Health and Safety
Executive
Ecotoxicology Annex II
and III data requirements
Mark Clook
Chemicals Regulation Directorate
Health and Safety Executive
UK
Outline of presentation
•
History
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Changes – general
•
Changes – to data requirements
History
•
Drafts developed in 2002 following
consultation with the Member States
– Mark Lynch of PCS – drew up first draft
and chaired first meetings
•
Several rounds of expert meetings
– Involved experts from IE, IT, RO, HU,
BE, AU, DK, PL, FR, DE, SE, UK, NL,
EFSA – comments received from
ECPA and other MS
History cont’d
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Revision 7 + MS + ECPA comments sent to EFSA PPR
Panel in 2006
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Comments in PPR opinion
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Commission asked PSD to revise/update data
requirements in light of PPR opinion + MS + ECPA
comments
•
EFSA commented on the revised version – then
MS+COM+EFSA produced the draft that is being
considered today
Changes
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Update data requirements in light of
EFSA opinions, guidance documents and
other scientific developments
•
‘Editorial issues’
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Moving some data requirements from
Annex III to Annex II
Changes
ECx vs NOEC
For new long-term/chronic/reproduction
studies the dose or concentration range
should be selected to enable the derivation
of an EC10 and EC20 along with
corresponding 95% confidence intervals
and a NOEC value
Changes
ECx vs NOEC – existing studies
ECx may not be available
In these circumstances the study should not be
repeated but an attempt should be made to
determine EC10 and EC20 along with
corresponding 95% confidence interval, as well as
the NOEC value
An assessment should also be made regarding
their statistical robustness
Changes
EQS
Review of aquatic data required
Used to establish environmental quality standards
(EQS) for Water Framework Directive
Annex II – 8.1.1.2
Avian dietary study is not a core data
requirement, only required if:
A short term dietary study should only be conducted for those
pesticides where the mode of action and/or results from
mammalian studies indicate a potential for the LD50 measured
by the short term study to be lower than the LD50 based on an
acute oral study. The short-term dietary test should not be
conducted for any other purpose than to determine intrinsic
toxicity through dietary exposure, unless the necessity can be
clearly justified
Annex II – 8.1.4
Data have been requested on the effects on
terrestrial vertebrate wildlife (birds,
mammals, reptiles and amphibians)
Not a request for more studies – ‘available
and relevant data’ required
Annex II – 8.1.5
Potential endocrine disrupting substances
Nothing specific in terms of data
requirements
Need to discuss with MS
Annex II – 8.2.1
Acute fish studies – reduced from two
species to just one species.
Always required – classification and
labelling
Annex II – 8.2.2
The need for chronic/long-term data is now a core
data requirement
This was due to concerns raised by EFSA PPR
and other MS
Two studies are required – an assay (OECD 229
or 230) followed by either a full fish life cycle study
or an early life stage study
Annex II – 8.2.2
A fish short-term reproduction screening assay
should be conducted.
If the results indicate the potential for reproductive
effects, then a full fish life cycle study is required.
If the results do not indicate the potential for
reproductive effects, then an early life stage study is
required.
Annex II – 8.2.2
If the active substance is considered to be a
potential endocrine disruptor, then a full fish life
cycle study is required.
In the specific case that the endocrine disrupting
effect is known to be based on aromatase
inhibition e.g. in certain ergosterolsynthesisinhibiting fungicides a Fish Sexual Development
Test (FSDT) is sufficient. In this case, the sexratio is the most sensitive endpoint, which is fully
covered by the FSDT.
Annex II – 8.2.4.2
Requirement for a study on Mysid shrimp –
insecticides only
New requirement to address concerns of
MS and EFSA regarding diversity of aquatic
inverts
Relevance of Mysid noted
Annex II – 8.2.5
Long-term and chronic toxicity to aquatic
invertebrates
Carried out on the either Daphnia magna or
Mysid shrimp – depending which is more
sensitive
Role of chironomid? IGR?
Annex II – 8.2.8
Amphibian metamorphosis assay
OECD 231 requested to address the
endocrine issue and cover amphibians as
well
Annex II – 8.3.1.2
Honeybee brood feeding test
Study requested to address long-term risk
to honeybees
Annex II – 8.4.1
Earthworm – sub-lethal effects
Addresses issues regarding longterm/reproductive effects on earthworms.
Dropped acute study.
Annex II – 8.4.2.1
Effects on non-target soil mesofauna (other than
earthworms)
Change from function/structure mix to structure
Studies on Hypoaspis aculeifer and Foslomia
candida are now required.
However the need is dependant upon the toxicity/risk
to non-target arthropods.
Annex II – 8.5
Effects on soil nitrogen transformation
No change, however there has been the removal
of the carbon mineralisation study
Annex III – 10.4.2.2
Higher tier testing for non-target soil mesofauna
(other than earthworms)
Removal of requirement for the litter bag, replaced
with species/structure based studies (e.g. Terrestrial
model ecosystem)
Annex II – 10.6
As for active substance
Effects on soil nitrogen transformation
No change, however there has been the removal
of the carbon mineralisation study