Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC) (repealed)

ANNEX II U.K. [F1 LIST OF SUBSTANCES WHICH MUST NOT FORM PART OF THE COMPOSITION OF COSMETIC PRODUCTS]

Textual Amendments

F1 Inserted by Council Directive of 17 May 1982 (82/368/EEC).

1.

N-5-Chlorobenzoxazol-2-ylacetamide

2.

[F1 2 -Acetoxyethyltrimethylammonium hydroxide (acetylcholine) and its salts]

3.

Deanol aceglumate(1)

4.

Spironolactone*

5.

[F1 [4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]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.

Sympathicomimetic 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

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.

[F1 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.

[F1 Imperatorin (9-(3-methoxylbut-2-enyloxy)furo[3,2-g]chromen-7-one)]

35.

Ammi majus and its galenical preparations

36.

2,3-Dichloro-2-methylbutane

37.

Substances with androgenic effect

38.

Anthracene oil

39.

Antibiotics [F2 ]

40.

Antimony and its compounds

41.

Apocynum cannabinum L. and its preparations

42.

[F1 Apomorphine (R 5,6,6a, 7-tetrahydro-6-methyl-4 H -dibenzo [de,g]quinoline-10,11-diol) and its salts]

43.

Arsenic and its compounds

44.

Atropa belladonna L. and its preparations

45.

Atropine, its salts and derivatives

46.

[F3 Barium salts, with the exception of barium sulphate, barium 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 ( ⁵ ) in Annex III, Part 2 and Annex IV, Part 2.]

47.

Benzene

48.

[F1 Benzimidazol-2(3 H )-one]

49.

[F1 Benzazepines and benzodiazepines]

50.

[F1 1-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and its salts]

51.

[F1 2,2,6-Trimethyl-4-piperidyl benzoate (benzamine) and its salts]

52.

[F1 Isocarboxazid*]

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.

[F1 Nitroderivatives of carbazole]

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.

[F1 Diphenoxylate* hydrochloride]

81.

4-Phenylazophenylene-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.

[F1 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.

[F1 Chlormezanone*]

92.

Triparanol*

93.

2-[2(4-Chiorophenyl)-2-phenylacetyl] indane-1,3-dione (chlorophacinone-ISO)

94.

Chlorphenoxamine*

95.

[F1 2-[2-(4-Chlorophenyl)-2-phenylacetyl]indan 1,3-dione (chlorophacinone - ISO)]

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.

Golchicum 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.

[F1 2-α-Cyclohexylbenzyl( N,N,N',N', -tetraethyl)trimethylenediamine (phenetamine)]

113.

Cyclomenol* and its salts

114.

Sodium hexacyclonate*

115.

Hexapropymate*

116.

Dextropropoxyphene*

117.

[F1 O,O' -Diacetyl- N -allyl- N -normorphine]

118.

Pipazetate* and its salts

119.

[F1 5 -(α β -Dibromophenethyl)-5-methylhydantoin]

120.

[F1 N,N' -Pentamethylenebis (trimethylammonium salts), e.g. pentamethonium bromide*]

121.

[F1 N,N' -[(Methylimino)diethylene]bis(ethyldimethylammonium) salts, e.g. azamethonium bromide*]

122.

Cyclarbamate*

123.

Clofenotane*; DDT (ISO)

124.

[F1 N,N' -Hexamethylenebis(trimethylammonium) salts, e.g. hexamethonium bromide*]

125.

Dichloroethanes (ethylene chlorides)

126.

Dichloroethylenes (acetylene chlorides)

127.

Lysergide* and its salts

128.

[F1 2-Diethylaminoethyl-3-hydroxy-4-phenylbenzoate and its salts]

129.

Cinchocaine* and its salts

130.

3-Diethylaminopropyl cinnamate

131.

[F1 O,O' -Diethyl O -4-nitrophenyl phosphorothioate (parathion-lSO)]

132.

[F1 [Oxalylbisiminoethylene)]bis[( o -chlorobenzyl)diethylammonium salts], e.g. ambenomium cloride*]

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.

[F1 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.

[F1 N -(3-Carbamoyl-3,3-diphenylpropyl)- N,N -diisopropylmethyl-ammonium salts, e.g. isopropamide iodide*]

157.

Benactyzine*

158.

Benzatropine* and its salts

159.

Cyclizine* and its salts

160.

[F1 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 [F4 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.

[F5 [X1 4-Benzyloxyphenol 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.

[F1 Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex III, Part 1]

192.

Furfuryltrimethylammonium salts, e.g. furtrethonium iodide*

193.

Galantamine*

194.

Progestogens [F2 ]

195.

1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO)

196.

[F1 (1 R ,4 S ,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-dimethano-naphthalene (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-dimethano-naphthalene (isodrin-ISO)

199.

Hydrastine, hydrastinine 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.

[F1 Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl) acetate and salts of the acid]

205.

Methocarbamol*

206.

Propatylnitrate*

207.

[F1 4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene) dicoumarin]

208.

Fenadiazole*

209.

Nitroxoline* and its salts

210.

Hyoscyamine, its salts and derivatives

211.

Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations)

212.

Pemoline* and its salts

213.

Iodine

214.

[F1 Decamethylenebis(trimethylammonium) salts, e.g. decamethonium bromide]

215.

Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations)

216.

(2-Isopropylpent.4-enoyl)urea (apronalide)

217.

[F1 α-Santonin [(3S,5a R ,9b S )-3,3a,4,5,5a,9b-hexahydro-3,5a,9-trimethylnaphto [1,2-b] furan-2,8-dione]]

218.

Lobelia inflata L. and its galenical preparations

219.

Lobeline* and its salts

220.

Barbiturates

221.

[F6 Mercury and its compounds, except those special cases included [F7 in Annex VI, Part 1] ]

222.

3,4,5-Trimethoxyphenethylamine and its salts

223.

Metaldehyde

224.

2-(4-Allyl-2-methoxyphenoxy)-N,N-diethylacetamide and its salts

225.

Coumetarol*

226.

Dextromethorphan* 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.

[F1 3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5 H -pyrano [3,2-c]-[1] benzopyran-5-one (cyclocoumarol)]

235.

Carisoprodol*

236.

Meprobamate*

237.

Tefazoline* and its salts

238.

Arecoline

239.

Poldine metilsulfate*

240.

Hydroxyzine*

241.

2-Naphthol

242.

1-and 2-Naphthylamines and their salts

243.

[F1 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 metal 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

159.

Guanethidine* and its salts

260.

Oestrogens [F8 ]

261.

Oleandrin

262.

Chlortalidone*

263.

Pelletierine and its salts

264.

Pentachloroethane

265.

Pentaerithrityl tetranitrate*

266.

Petrichloral*

267.

Octamylamine* and its salts

268.

[F1 Picric acid]

269.

Phenacemide*

270.

Difendoxazine*

271.

[F1 2-Phenylindan-1,3-dione (phenindione)]

272.

Ethylphenacemide*

273.

Phenprocoumon*

274.

Fenyramidol*

275.

Triamterene* and its salts

276.

[F1 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.

[F1 α-Piperidin-2-ylbenzyl acette (SIC! acetate) laevorotatory threoform (levophacetoperane) and its salts]

285.

Pipradrol* and its salts

286.

Azacyclonol* and its salts

287.

Bietamiverine*

288.

Butopiprine* and its salts

289.

Lead and its [F9 compounds, with the exception of that mentioned in Annex III, No 55 under the conditions stated]

290.

Coniine

291.

Prunus laurocerasus L. (‘cherry laurel water’)

292.

Metyrapone*

293.

[F10 Radioactive substances, as defined by Directive 96/29/Euratom (2) laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation.]

294.

Juniperus sabina L. (leaves, essential oil and galenical preparations)

295.

Hyoscine, its salts and derivatives

296.

Gold salts

297.

[F4 Selenium and its compounds with the exception of selenium disulphiele under the conditions set out under reference No 49 in Annex Ill, Part 1]

298.

Solanum nigrum L. and its galenical preparations

299.

Sparteine and its salts

300.

Glucocorticoids

301.

Datura stramonium L. and its galenical preparations

302.

Strophantines, their aglucones and 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 Tables I and II of the single Convention on narcotic drugs signed in New York on 30 March 1961

307.

[F1 Sulphonamides (sulphanilamide and its derivatives…) and their salts obtained by substitution of one or more H-atoms of the -NH ₂ 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.

[F1 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.

[F1 Thiourea and its derivatives, with the exception of the one listed in Annex III, Part 1]

322.

Mephenesin* and its esters

323.

Vaccines, toxins or serums listed in the Annex to the second Council Directive of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ No L 147, 9. 6. 1975, p. 13)

324.

Tranylcypromine* and its salts

325.

Trichloronitromethane (chloropicrine)

326.

2,2,2-Tribromoethanol (tribromoethyl alcohol)

327.

Trichiormethine* and its salts

328.

Tretamine*

329.

Gallamine triethiodide*

330.

Urginea scilla Stern. and its galenical preparations

331.

Veratrine, its salts and galenical preparations

332.

Schoenocaulon olficinale Lind. (seeds and galenical preparations)

333.

[F11 Veratrum Spp . and their preparations]

334.

Vinyl chloride monomer

335.

Ergocalciferol* and cholecalciferol (vitamins D₂ and D₃)

336.

Salts of O-alkyldithiocarbonic acids

337.

Yobimbine 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.

Pyretbrum album L. and its galenical preparations

346.

[F1 2-[4-Methoxybenzyl- N -(2-pyridyl)amino]ethyldimethylamine maleate]

347.

Tripelennamine*

348.

Tetrachlorosalicylanilides

349.

Dichlorosalicylanilides

350.

[F1 Tetrabromosalicylanilides [F12 ]

351.

Dibromosalicylanilides ] [F12 ]

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.

[F13 Furocoumarines (e.g. trioxysalan*, 8-methoxypsoralen, 5-methoxypsoralen) except for normal content in natural essences used.

In sun protection and in bronzing products, furocoumarines shall be below 1 mg/kg.]

359.

Oil from the seeds of Laurus nobilis L.

360.

[F1 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.

[F14 . . . . .]

362.

[F15 3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone or 7-acetyl-6-ethyl-1,1,4,4-tetramethyl-1,2,3,4-tetrahydronaphtalen]

363.

[F16 O -phenylenediamine and its salts

364.

4-methyl- m -phenylenediamine and its salts.]

365.

[F14 . . . . .]

365.

[F15 Aristolochic acid and its salts; Aristolochia spp. and their preparations]

366.

[F17 Chloroform

367.

[F14 . . . . .]

367.

[F15 2,3,7,8-Tetra chlorodibenzo-p-dioxin]

368.

2,6-Dimethyl-1,3-dioxan-4-yl acetate (Dimethoxane)

369.

Pyrithione sodium (INNM)]

370.

[F18 N -(Trichloromethylthio)-4-cyclohexene-1,2-dicarboximide (captan)

371.

2,2'-Dihydroxy-3,3',5,5',6,6'-hexachlorodiphenylmethane (hexachlorophene)]

372.

[F14 . . . . .]

373.

[F14 . . . . .

374.

. . . . .]

372.

[F19 [F15 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) [F9 and their salts]

377.

1-Methoxy-2,5-diaminobenzene (2,5-diaminoanisole) [F9 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.

[F20 Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN))

382.

[F21 . . . . .]

383.

2-Amino.4-nitrophenol

384.

2-Amino-5-nitrophenol]

385.

[F9 11 α-Hydroxypregn-4-ene-3,20-dione and its esters

385.

[F15 11α-Hydroxypregn-4-ene-3, 20-dione) and its esters]

386.

[F14 . . . . .]

386.

[F15 Colouring agent C.I. 42 640]

387.

Colouring agent CI 13 065

388.

Colouring agent CI 42 535

389.

Colouring agent CI 61 554]

390.

[F14 . . . . .

391.

. . . . .

392.

. . . . .

393.

. . . . .

394.

. . . . .]

390.

[F15 Anti-androgens of steroidal structure

391.

Zirconium and its compounds, with the exception of the substances listed under reference number 50 in Annex III, Part One, and the zirconium lakes, pigments or salts of the colouring agents listed in Annex IV, Part One, with reference number 3

393.

Acetonitrile

394.

Tetrahydrozoline and its salts]

395.

[F7 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 with 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]

400.

[F22 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.

Catechol

409.

Pyrogallol

410.

Nitrosamines

411.

[F5 Secondary alkyl- and alkanolamines and their salts] ]

412.

[F23 4-Amino-2-nitrophenol]

413.

[F24 2-Methyl-m-phenylenediamine]

414.

[F13 4-tert-Butyl-3-methoxy-2,6-dinitrotoluene (Musk Ambrette)]

427.

[F25 . . . . .]

416.

[F13 Cells, tissues or products of human origin

417.

3,3-Bis(4-hydroxyphenyl)phthalide (Phenolphthalein*)]

418.

[F26 3-Imidazol-4-ylacrylic acid and its ethyl ester (urocanic acid)]

419.

[F27 [F28 From the date referred to in Article 22(1) of Regulation (EC) No 999/2001 of the European Parliament and of the Council (3) , the specified risk materials as designated in Annex V to that Regulation, and ingredients derived therefrom.

Until that date, the specified risk materials as designated in Annex XI Part A to Regulation (EC) No 999/2001, and ingredients derived therefrom.]

However, tallow derivatives may be used provided that the following methods have been used and strictly certified by the producer:

• [F29 Transesterification or hydrolysis at at least 200 °C and at an appropriate corresponding pressure, for 20 minutes (glycerol, fatty acids and fatty acid esters),]

• Saponification with NaOH 12M (glycerol and soap):

  • Batch process: at 95 °C for three hours

    or

  • Continuous process: at 140 °C, two bars ( 2 000  hPa) for eight minutes or equivalent conditions.]

420.

[F30 Crude and refined coal tars]

421.

[F31 1,1,3,3,5,-Pentamethyl-4,6-dinitroindane (moskene)

422.

5- tert- Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (musk tibetene).]

423.

[F32 Alanroot oil ( Inula helenium ) (CAS No 97676-35-2), when used as a fragrance ingredient.

424.

Benzyl cyanide (CAS No 140-29-4), when used as a fragrance ingredient.

425.

Cyclamen alcohol (CAS No 4756-19-8), when used as a fragrance ingredient.

426.

Diethyl maleate (CAS No 141-05-9), when used as a fragrance ingredient.

427.

Dihydrocoumarine (CAS No 119-84-6), when used as a fragrance ingredient.

428.

2,4-Dihydroxy-3-methylbenzaldehyde (CAS No 6248-20-0), when used as a fragrance ingredient.

429.

3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol) (CAS No 40607-48-5), when used as a fragrance ingredient.

430.

4,6-Dimethyl-8- tert -butylcoumarin (CAS No 17874-34-9), when used as a fragrance ingredient.

431.

Dimethyl citraconate (CAS No 617-54-9), when used as a fragrance ingredient.

432.

7,11-Dimethyl-4,6,10-dodecatrien-3-one (CAS No 26651-96-7), when used as a fragrance ingredient.

433.

6,10-Dimethyl-3,5,9-undecatrien-2-one (CAS No 141-10-6), when used as a fragrance ingredient.

434.

Diphenylamine (CAS No 122-39-4), when used as a fragrance ingredient.

435.

Ethyl acrylate (CAS No 140-88-5), when used as a fragrance ingredient.

436.

Fig leaf absolute ( Ficus carica ) (CAS No 68916-52-9), when used as a fragrance ingredient.

437.

trans -2-Heptenal (CAS No 18829-55-5), when used as a fragrance ingredient.

438.

trans -2-Hexenal diethyl acetal (CAS No 67746-30-9), when used as a fragrance ingredient.

439.

trans -2-Hexenal dimethyl acetal (CAS No 18318-83-7), when used as a fragrance ingredient.

440.

Hydroabietyl alcohol (CAS No 13393-93-6), when used as a fragrance ingredient.

441.

6-Isopropyl-2-decahydronaphthalenol (CAS No 34131-99-2), when used as a fragrance ingredient.

442.

7-Methoxycoumarin (CAS No 531-59-9), when used as a fragrance ingredient.

443.

4-(4-Methoxyphenyl)-3-butene-2-one (CAS No 943-88-4), when used as a fragrance ingredient.

444.

1-(4-Methoxyphenyl)-1-penten-3-one (CAS No 104-27-8), when used as a fragrance ingredient.

445.

Methyl tran s-2-butenoate (CAS No 623-43-8), when used as a fragrance ingredient.

446.

7-Methylcoumarin (CAS No 2445-83-2), when used as a fragrance ingredient.

447.

5-Methyl-2,3-hexanedione (CAS No 13706-86-0), when used as a fragrance ingredient.

448.

2-Pentylidenecyclohexanone (CAS No 25677-40-1), when used as a fragrance ingredient.

449.

3,6,10-Trimethyl-3,5,9-undecatrien-2-one (CAS No 1117-41-5), when used as a fragrance ingredient.

450.

Verbena oil ( Lippia citriodora Kunth.) (CAS No 8024-12-2), when used as a fragrance ingredient.

451.

[X2 Methyleugenol (CAS No 93-15-2)] except for normal content in the natural essences used and provided that the concentration does not exceed:

(a)

0,01 % in fine fragrance

(b)

0,004 % in eau de toilette

(c)

0,002 % in fragrance cream

(d)

0,001 % in rinse-off products

(e)

0,0002 % in other leave-on products and oral hygiene products.]

Editorial Information

X1 Substituted by Corrigendum to Commission Directive 2003/83/EC of 24 September 2003 adapting to technical progress Annexes II, III and VI to Council Directive 76/768/EEC on the approximation of the laws of Member States relating to cosmetic products (Official Journal of the European Union L 238 of 25 September 2003).

X2 Substituted by Corrigendum to the twenty-sixth Commission Directive 2002/34/EC of 15 April 2002 adapting to technical progress Annexes II, III and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Official Journal of the European Communities L 102 of 18 April 2002).

Textual Amendments

F2 Deleted by Commission Directive of 20 February 1990 (90/121/EEC).

F3 Inserted by Commission Directive of 30 March 1983 (83/191/EEC).

F4 Inserted by Commission Directive of 16 July 1985 (85/391/EEC).

F5 Substituted by Commission Directive 2003/83/EC of 24 September 2003 adapting to technical progress Annexes II, III and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance).

F6 Inserted by Commission Directive of 26 March 1986 (86/199/EEC).

F7 Inserted by Commission Directive of 12 March 1991 (91/184/EEC).

F8 Deleted by Commission Directive of 21 February 1989 (89/174/EEC).

F9 Inserted by Commission Directive of 20 February 1990 (90/121/EEC).

F10 Substituted by Commission Directive 2002/34/EC of 15 April 2002 adapting to technical progress Annexes II, III and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance).

F11 Inserted by Commission Directive of 18 July 1984 (84/415/EEC).

F12 Deleted by Commission Directive of 2 March 1988 (88/233/EEC).

F13 Inserted by Commission Directive of 10 July 1995 (95/34/EC).

F14 Deleted by Commission Directive 2000/11/EC of 10 March 2000 adapting to technical progress Annex II to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance).

F15 Inserted by Commission Directive 2000/11/EC of 10 March 2000 adapting to technical progress Annex II to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance).

F16 Inserted by Commission Directive of 29 June 1983 (83/341/EEC).

F17 Inserted by Commission Directive of 28 February 1986 (86/179/EEC).

F18 Inserted by Commission Directive of 2 February 1987 (87/137/EEC).

F19 Inserted by Commission Directive of 2 March 1988 (88/233/EEC).

F20 Inserted by Commission Directive of 21 February 1989 (89/174/EEC).

F21 Deleted by Commission Directive 2003/83/EC of 24 September 2003 adapting to technical progress Annexes II, III and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance).

F22 Inserted by Commission Directive of 21 October 1992 (92/86/EEC).

F23 Inserted by Commission Directive of 22 June 1993 (93/47/EEC).

F24 Inserted by Commission Directive of 29 June 1994 (94/32/EC).

F25 Deleted by Commission Directive of 14 July 1997 (97/45/EC).

F26 Inserted by Commission Directive of 25 June 1996 (96/41/EC).

F27 Inserted by Commission Directive of 5 March 1998 (98/16/EC).

F28 Substituted by Commission Directive 2003/1/EC of 6 January 2003 adapting to technical progress Annex II to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance).

F29 Substituted by Commission Directive 2000/6/EC of 29 February 2000 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance).

F30 Inserted by Commission Directive of 14 July 1997 (97/45/EC).

F31 Inserted by Commission Directive of 3 September 1998 (98/62/EC).

F32 Inserted by Commission Directive 2002/34/EC of 15 April 2002 adapting to technical progress Annexes II, III and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance).

(1)

In this Directive, names followed by an asterisk are those published in ‘Computer print-out 1975, International Non-proprietary Names (INN) for pharmaceutical products, Lists 1-33 of proposed INN’, WHO, Geneva, August 1975.

(2)

[F10 OJ L 159, 29.6.1996, p. 1 .]

(3)

[F27 [F28 OJ L 147, 31.5.2001, p. 1 .] ]

Textual Amendments

F10 Substituted by Commission Directive 2002/34/EC of 15 April 2002 adapting to technical progress Annexes II, III and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance).

F27 Inserted by Commission Directive of 5 March 1998 (98/16/EC).

F28 Substituted by Commission Directive 2003/1/EC of 6 January 2003 adapting to technical progress Annex II to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance).