EFSA evaluated glyphosate for reapproval
In December 2019, a consortium of 8 companies, known as the the Glyphosate Renewal Group (GRG), submitted an application for the renewal of the approval of the active substance glyphosate in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (now repealed by Commission Implementing Regulation (EU) 2020/1740).
The initial approval of glyphosate expired, in fact, on 15 December 2022.
In the meantime, on 2 December 2022, the European Commission decided to extend this approval until 15 December 2023, through Regulation (EU) 2022/2364. Such an extension resulted from the fact that the European Food Safety Authority (EFSA) could not complete its reassessment in time, which should have been delivered by May 2022.
Following EFSA assessment, the European Commission and EU Member States must take a decision on the renewal of the approval of glyphosate.
In its assessment, EFSA evaluated the data and information provided for glyphosate and notably the following aspects:
- identity, physical-chemical and technical properties of the active substance and the formulation
- mammalian toxicology and non-dietary exposure
- consumer risk assessment
- groundwater exposure assessment
- impact on biodiversity
- microbiome impact
While for identity, physical-chemical and technical properties of the active substance and the formulation no issues were identified. There was a lack of data for consumer risk assessment, mammalian toxicology and non-dietary exposure, the impact on biodiversity and the impact of glyphosate on the microbiome.
Identity, physical-chemical and technical properties of the active substance and the formulation
The assessment of the data package revealed no issues that could not be finalized or needed to be included as critical areas of concern with respect to identity, physical-chemical and technical properties of the active substance and the formulation for representative uses, and analytical methods.
Mammalian toxicology and non-dietary exposure
In the area of mammalian toxicology and non-dietary exposure, no critical areas of concern were identified. The assessment of the reference specification could not be finalized due to an impurity showing potential for clastogenicity in an in vitro chromosome aberration test that was not appropriately followed up in vivo.
Consumer risk assessment
In the area of residues, the consumer risk assessment could not be finalized, as the number of rotational crop field trials was insufficient to address all relevant scenarios.
Groundwater exposure
The groundwater exposure assessment was finalized for most typical small hydrological catchments and most typical larger river systems, where the connectivity of surface water bodies to groundwater aquifers is limited. The assessment for aquatic macrophytes, when contact exposure via spray drift occurs, could not be finalized.
Biodiversity
Insufficient information was provided to draw a firm conclusion on the impact to biodiversity via indirect effects and trophic interactions for the representative uses.
Microbiome
Further research in the field of microbiome is needed to understand its relevance for risk assessment and develop dedicated strategies and methodologies accordingly. Glyphosate does not meet the criteria for endocrine disruption as laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No1107/2009, as amended by Commission Regulation (EU) No 2018/605.
Outstanding Issues
While no critical areas of concern were identified, the EFSA committee identified a number of outstanding issues, which include, beyond what is mentioned above, validation for several methods of analysis used for generating the data, and for monitoring glyphosate and its metabolite AMPA (aminomethyl)phosphonic acid) in several matrices, including honey.
The published EFSA manuscript can be found here.
Following the EFSA evaluation, the European Commission decides whether or not to include the substance in the EU’s list of approved active substances. This determines whether the substance can be used in plant protection products in the EU. EU Member States assess or re-assess the safety of plant protection products containing the active substance that are sold in their territory. The same process is followed for the renewal of the approval of active substances.
