📢 Do you know that from September onwards, the ERA reports must comply with the new requirements of the new EMA guideline on the Environmental Risk Assessment (ERA)?
This guideline proposes a dual approach that includes risk assessment and hazard (PBT/vPvB) assessment. Both assessments are presented as a decision tree.
– The risk assessment reflects the possibility of an effect occurring and is an evaluation of both the exposure of organisms in the environment to the active substance, and the ecotoxicity of the substance.
– The PBT assessment concerns the identification of intrinsic properties of an active substance that could render it harmful to the environment regardless of the levels of exposure.
👉 Dalia Global‘s team of toxicologists have extensive experience in conducting environmental risk assessments according to the new requirements, so contact us if you need more information!