The request to assess the safety and suitability for particular nutritional use by infants of fructooligosaccharides in infant formulae and follow-on formulae has been evaluated by the Panel on the basis of data submitted and from the literature.
Data submitted included the reports on two studies: 1) a growth study in healthy infants fed with an infant formula supplemented with 1.5 or 3.0 g/L fructooligosaccharides; 2) a study of the faecal microbiota in healthy infants fed with an infant formula supplemented with 1.5 or 3.0 g/L fructooligosaccharides.
The data submitted indicate:
1. In the growth study, the anthropometric data suggest that the use of infant formula supplemented with either 1.5 or 3.0 g/L of fructooligosaccharides results in a normal growth pattern in healthy term infants less than two weeks of age for periods of up to twelve weeks. Serum markers of protein and mineral status and kidney function were also in the normal range.
2. No effect of fructooligosaccharides in rendering the faecal microbiota more similar to that in human milk-fed infants was demonstrated in infants fed an infant formula supplemented with either 1.5 or 3.0 g/L of fructooligosaccharides for one week.
3. Under the described conditions of use, fructooligosaccharides added to infant formula showed variable effects on consistency and frequency of stools. There was an increased prevalence of adverse effects, including loose stools, in infants fed formula with added fructooligosaccharides. As no measures were made to demonstrate satisfactory water balance, the possibility of increased risk of dehydration can not be excluded, raising concerns with respect to the safety of such formulae.
The Panel concludes that there is no evidence of benefits to infants from the addition of fructooligosaccharides to infant formula at the conditions specified by the manufacturer while there are reasons for safety concerns.
As no data have been submitted nor were available from the literature on the use of fructooligosaccharides in follow-on formula, the Panel is not in the position to evaluate the safety and suitability of FOS for such use.