Scientific Opinion on the safety of ferrous ammonium phosphate as a source of iron added for nutritional purposes to foods for the general population (including food supplements) and to foods for particular nutritional uses

Abstract

Suggested citation purposes: EFSA Panel on Food Additives and Nutrient Sources (ANS); Scientific Opinion on the safety of ferrous ammonium phosphate as a source of iron added for nutritional purposes to foods for the general population (including food supplements) and to foods for particular nutritional uses. ABSTRACTThe Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the safety of Ferrous Ammonium Phosphate (FAP) when added for nutritional purposes in foodstuffs for particular nutritional uses (PARNUTS) and foods intended for the general population (including food supplements) as a source of iron and on the bioavailability of iron from this source. FAP is stable at neutral pH in formulated foods. The bioavailability of iron from FAP was shown to be within the range of that from other iron salts used for fortification purposes, and specifically, less than that from ferrous sulphate and greater than that from ferric pyrophosphate. In intended food categories, FAP provides between 0.7 to 14 mg of iron per serving, which corresponds to 5 to 100% of the RDA for iron in adults. Studies evaluating the toxicity of FAP in experimental animals have not been conducted. FAP dissociates under the low pH conditions of the stomach in its components, thus releasing ferrous, ammonium and phosphate ions. Given the previous evaluations of ferrous, ammonium and phosphate salts as food additives and as nutrient sources by the SCF, EFSA and JECFA and that the available information on their toxicity did not identify toxicological effects, the Panel considers that additional toxicological data on FAP are not required. The Panel concludes that the use of FAP as a source of iron in PARNUTS and in foods intended for the general population (including food supplements), at the proposed use levels, is not of safety concern provided that established upper safety limits for iron are not exceeded. KEY WORDSFerrous ammonium phosphate, FAP, CAS Registry Number 10101-60-7, Iron(II) ammonium phosphate, Ammonium iron(II) phosphate, Phosphoric acid ammonium iron(II) salt (1:1:1).

Scientific opinion on the tolerable upper intake level for iron

“…The safety evaluation of several forms of iron when added for nutritional purposes to foods and/or for use as food supplements, or foods intended for particular nutritional uses, has been carried out by EFSA. EFSA concluded the following iron sources were of no safety concern under the proposed conditions of use: ferrous ammonium phosphate (EFSA ANS Panel, 2010a ), ferrous phosphate (EFSA ANS Panel, 2009a ), iron (II) taurate (EFSA ANS Panel, 2009b ), iron l ‐pidolate (EFSA AFC Panel, 2007 ), ferrous bisglycinate (EFSA AFC Panel, 2006 ) and ferric sodium ethylenediaminetetraacetic acid (EDTA) as long as it does not lead to an exposure to EDTA above 1.9 mg EDTA/kg bw per day (EFSA ANS Panel, 2010b ).…”

Preparation and characterization of an iron–β-cyclodextrin inclusion complex: factors influencing the host–guest interaction

“…It is considered as a Generally Recognized As Safe (GRAS) iron source. 41 Prior studies have shown that it has higher bioavailability than ferric pyrophosphate, but less than that of ferrous sulphate. 39…”