The Danish bioscience specialist already supplies HMO ingredient 2’-fucosyllactose (2’-FL) to several global markets, but the latest authorisations greatly extend its geographical mandate within Europe, America and in Israel.
Senior Vice President HMO, Jesper Sig Mathiasen told Nutraingredients.com: “The new regulatory approvals make it possible to include HMOs in more infant formula products in new geographies, and it enables a higher penetration of HMOs in infant formula, which is an important growth driver for the HMO industry.”
The latest positive endorsements relate to HMO applications in infant formula and for other purposes, such as in medical and sports nutrition, and includes a landmark EU approval on dose supporting the addition of up to 1.8g/L of Lacto-N-tetraose (LNT) in infant and follow-on formula, food for infants and young children, food for special medical purposes and in food supplements.
Mathiasen said: “The EU approvals confirm the highest dosage levels in the market and make it possible with HMO blends of more product to bring infant formula closer to the natural concentration level in breastmilk, to the benefit of infants.
“Chr. Hansen is continuously working on increasing the dosage levels and on expanding market access into new geographies on several single HMOs as well as mixes.”
HMOs are prebiotics and the main component of breast milk comprising complex sugars that serve as an energy source. HMOs have a significant impact on infant health and promote intestinal microbiome diversity.
Chr. Hansen ramped up HMO development after acquiring Jennewein Biotechologie in 2020 in a bid to leverage market potential - estimated to reach €400 million by 2025 and €1 billion in the long-term - with a capital investment of €200 million and has since established an HMO division dedicated to developing premium infant formula.
The company has five individual HMOs in its portfolio as well as a 5 HMO mix designed to ”bring infant formula closer to breastmilk”. The ”unique blend” contains 2’-FL, 3-fucosyllactose (3-FL), 6’-sialyllactose (6’-SL), 3’-sialyllactose (3’-SL), and LNT HMOs and is supported by a scientific safety and tolerance study. The blend was recognised as safe (GRAS) at the highest level of 2.5g per litre in the US and Israel in 2021.
Major HMO markets with current approvals in infant formula include the USA, EU, Canada, Brazil, Singapore, Australia, and New Zealand, and parts of Latin America and Asia, although there is an “an ongoing journey” with “numerous” approvals in the pipeline.
This includes China - the world’s largest infant formula market - where approvals are pending but “expected”, Mathiasen said.
New approval notices
The European Food Safety Authority (EFSA) presented a positive opinion of HMOs LNT, 3-FL and 3’-SL, and represents the first milestone to Novel Food approval.
A Generally Recognised as Safe (GRAS) notice was issued by the US Food and Drug Administration for 2’-FL, 6’-SL, 3’-SL and LNT for use in additional food categories beyond infant formula, including formula for young children, meal replacement drinks, breakfasts bars, and sports drinks, and adds to existing safe status in infant formula.
Meanwhile, Health Canada released a ‘letter of no objection’ for 2’-FL to certify its application in infant and toddler formula, and Israel granted regulatory approval of HMO’s 3-FL, LNT, 3’-SL and 6’-SL as ingredients for infant and follow-on formula (in addition to previous clearance for 2’-FL).