Commission Recommendation of 4 July 2002 on the results of the risk evaluation for the substances: ethyl acetoacetate, 4-Chloro-o-cresol, Dimethyldioctadecylammonium chloride (Text with EEA relevance) (notified under document number C(2002) 2490)
Date: 2002-07-04
Institutions: European Commission
Subjects: chemical product, dangerous substance, environmental protection, environmental risk prevention, health control, health risk, occupational safety, public health

11.7.2002

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Official Journal of the European Communities

L 181/35

COMMISSION RECOMMENDATION

of 4 July 2002

on the results of the risk evaluation for the substances: ethyl acetoacetate, 4-Chloro-o-cresol,
Dimethyldioctadecylammonium chloride

(notified under document number C(2002) 2490)

(Text with EEA relevance)

(2002/576/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Regulation (EEC) No 793/93 of 23
March 1993 on the evaluation and control of the risks of
existing substances (1), and in particular Article 11(2) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

Article 10 of the Regulation (EEC) No 793/93 establishes
the procedure to be followed for the risk evaluation of
the substances on the priority lists at the level of the
Member State designated as rapporteur.

Commission Regulation (EC) No 1488/94 (2) outlines the
principles for the assessment of risks to man and the
environment of existing substances in accordance with
Regulation (EEC) No 793/93.

The rapporteur Member State, after evaluating the risk of
a given priority substance to man and the environment,
should suggest, where appropriate, a strategy for limiting
the risk, including control measures and/or surveillance
programmes.

Article 11 of Regulation (EEC) No 793/93 provides that
the results of the risk evaluation and the recommended
strategy for limiting risks in respect to substances on the
priority lists should be adopted at Community level in
accordance with the procedure laid down in Article 15
and shall be published by the Commission.

Article 1 of Regulation (EEC) No 793/93 provides that
that Regulation shall apply without prejudice to Commu-
nity legislation on the protection of consumers and on
safety and protection of health of workers at work, in
particular Council Directive 98/24/EC (3) on the protec-
tion of the safety and health of workers from the risks
related to chemical agents at work, Council Directive 90/
394/EEC (4) on the protection of workers from risks
related to exposure to carcinogens at work and Council
Directive 92/85/EEC (5) on the introduction of measures

(1) OJ L 84, 5.4.1993, p. 1.
(2) OJ L 161, 29.6.1994, p. 3.
(3) OJ L 131, 5.5.1998, p. 11.
(4) OJ L 196, 26.7.1990, p. 1.
(5) OJ L 348, 28.11.1992, p. 1.

to encourage improvements in the safety and health at
work of pregnant workers and workers who have
recently given birth or are breastfeeding.

A first priority list identifying substances requiring atten-
tion has been adopted by Commission Regulation (EC)
No 1179/94 (6). This priority list provides, among other
substances, for the evaluation of the following:

— ethyl acetoacetate,

— 4-Chloro-o-cresol,

— Dimethyldioctadecylammonium chloride.

The rapporteur Member States have completed all the
risk evaluation activities with regard to man and the
environment for the above three substances (7).

The results of the risk evaluation of the three substances
concerned should be adopted at the Community level.

The Scientific Committee on Toxicity, Ecotoxicity and
the Environment (CSTEE) has been consulted and has
issued an opinion with respect to the risk assessment
reports referred to in this recommendation (8).

(6)

(7)

(8)

(9)

(10)

The measures provided for in this recommendation are
in accordance with the opinion of the Committee set up
pursuant to Article 15 of Regulation (EEC) No 793/93,

HEREBY RECOMMENDS:

All sectors importing, producing, transporting, storing, formu-
lating into a preparation or other processing, using and
disposing or recovering the following substances:

— ethyl acetoacetate

CAS No 141-97-9

Einecs No 205-516-1,

(6) OJ L 131, 26.5.1994, p. 3.
(7) The comprehensive risk assessment reports as forwarded to the
Commission by the rapporteur Member States are publicly available.
Short summaries are also available. Both can be found on the
internet site of the European Chemicals Bureau, Institute for Health
and Consumer Protection of the Joint Research Centre in Ispra, Italy
(http://ecb.jrc.it/existing-chemicals/).

(8) The risk assessment reports were peer-reviewed by the CSTEE. The
CSTEE opinions can be found on the internet site: http://euro-
pa.eu.int/comm/food/fs/sc/sct/outcome_en.html.

L 181/36

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Official Journal of the European Communities

11.7.2002

— 4-Chloro-o-cresol

CAS No 1570-64-5

Einecs No 216-381-3,

— Dimethyldioctadecylammonium chloride

CAS No 107-64-2

Einecs No 203-508-2,

should take into account the results of the risk evaluation as
summarised in Parts 1, 2 and 3 of the Annex to this recom-
mendation and include them, where appropriate, in the safety

data sheets (1). These results were formulated in the light of the
opinions delivered by the Scientific Committee on Toxicity,
Ecotoxicity and the Environment (CSTEE).

Done at Brussels, 4 July 2002.

For the Commission

Margot WALLSTRÖM

Member of the Commission

(1) In accordance with the provisions of Council Directive 67/548/EEC
of 27 June 1967 on the approximation of laws, regulations and
administrative provisions relating to the classification, packaging
and labelling of dangerous substances (OJ 196, 1.8.1967, p. 1),
Commission Directive 91/155/EEC of 5 March 1991 defining and
laying down the detailed arrangements for the system of specific
information relating to dangerous preparations in implementation
of Article 10 of Directive 88/379/EEC (OJ L 76, 22.3.1991, p. 35),
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, OJ L 131, 5.5.1998, p.
11) and Directive 1999/45/EC of the European Parliament and of
the Council of 31 May 1999 concerning the approximation of the
laws, regulations and administrative provisions of the Member States
relating to the classification, packaging and labelling of dangerous
preparations (OJ L 200, 30.7.1999, p. 1).

11.7.2002

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Official Journal of the European Communities

L 181/37

ANNEX

PART ONE

CAS-No. 141-97-9

Einecs-No. 205-516-1

Molecular Formula:

C6H10O3

Einecs Name:

Rapporteur:

Classification (1):

ethyl acetoacetate

Germany

Not classified

(1) Based on the information available, no classification of the substance is justified, following the criteria set out in Annex VI of Council
Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the
classification, packaging and labelling of dangerous substances (OJ 196, 1.8.1967, p. 1).

The risk assessment is based on current practices related to the life-cycle of the substance produced in or imported into
the European Community as described in the comprehensive Risk Assessment Reports as forwarded to the Commission
by the Member State Rapporteur.

The risk assessment has, based on the available information, determined that in the European Community the substance is
mainly used as an intermediate in the production of pharmaceuticals, plant protection products, stabilisers, additives,
catalysts and other products. Other uses are in a wide range of household and cosmetic products, as a food additive, in
the manufacture of colour films, as a paper impregnation agent and as a solvent in paints and lacquers. It was not possible
to obtain information on the use of the total volume of substance produced in or imported into the European
Community, therefore, some uses may exist which are not covered by this risk assessment.

RISK ASSESSMENT

A. HUMAN HEALTH

The conclusion of the assessment of the risks to

Workers, consumers and humans exposed via the environment

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:
— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

The conclusion of the assessment of the risks to

Human health (physico-chemical properties)

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:
— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

The conclusion of the assessment of the risks to the

Atmosphere, aquatic and terrestrial ecosystem

B. ENVIRONMENT

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:
— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

The conclusion of the assessment of the risks to

Micro-organisms in the sewage treatment plant

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:
— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

L 181/38

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Official Journal of the European Communities

11.7.2002

PART TWO

CAS-No. 1570-64-5

Einecs-No. 216-381-3

Molecular Formula:

C7H7ClO

Einecs Name:

IUPAC Name:

Rapporteur:

Classification (2):

4-Chloro-o-cresol

4-Chloro-2-Methyl Phenol

Denmark

T; R23
C; R35
N; R50

(2) The classification of the substance is established by Commission Directive 2000/32/EC of 19 May 2000 adapting to technical progress
for the 26th time Council Directive 67/548 on the approximation of the laws, regulations and administrative provisions relating to the
classification, packaging and labelling of dangerous substances (OJ L 136, 8.6.2000, p. 1).

The risk assessment is based on current practices related to the life-cycle of the substance produced in or imported into
the European Community as described in the comprehensive Risk Assessment Reports as forwarded to the Commission
by the Member State Rapporteur.

The risk assessment has, based on the available information, determined that in the European Community the substance is
used as starting material for the manufacture of herbicides. It was not possible to obtain information on the use of the
total volume of substance produced in or imported into the European Community, therefore, some uses may exist which
are not covered by this risk assessment.

The risk assessment does not cover the possible risks caused by the presence of the substance as an impurity in certain
herbicides nor does it cover the possible risks arising from the formation of the substance during environmental
degradation of the herbicides.

RISK ASSESSMENT

A. HUMAN HEALTH

The conclusion of the assessment of the risks to

Workers, consumers and humans exposed via the environment

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:
— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

The conclusion of the assessment of the risks to

Human health (physico-chemical properties)

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:
— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

The conclusion of the assessment of the risks to the

Aquatic ecosystem, atmosphere and terrestrial ecosystem

B. ENVIRONMENT

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:
— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

The conclusion of the assessment of the risks to

Micro-organisms in the sewage treatment plant

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:
— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

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CAS-No. 107-64-2

Einecs-No. 203-508-2

PART THREE

Molecular Formula:

C38H80N.Cl

Einecs Name:

Rapporteur:

Classification (3):

Dimethyldioctadecylammonium chloride

Germany

Xi; R41
N; R50-53

(3) The classification of the substance is established by Commission Directive 2001/59/EC of 6 August 2001 adopting to technical progress
for the 28th time Council Directive 67/548 on the approximation of the laws, regulations and administrative provisions relating to the
classification, packaging and labelling of dangerous substances (OJ L 225, 21.8.2001, p. 1).

The risk assessment is based on current practices related to the life-cycle of the substance produced in or imported into
the European Community as described in the comprehensive Risk Assessment Reports as forwarded to the Commission
by the Member State Rapporteur.

is

such, but

the main component of

The risk assessment has, based on the available information, determined that in the European Community the substance is
not used as
the technical product Quarterny Ammonium compound,
bis(hydrogenated tallow alkyl) dimethyl, chlorides (CAS-No 61789-80-8). This substance, in turn, is mainly used as a
fabric softener and in the synthesis of organic clays. Other uses are as a conditioning agent in cosmetics (shampoos, hair
conditioners, emulsifier in lotions) and in car washing agents. It was not possible to obtain information on the use of the
total volume of substance produced in or imported into the European Community, therefore, some uses may exist which
are not covered by this risk assessment.

RISK ASSESSMENT

A. HUMAN HEALTH

The conclusion of the assessment of the risks to

Workers, consumers and humans exposed via the environment

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:
— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

The conclusion of the assessment of the risks to

Human health (physico-chemical properties)

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:
— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

B. ENVIRONMENT

The conclusion of the assessment of the risks to the

Atmosphere, aquatic and terrestrial ecosystem

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:
— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

The conclusion of the assessment of the risks to

Micro-organisms in the sewage treatment plant

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:
— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.