From terminology to approval: reviewing EU regulation of low-risk pesticides

The European Commission’s recent “Vision for Agriculture and Food” aims to accelerate market access to Low-Risk Pesticides, yet the introduction of these products remains slower than warranted. This study consolidates and reviews the fragmented knowledge concerning the current status of Low-Risk Pesticides in the EU market, including their applications, regulatory constraints, stakeholder expectations, and market dynamics, to support the development of a more coherent and effective risk assessment framework at the EU level. A detailed analysis of the current data requirements, regulatory documents, guidance documents, and manuals necessary to complete the risk assessment, in accordance with the framework outlined in Reg. 1107/2009, is provided. A comparison of the EU and US regulatory frameworks for pLRPs highlights potential regulatory barriers, e.g., the absence of formally adopted data requirements for several pLRP categories (botanicals, semiochemicals, and dsRNA), and substantially longer approval timelines relative to the US. We further investigated (i) how regulatory guidance can support National Authorities in interpreting the data requirements for risk assessment, and (ii) whether National Authorities have sufficient resources to assess potential Low-Risk Pesticides. To this end, an inventory of these documents and requirements was compiled and grouped by legal status and product category (microorganisms, botanicals, pheromones/semiochemicals, and dsRNA). In parallel, 19 EU Member States were surveyed regarding their expertise, resources, timelines, and fee structures. Results show wide disparities in National Authorities’ expertise, dedicated expert groups, and application fees. Respondents highlighted the importance of harmonizing waiver criteria, developing fast-track procedures, and improving guidance for specific low-risk pesticide categories as key opportunities. The current EU regulatory framework for Plant Protection Products, while ensuring high safety standards, presents notable hurdles for the assessment and authorisation of Low-Risk Pesticides. To improve the efficiency-and ultimately the speed-of approving and introducing potential Low-Risk Pesticides into the EU market, while maintaining the adequacy, safety, and rigour of the risk assessment process, regulatory adjustments are required. These include the establishment of dedicated expert teams within National Authorities, harmonized guidance on waiving data requirements, and the adoption of novel assessment tools. These findings suggest concrete steps for enhancing the EU’s regulatory framework to accelerate potential Low-Risk Pesticides authorization while safeguarding health and environmental standards.