EFSA Finds No Critical Health Concerns for Herbicide Glyphosate
Image credit: MUS LIHAT via Unsplash
Based on an assessment of the impact of glyphosate on the health of humans, animals, and the environment, the European Food Safety Authority (EFSA) has determined that there do not exist any critical areas of concern. However, some data gaps were identified in EFSA’s conclusions for the European Commission and EU Member States to consider in the next stage of the renewal of approval process for the chemical.
A concern is defined as critical when it affects all proposed uses of the active substance under evaluation (e.g., pre-sowing uses, post-harvest uses, and etc.), thus preventing its approval or renewal.
Glyphosate is a chemical substance used in a number of herbicide products, and its use in Europe is subject to strict regulation. Glyphosate is currently approved for use in the EU until December 15, 2023. The risk assessment by Member States and the subsequent peer review by EFSA was carried out as part of the legal process to renew the approval of its use in Europe.
The risk assessment and peer review of glyphosate represents the work of dozens of scientists from EFSA and the Member States in a process that has spanned over three years. It is based on an evaluation of many thousands of studies and scientific articles, and also incorporates input gathered during public consultation.
In 2022, the European Chemicals Agency (ECHA) carried out a hazard assessment of glyphosate and concluded that it did not meet the scientific criteria to be classified as a carcinogenic, mutagenic, or reprotoxic substance. EFSA used ECHA’s hazard classification for the purposes of the EU risk assessment on glyphosate. Where data gaps are identified, they are reported in EFSA’s conclusions as either issues that could not be finalized or outstanding issues.
Issues that could not be finalized include the assessment of one of the impurities in glyphosate, the consumer dietary risk assessment, and the assessment of risks to aquatic plants. Outstanding issues include, but are not limited to, a lack of information about the toxicity of one of the components present in the glyphosate-based pesticide formulation submitted for evaluation, which is needed to conclude the risk assessment of the formulation for representative uses. For the formulation, there were no indications of acute toxicity and genotoxicity.
Regarding biodiversity, experts recognized that the risks associated with the representative uses of glyphosate are complex and depend on multiple factors. They also noted a lack of harmonized methodologies and agreed specific protection goals. Overall, the available information does not allow firm conclusions to be drawn on this aspect of the risk assessment, and risk managers are encouraged to consider mitigation measures. Additionally, with respect to ecotoxicology, the data package allowed a conservative risk assessment approach, which identified a high long-term risk to mammals in 12 out of 23 proposed uses of glyphosate.
Looking for quick answers on food safety topics?
Try Ask FSM, our new smart AI search tool.
Ask FSM →
EFSA’s conclusions on the peer review of the risk assessment for glyphosate have been shared with the European Commission and Member States to inform the decision they will take about whether to keep glyphosate on the EU list of approved pesticide active substances.
As with all peer-reviews of pesticide active substances, and according to EU legislation for pesticides, EFSA provides materials intended for publication to the applicant, which is entitled to request confidentiality for elements relating to personal data or commercially sensitive information. Applicants are not able to request changes to the conclusions or the assessment itself nor submit additional information.
As soon as the process is complete, EFSA will publish its conclusions and all background documents related to the peer review and risk assessment in full on its website. The conclusions are expected to be published by the end of July 2023 and the background documents, which include several thousands of pages, are expected to be published after that time.Update, July 26, 2023: EFSA has published its conclusions and all background documents related to the peer review and risk assessment of glyphosate.
