Osteopontin is a protein found in milk, which is suspected to have a role in the development of ilmmlune system and bone/theeth health. Following an application from Arla Foods Ingredients, EFSA has just published a scientific opinion on the safety of bovine milk osteopontin as novel food.
The novel food is intended to be used at a maximum use level of 151 mg/L, in infant formula (IF), follow-on formula (FoF) and ready-to-eat dairy-based meals for children up to 35 months of age. The proposed dosage is 10-fold higher than the concentration naturally found in cow milk and existing IF.
The applicant provided a full panel of toxicity studies (genotoxicity/mutagenicity, 90-day sub-chronic toxicity and teratogenicity). Moreover, a clinical trial conducted in infants has been provided, and despite some limitations, EFSA considered that the available data substantiate the safety of bovine milk osteopontin under the proposed conditions of use. Interestingly, the margin of exposure is low (36 vs. 200 generally required by EFSA), but due to the source of the novel food and its safety in in vitro and animal studies, EFSA accepts this low margin of exposure.
EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens),Turck D, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Kearney J, Maciuk A, Mangelsdorf I, McArdleHJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T,Heinonen M, Maradona MP, Marchelli R, Neuhauser-Berthold M, Poulsen M, Schlatter JR, van LoverenH, Gelbmann W and Knutsen HK, 2022. Scientific Opinion on the safety of bovine milk osteopontin as a Novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2022;20(5):7137.