EFSA Confirms Safety of human-identical milk oligosaccharide (HiMO) 3?-Sialyllactose as Novel Sodium Salt for Infant Food

The European Food Safety Authority (EFSA) has concluded that 3?-sialyllactose (3?-SL) sodium salt remains safe as a novel food following proposed changes to its production process and specifications under Regulation (EU) 2015/2283. The assessment was conducted by EFSAs Panel on Nutrition, Novel Foods and Food Allergens (NDA) at the request of the European Commission. The novel food (NF) consists primarily of the human-identical milk oligosaccharide (HiMO) 3?-SL in its sodium salt form, along with minor components such as lactose, sialic acid, 3?-sialyllactulose, and related saccharides.

The product is manufactured ??????? fermentation using a genetically modified strain of Escherichia coli K-12 MG1655. EFSA noted that 3?-SL sodium salt produced using other genetically modified strains of E. coli is already authorised and included in the EU list of novel foods. The current application concerns only modifications to the production process and product specifications, with no changes to intended uses, target population, or anticipated intake levels.

Based on the data provided including information on identity, production process, composition, specifications, and toxicology EFSA identified no safety concerns. The Panel also determined that the presence and intake of structurally related carbohydrate compounds do not pose a risk.
Food Category and Maximum Level (ready for use) are as follows:
Infant formula-0.28 g/L
Follow-on formula-0.28 g/L
Baby foods-0.28 g/kg

Consistent with the assessment approach for other human-identical milk oligosaccharides, safety evaluation was primarily based on comparing estimated intake levels with those naturally consumed by breastfed infants. EFSA concluded that, since consumption levels remain unchanged from previously authorised forms, the novel food is safe under the proposed conditions of use. This opinion supports the continued use of 3?-SL sodium salt in food applications within the EU, reinforcing regulatory confidence in fermentation-derived human milk oligosaccharides.