In recent years, the European Union (EU) has paid particular attention to the category of Novel Foods during its approval process, with a focus on Human Milk Oligosaccharides (HMOs). HMOs, as crucial components of breast milk, possess various physiological functions such as promoting infant gut health and enhancing immunity, making them promising for applications in infant formula and other sectors.

2'-FL (2'-Fucosyllactose) stands out as a well-researched and commercially mature member of the HMOs family. It has gained widespread recognition and application in various global markets, including the EU, the United States, Australia and New Zealand, and China. The EU initiated the process by issuing Regulation (EU) 2016/376 in March 2016, allowing 2'-FL to be marketed as a novel food ingredient. Subsequent regulations such as (EU) 2017/2201 and (EU) 2023/859 further confirmed its safety and expanded its scope of use.

3-FL(3'-Fucosyllactose), a purified and concentrated white to off-white powder, is produced through microbial fermentation using the Escherichia coli K-12 DH1 strain. It contains limited amounts of D-lactose, 3-fucosyllactulose, and L-fucose. The EU's approval of 3-FL encompasses a broad range of applications, spanning from unflavored pasteurized and sterilized milk products, flavored or unflavored fermented milk products, milk analogues, flavored drinks, energy and sports drinks, cereal bars, infant formulas, follow-on formulas, toddler milk-based drinks and similar products, processed cereal-based foods and baby foods for infants and young children, meal replacements for weight control, foods for special medical purposes, and food supplements.

On October 23, 2023, the EU approved 6'-Sialyllactose Sodium Salt (6′-SL) as a novel food for marketing. 6′-SL is a purified white to off-white powder produced through microbial fermentation using the Escherichia coli W (ATCC 9637) strain, followed by further isolation, purification, and concentration. It contains low levels of sialic acid, D-lactose, D-glucose, 6'-sialyllactulose, and 3'-sialyllactose sodium salt. This ingredient can be used in food products requiring HMOs, such as infant formulas, dairy products, and functional foods.

In conclusion, the newly approved HMOs ingredients in the EU, including 2'-FL, 3-FL, and 6'-SL (presumably referring to 6'-Sialyllactose Sodium Salt), have garnered widespread recognition and application due to their unique nutritional value and broad application prospects.