
1996 No. 2925
CONSUMER PROTECTION
The Cosmetic Products (Safety) Regulations 1996
Made 21st November 1996
Laid before Parliament 25th November 1996
Coming into forcein accordance with regulation 1(1)–(8)

Whereas the Secretary of State has, in accordance with section 11(5) of the Consumer Protection Act 1987, consulted such organisations as appear to him to be representative of interests substantially affected by these Regulations, such other persons as he considers appropriate and the Health and Safety Commission:
And whereas the Secretary of State is a Minister designated for the purposes of section 2 of the European Communities Act 1972 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 powers conferred on him by sections 11, 28 and 30 of the said Act of 1987 and by section 2 of the said Act of 1972 and of all other powers enabling him in that behalf hereby makes the following Regulations:—
Citation, commencement and revocation
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(1) These Regulations may be cited as the Cosmetic Products (Safety) Regulations 1996 and except as provided by paragraphs (2) to (8) below shall come into force on 16th December 1996.
(2) Regulations 3(1)(b), 3(3), 4(4), 4(5), 6(1), 6(2)(h), 6(5)(a) (in so far as it relates only to regulation 6(2)(h)), 6(5)(b), 6(6), 6(7) and 6(9) to (12) shall come into force—
(a) on 1st January 1997 in relation to the supply of cosmetic products 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, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st January 1998; and
(b) in all other cases on 1st January 1998.
(3) The following provisions shall come into force in accordance with paragraph (4) below—
(a) regulation 4(2)(a) and Schedule 1, in so far as they relate only to entry numbers 81, 92, 98, 113, 132, 154, 356, 462, 489, 557, 620 and 743 in that Schedule;
(b) regulations 4(2)(e)(ii), 4(2)(f) and 4(2)(g) and Part II of Schedule 4, in so far as they relate only to the deletion of entry number 15 in that Part; and
(c) regulations 4(2)(h)(i) and 4(2)(i) and Part I of Schedule 5, in so far as they relate only to entry number 10 in that Part.
(4) The provisions referred to in paragraph (3) above shall come into force—
(a) on 16th December 1996 in relation to the supply of cosmetic products 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, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st July 1997; and
(b) in all other cases on 1st July 1997.
(5) The following provisions shall come into force in accordance with paragraph (6) below—
(a) regulation 4(2)(a) and Schedule 1, in so far as they relate only to entry numbers 342, 405 and 751 in that Schedule;
(b) regulation 4(2)(b) and Part I of Schedule 2, in so far as they relate only to entry numbers 15a, 15b and 15c in that Part;
(c) regulations 4(2)(e)(i) and 4(2)(f) and Part I of Schedule 4, in so far as they relate only to entry numbers 50, 51 and 52 in that Part;
(d) regulations 4(2)(e)(ii) and 4(2)(g) and Part II of Schedule 4, in so far as they relate only to the deletion of entry numbers 2 and 30 in that Part;
(e) regulations 4(2)(h)(i) and 4(2)(i) and Part I of Schedule 5, in so far as they relate only to entry number 11 in that Part; and
(f) regulations 4(2)(h)(ii) and 4(2)(i) and Part II of Schedule 5, in so far as they relate only to the deletion of entry numbers 33 and 34 in that Part.
(6) The provisions referred to in paragraph (5) above shall come into force—
(a) on 1st July 1997 in relation to the supply of cosmetic products 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, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st July 1998; and
(b) in all other cases on 1st July 1998.
(7) Paragraph 6(41) of Schedule 8 shall come into force on 30th September 1997.
(8) Regulation 4(3) shall come into force on 1st January 1998.
(9) Subject to paragraph (10) below, the Regulations specified in Schedule 9 hereto are revoked with effect from 16th December 1996 provided that the Cosmetic Products (Safety) Regulations 1989 shall continue to apply to cosmetic products which are supplied before 16th December 1996.
(10) The notes in Part I of Schedule 2, Part II of Schedule 4 and Part II of Schedule 5 shall apply.
Interpretation
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(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, as amended or substituted from time to time;
 “the Community” means the European Economic Community and other States in the European Economic Area;
 “the Confidentiality Directive” means Commission Directive 95/17/EC;
 “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, as amended by Council Directive 82/368/EEC, Commission Directive 82/147/EEC, Commission Directive 83/191/EEC, Commission Directive 83/341/EEC, Council Directive 83/574/EEC, Commission Directive 83/496/EEC, Commission Directive 84/415/EEC, Commission Directive 85/391/EEC, Commission Directive 86/179/EEC, Commission Directive 86/199/EEC, Commission Directive 87/137/EEC, Commission Directive 88/233/EEC, Council Directive 88/667/EEC, Commission Directive 89/174/EEC, Council Directive 89/679/EEC, Commission Directive 90/121/EEC, Commission Directive 91/184/EEC, Commission Directive 92/8/EEC, Commission Directive 92/86/EEC, Commission Directive 93/47/EEC, Council Directive 93/35/EEC, Commission Directive 94/32/EC, Commission Directive 95/34/EC, and Commission Directive 96/41/EC;
 “EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2 May 1992 as adjusted by the Protocol signed at Brussels on 17 March 1993;
 “market research experiment” means any activities conducted for the purpose of ascertaining the opinion of persons of—
(a) any cosmetic product; or
(b) anything in, on or with which the cosmetic product is supplied; or
(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—
(a) 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
(b) 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
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(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
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(1) The following provisions of this regulation are without prejudice to regulation 3 and are subject to regulation 5.
(2) No person shall supply a cosmetic product which contains—
(a) any substance listed in column 2 of Schedule 1, 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 Schedule 2, 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;
(c) any colouring agent listed in columns 1 and 2 of Schedule 3 with the exception of cosmetic products containing colouring agents 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;
(d) any colouring agent which is not listed in Schedule 3 with the exception of cosmetic products containing colouring agents intended solely to colour hair;
(e) any preservative listed in column 2 of Schedule 4 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;
(f) any preservative which is not listed in Schedule 4;
(g) any preservative listed in column 2 of Part II of Schedule 4 after the date specified in column 7 of that Part;
(h) any UV filter listed in column 2 of Schedule 5 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;
(i) any UV filter which is not listed in Schedule 5.
(3) No person shall supply a cosmetic product which contains any ingredients or combinations of ingredients which are tested on animals where such testing takes place after 1st January 1998 and is undertaken in order that the cosmetic product may satisfy any requirements of these Regulations.
(4) 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.
(5) No person shall supply any cosmetic product in respect of which the requirements of paragraph (4) above are not satisfied.
Authorisation by the Secretary of State
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(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 listed in Schedule 1 or 2.
(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 he considers appropriate for bringing it to the attention of persons who, in his opinion, would be likely to have an interest in it.
(5) No person shall be convicted of an offence under section 12 of the Consumer Protection Act 1987 by reason of a cosmetic product’s 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
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(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) and (13) to (16) 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 3 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 2, 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 4, 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 5, 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 sub-paragraph (a) of paragraph (2) above may be abbreviated if such abbreviation does not prevent the person concerned from being identified.
(4) The date referred to in sub-paragraph (b) of paragraph (2) above shall include the month and the year, and the month shall precede the year.
(5) The particulars referred to—
(a) in sub-paragraphs (b) to (f) and (h) of paragraph (2) above shall be in English, but this shall not prohibit the additional use of other languages;
(b) in paragraph (1) above shall be in a language easily understood by the consumer.
(6) Where it is impossible for practical reasons for the particulars referred to in sub-paragraphs (c) to (f) of paragraph (2) 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 6, 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 sub-paragraph (g) of paragraph (2) 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 sub-paragraphs (a) and (g) of paragraph (2) above, and in so far as any of the particulars referred to in sub-paragraphs (b) to (f) and (h) of paragraph (2) 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 sub-paragraphs (a) and (g) of paragraph (2) 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% may be listed in any order after those in concentrations of 1% 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 3;
(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 its common name as provided for in the common ingredients nomenclature or, in the absence of the nomenclature or of a common name, by its chemical name, its CTFA name, its European Pharmacopoeia name, its International Non-proprietary Name as recommended by the World Health Organisation, its EINECS, IUPAC or CAS identification reference or its colour index number.
(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 displayed 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 6, 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 sub-paragraphs (c) to (f) of paragraph (2) 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 displayed in immediate proximity to that container.
(15) In the case of a cosmetic product supplied before paragraph (6) above has come into force, where it is impracticable by reason of the size or shape of the container or packaging (if any) for the particulars referred to in sub-paragraphs (c) to (f) of paragraph (2) above to appear on the container and packaging, or on one of them, the said particulars shall appear on an enclosed leaflet and an indication shall appear on both the container and the packaging (if any) referring the consumer to the information in that leaflet.
(16) Where, before paragraph (7) above has come into force, a cosmetic product is supplied or delivered pursuant to any supply in a container and packaging and it is impracticable, for reasons of size, for the particulars referred to in sub-paragraph (g) of paragraph (2) above to appear on the container, the said particulars shall appear on the packaging.
Responsible Persons and Competent Authorities
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(1) For the purposes of regulations 8, 9, 10 and 11—
(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 he may from time to time appoint such persons as he thinks fit to be a United Kingdom competent authority in addition to or in substitution for himself.
Product Information
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(1) Subject to paragraph (5) 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 6(2)(a) 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 sub-paragraph (d) of paragraph (1) 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 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 sub-paragraph (e) of paragraph (1) above must be a registered pharmacist within the meaning of the Pharmacy Act 1954 or a registered medical practitioner within the meaning of the Medical Act 1983.
(4) 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.
(5) 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.
(6) 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.
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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.
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(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.
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(1) Without prejudice to the provisions of regulations 3, 4, 8 and 10, 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 6(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 7; 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 6(1), the said number to be allocated to the product in accordance with the procedure provided for in Part II of Schedule 7.
(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 regulations 8, 9 and 10
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(1) Subject to paragraph (2) below, any contravention of a requirement of regulation 8, 9 or 10 shall be treated for all purposes as though it were a contravention of a requirement of safety regulations made under section 11 of the Consumer Protection Act 1987.
(2) The term of imprisonment to which a person guilty of an offence of contravening any requirement of regulation 8, 9 or 10 shall be liable on summary conviction shall not exceed three months.
Enforcement
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(1) No proceedings shall be brought and no enforcement action taken in respect of—
(a) any failure to comply with regulations 3, 4, 6, 7, 8, 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 6(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 4(4), 4(5), 6(1), 6(2)(h), 6(5)(a) (in so far as it relates only to regulation 6(2)(h)), 6(5)(b), 6(6), 6(7) or 6(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, provided that, in the case of a failure to comply with regulation 6(6), the cosmetic product complies with the requirements of regulation 6(15) and, in the case of a failure to comply with regulation 6(7), the product complies with the requirements of regulation 6(16).
(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 Consumer Protection Act 1987.
14 
Any test of goods purchased under section 28 or seized under section 29 of the Consumer Protection Act 1987 (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 8 and any test for which a method is specified in paragraph 6 of Schedule 8 shall be carried out in accordance with that method.
John M Taylor
Parliamentary Under-Secretary of State for Corporate and Consumer Affairs,
Department of Trade and Industry
21st November 1996
SCHEDULE 1
LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN
Regulations 4(2) and 5(1)

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 4(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.

(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) 396 254
2 Acetonitrile — 393
3 3-(α-Acetonylbenzyl)-4-hydroxycoumarin and its salts 398, 760 203
4 2-Acetoxyethyltrimethylammonium hydroxide and its salts 6 2
5 2-Acetylamino-5-chlorobenzoxazole 164 1
6 Acetylcholine and its salts 4 2
7 Acetylene chlorides 249, 757 126
8 Acetylenic alcohols, their esters, ethers and salts 17 16
9 Acetylethyltetramethyltetralin (AETT) 341 362
10 7α-Acetylthio-3-oxopregn-4-ene-17α,17β-propionolactone 649 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 269, 314 14
15 Alkali pentacyanonitrosylferrate(2-) 602–3, 644–5 255
16 O-Alkyldithiocarbonic acids, salts of 761 336
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 492 20
22 2-Allyloxy-4-chloro-N-[2-(diethylamino)-ethyl]benzamide and its salts 18 19
23 Alypine and its salts 45, 109 143
24 Ambenonium chloride (INN) (527) 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 768 24
29 4-Amino-N-(2-diethylaminoethyl)benzamide, its salts and derivatives 607 25
30 Aminoheptane, its isomers and salts 748 25
31 6-Aminohexanoic acid and its salts 27 7
32 α-(Aminomethyl)-3,4-dihydroxybenzyl alcohol and its salts 517–8 257
33 4-Amino-N10-methylfolic acid 452 6
34 2-Amino-6-methylheptane and its salts 287, 523 28
35 2-Amino-4-methylhexane and its salts 288, 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 716 32
41 Aminoxylenes, their isomers, salts and halogenated and sulphonated derivatives 763 33
42 Amitriptyline (INN) and its salts 283 146
43 Ammi majus and its galencial preparations — 35
44 Amphetamine (INN), its salts and derivatives and salts of those derivatives (678) 21
45 Amydricaine and its salts 23, 109 143
46 Amylene chloride 250 36
47 Amyl 4-dimethylaminobenzoate, mixed isomers 532 381
48 Amyl nitrites — 247
49 Amylobarbitone and its salts (69) 220
50 Amylocaine and its salts 281 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 694 42
60 Apronalide 419 216
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 304 286
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 2 for alkaline earth sulphides, and lakes, salts and pigments prepared from those colouring agents identified in column 1 of Schedule 3 by “*” immediately after the name or colour index number) — 46
71 Bemegride (INN) and its salts 336, 337 183
72 Benactyzine (INN) 257 157
73 Bendrofluazide and its derivatives 74, 90 53
74 Bendroflumethiazide (INN) and its derivatives 73, 90 53
75 Benzamine and its salts 741 51
76 Benzatropine (INN) and its salts 300 158
77 Benzazepines, their salts and derivatives 89 49
78 Benzene — 47
79 Benzene-1,2-diol 153, 627 408
80 Benzene-1,2,3-triol 628 409
81 Benzethonium chloride (INN) 92 415
82 2-Benzhydryloxyethyldimethylamine and its salts 295 339
83 Benzidine 242 26
84 Benzilonium bromide (INN) 95 60
85 2-Benziloyloxymethyl-1,1-dimethylpyrrolidinium methyl sulphate 599 239
86 Benzimidazolone 87, 266 48
87 Benzimidazol-2(3H)-one 86, 266 48
88 Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol (except natural content of essences) 211 357
89 Benzodiazepines, their salts and derivatives 77 49
90 Benzothiadiazine and its derivatives 73, 74 53
91 Benzoyl peroxide — 382
92 Benzyl(dimethyl)(2-{2-[4-(1,1,3,3-tetramethybutyl)phenoxy]ethoxy}-ethyl)ammonium chloride 81 415
93 3-(N-Benzylhydrazinocarbonyl)-5-methylisoxazole 414 52
94 Benzylideneacetone 564 356
95 3-Benzyloxy-1,1-diethylpyrrolidine hydrobromide 84 60
96 4-Benzyloxyphenol (390), 487 178
97 2-[Benzyl-N-(2-pyridyl)amino]-ethyldimethylamine 623, 745 347
98 Bergapten(e) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg (356) 358
99 Beryllium and its compounds — 54
100 Betamethasone (INN) (360) 300
101 Betoxycaine (INN) and its salts 256 23
102 BHC (ISO) (gamma-BHC) 369, 371, 428 195
103 Bietamiverine (INN) 260 287
104 1,6-Bis(2-chloroethylamino)-1,6-dideoxymannitol and its salts 436 89
105 2-[Bis(2-chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane 2-oxide and its salts 108, 230 88
106 N,N-Bis(2-chloroethyl)methylamine and its salts 160, 490 87
107 N,N-Bis(2-chloroethyl)methylamine N-oxide and its salts 491 86
108 N,N-Bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-ylamine p-oxide and its salts 105, 230 88
109 1,1-Bis(dimethylaminomethyl)propyl benzoate and its salts 23, 45 143
110 Bis(hydroxyalkyl)amines, not further N-substituted 254, 273, 640 411
111 2,2-Bis(hydroxymethyl)butan-1-ol trinitrate 613 206
112 2,6-Bis(β-hydroxyphenethyl)-1-methylpiperidine and its salts 430 219
113 3,3-Bis(4-hydroxyphenyl)phthalide 557 417
114 Bis(8-hydroxyquinolinium) sulphate, except for the uses provided for in entry number 51 in Part 1 of Schedule 2 (400, 531) 395
115 Bithionol (INN) 705 352
116 Bretylium tosilate (INN) (Bretylium tosylate) 119 56
117 Bromine, elemental — 55
118 Bromisoval (INN) 121 58
119 p-Bromobenzylethyldimethylammonium p-toluenesulphonate 116 56
120 2-Bromo-2-ethylbutyrylurea 149 57
121 2-Bromo-3-methylbutylrylurea 118 58
122 1-p-Bromophenyl-1-(2-pyridyl)-3-dimethylaminopropane and its salts 123 59
123 Brompheniramine (INN) and its salts 122 59
124 Brucine — 62
125 Butanilicaine (INN) and its salts 466 90
126 Butobarbitone and its salts (69) 220
127 Butopiprine (INN) and its salts 129 288
128 2-Butoxy-N-(2-diethylaminoethyl)-cinchoninamide and its salts 191 129
129 2-Butoxyethyl phenyl(piperidino)acetate and its salts 127 288
130 1-Butyl-3-(N-crotonoylsulphanilyl)urea — 108
131 4-Butyl-1,2-diphenylpyrazolidine-3,5-dione 563 67
132 4-tert-Butyl-3-methoxy-2,6-dinitrotoluene 489 414
133 4-Butyl-1-phenylpyrazolidine-3,5-dione 486 64
134 1-Butyl-3-(p-methylbenzenesulphonyl)urea 715 65
135 1-Butyl-3-sulphanilylurea 150 66
136 4-Butylthiobenzhydryl 2-(dimethylamino)ethyl sulphide 143 140
137 Cadmium and its compounds — 68
138 Calabar bean 585 281
139 Calciferol 316, (759) 335
140 Cantharides, Cantharis vesicatoria 647 69
141 Cantharidin 378 70
142 Captan (ISO) 734 370
143 Captodiame (INN) 136 140
144 Caramiphen (INN) and its salts 567 169
145 N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethylammonium salts 418 156
146 Carbazole, nitroderivatives of 508 72
147 Carbon disulphide — 73
148 Carbon tetrachloride 690 315
149 Carbromal (INN) 120 57
150 Carbutamide (INN) 135 66
151 Carisoprodol (INN) 480 235
152 Catalase — 74
153 Catechol 79, 627 408
154 Cells, tissues or products of human origin — 416
155 Cephaeline and its salts — 75
156 Chenopodium ambrosioides (essential oil) — 76
157 Cherry laurel water 618 291
158 Chloral hydrate 732 77
159 Chlorine — 78
160 Chlormethine (INN) and its salts 106, 490 87
161 Chlormezanone (INN) 175 91
162 4-Chlorobenzene-1,3-disulfonamide 194 85
163 5-Chloro-1,3-benzoxazol-2(3H)-one 186 82
164 N-5-Chlorobenzoxazol-2-ylacetamide 5 1
165 2-Chloro-4-dimethylamino-6-methylpyrimidine 169, 216 83
166 2-Chloro-9-[3-(dimethylamino)-propylidene]thioxanthene (cis-form) and its salts 183 84
167 Chloroethane 327 96
168 Chloroform 733 366
169 2-Chloro-6-methylpyrimidin-4-yldimethylamine 165, 216 83
170 Chlorophacinone (ISO) 176 93
171 1-(p-Chloro-α-phenylbenzyl)-4-(2-hydroxyethoxyethyl)piperazine 401 240
172 2-(4-Chlorophenyl)-1-[4-(2-diethylaminoethoxyl)phenyl]-1-p-tolylethanol 744 92
173 4-[4-(4-Chlorophenyl)-4-hydroxypiperidin-1-yl]-1-(4-fluorophenyl)butan-1-one 368 185
174 2-(4-Chlorophenyl)-3-methylbutane-2,3-diol 551 95
175 2-(4-Chlorophenyl-3-methyl-1,3-thiazinan-4-one 1,1-dioxide 161 91
176 2-[2-(4-Chlorophenyl)-2-phenylacetyl]indane-1,3-dione 170 93
177 2-[1-(4-Chlorophenyl)-1-phenylethoxy]ethyl-(dimethyl)amine 180 94
178 Chloropicrin 735 325
179 3-(4-Chloro-3-sulphamoylphenyl)-3-hydroxyisoindolin-1-one 184, 185 262
180 Chlorphenoxamine (INN) 177 94
181 Chlorpromazine (INN) (558) 320
182 Chlorpropamide (INN) 614 79
183 Chlorprothixene (INN) and its salts 166 84
184 Chlortalidone (INN) 179, 185 262
185 Chlorthalidone 179, 184 262
186 Chlorzoxazone (INN) 163 82
187 Cholecalciferol (759) 335
188 Choline salts and their esters — 168
189 Chromium, chromic acid and salts of the acid — 97
190 Chrysoidine citrate hydrochloride 562 81
191 Cinchocaine (INN) and its salts 128 129
192 Cincophen (INN), its salts and derivatives and salts of those derivatives 577 8
193 Claviceps purpurea Tul., its alkaloids and galenical preparations 317 98
194 Clofenamide (INN) 162 85
195 Clofenotane (INN) 232, 731 123
196 Cobalt benzenesulphonate — 101
197 Cocculin 589 282
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 61554 — 389
210 Colouring agent CI 45170 and CI 45170:1 — 398
211 Coniferyl benzoate (except natural content of essences) 88 357
212 Coniine 615 290
213 Conium maculatum L. (fruit, powder, galenical preparations) — 99
214 Convallatoxin — 105
215 Coumetarol (INN) 454 225
216 Crimidine (ISO) 165, 169 83
217 Croton tiglium (oil) — 107
218 Curare and curarine — 109
219 Curarizants, synthetic — 110
220 1-(3-Cyano-3,3-diphenylpropyl)-4-ethoxycarbonyl-4-phenylpiperidinium chloride 296 80
221 Cyclarbamate (INN) 229 122
222 Cyclizine (INN) and its salts 301 159
223 Cyclobarbitone and its salts (69) 220
224 Cyclocoumarol 267 234
225 2-α-Cyclohexylbenzyl(N,N',N'-tetraethyl)trimethylenediamine 552 112
226 2-Cyclohexyl-3,5-dimethylphenol and its salts 228 113
227 1-Cyclohexyl-3-(p-methylbenzenesulphonyl)urea 363 100
228 Cyclomenol (INN) and its salts 226 113
229 Cyclopentane-1,1-dimethanol dicarbanilate 221 122
230 Cyclophosphamide (INN) and its salts 105, 108 88
231 Datura stramonium L. and its galenical preparations 651 301
232 DDT (ISO) (pp'-DDT) 195, 731 123
233 Deanol aceglumate (INN) 278 3
234 Decamethonium bromide (INN) (235) 214
235 Decamethylenebis(trimethylammonium) salts 234 214
236 Dextromethorphan (INN) and its salts 457 226
237 Dextropropoxyphene (INN) 280 116
238 O,O'-Diacetyl-N-allyl-N-normorphine — 117
239 2,4-Diaminoanisole and its salts 455, 461 376
240 2,5-Diaminoanisole and its salts 456, 460 377
241 1,2-Diaminobenzene and its salts 570 363
242 p,p'-Diaminodiphenyl 82 26
243 2-(2,4-Diaminophenyl)ethanol and its salts — 407
244 1,4:3,6-Dianhydrosorbitol 2,5-dinitrate 421 148
245 5-(α,β-Dibromophenethyl)-5-methylhydantoin — 119
246 Dibromosalicylanilides 247, 443 351
247 Dibromsalan (INN) (246) 351
248 Dichloroethanes 329, 334 125
249 Dichloroethylenes 7, 757 126
250 2,3-Dichloro-2-methylbutane 46 36
251 Dichlorosalicylanilides — 349
252 Dicoumarin 253, 469 231
253 Dicoumarol (INN) 252, 469 231
254 Diethanolamine (110, 640) 411
255 2-(Diethylaminoethoxy)ethyl α-phenylpiperidine-1-acetate dimethiodide 598 137
256 2-Diethylaminoethyl 3-amino-4-butoxybenzoate and its salts 101 23
257 2-Diethylaminoethyl benzilate 72 157
258 2-Diethylaminoethyl 4-ethoxybenzoate and its salts 410, 536 179
259 2-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts — 128
260 2-Diethylaminoethyl phenyl(piperidino)acetate 103 287
261 3-Diethylaminopropyl cinnamate — 130
262 Diethyl 4-nitrophenyl phosphate 534 170
263 O,O-Diethyl O-4-nitrophenyl phosphorothioate 535 131
264 Difencloxazine (INN) 566 270
265 Digitaline and all heterosides of Digitalis purpurea L. — 134
266 4,5-Dihydrobenzimidazol-4-one 86, 87 48
267 3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano[3,2-c]-[1]-benzopyran-5-one 224 234
268 Dihydrotachysterol (INN) — 342
269 3,4-Dihydroxy-α-(methylaminomethyl)benzyl alcohol 14, 314 14
270 4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene)dicoumarin — 207
271 1-(3,4-Dihydroxyphenyl)-2-ethylaminopropan-1-ol and its salts 293 136
272 1-(3,4-Dihydroxyphenyl)-2-isopropylaminoethanol 417, 420 17
273 Diisopropanolamine (110, 640) 411
274 5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite 412 361
275 Dimethoxane 285 368
276 4-[2-(3,4-Dimethoxyphenyl)ethyl]-1-(2-chlorophenyl)piperazine and its salts 438 141
277 Dimethylamine — 142
278 2-Dimethylaminoethyl N-acetylglutamate 233 3
279 2-Dimethylaminoethyl p-butylaminobenzoate and its salts 687 63
280 (+)-4-Dimethylamino-3-methyl-1,2-diphenyl-2-propionyloxybutane 237 116
281 1-Dimethylaminomethyl-1-methylpropyl benzoate and its salts 50 50
282 2-Dimethylaminopropiophenone and its salts 445 145
283 3-(3-Dimethylaminopropylidene)-1,2:4,5-dibenzocyclohepta-1,4-diene and its salts 42 146
284 1,1-Dimethylbiguanide and its salts 447 147
285 2,6-Dimethyl-1,3-dioxan-4-yl acetate 275 368
286 Dimethylformamide — 355
287 1,5-Dimethylhexylamine and its salts 34, 523 28
288 1,3-Dimethylpentylamine and its salts 35, 471 30
289 Dimethyl sulfoxide (INN) — 338
290 Dimevamide (INN) and its salts 297 153
291 Dinitrophenol isomers — 151
292 Dioxane — 343
293 Dioxethedrin (INN) and its salts 271 136
294 2,5-Dioxo-3,3-diethyl-5-methylpiperidine and its salts 483 133
295 Diphenhydramine (INN) and its salts 81 339
296 Diphenoxylate hydrochloride (INNM) 220 80
297 2,2-Diphenyl-4-dimethylaminovaleramide and its salts 290 153
298 5,5-Diphenyl-4-imidazolidone — 160
299 4-Diphenylmethoxy-1-methylpiperidine and its salts 305 154
300 3-Diphenylmethoxytropane and its salts 76 158
301 1-Diphenylmethyl-4-methylpiperazine and its salts 222 159
302 1,2-Diphenyl-4-(2-phenylsulphinylethyl)-pyrazolidine-3,5-dione 661 155
303 α,α-Diphenyl-2-piperidinemethanol and its salts 597 285
304 α,α-Diphenyl-4-piperidinemethanol and its salts 66 286
305 Diphenylpyraline (INN) and its salts 299 154
306 2,5-Dipropoxy-3,6-bis(ethyleneimino)-1,4-benzoquinone 409 152
307 4-Dipropylsulphamoylbenzoic acid 606 161
308 Disulfiram (INN) 699, 710 162
309 Dithio-2,2'-bis(pyridine 1-oxide) 1,1' (additive with trihydrated magnesium sulphate) 625 396
310 Doxylamine (INN) and its salts 576 176
311 Emetine, its salts and derivatives — 163
312 Endrin (ISO) 372 196
313 Ephedrine and its salts — 164
314 Epinephrine (INN) 14, 269 14
315 1,2-Epoxybutane — 400
316 Ergocalciferol (INN) 139, (759) 335
317 Ergot and its alkaloids 193 98
318 Eserine and its salts 586 166
319 Ethionamide (INN) 335 319
320 Ethoheptazine (INN) and its salts 476 173
321 Ethopropazine and its salts (558) 320
322 4-Ethoxyphenol (390) 178
323 4-Ethoxy-m-phenylenediamine and its salts — 406
324 2-Ethylamino-5-phenyloxazolin-4-one 344 180
325 Ethyl bis(4-hydroxycoumarinyl)acetate and salts of the acid 326 204
326 Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl)acetate and salts of the acid 325 204
327 Ethyl chloride 167 96
328 Ethyl 1,3-dimethyl-4-phenylazepane-4-carboxylate and its salts 446 171
329 Ethylene dichloride (248) 125
330 Ethylene oxide — 182
331 2-Ethyl-2,3-epoxyhexamide and its derivatives 528 165
332 Ethyl p-fluorophenyl sulphone 347 189
333 Ethyl 1-(2-hydroxy-2-phenylethyl)-4-phenylpiperidine-4-carboxylate and its salts 530 172
334 Ethylidene dichloride (248) 125
335 3-Ethylisothionicotinamide 319 319
336 3-Ethyl-3-methylglutarimide and its salts 71, 337 183
337 4-Ethyl-4-methylpiperidine-2,6-dione and its salts 71, 336 183
338 2-Ethyl-3-methylvaleramide 753 184
339 Ethylphenacemide 553, 565 272
340 2-Ethyl-2-phenylglutarimide and its salts 361 181
341 3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone 9 362
342 Ethyl urocanate (405) 418
343 Fenadiazole (INN) 526 208
344 Fenozolone (INN) 324 180
345 Fenyramidol (INN) 575, 579 274
346 Fluanisone (INN) 350 187
347 Fluoresone (INN) 332 189
348 4'-Fluoro-4-[4-hydroxy-4-(α,α,α-trifluoro-m-tolyl)piperino]butyrophenone 738 188
349 6-Fluoro-16-methyl-11β,17α,21-trihydroxypregna-1,4-diene-3,20-dione 533 186
350 1-(4-Fluorophenyl)-4-[4-(2-methoxyphenyl)-1-piperazinyl]butan-1-one 346 187
351 5-Fluoropyrimidine-2,4-dione 352 190
352 Fluorouracil (INN) 351 190
353 Fluphenazine (INN) (558) 320
354 Furazolidone (INN) 511 252
355 Furfuryltrimethylammonium salts 357 192
356 Furocoumarins (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg 98, 462, 620, 743 358
357 Furtrethonium iodide (INN) (355) 192
358 Galantamine (INN) — 193
359 Gallamine triethiodide (INN) 516 329
360 Glucocorticoids 100 300
361 Glutethimide (INN) and its salts 340 181
362 Glycerol trinitrate 512, 612 253
363 Glycyclamide (INN) 227 100
364 Gold salts — 296
365 Guaifenesin (INN) 459 230
366 Guanethidine (INN) and its salts 367 259
367 N-(2-Guanidinoethyl)azocane and its salts 366 259
368 Haloperidol (INN) 173 185
369 HCH (ISO) (gamma-HCH) 102, 371, 428 195
370 HETP 377 316
371 1,2,3,4,5,6-Hexachlorocyclohexane 102, 369, 428 195
372 (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 312 196
373 Hexachloroethane — 197
374 3,3',4,4',6,6'-Hexachloro-2,2'-methylenediphenol 375 371
375 Hexachlorophene (INN) 374 371
376 (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethanonaphthalene 415 198
377 Hexaethyl tetraphosphate 370 316
378 (1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride 141 70
379 (3S,5aR,9bS)-3,3a,4,5,5a,9b-Hexahydro-3,5a,9-trimethylnaphtho[1,2-b]furan-2,8-dione 636 217
380 Hexamethonium bromide (INN) (381) 124
381 N,N'-Hexamethylenebis(trimethylammonium) salts 380 124
382 Hexapropymate (INN) 616 115
383 Hydrastine, hydrastinine and their salts — 199
384 Hydrazides and their salts — 200
385 Hydrazine, its derivatives and their salts — 201
386 2-Hydrazino-octane and its salts 521 202
387 Hydrocyanic acid and its salts 389, 408, 601, 642 111
388 Hydrofluoric acid, its normal salts, complexes and hydrofluorides (except those listed in Part I of Schedule 2) — 191
389 Hydrogen cyanide and its salts 387, 408, 601, 642 111
390 Hydroquinone monobenzyl, monoethyl and monomethyl ethers 96, 322, 458, 487 178
391 7-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline 762 135
392 [4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid and its salts 739 5
393 3-[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]propionic acid and its salts 713 9
394 2-Hydroxy-3-(2-methoxyphenyl)propyl carbamate 450 205
395 1-Hydroxymethyl-1-cyclohexylacetic acid, sodium salt 643 114
396 4-Hydroxy-3-[1-(4-nitrophenyl)-3-oxobutyl]coumarin 1 254
397 8-Hydroxy-5-nitroquinoline and its salts 515 209
398 4-Hydroxy-3-(3-oxo-1-phenylbutyl)coumarin and its salts 3, 760 203
399 11α-Hydroxypregn-4-ene-3,20-dione and its esters — 385
400 Hydroxy-8-quinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 2 114, 531, 630 395
401 Hydroxyzine (INN) 171 240
402 Hyoscine, its salts and derivatives 638 295
403 Hyoscyamine, its salts and derivatives — 210
404 Hyoscyamus niger L.(leaves, seeds, powder and galenical preparations) — 211
405 3-Imidazol-4-ylacrylic acid and its ethyl ester 342, 751 418
406 2-Imino-5-phenyloxazolidin-4-one and its salts 538 212
407 Imperatorin 465 34
408 Inorganic cyanides (387, 389) 601, 642 111
409 Inproquone (INN) 306 152
410 Intracaine and its salts 258, 536 179
411 Iodine — 213
412 Iodothymol 274 361
413 Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations) — 215
414 Isocarboxazid (INN) 93 52
415 Isodrin 376 198
416 Isometheptene (INN) and its salts 463 228
417 Isoprenaline (INN) 272, 420 17
418 Isopropamide iodide (INN) (145) 156
419 (2-Isopropylpent-4-enoyl)urea 60 216
420 Isoproterenol 272, 417 17
421 Isosorbide dinitrate (INN) 244 148
422 Juniperus sabina L. (leaves, essential oil and galenical preparations) — 294
423 Laurel oil 424 359
424 Laurus nobilis L. (oil from seeds) 423 359
425 Lead and its compounds (except lead acetate subject to the restrictions laid down in entry number 55 in Part I of Schedule 2) — 289
426 Levophacetoperane and its salts 594 284
427 Lidocaine (INN) (Lignocaine) — 399
428 Lindane 102, 369, 371 195
429 Lobelia inflata L. and its galenical preparations — 218
430 Lobeline (INN) and its salts 112 219
431 LSD (433, 434) 127
432 Lupinidine and its salts 648 299
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 104 89
437 Mecamylamine (INN) 698 229
438 Mefeclorazine (INN) and its salts 276 141
439 Mephenesin (INN) and its esters 718 322
440 Meprobamate (INN) 481 236
441 Mercury and its compounds (except those listed in Part I of Schedule 4) — 221
442 Mescaline and its salts 740 222
443 Metabromsalan (INN) (246) 351
444 Metaldehyde 600 223
445 Metamfepramone (INN) and its salts 282 145
446 Metethoheptazine (INN) and its salts 328 171
447 Metformin (INN) and its salts 284 147
448 Methapyrilene (INN) and its salts 624 144
449 Metheptazine (INN) and its salts 468 174
450 Methocarbamol (INN) 394 205
451 Methohexitone and its salts (69) 220
452 Methotrexate (INN) 33 6
453 2-[4-Methoxybenzyl-N-(2-pyridyl)amino]-ethyldimethylamine maleate 622 346
454 1-Methoxy-2,2-bis(4-hydroxy-3-coumarinyl)ethane 215 225
455 1-Methoxy-2,4-diaminobenzene and its salts 239, 461 376
456 1-Methoxy-2,5-diaminobenzene and its salts 240, 460 377
457 (+)-3-Methoxy-N-methylmorphinan and its salts 236 226
458 4-Methoxyphenol (390) 178
459 3-(2-Methoxyphenoxy)propane-1,2-diol 365 230
460 2-Methoxy-p-phenylenediamine and its salts 240, 456 377
461 4-Methoxy-m-phenylenediamine and its salts 239, 455 376
462 Methoxypsoralens (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg (356) 358
463 6-Methylamino-2-methylhept-2-ene and its salts 416 228
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 407 34
466 2-Methyl-6-chloroanilide of n-butylaminoacetic acid and its salts 125 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) 252, 253 231
470 2-Methylheptylamine and its salts — 227
471 4-Methyl-2-hexylamine and its salts 35, 288 30
472 1-Methylimidazole-2-thiol 474, 704 233
473 N-N'-[(Methylimino)diethylene]bis-(ethyldimethylammonium) salts 67 121
474 1-Methyl-2-mercaptoimidazole 472, 704 233
475 Methylphenidate (INN) and its salts 572 175
476 1-Methyl-4-phenyl-4-carbethoxyhexa-methyleneimine and its salts 320 173
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 555 232
480 2-Methyl-2-propyl-1-isopropylcarbamoyloxy-3-carbamoyloxypropane 151 235
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 294 133
484 Metyrapone (INN) 464 292
485 Minoxidil (INN), its salts and derivatives 596 372
486 Mofebutazone (INN) 133 64
487 Monobenzone (INN) 96, (390) 178
488 Morpholine and its salts — 344
489 Musk ambrette 132 414
490 Mustine and its salts 106, 160 87
491 Mustine N-oxide and its salts 107 86
492 Nalorphine (INN), its salts and ethers 21 20
493 Naphazoline (INN) and its salts 499 244
494 2-Naphthol 495 241
495 β-Naphthol 494 241
496 1- and 2-Naphthylamines and their salts 497 242
497 α- and β-Naphthylamines and their salts 496 242
498 3-(1-Naphthyl)-4-hydroxycoumarin — 243
499 2-(1-Naphthylmethyl)-2-imidazoline and its salts 493 244
500 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
501 Narcotine and its salts 519 258
502 Neodymium and its salts — 309
503 Neostigmine and its salts — 245
504 Nicotine and its salts — 246
505 Nitrites, inorganic (except sodium nitrite) — 248
506 Nitrobenzene — 249
507 Nitrocresols and their alkali metal salts — 250
508 Nitroderivatives of carbazole 146 72
509 Nitrofurantoin (INN) 510 251
510 N-(5-Nitro-2-furfurylidene)-1-aminohydantoin 509 251
511 3-(5-Nitrofurfurylideneamino)oxazolidin-2-one 354 252
512 Nitroglycerine 362, 612 253
513 Nitrosamines — 410
514 Nitrostilbenes, their homologues and derivatives — 256
515 Nitroxoline (INN) and its salts 397 209
516 N,N,N,N',N',N',N",N",N"-Nonaethyl-2,2',2"-(benzene-1,2,3-triyltrioxy)-tris(ethanaminium) triiodide 359 329
517 Noradrenaline and its salts 32, 518 257
518 Norepinephrine (INN) and its salts 32, 517 257
519 Noscapine (INN) and its salts 501 258
520 Nux vomica and its preparations (658) 305
521 Octamoxin (INN) and its salts 386 202
522 Octamylamine (INN) and its salts — 267
523 Octodrine (INN) and its salts 34, 287 28
524 Oestrogens — 260
525 Oleandrin — 261
526 2-(1,3,4-Oxadiazol-2-yl)phenol 343 208
527 [Oxalylbis(iminoethylene)]bis[(o-chlorobenzyl)diethylammonium] salts 24 132
528 Oxanamide (INN) and its derivatives 331 165
529 2-Oxo-3-isobutyl-9,10-dimethoxy-1,2,3,4,6,7-hexahydro-11bH-benzo[a]quinolizine and its salts 685 139
530 Oxpheneridine (INN) and its salts 333 172
531 Oxyquinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 2 114, 400, 630 395
532 Padimate A 47 381
533 Paramethasone (INN) 349 186
534 Paraoxon 262 170
535 Parathion (ISO) 263 131
536 Parethoxycaine (INN) and its salts 258, 410 179
537 Pelletierine and its salts 595 263
538 Pemoline (INN) and its salts 406 212
539 Pentachloroethane — 264
540 Pentaerythritol chloral 549 266
541 Pentaerythritol tetranitrate 542, 548 265
542 Pentaerythrityl tetranitrate (INN) 541, 548 265
543 Pentamethonium bromide (INN) (544) 120
544 N,N'-Pentamethylenebis(trimethyl-ammonium) salts 543 120
545 Pentobarbitone and its salts (69) 220
546 Perchloroethylene 689 314
547 Perphenazine (INN) and its salts (558) 320
548 PETN 541, 542 265
549 Petrichloral (INN) 540 266
550 Phenacemide (INN) 561 269
551 Phenaglycodol (INN) 174 95
552 Phenetamine 225 112
553 Pheneturide (INN) 339, 565 272
554 Phenindone (INN) 571 271
555 Phenmetrazine (INN), its derivatives and salts 479 232
556 Phenobarbitone and its salts (69) 220
557 Phenolphthalein (INN) 113 417
558 Phenothiazine (INN) and its compounds various 320
559 Phenprobamate (INN) 573 71
560 Phenprocoumon (INN) 574 273
561 N-Phenylacetylurea 550 269
562 4-Phenylazophenylene-1,3-diamine citrate hydrochloride 190 81
563 Phenylbutazone (INN) 131 67
564 4-Phenylbut-3-en-2-one 94 356
565 (2-Phenylbutyryl)urea 339, 553 272
566 N-[2-(α-Phenyl-p-chlorobenzyl)-ethyl]morpholine 264 270
567 1-Phenylcyclopentanecarboxylic acid diethylaminoethyl ester and its salts 144 169
568 2-Phenylcyclopropylamine (trans-form) and its salts 719 324
569 1-Phenyl-2,3-dimethyl-4-isopropylpyrazol-5-one 617 138
570 o-Phenylenediamine and its salts 241 363
571 2-Phenylindan-1,3-dione 554 271
572 α-Phenyl-2-piperidineacetic acid methyl ester and its salts 475 175
573 3-Phenylpropyl carbamate 559 71
574 3-(α-Phenylpropyl)-4-hydroxycoumarin 560 273
575 1-Phenyl-2-(2-pyridylamino)ethanol 345, 579 274
576 2-[1-Phenyl-1-(2-pyridyl)ethoxy]-ethyldimethylamine and its salts 310 176
577 2-Phenylquinoline-4-carboxylic acid, its salts and derivatives and salts of those derivatives 192 8
578 6-Phenyl-2,4,7-triaminopteridine and its salts 722 275
579 Phenyramidol 345, 575 274
580 Phosphides, metal — 279
581 Phosphorus — 279
582 4-Phosphoryloxy-N,N-dimethyltryptamine 619 278
583 3-Phthalimidopiperidine-2,6-dione and its salts 701 280
584 Phthalylsulphathiazole (INN) and its salts (675) 307
585 Physostigma venenosum Balf. 138 281
586 Physostigmine and its salts 318 166
587 Phytolacca Spp and their preparations — 374
588 Picric acid 742 268
589 Picrotoxin 197 282
590 Pilocarpine and its salts — 283
591 Pilocarpus jaborandi Holmes and its galenical preparations — 311
592 Pipazetate (INN) and its salts 593 118
593 2-(2-Piperidinoethoxy)ethyl 10-thia-1,9-diazaanthracene-9-carboxylate and its salts 592 118
594 α-Piperidin-2-ylbenzyl acetate, laevorotatory threo-form and its salts 426 284
595 1-(2-Piperidyl)propan-2-one and its salts 537 263
596 6-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide, its salts and derivatives 485 372
597 Pipradrol (INN) and its salts 303 285
598 Piprocurarium iodide (INN) 255 137
599 Poldine metilsulfate (INN) (Poldine methylsulphate) 85 239
600 Polyacetaldehyde 444 223
601 Potassium cyanide (387, 389, 408) 111
602 Potassium nitroferricyanide (15), 603 255
603 Potassium nitroprusside (15), 602 255
604 Pramocaine (INN) 605 405
605 Pramoxine 604 405
606 Probenecid (INN) 307 161
607 Procainamide (INN), its salts and derivatives 29 25
608 Prochlorperazine (INN) and its salts (558) 320
609 Progestogens — 194
610 Promazine (INN) and its salts (558) 320
611 Promethazine (INN) and its salts (558) 320
612 Propane-1,2,3-triyl trinitrate 362, 512 253
613 Propatylnitrate (INN) 111 206
614 1-Propyl-3-(4-chlorobenzenesulphonyl)urea 182 79
615 2-Propylpiperidine 212 290
616 1-(2-Propynyl)cyclohexyl carbamate 382 115
617 Propyphenazone (INN) 569 138
618 Prunus laurocerasus L. 157 291
619 Psilocybine (INN) 582 278
620 Psoralen (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg (356) 358
621 Pyrethrum album L. and its galenical preparations — 345
622 Pyrianisamine maleate 453 346
623 Pyribenzamine 97, 745 347
624 2-(N-2-Pyridyl-N-2-thienylamino)ethyl-dimethylamine and its salts 448 144
625 Pyrithione disulphide+magnesium sulphate 309 396
626 Pyrithione sodium (INNM) — 369
627 Pyrocatechol 79, 153 408
628 Pyrogallol — 409
629 Quinalbarbitone and its salts (69) 220
630 Quinolin-8-ol except for the uses provided for in entry number 51 in Part I of Schedule 2 (400, 531) 395
631 Radioactive substances (except substances which are radioactive naturally or by reason of contamination from the environment, which have not been enriched for manufacturing purposes, and of which the concentration complies with Council Directive No. 76/579/Euratom) — 293
632 Rauwolfia serpentina alkaloids and their salts 633 15
633 Reserpine (INN) and its salts (632) 15
634 Retinoic acid and its salts 721, 758 375
635 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
636 α-Santonin 379 214
637 Schoenocaulon officinale Lind. (seeds and galenical preparations) — 332
638 Scopolamine, its salts and derivatives 402 295
639 Secbutobarbitone and its salts (69) 220
640 Secondary dialkanolamines 110, 254, 273 411
641 Selenium and its compounds except when permitted under the restrictions laid down in Part I of Schedule 2 — 297
642 Sodium cyanide (387, 389, 408) 111
643 Sodium hexacyclonate (INN) 395 114
644 Sodium nitroferricyanide (15), 645 255
645 Sodium nitroprusside (15), 644 255
646 Solanum nigrum L. and its galenical preparations — 298
647 Spanish Fly 140 69
648 Sparteine (INN) and its salts 432 299
649 Spironolactone (INN) 10 4
650 Squill and its preparations 750 330
651 Stramonium and its preparations 231 301
652 Strontium lactate — 402
653 Strontium nitrate — 403
654 Strontium polycarboxylate — 404
655 Strophanthines and their aglucones and their respective derivatives — 302
656 Strophanthus species and their galenical preparations — 303
657 Strychnine and its salts — 304
658 Strychnos species and their galenical preparations 520 305
659 Succinonitrile — 150
660 Succinylsulphathiazole and its salts (675) 307
661 Sulfinpyrazone (INN) 302 155
662 Sulphacetamide and its salts (675) 307
663 Sulphadiazine and its salts (675) 307
664 Sulphadimethoxine and its salts (675) 307
665 Sulphadimidine and its salts (675) 307
666 Sulphafurazole and its salts (675) 307
667 Sulphaguanidine and its salts (675) 307
668 Sulphamethizole and its salts (675) 307
669 Sulphamethoxazole and its salts (675) 307
670 Sulphamethoxydiazine and its salts (675) 307
671 Sulphamethoxypyridazine and its salts (675) 307
672 Sulphanilamide and its salts (675) 307
673 Sulphapyridine and its salts (675) 307
674 Sulphathiazole and its salts (675) 307
675 Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the −NH2 groups) and their salts 584, 660, 662–674 307
676 Sulthiame 677, 696 308
677 Sultiame (INN) 676, 696 308
678 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
679 Tefazoline (INN) and its salts 695 237
680 Tellurium and its compounds — 312
681 TEPP (ISO) 693 276
682 2-(4-tert-Butyl-2,6-dimethylbenzyl)-2-imidazoline and its salts 764 313
683 4-tert-Butylphenol — 340
684 4-tert-Butylpyrocatechol — 341
685 Tetrabenazine (INN) and its salts 529 139
686 Tetrabromosalicylanilides — 350
687 Tetracaine (INN) and its salts 279 63
688 2,3,7,8-Tetrachlorodibenzo-p-dioxin — 367
689 Tetrachloroethylene 546 314
690 Tetrachloromethane 148 315
691 Tetrachlorosalicylanilides — 348
692 Tetraethylammonium bromide 700 61
693 Tetraethyl pyrophosphate 681 276
694 (R)-5,6,6a,7-Tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol and its salts 59 42
695 2-(5,6,7,8-Tetrahydro-1-naphthylmethyl)-2-imidazoline and its salts 679 237
696 4-(Tetrahydro-2H-1,2-thiazin-2-yl)-benzenesulphonamide S,S-dioxide 676, 677 308
697 Tetrahydrozoline and its salts — 394
698 N,2,3,3-Tetramethyl-2-norcamphanamine 437 229
699 Tetramethylthiuram disulphide 710 162
700 Tetrylammonium bromide (INN) 692 61
701 Thalidomide (INN) and its salts 583 280
702 Thallium and its compounds — 317
703 Thevetia neriifolia Juss., glycoside extract — 318
704 Thiamazole (INN) 472, 474 233
705 2,2'-Thiobis(4,6-dichlorophenol) 115 352
706 Thiopentone and its salts (69) 220
707 Thioridazine (INN) and its salts (558) 320
708 Thiotepa (INN) 723 310
709 Thiourea and its derivatives (except those listed in Part I of Schedule 2) — 321
710 Thiram (ISO) 699 162
711 Thiuram disulphides — 354
712 Thiuram monosulphides — 353
713 Thyropropic acid (INN) and its salts 393 9
714 Tolboxane (INN) 717 177
715 Tolbutamide (INN) 134 65
716 Toluidines, their isomers, salts and halogenated and sulphonated derivatives 40 32
717 p-Tolylboric acid ester of 2-methyl-2-propylpropane-1,3-diol 714 177
718 3-o-Tolyloxypropane-1,2-diol (439) 322
719 Tranylcypromine (INN) and its salts 568 324
720 Tretamine (INN) 724 328
721 Tretinoin (INN) and its salts 634, 758 375
722 Triamterene (INN) and its salts 578 275
723 Tri(aziridin-1-yl)phosphine sulphide 708 310
724 2,4,6-Tri(aziridin-1-yl)-1,3-triazine 720 328
725 2,2,2-Tribromoethanol (726) 326
726 Tribromoethyl alcohol 725 326
727 Tribromsalan (INN) 728 373
728 3,4',5-Tribromosalicylanilide 727 373
729 Trichlormethine (INN) and its salts 746 327
730 Trichloroacetic acid — 10
731 1,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane 195, 232 123
732 2,2,2-Trichloroethane-1,1-diol 158 77
733 Trichloromethane 168 366
734 N-(Trichloromethylthio)cyclohex-4-ene-1,2-dicarboximide 142 370
735 Trichloronitromethane 178 325
736 Tricresyl phosphate 747 277
737 Trifluoperazine (INN) and its salts (558) 320
738 Trifluperidol (INN) 348 188
739 3,3',5-Triiodothyroacetic acid and its salts 392 5
740 3,4,5-Trimethoxyphenethylamine and its salts 442 222
741 2,2,6-Trimethyl-4-piperidyl benzoate and its salts 75 51
742 2,4,6-Trinitrophenol 588 268
743 Trioxysalen (INN) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg (356) 358
744 Triparanol (INN) 172 92
745 Tripelennamine (INN) 97, 623 347
746 Tris(2-chloroethyl)amine 729 327
747 Tritolyl phosphate 736 277
748 Tuaminoheptane (INN), its isomers and salts 30 27
749 Tyrothricin (INN) — 392
750 Urginea scilla Stern. and its galenical preparations 650 330
751 Urocanic acid (405) 418
752 Vaccines, toxins and serums listed in the Annex to Council Directive No. 75/319/EEC — 323
753 Valnoctamide (INN) 338 184
754 Veratrine, its salts and galenical preparations — 331
755 Veratrum spp and their preparations — 333
756 Vinyl chloride monomer — 334
757 Vinylidene chloride (7, 249) 126
758 Vitamin A acid and its salts 634, 721 375
759 Vitamins D2 and D3 139, 187, 316 335
760 Warfarin (ISO) and its salts 3, 398 203
761 Xanthates 16 336
762 Xanthinol 391 135
763 Xylidines, their isomers, salts and halogenated and sulphonated derivatives 41 33
764 Xylometazoline (INN) and its salts 682 313
765 Yohimbine and its salts — 337
766 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 2 and zirconium lakes, salts and pigments prepared from those colouring agents identified in column 1 of Part I of Schedule 3 by “*” immediately after the name or colour index number) — 391
767 Zoxazolamine (INN) 28 24

SCHEDULE 2
LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS
Regulations 4(2), 5(1) and 6(2)
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.

PART I SUBSTANCES LISTED IN ANNEX III, PART I 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
1 Boric acid Talcum powder 5 per cent Not to be used in products intended for children less than three years old Not to be used for children under three years of age
  Oral hygiene products 0.5 per cent — —
  Other products 3 per cent — —
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 abovementioned 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 abovementioned 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 Tosylchloramide 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 Dichloromethane 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-Phenylenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-phenylenediamines Oxidizing colouring agents for hair-dyeing for general use 6 per cent calculated as a free base, subject to the provision 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 phenylenediamines. 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 afree 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 released4 per cent of H2O2 present or released2 per cent of H2O2 present or released0.1 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 4) 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 2 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 2 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
  Agents for localised skin lightener 2 per cent — Contains hydroquinone. Avoid contact with eyes. Apply to small areas. If irritation develops discontinue use. Do not use on children under the age of 12
15a Potassium hydroxide and sodium hydroxide (see Note 1) 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
  Other uses — — —
15c Calcium hydroxide Hair straighteners containing two components: calcium hydroxide and guanidine salt 7 per cent — Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
  Other uses — — —
16 α-Naphthol[1-Naphthol] Colouring agent for hair dyeing 0.5 per cent — Contains α-napthol
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 0.5 per cent calculated as quinine base — —
  Hair lotions 0.2 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-hydroxybenzenesulphonate 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 monofluorophosphate 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 monofluorophosphate Oral hygiene products As for ammonium monofluorophosphate — Contains sodium monofluorophosphate
28 Potassium monofluorophosphate Oral hygiene products As for ammonium monofluorophosphate — Contains potassium monofluorophosphate
29 Calcium monofluorophosphate Oral hygiene products As for ammonium monofluorophosphate — Contains calcium monofluorophosphate
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)ammonium difluoride
38 N,N',N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride [Palmityl trihydroxyethyl propylenediamine dihydrofluoride] Oral hygiene products As for ammonium monofluorophosphate — Contains N,N',N'-tris(polyoxyethylene)-N-hexadecylpropylenediamine 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 4) 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 10The ratio of the number of (Al+Zr) atoms to chlorine atoms must be between 0.9 and 2.1Not 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 II of this Schedule) [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 careSoap 1.5 per cent expressed as etidronic acid0.2 per cent expressed as etidronic acid —— ——
54 1-Phenoxypropan-2-ol (See also Part I of Schedule 4) [Phenoxyisopropanol] Products rinsed off after use. Prohibited in oral hygiene products 2 per cent — —
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 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. Use by children is not advisable
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-nitrosodialkanolamine content: 50 μ g/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 μ g/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-nitrosodialkanolamine content: 50 μ g/kg (applies to raw materials). Keep in nitrite-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
Note 1: Entry 15a is substituted with effect from the dates specified in regulation 1(6). Until then, entry number 15 in Part I of Schedule 2 to S.I.1989/2233 continues in force.Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as percentage of sodium hydroxide. In cases of mixtures, the sum must not exceed the limits given in column (4).
PART II SUBSTANCES LISTED IN ANNEX III, PART 2 (FORMERLY ANNEX IV, PART 1) OF THE DIRECTIVEAS 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 use until
      
      
      
NOTE—There are presently no entries in this Part.Combination RulesA. 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.
SCHEDULE 3
LIST OF COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS AND EXCEPT COLOURING AGENTS INTENDED SOLELY TO COLOUR HAIR
Regulations 4(2) and 6(9)
In this Schedule the colouring agents referred to in regulation 4(2)(c) 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 1.
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 23 October 1962 on the approximation of the rules of member States concerning foodstuffs and colouring matter, as amended, adapted and replaced in part must fulfil the purity requirements laid down in those Directives.

PART I COLOURING AGENTS LISTED IN ANNEX IV PART 1 (FORMERLY ANNEX III PART 2) OF THE DIRECTIVEAS 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 index number Colour Type of product Field of application Other requirements
  1 2 3 4 
10006 Green    X 
10020 Green   X  
10316* Yellow  X   
11680 Yellow   X  
11710 Yellow   X  
11725 Orange    X 
11920 Orange X    
12010 Red   X  
12085* Red X    3 per cent maximum concentration in the finished product
12120 Red    X 
12150 Red X    
12370 Red    X 
12420 Red    X 
12480 Brown    X 
12490 Red X    
12700 Yellow    X 
13015 Yellow X    E 105
14270 Orange X    E 103
14700 Red X    
14720 Red X    E 122
14815 Red X    E 125
15510* Orange  X   
15525 Red X    
15580 Red X    
15620 Red    X 
15630* Red X    3 per cent maximum concentration in the finished product
15800 Red   X  
15850* Red X    
15865* Red X    
15880 Red X    
15980 Orange X    E 111
15985* Yellow X    E 110
16035 Red X    
16185 Red X    E 123
16230 Orange   X  
16255* Red X    E 124
16290 Red X    E 126
17200* Red X    
18050 Red   X  
18130 Red    X 
18690 Yellow    X 
18736 Red    X 
18820 Yellow    X 
18965 Yellow X    
19140* Yellow X    E 102
20040 Yellow    X Maximum 3,3'-dimethyl-benzidine concentration in the colouring agent: 5 mg/kg
20170 Orange   X  
20470 Black    X 
21100 Yellow    X Maximum 3,3'-dichloro-benzidine concentration in the colouring agent: 5 mg/kg
21108 Yellow    X Maximum 3,3'-dichloro-benzidine concentration in the colouring agent: 5 mg/kg
21230 Yellow   X  
24790 Red    X 
26100 Red   X  Purity criteria: aniline ≤0.2 per cent, 2-naphthol ≤0.2 per cent, azobenzen-4-amine ≤0.1 per cent, 1-phenylazo-2-naphthol ≤3 per cent, 1-[2-(phenylazo)phenylazo]-2-naphthol ≤2 per cent
27290* Red    X 
27755 Black X    E 152
28440 Black X    E 151
40215 Orange    X 
40800 Orange X    
40820 Orange X    E 160e
40825 Orange X    E 160f
40850 Orange X    E 161g
42045 Blue   X  
42051* Blue X    E 131
42053 Green X    
42080 Blue    X 
42090 Blue X    
42100 Green    X 
42170 Green    X 
42510 Violet   X  
42520 Violet    X Maximum concentration in the finished product: 5 mg/kg
42735 Blue   X  
44045 Blue   X  
44090 Green X    E 142
45100 Red    X 
45190 Violet    X 
45220 Red    X 
45350 Yellow X    6 per cent maximum concentration in the finished product
45370* Orange X    Not more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 2 per cent 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid
45380* Red X    as immediately above
45396 Orange X    When used in lipstick, the colouring agent is allowed only in free acid form and in a maximum concentration of 1 per cent
45405 Red  X   Not more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 2 per cent 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid
45410* Red X    as immediately above
45425 Red X    Not more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 3 per cent 2-(iodo-6-hydroxyl-3-oxo-3H-xanthen-9-yl)benzoic acid
45430* Red X    as immediately above, E 127
47000 Yellow   X  
47005 Yellow X    E 104
50325 Violet    X 
50420 Black   X  
51319 Violet    X 
58000 Red X    
59040 Green   X  
60724 Violet    X 
60725 Violet X    
60730 Violet   X  
61565 Green X    
61570 Green X    
61585 Blue    X 
62045 Blue    X 
69800 Blue X    E 130
69825 Blue X    
71105 Orange   X 
73000 Blue X    
73015 Blue X    E 132
73360 Red X    
73385 Violet X    
73900 Violet    X 
73915 Red    X 
74100 Blue    X 
74160 Blue X    
74180 Blue    X 
74260 Green  X   
75100 Yellow X    
75120 Orange X    E 160b
75125 Yellow X    E 160d
75130 Orange X    E 160a
75135 Yellow X    E 161d
75170 White X    
75300 Yellow X    E 100
75470 Red X    E 120
75810 Green X    E 140 and E 141
77000 White X    E 173
77002 White X    
77004 White X    
77007 Blue X    
77015 Red X    
77120 White X    
77163 White X    
77220 White X    E 170
77231 White X    
77266 Black X    
77267 Black X    
77268:1 Black X    E 153
77288 Green X    Free from chromate ions
77289 Green X    Free from chromate ions
77346 Green X    
77400 Brown X    
77480 Brown X    E 175
77489 Orange X    E 172
77491 Red X    E 172
77492 Yellow X    E 172
77499 Black X    E 172
77510 Blue X    Free from cyanide ions
77713 White X    
77742 Violet X    
77745 Red X    
77820 White X    E 174
77891 White X    E 171
77947 White X    
Acid red 195 Red   X 
Aluminium, zinc, magnesium and calcium stearates White X    
Anthocyanins Red X    E 163
Beetroot red Red X    E 162
Bromocresol green Green    X 
Bromothymol blue Blue    X 
Caramel Brown X    E 150
Capsanthin, capsorubin Orange X    E 160c
Lactoflavin Yellow X    E 101
PART II COLOURING AGENTS LISTED IN ANNEX IV OF PART 2 OF THE DIRECTIVEAS COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE COSMETIC PRODUCT SUPPLIED BEFORE A CERTAIN DATE
Field of application
In column 3 of this Schedule, the entry “X” in a sub-column means that the colouring agent must not be used other than as follows—
 Sub-column 1 = Colouring agents allowed in all cosmetic products;
 Sub-column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;
 Sub-column 3 = Colouring agents allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes;
 Sub-column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.

(1) (2) (3) (4) (5)
Name or colour index number Colour Type of product Field of application Other requirements Cosmetic product supplied until
  1 2 3 4  
       
       
       
NOTE: There are presently no entries in this part.
SCHEDULE 4
LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS
Regulations 4(2) and 6(2)
In this Schedule, the matters specified in columns 3, 4, 5 and 6 which apply to a particular substance are those set out to the right of its name as mentioned in column 2; and the matters specified in columns 4, 5 and 6 which apply in any particular case are those set out to the right of the matter specified in column 3 which applies in that case. The substance may not be used or contained other than in the types of product specified in column 3. The concentration of the substance, when it is used as a preservative, in a product may not exceed the limit set out in column 4. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 5.
In column 4 of this Schedule, “A” indicates that the concentration of the substance in a product may exceed the limit set out in that column provided that—
(a) the presence of any excess of the substance in a product over the concentration so set out is not for the primary purpose of inhibiting the development of micro-organisms; and
(b) the purpose for which any such excess is present in the product is apparent from the labelling of the product.
In this Schedule—
 “salts” means salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines and of the anions chloride, bromide, sulphate and acetate;
 “esters” means esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl and phenyl.
In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.
All preservative substances containing formaldehyde or any substances named in this Schedule which release formaldehyde must be labelled with the warning “contains formaldehyde” when the concentration of formaldehyde in the final product exceeds 0.05 per cent.
Names which appear in square brackets in column 2 of this Schedule are the 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.

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

(1) (2) (3) (4)  (5) (6)
Reference Number Name of substance Purpose of substance or type of product Maximum concentration of substance in product  Other requirements Required information
1 Benzoic acid, its salts and esters All products 0.5 per cent (acid) A — —
2 Propionic acid and its salts All products 2 per cent (acid) A — —
3 Salicylic acid and its salts All products 0.5 per cent (acid) A Not to be used in preparations for children under three years of age except for shampoos Not to be used for children under three years of age (Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin)
4 Sorbic acid (hexa-2,4-dienoic acid) and its salts All products 0.6 per cent (acid) A — —
5 Formaldehyde and paraformaldehyde For oral hygiene 0.1 per cent (expressed as free formaldehyde)  Not to be used in aerosol dispensers (sprays) —
  Except for oral hygiene (see also Part I of Schedule 2) 0.2 per cent (expressed as free formaldehyde)   
6 ENTRY DELETED     
7 Biphenyl-2-ol [o-phenylphenol] and its salts All products 0.2 per cent (expressed as the phenol) A — —
8 Pyrithione zinc (INN) [Zinc pyrithione] Products rinsed off after use 0.5 per cent A Not to be used in oral hygiene products —
9 Inorganic sulphites and hydrogen sulphites All products 0.2 per cent (expressed as free SO2) A — —
10 Sodium iodate Products rinsed off after use 0.1 per cent  — —
11 Chlorobutanol (INN) All products 0.5 per cent  Not to be used in aerosol dispensers (sprays) Contains chlorobutanol
12 4-Hydroxybenzoic acid and its salts and esters [the Parabens] All products 0.4 per cent (acid) for 1 ester, 0.8 per cent (acid) for mixtures of esters A — —
13 3-Acetyl-6-methylpyran-2,4(3H)-dione [Dehydroacetic acid] and its salts All products 0.6 per cent (acid)  Not to be used in aerosol dispensers (sprays) —
14 Formic acid and its sodium salt All products 0.5 per cent (expressed as acid) A — —
15 3,3'-Dibromo-4,4'-hexamethylene-dioxydibenzamidine [Dibromohexamidine] and its salts (including isethionate) All products 0.1 per cent  — —
16 Thiomersal (INN) [Thimerosal] Eye make-up and eye make-up remover 0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent  — Contains thiomersal
17 Phenylmercuric salts (including borate) Eye make-up and eye make-up remover 0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent  — Contains phenylmercuric compounds
18 Undec-10-enoic acid [Undecylenic acid] and its salts All products 0.2 per cent (acid) A — —
19 Hexetidine (INN) Products rinsed off after use 0.1 per cent A — —
20 5-Bromo-5-nitro-1,3-dioxane Products rinsed off after use 0.1 per cent  Avoid formation of nitrosamines —
21 Bronopol (INN) [2-Bromo-2-nitropropane-1,3-diol] All products 0.1 per cent A Avoid formation of nitrosamines —
22 2,4-Dichlorobenzyl alcohol [Dichlorobenzyl alcohol] All products 0.15 per cent A — —
23 Triclocarban (INN) All products 0.2 per cent A Purity criteria:3,3'4,4'-tetrachloro-azobenzene<1 mg/kg3,3',4,4'-tetrachloro-azoxybenzene<1 mg/kg —
24 4-Chloro-m-cresol [p-Chloro-m-cresol] Not to be used in products intended to come into contact with mucous membranes 0.2 per cent A — —
25 Triclosan (INN) All products 0.3 per cent A — —
26 4-Chloro-3,5-xylenol [Chloroxylenol] All products 0.5 per cent A — —
27 3,3'-Bis(1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea [Imidazolidinyl urea] All products 0.6 per cent A — —
28 Poly(1-hexamethylene-biguanide hydrochloride) [Polyaminopropyl biguanide] All products 0.3 per cent A — —
29 2-Phenoxyethanol [Phenoxyethanol] All products 1.0 per cent A — —
30 Hexamethylenetetramine (Methenamine (INN)) [Methenamine] All products 0.15 per cent A — —
31 Methenamine 3-chloroallylochloride (INNM) [Quaternium-15] All products 0.2 per cent  — —
32 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one (Climbazole (INN)) [Climbazole] All products 0.5 per cent A — —
33 1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione [DMDM Hydantoin] All products 0.6 per cent A — —
34 Benzyl alcohol (See also Part I of Schedule 2) All products 1.0 per cent A — —
35 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone and its monoethanolamine salt [Piroctone olamine] Products rinsed off after useOther products 1.0 per cent0.5 per cent AA —— ——
36 1,2-Dibromo-2,4-dicyanobutane [Methyldibromo glutaronitrile] All products 0.1 per cent  Not to be used in cosmetic sunscreen products at a concentration exceeding 0.025 per cent —
37 6,6-Dibromo-4,4-dichloro-2,2'-methylenediphenol [Bromochlorophen] All products 0.1 per cent A — —
38 4-Isopropyl-m-cresol [o-Cymen-5-ol] All products 0.1 per cent  — —
39 Mixture of 5-chloro-2-methylisothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate [Methylchloroisothiazolinone and Methylisothiazolinone] All products 0.0015 per cent of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol-3(2H)-one to 2-methylisothiazol-3(2H)-one  — —
40 2-Benzyl-4-chlorophenol [Chlorophene] All products 0.2 per cent  — —
41 2-Chloroacetamide [Chloroacetamide] All products 0.3 per cent  — Contains chloroacetamide
42 Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride All products 0.3 per cent A — —
43 1-Phenoxypropan-2-ol [Phenoxyisopropanol] (see also Part I of Schedule 2) Products rinsed off after use 1.0 per cent  — —
44 Alkyl (C12-C22)-trimethylammonium bromide and chloride (Cetrimonium bromide (INN) and Cetrimonium chloride (INNM)) All products 0.1 per cent A — —
45 4,4-Dimethyl-1,3-oxazolidine [Dimethyl oxazolidine] All products 0.1 per cent  The pH of the finished product must not be lower than 6 —
46 1-[1,3-Bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea [Diazolidinyl urea] All products 0.5 per cent  — —
47 Hexamidine (INN) (4,4'-(Hexamethylene-dioxy)dibenzamidine) and its salts, including isethionate and p-hydroxybenzoate All products 0.1 per cent A — —
48 Glutaraldehyde (pentane-1,5-dial) [Glutaral] All products 0.1 per cent  Prohibited in aerosols (sprays) Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0.05 per cent)
49 5-Ethyl-3,7-dioxa-1-azabicyclo[3.3.0]octane[7-Ethylbicyclooxazolidine] All products 0.3 per cent  Prohibited in oral hygiene products and in products intended to come into contact with mucous membranes —
50 Chlorphenesin (INN) [Chlorphenesin] All products 0.3 per cent  — —
51 Sodium N-hydroxymethylglycinate [Sodium hydroxymethyl-glycinate] All products 0.5 per cent  — —
52 Silver chloride deposited on titanium dioxide Not to be used in products for children under three years of age, in oral hygiene products and in products intended for application around the eyes and on the lips 0.004 per cent calculated as silver chloride  The ratio of titanium dioxide to silver chloride shall be 4:1 by mass —
PART II PRESERVATIVES LISTED IN ANNEX VI PART 2 OF THE DIRECTIVEAS PRESERVATIVES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE

(1) (2) (3) (4) (5) (6) (7)
Reference Number in Annex VI Part 2 of the Directive Name of substance Purpose of substance or type of product Maximum concentration of substance in product Other requirements Required information Preservative supplied until
1 to 15 ENTRIES DELETED (see Note)     
16 Benzalkonium chloride (INN), bromide and saccharinate (Alkyl(C8-C18) benzyldimethyl-ammonium chloride, bromide and saccharinate) All products 0.1 per cent A — — 30.06.1997
17 to 20 ENTRIES DELETED     
21 Benzylhemiformal (a 1:1 mixture of benzyloxymethanol and benzyloxy-methoxymethanol) Products rinsed off after use 0.03 per cent — — 30.06.1997
22 to 28 ENTRIES DELETED     
29 3-lodoprop-2-ynyl butylcarbamate All products 0.1 per cent — — 30.06.1997
30 ENTRY DELETED (see Note)     
Note: Entry number 15 is deleted with effect from the dates specified in regulation 1(4) and entry numbers 2 and 30 are deleted with effect from the dates specified in regulation 1(6). Until then entry number 15 in Part II of Schedule 4 to S.I. 1989/2233 (as amended by S.I. 1995/1478 but not by S.I. 1996/1446) and entry numbers 2 and 30 in Part II of Schedule 4 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force.
SCHEDULE 5
LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS
Regulations 4(2) and 6(2)
In this Schedule, the matters specified in columns 3, 4 and 5 which apply to a particular substance are those set out to the right of its name as mentioned in column 2. The concentration of the substance in a product may not exceed the limit specified in column 3. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 4. In column 3 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.
Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC

PART I UV FILTERS LISTED IN ANNEX VII PART I OF THE DIRECTIVEAS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

(1) (2) (3) (4) (5)
Reference Number Name of substance Maximum concentration of substance in product Other requirements Required information
1 4-Aminobenzoic acid [PABA] 5 per cent — —
2 N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl)anilinium methyl sulphate [Camphor benzalkonium methosulfate] 6 per cent — —
3 Homosalate (INN) 10 per cent — —
4 Oxybenzone (INN) [Benzophenone-3] 10 per cent — Contains oxybenzone. (Not required when concentration is not more than 0.5 per cent, and when the substance is only intended to protect the product.)
5 ENTRY DELETED   
6 2-Phenylbenzimidazole-5-sulphonic acid [Phenylbenzimidazole sulfonic acid] and its potassium, sodium and triethanolamine salts 8 per cent (expressed as acid) — —
7 3,3'-(1,4-Phenylenedimethylene)bis(7,7-dimethyl-2-oxo-bicyclo[2.2.1]hept-1-ylmethanesulfonic acid) [Terephthalylidene dicamphor sulfonic acid] and its salts 10 per cent (expressed as acid) — —
8 1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl) propane-1,3-dione (Avobenzone (INN)) [Butyl methoxy dibenzoylmethane] 5 per cent — —
9 α-(2-Oxoborn-3-ylidene)toluene-4-sulphonic acid [Benzylidene camphor sulfonic acid] and its salts 6 per cent (expressed as acid) — —
10 2-Ethylhexyl-2-cyano-3,3-diphenylacrylate [Octocrylene] 10 per cent (expressed as acid) — —
11 Polymer of N-{(2 and 4)-[2-oxoborn-3-ylidene)methyl]benzyl}acrylamide [Polyacrylamidomethyl benzylidene camphor] 6 per cent — —
PART II UV FILTERS LISTED IN ANNEX VII PART 2 OF THE DIRECTIVEAS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE

(1) (2) (3) (4) (5) (6)
Reference Number Name of substance Maximum concentration of substance in product Other requirements Required information UV filter supplied until
1 ENTRY DELETED    
2 Ethoxylated ethyl 4-aminobenzoate [PEG-25 PABA] 10 per cent — — 30.6.1997
3–4 ENTRIES DELETED    
5 2-Ethylhexyl 4-dimethylamino-benzoate [Octyl dimethyl PABA] 8 per cent — — 30.6.1997
6 2-Ethylhexyl salicylate [Octyl salicylate] 5 per cent — — 30.6.1997
7–11 ENTRIES DELETED    
12 Isopentyl 4-methoxycinnamate, mixed isomers [Isoamyl p-methoxycinnamate] 10 per cent — — 30.6.1997
13 2-Ethylhexyl 4-methoxycinnamate [Octyl methoxycinnamate] 10 per cent — — 30.6.1997
14–16 ENTRIES DELETED    
17 2-Hydroxy-4-methoxybenzo-phenone-5-sulphonic acid [Benzophenone-4] and its sodium salt [Benzophenone-5] (Sulisobenzone (INN) and Sulisobenzone sodium (INNM)) 5 per cent (expressed as acid) — — 30.6.1997
18–24 ENTRIES DELETED    
25 3-(4-Methylbenzyl-idene)bornan-2-one [4-Methylbenzylidene camphor] 6 per cent — — 30.6.1997
26 3-Benzylidenebornan-2-one [3-Benzylidene camphor] 6 per cent — — 30.6.1997
27–28 ENTRIES DELETED    
29 4-Isopropylbenzyl salicylate [Isopropylbenzyl salicylate] 4 per cent — — 30.6.1997
30–31 ENTRIES DELETED    
32 Tris(2-ethylhexyl) 4,4',4"-(1,3,5-triazin-2,4,6-triyltriimino)- tribenzoate [Octyl triazone] 5 per cent — — 30.6.1997
33–34 ENTRIES DELETED (see Note)    
Note: Entry numbers 33 and 34 are deleted with effect from the dates specified in regulation 1(6). Until then the corresponding entries in Part II of Schedule 5 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force.
SCHEDULE 6
SYMBOL IN ANNEX VIII OF THE DIRECTIVE WHICH IS REQUIRED FOR THE PURPOSES OF REGULATIONS 6(6) AND 6(11)
Regulations 6(6) and (11)

SCHEDULE 7
Regulation 11
PART I PARTICULARS TO BE INCLUDED WITH A REQUEST FOR CONFIDENTIALITY
1 
The name or trade name and address or registered office of the applicant.
2 
Precise identification of the cosmetic ingredient for which confidentiality is requested, namely—
(a) where they exist, the CAS, EINECS and colour index numbers, the chemical name, the IUPAC name, the INCI name, the European Pharmacopoeia name, the International Non-proprietary Name as recommended by the World Health Organization and the common name as provided for in the common ingredients nomenclature;
(b) the Elincs name and the official number allocated to it if it has been notified pursuant to Council Directive 67/548/EEC and an indication of the decision to approve or refuse any request for confidentiality made under Article 19 of that Directive;
(c) where the names or numbers referred to in sub-paragraphs (a) and (b) above do not exist, for example in the case of certain ingredients of natural origin, the name of the base material, the name of the part of the plant or animal used and the names of the cosmetic ingredient’s compounds, such as solvents.
3 
The evaluation of the safety for human health of the cosmetic ingredient as used in the finished cosmetic product or products taking into account the cosmetic ingredient’s toxicological profile, chemical structure and the level of exposure as specified in regulation 8(1)(d) and carried out in accordance with the requirements of regulations 8(2) and (3).
4 
The envisaged use of the cosmetic ingredient and in particular the different categories of cosmetic products in which it will be used.
5 
A detailed justification of why confidentiality is sought addressing for example—
(a) the fact that the identity of the cosmetic ingredient or its function in the cosmetic product to be supplied has not been described in the literature accompanying the cosmetic product and is unknown to other manufacturers or suppliers of cosmetic products;
(b) the fact that the information is not yet in the public domain even though a patent application has been lodged for the cosmetic ingredient or its use;
(c) the fact that if the information were known it would be easily reproducible, to the detriment of the applicant.
6 

(a) If known, the name of each cosmetic product which is to contain the cosmetic ingredient and if different names are to be used in other member States, precise details of each one of them.
(b) If the name of a cosmetic product is not yet known, it may be communicated at a later date, but at least 15 days before the cosmetic product is supplied.
(c) If the cosmetic ingredient is used in several products, one request shall suffice, provided that the cosmetic products are clearly indicated to the competent authority.
7 
A statement setting out whether a request has been submitted to the competent authority of any other member State in respect of the cosmetic ingredient for which confidentiality is sought and particulars on the outcome of any such request.
PART II PROCEDURE FOR GRANT OF REGISTRATION NUMBER
1 
The registration number referred to in regulation 11(5) shall consist of seven digits, the first two corresponding to the year of approval of confidentiality, the second two to the code assigned to each member State, as referred to in paragraph 2 below, and the final three digits assigned by the competent authority.
2 
The code allocated to the United Kingdom is 06.
SCHEDULE 8
SAMPLING AND TESTING
Regulation 14
1 
In this Schedule—
 “Annex A” means the Annex to Commission Directive No. 80/1335/EEC as amended by Commission Directive No. 87/143/EEC;
 “Annex B” means the Annex to Commission Directive No. 82/434/EEC as amended by Commission Directive No. 90/207/EEC;
 “Annex C” means the Annex to Commission Directive No. 83/514/EEC;
 “Annex D” means the Annex to Commission Directive No. 85/490/EEC;
 “Annex E” means the Annex to Commission Directive No. 93/73/EEC;
 “Annex F” means the Annex to Commission Directive No. 95/32/EC;
 “Annex G” means the Annex to Commission Directive No. 96/45/EC;
 “purchase” means purchase for the purpose of carrying out a test.
2 
An enforcement authority intending to purchase a cosmetic product shall purchase a sufficient laboratory sample, as defined in paragraph 2.3 of Part I of Annex A, for the purpose of Annex A; and, for the purposes of the definition of “total sample” in paragraph 2.2 of Part I of Annex A, samples shall be regarded as having the same batch number if—
(a) the means of identifying the batch referred to in regulation 6(2)(g) above shows that they were manufactured in the same batch; or
(b) in the case of a product not manufactured in a batch, the reference referred to in regulation 6(2)(g) above shows that they are derived from the same unit of production; or
(c) in the case of a product which does not comply with the requirements of regulation 6(2)(g) above, the officer effecting the purchase has reasonable cause to believe that they were manufactured in the same batch or are derived from the same unit of production, as the case may be.
3 
The immediate container, if any, of a cosmetic product purchased by an enforcement authority shall not have been opened by, on behalf of or at the request of the enforcement authority before the purchase takes place and the container shall not thereafter be opened except in accordance with paragraph 5.3 of Part I of Annex A and paragraph 1.2 of Part II of Annex A.
4 
As soon as an enforcement authority has purchased a cosmetic product, the officer effecting the purchase shall—
(a) either—
(i) place a seal on the product’s container or outer packaging, or
(ii) place the product in a container and forthwith place a seal on that container, in such a way that the product’s immediate container cannot be opened or (in the case of a product which was not in a container when it was purchased) the product cannot be touched without (in either case) the seal being broken in such a manner that it would be apparent thereafter that it had been broken, and
(b) attach to the product a label indicating—
(i) the name of the product,
(ii) the date, time and place at which the product was purchased,
(iii) his own name, and
(iv) the name of the enforcement authority making the purchase.
5 

(1) Subject to sub-paragraph (2) below, the provisions of Part I of Annex A, other than paragraphs 3.1, 3.2 and 4, and of Part II of Annex A, other than paragraph 1.4, shall be complied with in the sampling of cosmetic products and the laboratory preparation of test portions.
(2) Where, because of the way in which a cosmetic product is put up for sale, it is not practicable for Part II of Annex A to be complied with, it shall be prepared for testing in accordance with good analytical practice, and the person so preparing it shall record in writing the method of preparation which he has used.
6 

(1) Any test to determine whether a cosmetic product contains a significant amount of free sodium hydroxide or free potassium hydroxide shall be carried out in accordance with paragraphs 1 to 4 of Part III of Annex A.
(2) Any test to determine the amount of free sodium hydroxide or free potassium hydroxide in a hair straightener product or a nail cuticle solvent product shall be carried out in accordance with paragraphs 1, 2, 3 and 5 of Part III of Annex A.
(3) Any test to determine whether a hair-care product contains oxalic acid or any alkaline salt of oxalic acid or to determine the amount of such a substance in a hair-care product shall, subject to the limitation specified in the second sentence of paragraph 1 of Part IV of Annex A, be carried out in accordance with the said Part IV.
(4) Any test to determine the amount of chloroform in toothpaste shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex A, be carried out in accordance with the said Part V.
(5) Any test to determine the amount of zinc chloride, zinc sulphate or zinc 4-hydroxybenzenesulphonate by virtue of their zinc contents in a cosmetic product shall be carried out in accordance with Part VI of Annex A and Commission Directive 87/143/EEC, and shall take into account paragraph 11 of Part VII of Annex A.
(6) Any test to determine whether a cosmetic product contained in an aerosol dispenser or a cream, emulsion, lotion, gel or oil intended to be applied to the skin contains 4-hydroxybenzenesulphonic acid, or to determine the amount of that acid in such a product, shall be carried out in accordance with Part VII of Annex A.
(7) Any test to determine whether a hair-care product contains persulphate, bromate or hydrogen peroxide shall be carried out in accordance with Part A of Part I of Annex B.
(8) Any test to determine whether a hair-care product contains barium peroxide shall be carried out in accordance with Part B of Part I of Annex B.
(9) Any test to determine the amount of hydrogen peroxide in a hair-care product shall be carried out in accordance with Part C of Part I of Annex B.
(10) Any test to determine whether a hair-dye contains any of the oxidation colourants specified in paragraph 1 of Part II of Annex B, or to determine the amount of such a substance in a hair-dye, shall be carried out in accordance with the said Part II.
(11) Any test to determine whether a cosmetic product contains nitrite, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part III of Annex B.
(12) Any test to determine whether a cosmetic product contains free formaldehyde, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part IV of Annex B.
(13) Any test to determine the amount of resorcinol in a shampoo or hair lotion shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex B, be carried out in accordance with the said Part V.
(14) Any test to determine the amount of methanol in relation to ethanol or propan-2-ol in a cosmetic product shall be carried out in accordance with Part VI of Annex B.
(15) Any test to determine the amount of dichloromethane or 1,1,1-trichloroethane in a cosmetic product shall be carried out in accordance with paragraphs 1 to 10 of that part of Annex C which is headed “Determination of dichloromethane and 1,1,1-trichloroethane”.
(16) Any test to determine whether a cosmetic product contains quinolin-8-ol or bis(8-hydroxyquinolinium) sulphate, or to determine the amount of such a substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed “Identification and determination of quinolin-8-ol and bis(8-hydroxyquinolinium) sulphate”.
(17) Any test to determine the amount of ammonia in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of ammonia”.
(18) Any test to determine whether a cosmetic product contains nitromethane, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 7 of that part of Annex C which is headed “Identification and determination of nitromethane”.
(19) Any test to determine whether a hair waving, hair straightening or depilatory product contains mercaptoacetic acid (thioglycolic acid), or to determine the amount of that substance in such a product, shall be carried out in accordance with paragraphs 1 to 6 of that part of Annex C which is headed “Identification and determination of mercaptoacetic acid in hair-waving, hair-straightening and depilatory products”.
(20) Any test to determine whether a cosmetic product contains hexachlorophene (INN) shall be carried out in accordance with paragraphs 1 to 7 of Part A of that part of Annex C which is headed “Identification and determination of hexachlorophene”.
(21) Any test to determine the amount of hexachlorophene (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of Part B of that part of Annex C which is headed “Identification and determination of hexachlorophene”.
(22) Any test to determine the amount of tosylchloramide sodium (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed “Quantitative determination of tosylchloramide sodium (INN) (chloramine-T)”.
(23) Any test to determine the total amount of fluorine in dental creams shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of total fluorine in dental creams”.
(24) Any test to determine whether a cosmetic product contains organomercury compounds shall be carried out in accordance with paragraphs 1 to 4 of Part A of that part of Annex C which is headed “Identification and determination of organomercury compounds”.
(25) Any test to determine the amount of organomercury compounds in a cosmetic product shall be carried out in accordance with paragraphs 1 to 7 of Part B of that part of Annex C which is headed “Identification and determination of organomercury compounds”.
(26) Any test to determine the amount of alkali sulphides or alkaline earth sulphides in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed “Determination of alkali and alkaline earth sulphides”.
(27) Any test for the identification and determination of the amount of glycerol 1-(4-aminobenzoate) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of glycerol 1-(4-aminobenzoate)”.
(28) Any test to determine the amount of chlorobutanol (INN) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Determination of chlorobutanol”.
(29) Any test for the identification and determination of the amount of quinine in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of quinine”.
(30) Any test for the identification and determination of inorganic sulphites and hydrogen sulphites in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of inorganic sulphites and hydrogen sulphites”.
(31) Any test for the identification and determination of chlorates of the alkali metals in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of chlorates of the alkali metals”.
(32) Any test for the identification and determination of sodium iodate in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed “Identification and determination of sodium iodate”.
(33) Any test for the identification and determination of silver nitrate in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of silver nitrate in cosmetic products”.
(34) Any test for the identification and determination of selenium disulphide in anti-dandruff shampoos shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of selenium disulphide in anti-dandruff shampoos”.
(35) Any test for the determination of soluble barium and soluble strontium in pigments in the form of salts or lakes shall be carried out in accordance with that part of Annex E which is headed “Determination of soluble barium and strontium in pigments in the form of salts or lakes”.
(36) Any test for the identification and determination of benzyl alcohol in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of benzyl alcohol in cosmetic products”.
(37) Any test for the identification of zirconium and the determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants shall be carried out in accordance with that part of Annex E which is headed “Identification of zirconium, and determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants”.
(38) Any test for the identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed “Identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine”.
(39) Any test for the identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed “Identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in cosmetic products”.
(40) Any test for the identification and determination of hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether and hydroquinone monobenzylether (monobenzone) in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed “Identification and determination of hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether and hydroquinone monobenzylether in cosmetic products”.
(41) Any test for the identification and determination of 2-phenoxyethanol, 1-phenoxypropan-2-ol, and methyl, ethyl, propyl, butyl and benzyl 4-hydroxybenzoate in a cosmetic product shall be carried out in accordance with Annex G.
SCHEDULE 9
REVOCATIONS
Regulation 1(9)


(1) (2)
Regulations revoked References
The Cosmetic Products (Safety) Regulations 1989 S.I. 1989/2233
The Cosmetic Products (Safety) (Amendment) Regulations 1990 S.I. 1990/1812
The Cosmetic Products (Safety) (Amendment) Regulations 1991 S.I. 1991/447
The Cosmetic Products (Safety) (Amendment) Regulations 1992 S.I. 1992/1525
The Cosmetic Products (Safety) (Amendment) Regulations 1993 S.I. 1993/1539
The Cosmetic Products (Safety) (Amendment) Regulations 1994 S.I. 1994/1529
The Cosmetic Products (Safety) (Amendment) Regulations 1995 S.I. 1995/1478
The Cosmetic Products (Safety) (Amendment) Regulations 1996 S.I. 1996/1446