Division 3.4.2.2 Phase IIB (more detailed ecotoxicological studies)

For those additives where, following Phase IIA assessment, an environmental risk cannot be excluded, more information is required on the effects on biological species in the environmental compartment(s) in which Phase IIA studies indicate possible concern. In this situation, further tests are needed to determine the chronic and more specific effects on appropriate microbial, plant, and animal species. This additional information will allow the application a lower safety factor.

Suitable additional ecotoxicity tests are described in a number of publications, e.g. in OECD Guidelines. Careful choice of such tests is necessary to ensure that they are appropriate to the situation in which the additive and/or its metabolites may be released and dispersed in the environment. The refinement of the effect assessment for soil (PNEC_soil) could be based on studies on the chronic effects on earthworms, additional studies on soil microflora and a number of relevant plant species, studies on grassland invertebrates (including insects) and feral birds.

The refinement of the effect assessment for water/sediment could be based on chronic toxicity tests on the most sensitive aquatic/benthic organisms identified in Phase IIA assessment.

Bioaccumulation studies, if necessary, should be performed according to OECD Guideline 305.