Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
other: review
Adequacy of study:
supporting study
Study period:
not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Secondary literature

Data source

Reference
Reference Type:
publication
Title:
Safety Assessment of Iron EDTA [Sodium Iron (Fe3+) Ethylenediaminetetraacetic Acid]: Summary of Toxicological, Fortification and Exposure Data
Author:
Heimbach, J., Rieth, S., Mohamedshah, F., Slesinski, R., Samuel-fernando, P., Sheehan, T., Dickmann, R., Borzelleca, J.
Year:
2000
Bibliographic source:
Food and Chemical Toxicology 38 99-111

Materials and methods

Test material

Constituent 1
Reference substance name:
Fe(III)EDTA
IUPAC Name:
Fe(III)EDTA

Results and discussion

Applicant's summary and conclusion

Executive summary:

Iron EDTA [sodium iron (Fe3+) ethylenediaminetetraacetic acid (EDTA)], shown to have a significant beneficial effect on iron status by increasing iron bioavailability in human diets, has been proposed for use as a fortificant in certain grain-based products including breakfast cereals and cereal bars. This paper presents an assessment of the safety of iron EDTA for its intended uses in these products. Iron EDTA, like other EDTA metal complexes, dissociates in the gastrointestinal tract to form iron, which is bioavailable, and an EDTA salt; absorption of the metal ion and EDTA are independent. Because of this dissociation, consideration of information on EDTA compounds other than iron EDTA is relevant to this safety assessment. EDTA compounds are poorly absorbed in the gastrointestinal tract and do not undergo significant metabolic conversion. They have a low degree of acute oral toxicity. EDTA compounds are not reproductive or developmental toxicants when fed with a nutrient-sufficient diet or minimal diets supplemented with zinc. In chronic toxicity studies, diets containing as much as 5% EDTA were without adverse effects. EDTA compounds were not carcinogenic in experimental animal bioassays and are not directly genotoxic. This lack of significant toxicity is consistent with a history of safe use of other EDTA compounds (CaNa2EDTA and Na2EDTA) approved by the FDA for use as direct food additives. An upper-bound estimated daily intake (EDI) of EDTA from iron EDTA (1.15 mg/kg bw/day for thepopulation) is less than half the acceptable daily intake (ADI) for EDTA of 2.5 mg/kg bw/day established by JECFA. The data collected and published over the past 20 to 30 years demonstrate that iron EDTA is safe and effective for iron fortification of food products and meets the standard of ``reasonable certainty of no harm''. Based on the published record, iron EDTA may be regarded as generally recognized as safe (GRAS) for the intended food uses and maximum use levels.

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