Regulatory Guidance

Guidance in a Nutshell: Efficacy and Product Performance

Safety evaluation of plant protection products in the European Union includes the evaluation of product effectiveness, phytotoxicity effects or adverse effects on food processing. Due to the variable climatic and agricultural conditions in the European Member States, efficacy evaluation requires special attention in the registration process of plant protection active substances and products. Some of these topics to be observed are highlighted in the following:

» Efficacy for Plant Protection: Active Substances

» Plant Protection: EPPO Zones

» Plant Protection: 3-Dimentional Crops and Leaf Wall Area

» Plant Protection: Low Risk Products

» Plant Protection: Product re-authorisations (Article 43)

» Precision and Digital Farming, Forecast Models and Decision Support Systems (DSS)

» Plant Protection: Integrated Pest Management (IPM)

» Plant Protection: Resistance

» Global Efficacy

» Biological Assessment Dossier (BAD)

» Efficacy Data Evaluation Tools

» Candidate for Substitution (CfS) and Comparative Assessment

» Plant Protection. Fast Track Approval for Products with New Active Subtance under Article 37(3)

» Plant Protection: Good Agriculture Practice – GAP = Use

» Good Experimental Practice (GEP)

» Minor and Major Uses in Efficacy Context

» Intergrated Production (IP) / Integrated Farming (IF)

» Efficacy Requirements for Fertilising Products Including Plant Biostimulants