1. New plant health Regulation: main elements of the upcoming Commission proposal Yannis Karamitsios European Commission DG SANCO (E.2)

2. New approach - Focus both on territorial protection (eradication and containment measures), as well as movement of plants/plant products - Coverage of all harmful organisms, including “quality pests” of the S&PM legislation

3. - Rules to determine phytosanitary risks of harmful organisms and measures to reduce them to an acceptable level - Not covering invasive alien plants To be covered by separate DG ENV proposal Subject matter and scope

4. - Regulated HOs, plants/plant products and requirements or prohibitions to be listed through secondary acts (no Annexes) - Listing according to specific risk assessment and risk management criteria (in new Annexes) Listing of HO and plants/plant products

5. The Regulation will cover both: - Territorial harmful organisms (“quarantine pests”); and - Non-territorial harmful organisms (“quality pests” of S&PM Directives) Harmful organisms

6. - Organisms not present in the Union territory or, if present, distributed to a limited extent, and with unacceptable economic, social and environmental effects - To be split between organisms relevant:  i) for the entire Union; and  ii) for protected zones only Territorial harmful organisms

7. - Current distinction between “known to occur” and “not known to occur” will remain - The organisms with the most severe economic, social and environmental effects may be designated as “priority organisms” - Organisms listed in Annexes I and II of Directive 2000/29 also to be listed without risk assessment Territorial harmful organisms relevant to the entire Union

8. Non-territorial harmful organisms (qualification) - They are present in, and are mainly transmitted through, plants for planting; - Unacceptable economic impacts on the use of those plants; - They do not qualify as territorial harmful organisms - Possibility that an organism qualifies as territorial for a PZ, but non-territorial outside the PZ

9. Non-territorial harmful organisms (listing) - To be listed with reference to specific plants for planting - Where applicable, tolerance thresholds to be established - Listing to take place on the basis of a risk assessment - Non-territorial organisms listed in the current S&PM Directives to be listed without risk assessment

10. - Notification obligation for operators and laboratories - Notification obligation for MS to the Commission and the other MS - Competent authorities to inform operators concerning presence of organisms - Operators to take immediately measures to avoid the spread of the organism Measures against territorial harmful organisms (1)

11. - Obligation of MS to take eradication measures, including establishment of demarcated areas - General surveillance for new HO in the EU - Notification of imminent dangers by MS - Competent authorities to inform the public Measures against territorial harmful organisms (2)

12. Priority organisms Additional obligations for priority organisms: - Contingency plans by MS - Enhanced surveys - Action plans in the case of outbreaks Also: additional support through Union co-financing

13. Temporary measures on non-listed territorial harmful organisms - Possibility for MS and the Commission to take temporary measures on non-listed organisms - All those measures to be terminated once a risk assessment is concluded

14. Protected zones - Established on the basis of three-years surveys - Annual surveys after the establishment - Any found organism must be eradicated within 24 months - Revocation of PZ in case of negligent reaction to presence of HO or no surveys

15. Non-territorial harmful organisms (qualification) - They are present in, and are mainly transmitted through, plants for planting; - Unacceptable economic impacts on the use of those plants; - They do not qualify as territorial harmful organisms - Possibility that an organism qualifies as territorial for a PZ, but non-territorial outside the PZ

16. Non-territorial harmful organisms (listing) - To be listed with reference to specific plants for planting - Where applicable, tolerance thresholds to be established - Listing to take place on the basis of a risk assessment - Non-territorial organisms listed in the current S&PM Directives to be listed without risk assessment

17. Measures on plants, plant products and other objects - Secondary acts to establish prohibitions or requirements (replacing current Annexes III and IV) - Frontier zones, derogations and equivalence measures – to keep existing logic

18. Temporary measures on plants, plant products and other objects - Temporary measures on plants for planting from third countries likely to pose previously unidentified risks and for which there is limited experience with trade - Those measures may include: (i) physical checks on each lot under an intensified sampling and testing regime (ii) imposition of a quarantine period (iii) prohibition - Maximum duration of two years, with a possibility to prolong for a another two years to allow for PRA

19. Small quantities and local circulation - No exceptions for small quantities of plants (e.g. passengers’ plants) - Local circulation of small qualities to be excepted

20. Quarantine stations and registers of operators - MS to designate quarantine stations for the implementation of the Regulation

21. Registration of operators - Obligation to establish registers of operators, - To be used also for the purposes of the new PRM Regulation

22. Plant passports (1) - All plants for planting at business to business level - Issued by operators under the official supervision of competent authorities - Issued by competent authorities only if requested so by the operators - Operators to issue plant passports only if registered and fulfil specific conditions

23. Plant passports (2) - Uniform format with distinct Union logo - Only four information items + PZ indication where applicable - Possibility to use barcode / hologram instead of logo - Combination in a single document of plant passport and official label of plant reproductive material

24. Other certification - Phytosanitary certificates for imports - Phytosanitary certificates for export and re-export - Mark for wood packaging material

25. Financial provisions The Union will co-finance: - General surveillance programmes (for new and priority organisms) - Eradication (administrative costs of eradication, inspection and co-ordination, compensation for direct losses of operators and compensation of private owners of plants) - Other actions (e.g. training, conferences) Enhanced financing for priority organisms

26. Thank you for your attention