Peer review of the pesticide risk assessment of the active substance glyphosate

**Background:** This document presents the conclusions of the European Food Safety Authority (EFSA) peer review of the pesticide risk assessment for the active substance glyphosate, conducted as part of the renewal process under Regulation (EC) No 1107/2009. The assessment was carried out by the Assessment Group on Glyphosate (AGG), comprising France, Hungary, the Netherlands, and Sweden, with EFSA organising the peer review. The representative uses evaluated were as a herbicide applied as a foliar spray in various agricultural and non-agricultural settings, including vegetables, sugar beet, orchards, vineyards, and railway tracks. The peer review considered the hazard assessment from the European Chemicals Agency (ECHA) and evaluated data on identity, physical-chemical properties, mammalian toxicology, residues, environmental fate, ecotoxicology, and endocrine disruption potential.

**Methods:** The peer review followed the procedures of Commission Implementing Regulation (EU) No 844/2012. The initial evaluation was provided by the AGG in a Renewal Assessment Report (RAR), which was then subject to public and Member State consultation. EFSA organised expert consultations in the areas of mammalian toxicology, residues, environmental fate and behaviour, and ecotoxicology. The assessment relied on regulatory studies submitted by the applicant consortium (Glyphosate Renewal Group) and relevant peer-reviewed scientific literature. The evaluation of endocrine disruption potential followed the ECHA/EFSA (2018) guidance. The risk assessment for non-target organisms followed relevant EFSA and European Commission guidance documents.

**Key Results:** The peer review concluded that glyphosate does not meet the criteria for endocrine disruption for humans or non-target organisms. No critical areas of concern were identified. The acceptable daily intake (ADI) was set at 0.5 mg/kg bw per day, the acute reference dose (ARfD) at 1.5 mg/kg bw, and the acceptable operator exposure level (AOEL) at 0.1 mg/kg bw per day. Glyphosate was considered unlikely to be genotoxic and not carcinogenic in rats up to 1,214 mg/kg bw per day (males) and 1,498 mg/kg bw per day (females). A high long-term risk to small herbivorous mammals was concluded for 12 of the 23 representative uses based on tier 1 assumptions, with no suitable higher-tier data available for refinement. The consumer dietary risk assessment could not be finalised due to insufficient data on residues in rotational crops, although preliminary results indicated residues above the limit of quantification. The risk assessment for aquatic macrophytes due to contact exposure via spray drift could not be finalised. The assessment of the reference specification could not be finalised due to an inconclusive genotoxicity profile of one impurity. The impact on biodiversity via indirect effects and trophic interactions could not be finalised due to a lack of harmonised methodologies and sufficient data.

**Clinical Implications:** This peer review provides the scientific basis for the European Commission and Member States to decide on the renewal of approval for glyphosate. The identified data gaps and areas of concern, particularly the high long-term risk to mammals for several uses and the incomplete consumer risk assessment, will need to be addressed by applicants and considered by risk managers. The conclusion that glyphosate does not meet the endocrine disruption criteria and is unlikely to be genotoxic or carcinogenic supports its continued use under specific conditions and with appropriate risk mitigation measures. The findings highlight the need for further research on the impact of glyphosate on biodiversity and the microbiome, as well as the development of harmonised methodologies for assessing these complex endpoints.