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Statutory Instruments

2003 No. 835

CONSUMER PROTECTION

The Cosmetic Products (Safety) Regulations 2003

Made

20th March 2003

Laid before Parliament

24th March 2003

Coming into force (except as provided in regulation 1(2))

15th April 2003

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

1. —

(1) These Regulations may be cited as the Cosmetic Products (Safety) Regulations 2003 and shall come into force on 15th April 2003 other than the provisions referred to in paragraph (2) below.

(2) The following provisions of these Regulations shall come into force on 15th April 2004—

(a) in Schedule 3, substance number 634 in Part I as amended and Part II in its entirety;

(b) in Schedule 4, substance numbers 8, 15b, 15c, 16 and 66 in Part I as amended and Part II in its entirety; and

(c) in Schedule 7, substance numbers 26 and 27 in Part I.

Revocation

2. The Regulations set out in Schedule 1 are hereby revoked, save that they continue to apply to the following substances until 15th April 2004—

(a) substance number 631 in Schedule 1 to the Cosmetic Products (Safety) Regulations 1996( 4 ); and

(b) substance numbers 8, 15b, 15c and 16 in Part I of Schedule 2 to those Regulations( 5 ).

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;

“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 6 ), 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 7 );

“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 8 ) 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 adjusted by the Protocol signed at Brussels on 17th March 1993( 9 );

“market research experiment” means any activities 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;

“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 which is used other than 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;

(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 columns 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 preservative 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 UV filter 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 10 ), 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) No person shall supply a cosmetic product which contains any ingredients or combinations of ingredients which are tested on animals where such testing took place after 30th June 2002 and was undertaken in order that the cosmetic product may satisfy any requirements of these Regulations.

(8) Any reference to testing on animals in the labelling, putting up for sale or advertising of a cosmetic product must state clearly whether the tests carried out involved the cosmetic product itself or its ingredients.

(9) No person shall supply any cosmetic product in respect of which the requirements of paragraph (8) above are not satisfied.

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 cosmetic 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 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 within 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 to so 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 containing a substance listed in column 2 of Schedule 4, the information specified in column 6 of that Schedule in relation to that substance;

(d) 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;

(e) 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;

(f) 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), (c), (d) and (e) above);

(g) 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

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

Provided that the requirements specified in sub-paragraphs (b) and (g) 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, and the month shall precede the year.

(5) The particulars referred to—

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

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

(6) Where it is impossible for practical reasons for the particulars referred to in paragraph (2)(c) to (f) 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 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)(g) above to appear on the container and packaging, the said particulars shall appear 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 (g) above, and in so far as any of the particulars referred to in paragraph (2)(b) to (f) and (h) 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 (g) 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 “flavour”;

(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 found 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” 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( 11 ).

(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 Schedule 9, which must appear on the packaging; and where it is impracticable for reasons of size or 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 container 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)(c) to (f) above shall appear on an enclosed leaflet and an indication shall appear on both the containers and on 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.

Responsible Persons and Competent Authorities

8. —

(1) For the purposes of regulations 9 (except regulation 9(3) and (4)), 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 persons 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 (6) below, where a cosmetic product is manufactured or supplied in the United Kingdom a responsible person shall for control purposes keep readily 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) assessment of the safety for human health of the finished product taking into consideration the general toxicological profile of each ingredient used, its chemical structure and its level of exposure;

(e) the name and address of the person or persons, qualified in accordance with paragraph (3) below, responsible for the assessment referred to in sub-paragraph (d) above;

(f) existing data on undesirable effects on human health resulting from use of the cosmetic product; and

(g) proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product.

(2) The assessment referred to in paragraph (1)(d) above shall be carried out in accordance with the principles of good laboratory practice referred to in Article 1 of Council Directive 12 ) on the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances.

(3) The person referred to in paragraph (1)(e) above must be—

(a) subject to paragraph (4) below, the holder of an appropriate European diploma within the meaning of section 4A of the Pharmacy Act 1954( 13 ) 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 (4) below, a person who is entitled to be registered under section 3(1) of the Medical Act 1983( 14 ) 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( 15 ) 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.

(4) Any diploma or other evidence of qualification required for the purposes of paragraph (3)(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).

(5) 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.

(6) 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.

(7) 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. 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 11, 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 name.

(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 regulation 9, 10 or 11

13. —

(1) Subject to paragraph (2) below, any contravention of a requirement of regulation 9, 10 or 11 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 of contravening any requirement of regulation 9, 10 or 11 shall be liable on summary conviction shall not exceed three months.

Enforcement

14. —

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

(a) any failure to comply with regulations 4, 5, 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 failure to comply with regulations 5(8), 5(9), 7(1), 7(2)(h), 7(5)(a) (in so far as it relates only to regulation 7(2)(h)), 7(5)(b), 7(6), 7(7) or 7(9) to (12) in the case of—

(a) any supply of a cosmetic product before 31st December 1997 by the manufacturer in or importer into the United Kingdom or, in relation to a cosmetic product manufactured or imported into the United Kingdom on behalf of another person, by that other person, except for a supply by retail in which case no proceedings shall be brought and no enforcement action taken in respect of a supply before 31st December 1998; or

(b) any other supply of a cosmetic product before 31st December 1998.

(3) 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.

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

Melanie Johnson,

Parliamentary Under Secretary of State for Competition, Consumers and Markets,

Department of Trade and Industry

20th March 2003

Regulation 2

SCHEDULE 1 REVOCATIONS

(1) (2)
Regulations revoked References
The Cosmetic Products (Safety) Regulations 1996 S.I. 1996/2925
The Cosmetic Products (Safety) (Amendment) Regulations 1997 S.I. 1997/2914
The Cosmetic Products (Safety) (Amendment) Regulations 1998 S.I. 1998/1727
The Cosmetic Products (Safety) (Amendment) Regulations 1999 S.I. 1999/1552
The Cosmetic Products (Safety) (Amendment) Regulations 2000 S.I. 2000/1679
The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2000 S.I. 2000/2765

Regulation 3(1)

SCHEDULE 2 COMMUNITY INSTRUMENTS AMENDING COUNCIL DIRECTIVE 76/768/EEC

1. Council Directive

2. Commission Directive

3. Commission Directive

4. Commission Directive

5. Council Directive

6. Commission Directive

7. Commission Directive

8. Commission Directive

9. Commission Directive

10. Commission Directive

11. Commission Directive

12. Commission Directive

13. Council Directive

14. Commission Directive

15. Council Directive

16. Commission Directive

17. Commission Directive

18. Commission Directive

19. Commission Directive

20. Commission Directive

21. Council Directive

22. Commission Directive

23. Commission Directive

24. Commission Directive

25. Commission Directive

26. Commission Directive

27. Commission Directive

28. Commission Directive

29. Commission Directive

30. Commission Directive

31. Commission Directive

32. Commission Directive

33. Commission Directive

34. Commission Directive

Regulations 5(2) and 6(1)

SCHEDULE 3 LIST 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 numbers given in columns 1, 3 and 4 are for information only. Those in column 3 are cross-references to other names listed for the same substances (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 substance falls). Those in column 4 are cross-references to Annex II of the Directive, from which this Schedule is derived.

PART I SUBSTANCES PROHIBITED WHEN USED OTHER THAN AS A FRAGRANCE INGREDIENT

(1) (2) (3) (4)
Number in this Schedule Name of substance Cross-reference to this Schedule Cross-reference to Annex II of the Directive
1 Acenocoumarol (INN) 397 254
2 Acetonitrile — 393
3 3-(α-Acetonylbenzyl)-4-hydroxycoumarin and its salts 399, 762 203
4 2-Acetoxyethyltrimethylammonium hydroxide and its salts 6 2
5 2-Acetylamino-5-chlorobenzoxazole 163 1
6 Acetylcholine and its salts 4 2
7 Acetylene chlorides 250, 759 126
8 Acetylenic alcohols, their esters, ethers and salts 17 16
9 Acetylethyltetramethyltetralin (AETT) 342 362
10 7α-Acetylthio-3-oxopregn-4-ene-17α,17β-propionolactone 652 4
11 Aconitine and its salts — 12
12 Aconitum napellus L. (leaves, roots and galenical preparations) — 11
13 Adonis vernalis L. and its preparations — 13
14 Adrenaline 270. 315 14
15 Alkali pentacyanonitrosylferrate(2-) 605-6, 647-8, 255
16 O-Alkyldithiocarbonic acids, salts of 763 336
17 Alkyne alcohols, their esters, ethers and salts 8 16
18 Alloclamide (INN) and its salts 22 19
19 Allyl isothiocyanate — 18
20 2-(4-Allyl-2-methoxyphenoxy)- N,N -diethylacetamide and its salts — 224
21 N -Allylnormorphine, its salts and ethers 494 20
22 2-Allyloxy-4-chloro- N -[2-(diethylamino)-ethyl]benzamide and its salts 18 19
23 Alypine and its salts 45, 107 143
24 Ambenonium chloride (INN) (529) 132
25 4-(or p -)Aminobenzoic acid esters — 167
26 2-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts — 29
27 Aminocaproic acid (INN) and its salts 31 7
28 2-Amino-5-chlorobenzoxazole 769 24
29 4-Amino- N -(2-diethylaniaminoethyl)benzamide, its salts and derivatives 610 25
30 Aminoheptane, its isomers and salts 751 25
31 6-Aminohexanoic acid and its salts 27 7
32 α-(Aminomethyl)-3,4-dihydroxybenzyl alcohol and its salts 519-520 257
33 4-Amino- N 10 -methylfolic acid 452 6
34 2-Amino-6-methylheptane and its salts 288, 525 28
35 2-Amino-4-methylhexane and its salts 289, 471 30
36 2-Amino-4-nitrophenol — 383
37 2-Amino-5-nitrophenol — 384
38 4-Amino-2-nitrophenol — 412
39 4-(or p -)Aminosalicylic acid and its salts — 31
40 Aminotoluenes, their isomers, salts and halogenated and sulphonated derivatives 719 32
41 Aminoxylenes, their isomers, salts and halogenated and sulphonated derivatives 765 33
42 Amitriptyline (INN) and its salts 284 146
43 Ammi majus and its galenical preparations — 35
44 Amphetamine (INN), its salts and derivatives and salts of those derivatives (681) 21
45 Amydricaine and its salts 23, 107 143
46 Amylene chloride 251 36
47 Amyl 4-dimethylaminobenzoate, mixed isomers 534 381
48 Amyl nitrites — 247
49 Amylobarbitone and its salts (69) 220
50 Amylocaine and its salts 282 50
51 Anamirta cocculus L. (fruit) — 106
52 Substances with androgenic effect — 37
53 Aniline, its salts and halogenated and sulphonated derivatives — 22
54 Anthracene oil — 38
55 Anti-androgens with steroid structure — 390
56 Antibiotics — 39
57 Antimony and its compounds — 40
58 Apocynum cannabinum L. and its preparations — 41
59 Apomorphine and its salts 697 42
60 Apronalide 420 216
61 Arecoline 482 238
62 Aristolochic acid and its salts — 365
63 Arsenic and its preparations — 43
64 Atropa belladonna L. and its preparations — 44
65 Atropine, its salts and derivatives — 45
66 Azacyclonol (INN) and its salts 305 286
67 Azamethonium bromide (INN) (473) 121
68 Barbitone and its salts (69) 220
69 Barbiturates various 220
70 Barium salts (except barium sulphate, barium sulphide under the condition laid down in Part I of Schedule 4 for alkaline earth sulphides, and lakes, salts and pigments prepared from those colouring agents identified in column 1 of Schedule 5 by “*” immediately after the name or colour index number) — 46
71 Bemegride (INN) and its salts 337, 338 183
72 Benactyzine (INN) 258 157
73 Bendrofluazide and its derivatives 74, 89 53
74 Bendroflumethiazide (INN) and its derivatives 73, 89 53
75 Benzamine and its salts 744 51
76 Benzatropine (INN) and its salts 301 158
77 Benzazepines, their salts and derivatives 88 49
78 Benzene — 47
79 Benzene-1,2-diol 152, 630 408
80 Benzene-1,2,3-triol 631 409
81 2-Benzhydryloxyethyldimethylamine and its salts 296 339
82 Benzidine 243 26
83 Benzilonium bromide (INN) 93 60
84 2-Benziloyloxymethyl-1,1-dimethylpyrrolidinium methyl sulphate 602 239
85 Benzimidazolone 86, 267 48
86 Benzimidazol-2(3 H )-one 85, 267 48
87 Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol (except natural content of essences) 211 357
88 Benzodiazepines, their salts and derivatives 77 49
89 Benzothiadiazine and its derivatives 73, 74 53
90 Benzoyl peroxide — 382
91 3-( N -Benzylhydrazinocarbonyl)-5-methylisoxazole 415 52
92 Benzylideneacetone 567 356
93 3-Benzyloxy-1,1-diethylpyrrolidine hydrobromide 83 60
94 4-Benzyloxyphenol (391), 487 178
95 2-[Benzyl- N -2-pyridyl)amino]-ethyldimethylamine 626, 748 347
96 Bergapten(e) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg (357) 358
97 Beryllium and its compounds — 54
98 Betamethasone (INN) (361) 300
99 Betoxycaine (INN) and its salts 257 23
100 BHC (ISO) ( gamma -BHC) 370, 372, 428 195
101 Bietamiverine (INN) 261 287
102 1,6-Bis(2-chloroethylamino)-1,6-dideoxymannitol and its salts 436 89
103 2-[Bis(2-chloroethyl)amino]-l-oxa-3-aza-2- phosphacyclohexane 2-oxide and its salts 106, 231 88
104 N,N -Bis(2-chloroethyl)methylamine and its salts 159, 492 87
105 N,N -Bis(2-chloroethyl)methylamine N -oxide and its salts 493 86
106 N,N -Bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-ylamine P -oxide and its salts 103, 231 88
107 1,1-Bis(dimethylaminomethyl)propyl benzoate and its salts 23, 45 143
108 Bis(hydroxyalkyl)amines, not further N -substituted 255, 274, 643 411
109 2,2-Bis(hydroxymethyl)butan-l-ol trinitrate 616 206
110 2,6-Bis(β-hydroxyphenethyl)-1-methylpiperidine and its salts 430 219
111 3,3-Bis(4-hydroxyphenyl)phthalide 560 417
112 Bis(8-hydroxyquinolinium) sulphate, except for the uses provided for in entry number 51 in Part 1 of Schedule 4 (401, 533) 395
113 Bithionol (INN) 708 352
114 Bretylium tosilate (INN) (Bretylium tosylate) 117 56
115 Bromine, elemental — 55
116 Bromisoval (INN) 119 58
117

p -Bromobenzylethyldimethylammonium

p -toluenesulphonate

114

56

118 2-Bromo-2-ethylbutyrylurea 148 57
119 2-Bromo-3-methylbutylrylurea 116 58
120 1- p -Bromophenyl-l-(2-pyridyl)-3-dimethylaminopropane and its salts 121 59
121 Brompheniramine (INN) and its salts 120 59
122 Brucine — 62
123 Butanilicaine (INN) and its salts 466 90
124 Butobarbitone and its salts (69) 220
125 Butopiprine (INN) and its salts 127 288
126 2-Butoxy- N -(2-diethylaminoethyl)-cinchoninamide and its salts 190 129
127 2-Butoxyethyl phenyl(piperidino)acetate and its salts 125 288
128 1-Butyl-3-( N -crotonoylsulphanilyl)urea — 108
129 4-Butyl-1,2-diphenylpyrazolidine-3,5-dione 566 67
130 4- tert -Butyl-3-methoxy-2,6-dinitrotoluene 490 414
131 4-Butyl-1-phenylpyrazolidine-3,5-dione 486 64
132 1-Butyl-3-( p -methylbenzenesulphonyl)urea 718 65
133 1-Butyl-3-sulphanilylurea 149 66
134 4-Butylthiobenzhydryl 2-(dimethylamino)ethyl sulphide 142 140
135 1- tert -Butyl-3,4,5-trimethyl-2,6-dinitrobenzene 491 422
136 Cadmium and its compounds — 68
137 Calabar bean 588 281
138 Calciferol 317, (761) 335
139 Cantharides, Cantharis vesicatoria 650 69
140 Cantharidin 379 70
141 Captan (ISO) 737 370
142 Captodiame (INN) 134 140
143 Caramiphen (INN) and its salts 570 169
144 N -(3-Carbamoyl-3,3-diphenylpropyl)- N,N - diisopropylmethylammonium salts 419 156
145 Carbazole, nitroderivatives of 510 72
146 Carbon disulphide — 73
147 Carbon tetrachloride 693 315
148 Carbromal (INN) 118 57
149 Carbutamide (INN) 133 66
150 Carisoprodol (INN) 480 235
151 Catalase — 74
152 Catechol 79, 630 408
153 Cells, tissues or products of human origin — 416
154 Cephaeline and its salts — 75
155 Chenopodium ambrosioides (essential oil) — 76
156 Cherry laurel water 621 291
157 Chloral hydrate 735 77
158 Chlorine — 78
159 Chlormethine (INN) and its salts 104, 492 87
160 Chlormezanone (INN) 174 91
161 4-Chlorobenzene-1,3-disulfonamide 193 85
162 5-Chloro-1,3-benzoxazol-2(3 H )-one 185 82
163 N -5-Chlorobenzoxazol-2-ylacetamide 5 1
164 2-Chloro-4-dimethylamino-6-methylpyrimidine 168, 216, 83
165 2-Chloro-9-[3-(dimethylamino)-propylidene]thioxanthene ( cis -form) and its salts 182 84
166 Chloroethane 328 96
167 Chloroform 736 366
168 2-Chloro-6-methylpyrimidin-4-yldimethylamine 164, 216 83
169 Chlorophacinone (ISO) 175 93
170 1-( p -Chloro--phenylbenzyl)-4-(2-hydroxyethoxyethyl)piperazine 402 240
171 2-(4-Chlorophenyl)-1-[4-(2-diethyl aminoethoxyl)] phenyl-1- p -tolylethanol 747 92
172 4-[4-(4-Chlorophenyl)-4-hydroxypiperidin-l-yl]-1-(4-fluorophenyl)butan-1-one 369 185
173 2-(4-Chlorophenyl)-3-methylbutane-2,3-diol 554 95
174 2-(4-Chlorophenyl-3-methyl-1,3-thiazinan-4-one1,1-dioxide 160 91
175 2[2-(4-Chlorophenyl)-2-phenylacetyl]indane-1,3-dione 169 93
176 2-[1-(4-Chlorophenyl)-1-phenylethoxy]ethyl- (dimethyl)amine 179 94
177 Chloropicrin 738 325
178 3-(4-Chloro-3-sulphamoylphenyl)-3- hydroxyisoindolin-1-one 183, 184 262
179 Chlorphenoxamine (INN) 176 94
180 Chlorpromazine (INN) (561) 320
181 Chlorpropamide (INN) 617 79
182 Chlorprothixene (INN) and its salts 165 84
183 Chlortalidone (INN) 178, 184 262
184 Chlorthalidone 178, 184 262
185 Chlorzoxazone (INN) 162 82
186 Cholecalciferol (761) 335
187 Choline salts and their esters — 168
188 Chromium, chromic acid and salts of the acid — 97
189 Chrysoidine citrate hydrochloride 565 81
190 Cinchocaine (INN) and its salts 126 129
191 Cincophen (INN), its salts and derivatives and salts of those derivatives 580 8
192 Claviceps purpurea Tul ., its alkaloids and galenical preparations 318 98
193 Clofenamide (INN) 161 85
194 Clofenotane (INN) 734 123
195 Coal tar, crude and refined 218 420
196 Cobalt benzenesulphonate — 101
197 Cocculin 592 282
198 Colchicine, its salts and derivatives — 102
199 Colchicoside and its derivatives — 103
200 Colchicum autumnale L. and its galenical preparations — 104
201 Colouring agent CI 12075 and its lakes, pigments and salts — 397
202 Colouring agent CI 12140 — 378
203 Colouring agent CI 13065 — 387
204 Colouring agent CI 15585 — 401
205 Colouring agent CI 26105 — 379
206 Colouring agent CI 42535 — 388
207 Colouring agents CI 42555, 42555:1 and 42555:2 — 380
208 Colouring agent CI 42640 — 386
209 Colouring agent CI 45170 and CI 45170:1 — 398
210 Colouring agent CI 61554 — 389
211 Coniferyl benzoate (except natural content of essences) 87 357
212 Coniine 618 290
213 Conium maculatum L. (fruit, powder, galenical prep- parations) — 99
214 Convallatoxin — 105
215 Coumetarol (INN) 454 225
216 Crimidine (ISO) 164, 168 83
217 Croton tiglium (oil) — 107
218 Crude and refined coal tars 195 420
219 Curare and curarine — 109
220 Curarizants, synthetic — 110
221 1-(3-Cyano-3,3-diphenylpropyl)-4-ethoxycarbonyl-4-phenylpiperidinium chloride 297 80
222 Cyclarbamate (INN) 230 122
223 Cyclizine (INN) and its salts 302 159
224 Cyclobarbitone and its salts (69) 220
225 Cyclocoumarol 268 234
226 2-α-Cyclohexylbenzyl( N,N,N',N' -tetraethyl)trimethylenediamine 555 112
227 2-Cyclohexyl-3,5-dimethylphenol and its salts 229 113
228 Cyclohexyl-3-( p -methylbenzenesulphonyl)urea 364 100
229 Cyclomenol (INN) and its salts 227 113
230 Cyclopentane-1,1-dimethanol dicarbanilate 222 122
231 Cyclophosphamide (INN) and its salts 103, 106 88
232 Datura stramonium L. and its galenical preparations 54 301
233 DDT (ISO) ( pp '-DDT) 194, 734 123
234 Deanol aceglumate (INN) 279 3
235 Decamethonium bromide (INN) (236) 214
236 Decamethylenebis(trimethylammonium) salts 235 214
237 Dextromethorphan (INN) and its salts 457 226
238 Dextropropoxyphene (INN) 281 116
239 O, O '-Diacetyl- N -allyl- N -normorphine — 117
240 2,4-Diaminoanisole and its salts 455, 461 376
241 2,5-Diaminoanisole and its salts 456, 460 377
242 1,2-Diaminobenzene and its salts 573 363
243 p,p '-Diaminodiphenyl 82 26
244 2-(2,4-Diaminophenyl)ethanol and its salts — 407
245 1,4:3,6-Dianhydrosorbitol 2,5-dinitrate 422 148
246 5-(α,B-Dibromophenethyl)-5-methylhydantoin — 119
247 Dibromosalicylanilides 248, 443 351
248 Dibromsalan (INN) (247) 351
249 Dichloroethanes 330, 335 125
250 Dichloroethylenes 7, 759 126
251 2,3-Dichloro-2-methylbutane 46 36
252 Dichlorosalicylanilides — 349
253 Dicoumarin 254, 469 231
254 Dicoumarol (INN) 253, 469 231
255 Diethanolamine (108, 643) 411
256 2-(Diethylaminoethoxy)ethylα-phenylpiperidine-1-acetate dimethiodide 601 137
257 2-Diethylaminoethyl 3-amino-4-butoxybenzoate and its salts 99 23
258 2-Diethylaminoethyl benzilate 72 157
259 2-Diethylaminoethyl 4-ethoxybenzoate and its salts 411, 538 179
260 2-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts — 128
261 2-Diethylaminoethyl phenyl(piperidino)acetate 101 287
262 3-Diethylaminopropyl cinnamate — 130
263 Diethyl 4-nitrophenyl phosphate 536 170
264 O,O -Diethyl O-4-nitrophenyl phosphorothioate 537 131
265 Difencloxazine (INN) 569 270
266 Digitaline and all heterosides of Digitalis purpurea L. — 134
267 4.5-Dihydrobenzimidazol-4-one 85, 86 48
268 3,4-Dihydro-2-methoxy-2-methyl-4-phenyl- 2H,5H -pyrano[3,2- c ]-[1]-benzopyran-5-one 225 234
269 Dihydrotachysterol (INN) — 342
270 3,4-Dihydroxy-α-(methylaminomethyl)benzyl alcohol 14, 315 14
271 4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene)dicoumarin — 207
272 1-(3,4-Dihydroxyphenyl)-2-ethylaminopropan-l-ol and its salts 294 136
273 1-(3,4-Dihydroxyphenyl)-2-isopropylaminoethanol 418, 421 17
274 Diisopropanolamine (108, 643) 411
275 5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite 413 361
276 Dimethoxane 286 368
277 4-[2-(3,4-Dimethoxyphenyl)ethyl]-1-(2-chlorophenyl)piperazine and its salts 438 141
278 Dimethylamine — 142
279 2-Dimethylaminoethyl N -acetylglutamate 234 3
280 2-Dimethylaminoethyl p -butylaminobenzoate and its salts 690 63
281 (+)-4-Dimethylamino-3-methyl-1,2-diphenyl-2-propionyloxybutane 238 116
282 1-Dimethylaminomethyl-1-methylpropyl benzoate and its salts 50 50
283 2-Dimethylaminopropiophenone and its salts 445 145
284 3-(3-Dimethylaminopropylidene)-1,2:4,5-dibenzocyclohepta-1,4-diene and its salts 42 146
285 1,1-Dimethylbiguanide and its salts 447 147
286 2,6-Dimethyl-1,3-dioxan-4-yl acetate 276 368
287 Dimethylformamide — 355
288 1,5-Dimethylhexylamine and its salts 34, 525 28
289 1,3-Dimethylpentylamine and its salts 35, 471 30
290 Dimethyl sulfoxide (INN) — 338
291 Dimevamide (INN) and its salts 298 153
292 Dinitrophenol isomers — 151
293 Dioxane — 343
294 Dioxethedrin (INN) and its salts 272 136
295 2,5-Dioxo-3,3-diethyl-5-methylpiperidine and its salts 483 133
296 Diphenhydramine (INN) and its salts 81 339
297 Diphenoxylate hydrochloride (INNM) 221 80
298 2,2-Diphenyl-4-dimethylaminovaleramide and its salts 291 153
299 5,5-Diphenyl-4-imidazolidone — 160
300 4-Diphenylmethoxy-1-methylpiperidine and its salts 306 154
301 3-Diphenylmethoxytropane and its salts 76 158
302 1-Diphenylmethyl-4-methylpiperazine and its salts 223 159
303 1,2-Diphenyl-4-(2-phenylsulphinylethyl)-pyrazolidine-3,5-dione 664 155
304 α,α-Diphenyl-2-piperidinemethanol and its salts 600 285
305 α,α-Diphenyl-4-piperidinemethanol and its salts 66 286
306 Diphenylpyraline (INN) and its salts 300 154
307 2,5-Dipropoxy-3,6-bis(ethyleneimino)-1,4- benzoquinone 410 152
308 4-Dipropylsulphamoylbenzoic acid 609 161
309 Disulfiram (INN) 702, 713 162
310 Dithio-2,2'-bis(pyridine 1-oxide) 1,1' (additive with trihydrated magnesium sulphate) 628 396
311 Doxylamine (INN) and its salts 579 176
312 Emetine, its salts and derivatives — 163
313 Endrin (ISO) 373 196
314 Ephedrine and its salts — 164
315 Epinephrine (INN) 14, 270 14
316 1,2-Epoxybutane — 400
317 Ergocalciferol (INN) 138 (761) 335
318 Ergot and its alkaloids 192 98
319 Eserine and its salts 589 166
320 Ethionamide (INN) 336 319
321 Ethoheptazine (INN) and its salts 476 173
322 Ethopropazine and its salts (561) 320
323 4-Ethoxyphenol (391) 178
324 4-Ethoxy- m -phenylenediamine and its salts — 406
325 2-Ethylamino-5-phenyloxazolin-4-one 345 180
326 Ethyl bis(4-hydroxycoumarinyl)acetate and salts of the acid 327 204
327 Ethyl bis(4-hydroxy-2-oxo-l-benzopyran-3-yl)acetate and salts of the acid 326 204
328 Ethyl chloride 166 96
329 Ethyl 1,3-dimethyl-4-phenylazepane-4-carboxylate and its salts 446 171
330 Ethylene dichloride (249) 125
331 Ethylene oxide — 182
332 2-Ethyl-2,3-epoxyhexamide and its derivatives 530 165
333 Ethyl p -fluorophenyl sulphone 348 189
334 Ethyl 1-(2-hydroxy-2-phenylethyl)-4- phenylpiperidine-4-carboxylate and its salts 532 172
335 Ethylidene dichloride (249) 125
336 3-Ethylisothionicotinamide 320 319
337 3-Ethyl-3-methylglutarimide and its salts 71, 338 183
338 4-Ethyl-4-methylpiperidine-2,6-dione and its salts 71, 337 183
339 2-Ethyl-3-methylvaleramide 755 184
340 Ethylphenacemide 556, 568 272
341 2-Ethyl-2-phenylglutarimide and its salts 362 181
342 3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone 9 362
343 Ethyl urocanate (406) 418
344 Fenadiazole (INN) 528 208
345 Fenozolone (INN) 325 180
346 Fenyramidol (INN) 578, 582 274
347 Fluanisone (INN) 351 187
348 Fluoresone (INN) 333 189
349 4'-Fluoro-4-[4-hydroxy-4-(α,α,α-trifluoro- m - tolyl)piperino]butyrophenone 741 188
350 6-Fluoro-16-methyl-11β,17,21-trihydroxypregna-1,4-diene-3,20-dione 535 186
351 1- (4-Fluorophenyl)-4-[4-(2-methoxyphenyl)-1- piperazinyl]butan-1-one 347 187
352 5-Fluoropyrimidine-2,4-dione 353 190
353 Fluorouracil (INN) 352 190
354 Fluphenazine (INN) (561) 320
355 Furazolidone (INN) 513 252
356 Furfuryltrimethylammonium salts 358 192
357 Furocoumarins (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg 96, 462, 623, 746 358
358 Furtrethonium iodide (INN) (356) 192
359 Galantamine (INN) — 193
360 Gallamine triethiodide (INN) 518 329
361 Glucocorticoids 98 300
362 Glutethimide (INN) and its salts 341 181
363 Glycerol trinitrate 514, 615 253
364 Glycyclamide (INN) 228 100
365 Gold salts — 296
366 Guaifenesin (INN) 459 230
367 Guanethidine (INN) and its salts 368 259
368 N -(2-Guanidinoethyl)azocane and its salts 367 259
369 Haloperidol (INN) 172 185
370 HCH (ISO) ( gamma -HCH) 100, 372, 428 195
371 HETP 378 316
372 1,2,3,4,5,6-Hexachlorocyclohexane 100, 370, 428 195
373 (1 R ,4 S ,5 R ,8S)-1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4:5,8 dimethanonaphthalene 313 196
374 Hexachloroethane — 197
375 3,3',4,4',6,6'-Hexachloro-2,2'-methylenediphenol 376 371
376 Hexachlorophene (INN) 375 371
377 (1 R ,4 S ,5 R ,8 S )-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethanonaphthalene 416 198
378 Hexaethyl tetraphosphate 371 316
379 (1 R ,2 S )-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride 140 70
380 (3S,5aR,9bS)-3,3a,4,5,5a,9b-Hexahydro-3,5a,9-trimethylnaphtho[1,2- b ]furan-2,8dione 639 217
381 Hexamethonium bromide (INN) (382) 124
382 N-N '-Hexamethylenebis(trimethylammonium) salts 381 124
383 Hexapropymate (INN) 619 115
384 Hydrastine, hydrastinine and their salts — 199
385 Hydrazides and their salts — 200
386 Hydrazine, its derivatives and their salts — 201
387 2-Hydrazino-octane and its salts 523 202
388 Hydrocyanic acid and its salts 390, 409, 604 111
389 Hydrofluoric acid, its normal salts, complexes and hydrofluorides (except those listed in Part I of Schedule 4) — 191
390 Hydrogen cyanide and its salts 388, 409, 604 111
391 Hydroquinone monobenzyl, monoethyl and monomethyl ethers 487 178
392 7-[2-Hydroxy-3-(2-hydroxyethyl- N - methylamino)propyl]theophylline 764 135
393 [4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl] acetic acid and its salts 742 5
394 3-[4-(4-Hydroxy-3-iodophenoxy)-3,5- diiodophenyl]propionic acid and its salts 716 9
395 2-Hydroxy-3-(2-methoxyphenyl)propyl carbamate 450 205
396 1-Hydroxymethyl-l-cyclohexylacetic acid, sodium salt 646 114
397 4-Hydroxy-3-[1-(4-nitrophenyl)-3-oxobutyl]coumarin 1 254
398 8-Hydroxy-5-nitroquinoline and its salts 517 209
399 4-Hydroxy-3-(3-oxo-l-phenylbutyl)coumarin and its salts 3, 762 203
400 11 a -Hydroxypregn-4-ene-3,20-dione and its esters — 385
401 Hydroxy-8-quinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 4 112, 533, 633 395
402 Hydroxyzine (INN) 170 240
403 Hyoscine, its salts and derivatives 641 295
404 Hyoscyamine, its salts and derivatives — 210
405 Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations) — 211
406 3-Imidazol-4-ylacrylic acid and its ethyl ester 343, 753 418
407 2-Imino-5-phenyloxazolidin-4-one and its salts 540 212
408 Imperatorin 465 34
409 Inorganic cyanides (388, 390), 604 111
410 Inproquone (INN) 307 152
411 Intracaine and its salts 259, 538 179
412 Iodine — 213
413 Iodothymol 275 361
414 Ipecacuanha ( Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations) — 215
415 Isocarboxazid (INN) 91 52
416 Isodrin 377 198
417 Isometheptene (INN) and its salts 463 228
418 Isoprenaline (INN) 273, 421 17
419 Isopropamide iodide (INN) (144) 156
420 (2-Isopropylpent-4-enoyl)urea 60 216
421 Isoproterenol 273, 418 17
422 Isosorbide dinitrate (INN) 245 148
423 Juniperus sabina L. (leaves, essential oil and galenical preparations) — 294
424 Laurus nobilis L . (oil from seeds) — 359
425 Lead and its compounds (except lead acetate subject to the restrictions laid down in entry number 55 in Part I of Schedule 4) — 289
426 Levophacetoperane and its salts 597 284
427 Lidocaine (INN) (Lignocaine) — 399
428 Lindane 100, 370, 372 195
429 Lobelia inflata L. and its galenical preparations — 218
430 Lobeline (INN) and its salts 110 219
431 LSD (433, 434) 127
432 Lupinidine and its salts 651 299
433 Lysergic acid diethylamide and its salts 431, 434 127
434 Lysergide (INN) and its salts 431, 433 127
435 Malononitrile — 149
436 Mannomustine (INN) and its salts 102 89
437 Mecamylamine (INN) 701 229
438 Mefeclorazine (INN) and its salts 277 141
439 Mephenesin (INN) and its esters 721 322
440 Meprobamate (INN) 481 236
441 Mercury and its compounds (except those listed in Part I of Schedule 6) — 221
442 Mescaline and its salts 743 222
443 Metabromsalan (INN) (247) 351
444 Metaldehyde 603 223
445 Metamfepramone (INN) and its salts 283 145
446 Metethoheptazine (INN) and its salts 329 171
447 Metformin (INN) and its salts 285 147
448 Methapyrilene (INN) and its salts 627 144
449 Metheptazine (INN) and its salts 468 174
450 Methocarbamol (INN) 395 205
451 Methohexitone and its salts (69) 220
452 Methotrexate (INN) 33 6
453 2-[4-Methoxybenzyl- N -(2-pyridyl)amino]- ethyldimethylamine maleate 625 346
454 1-Methoxy-2,2-bis(4-hydroxy-3-coumarinyl)ethane 215 225
455 1-Methoxy-2,4-diaminobenzene and its salts 240, 461 376
456 1-Methoxy-2,5-diaminobenzene and its salts 241, 460 377
457 (+)-3-Methoxy- N -methylmorphinan and its salts 237 226
458 4-Methoxyphenol (391) 178
459 3-(2-Methoxyphenoxy)propane-1,2-diol 366 230
460 2-Methoxy- p -phenylenediamine and its salts 241, 456 377
461 4-Methoxy- m -phenylenediamine and its salts 240, 455 376
462 Methoxypsoralens (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg (357) 358
463 6-Methylamino-2-methylhept-2-ene and its salts 417 228
464 2-Methyl-1,2-bis(3-pyridyl)propan-1-one 484 292
465 9-(3-Methylbut-2-enyloxy)furo-[3,2- g ]chromen-7-one 408 34
466 2-Methyl-6-chloroanilide of n-butylaminoacetic acid and its salts 123 90
467 1-Methyl-2,4-diaminobenzene and its salts 477 364
468 Methyl 1,2-dimethyl-4-phenylazepane-4-carboxylate and its salts 449 174
469 3,3-Methylenebis-(4-hydroxycoumarin) 253, 254 231
470 2-Methylheptylamine and its salts — 227
471 4-Methyl-2-hexylamine and its salts 35, 289 30
472 1-Methylimidazole-2-thiol 474, 707 233
473 N-N '-[(Methylimino)diethylene] bis- (ethyldimethylammonium) salts 67 121
474 1-Methyl-2-mercaptoimidazole 472, 707 233
475 Methylphenidate (INN) and its salts 575 175
476 1-Methyl-4-phenyl-4-carbethoxyhexa-methyleneimine and its salts 321 173
477 4-Methyl- m -phenylenediamine and its salts 467 364
478 2-Methyl- m -phenylenediamine — 413
479 3-Methyl-2-phenylmorpholine, its derivatives and salts 558 232
480 2-Methyl-2-propyl-1-isopropylcarbamoyloxy-3-carbamoyloxypropane 150 235
481 2-Methyl-2-propyltrimethylene dicarbamate 440 236
482 N -Methyl-1,2,5,6-tetrahydro-3-nicotinic acid methyl ester 61 238
483 Methyprylon (INN) and its salts 295 133
484 Metyrapone (INN) 464 292
485 Minoxidil (INN), its salts and derivatives 599 372
486 Mofebutazone (INN) 131 64
487 Monobenzone (INN) 94, (391) 178
488 Morpholine and its salts — 344
489 Moskene 546 421
490 Musk ambrette 130 414
491 Musk tibetene 135 422
492 Mustine and its salts 104, 159 87
493 Mustine N -oxide and its salts 105 86
494 Nalorphine (INN), its salts and ethers 21 20
495 Naphazoline (INN) and its salts 501 244
496 2-Naphthol 497 241
497 β-Naphthol 496 241
498 1- and 2-Naphthylamines and their salts 499 242
499 α- and β-Naphthylamines and their salts 498 242
500 3-(1-Naphthyl)-4-hydroxycoumarin — 243
501 2-(1-Naphthylmethyl)-2-imidazoline and its salts 495 244
502 Narcotics, natural and synthetic: All substances listed in Tables I and II of the Single Convention on Narcotic Drugs 1961 (Treaty Series No. 34 (1965), Cmnd. 2631) — 306
503 Narcotine and its salts 521 258
504 Neodymium and its salts — 309
505 Neostigmine and its salts — 245
506 Nicotine and its salts — 246
507 Nitrites, inorganic (except sodium nitrite) — 248
508 Nitrobenzene — 249
509 Nitrocresols and their alkali metal salts — 250
510 Nitroderivatives of carbazole 145 72
511 Nitrofurantoin (INN) 512 251
512 N -(5-Nitro-2-furfurylidene)-1-aminohydantoin 511 251
513 3-(5-Nitrofurfurylideneamino)oxazolidin-2-one 355 252
514 Nitroglycerine 363, 615 253
515 Nitrosamines — 410
516 Nitrostilbenes, their homologues and derivatives — 256
517 Nitroxoline (INN) and its salts 398 209
518 N,N,N,N',N',N',N",N",N" -Nonaethyl-2,2',2"-(benzene- 1,2,3-triyltrioxy)-tris(ethanaminium) triiodide 360 329
519 Noradrenaline and its salts 32, 520 257
520 Norepinephrine (INN) and its salts 32, 519 257
521 Noscapine (INN) and its salts 503 258
522 Nux vomica and its preparations (661) 305
523 Octamoxin (INN) and its salts 387 202
524 Octamylamine (INN) and its salts — 267
525 Octodrine (INN) and its salts 34, 288 28
526 Oestrogens — 260
527 Oleandrin — 261
528 2-(1,3,4-Oxadiazol-2-yl)phenol 344 208
529 [Oxalylbis(iminoethylene)]bis[( o -chlorobenzyl)diethylammonium] salts 24 132
530 Oxanamide (INN) and its derivatives 332 165
531 2-Oxo-3-isobutyl-9,10-dimethoxy-1,2,3,4,6,7-hexahydro-1lb H -benzo[α]quinolizine and its salts 688 139
532 Oxpheneridine (INN) and its salts 334 172
533 Oxyquinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 4 112, 401, 633 395
534 Padimate A 47 381
535 Paramethasone (INN) 350 186
536 Paraoxon 263 170
537 Parathion (ISO) 264 131
538 Parethoxycaine (INN) and its salts 259, 411 179
539 Pelletierine and its salts 598 263
540 Pemoline (INN) and its salts 407 212
541 Pentachloroethane — 264
542 Pentaerythritol chloral 552 266
543 Pentaerythritol tetranitrate 544, 551 265
544 Pentaerythrityl tetranitrate (INN) 543, 551 265
545 Pentamethonium bromide (INN) (547) 120
546 1,1,3,3,5-Pentamethyl-4,6-dinitroindane 489 421
547 N,N '-Pentamethylenebis(trimethyl-ammonium) salts 545 120
548 Pentobarbitone and its salts (69) 220
549 Perchloroethylene 692 314
550 Perphenazine (INN) and its salts (561) 320
551 PETN 543, 544 265
552 Petrichloral (INN) 542 266
553 Phenacemide (INN) 564 269
554 Phenaglycodol (INN) 173 95
555 Phenetamine 226 112
556 Pheneturide (INN) 340, 568 272
557 Phenindone (INN) 574 271
558 Phenmetrazine (INN), its derivatives and salts 479 232
559 Phenobarbitone and its salts (69) 220
560 Phenolphthalein (INN) 111 417
561 Phenothiazine (INN) and its compounds various 320
562 Phenprobamate (INN) 576 71
563 Phenprocoumon (INN) 577 273
564 N -Phenylacetylurea 553 269
565 4-Phenylazophenylene-1,3-diamine citrate hydrochloride 189 81
566 Phenylbutazone (INN) 129 67
567 4-Phenylbut-3-en-2-one 92 356
568 (2-Phenylbutyryl)urea 340, 556 272
569 N-[2-(α-Phenyl- p -chlorobenzyl)-ethyl]morpholine 265 270
570 1-Phenylcyclopentanecarboxylic acid diethylaminoethyl ester and its salts 143 169
571 2-Phenylcyclopropylamine ( trans -form) and its salts 722 324
572 1-Phenyl-2,3-dimethyl-4-isopropylpyrazol-5-one 620 138
573 o -Phenylenediamine and its salts 242 363
574 2-Phenylindan-1,3-dione 557 271
575 α-Phenyl-2-piperidineacetic acid methyl ester and its salts 475 175
576 3-Phenylpropyl carbamate 562 71
577 3-(α-Phenylpropyl)-4-hydroxycoumarin 563 273
578 1-Phenyl-2-(2-pyridylamino)ethanol 346, 582 274
579 2-[1-Phenyl-1-(2-pyridyl)ethoxy]-ethyldimethylamine and its salts 311 176
580 2-Phenylquinoline-4-carboxylic acid, its salts and derivatives and salts of those derivatives 191 8
581 6-Phenyl-2,4,7-triaminopteridine and its salts 725 275
582 Phenyramidol 346, 578 274
583 Phosphides, metal — 279
584 Phosphorus — 279
585 4-Phosphoryloxy- N,N -dimethyltryptamine 622 278
586 3-Phthalimidopiperidine-2,6-dione and its salts 704 280
587 Phthalylsulphathiazole (INN) and its salts (678) 307
588 Physostigma veneriosum Balf . 137 281
589 Physostigmine and its salts 319 166
590 Phytolacca spp and their preparations — 374
591 Picric acid 745 268
592 Picrotoxin 197 282
593 Pilocarpine and its salts — 283
594 Pilocarpus jaborandi Holmes and its galenical pre-parations — 311
595 Pipazetate (INN) and its salts 596 118
596 2-(2-Piperidinoethoxy)ethyl 10-thia-1, 9-diazaanthracene-9-carboxylate and its salts 595 118
597 α-Piperidin-2-ylbenzyl acetate, laevorotatory threo -form and its salts 426 284
598 1-(2-Piperidyl)propan-2-one and its salts 539 263
599 6-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide, its salts and derivatives 485 372
600 Pipradrol (INN) and its salts 304 285
601 Piprocurarium iodide (INN) 256 137
602 Poldine metilsulfate (INN) (Poldine methylsulphate) 84 239
603 Polyacetaldehyde 444 223
604 Potassium cyanide (388, 390, 409) 111
605 Potassium nitroferricyanide (15), 606 255
606 Potassium nitroprusside (15), 605 255
607 Pramocaine (INN) 608 405
608 Pramoxine 607 405
609 Probenecid (INN) 308 161
610 Procainamide (INN) its salts and derivatives 29 25
611 Prochlorperazine (INN) and its salts (561) 320
612 Progestogens — 194
613 Promazine (INN) and its salts (561) 320
614 Promethazine (INN) and its salts (561) 320
615 Propane-1'2,3-triyl trinitrate 363, 514 253
616 Propatylnitrate (INN) 109 206
617 1-Propyl-3-(4-chlorobenzenesulphonyl)urea 181 79
618 2-Propylpiperidine 212 290
619 1-(2-Propynyl)cyclohexyl carbamate 383 115
620 Propyphenazone (INN) 572 138
621 Prunus laurocerasus L. 156 291
622 Psilocybine (INN) 585 278
623 Psoralen (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg (357) 358
624 Pyrethrum album L. and its galenical preparations — 345
625 Pyrianisamine maleate 453 346
626 Pyribenzamine 95, 748 347
627 2-( N -2-Pyridyl- N -2-thienylamino)ethyl-dimethylamine and its salts 448 144
628 Pyrithione disulphide+magnesium sulphate 310 396
629 Pyrithione sodium (INNM) — 369
630 Pyrocatechol 79, 152 408
631 Pyrogallol 80 409
632 Quinalbarbitone and its salts (69) 220
633 Quinolin-8-ol except for the uses provided for in entry number 51 in Part I of Schedule 4 (401, 533) 395
634 Radioactive substances (within the meaning of Article 1 of Council Directive 96/29/Euratom( 16 ) laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation) — 293
635 Rauwolfia serpentina alkaloids and their salts 636 15
636 Reserpine (INN) and its salts (635) 15
637 Retinoic acid and its salts 724, 760 375
638

Safrole (except natural content of essences in cases where the concentration of such safrole in the cosmetic product does not exceed—

(a)

in the case of oral hygiene or dental products other than toothpaste intended specifically for children, 50 mg/kg; or

(b)

in the case of products other than oral hygiene or dental products, 100 mg/kg)

— 360
639 α-Santonin 380 214
640 Schoenocaulon officinale Lind. (seeds and galenical preparations) — 332
641 Scopolamine, its salts and derivatives 403 295
642 Secbutobarbitone and its salts (69) 220
643 Secondary dialkanolamines 108, 255, 274 411
644 Selenium and its compounds (except when permitted under the restrictions laid down in Part I of Schedule 4) — 297
645 Sodium cyanide (388, 390, 409) 111
646 Sodium hexacyclonate (INN) 396 114
647 Sodium nitroferricyanide (15), 648 255
648 Sodium nitroprusside (15), 647 255
649 Solanum nigrum L. and its galenical preparations — 298
650 Spanish Fly 139 69
651 Sparteine (INN) and its salts 432 299
652 Spironolactone (INN) 10 4
653 Squill and its preparations 752 330
654 Stramonium and its preparations 232 301
655 Strontium lactate — 402
656 Strontium nitrate — 403
657 Strontium polycarboxylate — 404
658 Strophanthines and their aglucones and their respective derivatives — 302
659 Strophanthus species and their galenical preparations — 303
660 Strychnine and its salts — 304
661 Strychnos species and their galenical preparations 522 305
662 Succinonitrile — 150
663 Succinylsulphathiazole and its salts (678) 307
664 Sulfinpyrazone (INN) 303 155
665 Sulphacetamide and its salts (678) 307
666 Sulphadiazine and its salts (678) 307
667 Sulphadimethoxine and its salts (678) 307
668 Sulphadimidine and its salts (678) 307
669 Sulphafurazole and its salts (678) 307
670 Sulphaguanidine and its salts (678) 307
671 Sulphamethizole and its salts (678) 307
672 Sulphamethoxazole and its salts (678) 307
673 Sulphamethoxydiazine and its salts (678) 307
674 Sulphamethoxypyridazine and its salts (678) 307
675 Sulphanilamide and its salts (678) 307
676 Sulphapyridine and its salts (678) 307
677 Sulphathiazole and its salts (678) 307
678 Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the - NH 2 groups) and their salts 665-677 307
679 Sulthiame 680, 699 308
680 Sultiame (INN) 679, 699 308
681 Sympathomimetic amines acting on the central nervous system: any substance contained in the first list of medicaments which are subject to medical prescription and are referred to in resolution AP (69) 2 of the Council of Europe 44 21
682 Tefazoline (INN) and its salts 698 237
683 Tellurium and its compounds — 312
684 TEPP (ISO) 696 276
685 2-(4- tert -Butyl-2,6-dimethylbenzyl)-2-imidazoline and its salts 766 313
686 4- tert -Butylphenol — 340
687 4- tert -Butylpyrocatechol — 341
688 Tetrabenazine (INN) and its salts 531 139
689 Tetrabromosalicylanilides — 350
690 Tetracaine (INN) and its salts 280 63
691 2,3,7,8-Tetrachlorodibenzo- p -dioxin — 367
692 Tetrachloroethylene 549 314
693 Tetrachloromethane 147 315
694 Tetrachlorosalicylanilides — 348
695 Tetraethylammonium bromide 703 61
696 Tetraethyl pyrophosphate 684 276
697 (R)-5,6,6a,7-Tetrahydro-6-methyl-4 H -dibenzo[ de,g ]quinoline-10,11-diol and its salts 59 42
698 2-(5,6,7,8-Tetrahydro-1-naphthylmethyl)-2-imidazoline and its salts 682 237
699 4-(Tetrahydro-2 H -1,2-thiazin-2-yl)-benzenesulphonamide S, S -dioxide 679, 680 308
700 Tetrahydrozoline and its salts — 394
701 N ,2,3,3-Tetramethyl-2-nocamphanamine 437 229
702 Tetramethylthiuram disulphide 713 162
703 Tetrylammonium bromide (INN) 695 61
704 Thalidomide (INN) and its salts 586 280
705 Thallium and its compounds — 317
706 Thevetia neriifolia Juss., glycoside extract — 318
707 Thiamazole (INN) 472, 474 233
708 2,2'-Thiobis(4,6-dichlorophenol) 113 352
709 Thiopentone and its salts (69) 220
710 Thioridazine (INN) and its salts (561) 320
711 Thiotepa (INN) 726 310
712 Thiourea and its derivatives (except those listed in Part I of Schedule 4) — 321
713 Thiram (ISO) 702 162
714 Thiuram disulphides — 354
715 Thiuram monosulphides — 353
716 Thyropropic acid (INN) and its salts 394 9
717 Tolboxane (INN) 720 177
718 Tolbutamide (INN) 132 65
719 Toluidines, their isomers, salts and halogenated and sulphonated derivatives 40 32
720 p -Tolylboric acid ester of 2-methyl-2-propylpropane-1,3-diol 717 177
721 3- o -Tolyloxypropane-1,2-diol (439) 322
722 Tranylcypromine (INN) and its salts 571 324
723 Tretamine (INN) 727 328
724 Tretinoin (INN) and its salts 637, 760 375
725 Triamterene (INN) and its salts 581 275
726 Tri(aziridin-1-yl)phosphine sulphide 711 310
727 2,4,6-Tri(aziridin-l-yl)-1,3-triazine 723 328
728 2,2,2-Tribromoethanol (729) 326
729 Tribromoethyl alcohol 728 326
730 Tribromsalan (INN) 731 373
731 3,4',5-Tribromosalicylanilide 730 373
732 Trichlormethine (INN) and its salts 749 327
733 Trichloroacetic acid — 10
734 1,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane 194, 233 123
735 2,2,2-Trichloroethane-1,1-diol 157 77
736 Trichloromethane 167 366
737 N -(Trichloromethylthio)cyclohex-4-ene-1,2-dicarboximide 141 370
738 Trichloronitromethane 177 325
739 Tricresyl phosphate 750 277
740 Trifluoperazine (INN) and its salts (561) 320
741 Trifluperidol (INN) 349 188
742 3,3',5-Triiodothyroacetic acid and its salts 393 5
743 3,4,5-Trimethoxyphenethylamine and its salts 442 222
744 2.2,6-Trimethy1-4-piperidyl benzoate and its salts 75 51
745 2,4,6-Trinitrophenol 591 268
746 Trioxysalen (INN) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg (357) 358
747 Triparanol (INN) 171 92
748 Tripelennamine (INN) 95, 626 347
749 Tris(2-chloroethyl)amine 732 327
750 Tritolyl phosphate 739 277
751 Tuaminoheptane (INN), its isomers and salts 30 27
752 Urginea scilla Stern . and its galenical preparations 653 330
753 Urocanic acid (406) 418
754 Vaccines, toxins and serums listed in the Annex to Council Directive No. 17 ) — 323
755 Valnoctamide (INN) 339 184
756 Veratrine, its salts and galenical preparations — 331
757 Veratrum spp and their preparations — 333
758 Vinyl chloride monomer — 334
759 Vinylidene chloride (7,250) 126
760 Vitamin A acid and its salts 637, 724 375
761 Vitamins D 2 and D 3 138, 186, 317 335
762 Warfarin (ISO) and its salts 3, 399 203
763 Xanthates 16 336
764 Xanthinol 392 135
765 Xylidines, their isomers, salts and halogenated and sulphonated derivatives 41 33
766 Xylometazoline (INN) and its salts 685 313
767 Yohimbine and its salts — 337
768 Zirconium and its compounds (except aluminium zirconium chloride hydroxide complexes and aluminium zirconium chloride hydroxide glycine complexes under the conditions laid down in Part I of Schedule 4 and zirconium lakes, salts and pigments prepared from those colouring agents identified in column 1 of Part I of Schedule 5 by “*” immediately after the name or colour index number) — 391
769 Zoxazolamine (INN) 28 24

PART II SUBSTANCES PROHIBITED WHEN USED AS A FRAGRANCE INGREDIENT

(1) (2) (3) (4)
Number in this Schedule Name of substance Cross-reference to this Schedule Cross-reference to Annex II of the Directive
1 Alanroot oil (Inula helenium) — 423
2 Benzyl cyanide 31 424
3 Cyclamen alcohol 22 425
4 Decahydro-6-isopropyl-2-naphthol 21 441
5 Diethyl maleate — 426
6 Dihydrocoumarin 8 427
7 6,7-Dihydrogeraniol 10 429
8 3,4-Dihydroxycoumarin 6 427
9 2,4-Dihydroxy-3-methylbenzaldehyde — 428
10 3,7-Dimethyl-2-octen-1-ol 7 429
11 4,6-Dimethyl-8- tert -butylcoumarin — 430
12 Dimethyl citraconate — 431
13 7,11-Dimethyl-4,6,10-dodecatrien-3-one — 432
14 6, 10-Dimethyl-3,5,9-undecatrien-2-one — 433
15 Diphenylamine — 434
16 Ethyl acrylate — 435
17 Fig leaf absolute (Ficus carica) — 436
18 trans -2-Heptenal — 437
19 trans -2-Hexenal diethyl acetal — 438
20 trans -2-Hexenal dimethyl acetal — 439
21 Hydroabietyl alcohol — 440
22 6-Isopropyl-2-decahydronaphthalenol 4 441
23 3-(4-Isopropylphenyl)-2-methylpropan-1-ol 3 425
24 7-Methoxycoumarin — 442
25 4-(4-Methoxyphenyl)-3-butene-2-one — 443
26 1-(4-Methoxyphenyl)-1-penten-3-one — 444
27 Methyl trans -2-butenoate — 445
28 7-Methylcoumarin — 446
29

Methyleugenol (except for normal content in the natural essences used and provided that the concentration does not exceed:

(a)

0.01 per cent in fine fragrance;

(b)

0.004 per cent in eau de toilette;

(c)

0.002 per cent in fragrance cream;

(d)

0.001 per cent in rinse-off products; and

(e)

0.0002 per cent in other leave-on products and oral hygiene products)

— 451
30 5-Methyl-2,3-hexanedione — 447
31 2-Pentylidenecyclohexanone — 448
32 2-Phenylacetonitrile 2 424
33 3,6,10-Trimethyl-3,5,9-undecatrien-2-one — 449
34 Verbena oil ( Lippia citriodora Kunth.) — 450

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

SCHEDULE 4 LIST 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 18 ).

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

(1) (2) (3) (4) (5) (6)
Reference Number Name of substance Purpose of substance or type of product Maximum concentration of substance in product Other requirements Required information
Note 1: These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.
Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as a percentage of sodium hydroxide. In cases of mixtures, the sum must not exceed the limits given in column (4).
1a Boric acid, borates, and tetraborates Talcum powder 5 per cent

Not to be used in products intended for children under three years old

Not to be used in products intended for peeling or irritated skin if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid

Not to be used for bathing children under three years old

Do not use on peeling or irritated skin (Only required if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid)

Oral hygiene products 0.1 per cent Not to be used in products intended for children under three years old

Do not swallow

Not to be used for children under three years old

Other products (excluding bath products and hair waving products) 3 per cent

Not to be used in products intended for children under three years old

Not to be used in products intended for peeling or irritated skin if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid

Not to be used for children under three years old

Do not use on peeling or irritated skin (Only required if the concentration of free soluble borate exceeds 1.5 per cent calculated as boric acid)

The above-mentioned percentages are calculated as boric acid
1b Tetraborates Bath products 18 per cent Not to be used in products for children under three years old Not to be used for bathing children under three years old
Hair waving products

8 per cent

The above-mentioned percentages are calculated as boric acid

2a Thioglycolic acid and its salts

(a) Hair waving or straightening products for general use

8 per cent ready for use pH 7 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children

(b) Hair waving or straightening products for professional use

11 per cent ready for use pH 7 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only

(c) Depilatories

5 per cent ready for use pH 7 to 12.7 Contains thioglycolate. Follow the instructions. Keep out of reach of children

(d) Other hair-care products which are removed after application

2 per cent ready for use pH 7 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children
The above-mentioned percentages are calculated as thioglycolic acid

(a), (b), (c) and (d): The directions for use must incorporate the following:

  • — Avoid contact with eyes

  • — In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice

  • — Wear suitable gloves ((a), (b) and (d) only)

2b Thioglycolic acid esters

(a) Hair waving or straightening products for general use

8 per cent ready for use pH 6 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children

(b) Hair waving or straightening products for professional use

11 per cent ready for use pH 6 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only
The above-mentioned percentages are calculated as thioglycolic acid

(a) and (b): The directions for use must incorporate the following:

  • — May cause sensitization in the event of skin contact

  • — Avoid contact with eyes

  • — In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice

  • — Wear suitable gloves

3 Oxalic acid, its esters and alkaline salts Hair care products 5 per cent — For professional use only
4 Ammonia All purposes and products 6 per cent calculated as NH3 — Contains ammonia (not required when concentration is not more than 2 per cent)
5 Tosylchlora-mide sodium (INN) [Chloramine-T] All purposes and products 0.2 per cent — —
6 Chlorates of alkali metals Toothpaste 5 per cent — —
Other uses 3 per cent — —
7 Dichloro-methane All purposes and products 35 per cent (and when mixed with 1,1,1-trichloroethane, total concentration must not exceed 35 per cent) Purity of the dichloromethane must be not less than 99.8 per cent —
8

m - and p -Phenylenedia-mines, their N -substituted derivatives and their salts;

N -substituted derivatives of o -phenylenediamines (see Note 1), with the exception of those derivatives listed elsewhere in this Schedule

Oxidizing colouring agents for hair-dyeing for general use 6 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below — Contains phenylenediamines Can cause an allergic reaction. Do not use to dye eyelashes or eyebrows
Oxidizing colouring agents for hair-dyeing for professional use 6 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below — Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Wear suitable gloves
9 Methylphenylenediamines (other than 4-methyl- m -phenylenediamine and its salts), their N -substituted derivatives and their salts (Toluenediamines (other than toluene-1, 3-diamine and its salts), their N -substituted derivatives and their salts) Oxidizing colouring agents for hair-dyeing for general use 10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below — Contains phenylene-diamines. Can cause an allergic reaction. Do not use to dye eyelashes or eyebrows
Oxidizing colouring agents for hair-dyeing for professional use 10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below — Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Wear suitable gloves
10 Diaminophenols Oxidizing colouring agents for hair-dyeing for general use 10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below — Contains diaminophenols. Can cause allergic reaction. Do not use to dye eyelashes or eyebrows
Oxidizing colouring agents for hair-dyeing for professional use 10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below — Contains diaminophenols. For professional use only. Can cause allergic reaction. Wear suitable gloves
11 Dichlorophen (INN) [Dichlorophene] All purposes and products 0.5 per cent — Contains dichlorophen
12 Hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide including hydrogen peroxide-urea (hydrogen peroxide-carbamide) and zinc peroxide

(a) Hair-care preparations

(b) Skin-care preparations

(c) Nail hardening preparations

(d) Oral hygiene products

  • 12 per cent of H 2 O 2 present or released

  • 4 per cent of H 2 O 2 present or released

  • 2 per cent of H 2 O 2 present or released

  • 0.1 per cent of H 2 O 2 present or released

  • —

  • —

  • —

  • (a): Wear suitable gloves

  • (a)(b)(c): Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them

  • —

13 Formaldehyde (see also Part I of Schedule 6) Nail hardeners 5 per cent — Contains formaldehyde. Protect cuticles with grease or oil. (Not required when concentration is not more than 0.05 per cent)
14 Hydroquinone Oxidizing colouring agent for hair dyeing for general use 0.3 per cent subject to the provisions of “Combination Rule B” set out below — Contains hydroquinone. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them
Oxidizing colouring agent for hair dyeing for professional use 0.3 per cent subject to the provisions of “Combination Rule B” set out below — Contains hydroquinone. For professional use only. Rinse eyes immediately if product comes into contact with them
15a Potassium hydroxide and sodium hydroxide Nail cuticle solvent 5 per cent calculated as sodium hydroxide (see Note 2) — Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
Hair straightener for general use 2 per cent calculated as sodium hydroxide (see Note 2) — Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
Hair straightener for professional use 4.5 per cent calculated as sodium hydroxide (see Note 2) — For professional use only. Avoid contact with eyes. Can cause blindness
pH adjuster for depilatories — pH value not to exceed 12.7 Keep out of reach of children Avoid contact with eyes
Other uses as pH adjuster — pH value not to exceed 11 —
15b Lithium hydroxide Hair straightener for general use 2 per cent calculated as sodium hydroxide (see Note 2) — Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
Hair straightener for professional use 4.5 per cent calculated as sodium hydroxide (see Note 2) — For professional use only. Avoid contact with eyes. Can cause blindness
pH adjuster for depilatories — pH value not to exceed 12.7 Contains alkali. Keep out of reach of children. Avoid contact with eyes
Other uses as pH adjuster (for rinse-off products only) — pH value not to exceed 11 —
15c Calcium hydroxide Hair straighteners containing two components: calcium hydroxide and aguanidine salt 7 per cent by weight of calcium hydroxide — Contains alkali. Avoid contact with eyes. Keep out of reach of children. Can cause blindness
pH adjuster for depilatories — pH value not to exceed 12.7 Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
Other uses e.g. pH adjuster processing aid — pH value not to exceed 11 —
16 α-Naphthol [1-Naphthol] and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent Can cause allergic reaction
17 Sodium nitrite Rust inhibitor 0.2 per cent Do not use with secondary and/or tertiary amines or other substances forming nitrosamines —
18 Nitromethane Rust inhibitor 0.3 per cent — —
19 Phenol and its alkali salts Soaps and shampoos 1 per cent calculated as phenol — Contains phenol
20 ENTRY DELETED
21 Quinine and its salts Shampoos 0.2 per cent calculated as quinine base — —
Hair lotions 0.5 per cent calculated as quinine base — —
22 Resorcinol Oxidizing colouring agent for hair dyeing for general use 5 per cent subject to the provisions of “Combination Rule B” set out below — Contains resorcinol. Rinse hair well after application. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them
Oxidizing colouring agent for hair dyeing for professional use 5 per cent subject to the provisions of “Combination Rule B” set out below — Contains resorcinol. For professional use only. Rinse eyes immediately if product comes into contact with them
Hair lotions and shampoos 0.5 per cent subject to the provisions of “Combination Rule B” set out below — Contains resorcinol
23a Alkali sulphides Depilatories 2 per cent calculated as sulphur pH value not to exceed 12.7 Keep out of reach of children. Avoid contact with eyes
23b Alkaline earth sulphides Depilatories 6 per cent calculated as sulphur pH value not to exceed 12.7 Keep out of reach of children. Avoid contact with eyes
24 Water-soluble zinc salts with the exception of zinc 4-hydroxybenzene-sulphonate All purposes and products 1 per cent calculated as zinc — —
25 Zinc 4-hydroxybenzene-sulphonate [Zinc phenolsulfonate] Deodorants, antiperspirants and astringent lotions 6 per cent calculated as percentage of anhydrous substance — Avoid contact with eyes
26 Ammonium monofluoro-phosphate Oral hygiene products 0.15 per cent calculated as fluorine. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent — Contains ammonium monofluorophosphate
27 Sodium monofluoro-phosphate Oral hygiene products As for ammonium monofluorophosphate — Contains sodium monofluoro-phosphate
28 Potassium monofluoro-phosphate Oral hygiene products As for ammonium monofluorophosphate — Contains potassium monofluoro-phosphate
29 Calcium monofluoro-phosphate Oral hygiene products As for ammonium monofluorophosphate — Contains calcium monofluoro-phosphate
30 Calcium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains calcium fluoride
31 Sodium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains sodium fluoride
32 Potassium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains potassium fluoride
33 Ammonium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains ammonium fluoride
34 Aluminium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains aluminium fluoride
35 Stannous fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains stannous fluoride
36 Hexadecylammonium fluoride [Cetylamine hydrofluoride] Oral hygiene products As for ammonium monofluorophosphate — Contains hexadecylammonium fluoride
37 3-( n -Hexadecyl- N -2-hydroxyethylammonio)-propylbis(2-hydroxyethyl)-ammonium difluoride [Stearyl trihydroxyethyl propylenediamine dihydrofluoride] Oral hygiene products As for ammonium monofluorophosphate — Contains 3-( n -hexadecyl- N -2-hydroxyethylammonio)- propylbis(2-hydroxyethyl)- ammoniumdifluoride
38 N,N',N '-Tris(polyoxyethylene)- N -hexadecylpropyl-enediamine dihydrofluoride [Palmityl trihydroxyethyl propylenediamine dihydrofluoride] Oral hygiene products As for ammonium monofluorophosphate — Contains N,N',N '-tris (polyoxyethylene)- N -hexa-decylpropylenediamine dihydrofluoride
39 Octadecenylammonium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains octadecenylammonium fluoride
40 Sodium fluorosilicate Oral hygiene products As for ammonium monofluorophosphate — Contains sodium fluorosilicate
41 Potassium fluorosilicate Oral hygiene products As for ammonium monofluorophosphate — Contains potassium fluorosilicate
42 Ammonium fluorosilicate Oral hygiene products As for ammonium monofluorophosphate — Contains ammonium fluorosilicate
43 Magnesium fluorosilicate Oral hygiene products As for ammonium monofluorophosphate — Contains magnesium fluorosilicate
44 1,3-Bis(hydroxymethyl)-imidazolidene-2-thione [Dimethylol ethylene thiourea] Hair care preparations 2 per cent Not to be used in aerosol dispensers Contains 1,3-bis(hydroxymethyl) imidazolidene-2-thione
Nail care preparations 2 per cent pH value as applied must be less than 4 Contains 1,3-bis(hydroxymethyl) imidazolidene-2-thione
45 Benzyl alcohol (See also Part I of Schedule 6) Solvent, perfumes and flavourings — — —
46 6-Methylcoumarin Oral hygiene products 0.003 per cent — —
47 Nicomethanol hydrofluoride Oral hygiene products As for ammonium monofluorophosphate — Contains nicomethanol hydrofluoride
48 Silver nitrate Products to dye eyelashes or eyebrows 4 per cent — Contains silver nitrate. Rinse eyes immediately if product comes into contact with them
49 Selenium disulphide [Selenium sulfide] Anti-dandruff shampoos 1 per cent — Contains selenium disulphide. Avoid contact with eyes or damaged skin
50 Aluminium zirconium chloride hydroxide complexes Al x Zr(OH) y Cl z and aluminium zirconium chloride hydroxide glycine complexes Anti-perspirants 20 per cent as anhydrous aluminium zirconium chloride hydroxide, 5.4 per cent as zirconium

The ratio of the number of aluminium atoms to that of zirconium atoms must be between 2 and 10

The ratio of the number of (Al + Zr) atoms to chlorine atoms must be between 0.9 and 2.1

Not to be used in aerosol dispensers (sprays)

Do not apply to irritated or damaged skin
51 Quinolin-8-ol and bis-(8-hydroxyquinolinium sulphate) (See also Part I of Schedule 3) [Oxyquinoline and Oxyquinoline sulfate] Stabilizer for hydrogen peroxide in rinse-off hair care preparations 0.3 per cent calculated as base — —
Stabilizer for hydrogen peroxide in non rinse-off hair care preparations 0.03 per cent calculated as base — —
52 Methanol Denaturant for ethanol and isopropyl alcohol 5 per cent calculated as a percentage of ethanol and isopropyl alcohol — —
53 Etidronic acid and its salts (1-hydroxyethylidene-diphosphonic acid and its salts) Hair care 1.5 per cent expressed as etidronic acid — —
Soap 0.2 per cent expressed as etidronic acid — —
54 1-Phenoxy-propan-2-ol (See also Part I of Schedule 6) [Phenoxy-isopropanol] Products rinsed off after use 2 per cent Prohibited in oral hygiene products —
55 Lead acetate Only for hair dyeing 0.6 per cent calculated as lead —

Contains lead acetate. Keep away from children. Avoid all contact with the eyes. Wash hands after use. Do not use to dye eyelashes, eyebrows or moustaches

If irritation develops discontinue use

56 Magnesium fluoride Dental hygiene products 0.15 per cent calculated as fluorine. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent — Contains magnesium fluoride
57 Strontium chloride hexahydrate

(a) Toothpaste

3.5 per cent calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 3.5 per cent — Contains strontium chloride Frequent use by children is not advisable

(b) Shampoo and face care products

2.1 per cent calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 2.1 per cent — —
58 Strontium acetate hemihydrate Toothpaste 3.5 per cent calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3.5 per cent — Contains strontium acetate. Use by children is not advisable
59 Talc: hydrated magnesium silicate

(a) Powdery products intended to be used for children under three years of age

— —

(a): Keep powder away from children’s nose and mouth

(b) other products

— —
60 Fatty acid dialkanolamides All purposes and products Maximum dialkanolamine content: 0.5 per cent Do not use with nitrosating systems. Maximum dialkanolamine content: 5 per cent (applies to raw materials. Maximum N -nitroso-dialkanolamine content: 50 μg/kg (applies to raw materials). Keep in nitrite-free containers —
61 Monoalkanolamines All purposes and products Maximum dialkanolamine content: 0.5 per cent

Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum dialkanolamine content: 0.5 per cent (applies to raw materials). Maximum N -nitrosodialkanolamine content:

50 μg/kg (applies to raw materials). Keep in nitrite-free containers

—
62 Trialkanolamines

(a) non-rinse-off

(b) other products

(a) 2.5 per cent

  • —

(a) (b): Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum dialkanolamine content: 0.5 per cent (applies to raw materials). Maximum N -nitroso-dialkanolamine content: 50 μg/kg (applies to raw materials). Keep in nitrate-free containers —
63 Strontium hydroxide pH-regulator in depilatory products 3.5 per cent calculated as strontium pH value not to exceed 12.7 Keep out of reach of children. Avoid contact with the eyes
64 Strontium peroxide Rinse-off hair care preparations for professional use 4.5 per cent calculated as strontium in the ready-for-use preparation All products must meet the hydrogen peroxide release requirements Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them. For professional use only. Wear suitable gloves
65 Benzalkonium chloride (INN), bromide and saccharinate (eg. Cetalkonium chloride Stearalkonium chloride, Cetearalkonium bromide) Hair care products rinsed off after use 3 per cent calculated as benzalkonium chloride In the finished product the concentration of benzalkonium chloride, bromide and saccharinate with an alkyl chain-length of C 14 or less must not exceed 0.1 per cent calculated as benzalkonium chloride Avoid contact with the eyes
Other products 0.1 per cent calculated as benzalkonium chloride — Avoid contact with the eyes
66 Polyacrylamides Body-care leave-on products — Maximum residual acrylamide content 0.1 μg/kg —
Other cosmetic products — Maximum residual acrylamide content 0.5 μg/kg —

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

(1) (2) (3) (4) (5) (6) (7)
Reference Number Name of substance Purpose of substance or type of product Maximum concentration of substance in product Other requirements Required information Permitted for supply until

Combination Rules

A.

Where a cosmetic product contains two or more substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 1.

B.

Where a cosmetic product contains the substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 2; but the concentration of each substance shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above.

C.

The relevant quotient for each substance is the actual concentration of the substance in the product divided by the maximum concentration specified for the substance in respect of the product in Column 4 of this Schedule.

1 C.I. Basic Blue 7 Non-oxidising colouring agents for hair dyeing 0.2 per cent — Can cause allergic reaction 30.9.2004
2 2-Amino-3-nitrophenol and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

3 per cent

3 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent

Can cause allergic reaction

Can cause allergic reaction

30.9.2004
3 4-Amino-3-nitrophenol and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

3 per cent

3 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent

Can cause allergic reaction

Can cause allergic reaction

30.9.2004
4 Naphthalene-2,7-diol and its salts Oxidising colouring agents for hair dyeing 1 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent — 30.9.2004
5 3-Aminophenol and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent Can cause allergic reaction 30.9.2004
6 3, 4-Dimethylpyridine-2, 6-diol and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent

Can cause allergic reaction

Can cause allergic reaction

30.9.2004
7 4-(3-Hydroxypropyl)- amino-3-nitrophenol and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

5.2 per cent

2.6 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 2.6 per cent

Can cause allergic reaction

Can cause allergic reaction

30.9.2004
8 6-Nitropyridine-2,5- diamine and its salts Non-oxidising colouring agent for hair dyeing 3 per cent — Can cause allergic reaction 30.9.2004
9 HC Blue No. 11 and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

3 per cent

2 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent

Can cause allergic reaction

Can cause allergic reaction

30.9.2004
10 2-(2-Nitro- p -toluidino)- ethanol and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

2 per cent

1 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent

Can cause allergic reaction

Can cause allergic reaction

30.9.2004
11 2-(2-Hydroxyethyl- amino)-4,6-dinitro- phenol and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

3 per cent

2 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent

Can cause allergic reaction

Can cause allergic reaction

30.9.2004
12 4-Methylaminophenol and its salts Oxidising colouring agent for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent Can cause allergic reaction 30.9.2004
13 2-(2,4-Diamino-5-methylphenoxy)ethanol and its salts Oxidising colouring agent for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent Can cause allergic reaction 30.9.2004
14 HC Violet No. 2 and its salts Non-oxidising colouring agent for hair dyeing 2 per cent — — 30.9.2004
15 2(2,6-Dinitro- p -anisidino)ethanol and its salts Non-oxidising colouring agent for hair dyeing 3 per cent — Can cause allergic reaction 30.9.2004
16 HC Blue No. 12 and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

1.5 per cent

1.5 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 0.75 per cent

Can cause allergic reaction

Can cause allergic reaction

30.9.2004
17 4-Ethoxy-6-methyl- m -phenylenediamine and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent Can cause allergic reaction 30.9.2004
18 4,4'-(Trimethylene- dioxy)di- m -phenylene-diamine and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent Can cause allergic reaction 30.9.2004
19 3-Amino-2,4-dichloro- phenol and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent Can cause allergic reaction 30.9.2004
20 3-Methyl-1-phenyl-5-pyrazolone and its salts Oxidising colouring agents for hair dyeing 0.5 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent — 30.9.2004
21 5-(2-Hydroxyethyl-amine)- o -cresol and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent Can cause allergic reaction 30.9.2004
22 3,4-Dihydro-2 H -1,4-benzoxazin-6-ol and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent Can cause allergic reaction 30.9.2004
23 Naphthalene-1,7-diol and its salts Oxidising colouring agents for hair dyeing 1 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent Can cause allergic reaction 30.9.2004
24 HC Yellow No. 10 and its salts Non-oxidising colouring agents for hair dyeing 0.2 per cent — — 30.9.2004
25 2,6-Dimethoxy-3,5-pyridinediamine and its salts Oxidising colouring agents for hair dyeing 0.5 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent Can cause allergic reaction 30.9.2004
26 HC Orange No. 2 and its salts Non-oxidising colouring agents for hair dyeing 1 per cent — — 30.9.2004
27 HC Violet No. 1 and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

0.5 per cent

0.5 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent — 30.9.2004
28 2-(3-Methylamino-4-nitrophenoxy) ethanol and its salts Non-oxidising colouring agents for hair dyeing 1 per cent — — 30.9.2004
29 2-(2-Methoxy-4-nitroanilino)ethanol and its salts Non-oxidising colouring agents for hair dyeing 1 per cent — — 30.9.2004
30 2-(4-Amino-2-chloro-5-nitroanilino)ethanol and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

2 per cent

1 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004
31 HC Red No. 13

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

2.5 per cent

2.5 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 1.25 per cent — 30.9.2004
32 Naphthalene-1,5-diol and its salts Oxidising colouring agents for hair dyeing 1 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent — 30.9.2004
33 2,2'-[2-Hydroxy-trimethylenebis(4-aminophenyl)imino] diethanol and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent Can cause allergic reaction 30.9.2004
34 2-Aminophenol and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004
35 5-Amino- o -cresol and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004
36 2-(2,4-Diamino- phenoxy)ethanol and its salts Oxidising colouring agents for hair dyeing 4 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 2 per cent — 30.9.2004
37 2-Methylresorcinol and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004
38 4-Amino- m -cresol and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004
39 2-Amino-4-hydroxyethyl- aminoanisole and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004
40 3,4-Diaminobenzoic acid and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004
41 6-Amino- o -cresol and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004
42 2-Aminomethyl- p -aminophenol and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004
43 4-Amino-2-(2-hydroxyethylaminomethyl) phenol and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004
44 N -(2-Hydroxyethyl)-3,4-methylenedioxyaniline and its salts Oxidising colouring agents for hair dyeing 3 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004
45 C.I. Acid Black 52 and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004
46 2-Nitro- p -phenylene- diamine and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

0.3 per cent

0.3 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent — 30.9.2004
47 HC Blue No. 2 and its salts Non-oxidising colouring agents for hair dyeing 2.8 per cent — — 30.9.2004
48 4-(2-Hydroxyethylamino)-3-nitrophenol and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

6 per cent

6 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 3 per cent — 30.9.2004
49 2-(4-Nitrophenylamino)- ethylurea and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

0.5 per cent

0.5 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent — 30.9.2004
50 HC Red No. 10 + HC Red No. 11 and their salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

2 per cent

1 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004
51 HC Yellow No. 6 and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

2 per cent

1 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004
52 HC Yellow No. 12 and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

1 per cent

0.5 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 0.5 per cent — 30.9.2004
53 HC Blue No. 10 and its salts Oxidising colouring agents for hair dyeing 2 per cent In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004
54 HC Blue No. 9 and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

2 per cent

1 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004
55 2-Chloro-6-ethylamino-4-nitrophenol and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

3 per cent

3 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 1.5 per cent — 30.9.2004
56 2-Amino-6-chloro-4-nitrophenol and its salts

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

2 per cent

2 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 1 per cent — 30.9.2004
57 C.I. Basic Blue 26

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

0.5 per cent

0.5 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 0.25 per cent — 30.9.2004
58 C.I. Acid Red 33 Non-oxidising colouring agents for hair dyeing 2 per cent — — 30.9.2004
59 C.I. Food Red 1 Non-oxidising colouring agents for hair dyeing 2 per cent — — 30.9.2004
60 C.I. Basic Violet 14

Oxidising colouring agents for hair dyeing

Non-oxidising colouring agents for hair dyeing

0.3 per cent

0.3 per cent

In combination with hydrogen peroxide the maximum use concentration upon application is 0.15 per cent — 30.9.2004
61 1- tert -Butyl-3,5-dimethyl-2,4,6-trinitro- benzene (musk xylene) All cosmetic products, with the exception of oral care products

1 per cent in fine fragrance

0.4 per cent in eau de toilette

0.03 per cent in other products

— — 30.9.2004
62 4'- tert -Butyl-2',6'-dimethyl-3',5'-dinitro- acetophenone (musk ketone) All cosmetic products, with the exception of oral care products

1.4 per cent in fine fragrance

0.56 per cent in eau de toilette

0.042 per cent in other products

— — 30.9.2004

Regulations 5(2) and 7(9)

SCHEDULE 5 LIST 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 third edition of The Colour Index published in 1971 by the Society of Dyers and Colourists);

(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 I COLOURING 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.
(1) (2) (3) (4)
Name or colour Colour Type of product Other requirements
index number Field of application
1 2 3 4
10006 Green X
10020 Green X
10316* Yellow X
11680 Yellow X
11710 Yellow X
11725 Orange X
11920 Orange X
12010 Red X
12085* Red X 3 per cent maximum concentration in the finished product
12120 Red X
12150 Red X
12370 Red X
12420 Red X
12480 Brown X
12490 Red X
12700 Yellow X
13015 Yellow X E 105
14270 Orange X E 103
14700 Red X
14720 Red X E 122
14815 Red X E 125
15510* Orange X
15525 Red X
15580 Red X
15620 Red X
15630* Red X 3 per cent maximum concentration in the finished product
15800 Red X
15850* Red X
15865* Red X
15880 Red X
15980 Orange X E 111
15985* Yellow X E 110
16035 Red X
16185 Red X E 123
16230 Orange X
16255* Red X E 124
16290 Red X E 126
17200* Red X
18050 Red X
18130 Red X
18690 Yellow X
18736 Red X
18820 Yellow X
18965 Yellow X
19140* Yellow X E 102
20040 Yellow X Maximum 3,3'-dimethyl-benzidine concentration in the colouring agent: 5 mg/kg
20170 Orange X
20470 Black X
21100 Yellow X Maximum 3,3'-dichloro-benzidine concentration in the colouring agent: 5 mg/kg
21108 Yellow X Maximum 3,3'-dichloro-benzidine concentration in the colouring agent: 5 mg/kg
21230 Yellow X
24790 Red X
26100 Red X Purity criteria: aniline <= 0.2 per cent, 2-naphthol <= 0.2 per cent, azobenzen-4-amine <= 0.1 per cent, 1-phenylazo-2-naphthol <= 3 per cent, 1-[2-(phenylazo) phenylazo]-2-naphthol <= 2 per cent
27290* Red X
27755 Black X E 152
28440 Black X E 151
40215 Orange X
40800 Orange X
40820 Orange X E 160e
40825 Orange X E 160f
40850 Orange X E 161g
42045 Blue X
42051* Blue X E 131
42053 Green X
42080 Blue X
42090 Blue X
42100 Green X
42170 Green X
42510 Violet X
42520 Violet X Maximum concentration in the finished product: 5 mg/kg
42735 Blue X
44045 Blue X
44090 Green X E 142
45100 Red X
45190 Violet X
45220 Red X
45350 Yellow X 6 per cent. maximum concentration in the finished product
45370* Orange X Not more than 1 per cent 2-(6-hydroxy-3-oxo- 3H -xanthen-9-yl)benzoic acid and 2 per cent 2-(bromo-6-hydroxy-3-oxo- 3H -xanthen-9-yl)benzoic acid
45380* Red X as immediately above
45396 Orange X When used in lipstick, the colouring agent is allowed only in free acid form and in a maximum concentration of 1 per cent
45405 Red X Not more than 1 per cent 2-(6-hydroxy-3-oxo- 3H -xanthen-9-yl)benzoic acid and 2 per cent 2-(bromo-6-hydroxy-3-oxo- 3H -xanthen-9-yl)benzoic acid
45410* Red X as immediately above
45425 Red X Not more than 1 per cent 2-(6-hydroxy-3-oxo- 3H -xanthen-9-yl)benzoic acid and 3 per cent 2-(iodo-6-hydroxy-3-oxo- 3H -xanthen-9-yl)benzoic acid
45430* Red X as immediately above, E 127
47000 Yellow X
47005 Yellow X E 104
50325 Violet X
50420 Black X
51319 Violet X
58000 Red X
59040 Green X
60724 Violet X
60725 Violet X
60730 Violet X
61565 Green X
61570 Green X
61585 Blue X
62045 Blue X
69800 Blue X E 130
69825 Blue X
71105 Orange X
73000 Blue X
73015 Blue X E 132
73360 Red X
73385 Violet X
73900 Violet X
73915 Red X
74100 Blue X
74160 Blue X
74180 Blue X
74260 Green X
75100 Yellow X
75120 Orange X E 160b
75125 Yellow X E 160d
75130 Orange X E 160a
75135 Yellow X E 161d
75170 White X
75300 Yellow X E 100
75470 Red X E 120
75810 Green X E 140 and E 141
77000 White X E 173
77002 White X
77004 White X
77007 Blue X
77015 Red X
77120 White X
77163 White X
77220 White X E 170
77231 White X
77266 Black X
77267 Black X
77268:1 Black X E 153
77288 Green X Free from chromate ions
77289 Green X Free from chromate ions
77346 Green X
77400 Brown X
77480 Brown X E 175
77489 Orange X E 172
77491 Red X E 172
77492 Yellow X E 172
77499 Black X E 172
77510 Blue X Free from cyanide ions
77713 White X
77742 Violet X
77745 Red X
77820 White X E 174
77891 White X E 171
77947 White X
Acid Red 195 Red X
Aluminium, zinc, magnesium and calcium stearates White X
Anthocyanins Red X E 163
Beetroot red Red X E 162
Bromocresol green Green X
Bromothymol blue Blue X
Caramel Brown X E 150
Capsanthin, capsorubin Orange X E 160c
Lactoflavin Yellow X E 101

PART II COLOURING 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-column 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.
(1) (2) (3) (4) (5)
Name or colour Colour Type of product Other requirements Cosmetic product supplied until
index number Field of application
1 2 3 4
Note: There are no entries in this Part at the date that these Regulations are made.

Regulations 5(2) and 7(2)

SCHEDULE 6 LIST 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 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 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 be 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—

(a) 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

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

In this Schedule—

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

“esters” 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 preservativesubstances 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 INCI 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 23 ).

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

(1) (2) (3) (4) (5) (6)
Reference Number Name of substance Purpose of substance or type of product Maximum concentration of substance in product Other requirements Required information
1 Benzoic acid, its salts and esters All products 0.5 per cent (expressed as acid) A — —
2 Propionic acid and its salts All products 2 per cent (expressed as acid) A — —
3 Salicylic acid and its salts All products 0.5 per cent (expressed as acid) A Not to be used in preparations for children under three years of age except for shampoos Not to be used for children under three years of age (solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin)
4 Sorbic acid (hexa-2,4-dienoic acid) and its salts All products 0.6 per cent (expressed as acid) A — —
5 Formaldehyde and para-formaldehyde For oral hygiene 0.1 per cent (expressed as free formaldehyde) Not to be used in aerosol dispensers (sprays) —
Except for oral hygiene (see also Part I of Schedule 4) 0.2 per cent (expressed as free formaldehyde)
6 ENTRY DELETED
7 Biphenyl-2- o l [o-phenylphenol] and its salts All products 0.2 per cent (expressed as the phenol) A — —
8 Pyrithione zinc (INN) [Zinc pyrithione] Products rinsed off after use 0.5 per cent A Not to be used in oral hygiene products —
9 Inorganic sulphites and hydrogen sulphites All products 0.2 per cent (expressed as free SO 2 ) A — —
10 Sodium iodate Products rinsed off after use 0.1 per cent — —
11 Chlorobutanol (INN) All products 0.5 per cent Not to be used in aerosol dispensers (sprays) Contains chlorobutanol
12 4-Hydroxybenzoic acid and its salts and esters [the Parabens] All products 0.4 per cent (expressed as acid) for 1 ester, 0.8 per cent (expressed as acid) for mixtures of esters A — —
13 3-Acetyl-6-methylpyran-2,4( 3H )-dione [Dehydroacetic acid] and its salts All products 0.6 per cent (expressed as acid) Not to be used in aerosol dispensers (sprays) —
14 Formic acid and its sodium salt All products 0.5 per cent (expressed as acid) A — —
15 3,3'-Dibromo-4,4'-hexamethylenedioxydi-benzamidine [Dibromo-hexamidine] and its salts (including isethionate) All products 0.1 per cent — —
16 Thiomersal (INN) [Thimerosal] Eye make-up and eye make-up remover 0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent — Contains thiomersal
17 Phenylmercuric salts (including borate) Eye make-up and eye make-up remover 0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent — Contains phenylmercuric compounds
18 Undec-10-enoic acid [Undecylenic acid] and its salts All products 0.2 per cent (expressed as acid) A — —
19 Hexetidine (INN) Products rinsed off after use 0.1 per cent A — —
20 5-Bromo-5-nitro-1,3-dioxane Products rinsed off after use 0.1 per cent Avoid formation of nitrosamines —
21 ENTRY DELETED
22 2,4-Dichlorobenzyl alcohol [Dichlorobenzyl alcohol] All products 0.15 per cent A —
23 Triclocarban (INN) All products 0.2 per cent A Purity criteria: 3,3',4,4'-tetrachloroazobenzene < 1 mg/kg —
24 4-Chloro- m -cresol [ p -Chloro- m -cresol] Not to be used in products intended to come into contact with mucous membranes 0.2 per cent A —
25 Triclosan (INN) All products 0.3 per cent A — —
26 4-Chloro-3,5-xylenol [Chloroxylenol] All products 0.5 per cent A — —
27 3,3'-Bis(1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea [Imidazolidinyl urea] All products 0.6 per cent A — —
28 Poly(1-hexamethylene-biguanide hydrochloride) [Polyaminopropyl biguanide] All products 0.3 per cent A — —
29 ENTRY DELETED
30 Hexamethylenetetramine (Methenamine (INN)) [Methenamine] All products 0.15 per cent A — —
31 Methenamine 3-chloroallylo-chloride (INNM) [Quaternium-15] All products 0.2 per cent — —
32 1-(4-Chlorophenoxy)-1-(imidazol-l-yl)-3,3-dimethylbutan-2-one (Climbazole (INN)) [Climbazole] All products 0.5 per cent A — —
33 1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione [DMDM Hydantoin] All products 0.6 per cent A — —
34 Benzyl alcohol (See also Part I of Schedule 4) All products 1.0 per cent A — —
35 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone and its monoethanolamine salt [Piroctone olamine]

Products rinsed off after use

Other products

1.0 per cent

0.5 per cent

A

A

—

—

—

—

36 1,2-Dibromo-2,4-dicyanobutane [Methyldibromo glutaronitrile] All products 0.1 per cent Not to be used in cosmetic sunscreen products at a concentration exceeding 0.025 per cent —
37 6,6-Dibromo-4,4-dichloro-2,2'-methylenediphenol [Bromochlorophen] All products 0.1 per cent A — —
38 4-Isopropyl- m -cresol [o-Cymen-5-ol] All products 0.1 per cent — —
39 Mixture of 5-chloro-2-methylisothiazol-3( 2H )-one and 2-methylisothiazol-3( 2H )-one with magnesium chloride and magnesium nitrate [Methylchloro- isothiazolinone and Methylisothiazolinone] All products 0.0015 per cent of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol-3( 2H )-one to 2-methylisothiazol-3( 2H )-one — —
40 2-Benzyl-4-chlorophenol [Chlorophene] All products 0.2 per cent — —
41 2-Chloroacetamide [Chloroacetamide] All products 0.3 per cent — Contains chloroacetamide
42 Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride All products 0.3 per cent A — —
43 1-Phenoxypropan-2-ol [Phenoxyisopropanol] (see also Part I of Schedule 4) Products rinsed off after use 1.0 per cent — —
44 Alkyl (C12-C22)-trimethyl- ammonium bromide and chloride (Cetrimonium bromide (INN) and Cetrimonium chloride (INNM)) All products 0.1 per cent A — —
45 4,4-Dimethyl-1,3-oxazolidine [Dimethyloxazolidine] All products 0.1 per cent The pH of the finished product must not be lower than 6 —
46 1-[1,3-Bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea [Diazolidinyl urea] All products 0.5 per cent — —
47 Hexamidine (INN) (4,4'-(Hexamethylenedioxy)- dibenzamidine) and its salts, including isethionate and p -hydroxybenzoate All products 0.1 per cent A — —
48 Glutaraldehyde (pentane-1,5-dial) [Glutaral] All products 0.1 per cent Prohibited in aerosols (sprays) Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0.05 per cent
49 5-Ethyl-3,7-dioxa-1-azabicyclo[3.3.0]octane [7-Ethylbicyclo-oxazolidine] All products 0.3 per cent Prohibited in oral hygiene products and in products intended to come into contact with mucous membranes —
50 Chlorphenesin (INN) [Chlorphenesin] All products 0.3 per cent — —
51 Sodium N -hydroxymethyl- glycinate [Sodium hydroxymethylglycinate] All products 0.5 per cent — —
52 Silver chloride deposited on titanium dioxide Not to be used in products for children under three years of age, in oral hygiene products and in products intended for application around the eyes and on the lips 0.004 per cent. calculated as silver chloride The ratio of titanium dioxide to silver chloride shall be 4:1 by mass —
53 Benzethonium chloride (INN) [Benzethonium chloride] Products rinsed off after use 0.1 per cent — —
54 Benzalkonium chloride, bromide and saccharinate All products 0.1 per cent calculated as benzalkonoium chloride A — Avoid contact with eyes
55 Benzylhemiformal Products rinsed off after use 0.15 per cent — —
56 3-Iodoprop-2-ynyl butylcarbamate [Iodopropynyl butylcarbamate] Not to be used in oral hygiene and lip products 0.05 per cent — Contains iodine (Only required where the 3-iodoprop-2-ynyl butylcarbamate concentration in products intended to remain on the skin exceeds 0.02 per cent)

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

(1) (2) (3) (4) (5) (6) (7)
Reference Number Name of substance Purpose of substance or type of product Maximum concentration of substance in product Other requirements Required information Permitted for supply until
Note: There are no entries in this Part at the date that these Regulations are made.

Regulations 5(2) and 7(2)

SCHEDULE 7 LIST 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 24 ).

PART I UV 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

(1) (2) (3) (4) (5)
Reference Number Name of substance Maximum concentration of substance in product Other requirements Required information
1 4-Aminobenzoic acid [PABA] 5 per cent — —
2 N,N,N -Trimethyl-4-(2-oxoborn-3-ylidenemethyl)anilinium methyl sulphate [Camphor benzalkonium methosulfate] 6 per cent — —
3 Homosalate (INN) 10 per cent — —
4 Oxybenzone (INN) [Benzophenone-3] 10 per cent — Contains oxybenzone. (Not required when concentration is not more than 0.5 per cent, and when the substance is only intended to protect the product.)
5 ENTRY DELETED.
6 2-Phenylbenzimidazole-5-sulphonic acid [Phenylbenzimidazole sulfonic acid] and its potassium, sodium and triethanolamine salts 8 per cent (expressed as acid) — —
7 3,3'(1,4-Phenylenedimethylene)- bis(7,7-dimethyl-2-oxo-bicyclo[2.2.1]hept-1-ylmethanesulfonic acid) [Terephthalylidene dicamphor sulfonic acid] and its salts 10 per cent (expressed as acid) — —
8 1-(4- tert -Butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione (Avobenzone (INN)) [Butyl methoxy dibenzoylmethane] 5 per cent — —
9 α-(2-Oxoborn-3-ylidene)toluene-4-sulphonic acid [Benzylidene camphor sulfonic acid] and its salts 6 per cent (expressed as acid) — —
10 2-Ethylhexyl 2-cyano-3,3-diphenylacrylate [Octocrylene] 10 per cent (expressed as acid) — —
11 Polymer of N-[(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl]acrylamide [Polyacrylamidomethyl benzylidene camphor] 6 per cent — —
12 2-Ethylhexyl 4-methoxycinnamate [Octyl methoxycinnamate] 10 per cent — —
13 Ethoxylated ethyl-4-aminobenzoate [PEG-25 PABA] 10 per cent — —
14 Isopentyl 4-methoxycinnamate [Isoamyl p -methoxycinnamate] 10 per cent — —
15 Tris(2-ethylhexyl) 4,4'4"-(1,3,5-triazine-2,4,6-triyltriimino)tribenzoate [Octyl triazone] 5 per cent — —
16 2-( 2H -Benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[1,3,3,3-tetramethyl-1-(trimethylsilyloxy)disiloxan-1-yl]propyl]phenol [Drometrizole trisiloxane] 15 per cent — —
17 Bis(2-ethylhexyl) 4,4'-[6- tert -butylcarbamoylanilino)-1,3,5-triazine-2,4-diyldiimino]dibenzoate 10 per cent — —
18 3-(4-Methylbenzylidene)bornan-2-one [4-Methylbenzylidene camphor] 4 per cent — —
19 3-Benzylidenebornan-2-one [3-Benzylidene camphor] 2 per cent — —
20 2-Ethylhexyl salicylate [Octyl salicylate] 5 per cent — —
21 2-Ethylhexyl 4-dimethylaminobenzoate [Octyl dimethyl PABA] 8 per cent — —
22 2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid [Benzophenone-4] and its sodium salt [Benzophenone-5] (Sulisobenzone (INN) and Sulisobenzone sodium (INNM)) 5 per cent (expressed as acid) — —
23 2-2'-Methylenebis[6-( 2H -benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol] 10 per cent — —
24 di Sodium 2,2'-(1,4-phenylene)bis(1 H -benzimidazole-4,6-disulfonate) 10 per cent (expressed as acid) — —
25 5,5'-Bis(2-ethylhexyloxy)-2,2'-(6- p -methoxyphenyl-1,3,5-triazine-2,4-diyl)diphenol 10 per cent — —
26 α-(Trimethylsilyl)- w -(trimethylsilyloxy)poly- [dimethyl)silylene]- co -[oxy(methyl)(2-[ p -[2,2-bis(ethoxycarbonyl)-vinyl]- phenoxy]-1-methyleneethyl)silylene]- co -[oxy(methyl)(2-[ p -[2,2-bis(ethoxycarbonyl)vinyl)]- phenoxy]prop-1-enyl)silylene] where there are usually 60 polymeric units, of which the first part of the copolymer provides 56 (Dimethicodiethyl/Benzalmalonate) 10 per cent — —
27 Titanium dioxide. 25 per cent — —

PART II UV FILTERS LISTED IN ANNEX VII, 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

(1) (2) (3) (4) (5) (6)
Reference Number Name of substance Maximum concentration of substance in product Other requirements Required informationUV filter supplied until
Note: There are no entries in this Part at the date that these Regulations are made.

Regulation 5(5)

SCHEDULE 8 METHODS OF MANUFACTURE OF TALLOW DERIVATIVES

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

(a) transesterification or hydrolysis at at least 200°C, 40 bars (40,000 hPa) for 20 minutes (glycerol and fatty acids and esters);

(b) saponification with sodium hydroxide solution, c (NaOH) = 12 mol/1 (glycerol and soap)—

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

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

Regulations 7(6) and (11)

SCHEDULE 9 SYMBOL IN ANNEX VIII OF THE DIRECTIVE WHICH IS REQUIRED FOR THE PURPOSES OF REGULATION 7(6) AND (11)

Regulation 12

SCHEDULE 10

PART I PARTICULARS 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 DirectiveDirective;

(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 carried out in accordance with the requirements of regulation 9(2) and (3).

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 identity 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. —

(a) 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.

(b) 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.

(c) 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 II PROCEDURE 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 15

SCHEDULE 11 SAMPLING AND TESTING

1. In this Schedule—

“Annex A” means the Annex to Commission Directive No. 25 ) as amended by Commission Directive No. 26 );

“Annex B” means the Annex to Commission Directive No. 27 ) as amended by Commission Directive No. 28 );

“Annex C” means the Annex to Commission Directive No. 29 );

“Annex D” means the Annex to Commission Directive No. 30 );

“Annex E” means the Annex to Commission Directive No. 31 );

“Annex F” means the Annex to Commission Directive No. 32 );

“Annex G” means the Annex to Commission Directive No. 33 );

“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 I 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 I of Annex A; samples shall be regarded as having the same batch number if—

(a) the means of identifying the batch referred to in regulation 7(2)(g) 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)(g) 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)(g) 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 I 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 34 ), 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 I 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 mercaptoacctic 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.

( 2 )

S.I. 1972/1811 , S.I. 1975/1707 and S.I. 1993/2661 .

( 4 )

S.I. 1996/2925 . Substance number 631 is renumbered substance number 634 in Part I of Schedule 3 to these Regulations.

( 5 )

These substances with the same numbers are situated in Part I of Schedule 4 to these Regulations.

( 6 )

O.J. No. L132, 1.6.96, p. 1.

( 7 )

O.J. No. L140, 23.6.95, p. 26.

( 8 )

O.J. No. L262, 27.9.76, p. 169.

( 9 )

The Directive is within the scope of the EEA Agreement by virtue of Chapter XVI of Annex II to that Agreement.

( 10 )

O.J. No. L147, 31.5.01, p. 1.

( 11 )

An ingredient’s CTFA name is the name given to it by the Cosmetics, Toiletries and Fragrances Association (CTFA) and listed in the ninth edition of the International Cosmetic Ingredient Dictionary Handbook published in 2002. Its EINECS identification reference is the reference given in the European Inventory of Existing Commercial Chemical Substances. Its IUPAC identification reference is the reference given by the International Union of Pure and Applied Chemistry. Its CAS identification reference is the reference assigned by the Chemical Abstracts Service. An ingredient’s colour index number is the number specified in the third edition of The Colour Index published in 1971 by the Society of Dyers and Colourists. European Pharmacopoeia names, International Non-proprietary Names and EINECS, IUPAC and CAS identification references are listed in Commission Decision 96/335/EC (O.J. No. L132, 1.6.96, p. 1.).

( 12 )

O.J. No. L15, 17.1.87, p. 29, implemented by the Notification of New Substances (Amendment) Regulations 1991 (S.I. 1991/1914 ). Article 1 was amended by Commission Directive 1999/11/EC (O.J. No. L77, 23.3.99, p. 8.), implemented by the Good Laboratory Practice Regulations 1999 (S.I. 1999/3106 ).

( 13 )

1954 c. 61 .

( 14 )

1983 c. 54 .

( 15 )

S.I. 1991/824 , to which there is an amendment not relevant to these Regulations.

( 16 )

O.J. No. L159, 29.6.96, p. 1.

( 17 )

O.J. No. L147, 9.6.75, p. 13.

( 18 )

O.J. No. L132, 1.6.1996, p.1.

( 19 )

O.J. No. 115, 11.11.62, p. 2645.

( 20 )

Council Directives Nos. 65/469/EEC , 67/653/EEC , 68/419/EEC , 70/358/EEC , 76/399/EEC , 78/144/EEC , 81/20/EEC and 85/7/EEC (O.J. Nos. L178, 26.10.65, p. 2793; L263, 30.10.67, p. 4; L309, 24.12.68, p. 24; L157, 18.7.70, p. 36; L108, 26.4.76, p. 19; L44, 15.2.78, p. 20; L43, 14.2.81, p. 11; L2, 3.1.85, p. 22).

( 21 )

Annexes I and VII to the Act of Accession of 22nd January 1972, as adjusted by the Council Decision of 1st January 1973 (O.J. No. L2, 1,1,73, p.1).

( 22 )

Council Directive 94/36/EC (O.J. No. L237, 10.9.94, p. 13) and Commission Directive 95/45/EC (O.J. No. L226, 22.9.95, p. 1).

( 23 )

O.J. No. L132, 1.6.96, p.1.

( 24 )

O.J. No. L132, 1.6.96, p.1.

( 25 )

O.J. No. L383, 31.12.80, p. 27.

( 26 )

O.J. No. L57, 27.2.87, p. 56.

( 27 )

O.J. No. L185, 30.6.82, p. 1.

( 28 )

O.J. No. L108, 28.4.90, p. 92.

( 29 )

O.J. No. L291, 24.10.83, p. 9.

( 30 )

O.J. No. L295, 7.11.85, p. 30.

( 31 )

O.J. No. L231, 14.9.93, p. 34.

( 32 )

O.J. No. L178, 28.7.95, p. 20.

( 33 )

O.J. No. L213, 2.7.96, p. 8.

( 34 )

O.J. No. L57, 27.2.87, p. 56.

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
The Cosmetic Products (Safety) Regulations 2003 (2003/835)

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Status of this instrument

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Defined TermSection/ArticleIDScope of Application
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Changes that affect Made by
Sort descending by Changed Legislation Sort descending by Year and Number Changed Provision Type of effect Sort descending by Affecting Legislation Title Sort descending by Year and Number Affecting Provision Sort descending by Changes made to website text Note
The Cosmetic Products (Safety) Regulations 2003 2003 No. 835 rev (transtl savings) The Cosmetic Products (Safety) Regulations 2004 2004 No. 2152 regs 1(3) regs 1(4) 2 16(3) Sch 1 Not yet
The Cosmetic Products (Safety) Regulations 2003 2003 No. 835 reg. 9(2) words substituted The Good Laboratory Practice (Codification Amendments Etc.) Regulations 2004 2004 No. 994 reg. 4 Not yet

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