The safety review was based on an application from dairy co-op FrieslandCampina for lactoferrin uses in various foods and infant formula.
Following a request from EU Member States, EFSA (Parma, Italy) has taken a look at the safety backing of bovine lactoferrin as a food ingredient for foods and infant formula. The safety review was based on a novel foods application from dairy co-op FrieslandCampina (Amersfoort, the Netherlands) with intended uses in food supplements, infant and follow-on formula, dietetic foods, sports nutrition, and other foods.
Naturally occurring in cow’s milk, lactoferrin is an iron-binding glycoprotein consisting of a single polypeptide chain of about 700 amino acids. It is already allowed for use in foods in the United States and foods and infant formula in Japan and South Korea.
FrieslandCampina’s toxicology studies included an in vitro genotoxicity study, a single-dose study, and 4-week rat study, and a 13-week rat study. No adverse effects were shown in the studies, and proposed intake for adults is 100 times lower than the dosages (by weight) ingested in the animal studies.
EFSA’s expert panel concluded that bovine lactoferrin is safe under the proposed use and use levels offered by the applicant.