|
The Assessment Group of Glyphosate (AGG) has finalised its tasks as Rapporteur Member State (RMS) for the application of renewal of approval for Glyphosate. |
The EU Pesticides legislation requires that the approval of all active substances must be periodically reviewed. This process starts with a scientific assessment by a rapporteur Member State, which is followed by a peer-review process overseen by the European Food Safety Authority (EFSA).
On 10 May 2019, four Member States (France, Hungary, the Netherlands and Sweden) were appointed to act jointly as rapporteurs for the assessment of the next application for renewal of the approval for glyphosate. The four Member States formed the Assessment Group on Glyphosate (AGG). The AGG carried out the scientific evaluation of the dossier submitted for the renewal of approval of glyphosate.
The content on this web page is under the sole responsibility of the AGG.
Contact for enquiries:
- E-mail: AGG
ec [dot] europa [dot] eu (AGG[at]ec[dot]europa[dot]eu) - Tel.: +32-2-295 1010
Draft Renewal Assessment Report submitted
The AGG submitted the draft Renewal Assessment Report (dRAR) on the renewal of glyphosate to the European Food Safety Authority (EFSA) on 15 June 2021. Simultaneously, the AGG sent the report on Harmonised Classification and Labelling of glyphosate to the European Chemicals Agency (ECHA).
In this document the main conclusions of the draft assessment are summarised and an explanation is given on the procedure followed by the AGG as well as the next steps.
As explained in this document, a literature search was performed by the applicant, GRG. The Excel list with references that were excluded by the GRG during screening of title/abstract is not part of the RAR but one of the underlying documents submitted by the applicant. The list was checked by AGG as to whether AGG could agree to the GRG justifications of excluding studies. As a result of this check, AGG requested GRG to submit some studies from the list. These studies and all other included studies were evaluated in the dRAR. The lists with studies excluded by the GRG can be found here: Literature Review - non relevant rapid - Jan 2010 - Dec 2019; Literature Review - non relevant rapid - Jan 2020 - June 2020
The AGG submitted an updated dRAR and Harmonised Classification and Labelling report (CLH) to the EU authorities on 10 August 2021 after qualitative and administrative checks were carried out, as foreseen by the applicable procedure.
The follow-up procedure was managed by EFSA and ECHA and information can be found on their websites.
The Risk Assessment Committee of ECHA (RAC) prepares the opinions of ECHA related to the risks of substances to human health and the environment in the following REACH and CLP processes. At its 60th meeting (March 14-18, 2022) the RAC scheduled an informative discussion on glyphosate. Please see the presentation from the AGG.
Pre-submission meetings in 2019
Prior to submitting a dossier for the renewal of approval of an active substance, an applicant may request pre-submission meeting(s) with the Rapporteur Member State(s) to discuss procedural and scientific topics and obtain guidance.
In the case of glyphosate, the applicants are represented by the Glyphosate Task Force 2 (GTF2), which was renamed as the Glyphosate Renewal Group (GRG) end of 2019. The GRG is a consortium of companies applying for the renewal of the approval in the EU for the active substance glyphosate in 2022. The AGG held five pre-submission meetings with the GRG in 2019 (three face-to-face meetings and two conference calls) and three in 2020 (all conference calls). EFSA also attended some of the pre-submission meetings as an observer. Presentations that have been discussed during the meetings, as well as minutes, are published here below.
General pre-submission teleconference of 4 July 2019
General pre-submission meeting of 27 September 2019
- Presentation: slides 1-30 and slides 31-42
- Minutes
Technical pre-submission meeting of 17 October 2019 (environmental fate, ecotoxicology and endocrine disruption properties)
- Ecotox presentation (including ED properties)
- Environmental fate presentation
- Minutes (environmental fate, ecotoxicology and endocrine disruption properties)
Technical pre-submission meeting of 18 October 2019 (toxicology and residues in food)
Teleconference of 11 December 2019 (Evaluation of scientific peer-reviewed open literature)
Teleconference of 16 April 2020 (Evaluation of impacts on biodiversity)
Teleconference of 4 June 2020 (Submission of the supplementary dossier)
Teleconference of 26 August 2020 (Sanitation and disclosure timelines)
- Minutes
- Appendix AGG comments on CBI-form
- Appendix SE info public access
- Appendix SE information and secrecy act
Application for renewal of glyphosate submitted
An application for renewal of the approval for glyphosate was submitted before the deadline of 15 December 2019 by a consortium of nine companies – the Glyphosate Renewal Group (GRG).
The application document contains information on new and ongoing studies and was sent to the four rapporteur Member States (AGG), the European Food Safety Authority (EFSA), the European Commission and all other EU Member States.
This application assessed by the AGG did not meet the criteria of Regulation (EU) n° 844/2012. Therefore, the applicant was requested to submit an amended application by 23 January 2020:
Download requests for amended application:
The AGG concluded that the updated application met the criteria of Regulation (EU) n° 844/2012. The application can be found on Open EFSA (Pesticide dossier, EFSA question number: EFSA-Q-2020-00140)
Download completeness decisions:
Supplementary dossier for renewal of glyphosate submitted
A supplementary dossier for renewal of the approval for glyphosate was submitted before the deadline of 15 June 2020 by the Glyphosate Renewal Group (GRG) to the four rapporteur Member States of AGG.
This supplementary dossier was checked by the AGG against the requirements of Regulation (EU) n° 844/2012and did not meet all criteria. Therefore, the applicant was requested to submit an amended application by 24 July 2020:
On 23 July, a revised supplementary dossier was received by the AGG-members. The AGG-members assessed the completeness of the updated supplementary dossier on Glyphosate and found that it contains all the elements provided for in Article 7 of Regulation (EU) n° 844/2012. The application was found admissible.
The updated supplementary dossier was sent to the other Member States, the European Commission and EFSA according to Article 8 (3) of Regulation (EU) No 844/2012.
In the letter, the AGG-members made remarks that need further clarification. In addition, the AGG-members took note that some final reports or studies were not yet available. These clarifications/reports were requested in accordance with Article 11(5) of Regulation (EU) No 844/2012.