Key issues in the regulation of microbial bioprotectants in the European Union: challenges and solutions to achieve more sustainable crop protection

Microbial bioprotectants, like chemical pesticides, are required to pass a risk assessment and risk management procedure prior to use in plant protection, which in many countries is an obstacle for market access, in particular, the European Union. Administrative issues and data requirements, adapted from those used for chemicals, cause issues for both applicants and evaluators. These issues are reviewed and improvements are proposed. Biology should be the basis of the evaluation and data requirements for microorganisms, with an emphasis in this chapter on microbial compounds and testing methods. Political actions involving the use of pesticides are reviewed and recommendations are made on how to improve the system for microbial bioprotectants, including new uses. New legislation is suggested for all microorganisms used in agriculture and related uses based on the assumption that well-known microorganisms are of low risk to human health and the environment.