Data decision tree for identifying potential risks for natural substances when used in plant protection

ABSTRACT Biocontrol, including Natural Substances can offer a balanced solution for problems caused by the widespread use of conventional chemical pesticides. Potential harmful side-effects of many conventional chemical pesticides are becoming increasingly clear, in terms of the potential for effects on non-target organisms, environmental pollution, worker safety and pest resistance. Concurrently, there is awareness that modern agriculture needs to grow crops even more sustainably. To maintain human and environmental safety, biocontrol substances used in plant protection including Natural Substances, are regulated mainly following the same regulatory system as for conventional chemical pesticides. However, this approach can pose an unnecessarily high and inappropriate regulatory burden because many data requirements and evaluation criteria are not relevant, appropriate or technically feasible. It is essential that registration of Natural Substances, which are biocontrol products made from natural sources, should focus on relevant potential risk areas. In this paper, a tiered approach was used to indicate potential risk areas and a progressive ‘Data Decision Tree’ and risk-based flow chart was developed. Considering relevant risk factors for Natural Substances, a branched Data Decision Tree has been developed that considers: Identification, characterisation and analysis, Effects on human health, Residues, Environmental fate and behaviour, Effects on non-target organisms. Such a scientific risk-based decision tree approach can streamline the development of data for the dossier and the evaluation. This will accelerate the placing on the market of Natural Substances, which is so important for the transition to agroecological approaches to farming that deliver more resilient cropping systems.