The regulatory obstacles to bio control agents from Directive (EC) No 128/2009

The EC Directive No 128/2009 (SUD) establishes a regulatory framework for Community action to achieve the sustainable use of pesticides (phyto-pharmaceuticals Regulation (EC) No 1107/2009) and promotes the use of Bio-Control Agents (BCA) for complementing, replacing or substituting for the use of chemical pesticides, although they do not have the same pattern of usages. To measure the effectiveness of this Directive (SUD), under renewal as a regulation (SUR), different indicators were set-up. Having previously qualified the evolution of BCA (entries and exits) approvals and their slow increase, we are now focusing on ways to promote BCAs more quickly. This is possible through the use of 120 days temporary or emergency authorizations under the plant protection products regulation, before approval of an active substance, if the uses are orphan. These emergency authorizations are also accounted for under the EC Directive No 128/2009 (SUD) as harmonised risk indicators (HRI) n°2. Indeed, these emergency authorizations targeted at Bio-Control Agents could be a way to accelerate their way to market. Not only are they not privileged choices by EU Member States but they remain clearly inferior to chemical ones in most cases; derogations for BCA in the last 3 years are only account for a maximum of 30% of the total amount of active substances! Thus, the SUD Directive, which was expected to promote and enhance BCA implementation is proving to be ineffective in its objective through rapid market accession by emergency authorizations.