EU approvals brings infant formula closer to breast milk nutrition

13 Jul 2023

Two recent EU regulatory approvals for 6’-SL, a human milk oligosaccharide (HMO) ingredient used in breast milk substitutes, will improve infant nutrition, say industry stakeholders.

6’-SL HMO is a powdered mixture mainly composed of 6′-SL sodium salt, as well as sialic acid, d-lactose and d-glucose. It can be added to a variety of foods, including infant formula, follow-on formula, food for special medical purposes and food supplements.

EU approvals brings infant formula closer to breast milk nutrition
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Benefits attributed to 6′-SL HMO include reducing the risk of adhesion of harmful bacteria and their proteins and support to the brain development in infants, by supplying sialic acid, an essential building block for neurons.

In the past month, Danish supplier Chr. Hansen received the authorisation necessary in order to place its 6’-SL ingredient on the EU market. The European Food Safety Authority (EFSA) also approved the safety of 6’-SL HMO as an ingredient in a request from ingredients manufacturer Kyowa Hakko Bio Co., Ltd. The two strains are different and Kyowa Hakko Bio’s ingredient is not yet approved for commercial use.

Shoring up infant nutrition supply

There has been a concentrated effort in recent years to improve the quality and nutrition standards of infant formula to match that of breast milk. Adding genetically engineered HMOs to formula helps, and is good for infant gut health.

Several startups are innovating in the industry as well. North Carolina-based Biomilq is working on lab-grown breast milk that could replace the real thing, though the company does not have a market-ready product yet.

“We’re committed to creating an infant nutrition alternative that's closer to the nutrition of breast milk,” Biomilq said.

“The fundamental methods we’re using are safe and widely used. We’re culturing mammary cells outside the body and leveraging their natural ability to produce many of the components of breast milk.”

Biomilq also points to the recent infant formula shortage as justification for a need in the industry for an alternate product. The impact of the shortage forced parents and caregivers to rethink their approach to nutrition for their babies.

The US Food and Drug Administration addressed the issue with a new national strategy this spring, in an attempt to make the industry more resilient against potential future shortages.

The agency plans to increase inspections of formula manufacturers, expedite the review of new formula products, develop a new forecasting model for formula supply, and improve relations with relevant government partners to mitigate setbacks in formula production, among other proposed initiatives.

“Safety and supply go hand-in-hand. We witnessed last year how a safety concern at one facility could be the catalyst for a nationwide shortage. That’s why we are looking to both strengthen and diversify the market, while also ensuring that manufacturers are producing infant formula under the safest conditions possible,” said Robert Califf, FDA Commissioner.