Plant Protection: Low Risk Products

Registration of low risk active substances and products is encouraged by regulatory authorities. Applicants receive benefits, such as extended approval periods and data protection, and lower authority fees (depending on Member State). Moreover, the evaluation time for low-risk plant protection products is 120 days, which is shorter compared to conventional plant protection products. In regards to financial investments and the value chain of a product, the efficacy data requirements for low risk plant protection products are very important, as costs for the efficacy data package could be significantly reduced.

The data/study requirements for low-risk product authorisations are described by EPPO standard PP1/296(1) on the “Principles of efficacy evaluation for low-risk plant protection products” dated 2017. This standard describes the framework for the minimum data requirements for demonstration of efficacy and crop safety for low-risk products. The standard uses a scientific approach to determine variations for study conduct, testing strategy, trial program, description and evaluation of results by authorities between low- and non-low-risk products. An approach based on the special characteristics of the individual low-risk active substance, for example with regards to its specific Mode of Action (MoA).

For the implementation of this scientific approach, certain principles need to be taken into account, such as the general requirement for scientific justifications of claims, the flexibility of the efficacy evaluation with regards to level of effectiveness, the use of lab trials and relevant published data as “important and valid source of information”, the acceptability of non-GEP data if scientifically sound or other possible benefits of low-risk products, for example resistance management or suitability for IP and IPM, or special cultivation systems such as organic farming.

EPPO standard PP1/296(1) sets a minimum number of fully supportive direct efficacy trials required for an area of similar conditions as 6 for a major pest on a major field crop, 4 for a major pest under protected conditions and 3 for other uses. At first glance this is similar to the minimum requirements for conventional plant protection products. However, the numbers of efficacy trials given in the standard do not only apply to a single pest or crop, but to pest and crop groups. The standard explicitly refers to existing extrapolation possibilities for minor uses and the use of these for major uses, in contrast to non-low risk products. Furthermore, an extrapolation from worst-case circumstances to intermediate or less-critical conditions is considered feasible by the standard. This also applies to the possibility to extrapolate between agro-climatic zones (including global scale), as comparable conditions do not depend on climatic factors only, but also on conditions such as, edaphic and agronomic factors, crop biology, pest/crop interrelationships, soil conditions, and application and cultivation techniques.

Full implementation of the possibilities and benefits of the EPPO standard PP1/296(1) in the registration strategy for a low-risk product requires applicants to use a completely different (new) approach to efficacy testing and dossier preparation. In addition, the standard requires in-depth knowledge not only with regards to their individual low-risk active substance and product, but also with regards to crop biology and physiology, environmental and agricultural conditions, and application and cultivation techniques such as IP and IPM.

EPPO standard PP1/296(1) represents a valuable incentive for plant protection product authorisation applications, fostering the availability of low-risk plant protection products on the market. This may, in the future, even include possibilities to fully exploit the potential of low-risk active substances including their use against abiotic stresses, or in the scope of IPM programs.