Biocontrol products: regulatory context
BIOPESTICIDES and BIOCONTROL: an adapted approach
Biopesticides are naturally-derived pesticides. These products contain botanical substances, which may actually be complex extracts, mineral or animal-derived substances, semiochemicals such as pheromones or kairomones, and finally viable or non-viable micro-organisms, such as bacteria, filamentous fungi, yeasts or even viruses.
They may be used as insecticides, fungicides, herbicides, nematicides, plant growth regulators, or even as elicitors.
Biopesticides are ruled at European level by Regulation (EC) 1107/2009. This regulation stipulates the approval of the active substances, followed by authorisation of the products in every Member State, in a zonal system.
The requirements for semiochemicals and naturally-derived substances (plant, animal or mineral) are the same as for chemicals. However, given their natural characteristics and the specific terms due to their nature and mode of action, specific guidance documents apply to these substances.
Micro-organisms have the ability to replicate or transfer genetic material. They must meet particular requirements. Specific guidance documents apply to these products, and the dossiers are put together differently for these “living” products.
Biocontrol is a set of regulatory measures adopted in France, in order to promote naturally derived products.
This regulation is applicable to phytopharmaceutical products whose active substance is naturally derived, as well as to macro-organisms. Admission to this product category involves certain conditions as regards safety.
Similarly, each MS may have to implement specific measures in order to develop biopesticides.
Given the particularities of biopesticides, their study protocols and regulatory strategy must be tailored.