Nestlé’s infant formula hydrolysate not linked to reduced dermatitis, EFSA concludes

21 Jun 2021 --- The European Food Safety Authority (EFSA) has rejected Nestlé’s claim request relating to the ability of one of its infant formulas to reduce the risk of developing atopic dermatitis (AD) in infants.

This comes just two months after EFSA also refuted a beta-glucan-based health claim from Nestlé – the Swiss food giant’s first EU health claim submission since 2010.

“We continue to engage with relevant scientific bodies and invest in scientific research that enables meaningful communication of our nutrition products and solutions,” a Nestlé spokesperson tells NutritionInsight.

Examining the potential for further health claims, they add: “We always have and will continue to invest in credible scientific research that enables meaningful communication.”

Decades in circulation
EFSA’s panel concludes that a cause-and-effect relationship has not been established.In the new case, the company argued that a specific protein hydrolysate derived from whey protein isolate and concentrate in the formula was associated with a reduced risk of AD in infants with a family history of allergy. 

This specific protein hydrolysate is in certain markets around the world and has been for over 30 years.

“The efficacy and safety is supported by more than 25 clinical trial publications. This hydrolysate was the first and is one of only two products in the EU that has been evaluated as safe and suitable. We comply with all relevant regulations on claims in different regions across the world,” states the spokesperson. 

It is produced from demineralized sweet whey protein derived from cow’s milk that is composed of:

• Sixty-three percent caseino-glycomacropeptide (CMP)-free whey protein isolate with a minimum protein content of 95 percent of dry matter.
• Thirty-seven percent sweet whey protein concentrate with a minimum protein content of 87 percent of dry matter.

A two-stage hydrolysis process is used to produce the hydrolysate. Specifically, at each stage, a trypsin preparation is added to the whey protein solution. 

The liquid hydrolysate is then mixed with free amino acids, minerals, vitamins, carbohydrates, oils and optionally nucleotides.  

EFSA responds negatively 
Overall, EFSA’s panel considers that, in relation to the effect that is claimed, the infant formula under evaluation “is not sufficiently characterized with respect to the molecular weight distribution of peptides.”

“From the human intervention studies submitted, no conclusions could be drawn on the efficacy of the infant formula in reducing the risk of developing atopic dermatitis,” EFSA continues. 

Therefore, the panel concluded that a cause-and-effect relationship has not been established between the consumption of the infant formula under evaluation and the reduction in the risk of developing atopic dermatitis in infants with a family history of allergy. 

Unpacking the evidence 
EFSA examined three human intervention studies reported in nine publications that were directly related to the efficacy of the formula, alongside 11 human and 12 animal studies as supporting evidence. 

The first study was non-randomized, and the panel states that no conclusion could be drawn from it. 

The second study examined 279 infants who had two atopic parents. It found that infants who consumed intact cow’s milk formula showed higher odds of developing atopic dermatitis at one year of age. 

EFSA notes that it is unclear to which feeding this was compared and whether exclusively breastfed infants were part of this analysis or not.

Owing to methodological limitations and the associated analysis, the panel states that no conclusion could be drawn from this study either.

Finally, the German Infant Nutritional Intervention (GINI) study examined healthy term infants less than 14 days of age, with at least one family member with an atopic disease, and with no prior consumption of cow’s milk-based formula.Demands for allergy-friendly infant nutrition have been picking up. 

In this study, three different formulas manufactured from hydrolyzed protein were compared to a formula manufactured from intact cow’s milk protein, with respect to their effect on reducing the risk of developing atopic manifestations. However, no statistically significant differences were observed between the study groups. 

Additionally, EFSA says that no conclusions can be drawn from this study due to methodological limitations and uncertainty about whether the formula investigated in the study was the same as the formula under evaluation.

Allergy demands pick up 
The dossier was first received by EFSA in 2019. Infant nutrition products catering to allergies have been picking up pace in recent years. 

“Atopic conditions is a major concern for parents, and AD is a common manifestation of allergy in babies. Our aim is to provide them with evidence-based nutrition solutions that can help their children,” states the spokesperson. 

In this space, Arla Foods Ingredients has also emphasized that milk protein hydrolysates can provide a key way to manage allergies and discomfort when breastfeeding is not possible. 

By Katherine Durrell