1. Health and Consumers Health and Consumers Reviewing the implementation of Regulation (EC) No 1107/2009 Crop Protection European Regulatory Conference 11-12 March 2015, Brussels, Belgium Wolfgang Reinert European Commission DG Health and Food Safety Unit Pesticides and Biocides

2. Health and Consumers Health and Consumers Commission to submit a report by December 2014 on - mutual recognition and the zonal system - application of the approval criteria and their impact on human health, environment and competiveness of agriculture More comprehensive ex-post analysis instead Joined with report according to Art. 62 (sharing of tests involving vertebrates) and review of Reg. 396/2005 Start of the analysis foreseen for 2016 Article 82 Review clause

3. Health and Consumers Health and Consumers Include all relevant stakeholders and other appropriate sources of information (e.g. workshop reports) Expectations on stakeholders: - provide clear and robust evidence - define realistic expectations More clearly separate technical from political discussion Point of departure for COM: - open and unbiased - having in mind political principles of the new Commission Article 82 Principles of the survey

4. Health and Consumers Health and Consumers Roadmap published in June 2014 Public consultation from Sep 2014 to Jan 2015 At least two studies needed: - 1st study will identify substances under options for criteria outlined in the roadmap - 2nd study will assess socio-economic and environmental impacts associated with the various options Commission proposal for criteria will take into account outcome of the Impact Assessment. Endocrine disruptors Impact Assessment

5. Health and Consumers Health and Consumers Endocrine disruptors Approval criteria Wish to proceed quickly is incompatible with need to carry out an for Impact Assessment "Interim criteria" of Annex II are legally valid More generally: Do elements like "may be considered", "that are or have to be classified" provide appropriate legal certainty to industry? Article 4(7) based on information included in the application MRL setting

6. Health and Consumers Health and Consumers 3 Main tasks: - Collect information on trade in illegal and counterfeit PPP - Evaluate existing control measures - Assess regulatory framework and suggest complementary measures Research included MS and stakeholders Report will be presented to stakeholders on 25 March Illegal trade of pesticides Ad hoc study

7. Health and Consumers Health and Consumers Market share ca. 10%, with large geographical differences Big seaports main entry point Illegal products circulate freely on the internal market Borderline inspection most important tool Market controls relevant complementary measures Shortcomings: too low level of harmonization and some legal uncertainty within Regulation 1107/2009 Way ahead on controls (Article 68) may become crucial Illegal trade of pesticides Main findings

8. Health and Consumers Health and Consumers Recent analyses from industry and MS on the functioning System is not yet working according to desire Yet, no thorough analysis: figures presented too divergent Complexity of the zonal vs. national authorisation: - Failure to comply with deadlines - Resource problems - Lack of streamlining in the procedure COM dedicated to the principle of mutual recognition and keen to enhance the functioning Zonal system New evidence since 2014?

9. Health and Consumers Health and Consumers Reduce work overload through enhanced harmonization and cooperation, in order to - increase throughput - decrease overall number of applications Fragmentation of the EU market impacts on, e.g. - competitiveness of industry and farmers; - administrative burden on industry and authorities; - fight against illegal trade; etc. Workshop zonal system / mutual recognition planned June 2015 Zonal system Consequences?

10. Health and Consumers Health and Consumers Secure online system to - submit applications - streamline the assessment process - increase cooperation - publish catalogue of authorisations Implemented so far: Zonal authorisation / mutual recognition Released in February 2015 The PPP IT system...more than an authorisation database

11. Health and Consumers Health and Consumers Kick-off training sessions Allow industry and MS to get to know the system Cover all types of authorisations / permits under Reg. 1107/2009 Incorporate existing entries from MS databases Next modules: Emergency authorisations, amendments of authorisation, pre-submission phase After a setting-in period the system shall become mandatory The PPP IT system Next steps

12. Health and Consumers Health and Consumers COM mandated EFSA to collect and assess new scientific data Application of the EFSA bee-GD still open: - principle of stepwise application not disputed - COM to draft a roadmap - Further timelines unsure Survey on the adaptation of agronomic practices by EU farmers to neonicotinoid restrictions - Case studies in 8 MS on OSR, maize and sunflower - First data expected in July 2015 Risk to Bees An uninvited update

13. Health and Consumers Health and Consumers Minor Uses Technical Secretariat Candidates for substitution Negligible exposure Miscellaneous Ongoing issues

14. Health and Consumers Health and Consumers Thank you very much for your attention!