Why has the authorization of microbial biological control agents been slower in the EU than in comparable jurisdictions?

The aim of this study was to identify reasons why the authorization of microbial pest control agents is lengthier under regulatory frameworks of the European Union (EU) than in comparable jurisdictions. A main conclusion is that although the EU's regulatory processes have strong scientific foundations, the most appropriate scientific concepts, knowledge and expertise have not been applied in the safety assessment of microorganisms and biological control. Tradition and conceptual legacies from assessments of conventional chemical pesticides have likely contributed to this by steering the evaluations of microorganisms in less appropriate directions. According to our investigation, the current framework for microbial plant protection products complies poorly with the principles that legislation should have legal predictability, proportionality, and that it should be non-discriminative, for instance in comparison to corresponding regulations in comparable jurisdictions. We also found that existing possibilities to take non-safety and ethical considerations into account can probably be used more. To rationalize the EU's authorization of microbial control products, both the basic legislation and the evaluations of agents and products need stronger rooting in fundamental microbiological science. © 2020 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

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© 2020 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.