Status of glyphosate in the EU

Glyphosate is currently approved in the EU until 15 December 2033

Therefore, glyphosate can be used as an active substance in Plant Protection Products (PPPs), until that date, subject to each PPP being authorised by national authorities following an evaluation of its safety.

Renewal process

An application was submitted by the Glyphosate Renewal Group and then checked by the AGG to ensure it fulfilled the requirements of the applicable EU legislation (Commission Implementing Regulation (EU) No 844/2012 on the renewal procedure for active substances).

The application was published on EFSA's website.

The supplementary dossiers containing the required set of scientific studies and literature data were submitted by the Glyphosate Renewal Group on 8 June 2020 (before the deadline of 15 June 2020).

The AGG carried out an admissibility check of the supplementary dossiers followed by an assessment of all available information.

On 15 June 2021, the AGG submitted to EFSA and ECHA its assessments in the form of a draft Renewal Assessment Report (dRAR) and a CLH Report containing a proposal for harmonised classification and labelling, respectively.

On 23 September 2021, EFSA and ECHA launched public consultations on the reports delivered by the AGG, which ended on 22 November 2021.

During the public consultation, a number of NGOs submitted an open letter to Commissioner Kyriakides highlighting their concerns about the renewal assessment procedure and in particular about the credibility of studies submitted by the applicant in the renewal dossier and about the use of scientific peer-reviewed open literature in the risk assessment.

The NGOs also asked for financial support from the Commission for an ongoing study by the Ramazzini Institute. The Commissioner responded invited the NGOs to submit the comments in the public consultation so that they will be fully considered during the peer-review process.

The AGG, together with EFSA and ECHA considered the comments received during the public consultation and the reactions of the GRG to them. Based on an initial analysis of the comments and the reactions of the GRG, EFSA - in consultation with the AGG - requested additional information from the GRG in accordance with the Regulation governing the renewal process (Regulation (EU) No 844/2012).

Given the volume of new information received through the public consultation, the amount of action points identified for AGG following the evaluation of those comments, and the need to evaluate additional information that was requested from the applicant by EFSA, the AGG indicated that more time is needed to provide an updated draft renewal assessment report (dRAR).

On 10 May 2022, EFSA and ECHA announced that taking into account the later delivery of the updated dRAR by the AGG and in order to complete the peer review process there would be a delay in delivering the EFSA Conclusion, which has eventually been delivered on 6 July 2023.

In addition to the public announcement, EFSA and ECHA wrote to Commissioner Kyriakides to explain the delay. Commissioner Kyriakides responded to EFSA and ECHA and also wrote to the Chair of the Committee on the Environment, Public Health and Food Safety of the European Parliament and to the French Minister of Agriculture and Food (since France occupies the presidency of the Council of the EU).

On 30 May 2022, ECHA's Committee for Risk Assessment (RAC) agreed that the current harmonised classification of glyphosate should be retained (i.e. as causing serious eye damage and being toxic to aquatic life).

Based on a wide-ranging review of the available scientific evidence, RAC concluded, as in 2017, that classifying glyphosate as a carcinogen is not justified. In June 2022, the Health and Environment Alliance (HEAL) published a report which argued 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 asked ECHA to consider the HEAL Report and respond to it. ECHA's response confirms that all available data was properly evaluated and that the conclusion reached is scientifically robust.

In accordance with the legal obligation laid down in 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

Further details about the peer review process and the process for harmonised classification and labelling can be found on the dedicated webpages of EFSA and ECHA respectively.

On 6 July 2023, EFSA adopted its Conclusion on the Peer review of the pesticide risk assessment of the active substance glyphosate ('EFSA Conclusion') and sent it to Member States and the Commission. EFSA published its Conclusion on 26 July, followed by the background documents in August and early September.

EFSA also published a Factsheet and News story to provide details about the renewal process and the overall findings of the peer review process.

On 12 July 2023, the Commission services initiated discussions with the Member States in the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee) – please see the summary of the discussions.

Following analysis of the Conclusion and the renewal assessment report prepared by the Member States acting jointly as rapporteur, the Commission services explained that they consider that the approval of glyphosate can be renewed, subject to certain conditions, and have put forward a draft Renewal Report to Member States on 13 July 2023 for their consideration and comments.

A further meeting of the PAFF Committee to discuss the draft Renewal Report and the draft Regulation was held on 22 September 2023. Please see the summary of the discussions.

Following discussion with the Member States in the PAFF Committee on 22 September, the Commission made available an updated Renewal Report which considered the comments received by Member States, as well as a draft Regulation setting out the conditions of approval. A further updated Renewal Report and an updated draft Regulation were made available to Member States on 5 October 2023. The texts put forward to Member States can be found below.

On 13 October 2023, Member States voted on the draft Regulation put forward by the Commission (see below for the texts on which Member States voted). The Committee did not deliver an opinion on this proposal (i.e. there was no qualified majority either in favour or against). Please see the summary of the discussion.

The Commission referred the Regulation to the Appeal Committee which was held on 16 November 2023. The Appeal Committee did not deliver an opinion.

Commission's proposal to the Member States

The EFSA Conclusion and the AGG's renewal assessment report have been carefully analysed by the Commission's services, which put forward an initial draft Renewal Report to the Member States on 13 July 2023 for their comments, in view of the renewal of approval of glyphosate.

On 19 September 2023, the Commission put forward to the Member States a revised Renewal Report and a draft Regulation proposing the renewal of approval of glyphosate.

• Renewal Report (Rev 1)
• Regulation (Rev 0) and Annexes (Rev 0)

On 5 October 2023, the Commission put forward to the Member States a further revised Renewal Report and a revised draft Regulation proposing the renewal of approval of glyphosate, following comments received from Member States after the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee) held on 22 September 2023.

• Renewal Report (Rev 2)
• Regulation (Rev 1) and Annexes (Rev 1)

On 13 October 2023, Member States voted on the following texts in the PAFF Committee.

• Renewal Report (Rev 2)
• Regulation and Annexes

The Committee did not deliver an opinion on this proposal (i.e. there was no qualified majority either in favour or against). The Commission referred the Regulation to the Appeal Committee which was held on 16 November 2023.

On 16 November 2023, Member States voted on the following texts in the Appeal Committee:

• Regulation and Annexes (Appeal Committee)

The Appeal Committee did not deliver an opinion (i.e. there was no qualified majority either in favour or against). Please see a summary of the discussion.

On 28 November 2023, the European Commission adopted the Implementing Regulation to renew, for 10 years, the approval of glyphosate. This is in line with the EU's legislation which obliges the Commission to adopt an Implementing Regulation when no qualified majority, either in favor or against, is reached in the Standing Committee and in the Appeal Committee, as in the case of glyphosate. The Implementing Regulation was published in the Official Journal of the EU on 29 November 2023.

Reactions from stakeholders and responses thereto

The Commission has received letters related to the renewal of approval of glyphosate. Those of public interest and the response thereto are made available below. For reasons of data protection all personal data is redacted.

• Letter from 15 civil society organisations to Commissioner Kyriakides. Response from EFSA and ECHA.
• Report from Générations Futures. Response from EFSA and ECHA.

Questions and answers

Why a group of RMS and not a single RMS?

In general, the European Commission appoints rapporteur Member States in a consensual way (i.e. 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.

Does the EU legislation allow multiple Member States to act as RMS?

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.

Which Member States are part of the AGG?

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.

How does EFSA carry out the peer review of the assessment carried out by the AGG?

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.

Despite the delay announced by EFSA and ECHA, could the Commission still take a decision earlier than 15 December 2023?

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.

Why did the Commission extend the approval of glyphosate beyond 15 December 2022?

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

Some facts about glyphosate

• Glyphosate is an active substance used in PPPs to control plants, which means it's a herbicide
• Glyphosate is the most frequently used herbicide both worldwide and in the EU and it has been used for several decades
• Glyphosate has been thoroughly assessed by Member States, the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) in recent years
• Glyphosate-based pesticides are used as herbicides in agriculture, horticulture and in some non-cultivated areas
• They are used primarily to combat weeds that compete with cultivated crops or present problems for other reasons (e.g. on railway tracks)
• They are typically applied before crops are sown to control weeds and therefore facilitate better growth of crops by eliminating competing plants
• This eliminates or minimises the need to use ploughing machines ("zero tillage" farming), thereby reducing soil erosion and carbon emissions
• Glyphosate is also used to a lesser extent as a pre-harvest treatment to facilitate better harvesting by regulating plant growth and ripening

Related links

• Press Release: Commission responds to European Citizens' Initiative
• Q&A: Commission replies to European Citizens' Initiative on Glyphosate
• 'Ban Glyphosate' European Citizens' Initiative
• EFSA page on Glyphosate
• ECHA page on Glyphosate

Further information