Currently, there is a high number of bio-protection technologies that provide effective and innovative phyto-protection in agriculture, making them essential tools to which the Directive 128/2009/EC on the sustainable use of phytosanitary products, may be implemented. However, there is no specialized regulatory framework in the EU. Therefore, biopesticides are regulated as phytosanitary products under EU Regulation 1107/2009.
The registration process has two stages, first, the phytosanitary product’s active ingredient (active substance) must be approved of by the European Union, following what is stipulated in the EU regulation 283/2013. A complete dossier will be presented: identity, physicochemical properties, analytical methods, toxicology, residues, environmental studies, and ecotoxicology.
Once the active substance is registered, the corresponding formulated product may be registered. The information requirements are identity, physicochemical properties, analytical methods, efficacy, toxicology, residues, destination, environmental studies, and ecotoxicology.