Regulation According to EU Directive 91/414: Data Requirements and Procedure Compared with Regulation Practice in Other OECD Countries

Summary

The data requirements and the administrative procedure needed for the registration of biological plant protection products and their active ingredients (micro-organisms including viruses, plant extracts, and semiochemicals) are described for the European Union, the USA, Canada und Australia and compared between these systems. Experiences from registration procedures are compared. While data requirements and formalities are rather similar in all systems considered, the time span needed for evaluation and the possibility to predict this time span are quite different. Alternative regulatory measures existing in different regulatory systems are described and initiatives for the facilitation are presented.