Extension of the approval period of glyphosate
On 27 September 2022, the Commission made available to Member States a draft Commission Implementing Regulation proposing to extend the existing approval by one year in accordance with Article 17 of Regulation (EC) No 1107/2009. Member States will be asked to vote on the draft Regulation at the meeting of the Standing Committee on Plants, Animals, Food and Feed on 13-14 October 2022.
The extension of the approval is required due to delays incurred during the ongoing peer review process (see below for further information). The current planning by EFSA indicates that its conclusions on the peer review will be available in July 2023. Consequently, the assessment as to whether the approval criteria are expected to be fulfilled for glyphosate in accordance with Article 4 of Regulation (EC) No 1107/2009 is still ongoing, so that the renewal procedure cannot be concluded prior to the current expiry of the approval on 15 December 2022.
This extension is without prejudice to the decision on whether the approval of glyphosate can be renewed or not, which can only be taken once the scientific evaluation will have been completed.
Status of glyphosate in the EU
Glyphosate is currently approved in the EU until 15 December 2022.
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.
On 10 May 2019, the Commission appointed four Member States (France, Hungary, the Netherlands and Sweden) acting jointly as 'rapporteurs' for the next assessment of glyphosate – this group of Member States is known as the Assessment Group on Glyphosate (AGG).
On 12 December 2019, the Glyphosate Renewal Group (a group of companies seeking the renewal of approval of glyphosate in the EU), sent an application for the renewal of approval of glyphosate post-2022 to the AGG, the other Member States, the European Food Safety Authority (EFSA) and the European Commission. This application formally initiated the renewal process in the EU as provided for by Regulation (EC) No 1107/2009.
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 and 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 will be a delay in delivering the EFSA Conclusion, which is now expected in 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.
At the end of the peer-review process, EFSA will adopt a Conclusion on the peer review of the pesticide risk assessment, which will also take into account the Opinion that the Risk Assessment Committee of ECHA will adopt on the harmonised classification and labelling for glyphosate.
The Conclusion and the AGG’s renewal assessment report will be analysed by the Commission which will then put forward a renewal report and a draft Regulation to the Member States, on whether the approval of glyphosate can be renewed, or not. Discussions will then take place in the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee) prior to a vote by the Member States on the Commission’s proposal.
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) and for each substance, one Rapporteur Member State and one co-rapporteur Member State are nominated.
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 for the implementation of 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.
The scientific work was carried out by their respective national agencies.
The AGG assessed the application dossier submitted by the Glyphosate Renewal Group and prepared a draft renewal assessment report (dRAR) which it 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 on glyphosate by the end of 2022, as initially foreseen?
In principle, such a decision could be taken at any time if EFSA or ECHA would identify evidence in the coming months demonstrating that glyphosate no longer fulfils the approval criteria laid down in the EU pesticides legislation.
What will happen to the existing approval of glyphosate beyond 15 December 2022, if the assessment is ongoing beyond that date?
- 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 will be put to a vote at the Standing Committee on Plants, Animals, Food and Feed on 13-14 October 2022.
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
- 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