Glyphosate: EFSA and ECHA update timelines for assessments
The consultations carried out by EFSA and ECHA on the draft assessments of glyphosate attracted an unprecedented number of comments, confirming the high level of interest in this substance. Such a level of public participation underlines the importance of transparency in the evaluation of active substances in the EU.
The input received from the consultations, together with the replies received by EFSA from the applicant (the Group on the Renewal of Glyphosate) in response to its request for additional information, added a significant amount of information to a dossier that already contained far more scientific data than are usually available for such assessments.
This additional information will be thoroughly considered by the Assessment Group on Glyphosate (AGG), composed of four EU Member States – France, Hungary, the Netherlands and Sweden – that is now updating their initial draft renewal assessment report (dRAR).
Against this background, EFSA and ECHA have revised the timeline for the remaining steps in the re-evaluation process.
ECHA’s Committee for Risk Assessment (RAC) will discuss the hazard A substance or activity which has the potential to cause adverse effects to living organisms or environments. classification of glyphosate during its plenary meeting on 30-31 May. The Committee will consider carcinogenicity Cancer-causing property of a substance when an animal or human is exposed to it., genotoxicity When a substance is capable of damaging the DNA in cells., reproductive and developmental toxicity Any adverse effect on the development of the unborn, babies, infants or children when exposed to a toxic substance., as well as the environmental classification. RAC’s opinion will be made available to EFSA and published on ECHA’s website within 8-10 weeks (i.e. end of July to mid-August 2022). EFSA will consider the RAC opinion during the peer review of the dRAR.
EFSA’s peer review
EFSA received 368 responses to its public consultation, many including multiple comments. EFSA also received approximately 2,400 comments from Member State experts and the Glyphosate Renewal Group (GRG). These contributions have resulted in a file of approximately 3,000 pages, which must be scrutinised by the GRG and subsequently by the AGG, and which will then serve as a basis for the preparation of the updated dRAR.
The AGG informed EFSA that they expect to submit the updated dRAR by 30 September 2022. EFSA will therefore be able to hold the Pesticides Peer Review meetings with Member State experts in November and December 2022 and to finalise the conclusions in July 2023. In its conclusions, EFSA will assess all possible risks that exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. to glyphosate might pose to humans, animals and the environment.
These updated timelines result from the obligation to thoroughly consider all comments received.
Timeline: Glyphosate re-assessments
Glyphosate Renewal Group (GRG) submits an application for renewal of approval.
GRG submits the full renewal dossier, and the Assessment Group on Glyphosate (AGG) starts working on the initial assessments.
AGG submits the draft renewal assessment report (dRAR) and Harmonised Classification and Labelling (CLH) report to EFSA and ECHA respectively.
AGG submits updated dRAR and CLH report to EFSA and ECHA following qualitative and administrative checks.
EFSA and ECHA launch parallel consultations.
The parallel consultations close.
- AGG provides their considerations to the comments received during the consultations, also taking into account the responses of the GRG to each of the comments.
- EFSA and ECHA review the comments and the information received during the consultations, including the AGG considerations to the comments.
- EFSA requests the GRG to provide additional information to complete the data package and sends agreed action points for follow up by the AGG
The Working Group of ECHA’s Committee for Risk Assessment (RAC) discusses the proposal for harmonised classification and labelling (CLH).
30 May/3 June
Meeting of ECHA’s RAC and expected date for adoption of RAC opinion on glyphosate classification.
AGG is expected to send updated dRAR to EFSA in response to the identified action points and following evaluation of the additional information provided by the GRG.
November - December
EFSA and EU Member States experts to meet to peer review the updated renewal assessment report (RAR). AGG then to review the RAR in light of the outcome of the expert meetings and, subsequently, EFSA to draft the peer review Conclusions with follow up consultations with the AGG and Member States experts.
Conclusions of EFSA’s peer review expected to be made available to the European Commission, Member States and the GRG.