Commission Regulation (EU) 2017/237Show full title

ANNEX U.K.

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. ‘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.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 (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. 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.Hair colourants can cause severe allergic reactions. (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. 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.Hair colourants can cause severe allergic reactions. (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. 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.Hair colourants can cause severe allergic reactions. (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. 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.Hair colourants can cause severe allergic reactions. (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. 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.Hair colourants can cause severe allergic reactions. (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: 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.Hair colourants can cause severe allergic reactions.
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. 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.Hair colourants can cause severe allergic reactions.
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. 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.Hair colourants can cause severe allergic reactions.
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. 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.Hair colourants can cause severe allergic reactions.
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. 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.Hair colourants can cause severe allergic reactions.
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’.