The European regulatory system for plant protection products consists of two steps – first the active substance is approved at European level, then the plant protection products are authorised at Member State level. For approval of active substances, an allocated Rapporteur Member State (RMS) drafts the evaluation of the properties, and following peer review by all the other Member States and possible evaluation by the European Food Safety Authority (EFSA) a list of end-points is finalized which allows regulators and industry to conduct risk assessments using commonly agreed input parameters (the list of end-points). A work programme (the Annex I Renewal or ‘AIR’ programs) is in place to manage the renewal of the approvals at the end of the 10 year inclusion period. We are involved in a range of AIR projects on behalf of our clients.
Regulation (EC) No 1107/2009 is the legal framework in the EU setting out the rules, requirements, procedures and timeframes governing the placing of plant protection products on the market. The Regulation lays down the basis for common decision-making criteria (the Uniform Principles) which must be taken into consideration in the granting of product authorisations.
To reduce the workload on industry and regulators and harmonise work sharing practices between Member States, the Regulation allows Mutual Recognition (MR) of an authorization within three defined zones, North, Central and South. We prepare full Annex III zonal dRR dossiers, and MR applications within zones.