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Commission Regulation (EU) 2017/237 of 10 February 2017 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance. )

Regulation (EU) 2017/237 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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Annex III to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.

Article 2

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This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Supplementary provisions

ANNEXSupplementary provisions

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ANNEX Annex III to Regulation (EC) No 1223/2009 is amended as follows: (1) The following entry is inserted as reference number 8c: Reference number Substance identification Restrictions Wordings 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 a b c d e f g h i ‘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 % (2) the text in entry 9, column b, is replaced by the following: ‘Methylphenylenediamines, their N-substituted derivatives and their salts ( 1 ) 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’; (3) the entry 9a is replaced by the following: Reference number Substance identification Restrictions Wordings 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 a b c d e f g h i ‘9a 1,4-Benzenediamine, 2-methyl- 2,5-Diaminotoluene sulphate Toluene-2,5-Diamine Toluene-2,5-Diamine Sulfate ( 1 ) 95-70-5 615-50-9 202-442-1 210-431-8 (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) (4) the following entry is inserted as a reference number 9b: Reference number Substance identification Restrictions Wordings 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 a b c d e f g h i ‘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 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”.’ (5) the entries 200, 206, 211, 243 and 272 are replaced by the following: Reference number Substance identification Restrictions Wordings 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 a b c d e f g h i ‘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 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.” (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 ‘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 ‘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 b‘lack 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 ‘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.” (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 ‘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 (6) the following entries 298 to 305 are added: Reference number Substance identification Restrictions Wordings 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 a b c d e f g h i ‘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”.’

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