Isabelle Rety-Guitton, EU Regulatory Manager, SynTech Research France
2011 sees implementation of the new legislation for the Plant Protection Products (PPP) (Authorization) – Regulation (EC1107/2009) – which will apply from 14 June. Some clarity on the resulting new procedures is beginning to emerge, including aspects of the new Zonal System and Efficacy Data requirements for formulated products (Section 7), In summary, the key points of this Section are:
- National aspects are to be kept to a minimum: The aim is to include as much information in core/zonal dossiers, rather than as national addenda: there will be recognition of data according to EPPO zones across regions and acceptance of data from other regions/sources, as long as relevant scientific justification is provided in the data package. If a Zonal Rapporteur Member State (ZRMS) has to evaluate efficacy for uses outside their normal area of expertise specialists in other Member States can be called on for advice.
- Official methods and standards: Data generated according to EPPO guidelines will be accepted, so the ZRMS should only need to determine compliance of the studies with EPPO standards. Specific country test methods, e.g. the French CEB, will only apply to trials conducted in that Member State -such as the inclusion of specific commercial standards.
- Numbers of trials: In theory, a maximum three Biological Assessment Dossiers (BADs) are needed (one per zone) for a formulated product, as it will not be necessary for applicants to submit any National BADs. The guidance documents which will arise from the continuing work on harmonization of data requirements will probably provide us with more information of the needs – but not necessarily precise number of trials needed to address the different situations.
But we believe that the option for Member States to require National Addenda, and the continued need for territorial data for country technical support and marketing, will still mean that high quality efficacy trials will still be needed in all EU territories where it is intended to market the product.