Commission Directive 2003/3/EC of 6 January 2003 relating to restrictions on the marketing and use of "blue colourant" (twelfth adaptation to technical progress of Council Directive 76/769/EEC) (Text with EEA relevance)
Date: 2003-01-06
Institutions: European Commission
Subjects: approximation of laws, dangerous substance, dyestuff, health risk, marketing, occupational safety

L 4/12

EN

Official Journal of the European Communities

9.1.2003

COMMISSION DIRECTIVE 2003/3/EC

of 6 January 2003

relating to restrictions on the marketing and use of ‘blue colourant’ (twelfth adaptation to tech-
nical progress of Council Directive 76/769/EEC)

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 76/769/EEC of 27 July
the laws, regulations and
1976 on the approximation of
administrative provisions of
the Member States relating to
restrictions on the marketing and use of dangerous substances
and preparations (1), as last amended by Commission Directive
2003/2/EC of 6 January 2003 relating to restrictions on the
marketing and use of arsenic (tenth adaptation to technical
progress to Council Directive 76/769/EEC) (2) and in particular
Article 2(a) thereof, introduced by Council Directive 89/678/
EEC (3),

Whereas:

(1)

(2)

(3)

(4)

the European Parliament

Under Directive 76/769/EEC as amended by Directive
2002/61/EC of
and the
Council (4) specified azocolourants are not to be used in
certain textiles and leather articles; nor may those textiles
or leather articles be placed on the market unless they
conform to the requirements in that directive.

to the health and environment of

The risks
‘blue
colourant Index No 611-070-00-2’ have been assessed
under Commission Directive 93/67/EEC of 20 July 1993
laying down the principles for the assessment of risks to
health and the environment of substances notified in
accordance with Council Directive 67/548/EEC (5); the
risk assessment identified a need for reducing risks of
the blue colourant
to the environment as this blue
is not easily
colourant has a high aquatic toxicity,
degradable and reaches the environment via waste water.

In order to protect the environment the placing on the
market and the use of the blue colourant should be
prohibited for colouring textile and leather articles. The
blue colourant should therefore be added to those
substances listed in Annex I to Directive 76/769/EEC.

The restrictions on the placing on the market and use of
the blue colourant laid down by this Directive take into
account the current state of knowledge and techniques
regarding suitable alternatives.

(1) OJ L 262, 27.9.1976, p. 201.
(2) See page 9 of this Official Journal.
(3) OJ L 398, 30.12.1989, p. 24.
(4) OJ L 243, 11.9.2002, p. 15.
(5) OJ L 227, 8.9.1993, p. 9.

for

the protection of workers,

should apply without prejudice

to
This Directive
Community legislation laying down minimum require-
ments
in particular
Council Directive 89/391/EEC of 12 June 1989 on the
introduction of measures to encourage improvements in
the safety and health of workers at work (6), and Council
Directive 90/394/EEC of 28 June 1990 on the protec-
tion of workers from the risks related to carcinogens at
work (Sixth individual Directive within the meaning of
Article 16(1) of Directive 89/391/EEC) (7),
last
amended by Directive 1999/38/EC (8).

as

(6)

The measures provided for in this Directive are in accor-
dance with the opinion of the Committee for the adapta-
the Directives on the
tion to technical progress of
removal of
technical barriers to trade in dangerous
substances and preparations,

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

Article 2

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Direc-
tive by 31 December 2003 at the latest. They shall forthwith
inform the Commission thereof. They shall apply these provi-
sions as from 30 June 2004.

those provisions,

When Member States adopt
these 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 20th day following
that of its publication in the Official Journal of the European
Communities.

(6) OJ L 183, 29.6.1989, p. 1.
(7) OJ L 196, 26.7.1990, p. 1.
(8) OJ L 138, 1.6.1999, p. 66.

9.1.2003

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Official Journal of the European Communities

L 4/13

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 6 January 2003.

For the Commission

Erkki LIIKANEN

Member of the Commission

L 4/14

EN

Official Journal of the European Communities

9.1.2003

— In Annex I to Directive 76/769/EEC, point 43 is replaced by the following:

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 2(a) 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. Azodyes, which are contained in the “List of azodyes” that is hereby added to the
Appendix, may not be placed on the market or used for colouring textile and leather
articles as a substance or constituent of preparations in concentrations higher than
0,1 % by mass.

4. Not later than 11 September 2005, the Commission shall,

in the light of new

scientific knowledge, review the provisions on azocolourants.’

— The following point shall be added to the Appendix:

‘Point 43 Azocolourants

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

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

9.1.2003

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Official Journal of the European Communities

L 4/15

CAS number

Index number

EC number

Substances

11

12

13

14

15

16

17

18

19

20

21

22

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
o-dianisidine

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

838-88-0

120-71-8

612-085-00-7

212-658-8

4,4'-methylenedi-o-toluidine

204-419-1

6-methoxy-m-toluidine
p-cresidine

101-14-4

612-078-00-9

202-918-9

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

101-80-4

139-65-1

95-53-4

95-80-7

137-17-7

90-04-0

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

60-09-3

611-008-00-4

200-453-6

4-amino azobenzene

List of azodyes

CAS number

Index number

EC number

Substances

1

Not allocated

611-070-00-2

405-665-4

Component 1:
CAS-No.: 118685-33-9
C39H23ClCrN7O12S.2Na
Component 2:
C46H30CrN10O20S2.3Na

A mixture of: disodium (6-(4-
anisidino)-3-sulfonato-2-(3,5-
dinitro-2-oxidopheny-
lazo)-1-naphtholato)(1-
(5-chloro-2-oxidophenylazo)-
2-naphtholato)chromate(1-);
trisodium bis(6-(4-anisidino)-3-
sulfonato-2-(3,5-dinitro-2-
oxidopheny-
lazo)-1-naphtholato)chromate(1-)’