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The EMA framework uses a stepwise environmental risk assessment for human medicinal products. Phase I focuses on environmental exposure screening; further assessment can move into Phase II when indicated by the screening and other environmental considerations.
Phase I estimates potential environmental exposure from the use of the medicinal product. The calculation considers the active substance dose and a population-use component to estimate the predicted environmental concentration in surface water (PECsw).
Under the EMA framework, a refined PECsw below 0.01 µg/L, together with no other environmental concerns requiring further assessment, can support a conclusion that no further risk assessment is required. A PECsw at or above the action level generally leads to further Phase II assessment.
Phase II moves beyond exposure screening to environmental fate and effects information and risk characterisation. Depending on the substance, this can include degradation, adsorption, bioaccumulation, effects studies and PEC/PNEC comparisons.
Not all substances require the same depth of environmental assessment. The assessment pathway depends on the active substance, use pattern, environmental exposure and relevant properties or concerns under the applicable guideline.
Share the substance, product context, intended market and regulatory requirement. ToxWriter can review the scope and confirm the appropriate assessment pathway.
Interactive decision-support tool for navigating Phase I and PBT/vPvB ERA pathways.