A recent study published in Nutrients has confirmed that a highly processed infant formula meets the EU’s legal requirements for safety and suitability as the sole source of nutrition for infants during the first few months of life. The study evaluated the effectiveness and eligibility of the eHF infant formula, developed with Peptigen IF 3080 protein, following European Food Safety Authority (EFSA) guidelines on protein hydrolysates.
Infants who are not exclusively breastfed and at risk of atopic disease are typically recommended to consume infant formula containing partially or extensively hydrolysed protein instead of cow’s milk protein-based formula. Previous studies have confirmed the safety and application of this formula for term and preterm infants, in line with Directive 2006/141/EC. However, a recent EU directive requires clinical evaluation of all new infant products before entering the market to ensure safety and suitability.
The random, double-blind, noninferiority trial involved 21 study sites across Europe, including Bulgaria, Germany, Hungary, and the Czech Republic, and infants up to 25 days old. The intervention lasted 120 days, followed by a subsequent follow-up to 180 days. There were 318 eligible infants who were randomised to one of two formula-fed groups, either eHF or cow’s milk protein-based formula. They exclusively consumed the formula for 26 days and were required to attend five study visits, which included follow-up to gather anthropometric measures of body weight, length, and head circumference.
Formula intake was monitored by parents in diaries three days prior to study visits while infants’ diets were introduced to complementary food or drink from 120 days. Infants who were exclusively breastfed for at least three months comprised the reference group in this study.
The study confirmed that healthy term infants who were fed eHF formula experienced noninferior weight gain up to 180 days, compared to those fed cow’s milk protein-based formula. Nevertheless, there was no substantial difference in overall growth between the two formula-fed groups, and infants in all groups exhibited healthy growth rates that fell within the normal range.
Overall, the study demonstrated that the formula meets the requirements for adequate infant growth and is safe and suitable as the sole source of nutrition for infants during the first few months of life. The authors noted a few factors that influenced weight gain observed at visits and conformed with studies on the impact of birth weight, maternal body mass index, and gestational age on infant growth.
The formula exhibits an energy content that is close to mature human milk and slightly reduced protein content in comparison to standard infant formula, making it a viable option for infants who are at an increased risk of atopic diseases not exclusively breastfed. The study confirmed that eHF adhered to values published by EFSA and exhibited similar growth rates to breastfed infants.
In conclusion, this study provides evidence that the formula meets EFSA’s requirements for safety and suitability and is a viable option for infants during their first few months. The authors recommend further research to confirm these findings in a larger and more diverse population.
