DIRECTIVES  
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)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to Council Directive 76/768/EEC of 27 July 
1976 on the approximation of the laws of the Member States 
relating to cosmetic products (  1 ), and in particular Article 8(2) 
thereof,  
After consulting the Scientific Committee on Consumer Safety,  
Whereas:  
(1) Following the publication of a scientific study in 2001, 
entitled ‘Use of permanent hair dyes and bladder cancer 
risk’, the Scientific Committee on Cosmetic Products and 
Non-Food Products intended for Consumers, 
subsequently replaced by the Scientific Committee on 
Consumer Products (‘SCCP’), pursuant to Commission 
Decision 2004/210/EC (  2 ), concluded that the potential 
risks were of concern. The SCCP recommended that 
the Commission take further steps to control the use 
of hair dye substances.  
(2) The SCCP further recommended an overall safety 
assessment strategy for hair dye substances including 
the requirements for testing substances used in hair dye 
products for their potential genotoxicity/mutagenicity.  
(3) Following the opinions of the SCCP, the Commission 
agreed with Member States and stakeholders on an 
overall strategy to regulate substances used in hair dye 
products according to which the industry was required to 
submit files, containing updated scientific data on the 
safety of hair dye substances, for a risk assessment by 
the SCCP.  (4) The SCCP, subsequently replaced by the Scientific 
Committee on Consumer Safety (‘SCCS’) pursuant to 
Commission Decision 2008/721/EC of 5 August 2008 
setting up an advisory structure of Scientific Committees 
and experts in the field of consumer safety, public 
health and the environment and repealing Decision 
2004/210/EC (  3 ), assessed the safety of individual 
substances for which updated files had been submitted 
by industry.  
(5) The last step of the safety assessment strategy was to 
evaluate possible consumer health risk by reaction 
products formed by oxidative hair dye substances 
during the hair dyeing process. In its opinion of 
21 September 2010 the SCCS did not raise any major 
concern regarding genotoxicity and carcinogenicity of 
hair dyes and their reaction products currently used in 
the Union.  
(6) Some hair dye substances are provisionally authorised for 
use in hair dye products until 31 December 2010 under 
the restrictions and conditions laid down in Part 2 of 
Annex III to Directive 76/768/EEC.  
(7) In the light of the risk assessment of the submitted safety 
data and the final opinions given by the SCCS on the 
safety of individual substances and of the reaction 
products, it is appropriate to include in Part 1 of 
Annex III to Directive 76/768/EEC provisionally au- 
thorised hair dye substances, currently listed in Part 2 
of that Annex.  
(8) The safety assessment by the SCCS concerning the 
substances hydroxyethyl-2-nitro-p-toluidine and HC Red 
No 10 + HC Red No 11, listed in Part 2 of Annex III to 
Directive 76/768/EEC, could not be finalised before 
31 December 2010. Therefore, the provisional use of 
the substances should be prolonged until 31 December 
2011.EN 14.5.2011 Official Journal of the European Union L 125/17  
( 1 ) OJ L 262, 27.9.1976, p. 169.  
( 2 ) OJ L 66, 4.3.2004, p. 45.  (  3 ) OJ L 241, 10.9.2008, p. 21.(9) Concerning the substance o-aminophenol, the SCCS 
stated in its opinion of 22 June 2010 that based on 
the available data no final conclusion on the safety of 
that substance could be drawn. Based on that opinion o- 
aminophenol cannot be considered safe when used in 
hair dye products and should therefore be listed in 
Annex II to Directive 76/768/EEC.  
(10) Directive 76/768/EEC should therefore be amended 
accordingly.  
(11) The measures provided for in this Directive are in 
accordance with the opinion of the Standing 
Committee on Cosmetic Products,  
HAS ADOPTED THIS DIRECTIVE:  
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 BARROSOEN L 125/18 Official Journal of the European Union 14.5.2011ANNEX  
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-nitro ­
phenol (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-Naphtha ­
lenediol (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-Amino- 
phenol (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)EN 14.5.2011 Official Journal of the European Union L 125/19Ref. 
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  
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 nitro ­
samine 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-Methylamino ­
phenol (CAS No 
150-75-4) (EC No 
205-768-2) and 
its sulphate 
p-Methylamino ­
phenol 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 nitro ­
samine content: 
50 μg/kg 
— Keep in nitrite-free 
containers  As mentioned in 
reference number 
205, column f (a)  
225  Ethanol, 2-[4- 
[Ethyl[(2-Hydro ­
xyethyl)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 nitro ­
samine content: 
50 μg/kg 
— Keep in nitrite-free 
containers  (a) As mentioned 
in reference 
number 205, 
column f (a)EN L 125/20 Official Journal of the European Union 14.5.2011Ref. 
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  
(b) Hair dye 
substance 
in non- 
oxidative 
hair dye 
products  (b) 1,5 % (as 
hydro ­
chloride)  
227  3-Amino-2,4-dich ­
lorophenol (CAS 
No 61693-42-3) 
(EC No 262-909- 
0) and its hydro ­
chloride 
3-Amino-2,4-dich ­
lorophenol 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 
hydro ­
chloride)  
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-hydro ­
xyethylamino- 
phenol (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 nitro ­
samine content: 
50 μg/kg 
— Keep in nitrite-free 
containers  As mentioned in 
reference number 
205, column f (a)  
234  Hydroxybenzo ­
morpholine (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 nitro ­
samine content: 
50 μg/kg 
— Keep in nitrite-free 
containers  As mentioned in 
reference number 
205, column f (a)EN 14.5.2011 Official Journal of the European Union L 125/21Ref. 
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  
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 
hydro ­
chloride)  
238  2,6-Dimethoxy- 
3,5-pyridine ­
diamine (CAS No 
85679-78-3 (free 
base)) and its 
hydrochloride 
2,6-Dimethoxy- 
3,5-pyridine ­
diamine 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 nitro ­
samine 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-Naphtha ­
lenediol (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 %EN L 125/22 Official Journal of the European Union 14.5.2011Ref. 
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  
242  Hydroxypropyl 
bis(N-hydro ­
xyethyl-p-pheny ­
lenediamine) (CAS 
No 128729-30-6) 
and its tetrahydro ­
chloride 
Hydroxypropyl 
bis(N-hydro ­
xyethyl-p-pheny ­
lenediamine) 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 tetrahy ­
drochloride)  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-Diaminophen ­
oxyethanol (CAS 
No 70643-19-5), 
its hydrochloride 
and its sulphate 
2,4-Diaminophen ­
oxyethanol HCl 
(CAS No 66422- 
95-5) (EC No 
266-357-1) 
2,4-Diaminophen ­
oxyethanol 
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 hydro ­
chloride)  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)EN 14.5.2011 Official Journal of the European Union L 125/23Ref. 
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  
248  2-Amino-4-hydro ­
xyethylami ­
noanisole (CAS No 
83763-47-7) (EC 
No 280-733-2) 
and its sulphate 
2-Amino-4-hydro ­
xyethylami ­
noanisole 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 nitro ­
samine content: 
50 μg/kg 
— Keep in nitrite-free 
containers  As mentioned in 
reference number 
205, column f (a)  
249  Hydroxyethyl-3,4- 
methylenedio ­
xyaniline and its 
hydrochloride 
Hydroxyethyl-3,4- 
methylenedio ­
xyaniline 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 nitro ­
samine content: 
50 μg/kg 
— Keep in nitrite-free 
containers  As mentioned in 
reference number 
205, column f (a)  
250  3-Nitro-p-hydro ­
xyethylamino- 
phenol (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 nitro ­
samine 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 nitro ­
samine 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 %EN L 125/24 Official Journal of the European Union 14.5.2011Ref. 
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  
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-ethy ­
lamino-4-nitro ­
phenol (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 nitro ­
samine 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’.EN 14.5.2011 Official Journal of the European Union L 125/25