Commission Directive 2006/65/EC of  19 July 2006  amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and III thereto to technical progress   (Text with EEA relevance)
Date: 2006-07-19
Institutions: European Commission
Subjects: analytical chemistry, cosmetic product, dyestuffs industry, product safety

20.7.2006

EN

Official Journal of the European Union

L 198/11

COMMISSION DIRECTIVE 2006/65/EC

of 19 July 2006

amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting
Annexes II and III thereto to technical progress

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 76/768/EEC of 27 July 1976
on the approximation of the laws of the Member States relating
to cosmetic products (1), and in particular Article 8(2) thereof,

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

Whereas:

(1)

(2)

(3)

Following the publication of a scientific study in 2001,
entitled ‘Use of permanent hair dyes and bladder cancer
risk’, the Scientific Committee on Cosmetic Products and
Non-Food
(the
intended
risks were of
SCCNFP) concluded that
concern.
the Commission take
further steps to control the use of hair dye chemicals.

recommended that

for Consumers

the potential

Products

It

The SCCNFP recommended in addition an overall safety
assessment
the
requirements for testing hair dye cosmetic ingredients
for their potential genotoxicity/mutagenicity.

including

strategy

dyes

hair

for

Following the opinions of the SCCNFP, the Commission
together with Member States and stakeholders agreed on
an overall strategy to regulate hair dyes according to
the files
which the industry was required to submit
with scientific data on hair dyes to be evaluated by the
SCCNFP.

(1) OJ L 262, 27.9.1976, p. 169. Directive as last amended by
Commission Directive 2005/80/EC (OJ L 303, 22.11.2005, p. 32).

As a first step in the implementation of the strategy it
was decided to give priority to permanent hair dye
substances for which no explicit interest was expressed
during the public consultation in defence of their use in
hair dyes. Those substances should therefore be banned.

therefore deleted from the positive

According to the opinion of the SCCNFP, certain azo
dyes pose a risk to the health of the consumer. They
were
list of
colouring agents allowed for use in cosmetic products
in Annex IV to Directive 76/768/EEC. For the same
reason they should also be banned for use in hair dyes.

For hair dye substances provisionally allowed in part 2 of
Annex III to Directive 76/768/EEC the provisional period
should be extended.

Annexes
therefore be amended accordingly.

II and III

to Directive 76/768/EEC should

The measures provided for
accordance with
opinion
Committee on Cosmetic Products,

the

in this Directive are in
Standing
the

of

(5)

(6)

(7)

(8)

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annexes II and III to Directive 76/768/EEC are amended in
accordance with the Annex to this Directive.

Article 2

Member States shall take all necessary measures to ensure that
from 1 December 2006 at the latest no cosmetic products
which fail to comply with this Directive are placed on the
market by Community manufacturers or by importers esta-
blished within the Community, nor sold or disposed of to the
final consumer.

L 198/12

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Official Journal of the European Union

20.7.2006

Article 3

Article 4

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 1 September 2006 at
the latest. They shall
forthwith communicate to the Commission the text of those
provisions and a correlation between those provisions and this
Directive.

When Member States adopt those provisions, 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.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

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

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 19 July 2006.

For the Commission

Günter VERHEUGEN
Vice-President

20.7.2006

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Official Journal of the European Union

L 198/13

ANNEX

Directive 76/768/EEC is amended as follows:

(1) In Annex II the following reference numbers 1212 to 1233 are added:

Ref. No

‘1212

Chemical name

6-Methoxy-2,3-Pyridinediamine and its HCl salt, when used as a
substance in hair dye products

CAS No

94166-62-8

1213

2,3-Naphthalenediol, when used as a substance in hair dye products

92-44-4

1214

1215

1216

1217

1218

1219

2,4-Diaminodiphenylamine, when used as a substance in hair dye
products

136-17-4

2,6-Bis(2-Hydroxyethoxy)-3,5-Pyridinediamine and its HCl salt, when
used as a substance in hair dye products

117907-42-3

2-Methoxymethyl-p-Aminophenol and its HCl salt, when used as a
substance in hair dye products

29785-47-5

4,5-Diamino-1-Methylpyrazole and its HCl salt, when used as a
substance in hair dye products

20055-01-0

4,5-Diamino-1-((4-Chlorophenyl)Methyl)-1H-Pyrazole Sulfate, when
used as a substance in hair dye products

163183-00-4

4-Chloro-2-Aminophenol, when used as a substance in hair dye
products

95-85-2

1220

4-Hydroxyindole, when used as a substance in hair dye products

2380-94-1

1221

1222

1223

1224

1225

1226

1227

4-Methoxytoluene-2,5-Diamine and its HCl salt, when used as a
substance in hair dye products

56496-88-9

5-Amino-4-Fluoro-2-Methylphenol Sulfate, when used as a substance
in hair dye products

163183-01-5

N,N-Diethyl-m-Aminophenol, when used as a substance in hair dye
products

91-68-9

N,N-Dimethyl-2,6-Pyridinediamine and its HCl salt, when used as a
substance in hair dye products

N-Cyclopentyl-m-Aminophenol, when used as a substance in hair dye
products

104903-49-3

N-(2-Methoxyethyl)-p-phenylenediamine and its HCl salt, when used
as a substance in hair dye products

72584-59-9

2,4-Diamino-5-methylphenetol and its HCl salt, when used as a
substance in hair dye products

113715-25-6

1228

1,7-Naphthalenediol, when used as a substance in hair dye products

575-38-2

1229

3,4-Diaminobenzoic acid, when used as a substance in hair dye
products

619-05-6

L 198/14

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Official Journal of the European Union

20.7.2006

Ref. No

1230

1231

1232

1233

Chemical name

2-Aminomethyl-p-aminophenol and its HCl salt, when used as a
substance in hair dye products

CAS No

79352-72-0

Solvent Red 1 (CI 12150), when used as a substance in hair dye
products

1229-55-6

Acid Orange 24 (CI 20170), when used as a substance in hair dye
products

Acid Red 73 (CI 27290), when used as a substance in hair dye
products

1320-07-6

5413-75-2’

(2) Column g in Part 2 of Annex III is amended as follows:

(a) the reference numbers 17, 23, 40, 42 are deleted;

(b) in reference numbers 1, 2, 8, 13, 15, 30, 34, 41, 43, 45, 46, 51, 52, 53, 54, 57, 59, 60 the date ‘31.8.2006’ is

replaced by ‘31.12.2007’;

(c) in reference numbers 3, 4, 5, 6, 7, 9, 10, 11, 12, 14, 16, 18, 19, 20, 21, 22, 24, 25, 26, 27, 28, 29, 31, 32, 33,
is replaced by ‘31.12.2007’.

35, 36, 37, 38, 39, 44, 47, 48, 49, 50, 55, 56 and 58 the date ‘31.12.2006’