Common Position (EC) No 31/2002 of 18 February 2002 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council amending for the 19th time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (azocolourants)
Date: 2002-02-18
Institutions: Council of the European Union
Subjects: approximation of laws, chemical product, dangerous substance, environmental protection, marketing restriction, public health

22.5.2002

EN

Official Journal of the European Communities

C 119 E/7

COMMON POSITION (EC) No 31/2002

adopted by the Council on 18 February 2002

with a view to adopting Directive 2002/. . ./EC of the European Parliament and of the Council
of . . . amending for the 19th time Council Directive 76/769/EEC relating to restrictions on the
marketing and use of certain dangerous substances and preparations (azocolourants)

(2002/C 119 E/02)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Commission, has confirmed that cancer risks posed by
textile and leather goods coloured by certain azodyes,
give cause for concern.

Having regard to the Treaty establishing the European
Community, 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) Textile and leather articles containing certain azodyes
have the capacity to release certain arylamines, which
may pose cancer risks.

(3) 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
field and,
the laws of
consequently,
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 Member States
to amend Annex I

in this

(4) The Scientific Committee on Toxicity, Ecotoxicity and the
(CSTEE), after being consulted by the

Environment

(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 and Decision of the European Parliament of . . .
(not yet
published in the Official Journal).

(4) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Com-
mission Directive 2001/91/EC (OJ L 286, 30.10.2001, p. 27).

(5) 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.

(6) 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
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.

(7) Harmonised testing methods

are necessary for
this Directive. The Commission,

the
application of
in
accordance with Article 2a of Directive 76/769/EEC,
should establish such methods. The testing methods
should preferably be developed at European level,
if
appropriate by the European Committee for Standard-
isation (CEN).

(8) In the light of new scientific knowledge, testing methods
for

including testing methods

should be
analysing 4-amino azobenzene.

reviewed,

(9) In the light of new scientific knowledge, the provisions on
in particular
certain azocolourants should be reviewed,
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.

(10) 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)
based
in particular Council Directive 90/394/EEC (6)
thereon,
and Directive 98/24/EC of the European Parliament and
of the Council (7),

in individual Directives

and

(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.

C 119 E/8

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Official Journal of the European Communities

22.5.2002

HAVE ADOPTED THIS DIRECTIVE:

Article 1

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

Article 2

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.

Article 3

the laws,

1. Member States shall adopt and publish, not later than
. . . (*),
regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
inform the Commission thereof.

They shall apply these provisions from . . . (*).

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.

Article 4

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

Article 5

This Directive is addressed to the Member States.

Done at . . .

For the European Parliament

The President

For the Council

The President

(*) Twelve months after the date of entry into force of this Directive.

22.5.2002

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Official Journal of the European Communities

C 119 E/9

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

ANNEX

1. The following point shall be added:

‘43. Azocolourants

in detectable concentrations,

1. Azodyes which, by reductive cleavage of one or more azo groups,
may release one or more of
the aromatic amines listed in the
i.e. above 30 ppm in the
Appendix,
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 concentrations below
70 ppm.

3. Not later than . . . (*) the Commission shall,

in the light of new

scientific knowledge, review the provisions on azocolourants.

(*) Thirty-six months after the date of entry into force of this Directive.’

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

‘Point 43 Azocolourants

List of aromatic amines

CAS No

Index No

EC No

Substances

1

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

2

3

4

5

6

7

8

9

C 119 E/10

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Official Journal of the European Communities

22.5.2002

CAS No

Index No

EC No

Substances

10

91-94-1

612-068-00-4

202-109-0

3,3'-dichlorobenzidine

3,3'-dichlorobiphenyl-4,4'-ylenediamine

11

119-90-4

612-036-00-X

204-355-4

3,3'-dimethoxybenzidine

o-dianisidine

12

119-93-7

612-041-00-7

204-358-0

3,3'-dimethylbenzidine

4,4'-bi-o-toluidine

13

14

838-88-0

612-085-00-7

212-658-8

4,4'-methylenedi-o-toluidine

120-71-8

204-419-1

6-methoxy-m-toluidine

p-cresidine

15

101-14-4

612-078-00-9

202-918-9

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

2,2'-dichloro-4,4'-methylene-dianiline

16

17

18

19

20

21

101-80-4

139-65-1

202-977-0

4,4'-oxydianiline

205-370-9

4,4'-thiodianiline

95-53-4

612-091-00-X

202-429-0

o-toluidine

2-aminotoluene

95-80-7

612-099-00-3

202-453-1

4-methyl-m-phenylenediamine

137-17-7

205-282-0

2,4,5-trimethylaniline

90-04-0

612-035-00-4

201-963-1

o-anisidine

2-methoxyaniline

22

60-09-3

611-008-00-4

200-453-6

4-amino azobenzene’

22.5.2002

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Official Journal of the European Communities

C 119 E/11

STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 10 December 1999 the Commission submitted a proposal for a Directive based on Article 95 of
the Treaty relating to restrictions on the marketing and use of certain dangerous substances and
preparations (azocolourants) (1).

2. The European Parliament adopted its opinion at first reading on 7 September 2000 (2). Following

this opinion, the Commission presented an amended proposal on 29 November 2000 (3).

3. The Economic and Social Committee delivered its opinion on 25 May 2000 (4).

4. On 18 February 2002 the Council adopted its Common Position in accordance with Article 251 of

the Treaty.

II. AIM

The aim of the Commission's proposal is to ban the use and marketing of textile and leather articles
containing certain azodyes.

III. ANALYSIS OF THE COMMON POSITION

1. The Council has been examining the proposal since the middle of 2000. The Council's Common

Position is generally consistent with the Commission's amended proposal.

2. The Council incorporated one European Parliament amendment and part of two others.

3. The Council welcomed amendment 1 on the need to take technical progress in testing methods into

account.

4. The Council incorporated partly amendments 3 and 6 by removing carpets from the non-exhaustive
list of product categories covered by the provisions and by adding two more products to the
non-exhaustive list.

5. The Council considers that the risk assessment procedures should be completed before extending
the scope of the Directive to other articles and substances. Consequently, the Council rejected
amendment 4 as well as part of amendment 3.

6. As regards testing methods, the Council has opted for a solution which guarantees that the most
therefore rejected

widely used and accepted methods are always applied, and the Council
amendment 5 on inclusion of a particular testing method.

IV. CONCLUSION

By incorporating wholly or partly the European Parliament amendments that improve and clarify the
provisions on testing methods and articles to be covered by the Directive, the Council has endeavoured
to achieve a balanced solution which takes account of the risk-assessment procedure and which
guarantees a high level of health and consumer protection.

(1) OJ C 89 E, 28.3.2000, p. 67.
(2) OJ C 135, 7.5.2001, p. 257.
(3) OJ C 96 E, 27.3.2001, p. 269.
(4) OJ C 204, 18.7.2000, p. 90.