Overview and details of ANSES’s work
Published on 19/05/2020
Plant protection products, Glyphosate, Active substances
Glyphosate is an active substance used in herbicides and approved by the European Union until December 2022. France is involved in its re-assessment, which will enable a decision to be taken on its re-approval. In 2018, France initiated a national glyphosate withdrawal plan designed to phase out its main uses by late 2020. ANSES is therefore conducting a series of studies on this active substance and the products containing it. Here is an overview of ANSES's missions.
Glyphosate is an active substance authorised in the European Union and used in many plant protection products. A low-cost herbicide that is effective against all plants, it has been widely used in France by professionals, amateur gardeners, industry and major infrastructures since the 1970s. Find out more about the uses of glyphosate (in French).
In recent years, the substance has been subject to controversy concerning in particular its carcinogenic potential. This being so, the European framework for assessing the substance and products containing it has been consolidated.
In France, as part of the 2018 national plan to reduce the use of plant protection products, a glyphosate withdrawal plan was set up to phase out its main uses by late 2020.
Furthermore, the "Labbé Act", designed to better regulate the use of plant protection products nationwide, prohibited the use of all plant protection products, including those containing glyphosate, from 1 January 2019 for non-professional uses, targeting amateur gardeners in particular.
Assessment of the substance at European level
In Europe, the risks and efficacy of active substances contained in plant protection products are regularly assessed (every 5, 10 or 20 years depending on the substance), in keeping with the legislation and in the light of new scientific knowledge.
In December 2017, the European Union re-approved glyphosate as an active substance for plant protection use. This approval is valid for 5 years, up to December 2022.
Work began in late 2019 to re-assess the substance looking ahead to the decision to re-approve it or to withdraw its approval. A single Member State is usually appointed to conduct the assessment and act as rapporteur for the European Union. However, in the light of the controversy over glyphosate’s hazardous nature, four Member States — Hungary, the Netherlands, Sweden and France — were jointly appointed.
Diverging opinions on the carcinogenicity of glyphosate
In 2015, while renewal of European approval was still being considered, the International Agency for Research on Cancer (IARC) published a study concluding that glyphosate was probably carcinogenic for humans.
For their part, the European Food Safety Authority (EFSA 2015) and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR 2016) concluded that glyphosate is not carcinogenic.
Having received a formal request in 2016 for an opinion on these diverging conclusions as to the hazardous nature of glyphosate for human health, ANSES concluded that:
- the level of evidence of carcinogenicity in animals and humans is considered relatively limited and cannot be used to propose a classification in Category 1A or 1B (respectively, known or presumed to be carcinogenic to humans) in application of the criteria of Regulation (EC) No 1272/2008 (CLP);
- the substance could arguably be classified in Category 2 (substances suspected of being carcinogenic to humans, CLP), without the Agency being in a position to take a decision in the absence of a detailed analysis of all the studies.
Since then, the European Chemicals Agency (ECHA 2017) and the United States Environmental Protection Agency (US EPA 2017) have also concluded that glyphosate is not carcinogenic on the basis of the available scientific data.
- In 2018, in order to broaden knowledge on the carcinogenicity of glyphosate, the French Ministers of Health, Agriculture and the Environment officially asked ANSES to conduct independent studies capable of answering the question of glyphosate's toxicity and, in particular, its carcinogenic nature. The Agency brought together a group of experts to draw up specifications on the research to be carried out and issued a call for tenders for that same research.
Marketing authorisations for products containing glyphosate in France
Following the renewal of European approval of the active substance in 2017, ANSES is currently re-assessing the plant protection products containing glyphosate, in order to decide on renewal of their marketing authorisation (MA) for France.
This assessment covers products for which an application for authorisation or re-authorisation has been submitted.
The European framework for product assessment by Member States now includes more requirements for glyphosate. Additional data must be provided on health and environmental risks, in particular on the genotoxicity of all the components in products containing glyphosate.
As part of the glyphosate withdrawal plan adopted by France, the Agency is also carrying out a comparative assessment with the available alternatives. Whenever there is an alternative to use of a glyphosate-based product that meets the substitution criteria, that use will be prohibited.
Decisions to withdraw products containing glyphosate:
In June 2016, ANSES withdrew 126 plant protection products combining glyphosate and POE-tallowamine due to concerns related to the toxicity of this co-formulant.
In December 2019, the Agency announced its withdrawal of 36 products containing glyphosate and its refusal to authorise four new products, as the data provided by the manufacturers did not enable it to reach a decision on their possible genotoxicity.
In addition, in November 2018, ANSES withdrew from the market 132 plant protection products containing glyphosate that had not applied to have their MA renewed.
For a list of plant protection products that have been granted a marketing authorisation or whose authorisation has been amended or withdrawn, see the E-Phy website (in French):
Presence of glyphosate in the environment and humans
As part of its phytopharmacovigilance scheme to detect any adverse effects related to the actual use of plant protection products, ANSES has published a summary of monitoring data on the substance glyphosate. In this, the Agency reviews the knowledge currently available in France on its presence in water and food, as well as on blood concentration levels in humans.
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