Bt Research 2024, Vol.15, No.1, 10-19 http://microbescipublisher.com/index.php/bt 12 Environmental Protection Agency (EPA), is considered more supportive and efficient, facilitating quicker market access for biopesticides. India, another major player in the biopesticide market, has its regulatory framework overseen by the Central Insecticides Board and Registration Committee (CIBRC), which has registered numerous microbial formulations despite facing challenges related to quality control and large-scale production. 3.3 Comparative analysis of regulations A comparative analysis of biopesticide regulations reveals significant disparities between regions, impacting the development and commercialization of these products. The EU's regulatory framework is often criticized for its complexity and the lengthy approval process, which can take approximately 1.6 years longer than in the US (Figure 1) (Frederiks and Wesseler, 2018). This complexity is attributed to the dual-level processes involving both EU and Member State (MS) regulations, leading to procedural bottlenecks at the national level. The regulatory framework for the registration of Microbial Biocontrol Agents (MBCA) in the EU is mainly divided into three stages: RMS stage, risk assessment stage and risk management stage, each stage has specific processes and requirements. The whole process is designed to ensure the safety and effectiveness of MBCA, and to safeguard public health and environmental safety through strict evaluation and management mechanisms. Through this comprehensive regulatory framework, the EU ensures that the application of MBCA in agriculture meets the highest standards, thereby promoting sustainable agricultural development. In contrast, the US regulatory system is more streamlined, allowing for faster approval and market entry (Balog et al., 2017; Frederiks and Wesseler, 2018). Moreover, the regulatory environment in the EU has resulted in fewer biopesticide-active substances being registered compared to the US, India, Brazil, and China. This discrepancy is partly due to the EU's stringent regulatory criteria, which can deter manufacturers from pursuing biopesticide registration (Sansinenea, 2016). On the other hand, countries like India have made significant strides in biopesticide registration, with a growing number of microbial formulations being approved despite regulatory and quality control challenges (Kumar et al., 2019). While international bodies like the IOBC, EPPO, and OECD strive to harmonize biopesticide regulations, national policies vary widely, affecting the global biopesticide market. The EU's stringent and complex regulatory framework contrasts with the more supportive and efficient systems in the US and other countries, highlighting the need for regulatory innovation and harmonization to promote the broader adoption of biopesticides. Figure 1 Regulatory framework for MBCA registration in the EU (Adopted from Frederiks and Wesseler, 2018)
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