Appropriateness to set a group health based guidance value for nivalenol and its modified forms

Helle Katrine Knutsen, Lars Barregård, Margherita Bignami, Beat Brüschweiler, Sandra Ceccatelli, Bruce Cottrill, Michael Dinovi, Lutz Edler, 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 WallaceChiara Dall'Asta, Arno C Gutleb, Manfred Metzler, Dominique Parent-Massin, Marco Binaglia, Hans Steinkellner, Jan Alexander, EFSA Panel on Contaminants in the Food Chain (CONTAM)

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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.
Original languageEnglish
Article numbere04751
Number of pages25
JournalEFSA Journal
Issue number4
Early online date19 Apr 2017
Publication statusPublished - Apr 2017

Bibliographical note

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


  • nivalenol
  • modified forms
  • group health based guidance value


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