Resistance risk evaluation, “a European regulatory perspective”

The European Union directive 91/414 on the inclusion of new and existing active substances requires an assessment of the potential risk of resistance being developed by target organisms and for management strategies to be introduced to address such risks. The European and Mediterranean Plant Protection Organisation (EPPO) worked with regulatory authorities and industry's Global Crop Protection Federation's (GCPF) Resistance Action Committees to develop a guideline that would satisfy these requirements. The new resistance risk analysis guideline was published in April 2000. Implementation of this guideline will force significant changes in the way crop protection products are developed. Applicants for registration of crop protection products will need to evaluate resistance risk and develop acceptable use patterns early in the development process. Registration applications for uses that are associated with an unacceptable resistance risk may be refused. In such cases, restriction or modification of supported use patterns to achieve acceptable levels of resistance risk, could result in use patterns which are no longer consistent with other elements of the registration dossier. It is therefore essential that resistance risk is evaluated early in development so that registration dossiers may be developed with this criteria in mind.