The Cosmetic Products (Safety) Regulations 1989

Type Statutory-Instrument
Publication 1989-11-29
State In force
Department King's Printer of Acts of Parliament
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Made: 29th November 1989

Laid before Parliament: 6th December 1989

Coming into force

Now, therefore, the Secretary of State in exercise of powers conferred on him by sections 11, 28 and 30 of the said Act of 1987 and by section 2 of the said Act of 1972 and of all other powers enabling him in that behalf hereby makes the following Regulations:–

Citation, commencement and revocation

1

Interpretation

2

General Requirements

3

Particular requirements

4

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.

5

Marking

6

and any particular precautions to be observed to ensure that the product does not so cease before that date.

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.

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.

Enforcement

7

8

Subject to regulations 5 and 7(2) and (3), no person shall supply any cosmetic product in respect of which any of the requirements of regulation 3, 4 or 6 is not satisfied.

9

Any test of goods purchased under section 28, or seized under section 29, of the Consumer Protection Act 1987 (which relates to enforcement) by or on behalf of an enforcement authority for the purpose of ascertaining whether the provisions of these Regulations have been contravened shall in all cases be carried out in accordance with the provisions of paragraphs 2 to 5 of Schedule 6 and any test for which a method is specified in paragraph 6 of that Schedule shall be carried out in accordance with that method.

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[^f00019]) — 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– in the case of oral hygiene or dental products other than toothpaste intended specifically for children, 50 ppm; or 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[^f00020] — 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.

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

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