The Cosmetic Products (Safety) Regulations 2004

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(1) 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(2), 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(3);

“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(4) 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—

(a)

any cosmetic product;

(b)

anything in, on or with which the cosmetic product is supplied;

(c)

the appearance or any other characteristic of the cosmetic product or any such thing; or

(d)

the name or description under which the cosmetic product is supplied;

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

(i)

any person to whom a cosmetic product is supplied in the course of the experiment is informed, at or before the time at which it is supplied to him, that it is supplied for the purpose of a market research experiment; and

(ii)

no consideration in money or money’s worth is given by such a person for the cosmetic product or any other cosmetic product supplied to him for comparison;

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

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

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

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

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

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

General requirements

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(5), 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(6).

(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 (7) 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(8) 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(9) 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(10) 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(11) 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.

Gerry Sutcliffe,

Parliamentary Under Secretary of State for Employment Relations, Competition and Consumers

Department of Trade and Industry

17th August 2004