Infant formula: Experts flag potential risk of EU’s new regulations

04 Nov 2019 --- Following the EU’s new regulations for infant and follow-on formulae, a position paper is calling for omega 6 fatty acid arachidonic acid (AA) to be added in at least the same amount as omega 3 fatty acid docosahexaenoic acid (DHA). Set to come into effect next February, the new standards stipulate the obligatory addition of DHA at concentrations two to three times higher than typically found in human milk, but there is no obligation to add AA. The paper from the European Academy of Paediatrics and the Child Health Foundation flags that this novel composition has not had its suitability and safety established in clinical studies.

“DHA is not a generally dangerous component, but the simple concept that more is always better does not hold true in human biology. DHA and AA are competitors for metabolic pathways and for incorporation into tissues and functionally important complex lipids of cell membranes,” Berthold Koletzko, Professor of Paediatrics at Ludwig Maximilian University, University of Munich, Germany and lead author of the paper, tells NutritionInsight.

For the last two decades, infant formula has contained much lower amounts of DHA – in line with breast milk – than the new standards. These formulae that have a similar composition to breast milk have been shown to be suitable and safe in numerous studies. As human breast milk is the first choice for feeding infants, the experts argue that it should guide the composition of bottle feeds. Breast milk always provides DHA and AA, with mean AA levels being higher (0.5 percent of fat) than those of DHA (0.3 percent).

However, the new regulation will see a DHA concentration of 20-50 mg/100 kcal, equivalent to about 0.5-1.0 percent of fatty acids (FAs), with no requirement to provide AA. Formulae with high levels of DHA without a concomitant increase of AA have been shown to attenuate the results of child development tests up to the age of nine, according to Koletzko.

“It also changes brain composition, with reduced tissue AA content in different areas of the brain,” he adds. This is because the complex DHA- and AA-containing fats are deposited in relatively large amounts in infants’ growing brains and in immune cells.

As human breast milk is the first choice for feeding infants, the experts argue that it should guide the composition of bottle feeds.“Very high amounts of DHA and AA in infant formula could raise issues in food manufacturing and require special precaution to prevent the occurrence of rancidity and a limitation of shelf life. Any component added to infant formula has a cost, but the contribution of the costs of any raw material used to the final price of the product paid by consumers is modest,” notes Koletzko. 

He continues that expensive components are also added, including some probiotic bacterial strains. “Some biotechnologically produced oligosaccharides may also be added. There is much less evidence for a benefit to the infant and hence, a much less favorable benefit to cost ratio.” Koletzko hopes that manufacturers will not put formula based on a completely novel compositional concept on the market without accountable data that demonstrates suitability and safety.

Published in The American Journal of Clinical Nutrition, the paper recommends that the DHA should equal at least the mean content in human milk globally (0.3 percent of FAs) but preferably reach 0.5 percent of FAs.  

It also notes that although optimal AA intake amounts remain to be defined, AA should be provided along with DHA. At amounts of DHA in infant formula up to ∼0.64 percent, AA contents should at least equal the DHA contents. Further well-designed clinical studies should evaluate the optimal intakes of DHA and AA in infants at different ages based on relevant outcomes.

This news comes as the race for industry to mimic breast milk continues. Last month, researchers identified glycerol monolaurate, a compound in human breast milk that could be easily added to formula or cows’ milk to inhibit the growth of pathogenic bacteria. Meanwhile, another study pinpointed the key proteins that deliver human milk oligosaccharides to nourish important bifidobacterium, contributing to a healthy infant gut microbiota. 

By Katherine Durrell