The Panel on
Food Additives and Nutrient Sources added to Food (ANS) provided a scientific opinion re-evaluating the safety of
sodium ferrocyanide (E 535),
potassium ferrocyanide (E 536), and evaluating the safety of
calcium ferrocyanide (E 538) as
food additives. The Panel considered that adequate exposure and toxicity data were available.
Ferrocyanides (E 535-538) are solely authorised in two food categories as
salt substitutes. To assess the dietary exposure to
ferrocyanides (E 535-538) from their use as
food additives, the exposure was calculated based on regulatory maximum level exposure assessment scenario (maximum permitted level (MPL)) and the refined exposure assessment scenario. Dietary exposure to
ferrocyanides was calculated based on mean and high levels consumption of
salts in both the regulatory maximum level and the refined scenario. In the MPL scenario, the exposure to
ferrocyanides (E 535-538) from their use as a
food additive was up to 0.009 mg/kg
body weight (bw) per day in children and adolescents. In the refined estimated exposure scenario, the exposure was up to 0.003 mg/kg bw per day in children and adolescents. Absorption of
ferrocyanides is low and there is no accumulation in human. There is no concern with respect to genotoxicity and carcinogenicity. Reproductive studies were not available, but a no observed adverse effect level (NOAEL) of 1,000 mg
sodium ferrocyanide/kg bw per day (highest dose tested) was identified from a prenatal developmental toxicity study. The kidney appeared to be the target organ for
ferrocyanides toxicity and 4.4 mg
sodium ferrocyanide/kg bw per day was identified as the NOAEL for the renal effects in a chronic (2-year) study in rats. Assuming that the toxicity of this compound is due to the
ferrocyanide ion only, the Panel established a group acceptable daily intake (ADI) for
sodium,
potassium and
calcium ferrocyanide of 0.03 mg/kg bw per day expressed as
ferrocyanide ion. The Panel concluded that
ferrocyanides (E 535-538) are of no safety concern at the current authorised use and use levels.