HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 315/34
EN
Official Journal of the European Union
26.11.2013
COMMISSION REGULATION (EU) No 1197/2013
of 25 November 2013
amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the
Council on 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 the industry.
Having regard to the Treaty on the Functioning of the European
Union,
(5) As
regards
the
evaluation
of
possible
consumer
health
risks by reaction products formed by oxidative hair dye
Having regard to Regulation (EC) No 1223/2009 of the
substances during the hair dyeing process, based on the
European Parliament and of the Council of 30 November
data yet available, the SCCS, in its opinion of
2009 on cosmetic products ( 1 ), and in particular Article 31(1)
21 September 2010, did not raise any major concern
thereof,
regarding genotoxicity and carcinogenicity of hair dyes
and their reaction products currently used in the Union.
After consulting the Scientific Committee on Consumer Safety,
(6) In
order
to
ensure
the
safety
of
hair
dye
products
for
human health it is appropriate to limit the maximum
Whereas:
concentrations of 21 assessed hair dye substances and
to list them in Annex III to Regulation (EC) No
1223/2009, by taking into account the final opinions
(1) Following
the
publication
of
a
scientific
study
in
2001,
given by the SCCS on their safety.
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
(7)
Following the assessment by the SCCS concerning the
Consumer Products (‘SCCP’), pursuant to Commission
substance Toluene-2,5-Diamine, listed in entry 9a of
Decision 2004/210/EC of 3 March 2004 setting up
Annex III to Regulation (EC) No 1223/2009, it is appro
Scientific Committees in the field of consumer safety,
priate to change the maximum authorised concentrations
public health and the environment (
thereof in the finished cosmetic product.

2 ), concluded that
the potential risks of the use of hair dyes were of
concern. The SCCP, in its opinions, recommended that
the Commission take further steps to control the use of
(8) The
definition
of
a
hair
product
in
Regulation
(EC)
No
hair dye substances.
1223/2009 excluded its application on eyelashes. This
exclusion was motivated by the fact that the level of
risk is different when cosmetic products are applied on
(2) The
SCCP
further
recommended
an
overall
safety
the hair on the head and on eyelashes respectively. A
assessment strategy for hair dye substances including
specific safety assessment was therefore needed for the
the requirements for testing substances used in hair dye
application of hair dye substances on eyelashes.
products for their potential genotoxicity or mutagenicity.
(9) The
SCCS,
in
its
opinion
on
oxidative
hair
dye
substances
(3)
Following the opinions of the SCCP, the Commission
and hydrogen peroxide used in products to colour
agreed with Member States and stakeholders on an
eyelashes of 12 October 2012, concluded that
overall strategy to regulate substances used in hair dye
oxidative hair dye substances p-Phenylenediamine, Resor
products according to which the industry was required to
cinol, 6-Methoxy-2-Methylamino-3-Aminopyridine HCl,
submit files, containing updated scientific data on the
m-Aminophenol, 2-Methyl-5-Hydroxyethyl Aminop
safety of hair dye substances, for a risk assessment by
henol, 4-Amino-2-Hydroxytoluene, 2,4-Diaminophen
the SCCP.
oxyethanol HCl, 4-Amino-m-Cresol, 2-Amino-4-Hydro
xyethylaminoanisole and 2,6-Diaminopyridine, listed in
Annex III to Regulation (EC) No 1223/2009 and found
(4) The
SCCP,
subsequently
replaced
by
the
Scientific
safe for use in hair dye products, can be safely used by
Committee on Consumer Safety (‘SCCS’) pursuant to
professionals in products intended for colouring
Commission Decision 2008/721/EC of 5 August 2008
eyelashes. In addition, the SCCS concluded that up to
setting up an advisory structure of Scientific Committees
2 % of hydrogen peroxide, which is listed under entry
and experts in the field of consumer safety, public health
12 in Annex III to Regulation (EC) No 1223/2009, can
and the environment and repealing Decision
be considered safe for consumers when applied on
eyelashes.
( 1 ) OJ L 342, 22.12.2009, p. 59.
( 2 ) OJ L 66, 4.3.2004, p. 45.
( 3 ) OJ L 241, 10.9.2008, p. 21.

---

EN
26.11.2013 Official
Journal
of
the
European
Union L
315/35
(10) On the basis of the scientific assessment of those
(14) The
measures
provided
for
in
this
Regulation
are
in
substances their use should be allowed in products
accordance with the opinion of the Standing
intended for colouring eyelashes in the same concen
Committee on Cosmetic Products,
trations as in hair dye products. However, in order to
avoid any risk connected with the self-application of
HAS ADOPTED THIS REGULATION:
products intended for colouring eyelashes by consumers,
they should be allowed for professional use only. In
Article 1
order to allow professionals to inform consumers
about possible adverse effects of eyelash colouring and
Annex III to Regulation (EC) No 1223/2009 is amended in
to lower the risk of skin sensitisation to those products,
accordance with the Annex to this Regulation.
appropriate warnings should be printed on their labels.
Article 2
(11) Regulation
(EC) No 1223/2009 should therefore be
This Regulation shall enter into force on the day following that
amended accordingly.
of its publication in the Official Journal of the European Union.
It shall apply from 11 July 2013.
(12) In order to avoid a disruption on the market due to the
transition from Council Directive 76/768/ECC of 27 July
However, the following provisions in the Annex shall apply
1976 on cosmetic products ( 1 ) to Regulation (EC) No
from 1 July 2014:
1223/2009, this Regulation should apply from the
same date as Regulation (EC) No 1223/2009.
(a) the provisions in column ‘i’ of point 1 and of points 3 to 9
relating to the use of the substances in products intended
(13) A sufficient transition period should be granted to
for colouring eyelashes;
economic operators in order to comply with the new
warnings for products intended for colouring eyelashes.
(b) points 2 and 10.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 November 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 262, 27.9.1976, p. 169.

---

L 315/36
ANNEX
Annex III to Regulation (EC) No 1223/2009 is amended as follows:
(1) the following entry 8b is inserted:
a
b
c
d
e
f
g
h
i
EN

‘8b p-Phenylene
p-Phenylenediamine;
106-50-3 /
203-404-7 /
Products intended for
After mixing under oxidative To be printed on the label:
diamine and its
624-18-0 /
210-834-9 /
colouring eyelashes
conditions the maximum
salts
p-Phenylenediamine
16245-77-5
240-357-1
concentration applied to
The mixing ratio.
HCl;
eyelashes must not exceed
2 % calculated as free base
“For professional use only.
p-Phenylenediamine
Sulphate
For professional use only.
This product can cause severe
allergic reactions.
Off
icial
Read and follow instructions.
Jour
This product is not intended for use on
nal
persons under the age of 16.
of
the
Temporary ‘black henna’ tattoos may
European
increase the risk of allergy.
Eyelashes shall not be coloured if the
consumer:
Union
— has a rash on the face or sensitive,
irritated and damaged scalp,
— has experienced any reaction after
colouring hair or eyelashes,
— has experienced a reaction to a
temporary ‘black henna’ tattoo in
the past.
Rinse eyes immediately if product
comes into contact with them.
26.11.2013
Contains phenylenediamines.
Wear suitable gloves.” ’

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26.11.2013 Off
(2) entry 9a is replaced by the following:
a
b
c
d
e
f
g
h
i
‘9a) 1,4-Benzene
Toluene-2,5-Diamine
95-70-5
202-442-1
Hair dye substance in
(a) General use (a)
To
be
printed
on
the
label:
diamine, 2-
oxidative hair dye
methyl-
Toluene-2,5-Diamine
615-50-9
210-431-8
products
The mixing ratio.
sulfate (1 )
EN
2,5-Diamino
“ Hair
colorants
can
cause

toluene sulphate
severe allergic reactions.
Read and follow instructions.
This product is not intended for
use on persons under the age
of 16.
Temporary ‘black henna’ tattoos
may increase your risk of allergy.
Do not colour your hair if:
icial
— you have a rash on your face
Jour
or sensitive, irritated and
damaged scalp,
nal
of
— you have ever experienced any
the
reaction after colouring your
hair,
European
— you have experienced a
reaction to a temporary ‘black
henna’ tattoo in the past.
Union
Contains phenylenediamines
(toluenediamines).
Do not use to dye eyelashes or
eyebrows.”
(b) Professional use
(b) To be printed on the label:
For (a) and (b): After mixing
The mixing ratio.
under oxidative conditions the
maximum concentration
“For professional use only
applied to hair must not
exceed 2 % (calculated as free
Hair colorants can cause severe
base) or 3,6 % (calculated as
allergic reactions.
sulfate salt)
Read and follow instructions.
L
This product is not intended for
315/37
use on persons under the age
of 16.

---

L 315/38
a
b
c
d
e
f
g
h
i
Temporary ‘black henna’ tattoos
may increase your risk of allergy.
Do not colour your hair if:
— you have a rash on your face
EN
or sensitive, irritated and

damaged scalp,
— you have ever experienced any
reaction after colouring your
hair,
— you have experienced a
reaction to a temporary ‘black
henna’ tattoo in the past.
Contains phenylenediamines
(toluenediamines).
Off
icial
Wear suitable gloves.” ’
Jour
nal
(3) entry 12 is replaced by the following:
of
the
a
b
c
d
e
f
g
h
i
European
‘12 Hydrogen
Hydrogen peroxide 7722-84-1 231-765-0 (a)
Hair
products (a)
12
%
of
For (a) and (f): Wear suitable gloves
peroxide and
H 2O 2 (40
other compounds
volumes),
For (a) (b) (c) and (e):
or mixtures that
present or
Union
release hydrogen
released
peroxide,
Contains hydrogen peroxide.
including
(b) Skin products (b)
4
%
of
carbamide
Avoid contact with eyes.
H
peroxide and zinc

2O 2,
present or
peroxide
released
Rinse immediately if product comes
into contact with them.
(c) Nail hardening
(c) 2 % of
products
H 2O 2,
present or
released
(d) Oral products,
(d) ≤ 0,1 % of
including mouth
H 2O 2,
rinse, tooth paste
present or
26.11.2013
and tooth
released
whitening or
bleaching
products

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26.11.2013 Off
a
b
c
d
e
f
g
h
i
(e) Tooth whitening (e) > 0,1 %
(e) To be only sold to dental (e) Concentration of H 2O 2 present or
or bleaching
≤ 6 % of
practitioners.
released indicated in percentage.
products
H 2O 2,
present or
For each cycle of use, first
Not to be used on a person under
released
use by dental practi
18 years of age.
EN
tioners as defined under

Directive 2005/36/EC (5 )
To be only sold to dental practi
or under their direct
tioners. For each cycle of use, the
supervision if an
first use to be only done by dental
equivalent level of safety
practitioners or under their direct
is ensured. Afterwards to
supervision if an equivalent level
be provided to the
of safety is ensured. Afterwards to
consumer to complete
be provided to the consumer to
the cycle of use.
complete the cycle of use.
Not to be used on a
person under 18 years of
icial
age.
Jour
(f) Products
(f) 2
% of
(f) For professional use only (f) To
be
printed
on
the
label:
nal
intended for
H 2O 2,
of
eyelashes
present or
“For professional use only.
the
released
European
Avoid contact with eyes.
Rinse eyes immediately if product
comes into contact with them.
Union
Contains hydrogen peroxide.”
(5 ) OJ L 255, 30.9.2005, p. 22.’
(4) entry 22 is replaced by the following:
a
b
c
d
e
f
g
h
i
‘22 1,3-benzenediol Resorcinol 108-46-3 203-585-2 (a)
Hair
dye
For (a) and (b):
(a) To be printed on the label:
substance in
oxidative hair
After mixing under oxidative
The mixing ratio.
dye products
conditions the maximum
L
concentration applied to hair
“ Hair
colorants
can
cause
315/39
or eyelashes must not exceed
severe allergic reactions.
1,25 %

---

L 315/40
a
b
c
d
e
f
g
h
i
Read and follow instructions.
This product is not intended for
use on persons under the age
of 16.
EN
Temporary ‘black henna’ tattoos

may increase your risk of allergy.
Do not colour your hair if:
— you have a rash on your face
or sensitive, irritated and
damaged scalp,
— you have ever experienced any
Off
reaction after colouring your
icial
hair,
Jour
— you have experienced a
reaction to a temporary ‘black
nal
henna’ tattoo in the past.
of
the
Contains resorcinol.
European
Rinse hair well after application.
Rinse eyes immediately if product
Union
comes into contact with them.
Do not use to dye eyelashes or
eyebrows.”
(b) Products
(b) For professional use only. (b) To
be
printed
on
the
label:
intended for
colouring
The mixing ratio.
eyelashes
“For professional use only.
Contains resorcinol.
This product can cause severe
allergic reactions.
26.11.2013
Read and follow instructions.

---

26.11.2013 Off
a
b
c
d
e
f
g
h
i
This product is not intended for
use on persons under the age
of 16.
Temporary ‘black henna’ tattoos
may increase the risk of allergy.
EN

Eyelashes shall not be coloured if
the consumer:
— has a rash on the face or
sensitive, irritated and
damaged scalp,
— has experienced any reaction
after colouring hair or
eyelashes,
icial
— has experienced a reaction to a
Jour
temporary ‘black henna’ tattoo
in the past.
nal
of
Rinse eyes immediately if product
the
comes into contact with them.”
European
(c) Hair lotions and (c) 0,5 % (c)
Contains
resorcinol.’
shampoos
Union
(5) entry 203 is replaced by the following:
a
b
c
d
e
f
g
h
i
‘203 6-Methoxy-N2- 6-Methoxy-2-Methyl
90817-34-8 / – / 280-622-9 (a) Hair
dye
For (a) and (c): After mixing (a) To be printed on the label:
methyl-2,3-pyri
amino-3-Amin
83732-72-3
substance in
under oxidative conditions the
dinediamine
opyridine HCl
oxidative hair
maximum concentration
The mixing ratio.
hydrochloride and
dye products
applied to hair or eyelashes
dihydrochloride
must not exceed 0,68 %
salt (17 )
calculated as free base (1,0 %
“ Hair
colorants
can
cause
as dihydrochloride).
severe allergic reactions.
Read and follow instructions.
L
This product is not intended for
315/41
use on persons under the age
of 16.

---

L 315/42
a
b
c
d
e
f
g
h
i
Temporary ‘black henna’ tattoos
may increase your risk of allergy.
Do not colour your hair if:
EN
— you have a rash on your face

or sensitive, irritated and
damaged scalp,
— you have ever experienced any
reaction after colouring your
hair,
— you have experienced a
reaction to a temporary ‘black
Off
henna’ tattoo in the past.”
icial
Jour
(b) Hair dye
(b) 0,68 % as For (a) (b) and (c):
(b) Can cause allergic reaction
substance in
free base
nal
non-oxidative
(1,0 % as
— Do not use with nitro
of
hair dye products
dihydro
sating agents
the
chloride)
European
— Maximum nitrosamine
content: 50 μg /kg
— Keep in nitrite-free
Union
containers
(c) Products
(c) For professional use only. (c) To
be
printed
on
the
label:
intended for
colouring
The mixing ratio.
eyelashes
“For professional use only.
This product can cause severe
allergic reactions.
Read and follow instructions.
26.11.2013
This product is not intended for
use on persons under the age
of 16.

---

26.11.2013 Off
a
b
c
d
e
f
g
h
i
Temporary ‘black henna’ tattoos
may increase the risk of allergy.
Eyelashes shall not be coloured if
the consumer:
EN

— has a rash on the face or
sensitive, irritated and
damaged scalp,
— has experienced any reaction
after colouring hair or
eyelashes,
— has experienced a reaction to a
temporary ‘black henna’ tattoo
in the past.
icial
Jour
Rinse eyes immediately if product
comes into contact with them.” ’
nal
of
the
(6) entry 217 is replaced by the following:
European
a
b
c
d
e
f
g
h
i
Union
‘217 m-Aminophenol m-Aminophenol
591-27-5 /
209-711-2 /
(a) Hair dye
For (a) and (b): After mixing (a) To be printed on the label:
and its salts
51-81-0 /
200-125-2 /
substance in
under oxidative conditions the
68239-81-6
269-475-1
oxidative hair
maximum concentration
m-Aminophenol HCl
/38171-54-9
dye products
applied to hair or eyelashes
The mixing ratio.
must not exceed 1,2 %
m-Aminophenol
“ Hair
colorants
can
cause
sulfate
severe allergic reactions.
Read and follow instructions.
This product is not intended for
use on persons under the age
of 16.
L
Temporary ‘black henna’ tattoos
315/43
may increase your risk of allergy.

---

L 315/44
a
b
c
d
e
f
g
h
i
Do not colour your hair if:
— you have a rash on your face
or sensitive, irritated and
damaged scalp,
EN

— you have ever experienced any
reaction after colouring your
hair,
— you have experienced a
reaction to a temporary ‘black
henna’ tattoo in the past.”
Off
(b) Products
(b) For professional use only. (b) To
be
printed
on
the
label:
icial
intended for
colouring
Jour
The mixing ratio.
eyelashes
nal
“For professional use only.
of
the
This product can cause severe
European
allergic reactions.
Read and follow instructions.
Union
This product is not intended for
use on persons under the age
of 16.
Temporary ‘black henna’ tattoos
may increase the risk of allergy.
Eyelashes shall not be coloured if
the consumer:
— has a rash on the face or
sensitive, irritated and damaged
scalp,
— has experienced any reaction
26.11.2013
after colouring hair or
eyelashes,

---

26.11.2013 Off
a
b
c
d
e
f
g
h
i
— has experienced a reaction to a
temporary ‘black henna’ tattoo
in the past.
Rinse eyes immediately if product
comes into contact with them.” ’
EN

(7) entry 229 is replaced by the following:
a
b
c
d
e
f
g
h
i
‘229 5-[(2-Hydroxye
2-Methyl-5-Hydro
55302-96-0 259-583-7 (a)
Hair
dye
For (a) and (b): After mixing (a) To be printed on the label:
thyl)amino]-o-
xyethyl Aminophenol
substance in
under oxidative conditions the
cresol
oxidative hair
maximum concentration
The mixing ratio.
dye products
applied to hair or eyelashes
icial
must not exceed 1,5 %
“ Hair
colorants
can
cause
severe allergic reactions.
Jour
— Do not use with nitro
nal
sating agents
Read and follow instructions.
of
— Maximum nitrosamine
This product is not intended for
the
content: 50 μg /kg
use on persons under the age
European
of 16.
— Keep in nitrite-free
containers
Temporary ‘black henna’ tattoos
may increase your risk of allergy.
Union
Do not colour your hair if:
— you have a rash on your face
or sensitive, irritated and
damaged scalp,
— you have ever experienced any
reaction after colouring your
hair,
— you have experienced a
reaction to a temporary ‘black
henna’ tattoo in the past.”
(b) Products
(b) For professional use only. (b) To
be
printed
on
the
label:
L
intended for
315/45
colouring
The mixing ratio.
eyelashes

---

L 315/46
a
b
c
d
e
f
g
h
i
“For professional use only.
This product can cause severe
allergic reactions.
EN
Read and follow instructions.

This product is not intended for
use on persons under the age
of 16.
Temporary ‘black henna’ tattoos
may increase the risk of allergy.
Eyelashes shall not be coloured if
Off
the consumer:
icial
— has a rash on the face or
Jour
sensitive, irritated and
damaged scalp,
nal
of
— has experienced any reaction
the
after colouring hair or
European
eyelashes,
— has experienced a reaction to a
temporary ‘black henna’ tattoo
Union
in the past.
Rinse eyes immediately if product
comes into contact with them.” ’
(8) entries 241 and 242 are replaced by the following:
a
b
c
d
e
f
g
h
i
‘241 5-Amino-o-cresol 4-Amino-2-Hydroxy
2835-95-2 220-618-6 (a)
Hair
dye
For (a) and (b): After mixing (a) To be printed on the label:
toluene
substance in
under oxidative conditions the
oxidative hair
maximum concentration
The mixing ratio.
dye products
applied to hair or eyelashes
26.11.2013
must not exceed 1,5 %
“ Hair
colorants
can
cause
severe allergic reactions.

---

26.11.2013 Off
a
b
c
d
e
f
g
h
i
Read and follow instructions.
This product is not intended for
use on persons under the age
of 16.
EN

Temporary ‘black henna’ tattoos
may increase your risk of allergy.
Do not colour your hair if:
— you have a rash on your face
or sensitive, irritated and
damaged scalp,
— you have ever experienced any
reaction after colouring your
icial
hair,
Jour
— you have experienced a
nal
reaction to a temporary ‘black
henna’ tattoo in the past.”
of
the
(b) Products
(b) For professional use only. (b) To
be
printed
on
the
label:
European
intended for
colouring
The mixing ratio.
eyelashes
Union
“For professional use only.
This product can cause severe
allergic reactions.
Read and follow instructions.
This product is not intended for
use on persons under the age
of 16.
Temporary ‘black henna’ tattoos
may increase the risk of allergy.
Eyelashes shall not be coloured if
the consumer:
L
315/47
— has a rash on the face or
sensitive, irritated and damaged
scalp,

---

L 315/48
a
b
c
d
e
f
g
h
i
— has experienced any reaction
after colouring hair or
eyelashes,
— has experienced a reaction to a
temporary ‘black henna’ tattoo
EN

in the past.
Rinse eyes immediately if product
comes into contact with them.”
242 2,4-Diaminophen 2,4-Diaminophenoxy
70643-19-5/
– / 266-357-1 (a) Hair dye
For (a) and (b): After mixing (a) To be printed on the label:
oxyethanol, its
ethanol HCl
66422-95-5 / / 274-713-2
substance in
under oxidative conditions the
hydrochloride and
70643-20-8
oxidative hair
maximum concentration
The mixing ratio.
its sulphate
2,4-Diaminophenoxy
dye products
applied to hair or eyelashes
Off
ethanol sulfate
must not exceed 2,0 % (as
hydrochloride)
“ Hair
colorants
can
cause
icial
severe allergic reactions.
Jour
Read and follow instructions.
nal
of
This product is not intended for
the
use on persons under the age
of 16.
European
Temporary ‘black henna’ tattoos
may increase your risk of allergy.
Union
Do not colour your hair if:
— you have a rash on your face
or sensitive, irritated and
damaged scalp,
— you have ever experienced any
reaction after colouring your
hair,
— you have experienced a
reaction to a temporary ‘black
henna’ tattoo in the past.”
26.11.2013
(b) Products
(b) For professional use only. (b) To
be
printed
on
the
label:
intended for
colouring
The mixing ratio.
eyelashes

---

26.11.2013 Off
a
b
c
d
e
f
g
h
i
“For professional use only.
This product can cause severe
allergic reactions.
EN
Read and follow instructions.

This product is not intended for
use on persons under the age
of 16.
Temporary ‘black henna’ tattoos
may increase the risk of allergy.
Eyelashes shall not be coloured if
the consumer:
icial
— has a rash on the face or
Jour
sensitive, irritated and
nal
damaged scalp,
of
— has experienced any reaction
the
after colouring hair or
European
eyelashes,
— has experienced a reaction to a
temporary ‘black henna’ tattoo
Union
in the past.
Rinse eyes immediately if product
comes into contact with them.” ’
(9) entries 244 and 245 are replaced by the following:
a
b
c
d
e
f
g
h
i
‘244 4-Amino-m-cresol 4-Amino-m-Cresol 2835-99-6 220-621-2 (a)
Hair
dye
For (a) and (b): After mixing (a) To be printed on the label:
substance in
under oxidative conditions the
oxidative hair
maximum concentration
The mixing ratio.
dye products
applied to hair or eyelashes
must not exceed 1,5 %
L
“ Hair
colorants
can
cause
315/49
severe allergic reactions.

---

L 315/50
a
b
c
d
e
f
g
h
i
Read and follow instructions.
This product is not intended for
use on persons under the age
of 16.
EN

Temporary ‘black henna’ tattoos
may increase your risk of allergy.
Do not colour your hair if:
— you have a rash on your face
or sensitive, irritated and
damaged scalp,
— you have ever experienced any
Off
reaction after colouring your
icial
hair,
Jour
— you have experienced a
nal
reaction to a temporary ‘black
henna’ tattoo in the past.”
of
the
(b) Products
(b) For professional use only. (b) To
be
printed
on
the
label:
European
intended for
colouring
The mixing ratio.
eyelashes
Union
“For professional use only.
This product can cause severe
allergic reactions.
Read and follow instructions.
This product is not intended for
use on persons under the age
of 16.
Temporary ‘black henna’ tattoos
may increase the risk of allergy.
Eyelashes shall not be coloured if
the consumer:
26.11.2013
— has a rash on the face or
sensitive, irritated and damaged
scalp,

---

26.11.2013 Off
a
b
c
d
e
f
g
h
i
— has experienced any reaction
after colouring hair or
eyelashes,
— has experienced a reaction to a
temporary ‘black henna’ tattoo
EN

in the past.
Rinse eyes immediately if product
comes into contact with them.”
245 2-[(3amino-4-
2-Amino-4-Hydroxye
83763-47-7 / 280-733-2 /
(a) Hair dye
For (a) and (b): After mixing (a) To be printed on the label:
methoxyphenyl)
thylaminoanisole
substance in
under oxidative conditions the
amino]ethanol
83763-48-8
280-734-8
oxidative hair
maximum concentration
The mixing ratio.
and its sulphate
2-Amino-4-Hydroxye
dye products
applied to hair or eyelashes
thylaminoanisole
must not exceed 1,5 % (as
“ Hair
colorants
can
cause
icial
sulfate
sulphate)
severe allergic reactions.
Jour
— Do not use with nitro
sating agents
Read and follow instructions.
nal
of
— Maximum nitrosamine
This product is not intended for
the
content: 50 μg /kg
use on persons under the age
of 16.
European
— Keep in nitrite-free
containers
Temporary ‘black henna’ tattoos
may increase your risk of allergy.
Union
Do not colour your hair if:
— you have a rash on your face
or sensitive, irritated and
damaged scalp,
— you have ever experienced any
reaction after colouring your
hair,
— you have experienced a
reaction to a temporary ‘black
henna’ tattoo in the past.”
(b) Products
(b) For professional use only. (b) To
be
printed
on
the
label:
L
intended for
315/51
colouring
The mixing ratio.
eyelashes

---

L 315/52
a
b
c
d
e
f
g
h
i
“For professional use only.
This product can cause severe
allergic reactions.
EN
Read and follow instructions.

This product is not intended for
use on persons under the age
of 16.
Temporary ‘black henna’ tattoos
may increase the risk of allergy.
Eyelashes shall not be coloured if
the consumer:
Off
icial
— has a rash on the face or
Jour
sensitive, irritated and
damaged scalp,
nal
of
— has experienced any reaction
the
after colouring hair or
eyelashes,
European
— has experienced a reaction to a
temporary ‘black henna’ tattoo
in the past.
Union
Rinse eyes immediately if product
comes into contact with them.” ’
(10) the following entries 265 to 285 are added:
a
b
c
d
e
f
g
h
i
‘265 1,4-Diaminoan
Disperse Violet 1 128-95-0 204-922-6 Hair
dye
substance
in
0,5 % Impurity
of
Disperse
Red
15
thraquinone
non-oxidative hair
in Disperse Violet 1 for hair
dye products
dye formulations should be
< 1 % (w/w)
266 Ethanol,
2-((4- HC Red No 3 2871-01-4 220-701-7 (a)
Hair
dye
(a) After mixing under
For (a): To be printed on the label:
26.11.2013
amino-2-nitrophe
substance in
oxidative conditions the
nyl)amino)-
oxidative hair
maximum concentration The mixing ratio.
dye products
applied to hair must not
exceed 0,45 %

---

26.11.2013 Off
a
b
c
d
e
f
g
h
i
(b) Hair dye
(b) 3,0 % For
(a)
and
(b):
For (a) and (b):
substance in
non-oxidative
— Do not use with nitro
“ Hair
colorants
can
cause
severe
hair dye products
sating agents
allergic reactions. Read and follow
instructions. This product is not
EN
— Maximum nitrosamine
intended for use on persons under the

content: 50 μg/kg
age of 16.
— Keep in nitrite-free
Temporary ‘black henna’ tattoos may
containers
increase your risk of allergy.
Do not colour your hair if:
— you have a rash on your face or
sensitive, irritated and damaged
scalp,
icial
Jour
— you have ever experienced any
reaction after colouring your hair,
nal
of
— you have experienced a reaction to
the
a temporary ‘black henna’ tattoo in
European
the past.”
267 [7-Hydroxy-8-[(2- Basic Red 76 68391-30-0 269-941-4 Hair
dye
substance
in
2,0 %
Union
methoxyphe
non-oxidative hair
nyl)azo]-2-naph
dye products
thyl]trimethyl
ammonium
chloride
268 2-[[4-(Dimethyl
Basic Red 51 77061-58-6 278-601-4 (a)
Hair
dye
(a) After mixing under
(a) To be printed on the label:
amino)phe
substance in
oxidative conditions the
nyl]azo]-1,3-
oxidative hair
maximum concentration
The mixing ratio.
dimethyl-1H-imid
dye products
applied to hair must not
azolium chloride
exceed 0,5 %
“ Hair
colorants
can
cause
severe allergic reactions.
Read and follow instructions.
L
This product is not intended for
315/53
use on persons under the age
of 16.

---

L 315/54
a
b
c
d
e
f
g
h
i
Temporary ‘black henna’ tattoos
may increase your risk of allergy.
Do not colour your hair if:
EN
— you have a rash on your face

or sensitive, irritated and
damaged scalp,
— you have ever experienced any
reaction after colouring your
hair,
— you have experienced a
reaction to a temporary ‘black
henna’ tattoo in the past.”
Off
icial
(b) Hair dye
(b) 1,0 %
Jour
substance in
non-oxidative
nal
hair dye products
of
the
269 Phenol,
2-Amino- 2-Amino-5-
149861-22-3 Hair
dye
substance
in After mixing under oxidative To be printed on the label:
European
5-Ethyl-, Hydro
Ethylphenol HCl
oxidative hair dye
conditions the maximum
chloride
products
concentration applied to hair The mixing ratio.
must not exceed 1,0 %
Union
“ Hair
colorants
can
cause
severe
allergic reactions.
Read and follow instructions.
This product is not intended for use on
persons under the age of 16.
Temporary ‘black henna’ tattoos may
increase your risk of allergy.
Do not colour your hair if:
— you have a rash on your face or
sensitive, irritated and damaged
scalp,
26.11.2013
— you have ever experienced any
reaction after colouring your hair,

---

26.11.2013 Off
a
b
c
d
e
f
g
h
i
— you have experienced a reaction to
a temporary ‘black henna’ tattoo in
the past.”
270 Fluorescein,
Acid Red 92 18472-87-2 242-355-6 (a)
Hair
dye
(a) After mixing under
(a) To be printed on the label:
2',4',5',7'-tetra
substance in
oxidative conditions the
EN
bromo-4,5,6,7-
oxidative hair
maximum concentration
The mixing ratio.

tetrachloro-,
dye products
applied to hair must not
disodium salt (CI
exceed 2,0 %
“ Hair
colorants
can
cause
45410)
severe allergic reactions.
Read and follow instructions.
This product is not intended for
use on persons under the age
of 16.
Temporary ‘black henna’ tattoos
icial
may increase your risk of allergy.
Jour
Do not colour your hair if:
nal
of
— you have a rash on your face
the
or sensitive, irritated and
damaged scalp,
European
— you have ever experienced any
reaction after colouring your
Union
hair,
— you have experienced a
reaction to a temporary ‘black
henna’ tattoo in the past.”
(b) Hair dye
(b) 0,4 %
substance in
non-oxidative
hair dye products
271 Mixture
of
(1),
(2) Disperse Blue 377 is a
Hair dye substance in 2,0 %
& (3) in dispersing mixture of three dyes:
non-oxidative hair
agent (lignosul
dye products
phate):
(1) 9,10-Anthra
(1) 1,4-bis[(2-hydro
(1) 4471-41- (1) 224-743-
cenedione-
xyethyl)amino]an
4
7
L
1,4-bis[(2-
thra-9,10-quinone
315/55
Hydroxye
thyl)amino]

---

L 315/56
a
b
c
d
e
f
g
h
i
(2) 9,10-Anthra
(2) 1-[(2-hydroxye
(2) 67674-
(2) 266-865-
cenedione-1-
thyl)amino]-4-[(3-
26-4
3
[(2-Hydroxye
hydroxypro
thyl)amino]-
pyl)amino]anthra-
4-[(3-
9,10-quinone
Hydroxypro
EN
pyl)amino]

(3) 9,10-anthra
(3) 1,4-bis[(3-
(3) 67701-
(3) 266-954-
cenedione-
hydroxypro
36-4
7
1,4-bis[(3-
pyl)amino]anthra-
hydroxypro
9,10-quinone
pyl)amino
272 4-Aminophenol p-Aminophenol 123-30-8 204-616-2 Hair
dye
substance
in
After mixing under oxidative To be printed on the label:
Off
oxidative hair dye
conditions the maximum
icial
products
concentration applied to hair The mixing ratio.
must not exceed 0,9 %
Jour
“ Hair
colorants
can
cause
severe
nal
allergic reactions.
of
Read and follow instructions.
the
European
This product is not intended for use on
persons under the age of 16.
Temporary ‘black henna’ tattoos may
Union
increase your risk of allergy.
Do not colour your hair if:
— you have a rash on your face or
sensitive, irritated and damaged
scalp,
— you have ever experienced any
reaction after colouring your hair,
— you have experienced a reaction to
a temporary ‘black henna’ tattoo in
the past.”
26.11.2013
273 4,5-Diamino-1-(2- 1-Hydroxyethyl-4,5-
155601-30-2 429-300-3 Hair
dye
substance
in
After mixing under oxidative To be printed on the label:
hydroxyethyl)-1H- Diamino Pyrazole
oxidative hair dye
conditions the maximum
pyrazole sulfate
Sulfate
products
concentration applied to hair The mixing ratio.
(1:1)
must not exceed 3,0 %

---

26.11.2013 Off
a
b
c
d
e
f
g
h
i
“ Hair
colorants
can
cause
severe
allergic reactions.
Read and follow instructions.
EN
This product is not intended for use on

persons under the age of 16.
Temporary ‘black henna’ tattoos may
increase your risk of allergy.
Do not colour your hair if:
— you have a rash on your face or
sensitive, irritated and damaged
scalp,
icial
— you have ever experienced any
Jour
reaction after colouring your hair,
nal
— you have experienced a reaction to
of
a temporary ‘black henna’ tattoo in
the
the past.”
European
274 Quinolinium,
4- 4-Formyl-1-Methylqui 223398-02-5 453-790-8 Hair
dye
substance
in
After mixing under oxidative To be printed on the label:
formyl-1-methyl-,
nolinium-p-Toluene
oxidative hair dye
conditions the maximum
Union
salt with 4-
sulfonate
products
concentration applied to hair The mixing ratio.
methylbenzene
must not exceed 2,5 %
sulfonic acid (1:1)
“ Hair
colorants
can
cause
severe
allergic reactions.
Read and follow instructions.
This product is not intended for use on
persons under the age of 16.
Temporary ‘black henna’ tattoos may
increase your risk of allergy.
Do not colour your hair if:
— you have a rash on your face or
L
sensitive, irritated and damaged
315/57
scalp,

---

L 315/58
a
b
c
d
e
f
g
h
i
— you have ever experienced any
reaction after colouring your hair,
— you have experienced a reaction to
a temporary ‘black henna’ tattoo in
the past.”
EN

275 Pyridinium,
1-
Basic Yellow 87 68259-00-7 269-503-2 (a)
Hair
dye
(a) After mixing under
(a) To be printed on the label:
methyl-4-[(
substance in
oxidative conditions the
methylphenylhy
oxidative hair
maximum concentration
The mixing ratio.
drazono)methyl]-,
dye products
applied to hair must not
methyl sulfate
exceed 1,0 %
“ Hair
colorants
can
cause
severe allergic reactions.
Read and follow instructions.
Off
icial
This product is not intended for
use on persons under the age
Jour
of 16.
nal
Temporary ‘black henna’ tattoos
of
may increase your risk of allergy.
the
European
Do not colour your hair if:
— you have a rash on your face
or sensitive, irritated and
Union
damaged scalp,
— you have ever experienced any
reaction after colouring your
hair,
— you have experienced a
reaction to a temporary ‘black
henna’ tattoo in the past.”
(b) Hair dye
(b) 1,0 %
substance in
non-oxidative
hair dye products
276 2-[(4-Aminophe
Basic Orange 31 97404-02-9 306-764-4 (a)
Hair
dye
(a) After mixing under
(a) To be printed on the label:
26.11.2013
nyl)azo]-1,3-
substance in
oxidative conditions the
dimethyl-1H-imid
oxidative hair
maximum concentration
The mixing ratio.
azolium chloride
dye products
applied to hair must not
exceed 0,5 %

---

26.11.2013 Off
a
b
c
d
e
f
g
h
i
“ Hair
colorants
can
cause
severe allergic reactions.
Read and follow instructions.
EN
This product is not intended for

use on persons under the age
of 16.
Temporary ‘black henna’ tattoos
may increase your risk of allergy.
Do not colour your hair if:
— you have a rash on your face
or sensitive, irritated and
damaged scalp,
icial
Jour
— you have ever experienced any
reaction after colouring your
nal
hair,
of
the
— you have experienced a
European
reaction to a temporary ‘black
henna’ tattoo in the past.”
Union
(b) Hair dye
(b) 1,0 %
substance in
non-oxidative
hair dye products
277 2,6-Pyridine
2,6-Diamino-3-
28365-08-4 421-430-9 (a)
Hair
dye
(a) After mixing under
(a) To be printed on the label:
diamine, 3-(3-
((Pyridine-3-yl)azo)Py
substance in
oxidative conditions the
pyridinylazo)
ridine
oxidative hair
maximum concentration
The mixing ratio.
dye products
applied to hair must not
exceed 0,25 %
“ Hair
colorants
can
cause
severe allergic reactions.
Read and follow instructions.
This product is not intended for
L
use on persons under the age
315/59
of 16.

---

L 315/60
a
b
c
d
e
f
g
h
i
Temporary ‘black henna’ tattoos
may increase your risk of allergy.
Do not colour your hair if:
EN
— you have a rash on your face

or sensitive, irritated and
damaged scalp,
— you have ever experienced any
reaction after colouring your
hair,
— you have experienced a
reaction to a temporary ‘black
henna’ tattoo in the past.”
Off
icial
(b) Hair dye
(b) 0,25 %
Jour
substance in
nal
non-oxidative
hair dye products
of
the
European
278 4-((4-Amino-3- Basic Violet 2 3248-91-7 221-831-7 (a)
Hair
dye
(a) After mixing under
(a) To be printed on the label:
methylphenyl)(4-
substance in
oxidative conditions the
imino-3-methyl-
oxidative hair
maximum concentration
The mixing ratio.
Union
2,5-cyclohex
dye products
applied to hair must not
adien-1-
exceed 1,0 %
ylidene)methyl)-2-
“ Hair
colorants
can
cause
methylpheny
severe allergic reactions.
lamine monohy
drochloride (CI
Read and follow instructions.
42520)
This product is not intended for
use on persons under the age
of 16.
Temporary ‘black henna’ tattoos
may increase your risk of allergy.
Do not colour your hair if:
26.11.2013
— you have a rash on your face
or sensitive, irritated and
damaged scalp,

---

26.11.2013 Off
a
b
c
d
e
f
g
h
i
— you have ever experienced any
reaction after colouring your
hair,
— you have experienced a
reaction to a temporary ‘black
EN
henna’ tattoo in the past.”

(b) Hair dye
(b) 0,5 %
substance in
non-oxidative
hair dye products
279 2,3-Diamino-6,7- 2,3-Diaminodihy
857035-95-1 469-500-8 Hair
dye
substance
in
After mixing under oxidative To be printed on the label:
dihydro-1H,5H-
dropyrazolopyra
oxidative hair dye
conditions the maximum
pyrazolo[1,2-a]
zolone Dimethosul
products
concentration applied to hair The mixing ratio.
Pyrazol-1-one
fonate
must not exceed 2,0 %
icial
dimethanesul
fonate
“ Hair
colorants
can
cause
severe
Jour
allergic reactions.
nal
Read and follow instructions.
of
the
This product is not intended for use on
European
persons under the age of 16.
Temporary ‘black henna’ tattoos may
increase your risk of allergy.
Union
Do not colour your hair if:
— you have a rash on your face or
sensitive, irritated and damaged
scalp,
— you have ever experienced any
reaction after colouring your hair,
— you have experienced a reaction to
a temporary ‘black henna’ tattoo in
the past.”
280 2-Amino-4,6-dini Picramic Acid and 96-91-3
202-544-6
(a) Hair dye
(a) After mixing under
(a) To be printed on the label:
trophenol and 2- Sodium Picramate
substance in
oxidative conditions the
L
amino-4,6-dinitro
831-52-7
212-603-8
oxidative hair
maximum concentration
The mixing ratio.
315/61
phenol, sodium
dye products
applied to hair must not
salt
exceed 0,6 %

---

L 315/62
a
b
c
d
e
f
g
h
i
“ Hair
colorants
can
cause
severe allergic reactions.
Read and follow instructions.
EN
This product is not intended for

use on persons under the age
of 16.
Temporary ‘black henna’ tattoos
may increase your risk of allergy.
Do not colour your hair if:
— you have a rash on your face
Off
or sensitive, irritated and
damaged scalp,
icial
Jour
— you have ever experienced any
reaction after colouring your
nal
hair,
of
the
— you have experienced a
European
reaction to a temporary ‘black
henna’ tattoo in the past.”
Union
(b) Hair dye
(b) 0,6 %
substance in
non-oxidative
hair dye products
281 1-Methylamino-2- 2-Nitro-5-Glyceryl
80062-31-3 279-383-3 (a)
Hair
dye
(a) After mixing under
(a) To be printed on the label:
nitro-5-(2,3-dihy
Methylaniline
substance in
oxidative conditions the
droxy-propyloxy)-
oxidative hair
maximum concentration
The mixing ratio.
benzene
dye products
applied to hair must not
exceed 0,8 %
“ Hair
colorants
can
cause
severe allergic reactions.
Read and follow instructions.
26.11.2013
This product is not intended for
use on persons under the age
of 16.

---

26.11.2013 Off
a
b
c
d
e
f
g
h
i
Temporary ‘black henna’ tattoos
may increase your risk of allergy.
Do not colour your hair if:
EN
— you have a rash on your face

or sensitive, irritated and
damaged scalp,
— you have ever experienced any
reaction after colouring your
hair,
— you have experienced a
reaction to a temporary ‘black
henna’ tattoo in the past.”
icial
(b) Hair dye
(b) 1,0 % For
(a)
and
(b):
Jour
substance in
non-oxidative
— Do not use with nitro
nal
hair dye products
sating agents
of
the
— Maximum nitrosamine
European
content: 50 μg/kg
— Keep in nitrite-free
containers
Union
282 1-Propanaminium, HC Blue 16 502453-61-4 481-170-7 Hair
dye
substance
in
3,0 % —
Do
not
use
with
nitro
3-[[9,10-dihydro-
non-oxidative hair
sating agents
4-(methylamino)-
dye products
9,10-dioxo-1-
— Maximum nitrosamine
anthracenyl]
content: 50 μg/kg
amino]-N,N-
dimethyl-N-
propyl-, bromide
— Keep in nitrite-free
containers
283 3-amino-2-chlor- 5-Amino-6-Chloro-o-
84540-50-1
283-144-9 (a)
Hair
dye
(a) After mixing under
(a) To be printed on the label:
6-methylphenol
Cresol
substance in
oxidative conditions the
80419-48-3
oxidative hair
maximum concentration
The mixing ratio.
3-amino-4-chloro- 5-Amino-6-Chloro-o-
dye products
applied to hair must not
6-methylphenol
Cresol HCl
exceed 1,0 %
“ Hair
colorants
can
cause
HCl
L
severe allergic reactions.
315/63
Read and follow instructions.

---

L 315/64
a
b
c
d
e
f
g
h
i
This product is not intended for
use on persons under the age
of 16.
Temporary ‘black henna’ tattoos
may increase your risk of allergy.
EN

Do not colour your hair if:
— you have a rash on your face
or sensitive, irritated and
damaged scalp,
— you have ever experienced any
reaction after colouring your
hair,
Off
icial
— you have experienced a
Jour
reaction to a temporary ‘black
henna’ tattoo in the past.”
nal
of
the
(b) Hair dye
(b) 0,5 %
European
substance in
non-oxidative
hair dye products
Union
284 Phenol,
2,2'-
2,2'-Methylenebis-4-
27311-52-0
440-850-3 (a)
Hair
dye
(a) After mixing under
(a) To be printed on the label:
methylenebis[4-
aminophenol HCl
substance in
oxidative conditions the
amino-], dihydro
63969-46-0
oxidative hair
maximum concentration
The mixing ratio.
chloride
dye products
applied to hair must not
exceed 1,0 %
“ Hair
colorants
can
cause
severe allergic reactions.
Read and follow instructions.
This product is not intended for
use on persons under the age
of 16.
26.11.2013
Temporary ‘black henna’ tattoos
may increase your risk of allergy.

---

26.11.2013 Off
a
b
c
d
e
f
g
h
i
Do not colour your hair if:
— you have a rash on your face
or sensitive, irritated and
damaged scalp,
EN

— you have ever experienced any
reaction after colouring your
hair,
— you have experienced a
reaction to a temporary ‘black
henna’ tattoo in the past.”
(b) Hair dye
(b) 1,0 %
substance in
non-oxidative
icial
hair dye products
Jour
nal
285 Pyridine-2,6-
2,6-Diaminopyridine 141-86-6 205-507-2 (a)
Hair
dye
For (a) and (b): After mixing (a) To be printed on the label:
of
diyldiamine
substance in
under oxidative conditions the
the
oxidative hair
maximum concentration
The mixing ratio.
dye products
applied to hair must not
European
exceed 0,15 %
“ Hair
colorants
can
cause
severe allergic reactions.
Union
Read and follow instructions.
This product is not intended for
use on persons under the age
of 16.
Temporary ‘black henna’ tattoos
may increase your risk of allergy.
Do not colour your hair if:
— you have a rash on your face
or sensitive, irritated and
damaged scalp,
L
— you have ever experienced any
315/65
reaction after colouring your
hair,

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L 315/66
a
b
c
d
e
f
g
h
i
— you have experienced a
reaction to a temporary ‘black
henna’ tattoo in the past.”
(b) Products
(b) For professional use only. (b) To
be
printed
on
the
label:
intended for
EN
colouring
The mixing ratio.

eyelashes
“For professional use only.
This product can cause severe
allergic reactions.
Read and follow instructions.
Off
This product is not intended for
icial
use on persons under the age
of 16.
Jour
Temporary ‘black henna’ tattoos
nal
may increase the risk of allergy.
of
the
Eyelashes shall not be coloured if
European
the consumer:
— has a rash on the face or
sensitive, irritated and damaged
Union
scalp,
— has experienced any reaction
after colouring hair or
eyelashes,
— has experienced a reaction to a
temporary ‘black henna’ tattoo
in the past.
Rinse eyes immediately if product
comes into contact with them.” ’
26.11.2013

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