The seminar on Problem Formulation for the Risk Assessment of Biopesticides stemmed from a previous CRP-sponsored event on Innovating Microbial Pesticide Testing that identified the need for an overarching guidance document to determine when in vivo tests are necessary. Problem Formulation, a common practice in pesticide risk assessment, was highlighted as a useful approach for addressing uncertainties in data requirements for biopesticides. The seminar featured presentations from various perspectives, including industry, regulatory bodies, and academia. Topics included the history and principles of Problem Formulation, industry perspectives on Problem Formulation and how it is applied internally for microbial pesticides, regulatory approaches, and specific case studies. The seminar provided an overview of the challenges, considerations, and potential solutions in harmonising Problem Formulation for biopesticide risk assessment. It emphasised the need for collaboration and discussion to develop Problem Formulation guidance for biopesticides.

1. Guidance to provide justifications as referred in point
1.5 of the Introduction of the Annexes of Regulations
(EU) No 283/2013 and No 284/2013:
Problem formulation for environmental risk assessment
in the context of Regulation (EC) No 1107/2009
Seminar on Problem formulation for the risk assessment of biopesticides
OECD Expert Group on BioPesticides
26 February 2024
Monica Garcia Aguilar
Unit E4 – Pesticides and Biocides
DG Health and Food Safety
https://food.ec.europa.eu/document/download/c4d6b7df-b7f9-4b3b-8ce5-b823ccdcf98c_en?filename=pesticides_ppp_app-proc_guide_horiz_problem-formulation-era.pdf

2. ➢ Background - why the need of this Guidance?
➢ Low hazard products and low exposure uses need to be placed faster in the market
➢ Different environmental impacts of plant protection products
➢ Environmental Risk Assessment and innovation
➢ Legal provisions for excluding studies – the “need to know approach”
➢ The Guidance and the template in practice
➢ Some examples
Contents

3. Low hazard active substances (microorganisms, pheromones, basics and plant
extracts) and low exposure uses are ready to be placed in the market,
contributing to the reduction of use and risk of chemical plant protection
products in Europe.

4. Dossiers of low hazard active substances (microorganisms, pheromones,
basics and plant extracts) admitted for the approval at the EU level.
Low
hazard AS
Other AS
AT 5
CZ 1
DE 1 2
DK 1
ES 6
FI 1
FR 2 2
LT 1
NL 6 4
NO 1
Total
EU 9 24
Dossiers with admissibility
dates in 2019
Low
hazard AS
Other AS
AT 10
BE 1
CZ 1
DE 1 2
DK 1
EE 1
EL 3
ES 4 2
FR 1 4
HU 1
IT 1 2
LV 1
MT 1
NL 4 8
PL 1 1
PT 1
SE 2 1
SI 1
SK 1
Total
EU
15 42
Dossiers with admissibility
dates in 2020
Low
hazard AS
Other AS
AT 3
BE 1 1
BG 1
DE 1 1
DK 1
EE 2
FR 1 2
HU 1
IT 1
MT 1
NL 8 1
SE 1
SI 1
Total
EU
13 15
Dossiers with admissibility
dates in 2021

5. How PPPs impact the environment varies depending on their intrinsic properties and use.
Some plant protection product uses are likely to have lower impacts on the environment
Workshop 2020

6. Challenge: the current ERA is not sufficiently flexible to accommodate
environmental scenarios different than spraying a conventional chemical PPP
with a conventional equipment in the field.
Regulation
1107/2009
Data
requirements
Uniform
principles
Risk Assessment guidance documents & test guidelines
And regulatory
science needs to
follow the new
developments…
e.g. new Regulations
on MoS!
New actives, new uses
Science evolves
Conventional chemicals
sprayed in the field

7. The Ecotoxicology Section is one of the longest in the
application dossiers and the draft renewal report.
Syngenta case: Comparing dossiers to authorize the same product supporting the same
GAP in one EU country 2009 and 2021. Source: Crop Life Europe Conference, 2022.
https://croplifeeurope.eu/media/events/croplife-europe-hybrid-conference-2022/

8. Data requirements for active substances and plant protection products*
1.5. The information shall include a full and unbiased report of the studies
conducted as well as a full description of them.
Such information shall not be required, where one of the following
conditions is fulfilled:
➢ (a) it is not necessary owing to the nature of the product or its
proposed uses, or it is not scientifically necessary;
➢ (b) it is technically not possible to supply.
• In such a case a justification shall be provided
There are legal provisions in the EU pesticides regulation that allow
to implement a need-to-know approach, e.g. exclusion of studies if
scientifically justified.
*Regulation (EU) No 283/2013 and Commission Regulation (EU) No 284/2013
Same approach as in the new Data Requirements for Microorganisms!!

9. How can the previous legal provision together with the outcome of
the workshop be used to encourage a faster placing on the market
of low hazard products and low exposure uses?
A fit for purpose risk assessment driven by a problem formulation step!
Scope:
- Environmental Risk Assessment (fate and behaviour and ecotox studies)
- Uses with potentially low environmental effects

10. Timeline – this document comes from far…
Informative
session with
80 experts
MS and
stakeholders
MS and
stakeholders
provided
comments on
the document
23 case studies
provided by MS
and
stakeholders
Draft
discussed in
the ScoPAFF
Guidance
document
endorsed!!
1.Some plant
protection
product uses are
likely to have
lower impacts
on the
environment
Consultation of the doc
2. Need of
scenarios to
consider
different types
of actives and
application
methods to
frame the ERA
2020 2021 2022 2023 2024
Input of the Working Group on
environmental relevant topics in the
context of the Reg (EC) No 1007/2009
+
Workshop
2020
EFSA
Guidance
2010 +
EFSA
Guidance
2016
Input Output

11. How to conduct problem formulation in practice?
Applicants should fill in this template. The burden of proof always remains
with the applicant!
Section 1 -DESCRIPTION OF THE SCENARIO
1.Description of the properties and conditions of use of the active substance / representative use of the formulated plant protection product
1.1. Physical and chemical and biological properties of the active substance/ representative use of the formulated plant protection product
e.g., volatility- deposition, solubility in water, mode of action, impurities… (for chemical substances), biology and ecology including host range, growing
conditions, … (for microorganisms)
Please state any other type of information that might be relevant (e.g., if a substance has been authorised as food additive, flavouring etc.)
1.2. Description of the conditions of use - Representative uses in the GAP table

12. How to conduct problem formulation in practice?
Applicants should fill in this template. The burden of proof always remains
with the applicant!
Section 2 -FATE AND BEHAVIOUR
Describe how the substance behaves in:
E.g., information on persistance, mobility, etc…
Based on Section 1, are there any studies that may be
excluded the ERA on the representative use? Please
justify.
Soil
Water:
Effects on biological method for sewage treatment systems (very relevant for greenhouse uses
and indoor uses)
-Can the representative use potentially trigger an effect on the sewage treatment plants? If so,
are there any routes of environmental exposure to consider, e.g., the application of sludge in
the field coming from the sewage plant?
Groundwater:
Air:

13. How to conduct problem formulation in practice?
Applicants should fill in this template.The burden of proof always remains
with the applicant!

14. Problem formulation has to be conducted at the very beginning of the regulatory
process. Applicants, RMS, co –RMS and EFSA will discuss if data are needed
based on the filled-in template during the pre-submission meetings.
The template will be also part of the IUCLID dossiers.
Pre-
submission
meetings
RMS
evaluation
EFSA Peer
Review
Commission
Decision
Harmonised guidance to
implement the legal
provisions and to identify
and provide scientific
justification as regards the
fate and behaviour and
ecotoxicological studies that
may not be required for the
RA.
If data was not submitted due to
expected low exposure, the
regulatory decisions are likely to
limit the approval/renewal of
approval to only low exposure
representative uses.
Uses for plant protection products
outside these restrictions and
leading to higher exposure cannot
be authorised at MS.
Further data can be always
be requested by the RMS,
Co- RMS or EFSA!!

15. List of the 23 Case studies provided to test the Guidance
1.Permanent greenhouse by drenching or spraying / chemical fungicide
2.Permanent greenhouse soil application via the drip irrigation system / botanical active
substance – nematicide
3.Greenhouse by foliar spraying /botanical active substance
4.In door - gas-tight storage structures/ chemical fumigant insecticide & rodenticide
5.In door by drenching or dipping / botanical active substance -fungicide / bactericide
6.In door by drenching or spraying / chemical fungicide
7.In door by dipping or drenching / lipopeptide - fungicide
8.Seed treatment in an ESTA certified site / chemical fungicide
9.Seed treatment in a non-ESTA certified site /micro-organism
10.Outdoor by foliar spraying/ botanical active substance
11.Outdoor spraying / glucose
12.Outdoor in a container-insect trap / chemical insecticide
13.Outdoor by burrow application / chemical fumigant insecticide & rodenticide
14.Outdoor by localised application -plant detection/chemical herbicide
15.Outdoor by broadcast application on established grassland / chemical – antibody
based
16.Outdoor by broadcast application / chemical herbicide
17.Outdoor by localised application - precision technique/chemical insecticide
18.Outdoor by localised application – precision sprayer / chemical – selective herbicide
19.Outdoor by spraying/ micro-organism (entomopathogenic)
20.Outdoor by spraying / formulation that reduces drift
21.Outdoor by spray application / lipopeptide fungicide
22.Outdoor by spraying / RNA insecticide
23.Outdoor pre-emergence application
after drilling /chemical herbicide
23 case studies
Physical,
chemical and
biological
properties
Conditions of
use
Potential
HAZARDs
Potential
Environmental
EXPOSURE

16. Representative use: Botanical AS
Post harvest use treatment by drenching or dipping in closed buildings
Are the properties of the active
substance/representative use of the PPP and/or its
exposure expected to lead to unacceptable effects on
the Relevant ES and these group of species?
Relevant Ecosystem
Services
Yes/No
Fresh water (surface water
and groundwater)
No
Erosion prevention and
maintenance of soil fertility
No
Pollination No
Biological control No
Habitats for species No
FIT FOR PURPOSE ERA
Botanical AS
Post harvest use
treatment by
drenching or
dipping in closed
buildings
Potential
HAZARDs
Potential
Environmental
EXPOSURE
Representative use
Justifications need to be provided in
the template!

17. Are the properties of the active
substance/representative use of the PPP and/or its
exposure expected to lead to unacceptable effects on
the Relevant ES and these group of species?
Fumigant
insecticide &
rodenticide
Applied inside
galleries with
an adapted
applicator
Potential
HAZARDs
Potential
Environmental
EXPOSURE
Representative use
Representative use: Fumigant insecticide & rodenticide
Outdoor use - Applied manually inside galleries of moles and voles with an
adapted applicator only by fumigators certified for handling this product
Relevant Ecosystem
Services
Yes/No
Fresh water (surface water
and groundwater)
Aquatic
invertebrates?
Erosion prevention and
maintenance of soil fertility
No
Pollination No
Biological control No
Habitats for species Potentially solved
with exposure
reduction measures
FIT FOR PURPOSE ERA
Justifications need to be provided in
the template!

18. Thank you!!
• © European Union 2020
• Unless otherwise noted the reuse of this presentation is authorised under the CC BY 4.0 license. For any use or reproduction of elements that
are not owned by the EU, permission may need to be sought directly from the respective right holders.
• Slide xx: element concerned, source: e.g. Fotolia.com; Slide xx: element concerned, source: e.g. iStock.com
https://food.ec.europa.eu/document/do
wnload/c4d6b7df-b7f9-4b3b-8ce5-
b823ccdcf98c_en?filename=pesticides
_ppp_app-proc_guide_horiz_problem-
formulation-era.pdf
The Guidance Document can
be found here: