INTRODUCTION
Infant formula is fed to babies up to the first 12 months of life and is intended to meet nutritional needs until suitable complementary foods are introduced. In principle, infant formula is intended to be as similar as possible to breast milk and to be an adequate substitute if the mother is unable to breastfeed. According to data from WHO, in industrialised countries, only 25% of infants are exclusively breastfed at the age of 6 months, with differing proportions of breastfeeding across Europe (1). Data on the global retail market of baby milk and food forecast stronger growth for the Asian market in terms of market volume and per capita consumption. In Europe, North and South America, the market tends to stagnate at a higher level (2). As infants are a particularly vulnerable group, the requirements for placing these products on the market are highly regulated in most markets.
Above all, the safety and tolerability of new, innovative ingredients must be proven in clinical trials, while special aspects must also be considered for these trials.
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