Hydrolyzed proteins, used in infant nutrition, are proteins that have been broken down into smaller components (peptides or amino acids) through a process called hydrolysis.
This makes them easier for infants, especially those with allergies or digestive issues, to digest and absorb. Hydrolyzed protein formulas are often recommended for infants with cow's milk protein allergy (CMPA), lactose intolerance or other gastrointestinal sensitivities.
The product broadens the options available for manufacturers, according to Jouke Veldman, marketing director of Early Life Nutrition at FrieslandCampina Ingredients.
“This approval gives infant nutrition manufacturers in Europe access to an alternative source of hydrolyzed proteins specifically developed for high-end infant and follow-on formulas,” he told Nutraingredients.
Updated regulations
Hyvital Whey HA 300 has been on the market since 2010, but it required a new evaluation following the 2022 EU regulations regarding labeling and compositional requirements for infant and follow-on formula.
The European Commission set specific rules to ensure the nutritional composition and safety of foods for infants (under 12 months) and young children (1 to 3 years).
It established that infant and follow-on formula designed to meet the specific nutritional needs of infants and have strict composition and labeling requirements, including rules on energy, nutrients and pesticide residue limits (0.01 mg/kg). Certain toxic pesticides are strictly prohibited.
The new regulation also restricted the use of claims or imagery idealizing formula use, aiming to facilitate better market monitoring by requiring notification of products to authorities.
Additionally, special rules apply to formula made from protein hydrolysates, with further updates possible based on safety assessments by the European Food Safety Authority (EFSA), particularly for allergy risk reduction.
Demand for hydrolysed proteins
The demand for hydrolyzed protein infant formulas has been increasing, particularly among infants with specific dietary needs, such as those with allergies or intolerances.
It is estimated that cow's milk protein allergy affects about 2% to 3% of infants, which may lead to a demand for hydrolyzed formulas.
Some studies suggest that approximately 10% to 20% of the infant formula market may consist of hydrolyzed formulas, particularly in areas with higher incidences of food allergies.
The approval of Hyvital Whey HA 300 reinforces FrieslandCampina Ingredients’ portfolio of early-life nutrition ingredients, which already includes products for infants, children and mothers to support development, digestion, immunity and gut health.
Veldman noted that it is too early to say how Hyvital Whey HA 300 has impacted sales or market share since its approval, but it is an important step in giving more infant nutrition innovators access to the company’s portfolio.
“Hyvital Whey HA 300 is the fourth protein hydrolysate that is allowed for use in infant nutrition in the EU,” Veldman said. “Out of this small number of approved ingredients, not all are available for third party use, whereas Hyvital Whey HA 300 is, meaning it is open to all European manufacturers looking for an alternative source of high-quality hydrolyzed proteins”.