China’s approval of 3’-Sialyllactose (3’-SL) as a new food nutrition enhancer marks a significant regulatory and commercial milestone for the global dairy ingredients and infant nutrition sectors. Issued under the National Health Commission’s (NHC) No.1 Announcement of 2026, the decision formally positions 3’-SL as the third authorised human milk oligosaccharide (HMO) in China, following 2’-FL and LNnT.
The approval, secured with regulatory support from CIRS for Meihua Group, underscores China’s increasingly structured yet selective approach to novel food ingredients. HMOs are among the most scientifically advanced dairy-derived bioactives, closely linked to infant gut health, immune development and cognitive outcomes. Their regulatory acceptance reflects growing confidence in both safety data and functional evidence.
For dairy ingredient manufacturers, the inclusion of 3’-SL expands the functional toolkit available for infant formula, medical nutrition and specialised functional foods. Compared with earlier HMO approvals, 3’-SL is particularly associated with brain development, pathogen defence and microbiota modulation, potentially enabling more differentiated product formulations in China’s tightly regulated infant nutrition market.
Strategically, the approval signals a broader shift in China’s dairy and nutrition policy from volume-led expansion to quality, functionality and science-backed innovation. Domestic producers such as Meihua Group are increasingly positioned to compete with multinational suppliers, supported by local manufacturing capabilities and regulatory alignment.
From a global perspective, China’s move strengthens Asia’s role as a key demand centre for advanced dairy ingredients, encouraging further investment in fermentation technologies, precision nutrition and regulatory science. However, the limited number of approved HMOs also highlights persistent entry barriers, favouring players with strong clinical data, traceability and compliance expertise.
Overall, the authorisation of 3’-SL reinforces the trajectory of dairy ingredients towards high-value, evidence-driven nutrition, with regulatory approvals now acting as a primary determinant of market access and competitive advantage.