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The Cosmetic Products (Safety) Regulations 1996

Type Statutory-Instrument
Publication 1996-11-21
State In force
Department King's Printer of Acts of Parliament
Source legislation.gov.uk
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(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) 396 254
2 Acetonitrile — 393
3 3-(α-Acetonylbenzyl)-4-hydroxycoumarin and its salts 398, 760 203
4 2-Acetoxyethyltrimethylammonium hydroxide and its salts 6 2
5 2-Acetylamino-5-chlorobenzoxazole 164 1
6 Acetylcholine and its salts 4 2
7 Acetylene chlorides 249, 757 126
8 Acetylenic alcohols, their esters, ethers and salts 17 16
9 Acetylethyltetramethyltetralin (AETT) 341 362
10 7α-Acetylthio-3-oxopregn-4-ene-17α,17β-propionolactone 649 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 269, 314 14
15 Alkali pentacyanonitrosylferrate(2-) 602–3, 644–5 255
16 O-Alkyldithiocarbonic acids, salts of 761 336
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 492 20
22 2-Allyloxy-4-chloro-N-[2-(diethylamino)-ethyl]benzamide and its salts 18 19
23 Alypine and its salts 45, 109 143
24 Ambenonium chloride (INN) (527) 132
25 4-(or p-)Aminobenzoic acid esters — 167
26 2-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts — 29
27 Aminocaproic acid (INN) and its salts 31 7
28 2-Amino-5-chlorobenzoxazole 768 24
29 4-Amino-N-(2-diethylaminoethyl)benzamide, its salts and derivatives 607 25
30 Aminoheptane, its isomers and salts 748 25
31 6-Aminohexanoic acid and its salts 27 7
32 α-(Aminomethyl)-3,4-dihydroxybenzyl alcohol and its salts 517–8 257
33 4-Amino-N¹⁰-methylfolic acid 452 6
34 2-Amino-6-methylheptane and its salts 287, 523 28
35 2-Amino-4-methylhexane and its salts 288, 471 30
36 2-Amino-4-nitrophenol — 383
37 2-Amino-5-nitrophenol — 384
38 4-Amino-2-nitrophenol — 412
39 4-(or p-)Aminosalicylic acid and its salts — 31
40 Aminotoluenes, their isomers, salts and halogenated and sulphonated derivatives 716 32
41 Aminoxylenes, their isomers, salts and halogenated and sulphonated derivatives 763 33
42 Amitriptyline (INN) and its salts 283 146
43 Ammi majus and its galencial preparations — 35
44 Amphetamine (INN), its salts and derivatives and salts of those derivatives (678) 21
45 Amydricaine and its salts 23, 109 143
46 Amylene chloride 250 36
47 Amyl 4-dimethylaminobenzoate, mixed isomers 532 381
48 Amyl nitrites — 247
49 Amylobarbitone and its salts (69) 220
50 Amylocaine and its salts 281 50
51 Anamirta cocculus L. (fruit) — 106
52 Substances with androgenic effect — 37
53 Aniline, its salts and halogenated and sulphonated derivatives — 22
54 Anthracene oil — 38
55 Anti-androgens with steroid structure — 390
56 Antibiotics — 39
57 Antimony and its compounds — 40
58 Apocynum cannabinum L. and its preparations — 41
59 Apomorphine and its salts 694 42
60 Apronalide 419 216
61 Arecoline 482 238
62 Aristolochic acid and its salts — 365
63 Arsenic and its preparations — 43
64 Atropa belladonna L. and its preparations — 44
65 Atropine, its salts and derivatives — 45
66 Azacyclonol (INN) and its salts 304 286
67 Azamethonium bromide (INN) (473) 121
68 Barbitone and its salts (69) 220
69 Barbiturates various 220
70 Barium salts (except barium sulphate, barium sulphide under the condition laid down in Part I of Schedule 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
71 Bemegride (INN) and its salts 336, 337 183
72 Benactyzine (INN) 257 157
73 Bendrofluazide and its derivatives 74, 90 53
74 Bendroflumethiazide (INN) and its derivatives 73, 90 53
75 Benzamine and its salts 741 51
76 Benzatropine (INN) and its salts 300 158
77 Benzazepines, their salts and derivatives 89 49
78 Benzene — 47
79 Benzene-1,2-diol 153, 627 408
80 Benzene-1,2,3-triol 628 409
81 Benzethonium chloride (INN) 92 415
82 2-Benzhydryloxyethyldimethylamine and its salts 295 339
83 Benzidine 242 26
84 Benzilonium bromide (INN) 95 60
85 2-Benziloyloxymethyl-1,1-dimethylpyrrolidinium methyl sulphate 599 239
86 Benzimidazolone 87, 266 48
87 Benzimidazol-2(3H)-one 86, 266 48
88 Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol (except natural content of essences) 211 357
89 Benzodiazepines, their salts and derivatives 77 49
90 Benzothiadiazine and its derivatives 73, 74 53
91 Benzoyl peroxide — 382
92 Benzyl(dimethyl)(2-{2-[4-(1,1,3,3-tetramethybutyl)phenoxy]ethoxy}-ethyl)ammonium chloride 81 415
93 3-(N-Benzylhydrazinocarbonyl)-5-methylisoxazole 414 52
94 Benzylideneacetone 564 356
95 3-Benzyloxy-1,1-diethylpyrrolidine hydrobromide 84 60
96 4-Benzyloxyphenol (390), 487 178
97 2-[Benzyl-N-(2-pyridyl)amino]-ethyldimethylamine 623, 745 347
98 Bergapten(e) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg (356) 358
99 Beryllium and its compounds — 54
100 Betamethasone (INN) (360) 300
101 Betoxycaine (INN) and its salts 256 23
102 BHC (ISO) (gamma-BHC) 369, 371, 428 195
103 Bietamiverine (INN) 260 287
104 1,6-Bis(2-chloroethylamino)-1,6-dideoxymannitol and its salts 436 89
105 2-[Bis(2-chloroethyl)amino]-1-oxa-3-aza-2-phosphacyclohexane 2-oxide and its salts 108, 230 88
106 N,N-Bis(2-chloroethyl)methylamine and its salts 160, 490 87
107 N,N-Bis(2-chloroethyl)methylamine N-oxide and its salts 491 86
108 N,N-Bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-ylamine p-oxide and its salts 105, 230 88
109 1,1-Bis(dimethylaminomethyl)propyl benzoate and its salts 23, 45 143
110 Bis(hydroxyalkyl)amines, not further N-substituted 254, 273, 640 411
111 2,2-Bis(hydroxymethyl)butan-1-ol trinitrate 613 206
112 2,6-Bis(β-hydroxyphenethyl)-1-methylpiperidine and its salts 430 219
113 3,3-Bis(4-hydroxyphenyl)phthalide 557 417
114 Bis(8-hydroxyquinolinium) sulphate, except for the uses provided for in entry number 51 in Part 1 of Schedule 2 (400, 531) 395
115 Bithionol (INN) 705 352
116 Bretylium tosilate (INN) (Bretylium tosylate) 119 56
117 Bromine, elemental — 55
118 Bromisoval (INN) 121 58
119 p-Bromobenzylethyldimethylammonium p-toluenesulphonate 116 56
120 2-Bromo-2-ethylbutyrylurea 149 57
121 2-Bromo-3-methylbutylrylurea 118 58
122 1-p-Bromophenyl-1-(2-pyridyl)-3-dimethylaminopropane and its salts 123 59
123 Brompheniramine (INN) and its salts 122 59
124 Brucine — 62
125 Butanilicaine (INN) and its salts 466 90
126 Butobarbitone and its salts (69) 220
127 Butopiprine (INN) and its salts 129 288
128 2-Butoxy-N-(2-diethylaminoethyl)-cinchoninamide and its salts 191 129
129 2-Butoxyethyl phenyl(piperidino)acetate and its salts 127 288
130 1-Butyl-3-(N-crotonoylsulphanilyl)urea — 108
131 4-Butyl-1,2-diphenylpyrazolidine-3,5-dione 563 67
132 4-tert-Butyl-3-methoxy-2,6-dinitrotoluene 489 414
133 4-Butyl-1-phenylpyrazolidine-3,5-dione 486 64
134 1-Butyl-3-(p-methylbenzenesulphonyl)urea 715 65
135 1-Butyl-3-sulphanilylurea 150 66
136 4-Butylthiobenzhydryl 2-(dimethylamino)ethyl sulphide 143 140
137 Cadmium and its compounds — 68
138 Calabar bean 585 281
139 Calciferol 316, (759) 335
140 Cantharides, Cantharis vesicatoria 647 69
141 Cantharidin 378 70
142 Captan (ISO) 734 370
143 Captodiame (INN) 136 140
144 Caramiphen (INN) and its salts 567 169
145 N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethylammonium salts 418 156
146 Carbazole, nitroderivatives of 508 72
147 Carbon disulphide — 73
148 Carbon tetrachloride 690 315
149 Carbromal (INN) 120 57
150 Carbutamide (INN) 135 66
151 Carisoprodol (INN) 480 235
152 Catalase — 74
153 Catechol 79, 627 408
154 Cells, tissues or products of human origin — 416
155 Cephaeline and its salts — 75
156 Chenopodium ambrosioides (essential oil) — 76
157 Cherry laurel water 618 291
158 Chloral hydrate 732 77
159 Chlorine — 78
160 Chlormethine (INN) and its salts 106, 490 87
161 Chlormezanone (INN) 175 91
162 4-Chlorobenzene-1,3-disulfonamide 194 85
163 5-Chloro-1,3-benzoxazol-2(3H)-one 186 82
164 N-5-Chlorobenzoxazol-2-ylacetamide 5 1
165 2-Chloro-4-dimethylamino-6-methylpyrimidine 169, 216 83
166 2-Chloro-9-[3-(dimethylamino)-propylidene]thioxanthene (cis-form) and its salts 183 84
167 Chloroethane 327 96
168 Chloroform 733 366
169 2-Chloro-6-methylpyrimidin-4-yldimethylamine 165, 216 83
170 Chlorophacinone (ISO) 176 93
171 1-(p-Chloro-α-phenylbenzyl)-4-(2-hydroxyethoxyethyl)piperazine 401 240
172 2-(4-Chlorophenyl)-1-[4-(2-diethylaminoethoxyl)phenyl]-1-p-tolylethanol 744 92
173 4-[4-(4-Chlorophenyl)-4-hydroxypiperidin-1-yl]-1-(4-fluorophenyl)butan-1-one 368 185
174 2-(4-Chlorophenyl)-3-methylbutane-2,3-diol 551 95
175 2-(4-Chlorophenyl-3-methyl-1,3-thiazinan-4-one 1,1-dioxide 161 91
176 2-[2-(4-Chlorophenyl)-2-phenylacetyl]indane-1,3-dione 170 93
177 2-[1-(4-Chlorophenyl)-1-phenylethoxy]ethyl-(dimethyl)amine 180 94
178 Chloropicrin 735 325
179 3-(4-Chloro-3-sulphamoylphenyl)-3-hydroxyisoindolin-1-one 184, 185 262
180 Chlorphenoxamine (INN) 177 94
181 Chlorpromazine (INN) (558) 320
182 Chlorpropamide (INN) 614 79
183 Chlorprothixene (INN) and its salts 166 84
184 Chlortalidone (INN) 179, 185 262
185 Chlorthalidone 179, 184 262
186 Chlorzoxazone (INN) 163 82
187 Cholecalciferol (759) 335
188 Choline salts and their esters — 168
189 Chromium, chromic acid and salts of the acid — 97
190 Chrysoidine citrate hydrochloride 562 81
191 Cinchocaine (INN) and its salts 128 129
192 Cincophen (INN), its salts and derivatives and salts of those derivatives 577 8
193 Claviceps purpurea Tul., its alkaloids and galenical preparations 317 98
194 Clofenamide (INN) 162 85
195 Clofenotane (INN) 232, 731 123
196 Cobalt benzenesulphonate — 101
197 Cocculin 589 282
198 Colchicine, its salts and derivatives — 102
199 Colchicoside and its derivatives — 103
200 Colchicum autumnale L. and its galenical preparations — 104
201 Colouring agent CI 12075 and its lakes, pigments and salts — 397
202 Colouring agent CI 12140 — 378
203 Colouring agent CI 13065 — 387
204 Colouring agent CI 15585 — 401
205 Colouring agent CI 26105 — 379
206 Colouring agent CI 42535 — 388
207 Colouring agents CI 42555, 42555:1 and 42555:2 — 380
208 Colouring agent CI 42640 — 386
209 Colouring agent CI 61554 — 389
210 Colouring agent CI 45170 and CI 45170:1 — 398
211 Coniferyl benzoate (except natural content of essences) 88 357
212 Coniine 615 290
213 Conium maculatum L. (fruit, powder, galenical preparations) — 99
214 Convallatoxin — 105
215 Coumetarol (INN) 454 225
216 Crimidine (ISO) 165, 169 83
217 Croton tiglium (oil) — 107
218 Curare and curarine — 109
219 Curarizants, synthetic — 110
220 1-(3-Cyano-3,3-diphenylpropyl)-4-ethoxycarbonyl-4-phenylpiperidinium chloride 296 80
221 Cyclarbamate (INN) 229 122
222 Cyclizine (INN) and its salts 301 159
223 Cyclobarbitone and its salts (69) 220
224 Cyclocoumarol 267 234
225 2-α-Cyclohexylbenzyl(N,N',N'-tetraethyl)trimethylenediamine 552 112
226 2-Cyclohexyl-3,5-dimethylphenol and its salts 228 113
227 1-Cyclohexyl-3-(p-methylbenzenesulphonyl)urea 363 100
228 Cyclomenol (INN) and its salts 226 113
229 Cyclopentane-1,1-dimethanol dicarbanilate 221 122
230 Cyclophosphamide (INN) and its salts 105, 108 88
231 Datura stramonium L. and its galenical preparations 651 301
232 DDT (ISO) (pp'-DDT) 195, 731 123
233 Deanol aceglumate (INN) 278 3
234 Decamethonium bromide (INN) (235) 214
235 Decamethylenebis(trimethylammonium) salts 234 214
236 Dextromethorphan (INN) and its salts 457 226
237 Dextropropoxyphene (INN) 280 116
238 O,O'-Diacetyl-N-allyl-N-normorphine — 117
239 2,4-Diaminoanisole and its salts 455, 461 376
240 2,5-Diaminoanisole and its salts 456, 460 377
241 1,2-Diaminobenzene and its salts 570 363
242 p,p'-Diaminodiphenyl 82 26
243 2-(2,4-Diaminophenyl)ethanol and its salts — 407
244 1,4:3,6-Dianhydrosorbitol 2,5-dinitrate 421 148
245 5-(α,β-Dibromophenethyl)-5-methylhydantoin — 119
246 Dibromosalicylanilides 247, 443 351
247 Dibromsalan (INN) (246) 351
248 Dichloroethanes 329, 334 125
249 Dichloroethylenes 7, 757 126
250 2,3-Dichloro-2-methylbutane 46 36
251 Dichlorosalicylanilides — 349
252 Dicoumarin 253, 469 231
253 Dicoumarol (INN) 252, 469 231
254 Diethanolamine (110, 640) 411
255 2-(Diethylaminoethoxy)ethyl α-phenylpiperidine-1-acetate dimethiodide 598 137
256 2-Diethylaminoethyl 3-amino-4-butoxybenzoate and its salts 101 23
257 2-Diethylaminoethyl benzilate 72 157
258 2-Diethylaminoethyl 4-ethoxybenzoate and its salts 410, 536 179
259 2-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts — 128
260 2-Diethylaminoethyl phenyl(piperidino)acetate 103 287
261 3-Diethylaminopropyl cinnamate — 130
262 Diethyl 4-nitrophenyl phosphate 534 170
263 O,O-Diethyl O-4-nitrophenyl phosphorothioate 535 131
264 Difencloxazine (INN) 566 270
265 Digitaline and all heterosides of Digitalis purpurea L. — 134
266 4,5-Dihydrobenzimidazol-4-one 86, 87 48
267 3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano[3,2-c]-[1]-benzopyran-5-one 224 234
268 Dihydrotachysterol (INN) — 342
269 3,4-Dihydroxy-α-(methylaminomethyl)benzyl alcohol 14, 314 14
270 4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene)dicoumarin — 207
271 1-(3,4-Dihydroxyphenyl)-2-ethylaminopropan-1-ol and its salts 293 136
272 1-(3,4-Dihydroxyphenyl)-2-isopropylaminoethanol 417, 420 17
273 Diisopropanolamine (110, 640) 411
274 5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite 412 361
275 Dimethoxane 285 368
276 4-[2-(3,4-Dimethoxyphenyl)ethyl]-1-(2-chlorophenyl)piperazine and its salts 438 141
277 Dimethylamine — 142
278 2-Dimethylaminoethyl N-acetylglutamate 233 3
279 2-Dimethylaminoethyl p-butylaminobenzoate and its salts 687 63
280 (+)-4-Dimethylamino-3-methyl-1,2-diphenyl-2-propionyloxybutane 237 116
281 1-Dimethylaminomethyl-1-methylpropyl benzoate and its salts 50 50
282 2-Dimethylaminopropiophenone and its salts 445 145
283 3-(3-Dimethylaminopropylidene)-1,2:4,5-dibenzocyclohepta-1,4-diene and its salts 42 146
284 1,1-Dimethylbiguanide and its salts 447 147
285 2,6-Dimethyl-1,3-dioxan-4-yl acetate 275 368
286 Dimethylformamide — 355
287 1,5-Dimethylhexylamine and its salts 34, 523 28
288 1,3-Dimethylpentylamine and its salts 35, 471 30
289 Dimethyl sulfoxide (INN) — 338
290 Dimevamide (INN) and its salts 297 153
291 Dinitrophenol isomers — 151
292 Dioxane — 343
293 Dioxethedrin (INN) and its salts 271 136
294 2,5-Dioxo-3,3-diethyl-5-methylpiperidine and its salts 483 133
295 Diphenhydramine (INN) and its salts 81 339
296 Diphenoxylate hydrochloride (INNM) 220 80
297 2,2-Diphenyl-4-dimethylaminovaleramide and its salts 290 153
298 5,5-Diphenyl-4-imidazolidone — 160
299 4-Diphenylmethoxy-1-methylpiperidine and its salts 305 154
300 3-Diphenylmethoxytropane and its salts 76 158
301 1-Diphenylmethyl-4-methylpiperazine and its salts 222 159
302 1,2-Diphenyl-4-(2-phenylsulphinylethyl)-pyrazolidine-3,5-dione 661 155
303 α,α-Diphenyl-2-piperidinemethanol and its salts 597 285
304 α,α-Diphenyl-4-piperidinemethanol and its salts 66 286
305 Diphenylpyraline (INN) and its salts 299 154
306 2,5-Dipropoxy-3,6-bis(ethyleneimino)-1,4-benzoquinone 409 152
307 4-Dipropylsulphamoylbenzoic acid 606 161
308 Disulfiram (INN) 699, 710 162
309 Dithio-2,2'-bis(pyridine 1-oxide) 1,1' (additive with trihydrated magnesium sulphate) 625 396
310 Doxylamine (INN) and its salts 576 176
311 Emetine, its salts and derivatives — 163
312 Endrin (ISO) 372 196
313 Ephedrine and its salts — 164
314 Epinephrine (INN) 14, 269 14
315 1,2-Epoxybutane — 400
316 Ergocalciferol (INN) 139, (759) 335
317 Ergot and its alkaloids 193 98
318 Eserine and its salts 586 166
319 Ethionamide (INN) 335 319
320 Ethoheptazine (INN) and its salts 476 173
321 Ethopropazine and its salts (558) 320
322 4-Ethoxyphenol (390) 178
323 4-Ethoxy-m-phenylenediamine and its salts — 406
324 2-Ethylamino-5-phenyloxazolin-4-one 344 180
325 Ethyl bis(4-hydroxycoumarinyl)acetate and salts of the acid 326 204
326 Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl)acetate and salts of the acid 325 204
327 Ethyl chloride 167 96
328 Ethyl 1,3-dimethyl-4-phenylazepane-4-carboxylate and its salts 446 171
329 Ethylene dichloride (248) 125
330 Ethylene oxide — 182
331 2-Ethyl-2,3-epoxyhexamide and its derivatives 528 165
332 Ethyl p-fluorophenyl sulphone 347 189
333 Ethyl 1-(2-hydroxy-2-phenylethyl)-4-phenylpiperidine-4-carboxylate and its salts 530 172
334 Ethylidene dichloride (248) 125
335 3-Ethylisothionicotinamide 319 319
336 3-Ethyl-3-methylglutarimide and its salts 71, 337 183
337 4-Ethyl-4-methylpiperidine-2,6-dione and its salts 71, 336 183
338 2-Ethyl-3-methylvaleramide 753 184
339 Ethylphenacemide 553, 565 272
340 2-Ethyl-2-phenylglutarimide and its salts 361 181
341 3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone 9 362
342 Ethyl urocanate (405) 418
343 Fenadiazole (INN) 526 208
344 Fenozolone (INN) 324 180
345 Fenyramidol (INN) 575, 579 274
346 Fluanisone (INN) 350 187
347 Fluoresone (INN) 332 189
348 4'-Fluoro-4-[4-hydroxy-4-(α,α,α-trifluoro-m-tolyl)piperino]butyrophenone 738 188
349 6-Fluoro-16-methyl-11β,17α,21-trihydroxypregna-1,4-diene-3,20-dione 533 186
350 1-(4-Fluorophenyl)-4-[4-(2-methoxyphenyl)-1-piperazinyl]butan-1-one 346 187
351 5-Fluoropyrimidine-2,4-dione 352 190
352 Fluorouracil (INN) 351 190
353 Fluphenazine (INN) (558) 320
354 Furazolidone (INN) 511 252
355 Furfuryltrimethylammonium salts 357 192
356 Furocoumarins (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg 98, 462, 620, 743 358
357 Furtrethonium iodide (INN) (355) 192
358 Galantamine (INN) — 193
359 Gallamine triethiodide (INN) 516 329
360 Glucocorticoids 100 300
361 Glutethimide (INN) and its salts 340 181
362 Glycerol trinitrate 512, 612 253
363 Glycyclamide (INN) 227 100
364 Gold salts — 296
365 Guaifenesin (INN) 459 230
366 Guanethidine (INN) and its salts 367 259
367 N-(2-Guanidinoethyl)azocane and its salts 366 259
368 Haloperidol (INN) 173 185
369 HCH (ISO) (gamma-HCH) 102, 371, 428 195
370 HETP 377 316
371 1,2,3,4,5,6-Hexachlorocyclohexane 102, 369, 428 195
372 (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 312 196
373 Hexachloroethane — 197
374 3,3',4,4',6,6'-Hexachloro-2,2'-methylenediphenol 375 371
375 Hexachlorophene (INN) 374 371
376 (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethanonaphthalene 415 198
377 Hexaethyl tetraphosphate 370 316
378 (1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride 141 70
379 (3S,5aR,9bS)-3,3a,4,5,5a,9b-Hexahydro-3,5a,9-trimethylnaphtho[1,2-b]furan-2,8-dione 636 217
380 Hexamethonium bromide (INN) (381) 124
381 N,N'-Hexamethylenebis(trimethylammonium) salts 380 124
382 Hexapropymate (INN) 616 115
383 Hydrastine, hydrastinine and their salts — 199
384 Hydrazides and their salts — 200
385 Hydrazine, its derivatives and their salts — 201
386 2-Hydrazino-octane and its salts 521 202
387 Hydrocyanic acid and its salts 389, 408, 601, 642 111
388 Hydrofluoric acid, its normal salts, complexes and hydrofluorides (except those listed in Part I of Schedule 2) — 191
389 Hydrogen cyanide and its salts 387, 408, 601, 642 111
390 Hydroquinone monobenzyl, monoethyl and monomethyl ethers 96, 322, 458, 487 178
391 7-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline 762 135
392 [4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid and its salts 739 5
393 3-[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]propionic acid and its salts 713 9
394 2-Hydroxy-3-(2-methoxyphenyl)propyl carbamate 450 205
395 1-Hydroxymethyl-1-cyclohexylacetic acid, sodium salt 643 114
396 4-Hydroxy-3-[1-(4-nitrophenyl)-3-oxobutyl]coumarin 1 254
397 8-Hydroxy-5-nitroquinoline and its salts 515 209
398 4-Hydroxy-3-(3-oxo-1-phenylbutyl)coumarin and its salts 3, 760 203
399 11α-Hydroxypregn-4-ene-3,20-dione and its esters — 385
400 Hydroxy-8-quinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 2 114, 531, 630 395
401 Hydroxyzine (INN) 171 240
402 Hyoscine, its salts and derivatives 638 295
403 Hyoscyamine, its salts and derivatives — 210
404 Hyoscyamus niger L.(leaves, seeds, powder and galenical preparations) — 211
405 3-Imidazol-4-ylacrylic acid and its ethyl ester 342, 751 418
406 2-Imino-5-phenyloxazolidin-4-one and its salts 538 212
407 Imperatorin 465 34
408 Inorganic cyanides (387, 389) 601, 642 111
409 Inproquone (INN) 306 152
410 Intracaine and its salts 258, 536 179
411 Iodine — 213
412 Iodothymol 274 361
413 Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations) — 215
414 Isocarboxazid (INN) 93 52
415 Isodrin 376 198
416 Isometheptene (INN) and its salts 463 228
417 Isoprenaline (INN) 272, 420 17
418 Isopropamide iodide (INN) (145) 156
419 (2-Isopropylpent-4-enoyl)urea 60 216
420 Isoproterenol 272, 417 17
421 Isosorbide dinitrate (INN) 244 148
422 Juniperus sabina L. (leaves, essential oil and galenical preparations) — 294
423 Laurel oil 424 359
424 Laurus nobilis L. (oil from seeds) 423 359
425 Lead and its compounds (except lead acetate subject to the restrictions laid down in entry number 55 in Part I of Schedule 2) — 289
426 Levophacetoperane and its salts 594 284
427 Lidocaine (INN) (Lignocaine) — 399
428 Lindane 102, 369, 371 195
429 Lobelia inflata L. and its galenical preparations — 218
430 Lobeline (INN) and its salts 112 219
431 LSD (433, 434) 127
432 Lupinidine and its salts 648 299
433 Lysergic acid diethylamide and its salts 431, 434 127
434 Lysergide (INN) and its salts 431, 433 127
435 Malononitrile — 149
436 Mannomustine (INN) and its salts 104 89
437 Mecamylamine (INN) 698 229
438 Mefeclorazine (INN) and its salts 276 141
439 Mephenesin (INN) and its esters 718 322
440 Meprobamate (INN) 481 236
441 Mercury and its compounds (except those listed in Part I of Schedule 4) — 221
442 Mescaline and its salts 740 222
443 Metabromsalan (INN) (246) 351
444 Metaldehyde 600 223
445 Metamfepramone (INN) and its salts 282 145
446 Metethoheptazine (INN) and its salts 328 171
447 Metformin (INN) and its salts 284 147
448 Methapyrilene (INN) and its salts 624 144
449 Metheptazine (INN) and its salts 468 174
450 Methocarbamol (INN) 394 205
451 Methohexitone and its salts (69) 220
452 Methotrexate (INN) 33 6
453 2-[4-Methoxybenzyl-N-(2-pyridyl)amino]-ethyldimethylamine maleate 622 346
454 1-Methoxy-2,2-bis(4-hydroxy-3-coumarinyl)ethane 215 225
455 1-Methoxy-2,4-diaminobenzene and its salts 239, 461 376
456 1-Methoxy-2,5-diaminobenzene and its salts 240, 460 377
457 (+)-3-Methoxy-N-methylmorphinan and its salts 236 226
458 4-Methoxyphenol (390) 178
459 3-(2-Methoxyphenoxy)propane-1,2-diol 365 230
460 2-Methoxy-p-phenylenediamine and its salts 240, 456 377
461 4-Methoxy-m-phenylenediamine and its salts 239, 455 376
462 Methoxypsoralens (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg (356) 358
463 6-Methylamino-2-methylhept-2-ene and its salts 416 228
464 2-Methyl-1,2-bis(3-pyridyl)propan-1-one 484 292
465 9-(3-Methylbut-2-enyloxy)furo-[3,2-g]chromen-7-one 407 34
466 2-Methyl-6-chloroanilide of n-butylaminoacetic acid and its salts 125 90
467 1-Methyl-2,4-diaminobenzene and its salts 477 364
468 Methyl 1,2-dimethyl-4-phenylazepane-4-carboxylate and its salts 449 174
469 3,3-Methylenebis-(4-hydroxycoumarin) 252, 253 231
470 2-Methylheptylamine and its salts — 227
471 4-Methyl-2-hexylamine and its salts 35, 288 30
472 1-Methylimidazole-2-thiol 474, 704 233
473 N-N'-[(Methylimino)diethylene]bis-(ethyldimethylammonium) salts 67 121
474 1-Methyl-2-mercaptoimidazole 472, 704 233
475 Methylphenidate (INN) and its salts 572 175
476 1-Methyl-4-phenyl-4-carbethoxyhexa-methyleneimine and its salts 320 173
477 4-Methyl-m-phenylenediamine and its salts 467 364
478 2-Methyl-m-phenylenediamine — 413
479 3-Methyl-2-phenylmorpholine, its derivatives and salts 555 232
480 2-Methyl-2-propyl-1-isopropylcarbamoyloxy-3-carbamoyloxypropane 151 235
481 2-Methyl-2-propyltrimethylene dicarbamate 440 236
482 N-Methyl-1,2,5,6-tetrahydro-3-nicotinic acid methyl ester 61 238
483 Methyprylon (INN) and its salts 294 133
484 Metyrapone (INN) 464 292
485 Minoxidil (INN), its salts and derivatives 596 372
486 Mofebutazone (INN) 133 64
487 Monobenzone (INN) 96, (390) 178
488 Morpholine and its salts — 344
489 Musk ambrette 132 414
490 Mustine and its salts 106, 160 87
491 Mustine N-oxide and its salts 107 86
492 Nalorphine (INN), its salts and ethers 21 20
493 Naphazoline (INN) and its salts 499 244
494 2-Naphthol 495 241
495 β-Naphthol 494 241
496 1- and 2-Naphthylamines and their salts 497 242
497 α- and β-Naphthylamines and their salts 496 242
498 3-(1-Naphthyl)-4-hydroxycoumarin — 243
499 2-(1-Naphthylmethyl)-2-imidazoline and its salts 493 244
500 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
501 Narcotine and its salts 519 258
502 Neodymium and its salts — 309
503 Neostigmine and its salts — 245
504 Nicotine and its salts — 246
505 Nitrites, inorganic (except sodium nitrite) — 248
506 Nitrobenzene — 249
507 Nitrocresols and their alkali metal salts — 250
508 Nitroderivatives of carbazole 146 72
509 Nitrofurantoin (INN) 510 251
510 N-(5-Nitro-2-furfurylidene)-1-aminohydantoin 509 251
511 3-(5-Nitrofurfurylideneamino)oxazolidin-2-one 354 252
512 Nitroglycerine 362, 612 253
513 Nitrosamines — 410
514 Nitrostilbenes, their homologues and derivatives — 256
515 Nitroxoline (INN) and its salts 397 209
516 N,N,N,N',N',N',N",N",N"-Nonaethyl-2,2',2"-(benzene-1,2,3-triyltrioxy)-tris(ethanaminium) triiodide 359 329
517 Noradrenaline and its salts 32, 518 257
518 Norepinephrine (INN) and its salts 32, 517 257
519 Noscapine (INN) and its salts 501 258
520 Nux vomica and its preparations (658) 305
521 Octamoxin (INN) and its salts 386 202
522 Octamylamine (INN) and its salts — 267
523 Octodrine (INN) and its salts 34, 287 28
524 Oestrogens — 260
525 Oleandrin — 261
526 2-(1,3,4-Oxadiazol-2-yl)phenol 343 208
527 [Oxalylbis(iminoethylene)]bis[(o-chlorobenzyl)diethylammonium] salts 24 132
528 Oxanamide (INN) and its derivatives 331 165
529 2-Oxo-3-isobutyl-9,10-dimethoxy-1,2,3,4,6,7-hexahydro-11bH-benzo[a]quinolizine and its salts 685 139
530 Oxpheneridine (INN) and its salts 333 172
531 Oxyquinoline and its sulphate, except for the uses provided for in entry number 51 in Part I of Schedule 2 114, 400, 630 395
532 Padimate A 47 381
533 Paramethasone (INN) 349 186
534 Paraoxon 262 170
535 Parathion (ISO) 263 131
536 Parethoxycaine (INN) and its salts 258, 410 179
537 Pelletierine and its salts 595 263
538 Pemoline (INN) and its salts 406 212
539 Pentachloroethane — 264
540 Pentaerythritol chloral 549 266
541 Pentaerythritol tetranitrate 542, 548 265
542 Pentaerythrityl tetranitrate (INN) 541, 548 265
543 Pentamethonium bromide (INN) (544) 120
544 N,N'-Pentamethylenebis(trimethyl-ammonium) salts 543 120
545 Pentobarbitone and its salts (69) 220
546 Perchloroethylene 689 314
547 Perphenazine (INN) and its salts (558) 320
548 PETN 541, 542 265
549 Petrichloral (INN) 540 266
550 Phenacemide (INN) 561 269
551 Phenaglycodol (INN) 174 95
552 Phenetamine 225 112
553 Pheneturide (INN) 339, 565 272
554 Phenindone (INN) 571 271
555 Phenmetrazine (INN), its derivatives and salts 479 232
556 Phenobarbitone and its salts (69) 220
557 Phenolphthalein (INN) 113 417
558 Phenothiazine (INN) and its compounds various 320
559 Phenprobamate (INN) 573 71
560 Phenprocoumon (INN) 574 273
561 N-Phenylacetylurea 550 269
562 4-Phenylazophenylene-1,3-diamine citrate hydrochloride 190 81
563 Phenylbutazone (INN) 131 67
564 4-Phenylbut-3-en-2-one 94 356
565 (2-Phenylbutyryl)urea 339, 553 272
566 N-[2-(α-Phenyl-p-chlorobenzyl)-ethyl]morpholine 264 270
567 1-Phenylcyclopentanecarboxylic acid diethylaminoethyl ester and its salts 144 169
568 2-Phenylcyclopropylamine (trans-form) and its salts 719 324
569 1-Phenyl-2,3-dimethyl-4-isopropylpyrazol-5-one 617 138
570 o-Phenylenediamine and its salts 241 363
571 2-Phenylindan-1,3-dione 554 271
572 α-Phenyl-2-piperidineacetic acid methyl ester and its salts 475 175
573 3-Phenylpropyl carbamate 559 71
574 3-(α-Phenylpropyl)-4-hydroxycoumarin 560 273
575 1-Phenyl-2-(2-pyridylamino)ethanol 345, 579 274
576 2-[1-Phenyl-1-(2-pyridyl)ethoxy]-ethyldimethylamine and its salts 310 176
577 2-Phenylquinoline-4-carboxylic acid, its salts and derivatives and salts of those derivatives 192 8
578 6-Phenyl-2,4,7-triaminopteridine and its salts 722 275
579 Phenyramidol 345, 575 274
580 Phosphides, metal — 279
581 Phosphorus — 279
582 4-Phosphoryloxy-N,N-dimethyltryptamine 619 278
583 3-Phthalimidopiperidine-2,6-dione and its salts 701 280
584 Phthalylsulphathiazole (INN) and its salts (675) 307
585 Physostigma venenosum Balf. 138 281
586 Physostigmine and its salts 318 166
587 Phytolacca Spp and their preparations — 374
588 Picric acid 742 268
589 Picrotoxin 197 282
590 Pilocarpine and its salts — 283
591 Pilocarpus jaborandi Holmes and its galenical preparations — 311
592 Pipazetate (INN) and its salts 593 118
593 2-(2-Piperidinoethoxy)ethyl 10-thia-1,9-diazaanthracene-9-carboxylate and its salts 592 118
594 α-Piperidin-2-ylbenzyl acetate, laevorotatory threo-form and its salts 426 284
595 1-(2-Piperidyl)propan-2-one and its salts 537 263
596 6-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide, its salts and derivatives 485 372
597 Pipradrol (INN) and its salts 303 285
598 Piprocurarium iodide (INN) 255 137
599 Poldine metilsulfate (INN) (Poldine methylsulphate) 85 239
600 Polyacetaldehyde 444 223
601 Potassium cyanide (387, 389, 408) 111
602 Potassium nitroferricyanide (15), 603 255
603 Potassium nitroprusside (15), 602 255
604 Pramocaine (INN) 605 405
605 Pramoxine 604 405
606 Probenecid (INN) 307 161
607 Procainamide (INN), its salts and derivatives 29 25
608 Prochlorperazine (INN) and its salts (558) 320
609 Progestogens — 194
610 Promazine (INN) and its salts (558) 320
611 Promethazine (INN) and its salts (558) 320
612 Propane-1,2,3-triyl trinitrate 362, 512 253
613 Propatylnitrate (INN) 111 206
614 1-Propyl-3-(4-chlorobenzenesulphonyl)urea 182 79
615 2-Propylpiperidine 212 290
616 1-(2-Propynyl)cyclohexyl carbamate 382 115
617 Propyphenazone (INN) 569 138
618 Prunus laurocerasus L. 157 291
619 Psilocybine (INN) 582 278
620 Psoralen (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg (356) 358
621 Pyrethrum album L. and its galenical preparations — 345
622 Pyrianisamine maleate 453 346
623 Pyribenzamine 97, 745 347
624 2-(N-2-Pyridyl-N-2-thienylamino)ethyl-dimethylamine and its salts 448 144
625 Pyrithione disulphide+magnesium sulphate 309 396
626 Pyrithione sodium (INNM) — 369
627 Pyrocatechol 79, 153 408
628 Pyrogallol — 409
629 Quinalbarbitone and its salts (69) 220
630 Quinolin-8-ol except for the uses provided for in entry number 51 in Part I of Schedule 2 (400, 531) 395
631 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[^f00038]) — 293
632 Rauwolfia serpentina alkaloids and their salts 633 15
633 Reserpine (INN) and its salts (632) 15
634 Retinoic acid and its salts 721, 758 375
635 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 mg/kg; or in the case of products other than oral hygiene or dental products, 100 mg/kg) — 360
636 α-Santonin 379 214
637 Schoenocaulon officinale Lind. (seeds and galenical preparations) — 332
638 Scopolamine, its salts and derivatives 402 295
639 Secbutobarbitone and its salts (69) 220
640 Secondary dialkanolamines 110, 254, 273 411
641 Selenium and its compounds except when permitted under the restrictions laid down in Part I of Schedule 2 — 297
642 Sodium cyanide (387, 389, 408) 111
643 Sodium hexacyclonate (INN) 395 114
644 Sodium nitroferricyanide (15), 645 255
645 Sodium nitroprusside (15), 644 255
646 Solanum nigrum L. and its galenical preparations — 298
647 Spanish Fly 140 69
648 Sparteine (INN) and its salts 432 299
649 Spironolactone (INN) 10 4
650 Squill and its preparations 750 330
651 Stramonium and its preparations 231 301
652 Strontium lactate — 402
653 Strontium nitrate — 403
654 Strontium polycarboxylate — 404
655 Strophanthines and their aglucones and their respective derivatives — 302
656 Strophanthus species and their galenical preparations — 303
657 Strychnine and its salts — 304
658 Strychnos species and their galenical preparations 520 305
659 Succinonitrile — 150
660 Succinylsulphathiazole and its salts (675) 307
661 Sulfinpyrazone (INN) 302 155
662 Sulphacetamide and its salts (675) 307
663 Sulphadiazine and its salts (675) 307
664 Sulphadimethoxine and its salts (675) 307
665 Sulphadimidine and its salts (675) 307
666 Sulphafurazole and its salts (675) 307
667 Sulphaguanidine and its salts (675) 307
668 Sulphamethizole and its salts (675) 307
669 Sulphamethoxazole and its salts (675) 307
670 Sulphamethoxydiazine and its salts (675) 307
671 Sulphamethoxypyridazine and its salts (675) 307
672 Sulphanilamide and its salts (675) 307
673 Sulphapyridine and its salts (675) 307
674 Sulphathiazole and its salts (675) 307
675 Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the −NH₂ groups) and their salts 584, 660, 662–674 307
676 Sulthiame 677, 696 308
677 Sultiame (INN) 676, 696 308
678 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
679 Tefazoline (INN) and its salts 695 237
680 Tellurium and its compounds — 312
681 TEPP (ISO) 693 276
682 2-(4-tert-Butyl-2,6-dimethylbenzyl)-2-imidazoline and its salts 764 313
683 4-tert-Butylphenol — 340
684 4-tert-Butylpyrocatechol — 341
685 Tetrabenazine (INN) and its salts 529 139
686 Tetrabromosalicylanilides — 350
687 Tetracaine (INN) and its salts 279 63
688 2,3,7,8-Tetrachlorodibenzo-p-dioxin — 367
689 Tetrachloroethylene 546 314
690 Tetrachloromethane 148 315
691 Tetrachlorosalicylanilides — 348
692 Tetraethylammonium bromide 700 61
693 Tetraethyl pyrophosphate 681 276
694 (R)-5,6,6a,7-Tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol and its salts 59 42
695 2-(5,6,7,8-Tetrahydro-1-naphthylmethyl)-2-imidazoline and its salts 679 237
696 4-(Tetrahydro-2H-1,2-thiazin-2-yl)-benzenesulphonamide S,S-dioxide 676, 677 308
697 Tetrahydrozoline and its salts — 394
698 N,2,3,3-Tetramethyl-2-norcamphanamine 437 229
699 Tetramethylthiuram disulphide 710 162
700 Tetrylammonium bromide (INN) 692 61
701 Thalidomide (INN) and its salts 583 280
702 Thallium and its compounds — 317
703 Thevetia neriifolia Juss., glycoside extract — 318
704 Thiamazole (INN) 472, 474 233
705 2,2'-Thiobis(4,6-dichlorophenol) 115 352
706 Thiopentone and its salts (69) 220
707 Thioridazine (INN) and its salts (558) 320
708 Thiotepa (INN) 723 310
709 Thiourea and its derivatives (except those listed in Part I of Schedule 2) — 321
710 Thiram (ISO) 699 162
711 Thiuram disulphides — 354
712 Thiuram monosulphides — 353
713 Thyropropic acid (INN) and its salts 393 9
714 Tolboxane (INN) 717 177
715 Tolbutamide (INN) 134 65
716 Toluidines, their isomers, salts and halogenated and sulphonated derivatives 40 32
717 p-Tolylboric acid ester of 2-methyl-2-propylpropane-1,3-diol 714 177
718 3-o-Tolyloxypropane-1,2-diol (439) 322
719 Tranylcypromine (INN) and its salts 568 324
720 Tretamine (INN) 724 328
721 Tretinoin (INN) and its salts 634, 758 375
722 Triamterene (INN) and its salts 578 275
723 Tri(aziridin-1-yl)phosphine sulphide 708 310
724 2,4,6-Tri(aziridin-1-yl)-1,3-triazine 720 328
725 2,2,2-Tribromoethanol (726) 326
726 Tribromoethyl alcohol 725 326
727 Tribromsalan (INN) 728 373
728 3,4',5-Tribromosalicylanilide 727 373
729 Trichlormethine (INN) and its salts 746 327
730 Trichloroacetic acid — 10
731 1,1,1-Trichloro-2,2-bis(4-chlorophenyl)ethane 195, 232 123
732 2,2,2-Trichloroethane-1,1-diol 158 77
733 Trichloromethane 168 366
734 N-(Trichloromethylthio)cyclohex-4-ene-1,2-dicarboximide 142 370
735 Trichloronitromethane 178 325
736 Tricresyl phosphate 747 277
737 Trifluoperazine (INN) and its salts (558) 320
738 Trifluperidol (INN) 348 188
739 3,3',5-Triiodothyroacetic acid and its salts 392 5
740 3,4,5-Trimethoxyphenethylamine and its salts 442 222
741 2,2,6-Trimethyl-4-piperidyl benzoate and its salts 75 51
742 2,4,6-Trinitrophenol 588 268
743 Trioxysalen (INN) (except natural content of essences). In sun protection and in bronzing products, furocoumarins content shall be below 1 mg/kg (356) 358
744 Triparanol (INN) 172 92
745 Tripelennamine (INN) 97, 623 347
746 Tris(2-chloroethyl)amine 729 327
747 Tritolyl phosphate 736 277
748 Tuaminoheptane (INN), its isomers and salts 30 27
749 Tyrothricin (INN) — 392
750 Urginea scilla Stern. and its galenical preparations 650 330
751 Urocanic acid (405) 418
752 Vaccines, toxins and serums listed in the Annex to Council Directive No. 75/319/EEC[^f00039] — 323
753 Valnoctamide (INN) 338 184
754 Veratrine, its salts and galenical preparations — 331
755 Veratrum spp and their preparations — 333
756 Vinyl chloride monomer — 334
757 Vinylidene chloride (7, 249) 126
758 Vitamin A acid and its salts 634, 721 375
759 Vitamins D₂ and D₃ 139, 187, 316 335
760 Warfarin (ISO) and its salts 3, 398 203
761 Xanthates 16 336
762 Xanthinol 391 135
763 Xylidines, their isomers, salts and halogenated and sulphonated derivatives 41 33
764 Xylometazoline (INN) and its salts 682 313
765 Yohimbine and its salts — 337
766 Zirconium and its compounds (except aluminium zirconium chloride hydroxide complexes and aluminium zirconium chloride hydroxide glycine complexes under the conditions laid down in Part I of Schedule 2 and zirconium lakes, salts and pigments prepared from those colouring agents identified in column 1 of Part I of Schedule 3 by “*” immediately after the name or colour index number) — 391
767 Zoxazolamine (INN) 28 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.

Names which appear in square brackets in column 2 are the International Nomenclature Cosmetic Ingredient names of the substances in question given in the inventory of ingredients employed in cosmetic products drawn up in accordance with the provisions of the Directive and contained in Commission Decision 96/335/EC[^f00040].

PART I — SUBSTANCES LISTED IN ANNEX III, PART I OF THE DIRECTIVE AS SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

(1) (2) (3) (4) (5) (6)
Reference Number Name of substance Purpose of substance or type of product Maximum concentration of substance in product Other requirements Required information
Note 1: Entry 15a is substituted with effect from the dates specified in regulation 1(6). Until then, entry number 15 in Part I of Schedule 2 to S.I. 1989/2233 continues in force. Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as percentage of sodium hydroxide. In cases of mixtures, the sum must not exceed the limits given in column (4). Note 1: Entry 15a is substituted with effect from the dates specified in regulation 1(6). Until then, entry number 15 in Part I of Schedule 2 to S.I. 1989/2233 continues in force. Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as percentage of sodium hydroxide. In cases of mixtures, the sum must not exceed the limits given in column (4). Note 1: Entry 15a is substituted with effect from the dates specified in regulation 1(6). Until then, entry number 15 in Part I of Schedule 2 to S.I. 1989/2233 continues in force. Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as percentage of sodium hydroxide. In cases of mixtures, the sum must not exceed the limits given in column (4). Note 1: Entry 15a is substituted with effect from the dates specified in regulation 1(6). Until then, entry number 15 in Part I of Schedule 2 to S.I. 1989/2233 continues in force. Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as percentage of sodium hydroxide. In cases of mixtures, the sum must not exceed the limits given in column (4). Note 1: Entry 15a is substituted with effect from the dates specified in regulation 1(6). Until then, entry number 15 in Part I of Schedule 2 to S.I. 1989/2233 continues in force. Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as percentage of sodium hydroxide. In cases of mixtures, the sum must not exceed the limits given in column (4). Note 1: Entry 15a is substituted with effect from the dates specified in regulation 1(6). Until then, entry number 15 in Part I of Schedule 2 to S.I. 1989/2233 continues in force. Note 2: The concentration of sodium, potassium or lithium hydroxide is expressed as percentage of sodium hydroxide. In cases of mixtures, the sum must not exceed the limits given in column (4).
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 — —
2a Thioglycolic acid and its salts (a) Hair waving or straightening products for general use 8 per cent ready for use pH 7 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children
(b) Hair waving or straightening products for professional use 11 per cent ready for use pH 7 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only
(c) Depilatories 5 per cent ready for use pH 7 to 12.7 Contains thioglycolate. Follow the instructions. Keep out of reach of children
(d) Other hair-care products which are removed after application 2 per cent ready for use pH 7 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children
The abovementioned percentages are calculated as thioglycolic acid (a), (b), (c) and (d): The directions for use must incorporate the following: Avoid contact with eyes In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice Wear suitable gloves ((a), (b) and (d) only)
2b Thioglycolic acid esters (a) Hair waving or straightening products for general use 8 per cent ready for use pH 6 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children
(b) Hair waving or straightening products for professional use 11 per cent ready for use pH 6 to 9.5 Contains thioglycolate. Follow the instructions. Keep out of reach of children. For professional use only
The abovementioned percentages are calculated as thioglycolic acid (a) and (b): the directions for use must incorporate the following: May cause sensitization in the event of skin contact Avoid contact with eyes In the event of contact with 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 (INN) [Chloramine-T] 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- and p-Phenylenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-phenylenediamines Oxidizing colouring agents for hair-dyeing for general use 6 per cent calculated as a free base, subject to the provision of “Combination Rule A” set out below — Contains phenylenediamines. Can cause an allergic reaction. 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. Wear suitable gloves
9 Methylphenylenediamines (other than 4-methyl-m-phenylenediamine and its salts), their N-substituted derivatives and their salts (Toluenediamines (other than toluene-1,3-diamine and its salts), their N-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. 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. Wear suitable gloves
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 allergic reaction. Do not use to dye eyelashes or eyebrows
Oxidizing colouring agents for hair-dyeing for professional use 10 per cent calculated as afree base, subject to the provisions of “Combination Rule A” set out below — Contains diaminophenols. For professional use only. Can cause allergic reaction. Wear suitable gloves
11 Dichlorophen (INN) [Dichlorophene] All purposes and products 0.5 per cent — Contains dichlorophen
12 Hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide including hydrogen peroxide-urea (hydrogen peroxide-carbamide) and zinc peroxide a Hair-care preparations b Skin-care preparations c Nail hardening preparations d Oral hygiene products 12 per cent of H₂O₂ present or released 4 per cent of H₂O₂ present or released 2 per cent of H₂O₂ present or released 0.1 per cent of H₂O₂ present or released — — — — (a): Wear suitable gloves (a)(b)(c): 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 provisions 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
15a Potassium hydroxide and sodium hydroxide (see Note 1) Nail cuticle solvent 5 per cent calculated as sodium hydroxide (see Note 2) — 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 (see Note 2) — 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 (see Note 2) — 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 —
15b Lithium hydroxide Hair straightener for general use 2 per cent calculated as sodium hydroxide (see Note 2) — 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 (see Note 2) — For professional use only. Avoid contact with eyes. Can cause blindness
Other uses — — —
15c Calcium hydroxide Hair straighteners containing two components: calcium hydroxide and guanidine salt 7 per cent — Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
Other uses — — —
16 α-Naphthol[1-Naphthol] Colouring agent for hair dyeing 0.5 per cent — Contains α-napthol
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 ENTRY DELETED
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
23a 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
23b 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-hydroxybenzene-sulphonate [Zinc phenolsulfonate] 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 the 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 Hexadecylammonium fluoride [Cetylamine hydrofluoride] Oral hygiene products As for ammonium monofluorophosphate — Contains hexadecylammonium fluoride
37 3-(n-Hexadecyl-N-2-hydroxyethylammonio)-propylbis(2-hydroxyethyl)-ammonium difluoride [Stearyl trihydroxyethyl propylenediamine dihydrofluoride] Oral hygiene products As for ammonium monofluorophosphate — Contains 3-(n-hexadecyl-N-2-hydroxyethylammonio)propylbis(2-hydroxyethyl)ammonium difluoride
38 N,N',N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride [Palmityl trihydroxyethyl propylenediamine dihydrofluoride] Oral hygiene products As for ammonium monofluorophosphate — Contains N,N',N'-tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride
39 Octadecenylammonium fluoride Oral hygiene products As for ammonium monofluorophosphate — Contains octadecenylammonium 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 [Dimethylol ethylene thiourea] Hair care preparations 2 per cent Not to be used in aerosol dispensers Contains 1,3-bis(hydroxymethyl)imidazolidene-2-thione
Nail care preparations 2 per cent pH value as applied must be less than 4 Contains 1,3-bis(hydroxymethyl)imidazolidene-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 [Selenium sulfide] 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 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 between 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-hydroxyquinolinium sulphate) (See also Part II of this Schedule) [Oxyquinoline and Oxyquinoline sulfate] 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-hydroxyethylidene-diphosphonic acid and its salts) Hair care Soap 1.5 per cent expressed as etidronic acid 0.2 per cent expressed as etidronic acid — — — —
54 1-Phenoxypropan-2-ol (See also Part I of Schedule 4) [Phenoxyisopropanol] Products rinsed off after use. Prohibited in oral hygiene products 2 per cent — —
55 Lead acetate Only for hair dyeing 0.6 per cent calculated as lead — Contains lead acetate. Keep away from children. Avoid all contact with the eyes. Wash hands after use. Do not use to dye eyelashes, eyebrows or moustaches. If irritation develops discontinue use
56 Magnesium fluoride Dental hygiene products 0.15 per cent calculated as fluorine. When mixed with other fluorine compounds the total fluorine concentration must not exceed 0.15 per cent — Contains magnesium fluoride
57 Strontium chloride hexahydrate Toothpaste 3.5 per cent calculated as strontium. When mixed with other permitted strontium compounds the total strontium content must not exceed 3.5 per cent — Contains strontium chloride. Use by children is not advisable
58 Strontium acetate hemihydrate Toothpaste 3.5 per cent calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3.5 per cent — Contains strontium acetate. Use by children is not advisable
59 Talc: hydrated magnesium silicate (a) Powdery products intended to be used for children under three years of age — — (a): Keep powder away from children’s nose and mouth
(b) other products — —
60 Fatty acid dialkanolamides All purposes and products Maximum dialkanolamine content: 0.5 per cent Do not use with nitrosating systems. Maximum dialkanolamine content: 5 per cent (applies to raw materials). Maximum N-nitrosodialkanolamine content: 50 μ g/kg (applies to raw materials). Keep in nitrite-free containers —
61 Monoalkanolamines All purposes and products Maximum dialkanolamine content: 0.5 per cent Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum dialkanolamine content: 0.5 per cent (applies to raw materials). Maximum N-nitrosodialkanolamine content: 50 μ g/kg (applies to raw materials). Keep in nitrite-free containers —
62 Trialkanolamines a non-rinse-off b other products a 2.5 per cent (a) (b): Do not use with nitrosating systems. Minimum purity: 99 per cent. Maximum dialkanolamine content: 0.5 per cent (applies to raw materials). Maximum N-nitrosodialkanolamine content: 50 μ g/kg (applies to raw materials). Keep in nitrite-free containers —
63 Strontium hydroxide pH-regulator in depilatory products 3.5 per cent calculated as strontium pH value not to exceed 12.7 Keep out of reach of children. Avoid contact with the eyes
64 Strontium peroxide Rinse-off hair care preparations for professional use 4.5 per cent calculated as strontium in the ready-for-use preparation All products must meet the hydrogen peroxide release requirements Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them. For professional use only. Wear suitable gloves

PART II — SUBSTANCES LISTED IN ANNEX III, PART 2 (FORMERLY ANNEX IV, PART 1) OF THE DIRECTIVE AS SUBSTANCES PROVISIONALLY ALLOWED

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