In carrying out a regulatory risk assessment for soil organisms, the risks arising specifically from the active substance(s) in the formulated product and from the formulation must be assessed. These assessments use toxicity data on the active substance and/or on the formulation; exposure estimates are based on the proposed use. The soil risk assessment uses a soil predicted environmental exposure (PEC) calculated by Environmental Fate. For guidance about how to calculate the soil PEC see the guidance on Environmental Fate soil.
Guidance Document on Terrestrial Ecotoxicology
Formulation guidance and combined risk
For applications under Regulation 1107/2009 (as it applies in Great Britain and Northern Ireland) the requirements for Ecotoxicology formulation testing are laid out in Part A, Section 10, Annex to the Regulation 284/2013.
This UK specific formulation guidance provides advice on the need for ecotoxicology formulation studies and their use in risk assessment, along with how to consider the combined risk for relevant groups. Formal sections of the data requirements and existing guidance documents are presented together with additional guidance. Applicants are advised to read this document before deciding on a formulation testing strategy.
The standard species are Eisenia fetida /Eisenia Andrei. OECD no. 222: 'Earthworm Reproduction Test' can be found on the OECD website.
Other soil invertebrates
The standard species are the Collembola, Folsomia candida and the predatory mite, Hypoaspis aculeifer. OECD no. 226 'Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil' and no. 232 'Collembolan Reproduction Test in Soil' can be found on the OECD website.
The standard study is on nitrogen transformation activity of soil microorganisms. OECD no. 216 'Soil Microorganisms: Nitrogen Transformation Test' can be found on the OECD website.