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Glyphosate-Hazard-Classification

Hazard Classification of Glyphosate by EFSA and ECHA

A record number of comments were received during EFSA and ECHA’s consultations on the draft assessments of glyphosate, indicating that it is a highly relevant substance. The level of public participation in the evaluation of active substances in the EU highlights the importance of transparency.

As of 10 May 2022, EFSA added significant new data to a dossier containing far more scientific evidence than are normally available for such assessments with the input received from the consultations and responses received from the applicant (the Group on the Renewal of Glyphosate) in response to the agency’s request for additional information.

The Assessment Group on Glyphosate (AGG), composed of four EU Member States – France, Hungary, the Netherlands and Sweden – that is currently updating its initial draft renewal assessment report (dRAR), will thoroughly review the additional information.

To accommodate this context, EFSA and ECHA revised the timeline for the remaining steps in the process of re-evaluation.

ECHA’s classification

As part of its plenary meeting on 30-31 May, the ECHA’s Committee for Risk Assessment (RAC) is scheduled to discuss the hazards of glyphosate. As part of its review, the Committee will examine carcinogenicity, genotoxicity, reproductive and developmental toxicity, as well as environmental classification. A draft of RAC’s opinion will be made available to EFSA and published on ECHA’s website within 8-10 weeks (i.e., mid-July to the end of August 2022). As part of the peer review of the dRAR, the EFSA will take into account the RAC opinion.

EFSA’s peer review

The EFSA received 368 responses to its public consultation, many of which included multiple comments. Additionally, EFSA received approximately 2400 comments from Member State experts and the Glyphosate Renewal Group (GRG). The GRG and the AGG will need to review approximately 3000 pages of these contributions, which will serve as the basis for developing an updated dRAR.

As per AGG’s notification to EFSA, the updated dRAR is scheduled for submission on 30 September 2022. The Pesticides Peer Review meetings will therefore be held between November and December 2022 at EFSA, and the conclusions will be finalized by July 2023. EFSA will evaluate all possible risks associated with glyphosate exposure, including those to humans, animals, and the environment. In addition to considering all comments, this updated timeline reflects our obligation to conduct a thorough risk assessment.

Timeline: Glyphosate re-assessments
  • December 2019: The Glyphosate Renewal Group (GRG) submits a renewal application.
  • June 2020: The Glyphosate Review Group submits a complete renewal dossier, and the Assessment Group on Glyphosate (AGG) begins working on the initial assessments.
  • June 2021: The AGG submits the draft renewal assessment report (dRAR) and the Harmonised Classification and Labelling (CLH) report to EFSA and ECHA, respectively.
  • August 2021: AGG updates dRAR and CLH reports for EFSA and ECHA based on qualitative and administrative checks.
  • September 2021: EFSA and ECHA launch parallel consultations.
  • November 2021: The parallel consultations close.
  • First half of 2022:
    • In addition, AGG takes into account the GRG’s response to each of the comments received during the consultations.
    • EFSA and ECHA review the comments and the information received during the consultations, including the AGG considerations.
    • EFSA requests additional information from GRG to complete the data package and sends agreed action points for AGG to follow up on
  • 21/22 April 2022: The ECHA’s Committee for Risk Assessment (RAC) Working Group discusses the proposal for harmonized classification and labelling (CLH).
  • 30 May – 3 June 2022: ECHA’s RAC will meet, and an opinion will be adopted on glyphosate’s classification.
  • End of September 2022: EFSA will receive an updated dRAR from the GRG following the identification of action points and the evaluation of additional information provided by the GRG.
  • November – December 2022: Experts from EFSA and EU Member States will meet to peer review the updated renewal assessment report (RAR). The AGG shall then review the RAR in light of the expert meeting outcomes and, subsequently, EFSA shall draft the peer review Conclusions in conjunction with follow-up consultations with AGG and Member States experts.
  • July 2023: The European Commission, member states, and the GRG will receive the conclusions of EFSA’s peer review.

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