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 96/335/EC(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 95/17/EC(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 76/768/EEC(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 of the European Parliament and of the Council(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 87/18/EEC(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 1REVOCATIONS
(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 2COMMUNITY INSTRUMENTS AMENDING COUNCIL DIRECTIVE76/768/EEC
1. Council Directive 82/368/EEC (O.J. No. L167, 15.6.82, p. 1).
2. Commission Directive 82/147/EEC (O.J. No. L63, 6.3.82, p. 26).
3. Commission Directive 83/191/EEC (O.J. No. L109, 26.4.83, p. 25).
4. Commission Directive 83/341/EEC (O.J. No. L188, 13.7.83, p. 15).
5. Council Directive 83/574/EEC (O.J. No. L332, 28.11.83, p. 38).
6. Commission Directive 83/496/EEC (O.J. No. L275, 8.10.83, p. 20).
7. Commission Directive 84/415/EEC (O.J. No. L228, 25.8.84, p. 31).
8. Commission Directive 85/391/EEC (O.J. No. L224, 22.8.85, p. 40).
9. Commission Directive 86/179/EEC (O.J. No. L138, 24.5.86, p. 40).
10. Commission Directive 86/199/EEC (O.J. No. L149, 3.6.86, p. 38).
11. Commission Directive 87/137/EEC (O.J. No. L56, 26.2.87, p. 20).
12. Commission Directive 88/233/EEC (O.J. No. L105, 26.4.88, p. 11).
13. Council Directive 88/667/EEC (O.J. No. L382, 31.12.88, p. 46).
14. Commission Directive 89/174/EEC (O.J. No. L64, 8.3.89, p. 10).
15. Council Directive 89/679/EEC (O.J. No. L398, 30.12.89, p. 25).
16. Commission Directive 90/121/EEC (O.J. No. L71, 17.3.90, p. 40).
17. Commission Directive 91/184/EEC (O.J. No. L91, 12.4.91, p. 59).
18. Commission Directive 92/8/EEC (O.J. No. L70, 17.3.92, p. 23).
19. Commission Directive 92/86/EEC (O.J. No. L325, 11.11.92, p. 18).
20. Commission Directive 93/47/EEC (O.J. No. L203, 13.8.93, p. 24).
21. Council Directive 93/35/EEC (O.J. No. L151, 23.6.93, p. 32).
22. Commission Directive 94/32/EC (O.J. No. L181, 15.7.94, p. 31).
23. Commission Directive 95/34/EC (O.J. No. L167, 18.7.95, p. 19).
24. Commission Directive 96/41/EC (O.J. No. L198, 8.8.96, p. 36).
25. Commission Directive 97/18/EC (O.J. No. L114, 1.5.97, p. 43).
26. Commission Directive 97/45/EC (O.J. No. L196, 24.7.97, p. 77).
27. Commission Directive 98/16/EC (O.J. No. L77, 14.3.98, p. 44).
28. Commission Directive 98/62/EC (O.J. No. L253, 15.9.98, p. 20).
29. Commission Directive 2000/6/EC (O.J. No. L56, 1.3.00, p. 42).
30. Commission Directive 2000/11/EC (O.J. No. L65, 14.3.00, p. 22).
31. Commission Directive 2000/41/EC (O.J. No. L145, 20.6.00, p. 25).
32. Commission Directive 2002/34/EC (O.J. No. L102, 18.4.02, p. 19).
33. Commission Directive 2003/1/EC (O.J. No. L5, 10.1.03, p. 14).
34. Commission Directive 2003/16/EC (O.J. No. L46, 20.2.03, p. 24).
Regulations 5(2) and 6(1)
SCHEDULE 3LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN
The alphabetical list set out in column 2 of this Schedule contains one or more of the names of each of the substances referred to in regulation 5(2); in certain cases a name is given of a group of substances, the names of particular examples of which are also given, and in such a case all substances comprised in the group are included, whether or not more specifically named.
The 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 ISUBSTANCES 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-N10-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(3H)-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(3H)-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
(1R,4S,5R,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
(1R,4S,5R,8S)-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
(1R,2S)-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
11a-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-1lbH-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 -NH2 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-4H-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-2H-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. 75/319/EEC(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 D2 and D3
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 IISUBSTANCES 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 4LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS
In this Schedule, the matters specified in columns 3, 4, 5 and 6 which apply to a particular substance are those set out to the right of its name as mentioned in column 2; and the matters specified in columns 4, 5 and 6 which apply in any particular case are those set out to the right of the matter specified in column 3 which applies in that case. The substance may not be used except for the purposes or contained other than in the types of product specified in column 3. The concentration of the substance in a product may not exceed the limit specified in column 4: where the names of two or more substances are mentioned in a single item as set out in column 2 and a product contains more than one of those substances, the limit specified in column 4 is the limit for all of those substances taken together; and where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 5. In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.
Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC(18).
PART ISUBSTANCES 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 H2O2 present or released
4 per cent of H2O2 present or released
2 per cent of H2O2 present or released
0.1 per cent of H2O2 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 AlxZr(OH)yClz 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 C14 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 IISUBSTANCES 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-2H-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 5LIST OF COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT COLOURING AGENTS INTENDED SOLELY TO COLOUR HAIR AND EXCEPT SUBJECT TO RESTRICTIONS
In this Schedule the colouring agents referred to in regulation 5(2)(d) are—
(i)those identified in column 1 either by name or by colour index number (the colour index numbers being those specified in the 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 ICOLOURING AGENTS LISTED IN ANNEX IV, PART 1 OF THE DIRECTIVE AS COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN
Field of application
In column 3 of this Schedule, the entry “X” in a sub-column means that the colouring agent must not be used other than as follows—
Sub-column 1
=
Colouring agents allowed in all cosmetic products;
Sub-column 2
=
Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;
Sub-column 3
=
Colouring agents allowed exclusively in cosmetic products except cosmetic products intended to come into contact with the mucous membranes;
Sub-column 4
=
Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.
(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