HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 208/8
EN
Official Journal of the European Union
3.8.2012
DIRECTIVES
COMMISSION IMPLEMENTING DIRECTIVE 2012/21/EU
of 2 August 2012
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,
2004/210/EC ( 3 ), assessed the safety of individual
substances for which updated files had been submitted
by industry.
Having regard to the Treaty on the Functioning of the European
Union,
(5) The
last
step
of
the
safety
assessment
strategy
was
to
Having regard to Council Directive 76/768/EEC of 27 July
evaluate possible consumer health risk by reaction
1976 on the approximation of the laws of the Member States
products formed by oxidative hair dye substances
relating to cosmetic products (
during the hair dyeing process. Based on the data yet

1 ), and in particular Article 8(2)
thereof,
available, the SCCS raised in its opinion of 21 September
2010 no major concern regarding genotoxicity and carci
nogenicity of hair dyes and their reaction products
After consulting the Scientific Committee on Consumer Safety,
currently used in the EU.
Whereas:
(6)
In the light of the risk assessment of the submitted safety
data and the final opinions given by the SCCS on the
(1) Following
the
publication
of
a
scientific
study
in
2001,
safety of individual substances and of the reaction
entitled ‘Use of permanent hair dyes and bladder cancer
products, it is appropriate to include in Part 1 of
risk’, the Scientific Committee on Cosmetic Products and
Annex III to Directive 76/768/EEC 24 assessed hair
Non-Food Products intended for Consumers,
dyes which are not regulated within Directive
subsequently replaced by the Scientific Committee on
76/768/EEC.
Consumer Products (‘SCCP’), pursuant to Commission
Decision 2004/210/EC ( 2 ), concluded that the potential
risks were of concern. The SCCP recommended that
(7) The
substances
Hydroxyethyl-2-Nitro-p-Toluidine
and
HC
the Commission take further steps to control the use
Red No 10 + HC Red No 11 were provisionally auth
of hair dye substances.
orised for use in hair dye products until 31 December
2011 under the restrictions and conditions laid down in
entries 10 and 50 in Part 2 of Annex III to Directive
(2) The
SCCP
further
recommended
an
overall
safety
76/768/EEC. Based on the final opinions given by the
assessment strategy for hair dye substances including
SCCS on their safety, Hydroxyethyl-2-Nitro-p-Toluidine
the requirements for testing substances used in hair dye
and HC Red No 10 + HC Red No 11 can be considered
products for their potential genotoxicity or mutagenicity.
safe in hair dye products and listed in Part 1 of Annex III
to Directive 76/768/EEC.
(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
(8)
Following the assessment by the SCCS concerning the
substances 1-Naphthol and Resorcinol, listed in Part 1
products according to which the industry was required to
of Annex III to Directive 76/768/EEC, their maximum
submit files, containing updated scientific data on the
authorised concentrations in the finished cosmetic
safety of hair dye substances, for a risk assessment by
product should be changed.
the SCCP.


(4) The
SCCP,
subsequently
replaced
by
the
Scientific (9) Concerning
the
substance
HC
Red
No
16,
the
SCCS
Committee on Consumer Safety (‘SCCS’) pursuant to
stated in its opinion of 14 December 2010 that based
Commission Decision 2008/721/EC of 5 August 2008
on the low margin of safety for the use in both oxidative
setting up an advisory structure of Scientific Committees
and non-oxidative hair dye formulations, HC Red No 16
and experts in the field of consumer safety, public health
poses a risk to the health of the consumer. Therefore, HC
and the environment and repealing Decision
Red No 16 should be listed in Annex II to Directive
76/768/EEC.
( 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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EN
3.8.2012 Official
Journal
of
the
European
Union L
208/9
(10) Directive 76/768/EEC should therefore be amended
reference on the occasion of their official publication. Member
accordingly.
States shall determine how such reference is to be made.
(11) The
measures provided for in this Directive are in
2. Member
States
shall
communicate
to
the
Commission
the
accordance with the opinion of the Standing
text of the main provisions of national law which they adopt in
Committee on Cosmetic Products,
the field covered by this Directive.
HAS ADOPTED THIS DIRECTIVE:
Article 3
Article 1
This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
Annexes II and III to Directive 76/768/EEC are amended in
European Union.
accordance with the Annex to this Directive.
Article 4
Article 2
This Directive is addressed to the Member States.
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.
Done at Brussels, 2 August 2012.
They shall apply those provisions from 1 September 2013.
For the Commission
When Member States adopt those provisions, they shall contain
The President
a reference to this Directive or be accompanied by such a
José Manuel BARROSO

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L 208/10
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
EN

‘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:
Restrictions
Ref. No Substance
Conditions of use and warnings
Off
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
icial
Jour
a
b
c
d
e
f
nal
‘253 2,2′-[(4-Aminophenyl))imino]bis
Hair dye substance in oxidative
After mixing under oxidative As mentioned in reference
of
(ethanol) sulphate
hair dye products
conditions the maximum concen number 205, column f (a)
the
tration applied to hair must not
N,N-bis(2-Hydroxyethyl)-
exceed 2,5 % (calculated as sulphate)
European
p-Phenylenediamine Sulfate
— Do not use with nitrosating agents
CAS No 54381-16-7
— Maximum nitrosamine content:
Union
EC No 259-134-5
50 μg/kg
— Keep in nitrite-free containers
254 1,3-Benzenediol,
4-chloro-
Hair dye substance in oxidative
After mixing under oxidative As mentioned in reference
hair dye products
conditions the maximum concen number 205, column f (a)
4-Chlororesorcinol
tration applied to hair must not
exceed 2,5 %
CAS No 95-88-5
EC No 202-462-0
255 2,4,5,6-Tetraaminopyrimidine
(a) Hair dye substance in
(a) After mixing under oxidative (a) As mentioned in reference
sulphate
oxidative hair dye products
conditions the maximum concen
number 205, column f (a)
tration applied to hair must not
Tetraaminopyrimidine Sulfate
exceed 3,4
% (calculated as
sulphate)
CAS No 5392-28-9
3.8.2012
(b) Hair dye substance in non- (b) 3,4 % (calculated as
EC No 226-393-0
oxidative hair dye products
sulphate)

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3.8.2012 Off
a
b
c
d
e
f
256 3-(2-Hydroxyethyl)-p- Hair dye substance in oxidative
After mixing under oxidative As mentioned in reference
phenylenediammonium sulphate
hair dye products
conditions the maximum concen number 205, column f (a)
tration applied to hair must not
Hydroxyethyl-p-
exceed 2,0 % (calculated as sulphate)
Phenylenediamine Sulfate
EN
CAS No 93841-25-9

EC No 298-995-1
257 1H-Indole-5,6-diol
(a) Hair dye substance in
(a) After mixing under oxidative (a) As mentioned in reference
oxidative hair dye products
conditions the maximum concen
number 205, column f (a)
Dihydroxyindole
tration applied to hair must not
exceed 0,5 %
CAS No 3131-52-0
(b) Hair dye substance in non- (b) 0,5 % (b)
As
mentioned
in
reference
EC No 412-130-9
oxidative hair dye products
number 208, column f
icial
258 5-Amino-4-chloro-2-methylphenol
Hair dye substance in oxidative
After mixing under oxidative As mentioned in reference
Jour
hydrochloride
hair dye products
conditions the maximum concen number 205, column f (a)
nal
tration applied to hair must not
5-Amino-4-Chloro-o-Cresol HCl
exceed 1,5 % (calculated as hydro
of
chloride)
the
CAS No 110102-85-7
European
259 1H-Indol-6-ol
Hair dye substance in oxidative
After mixing under oxidative As mentioned in reference
hair dye products
conditions the maximum concen number 205, column f (a)
6-Hydroxyindole
tration applied to hair must not
Union
exceed 0,5 %
CAS No 2380-86-1
EC No 417-020-4
260 1H-Indole-2,3-Dione
Hair dye substance in non- 1,6 % As
mentioned
in
reference
oxidative hair dye products
number 208, column f
Isatin
CAS No 91-56-5
EC No 202-077-8
261 2-Aminopyridin-3-ol
Hair dye substance in oxidative
After mixing under oxidative As mentioned in reference
hair dye products
conditions the maximum concen number 205, column f (a)
2-Amino-3-Hydroxypyridine
tration applied to hair must not
exceed 1,0 %
L
CAS No 16867-03-1
208/11
EC No 240-886-8

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L 208/12
a
b
c
d
e
f
262 2-Methyl-1-naphthyl
acetate
Hair dye substance in oxidative
After mixing under oxidative As mentioned in reference
hair dye products
conditions the maximum concen number 205, column f (a)
1-Acetoxy-2-Methylnaphthalene
tration applied to hair must not
exceed 2,0 % (When both 2-Methyl-
CAS No 5697-02-9
1-Naphthol and 1-Acetoxy-2-Methyl
naphthalene are present in a hair
EN
EC No 454-690-7
dye formulation, the maximum

concentration on the head of 2-
Methyl-1-Naphthol should not
exceed 2,0 %.)
263 1-Hydroxy-2-methylnaphthalene
Hair dye substance in oxidative
After mixing under oxidative As mentioned in reference
hair dye products
conditions the maximum concen number 205, column f (a)
2-Methyl-1-Naphthol
tration applied to hair must not
exceed 2,0 % (When both 2-Methyl-
CAS No 7469-77-4
1-Naphthol and 1-Acetoxy-2-Methyl
Off
naphthalene are present in a hair
EC No 231-265-2
dye formulation, the maximum
icial
concentration on the head of 2-
Jour
Methyl-1-Naphthol should not
exceed 2,0 %.)
nal
of
264 Disodium
5,7-dinitro-8-oxido-2-
(a) Hair dye substance in
(a) After mixing under oxidative (a) As mentioned in reference
the
naphthalenesulfonate
oxidative hair dye products
conditions the maximum concen
number 205, column f (a)
tration applied to hair must not
European
Acid Yellow 1
exceed 1,0 %
CAS No 846-70-8
(b) Hair dye substance in non- (b) 0,2 % (b)
As
mentioned
in
reference
Union
oxidative hair dye products
number 208, column f
EC No 212-690-2
CI 10316
265 4-Nitro-1,2-phenylenediamine
Hair dye substance in oxidative
After mixing under oxidative As mentioned in reference
hair dye products
conditions the maximum concen number 205, column f (a)
4-Nitro-o-Phenylenediamine
tration applied to hair must not
exceed 0,5 %
CAS No 99-56-9
EC No 202-766-3
266 2-(4-Amino-3-nitroanilino)ethanol
Hair dye substance in non- 1,0 % —
Do
not
use
with
nitrosating
agents
As mentioned in reference
oxidative hair dye products
number 208, column f
HC Red No 7
— Maximum nitrosamine content:
50 μg/kg
3.8.2012
CAS No 24905-87-1
— Keep in nitrite-free containers
EC No 246-521-9

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3.8.2012 Off
a
b
c
d
e
f
267 2-[bis(2-Hydroxyethyl)amino]-5-
Hair dye substance in non- 1,5 % —
Do
not
use
with
nitrosating
agents
nitrophenol
oxidative hair dye products
— Maximum nitrosamine content:
HC Yellow No 4
50 μg/kg
CAS No 59820-43-8
— Keep in nitrite-free containers
EN

EC No 428-840-7
268 2-[(2-Nitrophenyl)amino] (a) Hair dye substance in
(a) After mixing under oxidative (a) As mentioned in reference
ethanol
oxidative hair dye products
conditions the maximum concen
number 205, column f (a)
tration applied to hair must not
HC Yellow No 2
(b) Hair dye substance in non- (b) 1,0 %
exceed 0,75 %
oxidative hair dye products
CAS No 4926-55-0
For (a) and (b):
EC No 225-555-8
— Do not use with nitrosating agents
icial
— Maximum nitrosamine content:
50 μg/kg
Jour
nal
— Keep in nitrite-free containers
of
the
269 4-[(2-Nitrophenyl)amino]phenol
Hair dye substance in non- 1,0 %
oxidative hair dye products
European
HC Orange No 1
CAS No 54381-08-7
Union
EC No 259-132-4
270 2-Nitro-N1-phenyl-benzene-1,4-
Hair dye substance in non- 1,0 % As
mentioned
in
reference
diamine
oxidative hair dye products
number 208, column f
HC Red No 1
CAS No 2784-89-6
EC No 220-494-3
271 1-Methoxy-3-(β-aminoethyl)
Hair dye substance in non- 0,5 % (calculated as hydro — Do not use with nitrosating agents
amino-4-nitrobenzene,
oxidative hair dye products
chloride)
hydrochloride
— Maximum nitrosamine content:
50 μg/kg
HC Yellow No 9
— Keep in nitrite-free containers
L
CAS No 86419-69-4
208/13
EC No 415-480-1

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L 208/14
a
b
c
d
e
f
272 1-(4’-Aminophenylazo)-2-methyl-
Hair dye substance in non- 0,25 %
4-(bis-2-hydroxyethyl)
oxidative hair dye products
aminobenzene
HC Yellow No 7
EN
CAS No 104226-21-3

EC No 146-420-6
273 N-(2-Hydroxyethyl)-2-nitro-4-
(a) Hair dye substance in
(a) After mixing under oxidative (a) As mentioned in reference
trifluormethyl-aniline
oxidative hair dye products
conditions the maximum concen
number 205, column f (a)
tration applied to hair must not
HC Yellow No 13
(b) Hair dye substance in non- (b) 2,5 %
exceed 2,5 %
oxidative hair dye products
CAS No 10442-83-8
For (a) and (b):
EC No 443-760-2
Off
— Do not use with nitrosating agents
icial
— Maximum nitrosamine content:
50 μg/kg
Jour
nal
— Keep in nitrite-free containers
of
274 Benzenaminium,
3-[(4,5-dihydro-
Hair dye substance in non- 2,0 %
the
3-methyl-5-oxo-1-phenyl-1H-
oxidative hair dye products
European
pyrazol-4-yl)azo]-N,N,Ntrimethyl-,
chloride
Basic Yellow 57
Union
CAS No 68391-31-1
EC No 269-943-5
275 Ethanol,
2,2′-[[4-[(4-aminophenyl) Hair dye substance in non- 0,3 % (of the mixture in the
azo]phenyl]imino]bis-
oxidative hair dye products
ratio 1:1 of 2,2’-[4-(4-
aminophenylazo)phenylimino]
Disperse Black 9
diethanol and lignosulfate)
CAS No 20721-50-0
EC No 243-987-5
276 9,10-Anthracenedione,
1,4-bis
Hair dye substance in non- 0,3 % —
Do
not
use
with
nitrosating
agents
[(2,3-dihydroxypropyl)amino]-
oxidative hair dye products
— Maximum nitrosamine content:
HC Blue No 14
50 μg/kg
3.8.2012
CAS No 99788-75-7
— Keep in nitrite-free containers
EC No 421-470-7

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3.8.2012 Off
a
b
c
d
e
f
277 2-(4-Methyl-2-nitroanilino)ethanol
(a) Hair dye substance in
(a) After mixing under oxidative (a) As mentioned in reference
oxidative hair dye products
conditions the maximum concen
number 205, column f (a)
Hydroxyethyl-2-Nitro-p-Toluidine
tration applied to hair must not
(b) Hair dye substance in non- (b) 1,0 %
exceed 1,0 %
CAS No 100418-33-5
oxidative hair dye products
For (a) and (b):
EC No 408-090-7
EN

— Do not use with nitrosating agents
— Maximum nitrosamine content:
50 μg/kg
— Keep in nitrite-free containers
278 1-Amino-2-nitro-4-(2′,3′-
(a) Hair dye substance in
(a) After mixing under oxidative (a) As mentioned in reference
dihydroxypropyl)amino-5-
oxidative hair dye products
conditions the maximum concen
number 205, column f (a)’
chlorobenzene + 1,4-bis-(2′,3′-
tration applied to hair must not
dihydroxypropyl)amino-2-nitro-
(b) Hair dye substance in non- (b) 2,0 %
exceed 1,0 %
5-chlorobenzene
oxidative hair dye products
For (a) and (b):
icial
HC Red No 10 + HC Red No 11
— Do not use with nitrosating agents
Jour
CAS No 95576-89-9 + 95576-
nal
92-4
— Maximum nitrosamine content:
50 μg/kg
of
the
— Keep in nitrite-free containers
European
(ii) the entries with reference numbers 16 and 22 are replaced by the following:
Restrictions
Union
Ref. No Substance
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-Naphthalenol
Hair dye substance in oxidative
After mixing under oxidative As mentioned in reference
hair dye products
conditions the maximum concen number 205, column f (a)
1-Naphthol
tration applied to hair must not
exceed 2,0 %
CAS No 90-15-3
EC No 201-969-4
22 1,3-benzenediol
(a) Hair dye substance in
(a) After mixing under oxidative (a) 1. Contains resorcinol
oxidative hair dye products
conditions the maximum concen
Resorcinol
tration applied to hair must not
Rinse hair well after appli
exceed 1,25 %
cation.
L
CAS No 108-46-3
1. general use
208/15
EC No 203-585-2
2. professional use

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L 208/16
a
b
c
d
e
f
Do not use to dye
eyelashes or eyebrows.
Rinse eyes immediately if
product comes into
contact with them.
EN

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
Off
number 205, column f (a)
icial
Jour
(b) Hair lotions and
(b) 0,5 % (b)
Contains
resorcinol.’
nal
shampoos
of
the
(b) in Part 2 the entries with reference numbers 10 and 50 are deleted.
European
Union
3.8.2012

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Document Outline

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