Scientific Opinion on the safety and efficacy of beta‐carotene as a feed additive for all animal species and categories

Abstract

The use of beta-carotene is safe for the target animals. Setting a maximum content in feed legislation is not considered necessary. However, this conclusion assumes that triphenylphosphine oxide does not exceed 100 mg/kg additive. In all food-producing animals (except veal calves) and laboratory rodents, beta-carotene is almost fully metabolised. In contrast, humans, non-human primates and ferrets absorb relatively high quantities of beta-carotene unchanged. Investigations with ferrets and hamsters as well as intervention studies in humans may indicate a certain dose-dependent potential of beta-carotene to promote lung carcinoma, particularly in smokers. A systematic literature review and meta-analysis of nine randomised controlled trials demonstrated an increased risk of lung and stomach cancers in smokers and asbestos workers at dose levels ≥ 20 mg/day. However, increased risk of lung cancer at such doses could be observed only if plasma levels of beta-carotene exceeded 3 µmol/L. The FEEDAP Panel considers it prudent, in the absence of an acceptable daily intake, that supplemental beta-carotene in animal feed should not significantly add to consumer exposure from other sources. The use of supplemental beta-carotene in feeds of food-producing animals, except veal calves, would not result in a significant additional exposure of consumers to beta-carotene; however, consumption of liver from veal calves could lead to additional exposure. Beta-carotene is not an irritant to eyes or skin and is not a skin sensitiser. Respiratory exposure from handling beta-carotene-containing additives is considered potentially hazardous. Taking the widespread occurrence of beta-carotene in nature and its oxidative susceptibility into account, the FEEDAP Panel considered it unlikely that the use of beta-carotene in animal nutrition at the recommended feed concentrations would pose a risk to the environment. Beta-carotene is utilised for the synthesis of retinol in almost all animal species except the cat. Effects on reproduction and immunity were not sufficiently demonstrated.