The possible impact on earthworms must be reported except where it can be justified that it is not likely that earthworms are exposed, directly or indirectly.
TER a and TER lt must be reported where:
=
LC 50 (mg a.s./kg)/realistic worst case PEC s (initial or short-term, in mg a.s./kg)
=
NOEC (mg a.s./kg)/long term PECs (mg a.s./kg).
The test should provide the LC 50 , where possible the highest concentration causing no mortality and the lowest concentration causing 100 % mortality and must include observed morphological and behavioural effects.
These studies are only required where
the product contains more than one active substance,
the toxicity of a new formulation cannot be reliably predicted from the formulation tested according to the provisions of Annex II, point 8.4 or of this point.
The tests must be conducted in accordance to OECD Method 207.
The test should provide the NOEC and the effects on growth, reproduction and behaviour.
These studies are only required where
the product contains more than one active substance,
the toxicity of a new formulation cannot be reliably predicted from the formulation tested according to the provisions of Annex II, point 8.4 or of this point,
there is an increase in the recommended application rate, above that previously tested.
The same provisions as under the corresponding paragraphs of Annex II, point 8.4.2 apply.
The test should provide sufficient data to evaluate the effects on earthworms in field conditions.
Where TER lt < 5 a field study to determine effects under practical field conditions must be conducted and reported.
Expert judgment is required to decide whether residue contents of earthworms should be investigated.
Fields selected shall have a reasonable earthworm population.
The test must be carried out at the maximum proposed application rate. A toxic reference product must be included in the test.
The test should provide sufficient data to evaluate the impact of the plant protection product on macro-organisms that contribute to the breakdown of dead plant and animal organic matter.
Testing is not required where in accordance with Annex III, point 9.1, it is evident that DT 90 values are less than 100 days, or the nature and manner of use of the plant protection product are such that exposure does not occur or when data from studies on the active substance performed in accordance with the provisions of Annex II, points 8.3.2, 8.4 and 8.5 indicate that there is no risk for soil macrofauna, earthworms or soil microflora.
Impact on organic matter breakdown must be investigated and reported, where the DT 90f values determined in field dissipation studies (point 9.1) are > 365 days.]