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
• - 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
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
Thank you for your attention