01 jvetten presentatie 2016-4-5 · • a specialised “greenteam” of assessors for intake and...
TRANSCRIPT
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Efficacy and low
risk productsIntroduction on the scope
Jacobijn van Etten (Ctgb)
Claudia Jilesen (NPPO)
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Ctgb
• Some background on the green deal
• Low risk definition
• Scope and objectives of this workshop
NPPO
• Efficacy approaches
• Lines of thinking
Content
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The “Green Deal”
Objectives:
• To stimulate sustainable plant protection by collaboration between government and industry
• To resolve obstacles in the authorisation process
• To stimulate the market access of low(er) risk products
• To stimulate farmers toolbox with low(er) risk products
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Issues for industry and RA
For the industry:
• Development of new active substances
and products
• Building a dossier and registration of
the products
For the regulatory agencies:
• To assist the SME’s
• To innovate along with industry instead
of stifling innovation
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Green Deal
• 8 pilots with products
• 2 pilots with active substances
• Contribution to harmonisation
• Document and share the lessons
learned
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Lessons learned 1
• A Pre Submission Meeting (PSM) is
important to clarify possibilities and
difficulties
• Managing of expectations
Efficacy important issue in PSMs
• A specialised “greenTEAM” of assessors
for intake and assessment
• Tailor made solutions for dossiers
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Lessons learned 2
• The current, “chemistry based”,
requirements are not always helpful
• Sometimes the data requirements are
not realistic
• There is a need to harmonise guidances
within EU and worldwide
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Lessons learned 3
Contribution to harmonisation
• Workshop micro-organisms and human toxicology assessment> PPE> exposure versus risk assessment> secundairy metabolites
• Workshop Efficacy requirements and
evaluation of PPP based on low-risk
active substances
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• Definition regulation 1107/2009
• Status new definition
• 5 substances approved low risk:Isaria fumosorosea strain Apopka 97 (renewal)
COS-OGA (new a.s.)
Cerevisane (new a.s.)
Ferric Phosphate (new a.s.)
Pepino mosaic virus strain CH2 (new a.s.)
• Criteria not subject of this workshop
Low risk
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• Not dealt with in active substance
dossier
• EPPO standards not for LR (micro’s)
• Mode of action important story
• Low risk > less harm > less efficacy??
• Justification of the claim
• Need for harmonisation
Efficacy and low risk
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• Start process of harmonisation:
- requirements
- efficacy evaluation
for low risk ppp
• Starting point for EPPO standards for
assessment of low risk ppp
• Without loosing flexibility or
complicating matters
Aim of this workshop
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Less hurdles