Stop Glyphosate

Glyphosate & Politics

What is the Glyphosate timeline?

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.

At present, the renewal process for glyphosate is ongoing and we have reached a critical point. The final decision on whether to re-approve the marketing approval for glyphosate for the years to come is expected by the end of 2023.

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 European Commission 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 harmonized classification and labeling report (dRAR/CLH).

In its assessment, the AGG concluded that glyphosate is not carcinogenic, nor posses 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 standardized and harmonized classification and labeling 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 harmonized 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 authorization of glyphosate. EFSA's Conclusion is expected in July 2023.

With  the authorization due to expire in mid-December 2022, the Commission proposed a temporary extension of the marketing authorization 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 authorization 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 favorably.

On July 6, 2023, EFSA issued its long-awaited Conclusion on the assessment of the impact of glyphosate on the health of humans, animals and the environment. The European Food Safety Agency pointed out that the assessment of the potential genotoxicity of impurities, the risk assessment for consumers and the risk assessment for aquatic plants remain incomplete. However, despite data gaps identified by EFSA, the Agency declares no "critical areas of concern" for human, animal and environmental health related to the use of glyphosate in agriculture. EFSA's conclusions have outraged civil society organisations, who denounce a political decision to pass the buck to the Commission and Member States. The question arises: how can it be concluded that glyphosate can be used safely in agriculture when crucial questions about the risks remain unanswered?

On July 11 and 12, the European Commission's DG Sante presented its draft glyphosate renewal report to member states, according to a leaked document. This came as a surprise, as the agenda for the SCoPAFF meeting of July only mentioned an "exchange of views" on EFSA's conclusions.

We now expect the Commission to put forward a proposal to re-approve glyphosate's licence and an accompanying Review Report to the Member States of the SCoPAFF in September. The Commission’s proposal and Review Report will be based on an analysis of EFSA’s Conclusion and of the AGG’s renewal assessment report. Paradoxically, EFSA will not publish the reference documents that led to its conclusions until October, meaning that scientists and civil society won’t have the chance to scrutinise EFSA's work until then. This is a sign that DG Sante is purposely accelerating the decision-making process with Member States in secret, in an effort to avoid scientific and public scrutiny of EFSA's work.

Following the Commission’s proposal, discussions will then take place between representatives of EU Member States in the SCoPAFF to find an agreement and vote on the Commission’s proposal. If a qualified majority of member states supports the proposal, the renewal authorisation will be granted. If there is a simple majority, the European Commission may refer it to the Appeal Committee.

EU Member States will decide the fate of glyphosate before the end of the year in the ScoPAFF Committee. The stakes are high: glyphosate could be re-authorized for up to 15 years.

The end of the process is fast approaching but there is still time to mobilise to obtain a ban on glyphosate!

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.

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