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You are here: BAILII >> Databases >> United Kingdom Statutory Instruments >> The Cosmetic Products (Safety) Regulations 1989 No. 2233 URL: http://www.bailii.org/uk/legis/num_reg/1989/uksi_19892233_en.html |
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Statutory Instruments
CONSUMER PROTECTION
Made
29th November 1989
Laid before Parliament
6th December 1989
Coming into force
(except as provided in regulation 1)
1st January 1990
Whereas the Secretary of State has, in accordance with section 11(5) of the Consumer Protection Act 1987(1), consulted such organisations as appear to him to be representative of interests substantially affected by these Regulations, such other persons as he considers appropriate and the Health and Safety Commission:
And whereas the Secretary of State is a Minister designated(2) for the purposes of section 2 of the European Communities Act 1972(3) in relation to measures for safety and consumer protection as respects cosmetic products and any provisions concerning the composition, labelling, marketing, classification or description of cosmetic products and in relation to indication of origin on imported goods:
Now, therefore, the Secretary of State in exercise of powers conferred on him by sections 11, 28 and 30 of the said Act of 1987 and by section 2 of the said Act of 1972 and of all other powers enabling him in that behalf hereby makes the following Regulations:-�
1.-(1) These Regulations may be cited as the Cosmetic Products (Safety) Regulations 1989 and except as provided by paragraphs (2) to (5) below shall come into force on 1st January 1990.
(2) Regulation 4(2) and Schedule 1, in so far as they relate only to entry numbers 37, 38, 47 (cross-referenced in column 3 with entry number 496) and 87 and to entry numbers 247, 558 and 680 (cross-referenced in column 3 with entry numbers 351, 454 and 132 respectively) in that Schedule, regulation 4(3) and Part I of Schedule 2, in so far as they relate only to entry number 52 in that Part, and regulation 4(5) and Part I of Schedule 4, in so far as they relate only to entry number 40 and the deletion of entry number 6 in that Part, shall come into force-�
(a)on 1st January 1990 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st January 1991; and
(b)in all other cases, on 1st January 1991.
(3) Regulation 4(3) and Schedule 2, in so far as they relate only to entry numbers 53 and 54 in Part 1 of Schedule 2, regulation 4(4)(a)(i) and Part I of Schedule 3, in so far as they relate to the deletion of colouring agent 13065, and regulation 4(5) and Part II of Schedule 4, in so far as they relate to the deletion of entry numbers 7 to 10, 14, 18, 22 and 24 in that Part, shall come into force-�
(a)on 1st January 1990 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st January 1992; and
(b)in all other cases, on 1st January 1992.
(4) Regulation 4(3) and Part II of Schedule 2, in so far as they relate only to entry number 1 in that Part, regulation 4(4) and Part II of Schedule 3, in so far as they relate only to the deletion of entry numbers 15800, 19120, 20470, 21115, 42170, 45190, 47000, 73905 and 75660 and the requirement in column 4 relating to entry number 42535 in that Part, regulation 4(5) and Part I of Schedule 4, in so far as they relate only to the requirement in column 4 relating to entry number 39 in that Part, and Part II of Schedule 4, in so far as they relate only to entry number 26 and the deletion of entry numbers 1, 3, 5, 19 and 25 in that Part, and regulation 4(6)(a)(ii) and Part II of Schedule 5 shall come into force-�
(a)on 1st January 1991 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st January 1993; and
(b)in all other cases, on 1st January 1993.
(5) Regulation 6 shall come into force-�
(a)on 1st January 1992 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case it shall come into force on 1st January 1994; and
(b)in all other cases on 1st January 1994.
(6) Subject to paragraph (7) below, the Regulations specified in Schedule 7 are hereby revoked:
(7) The notes in Schedules 3 and 4 shall apply.
2.-(1) In these Regulations-�
"the Directive" means Council Directive No. 76/768/EEC(4) as amended by Council Directive No. 82/368/EEC(5), Commission Directive No. 82/147/EEC(6), Commission Directive No. 83/191/EEC(7), Commission Directive No. 83/341/EEC(8), Council Directive No. 83/574/EEC(9), Commission Directive No. 83/496/EEC(10), Commission Directive No. 84/415/EEC(11), Commission Directive No. 85/391/EEC(12), Commission Directive No. 86/179/EEC(13), Commission Directive No. 86/199/EEC(14), Commission Directive No. 87/137/EEC(15), Commission Directive No. 88/233/EEC(16), Council Directive No. 88/667/EEC(17) and Commission Directive No. 89/174/EEC(18);
"cosmetic product" means any substance or preparation intended to be applied to 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 to the teeth or buccal mucosa wholly or mainly for the purpose of cleaning, perfuming or protecting them or keeping them in good condition or changing their appearance or combating body odour or perspiration except where such cleaning, perfuming, protecting, keeping, changing or combating 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;
"market research experiment" means any activities conducted for the purpose of ascertaining the opinion of persons of-�
any cosmetic product; or
anything in, on or with which the cosmetic product is supplied; or
the appearance or any other characteristic of the cosmetic product or any such thing; or
the name or description under which the cosmetic product is supplied.
A cosmetic product is not the subject of a market research experiment unless-�
any person to whom a cosmetic product is supplied in the course of the experiment is informed, at or before the time at which it is supplied to him, that it is supplied for the purpose of a market research experiment and
no consideration in money or money's worth is given by such a person for the cosmetic product or any other cosmetic product supplied to him for comparison.
"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) References in these Regulations to a numbered regulation or Schedule are references to the regulation or Schedule so numbered in these Regulations.
3.-(1) Subject to paragraph (2) below, a cosmetic product shall not be liable to cause damage to human health when it is applied under normal conditions of use.
(2) For the purposes of regulation 8, 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.
4.-(1) The following provisions of this regulation are without prejudice to regulation 3 and are subject to regulation 5.
(2) A cosmetic product shall not contain any substance listed in column 2 of Schedule 1:
Provided that no account shall be taken of any such substance which is present only as a trace which could not reasonably have been removed during or after manufacture.
(3) A cosmetic product shall not contain any substance listed in column 2 of Schedule 2 unless the requirements in columns 3, 4, 5 and (in the case of Part II) 7 of that Schedule in relation to that substance are satisfied.
(4) A cosmetic product shall not contain-�
(a)any colouring agent listed in columns 1 and 2 of Schedule 3 with the exception of cosmetic products containing colouring agents intended solely to colour hair unless-�
(i)the requirements in columns 3 and 4 of Part I of that Schedule in relation to that colouring agent are satisfied; or
(ii)the requirements in columns 3 and 4 of Part II of that Schedule in relation to that colouring agent are satisfied and the cosmetic product in question was supplied on or before the date specified in column 5 of that Part;
(b)any colouring agent which is not listed in that Schedule with the exception of cosmetic products containing colouring agents intended solely to colour hair;
(5) A cosmetic product shall not contain-�
(a)any preservative listed in column 2 of Schedule 4 unless-�
(i)the requirements in columns 3, 4 and 5 of Part I of that Schedule in relation to that preservative are satisfied; or
(ii)the requirements in columns 3, 4 and 5 of Part II of that Schedule in relation to that preservative are satisfied and the preservative in question is supplied on or before the date specified in column 7 of that Part;
(b)any preservative which is not listed in that Schedule;
(c)any preservative listed in column 2 of Part II of Schedule 4 after the date specified in column 7 of that Part.
(6) A cosmetic product shall not contain-�
(a)any UV filter listed in column 2 of Schedule 5 unless-�
(i)the requirements in columns 3 and 4 of Part I of that Schedule in relation to that UV filter are satisfied; or
(ii)the requirements in columns 3 and 4 of Part II of that Schedule in relation to that UV filter are satisfied and the UV filter in question is supplied on or before the date specified in column 6 of that Part;
(b)any UV filter which is not listed in that Schedule.
5.-(1) The Secretary of State may authorise the use in a cosmetic product of a particular substance, not being a substance listed in Schedule 1 or 2.
(2) In giving an authorisation the Secretary of State may impose conditions relating to the use of a particular substance in a cosmetic product. The conditions may relate to any matter which the Secretary of State considers appropriate including-�
(a)the purpose of the substance;
(b)the type of cosmetic product;
(c)the maximum concentration of the substance in any cosmetic product; and
(d)information and marking requirements.
(3) The Secretary of State may on reasonable notice vary or revoke any authorisation given under paragraph (1) above.
(4) On giving, varying or revoking an authorisation, the Secretary of State shall arrange for the authorisation, variation or revocation, as the case may be, to be published in such manner as he considers appropriate for bringing it to the attention of persons who, in his opinion, would be likely to have an interest in it.
(5) No person shall be convicted of an offence under section 12 of the Consumer Protection Act 1987 by reason of a cosmetic product's containing a particular substance provided that at the time when but for this regulation an offence would have been committed-�
(a)the use of that particular substance in that cosmetic product was duly authorised; and
(b)all of the conditions imposed by the authorisation were complied with.
6.-(1) Subject to the following provisions of this regulation, the container and the outer packaging (if any) in which a cosmetic product is supplied or delivered pursuant to any supply, or a label affixed to the product, the container and the outer packaging, shall bear the following particulars:-�
(a)the name or trade name and the address or registered office of the manufacturer of the product or of a supplier thereof, being a manufacturer or supplier established within a member State of the European Economic Community;
(b)in the case of a cosmetic product likely within 30 months from the manufacture thereof to cease either to comply with the requirements of regulation 3 or to fulfil the purpose for which it was intended, the words "Best before ... ... ... ..." immediately followed by
(i)the earliest date on which it is likely to so cease; or
(ii)an indication of where that date appears on the labelling
and any particular precautions to be observed to ensure that the product does not so cease before that date.
(c)in the case of a cosmetic product containing a substance listed in column 2 of Schedule 2, the information specified in column 6 of that Schedule in relation to that substance;
(d)in the case of a cosmetic product containing a preservative listed in column 2 of Schedule 4, the information specified in column 6 of that Schedule in relation to that preservative;
(e)in the case of a cosmetic product containing a UV filter listed in column 2 of Schedule 5, the information specified in column 5 of that Schedule in relation to that UV filter;
(f)any particular precautions to be observed in use (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):
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.
(2) The particulars referred to in sub-paragraphs (a) to (g) of paragraph (1) above shall be in lettering which is visible, indelible and easily legible.
(3) The particulars referred to in sub-paragraph (a) of paragraph (1) above may be abbreviated if such abbreviation does not prevent the person concerned from being identified.
(4) The date referred to in sub-paragraph (b) of paragraph (1) above shall include the month and the year, and the month shall precede the year.
(5) The particulars referred to in sub-paragraphs (b) to (f ) of paragraph (1) above shall be in the English language; but this shall not prohibit the additional use of other languages.
(6) The particulars referred to in sub-paragraphs (c) to (f ) of paragraph (1) above and any special precautionary information on cosmetic products for professional use, in particular, in hairdressing shall appear on the container or on a label attached thereto: provided that where-�
(a)it is impracticable by reason of the size or shape of the container for the said particulars so to appear, or
(b)two or more products are supplied together as a single item, each product being in a separate container and the containers being enclosed together in outer packaging which bears clear and conspicuous instructions to the effect that the product must be mixed together in specified proportions before use,
the said particulars shall appear on an enclosed leaflet and an indication shall appear on both the container and the outer packaging (if any) or on a label if attached thereto referring the consumer to the information in the leaflet.
(7) Where it is impracticable, for reasons of size, for the particulars referred to in sub-paragraph (g) of paragraph (1) above to appear on the container and outer packaging, the said particulars shall appear on the packaging in which the product is exposed for supply.
(8) In the case of a supply of soap which is not in a container, either the soap itself or the packaging in which it is exposed for supply or the container in which it was last contained before the supply shall bear the particulars referred to in sub-paragraphs (a) and (g) of paragraph (1) above, and in so far as any of the particulars referred to in sub-paragraphs (b) to (f) of paragraph (1) above are required they shall appear on a leaflet which shall be delivered to the buyer with the soap; and where either of the particulars referred to in sub-paragraphs (a) and (g) of paragraph (1) above appears on the soap itself the requirement of indelibility shall apply only until it has been put into use.
7.-(1) No proceedings for an offence under section 12 of the Consumer Protection Act 1987 in respect of a contravention of regulation 8 by reason of the requirements of regulation 3 being not satisfied shall be brought in England or Wales except by or with the consent of the Secretary of State or the Director of Public Prosecutions and in Northern Ireland except by or with the consent of the Secretary of State or the Director of Public Prosecutions for Northern Ireland.
(2) Regulations 3, 4 and 6 do not apply 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 of the European Economic Community.
(3) Regulation 6(5) does not apply in any case in which the person supplying the cosmetic product reasonably believes that it will not be used in the United Kingdom.
8. Subject to regulations 5 and 7(2) and (3), no person shall supply any cosmetic product in respect of which any of the requirements of regulation 3, 4 or 6 is not satisfied.
9. Any test of goods purchased under section 28, or seized under section 29, of the Consumer Protection Act 1987 (which relates 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 6 and any test for which a method is specified in paragraph 6 of that Schedule shall be carried out in accordance with that method.
Eric Forth
Parliamentary Under-Secretary of State,
Department of Trade and Industry
29th November 1989
Regulation 4(2)
The alphabetical list set out in column 2 of this Schedule contains one or more of the names of each of the substances referred to in regulation 4(2); in certain cases a name is given of a group of substances, the names of particular examples of which are also given, and in such a case all substances comprised in the group are included, whether or not more specifically named.
The numbers given in columns 1, 3 and 4 are for information only. Those in column 3 are cross-references to other names listed for the same substances (except that where a name is that of a group of substances, the cross-references are to particular examples of that group, and any cross-reference in parenthesis is to the name of a group of substances within which the particular substance falls). Those in column 4 are cross-references to Annex II of the Directive, from which this Schedule is derived.
| (1) | (2) | (3) | (4) |
|---|---|---|---|
| Number in this Schedule | Name of substance | Cross-reference to this Schedule | Cross-reference to Annex II of the Directive |
| 1 | Acenocoumarol (INN) | 3 | 254 |
| 2 | 3-(α-Acetonylbenzyl)-4-hydroxycoumarin and its salts | 372, 704 | 203 |
| 3 | 3-(α-Acetonyl-p-nitrobenzyl)-4-hydroxycoumarin | 1 | 254 |
| 4 | 2-(or β-)Acetoxyethyltrimethylammonium hydroxide and its salts | 6 | 2 |
| 5 | 2-Acetylamino-5-chlorobenzoxazole | 151 | 1 |
| 6 | Acetylcholine and its salts | 4 | 2 |
| 7 | Acetylene chlorides | 227, 702 | 126 |
| 8 | Acetylenic alcohols, their esters, ethers and salts | 17 | 16 |
| 9 | Acetylethyltetramethyltetralin (AETT) | 317 | 362 |
| 10 | β-(7α-Acetylthio-17β-hydroxy-3-oxoandrost-4-en-17α-yl)propionic acid lactone | 599 | 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 | 249, 294 | 14 |
| 15 | Alkali pentacyanonitrosylferrate (2-) | 563-�4, 594-�5 | 255 |
| 16 | O-Alkyldithiocarbonic acids, salts of | 705 | 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 | 460 | 20 |
| 22 | 2-Allyloxy-4-chloro-N-[2'-(diethylamino)ethyl]benzamide and its salts | 18 | 19 |
| 23 | Alypine and its salts | 45, 103 | 143 |
| 24 | Ambenomium chloride (INN) | (492) | 132 |
| 25 | 4-(orp-)Aminobenzoic acid esters except glycerol 1-(4-aminobenzoate) when provisionally permitted for use as a UV filter in accordance with the requirements specified in item 4 of Part II of Schedule 5 | - | 167 |
| 26 | 2-Amino-1,2-bis(4-methoxyphenyl) ethanol and its salts | - | 29 |
| 27 | 3-Amino-4-butoxybenzoic acid 2-diethylaminoethyl ester and its salts | 95, 234 | 23 |
| 28 | Aminocaproic acid (INN) and its salts | 32 | 7 |
| 29 | 2-Amino-5-chlorobenzoxazole | 710 | 24 |
| 30 | 4-Amino-N-(2'-diethylaminoethyl) benzamide, its salts and derivatives | 566 | 23 |
| 31 | Aminoheptane, its isomers and salts | 695 | 27 |
| 32 | 6-Aminohexanoic acid and its salts | 28 | 7 |
| 33 | α-(Aminomethyl)-3,4-dihydroxybenzyl alcoholand its salts | 483, 484 | 257 |
| 34 | 4-Amino-N10-methylfolic acid | 425 | 6 |
| 35 | 2-Amino-6-methylheptane and its salts | 390, 489 | 28 |
| 36 | 2-Amino-4-methylhexane and its salts | 267, 442 | 30 |
| 37 | 2-Amino-4-nitrophenol | - | 383 |
| 38 | 2-Amino-5-nitrophenol | - | 384 |
| 39 | 4-(orp-)Aminosalicylic acid and its salts | - | 31 |
| 40 | Aminotoluenes, their isomers, salts and halogenated and sulphonated derivatives | 662 | 32 |
| 41 | Aminoxylenes, their isomers, salts and halogenated and sulphonated derivatives | 707 | 33 |
| 42 | Amitriptyline (INN) and its salts | 263 | 146 |
| 43 | Ammi majus and its galenical preparations | - | 35 |
| 44 | Amphetamine (INN), its salts and derivatives and salts of those derivatives | (625) | 21 |
| 45 | Amydricaine and its salts | 23, 103 | 143 |
| 46 | Amylene chloride | 228 | 36 |
| 47 | Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN)) | 496 | 381 |
| 48 | Amyl nitrites | - | 247 |
| 49 | Amylobarbitone and its salts | (68) | 220 |
| 50 | Amylocaine and its salts | 261 | 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 | Antibiotics (except tyrothricin) | - | 39 |
| 56 | Antimony and its compounds | - | 40 |
| 57 | Apocynum cannabinum L. and its preparations | - | 41 |
| 58 | Apomorphine and its salts | 641 | 42 |
| 59 | Apronalide | 393 | 216 |
| 60 | Arecoline | 451 | 238 |
| 61 | Aristolochic acid and its salts | - | 365 |
| 62 | Arsenic and its compounds | - | 43 |
| 63 | Atropa belladonna L. and its compounds | - | 44 |
| 64 | Atropine, its salts and derivatives | - | 45 |
| 65 | Azacyclonol (INN) and its salts | 285 | 286 |
| 66 | Azamethonium bromide (INN) | 443 | 121 |
| 67 | Barbitone and its salts | (68) | 220 |
| 68 | Barbiturates | various | 220 |
| 69 | Barium salts (except barium sulphate, barium sulphide under the condition laid down in Part I of Schedule 2, for alkaline earth sulphides and lakes, salts and pigments prepared from those colouring agents identified in Column 1 of Schedule 3 by "*" immediately after the name or colour index number) | - | 46 |
| 70 | Bemegride (INN) and its salts | 311, 312 | 183 |
| 71 | Benactyzine (INN) | 235 | 157 |
| 72 | Bendrofluazide and its derivatives | 73, 86 | 53 |
| 73 | Bendroflumethiazide (INN) and its derivatives | 72, 86 | 53 |
| 74 | Benzamine and its salts | 688 | 51 |
| 75 | Benzatropine (INN) and its salts | 281 | 158 |
| 76 | Benzazepines, their salts and derivatives | 85 | 49 |
| 77 | Benzene | - | 47 |
| 78 | 2-Benzhydryloxyethyldimethylamine and its salts | 276 | 339 |
| 79 | Benzidine | 221 | 26 |
| 80 | Benzilonium bromide (INN) | 90 | 60 |
| 81 | 2-Benziloyloxymethyl-1,1-dimethylpyrrolidinium methylsulphate | 561 | 239 |
| 82 | Benzimidazolone | 83, 244 | 48 |
| 83 | Benzimidazol-2(3H)-one | 82, 244 | 48 |
| 84 | Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol (except natural content of essences) | 191 | 357 |
| 85 | Benzodiazepines, their salts and derivatives | 76 | 49 |
| 86 | Benzothiadiazine and its derivatives | 72, 73 | 53 |
| 87 | Benzoyl peroxide | - | 382 |
| 88 | 3-(N-Benzylhydrazinocarbonyl)-5-methylisoxazole | 387 | 52 |
| 89 | Benzylideneacetone | 527 | 356 |
| 90 | 3-Benzyloxy-1,1-diethylpyrrolidine hydrobromide | 80 | 60 |
| 91 | 4-Benzyloxyphenol | (366, 456) | 178 |
| 92 | 2-[Benzyl-N-(2-pyridyl)amino]-ethyldimethylamine | 581, 692 | 347 |
| 93 | Beryllium and its compounds | - | 54 |
| 94 | Betamethasone (INN) | (337) | 300 |
| 95 | Betoxycaine (INN) and its salts | 27, 95, 234 | 23 |
| 96 | BHC (ISO) (gamma-BHC) | 346, 348, 401 | 195 |
| 97 | Bietamiverine (INN) | 238 | 287 |
| 98 | 1,6-Bis(2-chloroethylamino)-1,6-dideoxymannitol and its salts | 409 | 89 |
| 99 | 2-[Bis(2-chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane 2-oxide and its salts | 102, 211 | 88 |
| 100 | N,N-Bis(2-chloroethyl)methylamine and its salts | 148, 458 | 87 |
| 101 | N,N-Bis(2-chloroethyl)methylamine N-oxide and its salts | 459 | 86 |
| 102 | N,N-Bis(2-chloroethyl)-N',O-propylenephosphoramide anhydride and its salts | 99, 211 | 88 |
| 103 | 1,1-Bis(dimethylaminomethyl)propyl benzoate and its salts | 23, 45 | 143 |
| 104 | 2,2-Bis(hydroxymethyl)butan-1-ol trinitrate | 572 | 206 |
| 105 | 2,6-Bis(β-hydroxyphenethyl)-1-methylpiperidine and its salts | 403 | 219 |
| 106 | Bithionol (INN) | 651 | 352 |
| 107 | Bretylium tosilate (INN) (or tosylate) | 110 | 56 |
| 108 | Bromine, elemental | - | 55 |
| 109 | Bromisoval (INN) | 113 | 58 |
| 110 | p-Bromobenzylethyldimethylammoniump-toluenesulphonate | 107 | 56 |
| 111 | Bromodiethylacetylurea | 112, 139 | 57 |
| 112 | α-Bromo-α-ethylbutyrylurea | 111, 139 | 57 |
| 113 | Bromoisovalerylurea | 109 | 58 |
| 114 | 1-p-bromophenyl-1-(2-pyridyl)-3-dimethylaminopropane and its salts | 115 | 59 |
| 115 | Brompheniramine (INN) and its salts | 114 | 59 |
| 116 | Brucine | - | 62 |
| 117 | Butanilicaine (INN) and its salts | 438 | 90 |
| 118 | Butobarbitone and its salts | (68) | 220 |
| 119 | Butopiprine (INN) and its salts | 121 | 288 |
| 120 | 2-Butoxy-N-(2-diethylaminoethyl) cinchoninamide and its salts | 178 | 129 |
| 121 | 2-Butoxyethyl α-phenyl-α-(N-piperidino)acetate and its salts | 119 | 288 |
| 122 | 1-Butyl-3-(N-crotonoylsulphanilyl) urea | - | 108 |
| 123 | 4-Butyl-1,2-diphenylpyrazolidine-3,5-dione | 526 | 67 |
| 124 | 4-Butyl-1-phenylpyrazolidine-3,5-dione | 455 | 64 |
| 125 | 1-Butyl-3-(p-methylbenzenesulphonyl) urea | 661 | 65 |
| 126 | 1-Butyl-3-sulphanilylurea | 140 | 66 |
| 127 | 4-Butylthiobenzohydryl dimethylaminoethyl sulphide | 133 | 140 |
| 128 | Cadmium and its compounds | - | 68 |
| 129 | Calabar bean | 547 | 281 |
| 130 | Cantharides,Cantharis vesicatoria | 597 | 69 |
| 131 | Cantharidin | 354 | 70 |
| 132 | Captan (ISO) | 680 | 370 |
| 133 | Captodiame (INN) | 127 | 140 |
| 134 | Caramiphen (INN) and its salts | 530 | 169 |
| 135 | N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethylammonium salts | 392 | 156 |
| 136 | Carbazole, nitroderivatives of | 476 | 72 |
| 137 | Carbon disulphide | - | 73 |
| 138 | Carbon tetrachloride | 637 | 315 |
| 139 | Carbromal (INN) | 111, 112 | 57 |
| 140 | Carbutamide (INN) | 126 | 66 |
| 141 | Carisoprodol (INN) | 449 | 235 |
| 142 | Catalase | - | 74 |
| 143 | Cephaeline and its salts | - | 75 |
| 144 | Chenopodium ambrosioides(essential oil) | - | 76 |
| 145 | Cherry laurel water | 577 | 291 |
| 146 | Chloral hydrate | 677 | 77 |
| 147 | Chlorine | - | 78 |
| 148 | Chlormethine (INN) and its salts | 100,458 | 87 |
| 149 | Chlormezanone (INN) | 162 | 91 |
| 150 | 5-Chlorobenzoxazolinone | 173 | 82 |
| 151 | N-5-Chlorobenzoxazol-2-ylacetamide | 5 | 1 |
| 152 | 2-Chloro-4-dimethylamino-6-methylpyrimidine | 157, 196 | 83 |
| 153 | 2-Chloro-9-(α-dimethylamino-propylidine)thioxanthene (trans-form) and its salts | 170 | 84 |
| 154 | 4-Chloro-1,3-disulphamoylbenzene | 181 | 85 |
| 155 | Chloroethane | 305 | 96 |
| 156 | Chloroform | 679 | 366 |
| 157 | 2-Chloro-6-methylpyrimidin-4-yldimethylamine | 152, 196 | 83 |
| 158 | Chlorophacinone (ISO) | 163 | 93 |
| 159 | 1-(p-Chloro-α-phenylbenzyl)-4-(2-hydroxyethoxyethyl)piperazine | 376 | 240 |
| 160 | 4-[4-(4-Chlorophenyl)-4-hydroxypiperidin-1-yl]-1-(4-fluorophenyl)butan-1-one | 345 | 185 |
| 161 | 2-(4-Chlorophenyl)-3-methylbutane-2,3-diol | 516 | 95 |
| 162 | 2-(4-Chlorophenyl-3-methyl-4-metathiazonone-1,1-dioxide | 149 | 91 |
| 163 | 2-[2-(4-Chlorophenyl)-2-phenylacetyl]indan-1,3-dione | 158 | 93 |
| 164 | 1-(4-Chlorophenyl)-1-phenyl-1-dimethylaminoethoxyethane | 167 | 94 |
| 165 | Chloropicrine | - | 325 |
| 166 | 3-(4-Chloro-3-sulphamoylphenyl)-3-hydroxyisoindolin-1-one | 171, 172 | 262 |
| 167 | Chlorphenoxamine (INN) | 164 | 94 |
| 168 | Chlorpromazine (INN) | (521) | 320 |
| 169 | Chlorpropamide (INN) | 573 | 79 |
| 170 | Chlorprothixene (INN) and its salts | 153 | 84 |
| 171 | Chlortalidone (INN) | 166, 172 | 262 |
| 172 | Chlorthalidone | 166, 171 | 262 |
| 173 | Chlorzoxazone (INN) | 150 | 82 |
| 174 | Cholecalciferol | (703) | 335 |
| 175 | Choline salts and their esters | - | 168 |
| 176 | Chromium, chromic acid and salts of the acid | - | 97 |
| 177 | Chrysoidine citrate hydrochloride | 525 | 81 |
| 178 | Cinchocaine (INN) and its salts | 120 | 129 |
| 179 | Cincophen (INN), its salts and derivatives and salts of those derivatives | 539 | 8 |
| 180 | Claviceps purpurea Tul., its alkaloids and galenical preparations | 296 | 98 |
| 181 | Clofenamide (INN) | 154 | 85 |
| 182 | Clofenotane (INN) | 213, 676 | 123 |
| 183 | Cobalt benzenesulphonate | - | 101 |
| 184 | Cocculin | 551 | 282 |
| 185 | Colchicine, its salts and derivatives | - | 102 |
| 186 | Colchicoside and its derivatives | - | 103 |
| 187 | Colchicum autumnale L. and its galenical preparations | - | 104 |
| 188 | Colouring agent CI 12140 | - | 378 |
| 189 | Colouring agent CI 26105 | - | 379 |
| 190 | Colouring agents CI 42555, 42555-�1 and 42555-�2 | - | 380 |
| 191 | Coniferyl benzoate (except natural content of essences) | 84 | 357 |
| 192 | Coniine | 574 | 290 |
| 193 | Conium maculatum L. (fruit, powder, galenical preparations) | - | 99 |
| 194 | Convallatoxin | - | 105 |
| 195 | Coumetarol (INN) | 427 | 225 |
| 196 | Crimidine (ISO) | 152, 157 | 83 |
| 197 | Croton tiglium(oil) | - | 107 |
| 198 | Curare and curarine | - | 109 |
| 199 | Curarizants, synthetic | - | 110 |
| 200 | Cyanides | 363, 365 | 111 |
| 201 | 1-(3-Cyano-3,3-diphenylpropyl)-4-phenyl-4-piperidinecarboxylic acid ethyl ester hydrochloride | 277 | 80 |
| 202 | Cyclarbamate (INN) | 210 | 122 |
| 203 | Cyclizine (INN) and its salts | 282 | 159 |
| 204 | Cyclobarbitone and its salts | (68) | 220 |
| 205 | Cyclocoumarol | 245 | 234 |
| 206 | 2-α-Cyclohexylbenzyl(N,N,N',N'-tetraethyl)trimethylenediamine | 517 | 112 |
| 207 | 2-Cyclohexyl-3,5-dimethylphenol and its salts | 209 | 113 |
| 208 | 1-Cyclohexyl-3-(p-methylbenzenesulphonyl)urea | 340 | 100 |
| 209 | Cyclomenol (INN) and its salts | 207 | 113 |
| 210 | Cyclopentane-1,1-dimethanol dicarbanilate | 202 | 122 |
| 211 | Cyclophosphamide (INN) and its salts | 99, 102 | 88 |
| 212 | Datura stramonium L. and its galenical preparations | 601 | 301 |
| 213 | DDT (ISO) (p,p'-DDT) | 182, 676 | 123 |
| 214 | Deanol aceglumate (INN) | 256 | 3 |
| 215 | Decamethonium bromide (INN) | 216 | 214 |
| 216 | Decamethylenebis(trimethylammonium) salts | 215 | 214 |
| 217 | Dextromethorphan (INN) and its salts | 430 | 226 |
| 218 | Dextropropoxyphene (INN) | 260 | 116 |
| 219 | O,O'-Diacetyl-N-allyl-N-normorphine | - | 117 |
| 220 | 1,2-Diaminobenzene and its salts | 533 | 363 |
| 221 | p,p'-Diaminodiphenyl | 79 | 26 |
| 222 | 1,4:3,6-Dianhydrosorbitol 2,5-dinitrate | 395 | 148 |
| 223 | 5-(α, β-Dibromophenethyl)-5-methylhydantoin | - | 119 |
| 224 | Dibromosalicylanilides | 225, 416 | 351 |
| 225 | Dibromsalan (INN) | (224) | 351 |
| 226 | Dichloroethanes | 306, 309 | 125 |
| 227 | Dichloroethylenes | 7, 702 | 126 |
| 228 | 2,3-Dichloro-2-methylbutane | 46 | 36 |
| 229 | Dichlorosalicylanilides | - | 349 |
| 230 | Dicoumarin | 231, 440 | 231 |
| 231 | Dicoumarol (INN) | 230, 440 | 231 |
| 232 | 2-(Diethylaminoethoxy)ethyl α-phenylpiperidine-1-acetate dimethiodide | 560 | 137 |
| 233 | 1-[4-(β-Diethylaminoethoxy)phenyl]-1-(4-tolyl)-2-(4-chlorophenyl)-ethanol | 691 | 92 |
| 234 | 2-Diethylaminoethyl 3-amino-4-butoxybenzoate and its salts | 27, 95 | 23 |
| 235 | 2-Diethylaminoethyl benzilate and its salts | 71 | 157 |
| 236 | 2-Diethylaminoethyl 4-ethoxybenzoate and its salts | 383, 500 | 179 |
| 237 | 2-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts | - | 128 |
| 238 | 2-Diethylaminoethyl α-phenyl-α-(N-piperidino)acetate | 97 | 287 |
| 239 | 3-Diethylaminopropyl cinnamate | - | 130 |
| 240 | Diethyl 4-nitrophenyl phosphate | 498 | 170 |
| 241 | O,O-DiethylO-4-nitrophenyl phosphorothioate | 499 | 131 |
| 242 | Difencloxazine (INN) | 529 | 270 |
| 243 | Digitaline and all heterosides ofDigitalis purpurea L. | - | 134 |
| 244 | 4,5-Dihydrobenzimidazol-4-one | 82, 83 | 48 |
| 245 | 3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H, 5H-pyrano [3,2-c]-[1]-benzopyran-5-one | 205 | 234 |
| 246 | Dihydrotachysterol (INN) | - | 342 |
| 247 | 2,2'-Dihydroxy-3,3',5,5'6,6'-hexachlorodiphenylmethane (hexachlorophene) | 351 | 371 |
| 248 | 3,4-Dihydroxy-α-(isopropylaminomethyl)benzyl alcohol | 391, 394 | 17 |
| 249 | 3,4-Dihydroxy-α-(methylaminomethyl)benzyl alcohol | 14, 294 | 14 |
| 250 | 4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene)dicoumarin | - | 207 |
| 251 | 1-(3,4-Dihydroxyphenyl)-2-ethylaminopropan-1-ol | 274 | 136 |
| 252 | 5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite | 385 | 361 |
| 253 | Dimethoxane | 265 | 368 |
| 254 | 4-[β-(3,4-Dimethoxyphenyl)ethyl]-1-(2-chlorophenyl)piperazine and its salts | 411 | 141 |
| 255 | Dimethylamine | - | 142 |
| 256 | 2-DimethylaminoethylN-acetylglutamate | 214 | 3 |
| 257 | 2-[α-(2-Dimethylaminoethoxy)-α-methylbenzyl]pyridine and its salts | 290 | 176 |
| 258 | 2-Dimethylaminoethylp-butylaminobenzoate and its salts | 634 | 63 |
| 259 | 2-[(2-Dimethylaminoethyl)-2-thienylamino]pyridine and its salts | 421 | 144 |
| 260 | (+)-4-Dimethylamino-3-methyl-1,2-diphenyl-2-propionyloxybutane | 218 | 116 |
| 261 | 1-Dimethylaminomethyl-1-methylpropyl benzoate and its salts | 50 | 50 |
| 262 | 2-Dimethylaminopropiophenone and its salts | 418 | 145 |
| 263 | 3-(3-Dimethylaminopropylidene)-1,2:4,5-dibenzocyclohepta-1,4-diene and its salts | 42 | 146 |
| 264 | N,N-Dimethyldiguanide and its salts | 420 | 147 |
| 265 | 2,6-Dimethyl-1,3-dioxan-4-yl acetate (Dimethoxane) | 253 | 368 |
| 266 | Dimethylformamide | - | 355 |
| 267 | 1,3-Dimethylpentylamine and its salts | 36, 442 | 30 |
| 268 | 1,2-Dimethyl-4-phenyl-4-carbmethoxyhexamethyleneimine and its salts | 422 | 174 |
| 269 | 1,3-Dimethyl-4-phenyl-4-carboxyethylhexamethyleneimine and its salts | 419 | 171 |
| 270 | Dimethyl sulphoxide (INN) | - | 338 |
| 271 | Dimevamide (INN) and its salts | 278 | 153 |
| 272 | Dinitrophenol isomers | - | 151 |
| 273 | Dioxane | - | 343 |
| 274 | Dioxethedrin (INN) and its salts | 251 | 136 |
| 275 | 2,5-Dioxo-3,3-diethyl-5-methylpiperidine and its salts | 452 | 133 |
| 276 | Diphenhydramine (INN) and its salts | 78 | 339 |
| 277 | Diphenoxylate hydrochloride (INNM) | 201 | 80 |
| 278 | 2,2-Diphenyl-4-dimethylamino-valeramide and its salts | 271 | 153 |
| 279 | 5,5-Diphenyl-4-imidazolidone | - | 160 |
| 280 | 4-Diphenylmethoxy-1-methylpiperidine and its salts | 286 | 154 |
| 281 | 3-Diphenylmethoxytropane and its salts | 75 | 158 |
| 282 | 1-Diphenylmethyl-4-methylpiperazine | 203 | 159 |
| 283 | 1,2-Diphenyl-4-(2-phenylsulphinylethyl)pyrazolidine-3,5-dione | 608 | 155 |
| 284 | α,α-Diphenyl-2-piperidinemethanol | 559 | 285 |
| 285 | α,α-Diphenyl-4-piperidinemethanol | 65 | 286 |
| 286 | Diphenylpyraline (INN) and its salts | 280 | 154 |
| 287 | 2,5-Dipropoxy-3,6-bis(ethyleneimino)-1,4-benzoquinone | 382 | 152 |
| 288 | 4-Dipropylsulphamylbenzoic acid | 565 | 161 |
| 289 | Disulfiram (INN) | 645, 656 | 162 |
| 290 | Doxylamine (INN) and its salts | 257 | 176 |
| 291 | Emetine, its salts and derivatives | - | 163 |
| 292 | Endrin (ISO) | 349 | 196 |
| 293 | Ephedrine and its salts | - | 164 |
| 294 | Epinephrine (INN) | 14, 249 | 14 |
| 295 | Ergocalciferol (INN) | (703) | 335 |
| 296 | Ergot, its alkaloids and galenical preparations | 180 | 98 |
| 297 | Eserine and its salts | 548 | 166 |
| 298 | Ethionamide (INN) | 310 | 319 |
| 299 | Ethoheptazine (INN) and its salts | 446 | 173 |
| 300 | Ethopropazine and its salts | (521) | 320 |
| 301 | 4-Ethoxyphenol | (366, 456) | 178 |
| 302 | 2-Ethylamino-5-phenyloxazolin-4-one | 319 | 180 |
| 303 | Ethyl bis(4-hydroxycoumarinyl)-acetate and salts of the acid | 304 | 204 |
| 304 | Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl)acetate and salts of the acid | 303 | 204 |
| 305 | Ethyl chloride | 155 | 96 |
| 306 | Ethylene dichloride | (226) | 125 |
| 307 | Ethylene oxide | - | 182 |
| 308 | 2-Ethyl-2,3-epoxyhexamide and its derivatives | 493 | 165 |
| 309 | Ethylidene chloride | (226) | 125 |
| 310 | 3-Ethylisothionicotinamide | 298 | 319 |
| 311 | β-Ethyl-β-methylglutarimide and its salts | 70, 312 | 183 |
| 312 | 4-Ethyl-4-methylpiperidine-2,6-dione and its salts | 70, 311 | 183 |
| 313 | β-Ethyl-β-methylvaleramide | 698 | 184 |
| 314 | Ethylphenacemide (INN) | 528 | 272 |
| 315 | 2-Ethyl-2-phenylglutarimide and its salts | 316, 338 | 181 |
| 316 | 3-Ethyl-3-phenylpiperidine-2,6-dione and its salts | 315, 338 | 181 |
| 317 | 3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone | 9 | 362 |
| 318 | Fenadiazole (INN) | 374 | 208 |
| 319 | Fenozolone (INN) | 302 | 180 |
| 320 | Fenyramidol (INN) | 538, 541 | 274 |
| 321 | Fluanisone (INN) | 326 | 187 |
| 322 | Fluoresone (INN) | 325 | 189 |
| 323 | 4'-Fluoro-4-[4-hydroxy-4-(α,α,α-trifluoro-m-tolyl)piperidino]-butyrophenone | 685 | 188 |
| 324 | 6-Fluoro-16-methyl-11β,17α,21-trihydroxypregna-1,4-diene-3,20-dione | 497 | 186 |
| 325 | p-Fluorophenylethylsulphone | 322 | 189 |
| 326 | 1-(4-Fluorophenyl)-4-[4-(2-methoxyphenyl)-1-piperazinyl]-butan-1-one | 321 | 187 |
| 327 | 5-Fluoropyrimidine-2,4-dione | 328 | 190 |
| 328 | Fluorouracil (INN) | 327 | 190 |
| 329 | Fluphenazine (INN) | (521) | 320 |
| 330 | Furazolidone (INN) | 479 | 252 |
| 331 | Furfuryltrimethylammonium salts | 334 | 192 |
| 332 | Furo[3,2-g]chromen-7-one and its alkyl-substituted derivatives (except natural content of essences) | 333, 434, 690 | 358 |
| 333 | Furocoumarin and its alkyl-substituted derivatives (except natural content of essences) | 332, 434, 690 | 358 |
| 334 | Furtrethonium iodide (INN) | 331 | 192 |
| 335 | Galantamine (INN) | - | 193 |
| 336 | Gallamine triethiodide (INN) | 693 | 329 |
| 337 | Glucocorticoids | 94 | 300 |
| 338 | Glutethimide (INN) and its salts | 315, 316 | 181 |
| 339 | Glycerol trinitrate | 480, 571 | 253 |
| 340 | Glycyclamide (INN) | 208 | 100 |
| 341 | Gold salts | - | 296 |
| 342 | Guaifenesin (INN) | 432 | 230 |
| 343 | Guanethidine (INN) and its salts | 344 | 259 |
| 344 | N-(2-Guanidinoethyl)heptamethyleneimine and its salts | 343 | 259 |
| 345 | Haloperidol (INN) | 160 | 185 |
| 346 | HCH (ISO) (gamma-HCH) | 96, 348, 401 | 195 |
| 347 | HETP | 353 | 316 |
| 348 | 1,2,3,4,5,6-Hexachlorocyclohexane | 96, 346, 401 | 195 |
| 349 | (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 | 292 | 196 |
| 350 | Hexachloroethane | - | 197 |
| 351 | Hexachlorophene (INN) | 247 | 371 |
| 352 | (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethanonaphthalene | 388 | 198 |
| 353 | Hexaethyl tetraphosphate | 347 | 316 |
| 354 | (1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride | 131 | 70 |
| 355 | (3S,5aR,9bS)-3,3a,4,5,5a,9b-Hexahydro-3,5a,9-trimethylnaphtho-[1,2-b]furan-2,8-dione | 587 | 217 |
| 356 | Hexamethonium bromide (INN) | (357) | 124 |
| 357 | N,N'-Hexamethylenebis(trimethylammonium) salts | 356 | 124 |
| 358 | Hexapropymate (INN) | 575 | 115 |
| 359 | Hydrastine, hydrastinine and their salts | - | 199 |
| 360 | Hydrazides and their salts | - | 200 |
| 361 | Hydrazine, its derivatives and their salts | - | 201 |
| 362 | 2-Hydrazino-octane and its salts | 487 | 202 |
| 363 | Hydrocyanic acid and its salts | 200, 365 | 111 |
| 364 | Hydrofluoric acid, its normal salts, complexes and hydrofluorides (except those listed in Part I of Schedule 2) | - | 191 |
| 365 | Hydrogen cyanide and its salts | 200, 363 | 111 |
| 366 | Hydroquinone monobenzyl, monoethyl and monomethyl ethers | 91, 301, 431, (456) | 178 |
| 367 | 7-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline | 706 | 135 |
| 368 | [4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid and its salts | 686 | 5 |
| 369 | 3-[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]propionic acid and its salts | 659 | 9 |
| 370 | 1-Hydroxymethyl-1-cyclohexylacetic acid, sodium salt | 593 | 114 |
| 371 | 8-Hydroxy-5(or 6)-nitroquinoline and its salts | 482 | 209 |
| 372 | 4-Hydroxy-3-(3-oxo-1-phenylbutyl)-coumarin and its salts | 2, 704 | 203 |
| 373 | 1-(4-Hydroxy-β-phenylethyl)-4-phenyl-4-carbethoxypiperidine and its salts | 495 | 172 |
| 374 | 2-(4-Hydroxyphenyl-1,3,4-oxadiazole | 318 | 208 |
| 375 | 1-Hydroxy-2,4,6-trinitrobenzene | 550, 689 | 268 |
| 376 | Hydroxyzine (INN) | 159 | 240 |
| 377 | Hyoscine, its salts and derivatives | 590 | 295 |
| 378 | Hyoscyamine, its salts and derivatives | - | 210 |
| 379 | Hyoscyamus niger L(leaves, seeds powder and galenical preparations) | - | 211 |
| 380 | 2-Imino-5-phenyloxazolidin-4-one and its salts | 502 | 212 |
| 381 | Imperatorin | 437 | 34 |
| 382 | Inproquone (INN) | 287 | 152 |
| 383 | Intracaine and its salts | 236, 500 | 179 |
| 384 | Iodine | - | 213 |
| 385 | Iodothymol | 252 | 361 |
| 386 | Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations) | - | 215 |
| 387 | Isocarboxazid (INN) | 88 | 52 |
| 388 | Isodrin | 352 | 198 |
| 389 | Isometheptene (INN) and its salts | 435 | 228 |
| 390 | 2-Isooctylamine and its salts | 35, 489 | 28 |
| 391 | Isoprenaline (INN) | 248, 394 | 17 |
| 392 | Isopropamide iodide (INN) | 135 | 156 |
| 393 | (2-Isopropylpent-4-enoyl)urea | 59 | 216 |
| 394 | Isoproterenol | 248, 391 | 17 |
| 395 | Isosorbide dinitrate (INN) | 222 | 148 |
| 396 | Juniperus sabina L. (leaves, essential oil and galenical preparations) | - | 294 |
| 397 | Laurel oil | 398 | 359 |
| 398 | Laurus nobilis L. (oil from seeds) | 397 | 359 |
| 399 | Lead and its compounds (except lead acetate) | - | 289 |
| 400 | Levophacetoperane and its salts | 556 | 284 |
| 401 | Lindane | 96, 346, 348 | 195 |
| 402 | Lobelia inflata L. and its galenical preparations | - | 218 |
| 403 | Lobeline (INN) and its salts | 105 | 219 |
| 404 | LSD | 406, 407 | 127 |
| 405 | Lupinidine and its salts | 598 | 299 |
| 406 | Lysergic acid diethylamide and its salts | 404, 407 | 127 |
| 407 | Lysergide (INN) and its salts | 404, 406 | 127 |
| 408 | Malononitrile | - | 149 |
| 409 | Mannomustine (INN) and its salts | 98 | 89 |
| 410 | Mecamylamine (INN) | 644 | 229 |
| 411 | Mefeclorazine (INN) and its salts | 254 | 141 |
| 412 | Mephenesin (INN) and its esters | 664 | 322 |
| 413 | Meprobamate (INN) | 450 | 236 |
| 414 | Mercury and its compounds (except those listed in Part III of Schedule 2 or in Part I of Schedule 4) | - | 221 |
| 415 | Mescaline and its salts | 687 | 222 |
| 416 | Metabromsalan (INN) | (224) | 351 |
| 417 | Metaldehyde | 562 | 223 |
| 418 | Metamfepramone (INN) and its salts | 262 | 145 |
| 419 | Metethoheptazine (INN) and its salts | 269 | 171 |
| 420 | Metformin (INN) and its salts | 264 | 147 |
| 421 | Methapyrilene (INN) and its salts | 259 | 144 |
| 422 | Metheptazine (INN) and its salts | 268 | 174 |
| 423 | Methocarbamol (INN) | 433 | 205 |
| 424 | Methohexitone and its salts | (68) | 220 |
| 425 | Methotrexate (INN) | 34 | 6 |
| 426 | 2-[4-Methoxybenzyl-N-(2-pyridyl)amino]ethyldimethylamine maleate | 580 | 346 |
| 427 | 1-Methoxy-2,2-bis(4-hydroxy-3-coumarinyl)ethane | 195 | 225 |
| 428 | 1-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole-CI 76050) | - | 376 |
| 429 | 1-Methoxy-2,5 diaminobenzene (2,5-diaminoanisole) | - | 377 |
| 430 | (+)-3-Methoxy-N-methylmorphinan and its salts | 217 | 226 |
| 431 | 4-Methoxyphenol | (366, 456) | 178 |
| 432 | 3-(4-Methoxyphenoxy)propane-1,2-diol | 342 | 230 |
| 433 | 3-(2-Methoxyphenoxy)propane-1,2-diol 1-carbamate | 423 | 205 |
| 434 | 8-Methoxypsoralen (except natural content of essences) | 332, 333, 690 | 358 |
| 435 | 6-Methylamino-2-methylhept-2-ene and its salts | 389 | 228 |
| 436 | 2-Methyl-1,2-bis(3-pyridyl)-propan-1-one | 453 | 292 |
| 437 | 9-(3-Methylbut-2-enyloxy)furo-[3,2-g]chromen-7-one | 381 | 34 |
| 438 | 2-Methyl-6-chloroanilide of n-butylaminoacetic acid and its salts | 117 | 90 |
| 439 | 1-Methyl-2,4-diaminobenzene and its salts | 447 | 364 |
| 440 | 3,3-Methylenebis-(4-hydroxycoumarin) | 230, 231 | 231 |
| 441 | 2-Methylheptylamine and its salts | - | 227 |
| 442 | 4-Methyl-2-hexylamine and its salts | 36, 267 | 30 |
| 443 | N,N'-[(Methylimino)diethylene]bis-(ethyldimethylammonium) salts | 66 | 121 |
| 444 | 1-Methyl-2-mercaptoimidazole | 650 | 233 |
| 445 | Methylphenidate (INN) and its salts | 535 | 175 |
| 446 | 1-Methyl-4-phenyl-4-carbethoxyhexamethyleneimine and its salts | 299 | 173 |
| 447 | 4-Methyl-m-phenylenediamine and its salts | 439 | 364 |
| 448 | 3-Methyl-2-phenylmorpholine, its derivatives and salts | 519 | 232 |
| 449 | 2-Methyl-2-propyl-1-isopropylcarbamoyloxy-3-carbamoyloxypropane | 141 | 235 |
| 450 | 2-Methyl-2-propylpropane-1,3-diol dicarbamate | 413 | 236 |
| 451 | N-Methyl-1,2,5,6-tetrahydro-3-nicotinic acid methyl ester | 60 | 238 |
| 452 | Methyprylon (INN) and its salts | 275 | 133 |
| 453 | Metyrapone (INN) | 436 | 292 |
| 454 | Minoxidil (INN), its salts and derivatives | 558 | 372 |
| 455 | Mofebutazone (INN) | 124 | 64 |
| 456 | Monobenzone (INN) | 91, 301, (366) 431 | 178 |
| 457 | Morpholine and its salts | - | 344 |
| 458 | Mustine and its salts | 100, 148 | 87 |
| 459 | MustineN-oxide and its salts | 101 | 86 |
| 460 | Nalorphine (INN), its salts and ethers | 21 | 20 |
| 461 | Naphazoline (INN) and its salts | 467 | 244 |
| 462 | 2-Naphthol | 463 | 241 |
| 463 | β-Naphthol | 462 | 241 |
| 464 | 1-and 2-Naphthylamines and their salts | 465 | 242 |
| 465 | α-and β-Naphthylamines and their salts | 464 | 242 |
| 466 | 3-(1-Naphthyl)-4-hydroxycoumarin | - | 243 |
| 467 | 2-(1-Naphthylmethyl)imidazoline and its salts | 461 | 244 |
| 468 | 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 |
| 469 | Narcotine and its salts | 485 | 258 |
| 470 | Neodymium and its salts | - | 309 |
| 471 | Neostigmine and its salts | - | 245 |
| 472 | Nicotine and its salts | - | 246 |
| 473 | Nitrites, inorganic (except sodium nitrite) | - | 248 |
| 474 | Nitrobenzene | - | 249 |
| 475 | Nitrocresols and their alkali metal salts | - | 250 |
| 476 | Nitroderivatives of carbazole | 136 | 72 |
| 477 | Nitrofurantoin (INN) | 478 | 251 |
| 478 | N-(5-Nitro-2-furfurylidene)-1-aminohydantoin | 477 | 251 |
| 479 | 3-(5-Nitrofurfurylideneamino)-oxazolidin-2-one | 330 | 252 |
| 480 | Nitroglycerine | 339, 571 | 253 |
| 481 | Nitrostilbenes, their homologues and derivatives | - | 256 |
| 482 | Nitroxoline (INN) and its salts | 371 | 209 |
| 483 | Noradrenaline and its salts | 33, 484 | 257 |
| 484 | Norepinephrine and its salts | 33, 483 | 257 |
| 485 | Noscapine (INN) and its salts | 469 | 258 |
| 486 | Nux vomica and its preparations | 605 | 305 |
| 487 | Octamoxin (INN) and its salts | 362 | 202 |
| 488 | Octamylamine (INN) and its salts | 510 | 267 |
| 489 | Octodrine (INN) and its salts | 35, 390 | 28 |
| 490 | Oestrogens | - | 260 |
| 491 | Oleandrin | - | 261 |
| 492 | [Oxalylbis(iminoethylene)]bis-[(o-chlorobenzyl)diethylammonium] salts | 24 | 132 |
| 493 | Oxanamide (INN) and its derivatives | 308 | 165 |
| 494 | 2-Oxo-3-isobutyl-9,10-dimethoxy-1,2,3,4,6,7-hexahydro-11bH-benzo-[a]quinolizine and its salts | 632 | 139 |
| 495 | Oxpheneridine (INN) and its salts | 373 | 172 |
| 496 | Padimate A | 47 | 381 |
| 497 | Paramethasone (INN) | 324 | 186 |
| 498 | Paraoxon | 240 | 170 |
| 499 | Parathion (ISO) | 241 | 131 |
| 500 | Parethoxycaine (INN) and its salts | 236, 383 | 179 |
| 501 | Pelletierine and its salts | 557 | 263 |
| 502 | Pemoline (INN) and its salts | 380 | 212 |
| 503 | Pentachloroethane | - | 264 |
| 504 | Pentaerythritol chloral | 514 | 266 |
| 505 | Pentaerythritol tetranitrate | 506, 513 | 265 |
| 506 | Pentaerythrityl tetranitrate (INN) | 505, 513 | 265 |
| 507 | Pentamethonium bromide (INN) | 508 | 120 |
| 508 | N,N'-Pentamethylenebis-(trimethylammonium) salts | 507 | 120 |
| 509 | Pentobarbitone and its salts | 68 | 220 |
| 510 | Pentylaminomethylheptane, its isomers and salts | 488 | 267 |
| 511 | Perchloroethylene | 636 | 314 |
| 512 | Perphenazine (INN) and its salts | (521) | 320 |
| 513 | PETN | 505, 506 | 265 |
| 514 | Petrichloral (INN) | 504 | 266 |
| 515 | Phenacemide (INN) | 524 | 269 |
| 516 | Phenaglycodol (INN) | 161 | 95 |
| 517 | Phenetamine | 206 | 112 |
| 518 | Phenindone (INN) | 534 | 271 |
| 519 | Phenmetrazine (INN), its derivatives and salts | 448 | 232 |
| 520 | Phenobarbitone and its salts | (68) | 220 |
| 521 | Phenothiazine (INN) and its compounds | various | 320 |
| 522 | Phenprobamate (INN) | 536 | 71 |
| 523 | Phenprocoumon (INN) | 537 | 273 |
| 524 | N-Phenylacetylurea | 515 | 269 |
| 525 | 4-Phenylazophenylene-1,3-diamine citrate hydrochloride | 177 | 81 |
| 526 | Phenylbutazone (INN) | 123 | 67 |
| 527 | 4-Phenylbut-3-en-2-one | 89 | 356 |
| 528 | N-(2-Phenylbutyryl)urea | 314 | 272 |
| 529 | N-[2-(α-Phenyl-p-chlorobenzyl)-ethyl]morpholine | 242 | 270 |
| 530 | 1-Phenylcyclopentanecarboxylic acid diethylaminoethyl ester and its salts | 134 | 169 |
| 531 | 2-Phenylcyclopropylamine (trans-form) and its salts | 665, 666 | 324 |
| 532 | 1-Phenyl-2,3-dimethyl-4-isopropylpyrazol-5-one | 576 | 138 |
| 533 | o-Phenylenediamine and its salts | 220 | 363 |
| 534 | 2-Phenylindan-1,3-dione | 518 | 271 |
| 535 | α-Phenyl-2-piperidineacetic acid methyl ester and its salts | 445 | 175 |
| 536 | 1-Phenylpropan-1-ol carbamate | 522 | 71 |
| 537 | 3-(α-Phenylpropyl)-4-hydroxycoumarin | 523 | 273 |
| 538 | 1-Phenyl-2-(2-pyridylamino)ethanol | 320, 541 | 274 |
| 539 | 2-Phenylquinoline-4-carboxylic acid, its saltsand derivatives and salts of those derivatives | 179 | 8 |
| 540 | 6-Phenyl-2,4,7-triaminopteridine and its salts | 669 | 275 |
| 541 | Phenyramidol | 320, 538 | 274 |
| 542 | Phosphides, metal | 543 | 279 |
| 543 | Phosphorus | 542 | 279 |
| 544 | 4-Phosphoryloxy-N,N-dimethyl-tryptamine | 578 | 278 |
| 545 | 3-Phthalimidopiperidine-2,6-dione and its salts | 647 | 280 |
| 546 | Phthalylsulphathiazole (INN) and its salts | (622) | 307 |
| 547 | Physostigma venenosum Balf. | 129 | 281 |
| 548 | Physostigmine and its salts | 297 | 166 |
| 549 | Phytolacca Spp and their preparations | - | 374 |
| 550 | Picric acid | 375, 689 | 268 |
| 551 | Picrotoxin | 184 | 282 |
| 552 | Pilocarpine and its salts | - | 283 |
| 553 | Pilocarpus jaborandi Holmes and its galenical preparations | - | 311 |
| 554 | Pipazetate (INN) and its salts | 555 | 118 |
| 555 | 2-(2-Piperidinoethoxy)ethyl-10-thia-1,9-diazaanthracene-9-carboxylate and its salts | 554 | 118 |
| 556 | α-Piperidin-2-ylbenzyl acetate, laevorotatorythreo-form | 400 | 284 |
| 557 | β-(2-Piperidyl)propionaldehyde and its salts | 501 | 263 |
| 558 | 6-(Piperidinyl)-2,4-pyrimidinediamine-3-oxide (Minoxidil) and its salts and derivatives | 454 | 372 |
| 559 | Pipradrol (INN) and its salts | 284 | 285 |
| 560 | Piprocurarium iodide (INN) | 232 | 137 |
| 561 | Poldine metilsulfate (INN) (or methylsulphate) | 81 | 239 |
| 562 | Polyacetaldehyde | 417 | 223 |
| 563 | Potassium nitroferricyanide | 15, 564, 594-�5 | 255 |
| 564 | Potassium nitroprusside | 15, 563, 594-�5 | 255 |
| 565 | Probenecid (INN) | 288 | 161 |
| 566 | Procainamide (INN), its salts and derivatives | 30 | 25 |
| 567 | Prochlorperazine (INN) and its salts | (521) | 320 |
| 568 | Progestogens (except progesterone and ethisterone) | - | 194 |
| 569 | Promazine (INN) and its salts | (521) | 320 |
| 570 | Promethazine (INN) and its salts | (521) | 320 |
| 571 | Propane-1,2,3-triyl trinitrate | 339, 480 | 253 |
| 572 | Propatylnitrate (INN) | 104 | 206 |
| 573 | 1-Propyl-3-(4-chlorobenzene-sulphonyl)urea | 169 | 79 |
| 574 | 2-Propylpiperidine | 192 | 290 |
| 575 | 1-(2-Propynyl)cyclohexyl carbamate | 358 | 115 |
| 576 | Propyphenazone (INN) | 532 | 138 |
| 577 | Prunus laurocerasus L. | 145 | 291 |
| 578 | Psilocybine (INN) | 544 | 278 |
| 579 | Pyrethrum album L. and its galenical preparations | - | 345 |
| 580 | Pyrianisamine maleate | 426 | 346 |
| 581 | Pyribenzamine | 92, 692 | 347 |
| 582 | Pyrithione sodium (INNM) | - | 369 |
| 583 | Quinalbarbitone and its salts | (68) | 220 |
| 584 | Radioactive substances (except substances which are radioactive naturally or by reason of contamination from the environment, which have not been enriched for manufacturing purposes, and of which the concentration complies with Council Directive No. 76/579/Euratom(19)) | - | 293 |
| 585 | Rauwolfia serpentina alkaloids and their salts | 586 | 15 |
| 586 | Reserpine (INN) and its salts | (585) | 15 |
| 587 | α-Santonin | 355 | 217 |
| 588 | 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 ppm; or (b) in the case of products other than oral hygiene or dental products, 100 ppm.) | - | 360 |
| 589 | Schoenocaulon officinale Lind.(seeds and galenical preparations) | - | 332 |
| 590 | Scopolamine, its salts and derivatives | 377 | 295 |
| 591 | Secbutobarbitone and its salts | (68) | 220 |
| 592 | Selenium and its compounds except when permitted under the restrictions laid down in Part I of Schedule 2 | - | 297 |
| 593 | Sodium hexacyclonate (INN) | 370 | 114 |
| 594 | Sodium nitroferricyanide | 15, 563, 564, 595 | 255 |
| 595 | Sodium nitroprusside | 15, 563, 564,594 | 255 |
| 596 | Solanum nigrum L. and its galenical preparations | - | 298 |
| 597 | Spanish Fly | 130 | 69 |
| 598 | Sparteine (INN) and its salts | 405 | 299 |
| 599 | Spironolactone (INN) | 10 | 4 |
| 600 | Squill and its preparations | 696 | 330 |
| 601 | Stramonium and its preparations | 212 | 301 |
| 602 | Strophanthines and their aglucones and their respective derivatives | - | 302 |
| 603 | Strophanthus species and their galenical preparations | - | 303 |
| 604 | Strychnine and its salts | - | 304 |
| 605 | Strychnos species and their galenical preparations | 486 | 305 |
| 606 | Succinonitrile | - | 150 |
| 607 | Succinylsulphathiazole and its salts | (622) | 307 |
| 608 | Sulfinpyrazone (INN) | 283 | 155 |
| 609 | Sulphacetamide and its salts | (622) | 307 |
| 610 | Sulphadiazine and its salts | (622) | 307 |
| 611 | Sulphadimethoxine and its salts | (622) | 307 |
| 612 | Sulphadimidine and its salts | (622) | 307 |
| 613 | Sulphafurazole and its salts | (622) | 307 |
| 614 | Sulphaguanidine and its salts | (622) | 307 |
| 615 | Sulphamethizole and its salts | (622) | 307 |
| 616 | Sulphamethoxazole and its salts | (622) | 307 |
| 617 | Sulphamethoxydiazine and its salts | (622) | 307 |
| 618 | Sulphamethoxypyridazine and its salts | (622) | 307 |
| 619 | Sulphanilamide and its salts | (622) | 307 |
| 620 | Sulphapyridine and its salts | (622) | 307 |
| 621 | Sulphathiazole and its salts | (622) | 307 |
| 622 | Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts | various | 307 |
| 623 | Sulthiame | 624, 643 | 308 |
| 624 | Sultiame (INN) | 623, 643 | 308 |
| 625 | 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 |
| 626 | Tefazoline (INN) and its salts | 642 | 237 |
| 627 | Tellurium and its compounds | - | 312 |
| 628 | TEPP (ISO) | 640 | 276 |
| 629 | 2-(4-tert-Butyl-2,6-dimethylbenzyl)-imidazoline and its salts | 708 | 313 |
| 630 | 4-tert-Butylphenol | - | 340 |
| 631 | 4-tert-butylpyrocatechol | - | 341 |
| 632 | Tetrabenazine (INN) and its salts | 494 | 139 |
| 633 | Tetrabromosalicylanilides | - | 350 |
| 634 | Tetracaine (INN) and its salts | 258 | 63 |
| 635 | 2,3,7,8-Tetrachlorodibenzo-p-dioxin | - | 367 |
| 636 | Tetrachloroethylene | 511 | 314 |
| 637 | Tetrachloromethane | 138 | 315 |
| 638 | Tetrachlorosalicylanilides | - | 348 |
| 639 | Tetraethylammonium bromide | 646 | 61 |
| 640 | Tetraethyl pyrophosphate | 628 | 276 |
| 641 | 5,6,6a,7-Tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-dihydric alcohol and its salts | 58 | 42 |
| 642 | 2-(5,6,7,8-Tetrahydro-1-methyl-2-naphthyl)-2-imidazoline and its salts | 626 | 237 |
| 643 | 4-(Tetrahydro-2H-1,2-thiazin-2-yl)-benzenesulphonamideS,S-dioxide | 623, 624 | 308 |
| 644 | N,2,3,3-Tetramethyl-2-norcamphanamine | 410 | 229 |
| 645 | Tetramethylthiuam disulphide | 289, 656 | 162 |
| 646 | Tetrylammonium bromide (INN) | 639 | 61 |
| 647 | Thalidomide (INN) and its salts | 545 | 280 |
| 648 | Thallium and its compounds | - | 317 |
| 649 | Thevetia neriifolia Juss., glycoside extract | - | 318 |
| 650 | Thiamazole (INN) | 444 | 233 |
| 651 | 2,2'-Thiobis(4,6-dichlorophenol) | 106 | 352 |
| 652 | Thiopentone and its salts | (68) | 220 |
| 653 | Thioridazine (INN) and its salts | (521) | 320 |
| 654 | Thiotepa (INN) | 670, 683 | 310 |
| 655 | Thiourea and its derivatives (except the one listed in Part I of Schedule 2) | - | 321 |
| 656 | Thiram (ISO) | 289, 645 | 162 |
| 657 | Thiuram disulphides | - | 354 |
| 658 | Thiuram monosulphides | - | 353 |
| 659 | Thyropropic acid (INN) and its salts | 369 | 9 |
| 660 | Tolboxane (INN) | 663 | 177 |
| 661 | Tolbutamide (INN) | 125 | 65 |
| 662 | Toluidines, their isomers, salts and halogenated and sulphonated derivatives | 40 | 32 |
| 663 | p-Tolylboric acid ester of 2-methyl-2-propylpropane-1,3-diol | 660 | 177 |
| 664 | 3-o-Tolyloxypropane-1,2-diol | 412 | 322 |
| 665 | trans-2-Phenylcyclopropylamine and its salts | 531, 666 | 324 |
| 666 | Tranylcypromine (INN) and its salts | 531, 665 | 324 |
| 667 | Tretamine (INN) | 682 | 328 |
| 668 | Tretinoin (INN) (retinoic acid and its salts) | - | 375 |
| 669 | Triamterene (INN) and its salts | 540 | 275 |
| 670 | Triaziridin-1-ylphosphine sulphide | 654, 683 | 310 |
| 671 | 2,2,2-Tribromoethanol | 672 | 326 |
| 672 | Tribromoethyl alcohol | 671 | 326 |
| 673 | 3,4,5-Tribromosalicylanilide (Tribromsalan) | - | 373 |
| 674 | Trichlormethine (INN) and its salts | 678 | 327 |
| 675 | Trichloroacetic acid | - | 10 |
| 676 | 1,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane | 182, 213 | 123 |
| 677 | 2,2,2-Trichloroethane-1,1-diol | 146 | 77 |
| 678 | Tri(β-chloroethyl)amine and its salts | 674 | 327 |
| 679 | Trichloromethane | 156 | 366 |
| 680 | N-(Trichloromethylthio)-4-cyclohex-4-ene-1,2-dicarboximide (Captan) | 132 | 370 |
| 681 | Tricresyl phosphate | 694 | 277 |
| 682 | 2,4,6-Triethyleneimino-1,3,5-triazine | 667 | 328 |
| 683 | N,N,N-Triethylenethiophosphamide | 654, 670 | 310 |
| 684 | Trifluoperazine (INN) and its salts | (521) | 320 |
| 685 | Trifluperidol (INN) | 323 | 188 |
| 686 | 3,3',5-Triiodothyroacetic acid and its salts | 368 | 5 |
| 687 | 3,4,5-Trimethoxyphenethylamine and its salts | 415 | 222 |
| 688 | 2-2-6-Trimethyl-4-piperidyl benzoate and its salts | 74 | 51 |
| 689 | 2,4,6-Trinitrophenol | 375, 550 | 268 |
| 690 | Trioxysalan (INN) (except natural content ofessences) | 332, 333, 434 | 358 |
| 691 | Triparanol (INN) | 233 | 92 |
| 692 | Tripelennamine (INN) | 92, 581 | 347 |
| 693 | 1,2,3-Tris(2-triethylammonium-ethoxy)benzene triiodide | 336 | 329 |
| 694 | Tritolyl phosphate | 681 | 277 |
| 695 | Tuaminoheptane (INN), its isomers and salts | 31 | 27 |
| 696 | Urginea scilla Stern. and its galenical preparations | 600 | 330 |
| 697 | Vaccines, toxins and serums listed in the Annex to Council Directive No. 75/319/EEC(20) | - | 323 |
| 698 | Valnoctamide (INN) | 313 | 184 |
| 699 | Veratrine, its salts and galenical preparations | - | 331 |
| 700 | Veratrum spp and their preparations | - | 333 |
| 701 | Vinyl chloride monomer | - | 334 |
| 702 | Vinylidene chloride | 7, 227 | 126 |
| 703 | Vitamins D2 and D3 | 174, 295 | 335 |
| 704 | Warfarin (ISO) and its salts | 2,372 | 203 |
| 705 | Xanthates | 16 | 336 |
| 706 | Xanthinol | 367 | 135 |
| 707 | Xylidines, their isomers, salts and halogenated and sulphonated derivatives | 41 | 33 |
| 708 | Xylometazoline (INN) and its salts | 629 | 313 |
| 709 | Yohimbine and its salts | - | 337 |
| 710 | Zoxazolamine (INN) | 29 | 24 |
Regulations 4(3) and 6(1)
In this Schedule, the matters specified in columns 3, 4, 5 and 6 which apply to a particular substance are those set out to the right of its name as mentioned in column 2; and the matters specified in columns 4, 5 and 6 which apply in any particular case are those set out to the right of the matter specified in column 3 which applies in that case. The substance may not be used except for the purposes or contained other than in the types of product specified in column 3. The concentration of the substance in a product may not exceed the limit specified in column 4: where the names of two or more substances are mentioned in a single item as set out in column 2 and a product contains more than one of those substances, the limit specified in column 4 is the limit for all of those substances taken together; and where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 5. In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.
| (1) | (2) | (3) | (4) | (5) | (6) |
|---|---|---|---|---|---|
| Reference Number | Name of substance | Purpose of substance or type of product | Maximum concentration of substance in product | Other requirements | Required information |
| 1 | Boric acid | Talcum powder | 5 per cent | Not to be used in products intended for children less than three years old | Not to be used for children under three years of age |
| Oral hygiene products | 0.5 per cent | - | - | ||
| Other products | 3 per cent | - | - | ||
| 2 | (a) Thioglycollic acid, its salts and esters | Hair waving or straightening products for general use | 8 per cent (calculated as thioglycollic acid) ready for use | pH value 7 to 9.5 | Contains thioglycollate. Follow the instructions. Keep out of reach of children. For professional use only (where applicable) |
| Hair waving or straightening products for professional use | 11 per cent (calculated as thioglycollic acid) ready for use | pH value 7 to 9.5 | |||
| Depilatories | 5 per cent (calculated as thioglycollic acid) ready for use | pH value 7 to 12.7 | |||
| Other hair care products which are removed after application | 2 per cent (calculated as thioglycollic acid) ready for use | pH value 7 to 9.5 The directions for use drawn up in national or official languages must incorporate the following instructions-Avoid contact with eyes. In the event of contact with the eyes rinse immediately with plenty of water and seek medical advice. Wear suitable gloves (this latter instruction does not apply to Depilatories) | |||
| (b) Thioglycollic acid esters | Hair waving or straightening products for general use | 8 per cent (calculated as thioglycollic acid) ready for use | pH value 6 to 9.5 | ||
| Hair waving or straightening products for professional use | 11 per cent (calculated as thioglycollic acid) ready for use | pH value 6 to 9.5 The directions for use drawn up in national or official languages must incorporate the following instructions-May cause sensitisation in the event of contact with the skin. Avoid contact with eyes. In the event of contact with the eyes rinse immediately with plenty of water and seek medical advice. Wear suitable gloves | |||
| 3 | Oxalic acid, its esters and alkaline salts | Hair care products | 5 per cent | - | For professional use only |
| 4 | Ammonia | All purposes and products | 6 per cent calculated as NH3 | - | Contains ammonia (not required when concentration is not more than 2 per cent) |
| 5 | Tosylchloramide Sodium | All purposes and products | 0.2 per cent | - | - |
| 6 | Chlorates of alkali metals | Toothpaste | 5 per cent | - | - |
| Other uses | 3 per cent | - | - | ||
| 7 | Dichloromethane | All purposes and products | 35 per cent (and when mixed with 1,1,1-trichloroethane, total concentration must not exceed 35 per cent) | Purity of the dichloromethane must be not less than 99.8 per cent | - |
| 8 | m-andp-Phenylenediamines, theirN-substituted derivativesand their salts;N-substituted derivatives ofo-phenylenediamines | Oxidizing colouring agents for hair dyeing for general use | 6 per cent calculated as a free base, subject to the provisions of "Combination Rule A" set out below | - | Contains phenylenediamines. Can cause an allergic reaction. Sensitivity test advisable before use. Do not use to dye eyelashes or eyebrows |
| Oxidizing colouring agents for hair dyeing for professional use | 6 per cent calculated as a free base, subject to the provisions of "Combination Rule A" set out below | - | Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Sensitivity test advisable before use | ||
| 9 | Methylphenylenediamines (other than 4-methyl-m-phenylenediamine and its salts), theirN-substituted derivatives and their salts | Oxidizing colouring agents for hair dyeing for general use | 10 per cent calculated as a free base, subject to the provisions of "Combination Rule A" set out below | - | Contains phenylenediamines. Can cause an allergic reaction. Sensitivity test advisable before use. Do not use to dye eyelashes or eyebrows |
| Oxidizing colouring agents for hair dyeing for professional use | 10 per cent calculated as a free base, subject to the provisions of "Combination Rule A" set out below | - | Contains phenylenediamines. For professional use only. Can cause an allergic reaction. Sensitivity test advisable before use | ||
| 10 | Diaminophenols | Oxidizing colouring agents for hair dyeing for general use | 10 per cent calculated as a free base, subject to the provisions of "Combination Rule A" set out below | - | Contains diaminophenols. Can cause an allergic reaction. Sensitivity test advisable before use. Do not use to dye eyelashes or eyebrows |
| Oxidizing colouring agents for hair dyeing for professional use | 10 per cent calculated as a free base, subject to the provisions of "Combination Rule A" set out below | - | Contains diaminophenols. For professional use only. Can cause allergic reaction. Sensitivity test advisable before use | ||
| 11 | Dichlorophen | All purposes and products | 0.5 per cent | - | Contains dichlorophen |
| 12 | Hydrogen peroxide | Hair care products preparations | 12 per cent of H2O2 (40 volumes) | - | Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them |
| Skin hygiene preparations | 4 per cent of H2O2 | - | Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them | ||
| Nail hardening preparations | 2 per cent of H2O2 | - | Contains hydrogen peroxide. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them | ||
| 13 | Formaldehyde (See also Part I of Schedule 4) | Nail hardeners | 5 per cent | - | Contains formaldehyde. Protect cuticles with grease or oil. (Not required when concentration is not more than 0.05 per cent) |
| 14 | Hydroquinone | Oxidizing colouring agent for hair dyeing for general use | 2 per cent subject to the provision of "Combination Rule B" set out below | - | Contains hydroquinone. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them |
| Oxidizing colouring agent for hair dyeing for professional use | 2 per cent subject to the provisions of "Combination Rule B" set out below | - | Contains hydroquinone. For professional use only. Rinse eyes immediately if product comes into contact with them | ||
| Agents for localised skin lightener | 2 per cent | - | Contains hydroquinone. Avoid contact with eyes. Apply to small areas. If irritation develops discontinue use. Do not use on children under the age of 12 | ||
| 15 | Potassium and sodium hydroxide | Nail cuticle solvent | 5 per cent calculated as sodium hydroxide | - | Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children |
| Hair straightener for general use | 2 per cent calculated as sodium hydroxide | - | Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children | ||
| Hair straightener for professional use | 4.5 per cent calculated as sodium hydroxide | - | For professional use only. Avoid contact with eyes. Can cause blindness | ||
| pH adjuster for depilatories | - | pH value not to exceed 12.7 | Keep out of reach of children. Avoid contact with eyes | ||
| Other uses as pH adjuster | - | pH value not to exceed 11 | Keep out of reach of children. Avoid contact with eyes | ||
| 16 | α-Naphthol | Colouring agent for hair dyeing | 0.5 per cent | - | Contains α-naphthol |
| 17 | Sodium nitrite | Rust inhibitor | 0.2 per cent | Do not use with secondary and/or tertiary amines or other substances forming nitrosamines | - |
| 18 | Nitromethane | Rust inhibitor | 0.3 per cent | - | - |
| 19 | Phenol and its alkali salts | Soaps and shampoos | 1 per cent calculated as phenol | - | Contains phenol |
| 20 | Pyrogallol | Oxidizing colouring agent for hair dyeing for general use | 5 per cent subject to the provisions of "Combination Rule B" set out below | - | Contains pyrogallol. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them |
| Oxidizing colouring agent for hair dyeing for professional use | 5 per cent subject to the provisions of "Combination Rule B" set out below | - | Contains pyrogallol. For professional use only. Rinse eyes immediately if product comes into contact with them | ||
| 21 | Quinine and its salts | Shampoos | 0.5 per cent calculated as quinine base | - | - |
| Hair lotions | 0.2 per cent calculated as quinine base | - | - | ||
| 22 | Resorcinol | Oxidizing colouring agent for hair dyeing for general use | 5 per cent subject to the provisions of "Combination Rule B" set out below | - | Contains resorcinol. Rinse hair well after application. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them |
| Oxidizing colouring agent for hair dyeing for professional use | 5 per cent subject to the provisions of "Combination Rule B" set out below | - | Contains resorcinol. For professional use only. Rinse eyes immediately if product comes into contact with them | ||
| Hair lotions and shampoos | 0.5 per cent subject to the provisions of "Combination Rule B" set out below | - | Contains resorcinol | ||
| 23 | (a) Alkali sulphides | Depilatories | 2 per cent calculated as sulphur | pH value not to exceed 12.7 | Keep out of reach of children. Avoid contact with eyes |
| (b) Alkaline earth sulphides | Depilatories | 6 per cent calculated as sulphur | pH value not to exceed 12.7 | Keep out of reach of children. Avoid contact with eyes | |
| 24 | Water-soluble zinc salts with the exception of zinc 4-hydroxybenzenesulphonate | All purposes and products | 1 per cent calculated as zinc | - | - |
| 25 | Zinc 4-hydroxybenzenesulphonate | Deodorants, antiperspirants and astringent lotions | 6 per cent calculated as percentage of anhydrous substance | - | Avoid contact with eyes |
| 26 | Ammonium monofluorophosphate | Oral hygiene products | 0.15 per cent calculated as fluorine. When mixed with other fluorine compounds total fluorine concentration must not exceed 0.15 per cent | - | Contains ammonium monofluorophosphate |
| 27 | Sodium monofluorophosphate | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains sodium monofluorophosphate |
| 28 | Potassium monofluorophosphate | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains potassium monofluorophosphate |
| 29 | Calcium monofluorophosphate | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains calcium monofluorophosphate |
| 30 | Calcium fluoride | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains calcium fluoride |
| 31 | Sodium fluoride | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains sodium fluoride |
| 32 | Potassium fluoride | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains potassium fluoride |
| 33 | Ammonium fluoride | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains ammonium fluoride |
| 34 | Aluminium fluoride | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains aluminium fluoride |
| 35 | Stannous fluoride | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains stannous fluoride |
| 36 | Hexadecyl ammonium fluoride | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains hexadecyl ammonium fluoride |
| 37 | 3-(n-Hexadecyl-N-2-hydroxyethylammonio)propyl-bis(2-hydroxyethyl)ammonium difluoride | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains 3-(n-hexadecyl-N-2-hydroxyethylammonio)propyl-bis(2-hydroxyethyl)ammonium difluoride |
| 38 | NN'N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride | Oral hygiene products | As for ammonium monofluorophosphate | - | ContainsNN'N'-tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride |
| 39 | Octadecenyl ammonium fluoride | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains octadecenyl ammonium fluoride |
| 40 | Sodium fluorosilicate | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains sodium fluorosilicate |
| 41 | Potassium fluorosilicate | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains potassium fluorosilicate |
| 42 | Ammonium fluorosilicate | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains ammonium fluorosilicate |
| 43 | Magnesium fluorosilicate | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains magnesium fluorosilicate |
| 44 | 1,3-Bis(hydroxymethyl)-imidazolidene-2-thione | Hair care preparations | 2 per cent | Not to be used in aerosol dispensers | Contains 1,3-Bis(hydroxymethyl)imidazoli-dene-2-thione |
| Nail care preparations | 2 per cent | pH as applied value must be less than 4 | Contains 1,3-Bis(hydroxymethyl)imidazoli-dene-2-thione | ||
| 45 | Benzyl alcohol (See also Part I of Schedule 4) | Solvent, perfumes and flavourings | - | - | - |
| 46 | 6-Methylcoumarin | Oral hygiene products | 0.003 per cent | - | - |
| 47 | Nicomethanol hydrofluoride | Oral hygiene products | As for ammonium monofluorophosphate | - | Contains nicomethanol hydrofluoride |
| 48 | Silver nitrate | Products to dye eyelashes or eyebrows | 4 per cent | - | Contains silver nitrate. Rinse eyes immediately if product comes into contact with them |
| 49 | Selenium disulphide | Anti-dandruff shampoos | 1 per cent | - | Contains selenium disulphide. Avoid contact with eyes or damaged skin |
| 50 | Aluminium zirconium chloride hydroxide complexes AlxZr(OH)yCLz and the aluminium zirconium chloride hydroxide glycine complexes | Anti-perspirants | 20 per cent as anhydrous aluminium zirconium chloride hydroxide 5.4 per cent as zirconium | The ratio of the number of aluminium atoms to that of zirconium atoms must be betweeen 2 and 10 The ratio of the number of (Al+Zr) atoms to chlorine atoms must be between 0.9 and 2.1 Not to be used in aerosol dispensers (sprays) | Do not apply to irritated or damaged skin |
| 51 | Quinolin-8-ol and bis(8-hydroxy-quinolinium sulphate) (See also Part II of this Schedule) | Stabilizer for hydrogen peroxide in rinse-off hair care preparations | 0.3 per cent calculated as base | - | - |
| Stabilizer for hydrogen peroxide in non-rinse-off hair care preparations | 0.03 per cent calculated as base | - | - | ||
| 52 | Methanol | Denaturant for ethanol and isopropyl alcohol | 5 per cent calculated as a percentage of ethanol and isopropyl alcohol | - | - |
| 53 | Etidronic acid and its salts (1-hydroxy-ethylidene-diphosphonic acid and its salts) | Hair care | 1.5 per cent expressed as etidronic acid | - | - |
| Soap | 0.2 per cent expressed as etidronic acid | - | - | ||
| 54 | 1-Phenoxypropan-2-ol (See also Part I of Schedule 4) | Products rinsed off after use. Prohibited in oral hygiene products | 2 per cent | - | - |
A. Where a cosmetic product contains two or more substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 1.
B. Where a cosmetic product contains the substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 2; but the concentration of each substance shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above.
C. The relevant quotient for each substance is the actual concentration of the substance in the product divided by the maximum concentration specified for the substance in respect of the product in Column 4 of this Schedule.
| (1) | (2) | (3) | (4) | (5) | (6) | (7) |
|---|---|---|---|---|---|---|
| Reference Number | Name of substance | Purpose of substance or type of product | Maximum concentration of substance in product | Other requirements | Required information | Permitted for use until |
| 1 | Quinolin-8-ol and bis(8 hydroxy-quinolium)-sulphate (See also Part I of this Schedule) | Skin hygiene products not rinsed off after use | 0.02 per cent calculated as base | - | Contains Quinolin-8-ol | 31.12.1990 |
| Foot hygiene products not rinsed off after use | 0.04 per cent calculated as base | - | ||||
| Mouth hygiene products | 0.01 per cent calculated as base | - | ||||
| 2 | 1,1,1-Trichloroethane (methyl chloroform) | Aerosol Spray | 35 per cent (and when mixed with dichloromethane total concentration must not exceed 35 per cent) | - | Do not spray on a naked flame or any incandescent material | 31.12.1989 |
| 3 | ENTRY DELETED | - | - | - | - | - |
| 4 | 2,2'-Dithiobis (pyridine 1-oxide), addition product with magnesium sulphate trihydrate | Rinsed-off hair care products | 1 per cent | - | - | 31.12.1989 |
| 5 | ENTRY DELETED |
| (1) | (2) | (3) | (4) | (5) | (6) |
|---|---|---|---|---|---|
| Reference Number | Name of substance | Purpose of substance or type of product | Maximum concentration of substance in product | Other requirements | Required information |
| 1 | Lead acetate | Hair care products | 3 per cent | - | Contains lead acetate. Wash hands after use. Do not use on broken or abraded skin. Keep out of reach of children |
| 2 | Thiomersal and phenylmercuric compounds | To preserve concentrated shampoos and hair creams which contain non-ionic emulsifiers which render other preservatives ineffective | 0.003 per cent calculated as mercury. When mixed with other mercury compounds the total mercury concentration must not exceed 0.007 per cent | - | - |
Regulation 4(4)
In this Schedule the colouring agents referred to in regulation 4(4)(a) are-�
(i)those identified in column 1 either by name or by colour index number (the colour index numbers being those specified in the third edition of The Colour Index published in 1971 by the Society of Dyers and Colourists);
(ii)lakes or salts of these colouring agents which do not use substances prohibited under Annex II or which are excluded under Annex V from the scope of the Directive.
In the case of colouring agents identified by the addition of (*) to the name or colour index number, the insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will be determined by the procedure laid down in Article 8 of the Directive.
Colouring agents whose number is preceded by the letter "E" in accordance with the EEC Directive of 23 October 1962 on the approximation of the rules of member States concerning foodstuffs and colouring matter(22), as amended,(23) and adapted(24) must fulfil the purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters where the letter "E" has been deleted therefrom.
In column 3 of this Schedule, the entry "X" in a sub-column means that the colouring agent must not be used other than as follows-�
Sub-column 1=Colouring agents allowed in all cosmetic products;
Sub-column 2=Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;
Sub-column 3=Colouring agents allowed exclusively in cosmetic products except cosmetic products intended to come into contact with the mucous membranes;
Sub-column 4=Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.
| (1) | (2) | (3) | (4) | |||
|---|---|---|---|---|---|---|
Type of product Field of application | ||||||
| Name or colour index number | Colour | 1 | 2 | 3 | 4 | Other requirements |
| 10006 | Green | X | ||||
| 10020 | Green | X | ||||
| 10316* | Yellow | X | ||||
| 11680 | Yellow | X | ||||
| 11710 | Yellow | X | ||||
| 11725 | Orange | X | ||||
| 11920 | Orange | X | ||||
| 12010 | Red | X | ||||
| 12075* | Orange | X | ||||
| 12085* | Red | X | 3 per cent maximum concentration in the finished product | |||
| 12120 | Red | X | ||||
| 12150 | Red | X | ||||
| 12370 | Red | X | ||||
| 12420 | Red | X | ||||
| 12480 | Brown | X | ||||
| 12490 | Red | X | ||||
| 12700 | Yellow | X | ||||
| 13015 | Yellow | X | E 105 | |||
| 13065(1)a | ||||||
| 14270 | Orange | X | E 103 | |||
| 14700 | Red | X | ||||
| 14720 | Red | X | E 122 | |||
| 14815 | Red | X | E 125 | |||
| 15510* | Orange | X | ||||
| 15525 | Red | X | ||||
| 15580 | Red | X | ||||
| 15585* | Red | X | ||||
| 15620 | Red | X | ||||
| 15630* | Red | X | 3 per cent maximum concentration in the finished product | |||
| 15800 | Red | X | ||||
| 15850* | Red | X | ||||
| 15865* | Red | X | ||||
| 15880 | Red | X | ||||
| 15980 | Orange | X | E 111 | |||
| 15985* | Yellow | X | E 110 | |||
| 16035 | Red | X | ||||
| 16185 | Red | X | E 123 | |||
| 16230 | Orange | X | ||||
| 16255* | Red | X | E 124 | |||
| 16290 | Red | X | E 126 | |||
| 17200 | Red | X | ||||
| 18050 | Red | X | ||||
| 18130 | Red | X | ||||
| 18690 | Yellow | X | ||||
| 18736 | Red | X | ||||
| 18820 | Yellow | X | ||||
| 18965 | Yellow | X | ||||
| 19140* | Yellow | X | E 102 | |||
| 20040 | Yellow | X | Maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm | |||
| 20170 | Orange | X | ||||
| 20470 | Black | X | ||||
| 21100 | Yellow | X | Maximum 3,3'-dichlorobenzidine concentration in the colouring agent: 5 ppm | |||
| 21108 | Yellow | X | Maximum 3,3'dichlorobenzidine concentration in the colouring agent: 5 ppm | |||
| 21230 | Yellow | X | ||||
| 24790 | Red | X | ||||
| 27290* | Red | X | ||||
| 27755 | Black | X | E152 | |||
| 28440 | Black | X | E151 | |||
| 40215 | Orange | X | ||||
| 40800 | Orange | X | ||||
| 40820 | Orange | X | E 160e | |||
| 40825 | Orange | X | E 160f | |||
| 40850 | Orange | X | E 161g | |||
| 42045 | Blue | X | See also Part II | |||
| 42051* | Blue | X | E 131 | |||
| 42053 | Green | X | ||||
| 42080 | Blue | X | ||||
| 42090 | Blue | X | ||||
| 42100 | Green | X | ||||
| 42170 | Green | X | ||||
| 42510 | Violet | X | ||||
| 42520 | Violet | X | 5 ppm maximum concentration in the finished product | |||
| 42640 | Violet | X | ||||
| 42735 | Blue | X | ||||
| 44045 | Blue | X | See also Part II | |||
| 44090 | Green | X | E 142 | |||
| 45100 | Red | X | ||||
| 45170* | Red | X | ||||
| 45170:1 | Red | X | ||||
| 45190 | Violet | X | ||||
| 45220 | Red | X | ||||
| 45350 | Yellow | X | 6 per cent maximum concentration in the finished product | |||
| 45370* | Orange | X | Not more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 2 per cent 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid | |||
| 45380* | Red | X | as immediately above | |||
| 45396 | Orange | X | When used in lipstick, thecolouring agent is allowed only in free acid form and in a maximum concentration of 1 per cent | |||
| 45405 | Red | X | Not more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 2 per cent 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid | |||
| 45410* | Red | X | as immediately above | |||
| 45425 | Red | X | Not more than 1 per cent 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid and 3 per cent 2-(iodo-6-hydroxy-3-oxo-3H-xanthen-9-yl)benzoic acid | |||
| 45430* | Red | X | as immediately above E 127 | |||
| 47000 | Yellow | X | ||||
| 47005 | Yellow | X | E 104 | |||
| 50325 | Violet | X | ||||
| 50420 | Black | X | ||||
| 51319 | Violet | X | ||||
| 58000 | Red | X | ||||
| 59040 | Green | X | ||||
| 60724 | Violet | X | ||||
| 60725 | Violet | X | ||||
| 60730 | Violet | X | ||||
| 61565 | Green | X | ||||
| 61570 | Green | X | ||||
| 61585 | Blue | X | ||||
| 62045 | Blue | X | ||||
| 69800 | Blue | X | E 130 | |||
| 69825 | Blue | X | ||||
| 71105 | Orange | X | ||||
| 73000 | Blue | X | ||||
| 73015 | Blue | X | E 132 | |||
| 73360 | Red | X | ||||
| 73385 | Violet | X | ||||
| 73900 | Violet | X | See also Part II | |||
| 73915 | Red | X | ||||
| 74100 | Blue | X | ||||
| 74160 | Blue | X | ||||
| 74180 | Blue | X | See also Part II | |||
| 74260 | Green | X | ||||
| 75100 | Yellow | X | ||||
| 75120 | Orange | X | E 160b | |||
| 75125 | Yellow | X | E 160d | |||
| 75130 | Orange | X | E 160a | |||
| 75135 | Yellow | X | E 161d | |||
| 75170 | White | X | ||||
| 75300 | Yellow | X | E 100 | |||
| 75470 | Red | X | E 120 | |||
| 75810 | Green | X | E 140 and E 141 | |||
| 77000 | White | X | E 173 | |||
| 77002 | White | X | ||||
| 77004 | White | X | ||||
| 77007 | Blue | X | ||||
| 77015 | Red | X | ||||
| 77120 | White | X | ||||
| 77163 | White | X | ||||
| 77220 | White | X | E 170 | |||
| 77231 | White | X | ||||
| 77266 | Black | X | ||||
| 77267 | Black | X | ||||
| 77268:1 | Black | X | E 153 | |||
| 77288 | Green | X | Free from chromate ions | |||
| 77289 | Green | X | Free from chromate ions | |||
| 77346 | Green | X | ||||
| 77400 | Brown | X | ||||
| 77480 | Brown | X | E 175 | |||
| 77489 | Orange | X | E 172 | |||
| 77491 | Red | X | E 172 | |||
| 77492 | Yellow | X | E 172 | |||
| 77499 | Black | X | E 172 | |||
| 77510 | Blue | X | Free from cyanide ions | |||
| 77713 | White | X | ||||
| 77742 | Violet | X | ||||
| 77745 | Red | X | ||||
| 77820 | White | X | E 174 | |||
| 77891 | White | X | E 171 | |||
| 77947 | White | X | ||||
| Acid red 195 | Red | X | ||||
| Aluminium, Zinc, magnesium and calcium stearates | White | X | ||||
| Anthocyanins | Red | X | E 163 | |||
| Beetroot red | Red | X | E 162 | |||
| Bromocresol green | Green | X | ||||
| Bromothymol blue | Blue | X | ||||
| Caramel | Brown | X | E 150 | |||
| Capsanthin capsorubin | Orange | X | E 160c | |||
| Lactoflavin | Yellow | X | E 101 | |||
In column 3 of this Schedule, the entry "X" in a sub-column means that the colouring agent must not be used other than as follows-�
Sub-column 1=Colouring agents allowed in all cosmetic products;
Sub-column 2=Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover;
Sub-column 3=Colouring agents allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes;
Sub-column 4=Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.
| (1) | (2) | (3) | (4) | (5) | |||
|---|---|---|---|---|---|---|---|
Type of product Field of application | |||||||
| Name or colour index number | Colour | 1 | 2 | 3 | 4 | Other requirements | Cosmetic product supplied until |
| 13065 | Yellow | X | 31.12.1989 | ||||
| 15800(1)a | |||||||
| 19120(1)a | |||||||
| 20470(1)a | |||||||
| 21110 | Orange | X | Maximum 3,3-dichlorobenzidine concentration in the colouring agent: 5 ppm | 31.12.1989 | |||
| 21115(1)a | |||||||
| 26100 | Red | X | 31.12.1989 | ||||
| 42045 | Blue | X | See also Part I | 31.12.1989 | |||
| 42170(1)a | |||||||
| 42535 | Violet | X | Solely in hair preparations at a maximum concentration of 100 ppm | 31.12.1989 | |||
| 44045 | Blue | X | See also Part I | 31.12.1989 | |||
| 45190(1)a | |||||||
| 47000(1)a | |||||||
| 61554 | Blue | X | Only in hair-care preparations in a maximum concentration of 50 ppm | 31.12.1989 | |||
| 73900 | Violet | X | See also Part I | 31.12.1989 | |||
| 73905(1)a | |||||||
| 74180 | Blue | X | See also Part I | 31.12.1989 | |||
| 75660(1)a | |||||||
Regulations 4(5) and 6(1)
In this Schedule, the matters specified in columns 3, 4, 5 and 6 which apply to a particular substance are those set out to the right of its name as mentioned in column 2; and the matters specified in columns 4, 5 and 6 which apply in any particular case are those set out to the right of the matter specified in column 3 which applies in that case. The substance may not be used or contained other than in the types of product specified in column 3. The concentration of the substance, when it is used as a preservative, in a product may not exceed the limit set out in column 4. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 5.
In column 4 of this Schedule, "A" indicates that the concentration of the substance in a product may exceed the limit set out in that column provided that-�
(a)the presence of any excess of the substance in a product over the concentration so set out is not for the primary purpose of inhibiting the development of micro-organisms; and
(b)the purpose for which any such excess is present in the product is apparent from the labelling of the product.
In this Schedule-�
"salts" means salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines and of the anions chloride, bromide, sulphate and acetate;
"esters" means esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl and phenyl.
In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.
All preservative substances containing formaldehyde or any substances named in this Schedule which release formaldehyde must be labelled with the warning "contains formaldehyde" when the concentration of formaldehyde in the final product exceeds 0.05 per cent.
| (1) | (2) | (3) | (4) | (5) | (6) |
|---|---|---|---|---|---|
| Reference Number | Name of substance | Purpose of substance or type of product | Maximum concentration of substance in product | Other requirements | Required information |
| 1 | Benzoic acid, its salts and esters | All products | 0.5 per cent (acid)A | - | - |
| 2 | Propionic acid and its salts | All products | 2 per cent (acid)A | - | - |
| 3 | Salicylic acid and its salts | All products | 0.5 per cent (acid)A | Not to be used in preparations for children under three years of age except for shampoos | Not to be used for children under three years of age (Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin) |
| 4 | Sorbic acid (hexa-2,4-dienoic acid) and its salts | All products | 0.6 per cent (acid)A | - | - |
| 5 | Formaldehyde and paraformaldehyde | For oral hygiene | 0.1 per cent (concentrations expressed as free formaldehyde) | Not to be used in aerosol dispensers (sprays) | - |
| Except for oral hygiene (see also Part I of Schedule 2) | 0.2 per cent (concentrations expressed as free formaldehyde) | ||||
| 6 | Hexachlorophene (INN) (1)a | ||||
| 7 | Biphenyl-2-ol (o-phenylphenol) and its salts | All products | 0.2 per cent expressed as the phenolA | - | - |
| 8 | Pyrithione zinc (INN) | Products rinsed off after use | 0.5 per centA | Not to be used in oral hygiene products | - |
| 9 | Inorganic sulphites and hydrogen sulphites | All products | 0.2 per cent expressed as free SO2A | - | - |
| 10 | Sodium iodate | Products rinsed off after use | 0.1 per cent | - | - |
| 11 | Chlorobutanol (INN) | All products | 0.5 per cent | Not to be used in aerosol dispensers (sprays) | Contains chlorobutanol |
| 12 | 4-Hydroxybenzoic acid and its salts and esters | All products | 0.4 per cent (acid) for 1 ester, 0.8 per cent (acid) for mixtures of estersA | - | - |
| 13 | 3-Acetyl-6-methylpyran-2,4-(3H)-dione (Dehydracetic acid) and its salts | All products | 0.6 per cent (acid) | Not to be used in aerosol dispensers (sprays) | - |
| 14 | Formic acid | All products | 0.5 per cent (acid)A | - | - |
| 15 | 3,3'-Dibromo-4,4'-hexamethylene-dioxydibenzamidine-(Dibromohexamidine) and its salts (including isethionate) | All products | 0.1 per cent | - | - |
| 16 | Thiomersal (INN) | Eye make-up and eye make-up remover | 0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent | - | Contains thiomersal |
| 17 | Phenylmercuric salts (including borate) | Eye make-up and eye make-up remover | 0.007 per cent calculated as mercury. When mixed with other authorised mercury compounds total mercury concentration must not exceed 0.007 per cent | - | Contains phenylmercuric compounds |
| 18 | Undec-10-enoic acid and its salts | All products | 0.2 per cent (acid)A | - | - |
| 19 | Hexetidine (INN) | Products rised off after use | 0.1 per centA | - | - |
| 20 | 5-Bromo-5-nitro-1,3-dioxane | Products rinsed off after use | 0.1 per cent | Avoid formation of nitrosamines | - |
| 21 | Bronopol (INN) | All products | 0.1 per centA | Avoid formation of nitrosamines | - |
| 22 | 2,4-Dichlorobenzyl alcohol | All products | 0.15 per centA | - | - |
| 23 | Triclocarban (INN) | All products | 0.2 per centA | Purity criteria: 3,3'4,4'-Tetrachloroazobenzene 1 ppm 3,3',4,4'-Tetrachloroazoxybenzene 1 ppm | - |
| 24 | 4-Chloro-m-cresol | Not to be used in products intended to come into contact with mucous membranes | 0.2 per centA | - | - |
| 25 | Triclosan (INN) | All products | 0.3 per centA | - | - |
| 26 | 4-Chloro-3,5-xylenol | All products | 0.5 per centA | - | - |
| 27 | 3,3'-Bis(1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea ("Imidazolidinyl urea") | All products | 0.3 per centA | - | - |
| 28 | Poly(1-hexamethylene-biguanide hydrochloride) | All products | 0.3 per centA | - | - |
| 29 | 2-Phenoxyethanol | All products | 1.0 per centA | - | - |
| 30 | Hexamethylenetetramine (methenamine (INN)) | All products | 0.15 per centA | - | - |
| 31 | Methenamine 3-chloroallylochloride (INNM) | All products | 0.2 per cent | - | - |
| 32 | 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-di-methylbutan-2-one | All products | 0.5 per centA | - | - |
| 33 | 1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione | All products | 0.6 per centA | - | - |
| 34 | Benzyl alcohol (See also Part I of Schedule 2) | All products | 1.0 per centA | - | - |
| 35 | 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone and its monoethanolamine salt | Products rinsed off after use | 1.0 per centA | - | - |
| For other products | 0.5 per centA | - | - | ||
| 36 | 1,2-Dibromo-2,4-dicyanobutane | All products | 0.1 per cent | Not to be used in cosmetic sunscreen products | - |
| 37 | 6,6-Dibromo-4,4-dichloro-2,2'-methylenediphenol (Bromochlorophen) | All products | 0.1 per centA | - | - |
| 38 | 4-Isopropyl-m-cresol | All products | 0.1 per cent | - | - |
| 39 | Mixture of 5-Chloro-2-methylisothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate | All products | 0.0015 per cent of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol,3(2H)-one and 2-methylisothiazol-3(2H)-one | - | - |
| 40 | 2-Benzyl-4-chlorophenol (Chlorophene) | All products | 0.2 per cent | - | - |
| 41 | 2-Chloroacetamide | All products | 0.3 per cent | - | Contains chloroacetamide |
| 42 | Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride | All products | 0.3 per centA | - | - |
| 43 | 1-Phenoxypropan-2-ol (see also Part I, of Schedule 2) | Products rinsed off after use | 1.0 per cent | - | - |
| (1) | (2) | (3) | (4) | (5) | (6) | (7) |
|---|---|---|---|---|---|---|
| Reference Number in Annex VI Part 2 of the Directive | Name of substance | Purpose of substance or type of product | Maximum concentration of substance in product | Other requirements | Required information | Preservative supplied until |
a Notes: (1) Prior to the coming into force of article 1(7) to Directive 88/233/EEC Chlorophensin (INN) item 2 above is permitted to be used up to a maximum concentration figure of 0.5 per cent. | ||||||
| 1 | ENTRY DELETED (2)b | |||||
| 2 | Chlorphenesin (INN) (see note (1))a | All products | 0.3 per cent | - | - | 31.12.1989 |
| 3 | ENTRY DELETED (2)b | |||||
| 4 | Alkyl (C12-�C22) trimethylammonium bromide and chloride (including Cetrimonium bromide (INN)) | All products | 0.1 per centA | - | - | 31.12.1989 |
| 5 | ENTRY DELETED (2)b | |||||
| 6 | 4,4-Dimethyl-1,3-oxazolidine | Products rinsed off after use | 0.1 per cent | The pH of the finished product shall not be lower than 6 | - | 31.12.1989 |
| 7 to 14 | ENTRIES DELETED (2)b | |||||
| 15 | Benzethonium chloride (INN) | Not to be used in products intended to come into contact with mucous membranes | 0.1 per centA | - | - | 31.12.1989 |
| 16 | Benzalkonium chloride (INN) bromide and saccharinate | All products | 0.25 per centA | - | - | 31.12.1989 |
| 17 | 1-[1,3-Bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea | All products | 0.5 per cent | - | - | 31.12.1989 |
| 18 to 19 | ENTRY DELETED (2)b | |||||
| 20 | Hexamidine (INN) and its salts (including isethionate and 4-hydroxybenzoate) | All products | 0.1 per centA | - | - | 31.12.1989 |
| 21 | Benzylhemiformal (a 1:1 mixture of benzyloxymethanol and (benzyloxymethoxy) methanol) | All products | 0.2 per cent | - | - | 31.12.1989 |
| 22 to 25 | ENTRIES DELETED (2)b | |||||
| 26 | Glutaraldehyde | Prohibited in aerosols (sprays) | 0.1 per cent | Contains glutaraldehyde where the glutaraldehyde concentration in the finished product exceeds 0.05 per cent | - | 31.12.1991 |
Regulations 4(6) and 6(1)
In this Schedule, the matters specified in columns 3, 4 and 5 which apply to a particular substance are those set out to the right of its name as mentioned in column 2. The concentration of the substance in a product may not exceed the limit specified in column 3. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 4. In column 3 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.
| (1) | (2) | (3) | (4) | (5) |
|---|---|---|---|---|
| Reference Number | Name of substance | Maximum concentration of substance in product | Other requirements | Required information |
| 1 | 4-Aminobenzoic acid | 5 per cent | - | - |
| 2 | N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl)anilinium methyl sulphate | 6 per cent | - | - |
| 3 | Homosalate (INN) | 10 per cent | - | - |
| 4 | Oxybenzone (INN) | 10 per cent | - | Contains oxybenzone. (Not required when concentration is not more than 0.5 per cent, and when the substance is only intended to protect the product.) |
| 5 | 3-Imidazol-4-ylacrylic acid and its ethyl ester | 2 per cent (expressed as acid) | - | - |
| 6 | 2-Phenylbenzimidazole-5-sulphonic acid and its potassium, sodium and triethanolamine salts | 8 per cent (expressed as acid) | - | - |
| (1) | (2) | (3) | (4) | (5) | (6) |
|---|---|---|---|---|---|
| Reference Number | Name of substance | Maximum concentration of substance in product | Other requirements | Required information | UV filter supplied until |
| 1 | N-Propoxylated ethyl 4-bis aminobenzoate, mixed isomers | 5 per cent | - | - | 31.12.1991 |
| 2 | Ethoxylated ethyl 4-aminobenzoate | 10 per cent | - | - | 31.12.1991 |
| 3 | ENTRY DELETED | ||||
| 4 | Glycerol 1-(4-aminobenzoate) | 5 per cent | Must not contain any benzocaine (INN) | - | 31.12.1991 |
| 5 | 2-Ethylhexyl 4-dimethylaminobenzoate | 8 per cent | - | - | 31.12.1991 |
| 6 | 2-Ethylhexyl salicylate | 5 per cent | - | - | 31.12.1991 |
| 7-�11 | ENTRIES DELETED | ||||
| 12 | Isopentyl 4-methoxycinnamate mixed isomers | 10 per cent | - | - | 31.12.1991 |
| 13 | 2-Ethylhexyl 4-methoxycinnamate | 10 per cent | - | - | 31.12.1991 |
| 14-�15 | ENTRIES DELETED | ||||
| 16 | 2-Hydroxy-4-methoxy-4-methylbenzophenone (Mexenone) | 4 per cent | - | Contains Mexenone (Not required when concentration is not more 0.5 per cent and when the substance is only intended to protect the product) | 31.12.1991 |
| 17 | 2-Hydroxy-4-methoxybenzophenone-5 sulphonic acid and sodium salt (Sulisobenzone and Sulisobenzone sodium) | 5 per cent (expressed as acid) | - | - | 31.12.1991 |
| 18-�23 | ENTRIES DELETED | ||||
| 24 | α-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts | 6 per cent (expressed as acid) | - | - | 31.12.1991 |
| 25 | 3-(4-Methylbenzylidene)-d-1-camphor | 6 per cent | - | - | 31.12.1991 |
| 26 | 3-Benzylidene camphor | 6 per cent | - | - | 31.12.1991 |
| 27 | ENTRY DELETED | ||||
| 28 | 4-Isopropyl dibenzoylmethane | 5 per cent | - | - | 31.12.1991 |
| 29 | 4-Isopropylbenzyl salicylate | 4 per cent | - | - | 31.12.1991 |
| 30 | ENTRY DELETED | ||||
| 31 | 1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)propane 1,3-dione | 5 per cent | - | - | 31.12.1991 |
| 32 | 2,4,6-Trianilino-(p-carbo-2' ethylhexyl-1'-oxi)-1,3,5-triazine | 5 per cent | - | - | 31.12.1991 |
Regulation 9
1. In this Schedule-�
"Annex A" means the Annex to Commission Directive No. 80/1335/EEC(31), as amended by Commission Directive No. 87/143/EEC(32);
"Annex B" means the Annex to Commission Directive No. 82/434/EEC(33);
"Annex C" means the Annex to Commission Directive No. 83/514/EEC(34);
"Annex D" means the Annex to Commission Directive No. 85/490/EEC(35);
"purchase" means purchase for the purpose of carrying out a test.
2. An enforcement authority intending to purchase a cosmetic product shall purchase a sufficient laboratory sample, as defined in paragraph 2.3 of Part I of Annex A, for the purpose of Annex A; and, for the purposes of the definition of "total sample" in paragraph 2.2 of Part I of Annex A, samples shall be regarded as having the same batch number if:
(a)the means of identifying the batch referred to in regulation 6(1)(g) above shows that they were manufactured in the same batch; or
(b)in the case of a product not manufactured in a batch, the reference referred to in regulation 6(1)(g) above shows that they are derived from the same unit of production; or
(c)in the case of a product which does not comply with the requirements of regulation 6(1)(g) above, the officer effecting the purchase has reasonable cause to believe that they were manufactured in the same batch or are derived from the same unit of production, as the case may be.
3. The immediate container, if any, of a cosmetic product purchased by an enforcement authority shall not have been opened by, on behalf of or at the request of the enforcement authority before the purchase takes place and the container shall not thereafter be opened except in accordance with paragraph 5.3 of Part I of Annex A and paragraph 1.2 of Part II of Annex A.
4. As soon as an enforcement authority has purchased a cosmetic product, the officer effecting the purchase shall-�
(a)either-�
(i)place a seal on the product's container or outer packaging, or
(ii)place the product in a container and forthwith place a seal on that container, in such a way that the product's immediate container cannot be opened or (in the case of a product which was not in a container when it was purchased) the product cannot be touched without (in either case) the seal being broken in such a manner that it would be apparent thereafter that it had been broken, and
(b)attach to the product a label indicating-�
(i)the name of the product,
(ii)the date, time and place at which the product was purchased,
(iii)his own name, and
(iv)the name of the enforcement authority making the purchase.
5.-(1) Subject to sub-paragraph (2) below, the provisions of Part I of Annex A, other than paragraphs 3.1, 3.2 and 4, and of Part II of Annex A, other than paragraph 1.4, shall be complied with in the sampling of cosmetic products and the laboratory preparation of test portions.
(2) Where, because of the way in which a cosmetic product is put up for sale, it is not practicable for Part II of Annex A to be complied with, it shall be prepared for testing in accordance with good analytical practice, and the person so preparing it shall record in writing the method of preparation which he has used.
6.-(1) Any test to determine whether a cosmetic product contains a significant amount of free sodium hydroxide or free potassium hydroxide shall be carried out in accordance with paragraphs 1 to 4 of Part III of Annex A.
(2) Any test to determine the amount of free sodium hydroxide or free potassium hydroxide in a hair straightener product or a nail cuticle solvent product shall be carried out in accordance with paragraphs 1, 2, 3 and 5 of Part III of Annex A.
(3) Any test to determine whether a hair-care product contains oxalic acid or any alkaline salt of oxalic acid or to determine the amount of such a substance in a hair-care product shall, subject to the limitation specified in the second sentence of paragraph 1 of Part IV of Annex A, be carried out in accordance with the said Part IV.
(4) Any test to determine the amount of chloroform in toothpaste shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex A, be carried out in accordance with the said Part V.
(5) Any test to determine the amount of zinc chloride, zinc sulphate or zinc 4-hydroxybenzenesulphonate by virtue of their zinc contents in a cosmetic product shall be carried out in accordance with Part VI of Annex A and Commission Directive 87/143/EEC(36), and shall take into account paragraph 11 of Part VII of Annex A.
(6) Any test to determine whether a cosmetic product contained in an aerosol dispenser or a cream, emulsion, lotion, gel or oil intended to be applied to the skin contains 4-hydroxybenzenesulphonic acid, or to determine the amount of that acid in such a product, shall be carried out in accordance with Part VII of Annex A.
(7) Any test to determine whether a hair-care product contains persulphate, bromate or hydrogen peroxide shall be carried out in accordance with Part A of Part 1 of Annex B.
(8) Any test to determine whether a hair-care product contains barium peroxide shall be carried out in accordance with Part B of Part 1 of Annex B.
(9) Any test to determine the amount of hydrogen peroxide in a hair-care product shall be carried out in accordance with Part C of Part 1 of Annex B.
(10) Any test to determine whether a hair-dye contains any of the oxidation colorants specified in paragraph 1 of Part II of Annex B, or to determine the amount of such a substance in a hair-dye, shall be carried out in accordance with the said Part II.
(11) Any test to determine whether a cosmetic product contains nitrite, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part III of Annex B.
(12) Any test to determine whether a cosmetic product contains free formaldehyde, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with Part IV of Annex B.
(13) Any test to determine the amount of resorcinol in a shampoo or hair lotion shall, subject to the limitation specified in the second sentence of paragraph 1 of Part V of Annex B, be carried out in accordance with the said Part V.
(14) Any test to determine the amount of methanol in relation to ethanol or propan-2-ol in a cosmetic product shall be carried out in accordance with Part VI of Annex B.
(15) Any test to determine the amount of dichloromethane or 1,1,1-trichloroethane in a cosmetic product shall be carried out in accordance with paragraphs 1 to 10 of that part of Annex C which is headed "Determination of dichloromethane and 1,1,1-trichloroethane".
(16) Any test to determine whether a cosmetic product contains quinolin-8-ol or bis(8-hydroxyquinolinium) sulphate, or to determine the amount of such a substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed "Identification and determination of quinolin-8-ol and bis(8-hydroxyquinolinium) sulphate".
(17) Any test to determine the amount of ammonia in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed "Determination of ammonia".
(18) Any test to determine whether a cosmetic product contains nitromethane, or to determine the amount of that substance in a cosmetic product, shall be carried out in accordance with paragraphs 1 to 7 of that part of Annex C which is headed "Identification and determination of nitromethane".
(19) Any test to determine whether a hair waving, hair straightening or depilatory product contains mercaptoacetic acid, or to determine the amount of that substance in such a product, shall be carried out in accordance with paragraphs 1 to 6 of that part of Annex C which is headed "Identification and determination of mercaptoacetic acid in hair-waving, hair-straightening and depilatory products".
(20) Any test to determine whether a cosmetic product contains hexachlorophene (INN) shall be carried out in accordance with paragraphs 1 to 7 of Part A of that part of Annex C which is headed "Identification and determination of hexachlorophene".
(21) Any test to determine the amount of hexachlorophene (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of Part B of that part of Annex C which is headed "Identification and determination of hexachlorophene".
(22) Any test to determine the amount of tosylchloramide sodium (INN) in a cosmetic product shall be carried out in accordance with paragraphs 1 to 9 of that part of Annex C which is headed "Quantitative determination of tosylchloramide sodium (INN) (chloramine-T)".
(23) Any test to determine the total amount of fluorine in dental creams shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed "Determination of total fluorine in dental creams".
(24) Any test to determine whether a cosmetic product contains organomercury compounds shall be carried out in accordance with paragraphs 1 to 4 of Part A of that part of Annex C which is headed "Identification and determination of organomercury compounds".
(25) Any test to determine the amount of organomercury compounds in a cosmetic product shall be carried out in accordance with paragraphs 1 to 7 of Part B of that part of Annex C which is headed "Identification and determination of organomercury compounds".
(26) Any test to determine the amount of alkali sulphides or alkaline earth sulphides in a cosmetic product shall be carried out in accordance with paragraphs 1 to 8 of that part of Annex C which is headed "Determination of alkali and alkaline earth sulphides".
(27) Any test for the identification and determination of the amount of glycerol 1-(4-aminobenzoate) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed "Identification and determination of glycerol 1-(4-aminobenzoate)".
(28) Any test to determine the amount of chlorobutanol (INN) in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed "Determination of chlorobutanol".
(29) Any test for the identification and determination of the amount of quinine in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed "Identification and determination of quinine".
(30) Any test for the identification and determination of inorganic sulphites and hydrogen sulphites in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed "Identification and determination of inorganic sulphites and hydrogen sulphites".
(31) Any test for the identification and determination of chlorates of the alkali metals in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed "Identification and determination of chlorates of the alkali metals".
(32) Any test for the identification and determination of sodium iodate in a cosmetic product shall be carried out in accordance with that part of Annex D which is headed "Identification and determination of sodium iodate".
Regulation 1(6)
| (1) | (2) |
|---|---|
| Regulations revoked | References |
| The Cosmetic Products (Safety) Regulations 1984 | S.I. 1984/1260 |
| The Cosmetic Products (Safety) (Amendment) Regulations 1985 | S.I. 1985/2045 |
| The Cosmetic Products (Safety) (Amendment) Regulations 1987 | S.I. 1987/1920 |
| The Cosmetic Products (Safety) (Amendment) Regulations 1988 | S.I. 1988/802 |
| The Cosmetic Products (Safety) (Amendment No. 2) Regulations 1988 | S.I. 1988/2121 |
(This note is not part of the Regulations)
These Regulations consolidate with amendments the Cosmetic Products (Safety) Regulations 1984 as amended. They implement the requirements of Council Directives No. 76/768/EEC, as amended the last amendments being Council Directive No. 88/667/EEC and Commission Directive 89/174/EEC, and of Commission Directives No. 80/1335/EEC, as amended, No. 82/434/EEC, No. 83/514/EEC and No. 85/490/EEC, relating to cosmetic products, and, as permitted by the Directives, impose certain additional requirements relating to the composition of cosmetic products. The Regulations are made under the Consumer Protection Act 1987 and the European Communities Act 1972.
The last amending Council and Commission Directives which are implemented for the first time by these Regulations-�
1. Require that marking information shall, if practicable, be borne on both the internal container and the outer packaging (regulation 6).
2. Prohibit four substances from use in cosmetic products by the addition of their names to Schedule 1 to these Regulations. The substances being Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN)), Benzoyl peroxide, 2-Amino-4-nitrophenol and 2-Amino-5-nitrophenol (Schedule 1, items 37, 38, 47 (496) and 87).
3. Remove the authority to use oestrone by deleting the exemptions previously given for item 490 of Schedule 1 (Schedule 1, item 490).
4. Remove the need for the requirement that the marking of hair care and soap products containing etidronic acid shall declare the fact (Schedule 2, Part I, item 53).
5. Approve, provisionally and until 31st December 1990, the use of Quinolin-8-ol and bis (8-hydroxyquinolium) sulphate in certain stated types of cosmetics and at concentrations set out (Schedule 2, Part II, item 1).
6. Delete from the list of provisionally approved colouring agents nine formerly allowed colouring agents, extend the authorisation dates for all other provisionally approved colouring agents to 31st December 1989 and limit the use of colouring agent 42535 in hair preparations to a maximum concentration of one hundred parts per million (Schedule 3, Part II).
7. Reduce the permitted concentration for the use of 5-chloro-2-methyl-isothiazol-3(2H) one and 2-methyl-isothiazol-3(2H) one with magnesium chloride and magnesium nitrate as a preservative from 0.003 per cent to 0.0015 per cent (Schedule 4, Part I, item 39).
8. Permit the use on a provisional basis, and until 31st December 1991, of Glutaraldehyde as a preservative (Schedule 4, Part II, item 26).
9. Remove five provisionally approved preservatives and extend the allowed use of four others to 31st December 1989 (Schedule 4, Part II, items 1, 3, 4, 5, 15, 16, 19, 20 and 25).
10. Reissue the list of currently provisionally approved ultra violet filters and extend their allowed use until 31st December 1991 (Schedule 5, Part 2).
The Colour Index referred to in these Regulations may be obtained from the Society of Dyers and Colourists, PO Box No. 244, 82, Grattan Road, Bradford BD1 2JB.
O.J. No. L262, 27.9.76, p. 169.
O.J. No. L167, 15.6.82, p. 1.
O.J. No. L63, 6.3.82, p. 26.
O.J. No. L109, 26.4.83, p. 25.
O.J. No. L188, 13.7.83, p. 15.
O.J. No. L332, 28.11.83, p. 38.
O.J. No. L275, 8.10.83, p. 20.
O.J. No. L228, 25.8.84, p. 31.
O.J. No. L224, 22.8.85, p. 40.
O.J. No. L138, 24.5.86, p. 40.
O.J. No. L149, 3.6.86, p. 38.
O.J. No. L56, 26.2.87, p. 20.
O.J. No. L105, 26.4.88, p. 11.
O.J. No. L382, 31.12.88, p. 46.
O.J. No. L64, 8.3.89, p. 10.
O.J. No. L187, 12.7.76, p. 1.
O.J. No. L147, 9.6.75, p. 13.
See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 88/667/EEC, 89/174/EEC.
O.J. No. 115, 11.11.62, p. 2645.
Council Directives Nos. 65/469/EEC, 67/653/EEC, 68/419/EEC, 70/758/EEC, 76/399/EEC and 78/144/EEC (O.J. Nos. L178, 26.10.65, p. 2793; L263, 30.10.67, p. 4; L309, 24.12.68, p. 24; L157, 18.7.70, p. 36; L108, 26.4.76, p. 19; L44, 15.2.78, p. 20).
Annexes I and VII to the Act of Accession of 22 January 1972, as adjusted by the Council Decision of 1 January 1973 (O.J. No. L2, 1.1.73, p. 1).
See Directives 86/179/EEC, 87/137/EEC, 88/233/EEC, 88/667/EEC, 89/174/EEC.
See Directives 86/179/EEC, 87/137/EEC, 88/233/EEC, 89/174/EEC.
See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 89/174/EEC.
See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 89/174/EEC.
See Directive 83/574/EEC.
See Directives 83/574/EEC, 89/174/EEC.
O.J. No. L383, 31.12.80, p. 27.
O.J. No. L57, 27.2.87, p. 56.
O.J. No. L185, 30.6.82, p. 1.
O.J. No. L291, 24.10.83, p. 9.
O.J. No. L295, 7.11.85, p. 30.
O.J. No. L57, 27.2.87, p. 56.