Fit‐for‐purpose risk assessment for low‐concern active substances and uses

This report describes a harmonised, stepwise methodology for the fit‐for‐purpose risk assessment of low‐concern active substances (LCASs), developed in response to EFSA's call GP/EFSA/PLANTS/2023/04. LCASs include substances such as semiochemicals, botanicals, inorganics, peptides, and double‐stranded RNA (dsRNA), which generally have lower risk profiles than conventional active substances. However, the current risk assessment framework - primarily designed for conventional substances - often lacks the flexibility required to appropriately address LCASs. The approach described here is based on problem formulation using generic pathways to harm. It offers a structured methodology aimed at harmonising case‐by‐case assessments based on the specific properties of individual LCASs. This approach supports both qualitative and quantitative assessments and covers hazards other than conventional toxicity, such as suffocation, desiccation and RNA interference. To apply this approach in practice, a problem formulation toolbox is provided, comprising three main elements:

1. Generic pathways to harm

2. Generic analysis plans, including the Analysis plan tool

3. Guidance on likelihood assessment