Supporting label efficacy claims under EU regulations
Dr Barry Brogan of Enviresearch discusses the importance of efficacy studies in meeting data requirements under EU plant protection product regulations
To place a plant protection product on the EU market, companies must comply with the requirements of Regulation( EC) No. 1107 / 2009, referred to as the Plant Protection Products Regulation( PPPR). This regulatory framework is designed to ensure the protection of human and animal health and the environment. These goals are widely recognised across industry and the general public, with high profile media coverage.
However, the regulations are also clear that products entering the EU market must demonstrate sufficient efficacy. A plant protection product must not only be safe, it must also work as described on the product label, controlling the target pests, be they weeds, insects, fungal disease or other organisms harmful to the crop.
Demonstrating product efficacy requires extensive planning and investment, often more than companies expect. This article outlines what is required to support efficacy claims for a successful product registration under the PPPR.
Efficacy data requirements associated with the PPPR are listed in a separate Regulation,( EU) No. 284 / 2013. According to these requirements applicants must show that the product controls the target pests while providing meaningful benefits to the crop, such as improved quality and yield.
It must also be demonstrated that use of the product does not result in harmful effects on the crop, neighbouring crops and crops sown in the following season. Consideration of resistance risk is also expected.
In regulatory terms, efficacy is therefore not simply about the control of a pest or disease, but rather a balanced profile of positive and negative effects under realworld agricultural conditions. For example, a product that controls the target well but consistently harms the crop or is otherwise assessed to have deleterious effects on non-target organisms will not meet this requirement.
EPPO guidance
Regulation 284 / 2013 provides what could best be described as a summary of efficacy data requirements, using broad strokes. It states, for example, that data supplied shall be‘ sufficient’ to permit an evaluation of‘ product performance’ but no thresholds for performance are included. Instead, the Regulation repeatedly points to the guidance of the European & Mediterranean Plant Protection Organization( EPPO).
EPPO coordinates a harmonised approach to plant health across Europe. Over decades, it has developed a comprehensive suite of guidance documents describing how efficacy trials should be designed, conducted and interpreted. These include general standards on trial
EPPO zones EU North zone EU Central zone EU South zone Other EPPO countries Not EPPO countries
Figure 1 – EPPO climactic zones & EU registration zones
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