Scientific Opinion on the safety and efficacy of vitamin D3 (cholecalciferol) as a feed additive for all animal species or categories based on a dossier submitted by Lohmann Animal Health GmbH

nutritional additive, vitamins and pro-vitamins, vitamin D3, cholecalciferol, safety
First published in the EFSA Journal
20 February 2014
Adopted
30 January 2014
Last Updated
19 March 2015. This version replaces the previous one/s.
Type
Scientific Opinion

Abstract

The principal physiological role of vitamin D in all vertebrates is in calcium and phosphorus homeostasis. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) notes that for turkeys for fattening, equines, bovines, ovines and pigs the maximum authorised content of vitamin D3 in feed does not provide any margin of safety, and that, except for pigs and fish, the maximum content is above the upper safe level, according to National Research Council data when animals were fed a supplemented diet for more than 60 days. The FEEDAP Panel is not in a position to draw final conclusions on the safety of vitamin D for target animals but considers the current maximum contents temporarily acceptable. The two vitamin sources under application are considered safe for the target animals provided the current maximum contents in feed are respected. Any administration of vitamin D3 via water for drinking could exceed the safe amounts of vitamin D and therefore represents a safety concern. Current nutritional surveys in 14 European countries showed that vitamin D intake is below the upper safe limit. The FEEDAP Panel assumes that foodstuffs of animal origin were produced following current production practices, including vitamin D3 supplementation of feed, and concludes that the use of vitamin D in animal nutrition at the currently authorised maximum dietary content has not and will not cause the tolerable upper intake level to be exceeded. Vitamin D3 should be considered as irritant to skin and eyes, and as a dermal sensitiser. Inhaled vitamin D3 is highly toxic; exposure to dust is harmful. No environmental risk resulting from the use of vitamin D3 in animal nutrition is expected. The vitamin D3 under application is regarded as an effective dietary source of the vitamin in animal nutrition.

Panel members at the time of adoption

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.
Panel on Additives and Products or Substances used in Animal Feed
Contact
FEEDAP [at] efsa.europa.eu
doi
10.2903/j.efsa.2014.3568
EFSA Journal 2014;12(2):3568
Question Number
On request from
European Commission