Risk assessment of new low risk pesticides

Concerns are mounting over the effects of pesticides on the environment, non-target organisms and human health. Member States and EU policies seek to reduce the reliance on chemical pesticides for crop protection through the design and implementation of approaches that are more integrated and include restrictions on the use of several active substances. To ensure the lowest risk to human health and the environment, the development of so-called low-risk substances[[Low-risk active substances for plant protection are defined according to criteria outlined in Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. They are subject to specific provisions for their approval and the authorisation of low-risk plant protection products containing them outlined in this Regulation and its implementing Regulations.]] is encouraged by several regulatory incentives in the EU. However, the changing nature of low-risk plant protection products requires increased capacities in risk assessment. The plant protection products approval and authorization process has to keep pace with scientific and technological developments aiming to advance assessment methods of new low-risk plant protection products.

New products may seek EU market regulatory approval, thus proposals should need to consider and address relevant EU regulatory requirements as well as relevant guidance documents that are to be followed for the specific hazard characterisation and exposure assessment to achieve an appropriate risk assessment.

Proposals should contribute to:

• improve the risk assessment of newly proposed or specifically adapted low-risk pesticides such as new species/strains of microorganisms, ds-RNA-based pesticides, pheromones, plant extracts, and/or microbiome solutions or a new mode of application with the use of relevant methods;
• develop and advance the integration of different tools, technologies and methodologies to support the comprehensive and consistent risk assessments of new low-risk pesticides to ensure safety and sustainability;
• contribute to understanding the biological effects of these new substances and/or products;
• assess the impacts and risks of these new substances and/or products;
• assess and improve the level of certainty in risk assessments of new low-risk pesticides;
• identify the relevant additional studies required for assessing these new low-risk pesticides in order to establish that they have a hazard profile compatible with their classification as low-risk substances and plant protection products;
• contribute to the standardisation and validation of the developed tools, technologies and methods for risk assessments.