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Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products Official Journal L 262 , 27/09/1976 P. 0169 - 0200 Greek special edition: Chapter 13 Volume 4 P. 0145 Spanish special edition: Chapter 15 Volume 1 P. 0206 Portuguese special edition Chapter 15 Volume 1 P. 0206 Finnish special edition: Chapter 13 Volume 5 P. 0198 Swedish special edition: Chapter 13 Volume 5 P. 0198

COUNCIL DIRECTIVE of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the Economic and Social Committee (2), Whereas the provisions laid down by law, regulation or administrative action in force in the Member States define the composition characteristics to which cosmetic products must conform and prescribe rules for their labelling and for their packaging ; whereas these provisions differ from one Member State to another; Whereas the differences between these laws oblige Community cosmetic producers to vary their production according to the Member State for which the products are intended ; whereas, consequently, they hinder trade in these products and, as a result, have a direct effect on the establishment and functioning of the common market; Whereas the main objective of these laws is the safeguarding of public health and whereas, as a result, the pursuit of the same objective must inspire Community legislation in this sector ; whereas, however, this objective must be attained by means which also take account of economic and technological requirements; Whereas it is necessary to determine at Community level the regulations which must be observed as regards the composition, labelling and packaging of cosmetic products; Whereas this Directive relates only to cosmetic products and not to pharmaceutical specialities and medicinal products ; whereas for this purpose it is necessary to define the scope of the Directive by delimiting the field of cosmetics from that of pharmaceuticals ; whereas this delimitation follows in particular from the detailed definition of cosmetic products, which refers both to their areas of application and to the purposes of their use ; whereas this Directive is not applicable to the products that fall under the definition of cosmetic product but are exclusively intended to protect from disease ; whereas, moreover, it is advisable to specify that certain products come under this definition, whilst products containing substances or preparations intended to be ingested, inhaled, injected or implanted in the human body do not come under the field of cosmetics; Whereas in the present state of research, it is advisable to exclude cosmetic products containing one of the substances listed in Annex V from the scope of this Directive; Whereas cosmetic products must not be harmful under normal or foreseeable conditions of use ; whereas in particular it is necessary to take into account the possibility of danger to zones of the body that are contiguous to the area of application; Whereas, in particular, the determination of the methods of analysis together with possible modifications or additions which may have to be made to them on the basis of the results of scientific and technical research, are implementing measures of a technical nature ; whereas it is advisable to entrust their adoption to the Commission, subject to certain conditions specified in this Directive, for the purpose of simplifying and accelerating the procedure; Whereas technical progress necessitates rapid adaptation of the technical provisions defined in this Directive and in subsequent Directives in this field ; whereas it is advisable, in order to facilitate implementation of the measures necessary for this purpose, (1)OJ No C 40, 8.4.1974, p. 71. (2)OJ No C 60, 26.7.1973, p. 16. to provide for a procedure establishing close cooperation between the Member States and the Commission within the Committee for adaptation to technical progress of Directives aimed at the removal of technical obstacles to trade in the cosmetic products sector; Whereas it is necessary, on the basis of scientific and technical research, to draw up proposals for lists of authorized substances which could include antioxidants, hair dyes, preservatives and ultraviolet filters, taking into account in particular the problem of sensitization; Whereas it could happen that although conforming to the provisions of this Directive and its Annexes, cosmetic products placed on the market might endanger public health ; whereas it is therefore advisable to provide for a procedure intended to remove this danger, HAS ADOPTED THIS DIRECTIVE: Article 1 1. A "cosmetic product" means any substance or preparation intended for placing in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or principally to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or correct body odours. 2. The products to be considered as cosmetic products within the meaning of this definition are listed in Annex I. 3. Cosmetic products containing one of the substances listed in Annex V and cosmetic products containing colouring agents other than those referred to in Annexes III and IV and which are not intended to come into contact with the mucous membranes are excluded from the scope of this Directive. Member States may take such measures as they deem necessary with regard to these products. Article 2 Cosmetic products put on the market within the Community must not be liable to cause damage to human health when they are applied under normal conditions of use. Article 3 Member States shall take all necessary measures to ensure that only cosmetic products which conform to the provisions of this Directive and its Annexes may be put on the market. Article 4 Without prejudice to their general obligations deriving from Article 2, Member States shall prohibit the marketing of cosmetic products containing: (a) substances listed in Annex II; (b) substances listed in the first part of Annex III, beyond the limits and outside the conditions laid down; (c) colouring agents other than those listed in the second part of Annex III, if these products are intended for application in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs; (d) colouring agents listed in the second part of Annex III, beyond the limits and outside the conditions laid down, if these products are intended for application in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs. Article 5 For a period of three years from notification of this Directive, Member States shall accept the marketing of cosmetic products containing: (a) the substances listed in Part 1 of Annex IV within the limits and under the conditions laid down; (b) the colouring agents listed in Part 2 of Annex IV within the limits and under the conditions laid down, if these products are intended for application in the vicinity of the eyes, on the lips, in the oral cavity, or to the external genital organs; (c) the colouring agents listed in Part 3 of Annex IV, if these products either are not intended to come into contact with the mucous membranes or are only intended to come into brief contact with the skin. On expiry of the three year period, these substances and colouring agents shall: - either be definitively permitted, - or definitively prohibited (Annex II), - or retained for a further period of three years in Annex IV, - or deleted from all Annexes to this Directive. Article 6 1. Member States shall take all measures necessary to ensure that cosmetic products may be marketed only if their packaging, containers or labels bear the following information in indelible, easily legible and visible lettering: (a) the name or style and the address or registered office of the manufacturer or the person responsible for marketing the cosmetic product who are established within the Community. Such information may be abbreviated in so far as the abbreviation makes it generally possible to identify the undertaking. Member States may require that the country of origin be specified for goods manufactured outside the Community; (b) the nominal content at the time of packaging; (c) the expiry date for products with a stability of less than three years; (d) particular precautions to be observed in use, and especially those listed in the column "Conditions of use and warnings which must be printed on the label" in Annexes III and IV, and which must appear on the container ; where this is impossible for practical reasons, this information must appear on the packaging or on an enclosed leaflet, but in the latter case an abbreviated external indication must appear on the container, referring the consumer to the information specified; (e) the batch number of manufacture or the reference for identifying the goods ; however, where this is impossible for practical reasons because the cosmetic articles are too small, such information need appear only on the multiple retail pack or sleeve of these articles. 2. Member States shall take all measures necessary to ensure that in the labelling, presentation for sale and advertising of cosmetic products, the wording, use of names, trade marks, images or other signs, figurative or otherwise, suggesting a characteristic which the products in question do not possess, shall be prohibited. Article 7 1. Member States may not, for reasons related to the requirements laid down in this Directive and the Annexes thereto, refuse, prohibit or restrict the marketing of any cosmetic products which comply with the requirements of this Directive and the Annexes thereto. 2. They may, however, require that the particulars provided for in Article 6 (1) (b), (c) and (d) be expressed at least in their own national or official language or languages. 3. Furthermore, a Member State may require, for purposes of prompt and appropriate medicial treatment in the event of difficulties, that adequate and sufficient information regarding substances contained in cosmetic products is made available to the competent authority, which shall ensure that this information is used only for the purposes of such treatment. Article 8 1. In accordance with the procedure laid down in Article 10 the following shall be determined: - the methods of analysis necessary for checking the composition of cosmetic products, - the criteria of microbiological and chemical purity for cosmetic products and methods for checking compliance with those criteria. 2. The amendments necessary for adapting Annex II to technical progress shall be adopted in accordance with the same procedure. Article 9 1. The Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector, hereinafter called "the Committee", is hereby set up. It shall consist of representatives of the Member States with a representative of the Commission as chairman. 2. The Committee shall adopt its own rules of procedure. Article 10 1. Where the procedure laid down in this Article is to be followed, matters shall be referred to the Committee by the chairman, either on his own initiative or at the request of the representative of a Member State. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be adopted. The Committee shall deliver its opinion on the draft within a time limit set by the chairman according to the urgency of the matter. Opinions shall be adopted by a majority of 41 votes, the votes of Member States being weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote. 3. (a) The Commission shall adopt the proposed measures when they are in accordance with the opinion of the Committee. (b) Where the proposed measures are not in accordance with the opinion of the Committee, or if no opinion is adopted, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall act by a qualified majority. (c) If, within three months of the proposal being submitted to it, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 11 Without prejudice to Article 5 and not later than one year after expiry of the period laid down in Article 14 (1) for implementation of this Directive by the Member States, the Commission shall, on the basis of the results of the latest scientific and technical research, submit to the Council appropriate proposals establishing lists of permitted substances. Article 12 1. If a Member State notes, on the basis of a substantiated justification, that a cosmetic product, although complying with the requirements of the Directive, represents a hazard to health, it may provisionally prohibit the marketing of that product in its territory or subject it to special conditions. It shall immediately inform the other Member States and the Commission thereof, stating the grounds for its decision. 2. The Commission shall, within six weeks, consult the Member States concerned, following which it shall deliver its opinion without delay and take the appropriate steps. 3. If the Commission is of the opinion that technical adaptations to the Directive are necessary, such adaptations shall be adopted by either the Commission or the Council in accordance with the procedure laid down in Article 10. In that event, the Member State which has adopted safeguard measures may maintain them until entry into force of the adaptations. Article 13 Precise reasons shall be stated for any individual measures placing a restriction or ban on the marketing of cosmetic products taken pursuant to this Directive. It shall be notified to the party concerned together with particulars of the remedies available to him under the laws in force in the Member States and of the time limits allowed for the exercise of such remedies. Article 14 1. Member States shall bring into force the provisions needed in order to comply with this Directive within 18 months of its notification and shall forthwith inform the Commission thereof. 2. Member States may, however, for a period of 36 months from notification of this Directive, authorize the marketing in their territory of cosmetic products which do not conform to the requirements of the Directive. 3. Member States shall ensure that the texts of such provisions of national law as they adopt in the field governed by this Directive are communicated to the Commission. Article 15 This Directive is addressed to the Member States. Done at Brussels, 27 July 1976. For the Council The President M. van der STOEL ANNEX I 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 LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN 1. N-5-Chlorobenzoxazol-2-ylacetamide 2. ß-Acetoxyethyl trimethyl ammonium hydroxide (acetylcholine and its salts) 3. Deanol aceglumate* 4. Spironolactone* 5. [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. 2-Amino-1,2-bis (4-methoxyphenyl)ethanol and its salts 30. 1,3-dimethylpentylamine and its salts (*) 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. 31. 4-Aminosalicylic acid and its salts 32. Toluidines, their isomers, salts and halogenated and sulphonated derivatives 33. Xylidines, their isomers, salts and halogenated and sulphonated derivatives 34. Imperatorin (9-(3-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, with the exception of that given in Annex IV 40. Antimony and its compounds 41. Apocynum cannabinum L. and its preparations 42. Apomorphine (5,6,6a 7-tetrahydro-6-methyl-4H-dibenzo [de, g]= quinoline-10,11-dihydric alcohol) and its salts 43. Arsenic and its compounds 44. Atropa belladonna L. and its preparations 45. Atropine, its salts and derivatives 46. Barium salts, with the exception of barium sulphate, lakes prepared from barium sulphate and pigments prepared from the colouring agents listed in Annex III, Part 2 and Annex IV, Parts 2 and 3 and marked Ba 47. Benzene 48. 4,5-Dihydrobenzimidazol-4-one 49. Benzazepines and benzadiazepines, their salts and derivatives 50. 1-Dimethylaminomethyl-1-methylpropyl benzoate and its salts (amylocaine) 51. 2,2,6-Trimethyl-4-piperidyl benzoate and its salts (benzamine) 52. Isocarboxazide* 53. Bendroflumethiazide* and its derivatives 54. Beryllium and its compounds 55. Bromine, elemental 56. Bretylium tosilate* 57. Carbromal* 58. Bromisoval* 59. Brompheniramine* and its salts 60. Benzilonium bromide* 61. Tetrylammonium bromide* 62. Brucine 63. Tetracaine* and its salts 64. Mofebutazone* 65. Tolbutamide* 66. Carbutamide* 67. Phenylbutazone* 68. Cadmium and its compounds 69. Cantharides, Cantharis vesicatoria 70. (1R, 2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (cantharidin) 71. Phenprobamate* 72. Nitroderivatives of carbazol 73. Carbon disulphide 74. Catalase 75. Cephaeline and its salts 76. Chenopodium ambrosioides (essential oil) 77. 2,2,2-Trichloroethane-1,1-diol 78. Chlorine 79. Chlorpropamide* 80. Diphenoxylate* (hydrochloride) 81. 4-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. 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. Chloromezanone* 92. Triparanol* 93. 2-[2(4-Chlorophenyl)-2-phenylacetyl] indane-1,3-dione (chlorophacinone-ISO) 94. Chlorphenoxamine* 95. Phenaglycodol* 96. Chloroethane 97. Chromium ; chromic acid and its salts 98. Claviceps purpurea Tul., its alkaloids and galenical preparations 99. Conium maculatum L. (fruit, powder, galenical preparations) 100. Glycyclamide* 101. Cobalt benzenesulphonate 102. Colchicine, its salts and derivatives 103. Colchicoside and its derivatives 104. Colchicum autumnale L. and its galenical preparations 105. Convallatoxin 106. Anamirta cocculus L. (fruit) 107. Croton tiglium (oil) 108. 1-Butyl-3-(N-crotonoylsulphanilyl)urea 109. Curare and curarine 110. Synthetic curarizants 111. Hydrogen cyanide and its salts 112. >PIC FILE= "T9000996"> 113. Cyclomenol* and its salts 114. Sodium hexacyclonate* 115. Hexapropymate* 116. Dextropropoxyphene* 117. O O-Diacetyl-N-allyl-N-normorphine 118. Pipazetate* and its salts 119. >PIC FILE= "T9000997"> 120. N N-Pentamethylenebis (trimethylammonium salts), e.g. Pentamethonium bromide* 121. N N'-[Methylimino) diethylene] bis (ethyldimethylammonium) salts, e.g. azamethonium bromide* 122. Cyclarbamate* 123. Clofenotane* ; DDT (ISO) 124. Hexamethylenebis (trimethylammonium salts), e.g. hexamethonium bromide* 125. Dichloroethanes (ethylene chlorides) 126. Dichloroethylenes (acetylene chlorides) 127. Lysergide* and its salts 128. 2-Diethylaminoethyl-3-hydroxy-4-phenylbenzoate and its salts 129. Cinchocaine* and its salts 130. 3-Diethylaminopropyl cinnamate 131. O O-Diethyl O-4-nitrophenyl phosphorothioate (parathion-ISO) 132. [Oxalylbis(iminoethylene)] bis [(o-chlorobenzyl)diethylammonium salts], e.g. ambenomium chloride* 133. Methyprylon* and its salts 134. Digitaline and all heterosides of Digitalis purpurea L. 135. 7-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline (xanthinol) 136. Dioxethedrin* and its salts 137. Piprocurarium* 138. Propyphenazone* 139. Tetrabenazine* and its salts 140. Captodiame* 141. Mefeclorazine* and its salts 142. Dimethylamine 143. 1,1-Bis(dimethylaminomethyl) propyl benzoate and its salts (amydricaine, alypine) 144. Methapyrilene* and its salts 145. Metamfepramone* and its salts 146. Amitriptyline* and its salts 147. Metformin* and its salts 148. Isosorbide dinitrate* 149. Malononitrile 150. Succinonitrile 151. Dinitrophenol isomers 152. Inproquone* 153. Dimevamide* and its salts 154. Diphenylpyraline* and its salts 155. Sulfinpyrazone* 156. N-(3-Carbamoyl-3, 3-diphenylpropyl)-N N-diisopropylmethylammonium salts, e.g. isopropamide iodide* 157. Benactyzine* 158. Benzatropine* and its salts 159. Cyclizine* and its salts 160. 5,5-Diphenyl-4 imidazolidone 161. Probenecid* 162. Disulfiram* ; thiram (ISO) 163. Emetine, its salts and derivatives 164. Ephedrine and its salts 165. Oxanamide* and its derivatives 166. Eserine or physostigmine and its salts 167. Esters of 4-aminobenzoic acid, with the free amino group, with the exception of that given in Annex IV, Part 1 168. 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. Monobenzone* 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. Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex IV, Part 1 192. Furfuryltrimethylammonium salts, e.g. furtrethonium iodide* 193. Galantamine* 194. Progestogens, with the exception of those listed in Annex V 195. 1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO) 196. (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,6,7,8,8a-octahydro-1,4 : 5,8-dimethanonaphthalene (endrin-ISO) 197. Hexachloroethane 198. (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4 : 5,8-dimethanonaphthalene (isodrin-ISO) 199. Hydrastine, 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. Ethyl bis(4-hydoxy-2-oxo-1-benzopyran-3-yl) acetate and salts of the acid 205. Methocarbamol* 206. Propatylnitrate* 207. 4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene) dicoumarin 208. Fenadiazole* 209. Nitroxoline* and its salts 210. Hyoscyamine, its salts and derivatives 211. Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations) 212. Pemoline* and its salts 213. Iodine 214. Decamethylenebis (trimethylammonium salts), e.g. decamethonium bromide* 215. Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations) 216. (2-Isopropylpent-4-enoyl)urea (apronalide) 217. >PIC FILE= "T9000998"> 218. Lobelia inflata L. and its galenical preparations 219. Lobeline* and its salts 220. Barbiturates 221. Mercury and its compounds, excluding the exceptions listed in Annex IV and Annex V 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. 3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano [3,2-c]-[1] benzopyran-5-one (cyclocoumarol) 235. Carisoprodol* 236. Meprobamate* 237. Tefazoline* and its salts 238. Arecoline 239. Poldine metilsulfate* 240. Hydroxyzine* 241. 2-Naphthol 242. 1-and 2-Naphthylamines and their salts 243. 3 (1-Naphtylmethyl)-2-imidazoline 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 259. Guanethidine* and its salts 260. Oestrogens, with the exception of those listed in Annex V 261. Oleandrin 262. Chlortalidone* 263. Pelletierine and its salts 264. Pentachloroethane 265. Pentaerithrityl tetranitrate* 266. Petrichloral* 267. Octamylamine* and its salts 268. Pheno and its alkali salts, excluding the exceptions listed in Annex III 269. Phenacemide* 270. Difencloxazine* 271. 2-Phenylindane-1,3-dione (phenindione) 272. Ethylphenacemide* 273. Phenprocoumon* 274. Fenyramidol* 275. Triamterene* and its salts 276. Tetraethylpyrophosphate ; 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. a-Piperidin-2-yl benzyl 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 compounds, with the exception of that mentioned in Annex V 290. Coniine 291. Prunus laurocerasus L. ("cherry laurel water") 292. Metyrapone* 293. Radioactive substances (1) 294. Juniperus sabina L. (leaves, essential oil and galenical preparations) 295. Hyoscine, its salts and derivatives 296. Gold salts 297. Selenium and its compounds 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. Sulphonamides (sulphanylamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts 308. Sultiame* 309. Neodymium and its salts (1)The presence of natural radioactive substances and of radioactive substances caused by artificial contamination from the environment is permitted, provided that the radioactive substances are not enriched for the manufacture of cosmetic products and that their concentration falls within the limits set in the Directive laying down the basic standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiations (OJ No 11, 20.2.1959, p. 221/59). 310. Thiotepa* 311. Pilocarpus jaborandi Holmes and its galenical preparations 312. Tellurium and its compounds 313. Xylometazoline and its salts 314. Tetrachloroethylene 315. Carbon tetrachloride 316. Hexaethyl tetraphosphate 317. Thallium and its compounds 318. Thevetia neriifolia Juss., glycoside extract 319. Ethionamide* 320. Phenothiazine* and its compounds 321. Thiourea and its derivatives, with the exception of those listed in Annex IV, 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. Trichlormethine* and its salts 328. Tretamine* 329. Gallamine triethiodide* 330. Urginea scilla Stern. and its galenical preparations 331. Veratrine, its salts and galenical preparations 332. Schoenocaulon officinale Lind. (seeds and galenical preparations) 333. Veratrum album L. (roots and galenical preparations) 334. Vinyl chloride monomer 335. Ergocalciferol* and cholecalciferol (vitamins D2 and D3) 336. Salts of O-alkyldithiocarbonic acids 337. Yohimbine and its salts 338. Dimethyl sulfoxide* 339. Diphenhydramine* and its salts 340. 4-tert-Butylphenol 341. 4-tert-Butylpyrocatechol 342. Dihydrotachysterol* 343. Dioxane 344. Morpholine and its salts 345. Pyrethrum album L. and its galenical preparations 346. 2-[4-Methoxybenzyl-N-(2-pyridyl)amino] ethyldimethylamine 347. Tripelennamine* 348. Tetrachlorosalicylanilides 349. Dichlorosalicylanilides 350. Tetrabromosalicylanilides 351. Dibromosalicylanilides, e.g. metabromsalan*, dibromsalan* 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. Furo [3,2-g] chromen-7-one and its alkyl-substituted derivatives (e.g. trioxysalan* and 8-methoxypsoralen), except for normal content in natural essences used 359. Oil from the seeds of Laurus nobilis L. 360. Sassafras officinale Nees oil containing safrole 361. 5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite >PIC FILE= "T0009550"> >PIC FILE= "T0009551"> >PIC FILE= "T0009552"> >PIC FILE= "T0009553"> >PIC FILE= "T0009554"> PART 2 >PIC FILE= "T0009555"> >PIC FILE= "T0009556"> >PIC FILE= "T0009557"> >PIC FILE= "T0009558"> >PIC FILE= "T0009559"> >PIC FILE= "T0009560"> >PIC FILE= "T0009561"> >PIC FILE= "T0009562"> >PIC FILE= "T0009563"> >PIC FILE= "T0009564"> PART 2 >PIC FILE= "T0009565"> >PIC FILE= "T0009567"> >PIC FILE= "T0009568"> PART 3 (A) LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR COSMETIC PRODUCTS WHICH DO NOT COME INTO CONTACT WITH THE MUCOUS MEMBRANES Reds 12310, 12335, 12420, 12430, 12440, 16140, 16155, 16250, 17200, 18000, 18050, 18055, 18065, 26105, 45100, 50240, E121 Oranges and yellows 11680, 11710, 13065, 15575, 16230, 18690, 18736, 18745, 19120, 19130, 21230, 71105 >PIC FILE= "T9001000"> (B) LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR COSMETIC PRODUCTS WHICH COME INTO CONTACT ONLY BRIEFLY WITH THE SKIN Reds 11210, 12090, 12155, 12170, 12315, 12370, 12459, 12460, 13020, 14895, 14905, 16045, 16180, 18125, 18130, 24790, 27300, 27306, 28160, 45220, 60505, 60710, 62015, 73300 Yellows and oranges 11720, 11725, 11730, 11765, 11850, 11855, 11860, 11870, 12055, 12140, 12700, 12740, 12770, 12790, 13900, 14600, 15970, 15975, 18820, 18900, 19555, 21090, 21096, 21100, 21108, 21110, 21115, 22910, 25135, 25220, 26090, 29020, 40215, 40640, 41000, 45376, 47035, 48040, 48055, 56205, 4-(3-chlorphenylazo)-3-hydroxy-2 naphth-0-anisidide, trisodium 3-hydroxypyren-5,8,10- trisulphonate Blues and greens 10025, 26360, 42052, 42085, 42095, 42100, 50315, 50320, 50400, 50405, 51175, 52015, 52020, 52030, 61505, 61585, 62045, 62100, 62105, 62125, 62130, 62500, 62560, 63010, 64500, 74180 Violets, browns, blacks and whites 12145, 14805, 15685, 17580, 20285, 20470, 21010, 25410, 30045, 30235, 40625, 42510, 42520, 42525, 42535, 42650, 48013, 57020, 60730, 61100, 61105, 61705, 62030, 63165, 63615 ANNEX V LIST OF SUBSTANCES EXCLUDED FROM THE SCOPE OF THE DIRECTIVE 1. Lead acetate (for use in hair treatment products only). 2. Hexachlorophene* (for all uses other than that stated in Part 1 of Annex III). 3. Hormones (a) - oestrone, - oestradiol and its esters, - oestriol and its esters; (b) - progesterone, - Ethisterone*. 4. p-Phenylenediamine and its salts. 5. Strontium and its salts, with the exception of those used in the colouring agents listed in Part 2 of Annex III and Parts 2 and 3 of Annex IV. 6. Zirconium and its derivatives. 7. Thiomersal* and phenylmercuric compounds (for use as preservatives in concentrated shampoos and creams containing non-ionic emulsifiers which render other preservatives ineffective ; maximum concentration 0.003 % calculated as Hg). 8. Lidocaine*. 9. Tyrothricin*.

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

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament (1),

Having regard to the opinion of the Economic and Social Committee (2),

Whereas the provisions laid down by law, regulation or administrative action in force in the Member States define the composition characteristics to which cosmetic products must conform and prescribe rules for their labelling and for their packaging ; whereas these provisions differ from one Member State to another;

Whereas the differences between these laws oblige Community cosmetic producers to vary their production according to the Member State for which the products are intended ; whereas, consequently, they hinder trade in these products and, as a result, have a direct effect on the establishment and functioning of the common market;

Whereas the main objective of these laws is the safeguarding of public health and whereas, as a result, the pursuit of the same objective must inspire Community legislation in this sector ; whereas, however, this objective must be attained by means which also take account of economic and technological requirements;

Whereas it is necessary to determine at Community level the regulations which must be observed as regards the composition, labelling and packaging of cosmetic products;

Whereas this Directive relates only to cosmetic products and not to pharmaceutical specialities and medicinal products ; whereas for this purpose it is necessary to define the scope of the Directive by delimiting the field of cosmetics from that of pharmaceuticals ; whereas this delimitation follows in particular from the detailed definition of cosmetic products, which refers both to their areas of application and to the purposes of their use ; whereas this Directive is not applicable to the products that fall under the definition of cosmetic product but are exclusively intended to protect from disease ; whereas, moreover, it is advisable to specify that certain products come under this definition, whilst products containing substances or preparations intended to be ingested, inhaled, injected or implanted in the human body do not come under the field of cosmetics;

Whereas in the present state of research, it is advisable to exclude cosmetic products containing one of the substances listed in Annex V from the scope of this Directive;

Whereas cosmetic products must not be harmful under normal or foreseeable conditions of use ; whereas in particular it is necessary to take into account the possibility of danger to zones of the body that are contiguous to the area of application;

Whereas, in particular, the determination of the methods of analysis together with possible modifications or additions which may have to be made to them on the basis of the results of scientific and technical research, are implementing measures of a technical nature ; whereas it is advisable to entrust their adoption to the Commission, subject to certain conditions specified in this Directive, for the purpose of simplifying and accelerating the procedure;

Whereas technical progress necessitates rapid adaptation of the technical provisions defined in this Directive and in subsequent Directives in this field ; whereas it is advisable, in order to facilitate implementation of the measures necessary for this purpose, (1)OJ No C 40, 8.4.1974, p. 71. (2)OJ No C 60, 26.7.1973, p. 16.

to provide for a procedure establishing close cooperation between the Member States and the Commission within the Committee for adaptation to technical progress of Directives aimed at the removal of technical obstacles to trade in the cosmetic products sector;

Whereas it is necessary, on the basis of scientific and technical research, to draw up proposals for lists of authorized substances which could include antioxidants, hair dyes, preservatives and ultraviolet filters, taking into account in particular the problem of sensitization;

Whereas it could happen that although conforming to the provisions of this Directive and its Annexes, cosmetic products placed on the market might endanger public health ; whereas it is therefore advisable to provide for a procedure intended to remove this danger,

HAS ADOPTED THIS DIRECTIVE:

1. A "cosmetic product" means any substance or preparation intended for placing in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or principally to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or correct body odours.

2. The products to be considered as cosmetic products within the meaning of this definition are listed in Annex I.

3. Cosmetic products containing one of the substances listed in Annex V and cosmetic products containing colouring agents other than those referred to in Annexes III and IV and which are not intended to come into contact with the mucous membranes are excluded from the scope of this Directive. Member States may take such measures as they deem necessary with regard to these products.

Cosmetic products put on the market within the Community must not be liable to cause damage to human health when they are applied under normal conditions of use.

Member States shall take all necessary measures to ensure that only cosmetic products which conform to the provisions of this Directive and its Annexes may be put on the market.

Without prejudice to their general obligations deriving from Article 2, Member States shall prohibit the marketing of cosmetic products containing: (a) substances listed in Annex II;

(b) substances listed in the first part of Annex III, beyond the limits and outside the conditions laid down;

(c) colouring agents other than those listed in the second part of Annex III, if these products are intended for application in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs;

(d) colouring agents listed in the second part of Annex III, beyond the limits and outside the conditions laid down, if these products are intended for application in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs.

For a period of three years from notification of this Directive, Member States shall accept the marketing of cosmetic products containing: (a) the substances listed in Part 1 of Annex IV within the limits and under the conditions laid down;

(b) the colouring agents listed in Part 2 of Annex IV within the limits and under the conditions laid down, if these products are intended for application in the vicinity of the eyes, on the lips, in the oral cavity, or to the external genital organs;

(c) the colouring agents listed in Part 3 of Annex IV, if these products either are not intended to come into contact with the mucous membranes or are only intended to come into brief contact with the skin.

On expiry of the three year period, these substances and colouring agents shall: - either be definitively permitted,

- or definitively prohibited (Annex II),

- or retained for a further period of three years in Annex IV,

- or deleted from all Annexes to this Directive.

1. Member States shall take all measures necessary to ensure that cosmetic products may be marketed only if their packaging, containers or labels bear the following information in indelible, easily legible and visible lettering: (a) the name or style and the address or registered office of the manufacturer or the person responsible for marketing the cosmetic product who are established within the Community. Such information may be abbreviated in so far as the abbreviation makes it generally possible to identify the undertaking. Member States may require that the country of origin be specified for goods manufactured outside the Community;

(b) the nominal content at the time of packaging;

(c) the expiry date for products with a stability of less than three years;

(d) particular precautions to be observed in use, and especially those listed in the column "Conditions of use and warnings which must be printed on the label" in Annexes III and IV, and which must appear on the container ; where this is impossible for practical reasons, this information must appear on the packaging or on an enclosed leaflet, but in the latter case an abbreviated external indication must appear on the container, referring the consumer to the information specified;

(e) the batch number of manufacture or the reference for identifying the goods ; however, where this is impossible for practical reasons because the cosmetic articles are too small, such information need appear only on the multiple retail pack or sleeve of these articles.

2. Member States shall take all measures necessary to ensure that in the labelling, presentation for sale and advertising of cosmetic products, the wording, use of names, trade marks, images or other signs, figurative or otherwise, suggesting a characteristic which the products in question do not possess, shall be prohibited.

1. Member States may not, for reasons related to the requirements laid down in this Directive and the Annexes thereto, refuse, prohibit or restrict the marketing of any cosmetic products which comply with the requirements of this Directive and the Annexes thereto.

2. They may, however, require that the particulars provided for in Article 6 (1) (b), (c) and (d) be expressed at least in their own national or official language or languages.

3. Furthermore, a Member State may require, for purposes of prompt and appropriate medicial treatment in the event of difficulties, that adequate and sufficient information regarding substances contained in cosmetic products is made available to the competent authority, which shall ensure that this information is used only for the purposes of such treatment.

1. In accordance with the procedure laid down in Article 10 the following shall be determined: - the methods of analysis necessary for checking the composition of cosmetic products,

- the criteria of microbiological and chemical purity for cosmetic products and methods for checking compliance with those criteria.

2. The amendments necessary for adapting Annex II to technical progress shall be adopted in accordance with the same procedure.

Article 9

1. The Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector, hereinafter called "the Committee", is hereby set up. It shall consist of representatives of the Member States with a representative of the Commission as chairman.

2. The Committee shall adopt its own rules of procedure.

1. Where the procedure laid down in this Article is to be followed, matters shall be referred to the Committee by the chairman, either on his own initiative or at the request of the representative of a Member State.

2. The representative of the Commission shall submit to the Committee a draft of the measures to be adopted. The Committee shall deliver its opinion on the draft within a time limit set by the chairman according to the urgency of the matter. Opinions shall be adopted by a majority of 41 votes, the votes of Member States being weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote.

3. (a) The Commission shall adopt the proposed measures when they are in accordance with the opinion of the Committee.

(b) Where the proposed measures are not in accordance with the opinion of the Committee, or if no opinion is adopted, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall act by a qualified majority.

(c) If, within three months of the proposal being submitted to it, the Council has not acted, the proposed measures shall be adopted by the Commission.

Article 11

Without prejudice to Article 5 and not later than one year after expiry of the period laid down in Article 14 (1) for implementation of this Directive by the Member States, the Commission shall, on the basis of the results of the latest scientific and technical research, submit to the Council appropriate proposals establishing lists of permitted substances.

1. If a Member State notes, on the basis of a substantiated justification, that a cosmetic product, although complying with the requirements of the Directive, represents a hazard to health, it may provisionally prohibit the marketing of that product in its territory or subject it to special conditions. It shall immediately inform the other Member States and the Commission thereof, stating the grounds for its decision.

2. The Commission shall, within six weeks, consult the Member States concerned, following which it shall deliver its opinion without delay and take the appropriate steps.

3. If the Commission is of the opinion that technical adaptations to the Directive are necessary, such adaptations shall be adopted by either the Commission or the Council in accordance with the procedure laid down in Article 10. In that event, the Member State which has adopted safeguard measures may maintain them until entry into force of the adaptations.

Precise reasons shall be stated for any individual measures placing a restriction or ban on the marketing of cosmetic products taken pursuant to this Directive. It shall be notified to the party concerned together with particulars of the remedies available to him under the laws in force in the Member States and of the time limits allowed for the exercise of such remedies.

Article 14

1. Member States shall bring into force the provisions needed in order to comply with this Directive within 18 months of its notification and shall forthwith inform the Commission thereof.

2. Member States may, however, for a period of 36 months from notification of this Directive, authorize the marketing in their territory of cosmetic products which do not conform to the requirements of the Directive.

3. Member States shall ensure that the texts of such provisions of national law as they adopt in the field governed by this Directive are communicated to the Commission.

Article 15

This Directive is addressed to the Member States.

Done at Brussels, 27 July 1976.

For the Council

The President

M. van der STOEL

ANNEX I 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 LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN

1. N-5-Chlorobenzoxazol-2-ylacetamide

2. ß-Acetoxyethyl trimethyl ammonium hydroxide (acetylcholine and its salts)

3. Deanol aceglumate*

4. Spironolactone*

5. [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. 2-Amino-1,2-bis (4-methoxyphenyl)ethanol and its salts

30. 1,3-dimethylpentylamine and its salts (*) 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.

31. 4-Aminosalicylic acid and its salts

32. Toluidines, their isomers, salts and halogenated and sulphonated derivatives

33. Xylidines, their isomers, salts and halogenated and sulphonated derivatives

34. Imperatorin (9-(3-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, with the exception of that given in Annex IV

40. Antimony and its compounds

41. Apocynum cannabinum L. and its preparations

42. Apomorphine (5,6,6a 7-tetrahydro-6-methyl-4H-dibenzo [de, g]= quinoline-10,11-dihydric alcohol) and its salts

43. Arsenic and its compounds

44. Atropa belladonna L. and its preparations

45. Atropine, its salts and derivatives

46. Barium salts, with the exception of barium sulphate, lakes prepared from barium sulphate and pigments prepared from the colouring agents listed in Annex III, Part 2 and Annex IV, Parts 2 and 3 and marked Ba

47. Benzene

48. 4,5-Dihydrobenzimidazol-4-one

49. Benzazepines and benzadiazepines, their salts and derivatives

50. 1-Dimethylaminomethyl-1-methylpropyl benzoate and its salts (amylocaine)

51. 2,2,6-Trimethyl-4-piperidyl benzoate and its salts (benzamine)

52. Isocarboxazide*

53. Bendroflumethiazide* and its derivatives

54. Beryllium and its compounds

55. Bromine, elemental

56. Bretylium tosilate*

57. Carbromal*

58. Bromisoval*

59. Brompheniramine* and its salts

60. Benzilonium bromide*

61. Tetrylammonium bromide*

62. Brucine

63. Tetracaine* and its salts

64. Mofebutazone*

65. Tolbutamide*

66. Carbutamide*

67. Phenylbutazone*

68. Cadmium and its compounds

69. Cantharides, Cantharis vesicatoria

70. (1R, 2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (cantharidin)

71. Phenprobamate*

72. Nitroderivatives of carbazol

73. Carbon disulphide

74. Catalase

75. Cephaeline and its salts

76. Chenopodium ambrosioides (essential oil)

77. 2,2,2-Trichloroethane-1,1-diol

78. Chlorine

79. Chlorpropamide*

80. Diphenoxylate* (hydrochloride)

81. 4-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. 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. Chloromezanone*

92. Triparanol*

93. 2-[2(4-Chlorophenyl)-2-phenylacetyl] indane-1,3-dione (chlorophacinone-ISO)

94. Chlorphenoxamine*

95. Phenaglycodol*

96. Chloroethane

97. Chromium ; chromic acid and its salts

98. Claviceps purpurea Tul., its alkaloids and galenical preparations

99. Conium maculatum L. (fruit, powder, galenical preparations)

100. Glycyclamide*

101. Cobalt benzenesulphonate

102. Colchicine, its salts and derivatives

103. Colchicoside and its derivatives

104. Colchicum autumnale L. and its galenical preparations

105. Convallatoxin

106. Anamirta cocculus L. (fruit)

107. Croton tiglium (oil)

108. 1-Butyl-3-(N-crotonoylsulphanilyl)urea

109. Curare and curarine

110. Synthetic curarizants

111. Hydrogen cyanide and its salts

112. >PIC FILE= "T9000996">

113. Cyclomenol* and its salts

114. Sodium hexacyclonate*

115. Hexapropymate*

116. Dextropropoxyphene*

117. O O-Diacetyl-N-allyl-N-normorphine

118. Pipazetate* and its salts

119. >PIC FILE= "T9000997">

120. N N-Pentamethylenebis (trimethylammonium salts), e.g. Pentamethonium bromide*

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

122. Cyclarbamate*

123. Clofenotane* ; DDT (ISO)

124. Hexamethylenebis (trimethylammonium salts), e.g. hexamethonium bromide*

125. Dichloroethanes (ethylene chlorides)

126. Dichloroethylenes (acetylene chlorides)

127. Lysergide* and its salts

128. 2-Diethylaminoethyl-3-hydroxy-4-phenylbenzoate and its salts

129. Cinchocaine* and its salts

130. 3-Diethylaminopropyl cinnamate

131. O O-Diethyl O-4-nitrophenyl phosphorothioate (parathion-ISO)

132. [Oxalylbis(iminoethylene)] bis [(o-chlorobenzyl)diethylammonium salts], e.g. ambenomium chloride*

133. Methyprylon* and its salts

134. Digitaline and all heterosides of Digitalis purpurea L.

135. 7-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline (xanthinol)

136. Dioxethedrin* and its salts

137. Piprocurarium*

138. Propyphenazone*

139. Tetrabenazine* and its salts

140. Captodiame*

141. Mefeclorazine* and its salts

142. Dimethylamine

143. 1,1-Bis(dimethylaminomethyl) propyl benzoate and its salts (amydricaine, alypine)

144. Methapyrilene* and its salts

145. Metamfepramone* and its salts

146. Amitriptyline* and its salts

147. Metformin* and its salts

148. Isosorbide dinitrate*

149. Malononitrile

150. Succinonitrile

151. Dinitrophenol isomers

152. Inproquone*

153. Dimevamide* and its salts

154. Diphenylpyraline* and its salts

155. Sulfinpyrazone*

156. N-(3-Carbamoyl-3, 3-diphenylpropyl)-N N-diisopropylmethylammonium salts, e.g. isopropamide iodide*

157. Benactyzine*

158. Benzatropine* and its salts

159. Cyclizine* and its salts

160. 5,5-Diphenyl-4 imidazolidone

161. Probenecid*

162. Disulfiram* ; thiram (ISO)

163. Emetine, its salts and derivatives

164. Ephedrine and its salts

165. Oxanamide* and its derivatives

166. Eserine or physostigmine and its salts

167. Esters of 4-aminobenzoic acid, with the free amino group, with the exception of that given in Annex IV, Part 1

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. Monobenzone*

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. Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex IV, Part 1

192. Furfuryltrimethylammonium salts, e.g. furtrethonium iodide*

193. Galantamine*

194. Progestogens, with the exception of those listed in Annex V

195. 1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO)

196. (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,6,7,8,8a-octahydro-1,4 : 5,8-dimethanonaphthalene (endrin-ISO)

197. Hexachloroethane

198. (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4 : 5,8-dimethanonaphthalene (isodrin-ISO)

199. Hydrastine, 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. Ethyl bis(4-hydoxy-2-oxo-1-benzopyran-3-yl) acetate and salts of the acid

205. Methocarbamol*

206. Propatylnitrate*

207. 4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene) dicoumarin

208. Fenadiazole*

209. Nitroxoline* and its salts

210. Hyoscyamine, its salts and derivatives

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

212. Pemoline* and its salts

213. Iodine

214. Decamethylenebis (trimethylammonium salts), e.g. decamethonium bromide*

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

216. (2-Isopropylpent-4-enoyl)urea (apronalide)

217. >PIC FILE= "T9000998">

218. Lobelia inflata L. and its galenical preparations

219. Lobeline* and its salts

220. Barbiturates

221. Mercury and its compounds, excluding the exceptions listed in Annex IV and Annex V

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

235. Carisoprodol*

236. Meprobamate*

237. Tefazoline* and its salts

238. Arecoline

239. Poldine metilsulfate*

240. Hydroxyzine*

241. 2-Naphthol

242. 1-and 2-Naphthylamines and their salts

243. 3 (1-Naphtylmethyl)-2-imidazoline

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

259. Guanethidine* and its salts

260. Oestrogens, with the exception of those listed in Annex V

261. Oleandrin

262. Chlortalidone*

263. Pelletierine and its salts

264. Pentachloroethane

265. Pentaerithrityl tetranitrate*

266. Petrichloral*

267. Octamylamine* and its salts

268. Pheno and its alkali salts, excluding the exceptions listed in Annex III

269. Phenacemide*

270. Difencloxazine*

271. 2-Phenylindane-1,3-dione (phenindione)

272. Ethylphenacemide*

273. Phenprocoumon*

274. Fenyramidol*

275. Triamterene* and its salts

276. Tetraethylpyrophosphate ; 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. a-Piperidin-2-yl benzyl 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 compounds, with the exception of that mentioned in Annex V

290. Coniine

291. Prunus laurocerasus L. ("cherry laurel water")

292. Metyrapone*

293. Radioactive substances (1)

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

295. Hyoscine, its salts and derivatives

296. Gold salts

297. Selenium and its compounds

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. Sulphonamides (sulphanylamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts

308. Sultiame*

309. Neodymium and its salts (1)The presence of natural radioactive substances and of radioactive substances caused by artificial contamination from the environment is permitted, provided that the radioactive substances are not enriched for the manufacture of cosmetic products and that their concentration falls within the limits set in the Directive laying down the basic standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiations (OJ No 11, 20.2.1959, p. 221/59).

310. Thiotepa*

311. Pilocarpus jaborandi Holmes and its galenical preparations

312. Tellurium and its compounds

313. Xylometazoline and its salts

314. Tetrachloroethylene

315. Carbon tetrachloride

316. Hexaethyl tetraphosphate

317. Thallium and its compounds

318. Thevetia neriifolia Juss., glycoside extract

319. Ethionamide*

320. Phenothiazine* and its compounds

321. Thiourea and its derivatives, with the exception of those listed in Annex IV, 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. Trichlormethine* and its salts

328. Tretamine*

329. Gallamine triethiodide*

330. Urginea scilla Stern. and its galenical preparations

331. Veratrine, its salts and galenical preparations

332. Schoenocaulon officinale Lind. (seeds and galenical preparations)

333. Veratrum album L. (roots and galenical preparations)

334. Vinyl chloride monomer

335. Ergocalciferol* and cholecalciferol (vitamins D2 and D3)

336. Salts of O-alkyldithiocarbonic acids

337. Yohimbine and its salts

338. Dimethyl sulfoxide*

339. Diphenhydramine* and its salts

340. 4-tert-Butylphenol

341. 4-tert-Butylpyrocatechol

342. Dihydrotachysterol*

343. Dioxane

344. Morpholine and its salts

345. Pyrethrum album L. and its galenical preparations

346. 2-[4-Methoxybenzyl-N-(2-pyridyl)amino] ethyldimethylamine

347. Tripelennamine*

348. Tetrachlorosalicylanilides

349. Dichlorosalicylanilides

350. Tetrabromosalicylanilides

351. Dibromosalicylanilides, e.g. metabromsalan*, dibromsalan*

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. Furo [3,2-g] chromen-7-one and its alkyl-substituted derivatives (e.g. trioxysalan* and 8-methoxypsoralen), except for normal content in natural essences used

359. Oil from the seeds of Laurus nobilis L.

360. Sassafras officinale Nees oil containing safrole

361. 5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite

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PART 2

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PART 2

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PART 3

(A) LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR COSMETIC PRODUCTS WHICH DO NOT COME INTO CONTACT WITH THE MUCOUS MEMBRANES

Reds

12310, 12335, 12420, 12430, 12440, 16140, 16155, 16250, 17200, 18000, 18050, 18055, 18065, 26105, 45100, 50240, E121

Oranges and yellows

11680, 11710, 13065, 15575, 16230, 18690, 18736, 18745, 19120, 19130, 21230, 71105

>PIC FILE= "T9001000"> (B) LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR COSMETIC PRODUCTS WHICH COME INTO CONTACT ONLY BRIEFLY WITH THE SKIN

Reds

11210, 12090, 12155, 12170, 12315, 12370, 12459, 12460, 13020, 14895, 14905, 16045, 16180, 18125, 18130, 24790, 27300, 27306, 28160, 45220, 60505, 60710, 62015, 73300

Yellows and oranges

11720, 11725, 11730, 11765, 11850, 11855, 11860, 11870, 12055, 12140, 12700, 12740, 12770, 12790, 13900, 14600, 15970, 15975, 18820, 18900, 19555, 21090, 21096, 21100, 21108, 21110, 21115, 22910, 25135, 25220, 26090, 29020, 40215, 40640, 41000, 45376, 47035, 48040, 48055, 56205, 4-(3-chlorphenylazo)-3-hydroxy-2 naphth-0-anisidide, trisodium 3-hydroxypyren-5,8,10- trisulphonate

Blues and greens

10025, 26360, 42052, 42085, 42095, 42100, 50315, 50320, 50400, 50405, 51175, 52015, 52020, 52030, 61505, 61585, 62045, 62100, 62105, 62125, 62130, 62500, 62560, 63010, 64500, 74180

Violets, browns, blacks and whites

12145, 14805, 15685, 17580, 20285, 20470, 21010, 25410, 30045, 30235, 40625, 42510, 42520, 42525, 42535, 42650, 48013, 57020, 60730, 61100, 61105, 61705, 62030, 63165, 63615

ANNEX V LIST OF SUBSTANCES EXCLUDED FROM THE SCOPE OF THE DIRECTIVE

1. Lead acetate (for use in hair treatment products only).

2. Hexachlorophene* (for all uses other than that stated in Part 1 of Annex III).

3. Hormones (a) - oestrone,

- oestradiol and its esters,

- oestriol and its esters;

(b) - progesterone, - Ethisterone*.

4. p-Phenylenediamine and its salts.

5. Strontium and its salts, with the exception of those used in the colouring agents listed in Part 2 of Annex III and Parts 2 and 3 of Annex IV.

6. Zirconium and its derivatives.

7. Thiomersal* and phenylmercuric compounds (for use as preservatives in concentrated shampoos and creams containing non-ionic emulsifiers which render other preservatives ineffective ; maximum concentration 0.003 % calculated as Hg).

8. Lidocaine*.

9. Tyrothricin*.