Directive 2002/61/EC of the European Parliament and of the Council of 19 July 2002 amending for the nineteenth time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (azocolourants)
Date: 2002-07-19
Institutions: Council of the European Union, European Parliament
Subjects: approximation of laws, dangerous substance, dyestuff, marketing restriction, public health, textile product

11.9.2002

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Official Journal of the European Communities

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DIRECTIVE 2002/61/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 19 July 2002

amending for the nineteenth time Council Directive 76/769/EEC relating to restrictions on the
marketing and use of certain dangerous substances and preparations (azocolourants)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 95 thereof,

Having regard to the proposals from the Commission (1),

Having regard to the opinion of the Economic and Social
Committee (2),

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3),

Whereas:

(1) Work on the internal market should gradually improve
the quality of life, health protection and consumer safety.
The measures provided for in this Directive ensure a
high level of health and consumer protection.

(2)

(3)

(4)

(5)

(6)

Textile and leather articles containing certain azodyes
have the capacity to release certain arylamines, which
may pose cancer risks.

Limitations already adopted or planned by certain
Member States on the use of azodyed textile and leather
articles concern the completion and functioning of the
internal market. It is therefore necessary to approximate
the laws of the Member States in this field and, conse-
quently, to amend Annex I to Council Directive 76/769/
EEC of 27 July 1976 on the approximation of the laws,
regulations and administrative provisions of the Member
States relating to restrictions on the marketing and use
of certain dangerous substances and preparations (4).

The Scientific Committee on Toxicity, Ecotoxicity and
the Environment (CSTEE), after being consulted by the
Commission, has confirmed that cancer risks posed by
textile and leather goods coloured by certain azodyes,
give cause for concern.

In order to protect human health, the use of dangerous
azodyes and the placing on the market of some articles
coloured with such dyes should be prohibited.

For textile articles made of recycled fibres, a maximum
concentration of 70 ppm for the amines listed in point
43 in the appendix to Directive 76/769/EEC should be

(7)

(8)

(9)

(10)

applied. This should be the case for a transitional period
until 1 January 2005 if the amines are released by the
residues deriving from the previous dyeing of the same
fibres. This will allow for the recycling of textiles, which
has overall benefits for the environment.

Harmonised testing methods are necessary for the appli-
cation of this Directive. The Commission, in accordance
with Article 2a of Directive 76/769/EEC, should establish
such methods. The testing methods should preferably be
if appropriate by the
developed at European level,
European Committee for Standardisation (CEN).

In the light of new scientific knowledge, testing methods
should be reviewed,
for
analysing 4-amino azobenzene.

including testing methods

In the light of new scientific knowledge, the provisions
on certain azocolourants should be reviewed,
in parti-
cular with regard to the need to include other materials
not covered by this Directive, as well as other aromatic
amines. Special attention should be paid to possible risks
to children.

This Directive applies without prejudice to Community
legislation laying down minimum requirements for the
protection of workers contained in Council Directive 89/
391/EEC (5) and in individual directives based thereon, in
particular Council Directive 90/394/EEC (6) and Directive
98/24/EC of
the
Council (7),

the European Parliament and of

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 76/769/EEC is hereby amended as set out
in the Annex to this Directive.

Article 2

(1) OJ C 89 E, 28.3.2000, p. 67 and
OJ C 96 E, 27.3.2001, p. 269.

(2) OJ C 204, 18.7.2000, p. 90.
(3) Opinion of the European Parliament of 7 September 2000 (OJ C
135, 7.5.2001, p. 257), Council Common Position of 18 February
2002 (OJ C 119 E, 22.5.2002, p. 7) and Decision of the European
Parliament of 11 June 2002 (not yet published in the Official
Journal).

(4) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commis-

sion Directive 2001/91/EC (OJ L 286, 30.10.2001, p. 27).

Testing methods for the application of point 43 of Annex I to
Directive 76/769/EEC shall be adopted by the Commission in
accordance with the procedure laid down in Article 2a of that
Directive.

(5) OJ L 183, 29.6.1989, p. 1.
(6) OJ L 196, 26.7.1990, p. 1. Directive as last amended by Directive

1999/38/EC (OJ L 138, 1.6.1999, p. 66).

(7) OJ L 131, 5.5.1998, p. 11.

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Article 3

1. Member States shall adopt and publish, not later than 11 September 2003, the laws, regulations and
administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commis-
sion thereof.

They shall apply these provisions from 11 September 2003.

2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be
accompanied by such reference on the occasion of their official publication. The methods of making such
reference shall be laid down by Member States.

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

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 19 July 2002.

For the European Parliament

The President

P. COX

For the council

The President

T. PEDERSEN

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Annex I to Directive 76/769/EEC is amended as follows:

1. The following point shall be added:

ANNEX

‘43. Azocolourants

1. Azodyes which, by reductive cleavage of one or more azo groups, may release one or
more of the aromatic amines listed in the Appendix, in detectable concentrations, i.e.
above 30 ppm in the finished articles or in the dyed parts thereof, according to the
testing method established in accordance with Article 2a of this Directive, may not be
used in textile and leather articles which may come into direct and prolonged contact
with the human skin or oral cavity, such as:

— clothing, bedding, towels, hairpieces, wigs, hats, nappies and other sanitary items,

sleeping bags,

— footwear, gloves, wristwatch straps, handbags, purses/wallets, briefcases, chair

covers, purses worn round the neck,

— textile or leather toys and toys which include textile or leather garments,

— yarn and fabrics intended for use by the final consumer.

2. Furthermore, the textile and leather Articles referred to in point 1 above may not be
placed on the market unless they conform to the requirements set out in that point.

By way of derogation, until 1 January 2005, this provision shall not apply to textile
articles made of recycled fibres if the amines are released by residues deriving from
previous dyeing of the same fibres and if the listed amines are released in concentra-
tions below 70 ppm.

3. Not later than 11 September 2005, the Commission shall, in the light of new scientific

knowledge, review the provisions on azocolourants.’

2. The following point shall be added to the Appendix:

‘Point 43 — Azocolourants

List of aromatic amines

CAS number

Index number

EC number

Substances

92-67-1

612-072-00-6

202-177-1

biphenyl-4-ylamine
4-aminobiphenyl
xenylamine

92-87-5

612-042-00-2

202-199-1

benzidine

95-69-2

202-441-6

4-chloro-o-toluidine

91-59-8

612-022-00-3

202-080-4

2-naphthylamine

97-56-3

611-006-00-3

202-591-2

o-aminoazotoluene
4-amino-2',3-dimethylazobenzene
4-o-tolylazo-o-toluidine

99-55-8

202-765-8

5-nitro-o-toluidine

106-47-8

612-137-00-9

203-401-0

4-chloroaniline

615-05-4

210-406-1

4-methoxy-m-phenylenediamine

101-77-9

612-051-00-1

202-974-4

4,4'-methylenedianiline
4,4'-diaminodiphenylmethane

1

2

3

4

5

6

7

8

9

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CAS number

Index number

EC number

Substances

10

91-94-1

612-068-00-4

202-109-0

119-90-4

612-036-00-X

204-355-4

119-93-7

612-041-00-7

204-358-0

3,3'-dichlorobenzidine
3,3'-dichlorobiphenyl-4,4'-ylenedia-
mine

3,3'-dimethoxybenzidine
dine

o-dianisi-

3,3'-dimethylbenzidine
4,4'-bi-o-toluidine

838-88-0

120-71-8

101-14-4

101-80-4

139-65-1

95-53-4

95-80-7

137-17-7

90-04-0

60-09-3

612-085-00-7

212-658-8

4,4'-methylenedi-o-toluidine

204-419-1

6-methoxy-m-toluidine p-cresidine

612-078-00-9

202-918-9

4,4'-methylene-bis-(2-chloro-aniline)
2,2'-dichloro-4,4'-methylene-dianiline

202-977-0

4,4'-oxydianiline

205-370-9

4,4'-thiodianiline

612-091-00-X

202-429-0

o-toluidine
2-aminotoluene

612-099-00-3

202-453-1

4-methyl-m-phenylenediamine

205-282-0

2,4,5-trimethylaniline

612-035-00-4

201-963-1

o-anisidine 2-methoxyaniline

611-008-00-4

200-453-6

4-amino azobenzene’

11

12

13

14

15

16

17

18

19

20

21

22