Communication from the Commission on the results of the risk evaluation and the risk reduction strategies for the substances: zinc oxide; zinc sulphate; trizinc bis(orthophosphate) (Text with EEA relevance)
Date: 2008-06-20
Institutions: European Commission
Subjects: dangerous substance, environmental impact, environmental risk prevention, exchange of information, health risk, oxide, public health

20.6.2008

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Official Journal of the European Union

C 155/1

II

(Information)

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

COMMISSION

Communication from the Commission on the results of the risk evaluation and the risk reduction
strategies for the substances: zinc oxide; zinc sulphate; trizinc bis(orthophosphate)

(Text with EEA relevance)

(2008/C 155/01)

Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of
existing substances (1) involves the data reporting, priority setting, risk evaluation and, where necessary,
development of strategies for limiting the risks of existing substances.

In the framework of Regulation (EEC) No 793/93 the following substances have been identified as priority
substances for evaluation in accordance with Commission Regulation (EC) No 2268/95 (2) concerning the
second list of priority substances as foreseen under Regulation (EEC) No 793/93:

— zinc oxide,

— zinc sulphate,

— trizinc bis(orthophosphate).

The rapporteur Member State designated pursuant to this Regulation has completed the risk evaluation
activities with regard to man and the environment for those substances in accordance with Commission
Regulation (EC) No 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man
and the environment of existing substances (3) and has suggested a strategy for limiting the risks in accord-
ance with Regulation (EEC) No 793/93.

The Scientific Committee on Toxicity, Ecotoxicity and the Environment (SCTEE) and the Scientific Committee
on Health and Environmental Risks (SCHER) have been consulted and have issued an opinion with respect
to the risk evaluations carried out by the rapporteur. These opinions can be found on the website of the
Scientific Committees.

Article 11(2) of Regulation (EEC) No 793/93 stipulates that the results of the risk evaluation and the recom-
mended strategy for limiting the risks shall be adopted at Community level and published by the
Commission. This Communication,
together with the corresponding Commission Recommendation
2008/468/EC (4), provides the results of risk evaluations (5) and strategies for limiting the risks for the above
mentioned substances.

(1) OJ L 84, 5.4.1993, p. 1.
(2) OJ L 231, 28.9.1995, p. 18.
(3) OJ L 161, 29.6.1994, p. 3.
(4) OJ L 161, 20.6.2008.
(5) The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the Internet site of the

European Chemicals Bureau:
http://ecb.jrc.it/existing-substances/

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Official Journal of the European Union

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The results of the risk evaluation and strategies for limiting the risks provided for in this communication
are in accordance with the opinion of the Committee set up pursuant to Article 15(1) of Regulation (EEC)
No 793/93.

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ANNEX

PART 1

CAS No: 1314-13-2

Einecs No: 215-222-5

Structural formula:

ZnO

Einecs name:

IUPAC name:

Rapporteur:

Zinc oxide

Zinc oxide

The Netherlands

Classification (1):

N; R50-53

The risk assessment is based on 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 been conducted in accordance with the methodology for metals applicable at the time and in line
with the Technical Guidance Document on Risk Assessment in support of Commission Regulation (EC) No 1488/94 on
risk assessment for existing substances.

The risk assessment has, based on the available information, determined that in the European Community the substance
is mainly used in rubber compounding material, in glass and ceramic products. Other uses are as a corrosion inhibitor in
paint, as raw material for the production of zinc chemicals, as fuel and lubricant additives, and as a zinc addition in fertili-
sers, animal feeds and human vitamin elements. Uses as nanomaterials have not been assessed.

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:

— concerns for metal fume fever as a consequence of acute inhalation toxicity during welding of zinc coated steel,

— concerns for systemic effects, as a consequence after repeated dermal exposure and repeated combined exposure (inha-

lation and dermal) arising from use of paint containing zinc oxide.

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 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:

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

sufficient.

(1) The classification of the substance is established by Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress
for the 29th 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 152, 30.4.2004, p. 1, amended by OJ L 216, 16.6.2004, p. 3).

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The conclusion of the assessment of the risks to

HUMAN HEALTH (physicochemical 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

Conclusions are given on local scenarios only. The conclusions regarding the regional risks to the environment as
described in the risk assessment for zinc metal (Einecs No 231-175-3) apply as well.

The conclusions of the assessment of the risks to

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 conclusions of the assessment of the risks to the

AQUATIC ECOSYSTEM INCLUDING SEDIMENT

1.1.

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

— concerns for effects on the local aquatic (including sediment) environment as a consequence of exposure arising
from the production at one site (sediment only) and from the use in the glass processing industry, ferrites
industry (sediment only), varistor industry, catalysts processing,
lubricants formulation, paints processing,
cosmetics pharmaceuticals formulation and cosmetics pharmaceuticals private use (sediment only). For a number
of production sites and processing scenarios (having emissions to water) no immediate concern has been identi-
fied but a potential risk at local scale cannot be excluded due to possible existence of high regional background
concentrations of zinc.

1.2.

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 for all local scenarios, including concerning secondary poisoning, except for those listed
under point 1.1 above. This conclusion is reached because:

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

ered sufficient.

The conclusion of the assessment of the risks to the

TERRESTRIAL ECOSYSTEM

2.1.

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

— concerns for the local terrestrial environment as a consequence of exposure arising from use in the glass proces-

sing industry, formulation of lubricants and formulation of cosmetics pharmaceuticals.

2.2.

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, for all local scenarios, including concerning secondary poisoning, except for those listed
under point 2.1 above. This conclusion is reached because:

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

ered sufficient.

The conclusion of the assessment of the risks to

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT

3.1.

is that there is a need for limiting the risks for some, but not all, local scenarios. This conclusion is reached because
of:

— concerns for micro-organisms in the sewage treatment plant as a consequence of exposure arising from the use
in the glass processing industry, varistor industry, catalysts processing, lubricants formulation, paints processing
and cosmetics pharmaceuticals formulation.

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3.2.

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 for all local scenarios, except for those listed under point 3.1 above. This conclusion is
reached because:

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

ered sufficient.

STRATEGY FOR LIMITING RISKS

For WORKERS

The legislation for workers' protection currently into force at Community level is generally considered to give an adequate
framework to limit the risks of zinc oxide to the extent needed and shall apply. Furthermore, based on the results of the
risk assessment report, it is recommended:

— to establish at Community level occupational exposure limit values for welding fumes according to Directive

98/24/EC (1) or Directive 2004/37/EC (2) as appropriate.

For the ENVIRONMENT

It is recommended:

— to consider under Directive 2008/1/EC (3) and Directive 2000/60/EC (4) if additional risk management is needed for
other sources of zinc emissions than those from the produced and imported chemical (for instance natural sources,
mining activities, historical pollution and the use of other zinc compounds), which the risk reduction strategy has
identified as contributing significantly to the emissions of zinc to the aquatic compartment,

— to facilitate permitting and monitoring under Directive 2008/1/EC, zinc oxide should be included in the ongoing

work to develop guidance on ‘Best Available Techniques’ (BAT).

PART 2

CAS No: 7733-02-0

Einecs No: 231-793-3

Structural formula:

Einecs name:

IUPAC name:

Rapporteur:

Classification (5):

ZnSO4

Zinc sulphate

Zinc sulphate

The Netherlands

Xn; R22

R41

N; R50-53

The risk assessment is based on 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 been conducted in accordance with the methodology for metals applicable at the time and in line
with the Technical Guidance Document on Risk Assessment in support of Regulation (EC) No 1488/94 on risk assess-
ment for existing substances.

The risk assessment has, based on the available information, determined that in the European Community the substance
is mainly used for the production of fertilisers and pesticides, for agriculture pharmaceutical purposes such as feedstuff
additives, and in the chemical industry. Other uses are applications in the viscose production, as flotation agent in the
treatment processes. Uses as
mining industry, as corrosion inhibitor
nanomaterials have not been assessed.

in the galvanising industry and in water

(1) OJ L 131, 5.5.1998, p. 11.
(2) OJ L 158, 30.4.2004, p. 50.
(3) OJ L 24, 29.1.2008, p. 8.
(4) OJ L 327, 22.12.2000, p. 1.
(5) The classification of the substance is established by Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress
for the 29th 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 152, 30.4.2004, p. 1, amended by OJ L 216, 16.6.2004, p. 3).

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RISK ASSESSMENT

A. Human health

The conclusion of the assessment of the risks to

WORKERS

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

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 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:

— 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 (physicochemical 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

Conclusions are given on local scenarios only. The conclusions regarding the regional risks to the environment as
described in the risk assessment for zinc metal (Einecs No 231-175-3) apply as well.

The conclusions of the assessment of the risks to

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 conclusions of the assessment of the risks to the

AQUATIC ECOSYSTEM INCLUDING SEDIMENT

1.1.

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 environment as a consequence of exposure arising from the use by the
agricultural fertiliser industry (formulation). For the use in agricultural feed industry (formulation) no immediate
concern has been identified but a potential risk at local scale cannot be excluded due to possible existence of
high regional background concentrations of zinc,

— concerns for effects on sediment dwelling organisms as a consequence of local exposure arising from the use in
the agricultural fertiliser industry (formulation), agricultural feed industry (formulation) and chemical industry
(processing). For a number of processing scenarios no immediate concern has been identified but a potential risk
at local scale cannot be excluded due to possible existence of high regional background concentrations of zinc.

1.2.

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 for all local scenarios, including concerning secondary poisoning, except for those listed
under point 1.1 above. This conclusion is reached because:

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

ered sufficient.

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The conclusion of the assessment of the risks to the

TERRESTRIAL ECOSYSTEM

2.1.

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

— concerns for the local terrestrial environment as a consequence of exposure arising from the use in chemical
industry (processing), agricultural pesticide industry (processing) and agricultural fertiliser industry (formulation).

2.2.

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, for all local scenarios, including concerning secondary poisoning, except for those listed
under point 2.1 above. This conclusion is reached because:

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

ered sufficient.

The conclusion of the assessment of the risks to

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT

3.1.

is that there is a need for limiting the risks. This conclusion is reached because of:

— concerns for micro-organisms in the sewage treatment plant as a consequence of exposure arising from the use
in chemical industry (processing), agricultural pesticide industry (processing) and agricultural fertiliser industry
(formulation).

3.2.

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 for all local scenarios, except for those listed under point 3.1 above. This conclusion is
reached because:

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

ered sufficient.

STRATEGY FOR LIMITING RISKS

For ENVIRONMENT

It is recommended:

— to consider under Directive 2008/1/EC (1) and Directive 2000/60/EC (2) if additional risk management is needed for
other sources of zinc emissions than those from the produced and imported chemical (for instance natural sources,
mining activities, historical pollution and the use of other zinc compounds), which the risk reduction strategy has
identified as contributing significantly to the emissions of zinc to the aquatic compartment,

— to facilitate permitting and monitoring under Directive 2008/1/EC, zinc sulphate should be included in the ongoing

work to develop guidance on ‘Best Available Techniques’ (BAT).

PART 3

CAS No: 7779-90-0

Einecs No: 231-944-3

Structural formula:

Einecs name:

IUPAC name:

Rapporteur:

Classification (3):

Zn3(PO4)2
Trizinc bis(orthophosphate)

Trizinc bis(orthophosphate)

The Netherlands

N; R50-53

The risk assessment is based on 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 been conducted in accordance with the methodology for metals applicable at the time and in line
with the Technical Guidance Document on Risk Assessment in support of Regulation (EC) No 1488/94 on risk assess-
ment for existing substances.

(1) OJ L 24, 29.1.2008, p. 8.
(2) OJ L 327, 22.12.2000, p. 1.
(3) The classification of the substance is established by Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress
for the 29th 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 152, 30.4.2004, p. 1, amended by OJ L 216, 16.6.2004, p. 3).

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The risk assessment has, based on the available information, determined that in the European Community the substance
is mainly used as an active inorganic anticorrosive pigment in primers and paints for corrosion protection of metal
substrates in paint, lacquers and varnishes industry. Uses as nanomaterials have not been assessed.

RISK ASSESSMENT

A. Human health

The conclusion of the assessment of the risks to

WORKERS

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

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 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:

— 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 (physicochemical 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

Conclusions are given on local scenarios only. The conclusions regarding the regional risks to the environment as
described in the risk assessment for zinc metal (Einecs No 231-175-3) apply as well.

The conclusions of the assessment of the risks to

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 conclusions of the assessment of the risks to the

AQUATIC ECOSYSTEM INCLUDING SEDIMENT

1.1.

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 environment (including sediment) as a consequence of exposure arising

from the use by the paint industry (formulation and processing).

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1.2.

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 for all local scenarios, including concerning secondary poisoning, except for those listed
under point 1.1 above. This conclusion is reached because:

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

ered sufficient.

The conclusion of the assessment of the risks to the

TERRESTRIAL ECOSYSTEM

2.1.

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

— concerns for the local terrestrial environment as a consequence of exposure arising from the use by the paint

industry (formulation).

2.2.

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, for all local scenarios, including concerning secondary poisoning, except for those listed
under point 2.1 above. This conclusion is reached because:

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

ered sufficient.

The conclusion of the assessment of the risks to

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT

3.1.

is that there is a need for limiting the risks. This conclusion is reached because of:

— concerns for micro-organisms in the sewage treatment plant as a consequence of exposure arising from the use

in the paint industry (formulation and processing).

3.2.

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 for all local scenarios, except for those listed under point 3.1 above. This conclusion is
reached because:

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

ered sufficient.

For ENVIRONMENT

It is recommended:

STRATEGY FOR LIMITING RISKS

— to consider under Directive 2008/1/EC ( 1) and Directive 2000/60/EC (2) if additional risk management is needed for
other sources of zinc emissions than those from the produced and imported chemical (for instance natural sources,
mining activities, historical pollution and the use of other zinc compounds), which the risk reduction strategy has
identified as contributing significantly to the emissions of zinc to the aquatic compartment,

— to facilitate permitting and monitoring under Directive 2008/1/EC, trizinc bis(orthophosphate) should be included in

the ongoing work to develop guidance on ‘Best Available Techniques’ (BAT).

(1) OJ L 24, 29.1.2008, p. 8.
(2) OJ L 327, 22.12.2000, p. 1.