
Revised EU Data Rules Set to Reshape Active Substance Approvals for Plant Protection Products
The EU is updating data requirements for active substances in plant protection products, raising safety standards and regulatory expectations.


The European Commission has officially renewed the approval of glyphosate, a widely used active substance in plant protection products, through the Commission Implementing Regulation (EU) 2023/2660, dated 28 November 2023. This decision follows extensive evaluation and public consultation, ensuring compliance with Regulation (EC) No 1107/2009, which governs the market placement of plant protection products.
Previously, the approval of glyphosate was extended until 15 December 2022, under Regulation (EU) 2017/2324. The Glyphosate Renewal Group, representing the applicants, sought renewal in December 2019. The Assessment Group on Glyphosate (AGG), comprising experts from France, Hungary, the Netherlands, and Sweden, conducted the renewal assessment.
After submitting the required dossiers and undergoing a rigorous evaluation process, including public consultation and review by the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA), glyphosate's approval was extended. The EFSA concluded that glyphosate, based on current scientific data, does not meet the criteria for classification as carcinogenic, mutagenic, or toxic for reproduction.
The European Commission's renewal of the approval for glyphosate under Commission Implementing Regulation (EU) 2023/2660 comes with several specific conditions and restrictions to ensure human health and environmental safety. Several key conditions include:
The regulation emphasises the need for Member States to monitor the use of glyphosate in various conditions, including its use on non-agricultural applications, to minimise potential environmental and health risks. Special attention is required for non-professional uses, pre-harvest applications, and the protection of sensitive areas like public parks and playgrounds.
The renewed approval period for glyphosate is set for ten years, reflecting the comprehensive assessments conducted since 2012, which have not identified concerns failing the approval criteria of Regulation (EC) No 1107/2009. However, the Commission remains open to reviewing the approval based on new scientific findings related to glyphosate's impact on health and the environment.
This renewal demonstrates the European Union's commitment to safeguarding public health and environmental integrity while considering the agricultural and economic implications of glyphosate use. The regulation enters into force three days post-publication in the Official Journal of the European Union and will apply from 16 December 2023.
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