The approval of active substances used in plant protection products is limited in time, the periodic re-evaluation of these substances being required by Regulation (EC) No 1107/2009. As a reminder, this process starts with the submission by the applicant of a renewal application, followed by a complete dossier including scientific and technical data. These data are subject to a scientific evaluation by one or more rapporteur Member State(s). In the case of glyphosate, the Assessment Group on Glyphosate (AGG) comprises national competent authorities of Hungary, France, the Netherlands and Sweden. This draft assessment is then open for public consultation and a peer-review process handled by EFSA (European Food Safety Authority) is organized.
Glyphosate is one of the most widely used active substances in pesticides, leading to a high level of interest. Its renewal application has begun on 15th December 2019, 3 years before the approval expiry date on next 15th December. The number of submissions received during the public consultations, completed on 22nd November 2021 and jointly conducted by EFSA and ECHA (European Chemicals Agency) was true to its reputation with over 400 submissions received. In addition, EFSA received more than 2000 comments from Member State experts and the applicant group for the glyphosate renewal. In this context, the timeline for the remaining steps in the re-evaluation process has been revised by EFSA and ECHA.
EFSA and ECHA have complementary roles in the assessment of active substances used in plant protection products. ECHA's role is to evaluate the hazards of these substances, in particular carcinogenicity, genotoxicity, reproductive and developmental toxicity, and environmental classification. EFSA, on the other hand, evaluates the possible risks related to the exposure to these substances for humans, animals and the environment. Within the scope of the glyphosate renewal, these two EU regulators have synchronized their assessment. The AGG proposal for harmonized classification and labeling will be submitted for discussion and adoption by ECHA's Risk Assessment Committee (RAC) during its plenary meeting on 30-31 May. RAC’s opinion will be made available to EFSA, which will take it into account during the peer review of the AGG's updated draft renewal assessment report on glyphosate. Ultimately, the conclusions of this assessment should be available to the European Commission, Member States and the AGG in July 2023.