Infant nutrition formulation is highly regulated everywhere in the world, which means disruptive innovations are rare. Since infant nutrition is often the exclusive food for the neonates, the requirements for safety and tolerability of the ingredients and the final products are tough, which makes formulating infant nutrition products a challenge.
Market authorizations for novel ingredients or novel recipes usually require clinical studies with infants, which makes innovation very slow, expensive, and risky. In addition, due to the controversy around pro- and pre-biotics and because of the difficult claim situation, infant formulas with probiotics are scarce and limited to some Asian countries.
It is therefore not surprising that most of the new launches in the last few years reflect rather incremental innovations, such as long-chain unsaturated fatty acids, reduced lactose content, alternative milk sources, or new packaging or dosing formats. In the EU, some manufacturers started re-formulating to meet the requirements of the Implementing Decision (EU) 2016/127 (European Commission, 2016a).2
Find ingredients for infant nutrition formulations
Prospector has listings for hundreds of ingredients for infant formulas - from proteins to additives, and more. Find what you need to move your project forward faster!
The first human milk oligosaccharides
But in 2017, we saw really disruptive innovations in infant nutrition as the first human milk oligosaccharides (HMOs) reached the market. 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.
Apart from fat, protein, lactose, vitamins and minerals, milk of all types contains oligosaccharides. It is thought that these oligosaccharides act as pre-biotics in the intestinal tract of the neonate mammal, helping the intestinal flora to develop. The intestinal microbiota in infants is associated with the susceptibility for certain types of infections, the development of allergies, obesity, and brain development,1 just to mention a few.
Human breast milk vs. animal milk
Human breast milk differs from animal milk, e.g. bovine milk, in many respects. One striking difference is the composition, complexity and concentration of the oligosaccharide fraction, which is much higher in breast milk as compared to bovine or other milk. Animal milk contains very little neutral, fucosylated oligosaccharides, whereas this fraction is the predominant type in breast milk. Hence, infant formulas were devoid of this essential fraction. Nowadays, many infant formulas contain oligosaccharides from other sources, e.g. galacto-oligosaccharides (GOS) and/or fructo-oligosaccharides (FOS) that substitute the HMO fraction.
The differences in health outcome between breast and bottle-fed infants suggest that there might be a more specific role of HMOs beyond feeding the microbiota, a role that cannot be fully mimicked by other oligosaccharides. The need to develop technologies to economically manufacture HMOs on a commercial scale was obvious. In parallel, huge progress was made during the last years with respect to understanding the structure of HMOs, their abundance in human breast milk, and their role in the development of the infant, especially in the development of the microbiota.1 At the same time, microbiome research advanced, elucidating the specific effects of breast milk on the development of the microbiota in the infantile digestive tract.
As early as 2016, Novel Food authorizations were granted to Glycom (DK) for their synthetic HMOs 2’-fucosyllactose (2’-FL) and Lacto-N-neotetraose (LNnT), which can be used individually in a range of food categories. In infant nutrition, however, they could only be used in a combination of 1.2 g/L 2’-FL with 0.6 g/L LNnT.3,4
The introduction of biotechnologically manufactured sugars and HMOs
The real breakthrough was the introduction of these HMOs manufactured by metabolically engineered bacteria. In June 2016, Glycom notified the EC about the substantial equivalence of their 2’-FL and LNnT produced by fermentation with a metabolically engineered bacterial strain. The same conditions of use as for the synthetic HMOs applied. At the end of 2017, Jennewein Biotechnology GmbH (DE) received the Novel Food authorization for 2’-FL manufactured by a different strain of metabolically engineered bacteria. With this authorization, 2’-FL can be used up to a level of 1.2 g/L as sole HMO.5 FrieslandCampina (NL) also introduced biotechnologically manufactured 2’-FL.
GLYCOM recently received an authorization for sialic acid manufactured by enzymatic synthesis which can be used in infant nutrition, follow-on formulas, and baby foods up to 0.02 g/L or 0.02 g/kg.6
With the entering into force of the new Novel Food Regulation (EU) 2015/2283 on January 1, 2018, these authorizations are generic.7 All mentioned ingredients are generally recognized as safe (GRAS) in the US, and authorization processes in other parts of the world are in progress.
The first infant nutrition manufacturers have already adopted these pioneer innovations. In 2017, Abbot Nutrition launched Similac Pro-Advance and Pro-Sensitive with 2'-FL in the US. Nestle introduced Nan Optipro Supreme 2 HM-O² in Spain, and in January 2018, Wyeth launched the follow-on formula Wyeth Iluma with 2’-FL in Hong Kong.
More products will certainly come, depending on how fast the HMOs will be authorized in other parts of the world, and on whether the necessary volumes can be consistently provided.
- Whey Protein: Formulating With Human Life’s Most Effective Protein
- Whey Protein: Formulation Considerations, Part 2
- Maltodextrin: The Multifunctional Ingredient
- Bode, L. (2012). Human milk oligosaccharides: every baby needs a sugar mama. Glycobiology 22, 1147-1162.
- European Commission (2016a). Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding
- European Commission (2016b). Commission Implementing decision (EU)2016/375 of March 11 2016 authorizing the placing on the market of lacto-N-neotetraose as a novel food ingredient under Regulation (EC) 258/97 of the European Parliament and the Council
- European Commission (2016c). COMMISSION IMPLEMENTING DECISION (EU) 2016/376 of 11 March 2016 authorising the placing on the market of 2′-O-fucosyllactose as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council.
- European Commission (2017a). Commission Implementing Decision (EU) 2017/2201 of 27 November 2017 authorising the placing on the market of 2′-fucosyllactose produced with Escherichia coli strain BL21 as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
- European Commission (2015) Commission Implementing Decision (EU) 2017/2375 of 15 December 2017 authorising the placing on the market of N-acetyl-D-neuraminic acid as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
- European Commission (2017b). Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods.
The views, opinions and technical analyses presented here are those of the author or advertiser, and are not necessarily those of ULProspector.com or UL. The appearance of this content in the UL Prospector Knowledge Center does not constitute an endorsement by UL or its affiliates.
All content is subject to copyright and may not be reproduced without prior authorization from UL or the content author.
The content has been made available for informational and educational purposes only. While the editors of this site may verify the accuracy of its content from time to time, we assume no responsibility for errors made by the author, editorial staff or any other contributor.
UL does not make any representations or warranties with respect to the accuracy, applicability, fitness or completeness of the content. UL does not warrant the performance, effectiveness or applicability of sites listed or linked to in any content.
One Response to “Oh, Baby! What’s New for Infant Nutrition Formulation”
Whole cow’s milk has too little iron, retinol, vitamin C, vitamin D, vitamin E. Another way, human breast milk has enough Cholesterol, Sodium, Potassium, Carbohydrate, Sugar, Proteins, Vitamins. Which is absolutely better than animal milk. I really like your post on this topics. Keep blogging.