Registration Dossier

Diss Factsheets

Administrative data

additional toxicological information
Type of information:
other: review
Adequacy of study:
supporting study
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Review assessing the use of sodium iron EDTA for food fortification.

Data source

Reference Type:
Toxicological Profile, Current Use, and Regulatory Issues on EDTA Compounds for Assessing Use of Sodium Iron EDTA for Food Fortification
Whittaker, P., Vanderveen, J.E., Dinovi, M.J., Kuznesof, P.M., Dunkel, V.C.
Bibliographic source:
Regulatory Toxicology and Pharmacology 18, 419-427

Materials and methods

Results and discussion

Applicant's summary and conclusion

Executive summary:

The U.S. Food and Drug Administration (FDA) has approved the use of disodium and calcium disodium ethylenediaminetetraacetate (EDTA) for direct addition to food. The international nutrition community is interested in obtaining approval for the use of sodium iron(IlI) EDTA (NaFeEDTA) for dietary iron fortification because of its high iron bioavailability. its enhancement of intrinsic food iron uptake and its stability under storage and food preparation conditions. A major concern in the United States has been the presumed extensive use of EDTA in the American food supply. Recently, an update of the estimated exposure to EDTA suggests that the expesure is much lower than previously assumed. This reduction may allow new uses of NaFeEDTA in food. The following issues are discussed in relation to the possible use of NaFeEDTA: toxicological profile of EDTA compounds, acceptable daily intake of EDTA. and estimated daily intake of EDTA in the United States.

NaFeEDTA provides a highly bioavailable form of iron for food fortification and promotes the absorption of intrinsic food iron in a meal with low iron bioavailability. Iron supplied in the form of NaFeEDTA may be two to three times more bioavailable than FeSO4 or food iron in some diets, and iron bioavailability of NaFeEDTA is not generally affected by adverse storage conditions or by food preparations such as cooking. Data also indicate that a lower level of fortification iron could be used to prevent iron deficiency anemia in a population relying mainly on a diet high in vegetables, which contain inhibitors of iron absorption such as phytate and limited amounts ofenhancers of iron absorption (ascorbic acid and meat). Because NaFeEDTA is absorbed well in foods containing dietary inhibitors of iron, smaller amounts may be used for iron fortification. In many countries the number ofprocessed foods in the food supply is low and the EDI (daily mean intake 15 mg/person/day) for EDTA is correspondingly lower than that for the United States. The introduction of NaFeEDTA into the food supply for iron fortification in those countries should not present a toxicological concern. However, if NaFeEDTA were used in countries where clinical manifestations of zinc deficiency exist or where calculated zinc intakes are marginal, the effects of EDTA consumption on zinc nutriture should be examined.