March 4, 2015
Dr. Matthias Weidenauer, Battelle
The registration of bio-pesticides in Europe is burdened by a regulatory framework that had originally been designed for chemical active substances. Unlike the position in the US, the EU has no separate legal provisions for “non-chemical” plant protection products. The result is a set of data requirements that is partly inappropriate or difficult to interpret for bio-pesticide active substances such as micro-organisms. In addition there is a lack of EU and OECD test guidelines for the conduction of toxicological and eco-toxicological studies with micro-organisms. Specific guidance documents from the European Commission are scarce, with several of them being published only as recently as December 2014. Whilst having ostensibly similar formal data requirements to the US, the data required to achieve authorization of the same strain in the EU tend to be more extensive which leads to significantly higher investment costs. Higher costs combined with a slower approval system, the EU presents a significant hurdle for bio-pesticides entering the market. Some of the specific requirements, issues and endeavours to improve and harmonize the global registration system for bio-pesticides will be discussed.