EU Glyphosate Renewal Dossier Submission

Glyphosate Renewal in the EU

Plant experts reviewing data in a cornfield

At Bayer, we are committed to living up to our responsibility as a leader to shape the future of agriculture for the benefit of our customers, consumers and the planet. We firmly believe in the safety of our products, including glyphosate. Like every other active ingredient in plant protection products, glyphosate is regularly re-evaluated in the EU. Risks to human and animal health, the environment and effectiveness are checked here. In late 2023, the European Commission renewed the approval of the active substance glyphosate in the EU for 10 years.


In 2017, the European Commission had granted a five-year approval for the active ingredient glyphosate which had since been extended for a further year until December 15, 2023. In November 2023, following a comprehensive and transparent scientific assessment carried out by the competent authorities and the EU Member States, the EU Commission renewed the approval for 10 years, effective from December 16th 2023 to December 15th 2033.


In addition, glyphosate-based products must be subjected to a safety evaluation by the national authorities of the EU member states and authorized in the individual countries. Only then can they be used in practice, for example in agriculture. The applicant for the re-approval process in the EU was the Glyphosate Renewal Group (GRG), an association of companies, including Bayer, seeking to renew the approval of the active ingredient glyphosate in the European Union.


To respond to the demand for greater transparency and inform on the process and all its constitutive elements, the GRG gives access to the scientific dossier submitted in 2012 and to the new studies that were added to the scientific evidence presented in 2012 and be part of the new dossier submitted in June 2020. More information can be found at


The EU re-approval process

Due to the extensive application documents to be expected, the EU Commission transferred the task to act as ”rapporteur” to four member states: France, Hungary, the Netherlands and Sweden. They formed the Assessment Group on Glyphosate (AGG). This group prepared the re-evaluation as a basis for the subsequent consultations and decisions at EU level.


On December 12, 2019, the Glyphosate Renewal Group submitted an Application for the re-approval of glyphosate to the AGG, the European Food Safety Authority (EFSA), the European Commission and all other EU member states. The application deadline was December 15, 2019, three years before the glyphosate approval was due to expire on December 15, 2022. The application took into account information on numerous new and ongoing studies and can be viewed on the internet.


In addition to the application for re-approval, the GRG submitted a Scientific Dossier to the AGG on June 8, 2020 to assess the safety of glyphosate. This dossier contains all regulatory documents and scientific publications that are required in the European Pesticide Regulation for the re-approval of glyphosate. With over 180,000 pages, it is the most extensive dossier that has ever been submitted and is also available on the internet. It contains over 1,500 studies, including more than 100 new studies, as well as the evaluation of over 12,000 scientific articles with regard to the relevance and reliability of the data presented. On August 18, 2020, the AGG member states confirmed the completeness and admissibility of the dossier.


Ten months later, on June 15, 2021, the re-approval process reached another important milestone: the evaluating authorities from France, Sweden, Hungary and the Netherlands published the summary of their 11,000-page draft Renewal Assessment Report. The most important key message: Glyphosate meets the criteria for renewed approval in Europe. That meant at the same time: From the AGG's point of view, glyphosate was neither carcinogenic nor mutagenic. "No acute or chronic risk for the consumer is to be expected from the treatment of crops with glyphosate," the experts wrote in summary.


As the next step, EFSA and the European Chemicals Agency (ECHA) opened a 60-days public consultation period for this report, between September and November 2021, which allowed Member States, applicants, stakeholders and the public to participate in the regulatory process by providing their comments.


There were a total of 416 submissions during the two consultations.These are publicly available together with statistics on the EFSA and ECHA websites.


On 10 May 2022, EFSA and ECHA had communicated the updated timelines for their assessments. The consultations carried out on the draft assessments of glyphosate had attracted an unprecedented number of comments, confirming the high level of interest in this substance. The input received from the consultations, together with the replies received by EFSA from the applicant (the Glyphosate Renewal Group) in response to its request for additional information, had added a significant amount of information to a dossier that already contained far more scientific data than are usually available for such assessments.
On May 30, 2022 ECHA's Committee for Risk Assessment (RAC) agreed to keep glyphosate’s current classification as causing serious eye damage and being toxic to aquatic life. Based on a wide-ranging review of scientific evidence, the committee again concluded that classifying glyphosate as a carcinogenic, mutagenic or reprotoxic substance is not justified.
The adopted opinion was published on ECHA’s website and sent to the European Commission and EFSA on July 7, 2022.
On September 30, 2022, the AGG submitted the updated renewal assessment report (RAR) to EFSA. For the revised report, the AGG considered additional information gathered through consultations with the public and with Member States, including additional data submitted by the applicant (GRG).


On October 14, 2022, representatives of the EU Member States had to vote at the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) on the 1-year extension of the glyphosate approval because the then valid approval of the active substance glyphosate in Europe was due to expire on December 15, 2022. 


Given that a qualified majority was not achieved, the Commission referred the draft regulation to the Appeal Committee for further deliberation. On November 15, the EU Member State representatives in the Appeal Committee voted on the 1-year temporary extension and, again, the proposal neither gathered sufficient support in favor nor against it from Member States.


Therefore, on December 2, 2022, the European Commission adopted Implementing Regulation (EU) 2022/2364, extending the approval of the active substance glyphosate by one year until December 15, 2023.


EFSA organized the Pesticides Peer Review meetings with Member States experts in November and December 2022 (minutes available here: Plant Protection Products and their Residues / EFSA (


On July 6, 2023, EFSA informed the GRG, EU Member States and the European Commission of the Conclusions of its safety evaluation for the renewal of the EU approval of glyphosate. EFSA did not identify any critical areas of concern in its peer review of the risk assessment of the active substance glyphosate in relation to the risk it poses to humans and animals or the environment.


Following comprehensive scientific review, EFSA concluded that glyphosate fulfils all required approval criteria according to the EU Plant Protection Regulation.


EFSA published its conclusions in full on its website at the end of July. On September 13, 2023 EFSA published the final Renewal Assessment Report (RAR) in the last batch of background documents on open.efsa


In a dedicated factsheet, EFSA explains the scientific assessment of glyphosate, the most comprehensive and transparent assessment of a pesticide that EFSA and the EU Member States have ever carried out, taking into account thousands of studies related to human and animal health and the environment, and involving dozens of scientists from EFSA and national authorities across Europe.


On September 20, 2023, the Commission put forward to the Member States a Renewal Report and a draft Regulation proposing the renewal of approval of glyphosate.


In its draft, the Commission stated that glyphosate had been subject to two comprehensive assessments since 2012, both of which had not identified concerns indicating that the approval criteria laid down in Regulation (EC) No 1107/2009 were not fulfilled. As such it could not be expected that in the near term enough new information would be accumulated to result in a different outcome. At the same time, the Commission noted that research on glyphosate had intensified in recent years and new insights on the properties of glyphosate relevant for the protection of human health and environment might arise. In order to balance those considerations, it was deemed appropriate to provide for a renewal of the approval of glyphosate for a period of 10 years.


The Commission and Member States initiated discussions of the first draft Regulation and Renewal Report at a SCoPAFF meeting, on September 22, including the proposal for a 10 years renewal of approval and leaving  flexibility to Member States during the products authorization process. 


On October 13, 2023, Member States voted on the draft Regulation put forward by the Commission. While a majority of European Member States – 18 of 27 – voted in favor of the European Commission's proposal to renew the approval of glyphosate for 10 years, with only 3 countries voting against the proposal (Austria, Croatia and Luxembourg) and 6 countries abstaining (including Germany and France), a qualified majority was not reached. A qualified majority is achieved when a majority of 55 percent of the member states representing at least 65 percent of the EU population vote for or against the Commission proposal. 


Therefore, the Commission refered the Regulation to the Appeal Committee, which also consists of representatives from all EU countries. During the vote in the Appeal Committee on November 16, 17 Member States voted in favor of the proposed Regulation. However, a qualified majority was not reached.


With this outcome, it was on the Commission to take a decision. Therefore, in line with its proposal, the Commission adopted an Implementing Regulation renewing the approval of glyphosate for 10 years. The European Commission has published the glyphosate re-approval Implementing Regulation in the Official Journal on November 29, 2023. This step completed the comprehensive and transparent scientific re-evaluation that has been carried out by the competent authorities and the EU Member States.


Additional information provided by the European Commission can be found here


The Glyphosate Renewal Group  

The Glyphosate Renewal Group (GRG) is a consortium of eight companies that have come together to support the continued use of glyphosate in Europe and who were seeking the routine renewal of the approval of glyphosate by EU authorities for 2022 and beyond. These companies have combined their efforts and expertise to prepare a dossier containing all of the scientific studies and information necessary to reaffirm the safety of glyphosate.


Re-approval FAQs

1. Is glyphosate safe for use? 
Glyphosate-based products have been used safely and successfully in Europe for more than 40 years. Leading health regulators in Europethe United StatesGermany, Canada, AustraliaKoreaNew ZealandJapan, and elsewhere around the world continue to conclude that glyphosate-based products are safe when used as directed. Glyphosate-based herbicides are one of the most thoroughly studied products of their kind, which is a major reason why farmers around the world continue to rely on these products. 


2. If glyphosate is so safe, why does its approval need to be renewed?
By law, all active ingredients approved in the EU undergo routine evaluations. These are conducted by designated Member States and then peer-reviewed by EFSA and all other EU Member States.


3. Doesn’t glyphosate pose a threat to environmental sustainability?
In its peer review of the risk assessment of the active substance glyphosate the European Food Safety Authority (EFSA) did not identify any critical areas of concern in relation to the risk it poses to humans and animals or the environment. Farmers in Europe and around the world rely on glyphosate not only for effective weed control, but also for its role in minimizing tillage farming practices, which results in significantly less soil erosion and compaction, conserved moisture in the soil, and preserved soil health. Beyond the farm, glyphosate is key to ensuring the safety of roadsides, railways and utility corridors in Europe by controlling invasive or noxious weeds and brush. 


4. Why was the previous renewal authorized for only five years instead of the typical fifteen years?
Glyphosate fulfilled all scientific requirements for a full 15-year renewal. Yet, in November 2017, Member States voted to re-approve glyphosate in the EU for a period of only 5 years. 


5. You talk about being transparent, but what does that really mean?
As a member of the GRG, we are instituting measures for greater transparency. In addition to documents related to the renewal of approval process for glyphosate already available on the GRG Transparency website, including minutes of meetings with regulatory agencies, the renewal dossier and safety data from the 2020 dossier has been made available after it was considered complete by AGG. As a result, this dossier provides an unprecedented level of transparency. It is also one of the most complete compilations of glyphosate studies ever assembled — and is entirely consistent with the commitment Bayer has made to openness and engagement. Increased transparency and dialogue can only help foster public trust in our regulatory process.