Commission Regulation (EU) No 284/2013Show full title

10.4.2. Effects on non-target soil meso- and macrofauna (other than earthworms) U.K.

Circumstances in which required U.K.

Effects on soil organisms (other than earthworms) shall be investigated for all plant protection products, except in situations where soil organisms are not exposed such as:

(a)

food storage in enclosed spaces that preclude exposure;

(b)

wound sealing and healing treatments;

(c)

enclosed spaces with rodenticidal baits.

Testing shall be required if:

• the plant protection product contains more than one active substance,

• the toxicity of a plant protection product cannot be reliably predicted to be either the same or lower than the active substance tested in accordance with point 8.4.2 of Part A of the Annex to Regulation (EU) No 283/2013.

For plant protection products applied as a foliar spray, data on the relevant two non target arthropod species might be taken into account for a preliminary risk assessment. If effects do occur on either species, testing on Folsomia candida and Hypoaspis aculeifer shall be required (see point 10.4.2.1).

If data on Aphidius rhopalosiphi and Typhlodromus pyri are not available then the data outlined in point 10.4.2.1 shall be required.

For plant protection products applied as soil treatments directly to soil either as a spray or as a solid formulation, then testing shall be required on both Folsomia candida and Hypoaspis aculeifer (see point 10.4.2.1).

10.4.2.1. Species level testing U.K.

The test shall provide sufficient information to perform an assessment of the toxicity of the plant protection product to the soil invertebrate indicator species Folsomia candida and Hypoaspis aculeifer.

Test conditions U.K.

Testing shall determine a dose-response relationship and the EC₁₀, EC₂₀ and NOEC shall enable the risk assessment to be conducted in accordance with the appropriate risk quotient analysis, taking into account likely exposure, the organic carbon content (f_oc) of the test medium and the lipophilic properties (Kow) of the active substance in the plant protection product. The plant protection product shall be incorporated into the soil to obtain a homogenous soil concentration.

10.4.2.2. Higher tier testing U.K.

The tests shall provide sufficient information to evaluate the risk of the plant protection product for soil organisms (other than earthworms) using a more realistic test substrate or exposure regime.

Circumstances in which required U.K.

Further testing shall be required where significant effects are seen following laboratory testing in accordance with the requirements set out in point 8.4.2.1 of Part A of the Annex to Regulation (EU) No 283/2013 or in accordance with point 10.4.2.1 of this Annex and where risk is indicated following the relevant risk quotient analysis.

The need to perform such studies and the type and conditions of the studies to be performed shall be discussed with the national competent authorities.

Test conditions U.K.

Higher-tier tests may take the form of community/population studies (for example. terrestrial model ecosystems, soil mesocosms) or field studies. Timing, levels and routes of exposure shall reflect those of the proposed use of the plant protection product. Key effect end-points include: changes in community and population structure of both micro and macro-organisms; species diversity; number and biomass of key species/groups.