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The Cosmetic Products (Safety) Regulations 2003


Published: 2003-03-20

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Statutory Instruments
2003 No. 835

CONSUMER PROTECTION
The Cosmetic Products (Safety) Regulations 2003

Made
20th March 2003

Laid before Parliament
24th March 2003

Coming into force (except as provided in regulation 1(2))
15th April 2003

Whereas the Secretary of State has, in accordance with section 11(5) of the Consumer Protection Act 1987(1), consulted such organisations as appear to her to be representative of interests substantially affected by these Regulations, such other persons as she considers appropriate and the Health and Safety Commission;
And whereas the Secretary of State is a Minister designated(2) for the purposes of section 2 of the European Communities Act 1972(3) in relation to measures for safety and consumer protection as respects cosmetic products and any provisions concerning the composition, labelling, marketing, classification or description of cosmetic products and in relation to indication of origin on imported goods;

Now, therefore, the Secretary of State in exercise of the powers conferred on her by sections 11, 28 and 30 of the 1987 Act and by section 2(2) of the 1972 Act, hereby makes the following Regulations—

Citation and commencement

1.  —

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

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

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

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

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

Revocation

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

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

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

Interpretation

3.  —

(1) In these Regulations—

“agent” means an agent established within the Community appointed by a manufacturer of a cosmetic product to act on his behalf in relation to these Regulations;

“common ingredients nomenclature” means the labelling nomenclature designated in the inventory of ingredients employed in cosmetic products, drawn up in accordance with the provisions of the Directive and contained in Commission Decision 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