Commission Recommendation of 7 November 2001 on the results of the risk evaluation and the risk reduction strategies for the substances: acrylaldehyde; dimethyl sulphate; nonylphenol phenol, 4-nonyl-, branched; tert-butyl methyl ether (Text with EEA relevance.) (notified under document number C(2001) 3380)
Date: 2001-11-07
Institutions: European Commission
Subjects: dangerous substance, environmental risk prevention, health risk, industrial hazard, occupational health, occupational safety

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COMMISSION RECOMMENDATION

of 7 November 2001

on the results of the risk evaluation and the risk reduction strategies for the substances:
acrylaldehyde; dimethyl sulphate; nonylphenol phenol, 4(cid:150)nonyl-, branched; tert-butyl methyl ether

(notified under document number C(2001) 3380)

(Text with EEA relevance)

(2001/838/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

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,

(7)

Whereas:

identifying substances

requiring
A first priority list
attention has been adopted by Commission Regulation
(EC) No 1179/94 (4); this priority list provides, among
other substances, for the evaluation of the following:

(cid:151) acrylaldehyde.

A second priority list identifying substances requiring
attention has been adopted by Commission Regulation
(EC) No 2268/95 (5). This second priority list provides,
among other
the
following:

the evaluation of

substances,

for

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

(cid:151) dimethyl sulphate,

(cid:151) nonylphenol,

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 Member State rapporteur 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 foresees 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 should apply without prejudice to
Community legislation on the protection of consumers
and on safety and protection of health of workers at
work, in particular Council Directive 89/391/EEC of 12
June 1989 on the
to
encourage improvements in the safety and health of
workers at work (3).

introduction of measures

(1) OJ L 84, 5.4.1993, p. 1.
(2) OJ L 161, 29.6.1994, p. 3.
(3) OJ L 183, 29.6.1989, p. 1.

(cid:151) phenol, 4-nonyl-, branched.

(8)

(9)

A third priority list
identifying substances requiring
attention has been adopted by Commission Regulation
(EC) No 143/97 (6). This third priority list provides,
among other
the
following:

the evaluation of

substances,

for

(cid:151) tert-butyl methyl ether.

The rapporteur Member States have completed all the
risk evaluation activities with regard to man and the
the above five substances (7) and,
environment
where appropriate, have suggested strategies for limiting
the risks.

for

(10)

The results of the risk evaluation of the five substances
and the recommended risk reduction strategies for the
five substances should be adopted at the Community
level.

(4) OJ L 131, 26.5.1994, p. 3.
(5) OJ L 231, 28.9.1995, p. 18.
(6) OJ L 25, 28.1.1997, p. 13.
(7) The comprehensive risk assessment reports as forwarded to the
Commission by the Member States
rapporteur 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.ei.jrc.it/existing-chemicals/).

(1)

(2)

(3)

(4)

(5)

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(11)

(12)

(13)

risks, when

the
in the

In accordance with Article 11(3) of Regulation (EEC) No
793/93, the Commission will consider the results of the
risk evaluation and the recommended strategy for
limiting
proposing Community
measures
framework of Council Directive
76/769/EEC of 27 July 1976 on the approximation of
the laws, regulations and administrative provisions of
the Member States
relating to restrictions on the
marketing and use of certain dangerous substances and
preparations (8) and in the framework of Directive
89/391/EEC as well as in the framework of other
relevant existing Community instruments.

(cid:151) nonylphenol

CAS No 25154-52-3
EINECS No 246-672-0

(cid:151) phenol, 4-nonyl-, branched
CAS No 84852-15-3
EINECS No 284-325-5

(cid:151) tert-butyl methyl ether
CAS No 1634-04-4
EINECS No 216-653-1

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.

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,

should take into account the results of the risk evaluation
as summarized in Section I (human health/environment) of
to this
Parts 1, 2, 3, 4 and 5 of
recommendation and include them, where appropriate, in
the safety data sheets (9). These results were formulated in
the light of
the opinions delivered by the Scientific
Committee on Toxicity, Ecotoxicity and the Environment
(CSTEE) (10).

the Annex

HEREBY RECOMMENDS:

1. All sectors

importing, producing,

storing,
formulating into a preparation or other processing, using,
disposing or recovering the following substances:

transporting,

(cid:151) acrylaldehyde

CAS No 107-02-8
EINECS No 203-453-4

(cid:151) dimethyl sulphate
CAS No 77-78-1
EINECS No 201-058-1

(8) OJ L 262, 27.9.1976, p. 201.

2. The risk reduction strategies described in Section II
(strategy for limiting risks) of Parts 1, 2, 3, 4, 5 of the
Annex to this recommendation should be implemented.

Done at Brussels, 7 November 2001.

For the Commission

Margot WALLSTR(cid:214)M

Member of the Commission

(9) 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 (14th 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).

(10) The risk assessment reports were peer-reviewed by the CSTEE and
its opinions were expressed at the 13th plenary meeting (Brussels,
4 February 2000), 15th plenary meeting (Brussels, 19 June 2000),
22nd plenary meeting (Brussels, 6 and 7 March 2001) and 23rd
plenary meeting (Brussels, 24 April 2001). The CSTEE opinions
can be found on the internet site:
(http://europa.eu.int/comm/food/fs/sc/sct/outcome_en.html).

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ANNEX

PART 1

CAS No 107-02-8

Einecs No 203-453-4

Molecular formula:

C3H4O

Einecs Name:

Rapporteur:

Classification (1):

Acrylaldehyde

The Netherlands

F; R11

T+; R26

T; R24/25

C: R34

N: R50

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 risk assessment 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 only used as an intermediate for the manufacturing of a number of different substances (e.g. animal feed additives,
biocides, pesticides, leather tanning agents, fragrances). Outside the European Community the substance is also used as
an effective broad-spectrum biocide, tissue fixative, in etherification of food starch and production of colloidal metals. 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 has identified other sources of exposure of the substance to man and the environment in particular
releases of the substance from industrial combustion processes, automobile exhaust gases and tobacco smoke, which do
not result from the life-cycle of the substance produced in or imported into the European Community. The assessment
of the risks arising from these exposures is not part of this risk assessment. The risk assessment forwarded to the
Commission by the Member State Rapporteur does however provide information that could be used to assess these
risks.

I. RISK ASSESSMENT

A. HUMAN HEALTH

The conclusions of the assessment of the risks to

WORKERS

are

1.

2.

that there is a need for specific measures to limit the risks. This conclusion is reached because of concerns for eye,
nose and respiratory tract irritation as a consequence of single and repeated inhalation exposure arising from the
production and processing of the substance;

and:

that, in addition to the conclusion given above, the risk assessment shows that there are uncertainties with regard
to the possible genotoxic and carcinogenic effects of the substance locally at the exposure site after long-term
exposure by inhalation to non-cytotoxic concentrations. However, at this moment no validated genotoxicity test
exists to investigate this, and the relatively low exposure levels do not justify the request for a carcinogenicity study
by inhalation.

The conclusion of the assessment of the risks to

(1) The classification of the substance is established by Commission Directive 2001/59/EC of 6 August 2001 adapting to technical
progress or 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).

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CONSUMERS

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:

(cid:151) the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient

The conclusion is reached, because the risk assessment shows that the substance is not used in products available for
consumers.

The conclusion of the assessment of the risks to

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:

(cid:151) 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:

(cid:151) 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 ECOSYSTEM 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:

(cid:151) the risk assessment shows that risks related to the environment spheres mentioned above are not expected. Risk

reduction measures already being applied are considered sufficient.

The conclusion of the assessment of the risks for

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:

(cid:151) the risk assessment shows that risks related to the environmental spheres mentioned above are not expected. Risk

reduction measures already being applied are considered sufficient.

II. STRATEGY FOR LIMITING RISKS

For WORKERS

The legislation for workers’ protection currently in force at Community level
adequate framework to limit the risks of the substance to the extent needed.

is generally considered to give an

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Within this framework it is recommended to develop at Community level occupational exposure limit values for the
substance to subirritating levels. Until such time as occupational exposure limit values for the substance have been
adopted at Community level, exposure in the workplace should be reduced as low as technically feasible because of
possible local carcinogenic effects.

CAS No 77-78-1

Einecs No 201-058-1

Molecular formula:

C2H6O4S

PART 2

Einecs Name:

IUPAC Name:

Rapporteur:

Classification (2):

Dimethyl sulphate

Dimethyl sulfate

The Netherlands

Carc. Cat.2; R45

Muta. Cat.2; R40

T+; R26

T; R25

C; R34

R43

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 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 and methylating agent in production of many organic chemicals (dyes, perfumes,
pharmaceuticals). Other uses reported are as a sulphating agent in the manufacturing of various products (e.g. dyes,
fabric softeners). 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 has identified other sources of exposure of this substance to man and the environment.
In
particular releases of the substance from combustion of sulphur containing fossil fuels and formation in the atmosphere
as a reaction product of sulphur dioxide and organic compounds, which does not result from the life-cycle of the
substance produced in or imported into the European Community. The assessment of the risks arising from these
exposures is not part of this risk assessment. The risk assessment forwarded to the Commission by the Member State
Rapporteur does however provide information which could be used to assess these risks.

This substance has not been tested for all aspects of reproductive toxicity and consequently the risk assessment does
not evaluate in full the risks to any population of this endpoint. This test has not been required, as the substance has
been identified as a non-threshold carcinogen.

I. RISK ASSESSMENT

A. HUMAN HEALTH

The conclusions of the assessment of the risks for

WORKERS

are that there is a need for specific measures to limit the risks. This conclusion is reached because of:

(cid:151) concerns for risks for respiratory tract irritation, mutagenicity and carcinogenicity as a consequence of inhalation

exposure arising from production, processing and use of the substance,

(cid:151) concerns for the pregnant population for adverse health effects as a consequence of repeated inhalation exposure

arising from the use of the substance as an intermediate.

(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).

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The conclusion of the assessment of the risks for

CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT

is that the risk assessment shows that risks cannot be excluded at any exposure, as the substance is identified as a
non-threshold carcinogen. However the risks covered by this risk assessment are not of a magnitude, that immediate
action is deemed necessary. Risk reduction measures already being applied are considered sufficient to impose pressure
in reducing and controlling exposure to the substance.

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:

(cid:151) 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 ECOSYSTEM 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:

(cid:151) the risk assessment shows that risks related to the environmental spheres mentioned above are not expected. Risk

reduction measures already being applied are considered sufficient.

The conclusion of the assessment of the risks for

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:

(cid:151) the risk assessment shows that risks related to the environmental spheres mentioned above are not expected. Risk

reduction measures already being applied are considered sufficient.

II. STRATEGY FOR LIMITING RISKS

For WORKERS:

The legislation for workers’ protection currently in force at Community level
adequate framework to limit the risks of the substance to the extent needed.

is generally considered to give an

Within this framework it is recommended:

(cid:151) to develop at Community level occupational exposure limit values for the substance.

PART 3

Einecs No 246-672-0

CAS No 25154-52-3

Molecular formula:

Einecs Name:

Rapporteur:

C15H24O

Nonylphenol

United Kingdom

Classification (3):

Xn; R22, C; R34

N: R50-53

(3) The classification of the substance is established by Commission Directive 2001/59/EC of 26 August 2001 adapting to technical
the laws, regulations and administrative

progress for the 28th time Council Directive 67/548/CEE on the approximation of
provisions relating to the classification, packaging and labelling of dangerous substances (OJ L 225, 21.8.2001, p. 1).

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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 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 nonylphenol ethoxylates (e.g. in detergents and paints) and in
the production of resins, plastics and stabilisers in the polymer industry. Other uses include the manufacture of
phenolic oximes for use outside the EU in the metal extraction industry and in some speciality paints.

I. 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 a need for further information and/or testing. This conclusion is reached because there is a need for
better information to adequately characterise the risks for human health.

This conclusion is reached while evaluation of the available data submitted in accordance with the relevant provisions
of Regulation (EEC) No 793/93 is underway (4).

B. ENVIRONMENT

The conclusion of the assessment of the risks to the

ATMOSPHERE

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:

(cid:151) the risk assessment shows that risks related to the environmental spheres mentioned above are not expected. Risk

reduction measures already being applied are considered sufficient.

The conclusions of the assessment of the risks to the

AQUATIC ECOSYSTEM and TERRESTRIAL ECOSYSTEM are:

1.

that there is need for further information and/or testing. This conclusion is reached because of:

(cid:151) concerns for effects on the aquatic spheres including sediment.

The information and/or test requirements are:

(cid:151) further toxicity testing on sediment organisms.

However, the implementation of the strategy for limiting risks for the environment in Section II Part 3 of the
Annex will eliminate the need for further information requirements.

and

2.

that there is a need for specific measures to limit the risks. This conclusion is reached because of:

(cid:151) concerns for effects on local and regional aquatic environmental spheres including sediment as a consequence
of exposure arising from nonylphenol production (5), production of phenolic oximes, phenol/formaldehyde
resins (6), epoxy resins (7) and other plastic stabilisers, nonylphenol ethoxylate production, formulation and
use,

(4) The need for further information and/or testing applies to one scenario only. The full conclusions of the human health risk

assessment will be published in a subsequent Commission recommendation.

(5) For these uses risks to the aquatic environment only occur because of the contribution of background concentrations to local levels.
The same applies to the use of nonylphenol ethoxylates in agricultural pesticide formulations, small scale photographic processes
and domestic and industrial emulsion paints.

(6) For these uses risks to the aquatic environment only occur because of the contribution of background concentrations to local levels.
The same applies to the use of nonylphenol ethoxylates in agricultural pesticide formulations, small scale photographic processes
and domestic and industrial emulsion paints.

(7) For these uses risks to the aquatic environment only occur because of the contribution of background concentrations to local levels.
The same applies to the use of nonylphenol ethoxylates in agricultural pesticide formulations, small scale photographic processes
and domestic and industrial emulsion paints.

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(cid:151) concerns for effects for terrestrial spheres as a consequence of exposure arising from the production,
formulation and uses of nonylphenol ethoxylates in veterinary medicines, captive use by the chemical industry,
electrical engineering,
in the
photographic, pulp and paper, polymer and textile industry, in paint manufacture and in civil and mechanical
engineering,

in leather processing, metal extraction,

industrial and institutional cleaning,

(cid:151) concerns for effects on secondary poisoning to fish and earthworm predators as a consequence of exposure
arising from nonylphenol ethoxylate production and formulation, and the use of nonylphenol ethoxylates in
industrial and institutional cleaning,
lacquers and varnish
industry, civil engineering, leather processing, metal extraction, the pulp, paper and board industry, and in
textile processing.

the electrical engineering industry,

the paints,

The conclusion of the assessment of the risks for

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:

(cid:151) the risk assessment shows that risks related to the environmental spheres mentioned above are not expected. Risk

reduction measures already being applied are considered sufficient.

II. STRATEGY FOR LIMITING RISKS

For the ENVIRONMENT:

Marketing and use restrictions should be considered at Community level to protect the environment from the use of
nonylphenol/nonylphenol ethoxylates (NP/NPEs) in particular in:

(cid:151) industrial, institutional and domestic cleaning,

(cid:151) textiles processing,

(cid:151) leather processing,

(cid:151) agriculture (biocidal products, in particular use in teat dips),

(cid:151) metal working,

(cid:151) pulp and paper industry,

(cid:151) cosmetics including shampoos and other personal care products.

Further work is necessary to establish those uses for which derogations can be justified.

In addition to the above, and recognising development of new Community procedures, additional measures for
nonylphenol and nonylphenol ethoxylates should be considered including pollution prevention measures (8) at
Community level, as appropriate, for the following sectors:

(cid:151) production of nonylphenol and nonylphenol ethoxylates;

(cid:151) use of nonylphenol ethoxylates in the synthesis of other chemicals (captive use);

(8) Work currently underway at Community level in the framework of Council Directive 96/61/EC of 24 September 1996 concerning
integrated pollution prevention and control (OJ L 257, 10.10.1996, p. 26) in developing BAT Reference Documents (BREFs) that
cover various chemical processes may be particularly significant in this respect. Further information on the matter can be obtained
consulting the European IPPC Bureau website: http://eippcb.jrc.es.

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(cid:151) use of nonylphenol ethoxylates in emulsion polymerisation in particular use in acrylic esters used for specialist

coatings, adhesives and fibre bonding;

(cid:151) production of phenol/formaldehyde resins using nonylphenol;

(cid:151) production of other plastic stabilisers using nonylphenol.

The results achieved through marketing and use restrictions and pollution control measures should be monitored and if
necessary additional measures should be considered. In particular, consideration should be given to other Community
instruments (9) to ensure control of environmental concentrations of nonylphenol and nonylphenol ethoxylates via the
objectives as set-out in those instruments. These measures should be applied to the above sectors and those listed
below:

(cid:151) formulation (in sectors where nonylphenol/nonylphenol etoxylates use will continue);

(cid:151) civil and mechanical engineering including the manufacture of wall construction materials, road surface materials

and also in the cleaning of metals;

(cid:151) additives in lubricating oil and in the blending of fuel additive packages;

(cid:151) electronics/electrical engineering in particular use in fluxes in the manufacture of painted circuit boards, in dyes to
identify cracks in printed circuit boards and as a component of chemical baths used in the etching of circuit
boards;

(cid:151) the photographic industry (small and large scale) in particular use in products intended for home use by amateur
photographers, for photo developers who develop film for amateur photographers, some professional products and
also use in x-ray film;

(cid:151) production of phenolic oximes/epoxy resins;

(cid:151) the preparation of paint resin and also as a paint mixture stabiliser.

The need for further marketing and use restrictions should be considered at Community level if the measures taken in
these sectors are shown to be inadequate.

For possible use in biocides as an active substance, within the legislative framework currently in force at Community
level for biocidal products, it is recommended that due consideration be taken of the results of the risk assessment.

For use in pesticides as an active substance, within the legislative framework currently in force at Community level for
plant protection products (10), national authorities when granting authorisation decisions and in particular in cases
where significant environmental impact is already experienced at local level should take into due consideration the
results of the risk assessment. In such cases encouragement should be given to the development and use of alternatives
to nonylphenol and nonylphenol ethoxylates.

For the use as an adjuvant/co-formulant (11) in pesticide and biocidal products national authorities when granting
authorisation decisions and in particular in cases where significant environmental impact is already experienced at local
level should take into due consideration the results of the risk assessment. Encouragement should be given to the
development and use of alternatives to nonylphenol and nonylphenol ethoxylates and the adoption of other measures
aimed at modifying consumer behaviour.

Furthermore, information should be disseminated to all interested parties in the Community to ensure protection of the
environment.

(9) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community
introduces provisions for pollution reduction measures at
action in the field of water policy (OJ L 327, 22.12.2000, p. 1)
Community level. Based on the list of priority substances in Annex X of the Directive, the Commission will propose quality
standards and emission controls, including emission limit values two years after adoption of the list. For certain (cid:145)priority hazardous
substances(cid:146) amongst the priority substances, the emission controls shall aim at the cessation or phase-out of discharges, emissions
and losses within 20 years. Nonylphenols are included as a (cid:145)priority hazardous substance(cid:146) in the first list of priority substances which
has been proposed by the Commission in February 2000 (COM (2000) 47 final (OJ C 177 E, 27.6.2000, p. 74) as amended by
COM (2001) 17 final of 16 January 2001). The first list of priority substances including nonylphenols was adopted on 11 June 2001
by the Council thus allowing the measures under Directive 2000/60/EC to be used as an additional instrument to reduce risks to or
via the aquatic environment.

(10) In the framework of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the
market (OJ L 230, 19.8.1991) it is foreseen that nonylphenol and nonylphenol ethoxylates as active substances in pesticides will be
withdrawn from the market as from July 2003.

(11) For the time being this use is not subject to Community evaluation in the framework of 91/414/EEC.

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For the possible uses of nonylphenol and nonylphenol ethoxylates in veterinary medicinal products, within the
legislative framework currently in force at Community level for veterinary medicinal products, it is recommended to
holders of marketing authorisations for products containing the substances that they should substitute them with less
harmful alternatives.

For the use of sludge containing nonylphenol and nonylphenol ethoxylates, within the legislative framework currently
in force at Community level for sludge management, it is recommended that consideration be given to the development
of provisions on concentration limit values for nonylphenol and nonylphenol ethoxylates when sludge is spread on
land.

The measures identified to protect the environment will also reduce human exposure.

CAS No 84852-15-3

Einecs No 284-325-5

PART 4

Molecular formula:

C15H24O

Einecs Name:

IUPAC Name:

Rapporteur:

Phenol, 4(cid:150)nonyl-, branched

4(cid:150)nonylphenol, branched

United Kingdom

Classification (12):

Xn; R22, C; R34

N; R50-53

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 risk assessment 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 nonylphenol ethoxylates e.g. in detergents and paints and in the
production of resins, plastics and stabilisers in the polymer industry. Other uses include the manufacture of phenolic
oximes for use outside the EU in the metal extraction industry and in some specialty paints.

I. RISK ASSESSMENT

A. HUMAN HEALTH

The conclusion of the assessment of the risks to

WORKERS, CONSUMERS, HUMANS EXPOSED VIA THE ENVIRONMENT

is that there is a need for further information and/or testing. This conclusion is reached because there is a need for
better information to adequately characterise the risks for human health.

This conclusion is reached while evaluation of the available data submitted in accordance with the relevant provisions
of Regulation (EEC) No 793/93 is underway (13).

B. ENVIRONMENT

The conclusion of the assessment of the risks to the

ATMOSPHERE

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:

(12) The classification of the substance is established by Commission Directive 2001/59/EC of 6 August 2001 adapting 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).

(13) The need for further information and/or testing applies to one scenario only. The full conclusions of the human health risk

assessment will be published in a subsequent Commission recommendation.

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4.12.2001

(cid:151) the risk assessment shows that risks related to the environmental spheres mentioned above are not expected. Risk

reduction measures already being applied are considered sufficient.

The conclusions of the assessment of the risks to the

AQUATIC ECOSYSTEM and TERRESTRIAL ECOSYSTEM are:

1.

that there is need for further information and/or testing. This conclusion is reached because of:

(cid:151) concerns for effects on the aquatic spheres including sediment.

The information and/or test requirements are:

(cid:151) further toxicity testing on sediment organisms.

However, the implementation of the strategy for limiting risks for the environment in Section II Part 4 of the
Annex will eliminate the need for further information requirements;

and

2.

that there is a need for specific measures to limit the risks. This conclusion is reached because of:

(cid:151) concerns for effects on local and regional aquatic environmental spheres including sediment as a consequence
oximes (15),
of
phenol/formaldehyde resins, epoxy resins (16) and other plastic stabilisers, nonylphenol ethoxylate production,
formulation and use,

from nonylphenol

production (14),

production

exposure

phenolic

arising

of

(cid:151) concerns for effects for terrestrial spheres as a consequence of exposure arising from the production,
formulation and uses of nonylphenol ethoxylates in veterinary medicines, captive use by the chemical industry,
electrical engineering,
in the
photographic, pulp and paper, polymer and textile industry, in paint manufacture and in civil and mechanical
engineering,

in leather processing, metal extraction,

industrial and institutional cleaning,

(cid:151) concerns for effects on secondary poisoning to fish and earthworm predators as a consequence of exposure
arising from nonylphenol ethoxylate production and formulation, and the use of nonylphenol ethoxylates in
lacquers and varnish
industrial and institutional cleaning,
industry, civil engineering, leather processing, metal extraction, the pulp, paper and board industry, and in
textile processing.

the electrical engineering industry,

the paints,

The conclusion of the assessment of the risks for

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:

(cid:151) the risk assessment shows that risks related to the environmental spheres mentioned above are not expected. Risk

reduction measures already being applied are considered sufficient.

II. STRATEGY FOR LIMITING RISKS

for the ENVIRONMENT:

Marketing and use restrictions should be considered at Community level to protect the environment from the use of
nonylphenol/nonylphenol ethoxylates (NP/NPEs) in particular in:

(cid:151) industrial, institutional and domestic cleaning,

(cid:151) textiles processing,

(14) For these uses risks to the aquatic environment only occur because of the contribution of background concentrations to local levels.
The same applies to the use of nonylphenol ethoxylates in agricultural pesticide formulations, small scale photographic processes
and domestic and industrial emulsion paints.

(15) For these uses risks to the aquatic environment only occur because of the contribution of background concentrations to local levels.
The same applies to the use of nonylphenol ethoxylates in agricultural pesticide formulations, small scale photographic processes
and domestic and industrial emulsion paints.

(16) For these uses risks to the aquatic environment only occur because of the contribution of background concentrations to local levels.
The same applies to the use of nonylphenol ethoxylates in agricultural pesticide formulations, small scale photographic processes
and domestic and industrial emulsion paints.

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Official Journal of the European Communities

L 319/41

(cid:151) leather processing,

(cid:151) agriculture (biocidal products, in particular use in teat dips),

(cid:151) metal working,

(cid:151) pulp and paper industry,

(cid:151) cosmetics including shampoos and other personal care products.

Further work is necessary to establish those uses for which derogations can be justified.

In addition to the above, and recognising development of new Community procedures, additional measures for
nonylphenol and nonylphenol ethoxylates should be considered including pollution prevention measures (17) at
Community level, as appropriate, for the following sectors:

(cid:151) production of nonylphenol and nonylphenol ethoxylates;

(cid:151) use of nonylphenol ethoxylates in the synthesis of other chemicals (captive use);

(cid:151) use of nonylphenol ethoxylates in emulsion polymerisation in particular use in acrylic esters used for specialist

coatings, adhesives and fibre bonding;

(cid:151) production of phenol/formaldehyde resins using nonylphenol;

(cid:151) production of other plastic stabilisers using nonylphenol.

The results achieved through marketing and use restrictions and pollution control measures should be monitored and if
necessary additional measures should be considered. In particular, consideration should be given to other Community
instruments (18) to ensure control of environmental concentrations of nonylphenol and nonylphenol ethoxylates via the
objectives as set-out in those instruments. These measures should be applied to the above sectors and those listed
below:

(cid:151) formulation (in sectors where nonylphenol/nonylphenol etoxylates use will continue);

(cid:151) civil and mechanical engineering including the manufacture of wall construction materials, road surface materials

and also in the cleaning of metals;

(cid:151) additives in lubricating oil and in the blending of fuel additive packages;

(cid:151) electronics/electrical engineering in particular use in fluxes in the manufacture of painted circuit boards, in dyes to
identify cracks in printed circuit boards and as a component of chemical baths used in the etching of circuit
boards;

(cid:151) the photographic industry (small and large scale) in particular use in products intended for home use by amateur
photographers, for photo developers who develop film for amateur photographers, some professional products and
also use in X-ray film;

(cid:151) production of phenolic oximes/epoxy resins;

(cid:151) the preparation of paint resin and also as a paint mixture stabiliser.

The need for further marketing and use restrictions should be considered at Community level if the measures taken in
these sectors are shown to be inadequate.

(17) Work currently underway at Community level in the framework of Directive 96/61/EC in developing BAT Reference Documents
(BREFs) that cover various chemical processes may be particularly significant in this respect. Further information on the matter can
be obtained consulting the European IPPC Bureau website: http://eippcb.jrc.es

(18) Directive 2000/60/EC introduces provisions for pollution reduction measures at Community level. Based on the list of priority
substances in Annex X of the Directive, the Commission will propose quality standards and emission controls, including emission
limit values two years after adoption of the list. For certain (cid:145)priority hazardous substances(cid:146) amongst the priority substances, the
emission controls shall aim at the cessation or phase-out of discharges, emissions and losses within 20 years. Nonylphenols are
included as a (cid:145)priority hazardous substance(cid:146) in the first list of priority substances which has been proposed by the Commission in
February 2000 (COM (2000) 47 final, OJ C 177 E, 27.6.2000, p. 74; as amended by COM (2001) 17 final of 16 January 2001).
The first list of priority substances including nonylphenols was adopted on 11 June 2001 by the Council thus allowing the
measures under Directive 2000/60/EC to be used as an additional instrument to reduce risks to or via the aquatic environment.

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4.12.2001

For possible uses in biocides as an active substance, within the legislative framework currently in force at Community
level for biocidal products, it is recommended that due consideration be taken of the results of the risk assessment.

For use in pesticides as an active substance, within the legislative framework currently in force at Community level for
plant protection products (19), national authorities when granting authorisation decisions and in particular in cases
where significant environmental impact is already experienced at local level should take into due consideration the
results of the risk assessment. In such cases encouragement should be given to the development and use of alternatives
to nonylphenol and nonylphenol ethoxylates.

For the use as an adjuvant/co-formulant (20) in pesticide and biocidal products national authorities when granting
authorisation decisions and in particular in cases where significant environmental impact is already experienced at local
level should take into due consideration the results of the risk assessment. Encouragement should be given to the
development and use of alternatives to nonylphenol and nonylphenol ethoxylates and the adoption of other measures
aimed at modifying consumer behaviour.

Furthermore, information should be disseminated to all interested parties in the Community to ensure protection of the
environment.

For the possible use of nonylphenol and nonylphenol ethoxylates in veterinary medicinal products, within the
legislative framework currently in force at Community level for veterinary medicinal products, it is recommended to
holders of marketing authorisations for products containing the substances that they should substitute them with less
harmful alternatives.

For the use of sludge containing nonylphenol and nonylphenol ethoxylates, within the legislative framework currently
in force at Community level for sludge management, it is recommended that consideration be given to the development
of provisions on concentration limit values for nonylphenol and nonylphenol ethoxylates when sludge is spread on
land.

The measures identified to protect the environment will also reduce human exposure.

CAS No 1634-04-4

Einecs No 216-653-1

PART 5

Molecular formula:

C5H12O

Einecs Name:

Rapporteur:

Classifcation:

tert-butyl methyl ether

Finland

not yet classified

The risk assessment is based on current practices related to the life-cycle of this substance produced in or imported into
the European Community as described in the Comprehensive Risk Assessment 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 a fuel-additive in petrol. Other uses are in chemical and pharmaceutical industry and laboratories.

I. RISK ASSESSMENT

A. HUMAN HEALTH

The conclusion of the assessment of the risks to

WORKERS

is that there is a need for specific measures to limit the risks. This conclusion is reached because of:

(cid:151) concerns for repeated dose local skin effects as a consequence of exposure arising from maintenance operations

and automotive repair.

(19) In the framework of Directive 91/414/EEC it is foreseen that nonylphenol and nonylphenol ethoxylates as active substances in

pesticides will be withdrawn from the market as from July 2003.

(20) For the time being this use is not subject to Community evaluation in the framework of Directive 91/414/EEC.

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Official Journal of the European Communities

L 319/43

The conclusion of the assessment of the risks to

CONSUMERS

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:

(cid:151) 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

HUMANS EXPOSED VIA THE ENVIRONMENT

is that there is a need for specific measures to limit the risks. This conclusion is reached because of:

(cid:151) concerns for the potability of drinking water in respect of taste and odour as a consequence of exposure arising

from leaking underground storage tanks and spillage from overfilling of the storage tanks.

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:

(cid:151) 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

AQUATIC ECOSYSTEM are:

1.

there is a need for further information and/or testing. This conclusion is reached because:

(cid:151) there is a need for better information to adequately characterise the risks to the aquatic eco-system regarding

the emission of the substance to surface water.

The information and/or test requirements are:

(cid:151) a tiered testing strategy for the investigation of the avoidance behaviour of fish and possibly wildlife related to

water contaminated with the substance;

and

2.

there is a need for specific measures to limit the risks. The conclusion is reached because of:

(cid:151) concerns for the aquatic eco-system as a consequence of exposure arising from releases to surface water from

terminal site storage tank bottom waters.

The conclusion of the assessment of the risks to

GROUNDWATER

is that there is a need for specific measures to limit the risks. The conclusion is reached because of:

(cid:151) concerns for the potability of groundwater in respect of taste and odour as a consequence of exposure arising from

leaking underground storage tanks and spillage from overfilling of the storage tanks.

The conclusion of the assessment of the risks to

ATMOSPHERE 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:

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Official Journal of the European Communities

4.12.2001

(cid:151) 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:

(cid:151) the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

For WORKERS:

II. STRATEGY FOR LIMITING RISKS

The legislation for workers’ protection currently in force at Community level
adequate framework to limit the risks of the substance to the extent needed.

is generally considered to give an

Furthermore, and without prejudice to Community legislation in force in the area (21), it is recommended to investigate
how to improve the design of fuel filter position in cars and fuel pumps so to facilitate maintenance and repair work
while aiming at minimum skin exposure to petrol.
It is therefore suggested to pursue discussions with relevant
organisations of industry branches in this respect.

For HUMANS EXPOSED VIA THE ENVIRONMENT:

It is considered that measures, presented below, aiming at protection of groundwater will contribute to preventing the
contamination of drinking water.

For the ENVIRONMENT:

The prevention of all anthropogenic inputs, including MTBE, to groundwater is a key objective of current Community
legislation (22). It is recommended therefore that monitoring programmes be undertaken, where appropriate, in order to
permit the early detection of groundwater contaminated by MTBE.

It is further recommended that the best available techniques be widely applied for the construction and operation of
petrol underground storage and distribution facilities at service stations. In this regard Member States should consider
mandatory requirements especially for all
is
recommended that harmonised technical standards for the construction and operation of
the storage tanks be
developed at a European level by the European Committee for Standardisation (CEN). Potential past release sites, located
on critical areas, should be investigated and, where necessary, remediated.

recharge areas. Furthermore,

in groundwater

service stations

it

Furthermore, exchange of information on these programmes and their results should be promoted.

It is also recommended that MTBE containing bottom waters of above-ground storage tanks be controlled by plant
permits (23) or national rules.

To facilitate the permitting (as well as any fixing of national rules) these issues are included in the ongoing work to
develop guidance on (cid:145)Best Available Techniques(cid:146) (BAT) (24).

It is recommended that Member States carefully monitor the implementation of BAT in this respect and report any
important developments in BAT to the Commission in the framework of the exchange of information on BAT.

(21) Council Directive 70/220/EEC of 20 March 1970 on the approximation of the laws of the Member States relating to measures to

be taken against air pollution by gases from positive-ignition engines of motor vehicles (OJ L 76, 6.4.1970, p. 1).

(22) Directive 2000/60/EC.
(23) Plant permits issued under Directive 96/61/EC.
(24) Work currently underway at Community level in the framework of Directive 96/61/EC in developing BAT Reference Documents

(BREFs) that cover MTBE production and handling, including design and management of storage modes.