TY - JOUR
T1 - Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed
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
U2 - 10.2903/j.efsa.2018.5367
DO - 10.2903/j.efsa.2018.5367
M3 - Article
VL - 16
JO - EFSA Journal
JF - EFSA Journal
SN - 1831-4732
IS - 8
M1 - e05367
ER -