The European Food Safety Authority (EFSA) has published a scientific report defining the problem formulation, evidence needs and methodological approach for revising the terrestrial ecotoxicology guidance, focusing on Tier 1 risk assessment for non-target arthropods (NTAs) other than bees, in-soil organisms and non-target terrestrial plants (NTTPs). The protocol, approved on 29 June 2026 and published on 31 July 2026, was developed by the Environmental Risk Assessment Working Group and the EFSA Panel on Plant Protection Products and their Residues (PPR Panel) under mandate M-2024-00086, which requests three separate guidance documents covering these organism groups.
The protocol translates the mandate's terms of reference into an assessment question and sub-questions on exposure characterisation, hazard characterisation and risk assessment for each guidance document. It follows the principles of the EFSA Guidance on protocol development for generic scientific assessments, although developing a protocol is not mandatory for guidance revisions; the working group and panel chose to do so given the mandate's complexity. The document acknowledges that the separation between above-ground NTAs and in-soil organisms is biologically arbitrary, as some species live in both habitats, but maintains this compartmentalisation at Tier 1 to keep assessments simple and conservative, while leaving room to reconsider higher-tier approaches in the revised guidance.
The protocol does not address risk assessment of mixtures of multiple plant protection products of unknown composition or sequential applications within a season, consistent with Regulation (EC) No 1107/2009, which only implements single product or active substance assessments. It also notes that the revision will consider ongoing projects such as AENEAS, EESE and PERA, and will integrate new approach methodologies (NAMs) where ready, following the European Commission's roadmap towards phasing out animal testing. The protocol was endorsed as a draft by the PPR Panel, shared for public consultation, and finalised after considering comments; deviations from the planned method during guidance development will be documented.
The report is a key step in updating the 2002 terrestrial ecotoxicology guidance, which currently underpins risk assessments for active substances and plant protection products under Regulations (EU) No 283/2013 and No 284/2013. The new guidance documents will affect pesticide producers, who face potential changes in data requirements and assessment costs; national regulatory authorities, which must implement the revised methodologies; and environmental stakeholders, who stand to benefit from more refined risk assessments that better protect non-target organisms. The protocol's focus on Tier 1 screening may streamline early assessments, but could also impose additional data generation burdens on applicants if new evidence needs are identified. The final guidance documents are expected to follow after further scientific work and consultation, with the protocol serving as a roadmap for the revision process.