Baby lying

No doubt that breastmilk is the best nutrition for infants. Therefore, health authorities worldwide recommend exclusive breastfeeding for 4-6 months. But especially in industrialised countries, only 25 % of infants are exclusively breastfed at the age of 6 months.

Manufacturers of infant nutrition are committed to improving their formulas and to mimic the composition of breastmilk as much as technically possible.

Because infant formulas may be the only nutrition for this vulnerable population group, infant nutrition is highly regulated. Nutrient profiles are defined, and only authorized ingredients can be used. Strict requirements for the demonstration of safety and tolerability make innovation in infant nutrition ingredients time-consuming and expensive. In addition, nutrition and health claims are not allowed, and restrictions to labelling and advertising apply.

Despite these challenges, the market has recently seen disruptive innovations, like the introduction of the first human milk oligosaccharides (HMOs), which are manufactured either by chemical synthesis or by fermentation with metabolically modified microorganisms. It is thought that these oligosaccharides act as prebiotics in the intestinal tract of the neonate mammal, helping the intestinal flora to develop. All milk types contain oligosaccharides, but in human breastmilk, the complexity and concentration of this fraction is much higher than in animal milk, e.g. cow or goat milk. Meanwhile, 2’-fucosyllactose alone or in combination with Lacto-N-neotetraose or Difucosyllactose is authorized as an ingredient in infant nutrition, and several applications for other HMOs are currently being evaluated by EFSA.

Another example is whey basic protein, a protein fraction from whey that is rich in bovine lactoferrin, lactoperoxidase, and TGF-β2, which can be used in infant nutrition. Bovine lactoferrin is very similar to human lactoferrin. This iron-binding protein is one the most abundant proteins in early breast milk and exhibits multiple biological activities.

However, in order to obtain a market authorization for novel foods as ingredients in infant formulas, or for nutrients or additives that are not yet authorized for this target group, clinical studies with infants might be required. At a&r, we have executed several growth and tolerance studies with more than 300 newborn (0 to 14 days after birth old) per study from different EU countries, including complex microbiota (sub)-studies. Due to our carefully selected and experienced investigator network, we mastered timely recruitment. Also, our regulatory team has developed a deep understanding of infant nutrition regulations and can support a smooth market access.

If you would like to know more about e.g. our clinical research services in infant nutrition, get in touch.