1. Cut-Offs and Candidates for Substitution:
Member State view

2. 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

3. 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

4. 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
Seite 4

5. 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
Seite 5

6. 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
Seite 6

7. 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
Seite 7

8. 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
Seite 8

9. Candidates for Substitution
From the draft study report it is clear that PBT criteria are
most important for identifying CfS,
Approximately 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
Seite 9

10. 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
Seite 10

11. 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
Seite 11

12. 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
Seite 12

13. Thank you for you attention!
contact:
BVL, Dienststelle Braunschweig Messeweg 11/12
38104 Braunschweig
Telefon: 0531 /
Internet:
BVL, Abteilung Pflanzenschutz, Dr. Martin Streloke