Scientific Opinion on the re-evaluation of iron oxides and hydroxides (E 172) as food additives


Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2015;13(12):4317 [57 pp.].
Panel Members
Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Agneta Oskarsson, Dominique Parent-Massin, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Younes Maged.
The Panel wishes to thank the members of the former Working Group ‘A’ Food Additives and Nutrient Sources (2011–2014) and the members of the Standing Working Group on the re-evaluation of food colours: Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Maria Jose Frutos, Pierre Galtier, David Gott, Claude Lambré, Jean-Charles Leblanc, Agneta Oskarsson, Jeanne Stadler, Paul Tobback, Ine Waalkens-Berendsen and Rudolf Antonius Woutersen for the preparatory work on this scientific opinion and EFSA staff members: Ana Maria Rincon, Alexandra Tard and Stavroula Tasiopoulou for the support provided to this scientific opinion. The ANS Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
17 November 2015
Published in the EFSA Journal
8 December 2015
European Food Safety Authority (EFSA), Parma, Italy
The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of iron oxides and hydroxides used as food additives (E 172): yellow iron oxide (FeO(OH)·H2O), red iron oxide (Fe2O3) and black iron oxide (FeO·Fe2O3). Brown Iron Oxide has been included in this assessment for completeness, due to its importance as a commercial blend. The Panel considered that the particle size and particle size distribution should be included in the specifications. In 1980, an ADI of 0-0.5 mg/kg bw/day was established by JECFA. Absorption of iron from iron oxides is low. The acute oral toxicity of iron oxides is greater than 10 g iron oxide/kg bw. From a subacute and a subchronic toxicity study, the Panel identified a NOAEL for red iron oxide of 1 000 mg/kg bw/day, the highest dose tested. Red (Fe2O3) and black (FeO·Fe2O3) iron oxide, both in nano- and micro-form, were positive in in vitro genotoxicity assays in mammalian cells. Due to the limitations of the database, and considering the impossibility to read-across between iron oxides with different redox state, the Panel considered that the genotoxicity of iron oxides cannot be evaluated based on the available data. Concerning carcinogenicity and reproductive and developmental toxicity, no signs of toxicity were observed in unpublished studies which were not available and could not be evaluated by the Panel. The Panel concluded that an adequate assessment of the safety of E 172 could not be carried out because a sufficient biological and toxicological database was not available. Refined exposure estimates show that exposure to E 172 ranged from 0.03 mg/kg bw/day for infants to 3.7 mg/kg bw/day for toddlers at the mean and from 0.1 mg/kg bw/day for infants to 9.5 mg/kg bw/day for toddlers at the 95th percentile for the non-brand-loyal scenario.
red iron oxide, black iron oxide, yellow iron oxide-hydroxide, E 172, CI 77492, CI 77491, CI 77499
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