Review of the Agency’s work on glyphosate
Glyphosate is a broad-spectrum herbicidal active substance used on plants in agricultural, forested and non-agricultural areas. Its approval in the European Union was renewed at the end of 2023. As well as assessing dossiers submitted by manufacturers wishing to renew their marketing authorisations for glyphosate products, ANSES assesses the risks of this class of herbicides as part of its scientific expert appraisal and phytopharmacovigilance missions.
Before a plant protection product can be marketed, the active substance(s) it contains must have been approved at European level. A substance is approved for a specific period of time. Its re-assessment takes account of developments in scientific knowledge and legislation. Commercial products must then obtain authorisation before they can be placed on the market in each Member State. Each plant protection product is subject to a scientific assessment at zonal level (three product assessment zones have been defined in the European Union by Regulation (EC) No 1107/2009) according to criteria laid down by European legislation.
What is glyphosate?
Glyphosate is an active substance found in various herbicide products and used to eliminate unwanted vegetation. It is applied by spraying and is effective on all types of plants. It can be used in a wide range of applications: weed control for vines and orchards, elimination of vegetation or intercrops before sowing annual crops such as wheat or rapeseed, weed control for railways and industrial sites, etc.
A few key dates for glyphosate
- June 2016: withdrawal from the French market of glyphosate products containing the co-formulant POE-tallowamine.
- December 2017: the European Union renewed approval of the active substance glyphosate for five years. The European regulation required additional data to be provided for assessing products containing glyphosate, mainly on their genotoxic properties.
- June 2018: implementation of the action plan for phasing out glyphosate in France.
- December 2018: withdrawal from the market of products for which companies had not submitted marketing authorisation renewal applications.
- December 2019: withdrawal from the market of products for which a lack of data meant that the assessment of their genotoxic potential could not be completed.
- 1 September 2020: withdrawal from the market of glyphosate products intended for amateurs, as part of France's ban on the use and possession of all plant protection products for non-professional use, with the exception of biocontrol products, low-risk products or products authorised for organic production (implementation of the 2017 Labbé Act).
- October 2020: publication of the comparative assessment of non-chemical alternatives to glyphosate, which led to changes in the conditions of use of products placed on the market and the inclusion of these conditions of use in any new marketing authorisations for glyphosate products. The use of glyphosate was banned in situations where it can be substituted by a non-chemical solution.
- May 2022: ECHA confirmed the hazard classification for glyphosate as the substance causes serious eye damage and is toxic to aquatic life. Based on the available scientific evidence, ECHA's Risk Assessment Committee concluded that classifying glyphosate as a carcinogenic, mutagenic or reprotoxic substance was not justified.
- December 2022: the European Commission extended the authorisation to use glyphosate by one year, until 15 December 2023, to allow EFSA to finalise the renewal assessment report with its peers in the EU Member States.
- November 2023: the European Commission renewed approval of the active substance glyphosate for a period of ten years from 16/12/23. It included a number of conditions and restrictions on use. In particular, special attention must be paid to protecting small herbivorous mammals such as voles, and non-target plants such as wild flowers, in the risk assessment. Risk mitigation measures must also be introduced to ensure the protection of non-target organisms and the environment.
ANSES and glyphosate
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 other plant 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 a comparative assessment of 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.
Did you know?
Glyphosate is an active substance and not a product
Glyphosate is a non-selective compound, meaning that it has a herbicidal effect on all plants. It is used as an ingredient in several plant protection products marketed by different companies. A product may contain several active substances. The class of products containing glyphosate are the most widely used herbicides in the world.
The quantities of glyphosate used in France are falling. This may be partly explained by restrictions on conditions of use.
While there were more than 200 products on the French market at the end of 2018, there were only around 20 by early 2023. However, when a product is withdrawn from the market, buyers tend to switch to other products (including glyphosate products) that can still be used: another glyphosate product may be used if it is still on the market and intended for the same use. Product withdrawals serve to refocus the product range on those offering the best safeguards to health and the environment.
Marketing authorisations are granted on a product-by-product basis, with conditions laid down for each of the use
A manufacturer wishing to market a glyphosate product must submit a marketing authorisation application in the country where it wishes to sell the product. The authorisations issued are product-specific, with the types of uses and quantities applied per hectare duly defined.
Product assessment takes place according to geographical zone
The assessments conducted on a product are pooled by several countries of the European Union. France is part of the "South" zone: a manufacturer can therefore apply for assessment in France, Italy or Spain. The marketing authorisation is then issued at national level by each country in this zone, on the basis of the common assessment carried out by one of the Member States.