Approval
Glyphosate was initially approved for use in Plant Protection Products (PPPs) in the EU for a 10-year period, beginning on 1 July 2002. Glyphosate’s initial approval had to be extended several times after 2012, to allow sufficient time for the first renewal process to be completed. In December 2017, the approval of glyphosate was renewed for 5 years, until 15 December 2022.
Extension and second renewal
In December 2022 glyphosate’s approval had to be extended by one year, because EFSA and ECHA required additional time to conclude their assessments.
Commission Implementing Regulation (EU) 2022/2364 – extension of glyphosate's approval period
The approval of glyphosate was ultimately renewed for the second time in November 2023. The approval process ran from 2019 to 2023. After which glyphosate was approved for another 10 years, until 15 December 2033.
Commission Implementing Regulation (EU) 2023/2660 renewing glyphosate's approval
Timeline of events
- 20192019
The Glyphosate Renewal Group (GRG) submits an application, which is then checked by the Assessment Group on Glyphosate – AGG to ensure it complies with the Commission Implementing Regulation (EU) 844/2012 on the renewal procedure for active substances. The application is published by EFSA.
The role of the AGG:
- conduct a scientific assessment applying the EU pesticide legislation.
- work jointly with EFSA and ECHA to assess the information provided by the GRG.
- assess if the GRG application and documents fulfil the Commission Implementing Regulation (EU) No 844/2012.
- request the GRG to provide additional information to comply with the required scientific studies and data.
- 20208 June
The Glyphosate Renewal Group submits the supplementary dossiers containing the required scientific studies and literature.
The AGG carries out an admissibility check followed by an assessment of all available information.
- 202115 June
The AGG submits the draft Renewal Assessment Report (dRAR) to EFSA and a CLH Report containing a proposal for harmonised classification and labelling to ECHA.
- 202123 September
EFSA and ECHA launch public consultations on the dRAR submitted by theAGG. The consultations end on 22 November 2021.
During the consultations, several NGOs submit an open letter to Commissioner Kyriakides highlighting their concerns about:
- the renewal assessment procedure
- the credibility of the studies submitted in the renewal dossier.
- scientific peer-reviewed open literature in the risk assessment
- 202113 October
NGOs also ask the Commission to financially support the Global Glyphosate Study by the Ramazzini Institute. The Commissioner responded by inviting NGOs to submit comments in the public consultation to be fully considered during the peer-review process.
- 202210 May
EFSA and ECHA announce that EFSA's conclusions will be delayed due to the late delivery of AGG's updated dRAR and the need to complete the peer review.
Commissioner Kyriakides responded to EFSA and ECHA and informed:
- the Chair of the Committee on the Environment, Public Health and Food Safety of the European Parliament
- the French Minister of Agriculture and Food (since France held the presidency of the Council of the EU at that time).”
- 202230 May
ECHA's Committee for Risk Assessment (RAC) agrees that the current harmonised classification of glyphosate should be retained (as causing serious eye damage and being toxic to aquatic life).
However, based on a wide-ranging review of the available scientific evidence, RAC concludes, as in 2017, that the available scientific evidence does not meet the criteria to classify glyphosate for specific target organ toxicity, or as a carcinogenic, mutagenic or reprotoxic substance.
This opinion is shared by most major regulatory agencies around the world, although the International Agency for Research on Cancer (IARC) has a different view.
- 2022June
The Health and Environment Alliance (HEAL) publishes a report arguing that "the cancer studies provided by pesticide companies for the carcinogenicity assessment of glyphosate show the clear potential for the substance to cause cancer." The Commission asks ECHA to consider the HEAL Report and respond to it.
The AGG, EFSA and ECHA consider the comments received during the public consultation and the responses of the GRG.
Based on an initial analysis of comments and reactions, EFSA - in consultation with the AGG - requests additional information from the GRG under Regulation (EU) No 844/2012.
ECHA's response confirms that all available data was properly evaluated, and that the conclusion reached is scientifically robust.
- 20222 December
As required by Article 17 of Regulation (EC) No 1107/2009, the Commission adopts an implementing regulation extending the approval of glyphosate until 15 December 2023.
- 20236 July
EFSA delivers its conclusion on the peer review of the pesticide risk assessment of glyphosate to Member States and the Commission.
- 202312-13 July
12 July - The Commission services initiate discussions with the Member States in the Standing Committee on Plants, Animals, Food and Feed (PAFF) Committee.
13 July - The Commission services conclude that the approval of glyphosate can be renewed, subject to certain conditions. A draft renewal report is made available to Member States for their consideration and comments.
- 202326 July
EFSA published its conclusion, followed by background documents in August and September. EFSA also publishes a Factsheet and News story to provide details about the renewal process and the overall findings of the peer review process.
- 2023September
Report from Générations Futures
The Commission asked EFSA and ECHA to respond – see below (6 October)
- 20237 September
Letter from 15 civil society organisations to Commissioner Kyriakides
The Commission asked EFSA and ECHA to respond – see below (5 October)
- 202319 September
The Commission informs Member States about the revised renewal report and draft implenting regulation proposing the renewal of glyphosate.
- 202322 September
The PAFF Committee meets again to discuss the draft renewal report and the draft implementing regulation put forward by the Commission. Following discussion, the Commission makes available
- an updated renewal report that reflects the comments received by Member States
- an updated draft implementing regulation setting out the conditions of approval.
- 20235 October
Following comments received from Member States after the Standing Committee meeting on Plants, Animals, Food and Feed (PAFF Committee) in September, the Commission makes available to Member States
- 202313 October
Member States vote on the draft regulation (see below for the texts on which Member States voted). The Committee does not deliver an opinion on this proposal, as there is no qualified majority in favour or against.
- 202316 November
The Commission refers the Regulation to the Appeal Committee.
The Appeal Committee does not deliver an opinion.
Member States vote on the following texts in the Appeal Committee:
- 202328 November
The Commission adopts the Implementing Regulation to renew, for 10 years, the approval of glyphosate.
This is in line with EU legislation, which obliges the Commission to adopt an implementing regulation when no qualified majority, in favour or against, is reached in the Standing Committee and in the Appeal Committee.
- 202329 November
The Implementing Regulation is published in the Official Journal of the EU. Glyphosate is approved in the EU until 15 December 2033.
The approval of glyphosate contains a number of conditions and restrictions, including:
- prohibition for use as a desiccant to control the time point of harvest or to optimise threshing;
- setting of maximum limits for 5 impurities in glyphosate;
- requirement for Member States to pay particular attention to certain aspects when carrying out risk assessments for plant protection products;
- requirement for the applicant to submit confirmatory information as regards the possible indirect effects on biodiversity via trophic interactions, within three years from the date of applicability of a relevant guidance document.
In general, the European Commission appoints rapporteur Member States in a consensual way (with the agreement of the Member State concerned). One Rapporteur Member State and one co-rapporteur Member State are nominated for each substance.
In the case of glyphosate, because of the expected very large application dossier and the related high workload, no single Member State volunteered to become rapporteur Member State or co-rapporteur Member State.
Following discussions with the Member States, a group of EU countries accepted to act jointly as rapporteur.
Commission Implementing Regulation (EU) No 844/2012 lays down the provisions necessary to implement the renewal procedure. An amendment to this Regulation to enable in exceptional cases a group of Member States to work jointly as rapporteur Member States, was adopted by Member States on 10 May 2019.
The following Member States have agreed to be part of the AGG: France, Hungary, the Netherlands and Sweden.
Their respective national agencies carried out the scientific work.
The AGG assessed the application dossier submitted by the Glyphosate Renewal Group and prepared a draft renewal assessment report (dRAR) which was sent to the European Food Safety Authority (EFSA) on 15 June 2021. On the same date, the AGG also submitted a CLH Report containing a proposal for harmonised classification and labelling to ECHA.
EFSA is responsible for the peer review of the risk assessment of active substances used in plant protection products in the EU. Further information on how EFSA carries out the peer review and the procedure can be found on EFSA's webpages
In principle, such a decision could be taken at any time if EFSA would identify evidence in the coming months demonstrating that glyphosate no longer fulfils the approval criteria laid down in the EU pesticides legislation.
The Commission is legally obliged to take account of the conclusion adopted by EFSA.
In cases where, for reasons beyond the control of the applicant, it appears that the approval is likely to expire before a decision has been taken on renewal, Article 17 of Regulation (EC) No 1107/2009 provides that the Commission must prolong the approval for a period sufficient to complete the renewal assessment.
Accordingly, on 27 September 2022, a draft Commission Implementing Regulation proposing to extend the existing approval by one year was made available to Member States and was put to a vote at the Standing Committee on Plants, Animals, Food and Feed on 14 October 2022.
Although a clear majority of Member States supported the proposal, a qualified majority was not achieved, and no opinion was reached. The Commission referred the draft Regulation to the Appeal Committee for further deliberation, which convened on 15 November 2022. The Appeal Committee also did not deliver an opinion.
In accordance with Article 17 of Regulation (EC) No 1107/2009 the Commission adopted an Implementing Regulation on 2 December 2022, extending the approval of glyphosate until 15 December 2023