Directive 2003/53/EC of the European Parliament and of the Council of 18 June 2003 amending for the 26th time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (nonylphenol, nonylphenol ethoxylate and cement) (Text with EEA relevance)
Date: 2003-06-18
Institutions: Council of the European Union, European Parliament
Subjects: cement, environmental impact, health risk, market approval, polishing and scouring preparations, toxic substance

L 178/24

EN

Official Journal of the European Union

17.7.2003

DIRECTIVE 2003/53/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 18 June 2003

amending for the 26th time Council Directive 76/769/EEC relating to restrictions on the marketing
and use of certain dangerous substances and preparations (nonylphenol, nonylphenol ethoxylate
and cement)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 95 thereof,

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

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

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

Whereas:

The risks posed to the environment by nonylphenol (NP)
and nonylphenol ethoxylate (NPE) have been assessed in
accordance with Council Regulation (EEC) No 793/93 of
23 March 1993 on the evaluation and control of the
risks of existing substances (4). The assessment identified
a need to reduce those risks and, in its opinion of 6 and
7 March 2001, the Scientific Committee on Toxicity,
Ecotoxicity and the Environment (CSTEE) confirmed that
conclusion.

NP is classified as a ‘priority hazardous substance’
in
Directive 2000/60/EC of the European Parliament and of
the Council of 23 October 2000 establishing a frame-
work for Community action in the field of water
policy (5). Pursuant to Article 16(6) of that Directive, the
Commission is to submit proposals of control for the
cessation or phasing-out of discharges, emissions and
losses of such substances.

(1)

(2)

(3)

(4)

(5)

(6)

In order to protect the environment the Commission is
invited to consider an amendment to Council Directive
86/278/EEC of 12 June 1986 on the protection of the
environment, and in particular of the soil, when sewage
sludge is used in agriculture (7), with a view to estab-
lishing a concentration limit value for NP and NPE in
sewage sludge that is to be spread on land.

In order further to protect the environment, the placing
on the market and the use of NP and NPE should be
restricted for specific uses which result in discharges,
emissions or losses to the environment. However, the
restriction concerning co-formulants in pesticides and
biocides should be without prejudice to the validity of
existing national authorisations of pesticides or biocidal
products containing NPE as a co-formulant, which have
been granted before the entry into force of this Directive,
until they expire.

Scientific studies have also shown that cement prepara-
tions containing chromium VI may cause allergic reac-
tions in certain circumstances,
there is direct and
prolonged contact with the human skin. All uses of
cement bear the risk of direct and prolonged contact
with the human skin, with the exception of controlled
closed and totally automated processes.

if

(7)

The CSTEE has confirmed the adverse health effects of
chromium VI in cement.

Commission Recommendation 2001/838/EC of 7
November 2001 on the results of the risk evaluation and
the risk reduction strategies for the substances: acrylalde-
hyde; dimethyl sulphate; nonylphenol phenol, 4-nonyl-,
branched; tert-butyl methyl ether (6), adopted within the
framework of Regulation (EEC) No 793/93, proposed a
risk limitation strategy for NP and NPE, recommending
restrictions be placed on their
that
in particular
marketing and use.

(8)

(1) Proposal of 16 August 2002 (not yet published in the Official

Journal).

(2) OJ C 133, 6.6.2003, p. 13.
(3) Opinion of the European Parliament of 27 March 2003 (not yet
published in the Official Journal) and Council Decision of 19 May
2003.

(4) OJ L 84, 5.4.1993, p. 1.
(5) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No

2455/2001/EC (OJ L 331, 15.12.2001, p. 1).

(6) OJ L 319, 4.12.2001, p. 30.

Individual protection measures are necessary, but not
sufficient to prevent skin contact with cement. More-
over, according to the hierarchy of protection provisions
contained in Council Directive 98/24/EC of 7 April
1998 on the protection of the health and safety of
workers from the risks related to chemical agents at
work
(Fourteenth individual Directive within the
meaning of Article 16(1) of Directive 89/391/EEC) (8),
the employer is to ensure as a priority that the level of
exposure is reduced to as low a level as possible when
substitution is impossible, and apply individual protec-
tion measures only where exposure cannot be prevented
by other means.

(7) OJ L 181, 4.7.1986, p. 6. Directive as last amended by the 1994

Act of Accession.

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

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Official Journal of the European Union

L 178/25

(9)

(10)

(11)

(12)

(13)

(14)

cement or

In order to protect human health, it therefore appears
necessary to restrict the placing on the market and the
use of cement. In particular, the placing on the market
and the use of
cement preparations
containing more than 2 ppm chromium VI should be
restricted in the case of activities where there is a possi-
bility of contact with the skin. In controlled closed and
totally automated processes this is not the case, and they
should therefore be exempted. Reducing agents should
be used at the earliest possible stage, i.e. at the point of
cement production.

(15)

This Directive does not affect the Community legislation
laying down minimum requirements for the protection
of workers, such as 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 (4), and 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 Direc-
tive 89/391/EEC) (5) and Directive 98/24/EC,

In order further to protect human health, the Commis-
sion is invited to consider an amendment to Annex I to
Directive 98/24/EC so as to establish a binding occupa-
tional exposure limit value for dust.

HAVE ADOPTED THIS DIRECTIVE:

The use of chromium VI has already been prohibited by
Directive 2000/53/EC of the European Parliament and of
the Council of 18 September 2000 on end-of-life vehi-
cles (1) and by Directive 2002/95/EC of the European
Parliament and of the Council of 27 January 2003 on
the restriction of the use of certain hazardous substances
in electrical and electronic equipment (2). Other uses of
chromium VI are being examined in the framework of a
risk assessment, and the Commission is
invited to
propose as soon as possible the appropriate legislation
to address any risks identified.

Council Directive 76/769/EEC of 27 July 1976 on the
approximation of the laws, regulations and administra-
tive provisions of the Member States relating to restric-
tions on the marketing and use of certain dangerous
substances and preparations (3)
should be amended
accordingly.

Article 1

Annex I to Directive 76/769/EEC is hereby amended as

1.
set out in the Annex to this Directive.

2.
The validity of existing national authorisations of pesti-
cides or biocidal products containing NPE as a co-formulant,
which have been granted before the entry into force of this
Directive, shall not be affected by this Directive until they
expire.

Article 2

A harmonised testing method for the application of point 47,
cement, 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 objective of this Directive is to introduce harmo-
nised provisions with regard to NP, NPE and cement,
thus preserving the internal market whilst ensuring a
high level of protection for health and the environment,
as required by Article 95 of the Treaty.

Before 17 July 2004 Member States shall adopt and publish the
provisions necessary to comply with this Directive. They shall
forthwith inform the Commission thereof.

They shall apply these provisions from 17 January 2005.

The adoption of a harmonised testing method is desir-
able for the application of this Directive as regards the
content of chromium VI in cement but should not delay
the entry into force of this Directive. Therefore,
the
Commission, in accordance with Article 2a of Directive
76/769/EEC, should establish such a method. The testing
method should preferably be developed at European
level,
if appropriate by the European Committee for
Standardisation (CEN).

Where these provisions are adopted by Member States, they
shall contain a reference to this Directive or shall be accompa-
nied by such reference on the occasion of their official publica-
tion. The methods of making such reference shall be laid down
by the Member States.

Article 4

(1) OJ L 269, 21.10.2000, p. 34. Directive as amended by Commission

Decision 2002/525/EC (OJ L 170, 29.6.2002, p. 81).

(2) OJ L 37, 13.2.2003, p. 19.
(3) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Directive
2003/36/EC of the European Parliament and of the Council (OJ L
156, 25.6.2003, p. 26).

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

(4) OJ L 183, 29.6.1989, p. 1.
(5) 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).

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Official Journal of the European Union

17.7.2003

This Directive is addressed to the Member States.

Article 5

Done at Luxembourg, 18 June 2003.

For the European Parliament

The President

P. COX

For the Council

The President

G. DRYS

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Official Journal of the European Union

L 178/27

The following points 46 and 47 shall be added to Annex I of Directive 76/769/EEC:

ANNEX

‘46.

(1) Nonylphenol C6H4(OH)C9H19
(2) Nonylphenol ethoxylate (C2H4O)nC15H24O

47. Cement

May not be placed on the market or used as a substance or constituent
of preparations in concentrations equal or higher than 0,1 % by mass
for the following purposes:
(1) industrial and institutional cleaning except:

— controlled closed dry cleaning systems where the washing liquid

is recycled or incinerated,

— cleaning systems with special
liquid is recycled or incinerated;

treatment where the washing

(2) domestic cleaning;

(3) textiles and leather processing except:

— processing with no release into waste water,
— systems with special treatment where the process water is pre-
treated to remove the organic fraction completely prior to biolo-
gical waste water treatment (degreasing of sheepskin);

(4) emulsifier in agricultural teat dips;

(5) metal working except:

— uses in controlled closed systems where the washing liquid is

recycled or incinerated;

(6) manufacturing of pulp and paper;

(7) cosmetic products;

(8) other personal care products except:

— spermicides;

(9) co-formulants in pesticides and biocides.

(1) Cement and cement-containing preparations may not be used or
placed on the market, if they contain, when hydrated, more than
the
0,0002 % soluble chromium VI of
cement.

the total dry weight of

(2) If reducing agents are used, then without prejudice to the applica-
tion of other Community provisions on the classification, packaging
and labelling of dangerous substances and preparations, the packa-
ging of cement or cement-containing preparations shall be legibly
and indelibly marked with information on the packing date, as well
as on the storage conditions and the storage period appropriate to
maintaining the activity of the reducing agent and to keeping the
content of soluble chromium VI below the limit indicated in para-
graph 1.

(3) By way of derogation, paragraphs 1 and 2 shall not apply to the
placing on the market for, and use in, controlled closed and totally
automated processes
in which cement and cement-containing
preparations are handled solely by machines and in which there is
no possibility of contact with the skin.’