After assessing animal and in vitro data, the NDA found no safety issues at proposed intakes ranging from 667mg/100 g for baby foods and foods intended for children aged 1 - 3 years to 4000mg/100 g for energy bars for sportsmen and women.
“The toxicological information provided by the applicant included information from an in vitro genotoxicity study, a single dose study, and a four week and a thirteen week oral repeated dose study in rats,” the NDA wrote.
“The Panel considers that bLF up to the highest dose (2,000mg/kg bw per day) tested in this subchronic rat study did not show adverse effects which could be attributed to the test substance.”
“The Panel concludes that the novel food ingredient bLF (Bovine lactoferrin) is safe under the proposed uses and use levels.”
Proposed concentrations of included 100mg/100g for infant formulae; 120mg/100g for non-alcoholic beverages; 125mg/100g for food for special medical purposes; 200mg/100g for dairy product foods intended for children up to 3 years; and 300mg/100g for beverages for sports nutrition.
Lactoferrin is an iron-binding glycoprotein of approximately and consists of a single polypeptide chain.
