Infant Formula Product Development
Broadly speaking we can divide infant formula product development and formulation into 3 stages which begins by selecting the basic macronutrient building blocks and relative concentrations and ratios of each of these key ingredients. From this basic foundation the product is refined and tailored to meet the specific needs of infants through the addition of various ingredients.
First Stage: focus on the appropriate amount of protein, fat, carbohydrates and other nutrients to guarantee the basic nutritional intake.
Second Stage: development of a more refined product containing a wider range of substances like nucleotides, special fatty acids, choline etc. and with a protein/fatty acid proportion adjusted to reflect recent advances made in infant nutritional science.
Third Stage: In recent years there has been significant progress in scientific understanding of important compounds found in human breast milk. The commercialization of this R&D has resulted in state of the art infant formula containing ingredients designed to mimic human milk. Examples include OPO, improve GOS + FOS prebiotic combination, add lutein etc.
HMOs: an overview
Human Milk Oligosaccharides (HMO) constitute a family of more than 1,000 different sugars naturally occurring in human milk. They are made up of five monomers: (D-glucose (Glc), D-galactose (Gal), N-acetylglucosamine (GlcNAc), L-fucose (Fuc) and sialic acid (Sia)). After lactose and lipids and excluding water, they are breast milk’s third most abundant component. Their importance in the growth of infants is fundamental and their irreplaceable role in developing a normal GI microbiome in newborns has been scientifically proven.
Average Composition of Human Milk and Main Human Milk Oligosaccharides
HMOs sold commercially are artificially synthesized and their role in breast milk substitutes like infant formula is to promote normal gut flora development in newborns and infants. 
Technological progress has meant that the once prohibitive price tag associated with use of HMOs in infant formula products has been reduced significantly. As such many infant formula manufacturers are beginning to use these ingredients. Scientific findings suggest that babies fed HMO-added infant formula have biomarkers much more similar to breastfed ones than those fed with conventional formula. Despite the diverse range found in human milk, only a few HMO are currently added to commercially available infant formula.
We are mainly talking about 2 Human Milk Oligosaccharides:
-Fucosyllactose (2'-FL & 3-FL), which is the most prevalent in human milk (approximately 30% of all occurring HMOs)
-Lacto-N-Neotetraose (LNnT), found in smaller concentrations.
Regulatory requirements on HMOs in China, USA and EU
In China HMOs haven’t been incorporated in the category of food additives yet which has hindered the development of this industry domestically and also meant that products containing these ingredients are not available. However in August 2016 CFSA published a draft for public consultation on the inclusion of 2’FL among into food additive standards. Even if they are approved as a food additive, they would still not allowed to be used in infant formula though, because of the rules set by GB10765 and GB10767.
The following chart shows how the main 2 human milk oligosaccharides are regulated in China, EU and USA laws:
Growth Perspectives
Ordinary prebiotics like galactooligosaccharides and fructooligosaccharides are currently preferred by IF producers over HMO because of their low cost and high availability, but HMOs show very interesting growth rates and are estimated by a recent study from Future Market Insights to reach 76 Million dollars value in 10 years and 14.6% CAGR between 2017 and 2027. This is due both to the growth of infant population all over the world and to the tendency to choose products more similar to human milk.
Main HMOs Manufacturers
Technology advances in Human Milk Oligosaccharides production will impact their availability and cost and more infant formula companies will consider including HMO ingredients in their products. Consequently, they might move from being niche products to capturing a larger market share and eventually become the new standard.
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