Communication from the Commission on the results of the risk evaluation and the risk reduction strategies for the substances: sodium chromate, sodium dichromate and 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol (tetrabromobisphenol A) Text with EEA relevance
Date: 2008-06-18
Institutions: European Commission
Subjects: chemical product, chemical salt, dangerous substance, environmental impact, health control, health risk, occupational safety, toxicology

18.6.2008

EN

Official Journal of the European Union

C 152/11

Communication from the Commission on the results of the risk evaluation and the risk reduction
strategies for the substances: sodium chromate, sodium dichromate and 2,2',6,6'-tetrabromo-4,4'-iso-
propylidenediphenol (tetrabromobisphenol A)

(Text with EEA relevance)

(2008/C 152/02)

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 Regulations (EC) No 143/97 (2) and (EC)
No 2364/2000 (3) respectively concerning the third and fourth list of priority substances as foreseen under
Regulation (EEC) No 793/93:

— sodium chromate,

— sodium dichromate,

— 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol (tetrabromobisphenol A).

The rapporteur Member States designated pursuant to those Regulations have 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 (4) and have 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 rapporteurs. 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
2008/454/EC (5), provides the results of risk evaluations (6) 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 25, 28.1.1997, p. 13.
(3) OJ L 237, 25.10.2000, p. 5.
(4) OJ L 161, 29.6.1994, p. 3.
(5) OJ L 158, 18.6.2008.
(6) 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/

C 152/12

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Official Journal of the European Union

18.6.2008

ANNEX

PART 1

CAS No: 7775-11-3

Einecs No: 231-889-5

Molecular formula:

Einecs name:

IUPAC name:

Rapporteur:

Classification (1):

Na2CrO4
Sodium chromate

Sodium chromate

United Kingdom

Carc. Cat. 2; R45

Muta. Cat. 2; R46

Repr. Cat. 2; R60-61

T+; R26

T; R25-48/23

C; R34

Xn; R21

R42/43

N; R50-53

The risk assessment is based on current practices related to the life-cycle of the five related chromium (VI) substances
produced in or imported into the European Community as described in the risk assessment forwarded to the Commission
by the Member State Rapporteur (2).

The risk assessment has, based on the available information, determined that in the European Community the five chro-
mium (VI) compounds are mainly used as source materials for other chromium (VI) and chromium (III) compounds, in
wood preservatives, in metal treatment products, in wax and vitamin K manufacture, in pigments and catalysts.

Other uses are as oxidants in dyeing of cotton, in photography, and as a corrosion inhibitor in cooling water and in
manufacture of activated carbon.

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 for all exposure scenarios because
of:

— concerns for respiratory tract sensory irritation,

— concerns for eye and skin irritation,

— concerns for acute toxicity as a consequence of short-term peak inhalation exposure,

— concerns for skin sensitisation,

— concerns for occupational asthma,

— concerns for reproductive toxicity (fertility and developmental toxicity) as a consequence of repeated inhalation expo-

sure,

— concerns for mutagenicity and carcinogenicity.

(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. 125).

(2) 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/

18.6.2008

EN

Official Journal of the European Union

C 152/13

The substance has not been sufficiently tested for effects to the respiratory tract and to the kidney as a consequence of
repeated inhalation exposure to the chromium (VI) compounds, specifically to identify the NOAELs and dose-response
characteristics. However, as the substance has been identified as a non-threshold carcinogen, it normally requires control
measures that would not be influenced by further information.

The conclusion of the assessment of the risks to

CONSUMERS

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

— concerns for mutagenicity and carcinogenicity as a consequence of dermal exposure arising from handling of dry
copper chrome arsenate (CCA)-treated wood, both for adults and for children exposed via wooden playing structures
because no threshold below which there would be no risk to human health can be identified for these endpoints.
However, the risk assessment indicates that risks are already low. This should be taken into account when considering
the adequacy of existing controls and the feasibility and practicability of further specific risk reduction measures.

No formal risk characterisation has been conducted for consumer exposure to wet CCA treated wood. In the UK the
supply of wood not fully dried following CCA treatment is prohibited as a condition of approval under the Control of
Pesticides Regulations (1986). Similar controls may already exist in all other Member States. However, if specific controls
are not available in each Member State, then there would be concerns for all relevant human health endpoints.

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:

— for mutagenicity and carcinogenicity because no threshold below which there would be no risk to human health can
be identified for these endpoints. However, the risk assessment indicates that risks are already low. This should be
taken into account when considering the adequacy of existing controls and the feasibility and practicability of further
specific risk reduction measures.

The conclusion of the assessment of the risks to

HUMAN HEALTH (physico-chemical properties)

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:

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

sufficient.

B. Environment

The conclusion of the assessment of the risks to the

ATMOSPHERE

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

1.

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

— concerns for effects on the sediment compartment as a consequence of exposure arising from production, pigment
production, chromium oxide production, tanning salts, wood preservative formulation, wood preservative applica-
tions, treated wood in use, metal treatment formulation, and metal treatment.

The information and/or testing requirements are:

— toxicity testing on sediment organisms.

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Official Journal of the European Union

18.6.2008

However, the implementation of the strategy for limiting risks for the environment in, together with the corresponding
Commission Recommendation 2008/454/EC (1), is expected to eliminate the need for further information require-
ments,

— concerns for non-compartment specific effects as a consequence of indirect exposure of predators through the
mussel-based food chain arising from pigment production, chromium oxide production, tanning salts, wood preser-
vative formulation, treated wood in use, metal treatment formulation, and metal treatment.

The information and/or testing requirements are:

— further investigation of the uptake of chromium into organisms other than fish, characterisation of the nature of
the chromium in organisms and consideration of the toxicity of chromium in other forms to organisms consuming
prey containing chromium.

However, the implementation of the strategy for limiting the risks for the environment in Section II, together with the
corresponding Recommendation 2008/454/EC, is expected to eliminate the need for further information requirements;

2.

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

— concerns for effects on the aquatic and terrestrial environment as a consequence of exposure arising from produc-
tion (aquatic only, 1 site), pigment production, chromium oxide production, tanning salts, wood preservative
formulation, wood preservative applications, treated wood in use, metal treatment formulation, and metal treat-
ment.

The conclusion of the assessment of the risks to

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT

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

— concerns for effects on the functioning of waste water treatment plants due to pigment production, chromium oxide
production, tanning salts, wood preservative formulation, treated wood in use, metal treatment formulation, and
metal treatment.

STRATEGY FOR LIMITING RISKS

For WORKERS

The legislation for workers' protection currently in force at Community level, particularly Directive 2004/37/EC of the
European Parliament and of the Council ( 2) (the Carcinogens and Mutagens Directive), is generally considered to give an
adequate framework to limit the risks of the substances to the extent needed and shall apply.

Within this framework it is recommended:

— to establish at Community level occupational exposure limit values for chromium (VI) compounds according to Direc-

tive 98/24/EC (3) or Directive 2004/37/EC as appropriate,

— to establish at Community level a biological

limit value for chromium (VI) compounds according to Directive

98/24/EC.

For CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT

— the existing legislative measures for consumer protection and humans exposed via the environment, in particular the
provisions of Council Directive 98/8/EC (the Biocidal Products Directive), and the provisions under Council Directive
76/769/EEC as regards CMR substances, are considered sufficient to address the identified risks to consumers.

(1) OJ L 158, 18.6.2008.
(2) OJ L 158, 30.4.2004, p. 50.
(3) OJ L 131, 5.5.1998, p. 11.

18.6.2008

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Official Journal of the European Union

C 152/15

For ENVIRONMENT

— it is recommended that the Commission considers the merit of including chromium in the revision of the list of

priority substances under the Water Framework Directive (Annex X of Directive 2000/60/EC),

— with particular regard to the on-site reduction of Cr (VI) compounds to Cr (III) tanning salts by plants involved in the
tanning of hides and skins, it is recommended that in the next amendment of the BAT reference document for plants
involved in the tanning of hides and skins, appropriate references are included to indicate that the on-site reduction of
Cr (VI) substances for the production of Cr (III) tanning salts should not be considered as BAT,

— it is recommended that the Commission considers the need to include limits on the contents of chromium (VI) in

sewage sludge and in soils as well as a limit on the annual load in the Directive 86/278/EEC on Sewage Sludge,

— the legislation currently in force at Community level for biocides (Directive 98/8/EC) is considered to give an adequate
framework to limit the risks associated with the use of wood preservatives that contain chromium (VI) substances and
the risks associated with the use of wood treated domestically with wood preservatives that contain chromium (VI)
substances.

PART 2

CAS No: 10588-01-9

Einecs No: 234-190-3

Molecular formula:

Na2Cr2O7

Einecs name:

IUPAC name:

Rapporteur:

Sodium dichromate

Sodium dichromate

United Kingdom

Classification (1):

O; R8

Carc. Cat. 2; R45

Muta. Cat. 2; R46

Repr. Cat. 2; R60-61

T+; R26

T; R25-48/23

C; R34

Xn; R21

R42/43

N; R50-53

The risk assessment is based on current practices related to the life-cycle of the five related chromium (VI) substances
produced in or imported into the European Community as described in the risk assessment forwarded to the Commission
by the Member State Rapporteur (2).

The risk assessment has, based on the available information, determined that in the European Community the five chro-
mium (VI) compounds are mainly used as source materials for other chromium (VI) and chromium (III) compounds, in
wood preservatives, in metal treatments, in wax and vitamin K manufacture, in pigments and catalysts.

Other uses are as oxidants in dyeing of cotton, in photography, and as a corrosion inhibitor in cooling water and in
manufacture of activated carbon.

(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. 125).

(2) 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/

C 152/16

EN

Official Journal of the European Union

18.6.2008

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 for all exposure scenarios because
of:

— concerns for respiratory tract sensory irritation,

— concerns for eye and skin irritation,

— concerns for acute toxicity as a consequence of short-term peak inhalation exposure,

— concerns for skin sensitisation,

— concerns for occupational asthma,

— concerns for reproductive toxicity (fertility and developmental toxicity) as a consequence of repeated inhalation expo-

sure,

— concerns for mutagenicity and carcinogenicity.

The substance has not been sufficiently tested for effects to the respiratory tract and to the kidney as a consequence of
repeated inhalation exposure to the chromium (VI) compounds, specifically to identify the NOAELs and dose-response
characteristics. However, as the substance has been identified as a non-threshold carcinogen, it normally requires control
measures that would not be influenced by further information.

The conclusion of the assessment of the risks to

CONSUMERS

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

— concerns for mutagenicity and carcinogenicity as a consequence of dermal exposure arising from handling of dry
copper chrome arsenate (CCA)-treated wood, both for adults and for children exposed via wooden playing structures
because no threshold below which there would be no risk to human health can be identified for these endpoints.
However, the risk assessment indicates that risks are already low. This should be taken into account when considering
the adequacy of existing controls and the feasibility and practicability of further specific risk reduction measures.

No formal risk characterisation has been conducted for consumer exposure to wet CCA treated wood. In the UK the
supply of wood not fully dried following CCA treatment is prohibited as a condition of approval under the Control of
Pesticides Regulations (1986). Similar controls may already exist in all other Member States. However, if specific controls
are not available in each Member State, then there would be concerns for all relevant human health endpoints.

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:

— for mutagenicity and carcinogenicity because no threshold below which there would be no risk to human health can
be identified for these endpoints. However, the risk assessment indicates that risks are already low. This should be
taken into account when considering the adequacy of existing controls and the feasibility and practicability of further
specific risk reduction measures.

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.

18.6.2008

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Official Journal of the European Union

C 152/17

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:

— 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

1.

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

— concerns for effects on the sediment compartment as a consequence of exposure arising from production, pigment
production, chromium oxide production, tanning salts, wood preservative formulation, wood preservative applica-
tions, treated wood in use, metal treatment formulation, and metal treatment.

The information and/or testing requirements are:

— toxicity testing on sediment organisms.

However, the implementation of the strategy for limiting risks for the environment in Section II, together with the
corresponding Recommendation 2008/454/EC ( 1), is expected to eliminate the need for further information require-
ments,

— concerns for non-compartment specific effects as a consequence of indirect exposure of predators through the
mussel-based food chain arising from pigment production, chromium oxide production, tanning salts, wood preser-
vative formulation, treated wood in use, metal treatment formulation, and metal treatment.

The information and/or testing requirements are:

— further investigation of the uptake of chromium into organisms other than fish, characterisation of the nature of
the chromium in organisms and consideration of the toxicity of chromium in other forms to organisms consuming
prey containing chromium.

However, the implementation of the strategy for limiting the risks for the environment in Section II, together with the
corresponding Recommendation 2008/454/EC, is expected to eliminate the need for further information requirements;

2.

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

— concerns for effects on the aquatic and terrestrial environment as a consequence of exposure arising from produc-
tion (aquatic only, 1 site), pigment production, chromium oxide production, tanning salts, wood preservative
formulation, wood preservative applications, treated wood in use, metal treatment formulation, and metal treat-
ment.

The conclusion of the assessment of the risks to

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT

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

— concerns for effects on the functioning of waste water treatment plants due to pigment production, chromium oxide
production, tanning salts, wood preservative formulation, treated wood in use, metal treatment formulation, and
metal treatment.

STRATEGY FOR LIMITING RISKS

For WORKERS

The legislation for workers' protection currently in force at Community level, particularly Directive 2004/37/EC ( 2) (the
Carcinogens and Mutagens Directive), is generally considered to give an adequate framework to limit the risks of the
substances to the extent needed and shall apply.

(1) OJ L 158, 18.6.2008.
(2) OJ L 158, 30.4.2004, p. 50.

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Official Journal of the European Union

18.6.2008

Within this framework it is recommended:

— to establish at Community level occupational exposure limit values for chromium (VI) compounds according to Direc-

tive 98/24/EC (1) or Directive 2004/37/EC as appropriate,

— to establish at Community level a biological

limit value for chromium (VI) compounds according to Directive

98/24/EC.

For CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT

— the existing legislative measures for consumer protection and humans exposed via the environment, in particular the
provisions of Directive 98/8/EC (the Biocidal Products Directive), and the provisions under Directive 76/769/EEC as
regards CMR substances, are considered sufficient to address the identified risks to consumers.

For ENVIRONMENT

— it is recommended that the Commission considers the merit of including chromium in the revision of the list of

priority substances under the Water Framework Directive (Annex X of Directive 2000/60/EC),

— with particular regard to the on-site reduction of Cr (VI) compounds to Cr (III) tanning salts by plants involved in the
tanning of hides and skins, it is recommended that in the next amendment of the BAT reference document for plants
involved in the tanning of hides and skins, appropriate references are included to indicate that the on-site reduction of
Cr (VI) substances for the production of Cr (III) tanning salts should not be considered as BAT,

— it is recommended that the Commission considers the need to include limits on the contents of chromium (VI) in

sewage sludge and in soils as well as a limit on the annual load in the Directive 86/278/EEC on Sewage Sludge,

— the legislation currently in force at Community level for biocides (Directive 98/8/EC) is considered to give an adequate
framework to limit the risks associated with the use of wood preservatives that contain chromium (VI) substances and
the risks associated with the use of wood treated domestically with wood preservatives that contain chromium (VI)
substances.

PART 3

CAS No: 79-94-7

Einecs No: 201-236-9

Structural formula:

Einecs name:

IUPAC name:

Rapporteur:

2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol (tetrabromobisphenol A)

2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol

United Kingdom

Classification (2):

None

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 (3).

The risk assessment has, based on the available information, determined that in the European Community the substance
is mainly used as a reactive and additive flame retardant in plastics. The main uses as a reactive flame retardant (chemi-
cally bonded into the polymeric material) are in epoxy and polycarbonate resins. The main uses as an additive flame retar-
dant are in acrylonitrile-butadiene-styrene (ABS) resins.

(1) OJ L 131, 5.5.1998, p. 11.
(2) This chemical substance is currently not included in the Annex I of Directive 67/548/EEC.
(3) 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/

18.6.2008

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Official Journal of the European Union

C 152/19

RISK ASSESSMENT

A. Human health

The conclusion of the assessment of the risks to

WORKERS, CONSUMERS AND HUMANS EXPOSED VIA THE ENVIRONMENT

is that there is at present no need for further information and 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 testing or for risk reduction measures beyond those which
are being applied. This conclusion is reached because:

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

sufficient.

B. Environment

The conclusion of the assessment of the risks to the

ATMOSPHERE

is that there is at present no need for further information or testing or for risk reduction measures beyond those which
are being applied. This conclusion is reached because:

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

sufficient.

The conclusion of the assessment of the risks to the

AQUATIC AND TERRESTRIAL ECOSYSTEM

1.

is that there is a need for further information and testing.

This conclusion is reached because:

— it is possible that TBBPA may be degraded to bisphenol-A in anaerobic freshwater and marine sediments. This
conclusions should be reconsidered once future aquatic effects data has been generated and the corresponding
PNECs for bisphenol-A are determined,

— another possible metabolite/degradation product — tetrabromobisphenol-A bis(methyl ether) — possibly meets the
screening criteria for a PBT substance. Although the results from present studies are inconclusive, it is suggested
that it is a very minor degradation product. Given that a need for risk reduction measures has already been identi-
fied for some uses (which should reduce the environmental burden of the parent compound), no further specific
work is recommended to address this issue at the present time,

— the risk characterisation ratios for the marine environment indicate a possible risk from some applications. The
need for further toxicity data with marine organisms should be evaluated once the implications of any risk reduc-
tion activities resulting from the assessment for fresh water and freshwater sediment are known.

However, the implementation of the strategy for limiting the risks for the environment in Section II, together with the
corresponding Recommendation 2008/454/EC ( 1), is expected to sufficiently reduce the concentrations in the aquatic
and terrestrial ecosystem and to eliminate the need for further information requirements;

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

— the PEC/PNEC is > 1 for surface water and sediment at compounding sites where TBBPA is used as an additive

flame retardant in ABS (acrylonitrile-butadiene-styrene resins),

(1) OJ L 158, 18.6.2008.

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Official Journal of the European Union

18.6.2008

— the PEC/PNEC is > 1 for the terrestrial compartment, where TBBPA is used as an additive flame retardant in ABS
from compounding and conversion sites. The conclusion for conversion sites is dependent on whether or not
sewage sludge from the site is applied to agricultural land (no risk is identified where sewage sludge is not applied
to land). For ABS compounding sites a risk is identified regardless of the assumptions made over the spreading of
sewage sludge.

The conclusion of the assessment of the risks to

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:

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

sufficient.

The results of the strategy for limiting the risks are set out in the corresponding Recommendation 2008/454/EC.

STRATEGY FOR LIMITING RISKS