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

Coen Frederiks, Justus H.H. Wesseler

Research output: Contribution to journalArticleAcademicpeer-review

7 Citations (Scopus)

Abstract

Background: Microbial biological control agents (MBCA) are biopesticides based on living microbes. They have huge potential for the control of pests and diseases, but have trouble reaching the European Union (EU) market. According to several authors, this is caused by the regulatory regime, which is less supportive compared with that in the USA. The main objective of this paper is to present regulatory differences between the USA and the EU, and the resulting effects and developments of registration in both regions. Results: Results show that EU registration is more complex due to differences between EU- and Member State (MS)-level processes, large actor heterogeneity and low flexibility. As a result, EU registration takes, on average, ∼ 1.6 years longer than US registration. Regulatory amendments have improved EU-level processes and led to a significant contraction of procedural time spans, but processes at the MS level have not improved and have become a larger procedural obstacle. Conclusion: The results correspond with the idea that EU registration is complex and lengthy compared with that in the USA. To improve regulation, national-level processes should be targeted for amendment. To that end, the authors suggest various ways of expanding the registration capacity of MS.

LanguageEnglish
Pages87-103
JournalPest Management Science
Volume75
Issue number1
Early online date1 Jul 2018
DOIs
Publication statusPublished - Jan 2019

Fingerprint

European Union
biological control agents
biopesticides
pest control
disease control
markets
microorganisms

Keywords

  • (M)BCA
  • (microbial) biocontrol agents
  • biopesticides
  • EU
  • registration
  • regulation
  • USA

Cite this

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abstract = "Background: Microbial biological control agents (MBCA) are biopesticides based on living microbes. They have huge potential for the control of pests and diseases, but have trouble reaching the European Union (EU) market. According to several authors, this is caused by the regulatory regime, which is less supportive compared with that in the USA. The main objective of this paper is to present regulatory differences between the USA and the EU, and the resulting effects and developments of registration in both regions. Results: Results show that EU registration is more complex due to differences between EU- and Member State (MS)-level processes, large actor heterogeneity and low flexibility. As a result, EU registration takes, on average, ∼ 1.6 years longer than US registration. Regulatory amendments have improved EU-level processes and led to a significant contraction of procedural time spans, but processes at the MS level have not improved and have become a larger procedural obstacle. Conclusion: The results correspond with the idea that EU registration is complex and lengthy compared with that in the USA. To improve regulation, national-level processes should be targeted for amendment. To that end, the authors suggest various ways of expanding the registration capacity of MS.",
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A comparison of the EU and US regulatory frameworks for the active substance registration of microbial biological control agents. / Frederiks, Coen; Wesseler, Justus H.H.

In: Pest Management Science, Vol. 75, No. 1, 01.2019, p. 87-103.

Research output: Contribution to journalArticleAcademicpeer-review

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