Safety of iron milk proteinate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of iron from this source in the context of Directive 2002/46/EC
Résumé
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver an opinion on iron milk proteinate as a novel food (NF)pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of iron from this source inthe context of Directive 2002/46/EC. The NF is a complex of iron, casein and phosphate, which isproduced from iron salts (i.e. ferric chloride or ferric sulfate), sodium caseinate and potassiumorthophosphate. The NF is proposed by the applicant to be used as a source of iron, of which the NFcontains 2–4%. The applicant intends to market the NF as an ingredient in a number of foodcategories; in food supplements, in total diet replacement for weight control and in foods for specialmedical purposes. The Panel considers that, taking into account the composition of the NF and theproposed conditions of use, consumption of the NF is not nutritionally disadvantageous. The studiesprovided for ADME and bioavailability indicate that iron from the NF is bioavailable. Overall, theevidence indicates that upon ingestion the NF undergoes digestion into small peptides to yield iron-bound caseinophosphopeptides that are normal constituents of the human diet, and that the iron fromthe NF does not bypass the homeostatic control of iron as a nutrient. The Panel concludes that the NF,iron milk proteinate, is safe under the proposed conditions of use. The Panel also concludes that theNF is a source from which iron is bioavailable.
Domaines
Sciences du Vivant [q-bio]
Fichier principal
EFSA Journal - 2022 - - Safety of iron milk proteinate as a novel food pursuant to Regulation EU 2015 2283 and.pdf (1.73 Mo)
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