Dairy Goat Co-Operative NZ Ltd made the application, and EFSA's Panel on Dietic Products, Nutrition and Allergies (NDA) said it had considered compositional data for infant and follow-on formula made from whole goat milk that retained the natural whey-to-casein ration of goat milk.
Also under the microscope was data from a double-blind, randomised, controlled, three-centre trial, and a reanalysis of trial data from that formed the basis of a panel evaluation in December 2005 that rejected a previous application.
Previous trial data flawed
At the time EFSA concluded that there was insufficient evidence to establish the suitability of goat milk as a protein source in infant formulae, with a supporting clinical study (examining goat milk protein-based formula) considered insufficient due to methodological flaws such as a small sample size and absence of a breast feeding reference group.
But for the current submission, EFSA’s NDA panel said that Dairy Goat Co-Operative’s technical dossier included a study of 200 Australian infants – randomised to receive infant formula with unmodified goat milk protein or a cow milk formula exclusively for at least four months and then in addition to complementary food until 12 months.
This did not show statistically significant or clinically relevant differences in infant weight, length or head circumference development between the two formula groups, EFSA’s panel said.
This study included a breast-fed reference group, while baseline characteristics between the participants were comparable between the two formula groups, EFSA’s panel said, although within the goat milk formula group more mothers smoked during pregnancy.
Compositional criteria compliance
The growth pattern for formula-fed infants differed, as expected (the NDA panel said) from that of the World Health Organisation (WHO) growth standard, particularly in respect to weight-for-length.
“The results of this study were supported by the results of the trial considered in the panel’s earlier assessment, in which, however, the sample size was insufficient to draw conclusions," the panel said in its opinion abstract.
“The panel concludes that protein from goat milk can be suitable as a protein source for infant and follow-on formulae, provided the final product complies with the compositional criteria laid down in Directive 2006/141/EC.”
Summing-up its opinion, which is available here, the panel added: “For goat milk protein to be used in infant and follow-on formulae, particular attention has to be given to the protein content and composition of the milk proteins, and to the amino acid content.”
This should comply with the above directive, EFSA’s NDA panel said, through the addition of free amino acids if necessary.