The request to assess goats’ milk protein as a protein source for infant formula and follow-on formula has been evaluated by the Panel on the basis of data submitted and of data from the literature.
The data submitted included the report on a pilot growth study in healthy infants with formula based on goats’ milk protein in comparison to formula based on cows’ milk protein, a digestibility study of formulae based on goats’ milk and cows’ milk in piglets and analyses of the nitrogen and amino acid content of goats’ milk protein in skim milk powder and in infant formula based on goats’ milk solids.
The amino acid pattern of goats’ milk protein is comparable to cows’ milk protein. The digestibility of goats’ milk protein is similar to cows’ milk protein in an animal model. Unmodified goats’ milk protein is deficient in cysteine and tryptophan in comparison to several reference amino acid patterns derived from the analysis of human milk protein. Unmodified goats’ milk protein, like unmodified cows’ milk protein, is unsuitable as a protein source for infant formula within the permitted range (Directive 91/321/EEC, as amended by Directive 96/4/EC) of protein concentration in infant formula.
There are no convincing data, either in the literature or submitted, to support the belief that the incidence of allergic reactions is lower when feeding goats’ milk-based infant formula compared to cows’ milk-based infant formula.
The clinical study of a goats’ milk protein-based formula submitted is insufficient to establish the nutritional adequacy and nutritional safety of goats’ milk protein as a protein source in infant formula due to methodological flaws including insufficient sample size, restriction to anthropometric parameters only, absence of a breast-fed reference group and non-adherence to the study protocol.
The Panel concludes that the data submitted are insufficient to establish the suitability of goats’ milk protein as a protein source for infant formula and that unmodified goats’ milk protein is not suitable to be used as a protein source in infant formula.
As no data have been submitted on the use of goats’ milk protein as a protein source in follow-on formula, the Panel is not in the position to evaluate the suitability of goats’ milk protein for such use.