TY - JOUR
T1 - Appropriateness to set a group health based guidance value for nivalenol and its modified forms
AU - Knutsen, Helle Katrine
AU - Barregård, Lars
AU - Bignami, Margherita
AU - Brüschweiler, Beat
AU - Ceccatelli, Sandra
AU - Cottrill, Bruce
AU - Dinovi, Michael
AU - Edler, Lutz
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 - Dall'Asta, Chiara
AU - Gutleb, Arno C
AU - Metzler, Manfred
AU - Parent-Massin, Dominique
AU - Binaglia, Marco
AU - Steinkellner, Hans
AU - Alexander, Jan
AU - EFSA Panel on Contaminants in the Food Chain (CONTAM)
N1 - The Panel wishes to thank the members of the Working Group on HBGV for mycotoxins and their modified forms: Jan Alexander, Chiara Dall'Asta, Arno Gutleb, Manfred Metzler, Isabelle P Oswald and Dominique Parent‐Massin for the preparatory work on this scientific output, and the EFSA staff members: Marco Binaglia and Hans Steinkellner for the support provided to this scientific output.
Adopted: 15 March 2017
PY - 2017/4
Y1 - 2017/4
N2 - The EFSA Panel on Contaminants in the Food Chain (CONTAM) reviewed new studies on nivalenol since the previous opinion on nivalenol published in 2013, but as no new relevant data were identified the tolerable daily intake (TDI) for nivalenol (NIV) of 1.2 ?g/kg body weight (bw) established on bases of immuno- and haematotoxicity in rats was retained. An acute reference dose (ARfD) of 14 ?g/kg bw was established based on acute emetic events in mink. The only phase I metabolite of NIV identified is de-epoxy-nivalenol (DE-NIV) and the only phase II metabolite is nivalenol-3-glucoside (NIV3Glc). DE-NIV is devoid of toxic activity and was thus not further considered. NIV3Glc can occur in cereals amounting up to about 50% of NIV. There are no toxicity data on NIV3Glc, but as it can be assumed that it is hydrolysed to NIV in the intestinal tract it should be included in a group TDI and in a group ARfD with NIV. The uncertainty associated with the present assessment is considered as high and it would rather overestimate than underestimate any risk.
AB - The EFSA Panel on Contaminants in the Food Chain (CONTAM) reviewed new studies on nivalenol since the previous opinion on nivalenol published in 2013, but as no new relevant data were identified the tolerable daily intake (TDI) for nivalenol (NIV) of 1.2 ?g/kg body weight (bw) established on bases of immuno- and haematotoxicity in rats was retained. An acute reference dose (ARfD) of 14 ?g/kg bw was established based on acute emetic events in mink. The only phase I metabolite of NIV identified is de-epoxy-nivalenol (DE-NIV) and the only phase II metabolite is nivalenol-3-glucoside (NIV3Glc). DE-NIV is devoid of toxic activity and was thus not further considered. NIV3Glc can occur in cereals amounting up to about 50% of NIV. There are no toxicity data on NIV3Glc, but as it can be assumed that it is hydrolysed to NIV in the intestinal tract it should be included in a group TDI and in a group ARfD with NIV. The uncertainty associated with the present assessment is considered as high and it would rather overestimate than underestimate any risk.
KW - nivalenol
KW - modified forms
KW - group health based guidance value
U2 - 10.2903/j.efsa.2017.4751
DO - 10.2903/j.efsa.2017.4751
M3 - Article
SN - 1831-4732
VL - 15
JO - EFSA Journal
JF - EFSA Journal
IS - 4
M1 - e04751
ER -