EPPO Guidelines and Zonal Authorisations - Lists of EPPO Standards

EPPO Guidelines and Zonal
Authorisations
David Richardson
Independent Consultant
dmrichardson@live.com

Contents
• EPPO standards
• Legal background
• Requirements for zonals
• Making it work
– Will it work
• A reflection

• Plant Protection:
EPPO Standards
• Specific standards
• General standards
• Standards for GPPP

EPPO Standards: where do they
come from?

EPPO Standards: where do they
come from?
Proposal for document
Technical discussion at Panel
(Ad hoc meeting or panel?)
Additional Panel discussion
Country consultation
Working Party
EPPO Council
• Publication
• Opportunity for revision or amendment

EPPO Standards
• Effective system for development in place
•E.g CA
– Identified as an issue arising from 1107/2009
– Involved a workshop, specialist EPPO panels and
WP
• All relevant parties involved via country
consultations
• Developed as an agreed standard – May 2011?
• EPPO – an enviable track record of guidance
development

Efficacy - Legal Background
• EC 1107/2009;
• PPP authorised where following UP’s….
– Sufficiently effective
– No unacceptable effects on plants
– Substances should only be included in PPPs where
it has been demonstrated that they present a clear
benefit for plant production
• What does it mean?

Legal Background
• Uniform principles - 1107/2009 refers to
Annex VI to 91/414. This provides detailed
requirements
– On efficacy
– Minimum necessary for the desired effect
– On areas of potential adverse effects (yield,
quality, succeeding and adjacent crops, plant parts
for propagation etc)

Legal Background; UP’s
• The judgments made by the competent
authorities of the Member States during
the evaluation and decision-making
process must be based on scientific
principles, preferably recognized at
international level (for example, by the
EPPO)

Legal Background; (efficacy
data requirements from EC93/71)
• The specific EPPO guidelines constitute
… the best available basis for setting the
minimum requirements to be applied in all
Member States
• The trials must be carried out in
accordance to specific EPPO guidelines
• The design, analysis and reporting of trials
must be in accordance with EPPO
guidelines 152 and 181.

Making zonals work
• Effectiveness: Harmonised requirements
• Plus an understanding there is a sound
scientific basis for the trials methodology
– Specific EPPO standards (c 250)
• Guidance on numbers of efficacy trials
(226)
• Efficacy and crop safety extrapolations
(257)

Making zonals work
• Adverse effects: Harmonised requirements
– Phytotoxicity assessment (135)
– Succeeding and adjacent crops (207, 256)
– Taint, transformation and vinification
– Plant parts for propagation

Making zonals work
Guidance on comparable climates

Making zonals work
• Common principals for design and analysis
of trials series e.g. EPPO 152
• And conduct and reporting of trials e.g.
EPPO 181
• OR standard
• Some areas need further work
– Dose expression
– Min effective dose (?)
– Major and minor crops

Making zonals work
• The foundations are laid to give
harmonised guidance for appropriate
trials, trials numbers and relevant
assessments.

Making zonals work
• What about decision making?
– Principals of acceptable efficacy (214)
(supporting information on balancing levels of
performance with adverse or beneficial
effects)
• Enables all MS to make the same decision
on the same dataset?

Making zonals work
• What about communication between MS
regarding nomenclature?
– EPPO Plant Protection Thesaurus
(EPPO/Bayer codes)
– Harmonised classification and coding of uses
of PPP’s

SO THE ZONALS CONCEPT SHOULD
WORK.
BUT.....

WILL IT WORK?
• Are competent authorities requiring data
sets and making decisions in line with the
guidance?
• Are they willing to accept the zonal
concept. E.g. re location of trials?

WILL IT WORK?
Are competent authorities requiring …
• …at least some information on yield of (new)
foliar insecticides and fungicides (is PP1/226
clear?)
• … at least preliminary data on succeeding
crops? (e.g. germination studies)
• …ensuring there is a ‘benefit’ from use of the
PPP? (Is benefit adequately defined?)

WILL IT WORK?
• Also requires TRUST
• Essential if MS are going to accept
evaluations of other MS.
• EPPO Workshop 2006 on minor uses:
‘Need to promote an atmosphere of trust
between regulators’

So In summary…
• Foundations are in place
• Some broader guidance needed
– Zonal submissions
– Major and minor crops
– Some clarification of some guidelines
– MS specific agronomic issues
– Benefits of PPP’s?
• So it can work - down to the ‘will’ of the
regulators

And Finally……
• We need to make it work
– Everyone benefits
• Think for a moment what are we trying to
achieve – at this meeting?
– Develop guidance?
– Determine how many trials for a zonal
authorisation?
– Solve the major-minor crop problem?

Objective; make it easier to get
more products approved for use
on crops across the EU.

• So aim towards simplicity
OR
• Avoid making things too complex

Thank you for your attention
dmrichardson@live.com