Glyphosate is an active substance that is widely used in pesticides. Glyphosate-based pesticides – i.e. formulations containing glyphosate and other chemicals – are used in agriculture and horticulture primarily to combat weeds that compete with cultivated crops. They are typically applied before crops are sown and as a pre-harvest desiccating treatment, accelerating and evening the ripening process.
In March 2019 the European Commission announced a plan to set up a group of Member States to act as co-rapporteurs for the next assessment of glyphosate. If the plan is approved, the Assessment Group on Glyphosate (AGG) will assess the application dossier and prepare a draft renewal assessment report to be reviewed by EFSA in 2021. The AGG will comprise France, Hungary, the Netherlands and Sweden.
The current approval of glyphosate expires on 15 December 2022, so the process for renewal must begin in December 2019, i.e. three years before the expiry date.
In September 2017, articles appeared in a number of European press outlets casting doubt on the integrity of the EU assessment of glyphosate, in particular the content of the assessment report submitted to EFSA by the German Federal Institute for Risk Assessment (BfR). EFSA responded with a statement in which it defended the robustness of the EU assessment and pointed out that the allegations were based on a misunderstanding of the peer review process.
On July 6 2017, upon request from the European Commission, EFSA and the European Chemicals Agency (ECHA) replied to a letter from Professor Christopher Portier to President Juncker regarding their evaluation of the carcinogenicity of glyphosate.
On June 8 2017 EFSA published a statement concerning the EU assessment of glyphosate following allegations made in the so-called “Monsanto papers”. The statement, which was requested by the European Commission, outlines the EU legislative framework concerning the submission of open scientific literature for the assessment of active substances and explains how such literature is considered by EU Member States and EFSA experts during the peer-review process.
It followed a previous statement published in May 2017 that brought together many of the public comments the Authority has made to help inform the debate on glyphosate and to ensure that the EU assessment of glyphosate is well understood.
Since 2003, EFSA has been responsible for the EU peer review of active substances used in plant protection products. This task is carried out by EFSA’s Pesticides Unit following procedures set out in the legislation and the latest scientific standards and methods. EFSA conducts its work in close collaboration with scientific experts from the Member States.
In general, active substances are evaluated through a phased approach:
- An application for approval of an active substance is submitted by the producer of the active substance to a designated rapporteur Member State (RMS), together with a dossier.
- For each substance an initial assessment report is produced by the RMS carrying out the first risk assessment.
List of available rapporteur Member State assessment Reports (published before 22 September 2014)
- The RMS’s risk assessment is peer reviewed by EFSA in cooperation with all Member States.
- EFSA drafts a conclusion on the active substance.
- The European Commission takes a legislative decision whether or not to include the substance in the Union’s list of approved active substances.
EFSA is also responsible for the EU peer review of applications for renewal of the approval of active substances. Active substances are generally approved for a period of 10 years, after which it is possible for an applicant to apply for renewal. The application is submitted to an RMS, which provides its initial evaluation in a renewal assessment report (RAR). EFSA then carries out a peer review of the RAR in collaboration with Member States.
Furthermore, EFSA provides scientific assistance for the evaluation of applications concerning “basic substances”. Basic substances are, broadly speaking, active substances that are not predominantly used as plant protection products but which may be of value for plant protection. Criteria for their approval are laid down in the framework Regulation.
Finally, EFSA gives its scientific view on confirmatory data. An approval may be made subject to the submission of further confirmatory information, where new requirements have been established during the evaluation or as a result of new scientific and technical knowledge.
The outcome of the peer review and/or other consultation processes is presented in EFSA’s conclusions and technical reports.