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Part 1:
CLE Contribution on the Assessment
of Innovative Biochemicals in the EU
Status update Q1-24
Rosa Criollo (FMC Corporation)
on behalf of the CLE Biopesticides Expert Group
Our industry is committed to the development of novel solutions for
agriculture
Innovative solutions to farmer, our goal
Industry aims to develop solutions that are:
▪ Innovative
▪ Effective
▪ Sustainable
CLE member companies are actively developing
novel solutions including:
▪ Conventional chemistry
▪ Biopesticides
▪ Digital
Our 2030 Commitments support the European
Green Deal policy initiative.
2
This Biochemicals contribution document describes how an applicant may prepare a dossier
for the assessment, in the context of an approval or renewal the approval of a biochemical active
substance, in view of the provision set in the point 1.5 of the introduction of the annexes of
Regulations (EU) No 283/2013 and No 284/2013. Where applicable, this document makes use of
approaches developed under guidance documents such as SANTE/12815/2014 rev. 5.2 and
SANCO/11470/2012 rev. 8.
Exemplary list of Biochemicals:
➢ Nature-identical synthetic plant extracts / nature-derived but functionally identical
➢ RNA
➢ Peptides and proteins, including enzymes and antibodies
➢ Dead cell, fermentation material, microbial extracts
➢ Metabolites from micro-organisms (purified)
Biochemicals
3
CropLife Europe drafted a Biochemicals contribution document, with the following
objectives:
– To identify and to propose a suitable data package to address EU Regulatory framework –
Lessons learnt from EC Reg 283/2013 and 284/2013, and from other regulatory bodies
addressing the human health and environmental safety of any novel technology.
– To identify and to propose suitable risk assessment requirements for those technologies.
CLE presented its contribution document in Nov-22 to EU COM BioPPP WG → Q:
How many submissions?; and in Nov-23 to OECD Biopesticides meeting
participation.
– To communicate aggregated figures to the EU COM and Member States to encourage
development of a fit for purpose regulatory framework for “Biochemicals”, an anonymous
SURVEY of 6 questions to map out the potential number and type of "biochemicals" (e.g.,
proteins, enzymes, RNA, etc.) that could enter in the EU market in the coming years. The
survey was launched in Dec-23.
– CLE members have shared the link to this survey with other companies/trades associations to
invite them to complete the survey.
– The survey is currently ongoing and publicly available, managed by a third-party legal firm.
The report will be available for any participant.
Background
4
Where are we?
5
➢ Technical Sub-team to the CLE
BioPPP EG dedicated to
development of this contribution
document including case studies.
➢ CLE regulatory expert teams
finalizing the technical commenting
(familiar with EC Reg 283/2013 and
284/2013).
• Common DR → CLE internal experts input
completed
• Specific DR to each biopesticide
technology (case studies) → CLE internal
experts ongoing
Data requirements on a “need to know
basis” (DR)
Public information, safe use
history, weight of evidence
approach…
6
Where are we? – Case Studies
7
➢ Case studies in discussion
(status: draft) under CLE
technical commenting:
✓ Case study 1 - Dead cells
✓ Case study 2 - Metabolites
from micro-organisms
(purified)
✓ Case study 3 - Peptide(s)-
based Plant Protection
Product (PPP), including
antibodies & enzymes (See
Part 2)
✓ Case study 4 - RNA-based
active substances
Example of Data requirements addressing
human toxicology according to EU REG 1107/2009
8
Endpoint OECD No Proposal CLE EG* Comment
Genotoxicity
QSAR n.a.
471 and 487
Follow up of
positives: 489,
488 or 470
(1) Literature/ TTC: if exposure <TTC, no need for data
generation
(2) QSAR on mutagenicity/clastogenicity
(3) If not appropriately covered (i.e. no literature, out of
applicability domain of QSAR or positive QSAR), then Ames and
MNT in vitro
(4) Any in vitro positive needs in vivo follow up (added to
repeated dose study if possible)
Adding TTC
Testing: In-line with most EFSA
panels
Detailed guidance really
important (not only “address”),
otherwise likely holdup of
registration process due to
different interpretation of
member states/EFSA vs.
applicant
Reproductive
toxicity
1. Is exposure of pregnant individuals expected as a result of the
ppp use?
2. History of safe use/health benefit/literature incl. regulatory
databases/ ToxCast
3. TTC/Safe use when threshold can be defined/has been defined
by regulators
4. As a last resort: Rat developmental tox (unless concern can be
excluded based on OECD 421/22)
No fertility study unless triggered by findings in reproductive organs
in the 90d study, and these findings driving the NOAEL
(reproductive organ weights/histopathology which are purely a
secondary consequence of body weight effects are not considered
relevant)
…”address” repro/dev if cannot
be excluded based on repeated
dose
*CropLife Europe Human Health Expert Group (H2EG)
Example of Data requirements addressing ecotoxicology
according to EU REG 1107/2009
9
Endpoint
CLE proposal
OECD no Proposal CLE EG* Comment
8.1.1 Acute oral
toxicity to birds
OECD 223 Base data
Assess available toxicity data from mammalian studies
or QSAR data.
Potential for dietary exposure should be assessed
e.g., soil application, ready biodegradable, metabolism
assessment.
Strategy should be aligned with principles of
3Rs to avoid unnecessary vertebrate testing.
8.1.1.3 Sub-chronic
and reproductive
toxicity to birds
OECD 206 Conditional.
Chronic risk can be assessed by applying 10x safety
factor to the acute bird LD50 (EFSA guidance, 2009; 7
(12):1438).
Study should only be conducted if acceptable
risk cannot be demonstrated, or evidence
indicates long-term toxicity
8.1.2.1 Acute oral
toxicity to mammals
Conditional
Data point address with toxicological requirements
(Data point 5.2.1). Further acute studies to address
ecotox assessment required
8.1.2.2 Long term and
reproduction toxicity
to mammals
Conditional.
Data point address with toxicological requirements
(Data point 5.6.1 and 5.6.2) Further acute studies to
address ecotox assessment not required
8.2.1 Acute toxicity to
fish
OECD 203 Base dataset
Study with one species, Rainbow trout.
Perform study at limit dose in line the
recommendation in the updated Central zone
ecotox manual
8.2.2.1 Fish early life
stage toxicity test
OECD 210 Conditional.
Use WoE justification to consider exposure (ready
biodegradability, low predicted exposure to water)
If acute toxicity LC50 is <1 mg/L ELS study should be
required.
Study should only be conducted if acceptable
risk cannot be demonstrated or evidence to
indicate long-term toxicity. Setting of the
MATC for endocrine studies could be used to
inform chronic risks if needed e.g. if MATC is
>1/10 of the LC50 then an OECD 210 should
be conducted
*CropLife Europe Environment Expert Group (EEG)
Milestones, and what is next?
Upcoming Milestone
* CLE Expert Groups consulted: Residues and efficacy still ongoing
1. Biochemical contribution Doc v1 complete Q2-22
2. Biochemical contribution Doc v1 shared with EU COM BioPPP WG – Nov-22 → Survey preparation
4. Draft case study peptides presented to EU COM BioPPP WG – Nov-23
3. CLE SURVEY on biochemicals in EU – Dec-23 to Mar-24
5. Explore potential collaboration with IBMA – 2023
8. Biochemical contribution Doc v2 including case studies to be shared with DG
SANTE BioPPP WG – planned in Q2-24
6. Biochemical contribution Doc v2 – Completed
Case studies under review by CLE EG’s – Q2-23-2024*
7. CLE Survey & related dissemination activities: Q2- Q4 24
10
We all agree - to support the access of the market to innovative products, such
as biopesticides and uses, a more flexible and modern approaches (data
requirements/risk assessment) are needed. How can we support this for
biopesticides?
➢ CLE approach considered different but precisely defined technologies, defining data
requirements to cover a wide range of novel technologies biopesticides.
➢ CLE approach focuses on identifying what studies (data package) would be the most
suitable scientific data to address biochemical pesticides (common and specific) → to
contribute to and support the development of specific guidance document(s) aiming fit
for purpose submissions/evaluations – See Part 2.
➢ A dedicated regulatory framework to cover a wide range of novel biopesticides
technologies to support innovation.
Conclusions
11
To consider the CLE Contribution document in the development of a
regulatory framework for Biochemicals with the ultimate goal to have a fit for
purpose data requirements in Europe for novel biopesticides, as already in
place in other OECD countries.
Can OECD support the EU COM BioPPP WG in the development of
technical guidance documents addressing the absence of EU technical data
requirements for novel biopesticides?
What is CLE asking to be considered?
11
Many thanks for your
attention!

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CLE Contribution on the Assessment of Innovative Biochemicals in the EU Status update Q1-24 by Rosa Crillo

  • 1. Part 1: CLE Contribution on the Assessment of Innovative Biochemicals in the EU Status update Q1-24 Rosa Criollo (FMC Corporation) on behalf of the CLE Biopesticides Expert Group
  • 2. Our industry is committed to the development of novel solutions for agriculture Innovative solutions to farmer, our goal Industry aims to develop solutions that are: ▪ Innovative ▪ Effective ▪ Sustainable CLE member companies are actively developing novel solutions including: ▪ Conventional chemistry ▪ Biopesticides ▪ Digital Our 2030 Commitments support the European Green Deal policy initiative. 2
  • 3. This Biochemicals contribution document describes how an applicant may prepare a dossier for the assessment, in the context of an approval or renewal the approval of a biochemical active substance, in view of the provision set in the point 1.5 of the introduction of the annexes of Regulations (EU) No 283/2013 and No 284/2013. Where applicable, this document makes use of approaches developed under guidance documents such as SANTE/12815/2014 rev. 5.2 and SANCO/11470/2012 rev. 8. Exemplary list of Biochemicals: ➢ Nature-identical synthetic plant extracts / nature-derived but functionally identical ➢ RNA ➢ Peptides and proteins, including enzymes and antibodies ➢ Dead cell, fermentation material, microbial extracts ➢ Metabolites from micro-organisms (purified) Biochemicals 3
  • 4. CropLife Europe drafted a Biochemicals contribution document, with the following objectives: – To identify and to propose a suitable data package to address EU Regulatory framework – Lessons learnt from EC Reg 283/2013 and 284/2013, and from other regulatory bodies addressing the human health and environmental safety of any novel technology. – To identify and to propose suitable risk assessment requirements for those technologies. CLE presented its contribution document in Nov-22 to EU COM BioPPP WG → Q: How many submissions?; and in Nov-23 to OECD Biopesticides meeting participation. – To communicate aggregated figures to the EU COM and Member States to encourage development of a fit for purpose regulatory framework for “Biochemicals”, an anonymous SURVEY of 6 questions to map out the potential number and type of "biochemicals" (e.g., proteins, enzymes, RNA, etc.) that could enter in the EU market in the coming years. The survey was launched in Dec-23. – CLE members have shared the link to this survey with other companies/trades associations to invite them to complete the survey. – The survey is currently ongoing and publicly available, managed by a third-party legal firm. The report will be available for any participant. Background 4
  • 5. Where are we? 5 ➢ Technical Sub-team to the CLE BioPPP EG dedicated to development of this contribution document including case studies. ➢ CLE regulatory expert teams finalizing the technical commenting (familiar with EC Reg 283/2013 and 284/2013).
  • 6. • Common DR → CLE internal experts input completed • Specific DR to each biopesticide technology (case studies) → CLE internal experts ongoing Data requirements on a “need to know basis” (DR) Public information, safe use history, weight of evidence approach… 6
  • 7. Where are we? – Case Studies 7 ➢ Case studies in discussion (status: draft) under CLE technical commenting: ✓ Case study 1 - Dead cells ✓ Case study 2 - Metabolites from micro-organisms (purified) ✓ Case study 3 - Peptide(s)- based Plant Protection Product (PPP), including antibodies & enzymes (See Part 2) ✓ Case study 4 - RNA-based active substances
  • 8. Example of Data requirements addressing human toxicology according to EU REG 1107/2009 8 Endpoint OECD No Proposal CLE EG* Comment Genotoxicity QSAR n.a. 471 and 487 Follow up of positives: 489, 488 or 470 (1) Literature/ TTC: if exposure <TTC, no need for data generation (2) QSAR on mutagenicity/clastogenicity (3) If not appropriately covered (i.e. no literature, out of applicability domain of QSAR or positive QSAR), then Ames and MNT in vitro (4) Any in vitro positive needs in vivo follow up (added to repeated dose study if possible) Adding TTC Testing: In-line with most EFSA panels Detailed guidance really important (not only “address”), otherwise likely holdup of registration process due to different interpretation of member states/EFSA vs. applicant Reproductive toxicity 1. Is exposure of pregnant individuals expected as a result of the ppp use? 2. History of safe use/health benefit/literature incl. regulatory databases/ ToxCast 3. TTC/Safe use when threshold can be defined/has been defined by regulators 4. As a last resort: Rat developmental tox (unless concern can be excluded based on OECD 421/22) No fertility study unless triggered by findings in reproductive organs in the 90d study, and these findings driving the NOAEL (reproductive organ weights/histopathology which are purely a secondary consequence of body weight effects are not considered relevant) …”address” repro/dev if cannot be excluded based on repeated dose *CropLife Europe Human Health Expert Group (H2EG)
  • 9. Example of Data requirements addressing ecotoxicology according to EU REG 1107/2009 9 Endpoint CLE proposal OECD no Proposal CLE EG* Comment 8.1.1 Acute oral toxicity to birds OECD 223 Base data Assess available toxicity data from mammalian studies or QSAR data. Potential for dietary exposure should be assessed e.g., soil application, ready biodegradable, metabolism assessment. Strategy should be aligned with principles of 3Rs to avoid unnecessary vertebrate testing. 8.1.1.3 Sub-chronic and reproductive toxicity to birds OECD 206 Conditional. Chronic risk can be assessed by applying 10x safety factor to the acute bird LD50 (EFSA guidance, 2009; 7 (12):1438). Study should only be conducted if acceptable risk cannot be demonstrated, or evidence indicates long-term toxicity 8.1.2.1 Acute oral toxicity to mammals Conditional Data point address with toxicological requirements (Data point 5.2.1). Further acute studies to address ecotox assessment required 8.1.2.2 Long term and reproduction toxicity to mammals Conditional. Data point address with toxicological requirements (Data point 5.6.1 and 5.6.2) Further acute studies to address ecotox assessment not required 8.2.1 Acute toxicity to fish OECD 203 Base dataset Study with one species, Rainbow trout. Perform study at limit dose in line the recommendation in the updated Central zone ecotox manual 8.2.2.1 Fish early life stage toxicity test OECD 210 Conditional. Use WoE justification to consider exposure (ready biodegradability, low predicted exposure to water) If acute toxicity LC50 is <1 mg/L ELS study should be required. Study should only be conducted if acceptable risk cannot be demonstrated or evidence to indicate long-term toxicity. Setting of the MATC for endocrine studies could be used to inform chronic risks if needed e.g. if MATC is >1/10 of the LC50 then an OECD 210 should be conducted *CropLife Europe Environment Expert Group (EEG)
  • 10. Milestones, and what is next? Upcoming Milestone * CLE Expert Groups consulted: Residues and efficacy still ongoing 1. Biochemical contribution Doc v1 complete Q2-22 2. Biochemical contribution Doc v1 shared with EU COM BioPPP WG – Nov-22 → Survey preparation 4. Draft case study peptides presented to EU COM BioPPP WG – Nov-23 3. CLE SURVEY on biochemicals in EU – Dec-23 to Mar-24 5. Explore potential collaboration with IBMA – 2023 8. Biochemical contribution Doc v2 including case studies to be shared with DG SANTE BioPPP WG – planned in Q2-24 6. Biochemical contribution Doc v2 – Completed Case studies under review by CLE EG’s – Q2-23-2024* 7. CLE Survey & related dissemination activities: Q2- Q4 24 10
  • 11. We all agree - to support the access of the market to innovative products, such as biopesticides and uses, a more flexible and modern approaches (data requirements/risk assessment) are needed. How can we support this for biopesticides? ➢ CLE approach considered different but precisely defined technologies, defining data requirements to cover a wide range of novel technologies biopesticides. ➢ CLE approach focuses on identifying what studies (data package) would be the most suitable scientific data to address biochemical pesticides (common and specific) → to contribute to and support the development of specific guidance document(s) aiming fit for purpose submissions/evaluations – See Part 2. ➢ A dedicated regulatory framework to cover a wide range of novel biopesticides technologies to support innovation. Conclusions 11
  • 12. To consider the CLE Contribution document in the development of a regulatory framework for Biochemicals with the ultimate goal to have a fit for purpose data requirements in Europe for novel biopesticides, as already in place in other OECD countries. Can OECD support the EU COM BioPPP WG in the development of technical guidance documents addressing the absence of EU technical data requirements for novel biopesticides? What is CLE asking to be considered? 11
  • 13. Many thanks for your attention!