The Cosmetic Products (Safety) Regulations 1996

Link to law: http://www.legislation.gov.uk/uksi/1996/2925/made/data.htm?wrap=true
Published: 1996-11-21

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:

Provided that the requirements specified in sub-paragraphs (b) and (g) above need not be complied with in relation to a cosmetic product which is the subject of a market research experiment.

(3) The particulars referred to in sub-paragraph (a) of paragraph (2) above may be abbreviated if such abbreviation does not prevent the person concerned from being identified.

(4) The date referred to in sub-paragraph (b) of paragraph (2) above shall include the month and the year, and the month shall precede the year.

(5) The particulars referred to—

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

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

(6) Where it is impossible for practical reasons for the particulars referred to in sub-paragraphs (c) to (f) of paragraph (2) above to appear on the container and packaging, they shall appear on a leaflet, label, tag, tape or card enclosed with the cosmetic product, to which the consumer is referred either by abbreviated information or by the symbol given in Schedule 6, which must appear on the container and packaging; and where it is impracticable for reasons of size or shape for the particulars so to appear, they shall appear on a label, tag, tape or card attached to the product.

(7) Where it is impossible, for reasons of size, for the particulars referred to in sub-paragraph (g) of paragraph (2) above to appear on the container and packaging, the said particulars shall appear on the packaging.

(8) In the case of a supply of soap which is not in a container, either the soap itself or the packaging in which it is exposed for supply or the container in which it was last contained before the supply shall bear the particulars referred to in sub-paragraphs (a) and (g) of paragraph (2) above, and in so far as any of the particulars referred to in sub-paragraphs (b) to (f) and (h) of paragraph (2) above are required they shall appear on a leaflet which shall be delivered to the buyer with the soap; and where either of the particulars referred to in sub-paragraphs (a) and (g) of paragraph (2) above appears on the soap itself the requirement of indelibility shall apply only until it has been put into use.

(9) In relation to the compilation of the list of ingredients referred to in paragraph (1) above—

(a)the following shall not be regarded as cosmetic ingredients—

(i)impurities in the raw materials used;

(ii)subsidiary technical materials used in the preparation of the cosmetic product but not present in the final product;

(iii)materials used in strictly necessary quantities as solvents or as carriers for perfumes and aromatic compositions;

(b)perfume and aromatic compositions and their raw materials shall be referred to by the words “perfume” or “flavour”;

(c)ingredients in concentrations of less than 1% may be listed in any order after those in concentrations of 1% or more;

(d)colouring agents may be listed in any order after the other ingredients, in accordance with the colour index number or denomination found in Schedule 3;

(e)for decorative cosmetic products marketed in several colour shades, all colouring agents used in the range may be listed, provided that the words “may contain” are added; and

(f)an ingredient shall be identified by its common name as provided for in the common ingredients nomenclature or, in the absence of the nomenclature or of a common name, by its chemical name, its CTFA name, its European Pharmacopoeia name, its International Non-proprietary Name as recommended by the World Health Organisation, its EINECS, IUPAC or CAS identification reference or its colour index number(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 Schedule
Name of substance
Cross-reference to this Schedule
Cross-reference to Annex II of the Directive

1

Acenocoumarol (INN)

396
254

2
Acetonitrile

393

3
3-(α-Acetonylbenzyl)-4-hydroxycoumarin and its salts
398, 760
203

4
2-Acetoxyethyltrimethylammonium hydroxide and its salts
6
2

5
2-Acetylamino-5-chlorobenzoxazole
164
1

6
Acetylcholine and its salts
4
2

7
Acetylene chlorides
249, 757
126

8
Acetylenic alcohols, their esters, ethers and salts
17
16

9

Acetylethyltetramethyltetralin (AETT)

341
362

10
7α-Acetylthio-3-oxopregn-4-ene-17α,17β-propionolactone
649
4

11
Aconitine and its salts

12

12

Aconitum napellus L. (leaves, roots and galenical preparations)

11

13

Adonis vernalis L. and its preparations

13

14
Adrenaline
269, 314
14

15
Alkali pentacyanonitrosylferrate(2-)
602–3, 644–5
255

16

O-Alkyldithiocarbonic acids, salts of
761
336

17
Alkyne alcohols, their esters, ethers and salts
8
16

18
Alloclamide (INN) and its salts
22
19

19
Allyl isothiocyanate

18

20
2-(4-Allyl-2-methoxyphenoxy)-N,N-diethylacetamide and its salts

224

21

N-Allylnormorphine, its salts and ethers
492
20

22
2-Allyloxy-4-chloro-N-[2-(diethylamino)-ethyl]benzamide and its salts
18
19

23
Alypine and its salts
45, 109
143

24
Ambenonium chloride (INN)
(527)
132

25
4-(or p-)Aminobenzoic acid esters

167

26
2-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts

29

27
Aminocaproic acid (INN) and its salts
31
7

28
2-Amino-5-chlorobenzoxazole
768
24

29
4-Amino-N-(2-diethylaminoethyl)benzamide, its salts and derivatives
607
25

30
Aminoheptane, its isomers and salts
748
25

31
6-Aminohexanoic acid and its salts
27
7

32

α-(Aminomethyl)-3,4-dihydroxybenzyl alcohol and its salts
517–8
257

33
4-Amino-N10-methylfolic acid
452
6

34
2-Amino-6-methylheptane and its salts
287, 523
28

35
2-Amino-4-methylhexane and its salts
288, 471
30

36
2-Amino-4-nitrophenol

383

37
2-Amino-5-nitrophenol

384

38
4-Amino-2-nitrophenol

412

39
4-(or p-)Aminosalicylic acid and its salts

31

40
Aminotoluenes, their isomers, salts and halogenated and sulphonated derivatives
716
32

41
Aminoxylenes, their isomers, salts and halogenated and sulphonated derivatives
763
33

42
Amitriptyline (INN) and its salts
283
146

43

Ammi majus and its galencial preparations

35

44
Amphetamine (INN), its salts and derivatives and salts of those derivatives
(678)
21

45
Amydricaine and its salts
23, 109
143

46
Amylene chloride
250
36

47
Amyl 4-dimethylaminobenzoate, mixed isomers
532
381

48
Amyl nitrites

247

49
Amylobarbitone and its salts
(69)
220

50
Amylocaine and its salts
281
50

51

Anamirta cocculus L. (fruit)

106

52
Substances with androgenic effect

37

53
Aniline, its salts and halogenated and sulphonated derivatives

22

54
Anthracene oil

38

55
Anti-androgens with steroid structure

390

56
Antibiotics

39

57
Antimony and its compounds

40

58

Apocynum cannabinum L. and its preparations

41

59
Apomorphine and its salts
694
42

60
Apronalide
419
216

61
Arecoline
482
238

62
Aristolochic acid and its salts

365

63
Arsenic and its preparations

43

64

Atropa belladonna L. and its preparations

44

65
Atropine, its salts and derivatives

45

66
Azacyclonol (INN) and its salts
304
286

67
Azamethonium bromide (INN)
(473)
121

68
Barbitone and its salts
(69)
220

69
Barbiturates
various
220

70
Barium salts (except barium sulphate, barium sulphide under the condition laid down in Part I of Schedule 2 for alkaline earth sulphides, and lakes, salts and pigments prepared from those colouring agents identified in column 1 of Schedule 3 by “*” immediately after the name or colour index number)

46

71
Bemegride (INN) and its salts
336, 337
183

72
Benactyzine (INN)
257
157

73
Bendrofluazide and its derivatives
74, 90
53

74
Bendroflumethiazide (INN) and its derivatives
73, 90
53

75
Benzamine and its salts
741
51

76
Benzatropine (INN) and its salts
300
158

77
Benzazepines, their salts and derivatives
89
49

78
Benzene

47

79
Benzene-1,2-diol
153, 627
408

80
Benzene-1,2,3-triol
628
409

81
Benzethonium chloride (INN)
92
415

82
2-Benzhydryloxyethyldimethylamine and its salts
295
339

83
Benzidine
242
26

84
Benzilonium bromide (INN)
95
60

85
2-Benziloyloxymethyl-1,1-dimethylpyrrolidinium methyl sulphate
599
239

86
Benzimidazolone
87, 266
48

87
Benzimidazol-2(3H)-one
86, 266
48

88
Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol (except natural content of essences)
211
357

89
Benzodiazepines, their salts and derivatives
77
49

90
Benzothiadiazine and its derivatives
73, 74
53

91
Benzoyl peroxide

382

92
Benzyl(dimethyl)(2-{2-[4-(1,1,3,3-tetramethybutyl)phenoxy]ethoxy}-ethyl)ammonium chloride
81
415

93
3-(N-Benzylhydrazinocarbonyl)-5-methylisoxazole
414
52

94
Benzylideneacetone
564
356

95
3-Benzyloxy-1,1-diethylpyrrolidine hydrobromide
84
60

96
4-Benzyloxyphenol
(390), 487
178

97
2-[Benzyl-N-(2-pyridyl)amino]-ethyldimethylamine
623, 745
347

98

Bergapten(e) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg

(356)
358

99
Beryllium and its compounds

54

100
Betamethasone (INN)
(360)
300

101
Betoxycaine (INN) and its salts
256
23

102

BHC (ISO) (gamma-BHC)

369, 371, 428
195

103
Bietamiverine (INN)
260
287

104
1,6-Bis(2-chloroethylamino)-1,6-dideoxymannitol and its salts
436
89

105
2-[Bis(2-chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane 2-oxide and its salts
108, 230
88

106

N,N-Bis(2-chloroethyl)methylamine and its salts
160, 490
87

107

N,N-Bis(2-chloroethyl)methylamine N-oxide and its salts
491
86

108

N,N-Bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-ylamine p-oxide and its salts
105, 230
88

109
1,1-Bis(dimethylaminomethyl)propyl benzoate and its salts
23, 45
143

110
Bis(hydroxyalkyl)amines, not further N-substituted
254, 273, 640
411

111
2,2-Bis(hydroxymethyl)butan-1-ol trinitrate
613
206

112
2,6-Bis(β-hydroxyphenethyl)-1-methylpiperidine and its salts
430
219

113
3,3-Bis(4-hydroxyphenyl)phthalide
557
417

114
Bis(8-hydroxyquinolinium) sulphate, except for the uses provided for in entry number 51 in Part 1 of Schedule 2
(400, 531)
395

115
Bithionol (INN)
705
352

116
Bretylium tosilate (INN) (Bretylium tosylate)
119
56

117
Bromine, elemental

55

118
Bromisoval (INN)
121
58

119

p-Bromobenzylethyldimethylammonium p-toluenesulphonate
116
56

120
2-Bromo-2-ethylbutyrylurea
149
57

121
2-Bromo-3-methylbutylrylurea
118
58

122
1-p-Bromophenyl-1-(2-pyridyl)-3-dimethylaminopropane and its salts
123
59

123
Brompheniramine (INN) and its salts
122
59

124
Brucine

62

125
Butanilicaine (INN) and its salts
466
90

126
Butobarbitone and its salts
(69)
220

127
Butopiprine (INN) and its salts
129
288

128
2-Butoxy-N-(2-diethylaminoethyl)-cinchoninamide and its salts
191
129

129
2-Butoxyethyl phenyl(piperidino)acetate and its salts
127
288

130
1-Butyl-3-(N-crotonoylsulphanilyl)urea

108

131
4-Butyl-1,2-diphenylpyrazolidine-3,5-dione
563
67

132
4-tert-Butyl-3-methoxy-2,6-dinitrotoluene
489
414

133
4-Butyl-1-phenylpyrazolidine-3,5-dione
486
64

134
1-Butyl-3-(p-methylbenzenesulphonyl)urea
715
65

135
1-Butyl-3-sulphanilylurea
150
66

136
4-Butylthiobenzhydryl 2-(dimethylamino)ethyl sulphide
143
140

137
Cadmium and its compounds

68

138
Calabar bean
585
281

139
Calciferol
316, (759)
335

140
Cantharides, Cantharis vesicatoria

647
69

141
Cantharidin
378
70

142
Captan (ISO)
734
370

143
Captodiame (INN)
136
140

144
Caramiphen (INN) and its salts
567
169

145

N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethylammonium salts
418
156

146
Carbazole, nitroderivatives of
508
72

147
Carbon disulphide

73

148
Carbon tetrachloride
690
315

149
Carbromal (INN)
120
57

150
Carbutamide (INN)
135
66

151
Carisoprodol (INN)
480
235

152
Catalase

74

153
Catechol
79, 627
408

154
Cells, tissues or products of human origin

416

155
Cephaeline and its salts

75

156

Chenopodium ambrosioides (essential oil)

76

157
Cherry laurel water
618
291

158
Chloral hydrate
732
77

159
Chlorine

78

160
Chlormethine (INN) and its salts
106, 490
87

161
Chlormezanone (INN)
175
91

162
4-Chlorobenzene-1,3-disulfonamide
194
85

163
5-Chloro-1,3-benzoxazol-2(3H)-one
186
82

164

N-5-Chlorobenzoxazol-2-ylacetamide
5
1

165
2-Chloro-4-dimethylamino-6-methylpyrimidine
169, 216
83

166
2-Chloro-9-[3-(dimethylamino)-propylidene]thioxanthene (cis-form) and its salts
183
84

167
Chloroethane
327
96

168
Chloroform
733
366

169
2-Chloro-6-methylpyrimidin-4-yldimethylamine
165, 216
83

170
Chlorophacinone (ISO)
176
93

171
1-(p-Chloro-α-phenylbenzyl)-4-(2-hydroxyethoxyethyl)piperazine
401
240

172
2-(4-Chlorophenyl)-1-[4-(2-diethylaminoethoxyl)phenyl]-1-p-tolylethanol
744
92

173
4-[4-(4-Chlorophenyl)-4-hydroxypiperidin-1-yl]-1-(4-fluorophenyl)butan-1-one
368
185

174
2-(4-Chlorophenyl)-3-methylbutane-2,3-diol
551
95

175
2-(4-Chlorophenyl-3-methyl-1,3-thiazinan-4-one 1,1-dioxide
161
91

176
2-[2-(4-Chlorophenyl)-2-phenylacetyl]indane-1,3-dione
170
93

177
2-[1-(4-Chlorophenyl)-1-phenylethoxy]ethyl-(dimethyl)amine
180
94

178
Chloropicrin
735
325

179
3-(4-Chloro-3-sulphamoylphenyl)-3-hydroxyisoindolin-1-one
184, 185
262

180
Chlorphenoxamine (INN)
177
94

181
Chlorpromazine (INN)
(558)
320

182
Chlorpropamide (INN)
614
79

183
Chlorprothixene (INN) and its salts
166
84

184
Chlortalidone (INN)
179, 185
262

185
Chlorthalidone
179, 184
262

186
Chlorzoxazone (INN)
163
82

187
Cholecalciferol
(759)
335

188
Choline salts and their esters

168

189
Chromium, chromic acid and salts of the acid

97

190
Chrysoidine citrate hydrochloride
562
81

191
Cinchocaine (INN) and its salts
128
129

192
Cincophen (INN), its salts and derivatives and salts of those derivatives
577
8

193

Claviceps purpurea Tul., its alkaloids and galenical preparations
317
98

194
Clofenamide (INN)
162
85

195
Clofenotane (INN)
232, 731
123

196
Cobalt benzenesulphonate

101

197
Cocculin
589
282

198
Colchicine, its salts and derivatives

102

199
Colchicoside and its derivatives

103

200

Colchicum autumnale L. and its galenical preparations

104

201
Colouring agent CI 12075 and its lakes, pigments and salts

397

202
Colouring agent CI 12140

378

203
Colouring agent CI 13065

387

204
Colouring agent CI 15585

401

205
Colouring agent CI 26105

379

206
Colouring agent CI 42535

388

207
Colouring agents CI 42555, 42555:1 and 42555:2

380

208
Colouring agent CI 42640

386

209
Colouring agent CI 61554

389

210
Colouring agent CI 45170 and CI 45170:1

398

211
Coniferyl benzoate (except natural content of essences)
88
357

212
Coniine
615
290

213

Conium maculatum L. (fruit, powder, galenical preparations)

99

214
Convallatoxin

105

215
Coumetarol (INN)
454
225

216
Crimidine (ISO)
165, 169
83

217

Croton tiglium (oil)

107

218
Curare and curarine

109

219
Curarizants, synthetic

110

220
1-(3-Cyano-3,3-diphenylpropyl)-4-ethoxycarbonyl-4-phenylpiperidinium chloride
296
80

221
Cyclarbamate (INN)
229
122

222
Cyclizine (INN) and its salts
301
159

223
Cyclobarbitone and its salts
(69)
220

224
Cyclocoumarol
267
234

225
2-α-Cyclohexylbenzyl(N,N',N'-tetraethyl)trimethylenediamine
552
112

226
2-Cyclohexyl-3,5-dimethylphenol and its salts
228
113

227
1-Cyclohexyl-3-(p-methylbenzenesulphonyl)urea
363
100

228
Cyclomenol (INN) and its salts
226
113

229
Cyclopentane-1,1-dimethanol dicarbanilate
221
122

230
Cyclophosphamide (INN) and its salts
105, 108
88

231

Datura stramonium L. and its galenical preparations
651
301

232
DDT (ISO) (pp'-DDT)
195, 731
123

233
Deanol aceglumate (INN)
278
3

234
Decamethonium bromide (INN)
(235)
214

235
Decamethylenebis(trimethylammonium) salts
234
214

236
Dextromethorphan (INN) and its salts
457
226

237
Dextropropoxyphene (INN)
280
116

238

O,O'-Diacetyl-N-allyl-N-normorphine

117

239
2,4-Diaminoanisole and its salts
455, 461
376

240
2,5-Diaminoanisole and its salts
456, 460
377

241
1,2-Diaminobenzene and its salts
570
363

242

p,p'-Diaminodiphenyl
82
26

243
2-(2,4-Diaminophenyl)ethanol and its salts

407

244
1,4:3,6-Dianhydrosorbitol 2,5-dinitrate
421
148

245
5-(α,β-Dibromophenethyl)-5-methylhydantoin

119

246
Dibromosalicylanilides
247, 443
351

247
Dibromsalan (INN)
(246)
351

248
Dichloroethanes
329, 334
125

249
Dichloroethylenes
7, 757
126

250
2,3-Dichloro-2-methylbutane
46
36

251
Dichlorosalicylanilides

349

252
Dicoumarin
253, 469
231

253
Dicoumarol (INN)
252, 469
231

254
Diethanolamine
(110, 640)
411

255
2-(Diethylaminoethoxy)ethyl α-phenylpiperidine-1-acetate dimethiodide
598
137

256
2-Diethylaminoethyl 3-amino-4-butoxybenzoate and its salts
101
23

257
2-Diethylaminoethyl benzilate
72
157

258
2-Diethylaminoethyl 4-ethoxybenzoate and its salts
410, 536
179

259
2-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts

128

260
2-Diethylaminoethyl phenyl(piperidino)acetate
103
287

261
3-Diethylaminopropyl cinnamate

130

262
Diethyl 4-nitrophenyl phosphate
534
170

263

O,O-Diethyl O-4-nitrophenyl phosphorothioate
535
131

264
Difencloxazine (INN)
566
270

265
Digitaline and all heterosides of Digitalis purpurea L.


134

266
4,5-Dihydrobenzimidazol-4-one
86, 87
48

267
3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano[3,2-c]-[1]-benzopyran-5-one
224
234

268
Dihydrotachysterol (INN)

342

269
3,4-Dihydroxy-α-(methylaminomethyl)benzyl alcohol
14, 314
14

270
4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene)dicoumarin

207

271
1-(3,4-Dihydroxyphenyl)-2-ethylaminopropan-1-ol and its salts
293
136

272
1-(3,4-Dihydroxyphenyl)-2-isopropylaminoethanol
417, 420
17

273
Diisopropanolamine
(110, 640)
411

274
5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite
412
361

275
Dimethoxane
285
368

276
4-[2-(3,4-Dimethoxyphenyl)ethyl]-1-(2-chlorophenyl)piperazine and its salts
438
141

277
Dimethylamine

142

278
2-Dimethylaminoethyl N-acetylglutamate
233
3

279
2-Dimethylaminoethyl p-butylaminobenzoate and its salts
687
63

280
(+)-4-Dimethylamino-3-methyl-1,2-diphenyl-2-propionyloxybutane
237
116

281
1-Dimethylaminomethyl-1-methylpropyl benzoate and its salts
50
50

282
2-Dimethylaminopropiophenone and its salts
445
145

283
3-(3-Dimethylaminopropylidene)-1,2:4,5-dibenzocyclohepta-1,4-diene and its salts
42
146

284
1,1-Dimethylbiguanide and its salts
447
147

285
2,6-Dimethyl-1,3-dioxan-4-yl acetate
275
368

286
Dimethylformamide

355

287
1,5-Dimethylhexylamine and its salts
34, 523
28

288
1,3-Dimethylpentylamine and its salts
35, 471
30

289
Dimethyl sulfoxide (INN)

338

290
Dimevamide (INN) and its salts
297
153

291
Dinitrophenol isomers

151

292
Dioxane

343

293
Dioxethedrin (INN) and its salts
271
136

294
2,5-Dioxo-3,3-diethyl-5-methylpiperidine and its salts
483
133

295
Diphenhydramine (INN) and its salts
81
339

296

Diphenoxylate hydrochloride (INNM)

220
80

297
2,2-Diphenyl-4-dimethylaminovaleramide and its salts
290
153

298
5,5-Diphenyl-4-imidazolidone

160

299
4-Diphenylmethoxy-1-methylpiperidine and its salts
305
154

300
3-Diphenylmethoxytropane and its salts
76
158

301
1-Diphenylmethyl-4-methylpiperazine and its salts
222
159

302
1,2-Diphenyl-4-(2-phenylsulphinylethyl)-pyrazolidine-3,5-dione
661
155

303

α,α-Diphenyl-2-piperidinemethanol and its salts
597
285

304

α,α-Diphenyl-4-piperidinemethanol and its salts
66
286

305
Diphenylpyraline (INN) and its salts
299
154

306
2,5-Dipropoxy-3,6-bis(ethyleneimino)-1,4-benzoquinone
409
152

307
4-Dipropylsulphamoylbenzoic acid
606
161

308
Disulfiram (INN)
699, 710
162

309
Dithio-2,2'-bis(pyridine 1-oxide) 1,1' (additive with trihydrated magnesium sulphate)
625
396

310
Doxylamine (INN) and its salts
576
176

311
Emetine, its salts and derivatives

163

312
Endrin (ISO)
372
196

313
Ephedrine and its salts

164

314
Epinephrine (INN)
14, 269
14

315
1,2-Epoxybutane

400

316
Ergocalciferol (INN)
139, (759)
335

317
Ergot and its alkaloids
193
98

318
Eserine and its salts
586
166

319
Ethionamide (INN)
335
319

320
Ethoheptazine (INN) and its salts
476
173

321
Ethopropazine and its salts
(558)
320

322
4-Ethoxyphenol
(390)
178

323
4-Ethoxy-m-phenylenediamine and its salts

406

324
2-Ethylamino-5-phenyloxazolin-4-one
344
180

325
Ethyl bis(4-hydroxycoumarinyl)acetate and salts of the acid
326
204

326
Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl)acetate and salts of the acid
325
204

327
Ethyl chloride
167
96

328
Ethyl 1,3-dimethyl-4-phenylazepane-4-carboxylate and its salts
446
171

329
Ethylene dichloride
(248)
125

330
Ethylene oxide

182

331
2-Ethyl-2,3-epoxyhexamide and its derivatives
528
165

332
Ethyl p-fluorophenyl sulphone
347
189

333
Ethyl 1-(2-hydroxy-2-phenylethyl)-4-phenylpiperidine-4-carboxylate and its salts
530
172

334
Ethylidene dichloride
(248)
125

335
3-Ethylisothionicotinamide
319
319

336
3-Ethyl-3-methylglutarimide and its salts
71, 337
183

337
4-Ethyl-4-methylpiperidine-2,6-dione and its salts
71, 336
183

338
2-Ethyl-3-methylvaleramide
753
184

339
Ethylphenacemide
553, 565
272

340
2-Ethyl-2-phenylglutarimide and its salts
361
181

341
3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone
9
362

342
Ethyl urocanate
(405)
418

343
Fenadiazole (INN)
526
208

344
Fenozolone (INN)
324
180

345
Fenyramidol (INN)
575, 579
274

346
Fluanisone (INN)
350
187

347
Fluoresone (INN)
332
189

348
4'-Fluoro-4-[4-hydroxy-4-(α,α,α-trifluoro-m-tolyl)piperino]butyrophenone
738
188

349
6-Fluoro-16-methyl-11β,17α,21-trihydroxypregna-1,4-diene-3,20-dione
533
186

350
1-(4-Fluorophenyl)-4-[4-(2-methoxyphenyl)-1-piperazinyl]butan-1-one
346
187

351
5-Fluoropyrimidine-2,4-dione
352
190

352
Fluorouracil (INN)
351
190

353
Fluphenazine (INN)
(558)
320

354
Furazolidone (INN)
511
252

355
Furfuryltrimethylammonium salts
357
192

356
Furocoumarins (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg
98, 462, 620, 743
358

357
Furtrethonium iodide (INN)
(355)
192

358
Galantamine (INN)

193

359
Gallamine triethiodide (INN)
516
329

360
Glucocorticoids
100
300

361
Glutethimide (INN) and its salts
340
181

362
Glycerol trinitrate
512, 612
253

363
Glycyclamide (INN)
227
100

364
Gold salts

296

365
Guaifenesin (INN)
459
230

366
Guanethidine (INN) and its salts
367
259

367

N-(2-Guanidinoethyl)azocane and its salts
366
259

368
Haloperidol (INN)
173
185

369

HCH (ISO) (gamma-HCH)

102, 371, 428
195

370
HETP
377
316

371
1,2,3,4,5,6-Hexachlorocyclohexane
102, 369, 428
195

372
(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4:5,8-dimethanonaphthalene
312
196

373
Hexachloroethane

197

374
3,3',4,4',6,6'-Hexachloro-2,2'-methylenediphenol
375
371

375
Hexachlorophene (INN)
374
371

376
(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethanonaphthalene
415
198

377
Hexaethyl tetraphosphate
370
316

378
(1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride
141
70

379
(3S,5aR,9bS)-3,3a,4,5,5a,9b-Hexahydro-3,5a,9-trimethylnaphtho[1,2-b]furan-2,8-dione
636
217

380
Hexamethonium bromide (INN)
(381)
124

381

N,N'-Hexamethylenebis(trimethylammonium) salts
380
124

382
Hexapropymate (INN)
616
115

383
Hydrastine, hydrastinine and their salts

199

384
Hydrazides and their salts

200

385
Hydrazine, its derivatives and their salts

201

386
2-Hydrazino-octane and its salts
521
202

387
Hydrocyanic acid and its salts
389, 408, 601, 642
111

388
Hydrofluoric acid, its normal salts, complexes and hydrofluorides (except those listed in Part I of Schedule 2)

191

389
Hydrogen cyanide and its salts
387, 408, 601, 642
111

390
Hydroquinone monobenzyl, monoethyl and monomethyl ethers
96, 322, 458, 487
178

391
7-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline
762
135

392
[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid and its salts
739
5

393
3-[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]propionic acid and its salts
713
9

394
2-Hydroxy-3-(2-methoxyphenyl)propyl carbamate
450
205

395
1-Hydroxymethyl-1-cyclohexylacetic acid, sodium salt
643
114

396
4-Hydroxy-3-[1-(4-nitrophenyl)-3-oxobutyl]coumarin
1
254

397
8-Hydroxy-5-nitroquinoline and its salts
515
209

398
4-Hydroxy-3-(3-oxo-1-phenylbutyl)coumarin and its salts
3, 760
203

399
11α-Hydroxypregn-4-ene-3,20-dione and its esters

385

400
Hydroxy-8-quinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 2
114, 531, 630
395

401
Hydroxyzine (INN)
171
240

402
Hyoscine, its salts and derivatives
638
295

403
Hyoscyamine, its salts and derivatives

210

404

Hyoscyamus niger L.(leaves, seeds, powder and galenical preparations)

211

405
3-Imidazol-4-ylacrylic acid and its ethyl ester
342, 751
418

406
2-Imino-5-phenyloxazolidin-4-one and its salts
538
212

407
Imperatorin
465
34

408
Inorganic cyanides
(387, 389) 601, 642
111

409
Inproquone (INN)
306
152

410
Intracaine and its salts
258, 536
179

411
Iodine

213

412
Iodothymol
274
361

413
Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations)

215

414
Isocarboxazid (INN)
93
52

415
Isodrin
376
198

416
Isometheptene (INN) and its salts
463
228

417
Isoprenaline (INN)
272, 420
17

418
Isopropamide iodide (INN)
(145)
156

419
(2-Isopropylpent-4-enoyl)urea
60
216

420
Isoproterenol
272, 417
17

421
Isosorbide dinitrate (INN)
244
148

422

Juniperus sabina L. (leaves, essential oil and galenical preparations)

294

423
Laurel oil
424
359

424

Laurus nobilis L. (oil from seeds)
423
359

425
Lead and its compounds (except lead acetate subject to the restrictions laid down in entry number 55 in Part I of Schedule 2)

289

426
Levophacetoperane and its salts
594
284

427
Lidocaine (INN) (Lignocaine)

399

428
Lindane
102, 369, 371
195

429

Lobelia inflata L. and its galenical preparations

218

430
Lobeline (INN) and its salts
112
219

431
LSD
(433, 434)
127

432
Lupinidine and its salts
648
299

433
Lysergic acid diethylamide and its salts
431, 434
127

434
Lysergide (INN) and its salts
431, 433
127

435
Malononitrile

149

436
Mannomustine (INN) and its salts
104
89

437
Mecamylamine (INN)
698
229

438
Mefeclorazine (INN) and its salts
276
141

439
Mephenesin (INN) and its esters
718
322

440
Meprobamate (INN)
481
236

441
Mercury and its compounds (except those listed in Part I of Schedule 4)

221

442
Mescaline and its salts
740
222

443
Metabromsalan (INN)
(246)
351

444
Metaldehyde
600
223

445
Metamfepramone (INN) and its salts
282
145

446
Metethoheptazine (INN) and its salts
328
171

447
Metformin (INN) and its salts
284
147

448
Methapyrilene (INN) and its salts
624
144

449
Metheptazine (INN) and its salts
468
174

450
Methocarbamol (INN)
394
205

451
Methohexitone and its salts
(69)
220

452
Methotrexate (INN)
33
6

453
2-[4-Methoxybenzyl-N-(2-pyridyl)amino]-ethyldimethylamine maleate
622
346

454
1-Methoxy-2,2-bis(4-hydroxy-3-coumarinyl)ethane
215
225

455
1-Methoxy-2,4-diaminobenzene and its salts
239, 461
376

456
1-Methoxy-2,5-diaminobenzene and its salts
240, 460
377

457
(+)-3-Methoxy-N-methylmorphinan and its salts
236
226

458
4-Methoxyphenol
(390)
178

459
3-(2-Methoxyphenoxy)propane-1,2-diol
365
230

460
2-Methoxy-p-phenylenediamine and its salts
240, 456
377

461
4-Methoxy-m-phenylenediamine and its salts
239, 455
376

462
Methoxypsoralens (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg
(356)
358

463
6-Methylamino-2-methylhept-2-ene and its salts
416
228

464
2-Methyl-1,2-bis(3-pyridyl)propan-1-one
484
292

465
9-(3-Methylbut-2-enyloxy)furo-[3,2-g]chromen-7-one
407
34

466
2-Methyl-6-chloroanilide of n-butylaminoacetic acid and its salts
125
90

467
1-Methyl-2,4-diaminobenzene and its salts
477
364

468
Methyl 1,2-dimethyl-4-phenylazepane-4-carboxylate and its salts
449
174

469
3,3-Methylenebis-(4-hydroxycoumarin)
252, 253
231

470
2-Methylheptylamine and its salts

227

471
4-Methyl-2-hexylamine and its salts
35, 288
30

472
1-Methylimidazole-2-thiol
474, 704
233

473

N-N'-[(Methylimino)diethylene]bis-(ethyldimethylammonium) salts
67
121

474
1-Methyl-2-mercaptoimidazole
472, 704
233

475
Methylphenidate (INN) and its salts
572
175

476
1-Methyl-4-phenyl-4-carbethoxyhexa-methyleneimine and its salts
320
173

477
4-Methyl-m-phenylenediamine and its salts
467
364

478
2-Methyl-m-phenylenediamine

413

479
3-Methyl-2-phenylmorpholine, its derivatives and salts
555
232

480
2-Methyl-2-propyl-1-isopropylcarbamoyloxy-3-carbamoyloxypropane
151
235

481
2-Methyl-2-propyltrimethylene dicarbamate
440
236

482

N-Methyl-1,2,5,6-tetrahydro-3-nicotinic acid methyl ester
61
238

483
Methyprylon (INN) and its salts
294
133

484
Metyrapone (INN)
464
292

485
Minoxidil (INN), its salts and derivatives
596
372

486
Mofebutazone (INN)
133
64

487
Monobenzone (INN)
96, (390)
178

488
Morpholine and its salts

344

489
Musk ambrette
132
414

490
Mustine and its salts
106, 160
87

491
Mustine N-oxide and its salts
107
86

492
Nalorphine (INN), its salts and ethers
21
20

493
Naphazoline (INN) and its salts
499
244

494
2-Naphthol
495
241

495

β-Naphthol
494
241

496
1- and 2-Naphthylamines and their salts
497
242

497

α- and β-Naphthylamines and their salts
496
242

498
3-(1-Naphthyl)-4-hydroxycoumarin

243

499
2-(1-Naphthylmethyl)-2-imidazoline and its salts
493
244

500

Narcotics, natural and synthetic: All substances listed in Tables I and II of the Single Convention on Narcotic Drugs 1961 (Treaty Series No. 34 (1965), Cmnd. 2631)


306

501
Narcotine and its salts
519
258

502
Neodymium and its salts

309

503
Neostigmine and its salts

245

504
Nicotine and its salts

246

505
Nitrites, inorganic (except sodium nitrite)

248

506
Nitrobenzene

249

507
Nitrocresols and their alkali metal salts

250

508
Nitroderivatives of carbazole
146
72

509
Nitrofurantoin (INN)
510
251

510

N-(5-Nitro-2-furfurylidene)-1-aminohydantoin
509
251

511
3-(5-Nitrofurfurylideneamino)oxazolidin-2-one
354
252

512
Nitroglycerine
362, 612
253

513
Nitrosamines

410

514
Nitrostilbenes, their homologues and derivatives

256

515
Nitroxoline (INN) and its salts
397
209

516

N,N,N,N',N',N',N",N",N"-Nonaethyl-2,2',2"-(benzene-1,2,3-triyltrioxy)-tris(ethanaminium) triiodide
359
329

517
Noradrenaline and its salts
32, 518
257

518
Norepinephrine (INN) and its salts
32, 517
257

519
Noscapine (INN) and its salts
501
258

520
Nux vomica and its preparations
(658)
305

521
Octamoxin (INN) and its salts
386
202

522
Octamylamine (INN) and its salts

267

523
Octodrine (INN) and its salts
34, 287
28

524
Oestrogens

260

525
Oleandrin

261

526
2-(1,3,4-Oxadiazol-2-yl)phenol
343
208

527
[Oxalylbis(iminoethylene)]bis[(o-chlorobenzyl)diethylammonium] salts
24
132

528
Oxanamide (INN) and its derivatives
331
165

529
2-Oxo-3-isobutyl-9,10-dimethoxy-1,2,3,4,6,7-hexahydro-11bH-benzo[a]quinolizine and its salts
685
139

530
Oxpheneridine (INN) and its salts
333
172

531
Oxyquinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 2
114, 400, 630
395

532
Padimate A
47
381

533
Paramethasone (INN)
349
186

534
Paraoxon
262
170

535
Parathion (ISO)
263
131

536
Parethoxycaine (INN) and its salts
258, 410
179

537
Pelletierine and its salts
595
263

538
Pemoline (INN) and its salts
406
212

539
Pentachloroethane

264

540
Pentaerythritol chloral
549
266

541
Pentaerythritol tetranitrate
542, 548
265

542
Pentaerythrityl tetranitrate (INN)
541, 548
265

543
Pentamethonium bromide (INN)
(544)
120

544

N,N'-Pentamethylenebis(trimethyl-ammonium) salts
543
120

545
Pentobarbitone and its salts
(69)
220

546
Perchloroethylene
689
314

547
Perphenazine (INN) and its salts
(558)
320

548
PETN
541, 542
265

549
Petrichloral (INN)
540
266

550
Phenacemide (INN)
561
269

551
Phenaglycodol (INN)
174
95

552
Phenetamine
225
112

553
Pheneturide (INN)
339, 565
272

554
Phenindone (INN)
571
271

555
Phenmetrazine (INN), its derivatives and salts
479
232

556
Phenobarbitone and its salts
(69)
220

557
Phenolphthalein (INN)
113
417

558
Phenothiazine (INN) and its compounds
various
320

559
Phenprobamate (INN)
573
71

560
Phenprocoumon (INN)
574
273

561

N-Phenylacetylurea
550
269

562
4-Phenylazophenylene-1,3-diamine citrate hydrochloride
190
81

563
Phenylbutazone (INN)
131
67

564
4-Phenylbut-3-en-2-one
94
356

565
(2-Phenylbutyryl)urea
339, 553
272

566
N-[2-(α-Phenyl-p-chlorobenzyl)-ethyl]morpholine
264
270

567
1-Phenylcyclopentanecarboxylic acid diethylaminoethyl ester and its salts
144
169

568
2-Phenylcyclopropylamine (trans-form) and its salts
719
324

569
1-Phenyl-2,3-dimethyl-4-isopropylpyrazol-5-one
617
138

570

o-Phenylenediamine and its salts
241
363

571
2-Phenylindan-1,3-dione
554
271

572

α-Phenyl-2-piperidineacetic acid methyl ester and its salts
475
175

573
3-Phenylpropyl carbamate
559
71

574
3-(α-Phenylpropyl)-4-hydroxycoumarin
560
273

575
1-Phenyl-2-(2-pyridylamino)ethanol
345, 579
274

576
2-[1-Phenyl-1-(2-pyridyl)ethoxy]-ethyldimethylamine and its salts
310
176

577
2-Phenylquinoline-4-carboxylic acid, its salts and derivatives and salts of those derivatives
192
8

578
6-Phenyl-2,4,7-triaminopteridine and its salts
722
275

579
Phenyramidol
345, 575
274

580
Phosphides, metal

279

581
Phosphorus

279

582
4-Phosphoryloxy-N,N-dimethyltryptamine
619
278

583
3-Phthalimidopiperidine-2,6-dione and its salts
701
280

584
Phthalylsulphathiazole (INN) and its salts
(675)
307

585
Physostigma venenosum Balf.
138
281

586
Physostigmine and its salts
318
166

587
Phytolacca Spp and their preparations

374

588
Picric acid
742
268

589
Picrotoxin
197
282

590
Pilocarpine and its salts

283

591

Pilocarpus jaborandi Holmes and its galenical preparations

311

592
Pipazetate (INN) and its salts
593
118

593
2-(2-Piperidinoethoxy)ethyl 10-thia-1,9-diazaanthracene-9-carboxylate and its salts
592
118

594

α-Piperidin-2-ylbenzyl acetate, laevorotatory threo-form and its salts
426
284

595
1-(2-Piperidyl)propan-2-one and its salts
537
263

596
6-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide, its salts and derivatives
485
372

597
Pipradrol (INN) and its salts
303
285

598
Piprocurarium iodide (INN)
255
137

599
Poldine metilsulfate (INN) (Poldine methylsulphate)
85
239

600
Polyacetaldehyde
444
223

601
Potassium cyanide
(387, 389, 408)
111

602
Potassium nitroferricyanide
(15), 603
255

603
Potassium nitroprusside
(15), 602
255

604
Pramocaine (INN)
605
405

605
Pramoxine
604
405

606
Probenecid (INN)
307
161

607
Procainamide (INN), its salts and derivatives
29
25

608
Prochlorperazine (INN) and its salts
(558)
320

609
Progestogens

194

610
Promazine (INN) and its salts
(558)
320

611
Promethazine (INN) and its salts
(558)
320

612
Propane-1,2,3-triyl trinitrate
362, 512
253

613
Propatylnitrate (INN)
111
206

614
1-Propyl-3-(4-chlorobenzenesulphonyl)urea
182
79

615
2-Propylpiperidine
212
290

616
1-(2-Propynyl)cyclohexyl carbamate
382
115

617
Propyphenazone (INN)
569
138

618
Prunus laurocerasus L.
157
291

619
Psilocybine (INN)
582
278

620
Psoralen (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg
(356)
358

621

Pyrethrum album L. and its galenical preparations

345

622
Pyrianisamine maleate
453
346

623
Pyribenzamine
97, 745
347

624
2-(N-2-Pyridyl-N-2-thienylamino)ethyl-dimethylamine and its salts
448
144

625
Pyrithione disulphide+magnesium sulphate
309
396

626
Pyrithione sodium (INNM)

369

627
Pyrocatechol
79, 153
408

628
Pyrogallol

409

629
Quinalbarbitone and its salts
(69)
220

630
Quinolin-8-ol except for the uses provided for in entry number 51 in Part I of Schedule 2
(400, 531)
395

631
Radioactive substances (except substances which are radioactive naturally or by reason of contamination from the environment, which have not been enriched for manufacturing purposes, and of which the concentration complies with Council Directive No. 76/579/Euratom(38))

293

632

Rauwolfia serpentina alkaloids and their salts
633
15

633
Reserpine (INN) and its salts
(632)
15

634
Retinoic acid and its salts
721, 758
375

635

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

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

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


360

636

α-Santonin
379
214

637

Schoenocaulon officinale Lind. (seeds and galenical preparations)

332

638
Scopolamine, its salts and derivatives
402
295

639
Secbutobarbitone and its salts
(69)
220

640
Secondary dialkanolamines
110, 254, 273
411

641
Selenium and its compounds except when permitted under the restrictions laid down in Part I of Schedule 2

297

642
Sodium cyanide
(387, 389, 408)
111

643
Sodium hexacyclonate (INN)
395
114

644
Sodium nitroferricyanide
(15), 645
255

645
Sodium nitroprusside
(15), 644
255

646

Solanum nigrum L. and its galenical preparations

298

647
Spanish Fly
140
69

648
Sparteine (INN) and its salts
432
299

649
Spironolactone (INN)
10
4

650
Squill and its preparations
750
330

651
Stramonium and its preparations
231
301

652
Strontium lactate

402

653
Strontium nitrate

403

654
Strontium polycarboxylate

404

655
Strophanthines and their aglucones and their respective derivatives

302

656

Strophanthus species and their galenical preparations

303

657
Strychnine and its salts

304

658

Strychnos species and their galenical preparations
520
305

659
Succinonitrile

150

660
Succinylsulphathiazole and its salts
(675)
307

661
Sulfinpyrazone (INN)
302
155

662
Sulphacetamide and its salts
(675)
307

663
Sulphadiazine and its salts
(675)
307

664
Sulphadimethoxine and its salts
(675)
307

665
Sulphadimidine and its salts
(675)
307

666
Sulphafurazole and its salts
(675)
307

667
Sulphaguanidine and its salts
(675)
307

668
Sulphamethizole and its salts
(675)
307

669
Sulphamethoxazole and its salts
(675)
307

670
Sulphamethoxydiazine and its salts
(675)
307

671
Sulphamethoxypyridazine and its salts
(675)
307

672
Sulphanilamide and its salts
(675)
307

673
Sulphapyridine and its salts
(675)
307

674
Sulphathiazole and its salts
(675)
307

675
Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the −NH2 groups) and their salts
584, 660, 662–674
307

676
Sulthiame
677, 696
308

677
Sultiame (INN)
676, 696
308

678
Sympathomimetic amines acting on the central nervous system: any substance contained in the first list of medicaments which are subject to medical prescription and are referred to in resolution AP (69) 2 of the Council of Europe
44
21

679
Tefazoline (INN) and its salts
695
237

680
Tellurium and its compounds

312

681
TEPP (ISO)
693
276

682
2-(4-tert-Butyl-2,6-dimethylbenzyl)-2-imidazoline and its salts
764
313

683
4-tert-Butylphenol

340

684
4-tert-Butylpyrocatechol

341

685
Tetrabenazine (INN) and its salts
529
139

686
Tetrabromosalicylanilides

350

687
Tetracaine (INN) and its salts
279
63

688
2,3,7,8-Tetrachlorodibenzo-p-dioxin

367

689
Tetrachloroethylene
546
314

690
Tetrachloromethane
148
315

691
Tetrachlorosalicylanilides

348

692
Tetraethylammonium bromide
700
61

693
Tetraethyl pyrophosphate
681
276

694
(R)-5,6,6a,7-Tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol and its salts
59
42

695
2-(5,6,7,8-Tetrahydro-1-naphthylmethyl)-2-imidazoline and its salts
679
237

696
4-(Tetrahydro-2H-1,2-thiazin-2-yl)-benzenesulphonamide S,S-dioxide
676, 677
308

697
Tetrahydrozoline and its salts

394

698

N,2,3,3-Tetramethyl-2-norcamphanamine
437
229

699
Tetramethylthiuram disulphide
710
162

700
Tetrylammonium bromide (INN)
692
61

701
Thalidomide (INN) and its salts
583
280

702
Thallium and its compounds

317

703

Thevetia neriifolia Juss., glycoside extract

318

704
Thiamazole (INN)
472, 474
233

705
2,2'-Thiobis(4,6-dichlorophenol)
115
352

706
Thiopentone and its salts
(69)
220

707
Thioridazine (INN) and its salts
(558)
320

708
Thiotepa (INN)
723
310

709
Thiourea and its derivatives (except those listed in Part I of Schedule 2)

321

710
Thiram (ISO)
699
162

711
Thiuram disulphides

354

712
Thiuram monosulphides

353

713
Thyropropic acid (INN) and its salts
393
9

714
Tolboxane (INN)
717
177

715
Tolbutamide (INN)
134
65

716
Toluidines, their isomers, salts and halogenated and sulphonated derivatives
40
32

717

p-Tolylboric acid ester of 2-methyl-2-propylpropane-1,3-diol
714
177

718
3-o-Tolyloxypropane-1,2-diol
(439)
322

719
Tranylcypromine (INN) and its salts
568
324

720
Tretamine (INN)
724
328

721
Tretinoin (INN) and its salts
634, 758
375

722
Triamterene (INN) and its salts
578
275

723
Tri(aziridin-1-yl)phosphine sulphide
708
310

724
2,4,6-Tri(aziridin-1-yl)-1,3-triazine
720
328

725
2,2,2-Tribromoethanol
(726)
326

726
Tribromoethyl alcohol
725
326

727
Tribromsalan (INN)
728
373

728
3,4',5-Tribromosalicylanilide
727
373

729
Trichlormethine (INN) and its salts
746
327

730
Trichloroacetic acid

10

731
1,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane
195, 232
123

732
2,2,2-Trichloroethane-1,1-diol
158
77

733
Trichloromethane
168
366

734

N-(Trichloromethylthio)cyclohex-4-ene-1,2-dicarboximide
142
370

735
Trichloronitromethane
178
325

736
Tricresyl phosphate
747
277

737
Trifluoperazine (INN) and its salts
(558)
320

738
Trifluperidol (INN)
348
188

739
3,3',5-Triiodothyroacetic acid and its salts
392
5

740
3,4,5-Trimethoxyphenethylamine and its salts
442
222

741
2,2,6-Trimethyl-4-piperidyl benzoate and its salts
75
51

742
2,4,6-Trinitrophenol
588
268

743
Trioxysalen (INN) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg
(356)
358

744
Triparanol (INN)
172
92

745
Tripelennamine (INN)
97, 623
347

746
Tris(2-chloroethyl)amine
729
327

747
Tritolyl phosphate
736
277

748
Tuaminoheptane (INN), its isomers and salts
30
27

749
Tyrothricin (INN)

392

750

Urginea scilla Stern. and its galenical preparations
650
330

751
Urocanic acid
(405)
418

752
Vaccines, toxins and serums listed in the Annex to Council Directive No. 75/319/EEC(39)

323

753
Valnoctamide (INN)
338
184

754
Veratrine, its salts and galenical preparations

331

755

Veratrum spp and their preparations

333

756
Vinyl chloride monomer

334

757
Vinylidene chloride
(7, 249)
126

758
Vitamin A acid and its salts
634, 721
375

759
Vitamins D2 and D3

139, 187, 316
335

760
Warfarin (ISO) and its salts
3, 398
203

761
Xanthates
16
336

762
Xanthinol
391
135

763
Xylidines, their isomers, salts and halogenated and sulphonated derivatives
41
33

764
Xylometazoline (INN) and its salts
682
313

765
Yohimbine and its salts

337

766
Zirconium and its compounds (except aluminium zirconium chloride hydroxide complexes and aluminium zirconium chloride hydroxide glycine complexes under the conditions laid down in Part I of Schedule 2 and zirconium lakes, salts and pigments prepared from those colouring agents identified in column 1 of Part I of Schedule 3 by “*” immediately after the name or colour index number)

391

767
Zoxazolamine (INN)
28
24


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 Number
Name of substance
Purpose of substance or type of product
Maximum concentration of substance in product
Other requirements
Required 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).

1
Boric acid
Talcum powder
5 per cent
Not to be used in products intended for children less than three years old
Not to be used for children under three years of age

Oral hygiene products
0.5 per cent



Other products
3 per cent



2a
Thioglycolic acid and its salts
(a) Hair waving or straightening products for general use
8 per cent ready for use
pH 7 to 9.5
Contains thioglycolate. Follow the instructions. Keep out of reach of children

(b) Hair waving or straightening products for professional use
11 per cent ready for use
pH 7 to 9.5
Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only

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

(d) Other hair-care products which are removed after application
2 per cent ready for use
pH 7 to 9.5
Contains thioglycolate. Follow the instructions. Keep out of reach of children

The abovementioned percentages are calculated as thioglycolic acid

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

Avoid contact with eyes

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

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

2b
Thioglycolic acid esters
(a) Hair waving or straightening products for general use
8 per cent ready for use
pH 6 to 9.5
Contains thioglycolate. Follow the instructions. Keep out of reach of children

(b) Hair waving or straightening products for professional use
11 per cent ready for use
pH 6 to 9.5
Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only

The abovementioned percentages are calculated as thioglycolic acid

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

May cause sensitization in the event of skin contact

Avoid contact with eyes

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

Wear suitable gloves

3
Oxalic acid, its esters and alkaline salts
Hair care products
5 per cent

For professional use only

4
Ammonia
All purposes and products
6 per cent calculated as NH3


Contains ammonia (not required when concentration is not more than 2 per cent)

5
Tosylchloramide sodium (INN) [Chloramine-T]
All purposes and products
0.2 per cent



6
Chlorates of alkali metals
Toothpaste
5 per cent



Other uses
3 per cent



7
Dichloromethane
All purposes and products
35 per cent (and when mixed with 1,1,1-trichloroethane, total concentration must not exceed 35 per cent)
Purity of the dichloromethane must be not less than 99.8 per cent


8

m- and p-Phenylenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-phenylenediamines
Oxidizing colouring agents for hair-dyeing for general use
6 per cent calculated as a free base, subject to the provision of “Combination Rule A” set out below

Contains phenylenediamines. Can cause an allergic reaction. Do not use to dye eyelashes or eyebrows

Oxidizing colouring agents for hair-dyeing for professional use
6 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below

Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Wear suitable gloves

9
Methylphenylenediamines (other than 4-methyl-m-phenylenediamine and its salts), their N-substituted derivatives and their salts (Toluenediamines (other than toluene-1,3-diamine and its salts), their N-substituted derivatives and their salts)
Oxidizing colouring agents for hair-dyeing for general use
10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below

Contains phenylenediamines. Can cause an allergic reaction. Do not use to dye eyelashes or eyebrows.

Oxidizing colouring agents for hair-dyeing for professional use
10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below

Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Wear suitable gloves

10
Diaminophenols
Oxidizing colouring agents for hair-dyeing for general use
10 per cent calculated as a free base, subject to the provisions of “Combination Rule A” set out below

Contains diaminophenols. Can cause allergic reaction. Do not use to dye eyelashes or eyebrows

Oxidizing colouring agents for hair-dyeing for professional use
10 per cent calculated as afree base, subject to the provisions of “Combination Rule A” set out below

Contains diaminophenols. For professional use only. Can cause allergic reaction. Wear suitable gloves

11
Dichlorophen (INN) [Dichlorophene]
All purposes and products
0.5 per cent

Contains dichlorophen

12
Hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide including hydrogen peroxide-urea (hydrogen peroxide-carbamide) and zinc peroxide

(a)Hair-care preparations

(b)Skin-care preparations

(c)Nail hardening preparations

(d)Oral hygiene products

12 per cent of H2O2 present or released

4 per cent of H2O2 present or released

2 per cent of H2O2 present or released

0.1 per cent of H2O2 present or released









(a): Wear suitable gloves

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



13
Formaldehyde (see also Part I of Schedule 4)
Nail hardeners
5 per cent

Contains formaldehyde. Protect cuticles with grease or oil. (Not required when concentration is not more than 0.05 per cent)

14
Hydroquinone
Oxidizing colouring agent for hair dyeing for general use
2 per cent subject to the provisions of “Combination Rule B” set out below

Contains hydroquinone. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them

Oxidizing colouring agent for hair dyeing for professional use
2 per cent subject to the provisions of “Combination Rule B” set out below

Contains hydroquinone. For professional use only. Rinse eyes immediately if product comes into contact with them

Agents for localised skin lightener
2 per cent

Contains hydroquinone. Avoid contact with eyes. Apply to small areas. If irritation develops discontinue use. Do not use on children under the age of 12

15a
Potassium hydroxide and sodium hydroxide (see Note 1)
Nail cuticle solvent
5 per cent calculated as sodium hydroxide (see Note 2)

Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children

Hair straightener for general use
2 per cent calculated as sodium hydroxide (see Note 2)

Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children

Hair straightener for professional use
4.5 per cent calculated as sodium hydroxide (see Note 2)

For professional use only. Avoid contact with eyes. Can cause blindness

pH adjuster for depilatories

pH value not to exceed 12.7
Keep out of reach of children. Avoid contact with eyes

Other uses as pH adjuster

pH value not to exceed 11


15b
Lithium hydroxide
Hair straightener for general use
2 per cent calculated as sodium hydroxide (see Note 2)

Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children

Hair straightener for professional use
4.5 per cent calculated as sodium hydroxide (see Note 2)

For professional use only. Avoid contact with eyes. Can cause blindness

Other uses




15c
Calcium hydroxide
Hair straighteners containing two components: calcium hydroxide and guanidine salt
7 per cent

Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children

Other uses




16

α-Naphthol[1-Naphthol]
Colouring agent for hair dyeing
0.5 per cent

Contains α-napthol

17
Sodium nitrite
Rust inhibitor
0.2 per cent
Do not use with secondary and/or tertiary amines or other substances forming nitrosamines


18
Nitromethane
Rust inhibitor
0.3 per cent



19
Phenol and its alkali salts
Soaps and shampoos
1 per cent calculated as phenol

Contains phenol

20
ENTRY DELETED

21
Quinine and its salts
Shampoos
0.5 per cent calculated as quinine base



Hair lotions
0.2 per cent calculated as quinine base



22
Resorcinol
Oxidizing colouring agent for hair dyeing for general use
5 per cent subject to the provisions of “Combination Rule B” set out below

Contains resorcinol. Rinse hair well after application. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them

Oxidizing colouring agent for hair dyeing for professional use
5 per cent subject to the provisions of “Combination Rule B” set out below

Contains resorcinol. For professional use only. Rinse eyes immediately if product comes into contact with them

Hair lotions and shampoos
0.5 per cent subject to the provisions of “Combination Rule B” set out below

Contains resorcinol

23a
Alkali sulphides
Depilatories
2 per cent calculated as sulphur
pH value not to exceed 12.7
Keep out of reach of children. Avoid contact with eyes

23b
Alkaline earth sulphides
Depilatories
6 per cent calculated as sulphur
pH value not to exceed 12.7
Keep out of reach of children. Avoid contact with eyes

24
Water-soluble zinc salts with the exception of zinc 4-hydroxybenzenesulphonate
All purposes and products
1 per cent calculated as zinc



25
Zinc 4-hydroxybenzene-sulphonate [Zinc phenolsulfonate]
Deodorants, antiperspirants and astringent lotions
6 per cent calculated as percentage of anhydrous substance

Avoid contact with eyes

26
Ammonium monofluorophosphate
Oral hygiene products
0.15 per cent calculated as fluorine. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent

Contains ammonium monofluorophosphate

27
Sodium monofluorophosphate
Oral hygiene products
As for ammonium monofluorophosphate

Contains sodium monofluorophosphate

28
Potassium monofluorophosphate
Oral hygiene products
As for ammonium monofluorophosphate

Contains potassium monofluorophosphate

29
Calcium monofluorophosphate
Oral hygiene products
As for ammonium monofluorophosphate

Contains calcium monofluorophosphate

30
Calcium fluoride
Oral hygiene products
As for ammonium monofluorophosphate

Contains calcium fluoride

31
Sodium fluoride
Oral hygiene products
As for ammonium monofluorophosphate

Contains sodium fluoride

32
Potassium fluoride
Oral hygiene products
As for ammonium monofluorophosphate

Contains potassium fluoride

33
Ammonium fluoride
Oral hygiene products
As for ammonium monofluorophosphate

Contains ammonium fluoride

34
Aluminium fluoride
Oral hygiene products
As for ammonium monofluorophosphate

Contains aluminium fluoride

35
Stannous fluoride
Oral hygiene products
As for ammonium monofluorophosphate

Contains stannous fluoride

36
Hexadecylammonium fluoride [Cetylamine hydrofluoride]
Oral hygiene products
As for ammonium monofluorophosphate

Contains hexadecylammonium fluoride

37
3-(n-Hexadecyl-N-2-hydroxyethylammonio)-propylbis(2-hydroxyethyl)-ammonium difluoride [Stearyl trihydroxyethyl propylenediamine dihydrofluoride]
Oral hygiene products
As for ammonium monofluorophosphate

Contains 3-(n-hexadecyl-N-2-hydroxyethylammonio)propylbis(2-hydroxyethyl)ammonium difluoride

38

N,N',N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride [Palmityl trihydroxyethyl propylenediamine dihydrofluoride]
Oral hygiene products
As for ammonium monofluorophosphate

Contains N,N',N'-tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride

39
Octadecenylammonium fluoride
Oral hygiene products
As for ammonium monofluorophosphate

Contains octadecenylammonium fluoride

40
Sodium fluorosilicate
Oral hygiene products
As for ammonium monofluorophosphate

Contains sodium fluorosilicate

41
Potassium fluorosilicate
Oral hygiene products
As for ammonium monofluorophosphate

Contains potassium fluorosilicate

42
Ammonium fluorosilicate
Oral hygiene products
As for ammonium monofluorophosphate

Contains ammonium fluorosilicate

43
Magnesium fluorosilicate
Oral hygiene products
As for ammonium monofluorophosphate

Contains magnesium fluorosilicate

44
1,3-Bis(hydroxymethyl)-imidazolidene-2-thione [Dimethylol ethylene thiourea]
Hair care preparations
2 per cent
Not to be used in aerosol dispensers
Contains 1,3-bis(hydroxymethyl)imidazolidene-2-thione

Nail care preparations
2 per cent
pH value as applied must be less than 4
Contains 1,3-bis(hydroxymethyl)imidazolidene-2-thione

45
Benzyl alcohol (See also Part I of Schedule 4)
Solvent, perfumes and flavourings




46
6-Methylcoumarin
Oral hygiene products
0.003 per cent



47
Nicomethanol hydrofluoride
Oral hygiene products
As for ammonium monofluorophosphate

Contains nicomethanol hydrofluoride

48
Silver nitrate
Products to dye eyelashes or eyebrows
4 per cent

Contains silver nitrate. Rinse eyes immediately if product comes into contact with them

49
Selenium disulphide [Selenium sulfide]
Anti-dandruff shampoos
1 per cent

Contains selenium disulphide. Avoid contact with eyes or damaged skin

50
Aluminium zirconium chloride hydroxide complexes AlxZr(OH)yClz and aluminium zirconium chloride hydroxide glycine complexes
Anti-perspirants
20 per cent as anhydrous aluminium zirconium chloride hydroxide, 5.4 per cent as zirconium

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

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

Not to be used in aerosol dispensers (sprays)

Do not apply to irritated or damaged skin

51
Quinolin-8-ol and bis(8-hydroxyquinolinium sulphate) (See also Part II of this Schedule) [Oxyquinoline and Oxyquinoline sulfate]
Stabilizer for hydrogen peroxide in rinse-off hair care preparations
0.3 per cent calculated as base



Stabilizer for hydrogen peroxide in non rinse-off hair care preparations
0.03 per cent calculated as base



52
Methanol
Denaturant for ethanol and isopropyl alcohol
5 per cent calculated as a percentage of ethanol and isopropyl alcohol



53
Etidronic acid and its salts (1-hydroxyethylidene-diphosphonic acid and its salts)

Hair care

Soap

1.5 per cent expressed as etidronic acid

0.2 per cent expressed as etidronic acid









54
1-Phenoxypropan-2-ol (See also Part I of Schedule 4) [Phenoxyisopropanol]
Products rinsed off after use. Prohibited in oral hygiene products
2 per cent



55
Lead acetate
Only for hair dyeing
0.6 per cent calculated as lead

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

56
Magnesium fluoride
Dental hygiene products
0.15 per cent calculated as fluorine. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent

Contains magnesium fluoride

57
Strontium chloride hexahydrate
Toothpaste
3.5 per cent calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 3.5 per cent

Contains strontium chloride. Use by children is not advisable

58
Strontium acetate hemihydrate
Toothpaste
3.5 per cent calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3.5 per cent

Contains strontium acetate. Use by children is not advisable

59
Talc: hydrated magnesium silicate
(a) Powdery products intended to be used for children under three years of age


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

(b) other products



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


61
Monoalkanolamines
All purposes and products
Maximum dialkanolamine content: 0.5 per cent
Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum dialkanolamine content: 0.5 per cent (applies to raw materials). Maximum N-nitrosodialkanolamine content: 50 μ g/kg (applies to raw materials). Keep in nitrite-free containers


62
Trialkanolamines

(a)non-rinse-off

(b)other products

(a)2.5 per cent

(a) (b): Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum dialkanolamine content: 0.5 per cent (applies to raw materials). Maximum N-nitrosodialkanolamine content: 50 μ g/kg (applies to raw materials). Keep in nitrite-free containers


63
Strontium hydroxide
pH-regulator in depilatory products
3.5 per cent calculated as strontium
pH value not to exceed 12.7
Keep out of reach of children. Avoid contact with the eyes

64
Strontium peroxide
Rinse-off hair care preparations for professional use
4.5 per cent calculated as strontium in the ready-for-use preparation
All products must meet the hydrogen peroxide release requirements
Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them. For professional use only. Wear suitable gloves

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 Number
Name of Substance
Purpose of substance or type of product
Maximum concentration of substance in product
Other requirements
Required information
Permitted for use until

NOTE—There are presently no entries in this Part.

Combination 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—

Sub-column 1 = Colouring agents allowed in all cosmetic products;

Sub-column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;

Sub-column 3 = Colouring agents allowed exclusively in cosmetic products except cosmetic products intended to come into contact with the mucous membranes;

Sub-column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.

(1)
(2)
(3)
(4)

Name or colour index number
Colour
Type of product Field of application
Other requirements

1
2
3
4

10006
Green

X

10020
Green

X

10316*
Yellow

X

11680
Yellow

X

11710
Yellow

X

11725
Orange

X

11920
Orange
X

12010
Red

X

12085*
Red
X

3 per cent maximum concentration in the finished product

12120
Red

X

12150
Red
X

12370
Red

X

12420
Red

X

12480
Brown

X

12490
Red
X

12700
Yellow

X

13015
Yellow
X

E 105

14270
Orange
X

E 103

14700
Red
X

14720
Red
X

E 122

14815
Red
X

E 125

15510*
Orange

X

15525
Red
X

15580
Red
X

15620
Red

X

15630*
Red
X

3 per cent maximum concentration in the finished product

15800
Red

X

15850*
Red
X

15865*
Red
X

15880
Red
X

15980
Orange
X

E 111

15985*
Yellow
X

E 110

16035
Red
X

16185
Red
X

E 123

16230
Orange

X

16255*
Red
X

E 124

16290
Red
X

E 126

17200*
Red
X

18050
Red

X

18130
Red

X

18690
Yellow

X

18736
Red

X

18820
Yellow

X

18965
Yellow
X

19140*
Yellow
X

E 102

20040
Yellow

X
Maximum 3,3'-dimethyl-benzidine concentration in the colouring agent: 5 mg/kg

20170
Orange

X

20470
Black

X

21100
Yellow

X
Maximum 3,3'-dichloro-benzidine concentration in the colouring agent: 5 mg/kg

21108
Yellow

X
Maximum 3,3'-dichloro-benzidine concentration in the colouring agent: 5 mg/kg

21230
Yellow

X

24790
Red

X

26100
Red

X

Purity criteria: aniline ≤0.2 per cent, 2-naphthol ≤0.2 per cent, azobenzen-4-amine ≤0.1 per cent, 1-phenylazo-2-naphthol ≤3 per cent, 1-[2-(phenylazo)phenylazo]-2-naphthol ≤2 per cent

27290*
Red

X

27755
Black
X

E 152

28440
Black
X

E 151

40215
Orange

X

40800
Orange
X

40820
Orange
X

E 160e

40825
Orange
X

E 160f

40850
Orange
X

E 161g

42045
Blue

X

42051*
Blue
X

E 131

42053
Green
X

42080
Blue

X

42090
Blue
X

42100
Green

X

42170
Green

X

42510
Violet

X

42520
Violet

X
Maximum concentration in the finished product: 5 mg/kg

42735
Blue

X

44045
Blue

X

44090
Green
X

E 142

45100
Red

X

45190
Violet

X

45220
Red

X

45350
Yellow
X

6 per cent maximum concentration in the finished product

45370*
Orange
X

Not more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 2 per cent 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid

45380*
Red
X

as immediately above

45396
Orange
X

When used in lipstick, the colouring agent is allowed only in free acid form and in a maximum concentration of 1 per cent

45405
Red

X

Not more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 2 per cent 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid

45410*
Red
X

as immediately above

45425
Red
X

Not more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 3 per cent 2-(iodo-6-hydroxyl-3-oxo-3H-xanthen-9-yl)benzoic acid

45430*
Red
X

as immediately above, E 127

47000
Yellow

X

47005
Yellow
X

E 104

50325
Violet

X

50420
Black

X

51319
Violet

X

58000
Red
X

59040
Green

X

60724
Violet

X

60725
Violet
X

60730
Violet

X

61565
Green
X

61570
Green
X

61585
Blue

X

62045
Blue

X

69800
Blue
X

E 130

69825
Blue
X

71105
Orange

X

73000
Blue
X

73015
Blue
X

E 132

73360
Red
X

73385
Violet
X

73900
Violet

X

73915
Red

X

74100
Blue

X

74160
Blue
X

74180
Blue

X

74260
Green

X

75100
Yellow
X

75120
Orange
X

E 160b

75125
Yellow
X

E 160d

75130
Orange
X

E 160a

75135
Yellow
X

E 161d

75170
White
X

75300
Yellow
X

E 100

75470
Red
X

E 120

75810
Green
X

E 140 and E 141

77000
White
X

E 173

77002
White
X

77004
White
X

77007
Blue
X

77015
Red
X

77120
White
X

77163
White
X

77220
White
X

E 170

77231
White
X

77266
Black
X

77267
Black
X

77268:1
Black
X

E 153

77288
Green
X

Free from chromate ions

77289
Green
X

Free from chromate ions

77346
Green
X

77400
Brown
X

77480
Brown
X

E 175

77489
Orange
X

E 172

77491
Red
X

E 172

77492
Yellow
X

E 172

77499
Black
X

E 172

77510
Blue
X

Free from cyanide ions

77713
White
X

77742
Violet
X

77745
Red
X

77820
White
X

E 174

77891
White
X

E 171

77947
White
X

Acid red 195
Red

X

Aluminium, zinc, magnesium and calcium stearates
White
X

Anthocyanins
Red
X

E 163

Beetroot red
Red
X

E 162

Bromocresol green
Green

X

Bromothymol blue
Blue

X

Caramel
Brown
X

E 150

Capsanthin, capsorubin
Orange
X

E 160c

Lactoflavin
Yellow
X

E 101

PART 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—

Sub-column 1 = Colouring agents allowed in all cosmetic products;

Sub-column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;

Sub-column 3 = Colouring agents allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes;

Sub-column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.

(1)
(2)
(3)
(4)
(5)

Name or colour index number
Colour
Type of product Field of application
Other requirements
Cosmetic product supplied until

1
2
3
4

NOTE: There are presently no entries in this part.

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 Number
Name of substance
Purpose of substance or type of product
Maximum concentration of substance in product

Other requirements
Required information

1
Benzoic acid, its salts and esters
All products
0.5 per cent (acid)
A



2
Propionic acid and its salts
All products
2 per cent (acid)
A



3
Salicylic acid and its salts
All products
0.5 per cent (acid)
A
Not to be used in preparations for children under three years of age except for shampoos
Not to be used for children under three years of age (Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin)

4
Sorbic acid (hexa-2,4-dienoic acid) and its salts
All products
0.6 per cent (acid)
A



5
Formaldehyde and paraformaldehyde
For oral hygiene
0.1 per cent (expressed as free formaldehyde)

Not to be used in aerosol dispensers (sprays)


Except for oral hygiene (see also Part I of Schedule 2)
0.2 per cent (expressed as free formaldehyde)

6
ENTRY DELETED

7
Biphenyl-2-ol [o-phenylphenol] and its salts
All products
0.2 per cent (expressed as the phenol)
A



8
Pyrithione zinc (INN) [Zinc pyrithione]
Products rinsed off after use
0.5 per cent
A
Not to be used in oral hygiene products


9
Inorganic sulphites and hydrogen sulphites
All products
0.2 per cent (expressed as free SO2)
A



10
Sodium iodate
Products rinsed off after use
0.1 per cent




11
Chlorobutanol (INN)
All products
0.5 per cent

Not to be used in aerosol dispensers (sprays)
Contains chlorobutanol

12
4-Hydroxybenzoic acid and its salts and esters [the Parabens]
All products
0.4 per cent (acid) for 1 ester, 0.8 per cent (acid) for mixtures of esters
A



13
3-Acetyl-6-methylpyran-2,4(3H)-dione [Dehydroacetic acid] and its salts
All products
0.6 per cent (acid)

Not to be used in aerosol dispensers (sprays)


14
Formic acid and its sodium salt
All products
0.5 per cent (expressed as acid)
A



15
3,3'-Dibromo-4,4'-hexamethylene-dioxydibenzamidine [Dibromohexamidine] and its salts (including isethionate)
All products
0.1 per cent




16
Thiomersal (INN) [Thimerosal]
Eye make-up and eye make-up remover
0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent


Contains thiomersal

17
Phenylmercuric salts (including borate)
Eye make-up and eye make-up remover
0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent


Contains phenylmercuric compounds

18
Undec-10-enoic acid [Undecylenic acid] and its salts
All products
0.2 per cent (acid)
A



19
Hexetidine (INN)
Products rinsed off after use
0.1 per cent
A



20
5-Bromo-5-nitro-1,3-dioxane
Products rinsed off after use
0.1 per cent

Avoid formation of nitrosamines


21
Bronopol (INN) [2-Bromo-2-nitropropane-1,3-diol]
All products
0.1 per cent
A
Avoid formation of nitrosamines


22
2,4-Dichlorobenzyl alcohol [Dichlorobenzyl alcohol]
All products
0.15 per cent
A



23
Triclocarban (INN)
All products
0.2 per cent
A

Purity criteria:

3,3'4,4'-tetrachloro-azobenzene
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