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

• 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

• Revision 7 + MS + ECPA comments sent to EFSA PPR Panel in 2006

• Comments in PPR opinion

• 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

• Update data requirements in light of EFSA opinions, guidance documents and other scientific developments

• ‘Editorial issues’

• 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 ergosterolsynthesis-inhibiting fungicides a Fish Sexual Development Test (FSDT) is sufficient. In this case, the sex-ratio 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 long-term/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