Issuing of marketing authorisations
Once an active substance has been approved in the European Union, products containing it can be sold, provided that they obtain marketing authorisation. As with otherplant protection products, ANSES assesses the risks and effectiveness of products and issues marketing authorisations in France in compliance with European legislation (Regulation (EC) No 1107/2009), which lays down assessment and decision-making criteria based on recognised scientific methodologies.
Contribution to the renewal of European approval for the active substance glyphosate (2019-2023)
On 10 May 2019, under a European Union regulation, four Member States (France, Hungary, the Netherlands and Sweden) were appointed as rapporteurs for the Assessment Group on Glyphosate (AGG). The AGG carried out a scientific assessment of the dossier submitted for the renewal of glyphosate's approval. This group's draft renewal assessment report (dRAR) on glyphosate was presented to the European Food Safety Authority (EFSA) on 15 June 2021. Scientists from ANSES contributed to this draft report. At the same time, the AGG sent its report on the harmonised classification and labelling of glyphosate to the European Chemicals Agency (ECHA). As with all assessments of active substances, a public consultation phase and a peer review of the draft report (i.e. by the competent scientific assessment bodies in each of the EU Member States) was organised by EFSA and ECHA from September 2021.
Comparative assessment of non-chemical alternatives
As part of the French government's plan to phase out glyphosate, launched in 2019, ANSES published acomparative assessmentof non-chemical alternatives to glyphosate in 2020. Based on INRAE's work, it identified situations where glyphosate could be substituted with a non-chemical solution (mainly mechanical weed control), provided that this solution was in general use with no implementation problems, as stipulated by the legislation. The marketing authorisations currently in force concern uses for which substitution has not been possible.
Publication of data from the phytopharmacovigilance scheme
In order to watch out for any possible adverse effects of plant protection products, the Agency collects a range of data on substance residues in treated agricultural products, and on the impacts on human or animal health and ecosystems.In March 2024, it published an updated summary of monitoring data on the presence of glyphosate and its main metabolite, aminomethylphosphonic acid (AMPA, which can also come from other products such as detergents), in different media (water, soil, food, air, dust, etc.), as well as on blood contamination levels in humans.
Research to understand the effects of glyphosate on trout
Based on experiments conducted with several generations of fish, an ANSES team explored the effects of glyphosate and glyphosate-based herbicides on the health of rainbow trout. This research showed that whether used pure or in herbicides, glyphosate could have effects on multiple generations of this species. The Agency submitted scientific publications on this work during the assessment dossier’s public consultation phase, with a view to the possible re-approval of the active substance glyphosate in 2021.
ANSES's work in 2016-2019 on the carcinogenicity of glyphosate
Following divergent opinions on the hazards to human health posed by glyphosate, ANSES received a formal request in 2015 to assess the conclusions of the IARC and the BfR with regard to the substance's carcinogenic properties.In February 2016 it concluded that the level of evidence for carcinogenicity in animals and humans was limited and could not be used to propose classifying glyphosate as a known or presumed human carcinogen.
Following on from this initial work, ANSES issued an internal request for a second expert appraisal to look more closely into questions about the genotoxicity of glyphosate products. As there were other scientific initiatives addressing the same concern, this second expert appraisal was not completed. Other steps were taken to address this concern: products with the co-formulant POE-tallowamine were all withdrawn from the market, a list of banned co-formulants was set out in legislation and ANSES systematically requested genotoxicity tests for all MA applications for products containing glyphosate after the product assessment, following the renewal of glyphosate's approval in 2017. In response to questions from several observers about the fate of its unfinalised expert appraisal, ANSES decided to publish the most recent working document, accompanied by an explanatory note. This initiative is part of the Agency's commitment to transparency.
Furthermore, in order to improve knowledge on the carcinogenicity of glyphosate, ANSES issued a call for applications in 2019 to study its carcinogenic potential, with a view to obtaining results for the re-assessment of the active substance in 2022. However, following the withdrawal of the selected candidates, studies meeting the conditions of the Agency's specifications were not able to be undertaken.
