Home→Resources
Persistence, bioaccumulation and toxicity are environmental hazard considerations that can require specific attention in an ERA. The current EMA guideline includes PBT/vPvB considerations within the environmental assessment framework.
PBT refers to substances meeting criteria for persistence, bioaccumulation and toxicity. The assessment considers the environmental fate and effects evidence available for the active substance.
A substance with environmental persistence or bioaccumulation potential may need a different assessment strategy from a substance that is readily removed or has low environmental persistence. The regulatory assessment should consider the applicable criteria and evidence.
A project-specific assessment can identify the relevant environmental properties, evaluate the available study and literature evidence, identify data gaps and document the rationale for the chosen assessment strategy.
Share the substance, product context, intended market and regulatory requirement. ToxWriter can review the scope and confirm the appropriate assessment pathway.