Commission Directive 2003/83/EC of 24 September 2003 adapting to technical progress Annexes II, III and VI 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: 2003-09-24
Institutions: European Commission
Subjects: chemical product, cosmetic product, market approval, withdrawal from the market

25.9.2003

EN

Official Journal of the European Union

L 238/23

COMMISSION DIRECTIVE 2003/83/EC

of 24 September 2003

adapting to technical progress Annexes II, III and VI 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,

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 2003/80/EC (2), and in particular Article 8(2)
thereof,

After consulting the Scientific Committee on Cosmetic Products
and Non-Food Products intended for consumers,

(4)

(5)

(6)

The SCCNFP is of the opinion that the use of 1,2-
dibromo-2,4-dicyanobutane
restricted to
rinse-off products at the current maximum permitted
level of 0,1 %. Therefore reference No 36 of Annex VI,
part 1 should be amended accordingly.

should be

Therefore, Directive 76/768/EEC should be amended
accordingly.

The measures provided for in this Directive are in accor-
dance with the opinion of the Standing Committee on
Cosmetic Products,

Whereas:

HAS ADOPTED THIS DIRECTIVE:

(1)

(2)

(3)

and

Products

peroxide

Benzoyl
hydroquinone methylether
(synonym of 4-methoxyphenol) are currently listed in
Annex II, hydroquinone is already subject to restrictions
and conditions laid down in Annex III. The Scientific
and Non-Food
Committee on Cosmetic
Products intended for consumers (hereinafter SCCNFP)
has come to the conclusion that, due to the very low
exposure to the consumer, the use of benzoyl peroxide,
hydroquinone and hydroquinone methylether in artificial
nail systems does not pose a risk. Therefore, reference
No 178 of Annex II and reference No 14 of Annex III,
part 1 should be amended accordingly; reference No
382 of Annex II should be deleted and reference Nos 94
and 95 should be added in Annex III, part 1.

It is the opinion of the SCCNFP that the toxicological
effects of the dialkanolamine salts, and,
in particular,
their readiness for nitrosamines' formation are similar to
the respective properties of the dialkanolamines and that
dialkylamines and their salts have very similar properties
with the respective dialkanolamines' analogues with
respect to nitrosamines' formation. The terms ‘dialkano-
lamines’ and ‘dialkylamines’ and synonymous with
‘secondary alkanolamines’ and ‘secondary alkylamines’
and the latter are less ambiguous. Therefore, reference
No 411 of Annex II and reference Nos 60, 61 and 62 of
Annex III, part 1, should be amended accordingly.

the
The SCCNFP has come to the conclusion that
compound 2,4-diamino-pyrimidine-3-oxide
(CAS No
74638-76-9) can be used safely in cosmetic products at
concentrations up to 1,5 %. Therefore, 2,4-diamino-pyri-
midine-3-oxide should be included in Annex III, part 1
as reference No 93.

(1) OJ L 262, 27.9.1976, p. 169.
(2) OJ L 224, 6.9.2003, p. 27.

Article 1

Annexes II,
amended as set out in the Annex to this Directive.

III and VI

to Directive 76/768/EEC shall be

Article 2

1. Member States shall
take the necessary measures to
ensure that from 24 March 2005 cosmetic products which fail
to comply with this Directive shall not be placed on the market
by Community manufacturers or by importers established
within the Community.

2. Member States shall
take the necessary measures to
ensure that the products referred to in paragraph 1 shall not be
sold or disposed of to the final consumer after 24 September
2005.

Article 3

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Direc-
tive by 24 September 2004 at the latest. They shall forthwith
inform the Commission thereof.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a refer-
ence on the occasion of their official publication. Member
States shall determine how such reference is to be made.

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Official Journal of the European Union

25.9.2003

This Directive shall enter into force on the 20th day following that of its publication in the Official Journal
of the European Union.

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 24 September 2003.

For the Commission

Erkki LIIKANEN

Member of the Commission

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

ANNEX

1. Annex II is amended as follows:

(a) reference No 178 is replaced by the following:

‘178. 4-Benzoyloxyphenol and 4-ethoxyphenol’

(b) reference No 382 is deleted.

(c) reference number 411 is replaced by the following:

‘411. Secondary alkyl- and alkanolamines and their salts’.

2. Annex III, part 1 is amended as follows:

(a) reference No 14 is 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 warn-
ings which must be printed
in the label

a

b

c

d

e

f

‘14

Hydroquinone (*)

(a) oxidising

colouring
agent for hair-dying:

0,3 %

(a) 1. — Do not use to
dye eyelashes or
eyebrows

1. General use

2. Professional use

— Rinse

the
immediately
the
comes
contact
them

eyes
if
product
into
with

— Contains hydro-

quinone

2. — For

professional

use only
— Contains
quinone

hydro-

— Rinse

the
immediately
the
comes
contact
them

eyes
if
product
into
with

(b) artificial nail systems 0,02 % (after mixing for

Professional use only

(b) — For professional use

use)

only

— Avoid skin contact
— Read directions for

use carefully’

(*) 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 refer-

ence to the maximum level authorized for each of them does not exceed 2.

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(b) reference Nos 60, 61 and 62 are replaced by the following:

Reference
number

Substance

Field of application and/or
use

Maximum authorised
concentration in the finished
cosmetic product

Other limitations and
requirements

Conditions of use and warn-
ings which must be printed
in the label

RESTRICTIONS

a

‘60

b

c

d

e

f

Fatty acid dialkylamides
and dialkanolamides

Maximum
amine content: 0,5 %

secondary

— Do not use with
nitrosating systems
— Maximum secondary
amine content: 5 %
(applies to raw mate-
rials)

— Maximum nitrosa-
mine content: 50 µg/
kg

— Keep in nitrite-free

containers

61

Monoalkylamines,
monoalkanolamines and
their salts

Maximum
amine content: 0,5 %

secondary

— Do not use with
nitrosating systems

62

Trialkylamines, trialkano-
lamines and their salts

(a) non-rinse-off
products
(b) other products

(a) 2,5 %

— Minimum
99 %

purity:

— Maximum secondary
amine content: 0,5 %
(applies to raw mate-
rials)

— Maximum nitrosa-
mine content: 50 µg/
kg

— Keep in nitrite-free

containers

(a) (b)
— Do not use with
nitrosating systems

— Minimum
99 %

purity:

— Maximum secondary
amine content: 0,5 %
(applies to raw mate-
rials)

— Maximum nitrosa-
mine content: 50 µg/
kg

— Keep in nitrite-free

containers’

(c) reference Nos 93, 94 and 95 are added:

Reference
number

Substance

Field of application and/or
use

Maximum authorised
concentration in the finished
cosmetic product

Other limitations and
requirements

Conditions of use and warn-
ings which must be printed
in the label

RESTRICTIONS

a

‘93

b

c

d

e

f

2,4-Diamino-pyrimidine-
3-oxide (CAS No 74638-
76-9)

Hair care formulations

1,5 %

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Reference
number

Substance

Field of application and/or
use

Maximum authorised
concentration in the finished
cosmetic product

Other limitations and
requirements

Conditions of use and warn-
ings which must be printed
in the label

RESTRICTIONS

a

b

c

d

e

f

94

Benzoyl peroxide

Artificial nail systems

0,7 % (after mixing)

Professional use only

— For professional use

95

Hydroquinone methy-
lether

Artificial nail systems

0,02 % (after mixing for
use)

only

— Avoid skin contact
— Read directions for use

carefully

Professional use only

— For professional use

only

— Avoid skin contact
— Read directions for use

carefully’

Reference
number

a

‘36

3. In Annex VI, part 1, reference No 36 is replaced by the following:

Substance

Maximum authorised concentration

Other limitations and requirements

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

b

c

d

e

1,2-Dibromo-2,4-dicyanobutane
(methyldibromo glutaronitrile)

0,1 %

Rinse-off products only’