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

Abstract

Folic acid, a synthetic folate compound, is converted in animals to biologically active folates. These are essential for DNA synthesis, repair and methylation, in particular nucleotide biosynthesis and remethylation of homocysteine. Oral administration routes of folic acid via feed or water for drinking are considered bioequivalent. Folic acid is safe for the target animals and there is no need to define a maximum content in feed. Population exposure to folic acid/folates in Europe is below the tolerable upper intake level (1 mg/adult/day and 200 µg/toddler/day). As folic acid supplementation of animal feedingstuffs is widespread and routine, exposure figures already contain the contribution from edible tissues and the products of animals fed folic acidsupplemented diets. Liver and milk folate is not influenced by dietary folic acid. The only variation to be expected is in the concentration of folates in eggs and meat. The potential exposure of adults and toddlers resulting from the consumption of eggs and meat from treated animals is, however, small and would be about 60 and 27 µg/person/day, respectively. The FEEDAP Panel concluded that the use of folic acid in animal nutrition is not of concern for the safety of consumers. In the absence of any information, the FEEDAP Panel considers it prudent to treat folic acid as an irritant to skin, eyes and the respiratory tract and as a sensitiser. Folates occur widely in nature (in green vegetables and certain fruits, e.g. citrus). Folic acid added to feed would be excreted as the physiological end-products of folate metabolism. The use of folic acid in animal nutrition does not pose a risk to the environment. Folic acid is regarded as an effective source of folate in animal nutrition. SUMMARYFollowing a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of folic acid an additive to feed and water for drinking for all animal species.Folic acid, a synthetic folate compound, is converted in animals to biologically active folates. They are essential for DNA synthesis, repair and methylation, in particular nucleotide biosynthesis and remethylation of homocysteine.Oral administration routes of folic acid via feed or water for drinking are considered bioequivalent.Folic acid is safe for the target animals and there is no need to define a maximum content in feed.Population exposure to folic acid/folates in Europe is below the tolerable upper intake level (1 mg/adult/day and 200 µg/toddler/day). As folic acid supplementation of animal feedingstuffs is widespread and routine, exposure figures already contain the contribution from edible tissues and the products of animals fed folic acid-supplemented diets. Liver and milk folate is not influenced by dietary folic acid. The only variation to be expected is in the concentration of folates in eggs and meat. The potential exposure of adults and toddlers resulting from the consumption of eggs and meat...

Assessment of the feed additive consisting of folic acid for all animal species for the renewal of its authorisation (Chr. Olesen A/S and DSM Nutritional Products Ltd)

“…Some studies were identified in the literature search reporting deposition of folates in food of animal origin. The FEEDAP Panel noted that new data derived from publications by Tactacan et al (2012), Altic et al (2016) and Bagheri et al (2019), all concerning deposition in the eggs, give very similar values to those retained in the former EFSA assessment (EFSA FEEDAP Panel, 2012). The study by Czarnowska-Kujawska et al (2020) concerning the deposition of folates in livers of chickens, turkeys, pigs and beef collected in retail/butchers, shows high deposition values however, no information was provided in the publication whether the samples were obtained from animals fed with folic acid-supplemented diets.…”

“…The safety of the additive was evaluated in a previous EFSA opinion (EFSA FEEDAP Panel, 2012). The FEEDAP Panel concluded that folic acid was safe for the target animals, the consumers and the environment.…”

“…For the functional group vitamins, pro-vitamins and chemically well-defined substances having similar effect, maximum contents are only provided for vitamin A and vitamin D. Vitamins from the so-called group B are generally considered to be not toxic even at higher dietary levels (NRC, 1987;EMA, 1997). For this reason, in its previous opinion, the FEEDAP Panel concluded that folic acid is safe for all animal species and there is no need to define a maximum content in feed (EFSA FEEDAP Panel, 2012). It was also noted that the amount of information on the tolerance and toxicity levels of folic acid in domestic animals was limited.…”

“…According to the applicant, no changes have been introduced in the manufacturing process, composition, purity or activity of the additive since the original authorisation (EFSA FEEDAP Panel, 2012).…”