
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 1 March 2013 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 1 September 2013.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 twentieth day following that of its publication in the Official Journal of the European Union.
Article 4 
This Directive is addressed to the Member States.
Done at Brussels, 2 August 2012.
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
‘1373 N-(2-Nitro-4-aminophenyl)-allylamine (HC Red No 16) and its salts CAS No 160219-76-1’
((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
a b c d e f
‘253 2,2′-[(4-Aminophenyl))imino]bis(ethanol) sulphateN,N-bis(2-Hydroxyethyl)-p-Phenylenediamine SulfateCAS No 54381-16-7EC No 259-134-5 Hair dye substance in oxidative hair dye products  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 % (calculated 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)
254 1,3-Benzenediol, 4-chloro-4-ChlororesorcinolCAS No 95-88-5EC No 202-462-0 Hair dye substance in oxidative hair dye products  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 % As mentioned in reference number 205, column f (a)
255 2,4,5,6-Tetraaminopyrimidine sulphateTetraaminopyrimidine SulfateCAS No 5392-28-9EC No 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) As mentioned in reference number 205, column f (a)


(b) Hair dye substance in non-oxidative hair dye products
 
(b) 3,4 % (calculated as sulphate)
  
256 3-(2-Hydroxyethyl)-p-phenylenediammonium sulphateHydroxyethyl-p-Phenylenediamine SulfateCAS No 93841-25-9EC No 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) As mentioned in reference number 205, column f (a)
257 1H-Indole-5,6-diolDihydroxyindoleCAS No 3131-52-0EC No 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) As mentioned in reference number 205, column f (a)


(b) Hair dye substance in non-oxidative hair dye products
 
(b) 0,5 %
  
(b) As mentioned in reference number 208, column f

258 5-Amino-4-chloro-2-methylphenol hydrochloride5-Amino-4-Chloro-o-Cresol HClCAS No 110102-85-7 Hair dye substance in oxidative hair dye products  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (calculated as hydrochloride) As mentioned in reference number 205, column f (a)
259 1H-Indol-6-ol6-HydroxyindoleCAS No 2380-86-1EC No 417-020-4 Hair dye substance in oxidative hair dye products  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 % As mentioned in reference number 205, column f (a)
260 1H-Indole-2,3-DioneIsatinCAS No 91-56-5EC No 202-077-8 Hair dye substance in non-oxidative hair dye products 1,6 %  As mentioned in reference number 208, column f
261 2-Aminopyridin-3-ol2-Amino-3-HydroxypyridineCAS No 16867-03-1EC No 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 % As mentioned in reference number 205, column f (a)
262 2-Methyl-1-naphthyl acetate1-Acetoxy-2-MethylnaphthaleneCAS No 5697-02-9EC No 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 %.) As mentioned in reference number 205, column f (a)
263 1-Hydroxy-2-methylnaphthalene2-Methyl-1-NaphtholCAS No 7469-77-4EC No 231-265-2 Hair dye substance in oxidative hair dye products  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (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 %.) As mentioned in reference number 205, column f (a)
264 Disodium 5,7-dinitro-8-oxido-2-naphthalenesulfonateAcid Yellow 1CAS No 846-70-8EC No 212-690-2CI 10316 
(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) 0,2 %
  
(b) As mentioned in reference number 208, column f

265 4-Nitro-1,2-phenylenediamine4-Nitro-o-PhenylenediamineCAS No 99-56-9EC No 202-766-3 Hair dye substance in oxidative hair dye products  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 % As mentioned in reference number 205, column f (a)
266 2-(4-Amino-3-nitroanilino)ethanolHC Red No 7CAS No 24905-87-1EC No 246-521-9 Hair dye substance in non-oxidative hair dye products 1,0 % 
— Do not use with nitrosating agents
— Maximum nitrosamine content: 50 μg/kg
— Keep in nitrite-free containers As mentioned in reference number 208, column f
267 2-[bis(2-Hydroxyethyl)amino]-5-nitrophenolHC Yellow No 4CAS No 59820-43-8EC No 428-840-7 Hair dye substance in non-oxidative hair dye products 1,5 % 
— Do not use with nitrosating agents
— Maximum nitrosamine content: 50 μg/kg
— Keep in nitrite-free containers 
268 2-[(2-Nitrophenyl)amino]ethanolHC Yellow No 2CAS No 4926-55-0EC No 225-555-8 
(a) Hair dye substance in oxidative hair dye products
  
(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,75 %
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) 1,0 %
 
269 4-[(2-Nitrophenyl)amino]phenolHC Orange No 1CAS No 54381-08-7EC No 259-132-4 Hair dye substance in non-oxidative hair dye products 1,0 %  
270 2-Nitro-N1-phenyl-benzene-1,4-diamineHC Red No 1CAS No 2784-89-6EC No 220-494-3 Hair dye substance in non-oxidative hair dye products 1,0 %  As mentioned in reference number 208, column f
271 1-Methoxy-3-(β-aminoethyl)amino-4-nitrobenzene, hydrochlorideHC Yellow No 9CAS No 86419-69-4EC No 415-480-1 Hair dye substance in non-oxidative hair dye products 0,5 % (calculated as hydrochloride) 
— Do not use with nitrosating agents
— Maximum nitrosamine content: 50 μg/kg
— Keep in nitrite-free containers 
272 1-(4’-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl) aminobenzeneHC Yellow No 7CAS No 104226-21-3EC No 146-420-6 Hair dye substance in non-oxidative hair dye products 0,25 %  
273 N-(2-Hydroxyethyl)-2-nitro-4-trifluormethyl-anilineHC Yellow No 13CAS No 10442-83-8EC No 443-760-2 
(a) Hair dye substance in oxidative hair dye products
  
(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 %
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) 2,5 %
 
274 Benzenaminium, 3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-N,N,Ntrimethyl-, chlorideBasic Yellow 57CAS No 68391-31-1EC No 269-943-5 Hair dye substance in non-oxidative hair dye products 2,0 %  
275 Ethanol, 2,2′-[[4-[(4-aminophenyl)azo]phenyl]imino]bis-Disperse Black 9CAS No 20721-50-0EC No 243-987-5 Hair dye substance in non-oxidative hair dye products 0,3 % (of the mixture in the ratio 1:1 of 2,2’-[4-(4-aminophenylazo)phenylimino]diethanol and lignosulfate)  
276 9,10-Anthracenedione, 1,4-bis[(2,3-dihydroxypropyl)amino]-HC Blue No 14CAS No 99788-75-7EC No 421-470-7 Hair dye substance in non-oxidative hair dye products 0,3 % 
— Do not use with nitrosating agents
— Maximum nitrosamine content: 50 μg/kg
— Keep in nitrite-free containers 
277 2-(4-Methyl-2-nitroanilino)ethanolHydroxyethyl-2-Nitro-p-ToluidineCAS No 100418-33-5EC No 408-090-7 
(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 %
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) 1,0 %
 
278 1-Amino-2-nitro-4-(2′,3′-dihydroxypropyl)amino-5-chlorobenzene + 1,4-bis-(2′,3′-dihydroxypropyl)amino-2-nitro-5-chlorobenzeneHC Red No 10 + HC Red No 11CAS No 95576-89-9 + 95576-92-4 
(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 %
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 %
 
((ii)) the entries with reference numbers 16 and 22 are replaced by the following:

Ref. No Substance Restrictions Conditions of use and warnings which must be printed on the label
Field of application and/or use Max. authorized concentration in the finished cosmetic product Other limitations and requirements
a b c d e f
‘16 1-Naphthalenol1-NaphtholCAS No 90-15-3EC No 201-969-4 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 mentioned in reference number 205, column f (a)
22 1,3-benzenediolResorcinolCAS No 108-46-3EC No 203-585-2 
(a) 

1.. general use
2.. professional use
  
(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,25 %
 
(a) 
1.. Contains resorcinol
Rinse hair well after application.
Do not use to dye eyelashes or eyebrows.
Rinse eyes immediately if product comes into contact with them.
As mentioned in reference number 205, column f (a).
2.. For professional use only
Contains resorcinol.
Rinse eyes immediately if product comes into contact with them.
As mentioned in reference number 205, column f (a)


(b) Hair lotions and shampoos
 
(b) 0,5 %
  
(b) Contains resorcinol.’

((b)) in Part 2 the entries with reference numbers 10 and 50 are deleted.
