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 for ‘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 in isolated and purified form. bLF is an iron-binding glycoprotein of approximately 77 kDa and consists of a single polypeptide chain of about 700 amino acids. The sequence homology between human and bLF is about 70 %. The tertiary structure of this glycoprotein has two iron-binding sites, giving it the capability to bind two Fe3+ ions per molecule of protein. Batch testing confirmed that the product complies with the given specifications. bLF from skimmed milk is concentrated via ion exchange and is subsequently subjected to filtration steps. Ultimately the bLF is dried by means of spray drying. The applicant provided sufficient information regarding the specification, manufacture, composition and stability of bLF.
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 foods such as non-alcoholic beverages, cakes and pastries, products derived from cheese, milk-based products, cold snacks and sweets. The intended maximum levels of bLF for foods in solid form vary from 667 mg/100 g for baby foods and foods intended for children aged 1 - 3 years to 4000 mg/100 g for energy bars for sportsmen and women. The proposed concentrations of bLF in mg/100 g for the various liquid products are for example: 100 mg/100 g for infant formulae, 120 mg/100 g for non-alcoholic beverages, 125 mg/100 g for food for special medical purposes, 200 mg/100 g for dairy products foods intended for children up to 3 years and 300 mg/100 g for beverages for sports nutrition.
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 assuming that the mean intake is 1.2 litres of infant formula per day. The mean estimated intake of bLF by infants of 8 - 10 months of age would amount to 1.9 g per day. For adults, the applicant’s calculation estimates a mean and 95th percentile intake of 19 and 39 mg/kg bodyweight per day, respectively, and a mean and 95th percentile daily intake of about 1.4 g and 3.4 g, respectively.
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 Panel considers that bLF up to the highest dose (2,000 mg/kg bw per day) tested in this subchronic rat study did not show adverse effects which could be attributed to the test substance.
In an overall evaluation, the Panel considered that the novel food ingredient, bLF, is essentially a protein, a constituent of cow milk. According to the information provided by the applicant, bLF is present in the novel food ingredient (NFI) mostly as non-denatured lactoferrin. The Panel notes that lactoferrin is a normal constituent of human milk, and that the intended consumption of the bLF as specified in the application is within the levels of human lactoferrin consumed in breast milk by infants; human lactoferrin is also non-denatured.
The Panel notes that the mean estimated intake of bLF 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 a subchronic thirteen week rat study, which did not show adverse effects related to bLF. For adults above 19 years of age the estimated intake is approximately 100 times lower. This maximum 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 bLF at the proposed levels of consumption.
The Panel concludes that the novel food ingredient bLF is safe under the proposed uses and use levels.