Proposal for a Directive of the European Parliament and of the Council 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: 1999-12-10
Institutions: European Commission
Subjects: carcinogenic substance, dyestuff, marketing restriction, single market, textile product

28.3.2000

EN

Official Journal of the European Communities

C 89 E/67

Proposal for a Directive of the European Parliament and of the Council amending for the nine-
teenth time Council Directive 76/769/EEC relating to restrictions on the marketing and use of
certain dangerous substances and preparations (azocolourants)

(2000/C 89 E/13)

(Text with EEA relevance)

COM(1999) 620 final (cid:151) 1999/0269(COD)

(Submitted by the Commission on 13 December 1999)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF
THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of
Committee,

the Economic and Social

(7) For common fabrics,

the test methods to be used in
demonstrating conformity with the rules set out in this
Directive are established in the Annex.

(8) This Directive applies without prejudice to Community
legislation laying down minimum requirements for the
protection of workers contained in Council Directive
89/391/EEC (2) and in individual directives based thereon,
in particular Council Directive 90/394/EEC (3) and Council
Directive 98/24/EC (4),

Acting in accordance with the procedure referred to in Article
251 of the Treaty,

HAS ADOPTED THIS DIRECTIVE:

Whereas:

(1) Under Article 14 of the Treaty, an area without internal
frontiers is to be established in which the free movement of
goods, persons, services and capital is ensured.

(2) 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.

(3) Azodyed textile and leather articles have the capacity to
release certain arylamines, which may pose cancer risks.

(4) 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 consequently to
amend Annex I to Council Directive 76/769/EEC (1).

(5) The Scientific Committee on Toxicity, Ecotoxicity and the
Environment
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.

(CSTEE),

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

Article 1

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

Article 2

1. Member States shall adopt and publish the laws, regu-
lations and administrative provisions necessary to comply
with this Directive no later than 31 December 2001 (one
year after the date of the entry into force of this Directive).
They shall forthwith inform the Commission thereof.

They shall apply those provisions from 1 July 2002 (eighteen
months after the date of entry into force of this Directive).

2. 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.

Article 3

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

Article 4

This Directive is addressed to the Member States.

(1) OJ L 262, 27.9.1976, p. 201. Directive as

last amended by

Commission Directive 99/77/EC (OJ L 207, 6.8.1999, p. 18).

(2) OJ L 183, 29.6.1989, p. 1.
(3) OJ L 196, 26.7.1990, p. 1.
(4) OJ L 131, 5.5.1998, p. 11.

C 89 E/68

EN

Official Journal of the European Communities

28.3.2000

ANNEX

The following point 43 is added to Annex I to Directive 76/769/EEC:

(cid:145)43

Azo colourants

1. Azodyes that may release, by reductive cleavage of one or more azo groups, one or
more of the aromatic amines listed in Appendix, in concentrations above 30 ppm
in the finished articles, according to the testing method specified in Appendix,

may not be used in textile and leather articles which have the potential of coming
into direct and prolonged contact with the human skin or oral cavity, such as:

(cid:151) clothing, bedding, towels, hairpieces, wigs, hats, nappies and other sanitary

items,

(cid:151) footwear, gloves, wristwatch straps, handbags, purses/wallets, briefcases, chair

covers,

(cid:151) textile or leather toys and toys which include textile or leather garments,

(cid:151) carpets.

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.(cid:146)

The following is added to the Appendix to Annex I to Directive 76/769/EEC:

(cid:145)Point 43 Azo colourants

A. List of aromatic amines

1

2

3

4

5

6

7

8

9

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

106-47-8

615-05-4

202-765-8

203-401-0

5-nitro-o-toluidine

4-chloroaniline

210-406-1

4-methoxy-m-phenylenediamine

101-77-9

612-051-00-1

202-974-4

4,4’-methylenedianiline
4,4’-diaminodiphenylmethane

3,3’-dichlorobenzidine
3,3’-dichlorobiphenyl-4,4’-ylenediamine

10

91-94-1

612-068-00-4

202-109-0

28.3.2000

EN

Official Journal of the European Communities

C 89 E/69

11

12

13

14

15

16

17

18

19

20

21

CAS number

Index number

EC number

Substances

119-90-4

612-036-00-X

204-355-4

119-93-7

612-041-00-7

204-358-0

3,3’-dimethoxybenzidine
o-dianisidine

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

838-88-0

612-085-00-7

212-658-8

4,4’-methylenedi-o-toluidine

120-71-8

204-419-1

101-14-4

612-078-00-9

202-918-9

6-methoxy-m-toluidine
p-cresidine

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

101-80-4

139-65-1

202-977-0

205-370-9

95-53-4

612-091-00-X

202-429-0

4,4’-oxydianiline

4,4’-thiodianiline

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

B. Analytical methods

Analysis

Method

1. Detection of the use of banned azodyes
in the manufacture and treatment of
coloured
commodities,
particularly those made of cellulose
and protein fibres
(cotton, viscose,
wool, silk).

textile

1. The presence of the amines listed in section A above are to be
tested according to the German official method of analysis referred
to as (cid:147)Untersuchung von Bedarfsgegenst(cid:228)nden (cid:151) Nachweis der
Verwendung bestimmter Azofarbstoffe aus textilen Bedarfsgegen-
st(cid:228)nden(cid:148) published in the (cid:147)Amtliche Sammlung von Unter-
suchungsverfahren nach § 35 des Lebensmittel- und Bedarfsgegen-
st(cid:228)ndegesetzes, Gliederungsnummer B 82.02-2, Januar 1998 (1)(cid:148).

2. Detection of the use of banned azodyes
in the manufacture and treatment of
coloured polyester fibres commodities.

3. Detection of the use of banned azodyes
in the manufacture and treatment of
coloured leather commodities.

2. The presence of the amines listed in section A above are to be
tested according to the German official method of analysis referred
to as (cid:147)Untersuchung von Bedarfsgegenst(cid:228)nden (cid:151) Nachweis der
Verwendung bestimmter Azofarbstoffe aus Polyesterfasern in Be-
darfsgegenst(cid:228)nden(cid:148) published in (cid:147)Amtliche Sammlung von Unter-
suchungsverfahren nach § 35 des Lebensmittel- und Bedarfsgegen-
st(cid:228)ndegesetzes, Gliederungsnummer B 82.02-4, Januar 1998 (1)(cid:148).

3. The presence of the amines listed in section A above are to be
tested according to the German official method of analysis referred
to as (cid:147)Untersuchung von Bedarfsgegenst(cid:228)nden (cid:151) Nachweis be-
stimmter Azofarbstoffe in Leder(cid:148) published in (cid:147)Amtliche Samm-
lung von Untersuchungsverfahren nach § 35 des Lebensmittel- und
Bedarfsgegenst(cid:228)ndegesetzes, Gliederungsnummer B 82.02-3, M(cid:228)rz
1997 (1)(cid:148).

(1) Obtainable from the Beuth-Verlag GmbH, Berlin and K(cid:246)ln(cid:146)