in Part 1 of Schedule 9; and

(b) any amendments to the particulars provided for in sub-paragraph (a) are communicated as quickly as possible to the competent authority and, in particular, that all changes to the names of cosmetic products containing the cosmetic ingredient in respect of which confidentiality is or has been sought, are communicated to the competent authority at least 15 days before those cosmetic products are supplied under their new names.

(4) Within four months of the receipt of a request for confidentiality in respect of which the requirements of paragraph (3)(a) are satisfied, the competent authority shall examine the request and inform the applicant in writing of its decision.

(5) If the competent authority decides to grant its approval to the applicant’s request it shall, in notifying the applicant of its decision, in accordance with paragraph (4), also notify the applicant of the registration number which will replace the cosmetic ingredient in question in the list referred to in regulation 12(2), the said number to be allocated to the product in accordance with the procedure provided for in Part 2 of Schedule 9.

(6) If the competent authority refuses to grant its approval to the applicant’s request it shall, in its notification of this refusal, include a statement of the reasons for refusal and a clear explanation of appeals procedures and their time limits.

(7) In exceptional cases the competent authority may inform the applicant in writing that a period of two months in addition to the four-month period referred to in paragraph (4) is required for the examination of the request.

(8) A decision granting confidentiality shall be valid for a period of five years.

(9) An applicant may, by submitting a reasoned request to the competent authority, request that the period of confidentiality referred to in paragraph (8) be extended.

(10) In the event of a reasoned request being submitted in accordance with paragraph (9), the competent authority shall deal with the request in accordance with paragraphs (4), (5) and (6).

(11) Any extension of the period of confidentiality shall not exceed three years.

(12) The competent authority may withdraw its approval to an applicant’s request for confidentiality if it considers this appropriate taking into account—

(a) any amendments to the particulars provided for in paragraph (3)(a) which are communicated to it in accordance with paragraph (3)(b); and

(b) any new information which comes to its attention which makes it imperative, particularly for compelling reasons of public health, for it to so act,

and in withdrawing its approval the competent authority shall comply with the provisions of paragraphs (4), (6) and (7).

Contravention of these Regulations

22.—(1) For the purposes of the 1987 Act—

(a) these regulations, with the exception of regulations 10, 11, 14 and 16(1)(i) are safety regulations made under section 11 of the 1987 Act;

(b) regulations 10,11,14 and 16(1)(i), which are not made under the 1987 Act, shall be treated as if they were safety regulations made for all purposes under section 11 of the 1987 Act.

(2) The term of imprisonment to which a person guilty of an offence of contravening a requirement of regulations 16, 17 or 19 shall be liable on summary conviction shall not exceed three months.

(3) Any person guilty of an offence under paragraph (1)(b) shall be liable, on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment not exceeding three months and, on conviction on indictment, to a fine or to imprisonment not exceeding six months.

Enforcement

23.—(1) No proceedings shall be brought and no enforcement action taken in respect of—

(a) a failure to comply with regulations 4 to 9, 12, 13, 16, 17 and 18 where the cosmetic product is supplied for the purposes of exporting that product to any country which is not a Member State; or

(b) a failure to comply with regulation 12(3)(a) in any case in which the enforcement authority is satisfied that the person supplying the cosmetic product reasonably believes that it will not be used in the United Kingdom.

(2) For the purposes of this regulation, “enforcement action” means action taken pursuant to or in connection with sections 13, 14, 16, 17, 28, 29, 30 or 31 of the 1987 Act.

24.  Any test of goods purchased under section 28 or seized under section 29 of the 1987 Act (which relate to enforcement) by or on behalf of an enforcement authority for the purpose of ascertaining whether the provisions of these Regulations have been contravened shall in all cases be carried out in accordance with the provisions of paragraphs 2 to 5 of Schedule 10 and any test for which a method is specified in paragraph 6 of Schedule 10 shall be carried out in accordance with that method.

Proceedings

25.  No proceedings for an offence under these Regulations shall be commenced after the earlier of—

(a) the end of the period of three years beginning with the date of the commission of the offence, or

(b) the end of the period of one year beginning with the date of the discovery of the offence by the prosecutor.

Amendment to Legislative and Regulatory Reform (Regulatory Functions) Order 2007

26.—(1) In the Schedule to the Legislative and Regulatory Reform (Regulatory Functions) Order 2007(9), Part 3 is amended as follows.

(2) In the heading “Consumer and business protection”, after the entry for the Consumer Protection from Unfair Trading Regulations 2008, insert “Cosmetic Products (Safety) Regulations 2008”.

Gareth Thomas

Parliamentary Under-Secretary of State for Trade and Consumer Affairs

Department for Business, Enterprise & Regulatory Reform

13th May 2008