Conclusion on Pesticides
Glyphosate
Glyphosate is a chemical that is widely used in herbicide products. Glyphosate-based pesticides – i.e., formulations containing the active substance glyphosate, co-formulants and possibly other chemicals – are used in agriculture and horticulture to combat weeds that compete with cultivated crops and in the maintenance of railway lines, amongst other uses.
Glyphosate is approved for use in the EU until 15 December 2023.
This means it can be used as an active substance in herbicide products until that date, subject to each product being authorised by national authorities following a safety evaluation. A step-by-step account of the renewal process, including latest developments, can be found on the EC website.
Latest
13 September 2023 EFSA publishes the final Renewal Assessment Report (RAR) in the last batch of background documents on open.efsa.
25 August 2023 The EU peer review report of the risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. of glyphosate is made available in open.efsa. The remaining background documents will be published by mid October 2023.
26 July 2023 EFSA publishes the conclusions on the peer review of glyphosate in the EFSA Journal. As with all peer-reviews of pesticide active substances, EFSA is legally required to ensure all content complies with rules on personal data protection and confidentiality. All background documents relating to the risk assessment and peer review will be published between the end of August and the middle of October 2023, as soon as these checks are completed.
6 July 2023 EFSA shares its conclusions on the peer review of glyphosate with the European Commission and Member States to inform the decision they will take about whether to keep glyphosate on the EU list of approved pesticide active substances. EFSA publishes a factsheet and a press release, summarising the conclusions. The full conclusions are expected to be published by the end of July 2023 and the background documents relating to the risk assessment and peer review are expected to be published between the end of August and the middle of October 2023.
22 December 2022 EFSA publishes high-level reports (HLR) from the peer review expert meetings that were held between 14 November and 2 December 2022. The documents, available here, provide a record of the points discussed and the conclusions reached for each point.
2 December 2022 The European Commission (EC) extends the approval for the use of glyphosate for one year until 15 December 2023. This decision was taken to allow EFSA sufficient time to conclude its peer review, which is due to be completed in July 2023.
30 September 2022 The Assessment Group on Glyphosate (AGG) submits the updated renewal assessment report (RAR) to EFSA, as planned. 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). In the next phase of the peer review, EFSA and the scientific experts appointed by the 27 EU Member States will discuss the evidence collected so far in a series of expert meetings. The conclusions of the peer review are expected by July 2023.
30 May 2022 ECHA confirms glyphosate’s current hazard classification as causing serious eye damage and being toxic to aquatic life. Based on the available scientific evidence, ECHA’s Committee for Risk Assessment (RAC) also concludes that classifying glyphosate as a carcinogenic, mutagenic or reprotoxic substance is not justified.
10 May 2022 EFSA and ECHA update the projected timeline for completion of the reassessment of glyphosate. The adjusted timeline follows consultations carried out by EFSA and ECHA which attracted an unprecedented number of comments, confirming the high level of interest in this issue.
22 November 2021 The parallel consultations held by EFSA and ECHA close. A total of 416 submissions were received from within and outside the EU during the two-month consultation period.
23 September 2021 EFSA and ECHA launch parallel consultations to seek feedback from interested parties on the renewal assessment report (RAR) and the harmonised classification and labelling (CLH) report on glyphosate. Everyone with an interest in this topic is encouraged to submit information, data, or studies. All contributions will be considered by the Member State competent authorities, EFSA and ECHA as the scientific assessment progresses.
30 August 2021 EFSA and ECHA announce that they will launch parallel consultations on the renewal assessment report (RAR) and the harmonised classification and labelling (CLH) report on glyphosate by 24 September 2021. All interested parties will be able to contribute to the ongoing scientific assessment by submitting relevant comments and information. The consultation will remain open for 60 days.
10 August 2021 The Assessment Group on Glyphosate (AGG) submits updated versions of the RAR and the CLH report to EFSA and ECHA respectively. The two EU regulatory agencies will now carry out the administrative work that is needed before the documents are made available for consultation.
Application for renewal
Glyphosate is currently approved for use in the EU until 15 December 2023, following a one-year extension in December 2022 [when its previous approval for five years granted by the European Commission (EC) in 2017 was due to expire]. In 2019, the applicant, which is a group of companies known as the Glyphosate Renewal Group (GRG), formally applied to renew the approval of glyphosate for use. This application initiated the renewal process as provided for by EU legislation.
The European Commission appointed four Member States – France, Hungary, the Netherlands and Sweden – to act as joint “rapporteurs” and carry out the initial assessment. This group is known as the Assessment Group on Glyphosate (AGG).
On 8 June 2020, the applicant submitted a dossier to the AGG containing the required set of scientific studies and literature data. All files that were submitted for the assessment and peer review process are available on the GRG website.
The AGG completed its assessment and on 15 June 2021 passed it to EFSA and ECHA, respectively in the form of a renewal assessment report (RAR) and Harmonised Classification and Labelling (CLH) report to initiate the peer review process. Updated versions of the RAR and the CLH report were submitted to EFSA and ECHA on 10 August 2021.
The RAR ran to approximately 11,000 pages. By comparison, a typical assessment report for an active substance comprises fewer than 5,000 pages. At the same time the AGG sent ECHA a proposal for harmonised classification and labelling (CLH dossier), which served as a basis for ECHA’s classification.
A summary of the AGG’s main draft findings is publicly available.
In parallel with the EFSA-led assessment, ECHA reviewed the classification of glyphosate under the EU’s Classification, Labelling and Packaging (CLP) Regulation.
The classification of chemicals is based solely on the hazardous properties of a substance and does not take into account the likelihood of exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. to the substance. Exposure is considered as part of the risk assessment process led by EFSA. In carrying out the exposure and risk assessment, EFSA adopted ECHA’s hazard A substance or activity which has the potential to cause adverse effects to living organisms or environments. assessment delivered on 30 May 2022.
Timeline
2019
December
Glyphosate Renewal Group (GRG) submits an application for renewal of approval.
2020
June
GRG submits the full renewal dossier, and the Assessment Group on Glyphosate (AGG) starts working on the initial assessments.
2021
June
AGG submits the draft renewal assessment report (dRAR) and Harmonised Classification and Labelling (CLH) report to EFSA and ECHA, respectively.
August
AGG submits updated dRAR and CLH report to EFSA and ECHA following qualitative and administrative checks.
September
EFSA and ECHA launch parallel consultations.
November
The parallel consultations close.
2022
First quarter
- AGG provides its considerations to the comments received during the consultations, also taking into account the responses of the GRG to each of the comments.
- EFSA and ECHA review the comments and the information received during the consultations, including the AGG considerations to the comments.
- EFSA requests the GRG to provide additional information to complete the data package and sends agreed action points for follow up by the AGG
21 - 22 April
The Working Group of ECHA’s Committee for Risk Assessment (RAC) discusses the proposal for harmonised classification and labelling (CLH).
30 May
Meeting of ECHA’s RAC and adoption of RAC opinion on glyphosate classification.
30 September
AGG submits updated dRAR to EFSA in response to the identified action points and following evaluation of the additional information provided by the GRG.
14 November - 2 December
EFSA and EU Member State experts meet to peer review the updated renewal assessment report (RAR). Following these meetings, the AGG reviews the RAR in light of the outcome of the experts' discussions and then EFSA drafts the peer review conclusions, in consultation with the AGG and Member State experts.
22 December
The high-level reports (HLR) of peer-review expert meetings are published on EFSA’s website.
2023
6 July
Conclusions of EFSA’s peer review are made available to the European Commission, Member States and the GRG.
26 July
Conclusions of EFSA’s peer review are published in the EFSA Journal.
25 August
The EU peer review report is made available on open.efsa.
13 September
The remaining background documents are published, including the final RAR.
Roles of EFSA and ECHA
EFSA and ECHA play two different but complementary roles in the assessment of active substances used in PPPs. ECHA is responsible for the hazard assessment of a given substance, while EFSA assesses the risks that being exposed to a certain substance might pose. ECHA’s hazard assessment complements EFSA’s risk assessment.
The two EU regulators have synchronised their work plans so as to carry out their assessments of glyphosate in parallel. This means risk managers will be able to take a decision on whether to renew the approval of the active substance based on the most comprehensive scientific information.
The two agencies have used the same draft assessment report produced by the AGG as the starting point for their assessments and carried out simultaneous public consultations. Interested parties were able to provide comments to EFSA and to ECHA separately.
More information on the renewal of approval and peer review process in the EU is available here.
Frequently asked questions
EFSA supports the EU Regulation on the approval of pesticides by assessing the risks that exposure to a certain substance might pose to humans, animals and the environment.
This is done through a peer review system, in which an initial assessment of an active substance is carried out by a Member State and then reviewed by EFSA. In the case of glyphosate, a renewal assessment report (RAR) has been prepared by four rapporteur Member States – France, Hungary, the Netherlands and Sweden, known as the Assessment Group on Glyphosate or AGG – to be peer-reviewed by EFSA and EU Member State authorities.
The outcome of the peer review will be shared with the European Commission to inform its decision on whether to renew the approval of the active substance.
In parallel with the EFSA-led assessment, ECHA – the EU authority responsible for the classification of chemicals – reviewed the classification of glyphosate under the Classification, Labelling and Packaging (CLP) Regulation. ECHA’s hazard assessment will be used by EFSA when drafting its conclusions.
Please see graphic above.
The draft RAR was published for public consultation on EFSA’s website, while EFSA’s final conclusions and all background documents will be published at the end of the peer review. These documents will include:
- A record of all comments provided by Member States, the Glyphosate Renewal Group (GRG), EFSA and members of the public on the RAR (comments from the public were published immediately after the public consultation closed.)
- A record of how the EU experts addressed the comments, including how the GRG and AGG reacted to the comments received
- Reports from all the expert consultations held with Member State scientists
- Comments received from Member States on the AGG assessment of any additional information submitted by the GRG
- Comments received from the AGG and Member States on EFSA’s draft conclusion
The peer review of pesticide active substances is conducted by EFSA staff and by experts employed by public authorities in Member States.
Experts from Member States may contribute to the process in a number of ways. They can: submit written comments on behalf of their Member State to the peer review of the draft assessment report; take part in expert consultations (meetings and teleconferences) organised by EFSA on different scientific areas (e.g. mammalian toxicology, ecotoxicology The study of the adverse impacts of substances, particularly chemicals, in relation to the environment and public health., etc.); and submit comments on EFSA’s draft conclusion.
The declarations of interests (DoIs) of these experts are checked by EFSA and made publicly available.
EFSA can also invite other external experts to take part in expert consultations, if deemed necessary. These experts are invited to contribute on the basis of their scientific expertise. They do not represent any Member State authority, and attend meetings in a personal capacity. External experts are required to submit a DoI that is assessed and validated in the same way that EFSA assesses DoIs for other external experts (e.g. those taking part in scientific panels or working group meetings).
Further information on EFSA’s Independence Policy is available here.
Under EU legislation, pesticide active substances in plant protection products (PPPs) are approved in the EU only if it may be expected that their use will not have any harmful effects on human and animal health or the environment.
For each substance, an initial draft assessment report (DAR) or renewal assessment report (RAR) is produced by a designated “rapporteur” Member State (RMS). In the case of glyphosate, four EU Member States – France, Hungary, the Netherlands and Sweden – are acting as joint rapporteurs.
The RMS’s risk assessment is peer reviewed by EFSA in cooperation with all Member States. EFSA drafts a report (“conclusion”) on the peer review of the risk assessment, which supports the European Commission in the approval process, the subsequent assessments of PPPs – carried out by Member States – and the setting of maximum residue levels in food.
It is up to the European Commission to decide whether to approve or renew an active substance. The role of EU Member States is to assess or reassess the safety of pesticides containing the active substances that are sold in their territory.