EFSA gave the green light to iron milk proteinate as a novel food (NF) and nutrient source. The NF is a complex of iron, casein, and phosphate, which is produced from iron salts, sodium caseinate, and potassium orthophosphate with a final iron content of 2-4%. Interestingly, the binding of iron to casein remains stable up to a pH value of about pH 5. The NF shall be used in various foods, food supplements, and foods for special medical purposes (FSMP) for adults and children four years of age to fortify iron at amounts up to 30% of the nutritional reference value (NRV).
The applicant conducted several pertinent in-vitro and human studies on ADME to prove that iron from the novel source is bioavailable. The panel concluded that the data show that the NF is digested into small peptides after ingestion, producing iron-bound caseinophosphopeptides, which are normal components of the human diet. Therefore, no further toxicity studies were required. Despite the possible presence of soft nano-sized entities, the panel concluded that the NF iron milk proteinate is safe and bioavailable under the proposed uses. In this context, however, it was mentioned that, while no upper level (UL) has yet been set for iron, EFSA is currently assessing the setting of an UL for iron.If you consider applying for the authorization of a novel food in the EU and need regulatory consulting, please contact our novel food experts.