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New Regulation on Plant Reproductive Material: main elements of the upcoming Commission proposal

New Regulation on Plant Reproductive Material: main elements of the upcoming Commission proposal. Yannis Karamitsios European Commission, DG SANCO. Background of new proposal. - 2007 – 2008: Evaluation study of the S&PM marketing legislation - October 2009: Presentation of the Action Plan

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New Regulation on Plant Reproductive Material: main elements of the upcoming Commission proposal

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  1. New Regulation on Plant Reproductive Material: main elements of the upcoming Commission proposal Yannis Karamitsios European Commission, DG SANCO

  2. Background of new proposal • - 2007 – 2008: Evaluation study of the S&PM marketing legislation • - October 2009: Presentation of the Action Plan • - 2011: Options and Analysis Paper • - April-May 2011: Web-based stakeholder consultation; 257 replies • - June 2011-March 2012: Impact assessment • - End of 2012: Submission of the legal proposal

  3. Scope and nature • - Single Regulation replacing 12 Directives • - Covers all types of plant reproductive material • - Exception of material intended solely for: • (a) tests and trials • (b) breeding • (c) gene banks

  4. Obligations for operators - Registration under the plant health register - Basic responsibilities for monitoring and co-operation with competent authorities - Traceability

  5. Requirements for listed species (1) - Production and marketing under four categories; • - Some of them could be produced and marketed only as pre-basic, basic or certified; • - Requirements for each category to be adopted through implementing acts; • - They must belong to registered varieties;

  6. Requirements for listed species (2) • - Official label (certification) for pre-basic, basic and certified; • - Operators to carry out certification only if they are authorised so; • - Competent authorities to carry out certification if requested so by operators; • - For standard material: operator's labels

  7. Requirements for listed species (3) • - Post-certification tests to confirm compliance with requirements • - Union certification reference centres • - Mixtures between particular species or varieties allowed only if explicitly allowed under secondary acts

  8. Requirements for listed species (4) Derogations to be allowed, upon approval at EU level, concerning: (a) temporary difficulties on supplies; (b) national more stringent requirements; (c) emergency measures; (d) temporary experiments; (e) varieties for which registration is pending

  9. Requirements for listed species (5) • - Imports allowed only upon implementing acts recognising EU equivalence; • - Existing Council decisions on equivalence to remain unless replaced; • - Exported material to comply with third countries rules

  10. Requirements for non-listed species • - Basic requirements for identity and fitness for purpose; • - Marketing with reference to varieties; • - Labelling; • - Imports only if notified

  11. Registration of varieties (1) • Varieties to be registered either: • A. in national variety registers; or • B. in Union variety register • In both cases, marketing of plant reproductive material will be free throughout the Union

  12. Registration of varieties (2) • - Requirements for registration: • (a) DUS, confirmed through an official description; • (Alternative for old varieties: no DUS, but officially recognised description) • (b) Suitable denomination – obligatory check by CPVO • (c) VCU for particular species – to harmonise at EU level requirements for 'sustainable VCU' • - Specific requirements for registration of clones

  13. Registration of varieties (3) - Technical examinations for DUS to be carried out by competent authorities; - Technical examinations to be carried out by operators if so delegated by the competent authorities; • - Premises of technical examinations to be audited by CPVO and competent authorities; • - Mutual recognition of technical examinations and official descriptions of DUS

  14. Registration of varieties (4) • - CPVO to manage that register; • - Appeal procedure against CPVO decisions; • - Union variety register also includes information on varieties of national registers (complete EU data-base)

  15. Forest reproductive material (1) • - Terms and definitions almost identical to current Directive; • - Maintenance of the current system: • approval of basic material => master certificate => marketing under one of the marketing categories

  16. Forest reproductive material (2) - National registers of basic material to be reflected in Union register managed by CPVO; - Implementation of harmonised controls - introduction of fees; - More stringent requirements approved by the Commission

  17. Financial provisions • There will be financing of: • - Union reference certification centres • - Studies for development of Union policy and legislation • - Training of staff • - Information tools of MS

  18. Thank you for your attention

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