DIRECTIVES  
COMMISSION DIRECTIVE 2009/36/EC  
of 16 April 2009  
amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting 
Annex III thereto to technical progress  
(Text with EEA relevance)  
THE COMMISSION OF THE EUROPEAN COMMUNITIES,  
Having regard to the Treaty establishing the European 
Community,  
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 
Products,  
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, currently 
the Scientific Committee on Consumer Products (here -
inafter SCCP) (  2 ), concluded that the potential risks 
were of concern. It 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, 
together with Member States and stakeholders, agreed 
on an overall strategy to regulate substances used in 
hair dye products, according to which the industry was 
required to submit files containing the scientific data on 
hair dye substances to be evaluated by the SCCP.  
(4) Substances for which updated safety files were submitted 
are currently being evaluated by the SCCP. For 17 hair dye substances final opinions have already been given by 
the SCCP. Therefore, definitive regulation of these hair 
dye substances, on the basis of such evaluations, can take 
place.  
(5) Directive 76/768/EEC should therefore be amended 
accordingly.  
(6) 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  
Annex III to Directive 76/768/EEC is amended in accordance 
with the Annex to this Directive.  
Article 2  
1. Member States shall adopt and publish, by 15 November 
2009 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 the provisions set out in the Annex to this 
Directive from 15 May 2010.  
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.EN 17.4.2009 Official Journal of the European Union L 98/31  
( 1 ) OJ L 262, 27.9.1976, p. 169.  
( 2 ) The name of the committee was changed by Commission Decision 
2004/210 (OJ L 66, 4.3.2004, p. 45).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, 16 April 2009.  
For the Commission  
Günter VERHEUGEN  
Vice-PresidentEN L 98/32 Official Journal of the European Union 17.4.2009ANNEX  
Directive 76/768/EEC is amended as follows:  
1. In Part 1 of Annex III the following reference numbers 189 - 205 are added:  
Reference 
number  Substance  Restrictions  
Conditions of use and 
warnings which must be 
printed on the label  Field of application and/or use  Maximum 
authorized 
concentration in 
the finished 
cosmetic product  Other limitations and 
requirements  
a b  c  d  e  f  
‘189  Trisodium 5-hydroxy-1-(4- 
sulphophenyl)-4-(4-sulphophe -
nylazo)pyrazole-3-carboxylate 
and aluminium lake (  15 ) 
Acid Yellow 23 
CAS 1934-21-0 
EINECS 217-699-5 
Acid Yellow 23 Aluminum 
lake 
CAS 12225-21-7 
EINECS 235-428-9 
CI 19140  Hair dye substance in non- 
oxidative hair dye products  0,5 %  
190  Benzenemethanaminium, N- 
ethyl-N-[4-[[4-[ethyl-[(3-sulfo -
phenyl)-methyl]-amino]- 
phenyl] [2-sulfophenyl) -
methylene]-2,5-cyclohexadien- 
1-ylidene]-3-sulfo, inner salt, 
disodium salt and its 
ammonium and aluminium 
salts (  15 ) 
Acid Blue 9 
CAS 3844-45-9 
EINECS 223-339-8 
Acid Blue 9 Ammonium salt 
CAS 2650-18-2 
EINECS 220-168-0 
Acid Blue 9 Aluminum lake 
CAS 68921-42-6 
EINECS 272-939-6 
CI 42090  Hair dye substance in non- 
oxidative hair dye products  0,5 %EN 17.4.2009 Official Journal of the European Union L 98/33a b  c  d  e  f  
191  Disodium 6-hydroxy-5-[(2- 
methoxy-4-sulphonato-m- 
tolyl)azo]naphthalene-2- 
sulphonate (  15 ) 
Curry Red 
CAS 25956-17-6 
EINECS 247-368-0 
CI 16035  Hair dye substance in non- 
oxidative hair dye products  0,4 %  
192  Trisodium 1-(1-naphthylazo)-2- 
hydroxynaphthalene-4 ′,6,8- 
trisulphonate and aluminium 
lake (  15 ) 
Acid Red 18 
CAS 2611-82-7 
EINECS 220-036-2 
Acid Red 18 Aluminum lake 
CAS 12227-64-4 
EINECS 235-438-3 
CI 16255  Hair dye substance in non- 
oxidative hair dye products  0,5 %  
193  Hydrogen 3,6-bis(diethy -
lamino)-9-(2,4-disulphonato -
phenyl)xanthylium, sodium 
salt (  15 ) 
Acid Red 52 
CAS 3520-42-1 
EINECS 222-529-8 
CI 45100  (a) Hair dye substance in 
oxidative hair dye 
products 
(b) Hair dye substance in 
non-oxidative hair dye 
products  (b) 0,6 %  (a) After mixing under 
oxidative conditions the 
maximum concen -
tration applied to hair 
must not exceed 1,5 %.  (a) The mixing ratio 
must be printed on 
the label.  
194  Disodium 5-amino-4-hydroxy- 
3-(phenylazo)naphthalene-2,7- 
disulphonate (  15 ) 
Acid Red 33 
CAS 3567-66-6 
EINECS 222-656-9 
CI 17200  Hair dye substance in non- 
oxidative hair dye products  0,5 %EN L 98/34 Official Journal of the European Union 17.4.2009a b  c  d  e  f  
195  Sodium 1-amino-4-(cyclohexy -
lamino)-9,10-dihydro-9,10- 
dioxoanthracene-2- 
sulphonate (  15 ) 
Acid Blue 62 
CAS 4368-56-3 
EINECS 224-460-9 
CI 62045  Hair dye substance in non- 
oxidative hair dye products  0,5 %  — Do not use with nitro -
sating systems 
— Maximum nitrosamine 
content: 50 μg/kg 
— Keep in nitrite-free 
containers  
196  1-[(2 ′-Methoxyethyl) 
amino]-2-nitro-4-[di-(2 ′-hydro -
xyethyl)amino] 
benzene (  15 ) 
HC Blue No 11 
CAS 23920-15-2 
EINECS 459-980-7  Hair dye substance in non- 
oxidative hair dye products  2,0 %  — Do not use with nitro -
sating systems 
— Maximum nitrosamine 
content: 50 μg/kg 
— Keep in nitrite-free 
containers  
197  1,5-Di-(ß-hydroxyethylamino)- 
2-nitro-4-chlorobenzene (  15 ) 
HC Yellow No 10 
CAS 109023-83-8 
EINECS 416-940-3  Hair dye substance in non- 
oxidative hair dye products  0,1 %  — Do not use with nitro -
sating systems 
— Maximum nitrosamine 
content: 50 μg/kg 
— Keep in nitrite-free 
containers  
198  3-Methylamino-4-nitrophenox -
yethanol (  15 ) 
3-Methylamino-4-nitrophenox -
yethanol (INCI) 
CAS 59820-63-2 
EINECS 261-940-7  Hair dye substance in non- 
oxidative hair dye products  0,15 %  — Do not use with nitro -
sating systems 
— Maximum nitrosamine 
content: 50 μg/kg 
— Keep in nitrite-free 
containers  
199  2,2 ′-[[4-[(2-hydroxyethyl) 
amino]-3-nitrophenyl]imino]bi -
sethanol (  15 ) 
HC Blue No 2 
CAS 33229-34-4 
EINECS 251-410-3  Hair dye substance in non- 
oxidative hair dye products  2,8 %  — Do not use with nitro -
sating systems 
— Maximum nitrosamine 
content: 50 μg/kg 
— Keep in nitrite-free 
containers  Can cause allergic 
reactionEN 17.4.2009 Official Journal of the European Union L 98/35a b  c  d  e  f  
200  1-Propanol, 3-[[4-[bis(2-hydro -
xyethyl)amino]-2-nitropheny -
l]amino] (  15 ) 
HC Violet No 2 
CAS 104226-19-9 
EINECS 410-910-3  Hair dye substance in non- 
oxidative hair dye products  2,0 %  — Do not use with nitro -
sating systems 
— Maximum nitrosamine 
content: 50 μg/kg 
— Keep in nitrite-free 
containers  Can cause allergic 
reaction  
201  Phenol, 2-chloro-6-(ethyl- 
amino)-4-nitro- (  15 ) 
2-Chloro-6-ethylamino-4-nitro -
phenol 
CAS 131657-78-8 
EINECS 411-440-1  Hair dye substance in non- 
oxidative hair dye products  3,0 %  — Do not use with nitro -
sating systems 
— Maximum nitrosamine 
content: 50 μg/kg 
— Keep in nitrite-free 
containers  Can cause allergic 
reaction  
202  4,4 ′-[1,3-Propanediylbis(oxy)] -
bisbenzene-1,3-diamine and its 
tetrahydrochloride salt (  15 ) 
1,3-bis-(2,4-Diaminophenoxy) -
propane 
CAS 81892-72-0 
EINECS 279-845-4 
1,3-bis-(2,4-Diaminophenoxy) -
propane HCl 
CAS 74918-21-1 
EINECS 278-022-7  (a) Hair dye substance in 
oxidative hair dye 
products 
(b) Hair dye substance in 
non-oxidative hair dye 
products  (b) 1,2 % 
as free 
base (1,8 % 
as tetrahy -
drochloride 
salt)  (a) After mixing under 
oxidative conditions the 
maximum concen -
tration applied to hair 
must not exceed 1,2 % 
calculated as free base 
(1,8 % as tetrahy -
drochloride salt).  (a) The mixing ratio 
must be printed on 
the label. 
For (a) and (b): 
Can cause allergic 
reaction  
203  6-Methoxy-N2-methyl-2,3-pyri -
dinediamine hydrochloride and 
dihydrochloride salt (  15 ) 
6-Methoxy-2-methylamino-3- 
aminopyridine HCl 
CAS 90817-34-8 (HCl) 
CAS 83732-72-3 (2HCl) 
EINECS 280-622-9 (2HCl)  (a) Hair dye substance in 
oxidative hair dye 
products 
(b) Hair dye substance in 
non-oxidative hair dye  (b) 0,68 % as 
free base 
(1,0 % as 
dihydro- 
chloride)  (a) After mixing under 
oxidative conditions the 
maximum concen -
tration applied to hair 
must not exceed 0,68 % 
calculated as free base 
(1,0 % as dihy -
drochloride). 
For a) and b): 
— Do not use with nitro -
sating systems 
— Maximum nitrosamine 
content: 50 μg/kg 
— Keep in nitrite-free 
containers  (a) The mixing ratio 
must be printed on 
the label. 
For (a) and (b): 
Can cause allergic 
reactionEN L 98/36 Official Journal of the European Union 17.4.2009a b  c  d  e  f  
204  2,3-Dihydro-1H-indole-5,6-diol 
and its hydrobromide salt (  15 ) 
Dihydroxyindoline 
CAS 29539-03-5 
Dihydroxyindoline HBr 
CAS 138937-28-7 
EINECS 421-170-6  Hair dye substance in non- 
oxidative hair dye products  2,0 %  Can cause allergic 
reaction  
205  4-Hydroxypropylamino-3- 
nitrophenol (  15 ) 
4-Hydroxypropylamino-3- 
nitrophenol (INCI) 
CAS 92952-81-3 
EINECS 406-305-9  (a) Hair dye substance in 
oxidative hair dye 
products 
(b) Hair dye substance in 
non-oxidative hair dye 
products  (b) 2,6 %  (a) After mixing under 
oxidative conditions the 
maximum concen -
tration applied to hair 
must not exceed 2,6 % 
calculated as free base. 
For (a) and (b): 
— Do not use with nitro -
sating systems 
— Maximum nitrosamine 
content: 50 μg/kg 
— Keep in nitrite-free 
containers  (a) The mixing ratio 
must be printed on 
the label.  
( 15 ) The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are permitted for use.’  
2. In columns ‘c’ and ‘d’ of entry 55 of Part 2 of Annex III section b is deleted.  
3. In Part 2 of Annex III reference numbers 7, 9, 14, 24, 28, 47, and 58 are deleted.EN 17.4.2009 Official Journal of the European Union L 98/37