Scientific Opinion on bovine lactoferrin

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out the additional assessment of ‘lactoferrin’ as a food ingredient in the context of Regulation (EC) No 258/97 taking into account the comments and objections of a scientific nature raised by Member States. Bovine lactoferrin (bLF) is a protein that occurs naturally in cow’s milk. The applicant intends to market bLF as an ingredient for food supplements, infant and follow-on formulae, dietetic food for special medical purposes and sports nutrition, and for a variety of foods. For infants with an age of 0 - 6 months, the applicant has estimated an intake of approximately 200 mg per kg bodyweight and 1.2 g bLF per day at the proposed use level. For adults, the mean and 95^th percentile daily intakes were calculated to be about 1.4 g and 3.4 g for an adult person. The toxicological information provided by the applicant included information from an in vitro genotoxicity study, a single dose study, a four week and a thirteen week oral repeated dose study in rats. The Panel notes that the estimated intake of "lactoferrin" for infants up to the age of one year of approximately 210 mg/kg bw per day would be around ten times lower than the highest dose (2,000 mg/kg bw per day) tested in the subchronic thirteen week rat study, which did not show adverse effects related to bLF. For adults above 19 years of age the proposed intake is approximately 100 times lower. This level of anticipated intake is considered a high intake scenario as opposed to a worst-case situation. The data provided suggest the absence of adverse effects of lactoferrin at the proposed levels of consumption. The Panel concludes that the novel food ingredient bLF is safe under the proposed uses and use levels.