Commission Recommendation of 5 March 2001 on the results of the risk evaluation and the risk reduction strategies for the substances: diphenylether/pentabromo derivative and cumene (Text with EEA relevance) (notified under document number C(2001) 439)
Date: 2001-03-05
Institutions: European Commission
Subjects: dangerous substance, environmental protection, health risk, impact study, occupational safety, public health

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COMMISSION RECOMMENDATION

of 5 March 2001

on the results of the risk evaluation and the risk reduction strategies for the substances:
diphenylether/pentabromo derivative and cumene

(notified under document number C(2001) 439)

(Text with EEA relevance)

(2001/194/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 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 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 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 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

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

(6)

(7)

(8)

(9)

(10)

work, 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 (3).

A first priority list identifying substances requiring atten-
tion has been adopted by Commission Regulation (EC)
No 1179/94 (4). This priority list provides, among other
substances, for the evaluation of the following:

— cumene.

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 substances,
the
following:

the evaluation of

for

— diphenylether, pentabromo derivative.

The rapporteur Member States have completed all the
risk evaluation activities with regard to man and the
environment for the above two substances (6) and where
appropriate, have suggested strategies for limiting the
risks.

The results of the risk evaluation of the two substances
and the recommened risk reduction strategies for one of
the two substances concerned should be adopted at the
Community level.

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 the risks, when proposing Community measures
in the framework of Council Directive 76/769/EEC of
27 July 1976 on the approximation of the laws, Regula-
tions and administrative provisions of the Member States
relating to restrictions on the marketing and use of
certain dangerous substances and preparations (7) and in
the framework of Directive 89/391/EEC, as well as in
the framework of other relevant existing Community
instruments.

(11)

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.

(3) OJ L 183, 29.6.1989, p. 1.
(4) OJ L 131, 26.5.1994, p. 3.
(5) OJ L 231, 28.9.1995, p. 18.
(6) 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 Inspra,
Italy (http://ecb.ei.jrc.it/existing-chemicals/).

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

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(12)

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:

1. All

sectors

importing, producing,

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

transporting,

— diphenylether, pentabromo derivative

CAS No 32534-81-9
Einecs No 251-084-2

should take into account the results of the risk evaluation as
summarised in Section I
(human health/environment) of
Annex I. These results were formulated in the light of the
opinions delivered by the Scientific Committee on Toxicity,
Ecotoxicity and the Environment (CSTEE) (1).

2. The risk reduction strategies described in Section II (strategy
for limiting risks) of Annex I should be implemented.

3. All

sectors

importing, producing,

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

transporting,

— Cumene

CAS No 98-82-8
Einecs No 202-704-5

should take into account the results of the risk evaluation as
summarised in Section I
(human health/environment) of
Annex II. These results were formulated in the light of the
opinion delivered by the Scientific Committee on Toxicity,
Ecotoxicity and the Environment (CSTEE) (2).

Done at Brussels, 5 March 2001.

For the Commission

Margot WALLSTRÖM

Member of the Commission

(1) The environment risk assessment report was peer-reviewed by the
CSTEE and its opinion was expressed at the 13th plenary meeting
held in Brussels on 4 February 2000 and the human health risk
assessment report was peer-reviewed by the CSTEE and its opinion
was expressed at the 16th plenary meeting held in Brussels on 19
June 2000. The CSTEE opinions can be found on the Internet site:
(http://europa.eu.int/comm/food/fs/sc/sct/outcome_en.html).

(2) The risk assessment report was peer-reviewed by the CSTEE and its
opinion was expressed at the 15th plenary meeting held in Brussels
on 5 May 2000. 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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CAS-No 32534-81-9

EINECS-No 251-084-2

ANNEX I

C12H5Br5O

Einecs name:

IUPAC name:

Rapporteur:

Classification (*):

diphenylether, pentabromo derivative

pentabromodiphenyl ether

United Kingdom

Xn; R48/21/22
R64
N; R50-53

(*) 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/EEC 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 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
used as a flame retardant additive in the manufacture of polyurethane foam in applications such as furniture and
upholstery. Use as a flame retardant additive in epoxy resins, phenolic resins, unsaturated polyesters and textiles has been
quoted in other reviews but has not been known of by industry supplying to the EU for more than 20 years. 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.

I. RISK ASSESSMENT

A. HUMAN HEALTH

The conclusion of the assessment of the risks to

WORKERS

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 regarding the lifetime exposure to the

substance.

The information requirements are:

— dermal exposure data on workers,

— the extent of dermal absorption (quantitative data) should be clarified by the conduct of an appropriate dermal
absorption study; depending upon the outcome of this study (i.e. an indication of significant skin absorption) then it
may be necessary to undertake an oral toxicokinetic study in order to provide adequate comparative information for
interpretation of the oral dosing toxicity studies available,

— health surveillance data are required to investigate signs of chloracne in workers,

— risk characterisation methodology for bioaccumulative substance (lifetime exposure); this may involve the conduct of a
lifetime study in rodents depending upon the way in which the methodology for assessing lifetime exposure is
developed and any data requirements that may be indicated for such a methodology.

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:

— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

The conclusions of the assessment of the risks to

MAN EXPOSED VIA THE ENVIRONMENT

are 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 regarding the lifetime exposure to the

substance.

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The information requirements are:

— risk characterisation methodology for bioaccumulative substance (lifetime exposure); this may involve the conduct of a
lifetime study in rodents depending upon the way in which the methodology for assessing lifetime exposure is
developed and any data requirements that may be indicated for such a methodology,

— actual measured exposure data from local sources.

The conclusion of the assessment of the risks to

INFANTS EXPOSED VIA MILK

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 regarding the exposure of infants to the

substance via breast milk and cows' milk.

The information requirements are:

— information on the toxicokinetics of the substance with respect to breast milk including uptake from breast milk into
the infant, the time course of the excretion via breast milk during lactation in humans and the future trends in levels
in human breast milk,

— information on the relative toxicity to the liver of the substance in young (neonatal) and adult animals,

— further studies on potential effects on behaviour following neonatal dosing in order to determine the reproducibility of

effects, the effects of repeated dosing and the significance of the effects to human development,

— a multi-generation reproduction study in order to investigate whether or not other effects might be observed through
exposure to breast milk. Designed correctly, such a study could address the issue of whether or not the young animal
is more sensitive to liver effects and whether or not differences in behaviour are produced,

— exposure estimates from local and regional sources on the concentration of the substance in cows' milk.

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

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 environment for

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:

— 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 environment for

AQUATIC ECOSYSTEM AND TERRESTRIAL ECOSYSTEM

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

— concerns for effects on the local aquatic (sediment) and terrestrial environment as a consequence of exposure arising

from polyurethane foam production,

— concerns for secondary poisoning to the environmental spheres mentioned above both locally and regionally as a

consequence of exposure arising from production and/or use of polyurethane foams.

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The conclusion of the assessment of the risks to the environment for

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT

is that there is a need for better information to adequately characterise the risk to micro-organisms in the sewage
treatment plant;

— a test on sewage treatment plant micro-organisms would be required if this data gap is to be filled.

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

For HUMAN HEALTH

II. STRATEGY FOR LIMITING RISKS

While the formal outcome of the human health risk assessment of the substance is that further information/testing is
required, Member States noted the uncertainties regarding the risk characterisation for infants exposed to the substance
from milk. In particular, there was concern about whether the concentration in human breast milk might increase during
the time it would take to obtain the information needed to refine the risk characterisation and to remove some of the
uncertainties. Any risk reduction measures proposed for the substance must take account of the concerns about infants
exposed via milk.

For THE ENVIRONMENT

Marketing and use restrictions should be considered at Community level for the substance, and articles containing the
substance, for controlling secondary poisoning risks arising from the production and use of polyurethane foams (1).

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

Any future use of the substance should be monitored.

Consideration should be given to the monitoring of imports of articles from outside the EU.

(1) Whereas the risk assessment and risk reduction strategy only identified the production and use of the substance in polyurethane

foams, all other uses resulting in emissions, discharges and losses to the environment would be unacceptable.

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ANNEX II

CAS-No. 98-82-8

EINECS-No. 202-704-5

C

H
9

12

Einecs name:

Rapporteur:

Classification (*)

cumene

Spain

R10
Xn; R65
Xi; R37
N; R51-53

(*) 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/EEC 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 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 chemical industry for the production of phenol and acetone. Other uses are as a starting
material for detergent production, in the synthesis of α-methylstyrene, acetophenone and di-isopropylbenzene and as a
catalyst for acrylic polyester-type resins. 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,
in petroleum products, 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 are not part of this risk assessment. The
comprehensive Risk Assessment Reports as forwarded to the Commission by the Member State rapporteur does however
provide information which could be used to assess these risks.

I. RISK ASSESSMENT

A. HUMAN HEALTH

The conclusion of the evaluation of the risks to

WORKERS, CONSUMERS and MAN 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 (1).

B. ENVIRONMENT

The conclusion of the evaluation of the risks to the environment for

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:

— 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.

(1) These measures include the use of occupational exposure limit values established at Community level for the protection of workers
from chemical risks. Cumene is included in the Annex to Commission Directive 2000/39/EC of 8 June 2000 (OJ L 142, 16.6.2000,
p. 47), establishing a first list of indicative occupational exposure limit values, pursuant to Council Directive 98/24/EC (OJ L 131,
5.5.1998, p. 11) on the protection of the health and safety of workers from the risks related to chemical agents at work.

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The conclusion of the evaluation of the risks to the environment 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:

— 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.

None

II. STRATEGY FOR LIMITING RISKS