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Statutory Instruments
1996 No. 2925
CONSUMER PROTECTION
The Cosmetic Products (Safety) Regulations 1996
Made
21st November 1996
Laid before Parliament
25th November 1996
Coming into forcein accordance with regulation 1(1)-“(8)
Whereas the Secretary of State has, in accordance with section 11(5) of the Consumer Protection Act 1987(1), consulted such organisations as appear to him to be representative of interests substantially affected by these Regulations, such other persons as he considers appropriate and the Health and Safety Commission:
And whereas the Secretary of State is a Minister designated(2) for the purposes of section 2 of the European Communities Act 1972(3) in relation to measures for safety and consumer protection as respects cosmetic products and any provisions concerning the composition, labelling, marketing, classification or description of cosmetic products and in relation to indication of origin on imported goods:
Now, therefore, the Secretary of State in exercise of powers conferred on him by sections 11, 28 and 30 of the said Act of 1987 and by section 2 of the said Act of 1972 and of all other powers enabling him in that behalf hereby makes the following Regulations:-
Citation, commencement and revocation
1.-(1) These Regulations may be cited as the Cosmetic Products (Safety) Regulations 1996 and except as provided by paragraphs (2) to (8) below shall come into force on 16th December 1996.
(2) Regulations 3(1)(b), 3(3), 4(4), 4(5), 6(1), 6(2)(h), 6(5)(a) (in so far as it relates only to regulation 6(2)(h)), 6(5)(b), 6(6), 6(7) and 6(9) to (12) shall come into force-
(a)on 1st January 1997 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st January 1998; and
(b)in all other cases on 1st January 1998.
(3) The following provisions shall come into force in accordance with paragraph (4) below-
(a)regulation 4(2)(a) and Schedule 1, in so far as they relate only to entry numbers 81, 92, 98, 113, 132, 154, 356, 462, 489, 557, 620 and 743 in that Schedule;
(b)regulations 4(2)(e)(ii), 4(2)(f) and 4(2)(g) and Part II of Schedule 4, in so far as they relate only to the deletion of entry number 15 in that Part; and
(c)regulations 4(2)(h)(i) and 4(2)(i) and Part I of Schedule 5, in so far as they relate only to entry number 10 in that Part.
(4) The provisions referred to in paragraph (3) above shall come into force-
(a)on 16th December 1996 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st July 1997; and
(b)in all other cases on 1st July 1997.
(5) The following provisions shall come into force in accordance with paragraph (6) below-
(a)regulation 4(2)(a) and Schedule 1, in so far as they relate only to entry numbers 342, 405 and 751 in that Schedule;
(b)regulation 4(2)(b) and Part I of Schedule 2, in so far as they relate only to entry numbers 15a, 15b and 15c in that Part;
(c)regulations 4(2)(e)(i) and 4(2)(f) and Part I of Schedule 4, in so far as they relate only to entry numbers 50, 51 and 52 in that Part;
(d)regulations 4(2)(e)(ii) and 4(2)(g) and Part II of Schedule 4, in so far as they relate only to the deletion of entry numbers 2 and 30 in that Part;
(e)regulations 4(2)(h)(i) and 4(2)(i) and Part I of Schedule 5, in so far as they relate only to entry number 11 in that Part; and
(f)regulations 4(2)(h)(ii) and 4(2)(i) and Part II of Schedule 5, in so far as they relate only to the deletion of entry numbers 33 and 34 in that Part.
(6) The provisions referred to in paragraph (5) above shall come into force-
(a)on 1st July 1997 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st July 1998; and
(b)in all other cases on 1st July 1998.
(7) Paragraph 6(41) of Schedule 8 shall come into force on 30th September 1997.
(8) Regulation 4(3) shall come into force on 1st January 1998.
(9) Subject to paragraph (10) below, the Regulations specified in Schedule 9 hereto are revoked with effect from 16th December 1996 provided that the Cosmetic Products (Safety) Regulations 1989(4) shall continue to apply to cosmetic products which are supplied before 16th December 1996.
(10) The notes in Part I of Schedule 2, Part II of Schedule 4 and Part II of Schedule 5 shall apply.
Interpretation
2.-(1) In these Regulations-
"agent" means an agent established within the Community appointed by a manufacturer of a cosmetic product to act on his behalf in relation to these Regulations;
"common ingredients nomenclature" means the labelling nomenclature designated in the inventory of ingredients employed in cosmetic products, drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC(5), as amended or substituted from time to time;
"the Community" means the European Economic Community and other States in the European Economic Area;
"the Confidentiality Directive" means Commission Directive 95/17/EC(6);
"cosmetic ingredient" means any chemical substance or preparation of synthetic or natural origin, except for perfume and aromatic compositions, used in the composition of a cosmetic product;
"cosmetic product" means any substance or preparation intended to be placed in contact with any part of the external surfaces of the human body (that is to say, the epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours except where such cleaning, perfuming, protecting, changing, keeping or correcting is wholly for the purpose of treating or preventing disease;
"cosmetic product intended to come into contact with the mucous membranes" means a cosmetic product intended to be applied in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs, and does not include any cosmetic product which is intended to come into only brief contact with the skin;
"the Directive" means Council Directive 76/768/EEC(7), as amended by Council Directive 82/368/EEC(8), Commission Directive 82/147/EEC(9), Commission Directive 83/191/EEC(10), Commission Directive 83/341/EEC(11), Council Directive 83/574/EEC(12), Commission Directive 83/496/EEC(13), Commission Directive 84/415/EEC(14), Commission Directive 85/391/EEC(15), Commission Directive 86/179/EEC(16), Commission Directive 86/199/EEC(17), Commission Directive 87/137/EEC(18), Commission Directive 88/233/EEC(19), Council Directive 88/667/EEC(20), Commission Directive 89/174/EEC(21), Council Directive 89/679/EEC(22), Commission Directive 90/121/EEC(23), Commission Directive 91/184/EEC(24), Commission Directive 92/8/EEC(25), Commission Directive 92/86/EEC(26), Commission Directive 93/47/EEC(27), Council Directive 93/35/EEC(28), Commission Directive 94/32/EC(29), Commission Directive 95/34/EC(30), and Commission Directive 96/41/EC(31);
"EEA Agreement" means the Agreement on the European Economic Area signed at Oporto on 2 May 1992 as adjusted by the Protocol signed at Brussels on 17 March 1993(32);
"market research experiment" means any activities conducted for the purpose of ascertaining the opinion of persons of-
any cosmetic product; or
anything in, on or with which the cosmetic product is supplied; or
the appearance or any other characteristic of the cosmetic product or any such thing; or
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-
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
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:
| ||||
| 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:
| ||||
| 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<1 mg/kg 3,3',4,4'-tetrachloro-azoxybenzene<1 mg/kg | - |
| 24 | 4-Chloro-m-cresol [p-Chloro-m-cresol] | Not to be used in products intended to come into contact with mucous membranes | 0.2 per cent | A | - | - |
| 25 | Triclosan (INN) | All products | 0.3 per cent | A | - | - |
| 26 | 4-Chloro-3,5-xylenol [Chloroxylenol] | All products | 0.5 per cent | A | - | - |
| 27 | 3,3'-Bis(1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea [Imidazolidinyl urea] | All products | 0.6 per cent | A | - | - |
| 28 | Poly(1-hexamethylene-biguanide hydrochloride) [Polyaminopropyl biguanide] | All products | 0.3 per cent | A | - | - |
| 29 | 2-Phenoxyethanol [Phenoxyethanol] | All products | 1.0 per cent | A | - | - |
| 30 | Hexamethylenetetramine (Methenamine (INN)) [Methenamine] | All products | 0.15 per cent | A | - | - |
| 31 | Methenamine 3-chloroallylochloride (INNM) [Quaternium-15] | All products | 0.2 per cent | - | - | |
| 32 | 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one (Climbazole (INN)) [Climbazole] | All products | 0.5 per cent | A | - | - |
| 33 | 1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione [DMDM Hydantoin] | All products | 0.6 per cent | A | - | - |
| 34 | Benzyl alcohol (See also Part I of Schedule 2) | All products | 1.0 per cent | A | - | - |
| 35 | 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone and its monoethanolamine salt [Piroctone olamine] | Products rinsed off after use Other products | 1.0 per cent 0.5 per cent | A A | - - | - - |
| 36 | 1,2-Dibromo-2,4-dicyanobutane [Methyldibromo glutaronitrile] | All products | 0.1 per cent | Not to be used in cosmetic sunscreen products at a concentration exceeding 0.025 per cent | - | |
| 37 | 6,6-Dibromo-4,4-dichloro-2,2'-methylenediphenol [Bromochlorophen] | All products | 0.1 per cent | A | - | - |
| 38 | 4-Isopropyl-m-cresol [o-Cymen-5-ol] | All products | 0.1 per cent | - | - | |
| 39 | Mixture of 5-chloro-2-methylisothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate [Methylchloroisothiazolinone and Methylisothiazolinone] | All products | 0.0015 per cent of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol-3(2H)-one to 2-methylisothiazol-3(2H)-one | - | - | |
| 40 | 2-Benzyl-4-chlorophenol [Chlorophene] | All products | 0.2 per cent | - | - | |
| 41 | 2-Chloroacetamide [Chloroacetamide] | All products | 0.3 per cent | - | Contains chloroacetamide | |
| 42 | Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride | All products | 0.3 per cent | A | - | - |
| 43 | 1-Phenoxypropan-2-ol [Phenoxyisopropanol] (see also Part I of Schedule 2) | Products rinsed off after use | 1.0 per cent | - | - | |
| 44 | Alkyl (C12-C22)-trimethylammonium bromide and chloride (Cetrimonium bromide (INN) and Cetrimonium chloride (INNM)) | All products | 0.1 per cent | A | - | - |
| 45 | 4,4-Dimethyl-1,3-oxazolidine [Dimethyl oxazolidine] | All products | 0.1 per cent | The pH of the finished product must not be lower than 6 | - | |
| 46 | 1-[1,3-Bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea [Diazolidinyl urea] | All products | 0.5 per cent | - | - | |
| 47 | Hexamidine (INN) (4,4'-(Hexamethylene-dioxy)dibenzamidine) and its salts, including isethionate and p-hydroxybenzoate | All products | 0.1 per cent | A | - | - |
| 48 | Glutaraldehyde (pentane-1,5-dial) [Glutaral] | All products | 0.1 per cent | Prohibited in aerosols (sprays) | Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0.05 per cent) | |
| 49 | 5-Ethyl-3,7-dioxa-1-azabicyclo[3.3.0]octane[7-Ethylbicyclooxazolidine] | All products | 0.3 per cent | Prohibited in oral hygiene products and in products intended to come into contact with mucous membranes | - | |
| 50 | Chlorphenesin (INN) [Chlorphenesin] | All products | 0.3 per cent | - | - | |
| 51 | Sodium N-hydroxymethylglycinate [Sodium hydroxymethyl-glycinate] | All products | 0.5 per cent | - | - | |
| 52 | Silver chloride deposited on titanium dioxide | Not to be used in products for children under three years of age, in oral hygiene products and in products intended for application around the eyes and on the lips | 0.004 per cent calculated as silver chloride | The ratio of titanium dioxide to silver chloride shall be 4:1 by mass | - |
PART IIPRESERVATIVES LISTED IN ANNEX VI PART 2 OF THE DIRECTIVE(50) AS PRESERVATIVES WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE
| (1) | (2) | (3) | (4) | (5) | (6) | (7) |
|---|---|---|---|---|---|---|
| Reference Number in Annex VI Part 2 of the Directive | Name of substance | Purpose of substance or type of product | Maximum concentration of substance in product | Other requirements | Required information | Preservative supplied until |
Note: Entry number 15 is deleted with effect from the dates specified in regulation 1(4) and entry numbers 2 and 30 are deleted with effect from the dates specified in regulation 1(6). Until then entry number 15 in Part II of Schedule 4 to S.I. 1989/2233 (as amended by S.I. 1995/1478 but not by S.I. 1996/1446) and entry numbers 2 and 30 in Part II of Schedule 4 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force. | ||||||
| 1 to 15 | ENTRIES DELETED (see Note) | |||||
| 16 | Benzalkonium chloride (INN), bromide and saccharinate (Alkyl(C8-C18) benzyldimethyl-ammonium chloride, bromide and saccharinate) | All products | 0.1 per cent A | - | - | 30.06.1997 |
| 17 to 20 | ENTRIES DELETED | |||||
| 21 | Benzylhemiformal (a 1:1 mixture of benzyloxymethanol and benzyloxy-methoxymethanol) | Products rinsed off after use | 0.03 per cent | - | - | 30.06.1997 |
| 22 to 28 | ENTRIES DELETED | |||||
| 29 | 3-lodoprop-2-ynyl butylcarbamate | All products | 0.1 per cent | - | - | 30.06.1997 |
| 30 | ENTRY DELETED (see Note) | |||||
Regulations 4(2) and 6(2)
SCHEDULE 5LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS
In this Schedule, the matters specified in columns 3, 4 and 5 which apply to a particular substance are those set out to the right of its name as mentioned in column 2. The concentration of the substance in a product may not exceed the limit specified in column 3. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 4. In column 3 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.
Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC(51)
PART IUV FILTERS LISTED IN ANNEX VII PART I OF THE DIRECTIVE(52) AS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN
| (1) | (2) | (3) | (4) | (5) |
|---|---|---|---|---|
| Reference Number | Name of substance | Maximum concentration of substance in product | Other requirements | Required information |
| 1 | 4-Aminobenzoic acid [PABA] | 5 per cent | - | - |
| 2 | N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl)anilinium methyl sulphate [Camphor benzalkonium methosulfate] | 6 per cent | - | - |
| 3 | Homosalate (INN) | 10 per cent | - | - |
| 4 | Oxybenzone (INN) [Benzophenone-3] | 10 per cent | - | Contains oxybenzone. (Not required when concentration is not more than 0.5 per cent, and when the substance is only intended to protect the product.) |
| 5 | ENTRY DELETED | |||
| 6 | 2-Phenylbenzimidazole-5-sulphonic acid [Phenylbenzimidazole sulfonic acid] and its potassium, sodium and triethanolamine salts | 8 per cent (expressed as acid) | - | - |
| 7 | 3,3'-(1,4-Phenylenedimethylene)bis(7,7-dimethyl-2-oxo-bicyclo[2.2.1]hept-1-ylmethanesulfonic acid) [Terephthalylidene dicamphor sulfonic acid] and its salts | 10 per cent (expressed as acid) | - | - |
| 8 | 1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl) propane-1,3-dione (Avobenzone (INN)) [Butyl methoxy dibenzoylmethane] | 5 per cent | - | - |
| 9 | α-(2-Oxoborn-3-ylidene)toluene-4-sulphonic acid [Benzylidene camphor sulfonic acid] and its salts | 6 per cent (expressed as acid) | - | - |
| 10 | 2-Ethylhexyl-2-cyano-3,3-diphenylacrylate [Octocrylene] | 10 per cent (expressed as acid) | - | - |
| 11 | Polymer of N-{(2 and 4)-[2-oxoborn-3-ylidene)methyl]benzyl}acrylamide [Polyacrylamidomethyl benzylidene camphor] | 6 per cent | - | - |
PART IIUV FILTERS LISTED IN ANNEX VII PART 2 OF THE DIRECTIVE(53) AS UV FILTERS WHICH COSMETIC PRODUCTS MAY NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN AND WHERE SUPPLIED BEFORE A CERTAIN DATE
| (1) | (2) | (3) | (4) | (5) | (6) |
|---|---|---|---|---|---|
| Reference Number | Name of substance | Maximum concentration of substance in product | Other requirements | Required information | UV filter supplied until |
Note: Entry numbers 33 and 34 are deleted with effect from the dates specified in regulation 1(6). Until then the corresponding entries in Part II of Schedule 5 to S.I. 1989/2233 (amended most recently by S.I. 1996/1446) continue in force. | |||||
| 1 | ENTRY DELETED | ||||
| 2 | Ethoxylated ethyl 4-aminobenzoate [PEG-25 PABA] | 10 per cent | - | - | 30.6.1997 |
| 3-“4 | ENTRIES DELETED | ||||
| 5 | 2-Ethylhexyl 4-dimethylamino-benzoate [Octyl dimethyl PABA] | 8 per cent | - | - | 30.6.1997 |
| 6 | 2-Ethylhexyl salicylate [Octyl salicylate] | 5 per cent | - | - | 30.6.1997 |
| 7-“11 | ENTRIES DELETED | ||||
| 12 | Isopentyl 4-methoxycinnamate, mixed isomers [Isoamyl p-methoxycinnamate] | 10 per cent | - | - | 30.6.1997 |
| 13 | 2-Ethylhexyl 4-methoxycinnamate [Octyl methoxycinnamate] | 10 per cent | - | - | 30.6.1997 |
| 14-“16 | ENTRIES DELETED | ||||
| 17 | 2-Hydroxy-4-methoxybenzo-phenone-5-sulphonic acid [Benzophenone-4] and its sodium salt [Benzophenone-5] (Sulisobenzone (INN) and Sulisobenzone sodium (INNM)) | 5 per cent (expressed as acid) | - | - | 30.6.1997 |
| 18-“24 | ENTRIES DELETED | ||||
| 25 | 3-(4-Methylbenzyl-idene)bornan-2-one [4-Methylbenzylidene camphor] | 6 per cent | - | - | 30.6.1997 |
| 26 | 3-Benzylidenebornan-2-one [3-Benzylidene camphor] | 6 per cent | - | - | 30.6.1997 |
| 27-“28 | ENTRIES DELETED | ||||
| 29 | 4-Isopropylbenzyl salicylate [Isopropylbenzyl salicylate] | 4 per cent | - | - | 30.6.1997 |
| 30-“31 | ENTRIES DELETED | ||||
| 32 | Tris(2-ethylhexyl) 4,4',4"-(1,3,5-triazin-2,4,6-triyltriimino)- tribenzoate [Octyl triazone] | 5 per cent | - | - | 30.6.1997 |
| 33-“34 | ENTRIES DELETED (see Note) | ||||
Regulations 6(6) and (11)
SCHEDULE 6SYMBOL IN ANNEX VIII OF THE DIRECTIVE WHICH IS REQUIRED FOR THE PURPOSES OF REGULATIONS 6(6) AND 6(11)
Regulation 11
SCHEDULE 7
PART IPARTICULARS TO BE INCLUDED WITH A REQUEST FOR CONFIDENTIALITY
1. The name or trade name and address or registered office of the applicant.
2. Precise identification of the cosmetic ingredient for which confidentiality is requested, namely-
(a)where they exist, the CAS, EINECS and colour index numbers, the chemical name, the IUPAC name, the INCI name, the European Pharmacopoeia name, the International Non-proprietary Name as recommended by the World Health Organization and the common name as provided for in the common ingredients nomenclature;
(b)the Elincs name and the official number allocated to it if it has been notified pursuant to Council Directive 67/548/EEC and an indication of the decision to approve or refuse any request for confidentiality made under Article 19 of that Directive;
(c)where the names or numbers referred to in sub-paragraphs (a) and (b) above do not exist, for example in the case of certain ingredients of natural origin, the name of the base material, the name of the part of the plant or animal used and the names of the cosmetic ingredient's compounds, such as solvents.
3. The evaluation of the safety for human health of the cosmetic ingredient as used in the finished cosmetic product or products taking into account the cosmetic ingredient's toxicological profile, chemical structure and the level of exposure as specified in regulation 8(1)(d) and carried out in accordance with the requirements of regulations 8(2) and (3).
4. The envisaged use of the cosmetic ingredient and in particular the different categories of cosmetic products in which it will be used.
5. A detailed justification of why confidentiality is sought addressing for example-
(a)the fact that the identity of the cosmetic ingredient or its function in the cosmetic product to be supplied has not been described in the literature accompanying the cosmetic product and is unknown to other manufacturers or suppliers of cosmetic products;
(b)the fact that the information is not yet in the public domain even though a patent application has been lodged for the cosmetic ingredient or its use;
(c)the fact that if the information were known it would be easily reproducible, to the detriment of the applicant.
6.-(a) If known, the name of each cosmetic product which is to contain the cosmetic ingredient and if different names are to be used in other member States, precise details of each one of them.
(b)If the name of a cosmetic product is not yet known, it may be communicated at a later date, but at least 15 days before the cosmetic product is supplied.
(c)If the cosmetic ingredient is used in several products, one request shall suffice, provided that the cosmetic products are clearly indicated to the competent authority.
7. A statement setting out whether a request has been submitted to the competent authority of any other member State in respect of the cosmetic ingredient for which confidentiality is sought and particulars on the outcome of any such request.
PART IIPROCEDURE FOR GRANT OF REGISTRATION NUMBER
1. The registration number referred to in regulation 11(5) shall consist of seven digits, the first two corresponding to the year of approval of confidentiality, the second two to the code assigned to each member State, as referred to in paragraph 2 below, and the final three digits assigned by the competent authority.
2. The code allocated to the United Kingdom is 06.
Regulation 14
SCHEDULE 8SAMPLING AND TESTING
1. In this Schedule-
"Annex A" means the Annex to Commission Directive No. 80/1335/EEC(54) as amended by Commission Directive No. 87/143/EEC(55);
"Annex B" means the Annex to Commission Directive No. 82/434/EEC(56) as amended by Commission Directive No. 90/207/EEC(57);
"Annex C" means the Annex to Commission Directive No. 83/514/EEC(58);
"Annex D" means the Annex to Commission Directive No. 85/490/EEC(59);
"Annex E" means the Annex to Commission Directive No. 93/73/EEC(60);
"Annex F" means the Annex to Commission Directive No. 95/32/EC(61);
"Annex G" means the Annex to Commission Directive No. 96/45/EC(62);
"purchase" means purchase for the purpose of carrying out a test.
2. An enforcement authority intending to purchase a cosmetic product shall purchase a sufficient laboratory sample, as defined in paragraph 2.3 of Part I of Annex A, for the purpose of Annex A; and, for the purposes of the definition of "total sample" in paragraph 2.2 of Part I of Annex A, samples shall be regarded as having the same batch number if-
(a)the means of identifying the batch referred to in regulation 6(2)(g) above shows that they were manufactured in the same batch; or
(b)in the case of a product not manufactured in a batch, the reference referred to in regulation 6(2)(g) above shows that they are derived from the same unit of production; or
(c)in the case of a product which does not comply with the requirements of regulation 6(2)(g) above, the officer effecting the purchase has reasonable cause to believe that they were manufactured in the same batch or are derived from the same unit of production, as the case may be.
3. The immediate container, if any, of a cosmetic product purchased by an enforcement authority shall not have been opened by, on behalf of or at the request of the enforcement authority before the purchase takes place and the container shall not thereafter be opened except in accordance with paragraph 5.3 of Part I of Annex A and paragraph 1.2 of Part II of Annex A.
4. As soon as an enforcement authority has purchased a cosmetic product, the officer effecting the purchase shall-
(a)either-
(i)place a seal on the product's container or outer packaging, or
(ii)place the product in a container and forthwith place a seal on that container, in such a way that the product's immediate container cannot be opened or (in the case of a product which was not in a container when it was purchased) the product cannot be touched without (in either case) the seal being broken in such a manner that it would be apparent thereafter that it had been broken, and
(b)attach to the product a label indicating-
(i)the name of the product,
(ii)the date, time and place at which the product was purchased,
(iii)his own name, and
(iv)the name of the enforcement authority making the purchase.
5.-(1) Subject to sub-paragraph (2) below, the provisions of Part I of Annex A, other than paragraphs 3.1, 3.2 and 4, and of Part II of Annex A, other than paragraph 1.4, shall be complied with in the sampling of cosmetic products and the laboratory preparation of test portions.
(2) Where, because of the way in which a cosmetic product is put up for sale, it is not practicable for Part II of Annex A to be complied with, it shall be prepared for testing in accordance with good analytical practice, and the person so preparing it shall record in writing the method of preparation which he has used.
6.-(1) Any test to determine whether a cosmetic product contains a significant amount of free sodium hydroxide or free potassium hydroxide shall be carried out in accordance with paragraphs 1 to 4 of Part III of Annex A.
(2) Any test to determine the amount of free sodium hydroxide or free potassium hydroxide in a hair straightener product or a nail cuticle solvent product shall be carried out in accordance with paragraphs 1, 2, 3 and 5 of Part III of Annex A.
(3) Any test to determine whether a hair-care product contains oxalic acid or any alkaline salt of oxalic acid or to determine the amount of such a substance in a hair-care product shall, subject to the limitation specified in the second sentence of paragraph 1 of Part IV of Annex A, be carried out in accordance with the said Part IV.
(4) Any test to determine the amount of chloroform in toothpaste shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex A, be carried out in accordance with the said Part V.
(5) Any test to determine the amount of zinc chloride, zinc sulphate or zinc 4-hydroxybenzenesulphonate by virtue of their zinc contents in a cosmetic product shall be carried out in accordance with Part VI of Annex A and Commission Directive 87/143/EEC(63), and shall take into account paragraph 11 of Part VII of Annex A.
(6) Any test to determine whether a cosmetic product contained in an aerosol dispenser or a cream, emulsion, lotion, gel or oil intended to be applied to the skin contains 4-hydroxybenzenesulphonic acid, or to determine the amount of that acid in such a product, shall be carried out in accordance with Part VII of Annex A.
(7) Any test to determine whether a hair-care product contains persulphate, bromate or hydrogen peroxide shall be carried out in accordance with Part A of Part I of Annex B.
(8) Any test to determine whether a hair-care product contains barium peroxide shall be carried out in accordance with Part B of Part I of Annex B.
(9) Any test to determine the amount of hydrogen peroxide in a hair-care product shall be carried out in accordance with Part C of Part I of Annex B.
(10) Any test to determine whether a hair-dye contains any of the oxidation colourants specified in paragraph 1 of Part II of Annex B, or to determine the amount of such a substance in a hair-dye, shall be carried out in accordance with the said Part II.
(11) Any test to determine whether a cosmetic product contains nitrite, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part III of Annex B.
(12) Any test to determine whether a cosmetic product contains free formaldehyde, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part IV of Annex B.
(13) Any test to determine the amount of resorcinol in a shampoo or hair lotion shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex B, be carried out in accordance with the said Part V.
(14) Any test to determine the amount of methanol in relation to ethanol or propan-2-ol in a cosmetic product shall be carried out in accordance with Part VI of Annex B.
(15) Any test to determine the amount of dichloromethane or 1,1,1-trichloroethane in a cosmetic product shall be carried out in accordance with paragraphs 1 to 10 of that part of Annex C which is headed "Determination of dichloromethane and 1,1,1-trichloroethane".
(16) Any test to determine whether a cosmetic product contains quinolin-8-ol or bis(8-hydroxyquinolinium) sulphate, or to determine the amount of such a substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed "Identification and determination of quinolin-8-ol and bis(8-hydroxyquinolinium) sulphate".
(17) Any test to determine the amount of ammonia in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed "Determination of ammonia".
(18) Any test to determine whether a cosmetic product contains nitromethane, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 7 of that part of Annex C which is headed "Identification and determination of nitromethane".
(19) Any test to determine whether a hair waving, hair straightening or depilatory product contains mercaptoacetic acid (thioglycolic acid), or to determine the amount of that substance in such a product, shall be carried out in accordance with paragraphs 1 to 6 of that part of Annex C which is headed "Identification and determination of mercaptoacetic acid in hair-waving, hair-straightening and depilatory products".
(20) Any test to determine whether a cosmetic product contains hexachlorophene (INN) shall be carried out in accordance with paragraphs 1 to 7 of Part A of that part of Annex C which is headed "Identification and determination of hexachlorophene".
(21) Any test to determine the amount of hexachlorophene (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of Part B of that part of Annex C which is headed "Identification and determination of hexachlorophene".
(22) Any test to determine the amount of tosylchloramide sodium (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed "Quantitative determination of tosylchloramide sodium (INN) (chloramine-T)".
(23) Any test to determine the total amount of fluorine in dental creams shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed "Determination of total fluorine in dental creams".
(24) Any test to determine whether a cosmetic product contains organomercury compounds shall be carried out in accordance with paragraphs 1 to 4 of Part A of that part of Annex C which is headed "Identification and determination of organomercury compounds".
(25) Any test to determine the amount of organomercury compounds in a cosmetic product shall be carried out in accordance with paragraphs 1 to 7 of Part B of that part of Annex C which is headed "Identification and determination of organomercury compounds".
(26) Any test to determine the amount of alkali sulphides or alkaline earth sulphides in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed "Determination of alkali and alkaline earth sulphides".
(27) Any test for the identification and determination of the amount of glycerol 1-(4-aminobenzoate) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed "Identification and determination of glycerol 1-(4-aminobenzoate)".
(28) Any test to determine the amount of chlorobutanol (INN) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed "Determination of chlorobutanol".
(29) Any test for the identification and determination of the amount of quinine in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed "Identification and determination of quinine".
(30) Any test for the identification and determination of inorganic sulphites and hydrogen sulphites in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed "Identification and determination of inorganic sulphites and hydrogen sulphites".
(31) Any test for the identification and determination of chlorates of the alkali metals in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed "Identification and determination of chlorates of the alkali metals".
(32) Any test for the identification and determination of sodium iodate in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed "Identification and determination of sodium iodate".
(33) Any test for the identification and determination of silver nitrate in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed "Identification and determination of silver nitrate in cosmetic products".
(34) Any test for the identification and determination of selenium disulphide in anti-dandruff shampoos shall be carried out in accordance with that part of Annex E which is headed "Identification and determination of selenium disulphide in anti-dandruff shampoos".
(35) Any test for the determination of soluble barium and soluble strontium in pigments in the form of salts or lakes shall be carried out in accordance with that part of Annex E which is headed "Determination of soluble barium and strontium in pigments in the form of salts or lakes".
(36) Any test for the identification and determination of benzyl alcohol in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed "Identification and determination of benzyl alcohol in cosmetic products".
(37) Any test for the identification of zirconium and the determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants shall be carried out in accordance with that part of Annex E which is headed "Identification of zirconium, and determination of zirconium, aluminium and chlorine in non-aerosol anti-perspirants".
(38) Any test for the identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine in a cosmetic product shall be carried out in accordance with that part of Annex E which is headed "Identification and determination of hexamidine, dibromohexamidine, dibromopropamidine and chlorhexidine".
(39) Any test for the identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed "Identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid and propionic acid in cosmetic products".
(40) Any test for the identification and determination of hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether and hydroquinone monobenzylether (monobenzone) in a cosmetic product shall be carried out in accordance with that part of Annex F which is headed "Identification and determination of hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether and hydroquinone monobenzylether in cosmetic products".
(41) Any test for the identification and determination of 2-phenoxyethanol, 1-phenoxypropan-2-ol, and methyl, ethyl, propyl, butyl and benzyl 4-hydroxybenzoate in a cosmetic product shall be carried out in accordance with Annex G.
Regulation 1(9)
SCHEDULE 9REVOCATIONS
| (1) | (2) |
|---|---|
| Regulations revoked | References |
| The Cosmetic Products (Safety) Regulations 1989 | S.I. 1989/2233 |
| The Cosmetic Products (Safety) (Amendment) Regulations 1990 | S.I. 1990/1812 |
| The Cosmetic Products (Safety) (Amendment) Regulations 1991 | S.I. 1991/447 |
| The Cosmetic Products (Safety) (Amendment) Regulations 1992 | S.I. 1992/1525 |
| The Cosmetic Products (Safety) (Amendment) Regulations 1993 | S.I. 1993/1539 |
| The Cosmetic Products (Safety) (Amendment) Regulations 1994 | S.I. 1994/1529 |
| The Cosmetic Products (Safety) (Amendment) Regulations 1995 | S.I. 1995/1478 |
| The Cosmetic Products (Safety) (Amendment) Regulations 1996 | S.I. 1996/1446 |
Explanatory Note
(This note is not part of the Regulations)
These Regulations consolidate with amendments the Cosmetic Products (Safety) Regulations 1989 as amended. They implement Council Directive 76/768/EEC (O.J. No. L262, 27.9.1976, p.169) on the approximation of the laws of the member States relating to cosmetic products, as amended ("the Cosmetics Directive"). They implement for the first time the amendments made to the Cosmetics Directive by Council Directive 93/35/EEC (O.J. No. L151, 23.6.1993, p.32) and Commission Directive 96/41/EC (O.J. No. L198, 8.8.1996, p.36). They also implement Commission Directives 95/32/EC (O.J. No. L178, 28.7.1995, p.20) and 96/45/EC (O.J. No. L213, 2.7.1996, p.8) relating to methods of analysis necessary for checking the composition of cosmetic products. Further, they implement Commission Directive 95/17/EC (O.J. No. L140, 23.6.1995, p.26) laying down detailed rules for the application of the Cosmetics Directive as regards the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic products.
These Regulations give effect to Council Directive 93/35/EEC and Commission Directive 96/41/EC as follows-
1. they contain an amended definition of "cosmetic product"(regulation 2(1));
2. they contain an expanded general safety requirement for cosmetic products (regulation 3(1));
3. they prohibit the use of urocanic acid and its ethyl ester in cosmetic products (regulation 4(2)(a) and Schedule 1, entry numbers 342, 405 and 751);
4. they permit the use in certain cosmetic products of potassium hydroxide, sodium hydroxide, lithium hydroxide and calcium hydroxide, subject to restrictions (regulation 4(2)(b) and Schedule 2, Part I, entry numbers 15a, 15b and 15c);
5. they permit the use as preservatives in cosmetic products of chlorphenesin, sodium hydroxymethylglycinate and silver chloride deposited on titanium dioxide, subject to restrictions (regulations 4(2)(e)(i) and 4(2)(f) and Schedule 4, Part I, entry numbers 50, 51 and 52);
6. they permit, subject to restrictions, the use in cosmetic products until 30 June 1997 of three preservatives listed as entry numbers 16, 21 and 29 in Schedule 4, Part II (regulation 4(2)(e)(ii) and Schedule 4, Part II);
7. they permit the use as a UV filter in cosmetic products of polymer N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl}acrylamide, subject to a restriction (regulation 4(2)(h)(i) and 4(2)(i) and Schedule 5, Part I, entry number 11);
8. they permit the use in cosmetic products until 30 June 1997 of 10 UV filters listed as entry numbers 2, 5, 6, 12, 13, 17, 25, 26, 29 and 32 in Schedule 5, Part II, subject to restrictions (regulation 4(2)(h)(ii) and Schedule 5, Part II);
9. they prohibit the use in cosmetic products of any ingredients which have been tested on animals after 1st January 1998 (regulation 4(3));
10. they provide that any reference to testing on animals in the labelling, putting up for sale or advertising of a cosmetic product must state clearly whether the tests carried out involved the cosmetic product itself or its ingredients (regulation 4(4) and (5));
11. they require cosmetic products to be labelled with information about their function, unless this is clear from their presentation (regulation 6(2)(h));
12. they require cosmetic products to be labelled with details of their ingredients, identified by their common names as provided for in the common ingredients nomenclature (an inventory of ingredients compiled by the Commission and contained in Commission Decision 96/335/EC (O.J. No. L132, 1.6.1996, p.1), and they make provision for the manner of labelling required and for cases where ingredients are not listed in the common ingredients nomenclature (regulation 6(1), (5)(b) and (9) to (12));
13. they require manufacturers, their agents, persons to whose order cosmetic products are manufactured and (in certain circumstances) persons responsible for supplying cosmetic products for the first time in the Community to keep for control purposes detailed information (which must be readily accessible to a United Kingdom competent authority) bearing on the composition, ingredients, method of manufacture, safety and effect of the cosmetic products in question (regulation 8);
14. they require manufacturers, their agents, persons to whose order cosmetic products are manufactured and (in certain circumstances) persons responsible for supplying cosmetic products for the first time in the Community to notify a United Kingdom competent authority of the address of the place of manufacture or initial importation into the Community of a type of cosmetic product before that type of product is first supplied in the Community, where the place of manufacture or initial importation is within the United Kingdom (regulation 9); and
15. they enable United Kingdom competent authorities to require that any holder of information on substances used in cosmetic products must make that information available where this may overcome or ease any difficulties encountered in providing prompt and appropriate medical treatment (regulation 10).
These Regulations give effect to the requirements of Commission Directives 95/32/EC and 96/45/EC by introducing procedures for the identification and determination of benzoic acid, 4-hydroxybenzoic acid, sorbic acid, salicylic acid, propionic acid, hydroquinone, hydroquinone monomethylether, hydroquinone monoethylether, hydroquinone monobenzylether (monobenzone), 2-phenoxyethanol, 1-phenoxypropan-2-ol, and methyl, ethyl, propyl, butyl and benzyl 4-hydrozybenzoate in cosmetic products (regulation 14 and Schedule 8, paragraph 6(39), (40) and (41)).
Finally, these Regulations give effect to the requirements of Commission Directive 95/17/EEC by providing that manufacturers, their agents, persons to whose order cosmetic products are manufactured and (in certain circumstances) persons responsible for supplying cosmetic products for the first time in the Community may, if for reasons of trade secrecy they do not wish to include a particular cosmetic ingredient in the list of cosmetic ingredients required for labelling purposes, apply to a competent authority for approval to use a reference number in that list rather than the ingredient's name. Provision is made for the particulars which must accompany such an application and for the procedures which apply to applications and to the withdrawal of any approval (regulation 11 and Schedule 7).
The Colour Index referred to in these Regulations may be obtained from the Society of Dyers and Colourists, PO Box No. 244, 82 Grattan Road, Bradford BD1 2JB.
The International Cosmetic Ingredient Dictionary referred to in these Regulations may be obtained from Micelle Press, 12 Ullswater Crescent, Weymouth, Dorset DT3 5HE.
A Compliance Cost Assessment is available, copies of which have been placed in the libraries of both Houses of Parliament. Copies are also available from the Consumer Affairs and Competition Policy Directorate of the Department of Trade and Industry, Room 4.D.2, 1 Victoria Street, London SW1H 0ET.
S.I. 1989/2233, amended by S.I. 1990/1812, 1991/447, 1992/1525, 1993/1539, 1994/1529, 1995/1478, 1996/1446.
O.J. No. L132, 1.6.1996, p.1.
O.J. No. L140, 23.6.1995, p.26.
O.J. No. L262, 27.9.1976, p.169.
O.J. No. L167, 15.6.1982, p.1.
O.J. No. L63, 6.3.1982, p.26.
O.J. No. L109, 26.4.1983, p.25.
O.J. No. L188, 13.7.1983, p.15.
O.J. No. L332, 28.11.1983, p.38.
O.J. No. L275, 8.10.1983, p.20.
O.J. No. L228, 25.8.1984, p.31.
O.J. No. L224, 22.8.1985, p.40.
O.J. No. L138, 24.5.1986, p.40.
O.J. No. L149, 3.6.1986, p.38.
O.J. No. L56, 26.2.1987, p.20.
O.J. No. L105, 26.4.1988, p.11.
O.J. No. L382, 31.12.1988, p.46.
O.J. No. L64, 8.3.1989, p.10.
O.J. No. L398, 30.12.1989, p.25.
O.J. No. L71, 17.3.1990, p.40.
O.J. No. L91, 12.4.1991, p.59.
O.J. No. L70, 17.3.1992, p.23.
O.J. No. L325, 11.11.1992, p.18.
O.J. No. L203, 13.8.1993, p.24.
O.J. No. L151, 23.6.1993, p.32.
O.J. No. L181, 15.7.1994, p.31.
O.J. No. L167, 18.7.1995, p.19.
O.J. No. L198, 8.8.1996, p.36..
The Directive is within the scope of the EEA Agreement by virtue of Chapter XVI of Annex II to that Agreement.
An ingredient's CTFA name is the name given to it by the Cosmetics Toiletries and Fragrances Association and listed in the sixth edition of the International Cosmetic Ingredient Dictionary published in 1995. Its EINECS identification reference is the reference given in the European Inventory of Existing Commercial Chemical Substances. Its IUPAC identification reference is the reference given by the International Union of Pure and Applied Chemistry. Its CAS identification reference is the reference assigned by the Chemical Abstracts Service. An ingredient's colour index number is the number specified in the third edition of The Colour Index published in 1971 by the Society of Dyers and Colourists. European Pharmacopoeia names, International Non-proprietary Names and EINECS, IUPAC and CAS identification references are listed in Commission Decision 96/335/EC (O.J. No. L132, 1.6.1996, p.1).
O.J. No. L15, 17.1.87, p.29.
O.J. No. L187, 12.7.76, p.1.
O.J. No. L147, 9.6.75, p.13.
O.J. No. L132, 1.6.1996, p.1.
See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 88/667/EEC, 89/174/EEC, 90/121/EEC, 91/184/EEC, 92/8/EEC, 92/86/EEC, 93/47/EEC, 94/32/EC, 95/34/EC.
O.J. No. 115, 11.11.62, p.2645.
Council Directives Nos. 65/469/EEC, 67/653/EEC, 68/419/EEC, 70/358/EEC, 76/399/EEC, 78/144/EEC, 81/20/EEC and 85/7/EEC (O.J. Nos. L178, 26.10.65, p.2793; L263, 30.10.67, p.4; L309, 24.12.68, p.24; L157, 18.7.70, p.36; L108, 26.4.76, p.19; L44, 15.2.78, p.20; L43, 14.2.81, p.11; L2, 3.1.85, p.22).
Annexes I and VII to the Act of Accession of 22 January 1972, as adjusted by the Council Decision of 1 January 1973 (O.J. No. L2, 1.1.73, p.1).
Council Directive 94/36/EC (O.J. No. L237, 10.9.1994, p.13) and Commission Directive 95/45/EC (O.J. No. L226, 22.9.1995, p.1).
See Directives 86/179/EEC, 87/137/EEC, 88/233/EEC, 88/667/EEC, 89/174/EEC, 90/121/EEC, 91/184/EEC, 92/8/EEC, 92/86/EEC.
See Directives 86/179/EEC, 87/137/EEC, 88/233/EEC, 89/174/EEC, 90/121/EEC, 91/184/EEC, 92/8/EEC, 92/86/EEC.
O.J. No. L132, 1.6.1996, p.1.
See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 89/174/EEC, 90/121/EEC, 91/184/EEC, 92/8/EEC, 92/86/EEC, 93/47/EEC, 94/32/EC, 95/34/EC, 96/41/EC.
See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 89/174/EEC, 91/184/EEC, 92/86/EEC, 94/32/EC, 96/41/EC.
O.J. No. L132, 1.6.1996, p.1.
See Directives 83/574/EEC, 91/184/EEC, 92/86/EEC, 93/47/EEC, 94/32/EC, 95/34/EC, 96/41/EC.
See Directives 83/574/EEC, 89/174/EEC, 90/121/EEC, 92/8/EEC, 92/86/EEC, 93/47/EEC, 94/32/EC, 95/34/EC, 96/41/EC.
O.J. No. L383, 31.12.80, p.27.
O.J. No. L57, 27.2.87, p.56.
O.J. No. L185, 30.6.82, p.1.
O.J. No. L108, 28.4.90, p.92.
O.J. No. L291, 24.10.83, p.9.
O.J. No. L295, 7.11.85, p.30
O.J. No. L231, 14.9.93, p.34.
O.J. No. L178, 28.7.95, p.20.
O.J. No. L213, 2.7.1996, p.8.
O.J. No. L57, 27.2.87, p.56.