ArticleEFSA journal. European Food Safety Authority2010
Scientific Opinion on the use of ferric sodium EDTA 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.
Article in EFSA journal. European Food Safety Authority, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A comparative analysis of heme vs non-heme iron administration: a systematic review and meta-analysis of randomized controlled trials.European journal of nutrition · 2024Pooled it
- Trial
- Micronutrient bioavailability: concepts, influencing factors, and strategies for improvement.Frontiers in nutrition · 2025Review
- Peer review of the pesticide risk assessment of the active substance elemental iron.EFSA journal. European Food Safety Authority · 2024Review
- Guidance on scientific principles and data requirements for the safety and relative bioavailability assessment of new micronutrient sources.EFSA journal. European Food Safety Authority · 2024Article
- Scientific opinion on the tolerable upper intake level for iron.EFSA journal. European Food Safety Authority · 2024Article
- Efficacy of ferric carboxy maltose in treatment of iron deficiency/iron deficiency anaemia during pregnancy.Przeglad menopauzalny = Menopause review · 2023Article
- The Influence of Iron and Zinc Supplementation on Iron Apparent Absorption in Rats Fed Vitamins and Minerals Reduced Diets.Biological trace element research · 2021Article
- The food additive EDTA aggravates colitis and colon carcinogenesis in mouse models.Scientific reports · 2021Article
- Fighting Iron-Deficiency Anemia: Innovations in Food Fortificants and Biofortification Strategies.Foods (Basel, Switzerland) · 2020Review
- Micronutrient-fortified rice can be a significant source of dietary bioavailable iron in schoolchildren from rural Ghana.Science advances · 2019Article
- Scientific opinion on the evaluation of authorised ferric sodium EDTA as an ingredient in the context of Regulation (EC) 258/97 on novel foods and Regulation (EU) 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control.EFSA journal. European Food Safety Authority · 2018Article
- Safety and efficacy of Diarr-Stop S PlusEFSA journal. European Food Safety Authority · 2016Article
- Reasons for raising the maximum acceptable daily intake of EDTA and the benefits for iron fortification of foods for children 6-24 months of age.Maternal & child nutrition · 2014Review
- Heme-bound iron in treatment of pregnancy-associated iron deficiency anemia.Journal of family medicine and primary careArticle
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1 author.
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Abstract
The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on ferric sodium EDTA added for nutritional purposes to foods for the general population (including food supplements) and to PARNUTS. Iron from ferric sodium EDTA is 2 to 3 times more bioavailable than from other mineral sources. In PARNUTS and food supplements ferric sodium EDTA would provide up to 22.3 mg iron/day (children) and 11.1 mg/day (adults). In fortified foods the proposed uses would result in an additional intake of iron of 2.2 mg/day (children) and 4.8 mg/day (male adults) on average and of 4.8 mg/day and 11.3/day respectively at the 95th percentile. The combined exposure to EDTA in the proposed applications amounts to 8.6 mg/kg bw/day (children) and 4.2 mg/kg bw/day (adults) on average and to 9.5 mg/kg bw/day and 4.8 mg/kg bw/day respectively at the 95th percentile. From two 90-day rat studies the Panel derives a NOAEL of 250 mg ferric sodium EDTA/kg bw/day. The Panel considers that from the information available there is no safety concern with respect to genotoxicity of ferric sodium EDTA as a source of iron added for nutritional purposes to foodstuffs. Chronic toxicity or carcinogenicity studies have not been provided. However, from relevant studies with other EDTA salts the Panel concludes that ferric sodium EDTA does not raise concern with respect to carcinogenicity. There is no concern on a carcinogenic potential of EDTA. No ADI for EDTA has been established. However, from the ADI of 2.5 mg/kg bw/day established for calcium disodium EDTA a value of 1.9 mg EDTA/kg bw/day can be calculated. The Panel concludes that ferric sodium EDTA as a source of iron in food supplements, PARNUTS and fortified foods is of no safety concern at the proposed use levels as long as it does not lead to an exposure to EDTA above 1.9 mg EDTA/kg bw/day.
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