Stop Glyphosate

Glyphosate & Politics

What was the renewal process for glyphosate (2019-2023)

In the European Union, the market-approval for active substances used in pesticides, such as glyphosate, are only granted for a limited period of time. As the end of an ongoing approval period approaches, the active substance must go through the renewal procedure, which involves a re-assessment of the safety of the substance and a decision on whether to renew its marketing approval. In principle, this process exists to ensure that an active substance continues to meet high standards of safety, efficacy, and environmental protection.

The last renewal process for glyphosate ran from December 2019 to November 2023. In November 2023, the European Commission (EC) decided to renew the market license of the active substance glyphosate for 10 years, despite failing to gather enough support from Member States on its proposal. Here is what happened:

1. Submission of an application request

In December 2019, a consortium of companies led by Bayer, known as the Glyphosate Renewal Group (GRG) formally applied to renew the approval of glyphosate for use in herbicide products, which was initially expiring at the end of 2022. This application initiated the renewal process as provided for by EU legislation. The GRG submitted a dossier containing the required set of scientific studies and literature data to a group of Rapporteur Member States (RMS) previously appointed by the EC in May 2019. France, Hungary, the Netherlands, Sweden form the assessment group on glyphosate. (AGG)

2. Scientific evaluation by the Assessment group on glyphosate

The AGG was responsible for conducting the first assessment of the data on glyphosate's potential risks and impacts provided by pesticide companies. In June 2021, the AGG submitted its findings to EFSA and ECHA in the form of a combined draft renewal assessment report (dRAR) and harmonised classification and labeling report (dRAR/CLH).

In its assessment, the AGG concluded that glyphosate is not carcinogenic, nor poses any other health risk for humans or unacceptable risk for the environment, and therefore it meets the criteria to be approved for use.

3. ECHA and EFSA: who does what ?

The evaluation of glyphosate is crucially dependent on the assessment of the two European Union agencies.

  • ECHA is responsible for evaluating the hazards associated with glyphosate and providing a scientific opinion on its hazard classification and labeling.
  • EFSA conducts a thorough risk assessment and delivers a scientific opinion on the potential risks and impacts of the active substance on human health, animal health, and the environment.

In September 2021, ECHA and EFSA jointly published their draft scientific assessment reports for public consultation, which lasted until November 2021 and gathered more than 400 contributions, with EFSA receiving the majority of them.

During the public consultation, 41 civil society organizations submitted an open letter to the European Commissioner for Health and Food, Stella Kyriakides, highlighting their concerns about the credibility of the studies that have been provided by industry to justify its authorisation renewal in Europe. Commissioner Kyriakides invited the NGOs to submit their comments in the public consultation.

4. ECHA’s opinion + EFSA’s conclusion postponed

The AGG together with EFSA and ECHA considered the comments received during the public consultation as well as the reactions of the GRG to them. On this basis, EFSA - in consultation with the AGG - requested additional information from the GRG. Given the volume of information to review, the AGG indicated that more time was needed to provide an updated draft renewal assessment report.

Between March and May 2022, the ECHA's risk assessment committee (RAC) evaluated the potential hazards of glyphosate and deliberated a proposal for a standardised and harmonised classification and labelling of the substance. On 30th May 2022, the RAC delivered its Opinion. The risk assessment committee concluded that classifying glyphosate as a carcinogen was not justified and that the current harmonised classification of glyphosate should be retained (i.e. as causing serious eye damage and being toxic to aquatic life). Health and environment groups that participated in the RAC discussions raised alarms over ECHA’s failure to classify glyphosate as a carcinogen for human health. Similarly, the "Ban Glyphosate" civil society coalition strongly criticised ECHA's opinion and denounced the dismissal of strong evidence to classify glyphosate as a suspected human carcinogen.

Meanwhile on May 10th 2022, EFSA announced the postponement of its Conclusion on the peer review of the risk assessment of glyphosate, elaborating on the later delivery of the updated dRAR by the AGG and the need to process a significant amount of contributions. Environmental NGOs have pointed to the mismanagement of the file by the European Agency as the cause of this delay and denounced that the delay could be used to justify an additional one year authorisation of glyphosate.

With the authorisation due to expire in mid-December 2022, the Commission proposed a temporary extension of the marketing authorisation for glyphosate, in the absence of EFSA’s conclusion. In the meetings of the Standing Committee on Plants, Animals, Food and Feed SCoPAFF [1] in October and November 2022, the Commission’s proposal did not obtain the necessary majority among the Member States. Despite the absence of a green light from a qualified majority of Member States, the Commission granted an additional one-year authorisation to glyphosate, running until December 15, 2023. Following this decision, 28 environmental and health groups collectively penned an open letter to the European Commissioner Kyriakides, urging for an immediate ban on glyphosate in the European market. The Commission did not respond favourably.

5. EFSA's conclusion

On July 6, 2023, the EFSA issued its long-awaited Conclusion on the assessment of the impact of glyphosate on the health of humans, animals and the environment. In its peer-review, EFSA points out that the assessment of the potential genotoxicity of impurities, the risk assessment for consumers and the risk assessment for aquatic plants remains incomplete. Furthermore, it acknowledges that data from the scientific literature indicate that glyphosate products may cause neurotoxicity and have impacts on the microbiome, while ‘firm conclusions’ on the risk of biodiversity could not be drawn. Despite the data gaps and outstanding issues identified, the Agency declared no "critical areas of concern" for human, animal and environmental health related to the use of glyphosate in agriculture. This means that EFSA wrongfully concluded that glyphosate fulfils all the safety criteria for human health and the environment to be approved.

The EFSA's Conclusions outraged civil society organisations, who denounced the Agency for taking a political decision aimed at passing the buck to the Commission and Member States. In short, EFSA failed to correctly inform the European Commission on the toxicity of glyphosate in the conclusions of its peer review.

5. The European Commission’s decision to renew glyphosate in spite the lack of a full support from Member States

On 22nd September 2023, the EC presented a renewal Regulation proposal to the Member States at the relevant standing committee (SCoPAFF). The proposal, which laid down a 10 year renewal of the EU approval of glyphosate as it, with hardly any restrictions to minimise its use besides pre-harvest desiccation, was heavily criticised by NGOs. Certain nonbinding recommendations of use were included in the text, which are considered insufficient to ensure the protection of the health of workers and residents of agricultural zones, including children, as well as of the environmental ecosystems and biodiversity.

In spite of the stark criticism, representatives of EU Member States were invited to vote on the proposal in SCoPAFF on 12-13th October. During this meeting, the EC’s proposal failed to reach the required support from a qualified majority of Member States. In accordance with comitology rules, the proposal was referred to an Appeal Committee.

On 25th October, before the Appeal Committee took place, a renowned research institute presented groundbreaking data from a new study showing that low levels of glyphosate herbicides - that have been previously assumed to be safe in the EU - caused cases of leukaemia in young rats, following early life exposures. One of the products tested was the representative formulation BioFlow (MON 52276) for which the EFSA had recently concluded there were “no critical areas of concern”. In an open letter, 106 NGOs alerted the President of the European Commission to the results of this new study and called for the immediate withdrawal of the renewal proposal. Despite the serious doubts about the safety of glyphosate and the representative formulation, the EC refused to withdraw its proposal.

On 16th November 2023, the renewal proposal failed to secure the required qualified majority vote from Member States in the Appeal Committee. Notably, only countries representing 42 % of EU citizens supported the renewal. Major countries like France, Germany, and Italy abstained, along with Belgium, Bulgaria, Malta, and the Netherlands. Austria, Croatia, and Luxembourg voted against the re-approval.

However, the EU legislation provides that if there is no opinion from Member States in the Appeal Committee, the European Commission may proceed with the adoption of its proposal, with a simple majority. Which is what it did. The Implementing Regulation to renew glyphosate was adopted officially and published in the Official Journal of the European Union on 29 November 2023.

The renewal of glyphosate is a disaster for health, biodiversity, soil and water. But despite this setback, the members of the Stop Glyphosate coalition remain determined. As we observe the accumulating evidence from independent literature highlighting the harm inflicted by glyphosate exposure on our health, biodiversity, and environment, this decision only underscores the critical importance of our cause. More than ever, our fight continues.

Several Members of the Stop Glyphosate Coalition have decided to challenge the EU glyphosate renewal in court. Pesticide Action Network (PAN) Europe, along with its members ClientEarth, Générations Futures, Global2000, PAN Germany and PAN Netherlands have completed the required first step in the procedure by submitting a request for internal review (RiR) [2] to the European Commission. If the European Commission rejects the request, the NGOs are resolute to take this case in front of the EU Court of Justice. The stakes of this case are high and extend far beyond the courtroom. It is a fight for our health, biodiversity, soil, water, and the legacy we leave for our children and future generations. For further details on this case and to lend your support to the NGOs, click here.

To explore our Member’s ongoing actions against glyphosate, click on the button below.

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References:

[1] The SCoPAFF is a technical committee made up of anonymous representatives from each Member State and chaired by the European Commission. It forms part of the opaque "comitology" system.

[2] A request for internal review (RIR) is a procedure available to eligible environmental non-governmental organisations and, under specific conditions, to members of the public. It involves submitting a formal request to the European Commission, asking for an internal review of the administrative acts, because it is deemed to be in violation of EU environmental legislation. The request must be filed within 8 weeks following the adoption or publication of the administrative act in the Official Journal.

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