Glyphosate Renewal in the EU
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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 2017, the European Commission granted a five-year approval for the active ingredient glyphosate, which is currently approved in the EU until December 15, 2022. The Federal Republic of Germany was the rapporteur for the joint examinations and evaluations at that time.
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 ongoing re-approval process is the Glyphosate Renewal Group (GRG), an association of companies, including Bayer, that are 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 glyphosate.eu.
Bayer will continue to support science-based regulatory decisions and will work transparently with the European Commission and the Member States to ensure glyphosate-based products remain available to farmers and other users in Europe to support agricultural sustainability and Industrial Vegetation Management. Farmers in Europe and around the world rely on glyphosate-based herbicides as safe, cost-effective components of their Integrated Weed Management practices, helping to ensure more productive harvests while preserving the environment. 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. More information is available on bayer.com/glyphosate
The EU re-approval process
Due to the extensive application documents to be expected, the EU Commission has transferred the task to act as ”rapporteur” to four member states: France, Hungary, the Netherlands and Sweden. They form 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 current glyphosate approval expires on December 15, 2022. The application takes 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 means at the same time: From the AGG's point of view, glyphosate is 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 write in summary.
What Happens Next?
On May 30, 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 will be published on ECHA’s website and sent to the European Commission and European Food Safety Authority (EFSA) by mid-August 2022.
Earlier, on May 10, EFSA and ECHA communicated the updated timelines for their assessments. The consultations carried out on the draft assessments of glyphosate 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, added a significant amount of information to a dossier that already contained far more scientific data than are usually available for such assessments.
EFSA will be able to hold the Pesticides Peer Review meetings with Member State experts in November and December 2022 and to finalize the conclusions in July 2023. In its conclusions, EFSA will assess all possible risks that exposure to glyphosate might pose to humans, animals and the environment.
The European Commission will analyze EFSA’s conclusions and the renewal assessment report that was prepared by Sweden, France, Hungary and The Netherlands. The Commission will then put forward a renewal report and a draft regulation to Member States on whether the approval of glyphosate can be renewed or not. The experts of the EU Member states then vote in the responsible committee (Standing Committee on Plants, Animals, Food and Feed, SCoPaff Committee).
On the basis of the vote, the EU Commission will approve the active ingredient in the EU, probably towards mid of 2024. That means: If there a qualified majority among the member states in favor of the renewal of the approval or a qualified majority against the renewal of the approval (also after a possible introduction of an amended Commission proposal), the Commission follows this vote.
A qualified majority is achieved when a majority of 55 percent of the states representing at least 65 percent of the EU population vote for or against the Commission proposal. If a qualified majority is not achieved, the committee has "no opinion". In this case, an appeal committee made up of representatives from all EU countries will deal with the possible renewal of the license.
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 are 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. While the companies are involved in the manufacturing and sale of glyphosate, the GRG welcomes other interested parties to join them in supporting the renewal of this essential crop protection product.
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 Europe, the United States, Germany, Canada, Australia, Korea, New Zealand, Japan, 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. Germany conducted the most recent EU-level evaluation of glyphosate in 2017, and following peer-review by EFSA, the evaluation concluded that glyphosate is safe for use and “is unlikely to pose a carcinogenic hazard to humans.” As this registration approval ends in December 2022, the process for another routine renewal began in December 2019.
3. Doesn’t glyphosate pose a threat to environmental sustainability?
In the EU, regulatory authorities only approve pesticides that can be used safely for the environment — and in 2017, the European Food Safety Authority (EFSA) concluded that glyphosate is safe when used as directed. In addition, glyphosate supports sustainable farming. 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. It also leads to improved water quality and reduces fuel inputs and greenhouse gas emissions. 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. Still, in November 2017, Member States voted to reauthorize the use of 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 this 2020 dossier will be made available after it is 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.