Communication from the Commission on the results of the risk evaluation and the risk reduction strategies for the substances: zinc; zinc chloride; zinc distearate (Text with EEA relevance)
Date: 2008-06-19
Institutions: European Commission
Subjects: chemical product, environmental impact, environmental monitoring, health control, health risk, hydrology, pollution control, zinc

19.6.2008

EN

Official Journal of the European Union

C 154/1

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; zinc chloride; zinc distearate

(Text with EEA relevance)

(2008/C 154/01)

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,

— zinc chloride,

— zinc distearate.

The rapporteur Member State designated pursuant to this Regulation has completed the risk evaluation activ-
ities with regard to man and the environment for those substances in accordance with Commission Regu-
lation (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 accordance
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
2008/464/EC (4), provides the results of risk evaluations (5) and strategies for limiting the risks for the above
mentioned substances.

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.

(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 160, 19.6.2008.
(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

19.6.2008

ANNEX

PART 1

CAS No: 7440-66-6

Einecs No: 231-175-3

Structural formula:

Einecs name:

IUPAC name:

Rapporteur:

Zn

Zinc

Zinc

The Netherlands

Classification (1):

F; R15-17 (zinc powder — zinc dust (pyrophoric))

N; R50-53 (zinc powder — zinc dust (pyrophoric))

N; R50-53 (zinc powder — zinc dust (stabilised))

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 for galvanising and in brass. Other uses are in die casting alloys, rolled/wrought zinc, pigments and chemi-
cals and for the production of other zinc compounds. Uses of zinc and certain zinc compounds as nanomaterials have
not been assessed.

The Predicted No-Effect Concentrations (PNECs) for zinc metal included in the risk assessment have been derived solely
for the purposes of this risk assessment. They must not be used for other purposes, such as setting environmental quality
standards or sanitation levels, without further in-depth consideration as to whether they are fit for that purpose. In every
case an appropriate bioavailability correction should be incorporated as an essential part of the process.

RISK ASSESSMENT

A. Human health

The conclusions 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 conclusions 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.

(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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Official Journal of the European Union

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The conclusions 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 conclusions 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

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 of zinc metal and from the use in continuous hot dip galvanising, electro galvanising, in
brass, as die casting alloy, as rolled/wrought zinc and as zinc powder/dust. For a number of production sites of
zinc metal and processing scenarios of zinc metal 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 the regional aquatic (including sediment) environment due to elevated regional zinc levels

in some, but not all, regional surface waters and sediments.

In regions where these waters (including sediment) are found, it is strongly recommended that the available informa-
tion on known and potential sources of zinc emissions, and region-specific natural background concentration are
carefully taken into account before taking decisions about risk reduction measures.

The findings of the risk assessment report are that the current uses of zinc and zinc compounds do not per se lead
to the elevated regional levels found in surface water and sediment.

The elevated zinc levels in those waters and sediments, where they are found, may be caused by a combination of
zinc and zinc compounds. The elevated levels come from various emission sources, including local industrial point
sources, historical contamination, mining activities, geology and diffuse sources. The contribution of each of these
sources may vary between regions.

Local industrial point sources may include industrial processes that use and emit zinc and zinc compounds, as well
as other processes that are unintentional sources and are not directly connected with the zinc producing or using
industries. These were not examined in the risk assessment report, but may nevertheless have emissions of zinc to
the aquatic environment.

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Official Journal of the European Union

19.6.2008

1.2.

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

— concerns for effects on the aquatic (including sediment) environment alongside motorways in the European
Union. Due to a number of uncertainties additional information is needed to refine this part of the risk assess-
ment.

1.3.

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 and regional scenarios, including concerning secondary poisoning, except for
those listed under point 1.1 and 1.2 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 for the specific scenarios listed below. This conclusion is
reached because of:

— concerns for the local terrestrial environment as a consequence of exposure arising from use in continuous hot

dip galvanising and electro galvanising.

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 and regional (line sources at terrestrial road borders and zinc accumulation in
regional soils) 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 some of
the production sites of zinc metal and from some of the processing sites of continuous hot dip galvanising,
electro galvanising, as brass and as die casting alloy.

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 the 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 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.

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Official Journal of the European Union

C 154/5

PART 2

CAS No: 7646-85-7

Einecs No: 231-592-0

Structural formula:

ZnCl2

Einecs name:

IUPAC name:

Rapporteur:

Classification (1):

Zinc chloride

Zinc chloride

The Netherlands

Xn; R22

C; R34

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 in the chemical industry, galvanising industry, battery industry and agrochemical industry (fungicides).
Other uses are in the printing and dye 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 a need for specific measures to limit the risks. This conclusion is reached because of:

— concerns for acute respiratory tract irritation as a consequence of inhalation exposure arising during the production of

zinc chloride.

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).

C 154/6

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Official Journal of the European Union

19.6.2008

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 production at
one site and exposure arising from the use by the dyes and inks industry (formulation and processing). For one
production site 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 production
at three sites and local exposure arising from the use in the chemical industry (processing), battery industry
(processing) and dyes and inks industry (formulation and processing). For a number of production sites and
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.

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 the chemical

industry (processing) and dyes and inks industry (formulation and processing).

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.

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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 produc-
tion at three sites and exposure arising from the use in the chemical industry (processing) and dyes and inks
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 WORKERS

STRATEGY FOR LIMITING RISKS

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 chloride to the extent needed and shall apply.

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 chloride should be included in the ongoing

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

CAS No: 557-05-1 and
91051-01-3 (3)

Structural formula:

Einecs name:

IUPAC name:

Rapporteur:

Classification:

PART 3

Einecs No: 209-151-9 and
293-049-4

Zinc distearate

Zinc dioctadecanoate

The Netherlands

No classification

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) Commercially produced stearic acid is always a mixture of what chemically was called stearic acid (C18) and palmitic acid (C16). In prac-
tice, the description ‘Fatty acids, C16-18, zinc salts’ registered under CAS No 91051-01-3 is a more exact fit with commercial zinc stea-
rate, but it is only listed on Einecs and Chemical Abstracts have never indexed a single article to this number. Based on these considera-
tions, the CAS No 91051-01-3 was added.

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The risk assessment has, based on the available information, determined that in the European Community the substance
is mainly used in the polymers industry as a stabiliser component, lubricant, mould release agent and dusting agent for
rubber.

Other uses are in the paints, lacquers and varnishing industry as a sanding and flatting agent, in the building industry as a
waterproofing agent in concrete, in the paper, pulp, board and textile industry as a waterproofing agent, in the cosmetics
and pharmaceutical industry, chemical and metal industries and other applications. 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 (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

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.

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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 in the
textile industry (formulation), paper, pulp and board industry (formulation), metal extraction, refining and proces-
sing industry (processing) and formulation and processing by other industries. For a number of production sites
and 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,

— concerns for effects on sediment dwelling organisms as a consequence of local exposure arising from the produc-
tion at two sites and local exposure arising from the use in the coating industry (formulation and industrial use),
in the textile industry (formulation and processing), paper, pulp and board industry (formulation and processing),
metal extraction, refining and processing industry (processing) and formulation and processing by other indus-
tries and personal and domestic use (formulation). For a number of production sites and processing scenarios no
immediate concern has been identified but a potential risk at local scale cannot be excluded due to possible exis-
tence 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 processing in the

chemical industry and ‘other’ industries.

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 chemical industry (processing), textile industry (formulation), paper, pulp and board industry (formulation),
metal extraction, refining and processing industry (processing) and formulation and processing by other indus-
tries.

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.

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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, zinc distearate 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.