Source: http://www.legislation.gov.uk/uksi/2004/2152/made
Timestamp: 2013-12-21 20:52:58
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Skip to main contentSkip to navigationlegislation.gov.ukThe National ArchivesHelpSite MapAccessibilityContact UsCymraegHomeAbout UsBrowse LegislationNew LegislationChanges To LegislationSearch LegislationSearch LegislationTitle: (or keywords in the title)Year:Number:Type:All Legislation (excluding draft)All Primary Legislation UK Public General Acts UK Local Acts Acts of the Scottish Parliament Acts of the National Assembly for Wales Measures of the National Assembly for Wales Church Measures Acts of the Northern Ireland Assembly Acts of the Old Scottish Parliament Acts of the English Parliament Acts of the Old Irish Parliament Acts of the Parliament of Great Britain Northern Ireland Orders in Council Measures of the Northern Ireland Assembly Acts of the Northern Ireland ParliamentAll Secondary Legislation UK Statutory Instruments Wales Statutory Instruments Scottish Statutory Instruments Northern Ireland Statutory Rules Church Instruments UK Ministerial Orders UK Statutory Rules and OrdersAll Draft Legislation UK Draft Statutory Instruments Scottish Draft Statutory Instruments Northern Ireland Draft Statutory RulesAll Impact Assessments UK Impact AssessmentsSearchAdvanced SearchThe Cosmetic Products (Safety) Regulations 2004You are here:2004 No. 2152Whole InstrumentTable of ContentsContentExplanatory MemorandumMore ResourcesPreviousNextPlain ViewPrint OptionsWhat VersionLatest available (Revised)Original (As made)Opening OptionsOpen whole InstrumentOpen Instrument without schedulesOpen Schedules onlyMore ResourcesOriginal Print PDFCorrection Slip - 05/12/2008View moreStatus:This is the original version (as it was originally made). This item of legislation is currently only available in its original format.Statutory Instruments2004 No. 2152CONSUMER PROTECTIONThe Cosmetic Products (Safety) Regulations 2004Made17th August 2004Laid before Parliament19th August 2004Coming into forcefor the purpose of regulations 7(2)(c) and 7(9)(b)11th March 2005for all other purposes11th September 2004 Whereas the Secretary of State has, in accordance with section 11(5) of the Consumer Protection Act 1987(1), consulted such organisations as appear to her to be representative of interests substantially affected by these Regulations, such other persons as she considers appropriate and the Health and Safety Commission;
And whereas the Secretary of State is a Minister designated (2) for the purposes of section 2 of the European Communities Act 1972(3) in relation to measures for safety and consumer protection as respects cosmetic products and any provisions concerning the composition, labelling, marketing, classification or description of cosmetic products and in relation to indication of origin on imported goods;
Now, therefore, the Secretary of State in exercise of the powers conferred on her by sections 11, 28 and 30 of the 1987 Act and by section 2(2) of the 1972 Act, hereby makes the following Regulations—
Citation and commencement and transitory provisions1. (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.
(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.
Revocation2. The Cosmetic Products (Safety) Regulations 2003 are hereby revoked.
“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 ;
“the Directive” means Council Directive 76/768/EEC(7) as amended by the Community instruments set out in Schedule 2;
(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;
(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;
General requirements4. (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—
Particular requirements5. (1) The following provisions of this regulation are without prejudice to regulation 4 and are subject to regulation 6.
(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—
(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—
(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—
(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.
(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.
(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.
(b)the ingredient or combination of ingredients is tested after the date given in column 5 of Part 1 or 2 of Schedule 12.
(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.
Authorisation by the Secretary of State6. (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.
Marking7. (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.
(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,
(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,
(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;
(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)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).
Responsible Persons and Competent Authorities8. (1) For the purposes of regulations 9 (except regulation 9(5) and (6)), 10, 11 and 12—
Product Information9. (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—
(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;
(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)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.
(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).
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.
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.
(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.
(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.
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.
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.
(a)to have been committed with the consent and connivance of the partner, or
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.
Enforcement16. (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.
(i)placed on the market before 24th March 2005; and
(ii)supplied before 24th September 2005.
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.
Proceedings18. No proceedings for an offence under these Regulations shall be commenced after—
Gerry Sutcliffe,Parliamentary Under Secretary of State for Employment Relations, Competition and ConsumersDepartment of Trade and Industry17th August 2004Regulations 1(3), 1(4) and 16(3)SCHEDULE 1PART 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.
SubstanceReference number or entry numberSchedule and Part number in the Cosmetic Products (Safety) Regulations 2003Benzoyl peroxide90Schedule 3, Part 1Hydroquinone monobenzyl, monoethyl and monomethyl ethers391Schedule 3, Part 14-Methoxyphenol458Schedule 3, Part 1Secondary dialkanolamines643Schedule 3, Part 1Hydroquinone14Schedule 4, Part 1Fatty acid dialkanolamides60Schedule 4, Part 1Monoalkanolamines61Schedule 4, Part 1Trialkanolamines62Schedule 4, Part 11,2-Dibromo-2,4-dicyanobutane [Methyldibromo glutaronitrile]36Schedule 6, Part 1 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.
SubstanceReference number or entry numberSchedule and Part number in these RegulationsSecondary alkyl- and alkanolamines and their salts643Schedule 3, Part 1Hydroquinone monobenzyl and monoethyl ethers391Schedule 3, Part 1Hydroquinone14Schedule 4, Part 1