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Statutory Instrument 2003 No. 835
The Cosmetic Products (Safety) Regulations 2003
(The document as of February, 2008)
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STATUTORY INSTRUMENTS
2003 No. 835
CONSUMER PROTECTION
The Cosmetic Products (Safety) Regulations 2003
| | Made | 20th March 2003 | | | | Laid before Parliament | 24th March 2003 | | | | Coming into force (except as provided in regulation 1(2)) | 15th April 2003 | |
Whereas the Secretary of State has, in accordance with section 11(5) of the Consumer Protection Act 1987[1], consulted such organisations as appear to her to be representative of interests substantially affected by these Regulations, such other persons as she considers appropriate and the Health and Safety Commission; And whereas the Secretary of State is a Minister designated[2] for the purposes of section 2 of the European Communities Act 1972[3] in relation to measures for safety and consumer protection as respects cosmetic products and any provisions concerning the composition, labelling, marketing, classification or description of cosmetic products and in relation to indication of origin on imported goods; Now, therefore, the Secretary of State in exercise of the powers conferred on her by sections 11, 28 and 30 of the 1987 Act and by section 2(2) of the 1972 Act, hereby makes the following Regulations - Citation and commencement 1. - (1) These Regulations may be cited as the Cosmetic Products (Safety) Regulations 2003 and shall come into force on 15th April 2003 other than the provisions referred to in paragraph (2) below. (2) The following provisions of these Regulations shall come into force on 15th April 2004 - (a) in Schedule 3, substance number 634 in Part I as amended and Part II in its entirety;
(b) in Schedule 4, substance numbers 8, 15b, 15c, 16 and 66 in Part I as amended and Part II in its entirety; and
(c) in Schedule 7, substance numbers 26 and 27 in Part I.
Revocation
2.The Regulations set out in Schedule 1 are hereby revoked, save that they continue to apply to the following substances until 15th April 2004 -
(a) substance number 631 in Schedule 1 to the Cosmetic Products (Safety) Regulations 1996[4]; and
(b) substance numbers 8, 15b, 15c and 16 in Part I of Schedule 2 to those Regulations[5].
Interpretation
3. - (1) In these Regulations -
"agent" means an agent established within the Community appointed by a manufacturer of a cosmetic product to act on his behalf in relation to these Regulations; "common ingredients nomenclature" means the labelling nomenclature designated in the inventory of ingredients employed in cosmetic products, drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC[6], as amended or substituted from time to time; "the Community" means the European Community and other States in the European Economic Area; "the Confidentiality Directive" means Commission Directive 95/17/EC[7]; "cosmetic ingredient" means any chemical substance or preparation of synthetic or natural origin, except for perfume and aromatic compositions, used in the composition of a cosmetic product; "cosmetic product" means any substance or preparation intended to be placed in contact with any part of the external surfaces of the human body (that is to say, the epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours except where such cleaning, perfuming, protecting, changing, keeping or correcting is wholly for the purpose of treating or preventing disease; "cosmetic product intended to come into contact with the mucous membranes" means a cosmetic product intended to be applied in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs, and does not include any cosmetic product which is intended to come into only brief contact with the skin; "the Directive" means Council Directive 76/768/EEC[8] as amended by the Community instruments set out in Schedule 2; "EEA Agreement" means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993[9]; "market research experiment" means any activities conducted for the purpose of ascertaining the opinion of persons of - (a) any cosmetic product;
(b) anything in, on or with which the cosmetic product is supplied;
(c) the appearance or any other characteristic of the cosmetic product or any such thing; or
(d) the name or description under which the cosmetic product is supplied;
but a cosmetic product is not the subject of a market research experiment unless -
(i) any person to whom a cosmetic product is supplied in the course of the experiment is informed, at or before the time at which it is supplied to him, that it is supplied for the purpose of a market research experiment; and
(ii) no consideration in money or money's worth is given by such a person for the cosmetic product or any other cosmetic product supplied to him for comparison;
"Member State" means a State which is a Contracting Party to the EEA Agreement; "preservative" means a substance which is added to a cosmetic product for the primary purpose of inhibiting the development of micro-organisms in that product; "supply" includes offering to supply, agreeing to supply, exposing for supply and possessing for supply, and cognate expressions shall be construed accordingly; and "UV filter" means a substance which is added to a sunscreen cosmetic product for the primary purpose of filtering ultra violet rays for the purpose of protecting the epidermis of the user from harmful effects of such ultra violet rays. (2) Unless the contrary intention appears, references in these Regulations to a numbered regulation or Schedule are references to the regulation or Schedule so numbered in these Regulations.
General requirements
4. - (1) Subject to paragraph (2) below, no person shall supply any cosmetic product which is liable to cause damage to human health when it is applied under -
(a) normal conditions of use; or
(b) conditions of use which are reasonably foreseeable taking into account all the circumstances, including the cosmetic product's presentation, labelling, any instructions for its use and disposal and any other information or indication provided by the manufacturer, his agent or the person who supplies the cosmetic product on the first occasion that it is supplied in the Community.
(2) Paragraph (1) above shall apply only to the supply by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person.
(3) The provision of any instructions, information or indication referred to in sub-paragraph (b) of paragraph (1) above shall not exempt any person from the obligation to comply with any other provisions of these Regulations which are applicable to him.
Particular requirements
5. - (1) The following provisions of this regulation are without prejudice to regulation 4 and are subject to regulation 6.
(2) No person shall supply a cosmetic product which contains -
(a) any substance listed in column 2 of Part I of Schedule 3 which is used other than as a fragrance ingredient in relation to a cosmetic product, provided that no account shall be taken of any such substance which is present only as a trace which could not reasonably have been removed during or after manufacture;
(b) any substance listed in column 2 of Part II of Schedule 3 which is used as a fragrance ingredient in relation to a cosmetic product, provided that no account shall be taken of any such substance which is present only as a trace which could not reasonably have been removed during or after manufacture;
(c) any substance listed in column 2 of Schedule 4, unless the requirements in columns 3, 4, 5 and (in the case of Part II) 7 of that Schedule in relation to that substance are satisfied;
(d) any colouring agent listed in columns 1 and 2 of Schedule 5 with the exception of a cosmetic product containing a colouring agent intended solely to colour hair unless -
(i) the requirements in columns 3 and 4 of Part I of that Schedule in relation to that colouring agent are satisfied; or
(ii) the requirements in columns 3 and 4 of Part II of that Schedule in relation to that colouring agent are satisfied and the cosmetic product in question was supplied on or before the date specified in column 5 of that Part;
(e) any colouring agent which is not listed in Schedule 5 with the exception of a cosmetic product containing a colouring agent intended solely to colour hair;
(f) any preservative listed in column 2 of Schedule 6 unless -
(i) the requirements in columns 3, 4 and 5 of Part I of that Schedule in relation to that preservative are satisfied; or
(ii) the requirements in columns 3, 4 and 5 of Part II of that Schedule in relation to that preservative are satisfied and the preservative in question is supplied on or before the date specified in column 7 of that Part;
(g) any preservative which is not listed in Schedule 6;
(h) any preservative listed in column 2 of Part II of Schedule 6 after the date specified in column 7 of that Part;
(i) any UV filter listed in column 2 of Schedule 7 unless -
(i) the requirements in columns 3 and 4 of Part I of that Schedule in relation to that UV filter are satisfied; or
(ii) the requirements in columns 3 and 4 of Part II of that Schedule in relation to that UV filter are satisfied and the UV filter in question is supplied on or before the date specified in column 6 of that Part; or
(j) any UV filter which is not listed in Schedule 7.
(3) Subject to paragraphs (4) to (6) below, no person shall supply a cosmetic product which contains any of the substances designated as a specified risk material in Annex V to Regulation (EC) No. 999/2001 of the European Parliament and of the Council[10], or any ingredient derived from any of those substances.
(4) For the purposes of paragraph (3) above, no account shall be taken of any substance referred to in that paragraph which is present in the cosmetic product only as a trace which could not reasonably have been removed during or after manufacture.
(5) Paragraph (3) above shall not prohibit the supply of a cosmetic product which contains any tallow derivative so long as the relevant method set out in Schedule 8 was used in the manufacture of that derivative and the manufacturer of the derivative has certified that that method was used in its manufacture.
(6) Paragraph (3) above shall not prohibit the supply of any cosmetic product which contains any substance or ingredient referred to in that paragraph but which was manufactured before 1st April 1998.
(7) No person shall supply a cosmetic product which contains any ingredients or combinations of ingredients which are tested on animals where such testing took place after 30th June 2002 and was undertaken in order that the cosmetic product may satisfy any requirements of these Regulations.
(8) Any reference to testing on animals in the labelling, putting up for sale or advertising of a cosmetic product must state clearly whether the tests carried out involved the cosmetic product itself or its ingredients.
(9) No person shall supply any cosmetic product in respect of which the requirements of paragraph (8) above are not satisfied.
Authorisation by the Secretary of State
6. - (1) The Secretary of State may authorise the use in a cosmetic product for a maximum period of three years of a particular substance, not being a substance or ingredient referred to in regulation 5(3) or a substance listed in Schedule 3 or 4.
(2) In giving an authorisation the Secretary of State may impose conditions relating to the use of a particular substance in a cosmetic product, and such conditions may relate to any matter which the Secretary of State considers appropriate including -
(a) the purpose of the substance;
(b) the type of cosmetic product;
(c) the maximum concentration of the substance in any cosmetic product; and
(d) information and marking requirements.
(3) The Secretary of State may on reasonable notice vary or revoke any authorisation given under paragraph (1) above.
(4) On giving, varying or revoking an authorisation, the Secretary of State shall arrange for the authorisation, variation or revocation, as the case may be, to be published in such manner as she considers appropriate for bringing it to the attention of persons who, in her opinion, would be likely to have an interest in it.
(5) No person shall be convicted of an offence under section 12 of the 1987 Act by reason of a cosmetic product containing a particular substance provided that at the time when but for this regulation an offence would have been committed -
(a) the use of that particular substance in that cosmetic product was duly authorised; and
(b) all of the conditions imposed by the authorisation were complied with.
Marking
7. - (1) Subject to paragraphs (5)(b) and (9) to (12) below, no person shall supply a cosmetic product unless the packaging in which it is supplied bears, in lettering which is visible, indelible and easily legible, a list of its cosmetic ingredients (preceded by the word "ingredients") in descending order of weight, the weight to be determined at the time the ingredients are added to the product.
(2) Subject to paragraphs (3), (4), (5)(a), (6) to (8), (13) and (14) below, no person shall supply a cosmetic product unless the container and packaging in which it is supplied bear the following particulars in lettering which is visible, indelible and easily legible -
(a) the name or trade name and the address or registered office of the manufacturer of the product or of the supplier thereof, being a manufacturer or supplier established within a Member State of the Community;
(b) in the case of a cosmetic product likely within 30 months from the manufacture thereof to cease either to comply with the requirements of regulation 4 or to fulfil the purpose for which it was intended, the words "Best before..." immediately followed by -
(i) the earliest date on which it is likely to so cease; or
(ii) an indication of where that date appears on the labelling,
and any particular precautions to be observed to ensure that the product does not so cease before that date;
(c) in the case of a cosmetic product containing a substance listed in column 2 of Schedule 4, the information specified in column 6 of that Schedule in relation to that substance;
(d) in the case of a cosmetic product containing a preservative listed in column 2 of Schedule 6, the information specified in column 6 of that Schedule in relation to that preservative;
(e) in the case of a cosmetic product containing a UV filter listed in column 2 of Schedule 7, the information specified in column 5 of that Schedule in relation to that UV filter;
(f) any particular precautions to be observed in use and any special precautionary information on a cosmetic product for professional use, in particular in hairdressing (not being precautions included in the information referred to in sub-paragraphs (b), (c), (d) and (e) above);
(g) a means of identifying the batch in which the product was manufactured (or, if the product was not manufactured in a batch, a reference from which the date and place of manufacture can be identified); and
(h) the function of the product unless this is clear from its presentation;
Provided that the requirements specified in sub-paragraphs (b) and (g) above need not be complied with in relation to a cosmetic product which is the subject of a market research experiment.
(3) The particulars referred to in paragraph (2)(a) above may be abbreviated if such abbreviation does not prevent the person concerned from being identified.
(4) The date referred to in paragraph (2)(b) above shall include the month and the year, and the month shall precede the year.
(5) The particulars referred to -
(a) in paragraph (2)(b) to (f) and (h) above shall be in English, but this shall not prohibit the additional use of other languages;
(b) in paragraph (1) above shall be in language easily understood by the consumer.
(6) Where it is impossible for practical reasons for the particulars referred to in paragraph (2)(c) to (f) above to appear on the container and packaging, they shall appear on a leaflet, label, tag, tape or card enclosed with the cosmetic product, to which the consumer is referred either by abbreviated information or by the symbol given in Schedule 9, which must appear on the container and packaging; and where it is impracticable for reasons of size or shape for the particulars so to appear, they shall appear on a label, tag, tape or card attached to the product.
(7) Where it is impossible, for reasons of size, for the particulars referred to in paragraph (2)(g) above to appear on the container and packaging, the said particulars shall appear on the packaging.
(8) In the case of a supply of soap which is not in a container, either the soap itself or the packaging in which it is exposed for supply or the container in which it was last contained before the supply shall bear the particulars referred to in paragraph (2)(a) and (g) above, and in so far as any of the particulars referred to in paragraph (2)(b) to (f) and (h) above are required they shall appear on a leaflet which shall be delivered to the buyer with the soap; and where either of the particulars referred to in paragraph (2)(a) and (g) above appears on the soap itself the requirement of indelibility shall apply only until it has been put into use.
(9) In relation to the compilation of the list of ingredients referred to in paragraph (1) above -
(a) the following shall not be regarded as cosmetic ingredients -
(i) impurities in the raw materials used;
(ii) subsidiary technical materials used in the preparation of the cosmetic product but not present in the final product;
(iii) materials used in strictly necessary quantities as solvents or as carriers for perfumes and aromatic compositions;
(b) perfume and aromatic compositions and their raw materials shall be referred to by the words "perfume" or "flavour";
(c) ingredients in concentrations of less than 1 per cent may be listed in any order after those in concentrations of 1 per cent or more;
(d) colouring agents may be listed in any order after the other ingredients, in accordance with the colour index number or denomination found in Schedule 5;
(e) for decorative cosmetic products marketed in several colour shades, all colouring agents used in the range may be listed, provided that the words "may contain" are added; and
(f) an ingredient shall be identified by the name provided for in the International Nomenclature of Cosmetic Ingredients (INCI) or, in the absence of such identification, by its chemical name, its CTFA name, its European Pharmacopoeia name, its International Non-proprietary Name (INN) as recommended by the World Health Organization, its EINECS, IUPAC or CAS identification reference or its colour index number[11].
(10) Subject to paragraph (11) below, where a cosmetic product has no packaging or it is impossible for practical reasons for the list of ingredients referred to in paragraph (1) above to appear on the packaging, the list shall appear on the container; and where a cosmetic product is supplied or delivered pursuant to any supply in neither a container nor packaging, the list shall appear on the container in which the product is exposed for supply or a notice in immediate proximity to that container.
(11) Subject to paragraph (12) below, where it is impossible for practical reasons for the list of ingredients referred to in paragraph (1) above to appear on the packaging or container of a cosmetic product, it shall appear on a leaflet, label, tag, tape or card enclosed with the product, to which the consumer is referred either by abbreviated information or by the symbol given in Schedule 9, which must appear on the packaging; and where it is impracticable for reasons of size or shape for the list so to appear, it shall appear on a label, tag, tape or card attached to the cosmetic product.
(12) In the case of soap, bathballs and other small products, where it is impracticable for reasons of size or shape for the list of ingredients referred to in paragraph (1) above to appear on an enclosed leaflet or on a label, tag, tape or card enclosed with or attached to the product, it shall appear on a notice in immediate proximity to the container in which the cosmetic product is exposed for sale.
(13) Where two or more cosmetic products are supplied together as a single item, each product being in a separate container and the containers being enclosed together in packaging which bears clear and conspicuous instructions to the effect that the products must be mixed together in specified proportions before use, the particulars referred to in paragraph (2)(c) to (f) above shall appear on an enclosed leaflet and an indication shall appear on both the containers and on the packaging referring the consumer to the information in the leaflet.
(14) Where a cosmetic product other than soap is supplied or delivered pursuant to a supply in neither a container nor packaging, the particulars referred to in paragraph (2) above shall appear on the container in which the product is exposed for supply or a notice in immediate proximity to that container.
Responsible Persons and Competent Authorities
8. - (1) For the purposes of regulations 9 (except regulation 9(3) and (4)), 10, 11 and 12 -
(a) "responsible person" means, in relation to a relevant cosmetic product,
(b) "competent authority" means a body responsible for requiring and receiving the information provided for in Articles 7.3, 7a.1 and 7a.4 of the Directive and granting and refusing requests for confidentiality pursuant to Article 4 of the Confidentiality Directive, and which is -
(i) a United Kingdom competent authority pursuant to paragraph (2) below; or
(ii) for the time being a competent authority of a Member State other than the United Kingdom, having been notified as a competent authority by the Member State concerned to the Commission pursuant to Articles 7.3 and 7a.5 of the Directive and Article 10 of the Confidentiality Directive.
(2) The United Kingdom competent authority shall be the Secretary of State provided that she may from time to time appoint such persons as she thinks fit to be a United Kingdom competent authority in addition to or in substitution for herself.
Product Information
9. - (1) Subject to paragraph (6) below, where a cosmetic product is manufactured or supplied in the United Kingdom a responsible person shall for control purposes keep readily accessible to a United Kingdom competent authority at the address or registered office specified on the container or packaging of the cosmetic product in accordance with regulation 7(2)(a) above the following information -
(a) the qualitative and quantitative composition of the product, except to the extent that the product is composed of any perfume or perfume composition, in which case the responsible person shall only be required to keep the name and code number of the perfume or perfume composition and the identity of the supplier;
(b) the physico-chemical and microbiological specifications of the raw materials and the finished product and the purity and microbiological control criteria of the cosmetic product;
(c) the method of manufacture which shall be in accordance with good manufacturing practice, that is to say that the cosmetic product shall be manufactured in such a way that under normal and reasonably foreseeable conditions of use it shall not endanger human health or safety;
(d) assessment of the safety for human health of the finished product taking into consideration the general toxicological profile of each ingredient used, its chemical structure and its level of exposure;
(e) the name and address of the person or persons, qualified in accordance with paragraph (3) below, responsible for the assessment referred to in sub-paragraph (d) above;
(f) existing data on undesirable effects on human health resulting from use of the cosmetic product; and
(g) proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product.
(2) The assessment referred to in paragraph (1)(d) above shall be carried out in accordance with the principles of good laboratory practice referred to in Article 1 of Council Directive 87/18/EEC[12] on the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances.
(3) The person referred to in paragraph (1)(e) above must be -
(a) subject to paragraph (4) below, the holder of an appropriate European diploma within the meaning of section 4A of the Pharmacy Act 1954[13] or any other person who has the right, granted by a competent authority in a Member State, to take up and pursue the activities of a pharmaceutical chemist;
(b) subject to paragraph (4) below, a person who is entitled to be registered under section 3(1) of the Medical Act 1983[14] as a fully registered medical practitioner and who has the right, granted by a competent authority in a Member State, to take up and pursue the activities of a doctor; or
(c) the holder of a diploma within the meaning of regulation 2(1) of the European Communities (Recognition of Professional Qualifications) Regulations 1991[15] showing that the holder has the qualifications required to practise as a chartered biologist or that he has the qualifications required to practise as a chartered chemist or that he has the qualifications required to practise a profession equivalent to the profession of chartered biologist or chartered chemist in a Member State other than the United Kingdom.
(4) Any diploma or other evidence of qualification required for the purposes of paragraph (3)(a) or (b) above shall satisfy that requirement only if -
(a) the education and training attested were received mainly within the European Community; or
(b) the holder has spent at least three years in lawful pursuit in a Member State of the relevant profession, and such professional experience has been certified by a competent authority in a Member State (being a State which recognised a diploma or other evidence of qualification obtained in a non-Member State).
(5) Where the responsible person is the manufacturer or the person who first imports the cosmetic product into the Community he must possess appropriate experience or an appropriate level of professional qualification in accordance with the legislation and practice of the United Kingdom if it is the place of manufacture or first importation.
(6) Where the manufacturer manufactures a cosmetic product at two or more places within the Community, and one of those places is within the United Kingdom, the responsible person may choose a single place of manufacture within the Community where the information referred to in paragraph (1) above will be kept available, provided that, if requested by a United Kingdom competent authority, he informs the said authority of the location at which the said information is to be kept.
(7) Where the information referred to in paragraph (1) above is to be kept accessible to a United Kingdom competent authority it must be in English or a language readily understood by the said authority.
10.Where the place of manufacture or initial importation into the Community of a type of cosmetic product is within the United Kingdom, the responsible person shall notify a United Kingdom competent authority of the address of the place of manufacture or, as the case may be, initial importation into the Community of that type of cosmetic product before its first supply in the Community.
11. - (1) A United Kingdom competent authority may, where difficulties are encountered in providing prompt and appropriate medical treatment, require that any holder of appropriate and adequate information on substances used in cosmetic products make such information available to it, where the difficulties referred to may be overcome or eased by the provision of the said information.
(2) Where the information referred to in paragraph (1) above is made available, the United Kingdom competent authority shall ensure that it is used solely for the purposes of the treatment referred to in paragraph (1) above.
12. - (1) Without prejudice to the provisions of regulations 4, 5, 9 and 11, a responsible person who for reasons of trade secrecy wishes not to include one or more cosmetic ingredients in the list of cosmetic ingredients referred to in regulation 7(1) above shall submit a request to that effect to the competent authority.
(2) In this regulation, "applicant" means a responsible person who submits a request for confidentiality.
(3) The applicant shall ensure that -
(a) the request for confidentiality includes the particulars laid down in Part I of Schedule 10; and
(b) any amendments to the particulars provided for in sub-paragraph (a) above are communicated as quickly as possible to the competent authority and, in particular, that all changes to the names of cosmetic products containing the cosmetic ingredient in respect of which confidentiality is or has been sought, are communicated to the competent authority at least 15 days before those cosmetic products are supplied under their new name.
(4) Within four months of the receipt of a request for confidentiality in respect of which the requirements of paragraph (3)(a) above are satisfied, the competent authority shall examine the request and inform the applicant in writing of its decision.
(5) If the competent authority decides to grant its approval to the applicant's request it shall, in notifying the applicant of its decision, in accordance with paragraph (4) above, also notify him of the registration number which will replace the cosmetic ingredient in question in the list referred to in regulation 7(1), the said number to be allocated to the product in accordance with the procedure provided for in Part II of Schedule 10.
(6) If the competent authority decides to refuse to grant its approval to the applicant's request it shall, in its notification of this refusal, include a statement of the reasons for refusal and a clear explanation of appeals procedures and their time limits.
(7) In exceptional cases the competent authority may inform the applicant in writing that a period of two months in addition to the four-month period referred to in paragraph (4) above is required for the examination of the request.
(8) Subject to paragraphs (9), (10), (11) and (12) below, a decision granting confidentiality shall be valid for a period of five years.
(9) An applicant may, by submitting a reasoned request to the competent authority, request that the period of confidentiality referred to in paragraph (8) above be extended.
(10) In the event of a reasoned request being submitted in accordance with paragraph (9) above, the competent authority shall deal with the request in accordance with paragraphs (4), (5) and (6) above.
(11) Any extension of the period of confidentiality shall not exceed three years.
(12) The competent authority may withdraw its approval to an applicant's request for confidentiality if it considers this appropriate taking into account -
(a) any amendments to the particulars provided for in paragraph (3)(a) above which are communicated to it in accordance with paragraph (3)(b) above; and
(b) any new information which comes to its attention which makes it imperative, particularly for compelling reasons of public health, for it to so act,
and in withdrawing its approval the competent authority shall comply with the provisions of paragraphs (4), (6) and (7) above.
Contravention of regulation 9, 10 or 11
13. - (1) Subject to paragraph (2) below, any contravention of a requirement of regulation 9, 10 or 11 shall be treated for all purposes as though it were a contravention of a requirement of safety regulations made under section 11 of the 1987 Act.
(2) The term of imprisonment to which a person guilty of an offence of contravening any requirement of regulation 9, 10 or 11 shall be liable on summary conviction shall not exceed three months.
Enforcement
14. - (1) No proceedings shall be brought and no enforcement action taken in respect of -
(a) any failure to comply with regulations 4, 5, 7, 9, 10 and 11 in any case in which the cosmetic product is supplied for the purposes of exporting that product to any country which is not a Member State; or
(b) any failure to comply with regulation 7(5)(a) in any case in which the enforcement authority is satisfied that the person supplying the cosmetic product reasonably believes that it will not be used in the United Kingdom.
(2) No proceedings shall be brought and no enforcement action taken in respect of any failure to comply with regulations 5(8), 5(9), 7(1), 7(2)(h), 7(5)(a) (in so far as it relates only to regulation 7(2)(h)), 7(5)(b), 7(6), 7(7) or 7(9) to (12) in the case of -
(a) any supply of a cosmetic product before 31st December 1997 by the manufacturer in or importer into the United Kingdom or, in relation to a cosmetic product manufactured or imported into the United Kingdom on behalf of another person, by that other person, except for a supply by retail in which case no proceedings shall be brought and no enforcement action taken in respect of a supply before 31st December 1998; or
(b) any other supply of a cosmetic product before 31st December 1998.
(3) For the purposes of this regulation, "enforcement action" means any action taken pursuant to or in connection with sections 13, 14, 16, 17, 28, 29, 30 or 31 of the 1987 Act.
15.Any test of goods purchased under section 28 or seized under section 29 of the 1987 Act (which relate to enforcement) by or on behalf of an enforcement authority for the purpose of ascertaining whether the provisions of these Regulations have been contravened shall in all cases be carried out in accordance with the provisions of paragraphs 2 to 5 of Schedule 11 and any test for which a method is specified in paragraph 6 of Schedule 11 shall be carried out in accordance with that method.
Melanie Johnson,
Parliamentary Under Secretary of State for Competition, Consumers and Markets, Department of Trade and Industry
20th March 2003
SCHEDULE 1Regulation 2 REVOCATIONS
| (1) | (2) | | Regulations revoked | References | | The Cosmetic Products (Safety) Regulations 1996 | S.I. 1996/2925 | | The Cosmetic Products (Safety) (Amendment) Regulations 1997 | S.I. 1997/2914 | | The Cosmetic Products (Safety) (Amendment) Regulations 1998 | S.I. 1998/1727 | | The Cosmetic Products (Safety) (Amendment) Regulations 1999 | S.I. 1999/1552 | | The Cosmetic Products (Safety) (Amendment) Regulations 2000 | S.I. 2000/1679 | | The Cosmetic Products (Safety) (Amendment) (No. 2) Regulations 2000 | S.I. 2000/2765 |
SCHEDULE 2Regulation 3(1) COMMUNITY INSTRUMENTS AMENDING COUNCIL DIRECTIVE76/768/EEC 1.Council Directive 82/368/EEC (O.J. No. L167, 15.6.82, p. 1). 2.Commission Directive 82/147/EEC (O.J. No. L63, 6.3.82, p. 26). 3.Commission Directive 83/191/EEC (O.J. No. L109, 26.4.83, p. 25). 4.Commission Directive 83/341/EEC (O.J. No. L188, 13.7.83, p. 15). 5.Council Directive 83/574/EEC (O.J. No. L332, 28.11.83, p. 38). 6.Commission Directive 83/496/EEC (O.J. No. L275, 8.10.83, p. 20). 7.Commission Directive 84/415/EEC (O.J. No. L228, 25.8.84, p. 31). 8.Commission Directive 85/391/EEC (O.J. No. L224, 22.8.85, p. 40). 9.Commission Directive 86/179/EEC (O.J. No. L138, 24.5.86, p. 40). 10.Commission Directive 86/199/EEC (O.J. No. L149, 3.6.86, p. 38). 11.Commission Directive 87/137/EEC (O.J. No. L56, 26.2.87, p. 20). 12.Commission Directive 88/233/EEC (O.J. No. L105, 26.4.88, p. 11). 13.Council Directive 88/667/EEC (O.J. No. L382, 31.12.88, p. 46). 14.Commission Directive 89/174/EEC (O.J. No. L64, 8.3.89, p. 10). 15.Council Directive 89/679/EEC (O.J. No. L398, 30.12.89, p. 25). 16.Commission Directive 90/121/EEC (O.J. No. L71, 17.3.90, p. 40). 17.Commission Directive 91/184/EEC (O.J. No. L91, 12.4.91, p. 59). 18.Commission Directive 92/8/EEC (O.J. No. L70, 17.3.92, p. 23). 19.Commission Directive 92/86/EEC (O.J. No. L325, 11.11.92, p. 18). 20.Commission Directive 93/47/EEC (O.J. No. L203, 13.8.93, p. 24). 21.Council Directive 93/35/EEC (O.J. No. L151, 23.6.93, p. 32). 22.Commission Directive 94/32/EC (O.J. No. L181, 15.7.94, p. 31). 23.Commission Directive 95/34/EC (O.J. No. L167, 18.7.95, p. 19). 24.Commission Directive 96/41/EC (O.J. No. L198, 8.8.96, p. 36). 25.Commission Directive 97/18/EC (O.J. No. L114, 1.5.97, p. 43). 26.Commission Directive 97/45/EC (O.J. No. L196, 24.7.97, p. 77). 27.Commission Directive 98/16/EC (O.J. No. L77, 14.3.98, p. 44). 28.Commission Directive 98/62/EC (O.J. No. L253, 15.9.98, p. 20). 29.Commission Directive 2000/6/EC (O.J. No. L56, 1.3.00, p. 42). 30.Commission Directive 2000/11/EC (O.J. No. L65, 14.3.00, p. 22). 31.Commission Directive 2000/41/EC (O.J. No. L145, 20.6.00, p. 25). 32.Commission Directive 2002/34/EC (O.J. No. L102, 18.4.02, p. 19). 33.Commission Directive 2003/1/EC (O.J. No. L5, 10.1.03, p. 14). 34.Commission Directive 2003/16/EC (O.J. No. L46, 20.2.03, p. 24). SCHEDULE 3Regulations 5(2) and 6(1) LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAINThe alphabetical list set out in column 2 of this Schedule contains one or more of the names of each of the substances referred to in regulation 5(2); in certain cases a name is given of a group of substances, the names of particular examples of which are also given, and in such a case all substances comprised in the group are included, whether or not more specifically named. The numbers given in columns 1, 3 and 4 are for information only. Those in column 3 are cross-references to other names listed for the same substances (except that where a name is that of a group of substances, the cross-references are to particular examples of that group, and any cross-reference in parenthesis is to the name of a group of substances within which the particular substance falls). Those in column 4 are cross-references to Annex II of the Directive, from which this Schedule is derived. PART ISUBSTANCES PROHIBITED WHEN USED OTHER THAN AS A FRAGRANCE INGREDIENT
| (1) | (2) | (3) | (4) | | Number in this Schedule | Name of substance | Cross-reference to this Schedule | Cross-reference to Annex II of the Directive | | 1 | Acenocoumarol (INN) | 397 | 254 | | 2 | Acetonitrile | - | 393 | | 3 | 3-(a-Acetonylbenzyl)-4-hydroxycoumarin and its salts | 399, 762 | 203 | | 4 | 2-Acetoxyethyltrimethylammonium hydroxide and its salts | 6 | 2 | | 5 | 2-Acetylamino-5-chlorobenzoxazole | 163 | 1 | | 6 | Acetylcholine and its salts | 4 | 2 | | 7 | Acetylene chlorides | 250, 759 | 126 | | 8 | Acetylenic alcohols, their esters, ethers and salts | 17 | 16 | | 9 | Acetylethyltetramethyltetralin (AETT) | 342 | 362 | | 10 | 7a-Acetylthio-3-oxopregn-4-ene-17a,17β-propionolactone | 652 | 4 | | 11 | Aconitine and its salts | - | 12 | | 12 | Aconitum napellus L. (leaves, roots and galenical preparations) | - | 11 | | 13 | Adonis vernalis L. and its preparations | - | 13 | | 14 | Adrenaline | 270. 315 | 14 | | 15 | Alkali pentacyanonitrosylferrate(2-) | 605-6, 647-8, | 255 | | 16 | O-Alkyldithiocarbonic acids, salts of | 763 | 336 | | 17 | Alkyne alcohols, their esters, ethers and salts | 8 | 16 | | 18 | Alloclamide (INN) and its salts | 22 | 19 | | 19 | Allyl isothiocyanate | - | 18 | | 20 | 2-(4-Allyl-2-methoxyphenoxy)-N,N-diethylacetamide and its salts | - | 224 | | 21 | N-Allylnormorphine, its salts and ethers | 494 | 20 | | 22 | 2-Allyloxy-4-chloro-N-[2-(diethylamino)-ethyl]benzamide and its salts | 18 | 19 | | 23 | Alypine and its salts | 45, 107 | 143 | | 24 | Ambenonium chloride (INN) | (529) | 132 | | 25 | 4-(or p-)Aminobenzoic acid esters | - | 167 | | 26 | 2-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts | - | 29 | | 27 | Aminocaproic acid (INN) and its salts | 31 | 7 | | 28 | 2-Amino-5-chlorobenzoxazole | 769 | 24 | | 29 | 4-Amino-N-(2-diethylaniaminoethyl)benzamide, its salts and derivatives | 610 | 25 | | 30 | Aminoheptane, its isomers and salts | 751 | 25 | | 31 | 6-Aminohexanoic acid and its salts | 27 | 7 | | 32 | a-(Aminomethyl)-3,4-dihydroxybenzyl alcohol and its salts | 519-520 | 257 | | 33 | 4-Amino-N10-methylfolic acid | 452 | 6 | | 34 | 2-Amino-6-methylheptane and its salts | 288, 525 | 28 | | 35 | 2-Amino-4-methylhexane and its salts | 289, 471 | 30 | | 36 | 2-Amino-4-nitrophenol | - | 383 | | 37 | 2-Amino-5-nitrophenol | - | 384 | | 38 | 4-Amino-2-nitrophenol | - | 412 | | 39 | 4-(or p-)Aminosalicylic acid and its salts | - | 31 | | 40 | Aminotoluenes, their isomers, salts and halogenated and sulphonated derivatives | 719 | 32 | | 41 | Aminoxylenes, their isomers, salts and halogenated and sulphonated derivatives | 765 | 33 | | 42 | Amitriptyline (INN) and its salts | 284 | 146 | | 43 | Ammi majus and its galenical preparations | - | 35 | | 44 | Amphetamine (INN), its salts and derivatives and salts of those derivatives | (681) | 21 | | 45 | Amydricaine and its salts | 23, 107 | 143 | | 46 | Amylene chloride | 251 | 36 | | 47 | Amyl 4-dimethylaminobenzoate, mixed isomers | 534 | 381 | | 48 | Amyl nitrites | - | 247 | | 49 | Amylobarbitone and its salts | (69) | 220 | | 50 | Amylocaine and its salts | 282 | 50 | | 51 | Anamirta cocculus L. (fruit) | - | 106 | | 52 | Substances with androgenic effect | - | 37 | | 53 | Aniline, its salts and halogenated and sulphonated derivatives | - | 22 | | 54 | Anthracene oil | - | 38 | | 55 | Anti-androgens with steroid structure | - | 390 | | 56 | Antibiotics | - | 39 | | 57 | Antimony and its compounds | - | 40 | | 58 | Apocynum cannabinum L. and its preparations | - | 41 | | 59 | Apomorphine and its salts | 697 | 42 | | 60 | Apronalide | 420 | 216 | | 61 | Arecoline | 482 | 238 | | 62 | Aristolochic acid and its salts | - | 365 | | 63 | Arsenic and its preparations | - | 43 | | 64 | Atropa belladonna L. and its preparations | - | 44 | | 65 | Atropine, its salts and derivatives | - | 45 | | 66 | Azacyclonol (INN) and its salts | 305 | 286 | | 67 | Azamethonium bromide (INN) | (473) | 121 | | 68 | Barbitone and its salts | (69) | 220 | | 69 | Barbiturates | various | 220 | | 70 | Barium salts (except barium sulphate, barium sulphide under the condition laid down in Part I of Schedule 4 for alkaline earth sulphides, and lakes, salts and pigments prepared from those colouring agents identified in column 1 of Schedule 5 by "*" immediately after the name or colour index number) | - | 46 | | 71 | Bemegride (INN) and its salts | 337, 338 | 183 | | 72 | Benactyzine (INN) | 258 | 157 | | 73 | Bendrofluazide and its derivatives | 74, 89 | 53 | | 74 | Bendroflumethiazide (INN) and its derivatives | 73, 89 | 53 | | 75 | Benzamine and its salts | 744 | 51 | | 76 | Benzatropine (INN) and its salts | 301 | 158 | | 77 | Benzazepines, their salts and derivatives | 88 | 49 | | 78 | Benzene | - | 47 | | 79 | Benzene-1,2-diol | 152, 630 | 408 | | 80 | Benzene-1,2,3-triol | 631 | 409 | | 81 | 2-Benzhydryloxyethyldimethylamine and its salts | 296 | 339 | | 82 | Benzidine | 243 | 26 | | 83 | Benzilonium bromide (INN) | 93 | 60 | | 84 | 2-Benziloyloxymethyl-1,1-dimethylpyrrolidinium methyl sulphate | 602 | 239 | | 85 | Benzimidazolone | 86, 267 | 48 | | 86 | Benzimidazol-2(3H)-one | 85, 267 | 48 | | 87 | Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol (except natural content of essences) | 211 | 357 | | 88 | Benzodiazepines, their salts and derivatives | 77 | 49 | | 89 | Benzothiadiazine and its derivatives | 73, 74 | 53 | | 90 | Benzoyl peroxide | - | 382 | | 91 | 3-(N-Benzylhydrazinocarbonyl)-5-methylisoxazole | 415 | 52 | | 92 | Benzylideneacetone | 567 | 356 | | 93 | 3-Benzyloxy-1,1-diethylpyrrolidine hydrobromide | 83 | 60 | | 94 | 4-Benzyloxyphenol | (391), 487 | 178 | | 95 | 2-[Benzyl-N-2-pyridyl)amino]-ethyldimethylamine | 626, 748 | 347 | | 96 | Bergapten(e) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg | (357) | 358 | | 97 | Beryllium and its compounds | - | 54 | | 98 | Betamethasone (INN) | (361) | 300 | | 99 | Betoxycaine (INN) and its salts | 257 | 23 | | 100 | BHC (ISO) (gamma-BHC) | 370, 372, 428 | 195 | | 101 | Bietamiverine (INN) | 261 | 287 | | 102 | 1,6-Bis(2-chloroethylamino)-1,6-dideoxymannitol and its salts | 436 | 89 | | 103 | 2-[Bis(2-chloroethyl)amino]-l-oxa-3-aza-2- phosphacyclohexane 2-oxide and its salts | 106, 231 | 88 | | 104 | N,N-Bis(2-chloroethyl)methylamine and its salts | 159, 492 | 87 | | 105 | N,N-Bis(2-chloroethyl)methylamine N-oxide and its salts | 493 | 86 | | 106 | N,N-Bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-ylamine P-oxide and its salts | 103, 231 | 88 | | 107 | 1,1-Bis(dimethylaminomethyl)propyl benzoate and its salts | 23, 45 | 143 | | 108 | Bis(hydroxyalkyl)amines, not further N-substituted | 255, 274, 643 | 411 | | 109 | 2,2-Bis(hydroxymethyl)butan-l-ol trinitrate | 616 | 206 | | 110 | 2,6-Bis(β-hydroxyphenethyl)-1-methylpiperidine and its salts | 430 | 219 | | 111 | 3,3-Bis(4-hydroxyphenyl)phthalide | 560 | 417 | | 112 | Bis(8-hydroxyquinolinium) sulphate, except for the uses provided for in entry number 51 in Part 1 of Schedule 4 | (401, 533) | 395 | | 113 | Bithionol (INN) | 708 | 352 | | 114 | Bretylium tosilate (INN) (Bretylium tosylate) | 117 | 56 | | 115 | Bromine, elemental | - | 55 | | 116 | Bromisoval (INN) | 119 | 58 | | 117 | p-Bromobenzylethyldimethylammonium
p-toluenesulphonate
| 114
| 56
| | 118 | 2-Bromo-2-ethylbutyrylurea | 148 | 57 | | 119 | 2-Bromo-3-methylbutylrylurea | 116 | 58 | | 120 | 1-p-Bromophenyl-l-(2-pyridyl)-3-dimethylaminopropane and its salts | 121 | 59 | | 121 | Brompheniramine (INN) and its salts | 120 | 59 | | 122 | Brucine | - | 62 | | 123 | Butanilicaine (INN) and its salts | 466 | 90 | | 124 | Butobarbitone and its salts | (69) | 220 | | 125 | Butopiprine (INN) and its salts | 127 | 288 | | 126 | 2-Butoxy-N-(2-diethylaminoethyl)-cinchoninamide and its salts | 190 | 129 | | 127 | 2-Butoxyethyl phenyl(piperidino)acetate and its salts | 125 | 288 | | 128 | 1-Butyl-3-(N-crotonoylsulphanilyl)urea | - | 108 | | 129 | 4-Butyl-1,2-diphenylpyrazolidine-3,5-dione | 566 | 67 | | 130 | 4-tert-Butyl-3-methoxy-2,6-dinitrotoluene | 490 | 414 | | 131 | 4-Butyl-1-phenylpyrazolidine-3,5-dione | 486 | 64 | | 132 | 1-Butyl-3-(p-methylbenzenesulphonyl)urea | 718 | 65 | | 133 | 1-Butyl-3-sulphanilylurea | 149 | 66 | | 134 | 4-Butylthiobenzhydryl 2-(dimethylamino)ethyl sulphide | 142 | 140 | | 135 | 1-tert-Butyl-3,4,5-trimethyl-2,6-dinitrobenzene | 491 | 422 | | 136 | Cadmium and its compounds | - | 68 | | 137 | Calabar bean | 588 | 281 | | 138 | Calciferol | 317, (761) | 335 | | 139 | Cantharides, Cantharis vesicatoria | 650 | 69 | | 140 | Cantharidin | 379 | 70 | | 141 | Captan (ISO) | 737 | 370 | | 142 | Captodiame (INN) | 134 | 140 | | 143 | Caramiphen (INN) and its salts | 570 | 169 | | 144 | N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N- diisopropylmethylammonium salts | 419 | 156 | | 145 | Carbazole, nitroderivatives of | 510 | 72 | | 146 | Carbon disulphide | - | 73 | | 147 | Carbon tetrachloride | 693 | 315 | | 148 | Carbromal (INN) | 118 | 57 | | 149 | Carbutamide (INN) | 133 | 66 | | 150 | Carisoprodol (INN) | 480 | 235 | | 151 | Catalase | - | 74 | | 152 | Catechol | 79, 630 | 408 | | 153 | Cells, tissues or products of human origin | - | 416 | | 154 | Cephaeline and its salts | - | 75 | | 155 | Chenopodium ambrosioides (essential oil) | - | 76 | | 156 | Cherry laurel water | 621 | 291 | | 157 | Chloral hydrate | 735 | 77 | | 158 | Chlorine | - | 78 | | 159 | Chlormethine (INN) and its salts | 104, 492 | 87 | | 160 | Chlormezanone (INN) | 174 | 91 | | 161 | 4-Chlorobenzene-1,3-disulfonamide | 193 | 85 | | 162 | 5-Chloro-1,3-benzoxazol-2(3H)-one | 185 | 82 | | 163 | N-5-Chlorobenzoxazol-2-ylacetamide | 5 | 1 | | 164 | 2-Chloro-4-dimethylamino-6-methylpyrimidine | 168, 216, | 83 | | 165 | 2-Chloro-9-[3-(dimethylamino)-propylidene]thioxanthene (cis-form) and its salts | 182 | 84 | | 166 | Chloroethane | 328 | 96 | | 167 | Chloroform | 736 | 366 | | 168 | 2-Chloro-6-methylpyrimidin-4-yldimethylamine | 164, 216 | 83 | | 169 | Chlorophacinone (ISO) | 175 | 93 | | 170 | 1-(p-Chloro-∝-phenylbenzyl)-4-(2-hydroxyethoxyethyl)piperazine | 402 | 240 | | 171 | 2-(4-Chlorophenyl)-1-[4-(2-diethyl aminoethoxyl)] phenyl-1-p-tolylethanol | 747 | 92 | | 172 | 4-[4-(4-Chlorophenyl)-4-hydroxypiperidin-l-yl]-1-(4-fluorophenyl)butan-1-one | 369 | 185 | | 173 | 2-(4-Chlorophenyl)-3-methylbutane-2,3-diol | 554 | 95 | | 174 | 2-(4-Chlorophenyl-3-methyl-1,3-thiazinan-4-one1,1-dioxide | 160 | 91 | | 175 | 2[2-(4-Chlorophenyl)-2-phenylacetyl]indane-1,3-dione | 169 | 93 | | 176 | 2-[1-(4-Chlorophenyl)-1-phenylethoxy]ethyl- (dimethyl)amine | 179 | 94 | | 177 | Chloropicrin | 738 | 325 | | 178 | 3-(4-Chloro-3-sulphamoylphenyl)-3- hydroxyisoindolin-1-one | 183, 184 | 262 | | 179 | Chlorphenoxamine (INN) | 176 | 94 | | 180 | Chlorpromazine (INN) | (561) | 320 | | 181 | Chlorpropamide (INN) | 617 | 79 | | 182 | Chlorprothixene (INN) and its salts | 165 | 84 | | 183 | Chlortalidone (INN) | 178, 184 | 262 | | 184 | Chlorthalidone | 178, 184 | 262 | | 185 | Chlorzoxazone (INN) | 162 | 82 | | 186 | Cholecalciferol | (761) | 335 | | 187 | Choline salts and their esters | - | 168 | | 188 | Chromium, chromic acid and salts of the acid | - | 97 | | 189 | Chrysoidine citrate hydrochloride | 565 | 81 | | 190 | Cinchocaine (INN) and its salts | 126 | 129 | | 191 | Cincophen (INN), its salts and derivatives and salts of those derivatives | 580 | 8 | | 192 | Claviceps purpurea Tul., its alkaloids and galenical preparations | 318 | 98 | | 193 | Clofenamide (INN) | 161 | 85 | | 194 | Clofenotane (INN) | 734 | 123 | | 195 | Coal tar, crude and refined | 218 | 420 | | 196 | Cobalt benzenesulphonate | - | 101 | | 197 | Cocculin | 592 | 282 | | 198 | Colchicine, its salts and derivatives | - | 102 | | 199 | Colchicoside and its derivatives | - | 103 | | 200 | Colchicum autumnale L. and its galenical preparations | - | 104 | | 201 | Colouring agent CI 12075 and its lakes, pigments and salts | - | 397 | | 202 | Colouring agent CI 12140 | - | 378 | | 203 | Colouring agent CI 13065 | - | 387 | | 204 | Colouring agent CI 15585 | - | 401 | | 205 | Colouring agent CI 26105 | - | 379 | | 206 | Colouring agent CI 42535 | - | 388 | | 207 | Colouring agents CI 42555, 42555:1 and 42555:2 | - | 380 | | 208 | Colouring agent CI 42640 | - | 386 | | 209 | Colouring agent CI 45170 and CI 45170:1 | - | 398 | | 210 | Colouring agent CI 61554 | - | 389 | | 211 | Coniferyl benzoate (except natural content of essences) | 87 | 357 | | 212 | Coniine | 618 | 290 | | 213 | Conium maculatum L. (fruit, powder, galenical prep- parations) | - | 99 | | 214 | Convallatoxin | - | 105 | | 215 | Coumetarol (INN) | 454 | 225 | | 216 | Crimidine (ISO) | 164, 168 | 83 | | 217 | Croton tiglium (oil) | - | 107 | | 218 | Crude and refined coal tars | 195 | 420 | | 219 | Curare and curarine | - | 109 | | 220 | Curarizants, synthetic | - | 110 | | 221 | 1-(3-Cyano-3,3-diphenylpropyl)-4-ethoxycarbonyl-4-phenylpiperidinium chloride | 297 | 80 | | 222 | Cyclarbamate (INN) | 230 | 122 | | 223 | Cyclizine (INN) and its salts | 302 | 159 | | 224 | Cyclobarbitone and its salts | (69) | 220 | | 225 | Cyclocoumarol | 268 | 234 | | 226 | 2-a-Cyclohexylbenzyl(N,N,N',N'-tetraethyl)trimethylenediamine | 555 | 112 | | 227 | 2-Cyclohexyl-3,5-dimethylphenol and its salts | 229 | 113 | | 228 | Cyclohexyl-3-(p-methylbenzenesulphonyl)urea | 364 | 100 | | 229 | Cyclomenol (INN) and its salts | 227 | 113 | | 230 | Cyclopentane-1,1-dimethanol dicarbanilate | 222 | 122 | | 231 | Cyclophosphamide (INN) and its salts | 103, 106 | 88 | | 232 | Datura stramonium L. and its galenical preparations | 54 | 301 | | 233 | DDT (ISO) (pp'-DDT) | 194, 734 | 123 | | 234 | Deanol aceglumate (INN) | 279 | 3 | | 235 | Decamethonium bromide (INN) | (236) | 214 | | 236 | Decamethylenebis(trimethylammonium) salts | 235 | 214 | | 237 | Dextromethorphan (INN) and its salts | 457 | 226 | | 238 | Dextropropoxyphene (INN) | 281 | 116 | | 239 | O, O'-Diacetyl-N-allyl-N-normorphine | - | 117 | | 240 | 2,4-Diaminoanisole and its salts | 455, 461 | 376 | | 241 | 2,5-Diaminoanisole and its salts | 456, 460 | 377 | | 242 | 1,2-Diaminobenzene and its salts | 573 | 363 | | 243 | p,p'-Diaminodiphenyl | 82 | 26 | | 244 | 2-(2,4-Diaminophenyl)ethanol and its salts | - | 407 | | 245 | 1,4:3,6-Dianhydrosorbitol 2,5-dinitrate | 422 | 148 | | 246 | 5-(a,B-Dibromophenethyl)-5-methylhydantoin | - | 119 | | 247 | Dibromosalicylanilides | 248, 443 | 351 | | 248 | Dibromsalan (INN) | (247) | 351 | | 249 | Dichloroethanes | 330, 335 | 125 | | 250 | Dichloroethylenes | 7, 759 | 126 | | 251 | 2,3-Dichloro-2-methylbutane | 46 | 36 | | 252 | Dichlorosalicylanilides | - | 349 | | 253 | Dicoumarin | 254, 469 | 231 | | 254 | Dicoumarol (INN) | 253, 469 | 231 | | 255 | Diethanolamine | (108, 643) | 411 | | 256 | 2-(Diethylaminoethoxy)ethyla-phenylpiperidine-1-acetate dimethiodide | 601 | 137 | | 257 | 2-Diethylaminoethyl 3-amino-4-butoxybenzoate and its salts | 99 | 23 | | 258 | 2-Diethylaminoethyl benzilate | 72 | 157 | | 259 | 2-Diethylaminoethyl 4-ethoxybenzoate and its salts | 411, 538 | 179 | | 260 | 2-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts | - | 128 | | 261 | 2-Diethylaminoethyl phenyl(piperidino)acetate | 101 | 287 | | 262 | 3-Diethylaminopropyl cinnamate | - | 130 | | 263 | Diethyl 4-nitrophenyl phosphate | 536 | 170 | | 264 | O,O-Diethyl O-4-nitrophenyl phosphorothioate | 537 | 131 | | 265 | Difencloxazine (INN) | 569 | 270 | | 266 | Digitaline and all heterosides of Digitalis purpurea L. | - | 134 | | 267 | 4.5-Dihydrobenzimidazol-4-one | 85, 86 | 48 | | 268 | 3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano[3,2-c]-[1]-benzopyran-5-one | 225 | 234 | | 269 | Dihydrotachysterol (INN) | - | 342 | | 270 | 3,4-Dihydroxy-a-(methylaminomethyl)benzyl alcohol | 14, 315 | 14 | | 271 | 4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene)dicoumarin | - | 207 | | 272 | 1-(3,4-Dihydroxyphenyl)-2-ethylaminopropan-l-ol and its salts | 294 | 136 | | 273 | 1-(3,4-Dihydroxyphenyl)-2-isopropylaminoethanol | 418, 421 | 17 | | 274 | Diisopropanolamine | (108, 643) | 411 | | 275 | 5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite | 413 | 361 | | 276 | Dimethoxane | 286 | 368 | | 277 | 4-[2-(3,4-Dimethoxyphenyl)ethyl]-1-(2-chlorophenyl)piperazine and its salts | 438 | 141 | | 278 | Dimethylamine | - | 142 | | 279 | 2-Dimethylaminoethyl N-acetylglutamate | 234 | 3 | | 280 | 2-Dimethylaminoethyl p-butylaminobenzoate and its salts | 690 | 63 | | 281 | (+)-4-Dimethylamino-3-methyl-1,2-diphenyl-2-propionyloxybutane | 238 | 116 | | 282 | 1-Dimethylaminomethyl-1-methylpropyl benzoate and its salts | 50 | 50 | | 283 | 2-Dimethylaminopropiophenone and its salts | 445 | 145 | | 284 | 3-(3-Dimethylaminopropylidene)-1,2:4,5-dibenzocyclohepta-1,4-diene and its salts | 42 | 146 | | 285 | 1,1-Dimethylbiguanide and its salts | 447 | 147 | | 286 | 2,6-Dimethyl-1,3-dioxan-4-yl acetate | 276 | 368 | | 287 | Dimethylformamide | - | 355 | | 288 | 1,5-Dimethylhexylamine and its salts | 34, 525 | 28 | | 289 | 1,3-Dimethylpentylamine and its salts | 35, 471 | 30 | | 290 | Dimethyl sulfoxide (INN) | - | 338 | | 291 | Dimevamide (INN) and its salts | 298 | 153 | | 292 | Dinitrophenol isomers | - | 151 | | 293 | Dioxane | - | 343 | | 294 | Dioxethedrin (INN) and its salts | 272 | 136 | | 295 | 2,5-Dioxo-3,3-diethyl-5-methylpiperidine and its salts | 483 | 133 | | 296 | Diphenhydramine (INN) and its salts | 81 | 339 | | 297 | Diphenoxylate hydrochloride (INNM) | 221 | 80 | | 298 | 2,2-Diphenyl-4-dimethylaminovaleramide and its salts | 291 | 153 | | 299 | 5,5-Diphenyl-4-imidazolidone | - | 160 | | 300 | 4-Diphenylmethoxy-1-methylpiperidine and its salts | 306 | 154 | | 301 | 3-Diphenylmethoxytropane and its salts | 76 | 158 | | 302 | 1-Diphenylmethyl-4-methylpiperazine and its salts | 223 | 159 | | 303 | 1,2-Diphenyl-4-(2-phenylsulphinylethyl)-pyrazolidine-3,5-dione | 664 | 155 | | 304 | a,a-Diphenyl-2-piperidinemethanol and its salts | 600 | 285 | | 305 | a,a-Diphenyl-4-piperidinemethanol and its salts | 66 | 286 | | 306 | Diphenylpyraline (INN) and its salts | 300 | 154 | | 307 | 2,5-Dipropoxy-3,6-bis(ethyleneimino)-1,4- benzoquinone | 410 | 152 | | 308 | 4-Dipropylsulphamoylbenzoic acid | 609 | 161 | | 309 | Disulfiram (INN) | 702, 713 | 162 | | 310 | Dithio-2,2'-bis(pyridine 1-oxide) 1,1' (additive with trihydrated magnesium sulphate) | 628 | 396 | | 311 | Doxylamine (INN) and its salts | 579 | 176 | | 312 | Emetine, its salts and derivatives | - | 163 | | 313 | Endrin (ISO) | 373 | 196 | | 314 | Ephedrine and its salts | - | 164 | | 315 | Epinephrine (INN) | 14, 270 | 14 | | 316 | 1,2-Epoxybutane | - | 400 | | 317 | Ergocalciferol (INN) | 138 (761) | 335 | | 318 | Ergot and its alkaloids | 192 | 98 | | 319 | Eserine and its salts | 589 | 166 | | 320 | Ethionamide (INN) | 336 | 319 | | 321 | Ethoheptazine (INN) and its salts | 476 | 173 | | 322 | Ethopropazine and its salts | (561) | 320 | | 323 | 4-Ethoxyphenol | (391) | 178 | | 324 | 4-Ethoxy-m-phenylenediamine and its salts | - | 406 | | 325 | 2-Ethylamino-5-phenyloxazolin-4-one | 345 | 180 | | 326 | Ethyl bis(4-hydroxycoumarinyl)acetate and salts of the acid | 327 | 204 | | 327 | Ethyl bis(4-hydroxy-2-oxo-l-benzopyran-3-yl)acetate and salts of the acid | 326 | 204 | | 328 | Ethyl chloride | 166 | 96 | | 329 | Ethyl 1,3-dimethyl-4-phenylazepane-4-carboxylate and its salts | 446 | 171 | | 330 | Ethylene dichloride | (249) | 125 | | 331 | Ethylene oxide | - | 182 | | 332 | 2-Ethyl-2,3-epoxyhexamide and its derivatives | 530 | 165 | | 333 | Ethyl p-fluorophenyl sulphone | 348 | 189 | | 334 | Ethyl 1-(2-hydroxy-2-phenylethyl)-4- phenylpiperidine-4-carboxylate and its salts | 532 | 172 | | 335 | Ethylidene dichloride | (249) | 125 | | 336 | 3-Ethylisothionicotinamide | 320 | 319 | | 337 | 3-Ethyl-3-methylglutarimide and its salts | 71, 338 | 183 | | 338 | 4-Ethyl-4-methylpiperidine-2,6-dione and its salts | 71, 337 | 183 | | 339 | 2-Ethyl-3-methylvaleramide | 755 | 184 | | 340 | Ethylphenacemide | 556, 568 | 272 | | 341 | 2-Ethyl-2-phenylglutarimide and its salts | 362 | 181 | | 342 | 3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone | 9 | 362 | | 343 | Ethyl urocanate | (406) | 418 | | 344 | Fenadiazole (INN) | 528 | 208 | | 345 | Fenozolone (INN) | 325 | 180 | | 346 | Fenyramidol (INN) | 578, 582 | 274 | | 347 | Fluanisone (INN) | 351 | 187 | | 348 | Fluoresone (INN) | 333 | 189 | | 349 | 4'-Fluoro-4-[4-hydroxy-4-(a,a,a-trifluoro-m- tolyl)piperino]butyrophenone | 741 | 188 | | 350 | 6-Fluoro-16-methyl-11β,17∝,21-trihydroxypregna-1,4-diene-3,20-dione | 535 | 186 | | 351 | 1- (4-Fluorophenyl)-4-[4-(2-methoxyphenyl)-1- piperazinyl]butan-1-one | 347 | 187 | | 352 | 5-Fluoropyrimidine-2,4-dione | 353 | 190 | | 353 | Fluorouracil (INN) | 352 | 190 | | 354 | Fluphenazine (INN) | (561) | 320 | | 355 | Furazolidone (INN) | 513 | 252 | | 356 | Furfuryltrimethylammonium salts | 358 | 192 | | 357 | Furocoumarins (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg | 96, 462, 623, 746 | 358 | | 358 | Furtrethonium iodide (INN) | (356) | 192 | | 359 | Galantamine (INN) | - | 193 | | 360 | Gallamine triethiodide (INN) | 518 | 329 | | 361 | Glucocorticoids | 98 | 300 | | 362 | Glutethimide (INN) and its salts | 341 | 181 | | 363 | Glycerol trinitrate | 514, 615 | 253 | | 364 | Glycyclamide (INN) | 228 | 100 | | 365 | Gold salts | - | 296 | | 366 | Guaifenesin (INN) | 459 | 230 | | 367 | Guanethidine (INN) and its salts | 368 | 259 | | 368 | N-(2-Guanidinoethyl)azocane and its salts | 367 | 259 | | 369 | Haloperidol (INN) | 172 | 185 | | 370 | HCH (ISO) (gamma-HCH) | 100, 372, 428 | 195 | | 371 | HETP | 378 | 316 | | 372 | 1,2,3,4,5,6-Hexachlorocyclohexane | 100, 370, 428 | 195 | | 373 | (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4:5,8 dimethanonaphthalene | 313 | 196 | | 374 | Hexachloroethane | - | 197 | | 375 | 3,3',4,4',6,6'-Hexachloro-2,2'-methylenediphenol | 376 | 371 | | 376 | Hexachlorophene (INN) | 375 | 371 | | 377 | (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethanonaphthalene | 416 | 198 | | 378 | Hexaethyl tetraphosphate | 371 | 316 | | 379 | (1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride | 140 | 70 | | 380 | (3S,5aR,9bS)-3,3a,4,5,5a,9b-Hexahydro-3,5a,9-trimethylnaphtho[1,2-b]furan-2,8dione | 639 | 217 | | 381 | Hexamethonium bromide (INN) | (382) | 124 | | 382 | N-N'-Hexamethylenebis(trimethylammonium) salts | 381 | 124 | | 383 | Hexapropymate (INN) | 619 | 115 | | 384 | Hydrastine, hydrastinine and their salts | - | 199 | | 385 | Hydrazides and their salts | - | 200 | | 386 | Hydrazine, its derivatives and their salts | - | 201 | | 387 | 2-Hydrazino-octane and its salts | 523 | 202 | | 388 | Hydrocyanic acid and its salts | 390, 409, 604 | 111 | | 389 | Hydrofluoric acid, its normal salts, complexes and hydrofluorides (except those listed in Part I of Schedule 4) | - | 191 | | 390 | Hydrogen cyanide and its salts | 388, 409, 604 | 111 | | 391 | Hydroquinone monobenzyl, monoethyl and monomethyl ethers | 487 | 178 | | 392 | 7-[2-Hydroxy-3-(2-hydroxyethyl-N- methylamino)propyl]theophylline | 764 | 135 | | 393 | [4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl] acetic acid and its salts | 742 | 5 | | 394 | 3-[4-(4-Hydroxy-3-iodophenoxy)-3,5- diiodophenyl]propionic acid and its salts | 716 | 9 | | 395 | 2-Hydroxy-3-(2-methoxyphenyl)propyl carbamate | 450 | 205 | | 396 | 1-Hydroxymethyl-l-cyclohexylacetic acid, sodium salt | 646 | 114 | | 397 | 4-Hydroxy-3-[1-(4-nitrophenyl)-3-oxobutyl]coumarin | 1 | 254 | | 398 | 8-Hydroxy-5-nitroquinoline and its salts | 517 | 209 | | 399 | 4-Hydroxy-3-(3-oxo-l-phenylbutyl)coumarin and its salts | 3, 762 | 203 | | 400 | 11a-Hydroxypregn-4-ene-3,20-dione and its esters | - | 385 | | 401 | Hydroxy-8-quinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 4 | 112, 533, 633 | 395 | | 402 | Hydroxyzine (INN) | 170 | 240 | | 403 | Hyoscine, its salts and derivatives | 641 | 295 | | 404 | Hyoscyamine, its salts and derivatives | - | 210 | | 405 | Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations) | - | 211 | | 406 | 3-Imidazol-4-ylacrylic acid and its ethyl ester | 343, 753 | 418 | | 407 | 2-Imino-5-phenyloxazolidin-4-one and its salts | 540 | 212 | | 408 | Imperatorin | 465 | 34 | | 409 | Inorganic cyanides | (388, 390), 604 | 111 | | 410 | Inproquone (INN) | 307 | 152 | | 411 | Intracaine and its salts | 259, 538 | 179 | | 412 | Iodine | - | 213 | | 413 | Iodothymol | 275 | 361 | | 414 | Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations) | - | 215 | | 415 | Isocarboxazid (INN) | 91 | 52 | | 416 | Isodrin | 377 | 198 | | 417 | Isometheptene (INN) and its salts | 463 | 228 | | 418 | Isoprenaline (INN) | 273, 421 | 17 | | 419 | Isopropamide iodide (INN) | (144) | 156 | | 420 | (2-Isopropylpent-4-enoyl)urea | 60 | 216 | | 421 | Isoproterenol | 273, 418 | 17 | | 422 | Isosorbide dinitrate (INN) | 245 | 148 | | 423 | Juniperus sabina L. (leaves, essential oil and galenical preparations) | - | 294 | | 424 | Laurus nobilis L. (oil from seeds) | - | 359 | | 425 | Lead and its compounds (except lead acetate subject to the restrictions laid down in entry number 55 in Part I of Schedule 4) | - | 289 | | 426 | Levophacetoperane and its salts | 597 | 284 | | 427 | Lidocaine (INN) (Lignocaine) | - | 399 | | 428 | Lindane | 100, 370, 372 | 195 | | 429 | Lobelia inflata L. and its galenical preparations | - | 218 | | 430 | Lobeline (INN) and its salts | 110 | 219 | | 431 | LSD | (433, 434) | 127 | | 432 | Lupinidine and its salts | 651 | 299 | | 433 | Lysergic acid diethylamide and its salts | 431, 434 | 127 | | 434 | Lysergide (INN) and its salts | 431, 433 | 127 | | 435 | Malononitrile | - | 149 | | 436 | Mannomustine (INN) and its salts | 102 | 89 | | 437 | Mecamylamine (INN) | 701 | 229 | | 438 | Mefeclorazine (INN) and its salts | 277 | 141 | | 439 | Mephenesin (INN) and its esters | 721 | 322 | | 440 | Meprobamate (INN) | 481 | 236 | | 441 | Mercury and its compounds (except those listed in Part I of Schedule 6) | - | 221 | | 442 | Mescaline and its salts | 743 | 222 | | 443 | Metabromsalan (INN) | (247) | 351 | | 444 | Metaldehyde | 603 | 223 | | 445 | Metamfepramone (INN) and its salts | 283 | 145 | | 446 | Metethoheptazine (INN) and its salts | 329 | 171 | | 447 | Metformin (INN) and its salts | 285 | 147 | | 448 | Methapyrilene (INN) and its salts | 627 | 144 | | 449 | Metheptazine (INN) and its salts | 468 | 174 | | 450 | Methocarbamol (INN) | 395 | 205 | | 451 | Methohexitone and its salts | (69) | 220 | | 452 | Methotrexate (INN) | 33 | 6 | | 453 | 2-[4-Methoxybenzyl-N-(2-pyridyl)amino]- ethyldimethylamine maleate | 625 | 346 | | 454 | 1-Methoxy-2,2-bis(4-hydroxy-3-coumarinyl)ethane | 215 | 225 | | 455 | 1-Methoxy-2,4-diaminobenzene and its salts | 240, 461 | 376 | | 456 | 1-Methoxy-2,5-diaminobenzene and its salts | 241, 460 | 377 | | 457 | (+)-3-Methoxy-N-methylmorphinan and its salts | 237 | 226 | | 458 | 4-Methoxyphenol | (391) | 178 | | 459 | 3-(2-Methoxyphenoxy)propane-1,2-diol | 366 | 230 | | 460 | 2-Methoxy-p-phenylenediamine and its salts | 241, 456 | 377 | | 461 | 4-Methoxy-m-phenylenediamine and its salts | 240, 455 | 376 | | 462 | Methoxypsoralens (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg | (357) | 358 | | 463 | 6-Methylamino-2-methylhept-2-ene and its salts | 417 | 228 | | 464 | 2-Methyl-1,2-bis(3-pyridyl)propan-1-one | 484 | 292 | | 465 | 9-(3-Methylbut-2-enyloxy)furo-[3,2-g]chromen-7-one | 408 | 34 | | 466 | 2-Methyl-6-chloroanilide of n-butylaminoacetic acid and its salts | 123 | 90 | | 467 | 1-Methyl-2,4-diaminobenzene and its salts | 477 | 364 | | 468 | Methyl 1,2-dimethyl-4-phenylazepane-4-carboxylate and its salts | 449 | 174 | | 469 | 3,3-Methylenebis-(4-hydroxycoumarin) | 253, 254 | 231 | | 470 | 2-Methylheptylamine and its salts | - | 227 | | 471 | 4-Methyl-2-hexylamine and its salts | 35, 289 | 30 | | 472 | 1-Methylimidazole-2-thiol | 474, 707 | 233 | | 473 | N-N'-[(Methylimino)diethylene] bis- (ethyldimethylammonium) salts | 67 | 121 | | 474 | 1-Methyl-2-mercaptoimidazole | 472, 707 | 233 | | 475 | Methylphenidate (INN) and its salts | 575 | 175 | | 476 | 1-Methyl-4-phenyl-4-carbethoxyhexa-methyleneimine and its salts | 321 | 173 | | 477 | 4-Methyl-m-phenylenediamine and its salts | 467 | 364 | | 478 | 2-Methyl-m-phenylenediamine | - | 413 | | 479 | 3-Methyl-2-phenylmorpholine, its derivatives and salts | 558 | 232 | | 480 | 2-Methyl-2-propyl-1-isopropylcarbamoyloxy-3-carbamoyloxypropane | 150 | 235 | | 481 | 2-Methyl-2-propyltrimethylene dicarbamate | 440 | 236 | | 482 | N-Methyl-1,2,5,6-tetrahydro-3-nicotinic acid methyl ester | 61 | 238 | | 483 | Methyprylon (INN) and its salts | 295 | 133 | | 484 | Metyrapone (INN) | 464 | 292 | | 485 | Minoxidil (INN), its salts and derivatives | 599 | 372 | | 486 | Mofebutazone (INN) | 131 | 64 | | 487 | Monobenzone (INN) | 94, (391) | 178 | | 488 | Morpholine and its salts | - | 344 | | 489 | Moskene | 546 | 421 | | 490 | Musk ambrette | 130 | 414 | | 491 | Musk tibetene | 135 | 422 | | 492 | Mustine and its salts | 104, 159 | 87 | | 493 | Mustine N-oxide and its salts | 105 | 86 | | 494 | Nalorphine (INN), its salts and ethers | 21 | 20 | | 495 | Naphazoline (INN) and its salts | 501 | 244 | | 496 | 2-Naphthol | 497 | 241 | | 497 | ß-Naphthol | 496 | 241 | | 498 | 1- and 2-Naphthylamines and their salts | 499 | 242 | | 499 | a- and ß-Naphthylamines and their salts | 498 | 242 | | 500 | 3-(1-Naphthyl)-4-hydroxycoumarin | - | 243 | | 501 | 2-(1-Naphthylmethyl)-2-imidazoline and its salts | 495 | 244 | | 502 | Narcotics, natural and synthetic: All substances listed in Tables I and II of the Single Convention on Narcotic Drugs 1961 (Treaty Series No. 34 (1965), Cmnd. 2631) | - | 306 | | 503 | Narcotine and its salts | 521 | 258 | | 504 | Neodymium and its salts | - | 309 | | 505 | Neostigmine and its salts | - | 245 | | 506 | Nicotine and its salts | - | 246 | | 507 | Nitrites, inorganic (except sodium nitrite) | - | 248 | | 508 | Nitrobenzene | - | 249 | | 509 | Nitrocresols and their alkali metal salts | - | 250 | | 510 | Nitroderivatives of carbazole | 145 | 72 | | 511 | Nitrofurantoin (INN) | 512 | 251 | | 512 | N-(5-Nitro-2-furfurylidene)-1-aminohydantoin | 511 | 251 | | 513 | 3-(5-Nitrofurfurylideneamino)oxazolidin-2-one | 355 | 252 | | 514 | Nitroglycerine | 363, 615 | 253 | | 515 | Nitrosamines | - | 410 | | 516 | Nitrostilbenes, their homologues and derivatives | - | 256 | | 517 | Nitroxoline (INN) and its salts | 398 | 209 | | 518 | N,N,N,N',N',N',N",N",N"-Nonaethyl-2,2',2"-(benzene- 1,2,3-triyltrioxy)-tris(ethanaminium) triiodide | 360 | 329 | | 519 | Noradrenaline and its salts | 32, 520 | 257 | | 520 | Norepinephrine (INN) and its salts | 32, 519 | 257 | | 521 | Noscapine (INN) and its salts | 503 | 258 | | 522 | Nux vomica and its preparations | (661) | 305 | | 523 | Octamoxin (INN) and its salts | 387 | 202 | | 524 | Octamylamine (INN) and its salts | - | 267 | | 525 | Octodrine (INN) and its salts | 34, 288 | 28 | | 526 | Oestrogens | - | 260 | | 527 | Oleandrin | - | 261 | | 528 | 2-(1,3,4-Oxadiazol-2-yl)phenol | 344 | 208 | | 529 | [Oxalylbis(iminoethylene)]bis[(o-chlorobenzyl)diethylammonium] salts | 24 | 132 | | 530 | Oxanamide (INN) and its derivatives | 332 | 165 | | 531 | 2-Oxo-3-isobutyl-9,10-dimethoxy-1,2,3,4,6,7-hexahydro-1lbH-benzo[a]quinolizine and its salts | 688 | 139 | | 532 | Oxpheneridine (INN) and its salts | 334 | 172 | | 533 | Oxyquinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 4 | 112, 401, 633 | 395 | | 534 | Padimate A | 47 | 381 | | 535 | Paramethasone (INN) | 350 | 186 | | 536 | Paraoxon | 263 | 170 | | 537 | Parathion (ISO) | 264 | 131 | | 538 | Parethoxycaine (INN) and its salts | 259, 411 | 179 | | 539 | Pelletierine and its salts | 598 | 263 | | 540 | Pemoline (INN) and its salts | 407 | 212 | | 541 | Pentachloroethane | - | 264 | | 542 | Pentaerythritol chloral | 552 | 266 | | 543 | Pentaerythritol tetranitrate | 544, 551 | 265 | | 544 | Pentaerythrityl tetranitrate (INN) | 543, 551 | 265 | | 545 | Pentamethonium bromide (INN) | (547) | 120 | | 546 | 1,1,3,3,5-Pentamethyl-4,6-dinitroindane | 489 | 421 | | 547 | N,N'-Pentamethylenebis(trimethyl-ammonium) salts | 545 | 120 | | 548 | Pentobarbitone and its salts | (69) | 220 | | 549 | Perchloroethylene | 692 | 314 | | 550 | Perphenazine (INN) and its salts | (561) | 320 | | 551 | PETN | 543, 544 | 265 | | 552 | Petrichloral (INN) | 542 | 266 | | 553 | Phenacemide (INN) | 564 | 269 | | 554 | Phenaglycodol (INN) | 173 | 95 | | 555 | Phenetamine | 226 | 112 | | 556 | Pheneturide (INN) | 340, 568 | 272 | | 557 | Phenindone (INN) | 574 | 271 | | 558 | Phenmetrazine (INN), its derivatives and salts | 479 | 232 | | 559 | Phenobarbitone and its salts | (69) | 220 | | 560 | Phenolphthalein (INN) | 111 | 417 | | 561 | Phenothiazine (INN) and its compounds | various | 320 | | 562 | Phenprobamate (INN) | 576 | 71 | | 563 | Phenprocoumon (INN) | 577 | 273 | | 564 | N-Phenylacetylurea | 553 | 269 | | 565 | 4-Phenylazophenylene-1,3-diamine citrate hydrochloride | 189 | 81 | | 566 | Phenylbutazone (INN) | 129 | 67 | | 567 | 4-Phenylbut-3-en-2-one | 92 | 356 | | 568 | (2-Phenylbutyryl)urea | 340, 556 | 272 | | 569 | N-[2-(a-Phenyl-p-chlorobenzyl)-ethyl]morpholine | 265 | 270 | | 570 | 1-Phenylcyclopentanecarboxylic acid diethylaminoethyl ester and its salts | 143 | 169 | | 571 | 2-Phenylcyclopropylamine (trans-form) and its salts | 722 | 324 | | 572 | 1-Phenyl-2,3-dimethyl-4-isopropylpyrazol-5-one | 620 | 138 | | 573 | o-Phenylenediamine and its salts | 242 | 363 | | 574 | 2-Phenylindan-1,3-dione | 557 | 271 | | 575 | a-Phenyl-2-piperidineacetic acid methyl ester and its salts | 475 | 175 | | 576 | 3-Phenylpropyl carbamate | 562 | 71 | | 577 | 3-(a-Phenylpropyl)-4-hydroxycoumarin | 563 | 273 | | 578 | 1-Phenyl-2-(2-pyridylamino)ethanol | 346, 582 | 274 | | 579 | 2-[1-Phenyl-1-(2-pyridyl)ethoxy]-ethyldimethylamine and its salts | 311 | 176 | | 580 | 2-Phenylquinoline-4-carboxylic acid, its salts and derivatives and salts of those derivatives | 191 | 8 | | 581 | 6-Phenyl-2,4,7-triaminopteridine and its salts | 725 | 275 | | 582 | Phenyramidol | 346, 578 | 274 | | 583 | Phosphides, metal | - | 279 | | 584 | Phosphorus | - | 279 | | 585 | 4-Phosphoryloxy-N,N-dimethyltryptamine | 622 | 278 | | 586 | 3-Phthalimidopiperidine-2,6-dione and its salts | 704 | 280 | | 587 | Phthalylsulphathiazole (INN) and its salts | (678) | 307 | | 588 | Physostigma veneriosum Balf. | 137 | 281 | | 589 | Physostigmine and its salts | 319 | 166 | | 590 | Phytolacca spp and their preparations | - | 374 | | 591 | Picric acid | 745 | 268 | | 592 | Picrotoxin | 197 | 282 | | 593 | Pilocarpine and its salts | - | 283 | | 594 | Pilocarpus jaborandi Holmes and its galenical pre-parations | - | 311 | | 595 | Pipazetate (INN) and its salts | 596 | 118 | | 596 | 2-(2-Piperidinoethoxy)ethyl 10-thia-1, 9-diazaanthracene-9-carboxylate and its salts | 595 | 118 | | 597 | a-Piperidin-2-ylbenzyl acetate, laevorotatory threo-form and its salts | 426 | 284 | | 598 | 1-(2-Piperidyl)propan-2-one and its salts | 539 | 263 | | 599 | 6-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide, its salts and derivatives | 485 | 372 | | 600 | Pipradrol (INN) and its salts | 304 | 285 | | 601 | Piprocurarium iodide (INN) | 256 | 137 | | 602 | Poldine metilsulfate (INN) (Poldine methylsulphate) | 84 | 239 | | 603 | Polyacetaldehyde | 444 | 223 | | 604 | Potassium cyanide | (388, 390, 409) | 111 | | 605 | Potassium nitroferricyanide | (15), 606 | 255 | | 606 | Potassium nitroprusside | (15), 605 | 255 | | 607 | Pramocaine (INN) | 608 | 405 | | 608 | Pramoxine | 607 | 405 | | 609 | Probenecid (INN) | 308 | 161 | | 610 | Procainamide (INN) its salts and derivatives | 29 | 25 | | 611 | Prochlorperazine (INN) and its salts | (561) | 320 | | 612 | Progestogens | - | 194 | | 613 | Promazine (INN) and its salts | (561) | 320 | | 614 | Promethazine (INN) and its salts | (561) | 320 | | 615 | Propane-1'2,3-triyl trinitrate | 363, 514 | 253 | | 616 | Propatylnitrate (INN) | 109 | 206 | | 617 | 1-Propyl-3-(4-chlorobenzenesulphonyl)urea | 181 | 79 | | 618 | 2-Propylpiperidine | 212 | 290 | | 619 | 1-(2-Propynyl)cyclohexyl carbamate | 383 | 115 | | 620 | Propyphenazone (INN) | 572 | 138 | | 621 | Prunus laurocerasus L. | 156 | 291 | | 622 | Psilocybine (INN) | 585 | 278 | | 623 | Psoralen (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg | (357) | 358 | | 624 | Pyrethrum album L. and its galenical preparations | - | 345 | | 625 | Pyrianisamine maleate | 453 | 346 | | 626 | Pyribenzamine | 95, 748 | 347 | | 627 | 2-(N-2-Pyridyl-N-2-thienylamino)ethyl-dimethylamine and its salts | 448 | 144 | | 628 | Pyrithione disulphide+magnesium sulphate | 310 | 396 | | 629 | Pyrithione sodium (INNM) | - | 369 | | 630 | Pyrocatechol | 79, 152 | 408 | | 631 | Pyrogallol | 80 | 409 | | 632 | Quinalbarbitone and its salts | (69) | 220 | | 633 | Quinolin-8-ol except for the uses provided for in entry number 51 in Part I of Schedule 4 | (401, 533) | 395 | | 634 | Radioactive substances (within the meaning of Article 1 of Council Directive 96/29/Euratom[16] laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation) | - | 293 | | 635 | Rauwolfia serpentina alkaloids and their salts | 636 | 15 | | 636 | Reserpine (INN) and its salts | (635) | 15 | | 637 | Retinoic acid and its salts | 724, 760 | 375 | | 638 | Safrole (except natural content of essences in cases where the concentration of such safrole in the cosmetic product does not exceed -
(a) in the case of oral hygiene or dental products other than toothpaste intended specifically for children, 50 mg/kg; or
(b) in the case of products other than oral hygiene or dental products, 100 mg/kg)
| - | 360 | | 639 | a-Santonin | 380 | 214 | | 640 | Schoenocaulon officinale Lind. (seeds and galenical preparations) | - | 332 | | 641 | Scopolamine, its salts and derivatives | 403 | 295 | | 642 | Secbutobarbitone and its salts | (69) | 220 | | 643 | Secondary dialkanolamines | 108, 255, 274 | 411 | | 644 | Selenium and its compounds (except when permitted under the restrictions laid down in Part I of Schedule 4) | - | 297 | | 645 | Sodium cyanide | (388, 390, 409) | 111 | | 646 | Sodium hexacyclonate (INN) | 396 | 114 | | 647 | Sodium nitroferricyanide | (15), 648 | 255 | | 648 | Sodium nitroprusside | (15), 647 | 255 | | 649 | Solanum nigrum L. and its galenical preparations | - | 298 | | 650 | Spanish Fly | 139 | 69 | | 651 | Sparteine (INN) and its salts | 432 | 299 | | 652 | Spironolactone (INN) | 10 | 4 | | 653 | Squill and its preparations | 752 | 330 | | 654 | Stramonium and its preparations | 232 | 301 | | 655 | Strontium lactate | - | 402 | | 656 | Strontium nitrate | - | 403 | | 657 | Strontium polycarboxylate | - | 404 | | 658 | Strophanthines and their aglucones and their respective derivatives | - | 302 | | 659 | Strophanthus species and their galenical preparations | - | 303 | | 660 | Strychnine and its salts | - | 304 | | 661 | Strychnos species and their galenical preparations | 522 | 305 | | 662 | Succinonitrile | - | 150 | | 663 | Succinylsulphathiazole and its salts | (678) | 307 | | 664 | Sulfinpyrazone (INN) | 303 | 155 | | 665 | Sulphacetamide and its salts | (678) | 307 | | 666 | Sulphadiazine and its salts | (678) | 307 | | 667 | Sulphadimethoxine and its salts | (678) | 307 | | 668 | Sulphadimidine and its salts | (678) | 307 | | 669 | Sulphafurazole and its salts | (678) | 307 | | 670 | Sulphaguanidine and its salts | (678) | 307 | | 671 | Sulphamethizole and its salts | (678) | 307 | | 672 | Sulphamethoxazole and its salts | (678) | 307 | | 673 | Sulphamethoxydiazine and its salts | (678) | 307 | | 674 | Sulphamethoxypyridazine and its salts | (678) | 307 | | 675 | Sulphanilamide and its salts | (678) | 307 | | 676 | Sulphapyridine and its salts | (678) | 307 | | 677 | Sulphathiazole and its salts | (678) | 307 | | 678 | Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts | 665-677 | 307 | | 679 | Sulthiame | 680, 699 | 308 | | 680 | Sultiame (INN) | 679, 699 | 308 | | 681 | Sympathomimetic amines acting on the central nervous system: any substance contained in the first list of medicaments which are subject to medical prescription and are referred to in resolution AP (69) 2 of the Council of Europe | 44 | 21 | | 682 | Tefazoline (INN) and its salts | 698 | 237 | | 683 | Tellurium and its compounds | - | 312 | | 684 | TEPP (ISO) | 696 | 276 | | 685 | 2-(4-tert-Butyl-2,6-dimethylbenzyl)-2-imidazoline and its salts | 766 | 313 | | 686 | 4-tert-Butylphenol | - | 340 | | 687 | 4-tert-Butylpyrocatechol | - | 341 | | 688 | Tetrabenazine (INN) and its salts | 531 | 139 | | 689 | Tetrabromosalicylanilides | - | 350 | | 690 | Tetracaine (INN) and its salts | 280 | 63 | | 691 | 2,3,7,8-Tetrachlorodibenzo-p-dioxin | - | 367 | | 692 | Tetrachloroethylene | 549 | 314 | | 693 | Tetrachloromethane | 147 | 315 | | 694 | Tetrachlorosalicylanilides | - | 348 | | 695 | Tetraethylammonium bromide | 703 | 61 | | 696 | Tetraethyl pyrophosphate | 684 | 276 | | 697 | (R)-5,6,6a,7-Tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol and its salts | 59 | 42 | | 698 | 2-(5,6,7,8-Tetrahydro-1-naphthylmethyl)-2-imidazoline and its salts | 682 | 237 | | 699 | 4-(Tetrahydro-2H-1,2-thiazin-2-yl)-benzenesulphonamide S,S-dioxide | 679, 680 | 308 | | 700 | Tetrahydrozoline and its salts | - | 394 | | 701 | N,2,3,3-Tetramethyl-2-nocamphanamine | 437 | 229 | | 702 | Tetramethylthiuram disulphide | 713 | 162 | | 703 | Tetrylammonium bromide (INN) | 695 | 61 | | 704 | Thalidomide (INN) and its salts | 586 | 280 | | 705 | Thallium and its compounds | - | 317 | | 706 | Thevetia neriifolia Juss., glycoside extract | - | 318 | | 707 | Thiamazole (INN) | 472, 474 | 233 | | 708 | 2,2'-Thiobis(4,6-dichlorophenol) | 113 | 352 | | 709 | Thiopentone and its salts | (69) | 220 | | 710 | Thioridazine (INN) and its salts | (561) | 320 | | 711 | Thiotepa (INN) | 726 | 310 | | 712 | Thiourea and its derivatives (except those listed in Part I of Schedule 4) | - | 321 | | 713 | Thiram (ISO) | 702 | 162 | | 714 | Thiuram disulphides | - | 354 | | 715 | Thiuram monosulphides | - | 353 | | 716 | Thyropropic acid (INN) and its salts | 394 | 9 | | 717 | Tolboxane (INN) | 720 | 177 | | 718 | Tolbutamide (INN) | 132 | 65 | | 719 | Toluidines, their isomers, salts and halogenated and sulphonated derivatives | 40 | 32 | | 720 | p-Tolylboric acid ester of 2-methyl-2-propylpropane-1,3-diol | 717 | 177 | | 721 | 3-o-Tolyloxypropane-1,2-diol | (439) | 322 | | 722 | Tranylcypromine (INN) and its salts | 571 | 324 | | 723 | Tretamine (INN) | 727 | 328 | | 724 | Tretinoin (INN) and its salts | 637, 760 | 375 | | 725 | Triamterene (INN) and its salts | 581 | 275 | | 726 | Tri(aziridin-1-yl)phosphine sulphide | 711 | 310 | | 727 | 2,4,6-Tri(aziridin-l-yl)-1,3-triazine | 723 | 328 | | 728 | 2,2,2-Tribromoethanol | (729) | 326 | | 729 | Tribromoethyl alcohol | 728 | 326 | | 730 | Tribromsalan (INN) | 731 | 373 | | 731 | 3,4',5-Tribromosalicylanilide | 730 | 373 | | 732 | Trichlormethine (INN) and its salts | 749 | 327 | | 733 | Trichloroacetic acid | - | 10 | | 734 | 1,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane | 194, 233 | 123 | | 735 | 2,2,2-Trichloroethane-1,1-diol | 157 | 77 | | 736 | Trichloromethane | 167 | 366 | | 737 | N-(Trichloromethylthio)cyclohex-4-ene-1,2-dicarboximide | 141 | 370 | | 738 | Trichloronitromethane | 177 | 325 | | 739 | Tricresyl phosphate | 750 | 277 | | 740 | Trifluoperazine (INN) and its salts | (561) | 320 | | 741 | Trifluperidol (INN) | 349 | 188 | | 742 | 3,3',5-Triiodothyroacetic acid and its salts | 393 | 5 | | 743 | 3,4,5-Trimethoxyphenethylamine and its salts | 442 | 222 | | 744 | 2.2,6-Trimethy1-4-piperidyl benzoate and its salts | 75 | 51 | | 745 | 2,4,6-Trinitrophenol | 591 | 268 | | 746 | Trioxysalen (INN) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg | (357) | 358 | | 747 | Triparanol (INN) | 171 | 92 | | 748 | Tripelennamine (INN) | 95, 626 | 347 | | 749 | Tris(2-chloroethyl)amine | 732 | 327 | | 750 | Tritolyl phosphate | 739 | 277 | | 751 | Tuaminoheptane (INN), its isomers and salts | 30 | 27 | | 752 | Urginea scilla Stern. and its galenical preparations | 653 | 330 | | 753 | Urocanic acid | (406) | 418 | | 754 | Vaccines, toxins and serums listed in the Annex to Council Directive No. 75/319/EEC[17] | - | 323 | | 755 | Valnoctamide (INN) | 339 | 184 | | 756 | Veratrine, its salts and galenical preparations | - | 331 | | 757 | Veratrum spp and their preparations | - | 333 | | 758 | Vinyl chloride monomer | - | 334 | | 759 | Vinylidene chloride | (7,250) | 126 | | 760 | Vitamin A acid and its salts | 637, 724 | 375 | | 761 | Vitamins D2 and D3 | 138, 186, 317 | 335 | | 762 | Warfarin (ISO) and its salts | 3, 399 | 203 | | 763 | Xanthates | 16 | 336 | </
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