Twenty-sixth Commission Directive 2002/34/EC of 15 April 2002 adapting to technical progress Annexes II, III and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance)
Date: 2002-04-15
Institutions: European Commission
Subjects: approximation of laws, cosmetic product, product quality, public health, technological change

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Official Journal of the European Communities

L 102/19

TWENTY-SIXTH COMMISSION DIRECTIVE 2002/34/EC

of 15 April 2002

adapting to technical progress Annexes II, III and VII to Council Directive 76/768/EEC on the
approximation of the laws of the Member States relating to cosmetic products

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

substances for other uses is being carried out by the
SCCNFP.

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), as last amended by Commis-
sion Directive 2000/41/EC (2), and in particular Article 8(2)
thereof,

(3)

The SCCNFP recommends that methyleugenol should
not be intentionally added as a cosmetic ingredient.
Therefore methyleugenol should be included in Annex
II. As methyleugenol
is however naturally present in
essential oils that are used as components in cosmetic
products, the SCCNFP has set specific maximum concen-
trations when present in cosmetic products.

After consulting the Scientific Committee on Cosmetic Prod-
ucts and Non-Food Products intended for consumers (SCCNFP),

(4)

Whereas:

(1)

(2)

Entry 293 of Annex II includes radioactive substances
among the substances prohibited in cosmetic products.
However, footnote 1 to entry 293 allows, under the
conditions set out therein, the presence of natural radio-
active substances and of radioactive substances caused
by artificial contamination from the environment by
making reference to Directives of 2 February 1959
laying down the basic standards for the protection of the
health of workers and the general public against the
dangers arising from ionising radiation (3). These Direct-
ives were
repealed by Council Directive 96/29/
Euratom (4), Article 6(5) thereof providing that Member
States shall permit neither the deliberate addition of
radioactive substances in the production of cosmetic
products nor the import and export of such goods.
Directive 96/29/Euratom also provides for the definition
of radioactive substances for the purpose of its applica-
tion. Therefore, entry 293 of Annex II should be
amended accordingly.

that must not

On the basis of IFRA (International Fragrance Associa-
listed 36
tion) Code of Practice,
the SCCNFP has
fragrance
form part of
substances
compounds used in cosmetic products. Of
these 36
fragrance ingredients, seven are already included in
Annex II and one (6-methylcoumarin) under reference
No 46 in Annex III, Part 1, which already restricts its use
to oral hygiene products. Therefore the 28 remaining
fragrance ingredients should be included in the list of
Annex II. The safety of these substances has only been
assessed by the SCCNFP for their use as fragrance ingre-
dients. Accordingly, it is necessary to regulate their use
these
for this purpose. Further safety assessment of

(1) OJ L 262, 27.9.1976, p. 169.
(2) OJ L 145, 20.6.2000, p. 25.
(3) OJ 11, 20.2.1959, p. 221/59.
(4) OJ L 159, 29.6.1996, p. 1.

(5)

(6)

(7)

On the basis of information on the use in cosmetic
products of lithium hydroxide and calcium hydroxide
and their safety evaluation, the SCCNFP recommends
that their use should be restricted. Therefore entries 15b
and 15c of Annex III, Part 1, should be amended accord-
ingly.

On the basis of a toxicological evaluation, the SCCNFP
the maximum residual acrylamide
recommends that
content needs to be restricted in the finished product.
Therefore, polyacrylamide should be included in Annex
III, Part 1.

The SCCNFP has made toxicological evaluations of 61
hair dyes, including recommendations on their field of
application, maximum concentration levels and specific
warnings. One is already included under reference No
therefore be
16 in Annex III, Part 1, which shall
amended. More information on the safety of some hair
dyes is still needed, in particular in order to investigate a
potential link between long term regular use of perma-
nent hair dyes and an increased risk for bladder cancer,
as requested by the SCCNFP. Therefore the 60 remaining
hair dyes should be included in Annex III, Part 2. Entry
8 of Annex III, Part 1, covers a group of phenylendia-
mine derivatives used as hair dyes. In order to avoid
double entries, the text in column b should be amended
to except those derivatives listed elsewhere in Annex III.

The SCCNFP recommends that musk xylene can be
safely used in cosmetic products, excluding oral care
products, up to a maximum daily theoretically absorbed
dose of about 10 µg/kg/day. Therefore, until the risk
assessment of
substance in the framework of
Council Regulation (EEC) No 793/93 (5) on the evalu-
ation and control of the risks of existing substances is
finalised, musk xylene should be included in Annex III,
Part 2.

this

(5) OJ L 84, 5.4.1993, p. 1.

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18.4.2002

(8)

(9)

(10)

(11)

The SCCNFP recommends that musk ketone can be
safely used in cosmetic products, excluding oral care
products, up to a maximum daily theoretically absorbed
dose of about 14 µg/kg/day. Therefore, until the risk
assessment of this substance in the framework of Regu-
lation (EEC) 793/93 is finalised, musk ketone should be
included in Annex III, Part 2.

The SCCNFP has expressed the opinion that the UV-filter
dimethicodiethylbenzalmalonate can be safely used in
cosmetic products under certain restrictions. Therefore,
dimethicodiethylbenzalmalonate should be included in
Annex VII, Part 1.

The SCCNFP has expressed the opinion that titanium
dioxide can be safely used as UV-filter in cosmetic prod-
ucts under certain restrictions. Therefore,
titanium
dioxide should be included in Annex VII, Part 1.

The measures provided for in this Directive are in
accordance with the opinion of the Committee on the
Adaptation to Technical Progress of the Directives on
the Removal of Technical Barriers to Trade in the
Cosmetic Products Sector,

HAS ADOPTED THIS DIRECTIVE:

Article 1

to this Directive, which are supplied to the final consumer after
15 April 2004, comply with the provisions of this Directive.

Article 3

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this
Directive by 15 April 2003 at the latest. They shall forthwith
inform the Commission thereof.

those provisions,

When Member States adopt
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.

Article 4

This Directive shall enter into force on the third day following
its publication in the Official Journal of the European Communities.

Article 5

This Directive is addressed to the Member States.

Directive 76/768/EEC is hereby amended as indicated in the
Annex to this Directive.

Done at Brussels, 15 April 2002.

Article 2

Member States shall take the necessary measures to ensure that
cosmetic products containing the substances listed in Annexes
II, III and VII to Directive 76/768/EEC, as set out in the Annex

For the Commission

Erkki LIIKANEN

Member of the Commission

18.4.2002

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Official Journal of the European Communities

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ANNEX

Annexes II, III and VII to Directive 76/768/EEC are amended as follows:

1.

In Annex II:

(i) Reference No 293 and corresponding footnote 1 are replaced by the following:

‘293. Radioactive substances, as defined by Directive 96/29/Euratom (1) laying down basic safety standards for the
protection of the health of workers and the general public against the dangers arising from ionising radiation.

(1) OJ L 159, 29.6.1996, p. 1.’

(ii) Reference Nos 423 to 451 are added as indicated below:

‘423. Alanroot oil (Inula helenium) (CAS No 97676-35-2), when used as a fragrance ingredient.

424. Benzyl cyanide (CAS No 140-29-4), when used as a fragrance ingredient.

425. Cyclamen alcohol (CAS No 4756-19-8), when used as a fragrance ingredient.

426. Diethyl maleate (CAS No 141-05-9), when used as a fragrance ingredient.

427. Dihydrocoumarine (CAS No 119-84-6), when used as a fragrance ingredient.

428. 2,4-Dihydroxy-3-methylbenzaldehyde (CAS No 6248-20-0), when used as a fragrance ingredient.

429. 3,7-Dimethyl-2-octen-1-ol

(6,7-Dihydrogeraniol)

(CAS No 40607-48-5), when used as a fragrance ingre-

dient.

430. 4,6-Dimethyl-8-tert-butylcoumarin (CAS No 17874-34-9), when used as a fragrance ingredient.

431. Dimethyl citraconate (CAS No 617-54-9), when used as a fragrance ingredient.

432. 7,11-Dimethyl-4,6,10-dodecatrien-3-one (CAS No 26651-96-7), when used as a fragrance ingredient.

433. 6,10-Dimethyl-3,5,9-undecatrien-2-one (CAS No 141-10-6), when used as a fragrance ingredient.

434. Diphenylamine (CAS No 122-39-4), when used as a fragrance ingredient.

435. Ethyl acrylate (CAS No 140-88-5), when used as a fragrance ingredient.

436. Fig leaf absolute (Ficus carica) (CAS No 68916-52-9), when used as a fragrance ingredient.

437. trans-2-Heptenal (CAS No 18829-55-5), when used as a fragrance ingredient.

438. trans-2-Hexenal diethyl acetal (CAS No 67746-30-9), when used as a fragrance ingredient.

439. trans-2-Hexenal dimethyl acetal (CAS No 18318-83-7), when used as a fragrance ingredient.

440. Hydroabietyl alcohol (CAS No 13393-93-6), when used as a fragrance ingredient.

441. 6-Isopropyl-2-decahydronaphthalenol (CAS No 34131-99-2), when used as a fragrance ingredient.

442. 7-Methoxycoumarin (CAS No 531-59-9), when used as a fragrance ingredient.

443. 4-(4-Methoxyphenyl)-3-butene-2-one (CAS No 943-88-4), when used as a fragrance ingredient.

444. 1-(4-Methoxyphenyl)-1-penten-3-one (CAS No 104-27-8), when used as a fragrance ingredient.

445. Methyl trans-2-butenoate (CAS No 623-43-8), when used as a fragrance ingredient.

446. 7-Methylcoumarin (CAS No 2445-83-2), when used as a fragrance ingredient.

447. 5-Methyl-2,3-hexanedione (CAS No 13706-86-0), when used as a fragrance ingredient.

448. 2-Pentylidenecyclohexanone (CAS No 25677-40-1), when used as a fragrance ingredient.

449. 3,6,10-Trimethyl-3,5,9-undecatrien-2-one (CAS No 1117-41-5), when used as a fragrance ingredient.

450. Verbena oil (Lippia citriodora Kunth.) (CAS No 8024-12-2), when used as a fragrance ingredient.

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451. Methyleugenol

(CAS No 95-15-2) except for normal content in the natural essences used and provided

that the concentration does not exceed:

(a) 0,01 % in fine fragrance

(b) 0,004 % in eau de toilette

(c) 0,002 % in fragrance cream

(d) 0,001 % in rinse-off products

(e) 0,0002 % in other leave-on products and oral hygiene products.’.

2.

In Annex III, Part 1:

(i) In reference No 8, column b is replaced by the following:

‘m- and p-Phenylenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-Phenyl-
enediamines (1), with the exception of those derivatives listed elsewhere in this Annex

(1) These substances may be used singly or in combination provided that the sum of the ratios of the levels of
each of them in the cosmetic product expressed with reference to the maximum level authorised for each of
them does not exceed 1.’

(ii) Reference Nos 15b and 15c are replaced by the following:

Reference
number

Substance

Field of application
and/or use

Restrictions

Maximum authorised
concentration in the
finished cosmetic
product

Other limitations
and requirements

Conditions of use and warnings
which must be printed on the label

a

b

c

d

e

f

‘15b

Lithium hydroxide

(a) Hair straighteners

(a)

(a)

1. General use

1. 2 % (3) by weight

1. Contains alkali

Avoid contact with eyes
Can cause blindness
Keep out of
children

reach of

2. Professional use

2. 4,5 % (3) by weight

use

professional

2. For
only
Avoid contact with eyes
Can cause blindness

15c

Calcium hydroxide

(b) pH ajuster — for

depilatories

(c) Other uses — as
(for
products

pH adjuster
rinse-off
only)

Hair
straighteners
containing two compo-
nents:
calcium
hydroxide and a guani-
dine salt

(b) pH ajuster — for

depilatories

(c) Other uses (e.g. pH
adjuster, processing
aid)

(a) 7 % by weight of
calcium hydroxide

(b) pH value not
exceed pH 12,7

to

(b) Contains alkali

Keep out of reach of chil-
dren
Avoid contact with eyes

(c) pH value not
exceed pH 11

to

(a) Contains alkali

Avoid contact with eyes
Keep out of reach of chil-
dren
Can cause blindness

to

(b) Contains alkali

Keep out of reach of chil-
dren
Avoid contact with eyes

(b) pH value not
exceed pH 12,7

(c) pH value not
exceed pH 11

to

(3) The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given

in column d.’

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(iii) Reference No 16 is replaced by the following:

Reference
number

Substance

Field of application
and/or use

a

‘16

b

c

1-Naphthol (CAS No
90-15-3) and its salts

Oxidising
colouring
agents for hair dyening

Restrictions

Maximum authorised
concentration in the
finished cosmetic
product

d

2,0 %

Other limitations
and requirements

Conditions of use and warnings
which must be printed on the label

e

f

Can cause allergie reaction’

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

(iv) Reference No 66 is inserted as shown in the following table:

Reference
number

Substance

Field of application
and/or use

Restrictions

Maximum authorised
concentration in the
finished cosmetic
product

Other limitations
and requirements

Conditions of use and warnings
which must be printed on the label

a

b

c

d

e

f

‘66

Polyacrylamides

(a) Body-care leave-on

products

(b) Other

cosmetic

products

(a) Maximum residual
acrylamide content
0,1 mg/kg

(b) Maximum residual
acrylamide content
0,5 mg/kg’

3.

In Annex III, Part 2:

Reference Nos 1 to 62 are inserted as shown in the following table:

Restrictions

Maximum
authorised
concentration
in the
finished cosmetic
product

d

0,2 %

Other limitations and
requirements

Conditions of use
and warnings which must
be printed on the label

Allowed until

e

f

g

Can cause allergic reaction

30.9.2004

Reference
number

Substance

Field of application
and/or use

a

b

c

Basic Blue 7 (CAS
No 2390-60-5)

Non-oxidising
colouring agents
hair dyeing

for

‘1

2

2-Amino-3-nitro-
phenol
(CAS No
603-85-0) and its
salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 3,0 %

(b) 3,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,5 %

(a) (b) Can cause allergic

30.9.2004

reaction

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Reference
number

Substance

Field of application
and/or use

Restrictions

Maximum
authorised
concentration
in the
finished cosmetic
product

Other limitations and
requirements

Conditions of use
and warnings which must
be printed on the label

Allowed until

a

b

c

d

e

f

g

4-Amino-3-nitro-
phenol
(CAS No
610-81-1) and its
salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 3,0 %

(b) 3,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,5 %

(a) (b) Can cause allergic

30.9.2004

reaction

2,7-Naphthalene-
diol (CAS no 582-
17-2) and its salts

Oxidising
colouring
agents for hair dyeing

1,0 %

m-Aminophenol
(CAS no 591-27-5)
and its salts

Oxidising
colouring
agents for hair dyeing

2,0 %

Oxidising
colouring
agents for hair dyeing

2,0 %

2,6-Dihydroxy-3,4-
dimethylpyridine
(CAS No 84540-
47-6) and its salts

4-Hydroxypropyla-
mino-3-nitrophenol
(CAS No 92952-
81-3) and its salts

30.9.2004

Can cause allergic reaction

30.9.2004

Can cause allergic reaction

30.9.2004

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 0,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 5,2 %

(b) 2,6 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 2,6 %

(a) (b) Can cause allergic

30.9.2004

reaction

6-Nitro-2,5-pyridi-
nediamine (CAS No
69825-83-8)
and
its salts

Non-oxidising
colouring
hair dyeing

agent

for

HC Blue No 11
(CAS No 23920-
15-2) and its salts

(a) Oxidising
colouring
for hair dyeing

agents

10

Hydroxyethyl-2-
nitro-p-toluidine
(CAS No 100418-
33-5) and its salts

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

3,0 %

Can cause allergic reaction

30.9.2004

(a) 3,0 %

(b) 2,0 %

(a) 2,0 %

(b) 1,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

(a) (b) Can cause allergic

30.9.2004

reaction

(a) (b) Can cause allergic

30.9.2004

reaction

3

4

5

6

7

8

9

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Reference
number

Substance

Field of application
and/or use

Restrictions

Maximum
authorised
concentration
in the
finished cosmetic
product

Other limitations and
requirements

Conditions of use
and warnings which must
be printed on the label

Allowed until

a

11

12

13

14

15

16

17

18

b

c

d

e

f

g

2-Hydroxyethylpi-
cramic acid (CAS
No
99610-72-7)
and its salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 3,0 %

(b) 2,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,5 %

(a) (b) Can cause allergic

30.9.2004

reaction

p-Methylaminophe-
nol (CAS No 150-
75-4) and its salts

Oxidising
colouring
agent for hair dyeing

3,0 %

2,4-Diamino-5-me-
thylphenoxyethanol
(CAS No 141614-
05-3) and its salts

Oxidising
colouring
agent for hair dyeing

3,0 %

HC Violet No 2
CAS No 104226-
19-9) and its salts

Non-oxidising
colouring
hair dyeing

agent

for

Hydroxyethyl-2,6-
dinitro-p-anisidine
(CAS No 122252-
11-3) and its salts

Non-oxidising
colouring
hair dyeing

agent

for

2,0 %

3,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,5 %

Can cause allergic reaction

30.9.2004

Can cause allergic reaction

30.9.2004

30.9.2004

Can cause allergic reaction

30.9.2004

HC Blue No 12
(CAS No 104516-
93-0) and its salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 1,5 %

(b) 1,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 0,75 %

(a) (b) Can cause allergic

30.9.2004

reaction

Oxidising
colouring
agents for hair dyeing

2,0 %

Oxidising
colouring
agents for hair dyeing

2,0 %

2,4-Diamino-5-
methylphenetol
(CAS No 141614-
04-2) and its salts

1,3-Bis-(2,4-diami-
nophenoxy)pro-
pane
(CAS
81892-72-0)
its salts

No
and

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

Can cause allergic reaction

30.9.2004

Can cause allergic reaction

30.9.2004

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Reference
number

Substance

Field of application
and/or use

b

c

colouring
Oxidising
agents for hair dyeing

Restrictions

Maximum
authorised
concentration
in the
finished cosmetic
product

d

2,0 %

3-Amino-2,4-
dichlorophenol
(CAS No 61693-
42-3) and its salts

Phenyl
pyrazolone
No 89-25-8)
its salts

methyl
(CAS
and

2-Methyl-5-hydrox-
yethylaminophenol
(CAS No 55302-
96-0) and its salts

Hydroxybenzomor-
(CAS No
pholine
26021-57-8)
and
its salts

Oxidising
colouring
agents for hair dyeing

0,5 %

Oxidising
colouring
agents for hair dyeing

2,0 %

Oxidising
colouring
agents for hair dyeing

2,0 %

1,7-Naphthalene-
diol (CAS No 575-
38-2) and its salts

Oxidising
colouring
agents for hair dyeing

1,0 %

Other limitations and
requirements

Conditions of use
and warnings which must
be printed on the label

Allowed until

e

f

g

Can cause allergic reaction

30.9.2004

30.9.2004

Can cause allergic reaction

30.9.2004

Can cause allergic reaction

30.9.2004

Can cause allergic reaction

30.9.2004

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 0,25 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 0,5 %

HC Yellow No 10
(CAS No 109023-
83-8) and its salts

Non-oxidising
colouring agents
hair dyeing

for

0,2 %

30.9.2004

2,6-Dimethoxy-3,5-
pyridinediamine
(CAS No 85679-
78-3) and its salts

Oxidising
colouring
agents for hair dyeing

0,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 0,25 %

Can cause allergic reaction

30.9.2004

HC Orange No 2
(CAS No 85765-
48-6) and its salts

Non-oxidising
colouring agents
hair dyeing

for

1,0 %

HC Violet No 1
(CAS No 82576-
75-8) and its salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 0,5 %

(b) 0,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 0,25 %

30.9.2004

30.9.2004

a

19

20

21

22

23

24

25

26

27

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Restrictions

Maximum
authorised
concentration
in the
finished cosmetic
product

d

1,0 %

Other limitations and
requirements

Conditions of use
and warnings which must
be printed on the label

Allowed until

e

f

g

Reference
number

Substance

Field of application
and/or use

b

c

Non-oxidising
colouring agents
hair dyeing

for

3-Methylamino-4-
nitro-phenoxy-
ethanol
59820-63-2)
its salts

(CAS No
and

2-Hydroxy-ethyla-
mino-5-nitro-
anisole
66095-81-6)
its salts

(CAS No
and

Non-oxidising
colouring agents
hair dyeing

for

1,0 %

30.9.2004

30.9.2004

30.9.2004

30.9.2004

30.9.2004

Can cause allergic reaction

30.9.2004

30.9.2004

30.9.2004

2-Chloro-5-
nitro-N-hydroxy-
ethyl-p-phenylene-
diamine (CAS No
50610-28-1)
and
its salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 2,0 %

(b) 1,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

HC Red No 13
(CAS No 29705-
39-3) and its salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 2,5 %

(b) 2,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,25 %

1,5-Naphthalene-
diol
(CAS No 83-
56-7) and its salts

Oxidising
colouring
agents for hair dyeing

1,0 %

Oxidising
colouring
agents for hair dyeing

3,0 %

Hydroxypropyl bis
(N-hydroxyethyl-p-
phenylenediamine)
(CAS No 128729-
30-6) and its salts

o-Aminophenol
(CAS No 95-55-6)
and its salts

Oxidising
colouring
agents for hair dyeing

2,0 %

4-Amino-2-hydro-
xytoluene (CAS No
2835-95-2) and its
salts

Oxidising
colouring
agents for hair dyeing

3,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 0,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,5 %

a

28

29

30

31

32

33

34

35

L 102/28

EN

Official Journal of the European Communities

18.4.2002

Reference
number

Substance

Field of application
and/or use

a

36

b

c

2,4-Diaminophe-
noxyethanol
No
and its salts

(CAS
70643-19-5)

colouring
Oxidising
agents for hair dyeing

Restrictions

Maximum
authorised
concentration
in the
finished cosmetic
product

d

4,0 %

37

38

39

40

41

42

43

44

2-Methylresorcinol
(CAS No 608-25-3)
and its salts

Oxidising
colouring
agents for hair dyeing

2,0 %

4-Amino-m-cresol
(CAS No 2835-99-
6) and its salts

Oxidising
colouring
agents for hair dyeing

3,0 %

2-Amino-4-hydrox-
yethylaminoanisole
(CAS No 83763-
47-7) and its salts

3,4-Diamino-
benzoicacid
(CAS
No 619-05-6) and
its salts

colouring
Oxidising
agents for hair dyeing

3,0 %

Oxidising
colouring
agents for hair dyeing

2,0 %

6-Amino-o-cresol
(CAS No 17672-
22-9) and its salts

Oxidising
colouring
agents for hair dyeing

3,0 %

Oxidising
colouring
agents for hair dyeing

3,0 %

Oxidising
colouring
agents for hair dyeing

3,0 %

colouring
Oxidising
agents for hair dyeing

3,0 %

2-Aminomethyl-p-
(CAS
aminophenol
No
79352-72-0)
and its salts

Hydroxyethylami-
no-methyl-p-
(CAS
aminophenol
No 110952-46-0)
and its salts

Hydroxyethyl-3,4-
methylenedioxyani-
No
line
(CAS
81329-90-0)
and
its salts

Other limitations and
requirements

Conditions of use
and warnings which must
be printed on the label

Allowed until

e

f

g

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 2,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,5 %

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18.4.2002

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Official Journal of the European Communities

L 102/29

Other limitations and
requirements

Conditions of use
and warnings which must
be printed on the label

Allowed until

e

f

g

Reference
number

Substance

Field of application
and/or use

a

45

b

c

Acid Black 52 (CAS
No
16279-54-2)
and its salts

colouring
Oxidising
agents for hair dyeing

Restrictions

Maximum
authorised
concentration
in the
finished cosmetic
product

d

2,0 %

2-Nitro-p-phenyl-
enediamine
(CAS
No 5307-14-2) and
its salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 0,3 %

(b) 0,3 %

HC Blue No 2 (CAS
No
33229-34-4)
and its salts

Non-oxidising
colouring agents
hair dyeing

for

2,8 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 0,15 %

3-Nitro-p-hydroxy-
ethylaminophenol
(CAS No 65235-
31-6) and its salts

4-Nitrophenyl
aminoethylurea
(CAS No 27080-
42-8) and its salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 6,0 %

(b) 6,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 3,0 %

(a) 0,5 %

(b) 0,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 0,25 %

HC
No
Red
10 + HC Red No
11
No
(CAS
95576-89-
9 + 95576-92-4)
and its salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 2,0 %

(b) 1,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

Yellow No 6 (CAS
No 104333-00-8)
and its salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 2,0 %

(b) 1,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

HC Yellow No 12
(CAS No 59320-
13-7) and its salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 1,0 %

(b) 0,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 0,5 %

46

47

48

49

50

51

52

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L 102/30

EN

Official Journal of the European Communities

18.4.2002

Reference
number

Substance

Field of application
and/or use

a

53

b

c

HC Blue No 10
(CAS No 173994-
75-7) and its salts

colouring
Oxidising
agents for hair dyeing

Restrictions

Maximum
authorised
concentration
in the
finished cosmetic
product

d

2,0 %

Other limitations and
requirements

Conditions of use
and warnings which must
be printed on the label

Allowed until

e

f

g

54

55

56

57

58

59

60

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,5 %

HC Blue No 9 (CAS
No 114087-47-1)
and its salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 2,0 %

(b) 1,0 %

2-Chloro-6-ethyla-
mino-4-nitrophenol
(CAS No 131657-
78-8) and its salts

(a) Oxidising
colouring
for hair dyeing

agents

(a) 3,0 %

(b) Non-oxidising co-
louring agents for
hair dyeing

(b) 3,0 %

2-Amino-6-chloro-
4-nitrophenol (CAS
No 6358-09-4) and
its salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 2,0 %

(b) 2,0 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 1,0 %

Basic Blue 26 (CAS
No 2580-56-5) (CI
44045) and its salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 0,5 %

(b) 0,5 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 0,25 %

Acid Red 33 (CAS
No 3567-66-6) (CI
17200) and its salts

Non-oxidising
colouring agents
hair dyeing

for

Ponceau SX (CAS
No 4548-53-2) (CI
14700) and its salts

Non-oxidising
colouring agents
hair dyeing

for

2,0 %

2,0 %

Basic
14
Violet
(CAS No 632-99-5)
(CI 42510) and its
salts

(a) Oxidising
colouring
for hair dyeing

agents

(b) Non-oxidising co-
louring agents for
hair dyeing

(a) 0,3 %

(b) 0,3 %

In combination with
hydrogen peroxide the
maximum use concen-
tration upon applica-
tion is 0,15 %

30.9.2004

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18.4.2002

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Official Journal of the European Communities

L 102/31

Reference
number

Substance

Field of application
and/or use

Restrictions

Maximum
authorised
concentration
in the
finished cosmetic
product

Other limitations and
requirements

Conditions of use
and warnings which must
be printed on the label

Allowed until

b

c

d

e

f

g

a

61

Musk xylene (CAS
no 81-15-2)

All cosmetic products,
with the exception of
oral care products

28.2.2003

28.2.2003’

(a) 1,0 % in
fine fra-
grance

(b) 0,4 % in
de
eau
toilette

(c) 0,03 %

in other
products

(a) 1,4 % in
fine fra-
grance

(b) 0,56 %
in
de
toilette

eau

(c) 0,042 %
in other
products

62

Musk ketone (CAS
No 81-14-1)

All cosmetic products,
with the exception of
oral care products

4.

In Annex VII, Part 1

Reference Nos 26 and 27 are inserted as shown in the following table:

Reference
number

Substance

Maximum authorised
concentration

Other limitations and
requirements

Conditions of use
and warnings which must
be printed on the label

‘26

27

Dimethicodiethylbenzalmalonate
(CAS No 207574-74-1)

Titanium dioxide

10 %

25 %’