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

Background of new proposal – 2008: Evaluation study of the S&PM marketing legislation - October 2009: Presentation of the Action Plan : 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

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

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

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;

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

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

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

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

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

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

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

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

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)

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

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

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

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