Statutory Instrument 2003 No. 835

      The Cosmetic Products (Safety) Regulations 2003


      © Crown Copyright 2003

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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,

          (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 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 1
      Regulation 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 2
      Regulation 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 3
      Regulations 5(2) and 6(1)


      LIST 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 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 I

      SUBSTANCES 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 t