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A comparison of the EU and US regulatory frameworks for the active substance registration of microbial biological

Coen Frederiks1, Justus Hh Wesseler2

  • 1Department of Social Sciences, Wageningen University, Brussels, Belgium.

Pest Management Science
|July 3, 2018
PubMed
Abstract

Insights

European Union (EU) biopesticide registration is significantly longer than in the USA due to complex national-level processes. Improving Member State (MS) registration capacity is crucial for market access.

Area of Science:

  • Agricultural Science
  • Regulatory Affairs
  • Microbial Biological Control Agents (MBCA)

Background:

  • Microbial biological control agents (MBCA) are potent biopesticides with significant potential for pest and disease management.
  • Market access for MBCA in the European Union (EU) is hindered by regulatory challenges compared to the United States (USA).
  • Existing literature suggests the EU's regulatory regime is less supportive for biopesticide registration than the USA's.

Purpose of the Study:

  • To delineate the key regulatory differences between the USA and the EU for MBCA registration.
  • To analyze the impact of these regulatory disparities on the registration process and market entry.
  • To examine the evolution of MBCA registration procedures in both geopolitical regions.

Main Methods:

  • Comparative analysis of regulatory frameworks and registration processes in the EU and USA.
  • Evaluation of procedural timelines and obstacles encountered during MBCA registration.
  • Assessment of the effects of regulatory amendments on registration efficiency.

Main Results:

  • EU registration is more complex, involving both EU- and Member State (MS)-level processes, leading to an average delay of approximately 1.6 years compared to US registration.
  • While EU-level regulatory amendments have shortened procedural times, MS-level processes remain a significant bottleneck and have not improved.
  • Actor heterogeneity and low flexibility characterize the EU registration landscape, contributing to its complexity.

Conclusions:

  • The findings confirm that EU MBCA registration is substantially more complex and time-consuming than in the USA.
  • Targeting national-level (MS) processes for regulatory improvement is essential to streamline MBCA registration in the EU.
  • Expanding the registration capacity of individual Member States is recommended to facilitate market access for biopesticides.
Keywords:
(M)BCA(microbial) biocontrol agentsEUUSAbiopesticidesregistrationregulation

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