• Open Access

Scientific Opinion on the safety and efficacy of vitamin K3 (menadione sodium bisulphite and menadione nicotinamide bisulphite) as a feed additive for all animal species

Authors

  • EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)


  • Panel members: Gabriele Aquilina, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf
  • Correspondence: feedap@efsa.europa.eu
  • Acknowledgement: The Panel wishes to thank the members of the Working Group on Vitamins, including Jürgen Gropp, Georges Bories and Alberto Mantovani, for the preparatory work on this scientific opinion.
  • Adoption date: 5 December 2013
  • Published date: 16 January 2014
  • Question number: EFSA-Q-2012-00111
  • On request from: European Commission

Abstract

Vitamin K describes a group of lipophilic vitamins that exist naturally in two forms: vitamin K1 (phylloquinone, found in green plants) and vitamin K2 (a group of menaquinones synthesised by bacteria in the intestine). Vitamin K3 (or menadione) is a synthetic form of vitamin K without a side chain. To become active, menadione needs to undergo prenylation. Vitamins K1, K2 and K3 are metabolically activated in the liver to become co-factors in the activation of vitamin K-dependent proteins, which are important for normal blood coagulation, and normality of bones and arteries (Gla proteins). Acute toxicity of menadione or its derivatives is reached at levels exceeding the requirements by a factor of at least 1 000. Menadione sodium bisulphite (MSB) and menadione nicotinamide bisulphite (MNB) are safe for all animal species at practical use levels in feed. The use of MSB in water for drinking is likely to increase the exposure of target animals to chromium(VI). Therefore, the FEEDAP Panel has concerns about the safety of MSB when administered by this route. The use of MSB and MNB in animal nutrition does not give rise to safety concerns for consumers. MSB is an eye irritant; in the absence of adequate data, the additive should be considered as a skin sensitiser. In the absence of data, MNB should be considered as irritant to skin and eyes and as a skin sensitiser. Considering the high dusting potential of MSB and MNB, the absence of data on inhalation toxicity and the chromium(VI) content of dust, inhalation exposure resulting from handling of MSB and MNB could be hazardous. The use of MSB and MNB in animal nutrition does not pose a risk to the environment. MSB and MNB are regarded as effective sources of vitamin K in animal nutrition.

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