Commission Directive 2011/59/EU of 13 May 2011 amending, for the purpose of adaptation to technical progress, Annexes II and III to Council Directive 76/768/EEC relating to cosmetic products (Text with EEA relevance) (c. 59)

ANNEX U.K.

Directive 76/768/EEC is amended as follows:

(1)

in Annex II, the following entry is added:

Ref. No	Chemical name	CAS No/EC No
‘1372	2-Aminophenol (o-Aminophenol; CI 76520) and its salts	CAS No 95-55-6/67845-79-8/51-19-4 EC No 202-431-1/267-335-4’

(2)

Annex III is amended as follows:

(a)

Part 1 is amended as follows:

(i)

the following entries are added:

Ref. No	Substance	Restrictions			Conditions of use and warnings which must be printed on the label
		Field of application and/or use	Max. authorised concentration in the finished cosmetic product	Other limitations and requirements
‘215	4-amino-3-nitrophenol (CAS No 610-81-1) (EC No 210-236-8)	(a) Hair dye substance in oxidative hair dye products		(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %	(a) As mentioned in reference number 205, column f (a)
		(b) Hair dye substance in non-oxidative hair dye products	(b) 1,0 %		(b) As mentioned in reference number 208, column f
216	2,7-Naphthalenediol (CAS No 582-17-2) (EC No 209-478-7)	(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 %	(a) As mentioned in reference number 205, column f (a)
		(b) Hair dye substance in non-oxidative hair dye products	(b) 1,0 %
217	m-Aminophenol (CAS No 591-27-5) (EC No 209-711-2) and its salts m-Aminophenol HCl (CAS No 51-81-0) (EC No 200-125-2) m-Aminophenol sulphate (CAS No 68239-81-6) (EC No 269-475-1) sodium m-Aminophenol (CAS No 38171-54-9)	Hair dye substance in oxidative hair dye products		After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,2 %	As mentioned in reference number 205, column f (a)
218	2,6-Dihydroxy-3,4-dimethylpyridine (CAS No 84540-47-6) (EC No 283-141-2)	Hair dye substance in oxidative hair dye products		After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %	As mentioned in reference number 205, column f (a)
222	2-Hydroxyethyl picramic acid (CAS No 99610-72-7) (EC No 412-520-9)	(a) Hair dye substance in oxidative hair dye products		(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % For (a) and (b): Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers	(a) As mentioned in reference number 205, column f (a)
		(b) Hair dye substance in non-oxidative hair dye products	(b) 2,0 %
223	p-Methylaminophenol (CAS No 150-75-4) (EC No 205-768-2) and its sulphate p-Methylaminophenol sulphate (CAS No 55-55-0/1936-57-8) (EC No 200-237-1/217-706-1)	Hair dye substance in oxidative hair dye products		After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,68 % (as sulphate) Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers	As mentioned in reference number 205, column f (a)
225	Ethanol, 2-[4-[Ethyl[(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-, (CAS No 104516-93-0) and its hydrochloride HC Blue No 12 (CAS No 132885-85-9) (EC No 407-020-2)	(a) Hair dye substance in oxidative hair dye products		(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,75 % (as hydrochloride) For (a) and (b): Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers	(a) As mentioned in reference number 205, column f (a)
		(b) Hair dye substance in non-oxidative hair dye products	(b) 1,5 % (as hydrochloride)
227	3-Amino-2,4-dichlorophenol (CAS No 61693-42-3) (EC No 262-909-0) and its hydrochloride 3-Amino-2,4-dichlorophenol HCl (CAS No 61693-43-4)	(a) Hair dye substance in oxidative hair dye products		(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (as hydrochloride)	(a) As mentioned in reference number 205, column f (a)
		(b) Hair dye substance in non-oxidative hair dye products	(b) 1,5 % (as hydrochloride)
230	Phenyl methyl pyrazolone (CAS No 89-25-8) (EC No 201-891-0)	Hair dye substance in oxidative hair dye products		After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 %	As mentioned in reference number 205, column f (a)
232	2-Methyl-5-hydroxyethylaminophenol (CAS No 55302-96-0) (EC No 259-583-7)	Hair dye substance in oxidative hair dye products		After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers	As mentioned in reference number 205, column f (a)
234	Hydroxybenzomorpholine (CAS No 26021-57-8) (EC No 247-415-5)	Hair dye substance in oxidative hair dye products		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 mentioned in reference number 205, column f (a)
237	2,2’-[(4-Amino-3-nitrophenyl)imino]bisethanol (CAS No 29705-39-3) and its hydrochloride HC Red No 13 (CAS No 94158-13-1) (EC No 303-083-4	(a) Hair dye substance in oxidative hair dye products		(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,25 % (as hydrochloride)	(a) As mentioned in reference number 205, column f (a)
		(b) Hair dye substance in non-oxidative hair dye products	(b) 2,5 % (as hydrochloride)
238	2,6-Dimethoxy-3,5-pyridinediamine (CAS No 85679-78-3 (free base)) and its hydrochloride 2,6-Dimethoxy-3,5-pyridinediamine HCl (CAS No 56216-28-5) (EC No 260-062-1)	Hair dye substance in oxidative hair dye products		After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 % (as hydrochloride)	As mentioned in reference number 205, column f (a)
239	HC Violet No 1 (CAS No 82576-75-8) (EC No 417-600-7)	(a) Hair dye substance in oxidative hair dye products		(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 % For (a) and (b): Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers	(a) As mentioned in reference number 205, column f (a)
		(b) Hair dye substance in non-oxidative hair dye products	(b) 0,28 %		(b) As mentioned in reference number 208, column f
241	1,5-Naphthalenediol (CAS No 83-56-7) (EC No 201-487-4	(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 %	(a) As mentioned in reference number 205, column f (a)
		(b) Hair dye substance in non-oxidative hair dye products	(b) 1,0 %
242	Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) (CAS No 128729-30-6) and its tetrahydrochloride Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) HCl (CAS No 128729-28-2) (EC No 416-320-2)	Hair dye substance in oxidative hair dye products		After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,4 % (as tetrahydrochloride)	As mentioned in reference number 205, column f (a)
243	4-Amino-2-hydroxytoluene (CAS No 2835-95-2) (EC No 220-618-6)	Hair dye substance in oxidative hair dye products		After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %	As mentioned in reference number 205, column f (a)
244	2,4-Diaminophenoxyethanol (CAS No 70643-19-5), its hydrochloride and its sulphate 2,4-Diaminophenoxyethanol HCl (CAS No 66422-95-5) (EC No 266-357-1) 2,4-Diaminophenoxyethanol sulphate (CAS No 70643-20-8) (EC No 274-713-2)	Hair dye substance in oxidative hair dye products		After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (as hydrochloride)	As mentioned in reference number 205, column f (a)
245	2-Methylresorcinol (CAS No 608-25-3) (EC No 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) As mentioned in reference number 205, column f (a)
		(b) Hair dye substance in non-oxidative hair dye products	(b) 1,8 %
246	4-Amino-m-cresol (CAS No 2835-99-6) (EC No 220-621-2)	Hair dye substance in oxidative hair dye products		After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %	As mentioned in reference number 205, column f (a)
248	2-Amino-4-hydroxyethylaminoanisole (CAS No 83763-47-7) (EC No 280-733-2) and its sulphate 2-Amino-4-hydroxyethylaminoanisole sulphate (CAS No 83763-48-8) (EC No 280-734-8)	Hair dye substance in oxidative hair dye products		After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (as sulphate) Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers	As mentioned in reference number 205, column f (a)
249	Hydroxyethyl-3,4-methylenedioxyaniline and its hydrochloride Hydroxyethyl-3,4-methylenedioxyaniline HCl (CAS No 94158-14-2) (EC No 303-085-5)	Hair dye substance in oxidative hair dye products		After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers	As mentioned in reference number 205, column f (a)
250	3-Nitro-p-hydroxyethylaminophenol (CAS No 65235-31-6) (EC No 265-648-0)	(a) Hair dye substance in oxidative hair dye products		(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3,0 % For (a) and (b): Do not use with nitrosating systems Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers	(a) As mentioned in reference number 205, column f (a)
		(b) Hair dye substance in non-oxidative hair dye products	(b) 1,85 %		(b) As mentioned in reference number 208, column f
251	4-Nitrophenyl aminoethylurea (CAS No 27080-42-8) (EC No 410-700-1)	(a) Hair dye substance in oxidative hair dye products		(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 % For (a) and (b): Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers	(a) As mentioned in reference number 205, column f (a)
		(b) Hair dye substance in non-oxidative hair dye products	(b) 0,5 %
252	2-Amino-6-chloro-4-nitrophenol (CAS No 6358-09-4) (EC No 228-762-1)	(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 %	(a) As mentioned in reference number 205, column f (a)
		(b) Hair dye substance in non-oxidative hair dye products	(b) 2,0 %		(b) As mentioned in reference number 208, column f’

(ii)

the entry with reference number 201 is replaced by the following:

‘201	2-Chloro-6-ethylamino-4-nitrophenol (CAS No 131657-78-8) (EC No 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) and (b): Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers	(a) As mentioned in reference number 205, column f (a)
		(b) Hair dye substance in non-oxidative hair dye products	(b) 3,0 %’

(b)

Part 2 is amended as follows:

(i)

the entries with reference numbers 3 to 6, 11, 12, 16, 19 to 22, 25, 27, 31 to 39, 44, 48, 49, 55 and 56 are deleted;

(ii)

in the entries with reference numbers 10 and 50, in column g, the date ‘31.12.2010’ is replaced by ‘31.12.2011’.