Minor Uses Developments in the European Union Global Minor Uses Summit 1-4 October 2017, Montreal, Canada Jeroen Meeussen – EU Minor Uses Coordination Facility Co-funded by the European Union

Content EU Regulatory Framework Regulatory hurdles

EU Pesticide Legislation Impact on minor uses PLACING ON THE MARKET RESIDUES IN FOOD/FEED Regulation 1107/2009 Regulation 396/2005

Regulation (EC) No 1107/2009 Approval vs Authorisation EU Approval Active Substance National Authorisation Plant Protection Product One decision applying to all 28 Member States One decision applying to one Member State

Minor Uses - definition Regulation (EC) No 1107/2009 – Article 3(26): Use of a plant protection product in a particular Member State on plants or plant products which are: (a) not widely grown in that Member State, or (b) widely grown to meet an exceptional plant protection need National dimension Minor crop Minor use on a major crop

Extension of Authorisation Existing authorisations can be extended to minor uses (derogation for efficacy and phytotoxicity) Member States may encourage /facilitate extension of uses Mutual recognition of extensions Regulation 1107/2009

EU Pesticide Legislation MRLs in food and feed EU: two residue zones Guidance Document: Rules for residue extrapolation RESIDUES IN FOOD/FEED Regulation 396/2005

REFIT Regulatory Fitness & Performance Program Formal evaluation process of Reg (EC) 1107/2009 and Reg (EC) 396/2005 Commission's commitment to ensure that EU legislation is effective and efficient in achieving its public policy objectives at minimum cost. Review Clause: Article 82: Reg (EC) 1107/2009 Article 47: Reg (EC) 396/2005

Content EU Regulatory Framework Regulatory hurdles

Minor Uses - Definition Is this a workable definition? Leaves it up to individual Member States to define what is considered a ‘minor use/crop’; Hinders the zonal procedure and mutual recognition; A definition based on acreage (at least per zone) is favoured by EU growers associations.

2, 3, 4 zones Reg 1107/2009 Zones EPPO Zones EPPO Zones vs

enGLOBAL RESIDUE STUDY GLOBAL RESIDUE STUDY-Blueberry enGLOBAL RESIDUE STUDY “European Commission and Member States considered these findings as interesting and worthwhile to be further explored in the long term and at international level.” 26 total field sites in 9 countries

Residue data generated outside the EU In general, Member States support the use of residue data generated outside the EU, when scientifically valid, in granting minor uses extensions. Active substance data requirements (Regulation (EC) No 283/2013) which state under Part A Section 6.3:  Part of the trials may be replaced by trials performed outside the Union, provided that they correspond to the critical GAP and that the production conditions (such as cultural practices, climatic conditions) are comparable.  What if all trials are generated outside the EU?

(Un)Harmonized Crop Grouping and Extrapolation

Some points for discussion… An EU wide definition of ‘minor crop’ and ‘minor pest’ is needed to facilitate minor use authorisations. Existing residue data from non-EU countries should be acceptable if the GAP is identical or comparable to the EU application. Applications for MRL’s should always be maximally extrapolated to the entire crop group. When a Member State grants an authorization it should put all minor crops within a crop group on the label, even though the application may only have been done for the major crop. It is critical to increase the availability of sustainable PPPs even more now the EUs ongoing (regular) review of active substances raises doubts about the safety of several substances which are currently approved, which might lead to a further loss of products that were in use –also for speciality crops- up to now.

THANK YOU FOR YOUR ATTENTION ANY QUESTIONS Jeroen Meeussen Coordinator European Union Minor Uses Coordination Facility 21 boulevard Richard Lenoir 75011 Paris FRANCE T +33(0)1 84 79 07 55 M +33(0)7 60 82 22 36 E jeroen.meeussen@minoruses.eu website: www.minoruses.eu The report was due by December 2011, but due to lengthy consultations with other Commission services, and to other more recent overriding priorities, it was ultimately postponed. Co-funding will be done by a grant of €350,000/year. ERANETs are research coordination instruments whereby Member States can coordinate their National research activities and ultimately fund joint projects.