Plant Protection – Global Efficacy

The regulatory basis for a “global efficacy approach” for registrations of plant protection products in EU is the “EPPO standard on Comparable climates on a global level”. This standard provides information on the comparability of climatic conditions between geographical areas on a global level. The standard links comparable global climatic areas with the four comparable climatic zones in the EPPO region with regards to plant protection products.

The standard is a valuable tool for research and development as well as registration projects in and outside the EU. Depending on the reliability and validity of the specific studies or study programs, global product performance and efficacy data may be used to reduce the total number of studies per product and lower the study costs considerably. Of course, this not only applies to registrations in EU, but also to other countries in which efficacy and product performance data are mandatory, such as California or New Zealand.

Especially for approval of new plant protection active substances, where often a full set of regulatory efficacy product studies is missing, global efficacy data may be used to fulfil the regulatory requirements.

In addition, global efficacy data may be used to support extrapolation possibilities e.g. for low risk products with regards to use extensions, by bridging from worst case conditions.

Similar possibilities exist for product performance and efficacy testing and evaluation of biostimulants and fertilisers, especially considering the new EU fertiliser Regulation.