Directive 2003/11/EC of the European Parliament and of the Council of 6 February 2003 amending for the 24th time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (pentabromodiphenyl ether, octabromodiphenyl ether)
Date: 2003-02-06
Institutions: Council of the European Union, European Parliament
Subjects: approximation of laws, dangerous substance, environmental protection, marketing restriction

15.2.2003

EN

Official Journal of the European Union

L 42/45

DIRECTIVE 2003/11/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 6 February 2003

amending for the 24th time Council Directive 76/769/EEC relating to restrictions on the marketing
and use of certain dangerous substances and preparations (pentabromodiphenyl ether, octabromo-
diphenyl ether)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(4)

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),

(5)

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3), in the light of the joint text approved by
the Conciliation Committee on 8 November 2002,

Whereas:

(1)

(2)

(3)

Under Article 14 of the Treaty, an area without internal
frontiers is to be established, in which the free move-
ment of goods, persons, services and capital is ensured.

and

(pentaBDE)

octabromo-diphenyl

The risks to the environment of pentabromodiphenyl
ether
ether
(octaBDE) have been assessed under Council Regulation
(EEC) No 793/93 of 23 March 1993 on the evaluation
and control of the risks of existing substances (4). The
risk assessments on pentaBDE and octaBDE identified a
need for reducing risks from these substances to the
environment. In its opinions of 4 February 2000 and 31
October 2002,
the Scientific Committee on toxicity,
ecotoxicity and the environment (CSTEE) confirmed the
these assessments of pentaBDE and
conclusions of
octaBDE on the need to reduce risks to protect the envir-
onment. Furthermore,
in its
opinion of 19 June 2000, the concern about exposure of
breast-fed children to pentaBDE and that the increasing
levels of pentaBDE in breast milk might be the result of
a use not yet identified.

the CSTEE confirmed,

The Commission has adopted Recommendations in the
framework of Regulation (EEC) No 793/93 on a risk
reduction strategy for pentaBDE (5) and octaBDE (6)
providing for
restrictions on marketing and use to
control risks to the environment. They also recom-
mended that any measures should take account of the
concerns about infants exposed via milk.

(1) OJ C 154 E, 29.5.2001, p. 112 and OJ C 25, 29.1.2002, p. 472.
(2) OJ C 193, 10.7.2001, p. 27.
(3) Opinion of the European Parliament of 6 September 2001 (OJ C 72
E, 21.3.2002, p. 235), Council Common Position of 6 December
2001 (OJ C 110 E, 7.5.2002, p. 23) and Decision of the European
Parliament of 10 April 2002 (not yet published in the Official
Journal).

(4) OJ L 84, 5.4.1993, p. 1.
(5) OJ L 69, 10.3.2001, p. 30.
(6) OJ L 249, 17.9.2002, p. 27.

In order to protect health and the environment
the
placing on the market and the use of pentaBDE and
octaBDE and the placing on the market of articles
containing one or both of these substances should be
prohibited.

The presence of pentaBDE or octaBDE in concentrations
higher than 0,1 % can be identified using standard analy-
tical techniques such as GC-MS (gas chromatography-
mass spectrometry).

The risk assessment on decaBDE was concluded in
August 2002 and has revealed a number of uncertainties
concerning possible effects on the environment of this
substance. Risk reduction measures should be taken by
the Community without delay and a risk reduction
strategy has therefore to be established immediately. The
Commission expects the results of the risk reduction
strategy not later than 30 June 2003. It should then
immediately assess these results and propose appropriate
and strict measures to address risks identified. The
European Parliament and the Council should consider
this proposal without delay. Restrictions approved by
the Community on the marketing and use of decaBDE
are to enter into force without further delay, unless the
further testing provided for in the above risk assessment
resolves the current uncertainties by concluding that
decaBDE gives no cause for concern.

This Directive does not affect Community legislation
laying down minimum requirements for the protection
of workers contained in 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 (7), and in individual directives based
thereon, in particular Council Directive 90/394/EEC of
28 June 1990 on the protection of workers from the
risks related to exposure to carcinogens at work (Sixth
individual Directive within the meaning of Article 16(1)
of Directive 89/391/EEC) (8) and Council Directive 98/
24/EC of 7 April 1998 on protection of health and
safety of workers from the risks related to chemical
agents at work (14th individual Directive within the
meaning of Article 16(1) of Directive 89/391/EEC) (9),

(6)

(7)

(7) OJ L 183, 29.6.1989, p. 1.
(8) 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).

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

L 42/46

EN

Official Journal of the European Union

15.2.2003

HAVE ADOPTED THIS DIRECTIVE:

Article 3

Article 1

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

Article 2

Member States shall adopt and publish the laws, regulations
and administrative provisions necessary to comply with this
Directive no later than 15 February 2004. They shall forthwith
inform the Commission thereof.

This Directive shall enter into force on the day of its publica-
tion in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

They shall apply those measures from 15 August 2004.

Done at Brussels, 6 February 2003.

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

For the European Parliament

The President

P. COX

For the Council

The President

P. EFTHYMIOU

The following point [XX] shall be added to Annex I of Directive 76/769/EEC:

ANNEX

‘[XX] diphenylether, pentabromo derivative C12H5Br5O

1. May not be placed on the market or used as a
substance or as a constituent of substances or of
preparations in concentrations higher than 0,1 % by
mass.

2. Articles may not be placed on the market if they, or
flame-retarded parts thereof, contain this substance
in concentrations higher than 0,1 % by mass.’

The following point [XXa] shall be added to Annex I of Directive 76/769/EEC:

‘[XXa] diphenylether, octabromo derivative C12H2Br8O

1. May not be placed on the market or used as a
substance or as a constituent of substances or of
preparations in concentrations higher than 0,1 % by
mass.

2. Articles may not be placed on the market if they, or
flame-retardant parts thereof, contain this substance
in concentrations higher than 0,1 % by mass.’