(2)

Annex III is amended as follows: (a) The following entries concerning reference numbers 198 to 200 are added: Reference number Substance identification Restrictions Wording of conditions of use and warnings Chemical name/INN Name of Common Ingredients Glossary CAS number EC number Product type, body parts Maximum concentration in ready use preparation Other ‘198 2,2'-[(4-Aminophenyl)imino]bis(ethanol) sulphate N,N-bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate 54381-16-7 259-134-5 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 % (calculated as sulphate) — Do not use with nitrosating agents — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ 199 1,3-Benzenediol, 4-chloro- 4-Chlororesorcinol 95-88-5 202-462-0 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 % To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ 200 2,4,5,6-Tetraaminopyrimidine sulphate Tetraaminopyrimidine Sulfate 5392-28-9 226-393-0 (a) Hair dye substance in oxidative hair dye products (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3,4 % (calculated as sulphate) (a) To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ ’ (b) Hair dye substance in non-oxidative hair dye products (b) 3,4 % (calculated as sulphate) (b) The following entries concerning reference numbers 206 to 214 are added: ‘206 3-(2-Hydroxyethyl)-p-phenylenediammonium sulphate Hydroxyethyl-p-Phenylenediamine Sulfate 93841-25-9 298-995-1 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (calculated as sulphate) To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ 207 1H-Indole-5,6-diol Dihydroxyindole 3131-52-0 412-130-9 (a) Hair dye substance in oxidative hair dye products (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 % (a) To be printed on the label: The mixing ratio. For (a) and (b): ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ (b) Hair dye substance in non-oxidative hair dye products (b) 0,5 % 208 5-Amino-4-chloro-2-methylphenol hydrochloride 5-Amino-4-Chloro-o-Cresol HCl 110102-85-7 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (calculated as hydrochloride) To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ 209 1H-Indol-6-ol 6-Hydroxyindole 2380-86-1 417-020-4 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 % To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ 210 1H-Indole-2,3-Dione Isatin 91-56-5 202-077-8 Hair dye substance in non-oxidative hair dye products 1,6 % ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ 211 2-Aminopyridin-3-ol 2-Amino-3-Hydroxypyridine 16867-03-1 240-886-8 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 % To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ 212 2-Methyl-1-naphthyl acetate 1-Acetoxy-2-Methylnaphthalene 5697-02-9 454-690-7 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (When both 2-Methyl-1-Naphthol and 1-Acetoxy-2-Methylnaphthalene are present in a hair dye formulation, the maximum concentration on the head of 2-Methyl-1-Naphthol should not exceed 2,0 %). To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ 213 1-Hydroxy-2-methylnaphthalene 2-Methyl-1-Naphthol 7469-77-4 231-265-2 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (When both 2-Methyl-1-Naphthol and 1-Acetoxy-2-Methylnaphthalene are present in a hair dye formulation, the maximum concentration on the head of 2-Methyl-1-Naphthol should not exceed 2,0 %.) To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ 214 Disodium 5,7-dinitro-8-oxido-2-naphthalenesulfonate CI 10316 Acid Yellow 1 846-70-8 212-690-2 (a) Hair dye substance in oxidative hair dye products (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 % (a) To be printed on the label: The mixing ratio. For (a) and (b): ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ ’ (b) Hair dye substance in non-oxidative hair dye products (b) 0,2 % (c) The entry with reference number 240 is replaced by the following: ‘240 4-Nitro-1,2-phenylenediamine 4-Nitro-o-Phenylenediamine 99-56-9 202-766-3 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 % To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ ’ (d) The entry with reference number 251 is replaced by the following: ‘251 2-(4-Amino-3-nitroanilino)ethanol HC Red No 7 24905-87-1 246-521-9 Hair dye substance in non-oxidative hair dye products 1,0 % — Do not use with nitrosating agents — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ ’ (e) The entry with reference number 253 is replaced by the following: ‘253 2-[bis(2-Hydroxyethyl)amino]-5-nitrophenol HC Yellow No 4 59820-43-8 428-840-7 Hair dye substance in non-oxidative hair dye products 1,5 % — Do not use with nitrosating agents — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers’ (f) The entries with reference numbers 255 and 256 are replaced by the following: ‘255 2-[(2-Nitrophenyl)amino]ethanol HC Yellow No 2 4926-55-0 225-555-8 (a) Hair dye substance in oxidative hair dye products (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,75 % For (a) and (b): — Do not use with nitrosating agents — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers (a) To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ (b) Hair dye substance in non-oxidative hair dye products b) 1,0 % 256 4-[(2-Nitrophenyl)amino]phenol HC Orange No 1 54381-08-7 259-132-4 Hair dye substance in non-oxidative hair dye products 1,0 %’ (g) The following entries concerning reference numbers 258 to 264 are added: ‘258 2-Nitro-N1-phenyl-benzene-1,4-diamine HC Red No 1 2784-89-6 220-494-3 Hair dye substance in non-oxidative hair dye products 1,0 % ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ 259 1-Methoxy-3-(β-aminoethyl)amino-4-nitrobenzene, hydrochloride HC Yellow No 9 86419-69-4 415-480-1 Hair dye substance in non-oxidative hair dye products 0,5 % (calculated as hydrochloride) — Do not use with nitrosating agents — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers 260 1-(4’-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl) aminobenzene HC Yellow No 7 104226-21-3 146-420-6 Hair dye substance in non-oxidative hair dye products 0,25 % 261 N-(2-Hydroxyethyl)-2-nitro-4-trifluormethyl-aniline HC Yellow No 13 10442-83-8 443-760-2 (a) Hair dye substance in oxidative hair dye products (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 % For (a) and (b): — Do not use with nitrosating agents — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers (a) To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ (b) Hair dye substance in non-oxidative hair dye products (b) 2,5 % 262 Benzenaminium, 3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-N,N,Ntrimethyl-, chloride Basic Yellow 57 68391-31-1 269-943-5 Hair dye substance in non-oxidative hair dye products 2,0 % 263 Ethanol, 2,2’-[[4-[(4-aminophenyl)azo]phenyl]imino]bis- Disperse Black 9 20721-50-0 243-987-5 Hair dye substance in non-oxidative hair dye products 0,3 % (of the mixture in the ratio 1:1 of 2,2’-[4-(4-aminophenylazo)phenylimino]diethanol and lignosulfate) 264 9,10-Anthracenedione, 1,4-bis[(2,3-dihydroxypropyl)amino]- HC Blue No 14 99788-75-7 421-470-7 Hair dye substance in non-oxidative hair dye products 0,3 % — Do not use with nitrosating agents — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers’ (h) The entries with reference numbers 16, 22, 221, 250 are replaced by the following: Reference number Substance identification Restrictions Wording of conditions of use and warnings Chemical name/INN Name of Common Ingredients Glossary CAS number EC number Product type, body parts Maximum concentration in ready use preparation Other ‘16 1-Naphthalenol 1-Naphthol 90-15-3 201-969-4 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ 22 1,3-benzenediol Resorcinol 108-46-3 203-585-2 (a) Hair dye substance in oxidative hair dye products (a) 1. general use 2. professional use For 1 and 2: After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,25 % (a) 1. To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Contains resorcinol. Rinse hair well after application. Rinse eyes immediately if product comes into contact with them. Do not use to dye eyelashes or eyebrows.’ 2. To be printed on the label: The mixing ratio. ‘For professional use only. Contains resorcinol. Rinse eyes immediately if product comes into contact with them. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ (b) Contains resorcinol. (b) Hair lotions and shampoos (b) 0,5 % 221 2-(4-Methyl-2-nitroanilino)ethanol Hydroxyethyl-2-Nitro-p-Toluidine 100418-33-5 408-090-7 (a) Hair dye substance in oxidative hair dye products (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 % For (a) and (b): — Do not use with nitrosating agents — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers (a) To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ (b) Hair dye substance in non-oxidative hair dye products (b) 1,0 % 250 1-Amino-2-nitro-4-(2’,3’-dihydroxypropyl)amino-5-chlorobenzene + 1,4-bis-(2’,3’-dihydroxypropyl)amino-2-nitro-5-chlorobenzene HC Red No 10 + HC Red No 11 95576-89-9 + 95576-92-4 (a) Hair dye substance in oxidative hair dye products (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 % For (a) and (b): — Do not use with nitrosating agents — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers (a) To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ ’ (b) Hair dye substance in non-oxidative hair dye products (b) 2,0 %