Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Helle Katrine Knutsen, Jan Alexander, Lars Barregård, Margherita Bignami, Beat Brüschweiler, Sandra Ceccatelli, Bruce Cottrill, Michael Dinovi, Bettina Grasl-Kraupp, Christer Hogstrand, Laurentius (Ron) Hoogenboom, Carlo Stefano Nebbia, Isabelle P. Oswald, Annette Petersen, Martin Rose, Alain-Claude Roudot, Tanja Schwerdtle, Christiane Vleminckx, Günter Vollmer, Heather Wallace & 14 others Sarah De Saeger, Gunnar Sundstøl Eriksen, Peter Farmer, Jean-Marc Fremy, Yun Yun Gong, Karsten Meyer, Dominique Parent-Massin, Hans van Egmond, Andrea Altieri, Paolo Colombo, Zsuzsanna Horvath, Sara Levorato, Lutz Edler, EFSA Panel on Contaminants in the Food Chain (CONTAM)

Research output: Contribution to journalArticle

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Abstract

4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the available data set, human acute and chronic health‐based guidance values (HBGV) were established based on data obtained in clinical trials of DAS as an anticancer agent (anguidine) after intravenous administration to cancer patients. The CONTAM Panel considered these data as informative for the hazard characterisation of DAS after oral exposure. The main adverse effects after acute and repeated exposure were emesis, with a no‐observed‐adverse‐effect level (NOAEL) of 32 μg DAS/kg body weight (bw), and haematotoxicity, with a NOAEL of 65 μg DAS/kg bw, respectively. An acute reference dose (ARfD) of 3.2 μg DAS/kg bw and a tolerable daily intake (TDI) of 0.65 μg DAS/kg bw were established. Based on over 15,000 occurrence data, the highest acute and chronic dietary exposures were estimated to be 0.8 and 0.49 μg DAS/kg bw per day, respectively, and were not of health concern for humans. The limited information for poultry, pigs and dogs indicated a low risk for these animals at the estimated DAS exposure levels under current feeding practices, with the possible exception of fattening chicken. Assuming similar or lower sensitivity than for poultry, the risk was considered overall low for other farm and companion animal species for which no toxicity data were available. In consideration of the similarities of several trichothecenes and the likelihood of co‐exposure via food and feed, it could be appropriate to perform a cumulative risk assessment for this group of substances.
Original languageEnglish
Article numbere05367
Number of pages106
JournalEFSA Journal
Volume16
Issue number8
Early online date16 Aug 2018
DOIs
Publication statusPublished - Aug 2018

Fingerprint

animal and human health
body weight
farmed animal species
cumulative risk assessment
poultry
diacetoxyscirpenol
toxicity
hazard characterization
acceptable daily intake
trichothecenes
dietary exposure
antineoplastic agents
food contamination
food chain
intravenous injection
mycotoxins
pets
Fusarium
pharmacokinetics
laboratory animals

Keywords

  • 4,15 ‐ diacetoxyscirpenol
  • DAS
  • anguidine
  • MAS
  • exposure
  • toxicity
  • human and animal risk assessment

Cite this

Knutsen, H. K., Alexander, J., Barregård, L., Bignami, M., Brüschweiler, B., Ceccatelli, S., ... EFSA Panel on Contaminants in the Food Chain (CONTAM) (2018). Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed. EFSA Journal, 16(8), [e05367]. https://doi.org/10.2903/j.efsa.2018.5367

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed. / Knutsen, Helle Katrine ; Alexander, Jan; Barregård, Lars; Bignami, Margherita; Brüschweiler, Beat ; Ceccatelli, Sandra; Cottrill, Bruce; Dinovi, Michael; Grasl-Kraupp, Bettina ; Hogstrand, Christer ; Hoogenboom, Laurentius (Ron) ; Nebbia, Carlo Stefano ; Oswald, Isabelle P.; Petersen, Annette ; Rose, Martin ; Roudot, Alain-Claude ; Schwerdtle, Tanja ; Vleminckx, Christiane ; Vollmer, Günter ; Wallace, Heather; De Saeger, Sarah; Eriksen, Gunnar Sundstøl; Farmer, Peter; Fremy, Jean-Marc; Gong, Yun Yun; Meyer, Karsten; Parent-Massin, Dominique ; van Egmond, Hans; Altieri, Andrea; Colombo, Paolo; Horvath, Zsuzsanna; Levorato, Sara; Edler, Lutz; EFSA Panel on Contaminants in the Food Chain (CONTAM).

In: EFSA Journal, Vol. 16, No. 8, e05367, 08.2018.

Research output: Contribution to journalArticle

Knutsen, HK, Alexander, J, Barregård, L, Bignami, M, Brüschweiler, B, Ceccatelli, S, Cottrill, B, Dinovi, M, Grasl-Kraupp, B, Hogstrand, C, Hoogenboom, LR, Nebbia, CS, Oswald, IP, Petersen, A, Rose, M, Roudot, A-C, Schwerdtle, T, Vleminckx, C, Vollmer, G, Wallace, H, De Saeger, S, Eriksen, GS, Farmer, P, Fremy, J-M, Gong, YY, Meyer, K, Parent-Massin, D, van Egmond, H, Altieri, A, Colombo, P, Horvath, Z, Levorato, S, Edler, L & EFSA Panel on Contaminants in the Food Chain (CONTAM) 2018, 'Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed', EFSA Journal, vol. 16, no. 8, e05367. https://doi.org/10.2903/j.efsa.2018.5367
Knutsen HK, Alexander J, Barregård L, Bignami M, Brüschweiler B, Ceccatelli S et al. Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed. EFSA Journal. 2018 Aug;16(8). e05367. https://doi.org/10.2903/j.efsa.2018.5367
Knutsen, Helle Katrine ; Alexander, Jan ; Barregård, Lars ; Bignami, Margherita ; Brüschweiler, Beat ; Ceccatelli, Sandra ; Cottrill, Bruce ; Dinovi, Michael ; Grasl-Kraupp, Bettina ; Hogstrand, Christer ; Hoogenboom, Laurentius (Ron) ; Nebbia, Carlo Stefano ; Oswald, Isabelle P. ; Petersen, Annette ; Rose, Martin ; Roudot, Alain-Claude ; Schwerdtle, Tanja ; Vleminckx, Christiane ; Vollmer, Günter ; Wallace, Heather ; De Saeger, Sarah ; Eriksen, Gunnar Sundstøl ; Farmer, Peter ; Fremy, Jean-Marc ; Gong, Yun Yun ; Meyer, Karsten ; Parent-Massin, Dominique ; van Egmond, Hans ; Altieri, Andrea ; Colombo, Paolo ; Horvath, Zsuzsanna ; Levorato, Sara ; Edler, Lutz ; EFSA Panel on Contaminants in the Food Chain (CONTAM). / Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed. In: EFSA Journal. 2018 ; Vol. 16, No. 8.
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abstract = "4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the available data set, human acute and chronic health‐based guidance values (HBGV) were established based on data obtained in clinical trials of DAS as an anticancer agent (anguidine) after intravenous administration to cancer patients. The CONTAM Panel considered these data as informative for the hazard characterisation of DAS after oral exposure. The main adverse effects after acute and repeated exposure were emesis, with a no‐observed‐adverse‐effect level (NOAEL) of 32 μg DAS/kg body weight (bw), and haematotoxicity, with a NOAEL of 65 μg DAS/kg bw, respectively. An acute reference dose (ARfD) of 3.2 μg DAS/kg bw and a tolerable daily intake (TDI) of 0.65 μg DAS/kg bw were established. Based on over 15,000 occurrence data, the highest acute and chronic dietary exposures were estimated to be 0.8 and 0.49 μg DAS/kg bw per day, respectively, and were not of health concern for humans. The limited information for poultry, pigs and dogs indicated a low risk for these animals at the estimated DAS exposure levels under current feeding practices, with the possible exception of fattening chicken. Assuming similar or lower sensitivity than for poultry, the risk was considered overall low for other farm and companion animal species for which no toxicity data were available. In consideration of the similarities of several trichothecenes and the likelihood of co‐exposure via food and feed, it could be appropriate to perform a cumulative risk assessment for this group of substances.",
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AU - Knutsen, Helle Katrine

AU - Alexander, Jan

AU - Barregård, Lars

AU - Bignami, Margherita

AU - Brüschweiler, Beat

AU - Ceccatelli, Sandra

AU - Cottrill, Bruce

AU - Dinovi, Michael

AU - Grasl-Kraupp, Bettina

AU - Hogstrand, Christer

AU - Hoogenboom, Laurentius (Ron)

AU - Nebbia, Carlo Stefano

AU - Oswald, Isabelle P.

AU - Petersen, Annette

AU - Rose, Martin

AU - Roudot, Alain-Claude

AU - Schwerdtle, Tanja

AU - Vleminckx, Christiane

AU - Vollmer, Günter

AU - Wallace, Heather

AU - De Saeger, Sarah

AU - Eriksen, Gunnar Sundstøl

AU - Farmer, Peter

AU - Fremy, Jean-Marc

AU - Gong, Yun Yun

AU - Meyer, Karsten

AU - Parent-Massin, Dominique

AU - van Egmond, Hans

AU - Altieri, Andrea

AU - Colombo, Paolo

AU - Horvath, Zsuzsanna

AU - Levorato, Sara

AU - Edler, Lutz

AU - EFSA Panel on Contaminants in the Food Chain (CONTAM)

N1 - The CONTAM Panel wishes to thank the hearing expert Chiara Dall'Asta, the WG member Hanspeter Naegeli and the EFSA staff member Mari Eskola for the support provided to this scientific output. The CONTAM Panel acknowledges all European competent institutions and other stakeholders that provided occurrence data on DAS in food and feed, and supported the data collection for the Comprehensive European Food Consumption database. Adopted: 29 June 2018

PY - 2018/8

Y1 - 2018/8

N2 - 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the available data set, human acute and chronic health‐based guidance values (HBGV) were established based on data obtained in clinical trials of DAS as an anticancer agent (anguidine) after intravenous administration to cancer patients. The CONTAM Panel considered these data as informative for the hazard characterisation of DAS after oral exposure. The main adverse effects after acute and repeated exposure were emesis, with a no‐observed‐adverse‐effect level (NOAEL) of 32 μg DAS/kg body weight (bw), and haematotoxicity, with a NOAEL of 65 μg DAS/kg bw, respectively. An acute reference dose (ARfD) of 3.2 μg DAS/kg bw and a tolerable daily intake (TDI) of 0.65 μg DAS/kg bw were established. Based on over 15,000 occurrence data, the highest acute and chronic dietary exposures were estimated to be 0.8 and 0.49 μg DAS/kg bw per day, respectively, and were not of health concern for humans. The limited information for poultry, pigs and dogs indicated a low risk for these animals at the estimated DAS exposure levels under current feeding practices, with the possible exception of fattening chicken. Assuming similar or lower sensitivity than for poultry, the risk was considered overall low for other farm and companion animal species for which no toxicity data were available. In consideration of the similarities of several trichothecenes and the likelihood of co‐exposure via food and feed, it could be appropriate to perform a cumulative risk assessment for this group of substances.

AB - 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the available data set, human acute and chronic health‐based guidance values (HBGV) were established based on data obtained in clinical trials of DAS as an anticancer agent (anguidine) after intravenous administration to cancer patients. The CONTAM Panel considered these data as informative for the hazard characterisation of DAS after oral exposure. The main adverse effects after acute and repeated exposure were emesis, with a no‐observed‐adverse‐effect level (NOAEL) of 32 μg DAS/kg body weight (bw), and haematotoxicity, with a NOAEL of 65 μg DAS/kg bw, respectively. An acute reference dose (ARfD) of 3.2 μg DAS/kg bw and a tolerable daily intake (TDI) of 0.65 μg DAS/kg bw were established. Based on over 15,000 occurrence data, the highest acute and chronic dietary exposures were estimated to be 0.8 and 0.49 μg DAS/kg bw per day, respectively, and were not of health concern for humans. The limited information for poultry, pigs and dogs indicated a low risk for these animals at the estimated DAS exposure levels under current feeding practices, with the possible exception of fattening chicken. Assuming similar or lower sensitivity than for poultry, the risk was considered overall low for other farm and companion animal species for which no toxicity data were available. In consideration of the similarities of several trichothecenes and the likelihood of co‐exposure via food and feed, it could be appropriate to perform a cumulative risk assessment for this group of substances.

KW - 4,15 ‐ diacetoxyscirpenol

KW - DAS

KW - anguidine

KW - MAS

KW - exposure

KW - toxicity

KW - human and animal risk assessment

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DO - 10.2903/j.efsa.2018.5367

M3 - Article

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