
Article 1 
Annexes II and III to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
Article 2 

1. Member States shall adopt and publish, by 3 January 2012 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.They shall apply those provisions from 3 January 2012.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3 
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 4 
This Directive is addressed to the Member States.
Done at Brussels, 13 May 2011.
For the Commission
The President
José Manuel BARROSO
ANNEX

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 95-55-6/67845-79-8/51-19-4EC 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 saltsm-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 sulphatep-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 hydrochlorideHC 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 hydrochloride3-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 hydrochlorideHC 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 hydrochloride2,6-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 tetrahydrochlorideHydroxypropyl 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 sulphate2,4-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 sulphate2-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 hydrochlorideHydroxyethyl-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’.
