DIRECTIVES  
COMMISSION DIRECTIVE 2009/130/EC  
of 12 October 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 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, currently 
the Scientific Committee on Consumer Safety (hereinafter 
SCCS) (  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 SCCS 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 SCCS, 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 SCCS.  
(4) Substances p-Phenylenediamine (PPD) and toluene-2,5- 
diamine (PTD) are currently regulated under generic 
entries 8 and 9 in part 1 of Annex III to Council 
Directive 76/768/EEC. The SCCS classified these 
substances as extreme sensitisers contributing to a great 
extent to the incidence of skin allergies among 
consumers to hair dye products. The risk assessment of 
the submitted additional data on PPD and PTD, and final 
decisions made by the SCCS on the safety of these 
substances might still require a considerable amount of 
time. As a precautionary measure to reduce the risk of 
allergies to hair dye products among consumers, the 
maximum authorised concentrations of PPD and PTD 
should be immediately decreased to the levels for 
which the industry submitted the safety files.  
(5) Since substances PPD and PTD are currently regulated 
under generic entries in part 1 of Annex III separate 
reference numbers should be created for these substances 
with decreased maximum authorised concentrations.  
(6) Commission Directive 2008/88/EC (  3 ) banned the use of 
hydroquinone in oxidative hair dye products by deleting 
the respective field of application in column ‘c’ of 
reference number 14 in Annex III, part 1. For the sake 
of clarity, the authorised concentration of 0,3 % in 
column ‘d’ and the conditions of use and warnings 
which must be printed on the label listed in paragraph 
(a) in column ‘f’ of reference number 14 should be 
deleted as well.  
(7) Directive 76/768/EEC should therefore be amended 
accordingly.  
(8) The measures provided for in this Directive are in 
accordance with the opinion of the Standing 
Committee on Cosmetic Products,EN 13.10.2009 Official Journal of the European Union L 268/5  
( 1 ) OJ L 262, 27.9.1976, p. 169.  
( 2 ) The name of the committee was changed by Commission Decision 
2008/721/EC (OJ L 241, 10.9.2008, p. 21).  (  3 ) OJ L 256, 24.9.2008, p. 12.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 April 2010 
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 July 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.  
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, 12 October 2009.  
For the Commission  
Günter VERHEUGEN  
Vice-PresidentEN L 268/6 Official Journal of the European Union 13.10.2009ANNEX  
Directive 76/768/EEC is amended as follows:  
Part 1 of Annex III is amended as follows:  
(a) In column ‘b’ of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N- 
substituted derivatives of o-Phenylenediamine (  5 ), with exception of those derivatives listed elsewhere in this Annex 
and under reference numbers 1309, 1311, and 1312 in Annex II’ are replaced by the following:  
‘N-substituted derivatives of p-Phenylenediamine and their salts; N-substituted derivatives of o-Phenylenediamine (  5 ), 
with exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 
1312 in Annex II’.  
(b) The following reference number 8a is inserted after reference number 8:  
Reference 
number  Substance  Restrictions  
Conditions of use and warnings 
which must be printed on the 
label  Field of application 
and/or use  Maximum 
authorised 
concentration 
in the finished 
cosmetic 
product  Other limitations 
and requirements  
a b  c  d  e  f  
‘8a p-Phenylenediamine 
and its salts (  5 ) 
CAS No 106-50-3 
Einecs 203-404-7 
p-Phenylenediamine 
HCl 
CAS No 624-18-0 
Einecs 210-834-9 
p-Phenylenediamine 
sulphate 
CAS No 16245-77-5 
Einecs 240-357-1  Hair dye 
substance in 
oxidative hair dye 
products 
(a) general use 
(b) professional 
use (a) and (b) 
After mixing 
under oxidative 
conditions the 
maximum 
concentration 
applied to hair 
must not 
exceed 2 % 
calculated as 
free base.  (a) Can cause an allergic 
reaction. Contains 
phenylenediamines. Do 
not use to dye eyelashes 
or eyebrows. 
(b) For professional use 
only. Contains pheny ­
lenediamines. Can cause 
an allergic reaction. 
Wear suitable gloves.’  
(c) In column ‘b’ of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their 
salts (  1 ) with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’ are replaced by 
the following:  
‘Methylphenylenediamines, their N-substituted derivatives and their salts (  1 ), with the exception of the substance under 
reference number 9a in this Annex and substances under reference numbers 364, 1310 and 1313 in Annex II’.EN 13.10.2009 Official Journal of the European Union L 268/7(d) The following reference number 9a is inserted after reference number 9:  
Reference 
number  Substance  Restrictions  
Conditions of use and warnings 
which must be printed on the 
label  Field of application 
and/or use  Maximum 
authorised 
concentration 
in the finished 
cosmetic 
product  Other limitations 
and requirements  
a b  c  d  e  f  
‘9a Toluene-2,5-diamine 
and its salts (  1 ) 
CAS No 95-70-5 
Einecs 202-442-1 
Toluene-2,5-diamine 
sulphate 
CAS No 615-50-9 
Einecs 210-431-8  Hair dye 
substance in 
oxidative hair dye 
products 
(a) general use 
(b) professional 
use (a) and (b) 
After mixing 
under oxidative 
conditions the 
maximum 
concentration 
applied to hair 
must not 
exceed 4 % 
calculated as 
free base.  As mentioned in reference 
number 9, column f.’  
(e) In reference number 14, the maximum authorised concentration in the finished cosmetic product of 0,3 % in column 
‘d’ and paragraph (a) in column ‘f’ are deleted.EN L 268/8 Official Journal of the European Union 13.10.2009