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14.5.2011 Official
Journal
of
the
European
Union L
125/17
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,
(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
Having regard to the Treaty on the Functioning of the European
and experts in the field of consumer safety, public
Union,
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.
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,
(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
After consulting the Scientific Committee on Consumer Safety,
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
Whereas:
hair dyes and their reaction products currently used in
the Union.
(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
(6) Some
hair
dye
substances
are
provisionally
authorised
for
Non-Food Products intended for Consumers,
use in hair dye products until 31 December 2010 under
subsequently replaced by the Scientific Committee on
the restrictions and conditions laid down in Part 2 of
Consumer Products (‘SCCP’), pursuant to Commission
Annex III to Directive 76/768/EEC.
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.
(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
(2) The
SCCP
further
recommended
an
overall
safety
products, it is appropriate to include in Part 1 of
assessment strategy for hair dye substances including
Annex III to Directive 76/768/EEC provisionally au-
the requirements for testing substances used in hair dye
thorised hair dye substances, currently listed in Part 2
products for their potential genotoxicity/mutagenicity.
of that Annex.
(3)
Following the opinions of the SCCP, the Commission
agreed with Member States and stakeholders on an
(8) The
safety
assessment
by
the
SCCS
concerning
the
overall strategy to regulate substances used in hair dye
substances hydroxyethyl-2-nitro-p-toluidine and HC Red
products according to which the industry was required to
No 10 + HC Red No 11, listed in Part 2 of Annex III to
submit files, containing updated scientific data on the
Directive 76/768/EEC, could not be finalised before
safety of hair dye substances, for a risk assessment by
31 December 2010. Therefore, the provisional use of
the SCCP.
the substances should be prolonged until 31 December
2011.
( 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.

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L 125/18
EN
Official Journal of the European Union
14.5.2011
(9) Concerning
the
substance
o-aminophenol,
the
SCCS They shall apply those provisions from 3 January 2012.
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-
When Member States adopt those provisions, they shall contain
aminophenol cannot be considered safe when used in
a reference to this Directive or be accompanied by such a
hair dye products and should therefore be listed in
reference on the occasion of their official publication. Member
Annex II to Directive 76/768/EEC.
States shall determine how such reference is to be made.
(10) Directive 76/768/EEC should therefore be amended
accordingly.
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.
(11) The
measures provided for in this Directive are in
accordance with the opinion of the Standing
Committee on Cosmetic Products,
Article 3
This Directive shall enter into force on the 20th day following
HAS ADOPTED THIS DIRECTIVE:
its publication in the Official Journal of the European Union.
Article 1
Article 4
Annexes II and III to Directive 76/768/EEC are amended in
This Directive is addressed to the Member States.
accordance with the Annex to this Directive.
Article 2
Done at Brussels, 13 May 2011.
1. Member
States
shall
adopt
and
publish,
by
3
January
2012 at the latest, the laws, regulations and administrative
For the Commission
provisions necessary to comply with this Directive. They shall
forthwith communicate to the Commission the text of those
The President
provisions.
José Manuel BARROSO

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EN
14.5.2011 Official
Journal
of
the
European
Union L
125/19
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
CAS No 95-55-6/67845-79-8/51-19-4
salts
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:
Restrictions
Conditions of use
Ref.
Max. authorised
and warnings which
No
Substance
Field of application concentration in
Other limitations and
must be printed on
and/or use
the finished
requirements
the label
cosmetic
product
‘215 4-amino-3-nitro
(a) Hair
dye
(a) After mixing under (a) As mentioned
phenol (CAS No
substance
oxidative conditions
in reference
610-81-1) (EC No
in oxidative
the maximum number 205,
210-236-8)
hair dye
concentration
column f (a)
products
applied to hair must
not exceed 1,5 %
(b) Hair
dye (b) 1,0 % (b)
As
mentioned
substance
in reference
in non-
number 208,
oxidative
column f
hair dye
products
216 2,7-Naphtha
(a) Hair
dye
(a) After mixing under (a) As mentioned
lenediol (CAS No
substance
oxidative conditions
in reference
582-17-2) (EC No
in oxidative
the maximum number 205,
209-478-7)
hair dye
concentration
column f (a)
products
applied to hair must
not exceed 1,0 %
(b) Hair
dye (b) 1,0 %
substance
in non-
oxidative
hair dye
products
217 m-Aminophenol Hair dye
After mixing under As mentioned in
(CAS No 591- substance in
oxidative conditions the reference number
27-5) (EC No oxidative hair
maximum concentration 205, column f (a)
209-711-2) and dye products
applied to hair must not
its salts
exceed 1,2 %
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)

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L 125/20
EN
Official Journal of the European Union
14.5.2011
Restrictions
Conditions of use
Ref.
Max. authorised
and warnings which
No
Substance
Field of application concentration in
Other limitations and
must be printed on
and/or use
the finished
requirements
the label
cosmetic
product
218 2,6-Dihydroxy-3,4- Hair dye
After mixing under As mentioned in
dimethylpyridine
substance in
oxidative conditions the reference number
(CAS No 84540- oxidative hair
maximum concentration 205, column f (a)
47-6) (EC No dye products
applied to hair must not
283-141-2)
exceed 1,0 %
222 2-Hydroxyethyl (a) Hair
dye
(a) After mixing under (a) As mentioned
picramic acid (CAS
substance
oxidative conditions
in reference
No 99610-72-7)
in oxidative
the maximum number 205,
(EC No 412- hair dye
concentration
column f (a)
520-9)
products
applied to hair must
not exceed 1,5 %
(b) Hair
dye (b) 2,0 %
For (a) and (b):
substance
in non-
— Do not use with
oxidative
nitrosating agents
hair dye
products
— Maximum
nitro
samine content:
50 μg/kg
— Keep in nitrite-free
containers
223 p-Methylamino
Hair dye
After mixing under As mentioned in
phenol (CAS No substance in
oxidative conditions the reference number
150-75-4) (EC No oxidative hair
maximum concentration 205, column f (a)
205-768-2) and dye products
applied to hair must not
its sulphate
exceed 0,68
% (as
sulphate)
p-Methylamino
phenol sulphate
— Do not use with
(CAS No 55-55-0/
nitrosating agents
1936-57-8) (EC
No 200-237-1/
— Maximum
nitro
217-706-1)
samine content:
50 μg/kg
— Keep in nitrite-free
containers
225 Ethanol, 2-[4- (a) Hair
dye
(a) After mixing under (a) As mentioned
[Ethyl[(2-Hydro
substance
oxidative conditions
in reference
xyethyl)Amino]-2-
in oxidative
the maximum number 205,
Nitrophenyl]-
hair dye
concentration
column f (a)
Amino]-, (CAS No
products
applied to hair must
104516-93-0) and
not exceed 0,75 %
its hydrochloride
(as hydrochloride)
HC Blue No 12
For (a) and (b):
(CAS No 132885-
85-9) (EC No 407-
— Do not use with
020-2)
nitrosating agents
— Maximum
nitro
samine content:
50 μg/kg
— Keep in nitrite-free
containers

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EN
14.5.2011 Official
Journal
of
the
European
Union L
125/21
Restrictions
Conditions of use
Ref.
Max. authorised
and warnings which
No
Substance
Field of application concentration in
Other limitations and
must be printed on
and/or use
the finished
requirements
the label
cosmetic
product
(b) Hair
dye (b) 1,5 % (as
substance
hydro
in non- chloride)
oxidative
hair dye
products
227 3-Amino-2,4-dich
(a) Hair
dye
(a) After mixing under (a) As mentioned
lorophenol (CAS
substance
oxidative conditions
in reference
No 61693-42-3)
in oxidative
the maximum number 205,
(EC No 262-909-
hair dye
concentration
column f (a)
0) and its hydro
products
applied to hair must
chloride
not exceed 1,5 % (as
hydrochloride)
3-Amino-2,4-dich
lorophenol HCl
(CAS No 61693- (b) Hair
dye (b) 1,5 % (as
43-4)
substance
hydro
in non- chloride)
oxidative
hair dye
products
230 Phenyl methyl Hair dye
After mixing under As mentioned in
pyrazolone (CAS substance in
oxidative conditions the reference number
No 89-25-8) (EC oxidative hair
maximum concentration 205, column f (a)
No 201-891-0)
dye products
applied to hair must not
exceed 0,25 %
232 2-Methyl-5-hydro
Hair dye
After mixing under As mentioned in
xyethylamino-
substance in
oxidative conditions the reference number
phenol (CAS No oxidative hair
maximum concentration 205, column f (a)
55302-96-0) (EC dye products
applied to hair must not
No 259-583-7)
exceed 1,5 %
— Do not use with
nitrosating agents
— Maximum
nitro
samine content:
50 μg/kg
— Keep in nitrite-free
containers
234 Hydroxybenzo
Hair dye
After mixing under As mentioned in
morpholine (CAS substance in
oxidative conditions the reference number
No 26021-57-8) oxidative hair
maximum concentration 205, column f (a)
(EC No 247- dye products
applied to hair must not
415-5)
exceed 1,0 %
— Do not use with
nitrosating agents
— Maximum
nitro
samine content:
50 μg/kg
— Keep in nitrite-free
containers

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L 125/22
EN
Official Journal of the European Union
14.5.2011
Restrictions
Conditions of use
Ref.
Max. authorised
and warnings which
No
Substance
Field of application concentration in
Other limitations and
must be printed on
and/or use
the finished
requirements
the label
cosmetic
product
237 2,2’-[(4-Amino-3- (a) Hair
dye
(a) After mixing under (a) As mentioned
nitrophenyl)
substance
oxidative conditions
in reference
imino]bisethanol
in oxidative
the maximum number 205,
(CAS No 29705-
hair dye
concentration
column f (a)
39-3) and its products
applied to hair must
hydrochloride
not exceed 1,25 %
(as hydrochloride)
HC Red No 13
(CAS No 94158-
13-1) (EC No (b) Hair
dye (b) 2,5 % (as
303-083-4
substance
hydro
in non- chloride)
oxidative
hair dye
products
238 2,6-Dimethoxy- Hair dye
After mixing under As mentioned in
3,5-pyridine
substance in
oxidative conditions the reference number
diamine (CAS No oxidative hair
maximum concentration 205, column f (a)
85679-78-3 (free dye products
applied to hair must not
base)) and its
exceed 0,25
% (as
hydrochloride
hydrochloride)
2,6-Dimethoxy-
3,5-pyridine
diamine HCl (CAS
No 56216-28-5)
(EC No 260-
062-1)
239 HC Violet No 1 (a) Hair
dye
(a) After mixing under (a) As mentioned
(CAS No 82576-
substance
oxidative conditions
in reference
75-8) (EC No in oxidative
the maximum number 205,
417-600-7)
hair dye
concentration
column f (a)
products
applied to hair must
not exceed 0,25 %
(b) Hair
dye (b) 0,28 %
For (a) and (b):
(b)
As
mentioned
substance
in reference
in non-
— Do not use with
number 208,
oxidative
nitrosating agents
column f
hair dye
products
— Maximum
nitro
samine content:
50 μg/kg
— Keep in nitrite-free
containers
241 1,5-Naphtha
(a) Hair
dye
(a) After mixing under (a) As mentioned
lenediol (CAS No
substance
oxidative conditions
in reference
83-56-7) (EC No
in oxidative
the maximum number 205,
201-487-4
hair dye
concentration
column f (a)
products
applied to hair must
not exceed 1,0 %
(b) Hair
dye (b) 1,0 %
substance
in non-
oxidative
hair dye
products

---

EN
14.5.2011 Official
Journal
of
the
European
Union L
125/23
Restrictions
Conditions of use
Ref.
Max. authorised
and warnings which
No
Substance
Field of application concentration in
Other limitations and
must be printed on
and/or use
the finished
requirements
the label
cosmetic
product
242 Hydroxypropyl
Hair dye
After mixing under As mentioned in
bis(N-hydro
substance in
oxidative conditions the reference number
xyethyl-p-pheny
oxidative hair
maximum concentration 205, column f (a)
lenediamine) (CAS dye products
applied to hair must not
No 128729-30-6)
exceed 0,4 % (as tetrahy
and its tetrahydro
drochloride)
chloride
Hydroxypropyl
bis(N-hydro
xyethyl-p-pheny
lenediamine) HCl
(CAS No 128729-
28-2) (EC No 416-
320-2)
243 4-Amino-2-
Hair dye
After mixing under As mentioned in
hydroxytoluene
substance in
oxidative conditions the reference number
(CAS No 2835-95- oxidative hair
maximum concentration 205, column f (a)
2) (EC No 220- dye products
applied to hair must not
618-6)
exceed 1,5 %
244 2,4-Diaminophen
Hair dye
After mixing under As mentioned in
oxyethanol (CAS substance in
oxidative conditions the reference number
No 70643-19-5), oxidative hair
maximum concentration 205, column f (a)
its hydrochloride dye products
applied to hair must not
and its sulphate
exceed 2,0 % (as hydro
chloride)
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)
245 2-Methylresorcinol (a) Hair
dye
(a) After mixing under (a) As mentioned
(CAS No 608-25-
substance
oxidative conditions
in reference
3) (EC No 210-
in oxidative
the maximum number 205,
155-8)
hair dye
concentration
column f (a)
products
applied to hair must
not exceed 1,8 %
(b) Hair
dye (b) 1,8 %
substance
in non-
oxidative
hair dye
products
246 4-Amino-m-cresol Hair dye
After mixing under As mentioned in
(CAS No 2835-99- substance in
oxidative conditions the reference number
6) (EC No 220- oxidative hair
maximum concentration 205, column f (a)
621-2)
dye products
applied to hair must not
exceed 1,5 %

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L 125/24
EN
Official Journal of the European Union
14.5.2011
Restrictions
Conditions of use
Ref.
Max. authorised
and warnings which
No
Substance
Field of application concentration in
Other limitations and
must be printed on
and/or use
the finished
requirements
the label
cosmetic
product
248 2-Amino-4-hydro
Hair dye
After mixing under As mentioned in
xyethylami
substance in
oxidative conditions the reference number
noanisole (CAS No oxidative hair
maximum concentration 205, column f (a)
83763-47-7) (EC dye products
applied to hair must not
No 280-733-2)
exceed 1,5
% (as
and its sulphate
sulphate)
2-Amino-4-hydro
— Do not use with
xyethylami
nitrosating agents
noanisole sulphate
(CAS No 83763-
— Maximum
nitro
48-8) (EC No
samine content:
280-734-8)
50 μg/kg
— Keep in nitrite-free
containers
249 Hydroxyethyl-3,4- Hair dye
After mixing under As mentioned in
methylenedio
substance in
oxidative conditions the reference number
xyaniline and its oxidative hair
maximum concentration 205, column f (a)
hydrochloride
dye products
applied to hair must not
exceed 1,5 %
Hydroxyethyl-3,4-
methylenedio
— Do not use with
xyaniline HCl (CAS
nitrosating agents
No 94158-14-2)
(EC No 303-
— Maximum
nitro
085-5)
samine content:
50 μg/kg
— Keep in nitrite-free
containers
250 3-Nitro-p-hydro
(a) Hair
dye
(a) After mixing under (a) As mentioned
xyethylamino-
substance
oxidative conditions
in reference
phenol (CAS No
in oxidative
the maximum number 205,
65235-31-6) (EC
hair dye
concentration
column f (a)
No 265-648-0)
products
applied to hair must
not exceed 3,0 %
(b) Hair
dye (b) 1,85 % (b)
As
mentioned
For (a) and (b):
substance
in reference
in non-
— Do not use with
number 208,
oxidative
nitrosating systems
column f
hair dye
products
— Maximum
nitro
samine content:
50 μg/kg
— Keep in nitrite-free
containers
251 4-Nitrophenyl
(a) Hair
dye
(a) After mixing under (a) As mentioned
aminoethylurea
substance
oxidative conditions
in reference
(CAS No 27080-
in oxidative
the maximum number 205,
42-8) (EC No hair dye
concentration
column f (a)
410-700-1)
products
applied to hair must
not exceed 0,25 %
(b) Hair
dye (b) 0,5 %
For (a) and (b):
substance
in non-
— Do not use with
oxidative
nitrosating agents
hair dye
products
— Maximum
nitro
samine content:
50 μg/kg
— Keep in nitrite-free
containers

---

EN
14.5.2011 Official
Journal
of
the
European
Union L
125/25
Restrictions
Conditions of use
Ref.
Max. authorised
and warnings which
No
Substance
Field of application concentration in
Other limitations and
must be printed on
and/or use
the finished
requirements
the label
cosmetic
product
252 2-Amino-6-chloro- (a) Hair
dye
(a) After mixing under (a) As mentioned
4-nitrophenol
substance
oxidative conditions
in reference
(CAS No 6358-09-
in oxidative
the maximum number 205,
4) (EC No 228-
hair dye
concentration
column f (a)
762-1)
products
applied to hair must
not exceed 2,0 %
(b) Hair
dye (b) 2,0 % (b)
As
mentioned
substance
in reference
in non-
number 208,
oxidative
column f’
hair dye
products
(ii) the entry with reference number 201 is replaced by the following:
‘201 2-Chloro-6-ethy
(a) Hair dye
(a) After mixing under (a) As mentioned
lamino-4-nitro
substance
oxidative conditions
in reference
phenol (CAS No
in oxidative
the maximum
number 205,
131657-78-8) (EC
hair dye
concentration
column f (a)’
No 411-440-1)
products
applied to hair must
not exceed 1,5 %
(b) Hair
dye (b) 3,0 %
(a) and (b):
substance
in non-
— Do not use with
oxidative
nitrosating agents
hair dye
— Maximum
nitro
products
samine content:
50 μg/kg
— Keep in nitrite-free
containers
(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’.

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