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of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC) (repealed)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 I U.K. ILLUSTRATIVE LIST BY CATEGORY OF COSMETIC PRODUCTS

• Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.).

• Face masks (with the exception of peeling products).

• Tinted bases (liquids, pastes, powders).

• Make-up powders, after-bath powders, hygienic powders, etc.

• Toilet soaps, deodorant soaps, etc.

• Perfumes, toilet waters and eau de Cologne.

• Bath and shower preparations (salts, foams, oils, gels, etc.).

• Depilatories.

• Deodorants and anti-perspirants.

• Hair care products:

  • hair tints and bleaches,

  • products for waving, straightening and fixing,

  • setting products,

  • cleansing products (lotions, powders, shampoos),

  • conditioning products (lotions, creams, oils),

  • hairdressing products (lotions, lacquers, brilliantines).

• Shaving products (creams, foams, lotions, etc.).

• Products for making up and removing make-up from the face and the eyes.

• Products intended for application to the lips.

• Products for care of the teeth and the mouth.

• Products for nail care and make-up.

• Products for external intimate hygiene.

• Sunbathing products.

• Products for tanning without sun.

• Skin-whitening products.

• Anti-wrinkle products.

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).

ANNEX III U.K.

[F1 PART 1 U.K. LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS AND CONDITIONS LAID DOWN

a These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorized for each of them does not exceed 1.
b Only if the concentration exceeds 0,05 %.
c These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorized for each of them does not exceed 2.
d [F26 The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column d.]
e [F32 These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.]
f [F32 The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column d.] ]
[F1 Reference number	Substance	Restrictions			Conditions of use and warnings which must be printed on the label
		Field of application and/or use	Maximum authorized concentration in the finished cosmetic product	Other limitations and requirements
a	b	c	d	e	f
[F29 1a	Boric acid, borates and tetraborates	(a) Talc	(a) 5 % (by mass/mass as boric acid)	(a) 1. Not to be used in products for children under 3 years of age 2. Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1,5 % (by mass/mass as boric acid) 1. Not to be used in products for children under 3 years of age 2. Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1,5 % (by mass/mass as boric acid)	(a) 1. Not to be used for children under 3 years of age 2. Not to be used on peeling or irritated skin 1. Not to be used for children under 3 years of age 2. Not to be used on peeling or irritated skin
		(b) Products for all hygiène	(b) 0,1 % (by mass/mass as boric acid)	(b) 1. Not to be used in products for children under 3 years of age 1. Not to be used in products for children under 3 years of age	(b) 1. Not to be swallowed 2. Not to be used for children under 3 years of age 1. Not to be swallowed 2. Not to be used for children under 3 years of age
		(c) Other products (excluding bath products and hair waving products)	(c) 3 % (by mass/mass as boric acid)	(c) 1. Not to be used in products for children under 3 years of age 2. Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1,5 % (by mass/mass as boric acid) 1. Not to be used in products for children under 3 years of age 2. Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1,5 % (by mass/mass as boric acid)	(c) 1. Not to be used for children under 3 years of age 2. Not to be used on peeling or irritated skin 1. Not to be used for children under 3 years of age 2. Not to be used on peeling or irritated skin
1b	Tetraborates	(a) Bath products	(a) 18 % (by mass/mass as boric acid)	(a) Not to be used in products for children under 3 years of age	(a) Not to be used of bathing children under 3 years of age
		(b) Hair waving products	(b) 8 % (by mass/mass as boric acid)		(b) Rinse well] ]
[F19 2a	Thioglycollic acid and its salts	(a) Hair waving or straightening products:		(a) (b) (c): The directions for use drawn up in the national or official language(s) must obligatorily incorporate the following sentences: 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) and (c) only)	(a): Contains thioglycolate Follow the instructions Keep out of reach of children For professional use only (b) and (c): Contains thioglycolate Follow the instructions Keep out of reach of children
		— general use	8 % ready for use pH 7 to 9,5
		— professional use	11 % ready for use pH 7 to 9,5
		(b) Depilatories	5 % ready for use pH 7 to 12,7
		(c) Other hair-caire products which are removed after application	2 % ready for use pH to 9,5 The abovementioned percentages are calculated as thioglycollic acid
2b	Thioglycollic acid esters	Hair waving or straightening products:		The directions for use drawn up in the national or official language(s) must obligatorily incorporate the following sentences: 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	Contains thioglycolate Follow the instructions Keep out of reach of children
		— general use	— 8 % ready for use pH 6 to 9,5
		— professional use	— 11 % ready for use pH 6 to 9,5		— For professional use only
			The abovementioned percentages are calculated as thioglycollic acid]
[F1 3	Oxalic acid, its esters and alcaline salts	Hair care products	5 %		For professional use only
4	Ammonia		6 % calculated as NH 3		Above 2 %: contains ammonia
5	Tosylchloramide sodium (*)		0·2 %
6	Chlorates of alkali metals	(a) Toothpaste (b) Other uses	(a) 5 % (b) 3 %
7	Dichloromethane		35 % (when mixed with 1,1,1-trichloroethane, total concentration must not exceed 35 %)	0·2 % as maximum impurity content
8	[F10 m- and p-Phenylenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-Phenylenediamines e , with the exception of those derivatives listed elsewhere in this Annex]	Oxidizing colouring agents for hair dyeing	6 % calculated as free base
		(a) general use			(a) Can cause an allergic reaction. [F33 ] Contains phenylenediamines. Do not use to dye eyelashes or eyebrows
		(b) professional use			(b) For professional use only. Contains phenylenediamines. Can cause an allergic reaction. [F33 ] [F23 Wear suitable gloves.]
9	[F16 Methylphenylenediamines, their N -substituted derivatives and their salts a with the exception of substance No 364 in Annex II]	Oxidizing colouring agents for hair dyeing	10 % calculated as free base
		(a) general use			(a) Can cause an allergic reaction. [F33 ] Contains phenylenediamines. Do not use to dye eyelashes or eyebrows
		(b) professional use			(b) For professional use only. Contains phenylenediamines. Can cause en allergic reaction. [F33 ] [F23 Wear suitable gloves.]
10	Diaminophenols a	Oxidizing colouring agents for hair dyeing	10 % calculated as free base
		(a) general use			(a) Can cause an allergic reaction. [F33 ] Contains diaminophenols. Do not use to dye eyelashes or eyebrows
		(b) professional use			(b) For professional use only. Contains diaminophenols. Can cause allergic reaction. [F33 ] [F23 Wear suitable gloves.] ]
[F18 11	Dichlorophen (*)		0,5 %		Contains dichlorophen]
[F22 12	Hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide	(a) Hair-caire preparations	12 % of H 2 O 2 (40 volumes), present or released		[F23 (a): Wear suitable gloves]
		(b) Skin-care preparations	4 % of H 2 O 2 , present or released		(a) (b) (c): Contains hydrogen peroxide.
		(c) Nail hardening preparations	2 % of H 2 O 2 , present or released		Avoid contact with eyes. Rinse immediately if product comes into contact with them
		(d) Oral hygiene products	0,1  % of H 2 O 2 , present or released		]
[F1 13	Formaldehyde	Nail hardeners	5 % calculated as formaldehyde		Protect cuticles with grease or oil. Contains formaldehyde b .]
[F5 14	Hydroquinone c	(a) Oxidising colouring agent for hair-dying:	0,3 %		(a) 1. Do not use to dye eyelashes or eyebrows
		1. General use			Rinse the eyes immediately if the product comes into contact with them Contains hydroquinone
		2. Professional use			2. For professional use only Contains hydroquinone Rinse the eyes immediately if the product comes into contact with them
		(b) Artificial nail systems	0,02 % (after mixing for use)	Professional use only	(b) For professional use only Avoid skin contact Read directions for use carefully]
[F26 15a	Potassium or sodium hydroxide	(a) Nail cuticle solvent	(a) 5 % by weight d		(a) Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
		(b) Hair straightener	(b)		(b)
		1. General use	1. 2 % by weight d		1. Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
		2. Professional use	2. 4,5 % by weight d		2. For professional use only. Avoid contact with eyes. Can cause blindness.
		(c) pH adjuster depilatories	(c) Up to pH 12,7		(c) Keep out of reach of children. Avoid contact with eyes
		(d) Other uses as pH adjuster	(d) Up to pH 11
[F10 15b	Lithium hydroxide	(a) Hair straighteners	(a)		(a)
		1. General use	1. 2 % f  by weight		1. Contains alkali Avoid contact with eyes Can cause blindness Keep out of reach of children
		2. Professional use	2. 4,5 % f  by weight		2. For professional use only Avoid contact with eyes Can cause blindness
		(b) pH ajuster — for depilatories		(b) pH value not to exceed pH 12,7	(b) Contains alkali Keep out of reach of children Avoid contact with eyes
		(c) Other uses — as pH adjuster (for rinse-off products only)		(c) pH value not to exceed pH 11
15c	Calcium hydroxide	Hair straighteners containing two components: calcium hydroxide and a guanidine salt	(a) 7 % by weight of calcium hydroxide		(a) Contains alkali Avoid contact with eyes Keep out of reach of children Can cause blindness
		(b) pH ajuster — for depilatories		(b) pH value not to exceed pH 12,7	(b) Contains alkali Keep out of reach of children Avoid contact with eyes
		(c) Other uses (e.g. pH adjuster, processing aid)		(c) pH value not to exceed pH 11	] ]
[F1 [F10 16	1-Naphthol (CAS No 90-15-3) and its salts	Oxidising colouring agents for hair dyening	2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %	Can cause allergie reaction]
17	Sodium nitrite	Rust inhibitor	0,2 %	Do not use with secondary and/or tertiary amines or other substances forming nitrosamines
18	Nitromethane	Rust inhibitor	0,3 %
19	Phenol and its alkali salts	Soaps and shampoos	1 % calculated as phenol		Contains phenol
[F33 ]
21	Quinine and its salts	(a) Shampoos	(a) 0,5 % calculated as quinine base
		(b) Hair lotions	(b) 0,2 % calculated as quinine base
22	Resorcinol c	(a) Oxidizing colouring agent for hair dyeing	(a) 5 %		(a)
		1. general use			1. 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
		2. professional use			2. For professional use only. Contains resorcinol. Rinse eyes immediately if product comes into contact with them
		(b) Hair lotions and shampoos	(b) 0,5 %		(b) Contains resorcinol
23	(a) Alkali sulphides	(a) Depilatories	(a) 2 % calculated as sulphur pH ≤ 12,7		(a) Keep out of reach of children. Avoid contact with eyes
	(b) Alkaline earth sulphides	(b) Depilatories	(b) 6 % calculated as sulphur pH ≤ 12,7		(b) Keep out of reach of children. Avoid contact with eyes
24	Water-soluble zinc salts with the exception of zinc 4-hydroxy-benzenesulphonate and zinc pyrithione		1 % calculated as zinc
25	Zinc 4-hydroxybenzene sulphonate	Deodorants, antiperspirants and astringent lotions	6 % calculated as % of anhydrous substance		Avoid contact with eyes
26	Sodium monofluorophosphate	Oral hygiene products	0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %		Contains ammonium monofluorophosphate
27	Sodium monofluorophosphate	Ditto	0,15 % Ditto		Contains sodium monofluorophosphate
28	Potassium monofluorophosphate	Ditto	0,15 % Ditto		Contains potassium monofluorophosphate
29	Calcium monofluorophosphate	Ditto	0,15 % Ditto		Contains calcium monofluorophosphate
30	Calcium fluoride	Ditto	0,15 % Ditto		Contains calcium fluoride
31	Sodium fluoride	Ditto	0,15 % Ditto		Contains sodium fluoride
32	Potassium fluoride	Ditto	0,15 % Ditto		Contains potassium fluoride
33	Ammonium fluoride	Ditto	0,15 % Ditto		Contains ammonium fluoride
34	Aluminium fluoride	Ditto	0,15 % Ditto		Contains aluminium fluoride
35	Stannous fluoride	Ditto	0,15 % Ditto		Contains stannous fluoride
36	Hexadecyl ammonium fluoride	Ditto	0,15 % Ditto		Contains hexadecyl ammonium fluoride
37	3-( N -Hexadecyl- N -2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride	Ditto	0,15 % Ditto		Contains 3-( N -Hexadecyl- N -2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride
38	NN'N' -Tris(polyoxyethylene)- N -hexadecylpropylenediamine dihydrofluoride	Ditto	0,15 % Ditto		Contains NN'N' -tris(polyoxyethylene)- N -hexadecylpropylenediamine dihydrofluoride
39	Octadecenyl-ammonium fluoride	Ditto	0,15 % Ditto		Contains octadecenyl-ammonium fluoride
40	Sodium fluorosilicate	Ditto	0,15 % Ditto		Contains sodium fluorosilicate
41	Potassium fluorosilicate	Ditto	0,15 % Ditto		Contains potassium fluorosilicate
42	Ammonium fluorosilicate	Ditto	0,15 % Ditto		Contains ammonium fluorosilicate
43	Magnesium fluorosilicate	Ditto	0,15 % Ditto		Containes (SIC! Contains) magnesium fluorosilicate]
[F17 44	1,3-Bis (hydroxymethyl)imidazolidine-2-thione	(a) Hair-care preparations (b) Nail-care preparations	(a) Up to 2 % (b) Up to 2 %	(a) Prohibited in aerosol dispensers (sprays) (b) The pH of the product as applied must be less than 4	Contains 1,3-bis (hydroxymethyl) immidazolidine-2-thione]
[F1 45	Benzyl alcohol	Solvents, perfumes and flavourings			]
[F3 46	6-methylcoumarin	Oral hygiene products	0,003 %		]
[F11 47	Nicomethanol hydrofluoride	Oral hygiene products	0,15 % calculated as F When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %		Contains nicomethanol hydrofluoride
48	Silver nitrate	Solely for products intended for colouring eyelashes and eyebrows	4 %		Contains silver nitrate Rinse the eyes immediately if product comes into contact with them]
[F4 49	Selenium disulphide	Antidandruff shampoos	1 %		Contains selenium disulphide Avoid contact with eyes or damaged skin
50	Aluminium zirconium chloride hydroxyde complexes Al x Zr(OH) y Cl z and the aluminium zirconium chloride sydroxide glycine complexes	Antiperspirants	20 % as anhydrous aluminium zirconium chloride hydroxide 5,4 % as zirconium	1. The ratio of the number of aluminium atoms to that of zirconium atoms must be between two an 10 2. The ratio of the number of (Al + Zr) atoms to that of chlorine atoms must be between 0,9 and 2,1 3. Prohibited in aerosol dispensers (sprays)	Do not apply to irritated or damaged skin]
[F19 51	Quinolin-8-ol and bis (8-hydroxy-quinolium) sulphate	Stabilizer for hydrogen peroxide in rinse-off hair-care preparations	0,3 % calculated as base
		Stabilizer for hydrogen peroxide in non-rinse-off hair-care preparations	0,03 % calculated as base		]
[F18 52	Methanol	Denaturant for ethanol and isopropyl alcohol	5 % calculated as a % ethanol and isopropyl acohol		]
[F19 53	Etidronic acid and its salts (1-hydroxyethylidene-di-phosphonic acid and its salts)	(a) Hair-care	1,5 % expressed as etidronic acid		[F8 ]
		(b) Soap	0,2 % expressed as etidronic acid
54	1-Phenoxy-propan-2-ol	— Rinse-off products only	2 %	As a preservative, see Annex VI, Part 1, No 43
		— Prohibited in oral hygiene products			]
[F9 55	Lead acetate	Only for hair-dyeing	0,6 % calculated in lead		Keep away from children. Avoid all contact with the eyes. Wash hands after use. Contains lead acetate. Do not use to dye eyelashes, eyebrows or moustasches. If irritation develops, discountinue use.]
[F7 56	Magnesium fluoride	Dental hygiene products	0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %		Contains magnesium fluoride]
[F31 57	Strontium chloride hexahydrate	(a) Toothpaste	3,5 %, calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3,5 %		Contains strontium chloride. Frequent use by children is not advisable
		(b) Shampoo and face care products	2,1 %, calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 2,1 %		]
[F22 58	Strontium acetate hemihydrate	Toothpaste	3,5 %, calculated as strontium. When mixed with other permitted strontium products the total strontium content must not exceed 3,5 %		Contains strontium acetate. Frequent use by children is not advisable]
[F24 59	Talc: Hydrated magnesium silicate	(a) Powdery products intended to be used for children under three years of age (b) other products			[X3 (a) Keep powder away from children's nose and mouth] ]
[F5 60	Fatty acid dialkylamides and dialkanolamides		Maximum secondary amine content: 0,5 %	Do not use with nitrosating systems Maximum secondary amine content: 5 % (applies to raw materials) Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers
61	Monoalkylamines, monoalkanolamines and their salts		Maximum secondary amine content: 0,5 %	Do not use with nitrosating systems Minimum purity: 99 % Maximum secondary amine content: 0,5 % (applies to raw materials) Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers
62	Trialkylamines, trialkanolamines and their salts	(a) Non-rinse-off products (b) Other products	(a) 2,5 %	(a) (b) Do not use with nitrosating systems Minimum purity: 99 % Maximum secondary amine content: 0,5 % (applies to raw materials) Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers	]
[F24 63	Strontium hydroxide	pH-regulator in depilatory products	3,5 % calculated as strontium, max. pH of 12,7		Keep out of reach of children Avoid contact with the eyes
64	Strontium peroxide	Rinse-off hair care preparations professional use	4,5 % 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]
[F34 65	Benzalkonium Chloride, bromide and saccharinate	(a) Rinse-off hair (head) care products	(a) 3 % (as benzalkonium chloride)	(a) In the final products the concentrations of benzalkonium chloride, bromide and saccharinate with an alkyl chain of C 14 , or less must not exceed 0,1 % (as benzalkonium chloride)	(a) Avoid contact with the eyes
		(b) Other products	(b) 0,1 % (as benzalkonium chloride)		(b) Avoid contact with the eyes]
[F32 66	Polyacrylamides	(a) Body-care leave-on products		(a) Maximum residual acrylamide content 0,1 mg/kg
		(b) Other cosmetic products		(b) Maximum residual acrylamide content 0,5 mg/kg	]
[F35 67	Amyl cinnamal (CAS No 122-40-7)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
68	Benzyl alcohol (CAS No 100-51-6)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
69	Cinnamyl alcohol (CAS No 104-54-1)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
70	Citral (CAS No 5392-40-5)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
71	Eugenol (CAS No 97-53-0)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
72	Hydroxy-citronellal (CAS No 107-75-5)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
73	Isoeugenol (CAS No 97-54-1)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
74	Amylcin namyl alcohol (CAS No 101-85-9)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
75	Benzyl salicylate (CAS No 118-58-1)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
76	Cinnamal (CAS No 104-55-2)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
77	Coumarin (CAS No 91-64-5)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
78	Geraniol (CAS No 106-24-1)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
79	Hydroxy-methylpentylcyclohexenecarboxaldehyde (CAS No 31906-04-4)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
80	Anisyl alcohol (CAS No 105-13-5)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
81	Benzyl cinnamate (CAS No 103-41-3)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
82	Farnesol (CAS No 4602-84-0)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
83	2-(4-tert-Butylbenzyl) propionaldehyde (CAS No 80-54-6)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
84	Linalool (CAS No 78-70-6)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
85	Benzyl benzoate (CAS No 120-51-4)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
86	Citronellol (CAS No 106-22-9)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
87	Hexyl cinnam-aldehyde (CAS No 101-86-0)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
88	d-Limonene (CAS No 5989-27-5)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
89	Methyl heptin carbonate (CAS No 111-12-6)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
90	3-Methyl-4-(2,6,6-tri-methyl-2-cyclohexen-1-yl)-3-buten-2-one (CAS No 127-51-5)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
91	Oak moss extract (CAS No 90028-68-5)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products
92	Treemoss extract (CAS No 90028-67-4)			The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products	]
[F36 93	2,4-Diamino-pyrimidine-3-oxide (CAS No 74638-76-9)	Hair care formulations	1,5 %
94	Benzoyl peroxide	Artificial nail systems	0,7 % (after mixing)	Professional use only	For professional use only Avoid skin contact Read directions for use carefully
95	Hydroquinone methylether	Artificial nail systems	0,02 % (after mixing for use)	Professional use only	For professional use only Avoid skin contact Read directions for use carefully]

Editorial Information

X3 Inserted by Corrigendum, OJ No L 273, 25. 10. 1994, p. 38 (94/32/EC).

Textual Amendments

F33 Deleted by Commission Directive of 21 October 1992 (92/86/EEC).

F34 Inserted 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).

F35 Inserted by Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance).

F36 Inserted 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 [F37 Part 2] U.K. LIST OF SUBSTANCES PROVISIONALLY ALLOWED

Reference number	Substance	Restrictions			Conditions of use and warnings which must be printed on the label	Allowed until
		Field of application and/or use	Maximum authorized concentration in the finished cosmetic product	Other limitations and requirements
a	b	c	d	e	f	g
[F32 1	Basic Blue 7 (CAS No 2390-60-5)	Non-oxidising colouring agents for hair dyeing	0,2 %		Can cause allergic reaction	30.9.2004
2	2-Amino-3-nitrophenol (CAS No 603-85-0) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 3,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %	(a) (b) Can cause allergic reaction	30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 3,0 %
3	4-Amino-3-nitrophenol (CAS No 610-81-1) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 3,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %	(a) (b) Can cause allergic reaction	30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 3,0 %
4	2,7-Naphthalenediol (CAS no 582-17-2) and its salts	Oxidising colouring agents for hair dyeing	1,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 %		30.9.2004
5	m-Aminophenol (CAS no 591-27-5) and its salts	Oxidising colouring agents for hair dyeing	2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %	Can cause allergic reaction	30.9.2004
6	2,6-Dihydroxy-3,4-dimethylpyridine (CAS No 84540-47-6) and its salts	Oxidising colouring agents for hair dyeing	2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %	Can cause allergic reaction	30.9.2004
7	4-Hydroxypropylamino-3-nitrophenol (CAS No 92952-81-3) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 5,2 %	In combination with hydrogen peroxide the maximum use concentration upon application is 2,6 %	(a) (b) Can cause allergic reaction	30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 2,6 %
8	6-Nitro-2,5-pyridinediamine (CAS No 69825-83-8) and its salts	Non-oxidising colouring agent for hair dyeing	3,0 %		Can cause allergic reaction	30.9.2004
9	HC Blue No 11 (CAS No 23920-15-2) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 3,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %	(a) (b) Can cause allergic reaction	30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 2,0 %
10	Hydroxyethyl-2-nitro-p-toluidine (CAS No 100418-33-5) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %	(a) (b) Can cause allergic reaction	30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 1,0 %
11	2-Hydroxyethylpicramic acid (CAS No 99610-72-7) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 3,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %	(a) (b) Can cause allergic reaction	30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 2,0 %
12	p-Methylaminophenol (CAS No 150-75-4) and its salts	Oxidising colouring agent for hair dyeing	3,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %	Can cause allergic reaction	30.9.2004
13	2,4-Diamino-5-methylphenoxyethanol (CAS No 141614-05-3) and its salts	Oxidising colouring agent for hair dyeing	3,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %	Can cause allergic reaction	30.9.2004
14	HC Violet No 2 CAS No 104226-19-9) and its salts	Non-oxidising colouring agent for hair dyeing	2,0 %			30.9.2004
15	Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No 122252-11-3) and its salts	Non-oxidising colouring agent for hair dyeing	3,0 %		Can cause allergic reaction	30.9.2004
16	HC Blue No 12 (CAS No 104516-93-0) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 1,5 %	In combination with hydrogen peroxide the maximum use concentration upon application is 0,75 %	(a) (b) Can cause allergic reaction	30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 1,5 %
17	[X4 2,4-Diamino-5 methyphenetol (CAS No 113715-25-6) and its salts]	Oxidising colouring agents for hair dyeing	2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %	Can cause allergic reaction	30.9.2004
18	1,3-Bis-(2,4-diaminophenoxy)propane (CAS No 81892-72-0) and its salts	Oxidising colouring agents for hair dyeing	2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %	Can cause allergic reaction	30.9.2004
19	[X4 3-Amino-2,4-dichlorophenol (CAS No 61693-43-4) and its salts]	Oxidising colouring agents for hair dyeing	2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %	Can cause allergic reaction	30.9.2004
20	Phenyl methyl pyrazolone (CAS No 89-25-8) and its salts	Oxidising colouring agents for hair dyeing	0,5 %	In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %		30.9.2004
21	2-Methyl-5-hydroxyethylaminophenol (CAS No 55302-96-0) and its salts	Oxidising colouring agents for hair dyeing	2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %	Can cause allergic reaction	30.9.2004
22	Hydroxybenzomorpholine (CAS No 26021-57-8) and its salts	Oxidising colouring agents for hair dyeing	2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %	Can cause allergic reaction	30.9.2004
23	1,7-Naphthalenediol (CAS No 575-38-2) and its salts	Oxidising colouring agents for hair dyeing	1,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 %	Can cause allergic reaction	30.9.2004
24	HC Yellow No 10 (CAS No 109023-83-8) and its salts	Non-oxidising colouring agents for hair dyeing	0,2 %			30.9.2004
25	2,6-Dimethoxy-3,5-pyridinediamine (CAS No 85679-78-3) and its salts	Oxidising colouring agents for hair dyeing	0,5 %	In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %	Can cause allergic reaction	30.9.2004
26	HC Orange No 2 (CAS No 85765-48-6) and its salts	Non-oxidising colouring agents for hair dyeing	1,0 %			30.9.2004
27	HC Violet No 1 (CAS No 82576-75-8) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 0,5 %	In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 0,5 %
28	3-Methylamino-4-nitro-phenoxyethanol (CAS No 59820-63-2) and its salts	Non-oxidising colouring agents for hair dyeing	1,0 %			30.9.2004
29	2-Hydroxy-ethylamino-5-nitro-anisole (CAS No 66095-81-6) and its salts	Non-oxidising colouring agents for hair dyeing	1,0 %			30.9.2004
30	2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS No 50610-28-1) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 1,0 %
31	[X4 HC Red No 13 (CAS No 94158-13-1) and its salts]	(a) Oxidising colouring agents for hair dyeing	(a) 2,5 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,25 %		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 2,5 %
32	1,5-Naphthalenediol (CAS No 83-56-7) and its salts	Oxidising colouring agents for hair dyeing	1,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 %		30.9.2004
33	Hydroxypropyl bis (N-hydroxyethyl-p-phenylenediamine) (CAS No 128729-30-6) and its salts	Oxidising colouring agents for hair dyeing	3,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %	Can cause allergic reaction	30.9.2004
34	o-Aminophenol (CAS No 95-55-6) and its salts	Oxidising colouring agents for hair dyeing	2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %		30.9.2004
35	4-Amino-2-hydroxytoluene (CAS No 2835-95-2) and its salts	Oxidising colouring agents for hair dyeing	3,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %		30.9.2004
36	[X4 2,4-Diaminophenoxyethanol (CAS No 66422-95-5) and its salts]	Oxidising colouring agents for hair dyeing	4,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 2,0 %		30.9.2004
37	2-Methylresorcinol (CAS No 608-25-3) and its salts	Oxidising colouring agents for hair dyeing	2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %		30.9.2004
38	4-Amino-m-cresol (CAS No 2835-99-6) and its salts	Oxidising colouring agents for hair dyeing	3,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %		30.9.2004
39	2-Amino-4-hydroxyethylaminoanisole (CAS No 83763-47-7) and its salts	Oxidising colouring agents for hair dyeing	3,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %		30.9.2004
40	3,4-Diamino-benzoicacid (CAS No 619-05-6) and its salts	Oxidising colouring agents for hair dyeing	2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %		30.9.2004
41	6-Amino-o-cresol (CAS No 17672-22-9) and its salts	Oxidising colouring agents for hair dyeing	3,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %		30.9.2004
42	2-Aminomethyl-p-aminophenol (CAS No 79352-72-0) and its salts	Oxidising colouring agents for hair dyeing	3,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %		30.9.2004
43	Hydroxyethylamino-methyl-p-aminophenol (CAS No 110952-46-0) and its salts	Oxidising colouring agents for hair dyeing	3,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %		30.9.2004
44	Hydroxyethyl-3,4-methylenedioxyaniline (CAS No 81329-90-0) and its salts	Oxidising colouring agents for hair dyeing	3,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %		30.9.2004
45	[X4 Acid Black 52 (CAS No 3618-58-4) and its salts]	Oxidising colouring agents for hair dyeing	2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %		30.9.2004
46	2-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 0,3 %	In combination with hydrogen peroxide the maximum use concentration upon application is 0,15 %		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 0,3 %
47	HC Blue No 2 (CAS No 33229-34-4) and its salts	Non-oxidising colouring agents for hair dyeing	2,8 %			30.9.2004
48	3-Nitro-p-hydroxyethylaminophenol (CAS No 65235-31-6) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 6,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 3,0 %		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 6,0 %
49	4-Nitrophenyl aminoethylurea (CAS No 27080-42-8) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 0,5 %	In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 0,5 %
50	HC Red No 10 + HC Red No 11 (CAS No 95576-89-9 + 95576-92-4) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 1,0 %
51	Yellow No 6 (CAS No 104333-00-8) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 1,0 %
52	HC Yellow No 12 (CAS No 59320-13-7) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 1,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 %		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 0,5 %
53	[X4 HC Blue No 10 (CAS No 102767-27-1) and its salts]	Oxidising colouring agents for hair dyeing	2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %		30.9.2004
54	HC Blue No 9 (CAS No 114087-47-1) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 1,0 %
55	2-Chloro-6-ethylamino-4-nitrophenol (CAS No 131657-78-8) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 3,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 3,0 %
56	2-Amino-6-chloro-4-nitrophenol (CAS No 6358-09-4) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 2,0 %	In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 2,0 %
57	Basic Blue 26 (CAS No 2580-56-5) (CI 44045) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 0,5 %	In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 0,5 %
58	Acid Red 33 (CAS No 3567-66-6) (CI 17200) and its salts	Non-oxidising colouring agents for hair dyeing	2,0 %			30.9.2004
59	Ponceau SX (CAS No 4548-53-2) (CI 14700) and its salts	Non-oxidising colouring agents for hair dyeing	2,0 %			30.9.2004
60	Basic Violet 14 (CAS No 632-99-5) (CI 42510) and its salts	(a) Oxidising colouring agents for hair dyeing	(a) 0,3 %	In combination with hydrogen peroxide the maximum use concentration upon application is 0,15 %		30.9.2004
		(b) Non-oxidising colouring agents for hair dyeing	(b) 0,3 %
61	Musk xylene (CAS no 81-15-2)	All cosmetic products, with the exception of oral care products	(a) 1,0 % in fine fragrance			[F38 30.9.2004]
			(b) 0,4 % in eau de toilette
			(c) 0,03 % in other products
62	Musk ketone (CAS No 81-14-1)	All cosmetic products, with the exception of oral care products	(a) 1,4 % in fine fragrance			[F38 30.9.2004]
			(b) 0,56 % in eau de toilette
			(c) 0,042 % in other products		] ]

Editorial Information

X4 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 76/748/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

F38 Substituted by Commission Directive 2003/16/EC of 19 February 2003 adapting to technical progress Annex III to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products.

Textual Amendments

F37 Inserted by Council Directive of 21 December 1988 (88/667/EEC).

ANNEX IV U.K.

[F17 [F37 PART 1] U.K.

LIST OF COLOURING AGENTS ALLOWED FOR USE IN COSMETIC PRODUCTS a
Field of application
a Lakes or salts of these colouring agents using substances not prohibited under Annex II or not excluded under Annex V from the scope of this Directive are equally allowed.
b Colouring agents whose number is preceded by the letter ‘ E ’ in accordance whith the EEC Directive of 1962 concerning foodstuffs and colouring matters must fulfil the purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters where the letter ‘ E ’ has been deleted therefrom.
c The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be permitted. They must pass the test for insolubility which will be determined by the procedure laid down in Article 8.
Column 1 = Colouring agents allowed in all cosmetic products. Column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover. Column 3 = Colouring agents allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes. Column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.]
Colour index number or denomination	Colour	Field of application				Other limitations and requirements b
		1	2	3	4
10006	Green				X
10020	Green			X
10316 c	Yellow		X
11680	Yellow			X
11710	Yellow			X
11725	Orange				X
11920	Orange	X
12010	Red			X
[F39 ]
12085 c	Red	X				3 % maximum concentration in the finished product
12120	Red				X
12150	Red	X
12370	Red				X
12420	Red				X
12480	Brown				X
12490	Red	X
12700	Yellow				X	[F8 ]
13015	Yellow	X				E 105
[F12 ]
14270	Orange	X				E 103
14700	Red	X
14720	Red	X				E 122
14815	Red	X				E 125
15510 c	Orange		X
15525	Red	X
15580	Red	X
[F39 ]
15620	Red				X
15630 c	Red	X				3 % maximum concentration in the finished product
15800	Red			X		[F8 ]
15850 c	Red	X
15865 c	Red	X
15880	Red	X
15980	Orange	X				E 111
15985 c	Yellow	X				E 110
16035	Red	X
16185	Red	X				E 123
16230	Orange			X
16255 c	Red	X				E 124
16290	Red	X				E 126
17200 c	Red	X
18050	Red			X
18130	Red				X
18690	Yellow				X
18736	Red				X
18820	Yellow				X
18965	Yellow	X
19140 c	Yellow	X				E 102
20040	Yellow				X	maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm
20170	Orange			X
20470	Black				X	[F8 ]
21100	Yellow				X	maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm
21108	Yellow				X	ditto
21230	Yellow			X
24790	Red				X
[F22 26100	Red			X		Purity criteria: aniline ≤ 0,2 % 2-naphtol ≤ 0,2 % 4-aminoazobenzene ≤ 0,1 % 1-(phenylazo)-2-naphtol ≤ 3 % 1-[2-(phenylazo)phenylazo]-2-napthalenol ≤ 2 %]
[F17 27290 c	Red				X
27755	Black	X				E 152
28440	Black	X				E 151
40215	Orange				X
40800	Orange	X
40820	Orange	X				E 160 e
40825	Orange	X				E 160 f
40850	Orange	X				E 161 g
42045	Blue			[F9 X]		[F2 ]
42051 c	Blue	X				E 131
42053	Green	X
42080	Blue				X
42090	Blue	X
42100	Green				X
42170	Green				X	[F8 ]
42510	Violet			X
42520	Violet				X	5 ppm maximum concentration in the finished product
[F2 ]
42735	Blue			X
44045	Blue			[F9 X]		[F2 ]
44090	Green	X				E 142
45100	Red				X
[F39 ]
[F39 ]
45190	Violet				X	[F8 ]
45220	Red				X
45350	Yellow	X				6 % maximum concentration in the finished product
45370 c	Orange	X				not more than 1 % 2-(6-hdroxy-3-oxo-3H-xanthen-9-y1) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
45380 c	Red	X				ditto
45396	Orange	X				when used in lipstick, the colouring agent is allowed only in free acid form and in a maximum concentration of 1 %
45405	Red		X			not more than 1 % 2-(6-hydroxy-3-oxo-3Η xanthen-9-yl) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
45410 c	Red	X				ditto
45425	Red	X				not more than 1 % 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid and 3 % 2-(iodo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
45430 c	Red	X				E 127 ditto
47000	Yellow			X		[F8 ]
47005	Yellow	X				E 104
50325	Violet				X
50420	Black			X
51319	Violet				X
58000	Red	X
59040	Green			X
60724	Violet				X
60725	Violet	X
60730	Violet			X
61565	Green	X
61570	Green	X
61585	Blue				X
62045	Blue				X
69800	Blue	X				E 130
69825	Blue	X
71105	Orange			X
73000	Blue	X
73015	Blue	X				E 132
73360	Red	X
73385	Violet	X
73900	Violet				X	[F33 ]
73915	Red				X
74100	Blue				X
74160	Blue	X
74180	Blue				X	[F33 ]
74260	Green		X
75100	Yellow	X
75120	Orange	X				E 160 b
75125	Yellow	X				E 160 d
75130	Orange	X				E 160 a
75135	Yellow	X				E 161 d
75170	White	X
75300	Yellow	X				E 100
75470	Red	X				E 120
75810	Green	X				E 140 and E 141
77000	White	X				E 173
77002	White	X
77004	White	X
77007	Blue	X
77015	Red	X
77120	White	X
77163	White	X
77220	White	X				E 170
77231	White	X
77266	Black	X
77267	Black	X
77268:1	Black	X				E 153]
[F18 77288	Green	X				free from chromate ion
77289	Green	X				free from chromate ion]
[F17 77346	Green	X
77400	Brown	X
77480	Brown	X				E 175
77489	Orange	X				E 172
77491	Red	X				E 172
77492	Yellow	X				E 172
77499	Black	X				E 172
77510	Blue	X				free from cyanide ions
77713	White	X
77742	Violet	X
77745	Red	X
77820	White	X				E 174
77891	White	X				E 171
77947	White	X
Lactoflavin	Yellow	X				E 101
Caramel	Brown	X				E 150
Capsanthin, capsorubin	Orange	X				E 160 c
Beetroot red	Red	X				E 162
Anthocyanins	Red	X				E 163
Aluminium, zinc, magnesium and calcium stearates	White	X
Bromothymol blue	Blue				X
Bromocresol green	Green				X	]
[F19 Acid red 195	Red			X		]

Textual Amendments

F39 Deleted by Commission Directive of 12 March 1991 (91/184/EEC).

[F17 PART 2 U.K.

LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR USE IN COSMETIC PRODUCTS a
Field of application
a Lakes or salts of these colouring agents using substances not prohibited under Annex II or not excluded under Annex V from the scope of this Directive are equally allowed.
b Colouring agents whose number is preceded by the letter ‘ E ’ in accordance with the EEC Directive of 1962 concerning foodstuffs and colouring matters must fulfil the purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters where the letter ‘ E ’ has been deleted therefrom.
Column 1 = Colouring agents allowed in all cosmetic products. Column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye make-up remover Column 3 = Colouring agents allowed exclusively in cosmetic products intended not to come into contact with the mucous membranes. Column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into contact only briefly with the skin.]
Colour index number or denomination	Colour	Field of application				Other limitations and requirements b	Authorization valid until
		1	2	3	4
[F12 ]
[F2 ]
[F33 ]
[F8 ]
[F2 ]
[F8 ]
[F33 ]
[F2 ]
[F8 ]
[F2 ]
[F12 ]
[F2 ]
[F8 ]
[F2 ]
[F12 ]
[F33 ]
[F8 ]
[F33 ]
[F8 ]
[F40 ]
[F12 ]
[F33 ]

Textual Amendments

F40 Deleted by Commission Directive of 2 February 1987 (87/137/EEC).

ANNEX V U.K. LIST OF SUBSTANCES EXCLUDED FROM THE SCOPE OF THE DIRECTIVE

1

[F2 . . . . .]

2

[F40 . . . . .]

3

[F2 . . . . .]

4

[F41 . . . . .]

5.

[F24 Strontium and its compounds, with the exception of strontium lactate, strontium nitrate and strontium polycarboxylate listed in Annex II, strontium sulphide, strontium chloride, strontium acetate, strontium hydroxide, strontium peroxide, under the conditions laid down in Annex III, Part 1 and of strontium lakes, pigments and salts of the colouring agents listed with the reference ( ³ ) in Annex IV, Part 1.]

6

[F2 . . . . .]

7

[F39 . . . . .]

8

[F2 . . . . .]

9

[F42 . . . . .]

10

[F43 . . . . .]

Textual Amendments

F41 Deleted by Commission Directive of 29 June 1983 (83/341/EEC).

F42 Deleted by Commission Directive of 28 February 1986 (86/179/EEC).

F43 Deleted by Commission Directive of 18 July 1984 (84/415/EEC).

[F6 ANNEX VI U.K. LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN

PREAMBLE U.K.

1.

Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms in such products.

2.

The substances marked with the symbol (*) may also be added to cosmetic products in concentration other than those laid down in this Annex for other specific purposes apparent from the presentation of the products, e.g. as deodorants in soaps or as anti-dandruff agents in shampoos.

3.

Other substances used in the formulation of cosmetic products may also have anti-microbial properties and thus help in the preservation of the products, as, for instance, many essential oils and some alcohols. These substances are not included in this Annex.

4.

For the purposes of this list:

• ‘ Salts ’ is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate.

• ‘ Esters ’ is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl.

5.

All finished products containing formaldehyde or substances in this Annex and which release formaldehyde must be labelled with the warning ‘ contains formaldehyde ’ where the concentration of formaldehyde in the finished product exceeds 0,05 %.

PART 1 U.K. LIST OF PRESERVATIVES ALLOWED

a Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.]
Reference number	Substance	Maximum authorized concentration	Limitations and requirements	Conditions of use and warnings which must be printed on the label
a	b	c	d	e
1	Benzoic acid, its salts and esters (*)	0,5 % (acid)
2	Propionic acid and its salts (*)	2 % (acid)
3	Salicylic acid and its salts (*)	0,5 % (acid)	Not to be used in preparations for children under three years of age, except for shampoos	Not to be used for children under three years of age a
4	Sorbic acid (hexa-2,4-dienoic acid) and its salts (*)	0,6 % (acid)
5	Formaldehyde paraformaldehyde	0,2 % (except for products for oral hygiene) 0,1 % (products for oral hygiene) expressed as free formaldehyde	Prohibited in aerosol dispensers (sprays)
[F40 ]
7	Biphenyl-2-ol (o-phenylphenol) and its salts (*)	0,2 % expressed as the phenol
8	Pyrithione zinc (INN) (*)	0,5 %	Authorized in products rinsed off Forbidden in products for oral hygiene
9	Inorganic sulphites and hydrogen- sulphites (*)	0,2 % expressed as free SO 2
10	Sodium iodate	0,1 %	Rinse-off products only
11	Chlorobutanol (INN)	0,5 %	Prohibited in aerosol dispensers (sprays)	Contains chlorobutanol
12	4-Hydroxybenzoic acid and its salts and esters (*)	4 % (acid) for 1 ester, 0,8 % (acid) for mixtures of esters
13	3-Acetyl-6-methylpyran-2,4 (3H)-dione (Dehydracetic acid) and its salts	0,6 % (acid)	Prohibited in aerosol dispensers (sprays)
[F24 14	Formic acid and its sodium salt (+)	0,5 % (expressed as acid)		]
[F6 15	3,3‘-Dibromo-4,4‘-hexamethylenedioxydi-benzamidine (Dibromohexamidine) and its salts (including isethionate)	0,1 %
16	Thiomersal (INN)	0,007 % (of Hg) If mixed with other mercurial compounds authorized by this Directive, the maximum concentration of Hg remains fixed at 0,007 %	For eye make-up and eye make-up remover only	Contains thiomersal
17	Phenylmercuric salts (including borate)	Ditto	Ditto	Contains phenylmercuric compounds
18	Undec-10-enoic acid and salts (*)	0,2 % (acid)	See Annex VI, Part 2, No 8
19	Hexetidine (INN) (*)	0,1 %	[F12 ]
20	5-Bromo-5-nitro-1,3-dioxane	0,1 %	Rinse-off products only Avoid formation of nitrosamines [F8 ]
21	Bronopol (INN) (*)	0,1 %	Avoid formation of nitrosamines
22	2,4-Dichlorobenzyl alcohol (*)	0,15 %
23	Triclocarban (INN) (*)	0,2 %	Purity criteria: 3,3',4,4'-Tetrachloroazobenzene <1 ppm 3,3',4,4'-Tetrachloroazoxybenzene <1 ppm
24	4-Chloro-m-cresol (*)	0,2 %	Prohibited in the products intended to come into contact with mucous membranes
25	Tricolosan (INN) (*)	0,3 %
26	4-Chloro-3,5-xylenol (*)	0,5 %
27	3,3'-Bis (1-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)-1,1'-methylenediurea ( ‘ Imidazolidinyl urea ’ ) (*)	0,6 %
28	Poly (1-hexamethylenebiguanide hydrochloride (*)	0,3 %
29	2-Phenoxyethanol (*)	1,0 %
30	Hexamethylenetetramine (*) (methenamine) (INN)	0,15 %
31	Methenamine 3-chloroallylochloride (INNM)	0,2 %
32	1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one (*)	0,5 %
33	1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (*)	0,6 %
34	Benzyl alchohol (*)	1,0 %
35	1-Hydroxy-4-methyl-6(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt (*)	1,0 % 0,5 %	Products rinsed off For other products
[F5 36	1,2-Dibromo-2,4-dicyanobutane (methyldibromo glutaronitrile)	0,1 %	Rinse-off products only	]
37	6,6-Dibromo-4,4-dichloro2,2‘-methylene-diphenol (Bromochlorophen) (*)	0,1 %
38	4-Isopropyl-m-cresol	0,1 %
39	Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate	[F20 0,0015 %] (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one		]
[F18 40	2-Benzyl-4-chlorophenol (clorophene)	0.2 %		]
[F19 41	2-Chloroacetamide	0,3 %		Contains chloroacetamide
42	Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride (+)	0,3 % expressed as clorhexidine
43	1-Phenoxypropan-2-ol	1,0 %	Only for rinse-off products	]
[F7 44	Alkyl (C12-C22) trimethyl ammonium, bromide and chloride (*)	0,1 %
45	4,4-dimethyl-1,3-oxizalidine	0,1 %	The pH of the finished product must not be lower than 6
46	N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N'-(hydroxymethyl) urea	0,5 %		]
[F22 47	1,6-Di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate) (+)	0,1 %		]
[F24 48	Glutaraldehyde (Pentane-1,5-dial)	0,1 %	Prohibited in aerosols (sprays)	Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0,05  %)
49	5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane	0,3 %	Prohibited in oral hygiene products and in products intended to come into contact with mucous membranes	]
[F26 50	3-(p-chlorophenoxy)-propane-1,2 diol (chlorphenesin)	0,3 %
51	Sodium hydroxymethylamino acetate (Sodium Hydroxymethylglycinate)	0,5 %
52	Silver chloride deposited on titanium dioxide	0,004 % calculated as AgCl	20 % AgCl (W/W) on TiO 2 . Prohibited in products for children under three years of age, in oral hygiene products and in products intended for application around the eyes and on the lips	]
[F30 53	Benzethonium chloride	0,1 %	Rinse-off products only	]
[F31 54	Belzalkonium chloride, bromide and saccharinate (+)	0,1% calculated as benzalkonium chloride		Avoid contact with eyes]
[F34 55	Benzylhemiformal	0,15 %	Only for products to be removed by rinsing
56	3-Iodo-2-propynylbutylcarbamate	0,05 %	1. Not to be used for oral hygiene and lipcare products
			2. If the concentration in products intended to remain on the skin exceeds 0,02 % add the phrase: Contains iodine	Contains iodine]

[F6 PART 2 U.K. LIST OF PRESERVATIVES PROVISIONALLY ALLOWED

Reference number	Substance	Maximum authorized concentration	Limitations and requirements	Conditions of use and warnings which must be printed on the label	Allowed until
a	b	c	d	e	f
[F8 ]
[F44 ]
[F8 ]
[F39 ]
[F8 ]
[F39 ]
[F12 ]
[F40 ]
[F12 ]
[F40 ]
[F12 ]
[F45 ]
[F46 ]
[F39 ]
[F12 ]
[F8 ]
[F33 ]
[ F47 ]
[F12 ]
[F8 ]
[F48 ]					]
[ F47 ]
[ F44 ]

Textual Amendments

F44 Deleted by Commission Directive of 25 June 1996 (96/41/EC).

F45 Deleted by Commission Directive of 10 July 1995 (95/34/EC).

F46 Deleted by Commission Directive of 3 September 1998 (98/62/EC).

F47 Deleted 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).

F48 Deleted by Commission Directive of 29 June 1994 (94/32/EC).

[F49 ANNEX VII U.K.

Textual Amendments

F49 Inserted by Council Directive of 26 October 1983 (83/574/EEC).

List of UV filters which cosmetic products may contain U.K.

For the purposes of this Directive, UV filters are substances which, contained in cosmetic sun-screen products, are specifically intended to filter certain UV rays in order to protect the skin from certain harmful effects of these rays.

These UV filters may be added to other cosmetic products within the limits and under the conditions laid down in this Annex.

Other UV filters used in cosmetic products solely for the purpose of protecting the product against UV rays are not included in this list.

PART 1 U.K. List of permitted UV filters which cosmetic products may contain

a Not requiered if concentration is 0,5 % or less and when it is used only for product protection purposes.]
Reference No	Substances	Maximum authorized concentration	Other limitations and requirements	Conditions of use and warnings which must be printed on the label
a	b	c	d	e
1	4-Aminobenzoic acid	5 %
2	N , N , N -Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate	6 %
3	Homosalate (INN)	10 %
4	Oxybenzone (INN)	10 %		Contains oxybenzone a
[F50 ]
6	2-phenylbenzimidazole-5-sulphonic acid and its potassium, sodium and triethanolamine salts	8 % (expressed as acid)
[F24 7	3,3'-(1,4-Phenylenedimethylene) bis (7, 7-dimethyl-2-oxobicyclo-[2,2,1]hept-1-yl-methanesulfonic acid) and its salts	10 % (expressed as acid)		]
[F23 8	1-(4-tert-butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione	5 %		]
[F24 9	alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts	6 % (expressed as acid)		]
[F13 10	2-cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl ester (Octocrylene)	10 % (expressed as acid)		]
[F26 11	Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl}acrylamide	6 %		]
[F30 12	Octyl methoxycinnamate	10 %		]
[F31 13	Ethoxylated Ethyl-4-Aminobenzoate (PEG-25 PABA)	10 %
14	Isopentyl-4-methoxycinnamate (Isoamyl p-Methoxycinnamate)	10 %
15	2,4,6-Trianilino-(p-Carbo-2‘-Ethylhexyl-1‘Oxy)-1,3,5-Triazine (Octyl Triazone)	5 %
16	Phenol,2-(2H-Benzotriazol-2-yl)-4-Methyl-6-(2-Methyl-3-(1,3,3,3-Tetramethyl-I-(Trimethylsilyl)Oxy)-Disiloxanyl)Propyl) (Drometrizole Trisiloxane)	15 %
17	Benzoic acid, 4,4-((6-(((1,1-dimethylethyl)amino)carbonyl)phenyl)amino) 1,3,5-triazine-2,4-diyl)diimino)bis-,bis-(2-ethylhexyl)ester)	10 %
18	3-(4‘-Methylbenxylidene)-d-1 camphor (4-Methylbenzylidene Camphor)	4 %
19	3-Benzylidene camphor (3-Benzylidene Camphor)	2 %
20	2-Ethylhexyl salicylate (Octyl-salicylate)	5 %		]
[F34 21	4-Dimethyl-amino-benzoate of ethyl-2-hexyl (octyl dimethyl PABA)	8 %
22	2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid (Benzophenone-5) and its sodium salt	5 % (of acid)
23	2,2'-Methylene-bis-6-(2H-benzotriazol-2yl)-4-(tetramethyl-butyl)-1,1,3,3-phenol	10 %
24	Monosodium salt of 2-2'-bis-(1,4-phenylene)1H-benzimidazole-4,6-disulphonic acid)	10 % (of acid)
25	(1,3,5)-Triazine-2,4-bis((4-(2-ethyl-hexyloxy)-2-hydroxy)-phenyl)-6-(4-methoxyphenyl)	10 %		]
[F32 26	Dimethicodiethylbenzalmalonate (CAS No 207574-74-1)	10 %
27	Titanium dioxide	25 %		]

Textual Amendments

F50 Deleted by Commission Directive of 22 June 1993 (93/47/EEC).

[F20 PART 2 U.K. LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MAY PROVISIONALLY CONTAIN

Reference number	Substances	Maximum authorized concentration	Other limitations and requirements	Conditions of use and warnings which must be printed on the label	Allowed until
a	b	c	d	e	f
[F33 ]
[F46 ]
[F33 ]
[ F47 ]
[F46 ]
[F46 ]
[F25 ]
[F33 ]
[ F47 ]
[F48 ]
[F46 ]
[F46 ]
[F48 ]
[ F47 ]
[F50 ]
[F46 ]
[F44 ]					]

[F51 ANNEX VIII] U.K.

Textual Amendments

F51 Inserted by Council Directive of 14 June 1993 (93/35/EEC).

[F35 ANNEX VIIIa] U.K.

(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).