Before a product can be marketed, the active substance(s) it contains must have been approved at European level. A substance is approved for a defined period, and is re-assessed according to developments in scientific knowledge and regulations. The products must then obtain authorisation before they can be placed on the market in each Member State. Each product is subject to a scientific assessment according to criteria laid down by the European regulations.
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 fruit trees, elimination of vegetation or intercrops between two seasons for arable crops such as wheat or rapeseed, weed control for railways and industrial sites, etc.
Glyphosate in five dates
- June 2016: withdrawal from the French market of glyphosate products containing the co-formulant POE-tallowamine.
- December 2017: the marketing of glyphosate in the European Union was re-approved for a period of five years. The European regulation requires additional data to be provided for assessing products containing glyphosate, mainly on the genotoxic properties of all components.
- June 2018: the action plan for the withdrawal of glyphosate in France was implemented.
- December 2018: withdrawal from the market of products for which no marketing authorisation renewal applications had been submitted.
- December 2019: withdrawal from the market of products for which a lack of data meant that the assessment of their ecotoxic potential could not be completed.
- August 2020: withdrawal from the market of glyphosate products intended for amateurs, as part of France's ban on the use and storage of all plant protection products for non-professional purposes (implementation of the 2017 Labbé Act), with the exception of biocontrol products, low-risk products or products authorised in organic production.
- October 2020: publication of the comparative assessment of non-chemical alternatives to glyphosate and changes to the conditions of use of products as part of the assessments of their marketing authorisation applications. The use of glyphosate was banned in situations where it can be substituted by a non-chemical solution.
- December 2022: the European Commission extended the authorisation to use glyphosate by one more year, until 15 December 2023. This decision was taken to allow EFSA to finish its peer review, which is expected to be completed in July 2023.
- July 2023: the conclusions of EFSA's peer review were forwarded to the European Commission.
ANSES's work on glyphosate
Renewal of European approval for the active substance glyphosate for 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 the renewal of glyphosate was submitted 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 members responsible for scientific assessment in each of the EU Member States) were carried out.
Issuing of marketing authorisations
Approval of the active substance glyphosate in the European Union was renewed for five years in 2017, then extended until 15 December 2023. Products containing glyphosate can be sold, provided that marketing authorisation is obtained. As with other plant protection products, ANSES assesses applications and issues marketing authorisations in France under European legislation (Regulation (EC) No 1107/2009), which enables the authority of a Member State to take charge of a dossier on behalf of all the other Member States in the same zone (France is in the South Zone).
Comparative assessment of non-chemical alternatives
ANSES conducted a comparative assessment of non-chemical alternatives to glyphosate. To do this, it identified situations where glyphosate could be substituted with a non-chemical solution (mainly mechanical weed control), provided that this solution is in general use and poses no implementation problems, as stipulated by the legislation. The use of glyphosate is now prohibited in these situations, and restricted in other cases.
Publication of data from the phytopharmacovigilance scheme
In order to watch out for any possible adverse effects of plant protection products, the Agency collects data on the presence of substance residues in the environment, as well as on exposure and the impacts on human health and ecosystems. In October 2019, it published a summary of monitoring data on the presence of glyphosate and its main metabolite, aminomethyl-phosphonic acid (AMPA), in water and food, as well as on blood contamination levels in humans.
ANSES's other work on glyphosate
Following divergent opinions on the dangers to human health from glyphosate, ANSES received a formal request in 2016 to assess the substance's carcinogenic potential. It concluded that the level of evidence of carcinogenicity in animals and humans was relatively limited and could not be used to propose a classification of glyphosate as a known or presumed human carcinogen. On the other hand, CLP classification in Category 2 (suspected human carcinogen) could be considered. This was confirmed by ECHA.
Furthermore, in order to improve knowledge on the carcinogenicity of glyphosate, in 2019 ANSES had issued a call for applications to study its carcinogenic potential, in order to obtain 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.
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.
Did you know?
Glyphosate is the most widely used herbicide in France and in the world
It owes its predominance to its ease of use, its effectiveness on all types of weeds, whether annual or perennial (it is known as a total or non-selective herbicide), and its low cost compared to other herbicides.
Glyphosate is an active substance and not a product
Glyphosate is a compound with a herbicidal effect, used as an ingredient in several plant protection products marketed by different companies. A product may contain several active substances.
The number of products containing glyphosate on the market varies, but is in decline
While there were more than 200 products on the French market at the end of 2018, there were only around 30 by the autumn of 2020. This decrease is due to the application of regulations restricting the use of glyphosate, as well as the strengthening of the assessment criteria (see above). However, this number fluctuates, with the finalisation of re-examinations of products on the market, and new applications for marketing authorisation.
What reduces the quantities used is not restrictions on the number of glyphosate products placed on the market, but rather restrictions on the conditions of their use (capped doses and situations where they are banned)
Just because a product is withdrawn from the market does not mean that users will necessarily stop using glyphosate: they can use another glyphosate product if it is still on the market and is intended for the same use. Only usage restrictions can have an effect on the quantities used. Product withdrawals are intended to prohibit those with health or environmental effects considered too severe, giving priority to those offering the most safeguards.
Marketing authorisations are granted on a product-by-product basis, with conditions laid down for each of the uses
A manufacturer wishing to market a glyphosate product must submit a marketing authorisation application in the country concerned. The authorisations issued are product-specific, for certain uses and according to a defined quantity used per hectare.
Product assessment takes place according to geographical zone
The assessments carried out on a product are valid in 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 decision is then taken by each country on the basis of the common assessment carried out by one of the Member States.