The Cosmetic Products (Safety) Regulations 1996 No. 2925


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Statutory Instruments

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(1), 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(2) for the purposes of section 2 of the European Communities Act 1972(3) in relation to measures for safety and consumer protection as respects cosmetic products and any provisions concerning the composition, labelling, marketing, classification or description of cosmetic products and in relation to indication of origin on imported goods:

Now, therefore, the Secretary of State in exercise of 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

1.-(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(4) 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

2.-(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(5), 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(6);

"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(7), as amended by Council Directive 82/368/EEC(8), Commission Directive 82/147/EEC(9), Commission Directive 83/191/EEC(10), Commission Directive 83/341/EEC(11), Council Directive 83/574/EEC(12), Commission Directive 83/496/EEC(13), Commission Directive 84/415/EEC(14), Commission Directive 85/391/EEC(15), Commission Directive 86/179/EEC(16), Commission Directive 86/199/EEC(17), Commission Directive 87/137/EEC(18), Commission Directive 88/233/EEC(19), Council Directive 88/667/EEC(20), Commission Directive 89/174/EEC(21), Council Directive 89/679/EEC(22), Commission Directive 90/121/EEC(23), Commission Directive 91/184/EEC(24), Commission Directive 92/8/EEC(25), Commission Directive 92/86/EEC(26), Commission Directive 93/47/EEC(27), Council Directive 93/35/EEC(28), Commission Directive 94/32/EC(29), Commission Directive 95/34/EC(30), and Commission Directive 96/41/EC(31);

"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(32);

"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

3.-(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

4.-(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

5.-(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

6.-(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:

(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(33).

(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

7.-(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

8.-(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(34) 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(35) or a registered medical practitioner within the meaning of the Medical Act 1983(36).

(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.

9. 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.

10.-(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.

11.-(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

12.-(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(37).

(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

13.-(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

Regulations 4(2) and 5(1)

SCHEDULE 1LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN

The alphabetical list set out in column 2 of this Schedule contains one or more of the names of each of the substances referred to in regulation 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 ScheduleName of substanceCross-reference to this ScheduleCross-reference to Annex II of the Directive
1Acenocoumarol (INN)396254
2Acetonitrile-393
33-(α-Acetonylbenzyl)-4-hydroxycoumarin and its salts398, 760203
42-Acetoxyethyltrimethylammonium hydroxide and its salts62
52-Acetylamino-5-chlorobenzoxazole1641
6Acetylcholine and its salts42
7Acetylene chlorides249, 757126
8Acetylenic alcohols, their esters, ethers and salts1716
9Acetylethyltetramethyltetralin (AETT)341362
107α-Acetylthio-3-oxopregn-4-ene-17α,17β-propionolactone6494
11Aconitine and its salts-12
12Aconitum napellus L. (leaves, roots and galenical preparations)-11
13Adonis vernalis L. and its preparations-13
14Adrenaline269, 31414
15Alkali pentacyanonitrosylferrate(2-)602-�3, 644-�5255
16O-Alkyldithiocarbonic acids, salts of761336
17Alkyne alcohols, their esters, ethers and salts816
18Alloclamide (INN) and its salts2219
19Allyl isothiocyanate-18
202-(4-Allyl-2-methoxyphenoxy)-N,N-diethylacetamide and its salts-224
21N-Allylnormorphine, its salts and ethers49220
222-Allyloxy-4-chloro-N-[2-(diethylamino)-ethyl]benzamide and its salts1819
23Alypine and its salts45, 109143
24Ambenonium chloride (INN)(527)132
254-(or p-)Aminobenzoic acid esters-167
262-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts-29
27Aminocaproic acid (INN) and its salts317
282-Amino-5-chlorobenzoxazole76824
294-Amino-N-(2-diethylaminoethyl)benzamide, its salts and derivatives60725
30Aminoheptane, its isomers and salts74825
316-Aminohexanoic acid and its salts277
32α-(Aminomethyl)-3,4-dihydroxybenzyl alcohol and its salts517-�8257
334-Amino-N10-methylfolic acid4526
342-Amino-6-methylheptane and its salts287, 52328
352-Amino-4-methylhexane and its salts288, 47130
362-Amino-4-nitrophenol-383
372-Amino-5-nitrophenol-384
384-Amino-2-nitrophenol-412
394-(or p-)Aminosalicylic acid and its salts-31
40Aminotoluenes, their isomers, salts and halogenated and sulphonated derivatives71632
41Aminoxylenes, their isomers, salts and halogenated and sulphonated derivatives76333
42Amitriptyline (INN) and its salts283146
43Ammi majus and its galencial preparations-35
44Amphetamine (INN), its salts and derivatives and salts of those derivatives(678)21
45Amydricaine and its salts23, 109143
46Amylene chloride25036
47Amyl 4-dimethylaminobenzoate, mixed isomers532381
48Amyl nitrites-247
49Amylobarbitone and its salts(69)220
50Amylocaine and its salts28150
51Anamirta cocculus L. (fruit)-106
52Substances with androgenic effect-37
53Aniline, its salts and halogenated and sulphonated derivatives-22
54Anthracene oil-38
55Anti-androgens with steroid structure-390
56Antibiotics-39
57Antimony and its compounds-40
58Apocynum cannabinum L. and its preparations-41
59Apomorphine and its salts69442
60Apronalide419216
61Arecoline482238
62Aristolochic acid and its salts-365
63Arsenic and its preparations-43
64Atropa belladonna L. and its preparations-44
65Atropine, its salts and derivatives-45
66Azacyclonol (INN) and its salts304286
67Azamethonium bromide (INN)(473)121
68Barbitone and its salts(69)220
69Barbituratesvarious220
70Barium 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
71Bemegride (INN) and its salts336, 337183
72Benactyzine (INN)257157
73Bendrofluazide and its derivatives74, 9053
74Bendroflumethiazide (INN) and its derivatives73, 9053
75Benzamine and its salts74151
76Benzatropine (INN) and its salts300158
77Benzazepines, their salts and derivatives8949
78Benzene-47
79Benzene-1,2-diol153, 627408
80Benzene-1,2,3-triol628409
81Benzethonium chloride (INN)92415
822-Benzhydryloxyethyldimethylamine and its salts295339
83Benzidine24226
84Benzilonium bromide (INN)9560
852-Benziloyloxymethyl-1,1-dimethylpyrrolidinium methyl sulphate599239
86Benzimidazolone87, 26648
87Benzimidazol-2(3H)-one86, 26648
88Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol (except natural content of essences)211357
89Benzodiazepines, their salts and derivatives7749
90Benzothiadiazine and its derivatives73, 7453
91Benzoyl peroxide-382
92Benzyl(dimethyl)(2-{2-[4-(1,1,3,3-tetramethybutyl)phenoxy]ethoxy}-ethyl)ammonium chloride81415
933-(N-Benzylhydrazinocarbonyl)-5-methylisoxazole41452
94Benzylideneacetone564356
953-Benzyloxy-1,1-diethylpyrrolidine hydrobromide8460
964-Benzyloxyphenol(390), 487178
972-[Benzyl-N-(2-pyridyl)amino]-ethyldimethylamine623, 745347
98Bergapten(e) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg(356)358
99Beryllium and its compounds-54
100Betamethasone (INN)(360)300
101Betoxycaine (INN) and its salts25623
102BHC (ISO) (gamma-BHC)369, 371, 428195
103Bietamiverine (INN)260287
1041,6-Bis(2-chloroethylamino)-1,6-dideoxymannitol and its salts43689
1052-[Bis(2-chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane 2-oxide and its salts108, 23088
106N,N-Bis(2-chloroethyl)methylamine and its salts160, 49087
107N,N-Bis(2-chloroethyl)methylamine N-oxide and its salts49186
108N,N-Bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-ylamine p-oxide and its salts105, 23088
1091,1-Bis(dimethylaminomethyl)propyl benzoate and its salts23, 45143
110Bis(hydroxyalkyl)amines, not further N-substituted254, 273, 640411
1112,2-Bis(hydroxymethyl)butan-1-ol trinitrate613206
1122,6-Bis(β-hydroxyphenethyl)-1-methylpiperidine and its salts430219
1133,3-Bis(4-hydroxyphenyl)phthalide557417
114Bis(8-hydroxyquinolinium) sulphate, except for the uses provided for in entry number 51 in Part 1 of Schedule 2(400, 531)395
115Bithionol (INN)705352
116Bretylium tosilate (INN) (Bretylium tosylate)11956
117Bromine, elemental-55
118Bromisoval (INN)12158
119p-Bromobenzylethyldimethylammonium p-toluenesulphonate11656
1202-Bromo-2-ethylbutyrylurea14957
1212-Bromo-3-methylbutylrylurea11858
1221-p-Bromophenyl-1-(2-pyridyl)-3-dimethylaminopropane and its salts12359
123Brompheniramine (INN) and its salts12259
124Brucine-62
125Butanilicaine (INN) and its salts46690
126Butobarbitone and its salts(69)220
127Butopiprine (INN) and its salts129288
1282-Butoxy-N-(2-diethylaminoethyl)-cinchoninamide and its salts191129
1292-Butoxyethyl phenyl(piperidino)acetate and its salts127288
1301-Butyl-3-(N-crotonoylsulphanilyl)urea-108
1314-Butyl-1,2-diphenylpyrazolidine-3,5-dione56367
1324-tert-Butyl-3-methoxy-2,6-dinitrotoluene489414
1334-Butyl-1-phenylpyrazolidine-3,5-dione48664
1341-Butyl-3-(p-methylbenzenesulphonyl)urea71565
1351-Butyl-3-sulphanilylurea15066
1364-Butylthiobenzhydryl 2-(dimethylamino)ethyl sulphide143140
137Cadmium and its compounds-68
138Calabar bean585281
139Calciferol316, (759)335
140Cantharides, Cantharis vesicatoria64769
141Cantharidin37870
142Captan (ISO)734370
143Captodiame (INN)136140
144Caramiphen (INN) and its salts567169
145N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethylammonium salts418156
146Carbazole, nitroderivatives of50872
147Carbon disulphide-73
148Carbon tetrachloride690315
149Carbromal (INN)12057
150Carbutamide (INN)13566
151Carisoprodol (INN)480235
152Catalase-74
153Catechol79, 627408
154Cells, tissues or products of human origin-416
155Cephaeline and its salts-75
156Chenopodium ambrosioides (essential oil)-76
157Cherry laurel water618291
158Chloral hydrate73277
159Chlorine-78
160Chlormethine (INN) and its salts106, 49087
161Chlormezanone (INN)17591
1624-Chlorobenzene-1,3-disulfonamide19485
1635-Chloro-1,3-benzoxazol-2(3H)-one18682
164N-5-Chlorobenzoxazol-2-ylacetamide51
1652-Chloro-4-dimethylamino-6-methylpyrimidine169, 21683
1662-Chloro-9-[3-(dimethylamino)-propylidene]thioxanthene (cis-form) and its salts18384
167Chloroethane32796
168Chloroform733366
1692-Chloro-6-methylpyrimidin-4-yldimethylamine165, 21683
170Chlorophacinone (ISO)17693
1711-(p-Chloro-α-phenylbenzyl)-4-(2-hydroxyethoxyethyl)piperazine401240
1722-(4-Chlorophenyl)-1-[4-(2-diethylaminoethoxyl)phenyl]-1-p-tolylethanol74492
1734-[4-(4-Chlorophenyl)-4-hydroxypiperidin-1-yl]-1-(4-fluorophenyl)butan-1-one368185
1742-(4-Chlorophenyl)-3-methylbutane-2,3-diol55195
1752-(4-Chlorophenyl-3-methyl-1,3-thiazinan-4-one 1,1-dioxide16191
1762-[2-(4-Chlorophenyl)-2-phenylacetyl]indane-1,3-dione17093
1772-[1-(4-Chlorophenyl)-1-phenylethoxy]ethyl-(dimethyl)amine18094
178Chloropicrin735325
1793-(4-Chloro-3-sulphamoylphenyl)-3-hydroxyisoindolin-1-one184, 185262
180Chlorphenoxamine (INN)17794
181Chlorpromazine (INN)(558)320
182Chlorpropamide (INN)61479
183Chlorprothixene (INN) and its salts16684
184Chlortalidone (INN)179, 185262
185Chlorthalidone179, 184262
186Chlorzoxazone (INN)16382
187Cholecalciferol(759)335
188Choline salts and their esters-168
189Chromium, chromic acid and salts of the acid-97
190Chrysoidine citrate hydrochloride56281
191Cinchocaine (INN) and its salts128129
192Cincophen (INN), its salts and derivatives and salts of those derivatives5778
193Claviceps purpurea Tul., its alkaloids and galenical preparations31798
194Clofenamide (INN)16285
195Clofenotane (INN)232, 731123
196Cobalt benzenesulphonate-101
197Cocculin589282
198Colchicine, its salts and derivatives-102
199Colchicoside and its derivatives-103
200Colchicum autumnale L. and its galenical preparations-104
201Colouring agent CI 12075 and its lakes, pigments and salts-397
202Colouring agent CI 12140-378
203Colouring agent CI 13065-387
204Colouring agent CI 15585-401
205Colouring agent CI 26105-379
206Colouring agent CI 42535-388
207Colouring agents CI 42555, 42555:1 and 42555:2-380
208Colouring agent CI 42640-386
209Colouring agent CI 61554-389
210Colouring agent CI 45170 and CI 45170:1-398
211Coniferyl benzoate (except natural content of essences)88357
212Coniine615290
213Conium maculatum L. (fruit, powder, galenical preparations)-99
214Convallatoxin-105
215Coumetarol (INN)454225
216Crimidine (ISO)165, 16983
217Croton tiglium (oil)-107
218Curare and curarine-109
219Curarizants, synthetic-110
2201-(3-Cyano-3,3-diphenylpropyl)-4-ethoxycarbonyl-4-phenylpiperidinium chloride29680
221Cyclarbamate (INN)229122
222Cyclizine (INN) and its salts301159
223Cyclobarbitone and its salts(69)220
224Cyclocoumarol267234
2252-α-Cyclohexylbenzyl(N,N',N'-tetraethyl)trimethylenediamine552112
2262-Cyclohexyl-3,5-dimethylphenol and its salts228113
2271-Cyclohexyl-3-(p-methylbenzenesulphonyl)urea363100
228Cyclomenol (INN) and its salts226113
229Cyclopentane-1,1-dimethanol dicarbanilate221122
230Cyclophosphamide (INN) and its salts105, 10888
231Datura stramonium L. and its galenical preparations651301
232DDT (ISO) (pp'-DDT)195, 731123
233Deanol aceglumate (INN)2783
234Decamethonium bromide (INN)(235)214
235Decamethylenebis(trimethylammonium) salts234214
236Dextromethorphan (INN) and its salts457226
237Dextropropoxyphene (INN)280116
238O,O'-Diacetyl-N-allyl-N-normorphine-117
2392,4-Diaminoanisole and its salts455, 461376
2402,5-Diaminoanisole and its salts456, 460377
2411,2-Diaminobenzene and its salts570363
242p,p'-Diaminodiphenyl8226
2432-(2,4-Diaminophenyl)ethanol and its salts-407
2441,4:3,6-Dianhydrosorbitol 2,5-dinitrate421148
2455-(α,β-Dibromophenethyl)-5-methylhydantoin-119
246Dibromosalicylanilides247, 443351
247Dibromsalan (INN)(246)351
248Dichloroethanes329, 334125
249Dichloroethylenes7, 757126
2502,3-Dichloro-2-methylbutane4636
251Dichlorosalicylanilides-349
252Dicoumarin253, 469231
253Dicoumarol (INN)252, 469231
254Diethanolamine(110, 640)411
2552-(Diethylaminoethoxy)ethyl α-phenylpiperidine-1-acetate dimethiodide598137
2562-Diethylaminoethyl 3-amino-4-butoxybenzoate and its salts10123
2572-Diethylaminoethyl benzilate72157
2582-Diethylaminoethyl 4-ethoxybenzoate and its salts410, 536179
2592-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts-128
2602-Diethylaminoethyl phenyl(piperidino)acetate103287
2613-Diethylaminopropyl cinnamate-130
262Diethyl 4-nitrophenyl phosphate534170
263O,O-Diethyl O-4-nitrophenyl phosphorothioate535131
264Difencloxazine (INN)566270
265Digitaline and all heterosides of Digitalis purpurea L.-134
2664,5-Dihydrobenzimidazol-4-one86, 8748
2673,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano[3,2-c]-[1]-benzopyran-5-one224234
268Dihydrotachysterol (INN)-342
2693,4-Dihydroxy-α-(methylaminomethyl)benzyl alcohol14, 31414
2704,4'-Dihydroxy-3,3'-(3-methylthiopropylidene)dicoumarin-207
2711-(3,4-Dihydroxyphenyl)-2-ethylaminopropan-1-ol and its salts293136
2721-(3,4-Dihydroxyphenyl)-2-isopropylaminoethanol417, 42017
273Diisopropanolamine(110, 640)411
2745,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite412361
275Dimethoxane285368
2764-[2-(3,4-Dimethoxyphenyl)ethyl]-1-(2-chlorophenyl)piperazine and its salts438141
277Dimethylamine-142
2782-Dimethylaminoethyl N-acetylglutamate2333
2792-Dimethylaminoethyl p-butylaminobenzoate and its salts68763
280(+)-4-Dimethylamino-3-methyl-1,2-diphenyl-2-propionyloxybutane237116
2811-Dimethylaminomethyl-1-methylpropyl benzoate and its salts5050
2822-Dimethylaminopropiophenone and its salts445145
2833-(3-Dimethylaminopropylidene)-1,2:4,5-dibenzocyclohepta-1,4-diene and its salts42146
2841,1-Dimethylbiguanide and its salts447147
2852,6-Dimethyl-1,3-dioxan-4-yl acetate275368
286Dimethylformamide-355
2871,5-Dimethylhexylamine and its salts34, 52328
2881,3-Dimethylpentylamine and its salts35, 47130
289Dimethyl sulfoxide (INN)-338
290Dimevamide (INN) and its salts297153
291Dinitrophenol isomers-151
292Dioxane-343
293Dioxethedrin (INN) and its salts271136
2942,5-Dioxo-3,3-diethyl-5-methylpiperidine and its salts483133
295Diphenhydramine (INN) and its salts81339
296Diphenoxylate hydrochloride (INNM)22080
2972,2-Diphenyl-4-dimethylaminovaleramide and its salts290153
2985,5-Diphenyl-4-imidazolidone-160
2994-Diphenylmethoxy-1-methylpiperidine and its salts305154
3003-Diphenylmethoxytropane and its salts76158
3011-Diphenylmethyl-4-methylpiperazine and its salts222159
3021,2-Diphenyl-4-(2-phenylsulphinylethyl)-pyrazolidine-3,5-dione661155
303α,α-Diphenyl-2-piperidinemethanol and its salts597285
304α,α-Diphenyl-4-piperidinemethanol and its salts66286
305Diphenylpyraline (INN) and its salts299154
3062,5-Dipropoxy-3,6-bis(ethyleneimino)-1,4-benzoquinone409152
3074-Dipropylsulphamoylbenzoic acid606161
308Disulfiram (INN)699, 710162
309Dithio-2,2'-bis(pyridine 1-oxide) 1,1' (additive with trihydrated magnesium sulphate)625396
310Doxylamine (INN) and its salts576176
311Emetine, its salts and derivatives-163
312Endrin (ISO)372196
313Ephedrine and its salts-164
314Epinephrine (INN)14, 26914
3151,2-Epoxybutane-400
316Ergocalciferol (INN)139, (759)335
317Ergot and its alkaloids19398
318Eserine and its salts586166
319Ethionamide (INN)335319
320Ethoheptazine (INN) and its salts476173
321Ethopropazine and its salts(558)320
3224-Ethoxyphenol(390)178
3234-Ethoxy-m-phenylenediamine and its salts-406
3242-Ethylamino-5-phenyloxazolin-4-one344180
325Ethyl bis(4-hydroxycoumarinyl)acetate and salts of the acid326204
326Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl)acetate and salts of the acid325204
327Ethyl chloride16796
328Ethyl 1,3-dimethyl-4-phenylazepane-4-carboxylate and its salts446171
329Ethylene dichloride(248)125
330Ethylene oxide-182
3312-Ethyl-2,3-epoxyhexamide and its derivatives528165
332Ethyl p-fluorophenyl sulphone347189
333Ethyl 1-(2-hydroxy-2-phenylethyl)-4-phenylpiperidine-4-carboxylate and its salts530172
334Ethylidene dichloride(248)125
3353-Ethylisothionicotinamide319319
3363-Ethyl-3-methylglutarimide and its salts71, 337183
3374-Ethyl-4-methylpiperidine-2,6-dione and its salts71, 336183
3382-Ethyl-3-methylvaleramide753184
339Ethylphenacemide553, 565272
3402-Ethyl-2-phenylglutarimide and its salts361181
3413'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone9362
342Ethyl urocanate(405)418
343Fenadiazole (INN)526208
344Fenozolone (INN)324180
345Fenyramidol (INN)575, 579274
346Fluanisone (INN)350187
347Fluoresone (INN)332189
3484'-Fluoro-4-[4-hydroxy-4-(α,α,α-trifluoro-m-tolyl)piperino]butyrophenone738188
3496-Fluoro-16-methyl-11β,17α,21-trihydroxypregna-1,4-diene-3,20-dione533186
3501-(4-Fluorophenyl)-4-[4-(2-methoxyphenyl)-1-piperazinyl]butan-1-one346187
3515-Fluoropyrimidine-2,4-dione352190
352Fluorouracil (INN)351190
353Fluphenazine (INN)(558)320
354Furazolidone (INN)511252
355Furfuryltrimethylammonium salts357192
356Furocoumarins (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg98, 462, 620, 743358
357Furtrethonium iodide (INN)(355)192
358Galantamine (INN)-193
359Gallamine triethiodide (INN)516329
360Glucocorticoids100300
361Glutethimide (INN) and its salts340181
362Glycerol trinitrate512, 612253
363Glycyclamide (INN)227100
364Gold salts-296
365Guaifenesin (INN)459230
366Guanethidine (INN) and its salts367259
367N-(2-Guanidinoethyl)azocane and its salts366259
368Haloperidol (INN)173185
369HCH (ISO) (gamma-HCH)102, 371, 428195
370HETP377316
3711,2,3,4,5,6-Hexachlorocyclohexane102, 369, 428195
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-dimethanonaphthalene312196
373Hexachloroethane-197
3743,3',4,4',6,6'-Hexachloro-2,2'-methylenediphenol375371
375Hexachlorophene (INN)374371
376(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethanonaphthalene415198
377Hexaethyl tetraphosphate370316
378(1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride14170
379(3S,5aR,9bS)-3,3a,4,5,5a,9b-Hexahydro-3,5a,9-trimethylnaphtho[1,2-b]furan-2,8-dione636217
380Hexamethonium bromide (INN)(381)124
381N,N'-Hexamethylenebis(trimethylammonium) salts380124
382Hexapropymate (INN)616115
383Hydrastine, hydrastinine and their salts-199
384Hydrazides and their salts-200
385Hydrazine, its derivatives and their salts-201
3862-Hydrazino-octane and its salts521202
387Hydrocyanic acid and its salts389, 408, 601, 642111
388Hydrofluoric acid, its normal salts, complexes and hydrofluorides (except those listed in Part I of Schedule 2)-191
389Hydrogen cyanide and its salts387, 408, 601, 642111
390Hydroquinone monobenzyl, monoethyl and monomethyl ethers96, 322, 458, 487178
3917-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline762135
392[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid and its salts7395
3933-[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]propionic acid and its salts7139
3942-Hydroxy-3-(2-methoxyphenyl)propyl carbamate450205
3951-Hydroxymethyl-1-cyclohexylacetic acid, sodium salt643114
3964-Hydroxy-3-[1-(4-nitrophenyl)-3-oxobutyl]coumarin1254
3978-Hydroxy-5-nitroquinoline and its salts515209
3984-Hydroxy-3-(3-oxo-1-phenylbutyl)coumarin and its salts3, 760203
39911α-Hydroxypregn-4-ene-3,20-dione and its esters-385
400Hydroxy-8-quinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 2114, 531, 630395
401Hydroxyzine (INN)171240
402Hyoscine, its salts and derivatives638295
403Hyoscyamine, its salts and derivatives-210
404Hyoscyamus niger L.(leaves, seeds, powder and galenical preparations)-211
4053-Imidazol-4-ylacrylic acid and its ethyl ester342, 751418
4062-Imino-5-phenyloxazolidin-4-one and its salts538212
407Imperatorin46534
408Inorganic cyanides(387, 389) 601, 642111
409Inproquone (INN)306152
410Intracaine and its salts258, 536179
411Iodine-213
412Iodothymol274361
413Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations)-215
414Isocarboxazid (INN)9352
415Isodrin376198
416Isometheptene (INN) and its salts463228
417Isoprenaline (INN)272, 42017
418Isopropamide iodide (INN)(145)156
419(2-Isopropylpent-4-enoyl)urea60216
420Isoproterenol272, 41717
421Isosorbide dinitrate (INN)244148
422Juniperus sabina L. (leaves, essential oil and galenical preparations)-294
423Laurel oil424359
424Laurus nobilis L. (oil from seeds)423359
425Lead and its compounds (except lead acetate subject to the restrictions laid down in entry number 55 in Part I of Schedule 2)-289
426Levophacetoperane and its salts594284
427Lidocaine (INN) (Lignocaine)-399
428Lindane102, 369, 371195
429Lobelia inflata L. and its galenical preparations-218
430Lobeline (INN) and its salts112219
431LSD(433, 434)127
432Lupinidine and its salts648299
433Lysergic acid diethylamide and its salts431, 434127
434Lysergide (INN) and its salts431, 433127
435Malononitrile-149
436Mannomustine (INN) and its salts10489
437Mecamylamine (INN)698229
438Mefeclorazine (INN) and its salts276141
439Mephenesin (INN) and its esters718322
440Meprobamate (INN)481236
441Mercury and its compounds (except those listed in Part I of Schedule 4)-221
442Mescaline and its salts740222
443Metabromsalan (INN)(246)351
444Metaldehyde600223
445Metamfepramone (INN) and its salts282145
446Metethoheptazine (INN) and its salts328171
447Metformin (INN) and its salts284147
448Methapyrilene (INN) and its salts624144
449Metheptazine (INN) and its salts468174
450Methocarbamol (INN)394205
451Methohexitone and its salts(69)220
452Methotrexate (INN)336
4532-[4-Methoxybenzyl-N-(2-pyridyl)amino]-ethyldimethylamine maleate622346
4541-Methoxy-2,2-bis(4-hydroxy-3-coumarinyl)ethane215225
4551-Methoxy-2,4-diaminobenzene and its salts239, 461376
4561-Methoxy-2,5-diaminobenzene and its salts240, 460377
457(+)-3-Methoxy-N-methylmorphinan and its salts236226
4584-Methoxyphenol(390)178
4593-(2-Methoxyphenoxy)propane-1,2-diol365230
4602-Methoxy-p-phenylenediamine and its salts240, 456377
4614-Methoxy-m-phenylenediamine and its salts239, 455376
462Methoxypsoralens (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg(356)358
4636-Methylamino-2-methylhept-2-ene and its salts416228
4642-Methyl-1,2-bis(3-pyridyl)propan-1-one484292
4659-(3-Methylbut-2-enyloxy)furo-[3,2-g]chromen-7-one40734
4662-Methyl-6-chloroanilide of n-butylaminoacetic acid and its salts12590
4671-Methyl-2,4-diaminobenzene and its salts477364
468Methyl 1,2-dimethyl-4-phenylazepane-4-carboxylate and its salts449174
4693,3-Methylenebis-(4-hydroxycoumarin)252, 253231
4702-Methylheptylamine and its salts-227
4714-Methyl-2-hexylamine and its salts35, 28830
4721-Methylimidazole-2-thiol474, 704233
473N-N'-[(Methylimino)diethylene]bis-(ethyldimethylammonium) salts67121
4741-Methyl-2-mercaptoimidazole472, 704233
475Methylphenidate (INN) and its salts572175
4761-Methyl-4-phenyl-4-carbethoxyhexa-methyleneimine and its salts320173
4774-Methyl-m-phenylenediamine and its salts467364
4782-Methyl-m-phenylenediamine-413
4793-Methyl-2-phenylmorpholine, its derivatives and salts555232
4802-Methyl-2-propyl-1-isopropylcarbamoyloxy-3-carbamoyloxypropane151235
4812-Methyl-2-propyltrimethylene dicarbamate440236
482N-Methyl-1,2,5,6-tetrahydro-3-nicotinic acid methyl ester61238
483Methyprylon (INN) and its salts294133
484Metyrapone (INN)464292
485Minoxidil (INN), its salts and derivatives596372
486Mofebutazone (INN)13364
487Monobenzone (INN)96, (390)178
488Morpholine and its salts-344
489Musk ambrette132414
490Mustine and its salts106, 16087
491Mustine N-oxide and its salts10786
492Nalorphine (INN), its salts and ethers2120
493Naphazoline (INN) and its salts499244
4942-Naphthol495241
495β-Naphthol494241
4961- and 2-Naphthylamines and their salts497242
497α- and β-Naphthylamines and their salts496242
4983-(1-Naphthyl)-4-hydroxycoumarin-243
4992-(1-Naphthylmethyl)-2-imidazoline and its salts493244
500Narcotics, 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
501Narcotine and its salts519258
502Neodymium and its salts-309
503Neostigmine and its salts-245
504Nicotine and its salts-246
505Nitrites, inorganic (except sodium nitrite)-248
506Nitrobenzene-249
507Nitrocresols and their alkali metal salts-250
508Nitroderivatives of carbazole14672
509Nitrofurantoin (INN)510251
510N-(5-Nitro-2-furfurylidene)-1-aminohydantoin509251
5113-(5-Nitrofurfurylideneamino)oxazolidin-2-one354252
512Nitroglycerine362, 612253
513Nitrosamines-410
514Nitrostilbenes, their homologues and derivatives-256
515Nitroxoline (INN) and its salts397209
516N,N,N,N',N',N',N",N",N"-Nonaethyl-2,2',2"-(benzene-1,2,3-triyltrioxy)-tris(ethanaminium) triiodide359329
517Noradrenaline and its salts32, 518257
518Norepinephrine (INN) and its salts32, 517257
519Noscapine (INN) and its salts501258
520Nux vomica and its preparations(658)305
521Octamoxin (INN) and its salts386202
522Octamylamine (INN) and its salts-267
523Octodrine (INN) and its salts34, 28728
524Oestrogens-260
525Oleandrin-261
5262-(1,3,4-Oxadiazol-2-yl)phenol343208
527[Oxalylbis(iminoethylene)]bis[(o-chlorobenzyl)diethylammonium] salts24132
528Oxanamide (INN) and its derivatives331165
5292-Oxo-3-isobutyl-9,10-dimethoxy-1,2,3,4,6,7-hexahydro-11bH-benzo[a]quinolizine and its salts685139
530Oxpheneridine (INN) and its salts333172
531Oxyquinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 2114, 400, 630395
532Padimate A47381
533Paramethasone (INN)349186
534Paraoxon262170
535Parathion (ISO)263131
536Parethoxycaine (INN) and its salts258, 410179
537Pelletierine and its salts595263
538Pemoline (INN) and its salts406212
539Pentachloroethane-264
540Pentaerythritol chloral549266
541Pentaerythritol tetranitrate542, 548265
542Pentaerythrityl tetranitrate (INN)541, 548265
543Pentamethonium bromide (INN)(544)120
544N,N'-Pentamethylenebis(trimethyl-ammonium) salts543120
545Pentobarbitone and its salts(69)220
546Perchloroethylene689314
547Perphenazine (INN) and its salts(558)320
548PETN541, 542265
549Petrichloral (INN)540266
550Phenacemide (INN)561269
551Phenaglycodol (INN)17495
552Phenetamine225112
553Pheneturide (INN)339, 565272
554Phenindone (INN)571271
555Phenmetrazine (INN), its derivatives and salts479232
556Phenobarbitone and its salts(69)220
557Phenolphthalein (INN)113417
558Phenothiazine (INN) and its compoundsvarious320
559Phenprobamate (INN)57371
560Phenprocoumon (INN)574273
561N-Phenylacetylurea550269
5624-Phenylazophenylene-1,3-diamine citrate hydrochloride19081
563Phenylbutazone (INN)13167
5644-Phenylbut-3-en-2-one94356
565(2-Phenylbutyryl)urea339, 553272
566N-[2-(α-Phenyl-p-chlorobenzyl)-ethyl]morpholine264270
5671-Phenylcyclopentanecarboxylic acid diethylaminoethyl ester and its salts144169
5682-Phenylcyclopropylamine (trans-form) and its salts719324
5691-Phenyl-2,3-dimethyl-4-isopropylpyrazol-5-one617138
570o-Phenylenediamine and its salts241363
5712-Phenylindan-1,3-dione554271
572α-Phenyl-2-piperidineacetic acid methyl ester and its salts475175
5733-Phenylpropyl carbamate55971
5743-(α-Phenylpropyl)-4-hydroxycoumarin560273
5751-Phenyl-2-(2-pyridylamino)ethanol345, 579274
5762-[1-Phenyl-1-(2-pyridyl)ethoxy]-ethyldimethylamine and its salts310176
5772-Phenylquinoline-4-carboxylic acid, its salts and derivatives and salts of those derivatives1928
5786-Phenyl-2,4,7-triaminopteridine and its salts722275
579Phenyramidol345, 575274
580Phosphides, metal-279
581Phosphorus-279
5824-Phosphoryloxy-N,N-dimethyltryptamine619278
5833-Phthalimidopiperidine-2,6-dione and its salts701280
584Phthalylsulphathiazole (INN) and its salts(675)307
585Physostigma venenosum Balf.138281
586Physostigmine and its salts318166
587Phytolacca Spp and their preparations-374
588Picric acid742268
589Picrotoxin197282
590Pilocarpine and its salts-283
591Pilocarpus jaborandi Holmes and its galenical preparations-311
592Pipazetate (INN) and its salts593118
5932-(2-Piperidinoethoxy)ethyl 10-thia-1,9-diazaanthracene-9-carboxylate and its salts592118
594α-Piperidin-2-ylbenzyl acetate, laevorotatory threo-form and its salts426284
5951-(2-Piperidyl)propan-2-one and its salts537263
5966-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide, its salts and derivatives485372
597Pipradrol (INN) and its salts303285
598Piprocurarium iodide (INN)255137
599Poldine metilsulfate (INN) (Poldine methylsulphate)85239
600Polyacetaldehyde444223
601Potassium cyanide(387, 389, 408)111
602Potassium nitroferricyanide(15), 603255
603Potassium nitroprusside(15), 602255
604Pramocaine (INN)605405
605Pramoxine604405
606Probenecid (INN)307161
607Procainamide (INN), its salts and derivatives2925
608Prochlorperazine (INN) and its salts(558)320
609Progestogens-194
610Promazine (INN) and its salts(558)320
611Promethazine (INN) and its salts(558)320
612Propane-1,2,3-triyl trinitrate362, 512253
613Propatylnitrate (INN)111206
6141-Propyl-3-(4-chlorobenzenesulphonyl)urea18279
6152-Propylpiperidine212290
6161-(2-Propynyl)cyclohexyl carbamate382115
617Propyphenazone (INN)569138
618Prunus laurocerasus L.157291
619Psilocybine (INN)582278
620Psoralen (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg(356)358
621Pyrethrum album L. and its galenical preparations-345
622Pyrianisamine maleate453346
623Pyribenzamine97, 745347
6242-(N-2-Pyridyl-N-2-thienylamino)ethyl-dimethylamine and its salts448144
625Pyrithione disulphide+magnesium sulphate309396
626Pyrithione sodium (INNM)-369
627Pyrocatechol79, 153408
628Pyrogallol-409
629Quinalbarbitone and its salts(69)220
630Quinolin-8-ol except for the uses provided for in entry number 51 in Part I of Schedule 2(400, 531)395
631Radioactive 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(38))-293
632Rauwolfia serpentina alkaloids and their salts63315
633Reserpine (INN) and its salts(632)15
634Retinoic acid and its salts721, 758375
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
636α-Santonin379214
637Schoenocaulon officinale Lind. (seeds and galenical preparations)-332
638Scopolamine, its salts and derivatives402295
639Secbutobarbitone and its salts(69)220
640Secondary dialkanolamines110, 254, 273411
641Selenium and its compounds except when permitted under the restrictions laid down in Part I of Schedule 2-297
642Sodium cyanide(387, 389, 408)111
643Sodium hexacyclonate (INN)395114
644Sodium nitroferricyanide(15), 645255
645Sodium nitroprusside(15), 644255
646Solanum nigrum L. and its galenical preparations-298
647Spanish Fly14069
648Sparteine (INN) and its salts432299
649Spironolactone (INN)104
650Squill and its preparations750330
651Stramonium and its preparations231301
652Strontium lactate-402
653Strontium nitrate-403
654Strontium polycarboxylate-404
655Strophanthines and their aglucones and their respective derivatives-302
656Strophanthus species and their galenical preparations-303
657Strychnine and its salts-304
658Strychnos species and their galenical preparations520305
659Succinonitrile-150
660Succinylsulphathiazole and its salts(675)307
661Sulfinpyrazone (INN)302155
662Sulphacetamide and its salts(675)307
663Sulphadiazine and its salts(675)307
664Sulphadimethoxine and its salts(675)307
665Sulphadimidine and its salts(675)307
666Sulphafurazole and its salts(675)307
667Sulphaguanidine and its salts(675)307
668Sulphamethizole and its salts(675)307
669Sulphamethoxazole and its salts(675)307
670Sulphamethoxydiazine and its salts(675)307
671Sulphamethoxypyridazine and its salts(675)307
672Sulphanilamide and its salts(675)307
673Sulphapyridine and its salts(675)307
674Sulphathiazole and its salts(675)307
675Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the −NH2 groups) and their salts584, 660, 662-�674307
676Sulthiame677, 696308
677Sultiame (INN)676, 696308
678Sympathomimetic 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 Europe4421
679Tefazoline (INN) and its salts695237
680Tellurium and its compounds-312
681TEPP (ISO)693276
6822-(4-tert-Butyl-2,6-dimethylbenzyl)-2-imidazoline and its salts764313
6834-tert-Butylphenol-340
6844-tert-Butylpyrocatechol-341
685Tetrabenazine (INN) and its salts529139
686Tetrabromosalicylanilides-350
687Tetracaine (INN) and its salts27963
6882,3,7,8-Tetrachlorodibenzo-p-dioxin-367
689Tetrachloroethylene546314
690Tetrachloromethane148315
691Tetrachlorosalicylanilides-348
692Tetraethylammonium bromide70061
693Tetraethyl pyrophosphate681276
694(R)-5,6,6a,7-Tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol and its salts5942
6952-(5,6,7,8-Tetrahydro-1-naphthylmethyl)-2-imidazoline and its salts679237
6964-(Tetrahydro-2H-1,2-thiazin-2-yl)-benzenesulphonamide S,S-dioxide676, 677308
697Tetrahydrozoline and its salts-394
698N,2,3,3-Tetramethyl-2-norcamphanamine437229
699Tetramethylthiuram disulphide710162
700Tetrylammonium bromide (INN)69261
701Thalidomide (INN) and its salts583280
702Thallium and its compounds-317
703Thevetia neriifolia Juss., glycoside extract-318
704Thiamazole (INN)472, 474233
7052,2'-Thiobis(4,6-dichlorophenol)115352
706Thiopentone and its salts(69)220
707Thioridazine (INN) and its salts(558)320
708Thiotepa (INN)723310
709Thiourea and its derivatives (except those listed in Part I of Schedule 2)-321
710Thiram (ISO)699162
711Thiuram disulphides-354
712Thiuram monosulphides-353
713Thyropropic acid (INN) and its salts3939
714Tolboxane (INN)717177
715Tolbutamide (INN)13465
716Toluidines, their isomers, salts and halogenated and sulphonated derivatives4032
717p-Tolylboric acid ester of 2-methyl-2-propylpropane-1,3-diol714177
7183-o-Tolyloxypropane-1,2-diol(439)322
719Tranylcypromine (INN) and its salts568324
720Tretamine (INN)724328
721Tretinoin (INN) and its salts634, 758375
722Triamterene (INN) and its salts578275
723Tri(aziridin-1-yl)phosphine sulphide708310
7242,4,6-Tri(aziridin-1-yl)-1,3-triazine720328
7252,2,2-Tribromoethanol(726)326
726Tribromoethyl alcohol725326
727Tribromsalan (INN)728373
7283,4',5-Tribromosalicylanilide727373
729Trichlormethine (INN) and its salts746327
730Trichloroacetic acid-10
7311,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane195, 232123
7322,2,2-Trichloroethane-1,1-diol15877
733Trichloromethane168366
734N-(Trichloromethylthio)cyclohex-4-ene-1,2-dicarboximide142370
735Trichloronitromethane178325
736Tricresyl phosphate747277
737Trifluoperazine (INN) and its salts(558)320
738Trifluperidol (INN)348188
7393,3',5-Triiodothyroacetic acid and its salts3925
7403,4,5-Trimethoxyphenethylamine and its salts442222
7412,2,6-Trimethyl-4-piperidyl benzoate and its salts7551
7422,4,6-Trinitrophenol588268
743Trioxysalen (INN) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg(356)358
744Triparanol (INN)17292
745Tripelennamine (INN)97, 623347
746Tris(2-chloroethyl)amine729327
747Tritolyl phosphate736277
748Tuaminoheptane (INN), its isomers and salts3027
749Tyrothricin (INN)-392
750Urginea scilla Stern. and its galenical preparations650330
751Urocanic acid(405)418
752Vaccines, toxins and serums listed in the Annex to Council Directive No. 75/319/EEC(39)-323
753Valnoctamide (INN)338184
754Veratrine, its salts and galenical preparations-331
755Veratrum spp and their preparations-333
756Vinyl chloride monomer-334
757Vinylidene chloride(7, 249)126
758Vitamin A acid and its salts634, 721375
759Vitamins D2 and D3139, 187, 316335
760Warfarin (ISO) and its salts3, 398203
761Xanthates16336
762Xanthinol391135
763Xylidines, their isomers, salts and halogenated and sulphonated derivatives4133
764Xylometazoline (INN) and its salts682313
765Yohimbine and its salts-337
766Zirconium 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
767Zoxazolamine (INN)2824

Regulations 4(2), 5(1) and 6(2)

SCHEDULE 2LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

In this Schedule, the matters specified in columns 3, 4, 5 and 6 which apply to a particular substance are those set out to the right of its name as mentioned in column 2; and the matters specified in columns 4, 5 and 6 which apply in any particular case are those set out to the right of the matter specified in column 3 which applies in that case. The substance may not be used except for the purposes or contained other than in the types of product specified in column 3. The concentration of the substance in a product may not exceed the limit specified in column 4: where the names of two or more substances are mentioned in a single item as set out in column 2 and a product contains more than one of those substances, the limit specified in column 4 is the limit for all of those substances taken together; and where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 5. In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC(40).

PART ISUBSTANCES 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 NumberName of substancePurpose of substance or type of productMaximum concentration of substance in productOther requirementsRequired information

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).

1Boric acidTalcum powder5 per centNot to be used in products intended for children less than three years oldNot to be used for children under three years of age
Oral hygiene products0.5 per cent--
Other products3 per cent--
2aThioglycolic acid and its salts(a) Hair waving or straightening products for general use8 per cent ready for usepH 7 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children
(b) Hair waving or straightening products for professional use11 per cent ready for usepH 7 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only
(c) Depilatories5 per cent ready for usepH 7 to 12.7Contains thioglycolate. Follow the instructions. Keep out of reach of children
(d) Other hair-care products which are removed after application2 per cent ready for usepH 7 to 9.5Contains 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)

2bThioglycolic acid esters(a) Hair waving or straightening products for general use8 per cent ready for usepH 6 to 9.5Contains thioglycolate. Follow the instructions. Keep out of reach of children
(b) Hair waving or straightening products for professional use11 per cent ready for usepH 6 to 9.5Contains 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

3Oxalic acid, its esters and alkaline saltsHair care products5 per cent-For professional use only
4AmmoniaAll purposes and products6 per cent calculated as NH3-Contains ammonia (not required when concentration is not more than 2 per cent)
5Tosylchloramide sodium (INN) [Chloramine-T]All purposes and products0.2 per cent--
6Chlorates of alkali metalsToothpaste5 per cent--
Other uses3 per cent--
7DichloromethaneAll purposes and products35 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-
8m- and p-Phenylenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-phenylenediaminesOxidizing colouring agents for hair-dyeing for general use6 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 use6 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
9Methylphenylenediamines (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 use10 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 use10 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
10DiaminophenolsOxidizing colouring agents for hair-dyeing for general use10 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 use10 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
11Dichlorophen (INN) [Dichlorophene]All purposes and products0.5 per cent-Contains dichlorophen
12Hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide including hydrogen peroxide-urea (hydrogen peroxide-carbamide) and zinc peroxide

(a)Hair-care preparations

(b)Skin-care preparations

(c)Nail hardening preparations

(d)Oral hygiene products

12 per cent of H2O2 present or released

4 per cent of H2O2 present or released

2 per cent of H2O2 present or released

0.1 per cent of H2O2 present or released

-

-

-

-

(a): Wear suitable gloves

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

-

13Formaldehyde (see also Part I of Schedule 4)Nail hardeners5 per cent-Contains formaldehyde. Protect cuticles with grease or oil. (Not required when concentration is not more than 0.05 per cent)
14HydroquinoneOxidizing colouring agent for hair dyeing for general use2 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 use2 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 lightener2 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
15aPotassium hydroxide and sodium hydroxide (see Note 1)Nail cuticle solvent5 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 use2 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 use4.5 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 12.7Keep out of reach of children. Avoid contact with eyes
Other uses as pH adjuster-pH value not to exceed 11-
15bLithium hydroxideHair straightener for general use2 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 use4.5 per cent calculated as sodium hydroxide (see Note 2)-For professional use only. Avoid contact with eyes. Can cause blindness
Other uses---
15cCalcium hydroxideHair straighteners containing two components: calcium hydroxide and guanidine salt7 per cent-Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
Other uses---
16α-Naphthol[1-Naphthol]Colouring agent for hair dyeing0.5 per cent-Contains α-napthol
17Sodium nitriteRust inhibitor0.2 per centDo not use with secondary and/or tertiary amines or other substances forming nitrosamines-
18NitromethaneRust inhibitor0.3 per cent--
19Phenol and its alkali saltsSoaps and shampoos1 per cent calculated as phenol-Contains phenol
20ENTRY DELETED
21Quinine and its saltsShampoos0.5 per cent calculated as quinine base--
Hair lotions0.2 per cent calculated as quinine base--
22ResorcinolOxidizing colouring agent for hair dyeing for general use5 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 use5 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 shampoos0.5 per cent subject to the provisions of "Combination Rule B" set out below-Contains resorcinol
23aAlkali sulphidesDepilatories2 per cent calculated as sulphurpH value not to exceed 12.7Keep out of reach of children. Avoid contact with eyes
23bAlkaline earth sulphidesDepilatories6 per cent calculated as sulphurpH value not to exceed 12.7Keep out of reach of children. Avoid contact with eyes
24Water-soluble zinc salts with the exception of zinc 4-hydroxybenzenesulphonateAll purposes and products1 per cent calculated as zinc--
25Zinc 4-hydroxybenzene-sulphonate [Zinc phenolsulfonate]Deodorants, antiperspirants and astringent lotions6 per cent calculated as percentage of anhydrous substance-Avoid contact with eyes
26Ammonium monofluorophosphateOral hygiene products0.15 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
27Sodium monofluorophosphateOral hygiene productsAs for ammonium monofluorophosphate-Contains sodium monofluorophosphate
28Potassium monofluorophosphateOral hygiene productsAs for ammonium monofluorophosphate-Contains potassium monofluorophosphate
29Calcium monofluorophosphateOral hygiene productsAs for ammonium monofluorophosphate-Contains calcium monofluorophosphate
30Calcium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains calcium fluoride
31Sodium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains sodium fluoride
32Potassium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains potassium fluoride
33Ammonium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains ammonium fluoride
34Aluminium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains aluminium fluoride
35Stannous fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains stannous fluoride
36Hexadecylammonium fluoride [Cetylamine hydrofluoride]Oral hygiene productsAs for ammonium monofluorophosphate-Contains hexadecylammonium fluoride
373-(n-Hexadecyl-N-2-hydroxyethylammonio)-propylbis(2-hydroxyethyl)-ammonium difluoride [Stearyl trihydroxyethyl propylenediamine dihydrofluoride]Oral hygiene productsAs for ammonium monofluorophosphate-Contains 3-(n-hexadecyl-N-2-hydroxyethylammonio)propylbis(2-hydroxyethyl)ammonium difluoride
38N,N',N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride [Palmityl trihydroxyethyl propylenediamine dihydrofluoride]Oral hygiene productsAs for ammonium monofluorophosphate-Contains N,N',N'-tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride
39Octadecenylammonium fluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains octadecenylammonium fluoride
40Sodium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contains sodium fluorosilicate
41Potassium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contains potassium fluorosilicate
42Ammonium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contains ammonium fluorosilicate
43Magnesium fluorosilicateOral hygiene productsAs for ammonium monofluorophosphate-Contains magnesium fluorosilicate
441,3-Bis(hydroxymethyl)-imidazolidene-2-thione [Dimethylol ethylene thiourea]Hair care preparations2 per centNot to be used in aerosol dispensersContains 1,3-bis(hydroxymethyl)imidazolidene-2-thione
Nail care preparations2 per centpH value as applied must be less than 4Contains 1,3-bis(hydroxymethyl)imidazolidene-2-thione
45Benzyl alcohol (See also Part I of Schedule 4)Solvent, perfumes and flavourings---
466-MethylcoumarinOral hygiene products0.003 per cent--
47Nicomethanol hydrofluorideOral hygiene productsAs for ammonium monofluorophosphate-Contains nicomethanol hydrofluoride
48Silver nitrateProducts to dye eyelashes or eyebrows4 per cent-Contains silver nitrate. Rinse eyes immediately if product comes into contact with them
49Selenium disulphide [Selenium sulfide]Anti-dandruff shampoos1 per cent-Contains selenium disulphide. Avoid contact with eyes or damaged skin
50Aluminium zirconium chloride hydroxide complexes AlxZr(OH)yClz and aluminium zirconium chloride hydroxide glycine complexesAnti-perspirants20 per cent as anhydrous aluminium zirconium chloride hydroxide, 5.4 per cent as zirconium

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

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

Not to be used in aerosol dispensers (sprays)

Do not apply to irritated or damaged skin
51Quinolin-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 preparations0.3 per cent calculated as base--
Stabilizer for hydrogen peroxide in non rinse-off hair care preparations0.03 per cent calculated as base--
52MethanolDenaturant for ethanol and isopropyl alcohol5 per cent calculated as a percentage of ethanol and isopropyl alcohol--
53Etidronic acid and its salts (1-hydroxyethylidene-diphosphonic acid and its salts)

Hair care

Soap

1.5 per cent expressed as etidronic acid

0.2 per cent expressed as etidronic acid

-

-

-

-

541-Phenoxypropan-2-ol (See also Part I of Schedule 4) [Phenoxyisopropanol]Products rinsed off after use. Prohibited in oral hygiene products2 per cent--
55Lead acetateOnly for hair dyeing0.6 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
56Magnesium fluorideDental hygiene products0.15 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
57Strontium chloride hexahydrateToothpaste3.5 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
58Strontium acetate hemihydrateToothpaste3.5 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
59Talc: 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--
60Fatty acid dialkanolamidesAll purposes and productsMaximum dialkanolamine content: 0.5 per centDo 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-
61MonoalkanolaminesAll purposes and productsMaximum dialkanolamine content: 0.5 per centDo 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-
62Trialkanolamines

(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-
63Strontium hydroxidepH-regulator in depilatory products3.5 per cent calculated as strontiumpH value not to exceed 12.7Keep out of reach of children. Avoid contact with the eyes
64Strontium peroxideRinse-off hair care preparations for professional use4.5 per cent calculated as strontium in the ready-for-use preparationAll products must meet the hydrogen peroxide release requirementsAvoid contact with eyes. Rinse eyes immediately if product comes into contact with them. For professional use only. Wear suitable gloves

PART IISUBSTANCES LISTED IN ANNEX III, PART 2 (FORMERLY ANNEX IV, PART 1) OF THE DIRECTIVE(41) AS SUBSTANCES PROVISIONALLY ALLOWED

(1)(2)(3)(4)(5)(6)(7)
Reference NumberName of SubstancePurpose of substance or type of productMaximum concentration of substance in productOther requirementsRequired informationPermitted for use until

NOTE-There are presently no entries in this Part.

Combination Rules

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

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

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

Regulations 4(2) and 6(9)

SCHEDULE 3LIST OF COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS AND EXCEPT COLOURING AGENTS INTENDED SOLELY TO COLOUR HAIR

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(42), as amended(43), adapted(44) and replaced in part(45) must fulfil the purity requirements laid down in those Directives.

PART ICOLOURING AGENTS LISTED IN ANNEX IV PART 1 (FORMERLY ANNEX III PART 2) OF THE DIRECTIVE(46) AS COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

Field of application

In column 3 of this Schedule, the entry "X" in a sub-column means that the colouring agent must not be used other than as follows-

PART IICOLOURING AGENTS LISTED IN ANNEX IV OF PART 2 OF THE DIRECTIVE(47) AS COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE COSMETIC PRODUCT SUPPLIED BEFORE A CERTAIN DATE

Field of application

In column 3 of this Schedule, the entry "X" in a sub-column means that the colouring agent must not be used other than as follows-

NOTE: There are presently no entries in this part.

Regulations 4(2) and 6(2)

SCHEDULE 4LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

In this Schedule, the matters specified in columns 3, 4, 5 and 6 which apply to a particular substance are those set out to the right of its name as mentioned in column 2; and the matters specified in columns 4, 5 and 6 which apply in any particular case are those set out to the right of the matter specified in column 3 which applies in that case. The substance may not be used or contained other than in the types of product specified in column 3. The concentration of the substance, when it is used as a preservative, in a product may not exceed the limit set out in column 4. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 5.

In column 4 of this Schedule, "A" indicates that the concentration of the substance in a product may exceed the limit set out in that column provided that-

(a)the presence of any excess of the substance in a product over the concentration so set out is not for the primary purpose of inhibiting the development of micro-organisms; and

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

In this Schedule-

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

"esters" means esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl and phenyl.

In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

All 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(48).

PART IPRESERVATIVES LISTED IN ANNEX VI, PART I OF THE DIRECTIVE(49) AS PRESERVATIVES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

(1)(2)(3)(4)(5)(6)
Reference NumberName of substancePurpose of substance or type of productMaximum concentration of substance in productOther requirementsRequired information
1Benzoic acid, its salts and estersAll products0.5 per cent (acid)A--
2Propionic acid and its saltsAll products2 per cent (acid)A--
3Salicylic acid and its saltsAll products0.5 per cent (acid)ANot to be used in preparations for children under three years of age except for shampoosNot 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)
4Sorbic acid (hexa-2,4-dienoic acid) and its saltsAll products0.6 per cent (acid)A--
5Formaldehyde and paraformaldehydeFor oral hygiene0.1 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)
6ENTRY DELETED
7Biphenyl-2-ol [o-phenylphenol] and its saltsAll products0.2 per cent (expressed as the phenol)A--
8Pyrithione zinc (INN) [Zinc pyrithione]Products rinsed off after use0.5 per centANot to be used in oral hygiene products-
9Inorganic sulphites and hydrogen sulphitesAll products0.2 per cent (expressed as free SO2)A--
10Sodium iodateProducts rinsed off after use0.1 per cent--
11Chlorobutanol (INN)All products0.5 per centNot to be used in aerosol dispensers (sprays)Contains chlorobutanol
124-Hydroxybenzoic acid and its salts and esters [the Parabens]All products0.4 per cent (acid) for 1 ester, 0.8 per cent (acid) for mixtures of estersA--
133-Acetyl-6-methylpyran-2,4(3H)-dione [Dehydroacetic acid] and its saltsAll products0.6 per cent (acid)Not to be used in aerosol dispensers (sprays)-
14Formic acid and its sodium saltAll products0.5 per cent (expressed as acid)A--
153,3'-Dibromo-4,4'-hexamethylene-dioxydibenzamidine [Dibromohexamidine] and its salts (including isethionate)All products0.1 per cent--
16Thiomersal (INN) [Thimerosal]Eye make-up and eye make-up remover0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent-Contains thiomersal
17Phenylmercuric salts (including borate)Eye make-up and eye make-up remover0.007 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
18Undec-10-enoic acid [Undecylenic acid] and its saltsAll products0.2 per cent (acid)A--
19Hexetidine (INN)Products rinsed off after use0.1 per centA--
205-Bromo-5-nitro-1,3-dioxaneProducts rinsed off after use0.1 per centAvoid formation of nitrosamines-
21Bronopol (INN) [2-Bromo-2-nitropropane-1,3-diol]All products0.1 per centAAvoid formation of nitrosamines-
222,4-Dichlorobenzyl alcohol [Dichlorobenzyl alcohol]All products0.15 per centA--
23Triclocarban (INN)All products0.2 per centA

Purity criteria:

3,3'4,4'-tetrachloro-azobenzene<1 mg/kg

3,3',4,4'-tetrachloro-azoxybenzene<1 mg/kg

-
244-Chloro-m-cresol [p-Chloro-m-cresol]Not to be used in products intended to come into contact with mucous membranes0.2 per centA--
25Triclosan (INN)All products0.3 per centA--
264-Chloro-3,5-xylenol [Chloroxylenol]All products0.5 per centA--
273,3'-Bis(1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea [Imidazolidinyl urea]All products0.6 per centA--
28Poly(1-hexamethylene-biguanide hydrochloride) [Polyaminopropyl biguanide]All products0.3 per centA--
292-Phenoxyethanol [Phenoxyethanol]All products1.0 per centA--
30Hexamethylenetetramine (Methenamine (INN)) [Methenamine]All products0.15 per centA--
31Methenamine 3-chloroallylochloride (INNM) [Quaternium-15]All products0.2 per cent--
321-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one (Climbazole (INN)) [Climbazole]All products0.5 per centA--
331,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione [DMDM Hydantoin]All products0.6 per centA--
34Benzyl alcohol (See also Part I of Schedule 2)All products1.0 per centA--
351-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone and its monoethanolamine salt [Piroctone olamine]

Products rinsed off after use

Other products

1.0 per cent

0.5 per cent

A

A

-

-

-

-

361,2-Dibromo-2,4-dicyanobutane [Methyldibromo glutaronitrile]All products0.1 per centNot to be used in cosmetic sunscreen products at a concentration exceeding 0.025 per cent-
376,6-Dibromo-4,4-dichloro-2,2'-methylenediphenol [Bromochlorophen]All products0.1 per centA--
384-Isopropyl-m-cresol [o-Cymen-5-ol]All products0.1 per cent--
39Mixture of 5-chloro-2-methylisothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate [Methylchloroisothiazolinone and Methylisothiazolinone]All products0.0015 per cent of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol-3(2H)-one to 2-methylisothiazol-3(2H)-one--
402-Benzyl-4-chlorophenol [Chlorophene]All products0.2 per cent--
412-Chloroacetamide [Chloroacetamide]All products0.3 per cent-Contains chloroacetamide
42Chlorhexidine (INN) and its digluconate, diacetate and dihydrochlorideAll products0.3 per centA--
431-Phenoxypropan-2-ol [Phenoxyisopropanol] (see also Part I of Schedule 2)Products rinsed off after use1.0 per cent--
44Alkyl (C12-C22)-trimethylammonium bromide and chloride (Cetrimonium bromide (INN) and Cetrimonium chloride (INNM))All products0.1 per centA--
454,4-Dimethyl-1,3-oxazolidine [Dimethyl oxazolidine]All products0.1 per centThe pH of the finished product must not be lower than 6-
461-[1,3-Bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea [Diazolidinyl urea]All products0.5 per cent--
47Hexamidine (INN) (4,4'-(Hexamethylene-dioxy)dibenzamidine) and its salts, including isethionate and p-hydroxybenzoateAll products0.1 per centA--
48Glutaraldehyde (pentane-1,5-dial) [Glutaral]All products0.1 per centProhibited in aerosols (sprays)Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0.05 per cent)
495-Ethyl-3,7-dioxa-1-azabicyclo[3.3.0]octane[7-Ethylbicyclooxazolidine]All products0.3 per centProhibited in oral hygiene products and in products intended to come into contact with mucous membranes-
50Chlorphenesin (INN) [Chlorphenesin]All products0.3 per cent--
51Sodium N-hydroxymethylglycinate [Sodium hydroxymethyl-glycinate]All products0.5 per cent--
52Silver chloride deposited on titanium dioxideNot 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 lips0.004 per cent calculated as silver chlorideThe ratio of titanium dioxide to silver chloride shall be 4:1 by mass-

PART IIPRESERVATIVES LISTED IN ANNEX VI PART 2 OF THE DIRECTIVE(50) AS PRESERVATIVES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE

(1)(2)(3)(4)(5)(6)(7)
Reference Number in Annex VI Part 2 of the DirectiveName of substancePurpose of substance or type of productMaximum concentration of substance in productOther requirementsRequired informationPreservative supplied until

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.

1 to 15ENTRIES DELETED (see Note)
16Benzalkonium chloride (INN), bromide and saccharinate (Alkyl(C8-C18) benzyldimethyl-ammonium chloride, bromide and saccharinate)All products0.1 per cent A--30.06.1997
17 to 20ENTRIES DELETED
21Benzylhemiformal (a 1:1 mixture of benzyloxymethanol and benzyloxy-methoxymethanol)Products rinsed off after use0.03 per cent--30.06.1997
22 to 28ENTRIES DELETED
293-lodoprop-2-ynyl butylcarbamateAll products0.1 per cent--30.06.1997
30ENTRY DELETED (see Note)

Regulations 4(2) and 6(2)

SCHEDULE 5LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

In this Schedule, the matters specified in columns 3, 4 and 5 which apply to a particular substance are those set out to the right of its name as mentioned in column 2. The concentration of the substance in a product may not exceed the limit specified in column 3. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 4. In column 3 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC(51)

PART IUV FILTERS LISTED IN ANNEX VII PART I OF THE DIRECTIVE(52) AS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

(1)(2)(3)(4)(5)
Reference NumberName of substanceMaximum concentration of substance in productOther requirementsRequired information
14-Aminobenzoic acid [PABA]5 per cent--
2N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl)anilinium methyl sulphate [Camphor benzalkonium methosulfate]6 per cent--
3Homosalate (INN)10 per cent--
4Oxybenzone (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.)
5ENTRY DELETED
62-Phenylbenzimidazole-5-sulphonic acid [Phenylbenzimidazole sulfonic acid] and its potassium, sodium and triethanolamine salts8 per cent (expressed as acid)--
73,3'-(1,4-Phenylenedimethylene)bis(7,7-dimethyl-2-oxo-bicyclo[2.2.1]hept-1-ylmethanesulfonic acid) [Terephthalylidene dicamphor sulfonic acid] and its salts10 per cent (expressed as acid)--
81-(4-tert-Butylphenyl)-3-(4-methoxyphenyl) propane-1,3-dione (Avobenzone (INN)) [Butyl methoxy dibenzoylmethane]5 per cent--
9α-(2-Oxoborn-3-ylidene)toluene-4-sulphonic acid [Benzylidene camphor sulfonic acid] and its salts6 per cent (expressed as acid)--
102-Ethylhexyl-2-cyano-3,3-diphenylacrylate [Octocrylene]10 per cent (expressed as acid)--
11Polymer of N-{(2 and 4)-[2-oxoborn-3-ylidene)methyl]benzyl}acrylamide [Polyacrylamidomethyl benzylidene camphor]6 per cent--

PART IIUV FILTERS LISTED IN ANNEX VII PART 2 OF THE DIRECTIVE(53) AS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE

(1)(2)(3)(4)(5)(6)
Reference NumberName of substanceMaximum concentration of substance in productOther requirementsRequired informationUV filter supplied until

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.

1ENTRY DELETED
2Ethoxylated ethyl 4-aminobenzoate [PEG-25 PABA]10 per cent--30.6.1997
3-�4ENTRIES DELETED
52-Ethylhexyl 4-dimethylamino-benzoate [Octyl dimethyl PABA]8 per cent--30.6.1997
62-Ethylhexyl salicylate [Octyl salicylate]5 per cent--30.6.1997
7-�11ENTRIES DELETED
12Isopentyl 4-methoxycinnamate, mixed isomers [Isoamyl p-methoxycinnamate]10 per cent--30.6.1997
132-Ethylhexyl 4-methoxycinnamate [Octyl methoxycinnamate]10 per cent--30.6.1997
14-�16ENTRIES DELETED
172-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-�24ENTRIES DELETED
253-(4-Methylbenzyl-idene)bornan-2-one [4-Methylbenzylidene camphor]6 per cent--30.6.1997
263-Benzylidenebornan-2-one [3-Benzylidene camphor]6 per cent--30.6.1997
27-�28ENTRIES DELETED
294-Isopropylbenzyl salicylate [Isopropylbenzyl salicylate]4 per cent--30.6.1997
30-�31ENTRIES DELETED
32Tris(2-ethylhexyl) 4,4',4"-(1,3,5-triazin-2,4,6-triyltriimino)- tribenzoate [Octyl triazone]5 per cent--30.6.1997
33-�34ENTRIES DELETED (see Note)

Regulations 6(6) and (11)

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

Regulation 11

SCHEDULE 7

PART IPARTICULARS 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 IIPROCEDURE 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.

Regulation 14

SCHEDULE 8SAMPLING AND TESTING

1. In this Schedule-

"Annex A" means the Annex to Commission Directive No. 80/1335/EEC(54) as amended by Commission Directive No. 87/143/EEC(55);

"Annex B" means the Annex to Commission Directive No. 82/434/EEC(56) as amended by Commission Directive No. 90/207/EEC(57);

"Annex C" means the Annex to Commission Directive No. 83/514/EEC(58);

"Annex D" means the Annex to Commission Directive No. 85/490/EEC(59);

"Annex E" means the Annex to Commission Directive No. 93/73/EEC(60);

"Annex F" means the Annex to Commission Directive No. 95/32/EC(61);

"Annex G" means the Annex to Commission Directive No. 96/45/EC(62);

"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(63), 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.

Regulation 1(9)

SCHEDULE 9REVOCATIONS

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

Explanatory Note

(This note is not part of the Regulations)

These Regulations consolidate with amendments the Cosmetic Products (Safety) Regulations 1989 as amended. They implement Council Directive 76/768/EEC (O.J. No. L262, 27.9.1976, p.169) on the approximation of the laws of the member States relating to cosmetic products, as amended ("the Cosmetics Directive"). They implement for the first time the amendments made to the Cosmetics Directive by Council Directive 93/35/EEC (O.J. No. L151, 23.6.1993, p.32) and Commission Directive 96/41/EC (O.J. No. L198, 8.8.1996, p.36). They also implement Commission Directives 95/32/EC (O.J. No. L178, 28.7.1995, p.20) and 96/45/EC (O.J. No. L213, 2.7.1996, p.8) relating to methods of analysis necessary for checking the composition of cosmetic products. Further, they implement Commission Directive 95/17/EC (O.J. No. L140, 23.6.1995, p.26) laying down detailed rules for the application of the Cosmetics Directive as regards the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic products.

These Regulations give effect to Council Directive 93/35/EEC and Commission Directive 96/41/EC as follows-

1. they contain an amended definition of "cosmetic product"(regulation 2(1));

2. they contain an expanded general safety requirement for cosmetic products (regulation 3(1));

3. they prohibit the use of urocanic acid and its ethyl ester in cosmetic products (regulation 4(2)(a) and Schedule 1, entry numbers 342, 405 and 751);

4. they permit the use in certain cosmetic products of potassium hydroxide, sodium hydroxide, lithium hydroxide and calcium hydroxide, subject to restrictions (regulation 4(2)(b) and Schedule 2, Part I, entry numbers 15a, 15b and 15c);

5. they permit the use as preservatives in cosmetic products of chlorphenesin, sodium hydroxymethylglycinate and silver chloride deposited on titanium dioxide, subject to restrictions (regulations 4(2)(e)(i) and 4(2)(f) and Schedule 4, Part I, entry numbers 50, 51 and 52);

6. they permit, subject to restrictions, the use in cosmetic products until 30 June 1997 of three preservatives listed as entry numbers 16, 21 and 29 in Schedule 4, Part II (regulation 4(2)(e)(ii) and Schedule 4, Part II);

7. they permit the use as a UV filter in cosmetic products of polymer N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl}acrylamide, subject to a restriction (regulation 4(2)(h)(i) and 4(2)(i) and Schedule 5, Part I, entry number 11);

8. they permit the use in cosmetic products until 30 June 1997 of 10 UV filters listed as entry numbers 2, 5, 6, 12, 13, 17, 25, 26, 29 and 32 in Schedule 5, Part II, subject to restrictions (regulation 4(2)(h)(ii) and Schedule 5, Part II);

9. they prohibit the use in cosmetic products of any ingredients which have been tested on animals after 1st January 1998 (regulation 4(3));

10. they provide that 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 (regulation 4(4) and (5));

11. they require cosmetic products to be labelled with information about their function, unless this is clear from their presentation (regulation 6(2)(h));

12. they require cosmetic products to be labelled with details of their ingredients, identified by their common names as provided for in the common ingredients nomenclature (an inventory of ingredients compiled by the Commission and contained in Commission Decision 96/335/EC (O.J. No. L132, 1.6.1996, p.1), and they make provision for the manner of labelling required and for cases where ingredients are not listed in the common ingredients nomenclature (regulation 6(1), (5)(b) and (9) to (12));

13. they require manufacturers, their agents, persons to whose order cosmetic products are manufactured and (in certain circumstances) persons responsible for supplying cosmetic products for the first time in the Community to keep for control purposes detailed information (which must be readily accessible to a United Kingdom competent authority) bearing on the composition, ingredients, method of manufacture, safety and effect of the cosmetic products in question (regulation 8);

14. they require manufacturers, their agents, persons to whose order cosmetic products are manufactured and (in certain circumstances) persons responsible for supplying cosmetic products for the first time in the Community to notify a United Kingdom competent authority of the address of the place of manufacture or initial importation into the Community of a type of cosmetic product before that type of product is first supplied in the Community, where the place of manufacture or initial importation is within the United Kingdom (regulation 9); and

15. they enable United Kingdom competent authorities to require that any holder of information on substances used in cosmetic products must make that information available where this may overcome or ease any difficulties encountered in providing prompt and appropriate medical treatment (regulation 10).

These Regulations give effect to the requirements of Commission Directives 95/32/EC and 96/45/EC by introducing procedures for the identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid, propionic acid, hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether, hydroquinone monobenzylether (monobenzone), 2-phenoxyethanol, 1-phenoxypropan-2-ol, and methyl, ethyl, propyl, butyl and benzyl 4-hydrozybenzoate in cosmetic products (regulation 14 and Schedule 8, paragraph 6(39), (40) and (41)).

Finally, these Regulations give effect to the requirements of Commission Directive 95/17/EEC by providing that manufacturers, their agents, persons to whose order cosmetic products are manufactured and (in certain circumstances) persons responsible for supplying cosmetic products for the first time in the Community may, if for reasons of trade secrecy they do not wish to include a particular cosmetic ingredient in the list of cosmetic ingredients required for labelling purposes, apply to a competent authority for approval to use a reference number in that list rather than the ingredient's name. Provision is made for the particulars which must accompany such an application and for the procedures which apply to applications and to the withdrawal of any approval (regulation 11 and Schedule 7).

The Colour Index referred to in these Regulations may be obtained from the Society of Dyers and Colourists, PO Box No. 244, 82 Grattan Road, Bradford BD1 2JB.

The International Cosmetic Ingredient Dictionary referred to in these Regulations may be obtained from Micelle Press, 12 Ullswater Crescent, Weymouth, Dorset DT3 5HE.

A Compliance Cost Assessment is available, copies of which have been placed in the libraries of both Houses of Parliament. Copies are also available from the Consumer Affairs and Competition Policy Directorate of the Department of Trade and Industry, Room 4.D.2, 1 Victoria Street, London SW1H 0ET.

(5)

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

(6)

O.J. No. L140, 23.6.1995, p.26.

(7)

O.J. No. L262, 27.9.1976, p.169.

(8)

O.J. No. L167, 15.6.1982, p.1.

(9)

O.J. No. L63, 6.3.1982, p.26.

(10)

O.J. No. L109, 26.4.1983, p.25.

(11)

O.J. No. L188, 13.7.1983, p.15.

(12)

O.J. No. L332, 28.11.1983, p.38.

(13)

O.J. No. L275, 8.10.1983, p.20.

(14)

O.J. No. L228, 25.8.1984, p.31.

(15)

O.J. No. L224, 22.8.1985, p.40.

(16)

O.J. No. L138, 24.5.1986, p.40.

(17)

O.J. No. L149, 3.6.1986, p.38.

(18)

O.J. No. L56, 26.2.1987, p.20.

(19)

O.J. No. L105, 26.4.1988, p.11.

(20)

O.J. No. L382, 31.12.1988, p.46.

(21)

O.J. No. L64, 8.3.1989, p.10.

(22)

O.J. No. L398, 30.12.1989, p.25.

(23)

O.J. No. L71, 17.3.1990, p.40.

(24)

O.J. No. L91, 12.4.1991, p.59.

(25)

O.J. No. L70, 17.3.1992, p.23.

(26)

O.J. No. L325, 11.11.1992, p.18.

(27)

O.J. No. L203, 13.8.1993, p.24.

(28)

O.J. No. L151, 23.6.1993, p.32.

(29)

O.J. No. L181, 15.7.1994, p.31.

(30)

O.J. No. L167, 18.7.1995, p.19.

(31)

O.J. No. L198, 8.8.1996, p.36..

(32)

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

(33)

An ingredient's CTFA name is the name given to it by the Cosmetics Toiletries and Fragrances Association and listed in the sixth edition of the International Cosmetic Ingredient Dictionary published in 1995. Its EINECS identification reference is the reference given in the European Inventory of Existing Commercial Chemical Substances. Its IUPAC identification reference is the reference given by the International Union of Pure and Applied Chemistry. Its CAS identification reference is the reference assigned by the Chemical Abstracts Service. An ingredient's colour index number is the number specified in the third edition of The Colour Index published in 1971 by the Society of Dyers and Colourists. European Pharmacopoeia names, International Non-proprietary Names and EINECS, IUPAC and CAS identification references are listed in Commission Decision 96/335/EC (O.J. No. L132, 1.6.1996, p.1).

(34)

O.J. No. L15, 17.1.87, p.29.

(38)

O.J. No. L187, 12.7.76, p.1.

(39)

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

(40)

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

(42)

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

(43)

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

(44)

Annexes I and VII to the Act of Accession of 22 January 1972, as adjusted by the Council Decision of 1 January 1973 (O.J. No. L2, 1.1.73, p.1).

(45)

Council Directive 94/36/EC (O.J. No. L237, 10.9.1994, p.13) and Commission Directive 95/45/EC (O.J. No. L226, 22.9.1995, p.1).

(48)

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

(51)

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

(54)

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

(55)

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

(56)

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

(57)

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

(58)

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

(59)

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

(60)

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

(61)

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

(62)

O.J. No. L213, 2.7.1996, p.8.

(63)

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

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