IE
S.I. No. 87/1997 - European Communities (Cosmetic Products) Regulations, 1997.
Table of Provisions (390)
Statutory Text (390 Articles)
1. The registration number referred to in Article 14 (4) shall consist of seven digits, the first two corresponding to the year of approval of confidentiality, the second two to the code assigned to Ireland, as indicated to in paragraph 2 below, and the final three digits being assigned by the Minister.
2. The cosmetic products Directives fall within the scope of the EEA Agreement by virtue of Chapter XVI of Annex II to that Agreement.
3.
76/768/EEC
— Official Journal of the European Communities, No. L262, 27/9/76 (pages 169-200). (
First Council Directive)
.
4.
79/661/EEC
— Official Journal of the European Communities, No. L192, 31/7/79 (page 35). (
First Amending Council Directive).
5.
82/368/EEC
— Official Journal of the European Communities, No. L167, 15/6/82 (pages 1-32). (
Second Amending Council Directive)
.
6.
83/574/EEC
— Official Journal of the European Communities, No. L332, 28/11/83 (pages 38-42). (
Third Amending Council Directive)
.
7.
88/667/EEC
— Official Journal of the European Communities, No. L382, 31/12/88 (pages 46-48).
(Fourth Amending Council Directive)
.
8.
89/679/EEC
— Official Journal of the European Communities, No. L398, 30/12/89 (page 25). (
Fifth Amending Council Directive
).
9.
93/35/EEC
— Official Journal of the European Communities, No. L151, 23/6/93 (pages 32-37). (
Sixth Amending Council Directive
).
10.
82/47/EEC
— Official Journal of the European Communities, No. L63, 6/3/82 (page 26). (
First Commission Directive
).
11.
83/191/EEC
— Official Journal of the European Communities, No. L109, 26/4/83 (pages 25-27). (
Second Commission Directive
).
12.
83/341/EEC
— Official Journal of the European Communities, No. L188, 13/7/83 (page 15). (
Third Commission Directive
).
13.
83/496/EEC
— Official Journal of the European Communities, No. L275, 8/10/83 (pages 20-21). (
Fourth Commission Directive
).
14.
84/415/EEC
— Official Journal of the European Communities, No. L228, 25/8/84 (pages 31-33). (
Fifth Commission Directive
).
15.
85/391/EEC
— Official Journal of the European Communities, No. L224, 22/8/85 (pages 40-41). (
Sixth Commission Directive)
.
16.
86/]79/EEC
— Official Journal of the European Communities, No. L138, 24/5/86 (pages 40-48). (
Seventh Commission Directive
).
17.
86/199/EEC
— Official Journal of the European Communities, No. L149, 3/6/86 (pages 38-45). (
Eight Commission Directive
).
18.
87/137/EEC
— Official Journal of the European Communities, No. L56, 26/2/87 (pages 20-21). (
Ninth Commission Directive
).
19.
88/233/EEC
— Official Journal of the European Communities, No. L105, 26/4/88 (pages 11-14) and corrigendum published on 24/6/88 in No. L157 (page 38) (
Tenth Commission Directive
).
20.
89/174/EEC
— Official Journal of the European Communities, No. L64, 8/3/89 (pages 10-13) and corrigendum published on 13/7/89 in No. L199 (page 23) (
Eleventh Commission Directive
).
21.
90/121/EEC
— Official Journal of the European Communities, No. L71, 17/3/90 (pages 40-42). (
Twelfth Commission Directive
).
22.
91/184/EEC
— Official Journal of the European Communities, No. L91, 12/4/91 (pages 56-62). (
Thirteenth Commission Directive)
.
23.
92/8/EEC
— Official Journal of the European Communities, No. L70, 17/3/92 (pages 23-24). (
Fourteenth Commission Directive
).
24.
92/86/EEC
— Official Journal of the European Communities, No. L325, 11/11/92 (pages 18-22). (
Fifteenth Commission Directive
).
25.
93/47/EEC
— Official Journal of the European Communities, No. L203, 13/8/93 (pages 24-26). (
Sixteenth Commission Directive
).
26.
94/32/EC
— Official Journal of the European Communities, No. L181, 15/7/94 (pages 31-34). (
Seventeenth Commission Directive
).
27.
95/34/EEC
— Official Journal of the European Communities, No. L167, 18/7/95 (pages 19-21). (
Eighteenth Commission Directive
).
28.
96/41/EC
— Official Journal of the European Communities, No. L198, 8/8/96 (pages 36-39). (
Nineteenth Commission Directive
).
29.
97/1/EC
— Official Journal of the European Communities, No. L16, 18/1/97 (pages 85-86). (
Twentieth Commission Directive)
.
30.
9S/17/EEC —
Official Journal of the European Communities, No. L140, 23/6/95 (pages 26-29). (
Non-disclosure for reasons of trade secrecy
).
31.
87/18/EEC
— Official Journal of the European Communities, No. L15, 17/1/87 (pages 29-30). (
Principles of Good Laboratory Practice
).
32.
80/1335/EEC
— Official Journal of the European Communities, No. L383, 31/12/80 (pages 27-46). (
Methods of analysis
).
33.
82/434/EEC
— Official Journal of the European Communities, No. L185, 30/6/82 (pages 1-28), (
Methods of analysis)
.
34.
83/514/EEC
— Official Journal of the European Communities, No. L291, 24/10/83 (pages 9-46). (
Methods of analysis
).
35.
85/490/EEC
— Official Journal of the European Communities, No. L295, 7/11/85 (pages 30-45). (
Methods of analysis
).
36.
87/143/EEC
— Official Journal of the European Communities, No. L57, 27/2/87 (pages 56). (
Methods of analysis
).
37.
90/207/EEC
— Official Journal of the European Communities, No. L108, 28/4/90 (pages 92-101). (
Methods of analysis
).
38.
93/73/EEC
— Official Journal of the European Communities, No. L231, 14/9/93 (pages 34-53). (
Methods of analysis
).
39.
95/32/EC
— Official Journal of the European Communities, No. L178, 28/7/95 (pages 20-35). (
Methods of analysis
).
GIVEN under the Official Seal of the Minister for Health, this 20th day of February, 1997.
MICHAEL NOONAN,
Minister for Health.
EXPLANATORY NOTE.
The purpose of the Regulations is to up-date the law in relation to the manufacture, marketing and sale of cosmetic products and to consolidate in one set of Regulations the laws in relation to cosmetic products.
The effect of the Regulations is to prohibit the placing on the market of cosmetic products which, under normal conditions of use, are liable to cause damage to human health. The presence in cosmetic products of certain listed substances is either prohibited absolutely or permitted subject to certain restrictions. Positive lists of colouring agents, anti-microbial preservatives and ultraviolet sun-screen filters are established which, subject to compliance with any prescribed restrictions, are permitted to be used.
Certain requirements in regard to labelling are also laid down and the use of words, names, trade marks, images or other signs either in the labelling, presentation for sale or advertising of cosmetic products is prohibited, where such suggests a characteristic which the product in question does not possess.
With effect from 1st March, 1997, full ingredient labelling will be required for all cosmetic products placed on the market. Furthermore, any reference to testing on animals must clearly indicate whether or not such testing was carried out and if so whether it was carried out on the cosmetic product itself, on any of its ingredients or to both.
The use of ingredients tested on animals after 1st January, 1998 with a view to use in cosmetic products is prohibited. This date may, however, be extended depending on the progress in the development of satisfactory alternative methods of testing.
The Regulations also lay down the information which must be kept available to the control authorities by the manufacturers and initial EU importers of cosmetic products. This information must include all the necessary particulars relating to the composition, quality and safety of the products, including information on the claimed effects and undesirable effects. An assessment, prepared by an appropriate qualified person, on safety for human health, must also be available on each product.
3. The evaluation of the safety for human health of the cosmetic ingredient as used in the finished cosmetic product or products, taking into account the cosmetic ingredient's toxicological profile, chemical structure and the level of exposure as specified in Article 11 (1) (
d
) and carried out in accordance with the requirements of sub-article (2) and (3) of Article 11.
4. The envisaged use of the cosmetic ingredient and in particular the different categories of cosmetic products in which it will be used.
5. A detailed justification of why, by way of exception, confidentiality is sought addressing, for example
(
a
) the fact that the identity of the cosmetic ingredient, or its function in the cosmetic product to be marketed, has not been described in the literature and is unknown to other manufacturers or suppliers of cosmetic products;
(
b
) the fact that the information is not yet in the public domain even though a patent application has been lodged for the cosmetic ingredient or its use;
(
c
) the fact that if the information were known it would be easily reproducible, to the detriment of the applicant.
6. (
a
) If known, the name of each cosmetic product which is to contain the cosmetic ingredient and if different names are to be used in other Member States, precise details of each one of them;
(
b
) If the name of a cosmetic product is not yet known, it may be communicated at a later date, but at least 15 days before the cosmetic product is placed on the market;
(
c
) If the cosmetic ingredient is used in several products, one request shall suffice, provided that the cosmetic products are clearly indicated to the competent authority.
7. A statement setting out whether a request has been submitted to the competent authority of any other Member State in respect of the cosmetic ingredient for which confidentiality is sought and particulars on the outcome of any such request.
PART 2
Registration Number
8. Cinchophen (INN), its salts, derivatives and salts of these derivatives.
9. Thyropropic acid (INN) and its salts.
10. Trichloroacetic acid.
11.
Aconitum napellus
L.
(its leaves, roots and galenical preparations).
11. Information to be retained by manufacturers.
12. Aconitine (the principal alkaloid of
aconitum
napellus L.
) and its salts.
13.
Adonis vernalis L
. and its preparations.
13. Authorisations for the use of ingredients not otherwise permitted.
14. Epinephrine (INN).
15.
Rauwolfia serpentina
alkaloids and their salts.
15. Prohibition of sales to consumers.
16. Alkyne Alcohols, their esters, ethers and salts.
17. Isoprenaline (INN)
18. Allyl isothiocyanate.
19. Alloclaimide (INN) and its salts.
20. Nalorphine (INN), its salts and ethers.
21. Sympathomimetic amines acting on the central nervous system, the following—
Amfecloral
Amfepentorex
Amfepramone
Aminorex
Amphetamine
Benzphetamine
Chlorphentermine
Clominorex
Clorforex
Dexamphetamine
Dimephenopane
Diphemethoxine
Doxapram
Ethylamphetamine
Fenbutrazate
Fencamfamin
Fenethylline
Fenfluramine
Fenmetramide
Fluminorex
Levamphetamine
Meclofenoxate
Mephentermine
Metampfepramone
Metamphetamine
Methylphenidate
Ortetamine
Paramethylamphetamine
Pemoline
Pentorex
Phacetoperane
Phenatine
Phendimetrazine
Phenmetrazine
Phentermine
Pipradol
Prolintane
Trifluorex
Xylopropamine
22. Aniline, its salts and its halogenated and sulphonated derivatives.
23. Betoxycaine (INN) and its salts.
24. Zoxazolamine (INN).
25. Procainamide (INN), it salts and derivatives.
26. Benzidine.
27. Tuaminoheptane (INN), its isomers and salts.
28. Octodrine (INN) and its salts.
29. 2 Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts.
30. 1,3-Dimethylpentylamine and its salts.
31. 4-Aminosalicylic acid and its salts.
32. Toluidines, their isomers, salts and halogenated and sulphonated derivatives.
33. Xylidines, their isomers, salts and halogenated and sulphonated derivatives.
34. Imperatorin (9-(3-methlbut-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.
40. Antimony and its compounds.
41.
Apocynum cannabinum
L.
and its preparations.
42. Apomorphine (R5,6,6a,7 Tetrahydro-6-methyl-4H-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. Barium salts, with the exception of barium sulphate and barium sulphite under the conditions laid down in Schedule 3, Part 1, and the lakes, salts and pigments prepared from the colouring agents listed with the reference
(
3
)
in Schedule 4, Part I and in Schedule 4, Part 2.
47. Benzene.
48. Benzimidazo-2(3H)-one.
49. Benzazepines and benzodiazepines.
50. l-Dimethylaminomethyl-1-methylpropyl benzoate (Amylocaine) and its salts.
51. 2,2,6-Trimethyl-4-piperidyl benzoate (Benzamine) and its salts.
52. Isocarboxazid (INN).
53. Bendroflumethiazide (INN) and its derivatives.
54. Beryllium and its compounds.
55. Bromine, elemental.
56. Bretylium tosilate (INN).
57. Carbromal (INN).
58. Bromisoval (INN).
59. Brompheniramine (INN) and its salts.
60. Benzilonium bromide (INN).
61. Tetrylammonium bromide (INN).
62. Brucine.
63. Tetracaine (INN) and its salts.
64. Mofebutazone (INN).
65. Tolbutamide (INN).
66. Carbutamide (INN).
67. Phenylbutazone (INN).
68. Cadmium and its compounds.
69. Cantharides,
Cantharis vesicatoria.
70. (
IR,2S
)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (Cantharidin).
71. Phenprobamate (INN)
72. Nitroderivatives of carbazol.
73. Carbon disulphide.
74. Catalase.
75. Cephaeline and its salts.
76.
Chenopodium ambrosioides
(essential oil).
77. 2,2,2-Trichloroethane-l, 1-diol.
78. Chlorine.
79. Chlorpropamide (INN).
80. Diphenoxylate (INN) hydrochloride.
81. 4-Phenylazophenylene-1,3-diamine citrate hydrochloride (Chrysoidine citrate hydrochloride).
82. Chlorzoxazone (INN).
83. 2-Chloro-6-methylpyrimidin-4-yldimethylamine (Crimidine-ISO)
84. Chlorprothixene (INN) and its salts.
85. Clofenamide (INN).
86. N, N-Bis (2-chloroethyl) methylaimine N-oxide and its salts.
87. Chlormethine (INN) and it salts.
88. Cyclophosphamide (INN) and its salts.
89. Mannomustine (INN) and its salts.
90. Butanilicaine (INN) and its salts.
91. Chlormezanone (INN).
92. Triparanol (INN).
93. 2-[2(4-Chlorophenyl)-2-phenylacetyl]indane-1,3-dione (Chlorophacinone-ISO).
94. Chlorphenoxamine (INN).
95. 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
. its fruit, powder and galenical preparations).
100. Glycyclamide (INN),
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 cyanaide and its salts.
112. 2-α-Cyclohexylbenzyl(N, N, N',N'-tetraethyl)trimethylenediamine; (Phenetamine).
113. Cyclomenol (INN) and its salts.
114. Sodium hexacyclonate (INN).
115. Hexapropymate (INN).
116. Dextropropoxyphene (INN).
117. O,O'-Diacetyl-N-allyl-N-normorphine.
118. Pipazetate (INN) and its salts.
119. 5-(α β-Dibromo-phenethyl)-5-methylhydantoin.
120. N,N'-Pentamethylenebis(trimethylammonium salts), eg. Pentamethonium bromide (INN).
121. N,N'-[(Methylimino)diethylene]bis(ethyldimethyl-ammonium) salts, eg. Azamethonium bromide (INN).
122. Cyclarbamate (INN).
123. Clofenotane (INN); DDT (ISO).
124. N,N'-Hexamethylenebis(trimethylammonium salts), eg. Hexamethonium bromide (INN).
125. Dichloroethanes (Ethylene chlorides).
126. Dichloroethylenes (Acetylene chlorides).
127. Lysergide (INN) and its salts.
128. 2-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts.
129. Cinchocaine (INN) 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]; eg. Ambenomium chloride (INN).
133. Methyprylon (INN) 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 (INN) and its salts.
137. Piprocurarium (INN).
138. Propylphenazone (INN).
139. Tetrabenazine (INN) and its salts.
140. Captodiame (INN).
141. Mefeclorazine (INN) and its salts.
142. Dimethylamine.
143. 1,1-Bis(dimethylaminomethyl)propyl benzoate and its salts; (Amydricaine, Alypine).
144. Methapyrilene (INN) and its salts,
145. Metamfepramone (INN) and its salts.
146. Amitriptyline (INN) and its salts.
147. Metformin (INN) and its salts.
148. Isosorbide dinitrate (INN).
149. Malononitrile.
150. Succinonitrile.
151. Dinitrophenol isomers.
152. Inproquone (INN).
153. Dimevamide (INN) and its salts.
154. Diphenylpyraline (INN) and its salts.
155. Sulfinpyrazone (INN).
156. N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethylammonium salt: eg. Isopropamide iodide (INN).
157. Benactyzine (INN).
158. Benzatropine (INN) and its salts.
159. Cyclizine (INN) and its salts.
160. 5,5- Diphenyl-4-imidazolidone.
161. Probenecid (INN)
162. Disulfiram (INN); Thiram (ISO).
163. Emetine, its salts and derivatives.
164. Ephedrine and its salts.
165. Oxanamide (INN) 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 Schedule 7, Part 2.
168. Choline salts and their esters; eg. Choline chloride.
169. Caramiphen (INN) and its salts.
170. Diethyl 4-nitrophenyl phosphate.
171. Metethoheptazine (INN) and its salts.
172. Oxpheneridine (INN) and its salts.
173. Ethoheptazine (INN) and its salts.
174. Metheptazine (INN) and its salts.
175. Methylphenidate (INN) and its salts.
176. Doxylamine (INN) and its salts.
177. Tolboxane (INN).
178. Monobenzone (INN).
179. Parethoxycaine (INN) and its salts.
180. Fenozolone (INN).
181. Glutethimide (INN) and its salts.
182. Ethylene oxide.
183. Bemegride (INN) and its salts.
184. Valnoctamide (INN).
185. Haloperidol (INN).
186. Paramethasone (INN).
187. Fluanisone (INN).
188. Trifluperidol (INN).
189. Fluoresone (INN).
190. Fluorouracil (INN).
191. Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Schedule 3, Part 1.
192. Furfuryltrimethylammonium salts; eg. Furtrethonium iodide (INN)
193. Galantamine (INN).
194. Progestogens.
195. 1,2,3,4,5,6-Hexachlorocyclohexane; (BHC-ISO).
196. (IR,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-6, 7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4:5,8-dimethanonaphthalene; (Endrin-ISO).
197. Hexachloroethane.
198. (IR,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8dimethanonaphthalene; (Isodrin-ISO).
199. Hydrastine, hydrastinine and their salts.
200. Hydrazides and their salts.
201. Hydrazine, its derivatives and their salts.
202. Octamoxin (INN) and its salts.
203. Warfarin (INN) and its salts.
204. Ethyl bis(4-hydoxy-2-oxo-1-benzopyran-3-yl) acetate and salts of the acid.
205. Methocarbamol (INN).
206. Propatylnitrate (INN).
207. 4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene) dicoumarin.
208. Fenadiazole (INN).
209. Nitroxoline (INN) and its salts.
210. Hyoscyamine, its salts and derivatives.
211.
Hyoscyamus niger L.
(its leaves, seeds, powder and galenical preparations),
212. Pemoline (INN) and its salts.
213. Iodine.
214. Decamethylenebis(trimethylammonium salts), eg. Decamethonium bromide (INN).
215. Ipecacuanha (
Cephaelis ipecacuanha Brot.
and related species) (roots, powder and galenical preparations).
216. (2-Isopropylpent-4-enoyl)urea; (Apronalide).
217. α-Santonin; [(3S,5aR, 9bS]-3,3a,4,5,5a,9b-hexahydro-3,5a,9- trimethylnaphtol[1,2-b]furan-2,8-dione].
218.
Lobelia inflata
L.
and its galenical preparations.
219. Lobeline (INN) and its salts.
220. Barbiturates.
221. Mercury and its compounds, excluding those listed in Schedule 6, Part 1.
222. 3,4,-Trimethoxyphenethylamine and its salts.
223. Metaldehyde.
224. 2-(4-Allyl-2-methoxyphenoxy)-N,N-diethylacetamide and its salts.
225. Coumetarol (INN).
226. Dextromethorphan (INN) and its salts.
227. 2-Methylheptylamine and its salts.
228. Isometheptene (INN) and its salts.
229. Mecamylamine (INN).
230. Guaifenesin (INN).
231. Dicoumarol (INN).
232. Phenmetrazine (INN), its derivatives and salts.
233. Thiamazole (INN).
234. 3,4— Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano- [3,2-c]-[l]benzopyran-5-one; (Cyclocoumarol).
235. Carisoprodol (INN).
236. Meprobamate (INN).
237. Tefazoline (INN) and its salts.
238. Arecoline.
239. Poldine metilsulfate (INN).
240. Hydroxyzine (INN).
241. 2-Naphthol.
242. l-and 2-Naphthylamines and their salts.
243. 3(l-Naphtylmethyl)-4-hydroxycoumarin.
244. Naphazoline (INN) and its salts.
245. Neostigmine and its salts: (eg. Neostigmine bromide (INN)).
246. Nicotine and its salts.
247. Amyl nitrates.
248. Inorganic nitrites, with the exception of sodium nitrite.
249. Nitrobenzene.
250. Nitrocresols and their alkali metal salts.
251. Nitrofurantoin (INN).
252. Furazolidone (INN).
253. Propane-1,2,3-triyl trinitrate.
254. Acenocoumarol (INN).
255. Alkali pentacyanonitrosylferrate (2-).
256. Nitrostilbenes, their homologues and their derivatives.
257. Noradrenaline and its salts.
258. Noscapine (INN) and its salts.
259. Guanethidine (INN) and its salts.
260. Oestrogens.
261. Oleandrin.
262. Chlorthalidone (INN).
263. Pelletierine and its salts.
264. Pentachloroethane.
265. Pentaerithrityl tetranitrate (INN).
266. Petrichloral (INN).
267. Octamylamine (INN) and its salts.
268. Picric acid.
269. Phenacemide (INN).
270. Difencloxazine (INN).
271. 2-Phenylindane-1,3-dione; (Phenindione).
272. Ethylphenacemide (INN).
273. Phenprocoumon (INN).
274. Fenyramidol (INN).
275. Triamterene (INN) and its salts.
276. Tetraethylpyrophosphate; TEPP (ISO).
277. Tritolyl phosphate.
278. Psilocybine (INN).
279. Phosphorus and metal phosphides.
280. Thalidomide (INN) and its salts.
281.
Physostigma venenosum Balf
.
282. Picrotoxin.
283. Pilocarpine and its salts.
284. α-Piperidin-2-ylbenzyl acetate, laevorotatory
threo
form, (Levophacetoperane) and its salts.
285. Pipradrol (INN) and its salts.
286. Azacyclonol (INN) and its salts.
287. Bietamiverine (INN).
288. Butopiprine (INN) and its salts.
289. Lead and its compounds with the exception of lead acetate under the conditions laid down for that substance in Schedule 3, Part I (No. 55).
290. Coniine.
291.
Prunus laurocerasus L.
("Cherry laurel water").
292. Metyrapone (INN).
293. Radioactive substances (except substances which are radioactive naturally or by reason of contamination from the environment, which have not been enriched for manufacturing purposes, and in respect of which the concentration complies with Council Directive No. 76/579/Euratom
(a)
).
294.
Juniperus sabina L.
(its leaves, essential oil and galenical preparations).
295. Hyoscine, its salts and derivatives.
296. Gold salts.
297. Selenium and its compounds, with the exception of Selenium disulphide under the conditions for that substance in Schedule 3, Part 1 (No. 49).
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 -NH
2
; groups) and their salts.
308. Sultiame (INN).
309. Neodymium and its salts.
310. Thiotepa (INN).
311.
Pilocarpus jaborandi Holmes
and its galenical preparations.
312. Tellurium and its compounds.
313. Xylometazoline (INN) and its salts.
314. Tetrachloroethylene.
315. Carbon tetrachloride.
316. Hexaethyl tetraphosphate.
317. Thallium and its compounds.
318.
Thevetia neriifolia
Juss
. glycoside extract.
319. Ethionamide (INN).
320. Phenothiazine (INN) and its compounds.
321. Thiourea and its derivatives, with the exception of those listed in Schedule 3, Part 1.
322. Mephenesin (INN) and its esters.
323. Vaccines, toxins and serums listed in the Schedule to Council Directive 75/319/EEC (O.J. No. L147, 9.6.1975. p.13).
324. Tranylcypromine (INN) and its salts.
325. Trichloronitromethane (Chloropicrine).
326. 2,2,2-Tribromoethanol (Tribromoethyl alcohol).
327. Trichlormethine (INN) and its salts.
328. Tretamine (INN).
329. Gallamine triethiodide (INN).
330.
Urginea scilla Stern.
and its galenical preparations.
331. Veratrine, its salts and galenical preparations.
332.
Schoenocaulon officinale Lind.
(its seeds and galenical preparations).
333.
Veratrum species
and their preparations.
334. Vinyl chloride monomer.
335. Ergocalciferol (INN) and Cholecalciferol (Vitamins D2 and D3).
336. O-Alkyldithiocarbonic acids, salts of.
337. Yohimbine and its salts.
338. Dimethyl sulfoxide (INN).
339. Diphenhydramine (INN) and its salts.
340. 4-
tert
-Butylphenol.
341. 4-
tert
-Butylpyrocatechol.
342. Dihydrotachysterol (INN).
343. Dioxane.
344. Morpholine and its salts.
345.
Pyrethrum album L.
and its galenical preparations.
346. 2-[4-Methoxybenzyl-N-(2-pyridyl)amino]ethyldimethylamine maleate.
347. Tripelennamine (INN).
348. Tetrachlorosalicylanilides.
349. Dichlorosalicylanilides.
350. Tetrabromosalicylanilides.
351. Dibromosalicylanilides (eg. Metabromsalan (INN), and Dibromsalan (INN)).
352. Bithionol (INN).
353. Thiuram monosulphides.
354. Thiuram disulphides.
355. Dimethylformamide.
356. 4-Phenylbut-3-en-2-one.
357. Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol except for normal content in natural essences used.
358. Furocoumarines (eg. Trioxysalan (INN), 8-Methoxypsoralen and 5-Methoxypsoralen) except for the normal content found in natural essences. In sun protection and bronzing products, the furocoumarines content shall be below 1 mg/kg.
359. Oil from the seed of
Laurus nobilis L.
360. Safrole except for normal content in the natural essences used and provided the concentration does not exceed
— 100ppm in the finished product;
— 50ppm 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 (INN).
362. 3'-Ethyl-5',6',7',8'-tetrahydro-5',6',8',8'-tetramethyl-2'-acetonaphthalene; (Acetylethyltetramethyltetralin, AETT),
363.
o
-Phenylenediamine and its salts.
364. 4-Methyl-
m
-phenylenediamine and its salts.
365. Aristolochic acid and its salts.
366. Chloroform.
367. 2,3,7,8-Tetrachlorodibenzo-
p
-dioxin.
368. 2,6-Dimethyl-1,3-dioxan-4-yl acetate; (Dimethicone).
369. Pyrithione sodium (INN).
370. N-(Trichloromethylthio)-4-cyclohexene-1,2-dicarboximide; (Captan).
371. 2,2'-Dihydroxy-3,3',5,5',6,6'-hexachlorodiphenylmethane; (Hexachlorophene).
372. 6-(Piperidinyl)-2,4-pyrimidinediamine-3-oxide (Minoxidil), its salts and derivatives.
373. 3,4',5-Tribromosalicylanilide; (Tribromsalan).
374.
Phytolacca species
, and their preparations.
375. Tretinoin (INN); (Retinoic acid and its salts).
376. l-Methoxy-2,4-diaminobenzene (2,4-Diaminoanisole – CI 76050) and its salts.
377. l-Methoxy-2,5-diaminobenzene (2,5-Diaminoanisole) and its salts.
378. Colouring agent CI 12140.
379. Colouring agent CI 26105.
380. Colouring agents CI 42555, CI 42555-1 and CI 42555-2.
381. Amyl-4-dimethylaminobenzoate, mixed isomers; (Padamate-A (INN)).
382. Benzoyl peroxide.
383. 2-Amino-4-nitrophenol.
384. 2-Amino-5-nitrophenol,
385. 11-
apha
-Hydroxypregn-4-ene-3,20-dione and its esters.
386. Colouring agent CI 42640.
387. Colouring agent CI 13065.
388. Colouring agent CI 42535.
389. Colouring agent CI 61554.
390. Antiandrogens with a steroid structure.
391. Zirconium and its compounds, with the exception of those zirconium complexes specified in Schedule 3, Part 1 (No. 50), and of those zirconium lakes, salts and pigments of colouring agents identified with the reference (3) in Schedule 4, Part 1.
392. Thyrothricine.
393. Acetonitrile.
394. Tetrahydrozoline and its salts.
395. Hydroxy-8-quinoline and its sulphate salt, except for the uses provided for under entry No. 51 in Schedule 3, Part 1.
396. Dithio-2,2'-bispyridinedioxide 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. 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, Secondary dialkanolamines.
412. 4-Amino-2-nitrophenol.
413. 2-Methyl-
m
-phenylenediamine.
414. 4-
tert
-Butyl-3-methoxy-2,6-dinitrotoluene; (Musk Ambrette).
415. Diisobutylphenoxyethoxyethyldimethylbenzylammonium chloride; (Benzethonium chloride).
416. Cells, tissues and products of human origin.
417. 3,3- Bis(4-hydroxyphenyl)phtalide; (Phenolphthalein (INN)).
418. 3-Imidazol-4-ylacrylic acid and its ethyl ester; (Urocanic acid).
419, Bovine, ovine and caprine tissues and fluids from the encephalon, the spinol chord and the eyes, and ingredients derived therefrom.
Notes:(
a
) Official Journal of the European Communities, No. L187, 12/7/76, pl.
(
b
) The designation (INN) indicates that the name is the International Nonproprietary Name for the substance concerned as published by the World Health Organisation for pharmaceutical substances.
SCHEDULE 3
PART I
List of Substances which Cosmetic Products must not Contain Except Subject to the Restrictions and Conditions Laid Down
Reference Number
Substance
Restictions
Conditions of use and warnings which must be printed on the label
Field of Application and or use
Maximum authorised concentration in the finished cosmetic product
Other limitations and requirements
a
b
c
d
e
f
1
Boric acid
(a) Talcum powder
(b) Products for oral hygiene
(c) Other products
(a) 5%
(b) 0.5%
(c) 3%
(a) Not to be used in productions for children under three years of age
(a) Not to be used for children under three year of age
2
Thioglycollic acid and its salts
(a) Hair waving or straightening products for
(i) general use
(ii) professional use
(b) Depilatories
(c) Other hair care products which are removed after application
(i) 8% ready for use pH 7-9.5
(ii) 11% ready for use pH 7-9.5
(b) 9.5% ready for use pH 7-12.7
(c) 2% ready for use pH 7-9.5
(percentages calculated as thioglycollc acid).
(a) (b) and (c)
- 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) (i)
- Contains thioglycolate.
- Follow the instructions.
- Keep out of reach of children.
(a) (ii)
- 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.
2b
Thioglycollic acid esters
(a) Hair waving or straightening products for—
(i) general use
(ii) professional use
(i)-8% ready for use pH
6-9.5
(ii)-11% ready for use pH 6-9.5
(percentages calculated as thioglycollic acid).
(a) (i) and (ii)
The directions for use must incorporate the following:—
- May cause sensitization in the event of skin contact.
- Avoid contact with eyes.
- In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice.
- Wear suitable gloves.
(a) (i)
- Contains thioglycolate.
- Follow the instructions.
- Keep out of reach of children.
(a) (ii)
- Contains thioglycolate.
- Follow the instructions.
- Keep out of reach of children.
- For professional use only.
3
Oxalic acid, its esters and alkaline salts
Hair care products
5%
For professional use only.
4
Ammonia
6% calculated as NH
3
Contains ammonia (not required when concentration is not more than 2%)
5
Tosylchloramide sodium (INN)
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%)
Purity of dichloromethane must be not less than 98%
8
m and p-Phenylenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-phenylenediamines (See Note (a) at end this Part of Schedule)
Oxidizing colouring agents for hair dyeing—
(a) general use
(b) professional use
6% calculated as free base
(a)- Contains phenylenediamines.
- Can cause an allergic reaction.
- Do not use to dye eyelashes or eyebrows.
(b)- Contains phenylenediamines.
- For professional use only.
- Can cause an allergic reaction.
- Wear suitable gloves.
9
Methylphenylenediamines (other than 4-methyl-m-phenylenediamine and its salts), their N-substituted derivatives and their salts (see Note (a) at end of this Part of Schedule)
Oxidizing colouring agents for hair dyeing for—
(a) general use
(b) professional use
10% calculated as free base
(a)- Contains phenylenediamines.
- Can cause an allergic reaction.
- Do not use to dye eyelashes or eyebrows.
(b)- Contains phenylenediamines.
- For professional use only.
- Can cause an allergic reaction.
- Wear suitable gloves.
10
Diaminophenols (See Note (a) at end this Part of Schedule)
Oxidizing colouring agents for hair dyeing for—
(a) general use
(b) professional use
10% calculated as free base
(a)- Contains diaminophenols.
- Can cause an allergic reaction.
- Do not use to dye eyelashes or eyebrows.
(b)- Contains diaminophenols.
- For professional use only 3.
- Can cause an allergic reaction.
- Wear suitable gloves.
11
Dichlorophen (INN)
0.5%
Contains dichlorophen
12
Hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide
(a) Hair-care preparations
(b) Skin-care preparations
(c) Nail hardening preparations
(d) Oral hygiene products
(a) 12% H
2
O
2
(40 volumes) present or released;
(b) 4% of H
2
O
2
; present or released;
(c) 2% of H
2
O
2
; present or released;
(d) 0.1% of H
2
O
2
; present or released;
(a) (b) and (c)
- Contains hydrogen peroxide
- Avoid contact with eyes.
- Rinse eyes immediately if product comes into contact with them.
(a) Wear suitable gloves.
13
Formaldehyde
Nail hardeners
5% calculated as formaldehyde
- Contains formaldehyde.
- Protect cuticles with grease or oil.
(Not required when concentration is not more than 0.05%)
14
Hydroquinone (See Note (b) at end this Part of Schedule)
(a) Oxidizing colouring agents for hair dyeing for—
(i) general use
(ii) professional use
(a) 2%
(a) (i)—
- Do not use to dye eyelashes or eyebrows.
- Rinse the eyes immediately if product comes into contact with them.
- Contains hydroquinone
(a) (ii)—
- For professional use only.
Contains hydroquinone
Rinse the eyes immediately if product comes into contact with them.
(b) Agents for localized skin lightener
(b) 2%
(b) Contains hydroquinone
- Avoid contact with the eyes
- Apply to small areas
- If irritation develops discontinue use
- Do not use on children under the age of 12
15a
Potassium or sodium hydroxide
(a) Nail cuticle solvent
(b) Hair straightener for
(i) general use
(ii) professional use
(c) pH adjuster for dipilatories
(d) Other uses as pH adjuster
(a) 5% by weight (See Note (c) at end this Part of Schedule)
(b)
(i) 2% by weight (See Note (c) at end this Part of Schedule)
(ii) 4.5% by weight (See Note (c) at end this Part of Schedule)
(c) pH not to exceed 12.7
(d) pH not to exceed 11.0
(a) contains alkali.
Avoid contact with eyes. Can cause blindness. Keep out of reach of children
(b)
(i) contains alkali. Avoid contact with eyes. Can cause blindness.
Keep out of reach of children
(ii) For professional use only. Avoid contact with eyes. Can cause blindness.
(c) Keep out of reach of children. Avoid contact with eyes
15b
Lithium hydroxide
(a) Hair straightener for—
(i) general use
(ii) professional use
(b) other uses
(i) 2% by weight of sodium hydroxide (See Note (c) at end this Part of Schedule)
(ii) 4.5% by weight of sodium hydroxide (See Note (c) at end this Part of Schedule)
(i) contains alkali. Avoid contact with eyes. Can cause blindness.
Keep out of reach of children
(ii) For professional use only. Avoid contact with eyes. Can cause blindness.
15c
Calcium hydroxide
(a) Hair straighteners containing two components: calcium hydroxide and a guanidine salt
(b) Other uses
7% by weight of calcium hydroxide
Contains alkali. Avoid contact with eyes. Can cause blindness. Keep out of reach of children
16
Alpha-naphthol
Colouring agent for hair dyeing
0.5%
Contains Alpha-nphthol
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
20
Entry deleted
21
Quinine and its salts
(a) Shampoos
(b) Hair lotions
(a) 0.5% calculated as quinine base
(b) 0.2% calculated as quinine base
22
Resorcinol (See Note (b) at end this Part of Schedule)
(a) Oxidizing colouring agent for hair dyeing for—
(i) general use
(ii) professional use
(b) Hair lotions and shampoos
(a) 5%
(b) 0.5%
(a) (i)
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.
(a) (ii)
Contains resorcinol. For professional use only. Rinse eyes immediately if product comes into contact with them.
(b) Contain resorcinol
23
(a) Alkali sulphides
(a) Depilatories
(a) 2% calculated as sulphur
pH not to exceed 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 not to exceed 12.7.
(b) Keep out of reach of children.
Avoid contact with eyes.
24
Water-soluble zinc salts with the exception of zinc
4-hydroxybenzenesulphonate and zinc pyrithione
1% calculated as zinc
25
Zinc 4—hydroxybenzenesulphonate
Deodorants, anti-perspirants and astringent lotions
6% calculated as % of anhydrous substance
Avoid contact with eyes
26
Ammonium monofluorophosphate
Oral hygiene products
0.15% calculated as F. When mixed with other fluorine compounds specified in this Schedule, the total F concentration must not exceed 0.15%
Contains ammonium monofluorophosphate
27
Sodium monofluorophosphate
Oral hygiene products
As for ammonium monofluorophosphate
Contains sodium monofluorophosphate
28
Potassium monofluorophosphate
Oral hygiene products
As for ammonium monofluorophosphate
Contains potassium monofluorophosphate
29
Calcium monofluorophosphate
Oral hygiene products
As for ammonium monofluorophosphate
Contains calcium monofluorophosphate
30
Calcium fluoride
Oral hygiene products
As for ammonium monofluorophosphate
Contains calcium fluoride
31
Sodium fluoride
Oral hygiene products
As for ammonium monofluorophosphate
Contains sodium fluoride
32
Potassium fluoride
Oral hygiene products
As for ammonium monofluorophosphate
Contains potassium fluoride
33
Ammonium fluoride
Oral hygiene products
As for ammonium monofluorophosphate
Contains ammonium fluoride
34
Aluminium fluoride
Oral hygiene products
As for ammonium monofluorophosphate
Contains aluminium fluoride
35
Stannous fluoride
Oral hygiene products
As for ammonium monofluorophosphate
Contains stannous fluoride
36
Hexadecylammonium fluoride
Oral hygiene products
As for ammonium monofluorophosphate
Contains hexadecylammonium fluoride
37
3-(n-Hexadecyl-N-2-
hydroxyethylammonio) propylbis(2-hydroxyethyl) ammonium difluoride
Oral hygiene products
As for ammonium monofluorophosphate
Contains 3-(n-Hexadecyl-N-2- hydroxyethylammonio) propylbis(2-hydroxyethyl) ammonium difluoride
38
N,N'N'-Tris(polyoxyethylene)-
n-hexadecylpropylenediamine dihydrofluoride
Oral hygiene products
As for ammonium monofluorophosphate
Contains N,N'N'tris(polyosyethylene
n-hexadecylpropylenediamine dihydrofluoride
39
Octadecenylammonium fluoride
Oral hygiene products
As for ammonium monofluorophosphate
Contains octadecenylammonium fluoride
40
Sodium fluorosilicate
Oral hygiene products
As for ammonium monofluorophosphate
Contains sodium fluorosilicate
41
Potassium fluorosilicate
Oral hygiene products
As for ammonium monofluorophosphate
Contains potassium fluorosilicate
42
Ammonium fluorosilicate
Oral hygiene products
As for ammonium monofluorophosphate
Contains ammonium fluorosilicate
43
Magnesium fluorosilicate
Oral hygiene products
As for ammonium monofluorophosphate
Contains magnesium fluorosilicate
44
1,3 Bis (hydroxymethy)-
imidazolidine-2-thione
(a) Hair care preparations
(b) Nail care preparations
(a) 2%
(b) 2%
(a) Not to be used in aerosol dispensers (sprays)
(b) The pH of the product as applied must be less than 4
(a) Contains
1,3-bis(hydroxymethyl)
imidazolidine-2-thione
(b) Contains
1,3-bis(hydroxymethyl) imidazolidine-2-thione
45
Benzyl alcohol
Solvent, perfumes and flavourings
46
6-Methylcoumarin
Oral hygiene products
0.003%
47
Nicomethanol hydrofluoride
Oral hygiene products
As for ammonium monofluorophosphate
Contains nicomethanol hydrofluoride
48
Silver nitrate
Products intended for colouring eyelashes and eyebrows
4%
- Contains silver nitrate
- Rinse the eyes immediately if product comes into contact with them
49
Selenium disulphide
Anti-dandruff shampoos
1%
- Contains selenium disulphide
- Avoid contact with eyes or damaged skin
50
Aluminium zirconium chloride hydroxide complexes A1
x
Zr(OH)
y
Clz and the aluminium zirconium chloride hydroxide glycine complexes
Anti-perspirants
20% as anhydrous aluminium zirconium chloride hydroxide;
5.4% as zirconium