The Cosmetic Products (Safety) Regulations 1989

Statutory Instruments

1989 No. 2233

CONSUMER PROTECTION

The Cosmetic Products (Safety) Regulations 1989

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:–

Citation, commencement and revocation

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.

Interpretation

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–

(a)

any cosmetic product; or

(b)

anything in, on or with which the cosmetic product is supplied; or

(c)

the appearance or any other characteristic of the cosmetic product or any such thing; or

(d)

the name or description under which the cosmetic product is supplied.

A cosmetic product is not the subject of a market research experiment unless–

(a)

any person to whom a cosmetic product is supplied in the course of the experiment is informed, at or before the time at which it is supplied to him, that it is supplied for the purpose of a market research experiment and

(b)

no consideration in money or money’s worth is given by such a person for the cosmetic product or any other cosmetic product supplied to him for comparison.

“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.

General Requirements

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.

Particular requirements

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.

Marking

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.

Enforcement

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)

SCHEDULE 1 LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN

The alphabetical list set out in column 2 of this Schedule contains one or more of the names of each of the substances referred to in regulation 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)

SCHEDULE 2 LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

In this Schedule, the matters specified in columns 3, 4, 5 and 6 which apply to a particular substance are those set out to the right of its name as mentioned in column 2; and the matters specified in columns 4, 5 and 6 which apply in any particular case are those set out to the right of the matter specified in column 3 which applies in that case. The substance may not be used except for the purposes or contained other than in the types of product specified in column 3. The concentration of the substance in a product may not exceed the limit specified in column 4: where the names of two or more substances are mentioned in a single item as set out in column 2 and a product contains more than one of those substances, the limit specified in column 4 is the limit for all of those substances taken together; and where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 5. In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

PART I substances listed in annex iii, part i of the directive as substances which cosmetic products must not contain except subject to the restrictions laid down

(1)	(2)	(3)	(4)	(5)	(6)
Reference Number	Name of substance	Purpose of substance or type of product	Maximum concentration of substance in product	Other requirements	Required information
Combination Rules A. Where a cosmetic product contains two or more substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 1. B. Where a cosmetic product contains the substances to which this Combination Rule applies, the concentration in the product of each of those substances shall be such that the sum of the relevant quotients for those substances (as defined in Rule C below) shall not exceed 2; but the concentration of each substance shall not in any event exceed the limit specified for the substance in respect of the product in column 4 above. C. The relevant quotient for each substance is the actual concentration of the substance in the product divided by the maximum concentration specified for the substance in respect of the product in Column 4 of this Schedule.
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	—	—

PART II substances listed in annex iii, part 2 (formerly annex iv, part i) of the directive(21) as substances provisionally allowed

(1)	(2)	(3)	(4)	(5)	(6)	(7)
Reference Number	Name of substance	Purpose of substance or type of product	Maximum concentration of substance in product	Other requirements	Required information	Permitted for use until
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

PART III substances excluded from the scope of the directive (mentioned in annex v)

(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)

SCHEDULE 3 LIST OF COLOURING AGENTS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS AND EXCEPT COLOURING AGENTS INTENDED SOLELY TO COLOUR HAIR

In this Schedule the colouring agents referred to in regulation 4(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.

PART I colouring agents listed in annex iv part 1 (formerly annex iii part 2) of the directive(25) as colouring agents which cosmetic products must not contain except subject to the restrictions laid down

Field of application

In column 3 of this Schedule, the entry “X” in a sub-column means that the colouring agent must not be used other than as follows–

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

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

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

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

(1)	(2)	(3)				(4)
		Type of product Field of application
Name or colour index number	Colour	1	2	3	4	Other requirements
a Note: (1) This entry is deleted with effect from the dates specified in regulation 1(3). Until then the corresponding entry in Part I of Schedule 3 to S.I. 1984/1260 (substituted by Schedule 3 to S.I. 1987/1920) continues in force.
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

PART II colouring agents listed in annex iv part 2 of the directive(26) as colouring agents which cosmetic products must not contain except subject to the restrictions laid down and where cosmetic product supplied before a certain date

Field of application

In column 3 of this Schedule, the entry “X” in a sub-column means that the colouring agent must not be used other than as follows–

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

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

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

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

(1)	(2)	(3)				(4)	(5)
		Type of product Field of application
Name or colour index number	Colour	1	2	3	4	Other requirements	Cosmetic product supplied until
a Note: (1) This entry is deleted with effect from the dates specified in regulation 1(4). Until then the corresponding entry in Part II of Schedule 3 to S.I. 1984/1260 (substituted by Schedule 3 to S.I. 1987/1920) continues in force.
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)

SCHEDULE 4 LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

In this Schedule, the matters specified in columns 3, 4, 5 and 6 which apply to a particular substance are those set out to the right of its name as mentioned in column 2; and the matters specified in columns 4, 5 and 6 which apply in any particular case are those set out to the right of the matter specified in column 3 which applies in that case. The substance may not be used or contained other than in the types of product specified in column 3. The concentration of the substance, when it is used as a preservative, in a product may not exceed the limit set out in column 4. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 5.

In column 4 of this Schedule, “A” indicates that the concentration of the substance in a product may exceed the limit set out in that column provided that–

(a) the presence of any excess of the substance in a product over the concentration so set out is not for the primary purpose of inhibiting the development of micro-organisms; and

(b) the purpose for which any such excess is present in the product is apparent from the labelling of the product.

In this Schedule–

“salts” means salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines and of the anions chloride, bromide, sulphate and acetate;

“esters” means esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl and phenyl.

In column 4 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

All preservative substances containing formaldehyde or any substances named in this Schedule which release formaldehyde must be labelled with the warning “contains formaldehyde” when the concentration of formaldehyde in the final product exceeds 0.05 per cent.

PART I preservatives listed in annex vi, part i of the directive(27) as preservatives which cosmetic products may not contain except subject to the restrictions laid down

(1)	(2)	(3)	(4)	(5)	(6)
Reference Number	Name of substance	Purpose of substance or type of product	Maximum concentration of substance in product	Other requirements	Required information
a Note: (1) This entry is deleted with effect from the dates specified in regulation 1(2). Until then the corresponding entry in Part I of Schedule 5 to S.I. 1984/1260 (substituted by Schedule 4 to S.I. 1987/1920) continues in force.
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	—	—

PART II preservatives listed in annex vi part 2 of the directive(28) as preservatives which cosmetic products may not contain except subject to the restrictions laid down and where supplied before a certain date

(1)	(2)	(3)	(4)	(5)	(6)	(7)
Reference Number in Annex VI Part 2 of the Directive	Name of substance	Purpose of substance or type of product	Maximum concentration of substance in product	Other requirements	Required information	Preservative supplied until
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.
b (1) Certain entries are deleted with effect from the dates specified in regulation 1(3) or (4). Until then the corresponding entries relating to the substances in question where appropriate in Part II of Schedule 5 to S.I. 1984/1260 (substituted by Schedule 4 to S.I. 1987/1920) continue in force.
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)

SCHEDULE 5 LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO RESTRICTIONS

In this Schedule, the matters specified in columns 3, 4 and 5 which apply to a particular substance are those set out to the right of its name as mentioned in column 2. The concentration of the substance in a product may not exceed the limit specified in column 3. Where a product is intended to be mixed with another product in specified proportions before use, the level of concentration shall be calculated by reference to the mixture. Other requirements are specified in column 4. In column 3 of this Schedule, the percentage concentration is measured by reference to mass (m/m) unless a contrary intention appears.

PART I uv filters listed in annex vii, part i, of the directive(29) as uv filters which cosmetic products may not contain except subject to the restrictions laid down

(1)	(2)	(3)	(4)	(5)
Reference Number	Name of substance	Maximum concentration of substance in product	Other requirements	Required information
1	4-Aminobenzoic acid	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)	—	—

PART II uv filters listed in annex vii, part 2 of the directive(30) as uv filters which cosmetic products may not contain except subject to the restrictions laid down and where supplied before a certain date

(1)	(2)	(3)	(4)	(5)	(6)
Reference Number	Name of substance	Maximum concentration of substance in product	Other requirements	Required information	UV filter supplied until
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

SCHEDULE 6 SAMPLING AND TESTING

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)

SCHEDULE 7 REVOCATIONS

(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

Explanatory Note

(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.

(1)

1987 c. 43.

(2)

S.I. 1972/1811, 1975/1707.

(3)

1972 c. 68.

(4)

O.J. No. L262, 27.9.76, p. 169.

(5)

O.J. No. L167, 15.6.82, p. 1.

(6)

O.J. No. L63, 6.3.82, p. 26.

(7)

O.J. No. L109, 26.4.83, p. 25.

(8)

O.J. No. L188, 13.7.83, p. 15.

(9)

O.J. No. L332, 28.11.83, p. 38.

(10)

O.J. No. L275, 8.10.83, p. 20.

(11)

O.J. No. L228, 25.8.84, p. 31.

(12)

O.J. No. L224, 22.8.85, p. 40.

(13)

O.J. No. L138, 24.5.86, p. 40.

(14)

O.J. No. L149, 3.6.86, p. 38.

(15)

O.J. No. L56, 26.2.87, p. 20.

(16)

O.J. No. L105, 26.4.88, p. 11.

(17)

O.J. No. L382, 31.12.88, p. 46.

(18)

O.J. No. L64, 8.3.89, p. 10.

(19)

O.J. No. L187, 12.7.76, p. 1.

(20)

O.J. No. L147, 9.6.75, p. 13.

(21)

See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 88/667/EEC, 89/174/EEC.

(22)

O.J. No. 115, 11.11.62, p. 2645.

(23)

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).

(24)

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).

(25)

See Directives 86/179/EEC, 87/137/EEC, 88/233/EEC, 88/667/EEC, 89/174/EEC.

(26)

See Directives 86/179/EEC, 87/137/EEC, 88/233/EEC, 89/174/EEC.

(27)

See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 89/174/EEC.

(28)

See Directives 86/199/EEC, 87/137/EEC, 88/233/EEC, 89/174/EEC.

(29)

See Directive 83/574/EEC.

(30)

See Directives 83/574/EEC, 89/174/EEC.

(31)

O.J. No. L383, 31.12.80, p. 27.

(32)

O.J. No. L57, 27.2.87, p. 56.

(33)

O.J. No. L185, 30.6.82, p. 1.

(34)

O.J. No. L291, 24.10.83, p. 9.

(35)

O.J. No. L295, 7.11.85, p. 30.

(36)

O.J. No. L57, 27.2.87, p. 56.