Application, environmental risk assessment and regulation of GM microbial biocontrol agents in the EU

Abstract: A desk study was performed to study developments, regulation and risk assessment of genetically modified microbial biocontrol agents (GM mBCAs) applied in agriculture as a plant protection product. It was concluded that existing risk assessment methodologies under EU regulation adequately cover potential risks of agricultural applications of GM mBCAs for food, feed, human health and the environment. Only cases where the GM mBCA or its newly produced metabolites are capable of changing the composition of the food/feed product, are not taken into account in the current risk assessment approach. It is suggested to include this aspect in the risk assessment of GM mBCAs on a case-by-case basis.