Seminar on Emerging Risk Assessment Approaches for Biopesticides | Session 3: Risk Assessment of Semiochemicals

The seminar aimed to foster dialogue on emerging risk assessment approaches for biopesticides, and to initiate a process for developing recommendations through the exchange of experiences and challenges faced by governments and stakeholders in this area.

Held over three half-days, the seminar focused on three critical topics:
- Proteins and peptides used for pest control
- Taxonomic changes of Bacillus thuringiensis (Bt)
- Semiochemicals

Presentations and discussions were delivered from a range of perspectives, including industry, regulatory authorities, and academia. The seminar provided an overview of the challenges and considerations in assessing risks associated with these biopesticide categories.

There was consensus that these three topics should remain areas of ongoing collaboration among OECD member countries and relevant stakeholders.

Find more information about the event at: https://www.oecd.org/en/events/2025/02/seminar-on-emerging-risk-assessment-approaches-for-biopesticides.html

1. Restricted Use -À usage restreint
Seminar on Emerging Risk Assessment Approaches for
Biopesticides
Session 3: Risk Assessment of Semiochemicals
The 13th Expert Group on Biopesticides
Day 2 –26 February 2025
OECD, Paris

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Background
•Semiochemicals are emittedbyplants, animals, andotherorganismsas
integraltointra-andinter-species communication.
•Semiochemicals are widelyacknowledgedas posingminimalconcerns
whenutilisedforplant protectionpurposes.
•Witha target-specificandnon-toxicmode of action, semiochemicals are
naturallyoccurringandeffectiveat verylow applicationrates, often
comparabletotheirnaturalbackground levels.
•Evaluation of semiochemicals shall take into consideration their unique
characteristics and science-based risk assessment frameworks.

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Purpose
To exchange informationbetween regulators, researchers, and other
stakeholders, on:
✓theirscientificproperties and their impact on risk assessment
✓effective regulatory frameworks tailored to semiochemicals’ unique characteristics
✓current OECD country activities and work towards harmonisingrisk assessment
frameworks.
✓possible next steps for fostering mutual acceptance of semiochemicalrisk assessments
among OECD and non-OECD countries.

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Scope
To be informed and discuss:
➢Semiochemicals’intrinsicnaturalcharacteristicsandtheirroleinplant
protection.
➢PracticalexamplesfromtheOECD projectupdatingOECD
ENV/JM/MONO(2017)33.
➢Insightsfromaregulatoryagencyimplementingaproportionaterisk
assessmentscheme.
➢Addressingmisconceptionsaboutsemiochemicalsinagriculture.

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Speakers
✓Vicente NAVARRO-LLOPIS, UniversitatPolitècnicade València, Spain
✓Tomasz MAGACZ, SynTechRegulatory, GAB Consulting GmbH, Germany
✓Eric Liégeois, European Commission, DG SANTE
✓Alessandra MOCCIA, IBMA

6. Restricted Use -À usage restreint
Natural background
of Semiochemicals-
Revised Calculation
Method
OECD The 13th Expert Group on BioPesticidesSeminar
–26 Feb 2025
Tomasz Magacz – SynTech Regulatory

7. Restricted Use - À usage restreint
Confirm method suitability with experimental phase
Propose harmonised natural background levels for a set of semiochemicals commonly
uses in plant protection in OECD countries (e.g. SCLPs, Mealybugs, …)
Refine the process including an additional step of verifying the reliability of the
peer-reviewed input data
Provide examples of the applicability of the method
OECD SemiochemicalsBackgroundprojectoutline
2

8. Restricted Use - À usage restreint
Confirm method suitability with experimental phase
Propose harmonised natural background levels for a set of semiochemicals commonly
uses in plant protection in OECD countries (e.g. SCLPs, Mealybugs, …)
Refine the process including an additional step of verifying the reliability of the
peer-reviewed input data
Provide examples of the applicability of the method
OECD SemiochemicalsBackgroundprojectoutline
3

9. Restricted Use - À usage restreint
Experimental phase –Conclusions
4
•Experimental determination of semiochemicals is extremely complex and, in most
cases, not possible. For this reason, a calculation method was developed, and
threshold values historically determined
•When measuring experimentally the airborne concentration of a semiochemical,
there is a dilution factor to take into account (L. botrana example)
•When using the calculation method, the laboratory determined released by female
may be an overestimation, however the pest presence on the crop is an
underestimation (P. citri example)
•Real exposure is most likely higher than that experimentally determined or
mathematically calculated

10. Restricted Use - À usage restreint
Confirm method suitability with experimental phase
Propose harmonised natural background levels for a set of semiochemicals commonly
uses in plant protection in OECD countries (e.g. SCLPs, Mealybugs, …)
Refine the process including an additional step of verifying the reliability of the
peer-reviewed input data
Provide examples of the applicability of the method
OECD SemiochemicalsBackgroundprojectoutline
5

11. Restricted Use - À usage restreint
Current calculation method
6
There is a calculation method for the determination of the natural background levels of
semiochemicals based on available peer-reviewed literature reported in three official
guidance documents:

•‘Guidance document on semiochemical active substances and plant protection
products’. DG SANTE, SANTE 12815/2014;
•‘Guidance document on semiochemical active substances and plant protection
products’. OECD, OECD ENV/JM/MONO(2017)33;
•‘Guidelines for the registration of microbial, botanical and semiochemical substances for
both plant protection and public health uses’. FAO International Code of Conduct on
Pesticide Management, 2016.

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Current calculation method
7
Where:
PRR (Population Release Rate) = release rate of the semiochemical from a justified high population of
the source organism in nanograms per hectare and hour (ng/ha/h).
RIO (Release of an individual organism) = release rate of the semiochemical by an individual organism
in one hour (ng/h).
NRO (Number of Releasing Organisms) = number of releasing organisms per hectare.
�??????�=
??????��
��??????
×
% ��??????
���
���
�????????????=??????�� �??????�
Where:
YLD (Yield) = total yield of the crop in one cropping cycle (Kg/ha)
MPY (Mass per yield unit) = average mass of a standard unit (Kg) of the crop
% INF (Infestation rate) = % of harvested units affected by the target organism
OCC (Occupancy) = no. of releasing individuals per individual plant part
All the input data come from published peer-
reviewed literature and/or official sources
�??????�=��� ×??????��
Where:
PPH (Plants per hectare) = number of plants per one hectare.
FIP (Female individuals per plant) = number of individual calling females per
single plant
or

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Assignment of criteria for reliability assessment
8
RIO (Release of Individual Organism) Assessment
CriteriaReliable without restriction Reliable with restrictions Not reliable
Source •Peer reviewed literature •Company reports
•Dissemination magazines
•Not peer reviewed literature
•Companies web pages
Analytical
method
•Volatile collection with adsorbents using
internal standard
•Gland extraction (solvent or thermal)
•Body extraction
•Volatile collection with adsorbents using
external standard
•Measurements without any calibration
EIP (Emitting Individuals per Plant) or NRO Assessment
Criteria Reliable without restriction Reliable with restrictions Not reliable
Source •Peer reviewed literature
•National competent authorities reports
•Company reports
•Dissemination magazines
•Not peer reviewed literature
•Companies web pages
PPH (Plants per Hectare) Assessment
Criteria Reliable without restriction Reliable with restrictions Not reliable
Source •Peer reviewed literature
•National competent authorities reports
•FAO Statistics
•Dissemination magazines/ webpages
•Not peer reviewed literature
•Companies web pages

14. Restricted Use - À usage restreint
Confirm method suitability with experimental phase
Propose harmonised natural background levels for a set of semiochemicals commonly
uses in plant protection in OECD countries (e.g. SCLPs, Mealybugs, …)
Refine the process including an additional step of verifying the reliability of the
peer-reviewed input data
Provide examples of the applicability of the method
Finalsteps
9

15. Restricted Use - À usage restreint
Confirm method suitability with experimental phase
Propose harmonised natural background levels for a set of semiochemicals commonly
uses in plant protection in OECD countries (e.g. SCLPs, Mealybugs, …)
Refine the process including an additional step of verifying the reliability of the
peer-reviewed input data
Provide examples of the applicability of the method
Finalsteps
10

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Lepidopterans – Lobesia botrana
•considered a major vineyard pest in its native range, as the larvae feed
on the interior of grapes. A quarantine and invasive species in
California.
•Pheromones are released by females like in all Lepidopterans.
•Pheromone blend release consists of a lead SCLP component of 7E,9Z-
dodecadienyl acetate
7E,9Z-dodecadienyl acetate
11
L. botrana adult
L. botranas larvae

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Hemipterans – Lobesiabotrana– Input data scoring
12
Endpoint Value used for calculations Scoring/Rationale Source
RIO •0.36 ng/h
•1 – reliable without restrictions - Volatile
collection with adsorbents using internal
standard / Peer reviewed literature
Tasin, (2005)
FIB
•60% infestation
•90% infestation
•50% tookfor calulations(1 individualper
berrywith / ratio of 1:1
•1 – reliable without restrictions - Peer
reviewed literature
Shoukat, (2012)
Pavanand Sbrissa, (1994)
PPH
•25000 kg /ha
•1 g weight of single grape
•1 – reliable without restrictions - Peer
reviewed literature
FAO, (2000)
Calderón-Orellanaet al., (2014)

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Hemipterans – Lobesiabotrana- calculation
13
Where:
PRR (Population Release Rate) = release rate of the semiochemical from a justified high population of
the source organism in nanograms per hectare and hour (ng/ha/h).
RIO (Release of an individual organism) = release rate of the semiochemical by an individual organism
in one hour (ng/h).
NRO (Number of Releasing Organisms) = number of releasing organisms per hectare.
�????????????=????????????� �??????�
�????????????=????????????� ×??????????????????× BPH
PRR = 0.36 ng/h ×0.5× (2500000 kg/ha /0.001 kg)= 4 500 000 ng/ha/h =
4.5 mg /ha / h

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Lepidopterans – Spodopteraexigua
• native to Asia, but has been introduced worldwide.Has a verybread
rangeof hosts: asparagus, beans and peas, sugar and table beets,
celery, cole crops, lettuce, potato, tomato, cotton, cereals, oilseeds,
tobacco, cannabis.
•Pheromones are released by females like in all Lepidopterans.
•Pheromone blend release consists of a lead SCLP component of
9Z,12E-tetradecadienyl acetate
9Z,E12-tertadeanienyl acetate
14
S. exigua adult
S. exigua larvae

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Hemipterans – Spodopteraexigua– Input data scoring
15
Endpoint Value used for calculations Scoring/Rationale Source
RIO •0.26 ng/h
•1 – reliable without restrictions - Volatile
collection with adsorbents using internal
standard / Peer reviewed literature
Acínet al, (2010).
IPP
•50% tookfor calulations(1 individualper
cottonballwith / ratio of 1:1
•1 – reliable without restrictions - Peer
reviewed literature
Smith, (1989)
PPH
•1500000 kg /ha
•3.5 g weight of single cottonball
•1 – reliable without restrictions - Peer
reviewed literature
Banuri, (1998)

21. Restricted Use - À usage restreint
Hemipterans – Spodopteraexigua- calculation
16
Where:
PRR (Population Release Rate) = release rate of the semiochemical from a justified high population of
the source organism in nanograms per hectare and hour (ng/ha/h).
RIO (Release of an individual organism) = release rate of the semiochemical by an individual organism
in one hour (ng/h).
NRO (Number of Releasing Organisms) = number of releasing organisms per hectare.
�????????????=????????????� �??????�
�????????????=????????????� ×??????��× PPH
PRR = 0.26 ng/h ×0.5× (1500000 kg /0.0035 kg)= 55 710 000 ng/ha/h =
55.7 mg /ha / h

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Hemipterans - Halyomorpha halys
•Ubiquitous and invasive species - feed on a wide array of plants
including apples, apricots, Asian pears, cherries, corn, grapes, lima
beans, peaches, peppers, tomatoes, and soybeans.
•Pheromones are released by males which in combination with
vibrational signals attract females for mating.
•Pheromone release consists of 2 main components being a mixture of
enentiomeres of: (3S,6S,7R,10S)-10,11-epoxy-1-bisabolen-3-ol and
(3R,6S,7R,10S)-10,11-epoxy-1-bisabolen-3-ol
(3R,6S,7R,10S)-10,11-epoxy-1-bisabolen-3-ol (3S,6S,7R,10S)-10,11-epoxy-1-bisabolen-3-ol
17
H. halys adult
H. halys eggs and nymphs

23. Restricted Use - À usage restreint
Hemipterans - Halyomorpha halys – Input data scoring
18
Endpoint Value used for calculations Scoring/Rationale Source
RIO •125 ng/h
•1 – reliable without restrictions - Volatile
collection with adsorbents using internal
standard / Peer reviewed literature
Harris et. al. (2015)
IPP
•160 per plant (320/2) – based on
number of individuals per plant of 320
and / ratio of 1:1
•1 – reliable without restrictions - Peer
reviewed literature Bergmann et. al. (2016)
PPH •1000 trees/ha
•1 – reliable without restrictions - Peer
reviewed literature
Wang et. al. (2015)

24. Restricted Use - À usage restreint
Hemipterans - Halyomorpha halys - calculation
19
Where:
PRR (Population Release Rate) = release rate of the semiochemical from a justified high population of
the source organism in nanograms per hectare and hour (ng/ha/h).
RIO (Release of an individual organism) = release rate of the semiochemical by an individual organism
in one hour (ng/h).
NRO (Number of Releasing Organisms) = number of releasing organisms per hectare.
�????????????=????????????� �??????�
�????????????=????????????� ×??????��× PPH
PRR = 125 ng/h ×160× 1000 = 20 000 000 ng/ha/h = 20 mg /ha / h

25. Restricted Use - À usage restreint
Hemipterans - Planococcus ficus
•Important vineyard pest that feed on all parts of the grape vine plant
and weedy plants. They are found on apples, avocados, banana, date
palm, fig, mango, and citrus fruits.
•Pheromones are released by females, which are sessile attracting
mobile males.
•Pheromone release consists of 2 main components being a mixture of
enentiomeres of: (S)-Lavandulyl senecioate and (R)-Lavandulyl
senecioate
(S)-Lavandulyl senecioate
20
P. ficus female
P. ficus winged males

26. Restricted Use - À usage restreint
Hemipterans - Planococcus ficus – Input data scoring - (S)-Lavandulyl senecioate
21
Endpoint Value used for calculations Scoring/Rationale Source
RIO •1.5 ng/h
•1 – reliable without restrictions - Volatile
collection with adsorbents using internal
standard / Peer reviewed literature
Levi-Zada et al., (2014).
IPP •750 per plant
•1 – reliable without restrictions - Peer
reviewed literature Lentini etal. (2008)
PPH •10000 vines/ha
•1 – reliable without restrictions - Peer
reviewed literature
Hunter, (1998); Grainger, (2009)

27. Restricted Use - À usage restreint
Hemipterans - Planococcus ficus – Input data scoring - (R)-Lavandulyl senecioate
22
Endpoint Value used for calculations Scoring/Rationale Source
RIO* •0.3 ng/h**
•1 – reliable without restrictions - Volatile
collection with adsorbents using internal
standard / PhD Thesis
Dublon, (2009)
IPP
•540 per plant (1080/2) – based on
number of individuals per plant of 1080
and / ratio of 1:1
•1 – reliable without restrictions - Peer
reviewed literature
Seal et al., (2013)
Araújo et al. (2007)
PPH •350000 plants/ha
•1 – reliable without restrictions - Peer
reviewed literature
Canko, (2014)
* P. ficus pheromone contains (R)-Lavandulyl senecioate, however it was not investigated in this species. A vicinal positional isomer [(R)-Lavandulyl 3-
methyl-3-butenoate] has been described to be the aggregation pheromone of the Melon thrip (Thrips palmi Karny) . As based on QSAR evaluation both
(R)-Lavandulyl senecioate and [(R)-Lavandulyl 3-methyl-3-butenoate shall be extremely similar in terms of toxicology and environmental fate it can be
used as a SURROGATE for calculations.
** Due to lack of data for P. ficus values are taken from a closely-related species of Frankliniella occidentalis.

28. Restricted Use - À usage restreint
Hemipterans - Planococcus ficus – Calculation - (S)-Lavandulyl senecioate
23
Where:
PRR (Population Release Rate) = release rate of the semiochemical from a justified high population of
the source organism in nanograms per hectare and hour (ng/ha/h).
RIO (Release of an individual organism) = release rate of the semiochemical by an individual organism
in one hour (ng/h).
NRO (Number of Releasing Organisms) = number of releasing organisms per hectare.
�????????????=????????????� �??????�
�????????????=????????????� ×??????��× PPH
PRR = 1.5 ng/h ×750× 10000 = 11 250 000 ng/ha/h = 11.3 mg /ha / h

29. Restricted Use - À usage restreint
Hemipterans - Planococcus ficus – Calculation - (R)-Lavandulyl senecioate
24
Where:
PRR (Population Release Rate) = release rate of the semiochemical from a justified high population of
the source organism in nanograms per hectare and hour (ng/ha/h).
RIO (Release of an individual organism) = release rate of the semiochemical by an individual organism
in one hour (ng/h).
NRO (Number of Releasing Organisms) = number of releasing organisms per hectare.
�????????????=????????????� �??????�
�????????????=????????????� ×??????��× PPH
PRR = 0.3 ng/h ×540× 350000 = 56 700 000 ng/ha/h = 56.7 mg /ha / h

30. Restricted Use - À usage restreint
Confirm method suitability with experimental phase
Propose harmonised natural background levels for a set of semiochemicals commonly
uses in plant protection in OECD countries (e.g. SCLPs, Mealybugs, …)
Refine the process including an additional step of verifying the reliability of the
peer-reviewed input data
Provide examples of the applicability of the method
Finalsteps
25

31. Restricted Use - À usage restreint
Harmonised Natural Background levels
•In the proposed update of OECD Semiochemical Guideline in Appendix VI the calculation method has been applied to
derive natural exposure levels for 16 Straight-Chained Lepidopteran Pheromones (SCLPs) and for the pheromones emitted
by 7 Hemiptera species.
26
LEPIDOPTERA
Species Sex pheromone molecule
Natural
background
(mg/ha*h)
Anarsia lineatella (E)-5-decen-1-yl acetate 7.8
Anarsia lineatella E-5-decen-1-ol 1.4
Trichoplusia ni (Z)-7-dodecen-1-yl acetate 99.0
Grapholita molesta (E)-8-dodecen-1-yl acetate 0.7
Grapholita molesta (Z)-8-dodecen-1-yl acetate 16.9
Grapholita molesta Z-8-dodecenol 5.1
Eupoecilia ambiguella(Z)-9-dodecen-1-yl acetate 31.3
Lobesia botrana (E,Z)-7,9-dodecadien-1-yl acetate 4.5
Adoxophyes orana (Z)-9-tetradecen-1-yl acetate 9.7
Platynota stultana (Z)-11-tetradecen-1-yl acetate 3.5
Spodoptera exigua (Z, E)-9,12-tetradecadien-1-yl acetate 55.7
Plutella xylostella Z-11-hexadecen-1-yl acetate 7.5
Cydia pomonella E,E-8,10-dodecadien-1-ol 9.1
Helicoverpa assulta Z-9-hexadecenal 36.4
Helicoverpa armigeraZ-11-hexadecenal 10.8
Eoreuma loftini Z-13-octadecenal 4.34
HEMIPTERA
Species Sex pheromone molecule
Natural
background
(mg/ha*h)
Pseudococcus longispinus
(2-(1,5,5-trimethylcyclopent-2-
en-1-yl)ethyl acetate)
1.31
Pseudococcus viburni
(1R*,2R*,3S*)-(2,3,4,4-
tetramethylcyclopentyl) methyl
acetate
0.57
Delottococcus aberiae
(4,5,5-trimethyl-3-
methylenecyclopent-1-en-1-yl)
methyl acetate
0.59
Planococcus citri Planococcyl acetate 2.24
Planococcus ficus (S)-Lavandulyl senecioate 11.2
Planococcus ficus (R)-Lavandulyl senecioate 56.7
Aonidiella aurantii Rescalure 2.23 to 25.3
Halyomorpha halys (3S,6S,7R,10S)-10,11-epoxy-1-
bisabolen-3-ol
20
Halyomorpha halys (3R,6S,7R,10S)-10,11-epoxy-1-
bisabolen-3-ol
20

32. Restricted Use - À usage restreint
Harmonised Natural Background levels
•The highest natural background level observed for SCLPs is 99.0
mg/ha*h, derived from Trichoplusia ni. In contrast, Hemiptera
pheromones present greater challenges in data availability, with
the highest value recorded being 25 mg/ha*h for Aonidiella
aurantii.
•Given these findings, it is proposed to extend the group approach
to align with natural background levels. A harmonized threshold
value of 99.0 mg/ha per hour is recommended for SCLPs, while a
threshold of 25 mg/ha per hour is suggested for Hemiptera and
terpenoid-like sex pheromones. In practice those values can be
used in conjunction with duration of infestation to propose a
yearly thresholdd to compare with the GAP table proposed for a
given product.
•It is important to note that multiplying the threshold value
identified for SCLPs by the expected duration of a pest infestation
(approximately 160 days, covering three generations) results in a
value of 380 g/ha per year. This is consistent with the threshold
values adopted in several geographies for SCLPs, such as 375 g/ha
per year specified in the Chilean Resolución Extenta 2082-2022
and the U.S. EPA threshold of 150 g/acre per year (equivalent to
375 g/ha per year) under FIFRA 40 CFR 158.2050 and 40 CFR
180.1153.
27

33. Restricted Use - À usage restreint
IBMA
International Biocontrol
Manufacturers Association AISBL
Rue de Trèves 61
1040 Brussels
Belgium
WWW.IBMA-GLOBAL.ORG
Thank you
28

34. Session 3: Risk Assessment of Semiochemicals
The EU amended Guidance Document on
Semiochemicals SANTE GD 12815/2014 -rev. 11
January 2024
Eric Liégeois,
European Commission, DG SANTE
Unit SANTE E.4, Pesticides and Biocides

35. Background of EU GD
•Basedon OECD Guidancedocument -Series on Pesticides No. 12.
•Aimedat providing practical solutions on how procedures and data
requirements can be applied to facilitate the approval of semiochemicals.
•No obligationtoauthorisesemiochemicals when:
•usedonlytoattractarthropodskilledbyaninsecticideorbyothermeans(e.g.bait).
•usedintrapstoattractarthropodsonlyforthepurposeofmonitoring.
•Straight Chain Lepidopteran Pheromones (SCLPs) well known group,
approval renewed mid-2022.
•Structural and functional definition: “unbranched, aliphaticshaving a chain of nine
to eighteen carbons, containing up to three double bonds, ending in an alcohol, acetate or
aldehyde functional group”

36. SCLPs
(Z)-9-Hexadecenal (SCLP -Aldehydes)
(Z)-11-Hexadecenal (SCLP -Aldehydes)
(Z)-13-Octadecenal (SCLP -Aldehydes)
(Z)-7-Tetradecenal (SCLP -Aldehydes)
(
E,Z)-2,13-Octadecadien-1-yl acetate (SCLP Acetates)
(E,E)-7,9-Dodecadien-1-yl acetate (SCLP - Acetates)
(Z,E)-7,11-Hexadecadien-1-yl acetate (SCLP - Acetates)
(Z,Z)-7,11-Hexadecadien-1-yl acetate (SCLP - Acetates)
(E,E)-8,10-Dodecadien-1-yl acetate (SCLP - Acetates)
(E)-8-Dodecen-1-yl acetate (SCLP - Acetates)
(Z)-11-Tetradecen-1-yl acetate (SCLP - Acetates)
(Z)-8-Dodecen-1-yl acetate (SCLP - Acetates)
(Z)-9-Dodecen-1-yl acetate (SCLP - Acetates)
(Z)-9-Tetradecen-1-yl acetate (SCLP - Acetates)
Dodecyl acetate (SCLP - Acetates)
(E,Z,Z)-3,8,11-Tetradecatrien-1-yl acetate (SCLP -
Acetates)
(E,Z)-3,8-Tetradecadien-1-yl acetate (SCLP - Acetates)
(Z)-8-Tetradecen-1-yl acetate (SCLP - Acetates)
n-Tetradecylacetate (SCLP - Acetates)
(E,Z)-7,9-Dodecadien-1-yl acetate (SCLP - Acetates)
(E)-5-Decen-1-yl acetate (SCLP - Acetates)
(E,Z)-3,13-Octadecadien-1-yl acetate (SCLP - Acetates)
(E)-5-Decen-1-ol (SCLP - Alcohols)
(E,E)-8,10-Dodecadien-1-ol (SCLP - Alcohols)
(Z)-11-Hexadecen-1-ol (SCLP - Alcohols)
(Z)-8-Dodecen-1-ol (SCLP - Alcohols)
Dodecan-1-ol (SCLP - Alcohols)
(Z)-8-Tetradecen-1-ol (SCLP - Alcohols)
Tetradecan-1-ol (SCLP - Alcohols)
(Z)-9-Tetradecen-1-ol (SCLP - Alcohols)
Alcohols
Aldehydes
Acetates

37. Amendment of EU GD
•Basedon a scientific literature review carried in FR (cooperation authorities
and IBMA France).
•Methodical screening of publicly available scientific publications.
•Expert judgement for classification of the findings, which was based on
different level of molecular similarities and structural analogies with the
SCLP group as defined
•➔ 3 new groups of substances listed with their related “pests”

38. AmendedGD with3 new groups
1.Straight Chain Arthropod Pheromones (SCAPs) – Appendix I:
SCLP definition (“structurally compliant”) + possible triple bonds
Disrupt Coleoptera, Diptera, Hemiptera, Acarida, Hymenoptera, Thysanoptera
2.Other Chained Arthropod Pheromones (OCAPs) – Appendix II:
structurally similar to SCLPs definition, i.e. consisting of acyclic,
branched or unbranched aliphatics, containing a five to thirty carbons,
zero to three unsaturated bonds and having zero to several functional
alcohol, ester, aldehyde, ketone or epoxide groups
Disrupt Coleoptera, Diptera, Hemiptera, Acarida, Hymenoptera,Thysanoptera

39. AmendedGD with3 new groups
3.Other Arthropod Pheromones (OAPs) – Appendix III :
not directly structurally related to SCLPs definition, i.e. consisting of
branched or unbranched aromatic or aliphatic (straight or cyclic)
hydrocarbons and containing two to thirty carbons zero to several
unsaturated bonds and having zero to several functional alcohol, ester,
aldehyde, ketone or epoxide groups.
Disrupt Coleoptera, Diptera, Hemiptera, Acarida, Hymenoptera,Thysanoptera

40. Groups of semiochemicals

41. Non-exhaustive listsin Appendixes
Example of Appendix II -OCAPs

42. ✓ Part A if:
ochemical substance (including semio-chemicals, extracts…)
oa metabolite produced by a micro-organism when:
➢metabolite purified from the micro-organism; or
➢metabolite (not purified) from a producing micro-organism which is no longer capable of replication or transferring
genetic material
✓Part Bifmicro-organism capable of replication or transferring genetic material (including
metabolites, if part of the mode of action)
EU Data requirements defined in Reg 283/2013
9

43. Point 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 ajustification is provided showing that:
(a)it isnotnecessaryowing to thenature of the plant protection product or its proposed uses, or it is
notscientificallynecessary; or
(b)it istechnicallynotpossibletosupply
General introduction of data requirements –
waiving possibilities
10

44. General introduction of data requirements –
waiving possibilities
11
The 3 new groups (SCAP, OCAP and OAP) could potentially be approved in the same
group as SCLP, subject to confirmation as regards their toxicological similarities with
the group of SCLP or subject to a peer review.
→ Extrapolating from one semiochemical active substance to another (read-across)
can be considered when accompanied by evidence of comparable relevant properties.
→Application of non-testing methods (e.g. the use of validated (Q)SAR models) could
also be taken into account when doing the assessment
→ Actual exposure due to the passive or active diffusion to be compared with natural
background levels.

45. Way forward
•We have three groups and similarities defined with SCLP
•We have three lists attached to the 3 groups with “responding” pests and
scientific references
•We have “need to know” approach based on :
✓Similarities between group members as regards properties, specificities, mode of action
✓QSAR to predict toxic concerns compared to known SCLPs
✓Methodologies to compare natural background levels with actual exposure
➔ Semi-quantitative risk assessment should be possible and accelerate
approvals of new semiochemicals

46. For this group of substances of low-concern, a ‘NEED TO KNOW’
approach to be recommended
A fit for purpose risk assessment driven by a problem formulation step!
https://food.ec.europa.eu/document/download/c4d6b7df-b7f9-4b3b-8ce5-
b823ccdcf98c_en?filename=pesticides_ppp_app-proc_guide_horiz_problem-formulation-era.pdf

47. 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
14

48. Keep in touch
EU Spotify
ec.europa.eu/
europa.eu/
@EU_Commission
@EuropeanCommission
European Commission
europeancommission
@Europea nCommission
@EuropeanCommission
EUTube
15

49. Restricted Use -À usage restreint
Debunking
Myths About
Semiochemicals
OECD Biopesticide EG –26 Feb 2025
Alessandra Moccia

50. Restricted Use - À usage restreint
Briefrecap, let’stune ourantennae
2
Lymantriadispar •Semiochemicals are substances naturally emitted by plants, animals
and other organisms used for intra-species and/or inter-species
communication
•They are poorly soluble in water, volatile and rapidly degrade in
the environment (according to their biological function).
•When used for pest control purposes, they do not have a -cydal
mode of action, i.e. they are not killing agents, and they are used at
concentrations comparable to those occurring during a natural
infestation
•Semiochemicals are intrinsically characterised by a low toxicity: they
have a non-toxic and target specific mode of action
•They are exempt from residue setting in most geographies

51. Restricted Use - À usage restreint
Platformscurrentlyauthorised formatingdistruption
3
VP formulations
AE formulations
CS formulations

52. Restricted Use - À usage restreint
Platformscurrentlyauthorised formatingdistruption
4
VP formulations
AE formulations
CS formulations
Theyare
ALL
dispensers
MACRO
Passive
Dispensers
MICRO
Passive
Dispensers
Active
Dispensers

53. Restricted Use - À usage restreint
Platformscurrentlyauthorised formatingdistruption
5
VP formulations
AE formulations
CS formulations
Theyare
ALL
dispensers
Retrievable
Passive
Dispensers
Unretrievable
Passive
Dispensers
Retrievable
Active
Dispensers
Oneof themostimportantand
technicalaspectswithpheromone
productsistoobtaina
controlledrelease

54. Restricted Use - À usage restreint
Goodbyepheromone
6

55. Restricted Use - À usage restreint
01
02
03
04
The wallsof themicrocapsulesare
naturally-occurring substances
All CS formulationsand anysprayable
formulationsare micro-dispensers
Theyare notnew. Theyhavebeen
aroundfor20 years
Liquidformulationscan representa benefit
for some growers in terms of resources
The truth about microcapsules and liquid formulations
7
Pheromone
coformulants
AIR
Capsule wall

56. Restricted Use - À usage restreint
Howdo sex pheromonesworkin nature?
8
Pheromone Plume: cast and surge model
•Alternation of clean air and pockets of pheromone is necessary
•Pheromone must dissipate rapidly

57. Restricted Use - À usage restreint
Howdo sex pheromonesworkin nature?
9
Pheromone perception in the antenna
Pheromone/odour molecule

58. Restricted Use - À usage restreint
Pheromone molecules are emitted into the air
Pheromone molecules are perceived by the antennae of the target species
The system is solely composed of pheromone molecules and the receptors in the
target species’ antennae
Howdo sex pheromonesworkin nature?
10
Climatic conditions, crop density or phenology and indoor/outdoor
settings play no role in the system and have no effect on it

59. Restricted Use - À usage restreint
EPPO PP 1/296 (1)
Principles of efficacy evaluation for low-risk plant protection products. Section 9.3
11
Existingguidelines
“Semiochemicals are often pest specific and act by modifying behaviour.
The plant species is not relevant in relation to the product’s performance.
For that reason, extrapolation is possible to other crops in which the same
pest appears.
In the case semiochemicals that have multiple targets, extrapolation to a
group of related species is possible”

60. Restricted Use - À usage restreint
Efficacyconclusions
Once efficacy on a target species has been demonstrated, it can be extrapolated
to:
•All crops
•All conditions (open crops, protected crops, greenhouse)
•All geographies*
Regardless of their ‘low-risk’ status or classification
12
* When extrapolating to other geographies, it is important to take intro account two factors:
•Potential influence of the temperature on the controlled release of the pheromone from the product
•Number of target species generations to be controlled and longevity of the product
Both aspects can be evaluated under laboratory conditions and no further efficacy tests are necessary from a
scientific point of view

61. Restricted Use - À usage restreint
Aquatic testing and semiochemicals intrinsic characteristics
13
Substance Watersolubility20°C Vapour pressureat 20°C
Rescalure 0.71 mg/L 150 mPa
Lavandulyl senecioate0.005 -6 mg/L 1700 Pa
SCLP Acetates 0.25 -138 mg/L 1 -1085 mPa
SCLP Aldehydes 0.1 –0.3 mg/L 13 –175 mPa
SCLP Alcohols 0.2 mg/L 1.5 –1360 mPa
•Poorly soluble in water
→Solvents need to be added
•Highly volatile
→Closed systems may be used
•Rapidly degrade in the environment
→Semi-static systems
(not always possible)
→Use stabilizers
Experimental DT
50
SOIL Experimental DT
50
WATER CalculatedDT
50
AIR
1.33 hours 0.13 days (ca. 3 hours)0.83 hours (ca. 50 minutes)
SCLP (E,E)-8,10-dodecadienol

62. Restricted Use - À usage restreint
Example: EU aquatic toxicity assessments of semiochemicals
14
Rescalure
0
(3 QSAR)
0
EFSA Conclusion
The risk to birds, mammals, aquatic organisms, bees, earthworms and soil macro- and
microorganisms, terrestrial non-target plants and methods for sewage treatment plants was considered as
low, being the exposure from the representative use in the range of natural occurrence.
Lavandulyl senecioate3 0
EFSA Conclusion
The available studies on aquatic organisms were not considered sufficiently reliable due to shortcomings
(i.e. test concentrations not fully maintained).
SCLPs 32 4
Review Report
7. List of studies to be generated
No further information was identified which is at this stage considered necessary in relation to the approval
of Straight Chain Lepidopteran Pheromones.
EFSA Conclusion
[…] In the absence of any valid studies, this approach could not be followed for fish and aquatic
invertebrates and, thus, the risk assessment could not be finalised
EU RAR Vol 3 B9
Some studies (indicated with *) were not considered valid or acceptable due to the lack of analytical
measurements or in the case the validity criteria set in the current guidelines were not fulfilled.
In other studies (indicated with **) the maintenance of the exposure concentrations during the tests was
not demonstrated, since the measured concentrations were detected at the beginning of the tests but
were below the LOQ or LOD at the end of the tests.
Substance
Experimental data
Europeanassessment
TotalAcceptable

63. Restricted Use - À usage restreint
Example: EU aquatic toxicity assessments of semiochemicals
15
Rescalure
0
(3 QSAR)
0
EFSA Conclusion
The risk to birds, mammals, aquatic organisms, bees, earthworms and soil macro- and
microorganisms, terrestrial non-target plants and methods for sewage treatment plants was considered as
low, being the exposure from the representative use in the range of natural occurrence.
Lavandulyl senecioate3 0
EFSA Conclusion
The available studies on aquatic organisms were not considered sufficiently reliable due to shortcomings
(i.e. test concentrations not fully maintained).
SCLPs 32 4
Review Report
7. List of studies to be generated
No further information was identified which is at this stage considered necessary in relation to the approval
of Straight Chain Lepidopteran Pheromones.
EFSA Conclusion
[…] In the absence of any valid studies, this approach could not be followed for fish and aquatic
invertebrates and, thus, the risk assessment could not be finalized.
EU RAR Vol 3 B9
Some studies (indicated with *) were not considered valid or acceptable due to the lack of analytical
measurements or in the case the validity criteria set in the current guidelines were not fulfilled.
In other studies (indicated with **) the maintenance of the exposure concentrations during the tests was
not demonstrated, since the measured concentrations were detected at the beginning of the tests but
were below the LOQ or LOD at the end of the tests.
Substance
Experimental data
Europeanassessment
TotalAcceptable

64. Restricted Use - À usage restreint
Istherea more appropriatepath?
16
If aquatic organisms are not exposed to an active substance due to its physico
chemical properties, is it appropriate to conduct artificially forced studies which
do not satisfy current validation criteria?
If aquatic organisms are not exposed to an active substance due to its
physicochemical properties and the product formulation, is it appropriate to
calculate a classification and apply it when it is not representative of the reality?

65. Restricted Use - À usage restreint
IBMA
International Biocontrol
Manufacturers Association AISBL
Rue de Trèves 61
1040 Brussels
Belgium
WWW.IBMA-GLOBAL.ORG
Thank you
17