Transcript Folie 1

Cut-Offs and Candidates for
Substitution:
Member State view
Outline
• Regulatory framework for plant protection products (PPP)
• Endocrine disruptors (ED),
• PBT, vPvB, POP
• Groundwater, Honeybees
• Candidates for Substitution
• Comparative Assessment
• Conclusions
BVL, Abteilung Pflanzenschutz, Dr. Martin Streloke
13.03.2014
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Introduction
• New pesticide regulation entered into force in June 2011
- 1107/2009/EC – Approval actives/Authorisation products,
- Annex II – Approval criteria for actives = cut-offs and for Candidates
for Substitution (CfS),
- No approval of a.s. at EU-level if cut-offs fulfilled (e.g. 3 PBT),
- Less hazardous compounds – CfS (e.g. 2 PBT)
- Regularly authorisations at zonal level but
- Comparative Assessment at MS-level (Art. 50).
BVL, Abteilung Pflanzenschutz, Dr. Martin Streloke
13.03.2014
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Endocrine disruptors
• Activities at EU and national level,
• DG Environment has the lead at EU-level for all types of compounds,
• But differences between groups of compounds to be considered; e.g.
a.s. of PPP are data rich!
• Assessment scheme was expected for the end of 2013 but impact
assessment still underway,
• Additional data requirements for some compounds have been raised
in DE,
• But no final identification as ED and subsequently no authorisation in
DE so far.
BVL, Abteilung Pflanzenschutz, Dr. Martin Streloke
13.03.2014
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Endocrine disruptors
• Assessment by mammalian toxicologists first,
• If ED-specific properties but no negative decision to be taken in this
area, environmental evaluation is triggered,
• Only if endocrine endpoint most sensitive it should become relevant
for decision making,
• According to DE approach substances with intended endocrine MoA
in non-vertebrates (e.g. insect growth regulators) not regarded as
EDs because selectivity of products is preferred,
• Preliminary evaluations of some substances were presented at
SETAC in Milan,
• In DE a paper summarising all ED-activities (health and environment)
was prepared and sent to DG Env.
• Overall situation currently not really clear.
BVL, Abteilung Pflanzenschutz, Dr. Martin Streloke
13.03.2014
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PBT and other cutoffs
• Activivities in OECD-group on PBTs have not made too much
progress, but new start announced,
• PBT-evaluation has been made over the last years for industrial
chemicals at EU-level, guidance exists,
• To which extent must approaches amongst industrial chemicals,
biocides, plant protection products be harmonised?
• Again, PPP are data rich and all data should be used if appropriate,
• Implications for decision-makings different; only for PPP „cutoff“-criteria.
BVL, Abteilung Pflanzenschutz, Dr. Martin Streloke
13.03.2014
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PBT and other cutoffs
• Items under discussion:
- Annex II of 1107/2009 don‘t follow a compartment approach,
- Use of data from field studies for P-evaluation unclear,
• Other cut-offs unclear e.g.:
- UP criteria for groundwater must be fulfiled,
- What to do if monitoring data are continously above 0.1 µg/l in
a considerable number of cases ?
- Honeybees – only UP must be fulfilled ?
BVL, Abteilung Pflanzenschutz, Dr. Martin Streloke
13.03.2014
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Candidates for Substitution (CfS)
• Preliminary criteria were developed in a small group of COM
and MS in 2012,
• In 2013 consultant worked through endpoint lists of active
substances of products on the market at the end of 2012,
• Report was made available until autum 2013,
• Authorisation holders and MS checked results of study,
• COM will present list of CfS in March meeting of standing committee.
BVL, Abteilung Pflanzenschutz, Dr. Martin Streloke
13.03.2014
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Candidates for Substitution
•
From the draft study report it is clear that PBT criteria are
most important for identifying CfS,
•
Approximately 80-100 compounds will become CfS,
•
Depending on transitional periods work for MS on
Comparative Assessment (CA) will start by end of 2014,
•
SWE has used CA for decision-making over a long time,
•
Some MS have started with case studies (e.g. NL) or even
circulated national guidance for conducting CA (UK),
•
National paper on CA in DE will be prepared subsequently
to finalisation of EU-Guidance.
BVL, Abteilung Pflanzenschutz, Dr. Martin Streloke
13.03.2014
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Comparative Assessment (CA)
•
Final version of EU-GD will be made available by COM in
March meeting of standing committee,
•
Role of applicants not really clear,
•
Each use of product with CfS must be evaluated,
•
First step: Looking for alternatives in efficacy area,
• Other products or non-chemical methods are available?
• Resistance management, IPM relevance, importance of CfS
for minor uses are important,
•
EPPO guidance available but more detailed criteria may be
needed in future,
BVL, Abteilung Pflanzenschutz, Dr. Martin Streloke
13.03.2014
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Comparative Assessment
• How many minor uses for example balance critical major crops?
• What are economic advantages/disadvantages
(e.g. non-chemical methods; hoeing - herbicide)?
• High number of uses/products with no alternative expected,
• If alternatives are available:
- relative risk to health and environment,
- first look to areas of concern decisive for identifying CfS,
- strength of risk mitigation measures important.
• Clear differences to alternative must be determined
• Otherwise no substitution
• Lot of work for MS expected
BVL, Abteilung Pflanzenschutz, Dr. Martin Streloke
13.03.2014
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Conclusions
•
“Cut-off”-criteria for approval of actives under 1107/2009 to
be specified,
•
Endocrine disruption and PBT… important, not too much work
on other parameter underway,
•
Some cut-off criteria are important for identifying CfS too,
•
Preliminary list of CfS will be made available by COM soon,
•
EU-GD are nearly finalised,
•
CA will be conducted at MS-level,
•
MS have started with work on conducting CA.
BVL, Abteilung Pflanzenschutz, Dr. Martin Streloke
13.03.2014
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Thank you for you
attention!
contact:
BVL, Dienststelle Braunschweig
Messeweg 11/12
38104 Braunschweig
Telefon: 0531 / 299-3609
E-Mail:
[email protected]
Internet: www.bvl.bund.de
BVL, Abteilung Pflanzenschutz, Dr. Martin Streloke
13.03.2014
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