Infant nutrition is regulated under the same ruling as FSMPs ((EU) No 609/2013). Due to the strict regulations, innovation in infant nutrition formulations is a complex and lengthy process. The requirements for safety and tolerability of the ingredients and final products are in a tough regulatory environment, as we are dealing in most cases with food for neonates.
New formulations and products represent a challenge as they usually require clinical trials with infants in order to obtain a new market authorization (for both novel ingredients and novel formulas). To learn more about infant nutrition and recent regulatory and clinical challenges please read our Newsletter issue from June 2017: click here.
In the last few years, there has been an incremental growth of innovation in infant nutrition formulations with new launches including long-chain unsaturated fatty acids, reduced lactose content, alternative milk sources, or and new packaging or dosing formats.
However, during 2016/17, there was a disruptive innovation in infant nutrition with the approval of the novel foods human milk oligosaccharides (HMOs) such as 2′-fucosyllactose (2’FL) and lacto-N-neotetraose. The assumption is that the oligosaccharides present in milk act as pre-biotics in the intestinal tract of the neonate, helping the intestinal flora to develop and protect infants from e.g. infections.
These oligosaccharides will enable manufacturers to overcome one of the detriments of artificial infant formulas and to develop formulas that are a step closer to breast milk.
For an extra reading on this subject click here.