Crop Protection European Regulatory Conference 11-12 March 2015, Brussels, Belgium

Reviewing the implementation of Regulation (EC) No 1107/2009

Wolfgang Reinert European Commission DG Health and Food Safety Unit Pesticides and Biocides

Health and Consumers

Article 82

Review clause

• • • • 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

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Article 82

Principles of the survey

• • • • 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

Health and Consumers

Endocrine disruptors

Impact Assessment

• • • • 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.

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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

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Illegal trade of pesticides

Ad hoc study

• • • 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

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Illegal trade of pesticides

Main findings

• • • • • • • 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

Health and Consumers

Zonal system

New evidence since 2014?

• • • • • 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

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Zonal system

Consequences?

• • • 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

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The PPP IT system

...more than an authorisation database

• • • 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

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The PPP IT system

Next steps

• • • • • • 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

Health and Consumers

Risk to Bees

An uninvited update

• • • 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

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Miscellaneous

Ongoing issues

• • • Minor Uses Technical Secretariat Candidates for substitution Negligible exposure

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Thank you very much for your attention!

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