IS 4707 (Part 2) : 2017 CJOn~ Jill Xlj91CfJ Indian Standard Cfii1fAl 3ltt fi1~4 ~ fllq~l fI~llICfi filqm CfiT q~ffCfi~ al "* ~ 2 ~ ~ ~ fen >rm~ ~ "3"1:f~ ~ t aQ'8)CK\ ~ (r1r~ Tffr~) Classification of Cosmetic Raw Materials and Adjuncts Part 2 List of Raw Materials Generally not Recognized as Safe for Use in Cosmetics (Fourth Revision) ICS 71.100.70 © BIS 2017 ~~~ BUREAU OF INDIAN STANDARDS lWf) l1RCf) 'qCR) 9 &I~IS)<~IIQ ~ ~ ~-110002 ~ __i iiii!IiiIiI""" MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG NEW DELHI-110002 . www.bis.org.in www.standardsbis.in March 2017 Price f1730 Cosmetics Sectional Committee, PCD 19 FOREWORD This Indian Standard (Part 2) (Fourth Revision) was adopted by the Bureau of Indian Standards, after the draft finalized by the Cosmetics Sectional Committee had been approved by the Petroleum, Coal and Related Products Division Council. . With the objective of taking effective step in guarding against harmful substances being used in .cosmetics, the Cosmetics Sectional Committee had decided to prepare broad-based classification of raw materials as (a) 'Generally Recognized as Safe' (GRAS) and (b) 'Generally Not Recognized as Safe' (GNRAS). In view of the large no. of raw materials which were likely to be used for different intended purposes in cosmetics fOnTIuJations, such as colourants, preservatives, U.v. filters, basic ingredients, adjuncts etc, it was more convenient and practical to prepare GRAS list for 'colourants' and GNRAS list for other raw materials and adjuncts to serve the intended purpose of safeguarding the interest of the consumer and simultaneously leaving enough scope for innovations in formulations. Towards this purpose, this standard (Part 2) was originally published in 1973 for GNRAS list of raw materials and adjuncts other than Dyes, Colour and Pigments and Part 1 was published in 1968 for GRAS list for Dyes, Colour and Pigments (sInce retitled as colourants). This standard (Part 2) was first revised in 1993 to update the list to align with the provisions of EEC Directive 761768/EEC-June 1991 and to include the lists of (a) substances which the cosmetic products shall not contain, except subject to conditions and restrictions laid down, (b) allowed preservatives, and (c) U.v. filters for use in cosmetics. Substances, which were provisionally allowed by EEC Directive, were also included in the first revision. Second revision of this standard was done in 2001 to update the list, aligning it with the provisions of EEC Directive 761768/EEC-200 1. Further, the raw materials listed in Annex A (substances which are generally not recognized as safe for use in cosmetics) and Annex B (the list of substances which cosmetic produ,cts must not contain except subject to restrictions and conditions laid down) were arranged in alphabetical order for easy referencing. The third revision of the standard was carried out in 2009 to further update the list, aligning it with the revised EEC Directive 761768/EEC-2007 with marginal differences in certain parameters as per the restrictions given in The Drugs and Cosfnetics Act and Rules1945 (such as permissible limits offluoride in dentifrice and m , p-phenylene diamines for use in hair dyes). Substances provisionally allowed by EEC Directive were not included in this revision. This standard (fourth revision) has been done to further align the standard with the EEC Directive 761768/EEC- 2012. Substances provisionally allowed by EEC Directive continue to be excluded from the Standard. It is not the intent of this standard to prescribe any specific composition of finished cosmetic products. The manufacturers are encouraged to develop any composition through innovations and keeping pace with the technological advancements, provided that the provisions of this standard are complied with. At present, there is no International Standard published by International Organization for Standardization (ISO) on the subject. It is acknowledged that though the title of this standard continues to be retained as same as it was published for the first time, that is, 'list of raw materials general\y not recognized as safe for use in cosmetics', it now provides four separate lists of raw materials and adjuncts, two of which are of ingredients which are actually permitted but with restrictions related to their qualtity or intended purpose of use. It is desirable to make separate standards for each category ofthe lists with their corresponding titles rather than the existing standard. This is expected to be undertaken in due course. IS 4707 (Part 2) : 2017 Indian Standard CLASSIFICATION OF COSMETIC RAW MATERIALS AND ADJUNCTS PART 2 liST OF RAW MATERIALS GENERALLY NOT RECOGNIZED AS SAFE FOR USE IN COSMETICS (Fourth Revision) I SCOPE 2.3 Preservatives Ingredent which prevents or retards microbial growth and thus protects cosmetic This standard (Part 2) lists cosmetics raw materials and products from spoilage. adjuncts in the following four classifications: 2.4 U.V. Filters '- Substances used in cosmetic a) List of ingredients termed as 'GNRAS' which products, which are specifically intended to tilter certain must not form part of the composition of U. V. rays in order to protect the skin from certain cosmetic products, harmful effects of these rays. b) List of ingredients which cosmetics products must not contain except subject to the NOTE - An ingredient classified as 'GNRAS' may be present as an impurity when its concentration is less than what can be restrictions and conditions laid down, detected by standard analytical method. It shall not, however, c) List of preservatives allowed with restrictions, be used as a component of a preparation. and 3 GNRASLISTS FOR RAW MATERIALS AND d) List of U. V. filters allowed with restrictions. ADJUNCTS 2 TERMINOLOGY The raw materials and adjuncts prescribed in this standard have been classified as follows: For the purpose of this standard, the following definitions shall apply. a) Annex A - Ingredients which must not form part ofthe composition of cosmetic products. 2.1 GRAS List - Ingredients which are generally recognized as safe and which when used in the b) Annex B Ingredients which cosmetic concentration conventionally adopted shall be products must not contain except subject to penllissible in cosmetics. restrictions and conditions laid down. c) Annex C Preservatives (with restrictions) 2.2 GNRAS List Ingredients which are generally which cosmetic products may contain. not recognized as safe and which shall not be permissible either in any amount whatsoever or in d) Annex D U.V. filters which cosmetic products (with restrictions) may contajn. amounts exceeding those specifically laid down for cosmetics. IS 4707 (Part 2) : 2017 ANNEXA (Clauses 1, 2 and 3.1) LIST OF SUBSTANCES WHICH MUST NOT FORM PART OFTHE COMPOSITION OF COSM.ETIC PRODUCTS [Names followed by an asterisk (*) are international non-proprietary names (INN) for pharmaceutical products] 1. N-5-Chlorobenzoxazol-2-ylacetamide 2. 2-Acetoxyethyltrimethylammonium 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 mixtures) 12. Aconitine (principal alkaloid of Aconitum napellus L.) and its salts 13. Adonis vernalis L. and its mixtures 14. Epinephrine (*) 15. Rauwo(fia serpentina alkaloids and their salts 16. Alkyne alcohols, their esters, ethers and salts 17. Isoprenaline (*) 18. Allyl isothiocyanate 19. AllocJamide (*) 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 resolutionAP (69) 2 ofthe Council of Europe 22. Aniline, its salts and its halogenated and sulphonated derivatives 23. Betoxycaine (*) and its salts 24. Zoxazolamine (*) 25. Procainamide (*), its salts and derivatives 26. Benzidine 27. Tuaminoheptane (*), its isomers and salts 28. Octodrine (*) and its salts 29. 2-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts 30. 1, 3-dimethylpentylamine and its salts 31. 4-Aminosalicylic acid and its salts 32. Toluidines, their isomers, salts and halogenated and sulphonated derivatives 33. Xylidines, their isomers, salts and halogenated and sulphonated derivatives 34. Imperatorin (9-(3-methoxylbut-2-enyloxy)furo[3,2-g]chromen-7-one 35. Ammi majus and its galenical mixtures 36. 2,3-Dichloro-2-methylbutane 37. Substances with androgenic effect 38. Anthracene oil 39. Antibiotics 40. Antimony and its compounds 2 IS 4707 (Part 2) : 2017 41. Apocynum cannabinum L. and its mixtures 42. Apomorphine (R 5,6,6a, 7-tetrahydro-6-methyl-4H-dibenzo [de,g] quinoline-10, II-diol) and its salts 43. Arsenic and its compounds 44. Atropa belladonna L. and its mixtures 45. Atropine, its salts and derivatives 46. Barium salts, with the exception of barium sulphate, barium sulphide under the conditions laid down in Annex B, and lakes, salts and pigments prepared from the colouring agents listed in IS 4707 (Part I). 47. Benzene 48. Benzimidazol-2(3H)-one 49. Benzazepines and benzodiazepines 50. I-Dimethylaminomethyl-l-methylpropyl benzoate (amylocaine) and its salts 51. 2,2,6· Trimethyl-4-piperidyl benzoate (benzamine) and its salts 52. Isocarboxazid (*) 53. Bendrotlumethiazide(*) and its derivatives 54. Beryllium and its compounds 55. Bromine, elemental 56. Bretylium tosilate (*) 57. Carbromal (*) 58. Brom isoval (*) 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 vesicatm'ia 70. (IR,2S)-Hexahydro-l,2-dimethyl-3,6-epoxyphthalic anhydride (cantharidin) 71. Phenprobamate 72. Nitroderivatives of carbazole 73. Carbon disulphide 74. Catalase 75. Cephaeline and its salts 76. Chenopodium ambrosioides (essential oil) 77. 2,2,2-Trichloroethane-l, l-diol 78. Chlorine 79. Chlorpropamide (*) 80. Diphenoxylate (*) hydrochloride 81. 4-Phenylazophenylene-l,3-diamine citrate hydrochloride (chrysoidine citrate hydrochloride) 82. Chlorzoxazone (*) 83. 2-Ch loro-6-methylpyrimidin-4-yldimethy lam ine (crim id ine-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 3 IS 4707 (Part 2) : 2017 88. Cyclophosphamide (*) and its salts 89. Mannomustine (*) and its salts 90. Butanilicaine (*) and its salts 91. Chlormezanone (*) 92. Triparanol (*) 93. 2-[2( 4-Chlorophenyl)-2-phenyJacetyl] indane-l ,3-dione (chlorophacinone-ISO) 94. Chlorphenoxamine (*) 95. 2-[2-(4-Ch lorophenyl)-2-phenylacetylJindan 1, 3-dione (chlorophacinone-ISO) 96. Chloroethane 97. Chromium; chromic acid and its salts 98. Claviceps purpurea Tul., its alkaloids and galenical mixtures 99. Conium maclIlalum L. (fruit, powder, galenical mixtures 100. Glycyc1amide (*) 101. Cobalt benzenesulphonate 102. Colchicine, its salts and derivatives 103. Coleh icos ide and its derivatives 104. Golchicum autl/mnale L. and its galenical mixtures 105. Convallatoxin 106. Anamirta cocculus L. (fruit) 107. Croton tiglium (oil) 108. I-Butyl-3-(N-crotonoylsulphanilyl)urea 109. Curare and curarine 110. Synthetic curarizants 1 J 1. Hydrogen cyanide and its salts 112. 2-a-Cyclohexylbenzyl(N,IV,N', N " -tetraethyl)trimethylenediamine (phenetamine) 113. Cyclomenol (*) and its salts 114. Sodium hexacyclonate (*) 115. Hexapropymate (*) 116. Dextropropoxyphene (*) ] 17. O,Q'-Diacetyl-N-allyl-N-normorphine 1 t 8. Pipazetate (*) and its salts 119. 5-(aa-Dibromophenethyl)-5-methylhydantoin 120. N,N'-Pentamethylenebis (trimethylammonium salts), e.g. pentamethonium bromide (*) 121. N,N'-[(Methylimino )diethylene]bis(ethyldimethylammonium) salts,e.g. azamethonium bromide (*) 122. Cyclarbamate (*) 123. Clofenotane (*): DDT (ISO) 124. N,N'-Hexamethylenebis(trimethylammonium) salts, e~g. hexamethonium bromide (*) 1.25. 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. 0,0 '-Diethyl 0-4-nitrophenyl phosphorothioate (parathion-ISO) 132. [Oxalylbisiminoethylene)]bis[(o-chlorobenzyl)diethylammonium salts], e.g. ambenomium chloride (*) 133. Methyprylon (*) and its salts 134. Digitaline and all heterosides of Digitalis purpurea 1. 135. 7-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophyl1ine (xanthino1) 4 IS 4707 (Part 2) : 2017 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, l-Bis(dimethyJaminomethyJ)propyl benzoate (amydi'icaine, alypine) and its salts 144. Methapyrilene (*) and its salts 145. Metamfepramone(*) and its salts 146. Amitriptyline (*) and its salts 147. Metformin (*) and its salts 148. lsosorbide dinitrate (*) 149. Malononitrile 150. Succinonitrile 151. Dinitrophenol isomers 152. Inproquone (*) ] 53. Dimevamide (*) and its salts 154. Diphenylpyraline (*) and its salts 155. Sulfinpyrazone (*) 156. N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethyl-ammonium salts, e.g. isopropamide iodide (*) 157. Benactyzine(*) 158. Benzatropine (*) and its salts 159. Cyclizine (*) and its salts 160. 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 physostigm ine and its salts 167. 4-aminobenzoic acid and its esters, with the free amino group 168. Choline salts and their esters, e.g. choline chloride 169. Caramiphen (*) and its salts 170. Diethyl4-nitrophenyl phosphate 171. .Metethoheptazine (*) and its salts 172. Oxpheneridine (*) and its salts 173. Ethoheptazine (*) and, its salts 174. Metheptazine (*) and its salts 175. Methylphenidate (*) and its salts 176. Doxylamine (*) and its salts 177. Tolboxane (*) 178. 4-Benzyloxyphenol and 4-ethoxyphenol 179. Parethoxycaine (*) and its salts 180. Fenozolone (*) 181. Glutethimide (*) and its salts 182. Ethylene oxide 5 IS 4707 (Part 2) : 2017 183. Bemegride (*) and its salts 184. Valnoctamide (*) 185. Haloper.idol (*) 186. Paramethasone (*) 187. Fluanisone (*) 188. Trit1uperidol (*) 189. Fluoresone 190, Fluorouracil (*) 191. Hydrofluoric acid, its normal salts, its complexes and hydrofluor.ides with the exception of those listed elsewhere in this standard 192. Furfuryltrimethylammonium salts, e.g. furtrethonium iodide (*) 193. Galantamine (*) 194. Progestogens 195. 1, 2,3,4,5,6-Hexachlorocyclohexane (BHe-fSO) 196. (I R,4S,5R,8S)-1 ,2,3,4, 10 , I 0-Hexachloro-6, 7-epoxy-I,4,4a,5,6, 7 ,8,8a-octahydro- 1,4:5,8-dimethano naphthalene (endrin-ISO) 197. Hexachloroethane 198. (l R,4S,5 R,8S)-l ,2,3,4, 10,1 O-Hexach loro-l ,4,4a,5 ,8,8a-hexahydro-l ,4:5,8- dimethano-naphthalene (isodrin-ISO) 199. Hydrastine, hydrastinine and their salts 200. Hydrazides and their salts 20 I. Hydrazine, its derivatives and their salts 202. Octamoxin (*) and its salts 203. Warfarin (*) and its salts 204. Ethyl bis(4-hydroxy-2-oxo-l-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 mixtures) 212. Pemoline (*) and its salts 213. Iodine 214. Decamethylenebis(trimethylammonium) salts, e.g. decamethonium bromide 215. Ipecacuanha (Cephaelis ipecacuanha Brat. and related species) (roots, powder and galenical mixtures) 216. (2-Isopropylpent.4-enoyl)urea (apronalide) 217. a-Santonin [(3 S,5aR,9bS)-3,3a,4,5,5a,9b-hexahydro-3,5a,9-trimethyl n aphto [1 ,2-b] furan-2,8-dione] 218. Lobelia in/lata L. and its galenical mixtures 219. Lobeline (*) and its salts 220. Barbiturates 221. Mercury and its compounds, except those special casesinc1uded in Annex C 222. 3,4,5-Trimethoxyphenethylamine and its salts 223. Metaldehyde 224. 2-(4-Allyl-2-methoxyphenoxy)-N, N-diethylacetam ide and its salts 225. Coumetarol (*) 226. Dextromethorphan (*) and its salts 2-Methylheptylamine and its salts 228. Isometheptene (*) and its salts 6 IS 4707 (Part 2) : 2017 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. l-and 2-Naphthylamines and their salts 243. 3-(1-NaphthyJ)-4-hydroxycoumarin 244. Naphazoline (*) and its salts 245. Neostigmine and its salts (for example 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-l ,2,3-triyl trinitrate 254. Acenocoumarol (*) 255. Alkali pentacyanonitrosylferrate (2-) 256. Nitrostilbenes, their homoJogues and their derivatives 257. Noradrenaline and its salts 258. Noscapine (*) and its salts 259. Guanethidine (*) and its salts 260. Oestrogens 261. 01eandrin 262. Chlortalidone (*) 263. Pe lletierine and its salts 264. Pentachloroethane 265. Pentaerithrityl tetranitrate(l) 266. Petrichloral (*) 267. Octamylamine (*) and its salts 268. Picric acid 269. Phenacemide (*) 270. Difendoxazine (*) 271. 2-Phenylindan-l,3-dione (phenindione) 272. Ethylphenacemide (*) 273. Phenprocoumon (*) 274. Fenyramidol (*) 275. Triamterene (*) and its salts for the individual ingredient see reference number 364 in Annex A. Ii 7 IS 4707 (Part 2) ; 2017 276. Tetraethyl pyrophosphate; TEPP (ISO) 277. Tritolyl phosphate 278. Psilocybine (*) 279. Phosphorus and metal phosphides 280. Thalidomide (*) and its salts 281. Physostigma venenosum Ba(f 282. Picrotoxin 283. Pilocarpine and its salts 284. a-Piperidin-2-ylbenzyl acette (SIC! acetate) laevorotatory threoform (levophacetoperane) and its salts 285. Pipradrol (*) and its salts 286. Azacyclol101 (*) and its salts 287. Bietamiverine (*) 288. Butopiprine (*) and its salts 289. Lead and its compounds 290. Coniine 291. Prunus laurocerasus L. ('cherry laurel water') 292. Metyrapone (*) 293. Radioactive substances 294. Juniperus sabina L. (leaves, essential oil and galenical mixtures) 295. Hyoscine, its salts and derivatives 296. Gold sahs 297. Selenium and its compounds with the exception ofselenium disulphide specified elsewhere in this standard. 298. Solanum nigrum 1. and its galenical mixtures 299. Sparteine and its salts 300. Glucocorticoids 30 I. Datura stramonium L. and its galenical mixtures 302. Strophantines, their aglucones and their respective derivatives 303. Strophantus species and their galenical mixtures 304. Strychnine and its salts 305. Strychnos species and their galenical mixtures 306. Narcotics, natural and synthetic 307. Sulphonamides (sulphanilamide and its derivatives ... ) and their salts obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts 308. Sultiame(*) 309. Neodymium and its salts 310. Thiotepa (*) 311. PilocarplIsjaborandi Holmes and its galenical mixtures 312. Tellurium and its compounds 313. XylometazoJine (*) and its salts 314. Tetracllloroethy Jene 31 5. Carbon tetrach loride 316. Hexaethyl tetraphosphate 317. Thallium and its compounds 318. Thevetia neri~lolia Juss., glycoside extract 319. Ethionamide(*) 320. Phenothiazine (*) and its compounds 321. Thiourea and its derivatives, with the exception of the one listed elsewhere in this standard 322. Mephenesin (*) and its esters 8