Authorisation Process

On 12 December 2017, the Commission renewed the EU approval of glyphosate for 5 years, following a favourable vote by a qualified majority of Member States. This means that glyphosate was approved for use in the EU as an active substance in Plant Protection Products (PPPs) until 15 December 2022. In December 2022, the Commission adopted an Implementing Regulation, extending the approval of Glyphosate until 15 Dec 2023 to allow the European Food Safety Authority (EFSA) sufficient time to conclude its peer review.

Each plant protection product needs to be authorised by the competent authorities within EU countries following an evaluation of their safety. Plant protection products are also called pesticides.

According to EU law, the approval of all active substances must be periodically reviewed; normally one EU Member State (so-called Rapporteur) is in charge of the scientific assessment of the active substance. This assessment is then validated by the competent authorities of all the other EU Member States, while this entire process is overseen by EFSA. A full description of the EU process for approval of active substances and authorisation of plant protection products can be found here.

In the case of glyphosate, because of the very large number of scientific studies to evaluate and the related high workload, Member States agreed that a group of them would act jointly as Rapporteur: France, Hungary, the Netherlands and Sweden. Those four countries form the so-called Assessment Group on Glyphosate (AGG), set up in April 2019.

In accordance with EU rules, three years before expiry of the approval (i.e. by 15 December 2019), companies wishing to maintain the approval of glyphosate have to submit to the European Commission an application for renewal. Subsequently, on 8 June 2020, a dossier comprising hundreds of studies and evaluations of thousands of scientific articles on glyphosate, its safety and its use was submitted to the evaluating Member States (AGG) and the European Food Safety Authority (EFSA). After checking that the dossier is complete, the competent national authorities of the AGG Member States will assess the studies and scientific articles that form the dossier and will prepare a draft Report on the Assessment of the Renewal (RAR). Considering the timeline provided by EU rules, in the case of glyphosate the RAR should be ready in July 2021. At this point, a period of public consultation is opened: anyone has the opportunity to comment on the content of the RAR online.

The Report is then sent to EFSA and the other EU Member States for peer-review. At the end of this exercise, EFSA publishes its Conclusions on the safety of glyphosate and sends those to the European Commission’s Directorate General for Health and Food Safety.

Building upon EFSA’s scientific conclusions, the European Commission drafts a legislative proposal for the renewal or non-renewal of the approval of glyphosate. This legislative proposal is discussed in a Committee chaired by the European Commission where experts from all the EU Member States participate. Those experts finally vote if glyphosate should be re-approved in the EU. A positive vote requires a qualified majority of Member States voting in favour of the active substance glyphosate. Information on the requirements for approval can also be found here.

Only after the successful renewal of approval of an active substance, the products containing this active substance can be (re-)authorised in each Member State for their intended uses.