# The Cosmetic Products (Safety) Regulations 1989

S.I. 1989/2233 · made 29 November 1989

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.

Made under: Consumer Protection Act 1987; European Communities Act 1972 (repealed) (Section 11, Section 28, Section 30, Section 2)

PDFs: Printed copy https://openlegislation.uk/cosmetic-products-safety-regulations-1989/pdf/uksi_19892233_en.pdf

## Introductory text

CONSUMER PROTECTION
Made 29th November 1989
Laid before Parliament 6th December 1989
Coming into force
(except as provided in regulation 1) 1st January 1990
Whereas the Secretary of State has, in accordance with section 11(5) of the Consumer Protection Act 1987, 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 for the purposes of section 2 of the European Communities Act 1972 in relation to measures for safety and consumer protection as respects cosmetic products and any provisions concerning the composition, labelling, marketing, classification or description of cosmetic products and in relation to indication of origin on imported goods:
Now, therefore, the Secretary of State in exercise of powers conferred on him by sections 11, 28 and 30 of the said Act of 1987 and by section 2 of the said Act of 1972 and of all other powers enabling him in that behalf hereby makes the following Regulations:–

## 1 Citation, commencement and revocation

(1) These Regulations may be cited as the Cosmetic Products (Safety) Regulations 1989 and except as provided by paragraphs (2) to (5) below shall come into force on 1st January 1990.
(2) Regulation 4(2) and Schedule 1, in so far as they relate only to entry numbers 37, 38, 47 (cross-referenced in column 3 with entry number 496) and 87 and to entry numbers 247, 558 and 680 (cross-referenced in column 3 with entry numbers 351, 454 and 132 respectively) in that Schedule, regulation 4(3) and Part I of Schedule 2, in so far as they relate only to entry number 52 in that Part, and regulation 4(5) and Part I of Schedule 4, in so far as they relate only to entry number 40 and the deletion of entry number 6 in that Part, shall come into force–
(a) on 1st January 1990 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st January 1991; and
(b) in all other cases, on 1st January 1991.
(3) Regulation 4(3) and Schedule 2, in so far as they relate only to entry numbers 53 and 54 in Part 1 of Schedule 2, regulation 4(4)(a)(i) and Part I of Schedule 3, in so far as they relate to the deletion of colouring agent 13065, and regulation 4(5) and Part II of Schedule 4, in so far as they relate to the deletion of entry numbers 7 to 10, 14, 18, 22 and 24 in that Part, shall come into force–
(a) on 1st January 1990 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st January 1992; and
(b) in all other cases, on 1st January 1992.
(4) Regulation 4(3) and Part II of Schedule 2, in so far as they relate only to entry number 1 in that Part, regulation 4(4) and Part II of Schedule 3, in so far as they relate only to the deletion of entry numbers 15800, 19120, 20470, 21115, 42170, 45190, 47000, 73905 and 75660 and the requirement in column 4 relating to entry number 42535 in that Part, regulation 4(5) and Part I of Schedule 4, in so far as they relate only to the requirement in column 4 relating to entry number 39 in that Part, and Part II of Schedule 4, in so far as they relate only to entry number 26 and the deletion of entry numbers 1, 3, 5, 19 and 25 in that Part, and regulation 4(6)(a)(ii) and Part II of Schedule 5 shall come into force–
(a) on 1st January 1991 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case they shall come into force on 1st January 1993; and
(b) in all other cases, on 1st January 1993.
(5) Regulation 6 shall come into force–
(a) on 1st January 1992 in relation to the supply of cosmetic products by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person, except where the cosmetic products are supplied by retail in which case it shall come into force on 1st January 1994; and
(b) in all other cases on 1st January 1994.
(6) Subject to paragraph (7) below, the Regulations specified in Schedule 7 are hereby revoked:
(7) The notes in Schedules 3 and 4 shall apply.

## 2 Interpretation

(1) In these Regulations–
“the Directive” means Council Directive No. 76/768/EEC as amended by Council Directive No. 82/368/EEC, Commission Directive No. 82/147/EEC, Commission Directive No. 83/191/EEC, Commission Directive No. 83/341/EEC, Council Directive No. 83/574/EEC, Commission Directive No. 83/496/EEC, Commission Directive No. 84/415/EEC, Commission Directive No. 85/391/EEC, Commission Directive No. 86/179/EEC, Commission Directive No. 86/199/EEC, Commission Directive No. 87/137/EEC, Commission Directive No. 88/233/EEC, Council Directive No. 88/667/EEC and Commission Directive No. 89/174/EEC;
“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.

## 3 General Requirements

(1) Subject to paragraph (2) below, a cosmetic product shall not be liable to cause damage to human health when it is applied under normal conditions of use.
(2) For the purposes of regulation 8, paragraph (1) above shall apply only to the supply by the manufacturer in or importer into the United Kingdom or, in the case of cosmetic products manufactured or imported into the United Kingdom on behalf of another person, by that other person.

## 4 Particular requirements

(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 Particular requirements

(1) The Secretary of State may authorise the use in a cosmetic product of a particular substance, not being a substance listed in Schedule 1 or 2.
(2) In giving an authorisation the Secretary of State may impose conditions relating to the use of a particular substance in a cosmetic product. The conditions may relate to any matter which the Secretary of State considers appropriate including–
(a) the purpose of the substance;
(b) the type of cosmetic product;
(c) the maximum concentration of the substance in any cosmetic product; and
(d) information and marking requirements.
(3) The Secretary of State may on reasonable notice vary or revoke any authorisation given under paragraph (1) above.
(4) On giving, varying or revoking an authorisation, the Secretary of State shall arrange for the authorisation, variation or revocation, as the case may be, to be published in such manner as he considers appropriate for bringing it to the attention of persons who, in his opinion, would be likely to have an interest in it.
(5) No person shall be convicted of an offence under section 12 of the Consumer Protection Act 1987 by reason of a cosmetic product’s containing a particular substance provided that at the time when but for this regulation an offence would have been committed–
(a) the use of that particular substance in that cosmetic product was duly authorised; and
(b) all of the conditions imposed by the authorisation were complied with.

## 6 Marking

(1) Subject to the following provisions of this regulation, the container and the outer packaging (if any) in which a cosmetic product is supplied or delivered pursuant to any supply, or a label affixed to the product, the container and the outer packaging, shall bear the following particulars:–
(a) the name or trade name and the address or registered office of the manufacturer of the product or of a supplier thereof, being a manufacturer or supplier established within a member State of the European Economic Community;
(b) in the case of a cosmetic product likely within 30 months from the manufacture thereof to cease either to comply with the requirements of regulation 3 or to fulfil the purpose for which it was intended, the words “Best before …” immediately followed by
(i) the earliest date on which it is likely to so cease; or
(ii) an indication of where that date appears on the labelling
and any particular precautions to be observed to ensure that the product does not so cease before that date.
(c) in the case of a cosmetic product containing a substance listed in column 2 of Schedule 2, the information specified in column 6 of that Schedule in relation to that substance;
(d) in the case of a cosmetic product containing a preservative listed in column 2 of Schedule 4, the information specified in column 6 of that Schedule in relation to that preservative;
(e) in the case of a cosmetic product containing a UV filter listed in column 2 of Schedule 5, the information specified in column 5 of that Schedule in relation to that UV filter;
(f) any particular precautions to be observed in use (not being precautions included in the information referred to in sub-paragraphs (b), (c), (d) and (e) above);
(g) a means of identifying the batch in which the product was manufactured (or, if the product was not manufactured in a batch, a reference from which the date and place of manufacture can be identified):
Provided that the requirements specified in sub-paragraphs (b) and (g) above need not be complied with in relation to a cosmetic product which is the subject of a market research experiment.
(2) The particulars referred to in sub-paragraphs (a) to (g) of paragraph (1) above shall be in lettering which is visible, indelible and easily legible.
(3) The particulars referred to in sub-paragraph (a) of paragraph (1) above may be abbreviated if such abbreviation does not prevent the person concerned from being identified.
(4) The date referred to in sub-paragraph (b) of paragraph (1) above shall include the month and the year, and the month shall precede the year.
(5) The particulars referred to in sub-paragraphs (b) to (f ) of paragraph (1) above shall be in the English language; but this shall not prohibit the additional use of other languages.
(6) The particulars referred to in sub-paragraphs (c) to (f ) of paragraph (1) above and any special precautionary information on cosmetic products for professional use, in particular, in hairdressing shall appear on the container or on a label attached thereto: provided that where–
(a) it is impracticable by reason of the size or shape of the container for the said particulars so to appear, or
(b) two or more products are supplied together as a single item, each product being in a separate container and the containers being enclosed together in outer packaging which bears clear and conspicuous instructions to the effect that the product must be mixed together in specified proportions before use,
the said particulars shall appear on an enclosed leaflet and an indication shall appear on both the container and the outer packaging (if any) or on a label if attached thereto referring the consumer to the information in the leaflet.
(7) Where it is impracticable, for reasons of size, for the particulars referred to in sub-paragraph (g) of paragraph (1) above to appear on the container and outer packaging, the said particulars shall appear on the packaging in which the product is exposed for supply.
(8) In the case of a supply of soap which is not in a container, either the soap itself or the packaging in which it is exposed for supply or the container in which it was last contained before the supply shall bear the particulars referred to in sub-paragraphs (a) and (g) of paragraph (1) above, and in so far as any of the particulars referred to in sub-paragraphs (b) to (f) of paragraph (1) above are required they shall appear on a leaflet which shall be delivered to the buyer with the soap; and where either of the particulars referred to in sub-paragraphs (a) and (g) of paragraph (1) above appears on the soap itself the requirement of indelibility shall apply only until it has been put into use.

## 7 Enforcement

(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 Enforcement

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 Enforcement

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.

## Signature

Eric Forth
Parliamentary Under-Secretary of State,
Department of Trade and Industry
29th November 1989

## 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)
—
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
—
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

## 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.

## 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
—
—

## II substances listed in annex iii, part 2 (formerly annex iv, part i) of the directive 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

## 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
—
—

## 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, as amended, and adapted 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.

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

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
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)
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

## II colouring agents listed in annex iv part 2 of the directive 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

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
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)
19120(1)
20470(1)
21110
Orange
X
Maximum 3,3-dichlorobenzidine concentration in the colouring agent: 5 ppm
31.12.1989
21115(1)
26100
Red
X
31.12.1989
42045
Blue
X
See also Part I
31.12.1989
42170(1)
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)
47000(1)
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)
74180
Blue
X
See also Part I
31.12.1989
75660(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.

## I preservatives listed in annex vi, part i of the directive 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
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)
7
Biphenyl-2-ol (o-phenylphenol) and its salts
All products
0.2 per cent expressed as the phenol A
—
—
8
Pyrithione zinc (INN)
Products rinsed off after use
0.5 per cent A
Not to be used in oral hygiene products
—
9
Inorganic sulphites and hydrogen sulphites
All products
0.2 per cent expressed as free SO2 A
—
—
10
Sodium iodate
Products rinsed off after use
0.1 per cent
—
—
11
Chlorobutanol (INN)
All products
0.5 per cent
Not to be used in aerosol dispensers (sprays)
Contains chlorobutanol
12
4-Hydroxybenzoic acid and its salts and esters
All products
0.4 per cent (acid) for 1 ester, 0.8 per cent (acid) for mixtures of esters A
—
—
13
3-Acetyl-6-methylpyran-2,4-(3H)-dione (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 cent A
—
—
20
5-Bromo-5-nitro-1,3-dioxane
Products rinsed off after use
0.1 per cent
Avoid formation of nitrosamines
—
21
Bronopol (INN)
All products
0.1 per cent A
Avoid formation of nitrosamines
—
22
2,4-Dichlorobenzyl alcohol
All products
0.15 per cent A
—
—
23
Triclocarban (INN)
All products
0.2 per cent A
Purity criteria: 3,3'4,4'-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 cent A
—
—
25
Triclosan (INN)
All products
0.3 per cent A
—
—
26
4-Chloro-3,5-xylenol
All products
0.5 per cent A
—
—
27
3,3'-Bis(1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea (“Imidazolidinyl urea”)
All products
0.3 per cent A
—
—
28
Poly(1-hexamethylene-biguanide hydrochloride)
All products
0.3 per cent A
—
—
29
2-Phenoxyethanol
All products
1.0 per cent A
—
—
30
Hexamethylenetetramine (methenamine (INN))
All products
0.15 per cent A
—
—
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 cent A
—
—
33
1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione
All products
0.6 per cent A
—
—
34
Benzyl alcohol (See also Part I of Schedule 2)
All products
1.0 per cent A
—
—
35
1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone and its monoethanolamine salt
Products rinsed off after use
1.0 per cent A
—
—
For other products
0.5 per cent A
—
—
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 cent A
—
—
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 cent A
—
—
43
1-Phenoxypropan-2-ol (see also Part I, of Schedule 2)
Products rinsed off after use
1.0 per cent
—
—

## II preservatives listed in annex vi part 2 of the directive 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
Notes:
(1) Prior to the coming into force of article 1(7) to Directive 88/233/EEC Chlorophensin (INN) item 2 above is permitted to be used up to a maximum concentration figure of 0.5 per cent.
(1) 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)
2
Chlorphenesin (INN) (see note (1))
All products
0.3 per cent
—
—
31.12.1989
3
ENTRY DELETED (2)
4
Alkyl (C12–C22) trimethylammonium bromide and chloride (including Cetrimonium bromide (INN))
All products
0.1 per cent A
—
—
31.12.1989
5
ENTRY DELETED (2)
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)
15
Benzethonium chloride (INN)
Not to be used in products intended to come into contact with mucous membranes
0.1 per cent A
—
—
31.12.1989
16
Benzalkonium chloride (INN) bromide and saccharinate
All products
0.25 per cent A
—
—
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)
20
Hexamidine (INN) and its salts (including isethionate and 4-hydroxybenzoate)
All products
0.1 per cent A
—
—
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)
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

## 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.

## I uv filters listed in annex vii, part i, of the directive 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)
—
—

## II uv filters listed in annex vii, part 2 of the directive 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

## Schedule 6: SAMPLING AND TESTING

## 1 

In this Schedule–
“Annex A” means the Annex to Commission Directive No. 80/1335/EEC, as amended by Commission Directive No. 87/143/EEC;
“Annex B” means the Annex to Commission Directive No. 82/434/EEC;
“Annex C” means the Annex to Commission Directive No. 83/514/EEC;
“Annex D” means the Annex to Commission Directive No. 85/490/EEC;
“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, 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”.

## 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.

---
Source: https://www.legislation.gov.uk/uksi/1989/2233 (the official version)
Page: https://openlegislation.uk/cosmetic-products-safety-regulations-1989
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.