Scientific Opinion on the safety of heme iron (blood peptonates) for the proposed uses as a source of iron added for nutritional purposes to foods for the general population, including food supplements

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion evaluating the safety of heme iron (blood peptonates) when added for nutritional purposes as a source of iron to food for the general population, including food supplements, and evaluating the bioavailability of iron from this source. The Panel concluded that iron from heme iron (blood peptonates) is bioavailable and absorbed to a significantly higher extent than iron from non-heme sources. No data on the toxicity of heme iron (blood peptonates) were provided by the petitioner except those from an acute toxicity study. The Panel is aware of the fact that heme iron is a constituent of the normal human diet and also an endogenous body constituent. However, given i) that the use levels of heme iron (blood peptonates) proposed by the petitioner result in exposure to iron at levels that are higher than the guidance value of 17 mg/day for supplemental intake of non-heme iron proposed by the EVM although they are in line with the Provisional Maximum Tolerable Daily Intake (PMTDI) value for iron of 0.8 mg/kg bw/day (50 mg/day for a 60 kg person) proposed by JECFA, ii) that the bioavailability of iron from heme iron as compared to iron from non-heme iron sources is significantly increased, iii) that epidemiological and animal model studies suggest that a high intake of heme iron may be associated with an increased risk of colon cancer, iv) that there are no genotoxicity data on heme iron (blood peptonates) but positive results reported for hemoglobin and hemin in a Comet assay in cells in vitro, and v) that there are no data from subchronic, reproductive, developmental, long-term toxicity and carcinogenicity studies on heme iron (blood peptonates), the Panel concludes that the available data are insufficient to demonstrate the safety of the proposed use and use levels of heme iron (blood peptonates) as a source of iron for nutritional purposes in foods intended for the general population, including food supplements.