The UK approval, effective June 28, marks the first two HMO approvals assessed by the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in post-Brexit UK. Not long after, the European Commission authorized the LNFP-I/2'-FL mixture. The supplier noted that it is the first to receive approval for LNFP-I.
The approvals enable dsm-firmenich to market GlyCare 3FL 9001 and GlyCare LNFP-I/2FL 8001 across a range of categories, including infant formula, follow-on formula, conventional foods, food for special medical purposes and food supplements.
As Dr Christoph Röhrig, head of global HMO regulatory affairs at dsm-firmenich explained to NutraIngredients, LNFP-I is one of the most abundant HMOs in human milk and the first pentasaccharide HMO structure ever approved, and can therefore help to reduce the compositional gap in infant formula concerning the HMO fraction.
“Given that human milk contains a high number of biologically-relevant HMO structures, dsm-firmenich 's ambition is to expand its HMO portfolio to more closely mimic the HMO profiles naturally found in human breast milk,” he said.
Growing applications
Röhrig said the UK approval breaks new ground by permitting the use of these HMOs in supplements for infants and young children, opening up new possibilities for supporting early-life nutrition from birth.
The EU authorization also introduced two significant changes. Regulators removed the phrase “intended for young children”, allowing these products to be consumed by all age groups.
Regulators also split the category into two subcategories, with different maximum permitted levels based on age: One is for infants and young children, and the other is for individuals beyond infancy up to adulthood.
Portfolio
Reports indicate that dsm-firmenich holds the widest portfolio of HMO products authorized in the EU and UK.
According to Röhrig, it is the only HMO supplier with authorizations encompassing eight unique HMO structures in a growing number of markets, including the EU, U.S. and UK.
This portfolio includes four neutral fucosylated HMOs: 2'fucosyllactose (2'FL), difucosyllactose (DFL), 3-fucosyllactose (3-FL), and lacto-N-fucopentaose I (LNFP-I); two neutral core HMOs: lacto-N-tetraose (LNT) and lacto-N-neotetraose (LNnT); and two acidic sialylated HMOs: 6'-sialyllactose (6'-SL) and 3'-sialyllactose (3'-SL) sodium salts.
“These diverse HMO structures provide unique biological functions,” Röhrig noted. “Depending on the food application, these HMOs can be formulated individually or in combinations with other ingredients such as probiotics.”
He explained that the EU and UK are leading markets for adding HMOs to formulas thanks to an innovation-friendly environment, which is continuing to gain traction due to rising consumer awareness of their health benefits.
Post-Brexit regulation
As Röhrig explained, companies commercialize HMOs differently across product categories based on multiple factors, including the specific food category and the regulatory strictness imposed by local governmental agencies.
For highly-regulated food categories falling under infant nutrition or medical nutrition, market entry requirements tend to be most rigorous, resulting in longer timelines to market.
The EU classifies dsm-firmenich’s HMOs as novel food ingredients, requiring a scientific safety risk assessment by the European Food Safety Authority (EFSA) for lawful marketing in the EU.
Before Brexit, these EU approvals were recognized in England, Wales and Northern Ireland. However, post-Brexit, HMOs now require a similar safety evaluation by UK authorities like the FSA and FSS.
While the safety standards remain consistent between the EU and the UK, the regulatory processes differ administratively, involving separate bodies, application processes and data protection rules.