Version in force 3 March 2017

Previous version, in force 12 August 2016 02009R1223-20160812 → this version, in force 3 March 2017 02009R1223-20170303

compared line by line: this provision is too large to compare word by word, so a marked line is a line that changed somewhere

ANNEX III LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1. … 17 unchanged lines … For use as a preservative, see Annex V, No 58. For use as a preservative, see Annex V, entry No 44. For other uses of potassium hydroxide, see Annex III, No 15d. For other uses of Potassium hydroxide, see Annex III, No 15a. For other uses of potassium hydroxide, see Annex III, No 15a. 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 for use preparation Other a b c d e f g h i … 122 unchanged lines … Rinse eyes immediately if product comes into contact with them. Contains phenylenediamines. Wear suitable gloves. 8c Ethanol, 2,2′-[(2-nitro-1,4-phenylene)diimino]bis-(9CI) N,N′-Bis(2-Hydroxyethyl)-2-Nitro-p-Phenylenediamine 84041-77-0 281-856-4 (a) Hair dye substance in oxidative hair dye products (a) As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 % For (a) and (b), as from 3 September 2017: Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers (a) As from 3 March 2018, to be printed on the label: The mixing ratio. Hair colourants 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) As from 3 September 2017: 1,5 % 9 Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of the substance under reference number 9a in this annex and substances under reference numbers 364, 1310 and 1313 in Annex II Hair dye substance in oxidative hair dye products (a) General use (a) To be printed on the label: with the exception of the substances under reference numbers 9a and 9b of this Annex and substances under reference numbers 364, 1310 and 1313 in Annex II Hair dye substance in oxidative hair dye products (a) General use (a) To be printed on the label: The mixing ratio. Hair colourants can cause severe allergic reactions. Read and follow instructions. … 21 unchanged lines … Wear suitable gloves. 9a 1,4-Benzenediamine, 2-methyl- 2,5-Diaminotoluene sulphate Toluene-2,5-Diamine Toluene-2,5-Diamine sulfate Toluene-2,5-Diamine Sulfate 95-70-5 615-50-9 202-442-1 210-431-8 Hair dye substance in oxidative hair dye products (a) General use (a) To be printed on the label: 210-431-8 (a) Hair dye substance in oxidative hair dye products (a) (i) General use (a) (ii) Professional use (a) To be printed on the label: The mixing ratio. Hair colourants 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 phenylenediamines (toluenediamines) (a) (i) Do not use to dye eyelashes. (a) (ii) Wear suitable gloves. For professional use only. (b) As from 3 March 2018, to be printed on the label: The mixing ratio. This product 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 the risk of allergy. Eyelashes shall not be coloured if the consumer: has a rash on the face or sensitive, irritated and damaged scalp, has experienced any reaction after colouring hair or eyelashes, has experienced a reaction to a temporary black henna tattoo in the past. Rinse eyes immediately if product comes into contact with them. Contains phenylenediamines (toluenediamines). Wear suitable gloves. For professional use only. (b) Products intended for colouring eyelashes (b) Professional use For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 2,0 % (calculated as free base) or 3,6 % (calculated as sulfate salt) 9b 1-Methyl-2,6-bis-(2-hydroxyethylamino)-benzene 2,6-Dihydroxyethylaminotoluene 149330-25-6 443-210-1 Hair dye substance in oxidative hair dye products As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 % Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers As from 3 March 2018, to be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. Hair colourants 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 phenylenediamines (toluenediamines). Do not use to dye eyelashes or eyebrows. (b) Professional use For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % (calculated as free base) or 3,6 % (calculated as sulfate salt) (b) To be printed on the label: The mixing ratio. For professional use only 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 phenylenediamines (toluenediamines). Wear suitable gloves. 10 11 Dichlorophen Dichlorophen 97-23-4 202-567-1 0,5 % Contains Dichlorophen 12 Hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide Hydrogen peroxide 7722-84-1 231-765-0 (a) Hair products (a) 12 % of H2O2 (40 volumes), present or released For (a) and (f): Wear suitable gloves For (a) (b) (c) and (e): … 503 unchanged lines … 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: 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) (c) After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 3,4 % (calculated as sulfate) (a) To be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. Hair colourants 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) (c) As from 3 March 2018, to be printed on the label: The mixing ratio. This product 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 the risk of allergy. Eyelashes shall not be coloured if the consumer: has a rash on the face or sensitive, irritated and damaged scalp, has experienced any reaction after colouring hair or eyelashes, has experienced a reaction to a temporary black henna tattoo in the past. For professional use only. Rinse eyes immediately if product comes into contact with them. (b) Hair dye substance in non-oxidative hair dye products (b) 3,4 % (calculated as sulfate) (c) Products intended for colouring eyelashes (c) Professional use 201 Phenol, 2-Chloro-6-(ethylamino)-4-nitro- 2-Chloro-6-ethylamino-4-nitrophenol 131657-78-8 411-440-1 (a) Hair dye substance in oxidative hair dye products (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (a) To be printed on the label: The mixing ratio. Hair colourants can cause severe allergic reactions. … 38 unchanged lines … 204 2,3-Dihydro-1H-indole-5,6-diol and its hydrobromide salt Dihydroxy indoline Dihydroxy indoline HBr 29539-03-5 / 138937-28-7 — / 421-170-6 Hair dye substance in non-oxidative hair dye products 2,0 % Can cause allergic reaction 205 See 219 206 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. 205 See 219 206 3-(2-Hydroxyethyl)- p-phenylenediammonium sulphate Hydroxyethyl-p- Phenylenediamine Sulfate 93841-25-9 298-995-1 (a) Hair dye substance in oxidative hair dye products (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (calculated as sulphate) (a) To be printed on the label: The mixing ratio. Hair colourants 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) As from 3 March 2018, to be printed on the label: The mixing ratio. This product 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 the risk of allergy. Eyelashes shall not be coloured if the consumer: has a rash on the face or sensitive, irritated and damaged scalp, has experienced any reaction after colouring hair or eyelashes, has experienced a reaction to a temporary black henna tattoo in the past. For professional use only. Rinse eyes immediately if product comes into contact with them. (b) Products intended for colouring eyelashes (b) After mixing under oxidative conditions the maximum concentration applied to eyelashes must not exceed 1,75 % (calculated as free base) (b) Professional use 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): … 34 unchanged lines … 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. 211 2-Aminopyridin-3-ol 2-Amino-3- Hydroxypyridine 16867-03-1 240-886-8 (a) Hair dye substance in oxidative hair dye products (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 % (a) To be printed on the label: The mixing ratio. Hair colourants 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) As from 3 March 2018, to be printed on the label: The mixing ratio. This product 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 the risk of allergy. Eyelashes shall not be coloured if the consumer: has a rash on the face or sensitive, irritated and damaged scalp, has experienced any reaction after colouring hair or eyelashes, has experienced a reaction to a temporary black henna tattoo in the past. For professional use only. Rinse eyes immediately if product comes into contact with them. (b) Products intended for colouring eyelashes (b) After mixing under oxidative conditions the maximum concentration applied to eyelashes must not exceed 0,5 % (b) Professional use 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. … 384 unchanged lines … has experienced any reaction after colouring hair or eyelashes, has experienced a reaction to a temporary black henna tattoo in the past. Rinse eyes immediately if product comes into contact with them. 243 1,3-benzenediol, 2-methyl 2-Methylresorcinol 608-25-3 210-155-8 (a) Hair dye substance in oxidative hair dye products (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,8 % (a) To be printed on the label: 243 1,3-Benzenediol, 2- methyl 2-Methylresorcinol 608-25-3 210-155-8 (a) Hair dye substance in oxidative hair dye products (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,8 % (a) To be printed on the label: The mixing ratio. Hair colourants 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) 1,8 % you have experienced a reaction to a temporary black h.enna tattoo in the past. (c) As from 3 March 2018, to be printed on the label: The mixing ratio. This product 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 the risk of allergy. Eyelashes shall not be coloured if the consumer: has a rash on the face or sensitive, irritated and damaged scalp, has experienced any reaction after colouring hair or eyelashes, has experienced a reaction to a temporary black henna tattoo in the past. For professional use only. Rinse eyes immediately if product comes into contact with them. (b) Hair dye substance in non-oxidative hair dye products (b) 1,8 % (c) Products intended for colouring eyelashes (c) After mixing under oxidative conditions the maximum concentration applied to eyelashes must not exceed 1,25 % (c) Professional use 244 4-Amino-m-cresol 4-Amino-m-Cresol 2835-99-6 220-621-2 (a) Hair dye substance in oxidative hair dye products For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 1,5 % (a) To be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. … 232 unchanged lines … (b) Hair dye substance in non-oxidative hair dye products (b) 0,4 % 271 Mixture of (1), (2) & (3) in dispersing agent (lignosulphate): Disperse Blue 377 is a mixture of three dyes: Hair dye substance in non-oxidative hair dye products 2,0 % (1) 9,10-Anthracenedione-1,4-bis[(2-Hydroxyethyl)amino] (1) 1,4-bis[(2-hydroxyethyl)amino]anthra-9,10-quinone (1) 4471-41-4 (1) 224-743-7 (2) 9,10-Anthracenedione-1-[(2-Hydroxyethyl)amino]-4-[(3-Hydroxypropyl)amino] (2) 1-[(2-hydroxyethyl)amino]-4-[(3-hydroxypropyl)amino]anthra-9,10-quinone (2) 67674-26-4 (2) 266-865-3 (3) 9,10-anthracenedione-1,4-bis[(3-hydroxypropyl)amino (3) 1,4-bis[(3-hydroxypropyl)amino]anthra-9,10-quinone (3) 67701-36-4 (3) 266-954-7 272 4-Aminophenol p-Aminophenol 123-30-8 204-616-2 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,9 % To be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. 272 4-Aminophenol p-Aminophenol 123-30-8 204-616-2 (a) Hair dye substance in oxidative hair dye products (a) (b) After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 0,9 % (a) To be printed on the label: The mixing ratio. Hair colourants 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) As from 3 March 2018, to be printed on the label: The mixing ratio. This product 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 the risk of allergy. Eyelashes shall not be coloured if the consumer: has a rash on the face or sensitive, irritated and damaged scalp, has experienced any reaction after colouring hair or eyelashes, has experienced a reaction to a temporary black henna tattoo in the past. For professional use only. Rinse eyes immediately if product comes into contact with them. (b) Products intended for colouring eyelashes (b) Professional use 273 4,5-Diamino-1-(2-hydroxyethyl)-1H-pyrazole sulfate (1:1) 1-Hydroxyethyl-4,5-Diamino Pyrazole Sulfate 155601-30-2 429-300-3 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3,0 % To be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. … 213 unchanged lines … (c) Rinse-off products other than hair dye products (c) 10 % (d) Other non-spray cosmetic products (d) 2,6 % (e) The following spray products: fine fragrances, hair sprays, antiperspirants and deodorants (e) 2,6 %298 Di[2-[4-[(E)-2-[4-[bis(2-hydroxyethyl)aminophenyl]vinyl]pyridin-1-ium] butanoyl]aminoethyl]di-sulfanyl dichloride HC Red No 17 1449471-67-3 Hair dye substance in non-oxidative hair dye products As from 3 September 2017: 0,5 % As from 3 September 2017: Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers 299 Di[2-[4-[(E)-2-[2,4,5-trimethoxyphenyl]vinyl]pyridinin-1-ium]butanoyl]aminoethyl]disulfanyl dichloride HC Yellow No 17 1450801-55-4 Hair dye substance in non-oxidative hair dye products As from 3 September 2017: 0,5 % As from 3 March 2018: Hair colourants 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. 300 1H-Pyrazole-4,5-diamine, 1-hexyl-, sulfate (2:1) 1-Hexyl 4,5-Diamino Pyrazole Sulfate 1361000-03-4 Hair dye substance in oxidative hair dye products As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 % As from 3 March 2018, to be printed on the label: The mixing ratio. Hair colourants 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. 301 4-Hydroxy-2,5,6-triaminopyrimidine sulfate 2,5,6-Triamino-4-Pyrimidinol Sulfate 1603-02-7 216-500-9 Hair dye substance in oxidative hair dye products As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 % As from 3 March 2018, to be printed on the label: The mixing ratio. Hair colourants 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. 302 2-[(3-Aminopyrazolo[1,5-a]pyridin-2-yl)oxy]ethanol hydrochloride Hydroxyethoxy Aminopyrazolopyridine HCl 1079221-49-0 695-745-7 Hair dye substance in oxidative hair dye products As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % As from 3 March 2018, to be printed on the label: The mixing ratio. Hair colourants 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. 303 Phenol, 3-amino-2,6-dimethyl 3-Amino-2,6-Dimethylphenol 6994-64-5 230-268-6 Hair dye substance in oxidative hair dye products As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % As from 3 March 2018, to be printed on the label: The mixing ratio. Hair colourants 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. 304 2-Naphthalenaminium, 8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-N,N,N-trimethyl-, chloride Basic Brown 17 68391-32-2 269-944-0 Hair dye substance in non-oxidative hair dye products As from 3 September 2017: 2,0 % 305 3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride Basic Blue 124 67846-56-4 267-370-5 Hair dye substance in non-oxidative hair dye products As from 3 September 2017: 0,5 % As from 3 September 2017: Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers As from 3 March 2018: Hair colourants 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.