Scope and Biopesticides
Over the last 5 years, there has been an increase in the number of ‘naturally derived’ pesticide active substances coming to the UK and EU markets (Damalas, Koutroubas, 2018). These substances can be broadly classified as being ‘of biological origin’, but the distinction of what is considered a biopesticide is not formalised within the EC 1107/2009. This means potential authorisation holders and investors, as well as regulatory authorities are faced with a difficult conundrum (Damalas, Koutroubas, 2020).
While these substances are not always strictly biological, as they are often refined from their source or produced in bioreactors, they tick many of the boxes of a (Balog et al, 2017). So how do we approach these substances in a way that represents a reasonable investment for businesses, but a proportional consideration of hazard and risk?
Specificity
The potential hazard of a compound/organisms to humans and the environment, and therefore the risk it poses can be attributed to the level of host/target specificity (Seidler et al. 2014). Generally speaking, any naturally derived compound that protects a crop against potential threats will have a level of specificity relating to potential threats to that organism or group of organisms (Seidler, et al. 2014).
This level of target-specificity can preclude activity against many groups of non-target organisms, as the compound may be successfully metabolised without causing harm to the organism (Butu, et al .2022). For the purposes of Ecotoxicological, and (to some extent) mammalian toxicological testing, this means the suite of studies required to support the regulatory process can be reduced based on robust evidence and preliminary testing.
Persistence
As ‘naturally derived’ compounds, the ability of these compounds to persist in the natural environment tends to be much reduced when compared to traditional synthetic chemistry (Hezakiel, et al. 2024). As biologically-derived molecules, naturally occurring metabolic processes in the soil microbial community and multicellular organisms are better able to break down these compounds or they may naturally degrade due to environmental factors such as moisture and temperature (Shi, et al. 2024).
Given these properties, a traditional suite of Environmental Fate and Behaviour studies used to derive DT50s and Koc values is not necessarily appropriate, and the outputs of modelling can be unreliable due to the quality of the underlying data (Fusar and Fontefrancesco, 2024). As such, it is important to ascertain the physicochemical properties of the substance at an early stage to inform the correct testing regime and prepare robust justification of where data requirements are waived (Helepciuc and Todor, 2022).
Scope
Currently a formal definition of biopesticides or naturally derived compounds does not currently exist, and substances assessed under EC 1107/2009 are considered to be either chemical or low risk (in addition to some more unusual niche cases). This essentially puts new innovations into 2 categories. However, generally biopesticides can be considered to fit into three main groups:
- Microbial agents
- Plant Extracts
- Pheremones
For the purposes of regulating these substances, these ‘classifications’ have been retrofitted into the existing regulatory system of either chemical or low risk categories. But, some naturally derived substances, that are not generally considered biopesticides (as as they are refined or synthesised) still do not necessarily fit into the ‘chemical’ or ‘low risk’ categories.
Applying data requirements based on these broad categories misses out any new innovations that fall in the gaps between categories. So fundamentally the definition of what is considered a biopesticide and what is considered a conventional or low risk pesticide is no longer fit for purpose. This is fundamental to the application of data requirements to new active substances, and therefore the proportional and cost-effective regulation of new technologies entering into the European market (IBMA, 2019).
References
Balog A, Hartel T, Loxdale HD, Wilson K. Differences in the progress of the biopesticide revolution between the EU and other major crop-growing regions. Pest Manag Sci. 2017;73:2203–08. https://doi.org/10.1002/ps.4596.
Butu, M., Rodino, S. and Butu, A., 2022. Biopesticide formulations-current challenges and future perspectives. In Biopesticides (pp. 19-29). Woodhead Publishing.
Damalas CA, Koutroubas SD. Botanical pesticides for eco-friendly pest management: drawbacks and limitations. In: Srivastava PK, Singh VP, Singh A, Tripathi DK, Singh S, Prasad SM, Chauhan DK, editors. Pesticides in crop production. Wiley; 2020. p. 181–93. https://doi.org/10.1002/9781119432241.ch10.
Damalas C, Koutroubas S. Current status and recent developments in biopesticide use. Agriculture. 2018;8:13. https://doi.org/10.3390/agriculture8010013.
Fusar Poli, E. and Fontefrancesco, M.F., 2024. Trends in the implementation of biopesticides in the Euro-Mediterranean region: A narrative literary review. Sustainable Earth Reviews, 7(1), p.14.
Helepciuc, F.E. and Todor, A., 2022. EU microbial pest control: A revolution in waiting. Pest Management Science, 78(4), pp.1314-1325.
Hezakiel, H.E., Thampi, M., Rebello, S. and Sheikhmoideen, J.M., 2024. Biopesticides: a green approach towards agricultural pests. Applied biochemistry and biotechnology, 196(8), pp.5533-5562.
IBMA Global (International Biocontrol Manufacturers Association). IBMA White Paper: visión de Mejora En El Marco Regulatorio de la Bioprotección. Phytoma España; 2019. p. 310.
Seiber, J.N., Coats, J., Duke, S.O. and Gross, A.D., 2014. Biopesticides: state of the art and future opportunities. Journal of agricultural and food chemistry, 62(48), pp.11613-11619.
Shi, Y., An, X., Zhang, B., Pan, X., Wu, X., Xu, J., Xiang, W., Dong, F., Wang, X. and Zheng, Y., 2022. Hydrolysis, photolysis, and biotoxicity assessment of a novel biopesticide, guvermectin. Journal of Agricultural and Food Chemistry, 70(51), pp.16117-16125.