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Mixtures:
What is Essential to Know for Risk Assessment
26th February 2024, Paris, France
Korinna Wend
German Federal Institute for Risk Assessment
Agenda
Data requirements
Precautionary sentence
Co-formulants
Publication
Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France
2/12
Data requirements for formulations
Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France
3/12
- Regulations
- EU: Commission Regulation EU (No) 284/2013;
its amending version: Commission Regulation (EU) 2022/1440
- US: Title 40, Chapter I, Subchapter E, Part 158,
Subpart V, § 158.2120 of the Code of Federal Regulations
- Approach to consider 3-R principles
1. Medical data
2. Weight of evidence approach
3. Toxicological studies
Data requirements for formulations
Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France
4/12
OPPTS / OECD Guideline / Other
Data requirements US EU
Acute oral tox. 870.1100 / 425 420,423
Acute dermal tox. 870.1200 / 402 402
Acute inhalation tox. 870.1300 / 403 403, 436
Acute dermal irritation 870.2500 / 404 404
in vitro tests acc. to OECD TG 430, 431, 435, 439
IATA for Skin Corrosion and Irritation, No. 203
Acute eye irritation 870.2400 / 405 405
in vitro tests acc. to OECD TG 437, 438, 460, 491, 492
Dermal sensitization 870.26001 / 4291 406, 429, 497
in vitro tests acc. to 442A, 442B, 442C, 442D, 442E
Additional toxicity information submitted case by case based on expert judgement case-by-case acc. to Reg
284/2013
1 Due to default label statement, dermal sensitization studies are not run for all TGAI and formulated products. Their applicability for microbial products is currently under discussion.
Reference: Wend, K., Zorrilla, L., Freimoser, F.M., Gallet, Armel, Microbial pesticides – challenges and future perspectives for testing and safety assessment with respect to human health. Submitted to Environmental Health in January 2024
Data requirements for formulations
Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France
5/12
 In vivo studies
 In vitro studies
 IATA
 NAMs
 ATE calculation method
OPPTS / OECD Guideline / Other
Data requirements US EU
Acute oral tox. 870.1100 / 425 420,423
Acute dermal tox. 870.1200 / 402 402
Acute inhalation tox. 870.1300 / 403 403, 436
Acute dermal irritation 870.2500 / 404 404
in vitro tests acc. to OECD TG 430, 431, 435, 439
IATA for Skin Corrosion and Irritation, No. 203
Acute eye irritation 870.2400 / 405 405
in vitro tests acc. to OECD TG 437, 438, 460, 491,
492
Dermal sensitization 870.26001 / 4291 406, 429, 497
in vitro tests acc. to 442A, 442B, 442C, 442D,
442E
Additional toxicity information submitted case by case based on expert judgement case-by-case acc. to
Reg 284/2013
1 Due to default label statement, dermal sensitization studies are not run for all TGAI and formulated products.
Their applicability for microbial products is currently under discussion.
Precautionary sentence – German proposal
Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France
6/12
- Two options for the label
Proposed sentence Explanation
"May have the potential to cause skin and/or respiratory
sensitization".
This phrase shall always be assigned as a precautionary statement (i.e., as a non-
specific risk mitigation measure) to a PPP containing a microorganism; personal
protective measures must be specified in these cases.
"May cause skin and/or respiratory sensitization". This phrase shall be assigned to a PPP containing a micro-organism where there is
clear evidence from experimental systems, documented human exposure or
available scientific literature that the PPP may show sensitizing effects; if the
attribution criteria is fulfilled for this second phrase, the first phrase will not apply.
Personal protective measures must be specified in these cases.
Reference: Wend, K., Zorrilla, L., Freimoser, F.M., Gallet, Armel, Microbial pesticides – challenges and future perspectives for testing and safety assessment with respect to human health. Submitted to Environmental Health in January 2024
Precautionary sentence – German proposal
Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France
7/12
- Four options for the scientific document
Proposed sentences
MAY HAVE THE POTENTIAL TO CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION.
MAY CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION and add the phrase "and there is evidence from animal studies (e.g., XY, 20XX) that the
microorganism ... is a skin /respiratory sensitizer".
MAY CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION and add the phrase "and there is evidence from human observations (e.g., XY, 20XX)
that the microorganism ... is a skin / respiratory sensitizer”.
MAY CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION and add the phrase "and there is evidence from animal studies (e.g., XY, 20XX) and
human observations (e.g., XY, 20XX) that the microorganism ... is a skin / respiratory sensitizer”.
Reference: Wend, K., Zorrilla, L., Freimoser, F.M., Gallet, Armel, Microbial pesticides – challenges and future perspectives for testing and safety assessment with respect to human health. Submitted to Environmental Health in January 2024
Precautionary sentence – German proposal
Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France
8/12
- Proposed consequences
 Sentence 1: low risk for MO
 Sentences 2-4: exclusion from low risk for MO
Proposed sentences
MAY HAVE THE POTENTIAL TO CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION.
MAY CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION and add the phrase "and there is evidence from
animal studies (e.g., XY, 20XX) that the microorganism ... is a skin /respiratory sensitizer".
MAY CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION and add the phrase "and there is evidence from
human observations (e.g., XY, 20XX) that the microorganism ... is a skin / respiratory sensitizer”.
MAY CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION and add the phrase "and there is evidence from
animal studies (e.g., XY, 20XX) and human observations (e.g., XY, 20XX) that the microorganism ... is a skin /
respiratory sensitizer”.
Co-formulants: assessment of their toxicological profile
(PPP containing chemical a.s.)
Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France
9/12
- Proposed EFSA approach from September 2023:
 Check whether the components added in the formulation(s) are listed as co-formulants which are not accepted
for inclusion in PPPs as referred to in Article 27 Commission Regulation (EU) 2021/383of 3 March 2021 amending
Annex III to Regulation (EC) No 1107/2009
 Assess the data submitted by the applicant and if needed complete by collecting all available data on each
component added in the formulation for representative uses other than the active substance
 List information from legal framework
 Evaluate the toxicological profile
Co-formulants: assessment of their toxicological profile
(PPP containing chemical a.s.)
Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France
10/12
 List information from legal framework
 Chemical
 Biocide active substance
 Pesticide active substance
 Cosmetic ingredient
 Feed additive
 Food additive
 Food contact material
 Excipient with a known action or effect
 Classification under CLP Regulation
 JMPR-FAO
 US EPA
 Canada: Pest Management Regulatory Agency (PRMA)
 Australia: Australian Pesticides and Veterinary Medicines Authority (APVMA)
Publication
Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France
11/12
Wend, K., Zorrilla, L., Freimoser, F.M., Gallet, Armel,
Microbial pesticides – challenges and future perspectives for testing and safety assessment
with respect to human health.
 Submitted to Environmental Health in January 2024
Publication
Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France
12/12
Wend, K., Zorrilla, L., Freimoser, F.M., Gallet, Armel, Microbial pesticides – challenges and future perspectives for testing and safety assessment with respect to human health.
Acknowledgement
The authors gratefully thank the reviewers for their valued comments on this document
(in alphabetical order):
Andrew, David Bothe, Hanno Borges, Shannon Brown, Patience
Burgdorf, Tanja Deserio, Domenico Dunst, Sebastian Feustel, Sabrina
Herman, Lieve Martin, Sabine Marx-Stoelting, Philip Michalski, Britta
Oelgeschlaeger, Michael Paege, Norman Sachana, Magdalini Tralau, Tewes
Visconti, Nicolo Webb, Elizabeth Zikova-Kloas, Andrea
Thank you
Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France
13
German Federal Institute for Risk Assessment
bfr.bund.de/en
Consumer health protection to go
BfR2GO – the BfR Science Magazine
bfr.bund.de/en/science_magazine_bfr2go.html
Follow us
@bfrde | @bfren | @Bf3R_centre
@bfrde
soundcloud.com/risikobewertung
linkedin.com/company/bundesinstitut-f-r-risikobewertung
youtube.com/@bfr_bund
social.bund.de/@bfr
Korinna Wend, PhD, ERT
phone +49 30 18412-0
Korinna.wend@bfr.bund.de

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How to Identify and Quantify Mixtures What is Essential to Know for Risk Assessment by Korinna Wend

  • 1. Mixtures: What is Essential to Know for Risk Assessment 26th February 2024, Paris, France Korinna Wend German Federal Institute for Risk Assessment
  • 2. Agenda Data requirements Precautionary sentence Co-formulants Publication Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France 2/12
  • 3. Data requirements for formulations Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France 3/12 - Regulations - EU: Commission Regulation EU (No) 284/2013; its amending version: Commission Regulation (EU) 2022/1440 - US: Title 40, Chapter I, Subchapter E, Part 158, Subpart V, § 158.2120 of the Code of Federal Regulations - Approach to consider 3-R principles 1. Medical data 2. Weight of evidence approach 3. Toxicological studies
  • 4. Data requirements for formulations Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France 4/12 OPPTS / OECD Guideline / Other Data requirements US EU Acute oral tox. 870.1100 / 425 420,423 Acute dermal tox. 870.1200 / 402 402 Acute inhalation tox. 870.1300 / 403 403, 436 Acute dermal irritation 870.2500 / 404 404 in vitro tests acc. to OECD TG 430, 431, 435, 439 IATA for Skin Corrosion and Irritation, No. 203 Acute eye irritation 870.2400 / 405 405 in vitro tests acc. to OECD TG 437, 438, 460, 491, 492 Dermal sensitization 870.26001 / 4291 406, 429, 497 in vitro tests acc. to 442A, 442B, 442C, 442D, 442E Additional toxicity information submitted case by case based on expert judgement case-by-case acc. to Reg 284/2013 1 Due to default label statement, dermal sensitization studies are not run for all TGAI and formulated products. Their applicability for microbial products is currently under discussion. Reference: Wend, K., Zorrilla, L., Freimoser, F.M., Gallet, Armel, Microbial pesticides – challenges and future perspectives for testing and safety assessment with respect to human health. Submitted to Environmental Health in January 2024
  • 5. Data requirements for formulations Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France 5/12  In vivo studies  In vitro studies  IATA  NAMs  ATE calculation method OPPTS / OECD Guideline / Other Data requirements US EU Acute oral tox. 870.1100 / 425 420,423 Acute dermal tox. 870.1200 / 402 402 Acute inhalation tox. 870.1300 / 403 403, 436 Acute dermal irritation 870.2500 / 404 404 in vitro tests acc. to OECD TG 430, 431, 435, 439 IATA for Skin Corrosion and Irritation, No. 203 Acute eye irritation 870.2400 / 405 405 in vitro tests acc. to OECD TG 437, 438, 460, 491, 492 Dermal sensitization 870.26001 / 4291 406, 429, 497 in vitro tests acc. to 442A, 442B, 442C, 442D, 442E Additional toxicity information submitted case by case based on expert judgement case-by-case acc. to Reg 284/2013 1 Due to default label statement, dermal sensitization studies are not run for all TGAI and formulated products. Their applicability for microbial products is currently under discussion.
  • 6. Precautionary sentence – German proposal Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France 6/12 - Two options for the label Proposed sentence Explanation "May have the potential to cause skin and/or respiratory sensitization". This phrase shall always be assigned as a precautionary statement (i.e., as a non- specific risk mitigation measure) to a PPP containing a microorganism; personal protective measures must be specified in these cases. "May cause skin and/or respiratory sensitization". This phrase shall be assigned to a PPP containing a micro-organism where there is clear evidence from experimental systems, documented human exposure or available scientific literature that the PPP may show sensitizing effects; if the attribution criteria is fulfilled for this second phrase, the first phrase will not apply. Personal protective measures must be specified in these cases. Reference: Wend, K., Zorrilla, L., Freimoser, F.M., Gallet, Armel, Microbial pesticides – challenges and future perspectives for testing and safety assessment with respect to human health. Submitted to Environmental Health in January 2024
  • 7. Precautionary sentence – German proposal Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France 7/12 - Four options for the scientific document Proposed sentences MAY HAVE THE POTENTIAL TO CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION. MAY CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION and add the phrase "and there is evidence from animal studies (e.g., XY, 20XX) that the microorganism ... is a skin /respiratory sensitizer". MAY CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION and add the phrase "and there is evidence from human observations (e.g., XY, 20XX) that the microorganism ... is a skin / respiratory sensitizer”. MAY CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION and add the phrase "and there is evidence from animal studies (e.g., XY, 20XX) and human observations (e.g., XY, 20XX) that the microorganism ... is a skin / respiratory sensitizer”. Reference: Wend, K., Zorrilla, L., Freimoser, F.M., Gallet, Armel, Microbial pesticides – challenges and future perspectives for testing and safety assessment with respect to human health. Submitted to Environmental Health in January 2024
  • 8. Precautionary sentence – German proposal Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France 8/12 - Proposed consequences  Sentence 1: low risk for MO  Sentences 2-4: exclusion from low risk for MO Proposed sentences MAY HAVE THE POTENTIAL TO CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION. MAY CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION and add the phrase "and there is evidence from animal studies (e.g., XY, 20XX) that the microorganism ... is a skin /respiratory sensitizer". MAY CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION and add the phrase "and there is evidence from human observations (e.g., XY, 20XX) that the microorganism ... is a skin / respiratory sensitizer”. MAY CAUSE SKIN AND/OR RESPIRATORY SENSITIZATION and add the phrase "and there is evidence from animal studies (e.g., XY, 20XX) and human observations (e.g., XY, 20XX) that the microorganism ... is a skin / respiratory sensitizer”.
  • 9. Co-formulants: assessment of their toxicological profile (PPP containing chemical a.s.) Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France 9/12 - Proposed EFSA approach from September 2023:  Check whether the components added in the formulation(s) are listed as co-formulants which are not accepted for inclusion in PPPs as referred to in Article 27 Commission Regulation (EU) 2021/383of 3 March 2021 amending Annex III to Regulation (EC) No 1107/2009  Assess the data submitted by the applicant and if needed complete by collecting all available data on each component added in the formulation for representative uses other than the active substance  List information from legal framework  Evaluate the toxicological profile
  • 10. Co-formulants: assessment of their toxicological profile (PPP containing chemical a.s.) Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France 10/12  List information from legal framework  Chemical  Biocide active substance  Pesticide active substance  Cosmetic ingredient  Feed additive  Food additive  Food contact material  Excipient with a known action or effect  Classification under CLP Regulation  JMPR-FAO  US EPA  Canada: Pest Management Regulatory Agency (PRMA)  Australia: Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • 11. Publication Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France 11/12 Wend, K., Zorrilla, L., Freimoser, F.M., Gallet, Armel, Microbial pesticides – challenges and future perspectives for testing and safety assessment with respect to human health.  Submitted to Environmental Health in January 2024
  • 12. Publication Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France 12/12 Wend, K., Zorrilla, L., Freimoser, F.M., Gallet, Armel, Microbial pesticides – challenges and future perspectives for testing and safety assessment with respect to human health. Acknowledgement The authors gratefully thank the reviewers for their valued comments on this document (in alphabetical order): Andrew, David Bothe, Hanno Borges, Shannon Brown, Patience Burgdorf, Tanja Deserio, Domenico Dunst, Sebastian Feustel, Sabrina Herman, Lieve Martin, Sabine Marx-Stoelting, Philip Michalski, Britta Oelgeschlaeger, Michael Paege, Norman Sachana, Magdalini Tralau, Tewes Visconti, Nicolo Webb, Elizabeth Zikova-Kloas, Andrea
  • 13. Thank you Wend | The 12th Expert Group on BioPesticides, Seminar on "Problem formulation for the risk assessment of biopesticides | 26.02.2024 | Paris, France 13
  • 14. German Federal Institute for Risk Assessment bfr.bund.de/en Consumer health protection to go BfR2GO – the BfR Science Magazine bfr.bund.de/en/science_magazine_bfr2go.html Follow us @bfrde | @bfren | @Bf3R_centre @bfrde soundcloud.com/risikobewertung linkedin.com/company/bundesinstitut-f-r-risikobewertung youtube.com/@bfr_bund social.bund.de/@bfr Korinna Wend, PhD, ERT phone +49 30 18412-0 Korinna.wend@bfr.bund.de