Scientific Opinion on the safety and efficacy of fumaric acid as a feed additive for all animal species

Fumaric acid is currently authorised as a preservative in feedingstuffs for all animal species. Fumaric acid is considered safe for pigs and poultry provided that an expected use level of 20 000 mg/kg in complete diets for pigs and poultry is not exceeded. The margin of safety for pigs and poultry is approximately two. The tolerated fumaric acid concentration in complete diets for ruminants is higher. The margin of safety for pigs, poultry and ruminants is sufficiently high that setting a maximum content is not necessary. In contrast, the maximum safe level in milk replacer for veal calves (and probably other young mammals) is provisionally estimated to be 10 000 mg/kg milk replacer, with no margin of safety. Fumaric acid is rapidly metabolised by well-recognised pathways, and neither fumarate nor its metabolites are expected to accumulate in animal tissues. Consequently, human exposure is not expected to be increased by the use of fumaric acid in animal nutrition. Fumaric acid is a severe irritant to eyes. Given the potential for eye irritation, the particle size and the dusting potential, exposure to other mucous membranes such as the respiratory tract may also be a concern and it is advisable to minimise exposure by inhalation. The use of fumaric acid in animal nutrition will not pose a risk to the environment. Fumaric acid has value as a food preservative only in the presence of significant moisture. Comparable situations in feed are limited to some feedingstuffs, feed processing and feeding techniques. In such situations, its function in feed is essentially the same as that in food and no further demonstration of efficacy is considered necessary. However, the FEEDAP Panel has reservations about the effectiveness of any preservative, including fumaric acid, in raw materials and compound feedingstuffs with a typical moisture content of ≤ 12 %.