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List of Substances Which Must Not Form Part of the Composition of Cosmetic Products

ANNEX II – Part 1

Reference Number Substance
1 N-5 Chlorobenzoxazol-2-ylacetamide
2 ß-Acetoxyethy trimethylammonium hydroxide (acetylcholine and its salts)
3 DEANOL ACEGLUMATE
4 Spironolactone
5 [4-(4-HYDROXY-3-IODOPHENOXY)-3,5-DIODOPHENYL] ACETIC ACID AND ITS SALTS
6 Methotrexate
7 Aminocaproic acid and its salts
8 Cinchophen,its salts,derivatives and salts of these derivatives
9 Thyropropic acid and its salts
10 Trichloroacetic acid
11 Aconitum napellus L. (leaves,roots and galenical preparations)
12 Aconitine (principal alkaloid of Aconitum napellus L.) and its salts
13 Adonis vernalis L. and its preparations
14 Epinephrine
15 Rauwolfia serpentina alkaloids and their salts
16 Alkyne alcohols,their esters,ethers and salts
17 Isoprenaline
18 Allyl isothiocyanate
19 Alloclamide and its salts
20 Nalorphine,its salts and ethers
21 Sympathomimetic amines acting on the central nervous system:
any substance contained in the first list of medicaments w/c are subject to medical
Prescription and are referred to in resolution AP(69) 2 of the Council of Europe
22 Aniline,its salts and its halogenated and sulphonated derivatives
23 Betoxycaine and its salts
24 Zoxazolamine
25 Procainamide,its salts and derivatives
26 Benzidine
27 Tuaminoheptane,its isomers and salts
28 Octodrine and its salts
29 2-Amino-1,2-bis (4-methoxyphenyl) ethanol and its salts
30 1,3-dimethylpentylamine  and its salts
31 4-Aminosalicylic acid and its salts
32 TOLUIDINES, THEIR ISOMERS, SALTS AND HALOGENATED AND SULPHONATED DERIVATIVES
33 Xylidines, their isomers, salts and halogenated and sulphonated derivatives
34 Imperatorin [9-(3-methylbut-2-enyloxy) furo(3,2-g)chromen-7-one]
35 Ammi majus and its galenical preparations
36 2,3-Dichloro-2-methylbutane
37 Subtances w/ androgenic effect
38 Anthrancene oil
39 Antibiotics
40 Antimony and its compounds
41 Apocynum cannabinum L. and its preparations
42 Apomorphine (5,6,6a,7-tetrahydro-6-methyl-4H-dibenzo (de, g)- quinoline-10,11- dyhydric alcohol) and its salts
43 Arsenic and its compounds
44 Atropa belladonna L. and its preparations
45 Atropine, its salts and derivatives
46 Barium salts with the exception of barrium sulfhate, baruim sulphide under the
conditions laid down in ANNEX  III, Part 1, and Lakes, salts and pigments prepared from the colouring
agents listed with the reference (3) in ANNEX IV, part 1, and ANNEX IV, Part 2
47 Benzene
48 Benzimidazol-2(3H)-one
49 Benzazepines and benzadiazepines
50 1-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and its salts
51 2,2,6-Trimethyl-4-piperidyl benzoate (benzamine) and its salts
52 Isocarboxazide
53 Bendroflumethiazide  and its derivatives
54 Beryllium and its compounds
55 Bromine, elemental
56 Bretylium tosilate
57 Carbromal
58 Bromisoval
59 Brompheniramine and its salts
60 Benzilonium bromide
61 Tetrylammonium bromide
62 Brucine
63 Tetracaine and its salts
64 Mofebutazone
65 Tolbutamide
66 Carbutamide
67 Phenylbutazone
68 Cadmium and its compounds
69 Cantharides, Cantharis vesicatoria
70 (1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (cantharidin)
71 Phenprobamate
72 Nitroderivatives of carbozol
73 Carbon disulphide
74 Catalase
75 Cephaeline and its salts
76 Chenopodium ambrosioides (essential oil)
77 2,2,2-Trichloroethane-1,1-diol
78 Chlorine
79 Chlorpropamide
80 Diphenoxylate hydrochloride
81 4-Phenylazophenyiene-1,3-diamine citrate hydrochloride (chrysoidine citrate hydrochloride)
82 Chlorzoxazone
83 2-Chloro-6-methylpyrimidin-4-yldimethylamine (crimidine-ISO)
84 Chlorprothixene and its salts
85 Clofenamide
86 N,N-bis (2-chloroethyl) methylamine N-oxide and its salts
87 Chlormethine and its salts
88 CYCLOPHOSPHAMIDE AND ITS SALTS
89 Mannomustine and its salts
90 Butanilicaine and its salts
91 Chlormezanone
92 Triparanol
93 2-[2-(4-Chlorophenyl)-2-phenylacetyl] indan 1,3-dione (chlorophacinone-ISO)
94 Chlorphenoxamine
95 PHENAGLYCODOL
96 Chloroethane
97 Chromium; chromic acid and its salts
98 Claviceps purpurea Tul., its alkaloids and galenical preparations
99 Conium maculatum L.(fruit,powder,galenical  preparations)
100 Glycyclamide
101 Cobalt benzenesulphonate
102 Colchicine, its salts and derivatives
103 Colchicoside and its derivatives
104 Colchicum autumnale L. and its galenical preparations
105 Convallatoxin
106 Anamirta cocculus L.(fruit)
107 Croton tiglium (oil)
108 1-Butyl-3-(N-crotonoylsulphanilyl) urea
109 Curare and curarine
110 Synthetic curarizants
111 Hydrogen cyanide and its salts
112 2-α-Cyclohexylbenz,yl  (N,N,N’,N’-tetraethyl)  trimethylenediamine (phenetamine)
113 Cyclomenol and its salts
114 Sodium hexacyclonate
115 Hexapropymate
116 Dextropropoxyphene
117 O,O’-Diacetyl-N-allyl-N-normorphine
118 Pipazetate and its salts
119 5-(α-ß- Dibromophenethyl)-5-  methylhydantoin
120 N,N’-Pentamethylenebis  (trimethylammonium)  salts,e.g. Pentamethonium bromide
121 N,N’-[(Methylimino)diethylene]bis(ethyldimethylammonium) salts,e.g. azamethonium bromide
122 Cyclarbamate
123 Clofenotane; DDT (ISO)
124 Hexamethylenebis (trimethylammonium)  salts e.g. hexamethonium bromide*
125 Dichloroethanes (ethylene chlorides)
126 Dichloroethylenes (acetylene chlorides)
127 Lysergide and its salts
128 2-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts
129 Cinchocaine and its salts
130 3-Diethylaminopropyl  cinnamate
131 O,O’-Diethyl O-4-nitrophenyl phosphorothioate (parathion-ISO)
132 (Oxalylbisiminoethylene)  bis [(O-chlorobenzyl) diethylammonium] salts, e.g. ambenomium chloride
133 Methyprylon and its salts
134 Digitaline and all heterosides of Digitalis purpurea L.
135 7-[2-Hydroxy-3-(2-hydroxyethyl)-N-methylamino) propyl]theophylline (xanthinol)
136 Dioxethedrin and its salts
137 Piprocurarium
138 Propyphenazone
139 Tetrabenazine and its salts
140 Captodiame
141 Mefeclorazine and its salts
142 Dimethylamine
143 1,1-Bis(dimethylaminomethyl) propyl benzoate (amydricaine,alypine)  and its salts
144 Methapyrilene and its salts
145 Metamfepramone and its salts
146 Amitriptyline and its salts
147 Metformin and its salts
148 Isosorbide dinitrate
149 Malononitrile
150 Succinonitrile
151 Dinitrophenol isomers
152 Inproquone
153 Dimevamide and its salts
154 Diphenylpyraline and its salts
155 Sulfinpyrazone
156 N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethylammonium salts, e.g. isopropamide iodide
157 Benactyzine
158 Benzatropine and its salts
159 Cyclizine and its salts
160 5,5-Diphenyl-4-imidazolidone
161 Probenecid
162 Disulfiram; thiram (ISO)
163 Emetine, its salts and derivatives
164 Ephedrine and its salts
165 Oxanamide and its derivatives
166 Eserine or physostigmine and its salts
167 Esters of 4-aminobenzoic acid, with the free amino group,with the exception of That given in Annex VII, Part 2
168 Choline salts and their esters, e.g.choline chloride
169 Caramiphen and its salts
170 Diethyl 4-nitrophenyl phosphate
171 Metethoheptazine and its salts
172 Oxpheneridine and its salts
173 Ethoheptazine and its salts
174 Metheptazine and its salts
175 Methylphenidate and its salts
176 Doxylamine and its salts
177 Tolboxane
178 4-Benzyloxyphenol,4-methoxyphenol and 4-ethoxyphenol
179 Parethoxycaine and its salts
180 Fenozolone
181 Glutethimide and its salts
182 Ethylene oxide
183 Bemegride and its salts
184 Valnoctamide
185 Haloperidol
186 Paramethasone
187 Fluanisone
188 Trifluperidol
189 Fluoresone
190 Fluorouracil
191 Hydroflouric acid,its normal salts,its complexes and hydrofluorides with the EXCEPTION OF THOSE GIVEN IN ANNEX III, PART1
192 FURFURYLTRIMETHYLAMMONIUM SALTS, E.G. FURTRETHONIUM IODIDE*
193 Galantamine
194 Progestogens
195 1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO) (lindane)
196 (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- dimethanonaphtalene  (endrin-ISO)
197 Hexachloroethane
198 (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4,5,8-dimethanonaphthalene  (isodrin-ISO)
199 Hydrastine, hydrastanine and their salts
200 Hydrazides and their salts
201 Hydrazine, its derivatives and their salts
202 Octamoxin and its salts
203 Warfarin and its salts
204 Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl) acetate and its salts of the acid
205 Methocarbamol
206 Propatylnitrate
207 4,4′-Dihydroxy-3,3′-(3-methylthiopropylidene) dicoumarin
208 Fenadiazole
209 Nitroxoline and its salts
210 Hyoscyamine,its salts and derivative
211 Hycoscyamus niger L. (leaves,seeds,powder  and galenical preparations)
212 Pemoline and its salts
213 Iodine
214 Decamethylenebis (trimethylammonium)  salts,e.g. decamethonium bromide
215 Ipecacuanha (Cephaelis ipecacuanha Brot. And related species) (roots,powder & galenical preparations
216 (2-Isopropylpent-4-enoyl) urea (apronalide)
217 α-Santonin (( 3S,5aR,9bS)-3,3a,4,5,5a,9b-hexahydro-3,5a,9-trimethyl-naphto(1,2-b)furan-2,8-dione
218 Lobelia inflata L. and its galenical preparations
219 Lobeline and its salts
220 Barbiturates
221 Mercury and its compounds except those special cases included in Annex VI, Part 1
222 3,4,5-Trimethoxyphenethylamine and its salts
223 Metaldehyde
224 2-(4-Allyl-2-methoxyphenoxy)-N,N-dietthylacetamide and its salts
225 Coumetarol
226 Dextromethrophan and its salts
227 2-Methylheptylamine  and its salts
228 Isometheptene and its salts
229 Mecamylamine
230 Guaifenesin
231 Dicoumarol
232 Phenmetrazine,its derivatives and salts
233 Thiamazole
234 3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H,pyrano(3,2-c)-(1)benzopyran-5-one(cyclocoumarol)
235 Carisoprodol
236 Meprobamate
237 Tefazoline and its salts
238 Arecoline
239 Poldine methylsulfate
240 Hydroxyzine
241 2-NAPHTHOL
242 1-and- 2-Naphthylamines and their salts
243 3-(1-Naphthyl)-4-hydroxycoumarin
244 Naphazoline and its salts
245 Neostigmine and its salts (e.g. neostigmine bromide)
246 Nicotine and its salts
247 Amyl nitrites
248 Inorganic nitrites, with the exception of sodium nitrite
249 Nitrobenzene
250 Nitrocresols and their alkali metals salts
251 Nitrofurantoin
252 Furazolidone
253 Propane-1,2,3-triyl trinitrate
254 Acenocoumarol
255 Alkali pentacyanonitrosylferrate (2-)
256 Nitrostilbenes, their homologues and their derivatives
257 Noradrenaline and its salts
258 Noscapine and its salts
259 Guanethidine and its salts
260 Oestrogens,with the exception of thosed listed in Annex V
261 Oleandrin
262 Chlortalidone
263 Pelletierine and its salts
264 Pentachloroethane
265 Pentaerithrityl tetranitrate
266 Petrichloral
267 Octamylamine and its salts
268 Picric acid
269 Phenacemide
270 Difencloxazine
271 2-Phenylindan-1,3-dione  (phenindione)
272 Ethylphenacemide
273 Phenprocoumon
274 Fenyramidol
275 Triamterence and its salts
276 Tetraethyl pyrophosphate; TEPP (ISO)
277 Tritolyl phosphate
278 Psilocybine
279 Phosphorus and metal phosphides
280 Thalidomide and its salts
281 Physostigma venenosum Balf
282 Picrotoxin
283 Pilocarpine and its salts
284 α-Piperidin-2-yl benzyl acetate laevorotatory thereoform (Levophacetoperane  and its salt)
285 Pipradrol and its salts
286 Azacyclonol and its salts
287 Bietamiverine
288 Butopiprine and its salts
289 Lead and its compounds,with the exception of that mentioned in ANNEX III, No 55 under the condition stated
290 Coniine
291 PRUNUS LAUROCERASUS L. (CHERRY LAUREL WATER)
292 Metyrapone
293 Radioactive substances (1)
294 Juniperus sabina L.(leaves,esential oil & galenical preparations)
295 Hyoscine, its salts and derivatives
296 Gold salts
297 Selenium and its compounds with the exception of selenium disulphide under
the conditions set out under the reference no 49 in ANNEX III, Part 1
298 Solanum nigrum L. and its galenical preparations
299 Sparteine and its salts
300 Glucocorticoids
301 Datura stramonium L. and its galenical preparatipns
302 Strophantines, their aglucones & their respective derivatives
303 Strophantus species and their galenical preparations
304 Strychnine and its salts
305 Strychnos species and their galenical preparations
306 Narcotics, natural and synthetic:
All substances listed in Table I and II of the Single Convension on narcotic drugs signed in New York on 30 March 1961.
307 Sulphonamides (sulphanilamide & its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts
308 Sultiame
309 Neodymium and its salts
310 Thiotepa
311 Pilocarpus jaborandi Holmes and its galenical preparations
312 Tellurium and its compounds
313 Xylometazoline and its salts
314 Tetrachloroethylene
315 Carbon Tetrachloride
316 Hexaethyl tetraphosphate
317 Thallium and its compounds
318 Thevetia neriifolia Juss. Glycoside extract
319 ETHIONAMIDE
320 Phenothiazine and its compounds
321 Thiourea and its derivatives, with exception of the one listed in Annex III,Part 1
322 Mephenesin and its esters
323 Vaccine, toxins or serums listed in the Annex to the Second Counsil Directive of
20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action
relating to proprietary medicinal products (O J N L 147,9.6.1975,p.13)
324 Tranylcypromine and its salts
325 Trichloronitromethane  (chloropicrine)
326 2,2,2-Tribromoethanol  (tribromoethyl alcohol)
327 Trichlormethine and its salts
328 Tretamine
329 Gallamine triethiodide
330 Urginea scilla Stern. And its galenical preparations
331 Veratrine, its salts and galenical preparations
332 Schoenoocaulon officinale Lind.(seeds and galenical preparations)
333 Veratrum Spp. And their preparations
334 Vinyl chloride monomer
335 Ergocalciferol and cholecalciferol (vitamins D2 and D3)
336 Salts of O-alkyldithiocarbonic  acids
337 Yohimbine and its salts
338 Dimethyl sulfoxide
339 Diphenhydramine and its salts
340 4-tert-Butylphenol
341 4-tert-Butylpyrocatechol
342 Dihydrotachysterol
343 Dioxane
344 Morpholine and its salts
345 Pyrethrum album L. and its galenical preparations
346 2-(4-Methoxybenzyl-N-(2-pyridyl)amino)ethyldimethylamine maleate
347 Tripelennamine
348 Tetrachlorosalicylanilides
349 Dichlorosalicylanilides
350 TETRABROMOSALICYLANILIDES
351 Dibromosalicylanilides
352 Bithionol
353 Thiuram monosulphides
354 Thiuram disulphides
355 Dimethylformamide
356 4-Phenylbut-3-en-2-one
357 Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol except for normal content in natural essences used
358 Furocoumarines (e.g. trioxysalan,8-methoxypsoralen, 5-methoxypsoralen),
except for normal content in natural essences used. In Sun protection and in
Bronzing products, urocoumarins shall be below 1 mg/kg
359 Oil from the seeds of Laurus nobilis L
360 Safrole except for normal content in the natural essences used and provided the
concentration does not exceed: 100 ppm in the finished product 50 ppm in products for dental and oral hygiene, and provided that
Safrole is not present in toothpastes intended specifically for children
361 5,5′-Di-isopropyl-2,2′-dimethylbiphenyl-4,4′-diyl dihypoiodite
362 3′-ethyl-5′,6′,7,8′-tetrahydro-5′,5′,8′,8′,-tetramethyl-2′-acetonaphthone or 7-acetyl-
6-ethyl-1,1,4,4- tetrametyl-1, 2,3,4-tetrahydronaphtalen
363 o-phenylenediamine  and its salts
364 4-Methyl-m-phenylenediamine and its salts
365 Aristolochic acid and its salts/;Aristolochia spp. and their preparations
366 Chloroform
367 2,3,7,8,-Tetra chlorodibenzo-p-dioxin
368 2,6-Dimethyl-1,3-dioxan-4-yl acetate (Dimethoxane)
369 Pyrithione sodium (INNM)
370 N-(Trichloromethylthio)-4-cyclohexene-1,2-dicarboximide (Captan)
371 2,2′-Dihydroxy-3,3’5,5′,6,6′-hexachlorodiphenylmethane (Hexachlorophene)
372 6-(Piperidinyl)-2,4-pyrimidinediamine-3-oxide (Minoxidil) and its salts
373 3,4’,5-Tribromosalicylanilide
374 Phytolacca Spp. And their preparations
375 Tretinoin (retinoic acid and its salts)
376 1-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole-CI  76050) & their salts
377 1-Methoxy-2,4-diamenobenzene (2,5-diaminoanisole)  and their salts
378 Colouring agent CI 12140
379 Colouring agent CI 26105
380 Colouring agent CI 42555

Colouring agent CI 42555-1

Colouring agent CI 42555-2

381 Amyl 4-dimethylaminobenzoate,mixed isomers (Padimate A (INN)
382 Benzoyl peroxide
383 2-Amino-4-nitrophenol
384 2-Amino-5-nitrophenol
385 11α-Hydroxypregn-4-ene-3,20-dione and its esters
386 Colouring agent CI 42640
387 Colouring agent CI 13065
388 Colouring agent CI 42535
389 Colouring agent CI 61554
390 Anti-androgens with steroid structure
391 Zirconium and its compounds, with the exception of the subtances listed under
reference number 50 in ANNEX III,Part One, and the zirconium lakes, pigments
or salts of colouring agents listed in ANNEX IV, Part One, with reference number 3
392 Thyrothricine
393 Acetonitrile
394 Tetrahydrozoline and its salts
395 Hydroxy-8-quinoline and its sulphate, except for the uses provided for in no 51 in Annex III, Part 1
396 Dithio-2,2′-bispyridine-dioxide 1,1′ ( additive w/ trihydrated magnesium sulphate)-(pyrithione disulphide + magnesium sulphate)
397 Colouring agent CI 12075 and its lakes, pigments and salts
398 Colouring agent CI 45170 and CI 45170:1
399 Lidocaine
450 1,2-Epoxybutane
401 Colouring agent CI 15585
402 STRONTIUM LACTATE
403 Strontium nitrate
404 Strontium polycarboxylate
405 Pramocaine
406 4-Ethoxy-m-phenylenediamine and its salts
407 2,4-Diaminophenylethanol and its salts
408 Cathechol
409 Pyrogallol
410 Nitrosamines
411 Secondary dialkanolamines
412 4-Amino-2-nitrophenol
413 2-Methyl-m-phenylenediamine
414 4-tert-Butyl-3-methoxy-2,6-dinitrotoluene (Musk ambrette)
416 Cells,tissues or products of human origin
417 3,3- Bis (4-hydroxyphenyl)phthalide (Phenolphthalein)
418 3-Imidazol-4-ylacrylic  acid and its ethyl ester (urocanic acid)
419 (a) the skull, including the brain and eyes, tonsil and spinal cord of:
-bovine animals aged 12 month -ovine and caprine animals which are aged over 12 months or have a
Permanent incisor tooth erupted through the gum;The spleens of ovine and caprine animals and ingredients derived therefrom. However,  tallow   derivatives may be used provided that the following methods have been used and strictly certified by the producer
transesterification or hydrolysis at at least 200ºC and at appropriate corresponding  pressure, for 20   minutes (glycerol and fatty acids and esters);
saponification with NaOH 12M (glycerol and soap): batch process: 95ºC for 3 hours or continuous  process: at 140ºC, 2 bars (2000 hPa) for 8 minutes or equivalent
420 Crude and refined coal tars
421 1,1,3,3,5-Pentamethyl-4,6-dinitroindane (moskene)
422 5-tert-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (musk tibetene)

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