Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) related to Ferrous bisglycinate as a source of iron for use in the manufacturing of foods ad in food supplements

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The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Foods (AFC Panel) has been asked to advise on the safety and bioavailability of ferrous bisglycinate when used as a source of iron in foods.

In 2004, The Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) evaluated the safety of iron in general, when present in fortified foods and food supplements, but considered that the available data were insufficient to establish a tolerable upper intake level for iron. The NDA Panel also indicated there are certain subgroups of the population (men and postmenopausal women) that may develop biochemical indicators of high iron stores by the additional intake of iron from food supplements. Based on estimates of current iron intakes in European countries, the NDA Panel concluded that the risk of adverse effects from high iron intake from food sources, including fortified foods in some countries, but excluding supplements, is considered to be low for the population as a whole, except for those homozygous for hereditary haemochromatosis.

The present opinion deals only with the safety and bioavailability of a particular source of iron, ferrous bisglycinate, intended for the general population, to be used in food supplements and in foods for particular nutritional uses. In addition, special attention has been paid to the use of ferrous bisglycinate as a source of iron in foods intended for infants and young children. The safety of iron itself, in terms of the amounts that may be consumed, is outside the remit of this Panel.

Ferrous bisglycinate consists of one molecule of ferrous iron bound to two molecules of glycine to form two heterocyclic rings. For food fortification and dietary supplementation, ferrous bisglycinate is formulated containing 77% ferrous bisglycinate and food-grade citric acid (17%), maltodextrin (2%), silicon dioxide (0.01%), and water (4%).

Studies to address the bioavailability and safety of ferrous bisglycinate have been conducted with ferrous bisglycinate. The absorption of iron from ferrous bisglycinate is regulated through the same physiological mechanisms as other inorganic forms of iron. Following oral administration, ferrous bisglycinate adds to the intestinal intraluminal pool of inorganic, non-haem iron and is absorbed intact into the mucosal cells of the intestine, and is subsequently hydrolysed into its iron and glycine components. The iron component of ferrous bisglycinate is metabolised like any other source of iron.

Use of an iron source such as ferrous bisglycinate should pose no safety concerns since the intended levels of use in foods are not anticipated to exceed those levels currently used for existing iron supplementation and food fortification programmes within the EU. Furthermore, following dissociation from ferrous bisglycinate, the free amino acid, glycine, will enter into normal metabolic processes.

Ferrous bisglycinate has been used in numerous field trials in developing countries for the iron fortification of foods providing between 2 and 23 mg/day of supplemental dietary iron without any reports of adverse effects. Additionally, dietary iron supplementation using ferrous bisglycinate, providing approximately 15 to 120 mg iron/day, has been well tolerated by adult males, pregnant females, non-pregnant females with normal iron statuses and more in particular by iron-deficient young children. In all cases substantial improvements in iron status indicators (serum levels of haemoglobin and ferritin, total iron binding capacity (TIBC), iron stores) were reported in the groups supplemented with ferrous bisglycinate compared to the controls. Moreover, there was no evidence of iron overloading in iron-replete individuals.

Ferrous bisglycinate has a low acute toxicity, with an oral LD₅₀ value of 2,800 mg/kg body weight in rats, corresponding to approximately 560 mg iron/kg body weight. The no-observed-adverse-effect-level (NOAEL) of 500 mg/kg body weight/day, which was reported for ferrous bisglycinate in a 90-day toxicity study in rats, corresponds to 100 mg iron/kg body weight/day, and provides a margin of safety that is 125-fold above the provisional maximum tolerable daily intake for iron of 0.8 mg/kg body weight established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

On the basis of the available studies on bioavailability, metabolism, toxicity, data on dietary supplementation and fortification studies in humans, including data from studies in foods intended for infants and young children, the AFC Panel considers that the use of ferrous bisglycinate, as a source of iron in foods intended for the general population, food supplements, and foods for particular nutritional uses including foods intended for infants and young children, meeting the specifications proposed, does not present a safety concern.

Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) related to Ferrous bisglycinate as a source of iron for use in the manufacturing of foods ad in food supplements