Citation and commencement and transitory provisions

1.—(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(4) 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

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

Interpretation

3.—(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(5), 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(6);

“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(7) 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—

but a cosmetic product is not the subject of a market research experiment unless—

“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

4.—(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

5.—(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(8), 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

6.—(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

7.—(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;

(b)in the case of a cosmetic product likely before the end of 30 months from the manufacture thereof to cease either to comply with the requirements of regulation 4 or to fulfil the purpose for which it was intended, the words “Best before ... ... ... ...” immediately followed by—

(i)the earliest date on which it is likely so to cease; or

(ii)an indication of where that date appears on the labelling,

and any particular precautions to be observed to ensure that the product does not so cease before that date;

(c)in the case of a cosmetic product—

(i)not falling within sub-paragraph (b) above; and

(ii)which may cease to comply with the requirements of regulation 4 after the container in which the product is contained has been opened,

the symbol given in Part II of Schedule 9 to these regulations together with an indication of the period of time after opening after which the cosmetic product is likely to cease to comply with the requirements of regulation 4;

(d)in the case of a cosmetic product containing a substance listed in column 2 of Schedule 4, the information specified in column 6 of that Schedule in relation to that substance;

(e)in the case of a cosmetic product containing a preservative listed in column 2 of Schedule 6, the information specified in column 6 of that Schedule in relation to that preservative;

(f)in the case of a cosmetic product containing a UV filter listed in column 2 of Schedule 7, the information specified in column 5 of that Schedule in relation to that UV filter;

(g)any particular precautions to be observed in use and any special precautionary information on a cosmetic product for professional use, in particular in hairdressing (not being precautions included in the information referred to in sub-paragraphs (b), (d), (e) and (f) above);

(h)a means of identifying the batch in which the product was manufactured (or, if the product was not manufactured in a batch, a reference from which the date and place of manufacture can be identified); and

(i)the function of the product unless this is clear from its presentation;

Provided that the requirements specified in sub-paragraphs (b), (c) and (h) above need not be complied with in relation to a cosmetic product which is the subject of a market research experiment.

(3) The particulars referred to in paragraph (2)(a) above may be abbreviated if such abbreviation does not prevent the person concerned from being identified.

(4) The date referred to in paragraph (2)(b) above shall include the month and the year or the day, month and year in the order given in this paragraph.

(5) The particulars referred to—

(a)in paragraph (2)(b) to (g) and (i) above shall be in English, but this shall not prohibit the additional use of other languages;

(b)in paragraph (1) above shall be in a language easily understood by the consumer.

(6) Where it is impossible for practical reasons for the particulars referred to in paragraph (2)(c) to (g) above to appear on the container and packaging, they shall appear on a leaflet, label, tag, tape or card enclosed with the cosmetic product, to which the consumer is referred either by abbreviated information or by the symbol given in Part 1 of Schedule 9, which must appear on the container and packaging; and where it is impracticable for reasons of size or shape for the particulars so to appear, they shall appear on a label, tag, tape or card attached to the product.

(7) Where it is impossible, for reasons of size, for the particulars referred to in paragraph (2)(h) above to appear on the container and packaging, it shall be sufficient for the said particulars to appear only on the packaging.

(8) In the case of a supply of soap which is not in a container, either the soap itself or the packaging in which it is exposed for supply or the container in which it was last contained before the supply shall bear the particulars referred to in paragraph (2)(a) and (h) above, and in so far as any of the particulars referred to in paragraph (2)(b) to (g) and (i) above are required they shall appear on a leaflet which shall be delivered to the buyer with the soap; and where either of the particulars referred to in paragraph (2)(a) and (h) above appears on the soap itself the requirement of indelibility shall apply only until it has been put into use.

(9) In relation to the compilation of the list of ingredients referred to in paragraph (1) above—

(a)the following shall not be regarded as cosmetic ingredients—

(i)impurities in the raw materials used;

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

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

(b)perfume and aromatic compositions and their raw materials shall be referred to by the words “perfume” or “aroma” except where the substance—

(i)is listed in column 2 of Schedule 4 to these regulations; and

(ii)is required to be mentioned by a requirement in column 5 of that Schedule;

(c)ingredients in concentrations of less than 1 per cent may be listed in any order after those in concentrations of 1 per cent or more;

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

(e)for decorative cosmetic products marketed in several colour shades, all colouring agents used in the range may be listed, provided that the words “may contain” or the symbol “+/-” are added; and

(f)an ingredient shall 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 CTFA name, its European Pharmacopoeia name, its International Non-proprietary Name (INN) as recommended by the World Health Organization, its EINECS, IUPAC or CAS identification reference or its colour index number(9).

(10) Subject to paragraph (11) below, where a cosmetic product has no packaging or it is impossible for practical reasons for the list of ingredients referred to in paragraph (1) above to appear on the packaging, the list shall appear on the container; and where a cosmetic product is supplied or delivered pursuant to any supply 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 to that container.

(11) Subject to paragraph (12) below, where it is impossible for practical reasons for the list of ingredients referred to in paragraph (1) above to appear on the packaging or container of a cosmetic product, it shall appear on a leaflet, label, tag, tape or card enclosed with the product, to which the consumer is referred either by abbreviated information or by the symbol given in Part 1 of Schedule 9, which must appear on the packaging; and where it is impracticable for reasons of size and shape for the list so to appear, it shall appear on a label, tag, tape or card attached to the cosmetic product.

(12) In the case of soap, bathballs and other small products, where it is impracticable for reasons of size or shape for the list of ingredients referred to in paragraph (1) above to appear on an enclosed leaflet or on a label, tag, tape or card enclosed with or attached to the product, it shall appear on a notice in immediate proximity to the consumer in which the cosmetic product is exposed for sale.

(13) 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 (2)(d) to (g) above 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.

(14) Where a cosmetic product other than soap is supplied or delivered pursuant to a supply in neither a container nor packaging, the particulars referred to in paragraph (2) above shall appear on the container in which the product is exposed for supply or a notice in immediate proximity to that container.

(15) Paragraphs 7(2)(c) and 7(9)(b) above shall not apply to cosmetic products placed on the market in the Community prior to 11th March 2005.

Responsible Persons and Competent Authorities

8.—(1) For the purposes of regulations 9 (except regulation 9(5) and (6)), 10, 11 and 12—

(a)“responsible person” means, in relation to a relevant cosmetic product,

(i)the manufacturer of that product;

(ii)the manufacturer’s agent;

(iii)the person to whose order that cosmetic product is manufactured; or

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

(aa)the manufacturer has not appointed an agent; or

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

the person who first supplies the cosmetic product in the Community;

(b)“competent authority” means a body responsible for requiring and receiving the information provided for in Articles 7.3, 7a.1 and 7a.4 of the Directive and granting and refusing requests for confidentiality pursuant to Article 4 of the Confidentiality Directive, and which is—

(i)a United Kingdom competent authority pursuant to paragraph (2) below; or

(ii)for the time being 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 pursuant to Articles 7.3 and 7a.5 of the Directive and Article 10 of the Confidentiality Directive.

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

Product Information

9.—(1) Subject to paragraph (8) below, where a cosmetic product is manufactured or supplied in the United Kingdom a responsible person shall for control purposes keep easily 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)an assessment of the safety for human health of the finished product taking into consideration the matters specified in paragraph (2) below;

(e)a specific assessment of the safety for human health of the finished product taking into consideration the matters specified in paragraph (2) below 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 person or persons, qualified in accordance with paragraph (5) below, responsible for the assessments referred to in sub-paragraphs (d) and (e) above;

(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;

(2) The assessments referred to in paragraphs (1)(d) and (1)(e) above 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 (10) 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) Subject to paragraph (4) below and 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) above shall be made easily accessible to the public by any appropriate means.

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

(5) The person referred to in paragraph (1)(f) must be—

(a)subject to paragraph (6) below, the holder of an appropriate European diploma within the meaning of section 4A of the Pharmacy Act 1954(11) 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 (6) below, a person who is entitled to be registered under section 3(1) of the Medical Act 1983(12) 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(13) 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.

(6) Any diploma or other evidence of qualification required for the purposes of paragraph (5)(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).

(7) 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.

(8) 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.

(9) 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.

(10) Paragraphs 9(1)(e), 9(1)(i), 9(2)(d) and 9(2)(e) above shall not apply in respect of cosmetic products placed on the market in the Community prior to 11th September 2004.

10.  Where the place of manufacture or initial importation into the Community 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 Community of that type of cosmetic product before its first supply in the Community.

11.—(1) A United Kingdom competent authority may, where difficulties are encountered in providing prompt and appropriate medical treatment, require that any holder of appropriate and adequate information on substances used in cosmetic products 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) above 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) above.

12.—(1) Without prejudice to the provisions of regulations 4, 5, 9 and 12, 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 7(1) above 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 I of Schedule 10; and

(b)any amendments to the particulars provided for in sub-paragraph (a) above 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) above 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) above, also notify him of the registration number which will replace the cosmetic ingredient in question in the list referred to in regulation 7(1), the said number to be allocated to the product in accordance with the procedure provided for in Part II of Schedule 10.

(6) If the competent authority decides to refuse 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) above is required for the examination of the request.

(8) Subject to paragraphs (9), (10), (11) and (12) below, 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) above be extended.

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

(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) above which are communicated to it in accordance with paragraph (3)(b) above; 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) above.

Contravention of these Regulations with the exception of regulations 5(7) to 5(13)

13.—(1) Subject to paragraph (2) below, any contravention of a requirement of these regulations with the exception of regulations 5(7)-5(13) shall be treated for all purposes as though it were a contravention of a requirement of safety regulations made under section 11 of the 1987 Act.

(2) The term of imprisonment to which a person guilty of an offence under regulations 9, 10 or 11 shall be liable on summary conviction shall not exceed three months.

Contravention of Regulations 5(7) to 5(13)

14.—(1) Any person who contravenes regulation 5(7), 5(8), 5(9),5(10), 5(11),5(12) or 5(13) or causes or permits another person to contravene those regulations, shall be guilty of an offence.

(2) Any person guilty of an offence under paragraph (1) above 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.

(3) Where an offence under paragraph (1) committed by a body corporate is proved—

(a)to have been committed with the consent or connivance of an officer, or

(b)to be attributable to any neglect on his part,

the officer as well as the body corporate shall be guilty of that offence and shall be liable to be proceeded against and punished accordingly.

(4) In paragraph (3), “officer” in relation to a body corporate, means a director, manager, secretary or other similar officer of the body, or a person purporting to act in any such capacity.

(5) If the affairs of the body corporate are managed by its members, paragraph (3) shall apply in relation to the acts and defaults of a member in connection with his functions of management as if he were a director of the body corporate.

(6) Where an offence under paragraph (1) committed by a partnership in Scotland is proved—

(a)to have been committed with the consent and connivance of the partner, or

(b)to be attributable to any neglect on his part,

the partner as well as the partnership shall be guilty of that offence and liable to be proceeded against and punished accordingly.

(7) In paragraph (6), partner includes a person purporting to act as a partner.

15.  For the purposes of enforcing regulations 5(7), 5(8), 5(9), 5(10), 5(11),5(12) and 5(13), those regulations shall be treated as if they were safety regulations made under section 11 of the 1987 Act provided that section 12 of that Act shall not apply.

Enforcement

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

(a)any failure to comply with regulations 4, 5 (with the exception of 5(11) and 5(12)), 7, 9, 10 and 11 in any case in which the cosmetic product is supplied for the purposes of exporting that product to any country which is not a Member State; or

(b)any failure to comply with regulation 7(5)(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) No proceedings shall be brought and no enforcement action taken in respect of any contravention of regulation 5(7) of the Cosmetic Products (Safety) Regulations 2003(14) once these regulations have come into force.

(3) No proceedings shall be brought and no enforcement action taken in respect of any contravention or failure to comply with these Regulations insofar as an entry in Part 2 of Schedule 1 to these Regulations is concerned in respect of a new substance in such an entry or where the cosmetic product in question complied with the entry as it appeared before 24th March 2005 and where the cosmetic product in question was—

(i)placed on the market before 24th March 2005; and

(ii)supplied before 24th September 2005.

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

17.  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 Schedule 11 and any test for which a method is specified in paragraph 6 of Schedule 11 shall be carried out in accordance with that method.

Proceedings

18.  No proceedings for an offence under these Regulations shall be commenced after—

(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,

whichever is earlier.

Regulations 1(3), 1(4) and 16(3)

SCHEDULE 1

PART 1

Schedules 3,4 and 6 to these Regulations shall have effect until 24th March 2005 with the insertion of the entries set out in Part 1 of this Schedule as they appear in the Cosmetic Products (Safety) Regulations 2003(15) in place of the corresponding entries in the those Schedules to these Regulations.

PART 2

Subject to regulation 1(3), the entries referred to in Part 2 of this Schedule shall not form part of the Schedules referred to in column 3 below until 24th March 2005.

Regulation 3(1)

SCHEDULE 2

1.  Council Directive 82/368/EEC (N.J. No. L167, 15.6.82, p.1).

2.  Commission Directive 82/147/EEC (O.J. No. L63, 6.3.82, p.26).

3.  Commission Directive 83/191/EEC (O.J. No. L109, 26.4.83, p.25).

4.  Commission Directive 83/341/EEC (O.J. No. L188, 13.7.83, p.15).

5.  Council Directive 83/574/EEC (O.J. No. L332, 28.11.83, P.38.)

6.  Commission Directive 83/496/EEC (O.J. L275, 8.10.83, P.20).

7.  Commission Directive 84/415/EEC (O.J. No. L228, 25.8.84, p.31).

8.  Commission Directive 85/391/EEC (O.J. L224, 22.8.85, p.40).

9.  Commission Directive 86/179/EEC (O.J. No. L138, 24.5.86, p.40).

10.  Commission Directive 86/199/EEC (O.J. No. L149, 3.6.86, p.38).

11.  Commission Directive 87/137/EEC (O.J. No. L56, 26.2.87, p.20).

12.  Commission Directive 88/233/EEC (O.J. L105, 26.4.88, p.11).

13.  Council Directive 88/667/EEC (O.J. No. L382, 31.12.88, p.46).

14.  Commission Directive 89/174/EEC (O.J. No, L64, 8.3.89, p.10).

15.  Council Directive 89/679/EEC (O.J. No. L398, 30.12.89, p.25).

16.  Commission Directive 90/12/EEC (O.J. No. L71, 17.3.90, p.40).

17.  Commission Directive 91/184/EEC (O.J. No. L91, 12.4.91, p.59).

18.  Commission Directive 92/8/EEC (O.J. No. L70, 17.3.92, p.23)

19.  Commission Directive 92/86/EEC (O.J. No.L325, 11.11.92, p.18).

20.  Commission Directive 93/47/EEC (O.J. No. L203, 13.8.93, p.24).

21.  Council Directive 93/35/EEC (O.J. No. L151, 23.6.93, p.32).

22.  Commission Directive 94/32/EC (O.J. No. L181, 15.7.94, p.31).

23.  Commission Directive 95/34/EC (O.J. No. L167, 18,7.95, p.19)

24.  Commission Directive 96/41/EC (OJ No. L198, 8.8.96, p.36).

25.  Commission Directive 97/18/EC (O.J. No. L114, 1.5.97, p.43).

26.  Commission Directive 97/45/EC (O.J. No. L196, 24.7.97, p.77).

27.  Commission Directive 98/16/EC (O.J. No. L77, 14.3.98, p.44).

28.  Commission Directive 98/62/EC (O.J. No. L253, 15.9.98, p.20).

29.  Commission Directive 2000/6/EC (O.J. No. L56, 1.3.00, p.42).

30.  Commission Directive 2000/11/EC (O.J. No. L65, 14.3.00, p.22).

31.  Commission Directive 2000/41/EC (O.J. No. L145, 20.6.00, p.25).

32.  Commission Directive 2003/1/EC (O.J. No. L102, 18.4.02, p.19).

33.  Commission Directive 2003/1/EC (O.J. No. L5, 10.1.03, p.14).

34.  Commission Directive 2003/16/EC (O.J. No. L46, 20.2.03, p.24).

35.  Commission Directive 2003/15/EC (O.J. No. L66, 11.3.03, p.26).

36.  Commission Directive 2003/80/EC (O.J. No. L224, 6.9.2003, p.27).

37.  Commission Directive 2003/83/EC (O.J. No. L238, 25.9.03, p.23)

Regulations 5(2) and 6(1)

SCHEDULE 3LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN

The alphabetical list set out in column 2 of this Schedule contains one or more of the names of each of the substances referred to in regulation 5(2); in certain cases a name is given of a group of substances, the names of particular examples of which are also given, and in such a case all substances comprised in the group are included, whether or not more specifically named.

The references given in columns 3 and 4 are for information only. Those in column 3 are cross-references to other names listed for the same substance (except that where a name is that of a group of substances, the cross-references are to particular examples of that group, and any cross-reference in parenthesis is to the name of a group of substances within which the particular substances falls).

Regulation 1(3) provides that until 24th March 2005 entries 90, 391, 458 and 643 shall be inserted into Part 1 of this Schedule as they appear Part 1, Schedule 3 to the Cosmetic Products (Safety) Regulations 2003. From 24th March 2005 the above entries shall have effect as they appear in Part 1 of this Schedule.

PART 1SUBSTANCES PROHIBITED IN ALL COSMETIC PRODUCTS

Regulation 5(2)

PART 2SUBSTANCES PROHIBITED WHEN USED AS A FRAGRANCE INGREDIENT

Regulations 5(2), 6(1) and 7(2), 7(9)

SCHEDULE 4LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

In this Schedule, the matters specified in columns 3, 4, 5 and 6 which apply to a particular substance are those set out to the right of its name as mentioned in column 2; and the matters specified in columns 4, 5 and 6 which apply in any particular case are those set out to the right of the matter specified in column 3 which applies in that case. The substance may not be used except for the purposes or contained other than in the types of product specified in column 3. The concentration of the substance in a product may not exceed the limit specified in column 4: where the names of two or more substances are mentioned in a single item as set out in column 2 and a product contains more than one of those substances, the limit specified in column 4 is the limit for all of those substances taken together; and where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 5. In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given 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(16).

Regulation 1(3) provides that until 24th March 2005 entries 14, 60, 61 and 62 shall be inserted into Part 1 of this Schedule as they appear in Part 1 of Schedule 4 to the Cosmetic (Products) (Safety) Regulations 2003(17). From 24th March 2005 the above entries shall have effect as they appear in Part 1 of this Schedule.

Regulation 1(4) provides that entries 93,94 and 95 in Part 1 of this Schedule shall not form part of this Schedule until 24th March 2005.

PART 1SUBSTANCES LISTED IN ANNEX III, PART I OF THE DIRECTIVE AS SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

PART 2SUBSTANCES LISTED IN ANNEX III, PART 2 OF THE DIRECTIVE AS SUBSTANCES PROVISIONALLY ALLOWED

Regulation 5(2) and 7(9)

SCHEDULE 5LIST OF COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT COLOURING AGENTS INTENDED SOLELY TO COLOUR HAIR AND EXCEPT SUBJECT TO RESTRICTIONS

In this Schedule the colouring agents referred to in regulation 5(2)(d) are—

(i)those identified in column 1 either by name or by colour index number (the colour index numbers being those specified in the fourth edition of The Colour Index published by the Society of Dyers and Colourists and the American Society of Textile Chemists and Colourists (available by on-line subscription at http://www.colour-index.org/). ;

(ii)lakes or salts of these colouring agents which do not use substances prohibited under Schedule 3.

In the case of colouring agents identified by the addition of (*) to the name or colour index number, the insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will be determined by the procedure laid down in Article 8 of the Directive.

Colouring agents whose number is preceded by the letter ‘E’ in accordance with the EEC Directive of 23rd October 1962 on the approximation of the rules of Member States concerning foodstuffs and colouring matter (19), as amended (20) adapted (21) and replaced in part (22) must fulfil the purity requirements laid down in those Directives.

PART ICOLOURING AGENTS LISTED IN ANNEX IV, PART 1 OF THE DIRECTIVE AS COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

Field of application

In column 3 of this Schedule, the entry “X” in a sub-column means that the colouring agent must not be used other than as follows—

Sub-column 1 = Colouring agents allowed in all cosmetic products;

Sub-column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;

Sub-column 3 = Colouring agents allowed exclusively in cosmetic products except cosmetic products intended to come into contact with the mucous membranes;

Sub-column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin

PART IICOLOURING AGENTS LISTED IN ANNEX IV, PART 2 OF THE DIRECTIVE AS COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE COSMETIC PRODUCT SUPPLIED BEFORE A CERTAIN DATE

Field of application

In column 3 of this Schedule, the entry “X” in a sub-column means that the colouring agent must not be used other than as follows—

Sub-column 1 = Colouring agents allowed in all cosmetic products;

Sub-column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;

Sub-section 3 = Colouring agents allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes;

Sub-column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.

Regulations 5(2) and 7(2)

SCHEDULE 6LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

In this Schedule, the matters specified in columns 3, 4, 5 and 6 which apply to a particular substance are those set out to the right of its name as mentioned in column 2; and the matters specified in column 4, 5 and 6 which apply in any particular case are those set out to the right of the matter specified in column 3 which applies in that case. The substance may not be used or contained other than in the types of product specified in column 3. The concentration of the substance, when it is used as a preservative, in a product may not exceed the limit set out in column 4. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall not calculated by reference to the mixture. Other requirements are specified in column 5.

In column 4 of this Schedule, “A” indicates that the concentration of the substance in a product may exceed the limit set out in that column provided that —

(b)the presence of any excess of the substance in a product over the concentration so set out is not for the primary purpose of inhibiting the development of micro-organisms; and

(c)the purpose for which any such excess is present in the product is apparent from the labelling of the product.

In this Schedule—

“salt” means salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines and of the anions chloride, bromide, sulphate and acetate;

“ester” means esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl and phenyl.

In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

All preservative substances containing formaldehyde or any substances named in this Schedule which release formaldehyde must be labelled with the warning “contains formaldehyde” when the concentration of formaldehyde in the final product exceeds 0.05 per cent.

Names which appear in square brackets in column 2 of this Schedule are the International Nomenclature Cosmetic Ingredient names of the substances in question given 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 (23).

Regulation 1(3) provides that until 24th March 2005 entry 36 in Part 1 of this Schedule shall be inserted into Part 1 of this Schedule as it appears in the Cosmetic Products (Safety) Regulations 2003(24). From 24th March 2004 entry 36 shall have effect as it appears in Part 1 of this schedule.

PART IPRESERVATIVES LISTED IN ANNEX VI, PART 1 OF THE DIRECTIVE AS PRESERVATIVES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

PART 2PRESERVATIVES LISTED IN ANNEX VI, PART 2 OF THE DIRECTIVE AS PRESERVATIVES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LIAD DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE

Regulations 5(2), 7(2) and 7(9)

SCHEDULE 7LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

In this schedule, the matters specified in columns 3, 4 and 5 which apply to a particular substance are those set out to the right of its name as mentioned in column 2. The concentration of the substance in a product may not exceed the limit specified in column 3. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 4. In column 3 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given 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 (25)

PART 1UV FILTERS LISTED IN ANNEX VII, PART 1 OF THE DIRECTIVE AS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

PART IIUV FILTERS LISTED IN ANNEX VIII, PART 2 OF THE DIRECTIVE AS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE

Regulation 5(5)

SCHEDULE 8METHODS OF MANUFACTURE OF TALLOW DERIVATIVES

The following are the methods of manufacture referred to in regulation 5(5)—

(a)transesterification or hydrolysis at a temperature of at least 200ºC and at an appropriate corresponding pressure for 20 minutes (glycerol, fatty acids and fatty acid esters);

(b)saponification with sodium hydroxide solution, c(NaOH) = 12mol/l (glycerol and soap)—

(i)batch process: at 95°C for three hours; or

(ii)continuous process: at 140°C, two bars (2,000hPa) for eight minutes, or equivalent conditions.

Regulations 7(2), 7(6) and 7(11)

SCHEDULE 9

PART 1SYMBOL IN ANNEX VIII OF THE DIRECTIVE WHICH IS REQUIRED FOR THE PURPOSES OF REGULATIONS 7(6) AND 7(11)

PART 2SYMBOL IN ANNEX VIIIa OF THE DIRECTIVE WHICH IS REQUIRED FOR THE PURPOSES OF REGULATION 7(2)(c)

Regulation 12(3) and (5)

SCHEDULE 10

PART 1PARTICULARS TO BE INCLUDED WITH A REQUEST FOR CONFIDENTIALITY

1.  The name or trade name and address or registered office of the applicant.

2.  Precise identification of the cosmetic ingredient for which confidentiality is requested, namely—

(a)where they exist, the CAS, EINECS and colour index numbers, the chemical name, the IUPAC name, the INCI name, the European Pharmacopoeia name, the International Non-proprietary Name as recommended by the World Health Organization and the common name as provided for in the common ingredients nomenclature;

(b)the European List of Notified Chemical Substances (ELINCS) name and the official number allocated to it if it has been notified pursuant to Council Directive 67/548/EEC(26) and an indication of the decision to approve or refuse any request for confidentiality made under Article 19 of that Directive;

(c)where the names or numbers referred to in sub-paragraphs (a) and (b) above do not exist, for example in the case of certain ingredients of natural origin, the name of the base material, the name of the part of the plant or animal used and the names of the cosmetic ingredient’s compounds, such as solvents.

3.  The evaluation of the safety for human health of the cosmetic ingredient as used in the finished cosmetic product or products taking into account the cosmetic ingredient’s toxicological profile, chemical structure and the level of exposure as specified in regulation 9(1)(d)and (e) and carried out in accordance with the requirements of regulations 9(2), 9(3) and 9(4).

4.  The envisaged use of the cosmetic ingredient and in particular the different categories of cosmetic products in which it will be used.

5.  A detailed justification of why confidentiality is sought addressing for example—

(a)the fact that the identify of the cosmetic ingredient or its function in the cosmetic product to be supplied has not been described in the literature accompanying the cosmetic product and is unknown to other manufacturers or suppliers of cosmetic products;

(b)the fact that the information is not yet in the public domain even though a patent application has been lodged for the cosmetic ingredient or its use;

(c)the fact that if the information were known it would be easily reproducible, to the detriment of the applicant.

6.—(1) If known, the name of each cosmetic product which is to contain the cosmetic ingredient and if different names are to be used in other Member States, precise details of each one of them.

(2) If the name of a cosmetic product is not yet known, it may be communicated at a later date, but at least 15 days before the cosmetic product is supplied.

(3) If the cosmetic ingredient is used in several products, one request shall suffice, provided that the cosmetic products are clearly indicated to the competent authority.

7.  A statement setting out whether a request has been submitted to the competent authority of any other Member State in respect of the cosmetic ingredient for which confidentiality is sought and particulars on the outcome of any such request.

PART IIPROCEDURE FOR GRANT OF REGISTRATION NUMBER

1.  The registration number referred to in regulation 12(5) shall consist of seven digits, the first two corresponding to the year of approval of confidentiality, the second two to the code assigned to each Member State, as referred to in paragraph 2 below, and the final three digits assigned by the competent authority.

2.  The code allocated to the United Kingdom is 06.

Regulation 17

SCHEDULE 11SAMPLING AND TESTING

1.  In this Schedule—

“Annex A” means the Annex to Commission Directive No. 80/1335/EEC(27) as amended by Commission Directive No.87/143/EEC(28)

“Annex B” means the Annex to Commission Directive No. 82/434/EEC(29) as amended by Commission Directive No.90/207/EEC(30)

“Annex C” means the Annex to Commission Directive No. 83/514/EEC(31);

“Annex D” means the Annex to Commission Directive No. 85/490/EEC(32);

“Annex E” means the Annex to Commission Directive No. 93/73/EEC(33);

“Annex F” means the Annex to Commission Directive No. 95/32/EC(34);

“Annex G” means the Annex to Commission Directive No. 96/45/EC(35);

“purchase” means purchase for the purpose of carrying out a test.

2.  An enforcement authority intending to purchase a cosmetic product shall purchase a sufficient laboratory sample, as defined in paragraph 2.3 of Part 1 of Annex A, for the purpose of Annex A; and, for the purposes of the definition of “total sample” in paragraph 2.2 of Part 1 of Annex A; samples shall be regarded as having the sample batch number if—

(a)the means of identifying the batch referred to in regulation 7(2)(h) above shows that they were manufactured in the same batch;

(b)in the case of a product not manufactured in a batch, the reference referred to in regulation 7(2)(h) above shows that they are derived from the same unit of production; or

(c)in the case of a product which does not comply with the requirements of regulation 7(2)(h) above, the officer effecting the purchase has reasonable cause to believe that they were manufactured in the same batch or are derived from the same unit of production, as the case may be.

3.  The immediate container, if any, of a cosmetic product purchased by an enforcement authority shall not have been opened by, on behalf of or at the request of the enforcement authority before the purchase takes place and the container shall not thereafter be opened except in accordance with paragraph 5.3 of Part I of Annex A and paragraph 1.2 of Part II of Annex A.

4.  As soon as an enforcement authority has purchased a cosmetic product, the officer effecting the purchase shall—

(a)either—

(i)place a seal on the product’s container or outer packaging; or

(ii)place the product in a container and forthwith place a seal on that container, in such a way that the product’s immediate container cannot be opened or (in the case of a product which was not in a container when it was purchased) the product cannot be touched without (in either case) the seal being broken in such a manner that it would be apparent thereafter that it had been broken, and

(b)attach to the product a label indicating—

(i)the name of the product,

(ii)the date, time and place at which the product was purchased,

(iii)his own name, and

(iv)the name of the enforcement authority making the purchase.

5.—(1) Subject to sub-paragraph (2) below, the provisions of Part 1 of Annex A, other than paragraphs 3.1, 3.2 and 4, and of Part II of Annex A, other than paragraph 1.4, shall be complied with in the sampling of cosmetic products and the laboratory preparation of test portions.

(2) Where, because of the way in which a cosmetic product is put up for sale, it is not practicable for Part II of Annex A to be complied with, it shall be prepared for testing in accordance with good analytical practice, and the person so preparing it shall record in writing the method of preparation which he has used.

6.—(1) Any test to determine whether a cosmetic product contains a significant amount of free sodium hydroxide or free potassium hydroxide shall be carried out in accordance with paragraphs 1 to 4 of Part III of Annex A.

(2) Any test to determine the amount of free sodium hydroxide or free potassium hydroxide in a hair straightener product or a nail cuticle solvent product shall be carried out in accordance with paragraphs 1, 2, 3 and 5 of Part III of Annex A.

(3) Any test to determine whether a hair-care product contains oxalic acid or any alkaline salt of oxalic acid or to determine the amount of such a substance in a hair-care product shall, subject to the limitation specified in the second sentence of paragraph 1 of Part IV of Annex A, be carried out in accordance with the said Part IV.

(4) Any test to determine the amount of chloroform in toothpaste shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex A, be carried out in accordance with the said Part V.

(5) Any test to determine the amount of zinc chloride, zinc sulphate or zinc 4-hydroxybenzene- sulphonate by virtue of their zinc contents in a cosmetic product shall be carried out in accordance with Part VI of Annex A and Commission Directive 87/143/EEC(36), and shall take into account paragraph 11 of Part VII of Annex A.

(6) Any test to determine whether a cosmetic product contained in an aerosol dispenser or a cream, emulsion, lotion, gel or oil intended to be applied to the skin contains 4-hydroxybenzene-sulphonic acid, or to determine the amount of that acid in such a product, shall be carried out in accordance with Part VII of Annex A.

(7) Any test to determine whether a hair-care product contains persulphate, bromate or hydrogen peroxide shall be carried out in accordance with Part A of Part I of Annex B.

(8) Any test to determine whether a hair-care product contains barium peroxide shall be carried out in accordance with Part B of Part 1 of Annex B.

(9) Any test to determine the amount of hydrogen peroxide in a hair-care product shall be carried out in accordance with Part C of Part I of Annex B.

(10) Any test to determine whether a hair dye contains any of the oxidation colourants specified in paragraph 1 of Part II of Annex B, or to determine the amount of such a substance in a hair-dye, shall be carried out in accordance with the said Part II.

(11) Any test to determine whether a cosmetic product contains nitrite, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part III of Annex B.

(12) Any test to determine whether a cosmetic product contains free formaldehyde, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part IV of Annex B.

(13) Any test to determine the amount of resorcinol in a shampoo or hair lotion shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex B, be carried out in accordance with the said Part V.

(14) Any test to determine the amount of methanol in relation to ethanol or propan-2-ol in a cosmetic product shall be carried out in accordance with Part VI of Annex B.

(15) Any test to determine the amount of dichloromethane or 1,1,1-trichloroethane in a cosmetic product shall be carried out in accordance with paragraphs 1 to 10 of that part of Annex C which is headed “Determination of dichloromethane and 1,1,1-trichloroethane”.

(16) Any test to determine whether a cosmetic product contains quinolin-8-ol or bis(8-hydroxyquinolinium) sulphate, or to determine the amount of such a substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed “Identification and determination of quinolin-8-ol-and bis(8-hydroxyquinolinium) sulphate”.

(17) Any test to determine the amount of ammonia in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of ammonia”.

(18) Any test to determine whether a cosmetic product contains nitromethane, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 7 of that part of Annex C which is headed “Identification and determination of nitromethane”.

(19) Any test to determine whether a hair waving, hair straightening or depilatory product contains mercaptoacetic acid (thioglycolic acid), or to determine the amount of that substance in such a product, shall be carried out in accordance with paragraphs 1 to 6 of that part of Annex C which is headed “Identification and determination of mercaptoacetic acid in hair waving, hair straightening and depilatory products”.

(20) Any test to determine whether a cosmetic product contains hexachlorophene (INN) shall be carried out in accordance with paragraphs 1 to 7 of Part A of that part of Annex C which is headed “Identification and determination of hexachlorophene”.

(21) Any test to determine the amount of hexachlorophene (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of Part B of that part of Annex C which is headed “Identification and determination of hexachlorophene”.

(22) Any test to determine the amount of tosylchloramide sodium (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed “Quantitative determination of tosylchloramide sodium (INN) (chloramine-T)”.

(23) Any test to determine the total amount of fluorine in dental creams shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of total fluorine in dental creams”.

(24) Any test to determine whether a cosmetic product contains organomercury compounds shall be carried out in accordance with paragraphs 1 to 4 of Part A of that part of Annex C which is headed “Identification and determination of organomercury compounds”.

(25) Any test to determine the amount of organomercury compounds in a cosmetic product shall be carried out in accordance with paragraphs 1 to 7 of Part B of that part of Annex C which is headed “Identification and determination of organomercury compounds”.

(26) Any test to determine the amount of alkali sulphides or alkaline earth sulphides in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of alkali and alkaline earth sulphides”.

(27) Any test for the identification and determination of the amount of glycerol 1-(4-aminobenzoate) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of glycerol 1-(4-aminobenzoate)”.

(28) Any test to determine the amount of chlorobutanol (INN) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Determination of chlorobutanol”.

(29) Any test for the identification and determination of the amount of quinine in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of quinine”.

(30) Any test for the identification and determination of inorganic sulphites and hydrogen sulphites in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of inorganic sulphites and hydrogen sulphites”.

(31) Any test for the identification and determination of chlorates of the alkali metals in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of chlorates of the alkali metals”.

(32) Any test for the identification and determination of sodium iodate in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of sodium iodate”.

(33) Any test for the identification and determination of silver nitrate in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of silver nitrate in cosmetic products”.

(34) Any test for the identification and determination of selenium disulphide in anti-dandruff shampoos shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of selenium disulphide in anti-dandruff shampoos”.

(35) Any test for the determination of soluble barium and soluble strontium in pigments in the form of salts or lakes shall be carried out in accordance with that part of Annex E which is headed “Determination of soluble barium and strontium in pigments in the form of salts or lakes”.

(36) Any test for the identification and determination of benzyl alcohol in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of benzyl alcohol in cosmetic products”.

(37) Any test for the identification of zirconium and the determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants shall be carried out in accordance with that part of Annex E which is headed “identification of zirconium, and determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants”.

(38) Any test for the identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine”.

(39) Any test for the identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed “Identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in cosmetic products”.

(40) Any test for the identification and determination of hydroquinone, hydroquinone monomethyl ether, hydroquinone monoethyl ether and hydroquinone monobenzyl ether (monobenzone) in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed “Identification and determination of hydroquinone, hydroquinone monomethyl ether, hydroquinone monoethyl ether and hydroquinone monobenzyl ether in cosmetic products”.

(41) Any test for the identification and determination of 2-phenoxyethanol, 1-phenoxypropan-2-ol, and methyl, ethyl, propyl, butyl and benzyl 4-hydroxybenzoate in a cosmetic product shall be carried out in accordance with Annex G.

Regulation 3(1), 5(7), (9) and (12)

SCHEDULE 12List of Alternative Methods to Animal Testing

PART 1

Part 1 of this Schedule lists the alternative methods validated by the European Centre for the Validation of Alternative Methods (“ECVAM”) which are necessary to meet the requirements of these Regulations and which are listed in Annex V to Council Directive 67/548/EEC of 27th June 1967 on the approximation of laws, regulations and administrative provisions relating to classification, packaging and labelling of dangerous substances (37).

The reference number given in the second column of the table in Part 1 refers to the reference number under which the type of test is listed in Annex V to Directive 67/548/EEC.

PART 2

Part 2 of this Schedule lists the alternative methods validated by ECVAM which are necessary to meet the requirements of these Regulations and which are listed in Annex IX to the Directive. As an alternative method may not replace completely the experimentation on animals, column 3 of the table below specifies whether the alternative method fully or partially replaces the animal test.

Regulation 5(15)

SCHEDULE 13LIST OF SUBSTANCES CLASSIFIED AS CARCINOGENIC, MUTAGENIC OR TOXIC FOR REPRODUCTION OF CATEGORY 3 UNDER DIRECTIVE 67/548/EEC WHICH APPEAR IN THE APPROVED SUPPLY LIST

The substances listed in this table are classified as carcinogenic, mutagenic or toxic for reproduction under directive 67/548/EEC(38) and in the approved supply list. These substances have been evaluated as safe by the Scientific Committee on Cosmetic Products(39) in accordance with article 4b of the Directive and are permitted for use in cosmetic products.

Explanatory Note

(This note is not part of the Order)

These Regulations revoke and re-enact the Cosmetic Products (Safety) Regulations 2003 (S.I. 2003/835) (“the 2003 Regulations”). The 2003 Regulations give effect to Council Directive 76/768/EEC (O.J. No. L262, 27.9.76, p.169) (“the Directive”) on the approximation of the laws of the Member States relating to cosmetic products, as amended by the Community instruments listed in Schedule 2 to these Regulations.

These Regulations also give effect for the first time to Council Directive 2003/15/EC (O.J. L66, 11.3.2003, p.26) which amends Directive 67/548/EEC for the 7th time, as follows:

(a)Prohibit the supply of cosmetic products where the final formulation or ingredients have been tested on animals using a method other than an “alternative method”. The Regulations also introduce an outright prohibition in respect of the supply of cosmetic products after specified dates (2009 and 2013);

(b)Prohibit the testing of “finished cosmetic products” on animals with immediate effect;

(c)Prohibit the testing of ingredients for use in cosmetic products after specified dates;

(d)Introduce provisions governing the use by cosmetic product manufacturers of claims in respect of animal testing;

(e)Prohibit the use in cosmetic products of substances which are classified under directive 67/548/EEC as carcinogenic, mutagenic or toxic to reproduction (and listed in the approved supply list) subject to an exemption in respect of substances which have been evaluated as safe by the Scientific Committee on Cosmetic Products(40);

(f)Requires manufacturers to label products with a symbol (contained in Schedule 9, Part 2) indicating the time after opening after which the product may harm the consumer (this only applies to products with a minimum durability of more than 30 months);

(g)Requires certain perfumes and aromatic compositions to be specifically listed on product packaging;

(h)Requires a specific safety assessment to be undertaken in respect of cosmetic products intended for children or for intimate hygiene;

(i)Inserts further entries into Schedule 4 to these Regulations;

These Regulations also give effect to Council Directive 2003/80/EC (O.J. No. 224, 6.9.2003, p.27) which amends the Directive for the 30th time. Directive 2003/80/EC amends the Directive by inserting a new Annex VIIIa containing a symbol to be used by manufacturers to indicate the time after opening after which the product may harm the consumer (as required by Directive 2003/15/EC).

These Regulations also give effect to Council Directive 2003/83 (O.J. No. L238, 25.9.2003, p.23) which amends the Directive by inserting, deleting or amending entries in Annexes II, III and VI. These Regulations make appropriate amendments to Schedules 3,4 and 6, which implement those Annexes. Directive 2003/83/EC requires Member States to ensure that cosmetic products, which fail to comply with that directive, shall not be placed on the market from 24th March 2005 and that they shall not be supplied to the final consumer from 24th September 2005. Accordingly, regulations 1(3) and 1(4) provide that newly inserted or amended entries in the schedules to the regulations shall not have effect until 24th March 2005. Equally, these regulations provide that certain entries, which are amended or deleted by 2003/83, shall continue to operate in their existing form (i.e. as they appear in the Cosmetic Products (Safety) Regulations 2003) until 24th March 2005. Regulation 16(3) provides that no proceedings or enforcement action shall be taken in respect of the new or amended entries where the cosmetic product in question is placed on the market before 24th March 2005 and is supplied before 24th September 2005.

The Colour Index referred to in these Regulations may be obtained from the Society of Dyers and Colourists and the American Society of Textile Chemists and Colourists by on-line subscription at http://www.colour-index.org/.

A full regulatory impact assessment of the effect that this instrument will have on costs to business is available from the Consumer and Competition Policy Directorate of the Department of Trade and Industry, 1 Victoria Street, London SW1H 0ET. Copies of a transposition note relating to these Regulations have been placed in the libraries of both Houses of Parliament. Copies are also available to the public from the Consumer and Competition Policy Directorate of the Department of Trade and Industry, 1 Victoria Street, London SW1H 0ET.